Drug delivery devices

Abstract

In one example, a drug delivery system, such as an on-body or off-body delivery system, is configured to deliver a therapeutic drug to a patient. This system comprises a curved track, a plunger, and a driver. The driver translates the plunger along the curved track, causing the plunger's flexible plunger rod to bend along the curved track, driving the plunger seal of the drug container to dispense the liquid drug from the container.

Description

Technical Field

[0001] The present disclosure relates to drug delivery systems, and more particularly, but not necessarily exclusively, to drug delivery systems for delivering liquid drugs.

Background Art

[0002] Pharmaceuticals (including macromolecular and small molecular pharmaceuticals, hereinafter referred to as "drugs") are administered to patients using various different drug delivery devices for the treatment of various different medical indications. Drug delivery devices for delivering liquid drugs include, for example, syringes, manual syringes, pen-type syringes, auto-injectors, on-body delivery devices, and off-body delivery devices. These delivery devices generally include an actuator, a drug container, and a needle or cannula. The drug container contains the liquid drug, and the actuator feeds the liquid drug from the drug container through the needle or cannula to the patient.

Brief Description of the Drawings

[0003] The following description of exemplary embodiments can be better understood when read in conjunction with the accompanying drawings. It is understood that the possible embodiments of the disclosed systems and methods are not limited to those depicted. ​​​​​​​​​​​​​​​​Figure 1 shows an example perspective view of an actuator and track that can be used to implement the actuator and track of the drug delivery system. [Figure 7] Figure 6 shows a plan view of the actuator with at least a portion of the track removed. [Figure 8] Figure 6 shows a perspective view of a portion of the actuator, including the flexible plunger rod. [Figure 9] Figure 8 shows an enlarged perspective view of a portion of the flexible plunger rod. [Figure 10] Figure 8 shows a cross-sectional view of a portion of the flexible plunger rod. [Figure 11] Figure 1 shows a perspective view of a flexible plunger rod and track in another example, which can be used to implement the flexible plunger rod and track of the drug delivery system. [Figure 12] Figure 1 shows a perspective view of yet another example of a flexible plunger rod that can be used in the drug delivery system. [Figure 13] The graph shows exemplary delivery forces required to deliver 100 cmpoise (cP) and 326 cmpoise fluids from a drug container using a linear plunger rod, at different flow rates and needle gauges. [Figure 14] The graph shows the performance envelope observed for the prototype drug delivery device of this disclosure. [Figure 15] A cross-sectional view of a portion of a drug delivery system is shown as another example. [Figure 16A] Figure 15 shows a cross-sectional view of a drug delivery system in one example, where the drug container is in the pre-puncture position. [Figure 16B] Figure 15 shows a cross-sectional view of a portion of a drug delivery system, illustrating one example where the drug container is located at the puncture site. [Figure 17A] A perspective view of a portion of a drug delivery system in another example, where the needle shield is in a shielding position, is shown. [Figure 17B] Figure 17A shows a perspective view of a portion of the drug delivery system with the needle shield in an exposed position. [Figure 18] Figure 15 shows a schematic diagram of a drug delivery system, illustrating an example in which the drug container moves between the pre-puncture position, the puncture position, and the removal position. [Figure 19] Figure 15 shows a schematic diagram of a drug delivery system as an example, illustrating the position of the drug container relative to the septum puncture needle and plunger. [Figure 20] Figure 15 shows another schematic diagram of the drug delivery system as an example, illustrating the position of the drug container relative to the septal puncture needle and plunger. [Figure 21] An exemplary method using a drug delivery system is shown. [Figure 22A] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22B] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22C] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22D] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22E] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22F] A schematic diagram of a drug delivery system in another example is shown, illustrating the various stages of drug delivery, including inserting the drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery. [Figure 22G]Schematic diagrams of another example of a drug delivery system during various stages of inserting a drug container, puncturing the drug container, delivering the drug from the drug container, and removing the drug container after drug delivery are shown. [Figure 23A] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23B] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23C] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23D] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23E] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23F] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23G] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23H] Schematic diagrams of another example of a drug delivery system during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering the drug from the second drug container are shown. [Figure 23I] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 23J] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 23K] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 23L] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 23M] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 23N] Schematic diagrams of a drug delivery system according to another example during various stages of delivering a drug from a first drug container, exchanging the first drug container with a second drug container, and delivering a drug from the second drug container are shown. [Figure 24] A perspective view of a drug delivery system according to another example is shown. [Figure 25] A perspective view of a drug delivery system according to an exemplary usage case is shown. [ [Figure 26] A perspective view of a drug delivery system according to another exemplary usage case is shown. [Figure 27] A perspective view of a drug delivery system according to another exemplary usage case is shown. [Figure 28] An exemplary method of using a drug delivery system according to an example is shown. [Figure 29] A cross-sectional view of a drug delivery system according to another example is shown. [Figure 30]Figure 29 shows a cross-sectional view of a portion of a drug delivery system, illustrating an example where the septum puncture assembly of the drug delivery system is in a non-puncture configuration. [Figure 31] Figure 29 shows a cross-sectional view of another part of a drug delivery system, illustrating an example where the drug container of the drug delivery system is in a non-puncture configuration. [Figure 32A] Another example shows a cross-sectional view of a portion of a drug delivery system in a disengagement configuration and a non-puncture configuration. [Figure 32B] Figure 32A shows a cross-sectional view of a portion of the drug system in the engagement configuration, but before puncture. [Figure 33] An example of using the drug delivery system shown in Figure 29 is presented. [Figure 34A] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34B] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34C] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34D] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34E] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34F] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34G] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 34H] Figure 29 shows cross-sectional views of the drug delivery system at various stages, including non-puncture, puncture, and post-puncture configurations. [Figure 35A] A cross-sectional view of a drug delivery system in another example is shown. [Figure 35B]A cross-sectional view of a drug delivery system in another example is shown. [Modes for carrying out the invention]

[0004] This disclosure relates to on-body delivery systems (OBDS) and off-body delivery systems configured to inject liquid therapeutic agents (e.g., drugs or pharmaceuticals) into patients. While several existing on-body delivery systems are at various stages of commercial development, the inventors have found that these existing systems may not meet the needs of some future therapeutic agents, particularly those of some future large-molecule (e.g., biological) therapeutic agents. Some of these therapeutic agents may require a system capable of delivering the drug to the patient using significantly higher driving force than the capabilities of existing on-body delivery systems. For example, some future therapeutic agents may have relatively high viscosity (discussed further below) that requires a higher driving force to deliver the drug. Whether a higher driving force is required may be determined by the need for subcutaneous injection, the need for a relatively fast flow rate, and the need for a relatively short infusion time. These future therapeutic agents may also require the ability to deliver multiple doses of the same therapeutic agent, distinct doses of different therapeutic agents, and / or variable volume doses based on, for example, the patient's weight and / or age. This application relates to drug delivery systems and their features that address the diverse needs of future therapeutic agents.

[0005] Referring to Figure 1, a simplified diagram of an example drug product is shown. The drug product includes a drug delivery system 100 and a liquid therapeutic agent 20 contained within the drug delivery system 100. The drug delivery system 100 can be a pre-filled drug delivery system 100, in which the therapeutic agent 20 is already contained and distributed, so that the user (e.g., healthcare worker or patient) does not need to fill the drug delivery system 100 with the therapeutic agent 20 before use. In an alternative example, the drug delivery system 100 may be distributed separately from the therapeutic agent 20, and the drug delivery system 100 must be filled with the therapeutic agent 20 before use.

[0006] The drug delivery system 100 is configured to dispense a liquid therapeutic agent 20 from a drug container 200 to a patient via a nozzle 101. The nozzle 101 is configured to be inserted into the patient, such as into the patient's skin. The nozzle 101 may be, for example, a needle or a cannula. Preferably, the drug delivery system 100 is a subcutaneous delivery system configured to deliver the therapeutic agent 20 to the subcutaneous layer of the patient's skin. Thus, the nozzle 101 may be configured to extend from the system 100 only a distance that extends into the subcutaneous layer but not beyond it. This distance may be, for example, in the range of about 6 mm to about 8 mm.

[0007] The drug delivery system 100 can be used as an on-body delivery system (OBDS) in which the drug delivery system 100 is in contact with the patient's body. In such an example, the nozzle 101 can extend from the housing of the drug delivery system 100 (e.g., 102 in Figures 3 to 5 below) into the patient, where the housing is in contact with the patient. Alternatively, the drug delivery system 100 can be used as an off-body delivery system in which, once the nozzle is inserted into the patient, the housing of the drug delivery system 100 is separated from the nozzle. In such an example, the drug delivery system 100 includes a conduit (e.g., a tube) that spans the gap between the housing of the drug delivery system 100 and the nozzle 101, allowing the drug to be delivered from the drug delivery system 100 to the nozzle 101. Further alternatively, the drug delivery system 100 may be selectively configured to be used as either an on-body or off-body delivery system.

[0008] The drug delivery system 100 may include a drug container 200, or the drug container 200 may be a separate component from the drug delivery system 100. The drug container 200 may be supported by the housing of the drug delivery system 100, or may be configured to be supported by the housing. In some examples, the drug container 200 may be detachably attached to or detachably inserted into the housing of the drug delivery system 100. In other examples, the drug container 200 may be fixedly attached to or fixedly inserted into the housing. In yet another example, the drug container 200 may be integrated with the housing.

[0009] The drug container 200 may be any suitable container for holding liquid drugs, such as a cartridge or syringe. Figure 2 shows an example of a drug container 200, in which case the drug container 200 is a cartridge. The drug container 200 comprises a container body 202 defining a cavity 202c configured to hold liquid drugs inside. The container body 202 has a first end 202a and a second end 202b. The container body 202 is oriented in the axial direction D A It may have a central axis extending along the cavity. The first end 202a may define an opening 202d within it that opens to the cavity 202c. The drug container 200 may include a seal 204 located in the cavity that forms a seal with the inner surface of the container body 202. The seal 204 may be received into the cavity 202c through the opening 202d. The seal 204 is configured to translate toward the second end 202b to drive the liquid drug out of the cavity 202c.

[0010] In some cases, such as when the drug container 200 is a cartridge, the drug container 200 may be equipped with a cap 206 on a second end 202b. The cap 206 may be formed from any suitable material, such as metal. The cap 206 may be crimped onto the head of the container body 202 at the second end 202b. The drug container may be equipped with a partition 208 supported by the cap 206. The partition 208 is configured to seal the second end 202b. The partition 208 is configured to be punctured by a lancet to open a fluid path into the drug container 200. The partition 208 may optionally be configured to reseal the second end 202b when the lancet is removed from the partition 208. The space between the cap 206 and the seal 204 is filled with a substantially incompressible fluid (e.g., a therapeutic agent and possibly air) that prevents the seal 204 from moving until the partition 208 is punctured.

[0011] Returning to Figure 1, the drug delivery system 100 includes an actuator 111 configured to drive the liquid therapeutic agent 20 from the drug container 200 to the outside of the needle or cannula 101. The actuator 111 may be any suitable actuator for dispensing the liquid therapeutic agent 20 from the drug container 200. The actuator 111 may include a plunger 112 configured to move the seal 204 of the drug container 200, thereby driving the liquid therapeutic agent 20 from the drug container 200. The actuator 111 may include a driver 114 configured to move the seal 204 to the plunger 112. The driver 114 may be any suitable driver, such as (non-limited) a motor, a spring, a hydraulic driver, or a pneumatic driver. The plunger 112 may be any suitable plunger, such as a flexible plunger or a nesting plunger.

[0012] The drug delivery system 100 may include a septum puncture needle 116 configured to puncture a septum 208 of a drug container 200. At least one of the septum puncture needle 116 and the drug container 200 may be configured to move toward the other, causing the puncture needle 116 to puncture the septum 208. By puncturing the septum 208, the septum puncture needle 116 can be fluidly connected to the liquid therapeutic drug 20 contained in the drug container 200. The drug delivery system 100 may also include a conduit 120, such as a tube, which fluidly connects the septum puncture needle 116 to a nozzle 101. Thus, by puncturing the septum 208, the nozzle 101 can be fluidly connected to the liquid therapeutic drug 20 contained in the drug container 200 via the septum puncture needle 116 and the conduit 120.

[0013] The drug delivery system 100 may optionally include a contamination guard 118 to protect the lancet 116 from contamination when the lancet 116 has not punctured the partition 208 of the drug container 200. For example, the contamination guard 118 may be configured to protect the lancet 116 from contamination before the drug container 200 is supported by the housing of the drug delivery system 100, while the drug container 200 is supported by the housing but before the partition 208 is punctured, and / or after the drug container 200 has been removed from the housing after injection.

[0014] The drug delivery system 100 may include a nozzle insertion mechanism 122 configured to insert the nozzle 101 into the patient, such as into the patient's skin. The nozzle insertion mechanism 122 may be configured to extend the nozzle 101 from the housing of the drug delivery system 100 into the patient. In some examples, the nozzle insertion mechanism 122 may be configured to retract the nozzle 101 into the housing after injection. Additionally or alternatively, the drug delivery system 100 may include a needle guard (not shown) that extends over the nozzle 101 after injection. By retracting and / or covering the nozzle 101 after injection, accidental needle sticks can be prevented and / or human contact with any biological material remaining on the nozzle 101 can be limited. The nozzle insertion mechanism 122 may be any preferred mechanism for inserting the nozzle 101 into the patient, including (non-limited) those known in the art. The nozzle insertion mechanism 122 may include a driver, such as a motor or spring, for inserting the nozzle 101 into the patient.

[0015] The drug delivery system 100 may include a control circuit 128 configured to control various features of the drug delivery system 100. For example, the control circuit 128 may be configured to control the operation of the driver 114 of the actuator 111. The control circuit 128 may be configured to cause the actuator 111 to start driving the liquid therapeutic drug 20 from the drug container 200. The control circuit 128 may be configured to control the flow rate at which the liquid therapeutic drug 20 is driven from the drug container 200. The control circuit 128 may be configured to cause the actuator 111 to stop driving the liquid therapeutic drug 20 when the injection is complete and / or when an error is detected during the injection. The control circuit 128 may also be configured to control the operation of the nozzle insertion mechanism 122 to cause the nozzle 101 to be inserted into the patient before injection and / or removed from the patient after injection.

[0016] The drug delivery system 100 may include a user interface 124 configured to involve a user, such as a healthcare professional or a patient, in order to operate the drug delivery system 100. The user interface 124 may be configured to provide the user with information about the drug delivery system 100. The user may be, for example, a patient, a patient's caregiver, or a healthcare professional assisting a patient when using the drug delivery system 100. The user interface 124 can have various configurations, and the drug delivery system 100 may include one type of user interface or two or more types of user interfaces. For example, the user interface 124 may include one or more lights, such as light-emitting diodes (LEDs) or other types of lights, configured to illuminate and provide various information. Examples of information displayed by the user interface 124 include power (on / off) status, error status (e.g., low power supply, improper nozzle entry into the patient, incompatible container 200 loaded into the drug delivery system 100), drug delivery status (e.g., indication that drug delivery is currently in progress), drug delivery progress information, orientation of the drug delivery system 100 relative to gravity, indication of the dosage of drug 20 supplied in each delivery of drug 20 to the patient, and other types of information.

[0017] In another example, the user interface 124 may include a display configured to show information on it, such as by using text and / or graphics. The display may include a display screen having any of the following configurations: a cathode ray tube (CRT), a liquid crystal display (LCD), a touchscreen, etc. In yet another example, the user interface 124 may include a vibration mechanism configured to vibrate, the vibration of which is configured to be felt by a patient wearing the drug delivery system 100. In yet another example, the user interface 124 may include a speaker configured to provide an audio signal. In yet another example, the user interface 124 may include a mechanical level configured to display the orientation of the pump.

[0018] In some examples, the system may comprise a data storage component 210 supported by a drug container 200 and a reader 130 configured to read the data storage component 210. The reader 130 may be supported, for example, by a housing 102. The data storage component 210 may be attached to the drug container 200, such as by bonding it to the drug container 200, or to the body 202 or cap 206 of the drug container 200, or otherwise become part of the container 200, such as by being printed on its surface. The data storage component 210 can have various configurations. For example, the data storage component 210 may include an integrated circuit configured to communicate reservoir data from a reservoir. An example of an integrated circuit is a near-field communication (NFC) tag, also known as a proximity-integrated circuit card (PICC). ISO14443A passive NFC tags, ISO15693 passive NFC tags, ISO18000-3 passive NFC tags, ISO14443A / B passive NFC tags, passive FeliCa® NFC tags, or other types of NFC tags (passive or active) can be used. In another example, the data storage component 210 may include a radio frequency identification (RFID) tag. In yet another example, the data storage component may be in the form of a barcode. An example of a barcode is a QR code®. Another example of a barcode is a Universal Product Code (UPC) code.

[0019] The drug container 200 includes a single data storage component 210 in this illustrated embodiment, but may include multiple data storage components. If multiple data storage components are used, each may be different from one another, which may help provide redundancy and / or enable data retrieval even when a particular type of data communication is currently unavailable, for example, when an RFID tag is absent or damaged to the point of being unreadable, and a QR code can still be read.

[0020] The data storage component 210 is configured to store data relating to the drug container 200, data relating to the drug 20 contained in the drug container 200, and / or data relating to the delivery parameters of the drug 20. For example, the data storage component 210 can store information relating to the dosing regimen of the drug 20 in the drug container 200. For example, the data storage component can store one or more of the following: the amount of drug 20 stored in the drug container 200, the amount of drug 20 delivered by the system 100 (dosage) (which may be less than the amount stored in the container 200), the flow rate at which the system 100 delivers the drug 20, or any suitable data for configuring the operating parameters of the system 100.

[0021] In some examples, the reader 130 can transmit and receive data, and optionally write that data to the data storage component 210. In some such examples, the data storage component 210 may be updated periodically (e.g., upon completion of each mL delivery) to contain a reasonably accurate record of the delivery progress at any given time. If system 100 fails during delivery and the dose is delivered partially, the reservoir containing the record of the partial dose can be transferred to a secondary system where the remaining dose can be delivered. In some such examples, the data storage component 210 may also be updated with information relating to the status of system 100 during delivery and delivery.

[0022] For example, the information may include the delivery date and time, the model and serial number of system 100, the ambient temperature of the system and container, system user input settings, system wireless communication events, system warning or alarm events, user-initiated downtime and duration, user interface events, and / or relevant system parameter settings and measurements during delivery (force, pressure, battery voltage / current, etc.). Thus, the data storage component 210 can function as a delivery record (e.g., a delivery "black box" record). The data storage component 210 can be designed to be easily detached from the reservoir, and as a result, it can be transferred to a monitoring party or HCP for subsequent reading, recording, and analysis. Once delivery is complete, the data storage component 210 is updated to a "delivery complete" state, thus preventing the reservoir from being refilled and reused.

[0023] The control circuit 128 is configured to control the administration of drug 20 from system 100 according to a drug administration regimen. This can be achieved using data read by the reader 130 from the data storage component 210 and / or data stored in the control circuit 128. A drug administration regimen refers to a specific mode in which drugs are delivered, including (non-limited) the formulation, route of administration, administration interval (frequency), dose or volume, delivery rate (flow rate), delivery duration, delivery pauses, pauses between delivery stages in a multi-drug delivery sequence, and the ordering sequence of a multi-drug delivery sequence. A drug administration regimen can be stored in the memory of the control circuit 128 as an algorithm configured to be executed by the processor of the control circuit 128. The algorithm is stored in the form of one or more sets of data points that define and / or represent commands, notifications, signals, etc., to control the administration of drugs from system 100.

[0024] Referring to Figures 3 to 5, an exemplary housing 102 is shown that can be used to implement the housing of the drug delivery system 100 of Figure 1. In an example where the drug delivery system 100 is an on-body system, the drug delivery device housing 102 can support, among other things, the actuator 111, the lancet 116, the contamination guard 118, the conduit 120, the nozzle insertion mechanism 122, the control circuit 128, and the user interface 124. In an alternative example where the drug delivery device is an off-body system, the housing 102 can support, among other things, the actuator 111, the lancet 116, the contamination guard 118, the control circuit 128, and the user interface 124, while the conduit 120 can extend from the housing 102 and from outside the housing 102 to the nozzle insertion mechanism 122 which is physically separated from the housing 102.

[0025] The housing 102 may be configured to support the drug container 200, such as by housing it within itself, at least a portion or the whole of the drug container 200. The housing 102 may optionally be configured to receive the drug container 200 in a removable manner. Thus, the drug container 200 may be insertable into and / or removable from the housing 102. The housing 102 may define an opening 106 inside which the drug container 200 is configured to be received at least partially or completely within the housing 102. In some examples, the housing 102 may include a closure 108, such as a door, configured to close at least a portion of the opening 106 to keep the drug container 200 within the opening 106. The opening 106 may be configured such that the drug container 200 is received within the opening 106 along an insertion direction I. The insertion direction I may be transverse to the longitudinal axis of the drug container 200 and / or the longitudinal axis of the opening 106.

[0026] The drug delivery device housing 102 may have a bottom 102a and an opposing top 102b that are opposite each other along a first direction D1. In this example, the drug delivery system 100 is an on-body delivery system, and the drug delivery system 100 is configured such that the bottom 102a faces the patient's skin when the drug delivery system 100 is attached to the patient. The housing 102 may have a first side 102c and a second side 102d that are opposite each other along a second direction D2. The first side 102c and the second side 102d may extend between the bottom 102a and the top 102b. The housing 102 may have a first end 102e and a second end 102f that are opposite each other along a third direction D3. When the drug container 200 is received in the opening 106, the central axis of the drug container 200 may extend along the second direction D2. Thus, the axial direction D A The first end 102e and the second end 102f may extend between the first side 102c and the second side 102d, and between the bottom 102a and the bottom 102b. The opening 106 extends into the upper 102b and the first end 102e. In an alternative example, the opening may extend into another preferred surface, such as the bottom 102a, the upper 102b, the first end 102e, and the second end 102f.

[0027] In this example, the drug delivery system 100 can be used as an on-body delivery system. Therefore, the drug delivery system 100 includes a fastener 104 configured to attach the housing 102 to the patient's body. The fastener 104 may be any suitable fastener for attachment to the patient's body, such as (non-limited) adhesive tape, a strap, or other suitable fastener. The fastener 104 may be supported by the bottom 102a of the housing 102. Additionally, or alternatively, the drug delivery system 100 can be used as an off-body delivery system. In such an alternative example, the drug delivery system 100 may not use the fastener 104.

