Medicament delivery system

Abstract

A medicament delivery system comprising a reusable injector device (100) and a cartridge (200) for use with the reusable injector device. The cartridge and device are combinable for medicament delivery and separable after medicament delivery. The cartridge comprises a cassette (210) and a pre-filled syringe (230). The pre-filled syringe is housed within the cassette and comprises a needle (233). The reusable injector device comprises a housing (110) and a drive mechanism (120) disposed in the housing. The drive mechanism has a plunger rod (121) configured to dispense medicament from the pre-filled syringe in use. The housing comprises a boss (113, 114) for engaging the pre-filled syringe and fixing the pre-filled syringe relative to the housing after the cartridge and device are combined. The cassette is displaceable within the housing relative to the pre-filled syringe to move the cassette between a needle safety position in which the needle is embedded within a proximal end of the cassette and a dose delivery position in which the needle extends from the proximal end of the cassette.

Description

Invention Field

[0001] The present invention relates to a drug delivery system comprising a cartridge and a reusable syringe device. Background Technology

[0002] Drug delivery devices (such as autoinjectors) are known in the art for dispensing medication to a patient's injection site. Such drug delivery devices typically include a needle in fluid communication with a syringe and a piston rod movable to dispense medication from the syringe through the needle to the injection site.

[0003] In such drug delivery devices, the piston rod is biased toward the injection site to dispense the drug. Once the drug has been dispensed, the needle is covered by a needle guard and / or needle cover, and the drug delivery device is discarded. Summary of the Invention

[0004] In a first aspect of the invention, a reusable syringe device is provided for use with a cartridge containing a pre-filled syringe, the device comprising a housing and a drive mechanism disposed within the housing, the drive mechanism having a plunger rod configured to dispense medication from the pre-filled syringe during use; wherein the housing includes a boss for engaging the pre-filled syringe and securing the pre-filled syringe relative to the housing when the cartridge and the device are combined.

[0005] By providing reusable syringe devices, less material needs to be discarded after drug delivery.

[0006] The housing may be elongated and may include openings in the side walls of the housing. The device may be configured to combine with a cartridge by moving the cartridge through the openings in a direction perpendicular to the longitudinal axis of the device.

[0007] Therefore, the device is configured to be easily combined with the cartridge by pressing the cartridge into the housing between the index finger and thumb.

[0008] The device may include a carriage configured to releasably hold a cartridge in use, the carriage being slidable within a housing against a carriage spring to move relative to a boss.

[0009] The device's slide can be configured to cooperate with the cartridge to releasably retain the cartridge within the housing against a slide spring. The slide spring can be configured to move the cartridge between a needle-safe position and a dose delivery position when the cartridge and device are combined.

[0010] By providing a spring-loaded carriage for attachment to the cartridge, the cartridge is biased to a needle-safe position. Furthermore, this design allows the spring components to be incorporated into the reusable portion of the drug delivery system, thereby reducing the number of parts discarded after drug delivery.

[0011] The boss may include a separate proximal boss and a distal boss, which are arranged to engage the respective ends of the prefilled syringe in use.

[0012] The plunger rod can move between a pre-delivery position and a second position, in which the cartridge can be combined with or separated from the device, and the second position is used to dispense the drug from the pre-filled syringe.

[0013] The carriage may include an arm arranged to contact the plunger rod when the plunger rod is in a pre-delivery position, the contact between the arm and the plunger rod defining a first proximal extension limit of the carriage spring to hold the carriage in a first position; and wherein, after the plunger rod moves to a second position, the carriage is free to move to the second position under the force of the carriage spring, the second position being more proximal than the first position; and optionally, wherein, when the carriage is in the second position, a surface of the carriage abuts against a surface of a boss to define a second proximal extension limit of the carriage spring.

[0014] The drive mechanism may include an interlocking pin configured to engage the carriage and cartridge during movement of the plunger rod between a first position and a second position when the cartridge and device are combined.

[0015] The interlocking pin locks the cartridge to the carriage during drug delivery to prevent the cartridge from dislodging due to improper handling of the device when it is assembled with the cartridge.

[0016] In a second aspect of the invention, a cartridge for use with a reusable syringe device is provided, the cartridge comprising a cassette, a cap, and a prefilled syringe comprising a needle, the prefilled syringe being housed within the cassette, the cartridge being configured to allow relative movement of the cassette and the prefilled syringe after the cap is removed, and wherein the cartridge is configured to prevent axial movement of the prefilled syringe relative to a housing of the device when the cartridge is attached to the device and to allow movement of the cassette relative to the housing of the device in a distal direction.

[0017] Before using the cartridge with the device, the cap can be locked to the box.

[0018] The cap may include a distal region extending into the cartridge, the distal region including two flexible segments extending around a blocking element of the cartridge to prevent removal of the cap before the cartridge is used with the device.

[0019] In a third aspect of the invention, a drug delivery system is provided, comprising a reusable syringe device and a cartridge; the cartridge and device are combinable for drug delivery and separable after drug delivery; the cartridge includes a cassette and a pre-filled syringe including a needle, the pre-filled syringe being housed within the cassette; the syringe device includes a housing and a drive mechanism disposed within the housing, the drive mechanism having a plunger rod configured to dispense a drug from the pre-filled syringe during use; wherein the housing includes a boss for engaging the pre-filled syringe after the cartridge and device are combined and for securing the pre-filled syringe relative to the housing, the cartridge being displaceable within the housing relative to the pre-filled syringe to move between a needle-safe position and a dose delivery position, in which the needle is embedded within the proximal end of the cartridge, and in the dose delivery position, the needle extends from the proximal end of the cartridge.

[0020] Therefore, a drug delivery system is provided in which the components of the system are reusable, thereby reducing waste. Furthermore, the cartridge has a simple construction, allowing the cartridge to serve both as a housing for pre-filling syringes and as a removable needle protector. This eliminates the need for a separate needle protector and reduces the number of components discarded after drug delivery.

[0021] The housing may be elongated and include openings in the side walls of the housing. The cartridge and the device are configured to be combined by moving the cartridge through the openings in a direction perpendicular to the longitudinal axis of the device.

[0022] Therefore, the device and cartridge are configured to be easily assembled by pressing the cartridge into the housing between the index finger and thumb.

[0023] The device may include a carriage; wherein the carriage and the cartridge are configured to cooperate when the cartridge and the device are combined to releasably retain the cartridge within the housing, the carriage being slidable within the housing against a carriage spring to move the cartridge between a needle-safe position and a dose delivery position; and optionally, wherein the cartridge includes clips configured to releasably attach to the carriage.

[0024] By providing a spring-loaded carriage for attachment to the cartridge, the cartridge is biased to a needle-safe position. Furthermore, this design allows the spring components to be incorporated into the reusable portion of the drug delivery system, thereby reducing the number of parts discarded after drug delivery.

[0025] The cartridge may include a cap for the sealing needle, which locks into the cartridge before the cartridge is assembled with the device.

[0026] Therefore, the needle is completely enclosed before use, thus eliminating any risk of needlestick injury.

