A medicament delivey 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 can be separated following 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) provided 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) to engage the pre-filled syringe and fix the pre-filled syringe relative to the housing following combination of the cartridge and the device. The cassette is displaceable within the housing relative to the pre-filled syringe to move the cassette between a needle safe position, in which the needle is recessed 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

[0001] A MEDICMENT DELIVEY SYSTEM

[0002] FIELD OF INVENTION

[0003] The present invention relates to a medicament delivery system comprising a cartridge and reusable injector device.

[0004] BACKGROUND

[0005] Medicament delivery devices, such as auto-injectors, are known in the art for dispensing a medicament to an injection site of a patient. Such medicament delivery devices typically comprise needle in fluid communication with a syringe and a piston rod that is moveable to dispense the medicament within the syringe through the needle into the injection site.

[0006] In such medicament delivery devices the piston rod is biased towards the injection site to dispense the medicament. Once the medicament has been dispensed, the needle is covered by a needle shield and / or needle cover and the medicament delivery device is dispensed of.

[0007] SUMMARY

[0008] In a first aspect of the invention, there is provided a reusable injector device for use with a cartridge containing a pre-filled syringe, the device comprising a housing and a drive mechanism provided in the housing, the drive mechanism having a plunger rod configured to dispense medicament from the pre-filled syringe in use; wherein the housing comprises a boss to engage the pre-filled syringe and fix the pre-filled syringe relative to the housing when the cartridge and the device are combined.

[0009] By providing a reusable injector device, less material need be discarded following medicament delivery.

[0010] The housing may be elongate and may comprise an opening in a lateral wall of the housing. The device may be configured for combination with a cartridge by moving a cartridge through the opening in a direction perpendicular to a longitudinal axis of the device.

[0011] Therefore, the device is configured for easy combination with a cartridge by pressing the cartridge into the housing between forefinger and thumb. The device may comprise a carriage configured to releasably hold the cartridge in use, the carriage being slidable within the housing against a carriage spring to move relative to the boss.

[0012] The carriage of the device may be configured to cooperate with a cassette of a cartridge to releasably hold the cassette within the housing against a carriage spring. The carriage spring may be configured to move the cassette between a needle safe position and a dose delivery position, when a cartridge and the device are combined.

[0013] By providing a spring-loaded carriage for attachment to the cassette, the cassette is biased into the needle safe position. Furthermore, this design allows the spring components to be provided in the reusable part of the medicament delivery system, reducing the number of components that are disposed of following medicament delivery.

[0014] The boss may comprise separate proximal and distal bosses that are arranged to engage respective ends of the pre-filled syringe in use.

[0015] The plunger rod may be moveable between a pre-delivery position, in which the cartridge may be combined or separated from the device, and a second position to dispense medicament from the pre-filled syringe.

[0016] The carriage may comprise an arm that is arranged for contact with the plunger rod when the plunger rod is in the pre-delivery position, the contact between the arm and the plunger rod defining a first limit of proximal extension of the carriage spring to retain the carriage in a first position; and wherein following movement of the plunger rod into the second position, the carriage is free to move under the force of the carriage spring into a second position, the second positing being further along in the proximal direction than the first position; and, optionally, wherein a surface of the carriage abuts a surface of the boss when the carriage is in the second position to define a second limit of proximal extension of the carriage spring.

[0017] The drive mechanism may comprise an interlock pin configured to engage the carriage, and a cassette when a cartridge and the device are combined, during movement of the plunger rod between the first and second positions.

[0018] The interlock pin locks the cassette to the carriage during medicament delivery, to prevent the cartridge becoming dislodged by improper handling of the device when combined with a cartridge. In a second aspect of the invention, there is provided a cartridge for use with a reusable injector device, the cartridge comprising a cassette, a cap and a pre-filled syringe comprising a needle, the pre-filled syringe being housed within the cassette, the cartridge being configured to allow relative movement of the cassette and the pre-filed syringe following removal of the cap, and wherein the cartridge is configured to prevent axial movement of the pre-filled syringe relative to the housing of the device and to allow the cassette to move in a distal direction relative to the housing of the device, when the cartridge is connected to the device.

[0019] The cap may be locked to the cassette prior to use of the cartridge with the device.

[0020] The cap may comprise a distal region that extends into the cassette, the distal region comprising two flexible segments that extend around a blocking element of the cassette to prevent the cap’s removal prior to use of the cartridge with the device.

[0021] In a third aspect of the invention, there is provided a medicament delivery system comprising a reusable injector device and a cartridge; the cartridge and device being combinable for medicament delivery and separable thereafter; the cartridge comprising a cassette and a prefilled syringe comprising a needle, the pre-filled syringe being housed within the cassette; the injector device comprising a housing and a drive mechanism provided in the housing, the drive mechanism having a plunger rod configured to dispense medicament from the pre-filled syringe in use; wherein the housing comprises a boss to engage the pre-filled syringe and fix the prefilled syringe relative to the housing following combination of the cartridge and the device, the cassette being displaceable within the housing relative to the pre-filled syringe to move the cassette between a needle safe position, in which the needle is recessed within a proximal end of the cassette, and a dose delivery position in which the needle extends from the proximal end of the cassette.

[0022] Therefore, a medicament delivery system is provided in which components of the system are reusable, reducing waste. Furthermore, the cartridge is simply formed, allowing the cassette to both be a housing for the prefilled syringe and a movable needle guard. This eliminates the need for a separate needle guard and reduces the number of components that are disposed of following medicament delivery.

[0023] The housing may be elongate and comprise an opening in a lateral wall of the housing, the cartridge and device being configured for combination by moving the cartridge through the opening in a direction perpendicular to a longitudinal axis of the device. Therefore, the device and cartridge are configured for easy combination by pressing the cartridge into the housing between forefinger and thumb.

[0024] The device may comprise a carriage; wherein the carriage and the cassette are configured to cooperate to releasably hold the cassette within the housing when the cartridge and device are combined, the carriage being slidable within the housing against a carriage spring to move the cassette between the needle safe position and the dose delivery position; and, optionally, wherein the cassette comprises clips that are configured to releasably attach to the carriage.

[0025] By providing a spring-loaded carriage for attachment to the cassette, the cassette is biased into the needle safe position. Furthermore, this design allows the spring components to be provided in the reusable part of the medicament delivery system, reducing the number of components that are disposed of following medicament delivery.