[0028] Drug delivery system actuators The ability of an on-body or off-body delivery system to deliver liquid medication to a patient depends on several parameters, including the viscosity of the medication, the type of medication (e.g., solution or suspension), the particle size of the medication, the needle gauge, and the flow rate. Variations in one or more of these parameters can significantly increase or decrease the amount of driving force required to deliver the liquid medication. Thus, for a given needle gauge and flow rate, a higher driving force is typically required to deliver medications of higher viscosity (e.g., 100 cp, 200 cp, 300 cp, or even 400 cp), while a lower driving force is typically required to deliver medications of lower viscosity (e.g., <100 cp). For a given viscosity and flow rate, a higher driving force is typically required to deliver the medication through a needle with a larger needle gauge, while a lower driving force is typically required to deliver the medication through a needle with a smaller needle gauge. For a given viscosity and needle gauge, a higher driving force is typically required to deliver the medication at a higher flow rate, while a lower driving force is typically required to deliver the medication at a lower flow rate. This problem can worsen if two or more of these factors change. For example, delivering a higher viscosity drug through a larger gauge needle at a higher flow rate usually requires a higher driving force. By varying these parameters, the force required to deliver the drug can exceed 50N, 75N, 100N, 150N, 200N, 250N, 300N, 350N, or even 400N. This is illustrated by Figure 13, which shows the exemplary delivery forces required to deliver a 100 cmpoise (cP) fluid and a 326 cmpoise fluid from a drug container at different flow rates and different needle gauges using a linear plunger rod.

[0029] Conventional on-body delivery systems are not typically designed to deliver drugs with such high force. Rather, conventional on-body delivery systems generally have drive mechanisms that deliver liquid drugs using relatively low driving force (e.g., <30N). This may be partly due to the fact that on-body delivery systems with higher driving force are not required, and / or due to size and weight constraints of on-body delivery systems. For example, on-body delivery systems tend to be used with drugs of lower viscosity that do not require higher driving force. The challenges in delivering these low-viscosity drugs can often be solved by simply reducing the flow rate of existing on-body delivery systems or by reducing the needle gauge (i.e., increasing the diameter) of existing on-body delivery systems. However, reducing the needle gauge may increase patient discomfort.

[0030] Conventional on-body delivery systems may also lack higher driving force due to preferences regarding the size and weight of the on-body delivery system. On-body delivery systems are attached to the patient's body or supported by the patient's body in other ways. Therefore, for the patient's comfort, it is desirable that on-body delivery systems be lightweight and compact. However, increasing the driving force of an on-body delivery system may require increasing the size, and therefore the weight, of the driver used to drive the on-body delivery system to such an extent that the on-body delivery system is no longer suitable for on-body use. In on-body delivery systems where the driving mechanism is electromechanical, increasing the size of the driving mechanism (e.g., motor) may also require increasing the size of other components, such as the power supply (e.g., battery) that powers the on-body delivery system, to accommodate the increased driving force.

[0031] More recently, there has been some interest in delivering drugs with higher viscosity (e.g., 100 cp, 150 cp, 200 cp, 250 cp, 300 cp, 350 cp, or even 400 cp) for patient comfort, and in delivering drugs using larger gauge needles (e.g., 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, or even 30 gauge). To meet these interests, there is a need for on-body delivery systems that can deliver drugs with higher driving forces (e.g., 50 N, 75 N, 100 N, 150 N, 200 N, 250 N, 300 N, 350 N, or even 400 N), and that are lightweight, compact, and further enhance patient comfort.

[0032] In a preferred example, the actuator 111 in Figure 1 can drive liquid pharmaceuticals from the pharmaceutical container 200 with a driving force greater than 30 N, such as greater than one of 50 N, 75 N, 100 N, 125 N, 150 N, 175 N, 200 N, 225 N, 250 N, 275 N, 300 N, 325 N, 350 N, 375 N, or 400 N. It should be noted that the actuator 111 may still be capable of driving lower forces below the values ​​mentioned above. The actuator 111 can deliver pharmaceuticals with higher viscosities, such as 100 cp, 125 cp, 150 cp, 175 cp, 200 cp, 225 cp, 250 cp, 275 cp, 300 cp, 325 cp, 350 cp, 375 cp, or 400 cp, in addition to, or instead of, pharmaceuticals with lower viscosities below any of the values ​​mentioned above. Furthermore, the actuator 111 can deliver drugs at lower or higher viscosities with larger gauge needles, such as 23-gauge, 24-gauge, 25-gauge, 26-gauge, 27-gauge, 28-gauge, 29-gauge, or 30-gauge needles. Figure 14 shows a graph of the performance envelope observed for the prototype drug delivery device of the present disclosure. In this example, a force of 400 N is applied to the plunger 302 (discussed below), and the surface represents the upper limit of the device's delivery capability at various flow rates, needle gauges, and viscosities.

[0033] Referring to Figures 6 and 7, the internal features of the drug delivery system 100 are shown, including an example of an actuator 300 that can be used to implement the actuator 111 of the drug delivery system 100. The drug delivery system 100 comprises at least one track 110 and an actuator 300. The actuator 300 comprises a plunger 302 configured to be guided by at least one track 110. The plunger 302 can implement the plunger 112 of Figure 1. The plunger 302 can be fixed so as to be rotatable and / or twistable with respect to its central axis. Note that the central axis may be curved along the length of the plunger 302.

[0034] The actuator 300 includes a driver 304 configured to translate a plunger 302 within the drug container 200, thereby driving the seal 204 of the drug container 200 and discharging liquid drug from the drug container 200. The driver 304 can implement the driver 114 shown in Figure 1. The driver 304 may be any suitable driver capable of driving the plunger 302, such as (non-limited) a motor, a spring, a pneumatic actuator, a hydraulic actuator, or an electric actuator. In a preferred example, the driver 304 comprises a motor and the actuator 300 comprises a threaded rod 303. The threaded rod 303 extends inside at least a portion of the plunger 302 and can engage with the female thread of the plunger 302. The actuator 304 may be configured such that when the motor rotates the threaded rod 303, the thread of the threaded rod 303 engages with the thread of the plunger 302, thereby translating the plunger 302 within the drug container 200.

[0035] The plunger 302 may have a flexible plunger rod 306, a first plunger end 306a, and a second plunger end 306b. The second plunger end 306b is configured to engage with the seal 204 of the drug container 200. The flexible plunger rod 306 is configured to bend when the second plunger end 306b is driven. The flexible plunger rod 306 may comprise a plurality of links 307 (as shown) pivotably connected to one another. In other examples, the flexible plunger rod 306 may additionally or alternatively include a flexible material that can be bent (e.g., an elongated rod made from a flexible material that bends). The first plunger end 306a may be configured to engage with a threaded rod 303. For example, the first plunger end 306a may define a female thread that engages with the threaded rod 303. In an alternative example, it will be understood that the plunger 302 may be driven by a mechanism other than the motor 304 and the threaded rod 303, such as by magnetic drive.

[0036] At least one track 110 can define a curved path that guides the plunger 302 to bend within a range of 45 to 225 degrees, such as about 90 degrees or preferably about 180 degrees. In some examples, the track 110 can define a U-shaped or J-shaped path for the plunger rod 306. The track may be defined by a recess or opening, as shown. Alternatively, the track may be defined by a rail. The flexible plunger rod 306 is configured to bend within a range of 45 to 225 degrees as it is guided around the track 110. By using the flexible plunger rod 306 and the curved track 110, the distance the plunger rod 306 extends behind the drug container 200 is significantly reduced compared to an equivalent device in which the plunger rod extends linearly behind the drug container. As a result, the overall length of the drug delivery system 100 can be shorter than the overall length of such an equivalent device, resulting in a smaller system for patient comfort.

[0037] The friction resulting from the bending of the flexible plunger rod 306 along the curved track 110 can cause a significant loss of force between the driver 304 and the point where the plunger 302 engages with the seal 204 of the drug container 200. This loss can be, for example, more than 50 percent. To drive the liquid drug from the drug container 200 with the higher driving force described above, the size of the driver 304 can be increased. However, increasing the size of the driver 304 (and related components such as the power supply) increases patient discomfort. In fact, the size of the driver 304 may need to be increased to the point where it is unsuitable for use in an on-body delivery system.

[0038] Instead of increasing the size of the driver 304, the interface between the plunger rod 306 and the track 110 may be implemented with friction reduction such that the force required to translate the plunger seal 204 in the container 200 via the plunger rod 306 does not exceed 30%, such as 25%, 20%, 15%, 10%, or 5% greater than the force required to translate the plunger seal in the container using a linear plunger rod. Using friction reduction at the interface between the plunger rod 306 and the track 110 may allow the drug delivery system 100 to implement a smaller driver (and therefore a smaller power supply) that is better suited to on-body use, while still having the ability to drive forces greater than those described above. In some examples, the interface may be implemented with a friction-reducing coating to reduce friction between the plunger rod 306 and the track 110. In other examples shown in Figures 6 to 12, the interface may include friction-reducing members 310, such as rollers or bearings, to reduce friction at the interface.

[0039] For example, the drug delivery system 100 may include at least one roller or bearing 310 configured to guide the flexible plunger rod 306 as it translates along the curved track 110, thereby limiting any loss of force. The flexible plunger rod 306 may support at least one roller or bearing 310 (see, for example, Figures 8-10) so that the roller or bearing 310 moves together with the flexible plunger rod 306 with the track 110 (for example, along it). Alternatively, the track 110 may support at least one roller or bearing 310 (see, for example, Figure 11) so that the plunger rod 306 moves together with the roller or bearing 310 with the track 110 (for example, along it).

[0040] Continuing to refer to Figures 6 to 9, the flexible plunger rod 306 may have a first outer portion 306a and a second outer portion 306b. The first outer portion 306a and the second outer portion 306b may face each other along the first direction D1. At least one roller or bearing 310 may constitute one or more rollers or bearings 310 located on the first outer portion 306a of the flexible plunger rod 306. In some examples, at least one roller or bearing 310 may constitute one or more rollers or bearings 310 located on the second outer portion 306b of the flexible plunger rod 306. In such examples, at least one track 110 may constitute a pair of tracks 110. The pair of tracks 110 may face each other along the first direction D1. One or more rollers or bearings 310 of the first outer portion 306a can move along the first track of the track 110, and one or more rollers or bearings 310 of the second outer portion 306b can move along the second track of the track 110. In an alternative example, at least one roller or bearing 310 may be located between the first outer portion 306a and the second outer portion 306b.

[0041] In examples of links 307 as shown in Figures 8 to 10, each link 307 may have opposing sides 307a and opposing ends 307b. The opposing sides 307a may face each other along a first direction D1. The opposing sides 307a may extend between the opposing ends 307b. The links 307 may be arranged adjacent to each other such that the opposing ends 307b are aligned end to end along the length of the plunger rod 306. Each pair of adjacent links 307 may be connected by a connector 307c. In some examples, each connector 307c may be pivotably connected to an adjacent pair of links 307, as shown in Figure 10. In other examples, as shown in Figure 12, each connector 307c may be fixedly attached to one end 307b of each link 307 and received between the opposing sides 307a of adjacent links 307. It will be understood that other configurations of the link are intended to be within the scope of this disclosure.

[0042] At least one roller or bearing 310 may be supported by mounting it on each of one or more links 307, extending to all of the links 307. Each roller or bearing 310 may be supported on the outside of the side 307a of each link 307, as shown. In other examples (not shown), each roller or bearing 310 may be supported between the opposing sides 307a of the link 307. In some examples, each link 307 may support at least one pair of rollers or bearings 310. Each pair of rollers or bearings 310 may be supported on the opposing sides 307a of each link 307. Each roller or bearing 310 is configured to roll along the track 110 and limit friction between the plunger rod 306 and the track 110. Each roller or bearing 310 may be supported by the respective axle 307d extending from or through the respective link 307.

[0043] Referring to Figure 11, in an alternative example, at least one roller or bearing 310 may be fixed in position relative to the housing 102 of the drug delivery system 100, and the plunger 306 may be configured to move relative to and along with at least one roller or bearing 310. Each link 307 of the plunger 306 may have an inner end 307e and an outer end 307f that are opposite each other. The inner end 307e and outer end 307f of each link may face each other in a plane defined by a second direction D2 and a third direction D3. The inner end 307e may face inward to define a curve at a bend of the plunger 306 having a first radius. The outer end 307f may face outward to define a curve at a bend having a second radius greater than the first radius. At least one roller or bearing 310 may be configured to engage with the outer end 307f of the link 307 of the plunger 306. At least one roller or bearing 310 may be positioned along the curved section defined by the track 110.

[0044] Referring back to Figures 6 and 7, driving the liquid drug from the drug container 200 with the higher driving force described above could exert a large counterforce on the drug delivery system 100, particularly on the housing 102. These counterforces can be applied by the plunger rod 306 at one end in the curved section defined by the track 110, as indicated by the arrows in Figure 7, and by the drug container 200 and / or driver 304 at the other end. These forces can become so large that, without reinforcement, the force could cause the housing 102 to rupture. Therefore, the drug delivery system 100 may be equipped with a reinforcing structure 126 configured to absorb at least some, and up to all, of the counterforces. The reinforcing structure 126 is configured to limit or prevent the counterforces from being exerted on the housing 102. In some examples, the reinforcing structure may comprise a rigid plate formed from a suitable rigid material such as metal. The reinforcing structure 126 may have a first end 126a that resists outward movement of at least one curved track at the first end of the drug delivery system along a selected direction (e.g., downward in Figures 6 and 7), and a second end 126b that resists outward movement of the drug container and / or driver at the second end of the drug delivery system along a direction opposite to the selected direction (e.g., upward in Figures 6 and 7).

[0045] The reinforcing structure 126 can define at least one track 110. For example, at least one track 110 can be defined by an opening or recess extending within or through the reinforcing structure 126. The opening or recess may be configured to receive at least one roller or bearing 310 inside. In some examples, the reinforcing structure 126 can be located on opposing sides of the plunger rod 306. For example, the reinforcing structure 126 may comprise a pair of opposing rigid plates located on opposing sides of the plunger rod 306, each rigid plate defining a corresponding track 110, and each corresponding track 110 being configured to receive at least one roller or bearing 310.

[0046] Referring to Figures 5 to 7, during operation, a method of delivering a drug to a patient using the drug delivery system 100 may include inserting the needle or cannula 101 of the drug delivery system 100 into the patient. This method includes translating the flexible plunger rod 306 of the drug delivery system 100 along at least one curved track 110 of the drug delivery system 100, which bends as it translates along at least one curved track 110 into the drug container 200 of the drug delivery system 100, driving the liquid drug from the drug container 200 to the patient. At least one roller or bearing 310 of the drug delivery system 100 can guide the flexible plunger rod 306 as it translates along at least one curved track 110. At least one roller or bearing 310 can move along at least one curved track 110 together with the flexible plunger rod 306 (e.g., Figures 6 and 7), or the plunger rod 306 can move along at least one roller or bearing 310 (e.g., Figure 11). Additionally or alternatively, the method may include translating the flexible plunger rod 306 of the drug delivery system 100 along at least one curved track 110 of the drug delivery system 100, the flexible plunger rod 306 bending as it translates along at least one curved track 110 into the drug container 200 of the drug delivery system 100, driving the liquid drug out of the drug container 200 with a force of at least 50 N, such as at least 100 N, 150 N, 200 N, 250 N, 300 N, 350 N, or 400 N. This method may include the step of rotating the threaded rod 303 on the driver 304 to translate the plunger 306 along at least one track 110.

[0047] Septal puncture assembly Referring to Figure 15, the internal features of the drug delivery system 100 are shown, including an example of a septum puncture assembly 400. The septum puncture assembly 400 may be configured to house a drug container 200 and to removably receive a portion of a drug container 600 which may be substantially similar thereto. The septum puncture assembly 400 can house the septum puncture needle 116 of the drug delivery system 100. The septum puncture assembly 400 may comprise a needle assembly 405 and a biasing assembly 410. The biasing assembly 410 may be movably attached to the needle assembly 405.

[0048] The needle assembly 405 may comprise a needle support 415 and a septum puncture needle 420. The septum puncture needle 420 may be received and / or attached to the needle support 415 by any preferred technique, such as mechanical fasteners, press-fit connections, adhesives, connecting members, and / or any other preferred technique. For example, the septum puncture needle 420 may be attached to the needle support 415 via a connecting member 425 that can be received in a cavity 430 formed in the needle support 415. The septum puncture needle 420 may include a hollow cavity that can be fluidly connected to the cavity 430 of the needle support 415, which can form part of the fluid connection between the septum puncture needle 420 and the nozzle 101, as described above. The septum puncture needle 420 may include a tip 422 for puncturing the septum of the drug container 600, for example, as described below.

[0049] The needle support 415 can be attached to a housing portion 435 of the housing 440, on which the housing 102 can be mounted, as will be further described below with reference to Figures 17A and 17B. Referring again to Figure 15, the housing portion 435 may be attached to the housing 440 and / or be an integral part thereof. The housing portion 435 may be fixedly attached to the housing 440 and / or integrated with it, so that the needle assembly 405 (e.g., including the septum puncture needle 420) is substantially fixed to the housing 440. The needle support 415 and the connecting member 425 can be formed from a material compatible with the drug 20. The needle support 415 and the connecting member 425 can be formed from any suitable material, such as structural plastic material (e.g., the material of the housing 440 may be similar to this material). The septum puncture needle 420 can be formed from any suitable material, such as metallic material (e.g., stainless steel).

[0050] The biasing assembly 410 may comprise a biasing member 445 and a needle shield 450. The biasing member 445 and the needle shield 450 may be movably supported (e.g., mounted) by the needle support 415 of the needle assembly 405.

[0051] The biasing member 445 may be any suitable member for biasing the needle shield 450 relative to the needle support 415. In some examples, the biasing member 445 may be configured to receive the needle support 415. The biasing member 445 may be a spring, such as a metal spring (e.g., a stainless steel spring), or a spring formed from any other suitable material that deforms to store potential energy that can be used to selectively bias the needle shield 450, as described below. The biasing member 445 may be any other suitable biasing member, such as an elastic or flexible member (e.g., an elastomer or rubber member), or any other suitable material for biasing the needle shield 450. The biasing member 445 may be compressed and expanded relative to the needle support 415 and the septum puncture needle 420 based on the position of the needle shield 450 and the drug container 600, as described below, for example, with reference to Figures 16A and 16B.

[0052] Returning to Figure 15, the needle shield 450 may be any suitable member for receiving a portion of the drug container 600 and selectively shielding the tip 422 of the septal puncture needle 420. The needle shield 450 may be located within the housing 440. For example, the needle shield 450 does not have to extend out of the housing 440 (e.g., outward). The needle shield 450 may be moved based on biasing from the biasing member 445 and the position of the drug container 600, as shown below, referring to Figures 17A and 17B. Returning to Figure 15, the needle shield 450 may be formed from the same material as the needle support 415, connecting member 425, and / or housing 440, for example, as described above.

[0053] The needle shield 450 can have any preferred dimensions and configuration for selectively covering and exposing the tip 422 of the septum puncture needle 420 and for receiving a portion of the drug container 600. For example, as illustrated in Figure 15, the needle shield 450 may comprise a needle receiving portion 455 and a container receiving portion 460. The needle receiving portion 455 and the container receiving portion 460 may be integrally formed or may be separate parts attached using any preferred technique (e.g., jointing, welding such as ultrasonic welding, adhesive and / or mechanical attachment via fasteners, etc.).

[0054] The needle receiving portion 455 may include a needle housing 465 that can form a needle cavity 470. The needle cavity 470 can selectively accommodate part or all of a septal puncture needle 420, for example, as further described below. The needle housing 465 may be configured and dimensionally determined to be movably received by a needle support 415. In some examples, the needle support 415 may include one or more recesses or slots for receiving one or more portions of the needle housing 465 to guide the movement of the needle housing 465 along the needle support 415 (or the needle housing 465 may include one or more recesses or slots for receiving one or more portions of the needle support 415). The needle housing 465 may include a biasing member portion 475 (e.g., a projection or lip) that abuts, engages with, and / or attaches to the end 480 of the biasing member 445. This allows the biasing member 445 to be compressed through contact of the biasing member portion 475 with the end 480. The biasing member 445 can bias the needle shield 450 through contact of its end portion 480 with the biasing member portion 475.

[0055] The container receiving portion 460 may be configured and dimensionally determined to receive the cap 606 of the drug container 600. The cap 606 may mount the cap 206 and may be substantially similar thereto. The cap 606 may mount the partition 208 and may include a partition 608 which may be substantially similar thereto. The container receiving portion 460 may include one or more receiving projections 485 which can form a container recess 490 that can receive (e.g., surround or enclose) part or substantially all of the cap 606. In some examples, one or more receiving projections 485 (e.g., the needle housing 465 of the needle receiving portion 455) may have a curved or ring-shaped form.

[0056] The needle shield 450 may include a needle aperture 495 positioned between the container receiving portion 460 and the needle receiving portion 455. The needle aperture 495 can form a passage connecting the needle cavity 470 and the container recess 490. The tip 422 of the partition puncture needle 420 may pass through the needle aperture 495 based on the position of the drug container 600 and / or the biasing of the needle shield 450 by the biasing member 445, for example, as further described below.

[0057] Referring to Figures 16A and 16B, the needle shield 450, the biasing member 445, and the drug container 600 can move between a pre-puncture position (exemplified in Figure 16A) and a puncture position (exemplified in Figure 16B) relative to the needle assembly 405 (e.g., including a septum puncture needle 420) attached to the housing portion 435 of the housing 440. The drug container 600 can be moved from the pre-puncture position (exemplified in Figure 16A) to the puncture position (exemplified in Figure 16B) based on the operation of a plunger (on which a plunger 112 may be mounted), as further described below.

[0058] As illustrated in Figure 16A, in the pre-puncture position, the biasing member 445 cannot be compressed (e.g., it does not substantially store potential energy). The biasing member portion 475 of the needle shield 450 may come into contact with the end portion 480 of the biasing member 445, but the drug container 600 is not moved by the plunger 500 (e.g., this may be equipped with a plunger 112, as further described below) to compress the biasing member 445. The septum puncture needle 420 may be entirely housed within the needle cavity 470 of the needle housing 465. The cap 606 may be received within the container recess 490.

[0059] As further described below, the plunger 500 can operate to move the drug container 600 from the pre-puncture position illustrated in Figure 16A to the puncture position illustrated in Figure 16B. At the puncture position, as illustrated in Figure 16B, the biasing member 445 can be compressed (for example, to store potential energy). Based on the operation of the plunger 500 as further described below, the drug container 600 can be moved toward the needle assembly 405. The cap 606 can contact the needle shield 450 and move it toward the needle assembly 405 from the pre-puncture position illustrated in Figure 16A to the puncture position illustrated in Figure 16B. When the needle shield 450 is moved toward the needle assembly 405, the needle receiving portion 455 moves toward the housing portion 435 along the needle support 415, and the biasing member 445 can be compressed based on the biasing member portion 475 of the needle receiving portion 455 biasing the end 480 of the biasing member 445. As the cap 606 of the drug container 600, positioned within the container recess 490 of the container receiving portion 460 (of the needle shield 450), moves toward the needle assembly 405 (for example, the puncture position illustrated in Figure 16B), the tip 422 of the septum puncture needle 420 can pass through the needle aperture 495 as the needle shield 450 moves until the septum 608 is punctured by the tip 422 of the septum puncture needle 420. As described above, the needle assembly 405, including the septum puncture needle 420, can remain fixed on the basis that it is attached to the housing portion 435 and the housing 440 once the needle shield 450 and drug container 600 have moved from the pre-puncture position illustrated in Figure 16A to the puncture position illustrated in Figure 16B.