[0027] When the cartridge and device are combined, the cap can abut against the boss, preventing the cartridge from moving within the housing until the cap is removed.

[0028] By preventing the cartridge from moving within the housing before the cap is removed, relative movement between the needle and the cartridge is also prevented when the cap is attached. This means that damage to the needle that could occur due to unwanted interaction between the needle and the cap is prevented.

[0029] The device can be configured to unlock the cap when the cartridge and the device are combined, allowing the cap to be removed from the cartridge.

[0030] Therefore, the action of combining the cartridge and the box makes it possible to remove the cap, eliminating any additional steps that might be required to unlock the cap and ensuring ease of use.

[0031] The cap may include a distal region that extends into the box when the box and the cap are attached, and wherein the distal region includes two flexible segments extending around a blocking element of the box to prevent removal of the cap before the cartridge and device are combined; wherein a boss is configured to separate the segments of the cap when the cartridge and device are combined to release these segments from the blocking element and allow the cap to be removed from the box; and optionally, wherein the boss includes a tapered protrusion configured to separate the segments of the cap.

[0032] Therefore, the cap release mechanism utilizes a boss to achieve a mechanically simple solution.

[0033] The boss may include separate proximal and distal bosses, which are arranged to engage the respective ends of the prefilled syringe via proximal and distal openings in the cartridge.

[0034] In this way, the pre-filled syringe can be constrained in the longitudinal direction of the device by simple contact with the surface.

[0035] The system can be configured such that when a distal force is applied to the proximal end of the cartridge after the device and cartridge are combined, the cartridge slides distally between the needle safety position and the dose delivery position.

[0036] Therefore, drug delivery can be achieved simply by pressing the proximal end of the cartridge down onto the injection site.

[0037] When the carriage is in the dose delivery position, the surface of the cartridge can abut against the surface of the boss.

[0038] The plunger rod can move between a pre-delivery position and a second position, in which the cartridge can be combined with or separated from the device, and the second position is used to dispense the drug from the pre-filled syringe.

[0039] The carriage may include an arm arranged to contact the plunger rod when the plunger rod is in a pre-delivery position, the contact between the arm and the plunger rod defining a first proximal extension limit of the carriage spring to hold the carriage in a first position; and wherein, after the plunger rod moves to a second position, the carriage is free to move to the second position under the force of the carriage spring, the second position being more proximal than the first position; and optionally, wherein, when the carriage is in the second position, a surface of the carriage abuts against a surface of a boss to define a second proximal extension limit of the carriage spring.

[0040] With the carriage in the second position, the locking mechanism of the cartridge can engage the distal flange of the prefilled syringe to lock the prefilled syringe into the cartridge.

[0041] In this way, separation of the pre-filled syringe from the cartridge is prevented after drug delivery. Therefore, the needle remains protected after use.

[0042] The drive mechanism may further include an interlocking pin configured to engage the carriage and the housing during movement of the plunger rod between a first position and a second position.

[0043] Interlocking pins lock the cartridge to the carriage during drug delivery to prevent cartridge dislodgement due to improper handling of the system.

[0044] In a fourth aspect of the invention, a method of using the system of the first aspect is provided, the method comprising attaching a cartridge to a device.

[0045] These and other aspects of the invention will become clear and explained with reference to the embodiments described below. Attached Figure Description

[0046] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0047] Exemplary embodiments of the present invention will be described with reference to the accompanying drawings, in which:

[0048] Figure 1 A schematic diagram of a cartridge according to an exemplary embodiment of the present invention is shown;

[0049] Figure 2 A schematic diagram of a reusable syringe device according to an exemplary embodiment of the present invention is shown;

[0050] Figure 3 It is a cross-section of the cartridge shown in a three-dimensional diagram;

[0051] Figure 4 This is a partial cross-section of a reusable autoinjector device shown in a three-dimensional diagram.

[0052] Figure 5A reusable autoinjector device and cartridge are shown;

[0053] Figure 6 It is a local cross-section aligned for assembly of a reusable autoinjector device and cartridge;

[0054] Figure 7 This is a detailed view of a reusable autoinjector;

[0055] Figure 8 It is a cross-section of the cartridge and reusable autoinjector device in its assembled, pre-use state.

[0056] Figure 9A to Figure 9C These are partial views of the cartridge and reusable autoinjector device in different assembly configurations;

[0057] Figure 10 It is a partial detailed view of the cartridge and reusable autoinjector device;

[0058] Figure 11 It is a partial cross-section of a cartridge and a reusable autoinjector device;

[0059] Figure 12 It is a partial cross-section of a cartridge and a reusable autoinjector device;

[0060] Figure 13 It is a partial cross-section of a cartridge and a reusable autoinjector device;

[0061] Figure 14 It is a partial cross-section of the cartridge and reusable automatic device in an assembled and ready state;

[0062] Figure 15 It is a detailed view of the cartridge and reusable autoinjector device;

[0063] Figure 16 It is a partial cross-section of the cartridge and reusable autoinjector device in an assembled configuration where drug delivery has been initiated;

[0064] Figure 17 It is a partial cross-section of the cartridge and reusable autoinjector device in the state after drug administration;

[0065] Figure 18 It is a partial cross-section of a cartridge and a reusable autoinjector device, wherein the cartridge case is in the needle protection position;

[0066] Figure 19 It is a detailed partial cross-section of the cartridge case;

[0067] Figure 20It is a partial cross-section of a cartridge and a reusable autoinjector device, wherein the cartridge is in the ejected position;

[0068] Figure 21 It is a detailed view of a cartridge and a reusable autoinjector device, with the cartridge in the ejected position;

[0069] Figure 22 Is it through Figure 21 The section captured by the view;

[0070] Figure 23 A cartridge and a reusable autoinjector device are shown, wherein the cartridge is in the ejected position;

[0071] Figures 24a and 24b are detailed cross-sections of a cartridge and a reusable auto-injector device according to another embodiment of the present invention;

[0072] Figures 25a and 25b are detailed cross-sections of a cartridge and a reusable auto-injector device according to another embodiment of the present invention;

[0073] Figure 26 This is a detailed cross-section of a cartridge and a reusable autoinjector device according to another embodiment of the present invention;

[0074] Figure 27 This is a detailed cross-section of a cartridge and a reusable autoinjector device according to another embodiment of the present invention; and

[0075] Figures 28a and 28b are detailed cross-sections of a cartridge and a reusable autoinjector device according to another embodiment of the present invention. Detailed Implementation

[0076] As described herein, drug delivery devices can be configured to inject medications into a patient. Delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by a patient or caregiver (such as a nurse or physician) and can include various types of safety syringes, pen syringes, or auto-injectors. The device can include a cartridge-based system that requires puncturing a sealed ampoule before use. The volume of medication delivered using these different devices can range from about 0.5 ml to about 2 ml. Another device can include a high-volume device (“LVD”) or patch pump configured to adhere to the patient’s skin for a sustained period of time (e.g., about 5 minutes, 15 minutes, 30 minutes, 60 minutes, or 120 minutes) to deliver a “large” volume of medication (typically about 2 ml to about 10 ml).