[0026] The cartridge may comprise a cap that encloses the needle, the cap being locked to the cassette prior to combination of the cartridge and the device.

[0027] Therefore, the needle is completely enclosed prior to use, eliminating the risk of any needle stick injury.

[0028] The cap may abut the boss when the cartridge and device are combined so that movement of the cassette within the housing is prevented prior to the removal of the cap.

[0029] By preventing the movement of the cassette within the housing prior to removal of the cap, relative movement of the needle and the cassette are also prevented when the cap is attached. This means that damage to the needle that might otherwise occur by an unwanted interaction between the needle and the cap is prevented.

[0030] The device may be configured to unlock the cap when the cartridge and the device are combined to allow the cap to be removed from the cassette.

[0031] Therefore, the action of combining the cartridge and the cassette enables the removal of the cap, removing any additional steps that may be required to unlock the cap and ensuring ease of use.

[0032] The cap may comprise a distal region that extends into the cassette when the cassette and cap are attached, and wherein the distal region comprises two flexible segments that extend around a blocking element of the cassette to prevent the cap’s removal prior to the cartridge and device being combined; wherein the boss is configured to separate the segments of the cap to release the segments from the blocking element when the cartridge and device are combined and to allow the cap to be removed from the cassette; and, optionally, wherein the boss comprises a tapered projection configured to separate the segments of the cap.

[0033] Therefore, the cap release mechanism makes use of the boss, making for a mechanically simple solution.

[0034] The boss may comprise separate proximal and distal bosses that are arranged to engage respective ends of the pre-filled syringe through proximal and distal openings in the cassette.

[0035] In this way, the prefilled syringe may be constrained in a longitudinal direction of the device by simple abutment of surfaces.

[0036] The system may be configured so that when a distal force is applied to a proximal end of the cassette following combination of the device and the cassette, the cassette slides in a distal direction between the needle safe position and the and the dose delivery position.

[0037] Therefore, medicament delivery can be simply effected by pressing the proximal end of the cassette down onto an injection site.

[0038] A surface of the cassette may abut a surface of the boss when the carriage is in the dose delivery position.

[0039] The plunger rod may be moveable between a pre-delivery position, in which the cartridge may be combined or separated from the device, and a second position to dispense medicament from the pre-filled syringe.

[0040] The carriage may comprise an arm that is arranged for contact with the plunger rod when the plunger rod is in the pre-delivery position, the contact between the arm and the plunger rod defining a first limit of proximal extension of the carriage spring to retain the carriage in a first position; and wherein following movement of the plunger rod into the second position, the carriage is free to move under the force of the carriage spring into a second position, the second positing being further along in the proximal direction than the first position; and, optionally, wherein a surface of the carriage abuts a surface of the boss when the carriage is in the second position to define a second limit of proximal extension of the carriage spring. With the carriage in the second position, a lockout mechanism of the cassette may engage a distal flange of the pre-filed syringe to lock the pre-filed syringe to the cassette.

[0041] In this way, separation of the pre-filed syringe and the cassette is prevented following medicament delivery. Therefore, the needle remains shielded after use.

[0042] The drive mechanism may further comprise an interlock pin configured to engage the carriage and the cassette during movement of the plunger rod between the first and second positions.

[0043] The interlock pin locks the cassette to the carriage during medicament delivery, to prevent the cartridge becoming dislodged by improper handling of the system.

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

[0045] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0046] BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0048] Exemplary embodiments of the present invention are described with reference to the accompanying drawings, in which:

[0049] Fig. 1 shows a schematic view of a cartridge according to an exemplary embodiment of the invention;

[0050] Fig. 2 shows a schematic view of a reusable injector device according to an exemplary embodiment of the invention;

[0051] Fig. 3 is a section of the cartridge shown in perspective;

[0052] Fig. 4 is a partial section of the reusable auto injector device shown in perspective view;

[0053] Fig. 5 shows the reusable auto injector device and the cartridge;

[0054] Fig. 6 is a partial section of the reusable auto injector device and the cartridge aligned for assembly;

[0055] Fig. 7 is a detail view of the reusable auto injector;

[0056] Fig. 8 is a section of the cartridge and the reusable auto injector device in an assembled preuse state; Figs. 9A-9C are partial views of the cartridge and the reusable auto injector device in varying states of assembly;

[0057] Fig. 10 is a partial, detail view of the cartridge and the reusable auto injector device;

[0058] Fig. 11 is a partial section of the cartridge and the reusable auto injector device;

[0059] Fig. 12 is a partial section of the cartridge and the reusable auto injector device;

[0060] Fig. 13 is a partial section of the cartridge and the reusable auto injector device;

[0061] Fig. 14 is partial section of the cartridge and the reusable auto device in an assembled and primed state;

[0062] Fig. 15 is a detail view of the cartridge and the reusable autoinjector device;

[0063] Fig. 16 is a partial section of the cartridge and the reusable autoinjector device in an assembled and dose-initiated configuration;

[0064] Fig. 17 is a partial section of the cartridge and the reusable autoinjector device in an end of dose state;

[0065] Fig. 18 is a partial section of the cartridge and the reusable autoinjector device with a cassette of the cartridge in a needle shielding position;

[0066] Fig. 19 is a detail, partial section of the cartridge;

[0067] Fig. 20 is a partial section of the cartridge and the reusable autoinjector device with the cartridge in an ejected state;

[0068] Fig. 21 is a detail view of the cartridge and the reusable autoinjector device with the cartridge in the ejected state;

[0069] Fig. 22 is a section taken through the view of Fig. 21 ;

[0070] Fig. 23 shows the cartridge and the reusable autoinjector device with the cartridge in the ejected state;

[0071] Figs. 24a-24b is a detail section of the cartridge and the reusable autoinjector device according to another embodiment of the invention;

[0072] Figs. 25a-25b is a detail section of the cartridge and the reusable autoinjector device according to another embodiment of the invention;

[0073] Fig. 26 is a detail section of the cartridge and the reusable autoinjector device according to another embodiment of the invention;

[0074] Fig. 27 is a detail section of the cartridge and the reusable autoinjector device according to another embodiment of the invention; and

[0075] Figs. 28a-28b is a detail section of the cartridge and the reusable autoinjector device according to another embodiment of the invention.

[0076] DETAILED DESCRIPTION

[0077] A drug delivery device, as described herein, may be configured to inject a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector. The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml. Yet another device can include a large volume device (“LVD”) or patch pump, configured to adhere to a patient’s skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volume of medicament (typically about 2 ml to about 10 ml).

