Medicament delivery device

Abstract

The present disclosure relates to a medicament delivery device comprising a housing, a button, and a plunger drive mechanism comprising a plunger drive shuttle and a biasing member. A first actuation of the button relative to the housing deflects the plunger drive shuttle to cause the plunger drive shuttle to be moved by the biasing member from an initial position to an intermediate position, to dispense the first dose of medicament from a medicament container. A second actuation of the button deflects the plunger drive shuttle to cause the plunger drive shuttle to be moved by the biasing member from the intermediate position to a final position to dispense a second dose of medicament from the medicament container. The present disclosure also relates to a medicament delivery system and to a method of using a medicament delivery system.

Description

[0001] Attorney Docket No.: 46567-1791 WO1

[0002] MEDICAMENT DELIVERY DEVICE

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims the benefit of priority to European Patent Application No.

[0005] 25159418.0, filed February 21, 2025, the contents of which are herein incorporated by reference.

[0006] TECHNICAL FIELD

[0007] The present disclosure relates to a medicament delivery device. The present disclosure also relates to a medicament delivery system and a method of using a medicament delivery device.

[0008] BACKGROUND

[0009] Medicaments can be administered using a variety of different methods and devices. For example, a medicament delivery device may comprise a hypodermic needle for piercing the skin of a patient and transferring medicament from a medicament source to the user intravenously, intramuscularly or subcutaneously.

[0010] The nasal administration of medicaments represents an alternative route to intravenous, intramuscular or subcutaneous medicament administration. Devices for nasal administration of medicaments may include a nozzle for insertion into the patient’s nose and delivering medicament to the patient’s nose from a medicament source. As nasal administration devices do not typically pierce the skin of the user, the process of administering the medicament may be less painful for the user. Nasal medicament administration devices are also relatively simple to use and can be operated with less training than conventional medicament delivery devices. They can also deliver relatively large volumes of medicament to a patient.

[0011] In some cases, it may be desirable to administer multiple doses of a medicament to a patient, such as delivering a dose to each nostril. Traditional devices that deliver only a single dose may require a healthcare professional to refill the device after each administration, which may be time-consuming, can compromise sterility, and may result in inaccurate dosing. While devices capable of administering multiple doses without refilling with medicament may exist, the operation of such devices may be complex and it may be challenging to execute accurate administration of multiple doses.Attorney Docket No.: 46567-1791 WO1

[0012] It may be desirable to provide a medicament delivery device that is easy to operate to administer a plurality of doses of a medicament.

[0013] SUMMARY

[0014] According to the present disclosure, there is provided a medicament delivery device comprising: a housing configured to contain a medicament container; a button; and a plunger drive mechanism comprising a plunger drive shuttle and a biasing member configured to bias the plunger drive shuttle in a distal direction (A1) relative to the housing; wherein the plunger drive shuttle is axially movable in the distal direction by the biasing member from an initial position relative to the housing to an intermediate position relative to the housing, to dispense a first dose of medicament from the medicament container, wherein the plunger drive shuttle is axially movable in the distal direction by the biasing member from the intermediate position to a final position relative to the housing, to dispense a second dose of medicament from the medicament container, wherein a first actuation of the button relative to the housing deflects the plunger drive shuttle to cause the plunger drive shuttle to move from the initial position to the intermediate position to dispense the first dose of medicament, and

[0015] wherein a second actuation of the button relative to the housing deflects the plunger drive shuttle to cause the plunger drive shuttle to move from the intermediate position to the final position to dispense the second dose of medicament.

[0016] In some embodiments, the medicament container may take the form of a syringe.

[0017] In some embodiments, the button comprises a first dose pin and a second dose pin, wherein the button is arranged such that: the first actuation of the button relative to the housing causes the first dose pin to deflect the plunger drive shuttle such that the plunger drive shuttle moves axially from the initial position to the intermediate position, and the second actuation of the button relative to the housing causes the second dose pin to deflect the plunger drive shuttle such that the plunger drive shuttle moves axially from the intermediate position to the final position.

[0018] In some embodiments, the plunger drive mechanism comprises a drive shuttle hold arrangement configured to releasably hold the plunger drive shuttle in the initial position and the intermediate position, wherein the button and the drive shuttle hold arrangement are configured such that: the first actuation of the button deflects the plunger drive shuttle to release the plunger drive shuttle from the drive shuttle hold arrangement, such that the plunger drive shuttle moves from the initial position to an intermediate position, and theAttorney Docket No.: 46567-1791 WO1

[0019] second actuation of the button deflects the plunger drive shuttle to releases the plunger drive shuttle from the drive shuttle hold arrangement, such that the plunger drive shuttle moves from the intermediate position to the final position.

[0020] In some embodiments, the drive shuttle hold arrangement comprises: a first stop element configured to engage a holding member of the plunger drive shuttle when the plunger drive shuttle is in the initial position, to hold the plunger drive shuttle in the initial position; and a second stop element configured to engage the holding member of the plunger drive shuttle when the plunger drive shuttle is in the intermediate position, to hold the plunger drive shuttle in the intermediate position, wherein the holding member is configured to engage the first stop element and the second stop element sequentially.

[0021] In some embodiments, the drive shuttle hold arrangement comprises a shuttle guide track for guiding the holding member as the plunger drive shuttle moves from the initial position to the intermediate position and from the intermediate position to the final position, wherein the shuttle guide track comprises the first stop element and the second stop element.

[0022] In some embodiments, the holding member is arranged on an axially-extending shuttle arm of the plunger drive shuttle, wherein the first actuation deflects the shuttle arm to disengage the holding member from the first stop element, and wherein the second actuation deflects the shuttle arm to disengage the holding member from the second stop element.

[0023] In some embodiments, the plunger drive shuttle comprises a plunger rod, a first plunger arm extending from the plunger rod and a second plunger arm extending from the plunger rod, wherein the second plunger arm comprises the holding member, wherein the first actuation causes the button to move the first plunger arm to rotate the plunger rod with a first rotation, and wherein the first rotation disengages the holding member from the first stop element such that the plunger drive shuttle moves from the initial position to the intermediate position.

[0024] In some embodiments, the second actuation causes the button to move the first plunger arm to rotate the plunger rod with a second rotation, and wherein the second rotation disengages the holding member from the second stop element such that the plunger drive shuttle moves from the intermediate position to the final position.

[0025] In some embodiments, the plunger drive shuttle comprises a plunger rod and a first plunger arm flexibly coupled to the plunger rod and extending radially from the plunger rod, wherein the first plunger arm comprises the holding member, and wherein first actuation causes theAttorney Docket No.: 46567-1791 WO1

[0026] button to flex the first plunger arm relative to the plunger rod to disengage the holding member from the first stop element, such that the plunger drive shuttle moves from the initial position to the intermediate position.

[0027] In some embodiments, the second actuation causes the button to flex the first plunger arm relative to the plunger rod to disengage the holding member from the second stop element, such that the plunger drive shuttle moves from the intermediate position to the final position.

[0028] In some embodiments, the button is configured such that the first actuation of the button deflects the plunger drive shuttle in a transverse direction (A2) that is substantially transverse to the distal direction, to disengage the holding member from the first stop element.

[0029] In some embodiments, the button is configured such that the second actuation of the button deflects the plunger drive shuttle in the transverse direction to disengage the holding member from the second stop element.

[0030] In some embodiments, the medicament delivery device further comprises a cap that is removably coupled to the housing, wherein the cap comprises a cap engagement element configured to: inhibit the first actuation and the second actuation of the button relative to the housing when the cap is coupled to the housing; and allow the first actuation and the second actuation of the button relative to the housing when the cap is uncoupled from the housing.

[0031] In some embodiments, the biasing member comprises a spring arranged between the housing and the plunger drive shuttle and configured to apply a biasing force to the plunger drive shuttle, optionally wherein the spring is pretensioned.

[0032] In some embodiments, the medicament delivery device is an intranasal medicament delivery device.

[0033] In some embodiments, the intranasal medicament delivery device is configured to deliver medicament to the nasal structures of the user. In some embodiments, the intranasal medicament delivery device is configured to deliver medicament to the nasal structures of the user to elicit an immune response.