[0077] The device described herein can also be customized to operate within a desired specification, depending on the specific medication being administered. For example, the device can be customized to inject the medication over a specific time period (e.g., approximately 3 seconds to approximately 20 seconds for an autoinjector, and approximately 10 minutes to approximately 60 minutes for an LVD). Other specifications may include minimal or no discomfort, or specific conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations can arise from various factors, such as drug viscosity, ranging from approximately 3 cP to approximately 50 cP. Therefore, drug delivery devices will often include hollow needles in sizes ranging from approximately 25 to approximately 31. Common sizes are 27 and 29.

[0078] The delivery device described herein may also include one or more automated functions. For example, one or more of needle insertion, drug injection, and needle retraction may be automated. Energy for one or more automated steps may be provided by one or more energy sources. Energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, mechanical energy sources may include springs, levers, elastomers, or other mechanical mechanisms for storing or releasing energy. One or more energy sources may be combined into a single device. The device may further include gears, valves, or other mechanisms for converting energy into movement of one or more components of the device.

[0079] One or more automated functions of an autoinjector can be activated individually via an activation mechanism. This activation mechanism may include one or more of a button, lever, needle sleeve, or other activation components. Activation of an automated function can be a one-step or multi-step process. That is, a user may need to activate one or more activation components to trigger the automated function. For example, in a one-step process, a user may press the needle sleeve against their body to trigger drug injection. Other devices may require multi-step activation of the automated function. For example, a user may need to press a button and retract the needle sheath to trigger injection.

[0080] Furthermore, activation of one automation function can activate one or more subsequent automation functions, forming an activation sequence. For example, activation of a first automation function can activate at least two of needle insertion, drug injection, and needle retraction. Some devices may also require a specific sequence of steps to trigger one or more automation functions. Other devices may operate in independent sequences of steps.

[0081] Some delivery devices may include one or more functions of a safety syringe, pen injector, or autoinjector. For example, a delivery device may include a mechanical power source (as is typically seen in autoinjectors) and a dosage setting mechanism (as is typically seen in pen injectors) configured to automatically inject the medication.

[0082] The present invention relates to a drug delivery system 1, which includes a reusable syringe device 100 and a cartridge 200 for use with the reusable syringe device 100. Figures 2 to 2 9 illustrates an exemplary embodiment of the present invention.

[0083] In the foregoing description, the terms "orthogonal" and "inclined" are used. Correspondingly, orthogonal and inclined refer to a planar surface that is perpendicular to and inclined to the longitudinal axis of the cartridge or syringe device. The term "distal" refers to a position relatively closer to the injection site, and the term "proximal" refers to a position relatively farther from the injection site.

[0084] medicine tube

[0085] 200 cartridges Figure 3 The image is shown in a longitudinal section. The cartridge 200 is a single-use component attached to the reusable syringe device 100 to administer a dose of medication to a patient. The cartridge 200 includes a housing 210, a pre-filled syringe 230, and a cap 260.

[0086] The box 210 includes an elongated body 211 having an internal chamber 212 extending longitudinally along the body 211 and open at the distal end of the box 210. The proximal end of the internal chamber 212 is closed by a cap 260. A prefilled syringe 230 (also referred to herein as "PFS 230") is positioned within the internal chamber 212 and extends through it.

[0087] The body 211 includes three openings 213, 214, and 215 spaced apart in the longitudinal direction. Openings 213, 214, and 215 are referred to herein as distal opening 213, intermediate opening 214, and proximal opening 215. Intermediate opening 214 includes a proximal inclined surface 214' and a distal inclined surface 214'' to aid in alignment of the cartridge when loaded into the syringe device, as explained further below. Longitudinally extending clips 216 (hereinafter referred to as "cassette clips 216") are provided on either side of intermediate opening 214. These longitudinally extending clips include spring arms 217, each terminating in a retaining block 218. Retaining blocks 218 include curved, inwardly facing surfaces 218' configured to straddle corresponding lips in the device 100, thereby temporarily holding the cartridge 200 in the device 100. This is achieved by… Figure 11 A partial cross-section is shown, in which the cartridge 200 and the device 100 are assembled together.

[0088] Body 211 further includes a proximal tilted alignment surface 219 and a distal tilted alignment surface 220, for example, Figure 5As shown. Proximal inclined surfaces 219 are disposed on both sides of the proximal opening 215, while distal inclined surfaces 220 are disposed on both sides of the distal opening 213. The inclined alignment surfaces 219 and 220 are configured to engage the corresponding inclined surfaces of the device when the cartridge 200 is connected to the device 100, as will be explained further below.

[0089] The cap 260 includes a cylindrical body 261 having a distal region 261' and a proximal region 261''. The distal region has a first outer diameter, and the proximal region has a second outer diameter, the second diameter being larger than the first diameter. A shoulder 262 separates the distal region 261' from the proximal region 261''. When the cap 260 is attached to the cartridge 200, the shoulder 262 abuts against the proximal end of the cartridge 210, and the distal region 261' is received within the proximal end of the internal chamber 212.

[0090] The cap 260 includes two blocking elements 263. The blocking elements 263 extend from the shoulder 262 on opposite sides of the distal region 261'. The box 210 includes two longitudinal slots 221 extending from the proximal end of the body 211. The slots 221 are formed in opposite sides of the body 211 to each receive a corresponding blocking element 263 of the cap 260. These slots 221 and one of the blocking elements 263 are visible in the illustrations of Figures 9A to 9c. One of the blocking elements 263 is also... Figure 12 and Figure 13 It can be seen in more detail in the local cross-section.

[0091] The pre-filled syringe 230 includes a cylindrical vial 231 filled with medication, a stopper 232, a needle 233, a rigid needle guard (RNS) 234, and a piston 235. The stopper 232 seals the proximal end of the vial 231, and the piston 235 seals the distal end of the vial. The needle 233 extends through the stopper 232 and into the vial 231. The piston 235 is configured to be displaced proximally through the vial 231 during operation of the syringe device to dispense medication through the needle 233. The needle 233 protrudes from an opening in the proximal end of the cartridge 210 and is surrounded by the RNS 234. The RNS 234 is a cylindrical block with a cavity made of protective material in which the needle 233 extends. The RNS 234 fits snugly within the internal cavity 266 of the cap 260 such that when the cap 260 is removed, the RNS 234 is removed along with the cap 260.

[0092] Reusable syringe device

[0093] Figure 4 The reusable syringe device 100 is shown in partial cross-section; Figure 5A reusable syringe device 100 is shown, wherein a cartridge 200 is positioned for connection to the reusable syringe device 100. For simplicity, the reusable syringe device 100 is simply referred to herein as "device 100".

[0094] Device 100 includes a housing 110. The housing 110 is generally elongated and encloses the drive mechanism 120 of device 100 at its distal end. The proximal end of the housing 110 includes an opening 111 located in a lateral wall 112 to allow a cartridge 200 to be loaded into the housing 110. The cartridge 200 and housing 110 are configured such that the cartridge 200 is loaded into device 100 in a direction perpendicular to the longitudinal axis Xd-Xd of the device.

