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 injectors, pen-type injectors, autoinjectors, 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 pumps the liquid drug from the drug container through the needle or cannula into 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] A simplified schematic diagram of a drug delivery system according to an example is shown. [Figure 2] A perspective view of a drug container according to an example that can be implemented in the drug delivery system of FIG. 1 is shown. [Figure 3] A perspective view of the drug delivery system of FIG. 1 according to an example with the closure in the closed position is shown. [Figure 4] Another perspective view of the drug delivery system of FIG. 1 according to an example with the closure in the open position and the container in the uninstalled position is shown. [Figure 5] A side view of the drug delivery system of FIG. 1 according to an example is shown. [Figure 6]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. [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 injection 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 illustrated. 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 therein. 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 AIt may have a central axis extending along the cavity. The first end 202a may define an opening 202d therein 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 FIG. 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 can be any suitable actuator for discharging the liquid therapeutic agent 20 from the drug container 200. The actuator 111 can include a plunger 112 configured to move the seal 204 of the drug container 200 to drive the liquid therapeutic agent 20 from the drug container 200. The actuator 111 can include a driver 114 configured to move the seal 204 to the plunger 112. The driver 114 can be any suitable driver, such as (but not limited to) a motor, a spring, a hydraulic driver, or a pneumatic driver. The plunger 112 can be any suitable plunger, such as a flexible plunger or a nested plunger.

[0012] The drug delivery system 100 can include a septum piercing needle 116 configured to pierce the septum 208 of the drug container 200. At least one of the septum piercing needle 116 and the drug container 200 can be configured to move toward the other to cause the piercing needle 116 to pierce the septum 208. By piercing the septum 208, the septum piercing needle 116 can be placed in fluid communication with the liquid therapeutic agent 20 contained within the drug container 200. The drug delivery system 100 can include a conduit 120, such as a tube, that fluidly connects the septum piercing needle 116 to the nozzle 101. Thus, by piercing the septum 208, the nozzle 101 can be placed in fluid communication with the liquid therapeutic agent 20 contained within the drug container 200 via the septum piercing needle 116 and the conduit 120.

[0013] The drug delivery system 100 can optionally include a contamination guard 118 that protects the piercing needle 116 from contamination when the piercing needle 116 has not pierced the partition wall 208 of the drug container 200. For example, the contamination guard 118 can be configured to protect the piercing needle 116 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 wall 208 is pierced, and / or after the drug container 200 is removed from the housing after injection.

[0014] The drug delivery system 100 can include a nozzle insertion mechanism 122 configured to insert the nozzle 101 into a patient, such as the patient's skin. The nozzle insertion mechanism 122 can 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 can be configured to retract the nozzle 101 into the housing after injection. Additionally, or alternatively, the drug delivery system 100 can 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 biological substances remaining on the nozzle 101 can be restricted. The nozzle insertion mechanism 122 can be any suitable mechanism (including, without limitation) known in the art for inserting the nozzle 101 into the patient. The nozzle insertion mechanism 122 can include a driver, such as a motor or spring, that inserts 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 so that the nozzle 101 is 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 being 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 show 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 126 configured to read the data storage component 210. The reader 126 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 administration 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 volume 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 126 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 event 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 126 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 a drug is 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. The 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 drug 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 with at least a portion or the whole of it. 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 internally configured to receive the drug container 200 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 retain 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 within the container 200 via the plunger rod 306 is 30% or less, such as 25%, 20%, 15%, 10%, or 5% or less, than the force required to translate the plunger seal within 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 all the way down to 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 curve 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 a curve 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 include 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 can be configured to receive at least one roller or bearing 310 therein. 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, and the flexible plunger rod 306 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, and 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 to drive a 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 herein. As schematically illustrated 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 similar to 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 similar to 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 similar to 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] In position A as illustrated in Figure 18, the plunger 500 may be in a pre-engagement position where the plunger end 510 cannot come into contact with 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, illustrated in Figure 18, the plunger 500 may be in an engagement position where the plunger end 510 can contact the seal 610. The needle shield 450 may be in a shielded position (Figure 17A). The drug container 600 may be in a pre-puncture position (Figure 16A).

[0067] The driver can operate 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, illustrated in Figure 18, the plunger end 510 can contact 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).