[0034] The intranasal medicament delivery device may be configured to atomize the medicament and, optionally, may further comprise an atomiser. Such atomiser may facilitate insertion ofAttorney Docket No.: 46567-1791 WO1

[0035] the atomiser and outlet into an orifice of a patient into which the medicament is to be delivered. The atomiser and / or outlet may comprise a luer lock to sealingly connect the atomiser to the nozzle outlet(s). In another embodiment, the nozzle outlet(s) itself is configured to atomize the medicament.

[0036] An atomiser, plug, adaptor or other component may be configured to atomise a liquid medicament as the medicament is expelled through the outlet and through a medicament passage in the atomiser, plug, adaptor or other component.

[0037] The medicament may be any medicament described herein. The medicament may be a vaccine adapted for nasal administration. The vaccine may be an RSV vaccine.

[0038] The intranasal medicament delivery device may be an intranasal atomization delivery device.

[0039] The intranasal medicament delivery device may be configured to deliver about % of a dose to each nostril.

[0040] The intranasal medicament delivery device may be configured to deliver about 0.2mL, wherein about 0.1 mL is delivered to each nostril.

[0041] The intranasal medicament delivery device may deliver an average droplet size Dv50 of about 10-120 pm.

[0042] The intranasal medicament delivery device may deliver an average droplet size Dv50 delivered to each nostril may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm.

[0043] The intranasal medicament delivery device may be configured so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.

[0044] In some embodiments, the intranasal medicament delivery device is configured to deliver in the range of 20 to 2000 microlitres (0.02 to 2 ml) volume of medicament and, preferably, in the range of 100 to 400 microlitres (0.1 to 0.4 ml) and, preferably, in the range of 10 to 300 microlitres (0.1 to 0.3 ml) and, preferably, about 200 microlitres (0.2 ml).Attorney Docket No.: 46567-1791 WO1

[0045] In some embodiments, the intranasal medicament delivery device is configured to deliver in the range of 10 to 1000 microlitres (0.01 to 1 ml) volume of medicament to each nostril of the user and, preferably, in the range of 50 to 200 microlitres (0.05 to 0.2 ml) and, preferably, in the range of 50 to 150 microlitres (0.05 to 0.1 ml) and, preferably, about 100 microlitres (0.1 ml) of medicament to each nostril of the user.

[0046] According to the present disclosure, there is also provided a medicament delivery system comprising a medicament delivery device as disclosed herein and a container of medicament and, preferably, wherein the medicament is a vaccine.

[0047] In some embodiments, the medicament delivery system is an intranasal medicament delivery system. The intranasal medicament delivery system may comprise an intranasal nozzle.

[0048] In some embodiments, the intranasal nozzle comprises first and second nozzle outlets for delivering medicament to a user. Advantageously, medicament can be delivered to both external nostrils of a user simultaneously.

[0049] In some embodiments, the intranasal nozzle comprises first and second medicament delivery conduits.

[0050] In other embodiments, the medicament delivery device is an oral medicament delivery device or an injection medicament delivery device.

[0051] According to the present disclosure, there is provided a medicament delivery system comprising: a medicament delivery device as disclosed herein; and a medicament container. In some embodiments, wherein the medicament container contains a medicament.

[0052] In some embodiments, the medicament delivery system further comprises a medicament delivery member. In some embodiments, the medicament delivery member may be an intranasal nozzle, a hollow needle, or an oral nozzle.

[0053] The intranasal nozzle may be configured to atomize the medicament and, optionally, may further comprise an atomiser. Such atomiser may facilitate insertion of the atomiser and outlet into an orifice of a patient into which the medicament is to be delivered. The atomiser and / or outlet may comprise a luer lock to sealingly connect the atomiser to an outlet of theAttorney Docket No.: 46567-1791 WO1

[0054] medicament container. In another embodiment, the outlet itself is configured to atomize the medicament.

[0055] An atomiser, plug, adaptor or other component may be configured to atomise a liquid medicament as the medicament is expelled through the outlet and through a medicament passage in the atomiser, plug, adaptor or other component.

[0056] The medicament may be any medicament described herein. The medicament may be a vaccine, for example a vaccine adapted for nasal administration. The vaccine may be an RSV vaccine.

[0057] The medicament delivery system may be an intranasal medicament delivery system. The intranasal medicament delivery system may comprise an intranasal atomization delivery device.

[0058] The intranasal medicament delivery system may be configured to deliver about % of a dose to each nostril.

[0059] The intranasal medicament delivery system may be configured to deliver about 0.2mL, wherein about 0.1 mL is delivered to each nostril.

[0060] The intranasal medicament delivery system may deliver an average droplet size DV5o of about 10-120 pm.

[0061] The intranasal medicament delivery system may deliver an average droplet size DV5o delivered to each nostril may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm

[0062] The intranasal medicament delivery system may be configured so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.

[0063] In some embodiments, the intranasal medicament delivery system is configured to deliver in the range of 20 to 2000 microlitres (0.02 to 2 ml) volume of medicament and, optionally, in the range of 100 to 400 microlitres (0.1 to 0.4 ml) and, optionally, in the range of 10 to 300 microlitres (0.1 to 0.3 ml) and, optionally, about 200 microlitres (0.2 ml).Attorney Docket No.: 46567-1791 WO1

[0064] In some embodiments, the intranasal medicament delivery system is configured to deliver in the range of 10 to 1000 microlitres (0.01 to 1 ml) volume of medicament to each nostril of the user and, optionally, in the range of 50 to 200 microlitres (0.05 to 0.2 ml) and, optionally, in the range of 50 to 150 microlitres (0.05 to 0.1 ml) and, optionally, about 100 microlitres (0.1 ml) of medicament to each nostril of the user.

[0065] In some embodiments, the intranasal nozzle comprises first and second medicament delivery conduits.

[0066] According to the present disclosure, there is provided a method of using a medicament delivery device according to any preceding claim, the method comprising: performing a first actuation of the button relative to the housing to cause the plunger drive shuttle to move from the initial position to the intermediate position to dispense the first dose of medicament, and subsequent to performing the first actuation.

[0067] In some embodiments, the method is during a priming operation of the device and the first dose of medicament is a first priming dose of medicament that is not administered to a patient

[0068] In some embodiments, the method further comprises performing a second actuation of the button relative to the housing to cause the plunger drive shuttle to move from the intermediate position to the final position to dispense the second dose of medicament.

[0069] In some embodiments, the method is during a priming operation of the device and the second dose of medicament is a second priming dose of medicament that is not administered to a patient

[0070] In some embodiments, the first actuation of the button relative to the housing deflects the plunger drive shuttle such that the plunger drive shuttle moves axially from the initial position to the intermediate position.

[0071] In some embodiments, the first actuation of the button relative to the housing deflects a shuttle arm of the plunger drive shuttle, to disengage a holding member arranged on the shuttle arm from a first stop element of drive shuttle hold arrangement, such that the plunger drive shuttle moves axially from the initial position to the intermediate position.Attorney Docket No.: 46567-1791 WO1

[0072] In some embodiments, the second actuation of the button relative to the housing deflects the plunger drive shuttle such that the plunger drive shuttle moves axially from the intermediate position to the final position.

[0073] In some embodiments, the second actuation of the button relative to the housing deflects the shuttle arm of the plunger drive shuttle, to disengage the holding member from a second stop element of drive shuttle hold arrangement, such that the plunger drive shuttle moves axially from the intermediate position to the final position

[0074] In some embodiments, the first actuation rotates a plunger rod of the plunger drive shuttle with a first rotation, and wherein the first rotation disengages a holding member of the plunger drive shuttle from a first stop element of a drive shuttle hold arrangement such that the plunger drive shuttle moves from the initial position to the intermediate position.

[0075] In some embodiments, the second actuation rotates the plunger rod with a second rotation, and wherein the second rotation disengages the holding member from a second stop element of the drive shuttle hold arrangement such that the plunger drive shuttle moves from the intermediate position to the final position.