[0060] In the puncture position illustrated in Figure 16B, a portion of the septum puncture needle 420 may be positioned within the container recess 490 of the needle cavity 470, needle aperture 495, and needle shield 450, such that the tip 422 punctures the septum 608 of the cap 606, which is positioned within the container recess 490. The biasing member 445 may be compressed. Based on the septum puncture needle 420, which includes a hollow cavity that can be fluidly connected to the cavity 430 as described above, the fluid connection may be formed from the cavity 602c (which can accommodate the cavity 202c) of the drug container 600 to the nozzle 101 via the septum puncture assembly 400.

[0061] Referring to Figures 17A and 17B, the container receiving portion 460 of the needle shield 450 may be positioned within the opening 505 (which can accommodate the opening 106) of the housing 440. The needle shield 450 can be moved between a shielded position as illustrated in Figure 17A and an exposed position as illustrated in Figure 17B. The shielded position of the needle shield 450 as illustrated in Figure 17A may correspond to the pre-puncture position of the needle shield 450 as illustrated in Figure 16A. The exposed position of the needle shield 450 as illustrated in Figure 17B may correspond to the puncture position of the needle shield 450 as illustrated in Figure 16B.

[0062] In the shielding position of the needle shield 450 illustrated in Figure 17A, the tip 422 of the septal puncture needle 420 may be shielded (e.g., covered) by the needle shield 450. In the shielding position, the tip 422 may not be located within or pass through the needle aperture 495. The septal puncture needle 420 may be substantially entirely (e.g., entirely) within the needle cavity 470, as illustrated in Figure 16A, when the needle shield 450 is in the shielding position illustrated in Figure 17A. In some examples, a user of the drug delivery system 100 (e.g., the user's finger) cannot come into contact with the tip 422 when the needle shield 450 is in the shielding position illustrated in Figure 17A.

[0063] In the exposed position of the needle shield 450 as illustrated in Figure 17B, the tip 422 of the septal puncture needle 420 can extend through the needle shield 450. In the exposed position, the tip 422 may be positioned within and / or pass through the needle aperture 495. A portion of the septal puncture needle 420 may be positioned within the needle cavity 470, the needle aperture 495, and the container recess 490, as illustrated in Figures 16B and 17B, when the needle shield 450 is in the exposed position of Figure 17B (for example, the drug container 600 is not shown within the opening 505 in Figure 17B in order to clearly show the needle shield 450 and the septal puncture needle 420). In some examples, a drug container 600 having a cap 606 positioned within a container recess 490 may have a partition 608 punctured by a tip 422 extending through a needle aperture 495, as illustrated in the puncture position in Figure 16B and the exposed position in Figure 17B (for example, when the needle shield 450 is in the exposed position and the drug container 600 is positioned within the opening 505).

[0064] Referring to Figure 18, the operation of the drug delivery system 100, including the septum puncture assembly 400, is described here. As schematically shown in Figure 18, the plunger 500 can move the drug container 600 relative to the septum puncture needle 420 of the needle assembly 405. The drug container 600 may include a seal 610, which may be substantially the same as the seal 204. The plunger 500 may be any suitable plunger for moving the drug container 600 as described above. For example, the plunger 500 may be substantially the same as the plunger 302 described above. The plunger 500 may comprise a plunger end 510 and a flexible plunger rod 515. The flexible plunger rod 515 may be any suitable flexible plunger rod, such as the examples described herein. For example, the flexible plunger rod 515 may be substantially the same as the flexible plunger rod 306 described above. For example, a driver similar to the exemplary driver described herein (e.g., driver 114 or driver 304) can drive the plunger 500.

[0065] At position A shown in Figure 18, the plunger 500 may be in a pre-engagement position where the plunger end 510 cannot contact the seal 610. The needle shield 450 may be in a shielding position (Figure 17A). The drug container 600 may be placed inside the opening 505 in a pre-puncture position (Figure 16A).

[0066] The driver can operate to move the plunger 500 in the drive direction DD from the pre-engagement position at position A to the engagement position at position B. At position B shown in Figure 18, the plunger 500 may be in the engagement position where the plunger end 510 can contact the seal 610. The needle shield 450 may be in the shielding position (Figure 17A). The drug container 600 may be in the pre-puncture position (Figure 16A).

[0067] The driver can be operated to move the plunger 500 in the drive direction DD from the engagement position at position B to the initial injection (dispensing) position at position C. At position C shown in Figure 18, the plunger end 510 can contact the seal 610. The needle shield 450 may be in the exposed position (Figure 17B). The drug container 600 may be in the puncture position (Figure 16B).

[0068] In some examples, based on the fact that the drug placed in the cavity 602c is substantially an incompressible liquid, the movement of the plunger 500 from position B (towards position C) can move the drug container 600 relative to the needle shield 450, thereby moving the drug container 600 and the needle shield 450 toward the needle assembly 405 and compressing the biasing member 445. For example, the pressing force applied by the plunger 500 to the seal 610 and drug container 600 can be greater than the spring force of the biasing member 445 so that the biasing member 445 is compressed. For example, the pressing force may be similar to the exemplary driving force disclosed above with respect to the actuator 111. For example, referring back to Figures 16A and 16B as described above, the drug container 600 can be moved from the pre-puncture position in Figure 16A to the puncture position in Figure 16B where the tip 422 of the septum puncture needle 420 punctures the septum 608 of the drug container 600. When the plunger 500 moves the drug container 600 from position B to position C, the needle shield 450 can also be moved from the shielded position in Figure 17A to the exposed position in Figure 17B. Therefore, at position C, the plunger 500 may be in the initial injection (dispensing) position, the drug container 600 may be in the puncture position in Figure 16B, and the needle shield 450 may be in the exposed position in Figure 17B.

[0069] The driver can operate to move the plunger 500 in the drive direction DD from the initial injection (dispensing) position C to the final injection (dispensing) position D. At position D shown in Figure 18, the plunger end 510 may be in contact with the seal 610. The needle shield 450 may be in an exposed position (Figure 17B). The drug container 600 may be in a puncture position (Figure 16B).

[0070] As the plunger 500 moves from position C to position D, the plunger end 510 moves the seal 610 into the cavity 602c, allowing the drug placed in the cavity 602c to be delivered via the septum puncture needle 420. Thus (referring to positions B, C, and D), during part of the movement of the plunger 500, the plunger 500 can push the drug container 600 and puncture the septum 608 against the tip 422 of the septum puncture needle 420 (movement of the plunger 500 from position B to position C), and during another part, the plunger 500 can push the seal 610 of the drug container 600 (movement of the plunger 500 from position C to position D).

[0071] The drug delivery system 100 may include a sensor 520 that can sense when the septum 608 is punctured at position C, so that the delivery of the drug from the drug container 600 can be controlled as the plunger 500 moves from position C to position D. The sensor 520 can measure the moment (e.g., the exact moment) when the septum 608 is punctured by the tip 422 of the septum puncture needle 420 and when the drug contained in the drug container 600 begins to be delivered. The sensor 520 may be any suitable displacement sensor, such as a position sensor (e.g., a linear position sensor) or a laser sensor. In some examples, the sensor 520 may measure the displacement of the needle shield 450. For example, the end stop of the needle shield 450 may occur at some point (e.g., exactly at a certain point) in the fluid flow of the drug 20, which may coincide with (e.g., be synchronized with) the activation of the limit switch. Alternatively, the sensor 520 may include a needle sensor, such as a microsensor tip or any other suitable sensor, for measuring when the septum 608 was punctured. In some examples, the sensor 520 may be integrated with the septum puncture needle. The sensor 520 may communicate with and be controlled by a controller, such as the control circuit 128 described above.

[0072] The controller (e.g., control circuit 128) can determine when the plunger 500 has moved the drug container to position C and the septum 608 has been punctured based on data or signals provided by the sensor 520, at which moment the plunger 500 completes the movement of the entire drug container 600, initiating the movement of the seal 610 within the cavity 602c and delivering the drug through the septum puncture needle 420. (The delivery of the drug between position C and position D is also schematically depicted in Figure 18 based on schematic switches, which are shown to be open at positions A, B, and D to represent drug delivery, and similarly shown to be closed at positions C and D.) Starting from the time and / or position where the septum 608 was punctured, the controller (e.g., control circuit 128) can determine the amount of drug delivered based on the movement of the plunger 500. Thus, the amount of drug delivered can be precisely controlled (e.g., a precise dose is supplied), as further described below with reference to Figure 19. In some situations (e.g., weight-based medication based on patient weight), the entire drug container may not be delivered (e.g., in the case of a child, a portion of the drug container 600 may be delivered, less than the entire drug contained in the container). In some cases, this control can allow the drug container 600 to be uniform in size while being used to deliver different suitable doses (e.g., the same-sized drug container 600 can be used to deliver drugs to adults or children). This can reduce manufacturing costs by allowing manufacturers to supply drug containers 600 of the same size to a wide range of users (e.g., users with different characteristics such as age, weight, and other factors affecting dosage). Also, as described above, the movement of the plunger 500 in the driving direction DD can result in a single mechanism that provides both puncture of the septum 608 and delivery of the drug from the drug container 600.

[0073] The amount of drug delivered from the drug container 600 can be determined by the distance the seal 610 is moved by the plunger 500 from position C to position D within the cavity 602c. Referring to Figure 19, the seal travel distance 525 describes the distance the seal 610 travels from position C to position D within the cavity 602c. The seal travel distance 525 can correspond to the plunger displacement that supplies the corresponding amount of drug to be delivered (for example, based on the dimensions of the cavity 602c, such as radius or width, which, in combination with the seal travel distance 525, can correspond to the desired volume to be delivered). The seal travel distance 525 can be any suitable distance for drug delivery, for example, about 10 mm to about 60 mm (e.g., about 45 mm). In some examples, the amount of drug delivered based on the plunger 500 moving the seal 610 from position C to position D can be about 5 mL to about 30 mL. Thereafter, dose accuracy can be provided based on supplying the amount of drug delivered based on the seal travel distance 525. In some examples, the position of the seal 610 at position D allows for a gap to be created within the cavity 602c between the seal 610 and the end of the cavity 602c (for example, the plunger 500 does not need to push the seal 610 into the front end of the drug container 600).

[0074] In some examples, as shown in Figure 19, the movement between position B and position C may provide any preferred travel distance 530. For example, the travel distance 530 may be about 5 mm to about 7 mm (e.g., about 6 mm). The initial engagement distance 535 may be any preferred distance between the end of the drug container 600 and the initial position of the seal 610 in the cavity 602c where it first makes contact with the plunger end 510 (e.g., position B). For example, the initial engagement distance 535 may be about 1 mm to about 40 mm. The initial clearance distance 540 may be any preferred distance between the plunger end 510 and the end of the drug container 600 (e.g., position A) to provide initial clearance for inserting the drug container 600 into the opening 505. For example, the initial clearance distance 540 may be about 1 mm or about 2 mm, or more than about 2 mm (e.g., based on the dimensions of the housing 440).

[0075] Returning to Figure 18, the driver can operate to move the plunger 500 in the reverse direction RD, which may be opposite to the drive direction DD, from the final injection (dispensing) position at position D to the post-engagement position at position E. The plunger 500 can be moved in the reverse direction RD such that the plunger end 510 is disengaged from the cavity 602c as the plunger 500 moves from position D to position E. Thus, the driver can move the plunger 500 in both the drive direction DD and the reverse direction RD.

[0076] When the plunger 500 first begins to move from position D to position E, the plunger end 510 may remain in contact with the seal 610. In some examples, the plunger end 510 may remain attached to the seal 610 (e.g., by any preferred technique such as a mechanical interlock (e.g., snap-fit), suction, or adhesive) as the plunger 500 moves in the reverse direction RD, thereby biasing or pulling both the seal 610 and the drug container 600 in the reverse direction RD away from the needle assembly 405 (e.g., in embodiments where a biasing member 445 may not be provided). In some examples, the plunger end 510 may remain attached to the seal 610 (e.g., this may be an elastomer seal that can provide a relatively low release force) based on a mechanical interlock such as a snap-fit. In other examples, when the plunger 500 moves in the reverse direction RD, the biasing member 445 can bias the needle shield 450 and the drug container 600 in the reverse direction RD, so that the plunger end 510 remains in contact with the seal 610 as the plunger 500 moves in the reverse direction RD. For example, the biasing member 445 can be biased so that the drug container 600 remains pressed against the plunger 500 as the plunger 500 retracts in the reverse direction RD by biasing the biasing member 445 when it releases its accumulated potential energy (e.g., accumulated from moving from position B to position C). When the needle shield 450 reaches the shielded position (e.g., as shown in Figure 17B), the biasing member 445 can stop biasing so that some or most of the accumulated potential energy is released and partially decompressed. In some examples, an end stop (e.g., of the housing 440) can control the position of the needle shield 450 in the shielded position. For example, some spring force (e.g., about 5N in some embodiments) may remain in the biasing member 445 to ensure that the end stop ensures that the partition puncture needle 420 retracts completely from needle friction to the partition 608. The plunger 500 can continue to move in the reverse direction RD until it reaches the post-engagement position at position E.At position E, the seal 610 can remain in the same position as at position D. For example, the seal 610 may be held in place by vacuum and thus remain in the same position at positions D and E. The plunger end 510 can be disengaged from the seal 610 as the plunger 500 moves from position D to position E.

[0077] At position E shown in Figure 18, the plunger 500 may be in a post-engagement position where the plunger end 510 cannot contact the seal 610 (for example, similar to the pre-engagement position at position A). The needle shield 450 may be in a shielded position (Figure 17A). The drug container 600 may be in a post-puncture position, which may be similar to the pre-puncture position shown in Figure 16A. The drug container 600 can then be removed from the opening 505 and replaced as desired during subsequent use of the drug delivery system 100.

[0078] In some examples, referring to Figure 20, the position control sensor 550 can be used for position control of the septum puncture assembly 400. The position control sensor 550 may be any suitable device for measuring the speed and / or position of a rotating device, such as the rotating components of the driver and / or plunger 500 (for example, as associated with the driver 304 and / or plunger 302, as described above). The position control sensor 550 may be a rotary encoder, such as a motor rotary shaft encoder. In some examples, the position control sensor 550 may be a magnetic rotary encoder or an optical rotary encoder. As the plunger 500 moves (for example, as described above, again referring to Figure 18), the position control sensor 550 can sense the position and / or speed of the rotating components of the driver and / or plunger 500, which can then be used to measure and control the position of the plunger 500 (for example, with respect to determining the seal travel distance 525). In some examples, the initial position of the plunger 500 can be determined using a position termination switch (for example, this can communicate with and / or be integrated with the control circuit 128). Also in some examples, the displacement of the drug container 600 and / or the plunger 500 can be controlled by any suitable preloading mechanism that can be integrated into the housing 440 (for example, a spring load assembly that can preload components of the plunger 500, such as a chain component, to remove slack).

[0079] In some examples, the drug delivery system 100 may comprise a curved track (e.g., similar to track 110), a plunger 500 having a flexible plunger rod 515 and a plunger end 510, a septum puncture needle 420, and a driver (e.g., similar to driver 114 and / or driver 304). The driver may be configured to translate the plunger 500 along the curved track, and the flexible plunger rod 515 may bend while translating along the curved track so that the plunger 500 is adapted to translate the drug container 600 from a pre-puncture position where the septum 608 of the drug container 600 has not been punctured by the septum puncture needle 420 to a puncture position where the septum 608 of the drug container 600 has been punctured by the septum puncture needle 420. The plunger end 510 may be configured to engage with the seal 610 of the drug container 600 to translate the drug container 600 from the pre-puncture position to the puncture position. When the drug container 600 is in the puncture position, the movement of the flexible plunger rod 515 causes the seal 610 of the drug container 600 to move within the drug container 600, allowing the drug to be delivered. The biasing assembly 410 may be configured to move the drug container 600 from the puncture position to the removal position where the septum puncture needle 420 is removed from the drug container 600. The sensor 520 may be configured to sense when the drug container 600 has been moved to the puncture position. A controller (e.g., control circuit 128) can control drug delivery based on the sensor 520 sensing when the drug container 600 has been moved to the puncture position where drug delivery begins. When the drug container 600 is in the puncture position, the controller (e.g., control circuit 128) can control the driver to translate the plunger 500 along the curved track, causing the plunger end 510 to move a seal travel distance 525. The amount of drug delivered via the septal puncture needle 420 can be based on the seal travel distance 525.

[0080] In some examples, the drug delivery system 100 may comprise a curved track (e.g., similar to track 110), a plunger 500 having a flexible plunger rod 515 and a plunger end 510, a partition puncture needle 420 spaced apart from the plunger end 510, a partition puncture needle 420 configured to puncture the partition 608 of the drug container 600, and a driver (e.g., similar to driver 114 and / or driver 304). The driver may be configured to translate the plunger 500 along the curved track in the driving direction DD, the flexible plunger rod 515 bending along the curved track to drive the seal 610 of the drug container 600 to discharge the liquid drug from the drug container 600, and after the discharge of the liquid drug from the drug container 600 is complete, translating away from the seal 610 in the reverse direction RD opposite to the driving direction DD. As the plunger 500 is translated along the reverse RD, the drug container 600 moves away from the septum puncture needle 420, allowing it to unpierce the septum 608. The biasing assembly 410 can be configured to translate the drug container 600 along the reverse RD, causing the septum puncture needle 420 to unpierce the septum 608. The biasing assembly 410 may include a needle shield 450 configured to house the tip 422 of the septum puncture needle 420 in a detached position when the drug container 600 is translated along the reverse RD. The biasing assembly 410 may include a biasing member 445 configured to translate the drug container 600 along the reverse RD when the plunger 500 is translated along the reverse RD. The plunger 500, including the plunger end 510, may be configured to pull the drug container 600 along the reverse RD. As the plunger 500 translates along the reverse direction RD, the plunger 500 may be configured to move the drug container 600 away from the septum puncture needle 420 in order to de-puncture the septum 608. The plunger 500 may be adapted to translate the drug container 600 in the drive direction DD from a pre-puncture position where the septum 608 of the drug container 600 has not been punctured by the septum puncture needle 420 to a puncture position where the septum 608 has been punctured by the septum puncture needle 420.The flexible plunger rod 515 may be able to translate between a disengaged position in which the plunger end 510 does not engage with the drug container 600 and an engaged position in which the plunger end 510 engages with the drug container 600. The driving direction DD and the reverse direction RD may be relative to the housing 440 that supports the septum puncture needle 420 in a stationary position. At least one roller or bearing positioned along the curved track may be configured to guide the flexible plunger rod 515 as it translates along the curved track. Reinforcement structures may be configured to resist counterforces applied by the plunger 500 at the curved section defined by the curved track at the first end of the drug delivery system 100, and by the drug container 600 or driver at the second end of the drug delivery system 100.

[0081] In some examples, the drug delivery system 100 may comprise a curved track (e.g., similar to track 110), a plunger 500 having a flexible plunger rod 515 and a plunger end 510, and a driver (e.g., similar to driver 114 and / or driver 304). The driver may be configured to translate the plunger 500 along the curved track in the driving direction DD, and the flexible plunger rod 515 bends along the curved track to drive the seal 610 of the drug container 600 to discharge the liquid drug from the drug container 600. A partition puncture needle 420 may be separated from the plunger end 510 and is configured to puncture the partition 608 of the drug container 600. The needle shield 450 may be configured to move between a shielded position, where the needle shield 450 extends beyond the tip 422 of the partition puncture needle 420, and an exposed position, where the tip 422 of the partition puncture needle 420 is exposed, allowing the partition puncture needle 420 to puncture the partition wall 608 of the drug container 600. The needle shield 450 may be configured to move from the exposed position to the shielded position after the partition puncture needle 420 has been removed from the partition wall 608 of the drug container 600. The biasing member 445 can bias the needle shield 450 from the exposed position to the shielded position when the plunger 500 is translated along the curved track in the reverse direction RD opposite to the drive direction DD, away from the seal 610. The needle shield 450 can move between the exposed position and the shielded position relative to the housing 440, which can support the partition puncture needle 420 in a stationary position.

[0082] In some examples, referring to Figure 21, an exemplary disclosed method using the drug delivery system 100 (e.g., process 700) may include the following steps: Process 700 may begin at step 705. In step 710, process 700 may include inserting a drug container 600 into an opening 505 of a housing 440, the housing 440 including a septum puncture needle 420. In step 715, process 700 may include driving a plunger 500, having a flexible plunger rod 515 and a plunger end 510, along a curved track and moving the drug container 600 toward the septum puncture needle 420 by pushing the drug container 600 with the plunger end 510. In step 720, process 700 may include puncturing the septum 608 of the drug container 600 with the septum puncture needle 420 based on driving the plunger 500 toward the septum puncture needle 420. In step 725, process 700 may include releasing the puncture of the septum 608 of the drug container 600 by the septum puncture needle 420 by driving the plunger 500 in the reverse direction RD, opposite to the drive direction DD. In step 730, process 700 may include removing the drug container 600 from the opening 505 of the housing 440. In step 735, process 700 may be terminated.

[0083] In some examples relating to process 700, the driving direction DD and the reverse direction RD may be relative to the housing 440 supporting the partition puncture needle 420 in a stationary position. The needle shield 450 can be moved between a shielded position in which the needle shield 450 extends beyond the tip 422 of the partition puncture needle 420 and an exposed position in which the tip 422 of the partition puncture needle 420 is exposed, allowing the partition puncture needle 420 to puncture the partition wall 608 of the drug container 600. The needle shield 450 may be configured to move from the exposed position to the shielded position after the partition puncture needle 420 has been removed from the partition wall 608 of the drug container 600. The needle shield 450 may be biased from the exposed position to the shielded position using a biasing member 445 as the plunger 500 translates along the curved track along the reverse direction RD.

[0084] Possibility of replacing the medication container while in use Referring to Figure 22A, another example of the exemplary drug delivery system disclosed is shown. The drug delivery system 800 may comprise components similar to those of the exemplary system disclosed above. The drug delivery system 800 may comprise a housing 810, a driver 820, a plunger 830, and a septum puncture assembly 840. The housing 810 may house the driver 820, which can drive the plunger 830 to the septum puncture assembly 840.

[0085] Housing 810 can accommodate housing 102, and may be similar to, for example, housing 102 and / or housing 440 described above. Housing 810 may include an opening 815. Opening 815 can accommodate opening 106, and may be similar to opening 106 and / or opening 505. Housing 810 may include a curved track 850, which can accommodate curved track 110. Housing 810 may include a sensor 858, which may be similar to sensor 520.