[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, and move the drug container 600 and the needle shield 450 toward the needle assembly 405, thereby 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 may 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 can be in the initial injection (dispensing) position, the drug container 600 can be in the puncture position in Figure 16B, and the needle shield 450 can 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, illustrated 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 partition 608 is punctured at position C, so that the delivery of the drug from the drug container 600 can be controlled when the plunger 500 moves from position C to position D. The sensor 520 can measure the moment (e.g., the exact moment) when the partition 608 is punctured by the tip 422 of the partition 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 can 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. Furthermore, for example, 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] A controller (e.g., controller circuit 128) can determine when the plunger 500 moves the drug container to position C and when the septum 608 is 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., controller 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 administration 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 the drug 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 characteristics that affect 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 illustrated 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 (e.g., position B) of the seal 610 in the cavity 602c where it first contacts the plunger end 510. 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 (e.g., position A) between the plunger end 510 and the end of the drug container 600 to provide initial clearance for insertion of 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 removed 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 needle shield 450 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 illustrated 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] In position E illustrated 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 in 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 illustrated 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, with the flexible plunger rod 515 bending during translation along the curved track, and the plunger 500 may be 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., controller 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., controller circuit 128) can control the driver to translate the plunger 500 along the curved track, moving the plunger end 510 by 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 separated 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 in the curve 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, the flexible plunger rod 515 bending along the curved track, and driving the seal 610 of the drug container 600 to dispense 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 away from the seal 610 along a curved track along the reverse direction RD opposite to the drive direction DD. The needle shield 450 may be moved 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 disclosure 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 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 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 a curved track along the reverse direction RD.

[0084] 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.

[0085] 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.

[0086] Conditional 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 are 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.

[0087] 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 has been said herein to imply that any particular feature, characteristic, step, module, or block is essential or indispensable. Indeed, 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.

[0088] 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.

[0089] Aspects of this disclosure that form part of this specification: 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, thereby driving 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.

[0090] 2. The drug delivery system according to embodiment 1, wherein the flexible plunger rod supports at least one roller or bearing so that at least one roller or bearing moves along at least one curved track together with the flexible plunger rod.

[0091] 3. The drug delivery system according to embodiment 1, wherein the track supports at least one roller or bearing so that the plunger rod moves along at least one roller or bearing.

[0092] 4. A drug delivery system according to any one of embodiments 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.

[0093] 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 may include a pair of tracks facing 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. A drug delivery system as described in Embodiment 4.

[0094] 6. The drug delivery system according to embodiment 4, wherein the flexible plunger rod has a first outer portion and a second outer portion facing each other, and at least one roller or bearing is disposed between the first outer portion and the second outer portion.

[0095] 7. A drug delivery system according to any one of embodiments 1 to 6, wherein the flexible plunger rod comprises a plurality of links pivotably connected to one another.

[0096] 8. The drug delivery system according to embodiment 6, wherein each of at least one roller or bearing is supported by one of a plurality of links.

[0097] 9. A drug delivery system according to any one of embodiments 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.

[0098] 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 embodiments 1 to 9, comprising:

[0099] 11. A drug delivery system according to any one of embodiments 1 to 10, comprising a reinforcing structure configured to resist opposing forces applied by a plunger in a curve 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.

[0100] 12. The drug delivery system according to embodiment 11, wherein the reinforcing structure comprises a rigid plate.

[0101] 13. A drug delivery system according to any one of embodiments 11 and 12, wherein a reinforcing structure defines at least one track.

[0102] 14. A drug delivery system according to any one of embodiments 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 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.

[0103] 15. The drug delivery system according to embodiment 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 inside.

[0104] 16. A drug delivery system according to any one of embodiments 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 a plunger is configured to engage with the seal to drive a liquid drug from the container.

[0105] 17. A drug delivery system according to any one of embodiments 1 to 16, wherein the drug delivery system is configured such that the force required to translate the seal within the drug container using a flexible plunger rod is 30% or less than the force required to translate the seal within the container using a linear plunger rod.

[0106] 18. A drug delivery system according to any one of embodiments 1 to 17, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 50 N.

[0107] 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 embodiments 1 to 18, comprising:

[0108] 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...

[0109] 21. The method according to embodiment 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.

[0110] 22. The method according to embodiment 20, wherein the step of translating the track supports at least one roller or bearing includes advancing a plunger rod along at least one roller or bearing.

[0111] 23. The method according to any one of embodiments 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.

[0112] 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 a flexible plunger rod bends along the curved track, driving the plunger seal of a drug container to dispense liquid drug from the drug container; Equipped with, A drug delivery system configured such that the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is 30% or less than the force required to translate the plunger seal within the container using a linear plunger rod.

[0113] 25. The drug delivery system according to embodiment 24, wherein the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is 25% or less than the force required for the driver to translate the plunger seal within the container using a linear plunger rod.