[0076] In some embodiments, the plunger drive shuttle comprises a plunger rod and a first plunger arm flexibly coupled to the plunger rod and extending radially from the plunger rod, wherein the first actuation causes the button to flex the first plunger arm relative to the plunger rod to disengage a holding member of the first plunger arm from a first stop element of a drive shuttle hold arrangement, such that the plunger drive shuttle moves from the initial position to the intermediate position.

[0077] In some embodiments, the second actuation causes the button to flex the first plunger arm relative to the plunger rod to disengage the holding member from a second stop element of the drive shuttle hold arrangement, such that the plunger drive shuttle moves from the intermediate position to the final position.

[0078] In some embodiments, the medicament delivery device comprises a cap that is removably coupled to the housing, wherein the cap comprises a cap engagement element configured to inhibit the first actuation and the second actuation of the button relative to the housing when the cap is coupled to the housing, and allow the first actuation and the second actuation of the button relative to the housing when the cap is uncoupled from the housing, the methodAttorney Docket No.: 46567-1791 WO1

[0079] further comprising: prior to the first actuation, uncoupling the cap from the housing to allow the first actuation and the second actuation of the button relative to the housing.

[0080] The method may comprise expelling / administering an RSV vaccine.

[0081] The medicament may be expelled / delivered intranasally with about % dose delivered to each nostril.

[0082] The intranasal dose of the medicament may be delivered in about 0.2 mL, wherein about 0.1 mL is delivered to each nostril.

[0083] The method may comprise intranasal atomization delivery of an average droplet size Dv50 of about 10-120 pm.

[0084] The method may comprise intranasal atomization delivery of an average droplet size Dv50 delivered to each nostril may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm.

[0085] The method may comprise intranasal atomization delivery so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pLto about 115 pL.

[0086] In some embodiments, the method comprises removing the medicament delivery device from a sealed pack.

[0087] In some embodiments, the method comprises coupling a delivery member to the housing. The delivery member may comprise a needle or an intranasal nozzle. In some embodiments, the method comprises removing the delivery member from a sealed pack and coupling the delivery member to the housing.

[0088] BRIEF DESCRIPTION OF THE DRAWINGS

[0089] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0090] Fig. 1 is a perspective view of a medicament delivery system comprising a medicament delivery device and a medicament container, according to a first embodiment;

[0091] Fig. 2 is an exploded view of the medicament delivery system of Fig. 1 ;Attorney Docket No.: 46567-1791 WO1

[0092] Figs. 3A-3D are perspective views of the medicament delivery system of Fig. 1 during various stages of operation;

[0093] Fig. 4 is a perspective view of a plunger drive mechanism that forms part of the medicament delivery device of Fig. 1 ;

[0094] Fig. 5 is a perspective view of an upper housing portion and a button, that form parts of the medicament delivery device of Fig. 1 , viewed from above;

[0095] Fig. 6 is a perspective view of the upper housing portion and button of Fig. 5, viewed from below;

[0096] Fig. 7 is a perspective view of a lower housing portion that form parts of the medicament delivery device of Fig. 1 , viewed from above;

[0097] Fig. 8 is a perspective view of the lower housing portion of Fig. 7, viewed from below;

[0098] Fig. 9A is a perspective view of a cap that forms part of the medicament delivery device of Fig. 1 , viewed from above;

[0099] Fig. 9B is a perspective view of the cap of Fig. 9A, viewed from below;

[0100] Fig. 10 is a perspective view of the lower housing portion of Fig. 7, when containing the medicament container and plunger drive mechanism;

[0101] Fig. 11 is a perspective view showing assembly of the medicament delivery system of Fig. 1 ; Fig. 12 is a sectional view of the medicament delivery system of Fig. 1 , when the medicament delivery device is in a first primed state;

[0102] Fig. 13 is a sectional view of the medicament delivery system of Fig. 12, when the medicament delivery device is in a first dose dispense state;

[0103] Fig. 14 is a detail view of a portion of the medicament delivery device of Fig. 13, when in the first dose dispense state;

[0104] Fig. 15 is a detail view of the portion of the medicament delivery device of Fig. 14, when the medicament delivery device is in a second primed state;

[0105] Fig. 16 is a detail view of the portion of the medicament delivery device of Fig. 15, when the medicament delivery device is in a second dose dispense state;

[0106] Fig. 17 is a detail view of the portion of the medicament delivery device of Fig. 16, when the medicament delivery device is in a final state;

[0107] Fig. 18 is a cross-sectional view of the medicament delivery device of Fig. 16;

[0108] Fig. 19A is a top view of a medicament delivery system comprising a medicament delivery device and a medicament container, according to a second embodiment;

[0109] Fig. 19E3 is a side view of the medicament delivery system of Fig. 19A;

[0110] Fig. 20 is a schematic view of the medicament delivery system of Fig. 19A, viewed from a side, prior to assembly;

[0111] Fig. 21 is a schematic detail view of a button of the medicament delivery system of Fig. 19A;Attorney Docket No.: 46567-1791 WO1

[0112] Fig. 22 is a schematic view of the medicament delivery system of Fig. 19A, viewed from a side, post-assembly;

[0113] Fig. 23 is a sectional view of the medicament delivery system of Fig. 19A, when viewed from a side;

[0114] Fig. 24 is a sectional view of the medicament delivery system of Fig. 19A, when viewed from above;

[0115] Fig. 25 is a schematic side view showing interaction between first and second dose pins and a plunger drive shuttle of the medicament delivery system of Fig. 19A;

[0116] Fig. 26 is a schematic rear view showing interaction between the first dose pin and the plunger drive shuttle of the medicament delivery system of Fig. 19A;

[0117] Fig. 27 is schematic view of shuttle guide tracks of the medicament delivery system of Fig.

[0118] 19A;

[0119] Fig. 28 is a schematic side view showing interaction between first and second dose pins and a plunger drive shuttle of the medicament delivery system of Fig. 19A;

[0120] Fig. 29 is a schematic rear view showing interaction between the first dose pin and the plunger drive shuttle of the medicament delivery system of Fig. 19A;

[0121] Fig. 30 is a schematic front view showing interaction between the second dose pin and the plunger drive shuttle of the medicament delivery system of Fig. 19A;

[0122] Fig. 31 is a schematic side view of an alternative plunger drive shuttle and first and second dose pins according to a third embodiment;

[0123] Fig. 32 is a schematic front view of the plunger drive shuttle and first and second dose pins of Fig. 31;

[0124] Fig. 33 is schematic view of shuttle guide tracks for use with the plunger drive shuttle and first and second dose pins of Fig. 31 ;

[0125] Fig. 34 is a block diagram illustrating a method of operating a medicament delivery device according to one or more aspects of the present disclosure;

[0126] Fig. 35 is a perspective view of an alternative medicament delivery member taking the form of a dual nozzle atomizer; and

[0127] Fig. 36 is a perspective view of an alternative medicament delivery member taking the form of a hollow needle.

[0128] DETAILED DESCRIPTION

[0129] A drug delivery device, as described herein, may be configured to inject a medicament into a patient or to deliver medicament intranasally or orally. For example, delivery could be subcutaneous, intramuscular, intravenous or the delivery could be to the mouth or nasal structures. Such a device could be operated by a patient or caregiver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector. TheAttorney Docket No.: 46567-1791 WO1

[0130] 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.

[0131] 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. 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.

[0132] 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.

[0133] The one or more automated functions of the drug delivery device 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 sleeve in order to cause injection.

[0134] 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,Attorney Docket No.: 46567-1791 WO1

[0135] 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.

[0136] 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).

[0137] The present disclosure relates to a medicament delivery device, and to a medicament delivery system comprising the medicament delivery device and a medicament container for use with the medicament delivery device. The medicament delivery device may be reusable or single-use.

[0138] 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 medicament delivery device or the medicament container. The term “distal” refers to a location that is relatively closer to a site of drug delivery, and the term "proximal" refers to a location that is relatively further away from the drug delivery site (e.g. the injection site when the medicament is delivered by injection, the patient’s nose when the medicament is delivered intranasally, or the patient’s mouth when the medicament is delivered orally).