[0078] In combination with a specific medicament, the presently described devices may also be customized in order to operate within required specifications. For example, the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.

[0079] The delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.

[0080] The one or more automated functions of an auto-injector may each be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament. Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection. In addition, activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, activation of a first automated function may activate at least two of needle insertion, medicament injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate with a sequence of independent steps.

[0081] Some delivery devices can include one or more functions of a safety syringe, pen-injector, or auto-injector. For example, a delivery device could include a mechanical energy source configured to automatically inject a medicament (as typically found in an auto-injector) and a dose setting mechanism (as typically found in a pen-injector).

[0082] The present invention relates to a medicament delivery system 1 comprising a reusable injector device 100 and a cartridge 200 for use with the reusable injector device 100. Figs. 2 to 29 represent an exemplary embodiment of the invention.

[0083] In the foregoing description, the terms ‘square’ and ‘ramped’ are used. Respectively, square and ramped refer to planar surfaces that extend perpendicular and obliquely to the longitudinal axis of either the cartridge or injector device. The term “distal” refers to a location that is relatively closer to a site of injection, and the term "proximal" refers to a location that is relatively further away from the injection site.

[0084] The Cartridge

[0085] The cartridge 200 is shown in longitudinal section in Fig. 3. The cartridge 200 is a single use component that is attached to the reusable injector device 100 to administer a dose of medicament to a patient. The cartridge 200 comprises a cassette 210, a pre-filled syringe 230 and a cap 260.

[0086] The cassette 210 comprises an elongate body 211 having an internal chamber 212 that extends in the longitudinal direction of the body 211 and is open a distal end of the cassette 210. A proximal end of the internal chamber 212 is closed by the cap 260. The pre-filled syringe 230 (herein also ‘PFS 23O’)is positioned within the internal chamber 212 and extends therethrough.

[0087] The body 211 comprises three openings 213, 214, 215 spaced apart in the longitudinal direction. The openings 213, 214, 215 are herein referred to as the distal opening 213, mid- opening 214 and proximal opening 215. The mid-opening 214 comprises proximal and distal ramped surfaces 214’, 214” to aid alignment of the cartridge when loaded into the injector device as explained further below. Longitudinally extending clips 216 (hereinafter ‘cassette clips 216’) are provided either side the mid-opening 214 that comprise spring arms 217 that each terminate in a retaining block 218. The retaining blocks 218 comprise curved inwardly facing surfaces 218’ that are configured to ride over a corresponding lip in the device 100 and thereby temporarily hold the cartridge 200 to the device 100. This is shown by the partial section of Fig. 11 , in which the cartridge 200 and the device 100 are assembled.

[0088] The body 211 further comprises proximal and distal ramped alignment surfaces 219, 220, as shown by Fig. 5, for example. The proximal ramped surfaces 219 are provided either side the proximal opening 215 and the distal ramped surfaces 220 are provided either side the distal opening 213. The ramped alignment surfaces 219, 220 are configured to engage corresponding ramped surfaces of the device 100 as the cartridge 200 is connected thereto, as will be explained further below.

[0089] The cap 260 comprises a cylindrical body 261 having a distal region 261 ’ with a first external diameter and a proximal region 261 ” with a second external diameter, the second diameter being greater than the first diameter. A shoulder 262 divides the distal region 261 ’ from the proximal region 261 ”. When the cap 260 is connected to the cartridge 200, the shoulder 262 abuts the proximal end of the cassette 210 and the distal region 261 ’ is received within a proximal end of the internal chamber 212.

[0090] The cap 260 comprises two blocking elements 263. The blocking elements 263 extend from the shoulder 262 on opposing sides of the distal region 261 ’. The cassette 210 comprises two longitudinal slots 221 that extend in from the proximal end of the body 211. The slots 221 are formed in opposing sides of the body 211 to each receive a respective blocking element 263 of the cap 260. One of these slots 221 and blocking elements 263 is visible in the illustrations of Figs. 9A-9c. One of the blocking elements 263 is also visible in more detail in the partial sections of Figs. 12 and 13.

[0091] The pre-filled syringe 230 comprises a cylindrical vial 231 filled with medicament, a bung 232, a needle 233, a rigid needle shield (RNS) 234 and a piston 235. The bung 232 seals the proximal end of the vial 231 and the piston 235 the distal end. The needle 233 extends through the bung 232 and into the vial 231 . The piston 235 is configured for proximal displacement through the vial 231 during operation of the injector device to dispense the medicament through the needle 233. The needle 233 protrudes from an opening in the proximal end of the cassette 210 and is enclosed by the RNS 234. The RNS 234 is a cylindrical block of protective material with a cavity in which the needle 233 extends. The RNS 234 is tightly fitted within an internal cavity 266 of the cap 260 so that the RNS 234 is removed with the cap 260 when the cap 260 is removed.

[0092] Reusable Injector Device

[0093] Fig. 4 shows the reusable injector device 100 in partial section; Fig. 5 shows the reusable injector device 100 with the cartridge 200 positioned for connection to the reusable injector device 100. The reusable injector device 100 is herein referred to simply as the ‘device 100’ for brevity.

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

[0095] The device 100 further comprises a sprung carriage 140 (hereinafter ‘carriage 140’), a proximal boss 113 and a distal boss 114. The proximal boss 113 and distal boss 114 are integrally formed with the housing 110 and spaced apart along its longitudinal axis. Both bosses 113, 114 are disposed within the opening 111 to meet the cartridge 200 when it is inserted therethrough.

[0096] The carriage 140 is configured to slide along a first internal surface 115 of the housing 110 against a carriage spring 140s (shown schematically in Fig. 2). Prior to use 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 coil spring that extends between a distal end of the housing 110 and a distal end of the carriage 140. With the carriage 140 in the first position, the carriage spring 140s is in a partially discharged state, meaning the carriage spring 140s is partially extended and may be compressed.

[0097] The carriage comprises a carriage floor 141 , a platform 142 atop the carriage floor 141 , and proximal and distal alignment ramps 143, 144. The proximal and distal alignment ramps 143, 144 extend above the platform 142 and are the first point of contact between the carriage 140 and the cartridge 200 when the cartridge 200 is connected thereto. The proximal alignment ramps 143 are positioned either side the proximal boss 113 and the distal alignment ramps 144 either side the distal boss 114. Proximal and distal cut outs 145, 146 in the carriage floor 141 allow the carriage 140 to slide between different operating positions, past the bosses 113, 114. A trailing arm 150 extends distally behind the carriage floor 141 and into contact with the drive mechanism 120. The trailing arm 150 holds the carriage 140 in the first position against the force of the carriage spring 140s.

