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

[0006] The drug delivery system 100 is configured to dispense a liquid therapeutic agent 20 from a drug container 200 to a patient via a nozzle 101. The nozzle 101 is configured to be inserted into the patient, such as into the patient's skin. The nozzle 101 may be, for example, a needle or a cannula. Preferably, the drug delivery system 100 is a subcutaneous delivery system configured to deliver the therapeutic agent 20 to the subcutaneous layer of the patient's skin. Therefore, 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 6 mm to 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 A It 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 Figure 1, the drug delivery system 100 includes an actuator 111 configured to drive the liquid therapeutic agent 20 from the drug container 200 to the outside of the needle or cannula 101. The actuator 111 may be any suitable actuator for dispensing the liquid therapeutic agent 20 from the drug container 200. The actuator 111 may include a plunger 112 configured to move the seal 204 of the drug container 200, thereby driving the liquid therapeutic agent 20 from the drug container 200. The actuator 111 may include a driver 114 configured to move the seal 204 to the plunger 112. The driver 114 may be any suitable driver, such as (non-limited) a motor, a spring, a hydraulic driver, or a pneumatic driver. The plunger 112 may be any suitable plunger, such as a flexible plunger or a nesting plunger.

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

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

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

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

[0016] The drug delivery system 100 may include a user interface 124 configured to be engaged by 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 can include a display configured to indicate information thereon, such as by using text and / or graphics. The display can include a display screen having any of various configurations, such as a cathode ray tube (CRT), a liquid crystal display (LCD), a touch screen, and the like. In yet another example, the user interface 124 can include a vibration mechanism configured to vibrate, which is configured to be felt by a patient wearing the drug delivery system 100. In yet another example, the user interface 124 can include a speaker configured to provide an audio signal. In another example, the user interface 124 can include a mechanical level configured to indicate 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] In the illustrated embodiment, the drug container 200 includes a single data storage component 210, but may include multiple data storage components. If multiple data storage components are used, each can be different from one another, which can provide redundancy and / or aid in enabling data retrieval even if a particular type of data communication is currently unavailable, e.g., if there are no RFID tags present or if the tags are damaged and unreadable, as long as the QR code can still be read.

[0020] The data storage component 210 is configured to store data regarding the drug container 200, data regarding the drug 20 contained in the drug container 200, and / or data regarding the delivery parameters of the drug 20. For example, the data storage component 210 can store information related to the dosing regimen of the drug 20 within the drug container 200. For example, the data storage component can store one or more of the volume of the drug 20 stored in the drug container 200, the amount (dosage) of the drug 20 delivered by the system 100 (which can 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 data, receive data, and optionally cause that data to be written to the data storage component 210. In some such examples, the data storage component 210 can be updated periodically (e.g., upon completion of delivery of each mL) to include a reasonably accurate record of the delivery progress at any given time. If the system 100 fails during delivery and a partial dose has been delivered, a reservoir containing a 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 can also be updated with information related to the delivery and the state of the system 100 during 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, the flow rate, and the back pressure of the patient's tissues. 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. Given a given viscosity and needle gauge, a higher driving force is typically required to deliver a drug at a higher flow rate, while a lower driving force is typically required to deliver a drug at a lower flow rate. This problem can worsen if two or more of these factors change. For example, a higher driving force is typically required to deliver a drug of higher viscosity through a larger gauge needle at a higher flow rate. By varying these parameters, the force required to deliver the drug can exceed 50 N, 75 N, 100 N, 150 N, 200 N, 250 N, 300 N, 350 N, or even 400 N. 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., 30 N or less). 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 using larger gauge needles, such as 23-gauge, 24-gauge, 25-gauge, 26-gauge, 27-gauge, 28-gauge, 29-gauge, or 30-gauge needles. Moreover, the actuator 111 can deliver drugs at higher flow rates than the infusion device, such as 0.25 mL / min, 0.5 mL / min, 1.0 mL / min, 1.5 mL / min, 2.0 mL / min, 2.5 mL / min, or 3 mL / min. Figure 14 shows a graph of the performance envelope observed for the prototype drug delivery device of this 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 no more than 25%, 20%, 15%, 10%, or 5% greater than the force required to translate the plunger seal within the container using a linear plunger rod, or less than 30%. 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 large counterforces 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 forces could cause the housing 102 to rupture. Therefore, the drug delivery system 100 may be equipped with a reinforcing structure 126 configured to absorb at least some, and up to all, of the counterforces. The reinforcing structure 126 is configured to limit or prevent the counterforces from being exerted on the housing 102. In some examples, the reinforcing structure may comprise a rigid plate formed from a suitable rigid material such as metal. The reinforcing structure 126 may have a first end 126a that resists outward movement of at least one curved track at the first end of the drug delivery system along a selected direction (e.g., downward in Figures 6 and 7), and a second end 126b that resists outward movement of the drug container and / or driver at the second end of the drug delivery system along a direction opposite to the selected direction (e.g., upward in Figures 6 and 7).