[0139] Figs. 1 and 2 show a medicament delivery device 100 according to a first embodiment of the present disclosure. The medicament delivery device 100 (hereafter referred to as “device 100” for brevity) is configured to dispense multiple doses of a medicament from a medicament container 200 held within the device 100. Together, the device 100 and the medicament container 200 form a medicament delivery system 1000 (hereafter referred to as “system 1000” for brevity). The medicament container 200 may take the form of a syringe, for example.

[0140] Fig. 1 shows the device 100 in an assembled state, ready for use, wherein the medicament container 200 is contained within the device 100. The device 100 extends along a device axis X-X.

[0141] Fig. 2 is an exploded view of the medicament delivery system 1000, wherein the device 100 is in a disassembled state to show various components of the device 100 and the medicament container 200 contained within.Attorney Docket No.: 46567-1791 WO1

[0142] As shown in Figs. 1 and 2, the device 100 comprises a housing 110 configured to contain the medicament container 200. The device 100 further comprises a plunger drive mechanism 300, a button 400 and a cap 500.

[0143] The housing 110 is substantially elongate and extends along a longitudinal device axis X-X. As shown in Fig. 2, the housing 110 comprises an upper housing portion 110a and a lower housing portion 110b, both of which may be substantially elongate. Fig. 2 shows the upper housing portion 110a and the lower housing portion 110b in a separated state, prior to assembly of the device 100. The housing 110 is configured to contain the medicament container 200 between the upper housing portion 110a and the lower housing portion 110b when the upper housing portion 110a and the lower housing portion 110b are coupled, as shown in Fig. 1. The housing 110 comprises an outlet 114 arranged at a distal end. As shown in Fig. 2, the outlet 114 may be formed by the upper housing portion 110a and the lower housing portion 110b when joined together.

[0144] The medicament container 200, which in Fig. 2 takes the form of a syringe, comprises a substantially cylindrical barrel 210 forming a reservoir 220 within for containing a medicament 230. The barrel 210 extends substantially along the device axis X-X when held within the housing 110. A plunger rod 240 is arranged to extend proximally from a proximal end of the barrel 210, through a proximal opening 212 in the proximal end of the barrel 210. The plunger rod 240 is axially-movable within the barrel, through the reservoir 220, to dispense the medicament 230 from the medicament container 200. Fig. 2 shows the plunger rod 240 at a proximal position relative to the barrel 210 of the medicament container 200. Axial movement of the plunger rod 240 relative to the barrel 210 in a distal direction A1 that is substantially parallel to the device axis X-X will translate the plunger rod 240 distally within the reservoir 220, applying a distal force to the medicament 230 contained within the reservoir 220 that causes the medicament 230 (or at least a portion thereof) to be dispensed from the barrel 210, through an outlet 214 arranged at a distal end of the barrel 210. In some examples, the plunger rod 240 forms part of the medicament container 200. In other examples, the plunger rod 240 forms part of the device 100.

[0145] Fig. 2 shows a plunger rod flange 242 arranged at a proximal end of the plunger rod 240, the plunger rod flange 242 extending radially from an outer surface of the plunger rod 240. Fig. 2 also shows a barrel flange 216 arranged at the proximal end of the barrel 210, the barrel flange 216 extending radially from an outer surface of the barrel 210.Attorney Docket No.: 46567-1791 WO1

[0146] Fig. 2 shows a medicament delivery member 250 coupled to the medicament container 200 and through which medicament 230 is to be dispensed to a patient. The medicament delivery member 250 is shown in the form of an intranasal nozzle coupled to the outlet 214 of the barrel 210 of the medicament container 200.

[0147] In some embodiments, the intranasal nozzle comprises one or more medicament delivery conduits 2501 (e.g., as shown in Fig. 3B). In some embodiments, each medicament delivery conduit 2501 comprises a respective nozzle outlet 2501 A, which may be configured to promote a spray of medicament as it is expelled from the respective conduit 2501. Each nozzle outlet 2501 A may be configured to atomize the medicament.

[0148] In the present example, the intranasal nozzle comprises a single medicament delivery conduit 2501 for delivering medicament to a nostril of a user.

[0149] When coupled to the outlet 214, the medicament delivery member 250 is in fluid communication with the reservoir 220 of the barrel 210, via the outlet 214 (and optionally a valve), such that distal movement of the plunger rod 240 in the distal direction A1 relative to the barrel 210 causes at least a portion of the medicament 230 to be dispensed from the barrel 210 via the outlet 214 and via the medicament delivery member 250.

[0150] In one or more examples, the medicament delivery member 250 may be permanently coupled to the medicament container 200 (e.g., the medicament delivery member 250 may be integrally formed with the medicament container 200). Alternatively, in one or more other examples, the medicament delivery member 250 may be releasably couplable to the medicament container 200 such that the medicament delivery member 250 may be coupled and uncoupled from the medicament container 200. For instance, the medicament delivery member 250 may be releasably couplable such that it can be replaced with a new medicament delivery member 250 between the dispensing of each dose of medicament 230 using the device 100.

[0151] The medicament delivery member 250 may be couplable to the medicament container 200 via any suitable coupling interface arranged between the medicament delivery member 250 and the medicament container 200, such as a Luer lock coupling interface, a Luer slip coupling interface, a bayonet coupling interface, an adhesive coupling interface, or the like. In some examples, the medicament delivery member 250 may be couplable to the medicament container 200 only once (i.e., once the medicament delivery member 250 hasAttorney Docket No.: 46567-1791 WO1

[0152] been coupled to the medicament container 200, it cannot be uncoupled from the medicament container 200).

[0153] Fig. 35 shows an alternative medicament delivery member 250’ suitable for use with one or more embodiments of the present disclosure. Similar to the medicament delivery member 250, the medicament delivery member 250’ takes the form of an intranasal nozzle, however the intranasal nozzle 250’ comprises first and second medicament delivery conduits 2501 , 2501’ comprising respective nozzle outlets 2501 A, 2501 A’, for delivering medicament to the respective nostrils of a user. The medicament delivery member 250’ may be known as a dual nozzle atomizer. The first and second medicament delivery conduits 2501 , 2501 ’ extend through the outlet 114 of the housing when the system 1000 is assembled. The medicament delivery member 250’ may allow medicament to be delivered to the respective nostrils of a user simultaneously.

[0154] Fig. 36 shows another alternative medicament delivery member 250” suitable for use with one or more embodiments of the present disclosure. In this example, the medicament delivery member 250” comprises a hollow needle 2502 for delivering medicament to the user, for example subcutaneously, intramuscularly or intravenously. The hollow needle 2502 extends through the outlet 114 ofthe housing when the system 1000 is assembled.

[0155] In examples in which the medicament delivery member 250, 250’ takes the form of an intranasal nozzle (e.g., an intranasal atomization nozzle, for atomising the medicament as it is dispensed), the device 100 may be, for example, an intranasal medicament delivery device (e.g., an intranasal atomization device) and the system 1000 may be an intranasal medicament delivery system (e.g., an intranasal atomization system). In some examples, where the medicament delivery member 250” takes the form of a hollow needle, the medicament delivery device 100 may be, for example, an injector device and the system 1000 may be an injector system. However, it should be recognised that in other examples the medicament delivery member may take a different form than an intranasal nozzle or hollow needle. For example, the medicament delivery member 250 may instead comprise an oral nozzle. Where the medicament delivery member 250 takes the form of an oral nozzle, the medicament delivery device 100 may be, for example, an oral medicament delivery device such as an inhaler and the system 1000 may be an oral medicament delivery system.

[0156] As shown in Fig. 2, a delivery member shield 260 may be coupled to the delivery member 250 such that the delivery member shield 260 covers at least a distal end ofthe delivery member 250. The delivery member shield 260 may maintain the sterility ofthe deliveryAttorney Docket No.: 46567-1791 WO1

[0157] member 250 prior to use and / or prevent an accidental needle stick injury by a user (in examples in which the delivery member 250 comprises a needle). The delivery member shield 260 is configured to be removed by a user prior to dispensing of the medicament 230 from the device 100.