[0098] The platform 142 comprises ramped proximal and distal surfaces 148, 149 and lips 147 that extend longitudinally either side the platform 142. The ramped surfaces 148, 149 are configured to engage the ramped surfaces 214’, 214” of the mid-opening 214 of the cassette body 211 to further aid alignment. The lips 147 are shaped to receive the retaining blocks 218 of the clips 216 of the cassette body 211 to hold the cartridge 200 to the device 100.

[0099] The device 100 further comprises first and second pairs of sprung pins 116, 117 that depend from internal surfaces of the housing 110, as shown in Fig. 7. The first pair of sprung pins 116 (hereinafter ‘first pins 116’) depend from the first internal surface 115 of the housing 110 and are arranged to prevent distal movement of the carriage 140 prior to engagement of the cartridge 200. The second pair of sprung pins 117 (hereinafter ‘second pins 117’) are arranged so that each pin is provided in an opposing wall of the housing 110. Both second pins 117 lie on a common axis and are arranged to engage a respective slot 221 in the body 211 of the cassette 210.

[0100] The drive mechanism 120 comprises a plunger rod 121 , a plunger drive spring 121s (shown schematically in Fig. 2) and a pair of sprung plunger interlock pins 122. The plunger rod 121 is configured to engage and displace the piston 235 under the force of the plunger rod spring 121s. Prior to use of the device, the plunger rod 121 is in a pre-delivery position, which is the most distal position of its axial range of motion. The plunger rod spring 121s is a helical coil spring that extends between a distal end of the housing 110 and a distal end of the plunger rod 121. With the plunger rod 121 in the pre-delivery position, the plunger rod spring 121s is in a charged state, meaning the plunger rod spring 121s is compressed ready for extension.

[0101] Cartridge and device assembly

[0102] Fig. 6 is a partial section of the cartridge 200 and device 100 aligned for assembly but separate. Fig. 8 shows the same partial section, but with cartridge 200 and the device 100 in an assembled pre-use state in which the cartridge 200 is connected to the device 100.

[0103] The cartridge 200 is connected to the device 100 by insertion of the cartridge 200 through the opening 111 in the housing 110. To effect the insertion through the opening 111 , the cartridge 200 is aligned with the opening 111 (as shown in Fig. 5) and then moved in a direction perpendicular to its axis Xc-Xc, in the direction of arrow A1 of Fig. 8. With the cartridge and device assembled, the cartridge and device axes are coaxial.

[0104] Figs. 9a to 9c illustrate the role of the alignment surfaces 219, 220 in the body 211 of the cassette 210. Fig. 9a shows the cassette 210 positioned immediately above the carriage 140 and correctly aligned for assembly. In this position, the cartridge 200 and device 100 may be assembled without any contact between the alignment surfaces 219, 220 and the carriage 140. Fig. 9b shows the cartridge 200 positioned too far in the proximal direction to be correctly aligned for assembly. In this position, when the cartridge 200 is pushed into the device in a direction perpendicular to its axis (downwards movement), the proximal alignment surface 219 contacts the proximal ramped surface 143 of the carriage 140. The surfaces 219, 143 slide over each other to convert the downwards movement of the cartridge 200 into a distal axial movement to relocate the cartridge 200 into the correct position. Similarly, although unillustrated, if the cartridge 200 is too far in the distal direction on initial positioning, the distal alignment surface 220 contacts the distal ramped surface 144 of the carriage 200 as it is moved downward, causing the surfaces 220, 144 to slide over one another to move the cartridge 200 in the proximal direction for correct alignment.

[0105] Fig. 9c shows the cartridge 200 in its assembled position. The proximal and distal ramped surfaces 144, 145 of the carriage 140 abut respective proximal and distal alignment surfaces 219, 220 of the cassette 210. In this way the axial position of the carriage 140 and cassette 210 are locked together. Any axial movement of the cassette 210 will cause a corresponding axial movement of the carriage 140. The second pins 117 are aligned with a respective longitudinal slot 221 of the cassette body so that, on removal of the cap 260 and blocking elements 263, each pin 117 extends into its respective slot 221 to lock the cartridge to the device 100 as illustrated in Fig. 15.

[0106] Fig 11. shows the engagement of the cassette clips 216 with the lips 147 of the carriage 140 platform 142 when the cartridge 200 and device 100 are in the assembled state. As the cartridge 200 is pressed onto the carriage 140, the spring arms 217 of the clips 216 are displaced outward by engagement of the curved inwardly facing surfaces 218’ of the retaining blocks 218 with corresponding lateral surfaces of the platform 142. This causes the retaining blocks 218 to ride over the lips 147, whereafter they adopt a seated position within respective cut outs of the platform 142 as shown in Fig. 11. In this way, the clips 216 are configured to temporarily hold the cartridge 200 to the device 100. By ‘temporarily’ it is meant that cartridge 200 can be readily removed by an operator by lifting the cartridge 200 out of the opening 111 , so long as sufficient force is used to overcome the force of the spring arms 217 and cause the retaining blocks 218 to disengage the cut outs.

[0107] Fig. 10 shows the interaction between the cassette body 211 and the first pins 116 when the cartridge 200 and device 100 are in the assembled state. The cassette body 211 compresses the first pins 116 so that the first pins 116 are flush with the first internal surface 115 of the housing 110. So arranged, the first pins 116 no longer prevent distal movement of the carriage 140.