[0086] Driver 820 can implement driver 114, and may be similar to driver 114 as described above. Plunger 830 can implement plunger 112, and may be similar to plunger 112 and / or plunger 500 as described above. Plunger 830 may comprise plunger end 855 and flexible plunger rod 860. Plunger end 855 may be similar to, for example, second plunger end 306b and / or plunger end 510. Flexible plunger rod 860 may be similar to, for example, flexible plunger rod 306 and / or flexible plunger rod 515. Driver 820 can operate to translate plunger 830 along curved track 850, the flexible plunger rod 860 bending while translating along curved track 850, and plunger end 855 driving plunger seal of exemplary disclosed drug container to dispense liquid drug from drug container.

[0087] The septal puncture assembly 840 can mount a septal puncture needle 116. The septal puncture assembly 840 may be similar to, for example, the septal puncture needle 116 and / or the septal puncture assembly 400. The septal puncture assembly 840 may comprise a needle assembly 865 and a biasing assembly 870. The needle assembly 865 may be similar to, for example, the needle assembly 405. The needle assembly 865 may comprise a septal puncture needle 875. The septal puncture needle 875 can mount a septal puncture needle 116 and may be similar to, for example, the septal puncture needle 116 and / or the septal puncture needle 420.

[0088] Space 880 may be defined between the plunger end 855 and the septum puncture needle 875, and space 880 is configured to receive an exemplary disclosed drug container when the drug container is received into the housing 810 through the opening 815. Space 880 can be associated with a distance 885 that can be defined from the edge of the tip 878 of the septum puncture needle 875 to the plunger end 855. Distance 885 can be defined, for example, the distance between the edge of the tip 878 of the septum puncture needle 875 and the plunger end 855 when the plunger 830 is in the pre-use position and the flexible plunger rod 860 is in the disengaged position, as shown in Figure 22A. In some examples, distance 885 may be greater than or equal to the height of the drug container received into the opening 815. For example, distance 885 may increase or decrease in proportion to the height of the drug container received into the opening 815 (for example, distance 885 may be driven by the total length of the drug container). In some examples, the distance 885 can vary based on the size of the drug container to be received within the opening 815 and / or can be defined with respect to the clearances at both ends of the drug container (e.g., clearance between the needle and the drug container + length of the drug container + clearance on the plunger side). For example, if the drug container is about 75 mm long, the distance 885 may be about 77 mm (e.g., length of the drug container + about 1 mm needle recess to the exemplary disclosed spring plate and about 1 mm clearance on the plunger side). In other examples, the distance 885 may be greater than or equal to the distance from the second end of the drug container (e.g., 202b) to the end of the plunger seal. In some examples, the drug container may also be inserted at an angle such that the plunger end 855 can be received at the distal end of the drug container (e.g., either separated from or in contact with the plunger seal).

[0089] The drug container 900 can be received into the space 880 of the housing 810 through the opening 815. The drug container 900 can house the drug container 200, which may be similar to, for example, the drug container 200 and / or the drug container 600. The drug container 900 can house a partition 208, which may include a partition 905, similar to the partition 208 and / or the partition 608. The drug container 900 can also house a seal 204, which may include a plunger seal such as seal 910, similar to seal 204 and / or seal 610. In some examples, seal 910 may be a plunger seal such as a plug seal. The drug container 900 can hold a liquid drug, which can be dispensed from the drug container 900, for example, as described above with respect to the drug container 200 and / or the drug container 600. The drug container 900 may also house a data storage component 915. The data storage component 915 may be, for example, a near-field communication tag or RFID tag, as described above.

[0090] The drug delivery system 800 may also include a control circuit 890, which may be similar to the control circuit 128, and a reader 895, which may be similar to the reader 130. The reader 895 may be configured to read a data storage component 915 of the drug container 900. The control circuit 890 may be configured to receive data from the data storage component 915 (e.g., a near-field communication tag or RFID tag on the drug container) via the reader 895, and / or to control the driver 820 based on the data.

[0091] Figures 22A to 22G illustrate exemplary operation of the drug delivery system 800. Figures 22A and 22B show the drug container 900 being received in the space 880 of the housing 810 through the opening 815 of the housing 810. The plunger 830 is shown in the pre-use position, and the flexible plunger rod 860 is shown in the disengaged position. The plunger end 855 and the flexible plunger rod 860 do not have to be engaged with the drug container 900 and / or located inside the drug container 900 in the pre-use / disengaged position. For example, the plunger end 855 may be located outside the drug container 900 when the plunger 830 is in the pre-use position, in which case the space 880 is defined between the septum puncture needle 875 (e.g., the edge of the tip 878 of the septum puncture needle 875) and the plunger end 855. The opening 815 may be selectively blocked using a lockable door (e.g., similar to the closure device 108) that can prevent foreign matter from entering the drug container during septal puncture and delivery. The lockable door may be lockable by the user or may be automatically lockable when an event occurs, such as the start of injection.

[0092] Figures 22B and 22C show a plunger 830 having a flexible plunger rod 860 and a plunger end 855 being driven along a curved track 850. The plunger 830 and the flexible plunger rod 860 can be moved from the pre-use / disengaged position shown in Figure 22B to the engaged position of the plunger 830 and the flexible plunger rod 860 as shown in Figure 22C. In the engaged position shown in Figure 22C, the plunger end 855 can be moved from the outside of the drug container 900 (e.g., shown in Figure 22B) to the inside or interior of the drug container 900 so that it engages with the plunger seal 910 of the drug container 900 when the plunger 830 is in the engaged position as shown in Figure 22C. In some examples, the drug container 900 may be inserted at an angle such that the plunger 830 is received inside the drug container 900 in the pre-use / disengaged position, but the plunger end 855 does not engage with the plunger seal 910. In other examples, the drug container 900 may be received such that the entire plunger 830 is outside the drug container 900 in the pre-use / disengaged position.

[0093] Figures 22C and 22D show the movement of the drug container 900 from the pre-puncture position to the puncture position, similar to what is described above with respect to, for example, Figures 16A, 16B, and 18. Sensor 858 can detect when the partition 905 is punctured, similar to the operation of, for example, sensor 520 described above.

[0094] Figures 22D and 22E show the driver 820 and plunger 830 being used to drive the seal 910 and discharge the liquid drug from the drug container 900. The plunger 830 can be bent while the flexible plunger rod 860 is translated along the curved track 850 so that the plunger end 855 can be driven to drive the seal 910 of the drug container 900 and discharge the liquid drug from the drug container 900. For example, the plunger 830 can move from an initial injection position to a final injection position to drive the seal 910, as described above with respect to Figure 18, for example.

[0095] Figures 22E and 22F show the plunger 830 returned to its pre-use / disengaged position. After dispensing the liquid drug from the drug container 900, the plunger 830 may be returned to its pre-use / disengaged position based on the driver 820 driving the plunger 830. The plunger end 855 may be separated from the septum puncture needle 875 so as to define a space 880 between the plunger end 855 and the septum puncture needle 875, as shown in Figure 22F.

[0096] Referring to Figures 22B to 22F, the drive speed of the plunger 830 can be constant or can be changed by the driver 820 based on control by the control circuit 890. For example, in Figures 22D to 22E (drug delivery), the plunger 830 can move at a relatively slow speed to deliver the drug at the desired flow rate. However, for example, in Figures 22B to 22D (septal puncture) and Figures 22E to 22F (plunger 830 withdrawal), the plunger 830 can move at a relatively faster speed (e.g., a fairly fast speed) so as not to excessively delay the user's use of the system. For example, the plunger 830 can move at a first speed in Figures 22D to 22E (drug delivery), at a second speed in Figures 22B to 22D (septal puncture), and at a third speed in Figures 22E to 22F (withdrawal of the plunger 830), with the first speed (drug delivery) being slower than the second speed (septal puncture) and / or the third speed (withdrawal of the plunger 830). Similarly, for example, at the first speed in Figures 22D to 22E (drug delivery), the drive speed of the plunger 830 may be constant or variable (e.g., discontinuous or intermittent delivery).

[0097] Figures 22F and 22G show the removal of the drug container 900 from the space 880 through the opening 815. Removal of the drug container 900 may include tool-free and / or non-destructive removal of the drug container 900. For example, tool-free removal may include the removal of the drug container 900 without the use of tools (e.g., by the user's fingers without tools). Similarly, non-destructive removal may include removing the drug container 900 from the housing 810 without damaging the drug container 900. Also, non-destructive removal may include removing the drug container 900 from the housing 810 without damaging the housing 810.

[0098] Figures 23A to 23N show another exemplary operation of the drug delivery system 800. Drug containers 900A ("A") and 900B ("B") can be selectively and removably inserted into and removed from the housing 810. Drug containers 900A and 900B may be similar to drug container 900. Drug containers 900A and 900B may contain the same or different liquid drugs. For example, drug container 900A may contain a liquid drug having the same or a different viscosity as a second liquid drug contained in drug container 900B.

[0099] As shown in Figures 23A to 23G, similar to the above regarding the drug container 900 in Figures 22A to 22G, the drug container 900A can be received into the space 880 of the housing 810, liquid drug can be dispensed from the drug container 900A, and the drug container 900A can be removed from the housing 810. The drug container 900B can be kept aside when the drug container 900A is being used as shown in Figures 23A to 23G.

[0100] As shown in Figures 23G and 23H, after drug container 900A is removed, drug container 900B may be received into the space 880 of the housing 810 through the opening 815. Drug container 900A may be used or consumed (e.g., liquid drug may be partially or substantially entirely consumed) and then removed. Drug container 900B may be new, unused (e.g., liquid drug may be substantially entirely unused), or partially consumed (e.g., liquid drug may be partially or substantially entirely consumed, or drug container 900B may contain less liquid drug than originally supplied by the manufacturer).

[0101] When a drug container (e.g., drug container 900A) is removed, the drug and / or blood may flow back into the exemplary disclosed device due to back pressure from the drug present in the patient and / or from the patient's skin. Therefore, the exemplary disclosed drug delivery system may include a backflow prevention valve. Referring back to Figure 1, an example of a backflow prevention valve 132 is shown. The backflow prevention valve 132 can be any suitable valve for preventing backflow, such as a check valve.

[0102] As shown in Figures 23H to 23N, similar to what is described above with respect to the drug container 900 in Figures 22A to 22G, the drug container 900B can be received into the space 880 of the housing 810, the liquid drug can be dispensed from the drug container 900B, and the drug container 900B can be removed from the housing 810. As shown in Figures 23H to 23N, when drug container 900B is in use, previously used or consumed drug container 900A can be kept aside. Similar to what is described above with respect to Figures 23A to 23N, an additional drug container containing liquid drug, having the same or different configuration as drug containers 900A and 900B, can be used after drug containers 900A and 900B.

[0103] According to some examples, driving the seal 910 of drug container 900A may include discharging a first amount of liquid drug from drug container 900A, as shown in Figures 23D and 23E. Driving the seal 910 of a second drug container 900B may include discharging a second amount of a second liquid drug from the second drug container 900B, which may differ from the first amount of liquid drug from drug container 900A (as shown, for example, in Figures 23K and 23L). The first and second amounts can be any suitable amounts, such as about 1 mL to about 50 mL, about 1 mL to about 30 mL, about 20 mL to about 50 mL, or about 15 mL to about 35 mL.

[0104] In some examples, driving the seal 910 of a drug container may include dispensing a liquid drug from a drug container 900A having a first volumetric capacity, as shown in Figures 23D and 23E. Driving the seal 910 of a second drug container 900B may include dispensing a second liquid drug from a drug container 900B having a second volumetric capacity, which may differ from the first volumetric capacity of drug container 900A (as shown, for example, in Figures 23K and 23L). In some examples, the drug containers having the first and second volumetric capacities may be filled to the same level or to different levels. The first and second volumetric capacities may be any suitable volumetric capacities, such as approximately 5 mL to approximately 50 mL, approximately 10 mL to approximately 50 mL, approximately 20 mL to approximately 50 mL, or approximately 30 mL to approximately 50 mL.

[0105] According to some examples, driving the seal 910 of drug container 900A may include discharging a liquid drug having a first viscosity from drug container 900A, as shown in Figures 23D and 23E. Driving the seal 910 of a second drug container 900B may include discharging a second liquid drug having a second viscosity, which may differ from the first viscosity of the liquid drug in drug container 900A, from drug container 900B, as shown, for example, in Figures 23K and 23L. The first and second viscosities may be any preferred viscosities, such as about 1 cP to about 300 cP, about 1 cP to about 200 cP, about 100 cP to about 300 cP, or about 100 cP to about 200 cP.

[0106] In some examples, the control circuit 890 can control the operation of the drug delivery system 800 differently for different drug containers (for example, differently for drug container 900A and drug container 900B, respectively). The control circuit 890 can control the driver 820 to drive the plunger 830 with a first driving force when drug container 900A is received in space 880. The control circuit 890 can also control the driver 820 to drive the plunger 830 with a second driving force different from the first driving force when drug container 900B is received in space 880. The first and second driving forces may be any preferred driving forces, such as the exemplary driving forces disclosed above.

[0107] In another example, when drug container 900A is received into space 880, the control circuit 890 can control driver 820 to drive plunger 830, which drives seal 910 with a first force and / or speed, causing liquid drug to be discharged from drug container 900A at a first flow rate. The control circuit 890 can also control driver 820 to drive plunger 830 when drug container 900B is received into space 880, which drives seal 910 with a second force and / or speed, causing liquid drug to be discharged from drug container 900B at a second flow rate different from the first flow rate. The first and second flow rates may be any preferred flow rates, for example, from about 0.1 mL / min to about 10 mL / min.

[0108] Referring to Figure 24, another example of the exemplary disclosed drug delivery system is shown. The drug delivery system 920 may be substantially similar to the drug delivery system 800 and can provide a pre-filled configuration and / or a pre-assembled configuration. For example, the exemplary disclosed cartridge may be similar to the drug container 900 and may be integrated with the exemplary disclosed housing which may be similar to the housing 810. In some examples, the cartridge may have a capacity of up to 50 mL (e.g., 10 mL, 20 mL, 30 mL, 40 mL, or 50 mL).

[0109] Referring to Figure 25, an example of the drug delivery system 800 is shown. In this example, drug containers 900A and 900B may contain the same drug. For example, in this example, the drug delivery system 800 can deliver a relatively large amount of drug through separate containers 900A and 900B, rather than one larger container, which would mean the size of the system 800 would be larger to accommodate the larger container. This example can reduce the weight and size of the system because it does not require the use of relatively large and / or heavy drug containers. The drug delivery system 800 can provide on-body cartridge replacement by the user. For example, the user may load additional cartridges during use (for example, after removing a consumed cartridge, as described above). In some examples, cartridges may have a capacity of 20 mL or more (e.g., 10 mL, 20 mL, 30 mL, 40 mL, or 50 mL). For example, additional capacity can be provided by the user adding additional cartridges. The drug delivery system 800 can provide increased infusion volume by enabling the use of multiple cartridges instead of relatively large cartridges that may be impractical to use (e.g., impractical for on-body use). The drug delivery system 800 is shown in a configuration similar to that shown in Figure 23F, in which the drug in the first drug container is dispensed and the second drug container is ready to be placed into the drug delivery system 800.

[0110] Referring to Figure 26, another use case of the drug delivery system 800 is shown, which is weight-based medication. In this case, the drug placed in the drug container may have a first quantity, and the system may deliver a second quantity of the drug, which may be less than or equal to the first quantity, depending on, for example, the patient's weight. The system may receive an input value and adjust to deliver the second quantity based on this input value. The input value may be an input value from a data storage component, or another input value from, for example, a user or a remote computing system. For example, the reader 130 and / or reader 895 may be used to read the exemplary data storage components of the cartridge and dispense the desired amount (for example, as described above). In some examples, the drug delivery system 800 may be used to provide weight-based medication based on data provided by exemplary disclosed data storage components, which may be, for example, data storage component 210 and / or data storage component 915. The drug delivery system 800 is shown in the same configuration as that shown in Figure 22A, Figure 23A, or Figure 23H, in which case the drug container is ready to be placed inside the drug delivery system 930.

[0111] Referring to Figure 27, another use case of the drug delivery system 800 is shown. In this use case, multiple doses of different drugs may be provided (for example, drug containers 900A and 900B may contain different drugs). This allows the drug delivery system 800 to provide multiple therapeutic uses. For example, the user may sequentially change cartridges during use (for example, as described above with respect to Figures 23A to 23N, a first drug may be dispensed from drug container 900A, followed by a second drug which may be different from the first drug, from drug container 900B). The drug delivery system 800 can provide sequential delivery of two or more drug types within a single session. The drug delivery system 800 is shown in a state similar to that shown in Figure 23H, with the first drug container 900A containing the first drug removed from the drug delivery system 800, and the second drug container 900B containing the second drug ready to be placed inside the drug delivery system 800.

[0112] Some or all features of the exemplary disclosed configurations can be used in the exemplary disclosed drug delivery systems. For example, a given exemplary disclosed drug delivery system may include some or substantially all features of drug delivery system 100, drug delivery system 800, drug delivery system 920, drug delivery system 925, drug delivery system 930 and / or drug delivery system 935. Furthermore, a given exemplary disclosed drug delivery system may implement one or more combinations, such as any combination of two or more of the use cases described herein. For example, a given exemplary disclosed drug delivery system may implement body weight-based dosing for two different drugs in two separate containers, or it may deliver multiple doses of a first drug using separate containers having one or more doses of a second drug in separate containers.

[0113] In some examples, referring to Figure 28, an exemplary disclosed method using the drug delivery system 800 (e.g., process 1000) may include the following steps: Process 1000 may begin at step 1005. In step 1010, process 1000 may include receiving the drug container 900 into the space 880 through the opening 815 of the housing 810. In step 1015, process 1000 may include driving the plunger 830, having a flexible plunger rod 860 and a plunger end 855, along the curved track 850 from the pre-use / disengaged position to the engaged position, for example, as described above with respect to Figures 22B and 22C. Returning to Figure 28, in step 1020, process 1000 may include dispensing a liquid drug, for example, as described above with respect to Figures 22D and 22E. In step 1025, it may be determined (e.g., based on the user and / or control circuit 890) whether another drug container should be loaded. For example, drug container 900A can be used in steps 1010 to 1020, as described above in Figures 23A to 23E. If it is determined in step 1025 that a different drug container should be loaded, process 1000 can proceed to step 1030.

[0114] Returning to Figure 28, in step 1030, process 1000 may include returning the plunger 830, having a flexible plunger rod 860 and a plunger end 855, to the pre-use position by driving it along the curved track 850 from the engaged position to the pre-use / disengaged position, as described above with respect to Figures 22E and 22F (for example, or Figures 23E and 23F). Returning to Figure 28, in step 1035, process 1000 may include removing the drug container 900 from the space 880 through the opening 815 of the housing 810. Process 1000 may then return to step 1010.

[0115] For example, drug container 900B can then be used in steps 1010 to 1020, as shown in Figures 23H to 23L. Next, in step 1025, it may be determined again whether or not another drug container should be loaded. If it is determined in step 1025 that an additional cartridge should be loaded, this can be repeated a desired number of times. If it is determined in step 1025 that an additional cartridge should not be loaded, the process 1000 can be terminated in step 1040. The process 1000 can also be applied to other exemplary drug delivery systems disclosed, such as drug delivery system 100, drug delivery system 925, drug delivery system 930, and drug delivery system 935.

[0116] In some examples, a drug delivery system 800 (e.g., and / or other exemplary drug delivery systems disclosed) may comprise a housing 810 defining an opening 815 inside which a drug container 900 is configured to be received within the housing 810; a curved track 850; a plunger 830 having a flexible plunger rod 860 and a plunger end 855; a driver 820 configured to bend while the flexible plunger rod 860 is translating along the curved track 850, causing the plunger 830 to translate along the curved track 850 such that the plunger end 855 drives a seal 910 of the drug container 900 to discharge a liquid drug from the drug container 900; and a partition puncture needle 875 configured to puncture a partition 905 of the drug container 900. The plunger end 855 may be separated from the septum puncture needle 875 so as to define a space 880 between the plunger end 855 and the septum puncture needle 875 when the plunger 830 is in the pre-use position, and the space 880 is configured to receive the drug container 900 when the drug container 900 is received into the housing 810 through the opening 815. The flexible plunger rod 860 may be configured so that the plunger end 855 is positioned outside the drug container 900 when the plunger 830 is in the pre-use position. The flexible plunger rod 860 may be configured to move the plunger end 855 away from the outside of the drug container 900 when the plunger 830 is in the pre-use position so as to engage with the drug container 900 when the plunger 830 is in the engagement position. The plunger end 855 may be configured to engage with the seal 910 of the drug container 900 in the engagement position. The plunger end 855 may be configured to be positioned inside the drug container 900 so as to engage with the seal 910 of the drug container 900 in the engagement position. The plunger end may be configured to engage with the seal 910, which may be a plug seal, in the engagement position. The control circuit 890 may be configured to receive data from a near-field wireless communication tag or RFID tag of the drug container 900 via a reader 895, and the control circuit 890 may be configured to control the driver based on the data.

[0117] In some examples, a drug delivery system 800 (e.g., and / or other exemplary drug delivery systems disclosed) may comprise a curved track 850, a plunger 830 having a flexible plunger rod 860 and a plunger end 855, and a driver 820 configured to bend while the flexible plunger rod 860 is translating along the curved track 850, causing the plunger end 855 to drive a seal 910 of a drug container 900 to discharge a liquid drug from the drug container 900. The flexible plunger rod 860 may be translatable between a disengaged position in which the plunger end 855 is not engaged with the drug container 900 and an engaged position in which the plunger end 855 is engaged with the drug container 900. In the disengaged position, the plunger end 855 may be located outside the drug container 900. In the engaged position, the plunger end 855 may be located inside the drug container 900.