[0158] In some examples, the delivery member shield 260 may take the form of a (rigid or flexible) nozzle sheath, for example in instances where the medicament delivery member 250 takes the form of an intranasal nozzle or an oral nozzle. In other examples, the delivery member shield 260 may take the form or a rigid needle shield (RNS) or a flexible needle shield, for example in instances where the medicament delivery member 250 takes the form of a needle for injection.

[0159] Fig. 2 shows the plunger drive mechanism 300 comprising a plunger drive shuttle 320 and a biasing member 380, each of which are arranged within the housing 110 when the device 100 is assembled, substantially along the device axis X-X. Fig. 2 shows the plunger drive shuttle 320 arranged proximal to the medicament container 200 and plunger rod 240, and the biasing member 380 arranged proximal to the plunger drive shuttle 320, the medicament container 200 and plunger rod 240.

[0160] The plunger drive shuttle 320 is axially movable within the housing 110 to dispense the medicament 230 from the medicament container 200. When moved axially in the distal direction A1 relative to the housing 110, the plunger drive shuttle 320 moves the plunger rod 240 axially in the distal direction A1 relative to the housing 110, due to engagement between the plunger drive shuttle 320 and the plunger rod 240. Distal movement of the plunger rod 240 causes at least a portion of the medicament 230 to be dispensed.

[0161] The biasing member 380 is configured to bias the plunger drive shuttle 320 in the distal direction A1 relative to the housing 110, for moving the plunger drive shuttle 320 in the distal direction A1 to dispense the medicament 230.

[0162] Fig. 2 shows the biasing member 380 taking the form of a spring, such as a helical compression spring. When the device 100 is assembled for use, the biasing member 380 is arranged between the housing 110 and the plunger drive shuttle 320. The biasing member 380 is configured to bias the plunger drive shuttle 320 in the distal direction A1 relative to the housing 110 by applying a biasing force to the plunger drive shuttle 320 in the distal direction A1 , for moving the plunger drive shuttle 320 distally to dispense the medicament 230.Attorney Docket No.: 46567-1791 WO1

[0163] It should be understood that the biasing member 380 taking the form of a helical compression spring is provided by way of example only, and that in one or more other examples the biasing member 380 may take the form of a spring other than a helical compression spring, such as, but not limited to, a wave spring, a leaf spring ora rubber spring. In other examples, the biasing member 380 may take a form other than a spring, for example, but not limited to, a pneumatic system, a hydraulic system or a memory foam arrangement.

[0164] Figs. 1 and 2 show the device 100 further comprising a button 400 arranged at the housing 110. The button 400 is configured to be actuated by a user to dispense a first dose of the medicament 230 and a second dose of the medicament 230 from the medicament container 200. The button 400 is actuated by the user applying an actuation force to the button 400, pushing the button 400 relative to the housing 110. Figs. 1 and 2 show the button 400 arranged at an outer surface of the housing, in this example at an outer surface of the upper housing portion 110a.

[0165] As shown in Figs. 1 and 2, the housing 110 may comprise a pair of windows 112a, 112b through which at least a portion of the medicament container 200 may be visible to a user when the device 100 is assembled. The windows 112a, 112b may allow a user to view at least a portion of the barrel 210 such that the user may determine an amount of the medicament 230 remaining in the barrel 210. For example, the windows 112a, 112b may be aligned with at least a portion of the barrel 210 such that a user can view the medicament 230 within the barrel 210 and / or the position of a piston within the barrel, the piston to be driven distally within the barrel 210 by the plunger rod 240 to dispense the medicament 230. The windows 112a, 112b may allow the user to determine a progress of medicament delivery.

[0166] Fig. 2 shows the housing 110 of the device 100 comprising two windows 112a, 112b, each located at an opposite side of the housing 110 about the device axis X-X and the barrel 210, with a first window 112a arranged at a distal portion of the upper housing portion 110a and a second window 112b arranged at a distal portion of the lower housing portion 110b.

[0167] However, it should be understood that this arrangement of the windows 112a, 112b is not meant to be limiting. For example, it should be understood that the first window 112a and / or the second window 112b may be arranged at different locations of the housing 110 to those shown in Fig. 2. Additionally / alternatively, it should be understood that the device 100 may in other examples have fewer or greater than two windows 112a, 112b, for example no windows, one window, three windows, or greater than three windows.Attorney Docket No.: 46567-1791 WO1

[0168] Figs. 1 and 2 further show the device 100 comprising a cap 500. When coupled to the housing 110 of the device 100 as shown in Fig. 1, the cap 500 is configured to cover the outlet 114 of the housing 110 through which the medicament 230 is to be dispensed from the medicament container 200. The cap 500 may maintain the sterility of the medicament container 200 and / or delivery member 250 prior to use of the device 100, and / or prevent an accidental needle stick injury by a user (in examples in which the delivery member 250 comprises a needle). The cap 500 is configured to be removed from the housing 110 by a user prior to dispensing the medicament 230, to uncover the outlet 114.

[0169] Figs. 1 and 2 show the cap 500 comprising a cover portion 510 configured to cover the outlet 114 when the cap 500 is coupled to the housing 110. The cover portion 510 may be substantially cylindrical and hollow, having an open proximal end for receiving the housing 110 and a closed distal end for inhibiting access to the outlet 114.

[0170] The cap 500 may be releasably coupled to the housing 110 using any suitable coupling arrangement including, but not limited to, a friction fit coupling arrangement, a threaded coupling arrangement, a bayonet coupling arrangement, a snap-fit coupling arrangement, a magnetic coupling arrangement, an adhesive coupling arrangement, or the like.

[0171] In the example shown in Figs. 1 and 2, the cap 500 may be configured to be uncoupled from the housing 110 by a user pulling the cap 500 in the distal direction A1 relative to the housing 110, thereby separating the cap 500 from the housing 110. As shown in Figs. 1 and 2, the cap 500 may comprise a grip element 520 coupled to the cover portion 510 of the cap 500, the grip element 520 providing a gripping surface to be gripped by the user for assisting the user in removing the cap 500 from the housing 110.

[0172] If a delivery member shield 260 is present within the device 100, the cap 500 may be configured to remove the delivery member shield 260 from the medicament delivery member 250 as the cap 500 is removed from the housing 110. For example, the cap 500 may be coupled to the delivery member shield 260 such the delivery member shield 260 is moved with the cap 500 as the cap 500 is removed from the housing 110. In some examples, the cap 500 and the delivery member shield 260 are not initially coupled, however the cap 500 and delivery member shield 260 are coupled as the cap 500 is removed from the housing 110 (e.g., the delivery member shield 260 is ‘grabbed’ by the cap 500 as cap 500 is moved relative to the housing 110).Attorney Docket No.: 46567-1791 WO1

[0173] As shown in Fig. 2, the cap 500 may comprise a cap engagement element 530 configured to inhibit actuation of the button 400 relative to the housing when the cap 500 is coupled to the housing 110. Fig. 2 shows the cap engagement element 530 extending proximally from a proximal end of the cover portion 510 of the cap 500, outside but adjacent to the housing 110, to engage the button 400 when the cap 500 is coupled to the housing 110. The cap engagement element 530 may comprise a tab 532 configured to engage the button 400 when the cap 500 is coupled to the housing 110 such that the button 400 is inhibited from being actuated relative to the housing 110. Engagement between the cap engagement element 530 and the button 400 may inhibit accidental dispensing of the medicament 230 when the cap 500 is coupled to the housing 110.

[0174] Uncoupling the cap 500 from the housing 110 may allow actuation of the button 400 relative to the housing 110. For example, removal of the cap 500 from the housing 110 in the distal direction A1 may disengage the cap engagement element 530 (e.g., the tab 532 of the cap engagement element 530) from the button 400, allowing the button 400 to be actuated by a user relative to the housing 110 to dispense the medicament 230. The cap 500 may therefore act as a transport lock, inhibiting accidental actuation of the button 400 after the device 100 has been assembled but prior to delivery of the device 100 to the end user.

[0175] While the system 1000 shown in Figs. 1 and 2 includes both a cap 500 and a delivery member shield 260, it should be understood that this is not meant to be limiting and that in other examples the system 1000 may include a cap 500 but no delivery member shield 260, or a delivery member shield 260 but no cap 500, or no delivery member shield 260 and no cap 500.