[0045] The reinforcing structure 126 can define at least one track 110. For example, at least one track 110 can be defined by an opening or recess extending within or through the reinforcing structure 126. The opening or recess 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] 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.

[0048] 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.

[0049] 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.

[0050] While certain exemplary embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of the invention disclosed herein. Therefore, nothing of the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is essential or indispensable. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications can be made in the forms of the methods and systems described herein without departing from the spirit of the invention disclosed herein. The appended claims and their equivalents are intended to cover such forms or modifications as being within the specific scope and spirit of the invention disclosed herein.

[0051] 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.

[0052] Aspects of this disclosure that form part of this specification: 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.

[0053] 2. The drug delivery system according to embodiment 1, wherein the flexible plunger rod supports at least one roller or bearing such that at least one roller or bearing moves together with the flexible plunger rod along at least one curved track.

[0054] 3. The drug delivery system according to embodiment 1, wherein the track supports at least one roller or bearing so that a plunger rod moves along at least one roller or bearing.

[0055] 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.

[0056] 5. At least one roller or bearing may include one or more rollers or bearings positioned on the second outer portion of the flexible plunger rod. At least one track can contain a pair of tracks that are on opposite sides of each other. One or more rollers or bearings of the first outer part move along the first track of the track, and one or more rollers or bearings of the second outer part move along the second track of the track. A drug delivery system as described in Embodiment 4.

[0057] 6. The drug delivery system according to embodiment 4, wherein the flexible plunger rod has a first outer portion and a second outer portion that are opposite to each other, and at least one roller or bearing is disposed between the first outer portion and the second outer portion.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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:

[0062] 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.

[0063] 12. The drug delivery system according to embodiment 11, wherein the reinforcing structure comprises a rigid plate.

[0064] 13. A drug delivery system according to any one of embodiments 11 and 12, wherein a reinforcing structure defines at least one track.

[0065] 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.

[0066] 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, and the opening or recess is configured to receive at least one roller or bearing inside the opening or recess.

[0067] 16. Equipped with a drug container, A drug delivery system according to any one of embodiments 1 to 15, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive a liquid drug from the container.

[0068] 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 does not exceed 30% greater than the force required to translate the seal within the container using a linear plunger rod.

[0069] 18. A drug delivery system according to any one of embodiments 1 to 17, which is capable of driving a plunger seal inside a container with a force of at least 50 N.

[0070] 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:

[0071] 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 the 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...

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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 by the driver to translate the plunger seal within the container using a flexible plunger rod does not exceed 30% greater than the force required to translate the plunger seal within the container using a linear plunger rod.

[0076] 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 configured not to be more than 25% greater than the force required for translating the plunger seal within the container using a linear plunger rod.

[0077] 26. 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 configured not to be more than 20% greater than the force required for translating the plunger seal within the container using a linear plunger rod.

[0078] 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 configured not to be more than 15% greater than the force required for translating the plunger seal within the container using a linear plunger rod.

[0079] 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:

[0080] 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.

[0081] 30. The drug delivery system according to embodiment 29, wherein the reinforcing structure comprises a rigid plate.

[0082] 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.

[0083] 32. Equipped with a drug container, A drug delivery system according to any one of embodiments 24 to 31, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive a liquid drug from the container.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 42. The drug delivery system according to embodiment 41, wherein the reinforcing structure comprises a rigid plate.

[0094] 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.

[0095] 44. Equipped with a drug container, A drug delivery system according to any one of embodiments 35 to 43, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive a liquid drug from the container.

[0096] 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:

[0097] 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...

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

Claims

1. A drug delivery system, At least one curved track, A plunger having a flexible plunger rod, A driver configured to translate the plunger along the at least one curved track, wherein the flexible plunger rod bends as it translates along the at least one curved track into the drug container, thereby driving liquid drug from the drug container to the patient. At least one roller or bearing configured to guide the flexible plunger rod as it translates along the at least one curved track, A drug delivery system equipped with the following features.

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

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

4. A drug delivery system according to any one of claims 1 to 3, wherein the flexible plunger rod has a first outer portion and a second outer portion that are opposite to each other, and the at least one roller or bearing includes one or more rollers or bearings disposed on the first outer portion of the flexible plunger rod.