[0114] 26. The drug delivery system according to embodiment 24, wherein the force required to translate the plunger seal within the container using a flexible plunger rod is configured to be 20% or less of the force required to translate the plunger seal within the container using a linear plunger rod.

[0115] 27. The drug delivery system according to embodiment 24, wherein the force required for the driver to translate the plunger seal within the container using a flexible plunger rod is 15% or less than the force required for the driver to translate the plunger seal within the container using a linear plunger rod.

[0116] 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 embodiments 24 to 27, comprising:

[0117] 29. A drug delivery system according to any one of embodiments 24 to 28, comprising a reinforcing structure configured to resist opposing forces applied by a plunger in a curve 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.

[0118] 30. The drug delivery system according to embodiment 29, wherein the reinforcing structure comprises a rigid plate.

[0119] 31. A drug delivery system according to any one of embodiments 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.

[0120] 32. A drug delivery system according to any one of embodiments 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 a plunger is configured to engage with the seal to drive a liquid drug from the container.

[0121] 33. A drug delivery system according to any one of embodiments 24 to 32, which is capable of driving a plunger seal inside a container with a force of at least 50 N.

[0122] 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 embodiments 24 to 33, comprising the above.

[0123] 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 a flexible plunger rod bends along the curved track, driving the plunger seal of a drug container to dispense liquid drug from the drug container; Equipped with, A drug delivery system capable of driving a plunger seal inside a container with a force of at least 50N.

[0124] 36. The drug delivery system according to embodiment 35, which is capable of driving a plunger seal inside a container with a force of at least 150 N.

[0125] 37. The drug delivery system according to embodiment 35, which is capable of driving a plunger seal inside a container with a force of at least 200 N.

[0126] 38. The drug delivery system according to embodiment 35, which is capable of driving a plunger seal inside a container with a force of at least 250 N.

[0127] 39. The drug delivery system according to embodiment 35, which is capable of driving a plunger seal inside a container with a force of at least 300 N.

[0128] 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 embodiments 35 to 39, comprising the above.

[0129] 41. A drug delivery system according to any one of embodiments 35 to 40, comprising a reinforcing structure configured to resist opposing forces applied by a plunger in a curve 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.

[0130] 42. The drug delivery system according to embodiment 41, wherein the reinforcing structure comprises a rigid plate.

[0131] 43. A drug delivery system according to any one of embodiments 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.

[0132] 44. A drug delivery system according to any one of embodiments 35 to 43, 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 a plunger is configured to engage with the seal to drive a liquid drug from the container.

[0133] 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 embodiments 40 to 44, comprising:

[0134] 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...

[0135] 47. The method according to embodiment 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 150 N.

[0136] 48. The method according to embodiment 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 200 N.

[0137] 49. The method according to embodiment 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 250 N.

[0138] 50. The method according to embodiment 46, wherein the drug delivery system is capable of driving a plunger seal in a container with a force of at least 300 N.

[0139] 51. The method according to any one of embodiments 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.

[0140] 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 during translation 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.

[0141] 2. The drug delivery system according to embodiment 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.

[0142] 3. A drug delivery system according to any one of embodiments 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.

[0143] 4. A drug delivery system according to any one of embodiments 1 to 3, further comprising a biasing assembly configured to move the drug container from the puncture site to a removal site where the septum puncture needle is removed from the drug container.

[0144] 5. A drug delivery system according to any one of embodiments 1 to 4, further comprising a sensor configured to detect when a drug container is moved to a puncture site.

[0145] 6. The drug delivery system according to embodiment 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.

[0146] 7. Equipped with an additional controller, A drug delivery system according to any one of embodiments 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.

[0147] 8. A drug delivery system according to embodiment 7, wherein the amount of drug delivered via a septal puncture needle is based on a predetermined distance.

[0148] 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.

[0149] 10. The drug delivery system according to embodiment 9, further comprising a biasing assembly configured to translate the drug container in the opposite direction so that the septum puncture needle de-punctures the septum.

[0150] 11. The drug delivery system according to embodiment 10, wherein the biasing assembly comprises a needle shield, the needle shield being configured to retract the tip of the septal puncture needle into a detachable position when the drug container is translated in the reverse direction.

[0151] 12. A drug delivery system according to any one of embodiments 10 to 11, wherein the biasing assembly includes a biasing member, the biasing member configured to cause the drug container to translate in the reverse direction when the plunger translates along the reverse direction.

[0152] 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 embodiments 9 to 12, wherein when the plunger is translated along the opposite direction, the plunger is configured to move the drug container away from the septum puncture needle and thereby de-puncture the septum.

[0153] 14. A drug delivery system according to any one of embodiments 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.