[0176] Figs. 3A to 3D show the system 1000 of Figs. 1 and 2 at various stages of use, for delivering two doses of the medicament 230 to a patient. The patient may be the user of the device 100, or a different person or non-human animal than the user.

[0177] Fig. 3A shows the device 100 in an initial state, prior to dispensing the medicament 230. The device 100 contains a medicament container 200 in which the medicament 230 is held. The medicament container 200 may have been inserted into the housing 110 of the device 100 during assembly of the device 100, for example either at a manufacturing / assembly plant, by the user of the device 100, or by a person other than the user, such as a healthcare professional / carer.Attorney Docket No.: 46567-1791 WO1

[0178] As shown in Fig. 3A, the cap 500 is coupled to the housing 110 of the device 100 such that actuation of the button 400 is inhibited.

[0179] Fig. 3B shows the device 100 in a first primed state, which follows the initial state but precedes medicament delivery. To move the device 100 into the first primed state, the user has removed the cap 500 from the housing 110 by moving the cap 500 in the distal direction A1 relative to the housing 110. The user may have grasped the grip element 520 of the cap 500 to assist with removal of the cap 500.

[0180] Removal of the cap 500 has uncovered the outlet 114 of the housing 110 and the medicament delivery member 250. Fig. 3E3 shows a distal portion of the medicament delivery member 250 extending through the outlet 114, with a distal end of the medicament delivery member 250 distal to the distal end of the housing 110. However, it should be understood that this is not meant to be limiting and that in other examples the medicament delivery member 250 may not extend through the outlet 114, or a distal end of the medicament delivery member 250 may not be distal to the distal end of the housing 110.

[0181] The delivery member shield 260 (if present) may have been removed from the medicament delivery member 250 by the cap 500, as the cap 500 was removed from the housing 110. Alternatively, the delivery member shield 260 (if present) may have been removed from the medicament delivery member 250 by the user gripping and moving the delivery member shield 260 distally relative to the medicament delivery member 250, after the cap 500 was removed from the housing 110.

[0182] As the cap 500 has been removed from the housing 110, the cap engagement element 530 (e.g., the tab 532 of the cap engagement element 530) has been moved out of engagement with the button 400 such that the cap engagement element 530 no longer inhibits actuation of the button 400. As such, the user is now able to actuate the button 400 relative to the housing 110 to dispense the medicament 230.

[0183] Once the device 100 is in the first primed state, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250) to a medicament delivery site, wherein the medicament delivery site is a site at which a first dose of the medicament 230 is to be delivered to a patient. For example, where the first dose of the medicament 230 is to be delivered intranasally to the patient, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250, which may be an intranasal nozzle) into or adjacent a nostril of the patient. In an alternativeAttorney Docket No.: 46567-1791 WO1

[0184] example in which the first dose of the medicament 230 is to be delivered orally to the patient, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250, which may be an oral nozzle) into or adjacent the mouth of the patient. In an alternative example in which the first dose of the medicament 230 is to be delivered parenterally to the patient, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250, which may comprise a hollow needle) into an injection site of the patient.

[0185] Fig. 3C again shows the device 100 in the first dose dispense state. To dispense a first dose of the medicament 230 contained within the medicament container 200 of the system 1000, the user actuates the button 400 relative to the housing 110 a first time, thereby performing a first actuation of the button 400 relative to the housing 110. The user performs the first actuation by applying a first actuation force F1 to the button 400, as shown in Fig. 3C. The user may provide the first actuation force F1 by pushing the button 400 with a finger or thumb. The first actuation of the button 400 may be substantially in a transverse direction A2 that is substantially transverse to the distal direction A1. The first actuation force F1 moves the button 400 relative to the housing 110, causing the device to move from the first primed state to a first dose dispense state. The first actuation moves (e.g., deflects) the plunger drive shuttle 320, causing the plunger drive shuttle 320 to be moved by the biasing member 380 from an initial position relative to the housing 110 to an intermediate position relative to the housing 110, to move the plunger rod 240 distally and dispense the first discrete dose of the medicament 230 to the patient.

[0186] After the button 400 has been actuated a first time to dispense the first dose of the medicament 230, it may now be actuated a second time to dispense a second dose of the medicament 230.

[0187] Fig. 3D shows the device 100 in a second primed state, which follows the first dose dispense state. The user has moved the device 100 from the first dose dispense state to the second primed state by releasing the button 400.

[0188] To dispense a second dose of the medicament 230, the user actuates the button 400 relative to the housing 110 a second time, thereby performing a second actuation of the button 400 relative to the housing 110. The user performs the second actuation by applying a second actuation force F2 to the button 400. The user may provide the second actuation force F2 by pushing the button 400 with a finger or thumb. The second actuation of the button 400 may, like the first actuation, be substantially in the transverse direction A2 that isAttorney Docket No.: 46567-1791 WO1

[0189] substantially transverse to the distal direction A1. The second actuation force F2 moves the button 400 relative to the housing 110, causing the device to move from the second primed state to a second dose dispense state. The second actuation moves (e.g., deflects) the plunger drive shuttle 320, causing the plunger drive shuttle 320 to be moved by the biasing member 380 from the intermediate position relative to the housing 110 to a final position relative to the housing 110, to move the plunger rod 240 distally and dispense the second discrete dose of the medicament 230 to the patient.

[0190] The second actuation force F2 may be substantially similar to the first actuation force F1 , with the user applying the second actuation force F2 in substantially the same direction as the first actuation force F1 , which may substantially be in the transverse direction A2.

[0191] Prior to actuating the button 400 to dispense the second dose of the medicament 230, the user may have moved the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250) to a new medicament delivery site that is different from the medicament delivery site at which the first dose of the medicament 230 was delivered to the patient. For example, where the second dose of the medicament 230 is to be delivered intranasally to the patient, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250, which may be an intranasal nozzle) into or adjacent the other nostril of the patient. In an alternative example in which the second dose of the medicament 230 is to be delivered parenterally to the patient, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250, which may comprise a hollow needle) into a new injection site of the patient that is different to the previous injection site. It should be understood that this is not meant to be limiting, and that in one or more other examples a user does not move the device 100 to a new medicament delivery site between the first dose delivery and the second dose delivery. Furthermore, it should be understood that in one or more other examples, the first dose and the second dose are delivered to different patients (e.g., the first dose of the medicament 230 is delivered to a first patient and the second dose of the medicament 230 is delivered to a second patient that is not the first patient).

[0192] The user may move the device 100 from the second dose dispense state to a final state by releasing the button 400.

[0193] In instances in which the device 100 is single-use, it may be disposed of after the first and second doses have been administered. Alternatively, in instances in which the device is re-Attorney Docket No.: 46567-1791 WO1

[0194] usable, the medicament container 200 contained within the device 100 may be replaced with a new medicament container.

[0195] Various components of the device 100 are now described in greater detail with reference to Figs. 4 to 11.

[0196] Fig. 4 is a perspective view of the plunger drive shuttle 320 previously described in relation to Fig. 2.

[0197] As shown in Fig. 4, the plunger drive shuttle 320 comprises a substantially U-shaped shuttle body 322 comprising a pair of shuttle arms 324a, 324b coupled by a shuttle crossmember 326. The elongate shuttle arms 324a, 324b each extend axially, substantially parallel to the device axis X-X when the device 100 is assembled, as shown in Fig. 9. The shuttle arms 324a, 324b are disposed substantially parallel to each other, and are situated on opposite sides of the device axis X-X, maintaining a substantially equidistant spacing from the device axis X-X along their length, with the first shuttle arm 324a and the second shuttle arm 324b symmetrically arranged about the device axis X-X.

[0198] The shuttle arms 324a, 324b are coupled at respective proximal ends by the shuttle crossmember 326, which extends between the first shuttle arm 324a and the second shuttle arm 324b substantially transverse to the device axis X-X.