[0095] The device 100 further includes a spring-loaded carriage 140 (hereinafter referred to as "carriage 140"), a proximal boss 113, and a distal boss 114. The proximal boss 113 and the distal boss 114 are integrally formed with the housing 110 and spaced apart along the longitudinal axis of the housing. Both bosses 113 and 114 are disposed within the opening 111 to contact the cartridge when the cartridge 200 is inserted through the opening.

[0096] The carriage 140 is configured to abut against the carriage spring 140s (in Figure 2 (Schematably shown) It slides along the first inner surface 115 of the housing 110. Before using the device, the carriage 140 is in a first position, in which the carriage 140 is disposed within the opening 111. The carriage spring 140s is a helical spring extending between the distal end of the housing 110 and the distal end of the carriage 140. With the carriage 140 in the first position, the carriage spring 140s is in a partially depleted state, meaning that the carriage spring 140s is partially extended and can be compressed.

[0097] The carriage includes a carriage base plate 141, a platform 142 located on top of the carriage base plate 141, and a proximal alignment ramp 143 and a distal alignment ramp 144. The proximal alignment ramp 143 and the distal alignment ramp 144 extend above the platform 142 and are the first contact points between the carriage and the cartridge 200 when the cartridge 200 is attached to the carriage 140. The proximal alignment ramp 143 is positioned on both sides of the proximal boss 113, and the distal alignment ramp 144 is positioned on both sides of the distal boss 114. Proximal cutouts 145 and 146 in the carriage base plate 141 allow the carriage 140 to slide between different operating positions past bosses 113 and 114. A trailing arm 150 extends distally behind the carriage base plate 141 and contacts the drive mechanism 120. The trailing arm 150 holds the carriage 140 in a first position against the force of the carriage spring 140s.

[0098] Platform 142 includes an inclined proximal surface 148 and an inclined distal surface 149, as well as lips 147 extending longitudinally on both sides of platform 142. The inclined surfaces 148 and 149 are configured to engage the inclined surfaces 214' and 214'' of the central opening 214 of cartridge body 211 to further aid alignment. Lip 147 is shaped as a retaining block 218 that receives the clip 216 of cartridge body 211 to hold cartridge 200 to device 100.

[0099] The device 100 further includes a first pair of spring-loaded pins 116 and a second pair of spring-loaded pins 117, which extend from the inner surface of the housing 110, such as Figure 7 As shown. A first pair of spring-loaded pins 116 (hereinafter referred to as "first pins 116") extend from a first inner surface 115 of the housing 110 and are arranged to prevent distal movement of the carriage 140 prior to engagement of the cartridge 200. A second pair of spring-loaded pins 117 (hereinafter referred to as "second pins 117") are arranged such that each pin is disposed in an opposing wall of the housing 110. The two second pins 117 are located on a common axis and are arranged to engage corresponding slots 221 in the body 211 of the cartridge 210.

[0100] The drive mechanism 120 includes a piston rod 121 and a piston drive spring 121s (in Figure 2 (Schematally shown) and a pair of spring-loaded plunger interlocking pins 122. The plunger rod 121 is configured to engage the piston 235 and displace it under the force of the plunger rod spring 121s. Before using the device, the plunger rod 121 is in the pre-delivery position, which is the furthest position of the axial range of motion of the plunger rod. The plunger rod spring 121s is a helical spring extending between the distal end of the housing 110 and the distal end of the plunger rod 121. When the plunger rod 121 is in the pre-delivery position, the plunger rod spring 121s is in a stored state, meaning that the plunger rod spring 121s is compressed and ready to extend.

[0101] cartridge and device components

[0102] Figure 6 It is a partial cross-section of the cartridge 200 and the device 100, which are aligned but still separated for assembly. Figure 8 The same partial cross-section is shown, but the cartridge 200 and the device 100 are in an assembled, pre-use state, with the cartridge 200 connected to the device 100.

[0103] The cartridge 200 is connected to the device 100 by inserting it through the opening 111 in the housing 110. To achieve insertion through the opening 111, the cartridge 200 is aligned with the opening 111 (e.g., ...). Figure 5 As shown), then in the direction perpendicular to its axis Xc-Xc, in Figure 8Move in the direction of arrow A1. When the cartridge and device are assembled, their axes are coaxial.

[0104] Figures 9a and 9c illustrate the role of alignment surfaces 219 and 220 within the body 211 of cartridge 210. Figure 9a shows cartridge 210 positioned directly above carriage 140 and correctly aligned for assembly. In this position, cartridge 200 and device 100 can be assembled without any contact between alignment surfaces 219 and 220 and carriage 140. Figure 9b shows cartridge 200 positioned too proximally for proper alignment for assembly. In this position, as cartridge 200 is pushed into device (moving downwards) in a direction perpendicular to its axis, proximal alignment surface 219 contacts proximal inclined surface 143 of carriage 140. Surfaces 219 and 143 slide over each other to convert the downward movement of cartridge 200 into distal axial movement, thereby repositioning cartridge 200 to the correct position. Similarly, although not shown, if the cartridge 200 is positioned too far to the distal direction during initial positioning, the distal alignment surface 220 contacts the distal inclined surface 144 of the carriage 200 as the cartridge moves downward, causing surfaces 220 and 144 to slide over each other so that the cartridge 200 moves in the proximal direction for proper alignment.

[0105] Figure 9c shows cartridge 200 in its assembled position. The proximal inclined surface 144 and distal inclined surface 145 of carriage 140 abut against the corresponding proximal alignment surface 219 and distal alignment surface 220 of cartridge 210. In this way, the axial positions of carriage 140 and cartridge 210 are locked together. Any axial movement of cartridge 210 will cause a corresponding axial movement of carriage 140. Second pins 117 are aligned with corresponding longitudinal slots 221 in the cartridge body such that when cap 260 and blocking element 263 are removed, each pin 117 extends into its corresponding slot 221 to lock the cartridge to device 100, as... Figure 15 What is shown.

[0106] Figure 11 The diagram shows the cartridge clip 216 engaging with the lip 147 of the platform 142 of the carriage 140 when the cartridge 200 and device 100 are in the assembled state. As the cartridge 200 is pressed onto the carriage 140, the spring arm 217 of the clip 216 displaces outward through engagement of the curved, inward-facing surface 218' of the retaining block 218 with the corresponding lateral surface of the platform 142. This causes the retaining blocks 218 to straddle the lip 147, thereafter taking a seated position within the corresponding cutout of the platform 142, such as... Figure 11As shown. In this way, clip 216 is configured to temporarily hold cartridge 200 to device 100. “Temporarily” means that the operator can easily remove cartridge 200 by lifting it away from opening 111, provided that sufficient force is applied to overcome the force of spring arm 217 and cause retaining block 218 to disengage from the opening.

[0107] Figure 10 The interaction between the cartridge body 211 and the first pin 116 is shown when the cartridge 200 and the device 100 are in the assembled state. The cartridge body 211 compresses the first pin 116 so that the first pin 116 is flush with the first inner surface 115 of the housing 110. In this arrangement, the first pin 116 no longer prevents the distal movement of the carriage 140.