5. The 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. The at least one track may include a pair of tracks that are opposite each other. The one or more rollers or bearings of the first outer part move along the first track of the track, and the one or more rollers or bearings of the second outer part move along the second track of the track. The drug delivery system according to claim 4.

6. The drug delivery system according to claim 4, wherein the flexible plunger rod has a first outer portion and a second outer portion that are opposite to each other, and the at least one roller or bearing is disposed between the first outer portion and the second outer portion.

7. The drug delivery system according to any one of claims 1 to 6, wherein the flexible plunger rod comprises a plurality of links pivotably connected to one another.

8. The drug delivery system according to claim 6, wherein each of the at least one roller or bearing is supported by one of the plurality of links.

9. The drug delivery system according to any one of claims 1 to 6, wherein the flexible plunger rod comprises a flexible material that can bend as the plunger rod translates along the at least one curved track.

10. A threaded rod configured to engage with the female thread of the plunger, A motor configured to rotate the threaded rod so as to translate the plunger along at least one track, A drug delivery system according to any one of claims 1 to 9, comprising:

11. A drug delivery system according to any one of claims 1 to 10, further comprising a reinforcing structure configured to resist opposing forces applied by the plunger at a bend defined by the at least one curved track at a first end of the drug delivery system, and by the drug container and / or the driver at a second end of the drug delivery system opposite to the first end.

12. The drug delivery system according to claim 11, wherein the reinforcing structure comprises a rigid plate.

13. The drug delivery system according to any one of claims 11 and 12, wherein the reinforcing structure defines the at least one track.

14. The drug delivery system according to any one of claims 11 to 13, wherein the reinforcing structure has a first end that resists outward movement of the at least one curved track at the first end of the drug delivery system along the selected direction, and a second end that resists outward movement of the drug container and / or the driver at the second end of the drug delivery system along the direction opposite to the selected direction.

15. The drug delivery system according to claim 13, wherein the at least one track is defined by an opening or recess extending within or through the reinforcing structure, and the opening or recess is configured to receive the at least one roller or bearing inside the opening or recess.

16. The aforementioned drug container is provided, The drug delivery system according to any one of claims 1 to 15, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive the liquid drug from the container.

17. The drug delivery system according to any one of claims 1 to 16, wherein the force required to translate the seal within the drug container using the flexible plunger rod does not exceed 30% greater than the force required to translate the seal within the container using a linear plunger rod.

18. A drug delivery system according to any one of claims 1 to 17, wherein the plunger seal in the container can be driven with a force of at least 50 N.

19. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of the drug delivery system into a patient, A drug delivery system according to any one of claims 1 to 18, comprising:

20. A method of delivering drugs to patients using a drug delivery system, Inserting the needle or cannula of the drug delivery system into the patient, The method involves translating a flexible plunger rod of the drug delivery system along at least one curved track of the drug delivery system, wherein the flexible plunger rod bends as it translates along the at least one curved track into the drug container of the drug delivery system, driving the 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 the at least one curved track. Methods that include...

21. The method according to claim 20, wherein the flexible plunger rod supports the at least one roller or bearing, and the translation step includes advancing the at least one roller or bearing together with the flexible plunger rod along the at least one curved track.

22. The method according to claim 20, wherein the track supports the at least one roller or bearing, and the translation step includes advancing the plunger rod along the at least one roller or bearing.

23. The method according to any one of claims 20 to 22, wherein the drug delivery system comprises a threaded rod configured to engage with a female thread of the plunger, and the method comprises rotating the threaded rod with a driver to translate the plunger along the at least one track.

24. A drug delivery system, Curved track and A plunger having a flexible plunger rod, A driver configured to translate the plunger along the curved track, wherein the flexible plunger rod bends along the curved track and drives the plunger seal of the drug container to discharge liquid drug from the drug container, Equipped with, A drug delivery system configured such that the force required by the driver to translate the plunger seal within the container using the flexible plunger rod does not exceed 30% greater than the force required to translate the plunger seal within the container using a linear plunger rod.

25. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using the flexible plunger rod is configured not to be more than 25% greater than the force required for the driver to translate the plunger seal within the container using a linear plunger rod.

26. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using the flexible plunger rod is configured not to be more than 20% greater than the force required for the driver to translate the plunger seal within the container using a linear plunger rod.