[0108] Fig. 12 is a partial section showing the interaction between the cap 260 and the proximal boss 113 when the cartridge 200 and the device 100 are in the assembled state. The cap 260 further comprises opposing slots 264’, 264” that extend from a 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 free to hinge between ends of the slots 264’, 264”. The proximal boss 113 comprises a tapered projection 113’ that is configured to push apart the two segments 265 of the cap 260 by engaging a lower slot 264”of the two slots 264’, 264”. The slot 264’ opposite the lower slot 264” is herein referred to as the upper slot 264’. The upper slot 264’ receives a blocking element 222 that depends from an internal surface of the body 211 of the cassette 210. The blocking element 222 prevents removal of the cap 260 prior to the segments 265 being pushed apart by the proximal boss 113. This is because a distal end of the upper slot 264’ comprises a constriction 266 that is too narrow to allow the blocking element 222 to pass through if a user attempts to pull the cap 260 away from the cassette 210 (as also shown by the partial section of Fig. 13) prior to its insertion into the device 100. When the cartridge 200 and the device 100 are in the assembled state, the tapered projection 113’ of the distal boss 113 pushes apart the segments 265 of the cap 260 widening the constriction 266 so that the blocking element 222 may pass therethrough. The direction in which the cap 260 is removed is shown in Fig. 14 by arrow A2. As will be appreciated, the cap 260 is pulled axially away from the cassette 210 to separate the cap 260 from the remainder of the cartridge 200. With the cap 260 removed, the needle 233 is recessed within a proximal end of the cassette 210. This position of the cassette 210 relative to the PFS 230 is referred to herein as the needle safe position.

[0109] With reference again to Fig. 8, prior to the removal of the cap 260, the cartridge 200 is prevented from axial distal movement 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 resolved through the cap 260 and into the boss 113, preventing relative movement of the cartridge 200 and the device 100. The proximal and distal bosses 113, 114 engage the PFS 230 through the respective proximal and distal openings 215, 213 in the body 211 of the cassette 211 . A neck 236 of the vial 231 rests in a seat 113” of the tapered projection 113’ of the proximal boss 113 (as shown in Fig. 12). The neck 236 is region of the vial 231 adjacent the bung 232 with a smaller external diameter than the remainder of the vial (herein vial body 237). The neck 236 flares into a shoulder 238 where the relatively small external diameter of the neck 236 meets the relatively larger external diameter of the vial body 237. The shoulder 238 abuts a distal surface 113”’ of the tapered projection 113’, preventing any proximal movement of the vial 231 relative to the housing 110. The vial 231 also comprises a flange 239 at its distal end. The flange 239 abuts a proximal surface of a lug 114’ projecting from the distal boss 114, preventing any distal movement of the vial 231 relative to the housing 110. In this way, axial movement of the PFS 230 relative to the housing 110 is prevented.

[0110] Fig. 14 is a partial section of the cartridge 200 and the device 100 in an assembled and primed state in which the cap 260 is removed. By removing the cap 260, the cassette 210 is free to move in a distal direction relative to the housing 110 and the PFS 230 to initiate injection (as shown by arrow A3 in Fig. 16). Holding the housing 110, the user presses the proximal end of the cassette 210 onto the injection site, displacing the cassette 210 on the carriage 140 a predetermined distance in the distal direction into a 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 cassette 210. The cassette 210 is displaced until a proximal surface 215’ of the proximal opening 215 abuts a proximal surface 113”” of the proximal boss 113 (as shown in Fig. 16). The predetermined distance is such that, when the cassette 210 and proximal boss 113 abut, the needle protrudes 233 from the proximal end of the cassette 210 by a distance equal to the desired depth of subcutaneous medicament delivery. In the present example, the size of the distal opening 213 in the body 211 of the cassette 210 is such that it does not impede movement of the cassette 210 over the predetermined distance. However, in another example, the predetermined distance may instead be set by the size of the distal opening 213, in which a proximal surface 213’of the distal opening 213 abuts a proximal surface 114” of the distal boss 114 after displacement of the cassette 210 over the predetermined distance.

[0111] As the cassette 210 is displaced over the predetermined distance the PFS 230 remains fixed relative to the housing 110, held in position by the proximal and distal bosses 113, 114 as explained above. The vial 231 slides along the internal chamber 212 until the needle 233 protrudes from the opening in the distal end of the cassette 210 and the cassette 210 abuts the proximal boss 114. The internal chamber 212 comprises longitudinally extending ribs 223 that are spaced around the internal chamber 212 to engage the external surface of the vial 231. The ribs 223 hold the PFS 230 securely within the internal chamber 212, while allowing the PFS 230 and cassette 210 to slide relative to each other.

[0112] Fig. 16 is a partial section of the cartridge 200 and the device 100 in an assembled and dose- initiated configuration. In this configuration, the cassette 210 has been distally displaced over the predetermined distance, allowing the needle 233 to extend from the proximal end of the cassette 210 into the injection site. The distal end of the cassette 210 is received under an edge of the opening 111 in the housing 110, thereby fully enclosing the drive mechanism 120 for safe operation. The distal movement of the cassette 210 and carriage 140 releases the plunger rod 121 into engagement with the piston 235, driving the piston 235 through the vial 231 under the force of the plunger rod spring 121s. Once the plunger rod 121 has fully traversed the vial 231 the cartridge 200 and device 100 are in an end of dose state, as shown in Fig. 17. The user is then indicated to remove the device 100 from the injection site.

[0113] The plunger rod 121 is released by a plunger rod release mechanism 190 (as illustrated in Figs. 29a and 29b). The plunger rod release mechanism 190 is provided adjacent a distal region of the plunger rod 121 so as not to interfere with the operation of the cassette 210. The plunger rod release mechanism 190 is powered by a battery (not shown) and comprises a magnetic spring arm 191 (hereinafter spring arm 191 for brevity) and an electromagnet 192. The electromagnet 192 forms part of an electrical circuit comprising the battery. To release the plunger rod 121 , the electrical circuit is completed by a switch, causing the electromagnet 192 to deflect the spring arm 191. The spring arm 191 is connected in cantilever fashion to the housing 110 and comprises 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 a 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 cassette 210 has been distally displaced over the predetermined distance, the cassette 210 contacts the switch to complete the electrical circuit. This activates the electromagnet 192 and deflects the spring arm 191 outward, away from the plunger rod 121 , releasing the retaining block 193 from the notch 126 (as shown in Fig. 29b). The plunger rod 121 is then free to advance proximally under the force of the plunger rod spring 121s.

[0114] The switch may be a conductive contact (not shown) provided on a distal end of the cassette 210. The conductive contact may bridge a gap in the electrical circuit. For ease of manufacture, the electrical circuit may comprise conductive tracks printed onto the internal surface of the housing 110. It will be appreciated that the exact manner of plunger rod 121 release may vary and that other solutions may be implemented without departing from the scope of the present invention.

[0115] The plunger interlock pins 122 are provided to stabilize the carriage 140 as shown in Fig. 16. Two interlock pins 122 are provided, one either side the plunger rod 121 . When the carriage 140 has been displaced over the predetermined distance, a proximal end of each pin 122 is received in a respective hole in the carriage located adjacent the distal ramped surface.