[0118] In some examples, the drug delivery system 800 (e.g., and / or other exemplary drug delivery systems disclosed) may comprise a housing 810 defining an opening 815 inside which a first drug container 900A and a second drug container 900B are configured to be received within the housing 810; a first drug container 900A containing a first liquid drug; a second drug container 900B containing a second liquid drug; a control circuit 890; a curved track 850; a plunger 830 having a flexible plunger rod 860 and a plunger end 855; and a driver 820 configured to move the plunger 830 along the curved track 850 such that the flexible plunger rod 860 bends while translating along the curved track 850. The opening 815 may be configured to removably receive a first drug container 900A, and the control circuit 890 may be configured to drive a driver 820 to drive a plunger end 855 to drive a seal 910 of the first drug container 900A, thereby discharging a first liquid drug from the first drug container 900A. The opening 815 may be configured to removably receive a second drug container 900B, and the control circuit 890 may be configured to drive a driver 820 to drive a plunger end 855 to drive a seal 910 of the second drug container 900B, thereby discharging a second liquid drug from the second drug container 900B. The first amount of the first liquid drug discharged from the first drug container 900A may differ from the second amount of the second liquid drug discharged from the second drug container 900B. The first liquid drug may be the same as the second liquid drug. The first liquid drug may be different from the second liquid drug. The first viscosity of the first liquid drug in the first drug container 900A may be different from the second viscosity of the second liquid drug in the second drug container 900B. The first volumetric capacity of the first drug container 900A may be different from the second volumetric capacity of the second drug container 900B. The control circuit 890 may be configured to cause the driver 820 to drive the plunger 830 with a first driving force when the first drug container 900A is received in the space 880, and with a second driving force which may be different from the first driving force when the second drug container 900B is received in the space 880.The control circuit 890 may be configured to have the driver 820 drive the plunger 830 to drive the seal 910 of the first drug container 900A to discharge the first liquid drug from the first drug container 900A at a first flow rate, and the control circuit 890 may be configured to have the driver 820 drive the plunger 830 to drive the seal 910 of the second drug container 900B to discharge the second liquid drug from the second drug container 900B at a second flow rate different from the first flow rate. The control circuit 890 may be configured to have the driver 820 drive the plunger 830 based on at least one of first data received from a first near-field wireless communication tag or first RFID tag of the first drug container 900A, or second data received from a second near-field wireless communication tag or second RFID tag of the second drug container 900B. The first data can identify at least one of the following: the amount of the first liquid to be discharged, the flow rate at which the first liquid is discharged, the viscosity of the first liquid, or the driving force that drives the plunger 830 to discharge the first liquid. The second data can identify at least one of the following: the amount of the second liquid to be discharged, the flow rate at which the second liquid is discharged, the viscosity of the second liquid, or the driving force that drives the plunger 830 to discharge the second liquid. Removably receiving the first drug container 900A and the second drug container 900B in space 880 may include non-destructive removal of the first drug container and the second drug container. Removably receiving the first drug container 900A and the second drug container 900B in space may include tool-free removal of the first drug container and the second drug container.

[0119] In some examples, the exemplary disclosed method may include receiving a drug container 900A into a space 880 of the housing 810 through an opening 815 of the housing 810, the space 880 being defined between a partition puncture needle 875 of the housing 810 and a plunger end 855 of a plunger 830 located within the housing 810. The exemplary disclosed method may also include driving a plunger 830 having a flexible plunger rod 860 and a plunger end 855 along a curved track 850, the plunger 830 and the curved track 850 being located inside the housing 810, the plunger 830 being arranged to interact with a drug container 900A located in the space 880 inside the housing 810, and the partition puncture needle 875 being configured to puncture a partition 905 of the drug container 900A. An exemplary disclosed method may further include bending the flexible plunger rod 860 while translating along the curved track 850, thereby driving the plunger 830 so that the plunger end 855 drives the seal 910 of the drug container 900A to discharge the liquid drug from the drug container 900A. An exemplary disclosed method may further include positioning the plunger end 855 outside the drug container 900A when the plunger 830 is in a pre-use position in which a space 880 is defined between the septum puncture needle 875 and the plunger end 855. An exemplary disclosed method may also include moving the plunger end 855 away from the outside of the drug container 900A when the plunger 830 is in a pre-use position so that it engages with the seal 910 of the drug container 900A when the plunger 830 is in an engagement position. An exemplary disclosed method may further include: discharging a liquid drug from drug container 900A, then returning the plunger 830 to its pre-use position by separating the plunger end 855 from the septum puncture needle 875 so as to define a space 880 between the plunger end 855 and the septum puncture needle 875; removing drug container 900A from the space 880 through the opening 815; and receiving a second drug container 900B into the space 880 of the housing 810 through the opening 815 after drug container 900A has been removed.

[0120] An exemplary disclosed method may further include the bending of a flexible plunger rod 860 as it translates along a curved track 850, causing the plunger end 855 to drive a plunger 830 to drive a seal 910 of a second drug container 900B, thereby discharging a second liquid drug from the second drug container 900B. Driving the seal 910 of drug container 900A may include discharging a first amount of liquid drug from drug container 900A, and driving the seal 910 of the second drug container 900B may include discharging a second amount of the second liquid drug from the second drug container 900B, which may differ from the first amount. Driving the seal 910 of drug container 900A may include discharging a liquid drug from drug container 900A having a first volumetric capacity, and driving the seal 910 of a second drug container 900B may include discharging a second liquid drug from a second drug container 900B having a second volumetric capacity which may differ from the first volumetric capacity. Driving the seal 910 of drug container 900A may include discharging a liquid drug which may be the same as the second liquid drug dispensed by driving the seal 910 of the second drug container 900B. Driving the seal 910 of drug container 900A may include discharging a liquid drug which is different from the second liquid drug dispensed by driving the seal 910 of the second drug container 900B. Driving the seal 910 of drug container 900A may include discharging a liquid drug having a first viscosity, and driving the seal 910 of a second drug container 900B may include discharging a second liquid drug having a second viscosity different from the first viscosity. The exemplary disclosed method may also include driving the plunger 830 with a first driving force when drug container 900A is received in space 880, and driving the plunger 830 with a second driving force which may be different from the first driving force when the second drug container 900B is received in space 880.An exemplary disclosed method may further include driving a plunger 830 to drive a seal 910 of a drug container 900A to discharge a liquid drug from the drug container 900A at a first flow rate, and driving a plunger 830 to drive a seal 910 of a second drug container 900B to discharge a second liquid drug from the second drug container 900B at a second flow rate which may differ from the first flow rate. An exemplary disclosed method may further include moving the plunger end 855 of the plunger 830 from the partition puncture needle 875 in a pre-use position before receiving the exemplary disclosed drug container into the space 880 of the housing 810.

[0121] Sterilization barrier Referring to Figures 29 to 31, another example of the exemplary drug delivery system disclosed is shown. Drug delivery system 1100 may comprise components similar to those of the exemplary system disclosed above. Drug delivery system 1100 may comprise a partition puncture assembly 1200 and a puncture member 1300 (e.g., shown in Figure 31) that can work together for sterile extraction of liquid drug from drug container 1400. Drug delivery system 1100 may be configured to work with components (e.g., drivers, plungers, and control circuits that can be located within a housing) similar to those described above with respect to drug delivery systems 100 and 800 (e.g., those described with respect to Figures 1 to 11, Figure 18, and Figures 22A to 23N). In some examples, drug delivery system 1100 may implement housing 102 and may be housed in housing 1110, which may be similar to housing 102, housing 440, and / or housing 810 described above. Furthermore, in some examples, plunger 1130, which can accommodate plunger 500 and / or plunger 830, can move drug container 1400, for example, as described above with respect to Figures 18 and 22A to 23N.

[0122] The septum puncture assembly 1200 can accommodate the septum puncture needle 116. The septum puncture assembly 1200 may be similar to, for example, the septum puncture needle 116, the septum puncture assembly 400, and / or the septum puncture assembly 840. In some examples, the septum puncture assembly 1200 may comprise a needle assembly 1205, which may be similar to the needle assembly 405, and a biasing assembly 1210, which may be similar to the biasing assembly 410. The needle assembly 1205 may comprise a needle support 1215, which may be similar to the needle support 415, and a septum puncture needle 1220, which may be similar to the septum puncture needle 420. The septum puncture needle 1220 may include a tip 1222, which may be similar to the tip 422 for puncturing the septum of the drug container 1400. The needle support 1215 can be attached to the housing portion 1235 of the housing 1110.

[0123] The biasing assembly 1210 may comprise a biasing member 1245, which may be similar to the biasing member 445, and a needle shield 1250, which may be similar to the needle shield 450. The biasing member 1245 and the needle shield 1250 may be movably supported by the needle support 1215 of the needle assembly 1205 (for example, they may be movably attached to the needle support 1215). The needle shield 1250 can selectively shield the tip 1222 of the septum puncture needle 1220. The needle shield 1250 may be moved based on biasing from the biasing member 1245 and / or the position of the drug container 1400, as described above with respect to Figures 17A and 17B.

[0124] Returning to Figure 30, the needle shield 1250 may include a needle housing 1265 that is similar to the needle housing 465 and can form a needle cavity 1270, which may be similar to the needle cavity 470. The needle cavity 1270 can selectively accommodate part or substantially all of the septum puncture needle 1220 when the drug delivery system 1100 is in a non-puncture configuration. The needle housing 1265 may be configured and dimensionally determined to be movably received by the needle support 1215, as described above with respect to the needle housing 465 and the needle support 415. The needle housing 1265 of the needle shield 1250 may include a needle aperture 1275 through which the septum puncture needle 1220 can selectively pass and extend, for example, as will be further described below. In some examples, the tip 1222 may be aligned with the needle aperture 1275 (e.g., it may be centered). The needle shield 1250 may further include a shield puncture element 1280. The shield puncture element 1280 may be a sterile barrier. The shield puncture element 1280 may be attached to the needle housing 1265 by any suitable technique, such as mechanical fastening, adhesive, mounting components, and / or any other suitable technique. In some examples, a mounting member 1285, which may be formed from a material similar to that of the needle housing 1265, may be attached to the needle housing 1265 or formed integrally with it. For example, the mounting member 1285 may receive the shield puncture element 1280, as shown in Figure 30, thereby attaching the shield puncture element 1280 to the needle housing 1265 (for example, the mounting member 1285 has an aperture 1285a that may be dimensionally and / or aligned similarly to the needle aperture 1275). The shield puncture element 1280 can be attached to the needle housing 1265 by any preferred technique, and as a result, the shield puncture element 1280 can cover substantially all (for example, or part) of the needle aperture 1275. The shield puncture element 1280 can seal the needle cavity 1270, reducing or substantially preventing the entry of bacteria into the needle cavity 1270.In some examples, the needle cavity 1270 may be formed between the shield puncture element 1280, the inner wall of the needle housing 1265 (e.g., the inner wall surface), and the surface of the needle support 1215 facing the needle cavity 1270. The needle cavity 1270 can thereby function as a sterilization chamber (e.g., it can be sterilized during manufacturing).

[0125] The shield puncture element 1280 may be a self-healing member. In some examples, the shield puncture element 1280 can be closed again after being punctured. The shield puncture element 1280 may be formed from any suitable self-healing (e.g., re-closing or re-sealing) material, such as an elastomer material. In some examples, the shield puncture element 1280 may be formed from a rubber or silicone material. The shield puncture element 1280 may be formed from a self-healing polymer material. The shield puncture element 1280 may include a shield puncture line 1290. The shield puncture line 1290 may be a cut line, a slit, a reduced thickness portion, and / or any other suitable feature to facilitate puncture by the puncture member 1300. For example, the shield puncture line 1290 can provide predictable opening and closing of the shield puncture element. The shield puncture line 1290 facilitates the puncture of the shield punctureable element 1280 by the puncture member 1300 and / or the self-recovery (e.g., re-closing or re-sealing) of the shield punctureable element 1280 when it is punctured by the puncture member 1300, for example, as further described below.

[0126] As shown in Figure 31, the drug container 1400 can house the drug container 200 and may be substantially similar to the drug container 600 and / or the drug container 900. The drug container 1400 may include a cavity 1402c, which may be similar to the cavity 602c, and a container end 1406 defining the container opening 1410. The container opening 1410 may be an opening to the cavity 1402c. The drug container 1400 may also include a partition 1408, which may be similar to the partition 608. The partition 1408 may be configured to seal the container opening 1410 and seal the liquid drug in the cavity 1402c.

[0127] The drug container 1400 may also include a cap assembly 1420. The cap assembly 1420 may include a cap housing 1425. The cap housing 1425 may be formed from a material similar to that of the needle support 1215 and / or needle shield 1250 (for example, similar to the structural material illustrated above). The cap housing 1425 may form a container cavity 1430 which can be configured to receive and / or attach to the container end 1406. The container cavity 1430 may be a sterile cavity. In some examples, the container cavity 1430 may be configured to receive, fit around, and / or attach to the container end 1406, for example, as shown in Figure 31. The cap housing 1425 may be attached to the container end 1406 and / or received within the container cavity 1430 by any preferred technique, such as crimping, snap-fitting or press-fitting, mechanical fasteners, adhesives, and / or any other preferred connection technique. In some examples, the cap housing 1425 can be attached to the container end 1406 by crimping (e.g., by aluminum crimping or any other suitable crimping). In some examples, the cap housing 1425 may be integrally formed with the container end 1406 (e.g., the cap assembly 1420 may be an integral part of the drug container 1400).

[0128] The cap housing 1425 may also form a cap cavity 1435. The cap cavity 1435 may be configured to receive (e.g., support and / or hold) components of the cap assembly 1420 and / or the puncture member 1300 (for example, in some embodiments). In some examples, the cap cavity 1435 may be configured to receive the sliding assembly 1440 and the puncture member 1300. The cap cavity 1435 may be a sterile cavity (e.g., a cartridge sterilization chamber that functions as a sterile environment).

[0129] The sliding assembly 1440 may be movably positioned within the cap cavity 1435. In some examples, the sliding assembly 1440 may move toward the partition wall 1408 within the cap assembly 1420 based on its movement within the cap cavity 1435. The cap cavity 1435 and / or the sliding assembly 1440 (e.g., the sliding member 1445 of the sliding assembly 1440) may be configured to have corresponding protrusions, slots, grooves and / or any other preferred features to allow the sliding assembly 1440 to move (e.g., translate) within the cap assembly 1420. The sliding member 1445 may be formed from the same material as the cap housing 1425. A sliding member aperture 1450 may be formed on the sliding member 1445. In some examples, the sliding member aperture 1450 may be formed on the central portion of the sliding member 1445 and may extend through the thickness of the sliding member 1445 (e.g., the entire thickness). The sliding member 1445 may also be configured to receive (e.g., hold and support) the container puncture element 1455. The container puncture element 1455 may cover substantially all (e.g., or part) of the sliding member aperture 1450. In some examples, the container puncture element 1455 may be concentric with the partition 1408 and the through-hole of the puncture member 1300, as shown in Figure 31 and further described below. The container puncture element 1455 may be similar to the shield puncture element 1280 and may be formed from the same material as the shield puncture element 1280, for example, as described above. For example, the container puncture element 1455 may be a sterile barrier. Also, for example, the container puncture element 1455 may include a container puncture line 1460 similar to the shield puncture line 1290.

[0130] The puncture member 1300 may be formed from a material similar to that of the needle support 1215 and / or needle shield 1250 (for example, similar to the structural material exemplified above). The puncture member 1300 may include a puncture portion 1305 having a puncture tip 1310. The puncture tip 1310 may have any preferred configuration (e.g., a tip and / or a relatively sharp edge) for puncturing the shield puncture element 1280 and / or the container puncture element 1455. A through hole 1315 may be formed in the puncture portion 1305. The puncture member 1300 may also include a member base 1320 that can be attached to other components of the drug delivery system 1100 to support the puncture member 1300 in a desired position and / or orientation (e.g., for puncturing the shield puncture element 1280 and / or the container puncture element 1455). The through-hole 1315 can extend substantially entirely through the puncture member 1300 (including, for example, along substantially the entire length of the puncture portion 1305 and substantially the entire thickness of the member base 1320).

[0131] In some examples, as shown in Figure 31, the puncture member 1300 may be received (e.g., supported and / or held) within the cap cavity 1435 of the cap assembly 1420. For example, the member base 1320 may be attached (e.g., fixedly attached) to the cap housing 1425 such that the through-hole 1315 aligns with the partition wall 1408. Alternatively, for example, the puncture tip 1310 may be aligned with the sliding member aperture 1450 and the container punctureable element 1455 of the sliding assembly 1440. The through-hole 1315 may thereby be positioned between the container punctureable element 1455 and the partition wall 1408 and aligned with them.

[0132] In other examples, as shown in Figure 32A (unengaged configuration) and Figure 32B (engaged configuration, before puncture of drug container 1400), an exemplary disclosed puncture member (e.g., puncture member 1300A) may be received (e.g., supported and / or held) within the needle cavity 1270 of the needle shield 1250. The puncture member 1300A may be substantially similar to the puncture member 1300 (e.g., including the puncture portion 1305A, puncture tip 1310A, through-hole 1315A, and base 1320A), as described above. The septum puncture needle 1220 may be positioned within the through-hole 1315A and may remain within the through-hole 1315A (e.g., at least partially or substantially entirely) during the operation of the exemplary disclosed drug delivery system. The needle support 1215 and the base 1320A are separated by an internal biasing member or spring 1255, which are compressed when the needle support 1215 is biased toward the base 1320A, thereby driving the puncture needle 1220 into the drug container 1400.

[0133] Accordingly, in some embodiments (e.g., Figure 31), the puncture member 1300 may be supported by a drug container 1400 (e.g., a cap assembly 1420), and in other embodiments (e.g., Figures 32A and 32B), the puncture member 1300A may be supported by a septum puncture assembly 1200. In some examples, the exemplary disclosed puncture members may be positioned either on the septum puncture assembly side or the drug container side of the drug delivery system 1100.

[0134] Figures 29 to 32 show exemplary embodiments of the drug delivery system 1100 in a non-puncture configuration. As will be further described below, the drug delivery system 1100 can be moved from a non-puncture configuration to a puncture configuration and a post-puncture configuration during operation of the drug delivery system 1100.

[0135] In some examples, referring to Figure 33, an exemplary disclosed method using the drug delivery system 1100 (e.g., process 1500) may include the following steps: Process 1500 may begin at step 1505. In step 1510, process 1500 may include receiving a drug container 1400. The drug container 1400 may be received in the housing 1110, for example, as described above with respect to the drug delivery system 800. Figure 34A schematically shows the non-puncture configuration of the drug delivery system 1100 when the drug container 1400 is received in step 1510. The drug container 1400 may be received with any suitable clearance between reference A and reference B, as shown in Figure 34A, and as described above with respect to Figures 19, 22A, and 23A, allowing the drug container 1400 to be introduced into the housing 1110 along a direction perpendicular to the movement axis of the drug container 1400 (for example, the movement axis when moved by the plunger 1130).

[0136] Returning to Figure 33, in step 1515, process 1500 may include moving the drug delivery system 1100 from a non-puncture configuration to a puncture configuration. As shown in Figures 34A and 34B, the drug container 1400 may be moved toward the septum puncture assembly 1200 based on contact and movement by the plunger 1130 (which may be driven, for example, as described above with respect to plunger 500 and / or plunger 830). As shown in Figure 34B, after the needle shield 1250 has contacted the sliding member 1445, the plunger 1130 may continue to move the drug container 1400 toward the septum puncture assembly 1200. At this point, as shown in Figures 34B and 34C, the movement of the drug container 1400 may move the sliding member 1445 within the cap housing 1425. In other words, the drug container 1400 can continue to move toward the septum puncture assembly 1200 so that a portion of the needle shield 1250 is received within the cap housing 1425, thereby moving the sliding member 1445 from the position shown in Figure 34B into the cap housing 1425, and as a result the sliding member 1445 comes into contact with the puncture member 1300 (e.g., member base 1320) as shown in Figure 34C. The force threshold that moves the sliding member 1445 may be smaller than the force threshold that deforms (e.g., compresses) the biasing member 1245, so the biasing member 1245 may not deform (e.g., compress) as the sliding member 1445 moves. In some examples, the sliding member 1445 may be biased by a biasing member similar to the biasing member 1245, but can be deformed (e.g., compressed) based on a smaller force than the biasing member 1245 (for example, the force threshold that moves the sliding member 1445 may be smaller than the force threshold that deforms the biasing member 1245). Therefore, the needle shield 1250 may not move relative to the needle support 1215 when the sliding member 1445 moves (for example, as shown in Figures 34B and 34C) based on the movement of the drug container 1400 by the plunger 1130.

[0137] Furthermore, as shown in Figures 34B and 34C, as the sliding member 1445 and needle shield 1250 move into the cap housing 1425 toward the puncture member 1300, the puncture tip 1310 of the puncture member 1300 first comes into contact with the container puncture element 1455, and can puncture the container puncture element 1455. For example, the puncture tip 1310 can come into contact with and puncture the container puncture line 1460 of the container puncture element 1455, and can pass through the opening formed in the container puncture element 1455. As the plunger 1130 continues to move the drug container 1400, the puncture tip 1310 and the puncture portion 1305 (for example, part, most, or substantially all of the puncture portion 1305) can pass through the container puncture element 1455. As the plunger 1130 continues to move the drug container 1400 toward the partition puncture assembly 1200, the puncture tip 1310 of the puncture member 1300 will then come into contact with the shield puncture element 1280, and will be able to puncture the shield puncture element 1280. For example, the puncture tip 1310 can come into contact with and puncture the shield puncture line 1290 of the shield puncture element 1280 and pass through the opening formed in the shield puncture element 1280. As the plunger 1130 continues to move the drug container 1400, the puncture tip 1310 and the puncture portion 1305 (for example, part, most, or substantially all of the puncture portion 1305) will be able to pass through the shield puncture element 1280 (for example, as shown in Figure 34C). After the puncture tip 1310 punctures the container puncture element 1455 and the shield puncture element 1280, the through-hole 1315 can function as an unblocking passage connecting the needle cavity 1270 (which may be, for example, sterile) and the puncture release partition 1408 (which may be, for example, sterile) facing the container cavity 1430. That is, for example, the through-hole 1315 can provide a sterile passage between the sterile needle cavity 1270 and the sterile container cavity 1430.

[0138] As the plunger 1130 continues to move the drug container 1400 toward the partition puncture assembly 1200, as shown in Figures 34C and 34D (for example, after the sliding member 1445 has contacted the puncture member 1300), the needle shield 1250, which is in contact with the sliding member 1445 being pressed toward the puncture member 1300, moves the needle shield 1250 toward the needle support 1215, thereby deforming (e.g., compressing) the biasing member 1245. As the drug container 1400, in contact with the needle shield 1250, moves toward the needle support 1215 and deforms the biasing member 1245, the puncture member 1300 moves toward the partition puncture needle 1220. The through hole 1315 cannot be blocked because the puncture tip 1310 has already punctured the container puncture element 1455 and the shield puncture element 1280. As the plunger 1130 continues to move the drug container 1400 toward the septum puncture assembly 1200, the puncture member 1300 is moved toward the needle support 1215 along with the rest of the drug container 1400, so that the septum puncture needle 1220 can enter the through hole 1315. The puncture member 1300 can move along a portion of the length of the septum puncture needle 1220 until the tip 1222 of the septum puncture needle 1220 contacts and punctures the septum 1408, passes through the drug container 1400, and forms a fluid connection, for example, as shown in the puncture configuration of Figure 34D. Thus, the septum puncture needle 1220 moves through the through hole 1315 without contacting any surface other than the septum 1408, thereby maintaining sterility.