27. The drug delivery system according to claim 24, wherein the force required for the driver to translate the plunger seal within the container using the flexible plunger rod is configured not to be more than 15% greater than the force required for the driver to translate the plunger seal within the container using a linear plunger rod.

28. A threaded rod configured to engage with the female thread of the plunger, A motor configured to rotate the threaded rod so as to translate the plunger along at least one track, A drug delivery system according to any one of claims 24 to 27, comprising:

29. A drug delivery system according to any one of claims 24 to 28, comprising a reinforcing structure configured to resist opposing forces applied by the plunger at a bend defined by the at least one curved track at a first end of the drug delivery system, and by the drug container and / or the driver at a second end of the drug delivery system opposite to the first end.

30. The drug delivery system according to claim 29, wherein the reinforcing structure comprises a rigid plate.

31. The drug delivery system according to any one of claims 29 to 30, wherein the reinforcing structure has a first end that resists outward movement of the at least one curved track at the first end of the drug delivery system along the selected direction, and a second end that resists outward movement of the drug container and / or the driver at the second end of the drug delivery system along the direction opposite to the selected direction.

32. The aforementioned drug container is provided, The drug delivery system according to any one of claims 24 to 31, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive the liquid drug from the container.

33. A drug delivery system according to any one of claims 24 to 32, wherein the plunger seal in the container can be driven with a force of at least 50 N.

34. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of the drug delivery system into a patient, A drug delivery system according to any one of claims 24 to 33, comprising:

35. A drug delivery system, Curved track and A plunger having a flexible plunger rod, A driver configured to translate the plunger along the curved track, wherein the flexible plunger rod bends along the curved track and drives the plunger seal of the drug container to discharge liquid drug from the drug container, Equipped with, A drug delivery system capable of driving the plunger seal in the container with a force of at least 50 N.

36. The drug delivery system according to claim 35, wherein the plunger seal in the container can be driven with a force of at least 150 N.

37. The drug delivery system according to claim 35, wherein the plunger seal in the container can be driven with a force of at least 200 N.

38. The drug delivery system according to claim 35, wherein the plunger seal in the container can be driven with a force of at least 250 N.

39. The drug delivery system according to claim 35, wherein the plunger seal in the container can be driven with a force of at least 300 N.

40. A threaded rod configured to engage with the female thread of the plunger, A motor configured to rotate the threaded rod so as to translate the plunger along at least one track, A drug delivery system according to any one of claims 35 to 39, comprising:

41. A drug delivery system according to any one of claims 35 to 40, comprising a reinforcing structure configured to resist opposing forces applied by the plunger at a bend defined by the at least one curved track at a first end of the drug delivery system, and by the drug container and / or the driver at a second end of the drug delivery system opposite to the first end.

42. The drug delivery system according to claim 41, wherein the reinforcing structure comprises a rigid plate.

43. The drug delivery system according to any one of claims 41 to 42, wherein the reinforcing structure has a first end that resists outward movement of the at least one curved track at the first end of the drug delivery system along the selected direction, and a second end that resists outward movement of the drug container and / or the driver at the second end of the drug delivery system along the direction opposite to the selected direction.

44. The aforementioned drug container is provided, The drug delivery system according to any one of claims 35 to 43, wherein the drug container is a cartridge comprising a container body and a seal that forms a sealing portion with the inner surface of the container body, and the plunger is configured to engage with the seal to drive the liquid drug from the container.

45. A needle or cannula, An insertion mechanism configured to insert a needle or cannula of the drug delivery system into a patient, A drug delivery system according to any one of claims 40 to 44, comprising:

46. A method of delivering drugs to patients using a drug delivery system, Inserting the needle or cannula of the drug delivery system into the patient, The method involves translating the flexible plunger rod of the drug delivery system along at least one curved track of the drug delivery system, wherein the flexible plunger rod bends as it translates along the at least one curved track into the drug container of the drug delivery system, thereby driving the liquid drug out of the drug container with a force of at least 50 N. Methods that include...

47. The method according to claim 46, wherein the drug delivery system can drive the plunger seal in the container with a force of at least 150 N.

48. The method according to claim 46, wherein the drug delivery system can drive the plunger seal in the container with a force of at least 200 N.

49. The method according to claim 46, wherein the drug delivery system can drive the plunger seal in the container with a force of at least 250 N.

50. The method according to claim 46, wherein the drug delivery system can drive the plunger seal in the container with a force of at least 300 N.

51. The method according to any one of claims 46 to 50, wherein the drug delivery system comprises a threaded rod configured to engage with a female thread of the plunger, and the method comprises rotating the threaded rod with a driver to translate the plunger along the at least one track.

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