[0108] Figure 12 This is a partial cross-section showing the interaction between the cap 260 and the proximal boss 113 when the cartridge 200 and the device 100 are in an assembled state. The cap 260 further includes opposing slots 264', 264'' extending from the distal end of the cap 260. The slots 264', 264'' separate two segments 265 of the distal region 261' of the cap 260, which are freely hinged between the ends of the slots 264', 264''. The proximal boss 113 includes a tapered protrusion 113' configured to push the two segments 265 of the cap 260 apart by engaging the lower slot 264'' of the two slots 264', 264''. The slot 264' opposite to the lower slot 264'' is referred to herein as the upper slot 264'. The upper slot 264' receives a blocking element 222, which extends from the inner surface of the body 211 of the cartridge 210. The blocking element 222 prevents the cap 260 from being removed before the segment 265 is pushed apart by the proximal boss 113. This is because the distal end of the upper slot 264' includes a constriction 266 that is too narrow for the blocking element 222 to pass through if the user attempts to pull the cap 260 away from the cartridge 210 before inserting the cartridge into the device 100 (also as...). Figure 13 (As shown in a partial cross-section). When the cartridge 200 and the device 100 are in the assembled state, the tapered protrusion 113' of the distal boss 113 pushes the section 265 of the cap 260 apart, thereby widening the contraction section 266 so that the blocking element 222 can pass through the contraction section. Figure 14 As indicated by arrow A2. As will be understood, cap 260 is axially pulled away from cartridge 210 to separate cap 260 from the remainder of cartridge 200. With cap 260 removed, needle 233 is embedded within the proximal end of cartridge 210. This position of cartridge 210 relative to PFS 230 is referred to herein as the needle safe position.

[0109] Refer again Figure 8Before the cap 260 is removed, axial distal movement of the cartridge 200 is prevented by contact between the proximal boss 113 and the distal end of the cap 260. Any force applied to the cartridge 200 in the proximal direction is distributed into the boss 113 through the cap 260, thereby preventing relative movement between the cartridge 200 and the device 100.

[0110] The proximal boss 113 and the distal boss 114 engage the PFS 230 through corresponding proximal openings 215 and distal openings 213 in the body 211 of the box 211. The neck 236 of the vial 231 rests in the seat 113'' of the conical protrusion 113' of the proximal boss 113 (e.g., Figure 12 (As shown). Neck 236 is the region of vial 231 adjacent to stopper 232, and its outer diameter is smaller than the rest of the vial (visual body 237). Neck 236 extends outward to shoulder 238, where the relatively small outer diameter of neck 236 transitions to the relatively large outer diameter of vial body 237. Shoulder 238 abuts against the distal surface 113''' of tapered protrusion 113', thereby preventing any proximal movement of vial 231 relative to housing 110. Vial 231 also includes a flange 239 at its distal end. Flange 239 abuts against the proximal surface of lug 114' projecting from distal boss 114, thereby preventing any distal movement of vial 231 relative to housing 110. In this way, axial movement of PFS 230 relative to housing 110 is prevented.

[0111] Figure 14 This is a partial cross-section of the cartridge 200 and device 100 in their assembled and ready state, with the cap 260 removed. By removing the cap 260, the cartridge 210 can move freely in the distal direction relative to the housing 110 and PFS 230 to initiate injection (e.g. Figure 16 (As shown by arrow A3 in the image). Holding the housing 110, the user presses the proximal end of the cartridge 210 onto the injection site, thereby displacing the cartridge 210 on the carriage 140 a predetermined distance in the distal direction into the dose delivery position. In this example, the predetermined distance is set by the size of the proximal opening 215 in the body 211 of the cartridge 210. The cartridge 210 is displaced until the proximal surface 215' of the proximal opening 215 abuts against the proximal surface 113'''' of the adjacent side boss 113 (as shown by arrow A3 in the image). Figure 16(As shown). The predetermined distance is such that when the box 210 and the proximal boss 113 abut, the needle 233 protrudes from the proximal end of the box 210 by a distance equal to the desired subcutaneous drug delivery depth. In this example, the size of the distal opening 213 in the body 211 of the box 210 is such that the distal opening does not impede the movement of the box 210 over the predetermined distance. However, in another example, the predetermined distance may alternatively be set by the size of the distal opening 213, wherein, after the box 210 has moved the predetermined distance, the proximal surface 213' of the distal opening 213 abuts against the proximal surface 114'' of the distal boss 114.

[0112] As the cartridge 210 is displaced a predetermined distance, the PFS 230 remains fixed relative to the housing 110, held in place by the proximal boss 113 and the distal boss 114, as explained above. The vial 231 slides along the inner chamber 212 until the needle 233 protrudes from an opening in the distal end of the cartridge 210 and the cartridge 210 abuts against the side boss 114. The inner chamber 212 includes longitudinally extending ribs 223 spaced around the inner chamber 212 to engage the outer surface of the vial 231. The ribs 223 securely hold the PFS 230 within the inner chamber 212 while allowing the PFS 230 and the cartridge 210 to slide relative to each other.

[0113] Figure 16 This is a partial cross-section of the cartridge 200 and device 100 in an assembled configuration with drug delivery initiated. In this configuration, the cartridge 210 has been displaced distally by a predetermined distance, allowing the needle 233 to extend from the proximal end of the cartridge 210 into the injection site. The distal end of the cartridge 210 is received below the edge of the opening 111 in the housing 110, thereby completely enclosing the drive mechanism 120 for safe operation. The distal movement of the cartridge 210 and carriage 140 releases the plunger rod 121 to engage with the piston 235, thereby driving the piston 235 through the vial 231 under the force of the plunger rod spring 121s. Once the plunger rod 121 has completely traversed the vial 231, the cartridge 200 and device 100 are in the drug delivery completed state, as shown below. Figure 17 As shown. The user is then instructed to remove device 100 from the injection site.

[0114] The plunger rod 121 is released by a plunger rod release mechanism 190 (as shown in Figures 29a and 29b). The plunger rod release mechanism 190 is located adjacent to the distal region of the plunger rod 121 to avoid interfering with the operation of the housing 210. The plunger rod release mechanism 190 is powered by a battery (not shown) and includes a magnetic spring arm 191 (hereinafter referred to as spring arm 191 for simplicity) and an electromagnet 192. The electromagnet 192 forms part of a circuit including the battery. To release the plunger rod 121, the circuit is switched on, causing the electromagnet 192 to deflect the spring arm 191. The spring arm 191 is cantilevered to the housing 110 and includes a retaining block 193 at its end. The spring arm 191 biases the retaining block 193 toward the plunger rod 121. When the plunger rod 121 is in the pre-delivery position, the retaining block 193 engages the notch 126 in the plunger rod 121 to hold the plunger rod 121 against the force of the plunger rod spring 121s (as shown in FIG. 29a). When the housing 210 has shifted a predetermined distance distally, the housing 210 contacts the switch to connect the circuit. This activates the electromagnet 192 and causes the spring arm 191 to deflect outward away from the plunger rod 121, thereby releasing the retaining block 193 from the notch 126 (as shown in FIG. 29b). The plunger rod 121 is then freely advanced proximally under the force of the plunger rod spring 121s.