[0199] As shown in Fig. 4, the plunger drive shuttle 320 may comprise a support mandrel 327 configured to stabilise the biasing member 380. The elongate support 327 is configured to receive at least a portion of the biasing member 380 such that the biasing member 380 is stabilised by the support mandrel 327, as later described in relation to Fig. 9. Fig. 4 shows the support mandrel 327 extending in a proximal direction from the shuttle body 322, in this example extending proximally from the shuttle crossmember 326. The support mandrel 327 extends substantially parallel to the device axis X-X, and may be substantially coaxial with the device axis. Fig. 4 shows the support mandrel 327 as cruciform, however this is not meant to be limiting.

[0200] The plunger drive shuttle 320 has a plunger rod engagement surface 328 configured to engage the plunger rod 240 of the medicament container 200 during distal axial movement of the plunger drive shuttle 320 to dispense the medicament 230. Fig. 4 shows the plunger rod engagement surface 328 taking the form of a distally-facing surface of the shuttle crossmember 326.Attorney Docket No.: 46567-1791 WO1

[0201] Each shuttle arm 324a, 324b comprises a holding member 330a, 330b for limiting axial movement of the plunger drive shuttle 320 in the distal direction A1. Each holding member 330a, 330b is configured to releasably engage a drive shuttle hold arrangement 350 of the device 100, as later described in relation to Fig. 6. Each holding member 330a, 330b is configured to engage the drive shuttle hold arrangement 350 to hold the plunger drive shuttle 320 in an initial position relative to the housing 110 and, subsequently, to hold the plunger drive shuttle 320 in an intermediate position relative to the housing 110, as later described in relation to Figs. 12 to 15.

[0202] As shown in Fig. 4, each holding member 330a, 330b is arranged at a distal end of its respective shuttle arms 324a, 324b. That is, a holding member 330a of the first shuttle arm 324a is arranged at a distal end of the first shuttle arm 324a and a holding member 330b of the second shuttle arm 324b is arranged at a distal end of the second shuttle arm 324b. Fig.

[0203] 4 shows each holding member 330a, 330b arranged between the shuttle arms 324a, 324b, with the holding member 330a of the first shuttle arm 324a extending inwards from the distal end of the first shuttle arm 324a towards the holding member 330b of the second shuttle arm 324b, and with the holding member 330b of the second shuttle arm 324b extending inwards from the distal end of the second shuttle arm 324b towards the holding member 330a of the first shuttle arm 324a.

[0204] Each holding member 330a, 330b comprises a respective stop engagement element 332a, 332b and a respective pin engagement element 334a, 334b.

[0205] Fig. 4 shows each stop engagement element 332a, 332b arranged at a distal end of the respective holding member 330a, 330b. Each stop engagement element 332a, 332b comprises a distally-facing engagement surface 3321a, 3321b. Each stop engagement element 332a, 332b is configured to releasably engage the drive shuttle hold arrangement 350 of the device 100 (e.g., via its respective distally-facing engagement surface 3321a, 3321 b), to hold the plunger drive shuttle 320 in the initial position relative to the housing 110 and, subsequently, to hold the plunger drive shuttle 320 in the intermediate position relative to the housing 110, as later described in relation to Figs. 12 to 15.

[0206] Fig. 4 shows each stop engagement element 332a, 332b further comprising a shuttle guide surface 3322a, 3322b. Each shuttle guide surface 3322a, 3322b is arranged proximal to a respective distally-facing engagement surface 3321a, 3321b and is configured to engage and slide along the drive shuttle hold arrangement 350 of the device 100 during axialAttorney Docket No.: 46567-1791 WO1

[0207] movement of the plunger drive shuttle 320, as later described. Each shuttle guide surface 3322a, 3322b extends substantially parallel to the device axis X-X and is substantially perpendicular to the respective distally-facing engagement surface 3321a, 3321b. Each shuttle guide surface 3322a, 3322b is upwards-facing, such that they face towards the upper housing portion 110a.

[0208] Each stop engagement element 332a, 332b may further comprise a chamfered surface 3323a, 3323b arranged between, and adjacent to, a respective distally-facing engagement surface 3321a, 3321b and respective shuttle guide surface 3322a, 3322b.

[0209] Each pin engagement element 334a, 334b is configured to be releasably engaged by the button 400 to cause a dose of medicament 230 to be dispensed, as later described in relation to Figs. 12 to 16. Fig. 4 shows each pin engagement element 334a, 334b comprising a respective pin engagement surface 3341a, 3341 b that is configured to be releasably engaged by the button 400, as later described in relation to Figs. 12 to 16. Each pin engagement surface 3341a, 3341b extends substantially parallel to the device axis X-X and is substantially perpendicular to the respective distally-facing engagement surface 3321a, 3321b. Each pin engagement surface 3341a, 3341b is upwards-facing, such that they face towards the upper housing portion 110a.

[0210] Fig. 4 shows each pin engagement surface 3341a, 3341b and corresponding shuttle guide surface 3322a, 3322b in a stepped arrangement, wherein each pin engagement surface 3341a, 3341b is offset from its corresponding shuttle guide surface 3322a, 3322b in a direction transverse to the device axis X-X. Each shuttle guide surface 3322a, 3322b is closer to the upper housing portion 110a than its corresponding pin engagement surface 3341a, 3341b.

[0211] Each pin engagement element 334a, 334b may comprise a chamfered surface 3342a, 3342b distal to, and adjacent to, its respective pin engagement surface 3341a, 3341b.

[0212] As shown in Fig. 4, each holding member 330a, 330b may further comprise a respective pin flexing surface 335a, 335b for flexing a portion of the button 400, as described later in relation to Fig. 18. Each pin flexing surface 335a, 335b is ramped such that it extends obliquely to the device axis X-X. The pin flexing surfaces 335a, 335b face each other, and face distally (i.e., in the distal direction A1).Attorney Docket No.: 46567-1791 WO1

[0213] As shown in Fig. 4, the plunger drive shuttle 320 may further comprise a pair of track guide elements 336a, 336b, a pair of first lateral guide elements 337a, 337b and a pair of second lateral guide elements 338a, 338b.

[0214] Each track guide element 336a, 336b is arranged to extend from an upper surface of a respective shuttle arm 324a, 324b, towards the upper housing portion 110a. Fig. 4 shows each track guide element 336a, 336b arranged at a distal end of a respective shuttle arm 324a, 324b, that is, with a first track guide element 336a arranged at a distal end of the first shuttle arm 324a and a second track guide element 336b arranged at a distal end of the second shuttle arm 324b. The track guide elements 336a, 336b may be adjacent the corresponding holding member 330a, 330b of each shuttle arm 324a, 324b. The track guide elements 336a, 336b are configured to guide the plunger drive shuttle 320 as it moves axially along the drive shuttle hold arrangement 350 of the device 100, as later described.

[0215] Fig. 4 shows each track guide element 336a, 336b taking the form a rib that extends substantially parallel to the device axis X-X, however it should be understood that this is not meant to be limiting and that in other examples each or both track guide element 336a, 336b may take a different form to a rib (e.g., a different form of projection to a rib, such as a stud). Additionally / alternatively, it should be understood that the location of the track guide elements 336a, 336b shown in Fig. 4 is shown by way of example, and that in other examples, one or both of the track guide elements 336a, 336b may be located at a different position on the shuttle arms 324a, 324b than shown in Fig. 4. For example, the first track guide element 336a may be located at a proximal end of the first shuttle arm 324a and / or the second track guide element 336b may be located at a proximal end of the second shuttle arm 324b.

[0216] The pair of first lateral guide elements 337a, 337b and the pair of second lateral guide elements 338a, 338b are configured to guide the plunger drive shuttle 320 as it moves axially along the drive shuttle hold arrangement 350 of the device 100. The pair of first lateral guide elements 337a, 337b and / or the pair of second lateral guide elements 338a, 338b may be configured to engage the inner surface of the housing 110 to inhibit lateral flexing and / or deformation of the shuttle arms 324a, 324b. Additionally / alternatively, the pair of first lateral guide elements 337a, 337b and / or the pair of second lateral guide elements 338a, 338b may be configured to reduce friction between the shuttle arms 324a, 324b and the inner surface of the housing 110 as the plunger drive shuttle 320 moves distally through the housing 110.Attorney Docket No.: 46567-1791 WO1

[0217] Each of the first lateral guide elements 337a, 337b project laterally outwards from a respective lateral outer surface 3241a, 3241b of a corresponding shuttle arm 324a, 324b, wherein the lateral outer surface 3241a of the first shuttle arm 324a faces away from, and in an opposite direction to, the lateral outer surface 3241b of the second shuttle arm 324b. Each of the first lateral guide elements 337a, 337b therefore project in opposing directions from their respective shuttle arms 324a, 324b, substantially away from the device axis X-X. The lateral outer surface 3241a and the first lateral guide element 337a of the first shuttle arm 324a are hidden from view in Fig. 4. The first lateral guide element 337a of the first shuttle arm 324a may take a similar form to the first lateral guide element 337b of the second shuttle arm 324b.