[0139] Returning to Figure 33, in step 1520, process 1500 may include dispensing liquid medication from the medication container 1400 when the medication delivery system 1100 is in the puncture configuration. Figure 34E shows a more detailed diagram of the puncture configuration of the medication delivery system 1100 shown in Figure 34D. As shown in Figures 34D and 34E, when the medication delivery system 1100 is in the puncture configuration, the septum puncture needle 1220 may be positioned substantially entirely within the through-hole 1315, from the attachment point of the septum puncture needle 1220 to the septum 1408 to be punctured by the septum puncture needle 1220. The septum puncture needle 1220 may thereby be kept substantially entirely within the sterile space (e.g., the through-hole 1315 after the septum 1408 has been punctured, the container cavity 1430, and inside the medication container 1400). For example, sterility can be maintained by the shield puncture element 1280 and the container puncture element 1455, which can function as punctureable sterile barriers. This allows liquid drugs to be delivered via the drug delivery system 1100, for example, as described above with respect to the drug delivery system 100 (for example, with respect to Figures 16B and 18) and / or the drug delivery system 800 (for example, based on the plunger 1130 moving a seal similar to the seal 610 in the drug container 1400, as described above).

[0140] Returning to Figure 33, in step 1525, it can be determined whether another drug container should be loaded, similar to what was described above with respect to step 1025 in Figure 28. If it is determined in step 1525 that another drug container should be loaded, process 1500 can proceed to step 1530.

[0141] In step 1530, process 1500 may include resetting the drug delivery system 1100 from a puncture configuration to a post-puncture configuration which may be substantially similar to a non-puncture configuration. The plunger 1130 can reverse its direction of movement so that the drug container 1400 moves away from the septum puncture assembly 1200, as shown in Figures 34E and 34F (for example, as described above with respect to Figure 18). For example, since the needle shield 1250 remains in contact with the sliding member 1445, the needle shield 1250 can move relative to the needle support 1215 to release potential energy from the biasing member 1245 (for example, by decompressing). The puncture member 1300 and the drug container 1400 can move relative to the partition puncture needle 1220, so that the partition puncture needle 1220 is released from the partition 1408, removed from the through hole 1315, and positioned in the needle cavity 1270 of the needle housing 1265, as shown in Figure 34F. At this point, the puncture tip 1310 may still be puncturing the container puncture element 1455 and the shield puncture element 1280, so that the through hole 1315 cannot still be blocked (however, for example, as shown in Figure 34F, the partition puncture needle 1220 may no longer be positioned in the through hole 1315).

[0142] As shown in Figures 34F and 34G, the sliding member 1445 and the needle shield 1250 can move away from the inside of the cap housing 1425 and the puncture member 1300 (for example, based on biasing of the sliding member 1445 by a biasing member similar to the biasing member 1245, as described above). As the plunger 1130 continues to move the drug container 1400 away from the partition puncture assembly 1200, the puncture tip 1310 of the puncture member 1300 is withdrawn from the shield puncture element 1280, allowing the puncture element 1280 to be depunctured. After the shield puncture element 1280 has been depunctured, the shield puncture element 1280 can self-recover (for example, re-close or re-seal). For example, the opening formed in the shield puncture element 1280 can be closed. The plunger 1130 continues to move away from the plunger seal, moving the drug container 1400 away from it. The biasing member 1245 moves the drug container 1400 away from the puncture member 1300. The puncture tip 1310 of the puncture member 1300 is withdrawn from the container puncture element 1455, allowing the container puncture element 1455 to be de-punctured. After the container puncture element 1455 has been de-punctured, the drug container 1400 may be discarded and not reused. However, the drug container 1400 may be reused. For example, the container puncture element 1455 may be self-recovering, similar to the shield puncture element 1280. Once the puncture member 1300 is released from the shield puncture element 1280 and the container puncture element 1455, the sliding member 1445 can move from a position in contact with the puncture member 1300 shown in Figure 34F to a position forming the cap cavity 1435 shown in Figure 34G. In some examples, an exemplary biasing member, similar to the biasing member 1245, can bias the sliding member 1445 to the position shown in Figure 34G. The plunger 1130 can continue to move the drug container 1400 further away from the partition puncture assembly 1200 from the position shown in Figure 34G to the post-puncture configuration shown in Figure 34H.In some cases, the self-recovery of the shield puncture element 1280 and the container puncture element 1455 described in step 1530, and the resetting of the drug delivery system 1100, can provide a reusable sterile connection (for example, by substantially preventing accidental infectious contact to the septum puncture needle 1220 during use of the drug delivery system 1100, such as during cartridge replacement in step 1510).

[0143] Returning to Figure 33, in step 1535, the drug container 1400 may be removed from the housing 1110. The process 1500 can then return to step 1510, where a new drug container 1400 can be received. Steps 1510 to 1535 may be repeated any number of times. If it is determined in step 1525 that no additional cartridge should be loaded, the process 1500 can be terminated in step 1540.

[0144] A process using an exemplary embodiment, shown in Figure 32, which includes the puncture member 1300A, may be substantially similar to process 1500. The puncture member 1300A, supported in the partition puncture assembly 1200, can puncture both the shield puncture element 1280 attached to the needle shield 1250 and the container puncture element 1455 attached to the drug container 1400, as described above with respect to Figure 33.

[0145] Figures 35A and 35B show another example of a drug delivery system. The drug delivery system 1100B may include a septum puncture assembly 1200B, which may be substantially similar to the septum puncture assembly 1200. The septum puncture assembly 1200B may include a needle assembly 1205B and a septum puncture needle 1220B positioned in a needle cavity 1270B, which may be similar to the needle cavity 1270. The septum puncture assembly 1200B may also include a shield punctureable element 1280B, which may be similar to the shield punctureable element 1280, and a mounting member 1285B, which may be similar to the mounting member 1285.

[0146] The drug delivery system 1100B may also include a drug container 1400B, which may be similar to the drug container 1400. The drug container 1400B may include a cap assembly 1420B having a cap housing 1425B, which may be substantially similar to the cap housing 1425. The drug container 1400B may also include a container puncture element 1455B, which may be substantially similar to the container puncture element 1455. The drug container 1400B may also include a partition wall 1408B, which may be similar to the partition wall 1408.

[0147] The drug delivery system 1100B may also include a puncture member 1300B, which may be similar to the puncture member 1300.

[0148] As shown in Figures 35A and 35B, the drug container 1400B can be moved toward the partition puncture assembly 1200B, as described above with respect to the drug delivery system 1100. The container puncture element 1455B can serve a similar purpose to the sliding member 1445 as it stretches and deforms, as described below. When the drug container 1400B is moved toward the partition puncture assembly 1200B, the mounting member 1285B can deform the container puncture element 1455B until the puncture member 1300B punctures the container puncture element 1455B, as shown in Figure 35B. As the drug container 1400B is moved further toward the septum puncture assembly 1200B, the puncture member 1300B can also puncture the shield puncture element 1280B so that the puncture member 1300B punctures both the container puncture element 1455B and the shield puncture element 1280B. As the drug container 1400B is moved further toward the septum puncture assembly 1200B, the puncture member 1300B can move along a portion of the length of the septum puncture needle 1220B until the septum puncture needle 1220B punctures the septum 1408B, as described above with respect to Figures 34D and 34E. The operation of the drug delivery system 1100B may be substantially the same as described above with respect to Figure 33.

[0149] In some examples, the drug delivery system 1100 may include a drug container 1400 comprising a container body configured to hold a liquid drug, the container body comprising a container end 1406 defining a container opening 1410 inside, a partition 1408 configured to seal the container opening 1410, and a first puncture element, which, when the drug delivery system 1100 is in a non-puncture configuration, comprises a first cavity (e.g., container cavity 1430 and The system includes a first punctureable element (e.g., container punctureable element 1455) separated from the partition 1408 to define a first cavity (and / or cap cavity 1435) to reduce or substantially prevent the entry of contaminants into the first cavity, and a puncture member 1300 that defines a through hole 1315 through the interior, the puncture member 1300 being positioned within the first cavity (e.g., container cavity 1430 and / or cap cavity 1435) when the drug delivery system 1100 is in a non-puncture configuration. The drug delivery system 1100 may also include a septum puncture assembly 1200, which includes a needle support 1215, a second punctureable element (e.g., a shield punctureable element 1280) that is separated from the needle support 1215 to define a second cavity (e.g., a needle cavity 1270) between the second punctureable element and the needle support 1215 when the drug delivery system 1100 is in a non-puncture configuration, in order to reduce or substantially prevent the entry of contaminants into the second cavity, and a needle 1220 that is supported by the needle support 1215 within the second cavity when the drug delivery system 1100 is in a non-puncture configuration. The drug delivery system 1100 is configured such that when the container 1400 and the partition puncture assembly 1200 are moved toward each other from a non-puncture configuration to a puncture configuration, the puncture member 1300 can puncture the first punctureable element and the second punctureable element, and the needle 1220 is received into the partition 1408 through the through hole 1315 of the puncture member 1300. The first and second cavities may be sterile chambers. When the drug delivery system 1100 moves from the puncture configuration to the post-puncture configuration, the first and second punctureable elements may be configured to close when the puncture member 1300 is removed.The first and second punctureable elements may be formed from an elastomer material. The first and second punctureable elements may be formed from a rubber or silicone material. The drug delivery system 1100 may be configured to revert to a post-puncture configuration, which may be identical to the non-puncture configuration, after delivery of the liquid drug in the puncture configuration, except that the partition 1408 may be punctured, and the amount of liquid drug in the container 1400 may be reduced. At least one of the first and second punctureable elements may include a notch or slit at the contact position of the puncture member. The drug delivery system 1100 may also include a sliding member 1445 that can be slidably supported within the cavity assembly (e.g., cap housing 1425) of the container 1400 forming the first cavity. The first punctureable element may cover the aperture of the sliding member 1445 (e.g., sliding member aperture 1450). A first cavity may be formed between the puncture member 1300, the inner wall of the cavity assembly, the sliding member 1445, and the first punctureable element. The sliding member 1445 may be configured to slide toward the partition 1408 within the cavity assembly, based on the fact that a portion of the partition puncture assembly 1200 is received within the cavity assembly and comes into contact with the sliding member 1445 when the drug delivery system 1100 moves from a non-puncture configuration to a puncture configuration. When the drug delivery system 1100 is in the puncture configuration, the puncture member 1300 is punctured through the first and second punctureable elements covering the aperture of the sliding member 1445. When the drug delivery system 1100 is in a puncture configuration, the needle 1220 can extend through the through-hole 1315 along the length of the puncture member 1300, through the first punctureable element, the aperture of the sliding member 1445, and the second punctureable element. When the drug delivery system 1100 moves from a non-puncture configuration to a puncture configuration, the tip 1222 of the needle 1220 can move from the second cavity, through the through-hole 1315 of the puncture member 1300 that punctures the first punctureable element and the second punctureable element, through the first cavity, and puncture the partition wall 1408.

[0150] In some examples, a first punctureable element (e.g., a container punctureable element 1455B) can cover the opening of a cavity assembly of a container 1400B that forms a first cavity, and the first punctureable element is attached to the cavity assembly at a fixed mounting portion of the first punctureable element. The first punctureable element may be configured to deflect without displacement from the fixed mounting portion when a partition puncture assembly 1200B comes into contact with the first punctureable element. The drug delivery system 1100B may be configured to move from a non-puncture configuration to a puncture configuration based on the movement of the container 1400B and the partition puncture assembly 1200B toward each other due to the deflection of the first punctureable element. When the drug delivery system 1100B is in a puncture configuration, the puncture member 1300B can be punctured through the first punctureable element and a second punctureable element (e.g., a shield punctureable element 1280B) that can be deflected. The first punctureable element may be deflected and extended inward toward the inside of the cavity assembly, thereby reducing the volume of the first cavity as the container 1400B and the septum puncture assembly 1200B move toward each other.

[0151] In some examples, the drug delivery system 1100 may include a container 1400, which is a container body configured to hold a liquid drug, and has a container end 1406 defining a container opening 1410 inside it, and a partition 1408 configured to seal the container opening 1410; a resettable partition puncture mechanism (e.g., partition puncture assembly 1200) including a needle support 1215; a puncture element (e.g., shield puncture element 1280) which is separated from the needle support 1215 to define a cavity between the puncture element and the needle support 1215 when the drug delivery system 1100 is in a non-puncture configuration, thereby reducing or substantially preventing the entry of bacteria into the cavity; and a needle 1220 which is supported by the needle support 1215 within the cavity when the drug delivery system 1100 is in a non-puncture configuration. The drug delivery system 1100 may further include a biasing member 1245 and a puncture member 1300 that defines a through-hole 1315 through its interior. The drug delivery system 1100 may be configured such that when the container 1400 and the resettable partition puncture mechanism are moved toward each other from a non-puncture configuration to a puncture configuration, the puncture member 1300 can puncture a punctureable element, and the needle 1220 can exit the cavity and extend into the partition 1408 through the through-hole 1315 of the puncture member 1300. When the container 1400 and the resettable partition puncture mechanism are moved away from each other from a puncture configuration to a non-puncture configuration, the biasing member 1245 moves at least one of the punctureable element or the needle support 1215 away from the other, and the needle 1220 can be returned to the cavity. The puncture member 1300 may be located within the cavity when the drug delivery system 1100 is in a non-puncture configuration. In some examples, the needle 1220 may be located within a through-hole (e.g., through-hole 1315A) of the puncture member (e.g., puncture member 1300A) when the drug delivery system 1100 is in a non-puncture configuration.The drug delivery system 1100 may further comprise a container puncture element 1455, which is separated from the partition 1408 to define a container cavity 1430 between the container puncture element 1455 and the partition 1408 when the drug delivery system 1100 is in a non-puncture configuration, thereby reducing or substantially preventing the entry of contaminants into the container cavity 1430. A puncture member 1300 may be placed inside the container 1400 when the drug delivery system 1100 is in a non-puncture configuration. The drug delivery system 1100 may be configured such that when the container 1400 and the reconfigurable partition puncture mechanism are moved toward each other from a non-puncture configuration to a puncture configuration, the puncture member 1300 can puncture the container puncture element 1455 and the puncture element, and the needle 1220 can exit the cavity and extend into the partition 1408 through the through hole 1315 of the puncture member 1300. The drug delivery system 1100 may further include a drive mechanism (e.g., including a plunger 1130) configured to contact the container 1400 and move the container 1400 toward the reconfigurable partition puncture assembly 1200. The drive mechanism retracts the plunger 1130 so that it exits the container 1400 away from the plunger seal. As the plunger 11300 moves away from the plunger seal, the biasing member 1245 allows the container 1400 to be pushed away from the puncture member 1300 to the post-puncture position. The drug delivery system 1100 may further include a drive mechanism configured to move at least one of the punctureable element or the needle support 1215 to return at least one of the punctureable element or the needle support 1215 from the puncture configuration to the initial position of the non-puncture configuration. The cavity may be a sterile chamber. When the container 1400 and the resettable partition puncture assembly 1200 are moved away from each other, the punctureable element may be configured to close when the puncture member 1300 is removed. The punctureable element may include a notch or slit at the contact point with the puncture member 1300.

[0152] In some examples, the methods disclosed herein may be methods for operating a drug delivery system 1100, the drug delivery system 1100 comprising a drug container 1400 including a partition 1408, a first punctureable element (e.g., a container punctureable element 1455) separated from the partition 1408 to define a first cavity, and a puncture member 1300 disposed within the first cavity, wherein the first punctureable element reduces the entry of bacteria into the first cavity or The method comprises a drug container 1400 that substantially prevents the entry of bacteria into the second cavity, and a septum puncture assembly 1200 including a needle support 1215, a second punctureable element (e.g., a shield punctureable element 1280) separated from the needle support 1215 to define a second cavity, and a needle 1220 supported by the needle support 1215 within the second cavity, wherein the second punctureable element reduces or substantially prevents the entry of bacteria into the second cavity. The method may include moving the drug container 1400 and the septum puncture assembly 1200 toward each other from a non-puncture configuration to a puncture configuration, and receiving the needle 1220 through a through-hole 1315 of the puncture member 1300 as the drug container 1400 and the septum puncture assembly 1200 move toward each other. The method may further include puncturing the partition 1408 with a needle 1220, and delivering the liquid drug contained in the drug container 1400 via the needle 1220 once the puncture member 1300 has punctured the first and second punctureable elements and the needle 1220 has been positioned within the through-hole 1315. The method may further include moving the drug container 1400 and the partition puncture assembly 1200 apart from each other from a non-puncture configuration to a post-puncture configuration which may be identical to the non-puncture configuration except that the partition 1408 has been punctured and the amount of liquid drug in the drug container 1400 has decreased. The drug container 1400 may be configured to be removable when the drug container 1400 is in the post-puncture configuration and interchangeable with a second drug container in the non-puncture configuration. The first and second cavities may be sterile chambers.When the drug container 1400 and the partition puncture assembly 1200 are moved away from each other, the first and second punctureable elements may be configured to close when the puncture member 1300 is removed. At least one of the first and second punctureable elements may include a notch or slit at the contact point of the puncture member 1300 for predictable opening and closing.

[0153] In some examples, the methods disclosed herein may be a method for operating a drug delivery system 1100, the drug delivery system 1100 comprising a container 1400, which is a container body configured to hold a liquid drug therein, and having a container end 1406 defining a container opening 1410 inside, and a partition 1408 configured to seal the container opening 1410; a resettable partition puncture mechanism (e.g., partition puncture assembly 1200) including a needle support 1215; and a puncturable element The drug delivery system 1100 comprises a punctureable element (e.g., a shield punctureable element 1280) separated from the needle support 1215 to define a cavity between the punctureable element and the needle support 1215 when the drug delivery system 1100 is in a non-puncture configuration, thereby reducing or substantially preventing the entry of contaminants into the cavity; a needle 1220 supported by the needle support 1215 within the cavity when the drug delivery system 1100 is in a non-puncture configuration; a biasing member 1245; and a puncture member 1300 that defines a through-hole 1315 through its interior. The method may include moving the container 1400 and the resettable partition puncture mechanism toward each other from a non-puncture configuration to a puncture configuration so that the puncture member 1300 can puncture a punctureable element and the needle 1220 can exit the cavity and extend into the partition 1408 through the through-hole 1315 of the puncture member 1300; and moving the container 1400 and the resettable partition puncture mechanism toward each other from a puncture configuration to a non-puncture configuration so that the biasing member 1245 moves at least one of the punctureable element or the needle support 1215 toward the other, and the needle 1220 can return to the cavity. The puncture member 1300 may be located within the cavity when the drug delivery system 1100 is in a non-puncture configuration. In some examples, the needle 1220 may be positioned within a through-hole (e.g., through-hole 1315A) of a puncture member (e.g., puncture member 1300A) when the drug delivery system 1100 is in a non-puncture configuration.The drug delivery system 1100 may further comprise a container puncture element 1455, which is separated from the partition 1408 to define a container cavity 1430 between the container puncture element 1455 and the partition 1408 when the drug delivery system 1100 is in a non-puncture configuration, thereby reducing or substantially preventing the entry of contaminants into the container cavity 1430. A puncture member 1300 may be positioned inside the container 1400 when the drug delivery system 1100 is in a non-puncture configuration. When the container 1400 and the reconfigurable partition puncture mechanism are moved toward each other from a non-puncture configuration to a puncture configuration, the puncture member 1300 can puncture the container puncture element 1455 and the puncture element, and the needle 1220 can exit the cavity and extend into the partition 1408 through the through-hole 1315 of the puncture member 1300.

[0154] It should be noted that the illustrations and descriptions of the embodiments and examples shown in the figures are for illustrative purposes only and should not be construed as limiting the disclosure. Those skilled in the art will understand that this disclosure intends to encompass a variety of embodiments. In addition, it should be understood that the above concepts may be used alone or in combination with any of the other embodiments and examples described above. Unless otherwise indicated, it should be further understood that the various alternative embodiments and examples described above relating to one embodiment are applicable to all embodiments and examples described herein.

[0155] Unless otherwise specified, each number and range should be interpreted as an approximation, as if preceded by the words “about,” “approximately,” or “substantially.” Unless otherwise specified, the terms “about,” “approximately,” and “substantially” can be understood to describe a range that is within 20 percent, 15 percent, 10 percent, or 5 percent of a given value.

[0156] The hypothetical language used herein, such as in particular "can," "could," "might," "may," and "e.g.," is generally intended to convey that certain features, elements, and / or steps are included in one embodiment and not in another, unless otherwise specifically stated or understood in the context in which they are used. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include, with or without the author's input or prompting, logic for determining whether these features, elements, and / or steps are included in or implemented in any particular embodiment. Terms such as "comprising," "including," and "having" are synonymous and used non-restrictively and comprehensively, without excluding additional elements, features, actions, or behaviors. Furthermore, when the term "or" is used, for example, to connect an enumeration of elements, it is used in its inclusive sense (and not its exclusive sense) to mean one, some, or all of the enumerated elements.

[0157] While certain exemplary embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of the invention disclosed herein. Therefore, nothing of the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is essential or indispensable. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications can be made in the forms of the methods and systems described herein without departing from the spirit of the invention disclosed herein. The appended claims and their equivalents are intended to cover such forms or modifications as being within the specific scope and spirit of the invention disclosed herein.

[0158] References to “a” or “one” in this specification to describe features such as components or steps will be understood not to exclude additional or numerous features. For example, a reference to a device having or defining “one” of features does not exclude the device having or defining two or more features, as long as the device has or defines at least one feature. Similarly, a reference to “one of” multiple features in this specification does not exclude the invention from including two or more, up to all, of the features. For example, a reference to a device having or defining “one of a projection and a recess” does not exclude the device having both a projection and a recess.