[0115] The switch may be a conductive contact (not shown) located at the distal end of housing 210. The conductive contact may bridge gaps in the circuit. For ease of manufacture, the circuit may include conductive tracks printed onto the inner surface of housing 110.

[0116] It should be understood that the exact manner in which the plunger rod 121 is released can vary, and other solutions can be implemented without departing from the scope of the invention.

[0117] A plunger interlock pin 122 is provided to stabilize the carriage 140, such as Figure 16 As shown, two interlocking pins 122 are provided, one on each side of the plunger rod 121. When the carriage 140 has been displaced a predetermined distance, the proximal end of each pin 122 is received in a corresponding hole positioned on the adjacent distal inclined surface in the carriage.

[0118] Each pin 122 is connected to a lug 123 of the drive mechanism 120 via a compression coil spring 124. The distal region of the interlocking pin 122 includes a shoulder 122', on which the proximal end of the corresponding coil spring 124 abuts. The lug 123 is rigidly connected to the plunger rod 121, such that displacement of the plunger rod 121 causes displacement of the compression coil spring 124, which in turn applies a force to the associated interlocking pin 122. The proximal region of each pin 122 slides freely through an associated hole 149 in the carriage 140 until the shoulder 122' abuts the distal surface of the carriage 140. As the interlocking pin 122 moves proximally, it engages a corresponding hole (not shown) in the body 211 of the cartridge 210. This helps stabilize the cartridge 210 as the plunger rod 121 displaces. Once the plunger rod 121 has completely traversed the vial (as shown in the image), the force is released. Figure 17 As shown), the compression spring 124 is compressed between its corresponding shoulder 122' and lug 123. This compression of the spring 124 exerts an additional proximal force on the carriage 140.

[0119] Before the plunger rod 121 is released, the trailing arm 150 of the carriage 140 extends to contact the distal end of the plunger rod 121, meaning that the mechanism holding the plunger rod 121 against the plunger drive spring 121s also holds the carriage 140 against the carriage spring 140s. After the plunger rod 121 is released, as the device 100 is removed from the injection site, the carriage 140 allows the cartridge 210 to move freely into the needle protection position, as... Figure 18 As shown, in the needle-protected position, the cartridge 210 is positioned further forward relative to the PFS 230 and the housing 110 than before injection when the cartridge 210 is in the initial needle-protected position (i.e., further along the proximal direction).

[0120] When the user lifts the device 100 away from the injection site, the carriage 140 and the housing 210 are proximal relative to the housing 110 and PFS 230 under the force of the carriage spring 140s and the compression spring 124 of the drive mechanism 120. The limit of this proximal movement is determined by the size of the distal cutout 146 in the base plate 141 of the carriage 140, wherein the carriage 140 is driven forward until the distal surface 146' of the cutout 146 abuts against the distal boss 114.

[0121] The box 210 further includes a locking mechanism 224 configured to engage the flange 239 of the vial 231 when the box 210 is in the needle-protected position. The locking mechanism 224 is composed of… Figure 19The device includes two resilient flexible arms 2241 extending within opposing cutouts 225 in the wall of an internal chamber 212. Each arm 2241 is integrally formed with the body 211 of the cassette 210 and extends distally from its attachment point to the wall of the internal chamber 212. The distal end of each arm 2241 includes a retaining block 2242 configured to lock the flange 239 of the vial 231. The retaining block 2242 includes an inclined surface 2243 leading to a pawl 2244 in which the flange 239 is received when locked to the cassette 210. After the device 100 is removed from the injection site, forward movement of the cassette 210 drives the inclined surface 2243 of the retaining block 2242 across the flange 239, thereby displacing the flexible arms 2241 outward until each pawl 2244 engages with the flange 239.

[0122] After removing the device from the injection site, the drive mechanism is then reset by moving the plunger rod 121 distally to compress the plunger drive spring 121s until the plunger rod 121 reaches its pre-injection position. Figure 20 As shown in Figures 29a and 29b, a plunger rod reset mechanism 194 (referred to herein as reset mechanism 194 for simplicity) is provided for this purpose. The reset mechanism 194 includes a pinion 195 with gears that cooperates with a rack 196 disposed in the distal region of the plunger rod 121. During operation, the pinion 195 rotates to drive the plunger rod 121 in the distal direction. The pinion 195 is powered by an electric motor 197, which is connected to a battery via circuitry. The reset mechanism 194 may share the battery of the plunger rod release mechanism 190.

[0123] The electric motor 197 is activated by a switch. The switch includes a conductive contact (not shown) disposed on the carriage 140, which bridges gaps in the circuit when the carriage 140 is advanced to its nearest side position. In this example, the circuit is broken again by a second switch when the plunger rod 121 returns to its pre-injection position. The second switch may be a conductive contact on the spring arm 191 that breaks the circuit when the retainer 193 returns to the notch 126 on the plunger rod 121. For ease of manufacture, the circuit may include conductive tracks printed onto the inner surface of the housing 110.

[0124] It should be understood that the exact manner in which the plunger rod 121 returns to its pre-injection position can vary, and other solutions can be implemented without departing from the scope of the invention.

[0125] With the plunger rod 121 returning to its pre-delivery position, the carriage 140 moves to a first position through contact between the plunger rod 121 and the drag arm 150. This causes the proximal end of the cartridge 210 to be ejected in the direction indicated by arrow A4. This ejection is caused by the interaction between the proximal inclined surface of the carriage 140 and the proximal inclined alignment surface of the cartridge body, as... Figure 21 As shown. When the carriage moves in the distal direction, the distal force exerted on the box by the interaction of the inclined planes is decomposed by the vial flange and the distal boss, thereby preventing distal movement of the box. The interaction of the inclined planes further exerts a force perpendicular to the axis of the device, such as... Figure 21 As indicated by arrow F1. This vertical force overcomes the cartridge clips, which disengage from the carriage to allow removal of the used cartridge 200. Figure 23 The used cartridge 200, which is presented as to be removed, is shown.

[0126] Figure 22 The ejection of cartridge 200 causes the first pin 116 to be released from its obstruction. Pin 116 thus returns freely to its position above the first inner surface of the housing, preventing the carriage from shifting from the first position. The device 100 can be reused if the used cartridge is removed.

[0127] In another embodiment of the invention, where the same features retain the same reference numerals, the ejection of the cartridge 200 may be assisted by an ejection mechanism 270, schematically shown in Figures 24a to 25b. In Figures 24a and 24b, the mechanism 270 includes a double-bar linkage 271 comprising an L-shaped bar 272 connected to a second bar 273 via a hinge 274. The L-shaped bar 272 includes a reaction member 272' extending into the path of the plunger rod 121; and a connecting member 272'' extending perpendicular to the reaction member 272' in the longitudinal direction of the device. Prior to operation of the ejection mechanism 270, the double-bar linkage 271 folds itself so that the second bar 273 extends over the connecting member 272'' of the L-shaped bar 272. The double-bar linkage 271 is biased in the proximal direction by a spring 275. As the plunger rod 121 returns to its pre-injection position, it contacts the reaction member 272' to pull the connecting member 272'' distally. This causes the double-bar linkage 271 to unfold and the second rod 273 to press the cartridge release button 276 toward the cartridge 210. When the release button 276 engages the cartridge 210, it pushes the cartridge 210 out of the opening 111, disengaging the cartridge clip 216.