[0116] Each pin 122 is connected to a lug 123 of the drive mechanism 120 by a compression coil spring 124. A distal region of the interlock pins 122 comprises a shoulder 122’ against which is abutted a proximal end of a respective coil spring 124. The lugs 123 are rigidly connected to the plunger rod 121 so that the displacement of the plunger rod 121 causes displacement of the compression coil springs 124 which, in turn, impart a force on the associated interlock pins 122. A proximal region of each pin 122 is free to slide through the associated hole 149 in the carriage 140 up until the shoulder 122’ abuts a distal surface of the carriage 140. As the interlock pins 122 move proximally, the engage a respective hole (not shown) in the body 211 of the cassette 210. This assists in stabilizing the cassette 210 as the plunger rod 121 is displaced. Once the plunger rod 121 has fully traversed the vial (as shown in Fig. 17), the compression springs 124 are compressed between their respective shoulder 122’ and lug 123. This compression of the springs 124 imparts an additional proximal force on the carriage 140.

[0117] Before the plunger rod 121 is released, the trailing arm 150 of the carriage 140 extends into contact with 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. Following release of the plunger rod 121 , the carriage 140 is free to move the cassette 210 into a needle shielding position when the device 100 is removed from the injection site, as illustrated by Fig. 18. In the needle shielding position, the cassette 210 is further forward relative to the PFS 230 and the housing 110 (i.e. further along in the proximal direction) than pre-injection when the cassette 210 is in the initial, needle safe, position.

[0118] As the user lifts the device 100 away from the injection site, the carriage 140 and the cassette 210 are advanced proximally relative to the housing 110 and the PFS 230 under the force of the carriage spring 140s and the compression springs 124 of the drive mechanism 120. The limit of this proximal movement is determined by the size of the distal cut out 146 in the floor 141 of the carriage 140, with the carriage 140 being driven forward until a distal surface 146’ of the cut out 146 abuts the distal boss 114. The cassette 210 further comprises a lock-out mechanism 224 that is configured to engage the flange 239 of the vial 231 when the cassette 210 is in the needle shielding position. The lock out mechanism 224 is illustrated by Fig. 19 and comprises two resiliently flexible arms 2241 that extend within opposing cut outs 225 in the wall of the internal chamber 212. Each arm 2241 is integrally formed with the body 211 of the cassette 210 and extends in a distal direction from a point of attachment with the wall of the internal chamber 212. A distal end of each arm 2241 comprises a retaining block 2242 configured to lock the flange 239 of the vial 231. The retaining block 2242 comprises a ramped surface 2243 leading to a detent 2244 in which the flange 239 is received when locked to the cassette 210. Following removal of the device 100 from the injection site, the forward movement of the cassette 210 drives the ramped surfaces 2243 of the retaining blocks 2242 over the flange 239, displacing the flexible arms 2241 outward until each detent 2244 clips over the flange 239.

[0119] Following removal of 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, as shown in Fig. 20. A plunger rod recharging mechanism 194 (herein recharging mechanism 194 for brevity) is provided for this purpose (as illustrated by Figs. 29a and 29b). The recharging mechanism 194 comprises a geared pinion 195 that cooperates with a rack 196 provided in the distal region of the plunger rod 121. During operation, the geared pinion 195 rotates to drive the plunger rod 121 in the distal direction. The geared pinion 195 is powered by an electric motor 197 that is connected to a battery by an electrical circuit. The recharging mechanism 194 may share the battery of the plunger rod release mechanism 190.

[0120] The electric motor 197 is activated by a switch. The switch comprises a conductive contact (not shown) provided on the carriage 140 that bridges a gap in the electrical circuit when the carriage 140 is advanced to its most proximal position. In this example, the circuit is broken again by a second switch when the plunger rod 121 is returned to its pre-injection position. The second switch may be a conductive contact on the spring arm 191 that breaks the circuit when the retaining block 193 is returned to the notch 126 on the plunger rod 121. For ease of manufacture, the electrical circuit may comprise conductive tracks printed onto the internal surface of the housing 110.

[0121] It will be appreciated that the exact manner by which the plunger rod 121 is returned to its pre- injection position may vary and that other solutions may be implemented without departing from the scope of the present invention. With the plunger rod 121 returned to its pre-delivery position, the carriage 140 is moved to the first position by contact between they plunger rod 121 and the trailing arm 150. This results in the proximal end of the cassette 210 being ejected in the direction shown by arrow A4. This ejection is caused by the interaction of the proximal ramped surfaces of the carriage 140 and the proximal ramped alignment surfaces of the body of the cassette, as shown in Fig. 21. As the carriage moves in the distal direction, the distal force imparted on the cassette by the interaction of the ramps is resolved through the vial flange and distal boss, preventing a distal movement of the cassette. The interaction of the ramps further imparts a force perpendicular to the device axis, shown by arrow F1 in Fig. 21 . This perpendicular force overcomes the cassette clips which disengage the carriage to allow removal of the used cartridge 200. The spent cartridge 200 as presented for removal is illustrated by Fig. 23.

[0122] Fig. 22 shows the unblocking of the first pins 116 caused by the ejection of the cartridge 200. The pins 116 are thereby free to return to their position upstanding above the first internal surface of the housing to prevent displacement of the carriage from the first position. With the spent cartridge removed, the device 100 is available for reuse.

[0123] In another embodiment of the invention in which like features retain the same reference numbers, the ejection of the cartridge 200 may be assisted by an ejection mechanism 270 as illustrated schematically in Figs. 24a-25b. In Figs. 24a-24b, the mechanism 270 comprises a two-bar linkage 271 comprising an L shaped bar 272 joined to a second bar 273 by a hinge 274. The L shaped bar 272 comprises a reaction member 272’ that extends into the path of the plunger rod 121 ; and a connecting member 272” that extends perpendicular to the reaction member 272’ in a longitudinal direction of the device. Prior to operation of the ejection mechanism 270, the two-bar linkage 271 is folded over on itself so that the second bar 273 extends over the connecting member 272” of the L shaped bar 272. The two-bar linkage 271 is biased in the proximal direction by a spring 275. When the plunger rod 121 is returned to its preinjection position, it contacts the reaction member 272’ to draw the connecting member 272” in a distal direction which unfolds the two-bar linkage 271 and causes the second bar 273 to press a cartridge release button 276 toward the cassette 210. As the release button 276 engages the cassette 210, it pushes the cassette 210 out of the opening 111 to disengage the cassette clips 216.