[0159] Aspects of this disclosure that form part of this specification:

[0160] Drug delivery system actuators 1. A drug delivery system, At least one curved track, A plunger having a flexible plunger rod, A driver configured to translate a plunger along at least one curved track, wherein the flexible plunger rod bends as it translates along at least one curved track into a drug container to drive liquid drug from the drug container to the patient, A flexible plunger rod is provided with at least one roller or bearing configured to guide the flexible plunger rod as it translates along at least one curved track, A drug delivery system equipped with the following features. 2. The drug delivery system according to claim 1, wherein the flexible plunger rod supports at least one roller or bearing such that at least one roller or bearing moves together with the flexible plunger rod along at least one curved track. 3. The drug delivery system according to claim 1, wherein the track supports at least one roller or bearing so that the plunger rod moves along at least one roller or bearing. 4. A drug delivery system according to any one of claims 1 to 3, wherein the flexible plunger rod has a first outer portion and a second outer portion that are opposite to each other, and at least one roller or bearing includes one or more rollers or bearings disposed on the first outer portion of the flexible plunger rod. 5. At least one roller or bearing may include one or more rollers or bearings positioned on the second outer portion of the flexible plunger rod. At least one track can contain a pair of tracks that are on opposite sides of each other. One or more rollers or bearings of the first outer part move along the first track of the track, and one or more rollers or bearings of the second outer part move along the second track of the track. The drug delivery system according to claim 4. 6. The drug delivery system according to claim 4, wherein the flexible plunger rod has a first outer portion and a second outer portion that are opposite to each other, and at least one roller or bearing is disposed between the first outer portion and the second outer portion. 7. A drug delivery system according to any one of claims 1 to 6, wherein the flexible plunger rod comprises a plurality of links pivotably connected to one another. 8. The drug delivery system according to claim 6, wherein each of at least one roller or bearing is supported by one of a plurality of links. 9. The drug delivery system according to any one of claims 1 to 6, wherein the flexible plunger rod comprises a flexible material that can bend as the plunger rod translates along at least one curved track. 10. A threaded rod configured to engage with the female thread of a plunger, A motor configured to rotate a threaded rod to translate a plunger along at least one track, A drug delivery system according to any one of claims 1 to 9, comprising: 11. A drug delivery system according to any one of claims 1 to 10, comprising a reinforcing structure configured to resist counteracting forces applied by a plunger in a curved portion defined by at least one curved track at a first end of the drug delivery system, and by a drug container and / or driver at a second end of the drug delivery system opposite to the first end. 12. The drug delivery system according to claim 11, wherein the reinforcing structure comprises a rigid plate. 13. The drug delivery system according to any one of claims 11 and 12, wherein the reinforcing structure defines at least one track. 14. A drug delivery system according to any one of claims 11 to 13, wherein the reinforcing structure has a first end that resists outward movement of at least one curved track at the first end of the drug delivery system along a selected direction, and a second end that resists outward movement of the drug container and / or driver at the second end of the drug delivery system along a direction opposite to the selected direction. 15. The drug delivery system according to claim 13, wherein at least one track is defined by an opening or recess extending within or through a reinforcing structure, the opening or recess being configured to receive at least one roller or bearing therein. 16. A drug delivery system according to any one of claims 1 to 15, comprising a drug container, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive a liquid drug from the container. 17. A drug delivery system according to any one of claims 1 to 16, wherein the force required to translate the seal within the drug container using a flexible plunger rod is configured not to be more than 30% greater than the force required to translate the seal within the container using a linear plunger rod. 18. A drug delivery system according to any one of claims 1 to 17, which is capable of driving a plunger seal inside a container with a force of at least 50 N. 19. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of a drug delivery system into a patient, A drug delivery system according to any one of claims 1 to 18, comprising: 20. A method of delivering a drug to a patient using a drug delivery system, Inserting a needle or cannula of the drug delivery system into the patient, A method for translating a flexible plunger rod of a drug delivery system along at least one curved track of the drug delivery system, wherein the flexible plunger rod bends as it translates along at least one curved track into a drug container of the drug delivery system, driving liquid drug from the drug container to the patient, and at least one roller or bearing of the drug delivery system guides the flexible plunger rod as it translates along at least one curved track. Methods that include... 21. The method according to claim 20, wherein the step of translating a flexible plunger rod supporting at least one roller or bearing includes advancing the at least one roller or bearing together with the flexible plunger rod along at least one curved track. 22. The method according to claim 20, wherein the step of translating the track supporting at least one roller or bearing includes advancing a plunger rod along at least one roller or bearing. 23. The method according to any one of claims 20 to 22, wherein the drug delivery system comprises a threaded rod configured to engage with a female thread of a plunger, and the method comprises rotating the threaded rod with a driver to translate the plunger along at least one track. 24. A drug delivery system, Curved track and A plunger having a flexible plunger rod, A driver configured to translate a plunger along a curved track, wherein the flexible plunger rod bends along the curved track and drives the plunger seal of a drug container to dispense liquid drug from the drug container, and Equipped with, A drug delivery system configured such that the force required by the driver to translate the plunger seal within the container using a flexible plunger rod does not exceed 30% greater than the force required to translate the plunger seal within the container using a linear plunger rod. 25. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is configured not to be more than 25% greater than the force required for translating the plunger seal within the container using a linear plunger rod. 26. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is configured not to be more than 20% greater than the force required for translating the plunger seal within the container using a linear plunger rod. 27. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is configured not to be more than 15% greater than the force required for the driver to translate the plunger seal within the container using a linear plunger rod. 28. A threaded rod configured to engage with the female thread of a plunger, A motor configured to rotate a threaded rod to translate a plunger along at least one track, A drug delivery system according to any one of claims 24 to 27, comprising: 29. A drug delivery system according to any one of claims 24 to 28, comprising a reinforcing structure configured to resist counteracting forces applied by a plunger in a curved portion defined by at least one curved track at a first end of the drug delivery system, and by a drug container and / or driver at a second end of the drug delivery system opposite to the first end. 30. The drug delivery system according to claim 29, wherein the reinforcing structure comprises a rigid plate. 31. The drug delivery system according to any one of claims 29 to 30, wherein the reinforcing structure has a first end that resists outward movement of at least one curved track at the first end of the drug delivery system along the direction of selection, and a second end that resists outward movement of the drug container and / or driver at the second end of the drug delivery system along the direction opposite to the direction of selection. 32. A drug delivery system according to any one of claims 24 to 31, comprising a drug container, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive a liquid drug from the container. 33. A drug delivery system according to any one of claims 24 to 32, which is capable of driving a plunger seal inside a container with a force of at least 50 N. 34. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of a drug delivery system into a patient, A drug delivery system according to any one of claims 24 to 33, comprising: 35. A drug delivery system, Curved track and A plunger having a flexible plunger rod, A driver configured to translate a plunger along a curved track, wherein the flexible plunger rod bends along the curved track and drives the plunger seal of a drug container to dispense liquid drug from the drug container, and Equipped with, A drug delivery system capable of driving a plunger seal inside a container with a force of at least 50N. 36. The drug delivery system according to claim 35, which is capable of driving a plunger seal inside a container with a force of at least 150 N. 37. The drug delivery system according to claim 35, which is capable of driving a plunger seal inside a container with a force of at least 200 N. 38. The drug delivery system according to claim 35, which is capable of driving a plunger seal inside a container with a force of at least 250 N. 39. The drug delivery system according to claim 35, which is capable of driving a plunger seal inside a container with a force of at least 300 N. 40. A threaded rod configured to engage with the female thread of a plunger, A motor configured to rotate a threaded rod to translate a plunger along at least one track, A drug delivery system according to any one of claims 35 to 39, comprising: 41. A drug delivery system according to any one of claims 35 to 40, comprising a reinforcing structure configured to resist counteracting forces applied by a plunger in a curved portion defined by at least one curved track at a first end of the drug delivery system, and by a drug container and / or driver at a second end of the drug delivery system opposite the first end. 42. The drug delivery system according to claim 41, wherein the reinforcing structure comprises a rigid plate. 43. A drug delivery system according to any one of claims 41 to 42, wherein the reinforcing structure has a first end that resists outward movement of at least one curved track at the first end of the drug delivery system along the direction of selection, and a second end that resists outward movement of the drug container and / or driver at the second end of the drug delivery system along the direction opposite to the direction of selection. 44. A drug delivery system according to any one of claims 35 to 43, comprising a drug container, the drug container being a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger being configured to engage with the seal to drive a liquid drug from the container. 45. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of a drug delivery system into a patient, A drug delivery system according to any one of claims 40 to 44, comprising: 46. ​​A method of delivering a drug to a patient using a drug delivery system, Inserting a needle or cannula of the drug delivery system into the patient, The invention involves translating a flexible plunger rod of a drug delivery system along at least one curved track of the drug delivery system, wherein the flexible plunger rod bends as it translates along at least one curved track into the drug container of the drug delivery system, thereby driving the liquid drug out of the drug container with a force of at least 50 N. Methods that include... 47. The method according to claim 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 150 N. 48. The method according to claim 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 200 N. 49. The method according to claim 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 250 N. 50. The method according to claim 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 300 N. 51. The method according to any one of claims 46 to 50, wherein the drug delivery system comprises a threaded rod configured to engage with a female thread of a plunger, and the method comprises rotating the threaded rod with a driver to translate the plunger along at least one track.

[0161] Septal puncture assembly 1. A drug delivery system, Curved track and A plunger having a flexible plunger rod and a plunger end, Septal puncture needle, A driver configured to translate a plunger along a curved track, wherein the flexible plunger rod bends while translating along the curved track, and the plunger is adapted to translate the drug container from a pre-puncture position where the partition of the drug container is not punctured by the partition puncture needle to a puncture position where the partition of the drug container is punctured by the partition puncture needle, A drug delivery system equipped with the following features. 2. The drug delivery system according to claim 1, wherein the plunger end is configured to engage with the seal of the drug container and to translate the drug container from the pre-puncture position to the puncture position. 3. A drug delivery system according to any one of claims 1 to 2, wherein when the drug container is at the puncture site, the movement of the flexible plunger rod causes the seal of the drug container to move within the drug container, thereby delivering the drug. 4. The drug delivery system according to any one of claims 1 to 3, further comprising a biasing assembly configured to move the drug container from the puncture position to a removal position in which the septum puncture needle is removed from the drug container. 5. The drug delivery system according to any one of claims 1 to 4, further comprising a sensor configured to detect when the drug container has been moved to the puncture site. 6. The drug delivery system according to claim 5, further comprising a controller that controls drug delivery based on a sensor that detects when the drug container has been moved to the puncture site where drug delivery begins. 7. Equipped with an additional controller, A drug delivery system according to any one of claims 1 to 5, wherein when the drug container is at the puncture site, the controller controls the driver to translate the plunger along a curved track, thereby moving the plunger end a predetermined distance. 8. The drug delivery system according to claim 7, wherein the amount of drug delivered via a septal puncture needle is based on a predetermined distance. 9. A drug delivery system, Curved track and A plunger having a flexible plunger rod and a plunger end, A partition puncture needle, which is separated from the plunger end and configured to puncture the partition of the drug container, A driver configured to translate a plunger along a curved track in the direction of drive, wherein the flexible plunger rod bends along the curved track, drives the seal of a drug container to discharge liquid drug from the drug container, and after the discharge of liquid drug from the drug container is complete, the driver translates away from the seal in the opposite direction to the direction of drive. Equipped with, A drug delivery system in which, as the plunger translates along the reverse direction, the drug container moves away from the septum puncture needle, thereby releasing the septum. 10. The drug delivery system according to claim 9, further comprising a biasing assembly configured to translate the drug container in the reverse direction so that the septum puncture needle de-punctures the septum. 11. The drug delivery system according to claim 10, wherein the biasing assembly comprises a needle shield, the needle shield being configured to house the tip of the septal puncture needle in a detachable position when the drug container is translated in the reverse direction. 12. The drug delivery system according to any one of claims 10 to 11, wherein the biasing assembly includes a biasing member, the biasing member configured to cause the drug container to translate in the opposite direction when the plunger translates along the opposite direction. 13. The plunger, including the plunger end, is configured to pull the drug container in the reverse direction. A drug delivery system according to any one of claims 9 to 12, wherein when the plunger translates along the reverse direction, the plunger is configured to move the drug container away from the septum puncture needle and thereby de-puncture the septum. 14. The drug delivery system according to any one of claims 9 to 13, wherein the plunger is adapted to translate the drug container in the driving direction from a pre-puncture position where the partition of the drug container is not punctured by the partition puncture needle to a puncture position where the partition is punctured by the partition puncture needle. 15. The drug delivery system according to any one of claims 9 to 14, wherein the flexible plunger rod is translationally movable between a disengaged position in which the plunger end does not engage with the drug container and an engaged position in which the plunger end engages with the drug container. 16. The drug delivery system according to any one of claims 9 to 15, wherein the driving direction and the reverse direction are relative to a housing supporting a septum puncture needle in a stationary position. 17. A drug delivery system according to any one of claims 9 to 16, further comprising at least one roller or bearing positioned along a curved track and configured to guide the flexible plunger rod as it translates along the curved track. 18. A drug delivery system according to any one of claims 9 to 17, further comprising a reinforcing structure configured to resist opposing forces applied by a plunger in a curved section defined by a curved track at a first end of the drug delivery system, and by a drug container or driver at a second end of the drug delivery system. 19. A drug delivery system, Curved track and A plunger having a flexible plunger rod and a plunger end, A driver configured to translate a plunger along a curved track in the direction of drive, wherein the flexible plunger rod bends along the curved track and drives the seal of a drug container to discharge liquid drug from the drug container, and A partition puncture needle, which is separated from the plunger end and configured to puncture the partition of the drug container, A needle shield, configured to move between a shielding position where the needle shield extends beyond the tip of a partition puncture needle and an exposed position where the tip of the partition puncture needle is exposed, allowing the partition puncture needle to puncture the partition of a drug container; A drug delivery system equipped with the following features. 20. The drug delivery system according to claim 19, wherein the needle shield is configured to move from an exposed position to a shielded position after the partition puncture needle has been removed from the partition of the drug container. 21. The drug delivery system according to claim 20, further comprising a biasing member that biases the needle shield from an exposed position to a shielded position when the plunger moves away from the seal and translates along a curved track in a reverse direction opposite to the driving direction. 22. The drug delivery system according to claim 19, wherein the needle shield moves between an exposed position and a shielded position relative to the housing supporting the partition puncture needle in a stationary position. 23. A method, A plunger having a flexible plunger rod and a plunger end is driven along a curved track, wherein the plunger and the curved track are located inside the housing. The plunger is arranged to interact with the drug container located inside the housing. The housing has a partition puncture needle. To drive, The plunger end pushes the drug container in, thereby moving the drug container toward the septum puncture needle in the driving direction, Based on driving the plunger in the driving direction, the partition of the drug container is punctured with a partition puncture needle, Based on driving the plunger in the opposite direction to the driving direction, the puncture of the septum of the drug container by the septum puncture needle is released, Methods that include... 24. The method according to claim 23, wherein the driving direction and the reverse direction are relative to the housing supporting the septum puncture needle in a stationary position. twenty five. The method according to any one of claims 23 and 24, further comprising moving the needle shield between a shielding position in which the needle shield extends beyond the tip of the septum puncture needle and an exposed position in which the tip of the septum puncture needle is exposed, allowing the septum puncture needle to puncture the septum of the drug container. 26. The method according to any one of claims 23 to 25, wherein the needle shield is configured to move from an exposed position to a shielded position after the partition puncture needle has been removed from the partition of the drug container. 27. The method according to claim 26, further comprising biasing the needle shield from an exposed position to a shielded position as the plunger translates along the curved track in the opposite direction. 28. The method according to any one of claims 23 to 27, further comprising providing an opening in the housing for receiving a drug container inside the housing and for removing the drug container from the housing.

[0162] Possibility of replacing the medication container while in use 1. A drug delivery system, A housing having an opening defined within it, the opening configured to receive a drug container inside the housing, Curved track and A plunger having a flexible plunger rod and a plunger end, A driver configured to move a plunger along a curved track, wherein the flexible plunger rod bends as it moves along the curved track, and the plunger end drives the plunger seal of a drug container to discharge liquid drug from the drug container, and A partition puncture needle configured to puncture the partition of a drug container, wherein the plunger end is separated from the partition puncture needle when the plunger is in the pre-use position, defining a space between the plunger end and the partition puncture needle, and the space is configured to receive the drug container when the drug container is received into the housing through the opening, and A drug delivery system equipped with the following features. 2. The drug delivery system according to claim 1, wherein the flexible plunger rod is configured such that the plunger end is positioned outside the drug container when the plunger is in the pre-use position. 3. The drug delivery system according to any one of claims 1 to 2, wherein the flexible plunger rod is configured to move the plunger end away from the outside of the drug container when the plunger is in the pre-use position and to engage with the drug container when the plunger is in the engagement position. 4. The drug delivery system according to any one of claims 1 to 3, wherein the plunger end is configured to engage with the seal of the drug container in the engagement position. 5. The drug delivery system according to any one of claims 1 to 4, wherein the plunger end is configured to be positioned inside the drug container so as to engage with the seal of the drug container at the engagement position. 6. The drug delivery system according to any one of claims 1 to 5, wherein the plunger end is configured to engage with a seal, which is a plug seal, in the engagement position. 7. The drug delivery system according to claim 1, further comprising a control circuit configured to receive data from a short-range wireless communication tag or RFID tag on a drug container via a reader, and configured to control a driver based on the data. 8. A drug delivery system, Curved track and A plunger having a flexible plunger rod and a plunger end, A driver configured to move a plunger along a curved track, wherein the flexible plunger rod bends as it moves along the curved track, and the plunger end drives the plunger seal of a drug container to discharge a liquid drug from the drug container, comprising: The flexible plunger rod is translationally movable between a disengaged position in which the plunger end does not engage with the drug container and an engaged position in which the plunger end engages with the drug container. Drug delivery system. 9. The drug delivery system according to claim 8, wherein in the disengaged position, the plunger end is positioned outside the drug container. 10. The drug delivery system according to any one of claims 8 to 9, wherein, at the engagement position, the plunger end is positioned inside the drug container. 11. A drug delivery system, A housing having an opening defined within its interior, the opening configured to receive a first drug container and a second drug container within the housing, the first drug container containing a first liquid drug, and the second drug container containing a second liquid drug, Control circuit and Curved track and A plunger having a flexible plunger rod and a plunger end, A driver configured to translate a plunger along a curved track, wherein the flexible plunger rod bends while translating along the curved track, and Equipped with, The opening is configured to removably receive the first drug container, and the control circuit is configured to drive the plunger end to the driver, thereby driving the plunger seal of the first drug container and discharging the first liquid drug from the first drug container. The opening is configured to removably receive a second drug container, and the control circuit is configured to drive a driver to operate the plunger end, thereby driving the plunger seal of the second drug container and discharging the second liquid drug from the second drug container. Drug delivery system. 12. The drug delivery system according to claim 11, wherein a first amount of a first liquid drug dispensed from a first drug container is different from a second amount of a second liquid drug dispensed from a second drug container. 13. The drug delivery system according to any one of claims 11 and 12, wherein the first liquid drug is the same as the second liquid drug. 14. A drug delivery system according to any one of claims 11 and 12, wherein the first liquid drug is different from the second liquid drug. 15. A drug delivery system according to any one of claims 11, 12, and 14, wherein the first viscosity of the first liquid drug in the first drug container is different from the second viscosity of the second liquid drug in the second drug container. 16. A drug delivery system according to any one of claims 11 and 12, wherein the first volumetric capacity of the first drug container is different from the second volumetric capacity of the second drug container. 17. The drug delivery system according to any one of claims 11 and 12, wherein the control circuit is configured to cause a driver to drive a plunger with a first driving force when a first drug container is received in space, and with a second driving force different from the first driving force when a second drug container is received in space. 18. The control circuit is configured to drive a plunger to a driver, which in turn drives the plunger seal of the first drug container, causing the first liquid drug to be discharged from the first drug container at a first flow rate. The control circuit is configured to drive a plunger to a driver, which in turn drives the plunger seal of the second drug container, causing the second liquid drug to be discharged from the second drug container at a second flow rate different from the first flow rate. A drug delivery system according to any one of claims 11, 12, and 17. 19. A drug delivery system according to any one of claims 11, 12, 17, and 18, wherein the control circuit is configured to cause a driver to drive a plunger based on at least one of first data received from a first short-range wireless communication tag or a first RFID tag of a first drug container, or second data received from a second short-range wireless communication tag or a second RFID tag of a second drug container. 20. The first data identifies at least one of the following: the amount of the first liquid to be discharged, the flow rate at which the first liquid is discharged, the viscosity of the first liquid, or the driving force that drives the plunger to discharge the first liquid, or The drug delivery system according to any one of claims 11, 12, and 17-19, wherein the second data identifies at least one of the following: the amount of a second liquid to be discharged, the flow rate for discharging the second liquid, the viscosity of the second liquid, or the driving force for driving the plunger to discharge the second liquid. 21. The drug delivery system according to claim 11, wherein the removal of a first drug container and a second drug container in a space includes the non-destructive removal of the first drug container and the second drug container. 22. A drug delivery system according to any one of claims 11 and 21, wherein the removal of a first drug container and a second drug container within a space includes tool-free removal of the first drug container and the second drug container. 23. A method, The drug delivery system involves receiving a drug container into the space of the housing through an opening in the housing, the space being defined between the septum puncture needle of the drug delivery system and the plunger end of the plunger of the drug delivery system, and the septum puncture needle being configured to puncture the septum of the drug container. A plunger having a flexible plunger rod and a plunger end is driven along a curved track, the plunger engaging with a drug container located in the space inside the housing, and the drive is performed. The act of driving a plunger involves a flexible plunger rod bending as it translates along a curved track, causing the plunger end to drive the plunger seal of the drug container, thereby discharging liquid drug from the drug container. Methods that include... 24. The method according to claim 23, wherein the receiving step includes receiving a drug container into the space such that the plunger is in a pre-use position where the plunger end does not engage with the plunger seal. 25. The method according to any one of claims 23 to 24, further comprising moving the plunger from a pre-use position where the plunger end is not engaged with the plunger seal to an engagement position where the plunger engages with the plunger seal of the drug container. 26. After dispensing the liquid drug from the drug container, the plunger is returned to its pre-use position by separating the plunger end from the plunger seal. After the drug container is removed, a second drug container is received into the housing space through the opening, The method according to claim 23, further comprising: 27. The method according to claim 26, further comprising driving a plunger such that a flexible plunger rod bends while translating along a curved track, and the plunger end drives a plunger seal of a second drug container to discharge a second liquid drug from the second drug container. 28. The method according to any one of claims 26 to 27, wherein driving the plunger seal of a drug container includes discharging a first amount of liquid drug from the drug container, and driving the plunger seal of a second drug container includes discharging a second amount of a second liquid drug, which is different from the first amount, from the second drug container. 29. The method according to any one of claims 26 to 28, wherein driving the plunger seal of a drug container includes discharging a liquid drug from a drug container having a first volumetric capacity, and driving the plunger seal of a second drug container includes discharging a second liquid drug from a second drug container having a second volumetric capacity different from that of the first volumetric capacity. 30. The method according to any one of claims 26 to 29, wherein driving the plunger seal of a drug container causes the same liquid drug to be discharged as the second liquid drug discharged by driving the plunger seal of a second drug container. 31. The method according to any one of claims 26 to 29, wherein driving the plunger seal of a drug container causes to discharge a liquid drug different from the second liquid drug discharged by driving the plunger seal of a second drug container. 32. The method according to any one of claims 26 to 29 and 31, wherein driving the plunger seal of a drug container includes discharging a liquid drug having a first viscosity, and driving the plunger seal of a second drug container includes discharging a second liquid drug having a second viscosity different from the first viscosity. 33. When the drug container is received in space, the plunger is driven by a first driving force, When the second drug container is received in space, the plunger is driven by a second driving force different from the first driving force, The method according to any one of claims 26 to 32, further comprising: 34. The plunger is driven to activate the plunger seal of the drug container, causing the liquid drug to be discharged from the drug container at a first flow rate. The plunger is driven to drive the plunger seal of the second drug container, causing the second liquid drug to be discharged from the second drug container at a second flow rate different from the first flow rate, The method according to any one of claims 26 to 33, further comprising: 35. Before receiving the drug container into the housing space, move the plunger end of the plunger away from the partition puncture needle in the pre-use position. The method according to any one of claims 24 to 34, further comprising:

[0163] Sterilization barrier 1. A drug delivery system, It is a container, A container body configured to hold a liquid drug inside, having a container end inside that defines the container opening, A partition configured to seal the container opening, A first punctureable element, which, when the drug delivery system is in a non-puncture configuration, defines a first cavity between the first punctureable element and the septum, and is separated from the septum to reduce or substantially prevent the entry of bacteria into the first cavity; A puncture member that defines a through-hole through the interior, and which is positioned in a first cavity when the drug delivery system is in a non-puncture configuration. A container including, A septal puncture assembly, needle support, A second punctureable element, which, when the drug delivery system is in a non-puncture configuration, defines a second cavity between the second punctureable element and the needle support, thereby reducing or substantially preventing the entry of bacteria into the second cavity, and A needle supported by a needle support within a second cavity when the drug delivery system is in a non-puncture configuration. A septal puncture assembly, Equipped with, A drug delivery system in which, when a container and a septum puncture assembly are moved toward each other from a non-puncture configuration to a puncture configuration, a puncture member punctures a first punctureable element and a second punctureable element, and the needle is received into the septum through a through-hole in the puncture member. 2. The drug delivery system according to claim 1, wherein the first cavity and the second cavity are sterile chambers. 3. The drug delivery system according to either claim 1 or 2, wherein when the drug delivery system moves from the puncture configuration to the post-puncture configuration, the first punctureable element and the second punctureable element are configured to close when the puncture member is removed. 4. The drug delivery system according to any one of claims 1 to 3, wherein the first punctureable element and the second punctureable element are formed from an elastomer material. 5. The drug delivery system according to any one of claims 1 to 4, wherein the first punctureable element and the second punctureable element are formed from a rubber or silicone material. 6. A drug delivery system according to any one of claims 1 to 5, wherein, after delivery of a liquid drug, the drug delivery system in a puncture configuration is configured to move to a post-puncture configuration which is identical to the non-puncture configuration except that the amount of liquid drug in the container has decreased. 7. The drug delivery system according to any one of claims 1 to 6, wherein at least one of the first punctureable element and the second punctureable element includes a notch or slit at the contact position of the puncture member. 8. The drug delivery system according to any one of claims 1 to 7, further comprising a sliding member slidably supported within a cavity assembly of a container forming a first cavity. 9. The drug delivery system according to any one of claims 1 to 8, wherein the first punctureable element covers the aperture of the sliding member. 10. A drug delivery system according to any one of claims 1 to 9, wherein a first cavity is formed between a puncture member, the inner wall of a cavity assembly, the inner wall of a sliding member, and the inner wall of a first punctureable element. 11. The drug delivery system according to any one of claims 1 to 10, wherein the sliding member is configured to slide toward the septum within the cavity assembly, based on the fact that a portion of the septum puncture assembly is received within the cavity assembly and comes into contact with the sliding member when the drug delivery system moves from a non-puncture configuration to a puncture configuration. 12. The drug delivery system according to any one of claims 1 to 11, wherein when the drug delivery system is in a puncture configuration, the puncture member is punctured through a first punctureable element and a second punctureable element covering the aperture of a sliding member. 13. The drug delivery system according to any one of claims 1 to 12, wherein when the drug delivery system is in a puncture configuration, the needle passes through a first punctureable element, an aperture of a sliding member, and a second punctureable element, and extends through a through hole along the length of the puncture member. 14. The drug delivery system according to any one of claims 1 to 13, wherein when the drug delivery system moves from a non-puncture configuration to a puncture configuration, the tip of the needle moves from the second cavity through the first punctureable element and the through-hole of the puncture member that punctures the second punctureable element, through the first cavity, and punctures the septum. 15. A drug delivery system according to any one of claims 1 to 7, wherein a first punctureable element covers the opening of a cavity assembly of a container forming a first cavity, and the first punctureable element is attached to the cavity assembly at a fixed mounting portion of the first punctureable element. 16. The drug delivery system according to any one of claims 1 to 7 and 15, wherein the first pierceable element is configured to deflect without displacement from the fixed attachment portion when the septum piercing assembly contacts the first pierceable element. 17. The drug delivery system according to any one of claims 1 to 7, 15 and 16, wherein the drug delivery system is configured to move from a non-piercing configuration to a piercing configuration based on the deflection of the first pierceable element and the movement of the container and the septum piercing assembly towards each other. 18. The drug delivery system according to any one of claims 1 to 7 and 15 to 17, wherein when the drug delivery system is in the piercing configuration, the piercing member is pierced through the deflected first pierceable element and the second pierceable element. 19. The drug delivery system according to any one of claims 1 to 7 and 15 to 18, wherein the first pierceable element is deflected and extended inwardly into the cavity assembly when the container and the septum piercing assembly move towards each other, thereby reducing the volume of the first cavity. 20. A drug delivery system, A container, A container body configured to contain a liquid drug therein, having a container end portion that defines a container opening therein, and A septum configured to seal the container opening A container including A resetable septum piercing mechanism, A needle support, A pierceable element that defines a cavity between the pierceable element and the needle support when the drug delivery system is in the non-piercing configuration, and is spaced apart from the needle support so as to reduce or substantially prevent the entry of contaminants into the cavity, A needle supported by the needle support within the cavity when the drug delivery system is in the non-piercing configuration, A biasing member, and A piercing member that defines a through hole therethrough A resetable septum piercing mechanism including Comprising, When the container and the needle are moved toward each other from a non-puncturing configuration to a puncturing configuration, the puncturing member punctures the puncturable element, and the needle exits the cavity and extends into the partition through the through-hole of the puncturing member. When the container and the reconfigurable partition puncturing mechanism are moved away from each other from a puncturing configuration to a non-puncturing configuration, the biasing member moves at least one of the puncturable element or the needle support away from the other, and the needle is returned to the cavity. A drug delivery system configured as described above. 21. The drug delivery system according to claim 20, wherein the puncturing member is disposed within the cavity when the drug delivery system is in a non-puncturing configuration. 22. The drug delivery system according to any one of claims 20 and 21, wherein the needle is disposed within the through-hole of the puncturing member when the drug delivery system is in a non-puncturing configuration. 23. Further comprising a container puncturable element, wherein the container puncturable element defines a container cavity between the container puncturable element and the partition when the drug delivery system is in a non-puncturing configuration, and is spaced apart from the partition so as to reduce or substantially prevent the intrusion of contaminants into the container cavity. The drug delivery system according to claim 20. 24. The drug delivery system according to any one of claims 20 and 23, wherein the puncturing member is disposed within the container when the drug delivery system is in a non-puncturing configuration. 25. When the container and the reconfigurable partition puncturing mechanism are moved toward each other from a non-puncturing configuration to a puncturing configuration, the puncturing member is configured to puncture the container puncturable element and the puncturable element, and the needle exits the cavity and extends into the partition through the through-hole of the puncturing member. The drug delivery system according to any one of claims 20, 23, and 24. 26. The drug delivery system according to claim 20, further comprising a drive mechanism configured to contact the container and move the container toward the reconfigurable partition puncturing assembly. 27. The drug delivery system according to claim 20, wherein the drive mechanism pulls the plunger rod out of the container and the container is moved to a post-puncture configuration. 28. The drug delivery system according to claim 20, wherein the biasing member is configured to move at least one of the punctureable element or the needle support to return at least one of the punctureable element or the needle support from the puncture configuration to the post-puncture configuration. 29. A drug delivery system according to any one of claims 20 to 28, wherein the cavity is a sterile chamber. 30. A drug delivery system according to any one of claims 20 to 29, wherein the punctureable elements are configured to close when the puncture member is removed, when the container and the resettable septum puncture assembly are moved away from each other. 31. The drug delivery system according to any one of claims 20 to 30, wherein the punctureable element includes a notch or slit at the contact position of the puncture member. 32. A method for operating a drug delivery system comprising a drug container and a septum puncture assembly, wherein the drug container comprises a septum, a first punctureable element separated from the septum to define a first cavity, and a puncture member disposed within the first cavity, the first punctureable element reducing or substantially preventing the entry of bacteria into the first cavity; the septum puncture assembly comprises a needle support, a second punctureable element separated from the needle support to define a second cavity, and a needle supported by the needle support within the second cavity, the second punctureable element reducing or substantially preventing the entry of bacteria into the second cavity; the method is, The step of moving the drug container and the septum puncture assembly toward each other from a non-puncture configuration to a puncture configuration is as follows: The puncture member is used to puncture the first punctureable element and the second punctureable element, Extending the needle through the through-hole of the puncture member, Methods that include... 33. The moving step involves puncturing the septum with a needle that extends through the through hole, The puncture member punctures the first punctureable element and the second punctureable element, and while the needle is positioned within the through-hole, the liquid drug placed in the drug container is delivered via the needle. The method according to claim 32, including the method described in claim 32. 34. The method according to any one of claims 32 and 33, further comprising moving the drug container and the septum puncture assembly away from each other from the non-puncture configuration to a post-puncture configuration which is identical to the non-puncture configuration except that the amount of liquid drug in the drug container has decreased. 35. The method according to any one of claims 32 to 34, wherein the drug container is removed and discarded when the drug container is in a post-puncture configuration and is replaceable with a second drug container in a non-puncture configuration. 36. The method according to any one of claims 32 to 35, wherein the first cavity and the second cavity are sterilization chambers. 37. The method according to any one of claims 32 to 36, wherein the drug container and the partition puncture assembly are moved away from each other, and the puncture member is removed, causing the first punctureable element and the second punctureable element to close. 38. The method according to any one of claims 32 to 37, wherein at least one of the first punctureable element and the second punctureable element includes a cut line or slit at the contact position of the puncture member. 39. A method for operating a drug delivery system, the drug delivery system comprising a container, a resettable partition puncture mechanism, a biasing member, and a puncture member that defines a through-hole through the interior, The container comprises a container body configured to hold a liquid drug inside, the container body having a container end that defines a container opening inside, and the container further comprises a partition configured to seal the container opening. The resettable septal puncture mechanism comprises a needle support, a punctureable element separated from the needle support to define a cavity between the punctureable element and the needle support when the drug delivery system is in a non-puncture configuration, thereby reducing or substantially preventing the entry of contaminants into the cavity, and a needle supported by the needle support within the cavity when the drug delivery system is in a non-puncture configuration. The method is, Moving a container and a reconfigurable partition puncture mechanism toward each other from a non-puncture configuration to a puncture configuration, wherein the puncture member punctures a punctureable element, and the needle exits the cavity, passes through the through-hole of the puncture member, and extends into the partition. A method for moving a container and a resettable septum puncture mechanism away from each other from a puncture configuration to a non-puncture configuration, wherein a biasing member moves at least one of the punctureable element or needle support away from the other, so that the needle is returned to the cavity. 40. The method according to claim 39, wherein when the drug delivery system is in a non-puncture configuration, the puncture member is positioned within the cavity. 41. The method according to either claim 39 or 40, wherein when the drug delivery system is in a non-puncture configuration, the needle is positioned within a through-hole of the puncture member. 42. The method according to claim 39, wherein the drug delivery system further comprises a container puncture element, the container puncture element being separated from a partition to define a container cavity between the container puncture element and the partition when the drug delivery system is in a non-puncture configuration, thereby reducing or substantially preventing the entry of bacteria into the container cavity. 43. The drug delivery system according to any one of claims 39 and 42, wherein when the drug delivery system is in a non-puncture configuration, a puncture member is placed inside the container. 44. A drug delivery system according to any one of claims 39, 42, and 43, wherein when the container and the resettable septum puncture mechanism are moved toward each other from a non-puncture configuration to a puncture configuration, a puncture member punctures the container puncture element and the puncture element, and the needle exits the cavity and extends into the septum through a through-hole of the puncture member.

Claims

1. A drug delivery system, It is a container, A container body configured to hold a liquid drug inside, having a container end that defines a container opening inside, A partition wall configured to seal the opening of the container, A first punctureable element, which, when the drug delivery system is in a non-puncture configuration, defines a first cavity between the first punctureable element and the partition, and is separated from the partition to reduce or substantially prevent the entry of bacteria into the first cavity; A puncture member, which defines a through-hole through its interior, and is positioned within the first cavity when the drug delivery system is in the non-puncture configuration. A container including, A septal puncture assembly, needle support, A second punctureable element, which, when the drug delivery system is in the non-puncture configuration, defines a second cavity between the second punctureable element and the needle support, thereby reducing or substantially preventing the entry of bacteria into the second cavity, and When the drug delivery system is in the non-puncture configuration, the needle is supported by the needle support within the second cavity. A septal puncture assembly, Equipped with, A drug delivery system wherein, when the container and the partition puncture assembly are moved toward each other from the non-puncture configuration to the puncture configuration, the puncture member is configured to puncture the first punctureable element and the second punctureable element, and the needle is received into the partition through the through-hole of the puncture member.

2. The drug delivery system according to claim 1, wherein the first cavity and the second cavity are sterilization chambers.

3. The drug delivery system according to any one of claims 1 and 2, wherein the first punctureable element and the second punctureable element are configured to close when the puncture member is removed, when the drug delivery system moves from the puncture configuration to the post-puncture configuration.

4. The drug delivery system according to any one of claims 1 to 3, wherein the first punctureable element and the second punctureable element are formed from an elastomer material.

5. The drug delivery system according to any one of claims 1 to 4, wherein the first punctureable element and the second punctureable element are formed from a rubber or silicone material.

6. The drug delivery system according to any one of claims 1 to 5, wherein, after the delivery of the liquid drug, the drug delivery system in the puncture configuration is configured to move to a post-puncture configuration which is identical to the non-puncture configuration except that the amount of liquid drug in the container has decreased.

7. The drug delivery system according to any one of claims 1 to 6, wherein at least one of the first punctureable element and the second punctureable element includes a notch or slit at the contact position of the puncture member.

8. The drug delivery system according to any one of claims 1 to 7, further comprising a sliding member slidably supported within the cavity assembly of the container forming the first cavity.

9. The drug delivery system according to any one of claims 1 to 8, wherein the first punctureable element covers the aperture of the sliding member.

10. The drug delivery system according to any one of claims 1 to 9, wherein the first cavity is formed between the puncture member, the inner wall of the cavity assembly, the inner wall of the sliding member, and the inner wall of the first punctureable element.

11. The drug delivery system according to any one of claims 1 to 10, wherein the sliding member is configured to slide toward the partition within the cavity assembly, based on the fact that a portion of the partition puncture assembly is received within the cavity assembly and comes into contact with the sliding member when the drug delivery system moves from the non-puncture configuration to the puncture configuration.

12. The drug delivery system according to any one of claims 1 to 11, wherein when the drug delivery system is in the puncture configuration, the puncture member is punctured through the first punctureable element and the second punctureable element covering the aperture of the sliding member.

13. The drug delivery system according to any one of claims 1 to 12, wherein when the drug delivery system is in the puncture configuration, the needle passes through the first punctureable element, the aperture of the sliding member and the second punctureable element, and extends through the through hole along the length of the puncture member.

14. The drug delivery system according to any one of claims 1 to 13, wherein when the drug delivery system moves from the non-puncture configuration to the puncture configuration, the tip of the needle moves from the second cavity, through the first punctureable element and the through hole of the puncture member that punctures the second punctureable element, through the first cavity, and punctures the partition wall.

15. A drug delivery system according to any one of claims 1 to 7, wherein the first punctureable element covers an opening of the cavity assembly of the container forming the first cavity, and the first punctureable element is attached to the cavity assembly at a fixed mounting portion of the first punctureable element.

16. The drug delivery system according to any one of claims 1 to 7 and 15, wherein the first punctureable element is configured to deflect without displacement from the fixed mounting portion when the septum puncture assembly comes into contact with the first punctureable element.

17. The drug delivery system according to any one of claims 1 to 7, 15, and 16, wherein the drug delivery system is configured to move from the non-puncture configuration to the puncture configuration based on the deflection of the first punctureable element causing the container and the partition puncture assembly to move toward each other.

18. The drug delivery system according to any one of claims 1 to 7 and 15 to 17, wherein when the drug delivery system is in the puncture configuration, the puncture member is punctured through the deflected first punctureable element and the second punctureable element.

19. A drug delivery system according to any one of claims 1 to 7 and 15 to 18, wherein as the container and the partition puncture assembly move toward each other, the first punctureable element is deflected and extended inward toward the inside of the cavity assembly, thereby reducing the volume of the first cavity.

20. A drug delivery system, It is a container, A container body configured to hold a liquid drug inside, having a container end that defines a container opening inside, and Partition configured to seal the opening of the container A container including, A resettable septal puncture mechanism, needle support, A punctureable element, which, when the drug delivery system is in a non-puncture configuration, defines a cavity between the punctureable element and the needle support, and is separated from the needle support to reduce or substantially prevent the entry of bacteria into the cavity, When the drug delivery system is in the non-puncture configuration, the needle is supported by the needle support within the cavity. biasing member, and A puncture member that defines a through-hole through the interior. A resettable septum puncture mechanism, Equipped with, When the container and the needle are moved toward each other from the non-puncturing configuration to the puncturing configuration, the puncturing member punctures the puncturable element, the needle exits the cavity and extends through the through-hole of the puncturing member into the partition wall, When the container and the resettable partition puncture mechanism are moved away from each other from the puncture configuration to the non-puncture configuration, the biasing member moves at least one of the punctureable element or the needle support away from the other, returning the needle to the cavity. A drug delivery system configured in such a way.

21. The drug delivery system according to claim 20, wherein when the drug delivery system is in the non-puncture configuration, the puncture member is arranged in the cavity.

22. The drug delivery system according to any one of claims 20 and 21, wherein when the drug delivery system is in the non-puncture configuration, the needle is positioned in the through-hole of the puncture member.

23. The drug delivery system according to claim 20, further comprising a container puncture element, wherein the container puncture element is separated from the partition to define a container cavity between the container puncture element and the partition when the drug delivery system is in the non-puncture configuration, thereby reducing or substantially preventing the entry of bacteria into the container cavity.

24. The drug delivery system according to any one of claims 20 and 23, wherein when the drug delivery system is in the non-puncture configuration, the puncture member is placed inside the container.

25. The drug delivery system according to any one of claims 20, 23, and 24, wherein when the container and the resettable partition puncture mechanism are moved toward each other from the non-puncture configuration to the puncture configuration, the puncture member punctures the container puncture element and the puncture element, and the needle exits the cavity and extends into the partition through the through-hole of the puncture member.

26. The drug delivery system according to claim 20, further comprising a drive mechanism configured to contact the container and move the container toward the resettable partition puncture assembly.

27. The drug delivery system according to claim 20, wherein the drive mechanism withdraws the plunger rod from the container and the container is moved to a post-puncture configuration.

28. The drug delivery system according to claim 20, wherein the biasing member is configured to move at least one of the punctureable element or the needle support to return at least one of the punctureable element or the needle support from the puncture configuration to the post-puncture configuration.

29. The drug delivery system according to any one of claims 20 to 28, wherein the cavity is a sterilization chamber.

30. A drug delivery system according to any one of claims 20 to 29, wherein the punctureable elements are configured to close when the puncture member is removed, as the container and the resettable partition puncture assembly are moved away from each other.

31. The drug delivery system according to any one of claims 20 to 30, wherein the punctureable element includes a notch or slit at the contact position of the puncture member.

32. A method for operating a drug delivery system comprising a drug container and a septum puncture assembly, wherein the drug container comprises a septum, a first punctureable element separated from the septum to define a first cavity, and a puncture member disposed within the first cavity, wherein the first punctureable element reduces or substantially prevents the entry of bacteria into the first cavity; the septum puncture assembly comprises a needle support, a second punctureable element separated from the needle support to define a second cavity, and a needle supported by the needle support within the second cavity, wherein the second punctureable element reduces or substantially prevents the entry of bacteria into the second cavity; and the method is as follows: The step of moving the drug container and the partition puncture assembly toward each other from a non-puncture configuration to a puncture configuration is: The puncture member is used to puncture the first punctureable element and the second punctureable element, The needle extends through the through hole of the puncture member, Methods that include...

33. The aforementioned step of moving, The needle extending through the through-hole punctures the partition wall, The puncture member punctures the first punctureable element and the second punctureable element, and while the needle is positioned within the through-hole, the liquid drug placed in the drug container is delivered via the needle. The method according to claim 32, including the method described in claim 32.

34. The method according to any one of claims 32 and 33, further comprising moving the drug container and the partition puncture assembly away from each other from the non-puncture configuration to a post-puncture configuration which is identical to the non-puncture configuration except that the amount of liquid drug in the drug container has decreased.

35. The method according to any one of claims 32 to 34, wherein the drug container is removed and discarded when the drug container is in the post-puncture configuration and is interchangeable with a second drug container in the non-puncture configuration.

36. The method according to any one of claims 32 to 35, wherein the first cavity and the second cavity are sterilization chambers.

37. The method according to any one of claims 32 to 36, wherein the drug container and the partition puncture assembly are moved away from each other and the puncture member is removed, causing the first punctureable element and the second punctureable element to close.

38. The method according to any one of claims 32 to 37, wherein at least one of the first punctureable element and the second punctureable element includes a cut line or slit at the contact position of the puncture member.

39. A method for operating a drug delivery system, the drug delivery system comprising a container, a resettable partition puncture mechanism, a biasing member, and a puncture member that defines a through-hole through the interior, The container comprises a container body configured to hold a liquid drug, the container body has a container end that defines a container opening inside, and the container further comprises a partition configured to seal the container opening. The resettable septal puncture mechanism comprises: a needle support; a punctureable element separated from the needle support such as defining a cavity between the punctureable element and the needle support when the drug delivery system is in a non-puncture configuration to reduce or substantially prevent the entry of bacteria into the cavity; and a needle supported by the needle support within the cavity when the drug delivery system is in the non-puncture configuration. The aforementioned method, The process involves moving the container and the resettable partition puncture mechanism toward each other from the non-puncture configuration to the puncture configuration, wherein the puncture member punctures the punctureable element, the needle exits the cavity, and extends through the through-hole of the puncture member into the partition. A method for moving the container and the resettable partition puncture mechanism away from each other from the puncture configuration to the non-puncture configuration, wherein the biasing member moves at least one of the punctureable element or the needle support away from the other, and the needle is moved back into the cavity.

40. The method according to claim 39, wherein when the drug delivery system is in the non-puncture configuration, the puncture member is placed in the cavity.

41. The method according to any one of claims 39 and 40, wherein when the drug delivery system is in the non-puncture configuration, the needle is positioned in the through-hole of the puncture member.

42. The method according to claim 39, wherein the drug delivery system further comprises a container puncture element, the container puncture element being separated from the partition so as to define a container cavity between the container puncture element and the partition when the drug delivery system is in the non-puncture configuration, thereby reducing or substantially preventing the entry of bacteria into the container cavity.

43. The drug delivery system according to any one of claims 39 and 42, wherein when the drug delivery system is in the non-puncture configuration, the puncture member is placed inside the container.

44. A drug delivery system according to any one of claims 39, 42, and 43, wherein when the container and the resettable partition puncture mechanism are moved toward each other from the non-puncture configuration to the puncture configuration, the puncture member punctures the container puncture element and the puncture element, the needle exits the cavity and extends into the partition through the through-hole of the puncture member.

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