[0128] In Figures 25a and 25b, an alternative ejection mechanism 270 is provided, which includes an L-shaped member 277 and a cam follower 278. The L-shaped member 277 includes a reaction member 277' extending into the path of the plunger rod 121; and a connecting member 277'' extending perpendicular to the reaction member 277' in the longitudinal direction of the device 100. A cam track 279 with an inclined surface 279' is provided in the connecting member 277''. The cam follower 278 is seated in the cam track 279 and connected to the cartridge release button 276. The L-shaped member 277 is biased in the proximal direction by a spring 275. When the plunger rod 121 returns to its pre-injection position, the plunger rod contacts the reaction member 277' to pull the connecting member 277'' in the distal direction. As the connecting member 277'' moves, the cam follower 278 traverses the cam track 279 and moves toward the box 210, thereby pressing the release button 276. When the release button 276 engages the box 210, it pushes the box 210 out of the opening 111, causing the box clip 216 to disengage.

[0129] exist Figure 26 In another example shown, the ejection mechanism 270 is simplified and consists only of a release button 276. When it is desired to remove the cartridge 200 from the device 100, the user can manually press the release button 276.

[0130] In another embodiment of the invention, where the same features retain the same reference numerals, the cap 260 may include a simplified release mechanism, such as... Figure 27 As shown. In this embodiment, the cap 260 is attached to the body 210 of the cartridge 200 via a flexible clip 267. The clip 267 includes a blocking element 2671 having an inclined surface 2671'. The inclined surface 2671' is positioned within the proximal opening 215. When the cartridge 200 is combined with the device 100, a surface of the device 100 contacts the inclined surface 2671', thereby releasing the blocking element 2671 from the proximal opening 215 and allowing the cap 260 to be removed.

[0131] In another embodiment of the invention, where the same features retain the same reference numerals, the interlocking pin 122 is replaced by sliding panels 125 that move into a cutout 118 in the inner surface of the housing 110. The cutout 118 is configured to adjoin the cartridge clip 216 when the cartridge 200 and device 100 are combined, and to allow the clip 216 to displace outward during insertion and removal of the cartridge 200. The sliding panels 125 are connected to the plunger rod 121 and configured such that when the plunger rod 121 is displaced into the vial 231, the sliding panels 125 fill the cutout 118, thereby locking the cartridge 210 to the carriage 140. When the plunger rod 121 returns to its pre-injection position, the sliding panels 125 are removed from the cutout 118 to allow the cartridge 200 to be removed from the device 100.

[0132] While the above embodiments relate to a mechanical device 100, specifically the energy sources for its drive mechanism 120 and carriage 140, including springs 121s and 140s, it should be understood that other energy sources can be used. For example, batteries and linear actuators can be used. This arrangement will be understood by those skilled in the art and will not be elaborated upon here.

[0133] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0134] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0135] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0136] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index 15.

[0137] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0138] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0139] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0140] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0141] Examples of oligonucleotides include, for instance, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0142] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0143] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0144] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0145] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0146] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0147] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0148] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0149] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0150] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0151] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0152] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0153] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0154] The operation of a drug delivery system can be summarized in the following steps:

[0155] S1 - The system operator begins by retrieving cartridge 200 from the storage area. The storage area can be a refrigerator or other suitable storage area for storing the medicines used.

[0156] S2 – The operator inserts the cartridge 200 through the opening 111 in the housing 110 and attaches the box 210 to the carriage 140.

[0157] S3 – The operator pulls the cap 260 and the box 210 apart.

[0158] S4 – The operator presses the proximal end of the cartridge 210 against the patient's injection site, causing the cartridge 210 to shift into the housing 110. This allows the needle 233 to penetrate the injection site, and the plunger rod 121 is released to dispense the medication.

[0159] S5 – The operator lifts the device 100 away from the injection site. This causes the cartridge 210 to be pushed back away from the housing 110 to surround the needle 233.

[0160] S6 – Device 100 is reset, thereby returning plunger rod 121 to the pre-delivery position.

[0161] S7 – The operator removes the cartridge 200 from the device 100, thereby allowing the device 100 to be reused by repeating steps S1 to S6.

[0162] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0163] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0164] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0165] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index 15.

[0166] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0167] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0168] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29. LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0169] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0170] Examples of oligonucleotides include, for instance, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0171] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0172] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0173] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0174] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(a'')2 fragments, which retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0175] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(a'')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0176] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0177] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0178] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0179] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0180] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:201(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0181] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0182] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0183] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems and embodiments of the substances described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0184] List of reference numerals

[0185] 100 – Device

[0186] 110 – Housing

[0187] 111 – Opening

[0188] 112 – Lateral wall

[0189] 113 – Proximal boss (which has: a tapered protrusion 113'; a seat 113''; a distal surface 113'''; and a proximal surface 113'''')

[0190] 114 – Distal boss (which has: lug 114'; proximal surface 114'')

[0191] 115 – First internal surface

[0192] 116 – First spring support pin (first pin)

[0193] 117 – Second pair of spring pins (second pin)

[0194] 118 – Incision

[0195] 120 – Drive mechanism

[0196] 121 – Piston Rod

[0197] 121s – Piston Drive Spring

[0198] 122 – Plunger interlock pin (which has: shoulder 122')

[0199] 123 – Protruding ears

[0200] 124 – Compression Coil Spring

[0201] 125 – Sliding Panel

[0202] 126 - Notch

[0203] 140 – Carriage

[0204] 140s – Carriage Spring

[0205] 141 – Base Plate

[0206] 142 – Platform

[0207] 143 – Proximal inclined surface

[0208] 144 – Distal inclined surface

[0209] 145 – Proximal incision

[0210] 146 – Distal incision

[0211] 147 – Lip Edge

[0212] 148 – Incision

[0213] 149 – Hole (for receiving interlocking pins)

[0214] 150 – Trailing Arm

[0215] 190 – Plunger rod release mechanism

[0216] 191 – Magnetic Spring Arm (also known as “Spring Arm”)

[0217] 192 – Electromagnet

[0218] 193 – Retention Block

[0219] 194 – Plunger rod reset mechanism (also known as “reset mechanism”)

[0220] 195 – Small gear with gears

[0221] 196 – Rack and pinion

[0222] 197 – Electric Motor

[0223] 200 – Medicine cartridge

[0224] 210 – Box

[0225] 211 – Ontology

[0226] 212 – Internal chamber

[0227] 213 – Distal opening (which has: proximal surface 213')

[0228] 214 – Open in the middle

[0229] 215 – Proximal opening (which has: proximal surface 215')

[0230] 216 – Longitudinal extension clip (also known as “box clip 216”)

[0231] 217 – Spring Arm

[0232] 218 – Retention block (which has: a curved, inward-facing surface 218')