[0124] In Figs. 25a-25b, an alternate ejection mechanism 270 is provided comprising an L-shaped member 277 and a cam follower 278. The L shaped member 277 comprises a reaction member 277’ that extends into the path of the plunger rod 121 ; and a connecting member 277” that extends perpendicular to the reaction member 277’ in a longitudinal direction of the device 100. A cam track 279 having a ramped 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 the spring 275. When the plunger rod 121 is returned to its pre-injection position, it contacts the reaction member 277’ to draw the connecting member 277” in a distal direction. As the connecting member 277” moves, the cam follower 278 traverses the cam track 279 and is displace toward the cassette 210, pressing the release button 276. As the release button 276 engages the cassette 210, it pushes the cassette 210 out of the opening 111 to disengage the cassette clips 216.

[0125] In another example illustrated in Fig. 26, the ejection mechanism 270 is simplified and consists of only the release button 276. The release button 276 may be manually pressed by the user when it is desired to remove the cartridge 200 from the device 100.

[0126] In another embodiment of the invention in which like features retain the same reference numbers, the cap 260 may comprise a simplified release mechanism as illustrated by Fig. 27. In this embodiment, the cap 260 is attached to the body 210 of the cassette 200 by a flexible clip 267. The clip 267 comprises a blocking element 2671 having a ramped surface 2671 ’. The ramped 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 ramped surface 2671 ’, releasing the blocking element 2671 from the proximal opening 215 and allowing the cap 260 to be removed.

[0127] In another embodiment of the invention in which like features retain the same reference numbers, the interlock pins 122 are replaced by sliding panels 125 that move into cut outs 118 in the internal surface of the housing 110. The cuts outs 118 are configured to be adjacent the cassette clips 216 when the cartridge 200 and device 100 are combined and serve to allow the outward displacement of the clips 216 during insertion and removal of the cartridge 200. The sliding panels 125 are connected to the plunger rod 121 and are configured so that as the plunger rod 121 is displaced into the vial 231 , the sliding panels 125 fill the cut outs 118, thereby locking the cassette 210 to the carriage 140. When the plunger rod 121 is returned to its pre-injection position, the sliding panels 125 are removed from the cut outs 118 to allow removal of the cartridge 200 from the device 100.

[0128] While the above-described embodiments relate to a mechanical device 100 insofar as the energy sources for the drive mechanism 120 and carriage 140 comprise springs 121s, 140s, it will be appreciated that other energy sources may be used. For example, a battery and linear actuators may be used. Such an arrangement would be understood by the skilled person and does not need to be elaborated on here.

[0129] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0130] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API 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 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 contemplated.

[0131] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0132] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0133] Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0134] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0135] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0136] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0137] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, 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, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0138] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0139] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0140] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin. Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0141] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0142] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0143] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0144] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0145] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0146] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0147] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0148] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0149] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0150] Operation of the medicament delivery system may be summarised in the following steps:

[0151] 51 - An operator of the system begins by removing the cartridge 200 from a storage area. The storage area may be a refrigerator or other storage area suitable for storing the medicament being used.

[0152] 52 - The operator inserts the cartridge 200 through the opening 111 in the housing 110 and attaches the cassette 210 to the carriage 140.

[0153] 53 - The operator pulls the cap 260 and cassette 210 apart.

[0154] 54 - The operator presses the proximal end of the cassette 210 against an injection site of a patient so that the cassette 210 is displaced into the housing 110. This causes the needle 233 to penetrate the injection site and the plunger rod 121 to be released to dispense medicament.

[0155] 55 - The operator lifts the device 100 away from the injection site. This causes the cassette 210 to advance back out of the housing 110 to surround the needle 233.

[0156] 56 - The device 100 is recharged, returning the plunger rod 121 to the pre-delivery position.

[0157] 57 - The operator removes the cartridge 200 from the device 100, thereby allowing the device 100 to be reused by repeating steps S1-S6.

[0158] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0159] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API 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 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 contemplated.

[0160] The drug or medicament may be cont”€ne’ in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about— 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0161] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0162] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as“"insulin receptor ligand”". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0163] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0164] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0165] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, 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, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0166] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport yndromem.

[0167] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0168] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0169] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0170] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(a")2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0171] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(a")2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0172] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0173] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab). Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0174] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0175] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :201€). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0176] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0177] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0178] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the substances, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0179] LIST OF REFERENCE NUMERALS

[0180] 100 - Device 145 - Proximal cut out

[0181] 146 - Distal cut out

[0182] 110 - Housing 40 147 - Lips

[0183] 111 - Opening 148 - Cut outs

[0184] 112 - Lateral wall 149 - hole (for receiving interlock pins)

[0185] 113 - Proximal boss (of which: tapered 150 - trailing arm projection 113’; seat 113”; distal surface 113’”; proximal surface 113””) 45 190 - plunger rod release mechanism

[0186] 114 - Distal boss (of which: lug 114’; 191 - magnetic spring arm (also ‘spring proximal surface 114”) arm’)

[0187] 115 - First internal surface 192 - electromagnet

[0188] 116 - First pair of sprung pins (first pins) 193 - retaining block

[0189] 117 - Second pair of spring pins (second 50 194 - plunger rod recharging mechanism pins) (also ‘recharging mechanism’)

[0190] 118 - Cut outs 195 - geared pinion

[0191] 196 - rack

[0192] 120 - Drive mechanism 197 - electric motor

[0193] 121 - Plunger rod 55

[0194] 121s - plunger drive spring 200 - Cartridge

[0195] 122 - plunger interlock pins (of which: shoulder 122’) 210 - Cassette

[0196] 123 - lugs 211 - Body

[0197] 124 - compression coil springs 60 212 - Internal chamber

[0198] 125 - sliding panels 213 - Distal opening (of which: proximal

[0199] 126 - notch surface 213’)

[0200] 214 - Mid-opening

[0201] 140 - Carriage 215 - Proximal opening (of which:

[0202] 140s - Carriage spring 65 proximal surface 215’)

[0203] 141 - Floor 216 - Longitudinally extending clips (also

[0204] 142 - Platform ‘cassette clips 216’)