[0154] 15. A drug delivery system according to any one of embodiments 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.

[0155] 16. A drug delivery system according to any one of embodiments 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.

[0156] 17. A drug delivery system according to any one of embodiments 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.

[0157] 18. A drug delivery system according to any one of embodiments 9 to 17, further comprising a reinforcing structure configured to resist opposing forces applied by a plunger in a curve 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.

[0158] 19. 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 in the direction of drive, wherein the flexible plunger rod bends along the curved track and drives the seal of a drug container to dispense 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.

[0159] 20. The drug delivery system according to embodiment 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.

[0160] 21. The drug delivery system according to embodiment 20, further comprising a biasing member that biases the needle shield from an exposed position to a shielded position when the plunger is translated away from the seal along a curved track in the opposite direction to the driving direction.

[0161] 22. The drug delivery system according to embodiment 19, wherein the needle shield moves between an exposed position and a shielded position relative to a housing supporting a partition puncture needle in a stationary position.

[0162] twenty three. 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...

[0163] 24. The method according to embodiment 23, wherein the driving direction and the reverse direction are relative to the housing supporting the septum puncture needle in a stationary position.

[0164] twenty five. The method according to any one of embodiments 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.

[0165] 26. The method according to any one of embodiments 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.

[0166] 27. The method according to embodiment 26, further comprising biasing the needle shield from an exposed position to a shielded position when the plunger is translated along a curved track aligned in the opposite direction.

[0167] 28. The method according to any one of embodiments 23 to 27, further comprising providing an opening in the housing for receiving a drug container within the housing and for removing the drug container from the housing.

Claims

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 the plunger along the curved track, wherein the flexible plunger rod bends during translation 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 move 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 is moved to the puncture site.

6. The drug delivery system according to claim 5, further comprising a controller that controls the delivery of the drug based on a sensor that senses when the drug container has been moved to the puncture site where the delivery of the drug 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 position, the controller controls the driver to translate the plunger along the curved track, thereby moving the plunger end a predetermined distance.

8. The drug delivery system according to claim 7, wherein the amount of the drug delivered via the septal puncture needle is based on the 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 the plunger along the curved track in the driving direction, wherein the flexible plunger rod bends along the curved track, drives the seal of the drug container to discharge the liquid drug from the drug container, and after the discharge of the liquid drug from the drug container is complete, the driver translates away from the seal in the opposite direction to the driving direction. Equipped with, A drug delivery system wherein, when the plunger is translated along the opposite 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 opposite direction so that the septum puncture needle releases the septum.

11. The drug delivery system according to claim 10, wherein the biasing assembly comprises a needle shield, the needle shield is configured to house the tip of the septum 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 is configured to cause the drug container to translate in the reverse direction when the plunger translates along the reverse direction.

13. The plunger, including the plunger end, is configured to pull the drug container in the opposite direction. The drug delivery system according to any one of claims 9 to 12, wherein when the plunger is translated along the opposite direction, the plunger is configured to move the drug container away from the septum puncture needle and release 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 the housing supporting the septum puncture needle in a stationary position.

17. The drug delivery system according to any one of claims 9 to 16, further comprising at least one roller or bearing positioned along the 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 the plunger in a curve defined by the curved track at a first end of the drug delivery system, and by the drug container or the 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 move the plunger along the curved track in the driving direction, wherein the flexible plunger rod bends along the curved track and drives the seal of the drug container to discharge liquid drug from the drug container, 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 be movable between a shielding position where the needle shield extends beyond the tip of the 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 the 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 the exposed position to the 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 the exposed position to the shielded position when the plunger moves away from the seal and translates along the curved track in the opposite direction to the driving direction.

22. The drug delivery system according to claim 19, wherein the needle shield moves between the exposed position and the shielded position relative to the housing supporting the partition puncture needle in a stationary position.

23. Driving a plunger having a flexible plunger rod and a plunger end along a curved track, The plunger and the curved track are located inside the housing. The plunger is arranged to interact with a drug container located inside the housing. The housing has a partition puncture needle and is driven, The drug container is pushed in by the plunger end, thereby moving the drug container toward the partition puncture needle in the driving direction, Based on driving the plunger in the aforementioned driving direction, the partition of the drug container is punctured with the partition puncture needle, By driving the plunger in the opposite direction to the aforementioned driving direction, the puncture of the partition wall of the drug container by the partition wall 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 that supports the partition puncture needle in a stationary position.

25. 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 the exposed position to the 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 the exposed position to the shielded position when the plunger is translated 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 the drug container within the housing and for removing the drug container from the housing.

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