[0233] 219 – Proximal tilt alignment surface (also known as “proximal alignment surface 219”)

[0234] 220 – Distal tilt alignment surface

[0235] 221 – Longitudinal slot

[0236] 222 – Blocking element

[0237] 223 – Longitudinal ribs

[0238] 224 – Locking Mechanism

[0239] 2241 – Flexible arm of locking mechanism

[0240] 2242 – Retention Block

[0241] 2243 – Inclined Surface

[0242] 2244 - Razor Claw

[0243] 225 – Incision in the wall of the internal chamber

[0244] 230 – Prefilled syringe (PFS)

[0245] 231 – Small Bottle

[0246] 232 – Stopper

[0247] 233 – Needle

[0248] 234 – Rigid Needle Shield (RNS)

[0249] 235 – Piston

[0250] 236 – Neck of the small bottle

[0251] 237 – Vial body

[0252] 238 – Shoulder

[0253] 239 - Flange

[0254] 260 – Hat

[0255] 261 – Cylindrical body (which has: distal region 261'; proximal region 261'')

[0256] 262 - Shoulders

[0257] 263 – Blocking element

[0258] 264 – Slotted opening (which has: upper slot 264', lower slot 264'')

[0259] 265 – Section

[0260] 266 – Contraction section

[0261] 267 – Flexible clip

[0262] 2671 – Blocking element (which has: inclined surface 2671')

[0263] 270 – Ejection Mechanism

[0264] 271 – Double-bar linkage

[0265] 272 – L-shaped bar (which has: reaction member 272'; connecting member 272'')

[0266] 273 – Second Shot

[0267] 274 – Hinge

[0268] 275 – Spring

[0269] 276 – Cartridge Release Button

[0270] 277 – L-shaped member (which has: reaction member 277'; connecting member 277'')

[0271] 278 – Cam Follower

[0272] 279 – Cam track (which has: inclined surface 279').

Claims

1. A reusable syringe device (100) for use with a cartridge (200), the cartridge comprising a box (210) for receiving a pre-filled syringe (230), the reusable syringe device comprising: Casing (110); as well as Drive mechanism (120), which is disposed in the housing; The drive mechanism has a plunger rod (121) configured to dispense medication from a pre-filled syringe during use; The housing includes bosses (113, 114) configured to engage a prefilled syringe when the cartridge and the reusable syringe assembly are combined and to fix the prefilled syringe relative to the housing.

2. The reusable syringe device (100) according to claim 1, wherein, The housing is elongated and includes an opening (111) in the side wall (112) of the housing. The device (100) is configured to be combined with the cartridge by moving the cartridge through the opening in a direction perpendicular to the longitudinal axis of the device.

3. The reusable syringe device (100) according to claim 1 or claim 2, further comprising a carriage (140); and in, The carriage is configured to cooperate with the cartridge (210) of the cartridge (200) to releasably retain the cartridge within the housing (110) against a carriage spring (140s). The carriage can slide within the housing against the carriage spring (150s) to move relative to the boss; and Optionally, the slide spring (150s) is configured to move the cartridge between a needle-safe position and a dose delivery position when the cartridge (200) and the reusable syringe device are combined.

4. The reusable syringe device (100) according to any one of the preceding claims, wherein, The plunger rod (121) is movable between a pre-delivery position and a second position, in which the cartridge (200) can be combined with or separated from the reusable syringe device, and the second position is used to dispense medication from the pre-filled syringe when the cartridge and the reusable syringe device are combined.

5. The reusable syringe device (100) according to claim 4, wherein, The carriage (140) includes an arm (150) arranged to contact the plunger rod (121) when the plunger rod is in the pre-delivery position. The contact between the arm and the plunger rod defines the first proximal extension limit of the carriage spring (150s) to hold the carriage in the first position; and After the plunger rod moves to the second position, the carriage moves freely to the second position under the force of the carriage spring. This second position is closer to the proximal side than the first position. Optionally, when the carriage is in the second position, the surface of the carriage abuts against the surface of the boss to limit the second proximal extension limit of the carriage spring.

6. The reusable syringe device (100) according to claim 4 or claim 5, wherein, The drive mechanism (120) further includes an interlocking pin (122) configured to engage the carriage (140) and the cartridge when the cartridge (200) and the reusable syringe device are combined, during the movement of the plunger rod (121) between the first position and the second position.

7. The reusable syringe device (100) according to any one of the preceding claims, wherein, The protrusion includes a separate proximal protrusion and a distal protrusion (113, 114) which are arranged to engage the respective ends of the prefilled syringe (230) through the proximal opening and the distal opening (215, 213) in the cartridge (210) when the cartridge (200) and the reusable syringe device are combined.

8. A cartridge (200) for use with a reusable syringe device (100), the cartridge comprising: Box (210); Hat (260); as well as A pre-filled syringe (230) comprising a needle (233) is contained within the box; The cap covers the needle; The cartridge is configured to allow relative movement between the cassette and the pre-filled syringe after the cap is removed, and The cartridge is configured to prevent axial movement of the prefilled syringe relative to the housing (110) of the device (100) when the cartridge is connected to the device.

9. The cartridge case (200) according to claim 8, wherein, Before using the cartridge with the reusable syringe device (100), lock the cap (260) to the box (210).

10. The cartridge case (200) according to claim 9, wherein, The cap (260) includes a distal region (261') extending into the cartridge (210), the distal region including flexible segments (265) extending around a blocking element (222) of the cartridge, the flexible segments being configured to prevent removal of the cap before the cartridge is used with a reusable syringe device (100).

11. A drug delivery system, comprising: The reusable syringe device (100) according to any one of claims 1 to 7. as well as The cartridge (200) according to any one of claims 8 to 10; The cartridge (210) is displaced within the housing of the reusable syringe device relative to the pre-filled syringe (230) of the cartridge, so that the cartridge can move between a needle-safe position and a dose delivery position, in which the needle (233) is embedded in the proximal end of the cartridge, and in the dose delivery position, the needle extends from the proximal end of the cartridge.

12. The drug delivery system according to claim 12, in, When the cartridge (200) and the reusable syringe device (100) are combined, the cap (260) of the cartridge abuts against the boss of the device, thereby preventing the cartridge (210) from moving within the housing (100) until the cap is removed.

13. The drug delivery system according to claim 12, in, The boss is configured to separate the flexible sections (265) of the cap (260) when the cartridge (200) and the reusable syringe device (100) are combined, so as to release these flexible sections from the blocking element (222) of the cartridge and allow the cap to be removed from the cartridge (210).

14. The drug delivery system according to any one of claims 11 to 13, wherein the drug delivery system is configured such that when a distal force is applied to the proximal end of the cartridge (210) after the reusable syringe device (100) and the cartridge (200) are combined, the cartridge slides in the distal direction between the needle safety position and the dose delivery position.

15. The drug delivery system according to any one of claims 11 to 14, wherein, With the carriage (140) of the reusable syringe device (100) in the second position, the locking mechanism (224) of the cartridge (210) engages the distal flange (239) of the prefilled syringe (230) to the cartridge (210).

Images