[0205] 143 - Proximal ramped surface 217 - Spring arm

[0206] 144 - Distal ramped surface 218 - Retaining block (of which: curved 260 - Cap inwardly facing surface 218’) 30 261 - Cylindrical body (of which: distal

[0207] 219 - Proximal ramped alignment surface region 261 ’; proximal region 261 ”) (also ‘proximal alignment surface 219’) 262 - Shoulder

[0208] 220 - Distal ramped alignment surface 263 - blocking elements

[0209] 221 - Longitudinal slots 264 - slotted openings (of which: ‘upper

[0210] 222 - Blocking element 35 slot 264’, ‘lower slot 264”)

[0211] 223 - Longitudinally extending ribs 265 - Segments

[0212] 224 - Lock-out mechanism 266 - constriction

[0213] 2241 - Flexible arms of the lock-out 267 - Flexible clip mechanism 2671 - Blocking element (of which:

[0214] 2242 - Retaining block 40 ramped surface 2671 ’)

[0215] 2243 - Ramped surface

[0216] 2244 - Detent 270 - Ejection mechanism

[0217] 225 - Cut outs in the wall of the internal 271 - Two-bar linkage chamber 272 - L-shaped bar (of which: reaction

[0218] 45 member 272’; connecting member 272”)

[0219] 230 - Pre-filled syringe (PFS) 273 - Second bar

[0220] 231 - Vial 274 - Hinge

[0221] 232 - Bung 275 - Spring

[0222] 233 - Needle 276 - Cartridge release button

[0223] 234 - Rigid needle shield (RNS) 50 277 - L-shaped member (of which:

[0224] 235 - Piston reaction member 277’; connecting

[0225] 236 - Neck of vial member 277”)

[0226] 237 - Vial body 278 - Cam follower

[0227] 238 - Shoulder 279 - Cam track (of which: ramped

[0228] 239 - Flange 55 surface 279’)

Claims

CLAIMS1 . A reusable injector device (100) for use with a cartridge (200) comprising a cassette (210) containing a pre-filled syringe (230), the reusable injector device comprising: a housing (110); and a drive mechanism (120) provided in the housing; the drive mechanism having a plunger rod (121) configured to dispense medicament from a pre-filled syringe during use; wherein the housing comprises a boss (113, 114) configured to engage a pre-filled syringe and fix the pre-filled syringe relative to the housing when a cartridge and the reusable injector device are combined.

2. The reusable injector device (100) according to claim 1 , wherein the housing is elongate and comprises an opening (111) in a lateral wall (112) of the housing, the device (100) being configured for combination with a cartridge by moving a cartridge through the opening in a direction perpendicular to a longitudinal axis of the device.

3. The reusable injector device (100) according to claim 1 or claim 2, further comprising a carriage (140); and wherein the carriage is configured to cooperate with a cassette (210) of a cartridge (200) to releasably hold the cassette within the housing (110) against a carriage spring (140s), the carriage being slidable within the housing against the carriage spring (150s) to move relative to the boss; and optionally, wherein the carriage spring (150s) is configured to move the cassette between a needle safe position and a dose delivery position, when a cartridge (200) and the reusable injector device are combined.

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

5. The reusable injector device (100) according to claim 4, wherein the carriage (140) comprises an arm (150) that is arranged for contact with the plunger rod (121) when the plunger rod is in the pre-delivery position, the contact between the arm and the plunger rod defining a first limit of proximal extension of the carriage spring (150s) to retain the carriage in the first position; and wherein, following movement of the plunger rod into the second position, the carriage is free to move under force of the carriage spring into a second position, the second position being further along in the proximal direction than the first position; and optionally, wherein a surface of the carriage abuts a surface of the boss when the carriage is in the second position to define a second limit of proximal extension of the carriage spring.

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

7. The reusable injector device (100) according to any one of the preceding claims, wherein the boss comprises separate proximal and distal bosses (113, 114) that are arranged to engage respective ends of a pre-filled syringe (230) through proximal and distal openings (215, 213) in a cassette (210), when a cartridge (200) and the reusable injector device are combined.

8. A cartridge (200) for use with a reusable injector device (100), the cartridge comprising: a cassette (210); a cap (260); and a pre-filled syringe (230) comprising a needle (233), the pre-filled syringe being housed within the cassette; wherein the cap encloses the needle; the cartridge being configured to allow relative movement of the cassette and the prefilled syringe following removal of the cap, and wherein the cartridge is configured to prevent axial movement of the pre-filled syringe relative to a housing (110) of a device (100), when the cartridge is connected to the device.

9. The cartridge (200) according to claim 8, wherein the cap (260) is locked to the cassette (210) prior to use of the cartridge with a reusable injector device (100).

10. The cartridge (200) according to claim 9, wherein the cap (260) comprises a distal region (261 ’) that extends into the cassette (210), the distal region comprising flexible segments (265) that extend around a blocking element (222) of the cassette, the flexible segments being configured to prevent removal of the cap prior to use of the cartridge with a reusable injector device (100).

11. A medicament delivery system comprising: a reusable injector device (100) according to any one of claim 1 to claim 7; and a cartridge (200) according to any one of claim 8 to claim 10; wherein a cassette (210) of the cartridge is displaceable within a housing of the reusable injector device relative to a pre-filled syringe (230) of the cartridge to move the cassette between a needle safe position, in which a needle (233) is recessed within a proximal end of the cassette, and a dose delivery position, in which the needle extends from the proximal end of the cassette.

12. The medicament delivery system according to claim 12, wherein a cap (260) of the cartridge (200) abuts a boss of the reusable injector device (100) when the cartridge and device are combined so that movement of the cassette (210) within the housing (100) is prevented prior to removal of the cap.

13. The medicament delivery system according to claim 12, wherein the boss is configured to separate flexible segments (265) of the cap (260) to release the flexible segments from a blocking element (222) of the cartridge (200) when the cartridge and the reusable injector device (100) are combined and to allow the cap to be removed from the cassette (210).

14. The medicament delivery system according to any one of claim 11 to claim 13 configured so that when a distal force is applied to the proximal end of the cassette (210) following combination of the reusable injector device (100) and the cartridge (200), the cassette slides in a distal direction between the needle safe position and the dose delivery position.

15. The medicament delivery system according to any one of claim 11 to claim 14, wherein, with the carriage (140) of the reusable injector device (100) is in the second position, a lockout mechanism (224) of the cassette (210) engages a distal flange (239) of the pre-filed syringe (230) to the cassette (210).

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