[0218] As shown in Fig. 4, each of the first lateral guide elements 337a, 337b may be arranged at a distal end of its corresponding shuttle arm 324a, 324b, adjacent the corresponding holding member 330a, 330b. However, it should be understood that such an arrangement is not meant to be limiting and that in one or more other examples, one or both of the first lateral guide elements 337a, 337b may be arranged at a different location with respect to its corresponding shuttle arm 324a, 324b than shown in Fig. 4. For example, the first lateral guide element 337a of the first shuttle arm 324a may instead be located at a proximal end of the first shuttle arm 324a and / or the first lateral guide element 337b of the second shuttle arm 324b may instead be located at a proximal end of the second shuttle arm 324b.

[0219] Fig. 4 shows the first lateral guide elements 337a, 337b each taking the form of a spherical projection, however it should be understood that in other examples one or both of the first lateral guide elements 337a, 337b may take a form other than a spherical projection, such as a rib.

[0220] Each of the second lateral guide elements 338a, 338b project laterally outwards from the respective lateral outer surface 3241a, 3241b of a corresponding shuttle arm 324a, 324b. Each of the second lateral guide elements 338a, 338b therefore project in opposing directions from their respective shuttle arms 324a, 324b, substantially away from the device axis X-X. The second lateral guide element 338a of the first shuttle arm 324a is hidden from view in Fig. 4, but may take a similar form to the second lateral guide element 338b of the second shuttle arm 324b.

[0221] As shown in Fig. 4, each of the second lateral guide elements 338a, 338b is arranged proximal to, and separated from, a corresponding first lateral guide element 337a, 337b. Each of the second lateral guide elements 338a, 338b may be arranged at a distal end of itsAttorney Docket No.: 46567-1791 WO1

[0222] corresponding shuttle arm 324a, 324b. However, it should be understood that such an arrangement is not meant to be limiting and that in one or more other examples, one or both of the second lateral guide elements 338a, 338b may be arranged at a different location with respect to its corresponding shuttle arm 324a, 324b than shown in Fig. 4.

[0223] Fig. 4 shows the second lateral guide elements 338a, 338b each taking the form of a rib that extends substantially along the lateral outer surface 3241a, 3241b of a corresponding shuttle arm 324a, 324b. However, it should be understood that this is not meant to be limiting and that in other examples, one or both of the first lateral guide elements 337a, 337b may take a form other than a rib, such as a stud.

[0224] While Fig. 4 shows two pairs of lateral guide elements (i.e., the first lateral guide elements 337a, 337b and the second lateral guide elements 338a, 338b), it should be understood that this number of lateral guide elements is not meant to be limiting. In some other examples, the plunger drive shuttle 320 may comprise only one pair of lateral guide elements (e.g., only the first lateral guide elements 337a, 337b or the second lateral guide elements 338a, 338b), or the plunger drive shuttle 320 may comprise more than two pairs of lateral guide elements (e.g., the first lateral guide elements 337a, 337b, the second lateral guide elements 338a, 338b, and one or more additional pairs of lateral guide elements that may be similar or different from the first lateral guide elements 337a, 337b and / or the second lateral guide elements 338a, 338b). In one or more other examples, the plunger drive shuttle 320 may not comprise the lateral guide elements (e.g., may not comprise the first lateral guide elements 337a, 337b and the second lateral guide elements 338a, 338b).

[0225] Figs. 5 and 6 show alternative perspective views of the upper housing portion 110a of the device 100. Fig. 5 shows a perspective view of the upper housing portion 110a when viewed from above, while Fig. 6 shows a perspective view of the upper housing portion 110a when viewed from below.

[0226] The upper housing portion 110a may be formed from one or more polymers including, but not limited to, polyethylene, polycarbonate, polypropylene, polyvinyl chloride and acrylonitrile butadiene styrene.

[0227] In some examples, the upper housing portion 110a may have been formed by one or more of injection moulding, blow moulding, thermoforming, three-dimensional (3D) printing, or the like, however this list is not exhaustive. In some examples, the upper housing portion 110a may be integrally formed from a single piece of material.Attorney Docket No.: 46567-1791 WO1

[0228] Figs. 5 and 6 show the upper housing portion 110a having a substantially elongate form that extends substantially parallel to the device axis X-X.

[0229] The first window 112a is arranged at an upper wall 1101a of the upper housing portion 110a, such that a user may view the medicament container 200 through the first window 112a when the device 100 is assembled. The housing 110 may comprise one or more delivery progress markings for indicating to the user the progress of delivery of the medicament 230. For example, Fig. 5 shows delivery progress markings taking the form of a pair of indicator elements 115a, 115b arranged at the upper housing portion 110a, at opposing sides of the first window 112a. The indicator elements 115a, 115b are formed as projections such as ribs extending towards one another, at least partially across the first window 112a.

[0230] The indicator elements 115a, 115b are arranged on opposite sides of the device axis X-X, but at the same axial position along the device axis X-X. The axial position of the indicator elements 115a, 115b along the device axis X-X corresponds to a predetermined volume of the medicament 230 having been delivered. For example, the axial position of the indicator elements 115a, 115b along the device axis X-X corresponds to the first dose of the medicament 230 having been dispensed from the device 100. An element of the medicament container 200 will be brought into axial alignment with the indicator elements 115a, 115b when the first dose of the medicament 230 has been dispensed. For example, the element of the medicament container 200 may be a portion of the plunger rod 240 or a portion of a piston within the barrel 210 that is moved by the plunger rod 240 to dispense the medicament 230. As such, the indicator elements 115a, 115b may indicate to the user whether the first dose of the medicament 230 has been dispensed.

[0231] Fig. 5 shows the delivery progress markings further comprising a label 116 arranged at the outer surface of the upper housing portion 110a, adjacent the first indicator element 115a. The label 116 may comprise text for indicating to the user that the first dose of the medicament 230 has been dispensed. The label 116 may indicate to the user that the first indicator element 115a can be used to determine whether the first dose of medicament 230 has been dispensed.

[0232] A distal end of the upper housing portion 110a forms, together with a distal end of the lower housing portion 110b when the housing 110 is assembled, the outlet 114 through which the medicament 230 is dispensed.Attorney Docket No.: 46567-1791 WO1

[0233] Figs 5 and 6 show part of a patient contact member 117 arranged at the distal end of the housing 110, that may contact the patient during delivery of the medicament 230. A distally-facing contact surface 1171 of the patient contact member 117 may be configured to be brought into contact with the patient when the device 100 is moved to a medicament delivery site of the patient. Contact between the distally-facing contact surface 1171 of the patient contact member 117 and the patient may stabilise the position of the device 100 relative to the patient, for medicament delivery.

[0234] Fig. 5 shows a semicircular upper portion 1172 of the patient contact member 117 surrounding an upper half of the outlet 114. The semicircular upper portion 1172 is configured to be brought into alignment with a corresponding semicircular lower portion 1173 of the patient contact member 117 arranged at the lower housing portion 110b, as later described in relation to Figs. 7 and 8. When the semicircular upper portion 1172 and the semicircular lower portion 1173 are brought into alignment during assembly of the upper housing portion 110a and the lower housing portion 110b, the upper portion 1172 and the lower portion 1173 together form a contact member 117 having an annular shape, the annular contact member 117 surrounding the outlet 114 as shown in Figs. 3B-3D. The distally-facing contact surface 1171 is also shown to have an annular shape, the annular distally-facing contact surface 1171 surrounding the outlet 114.

[0235] In examples in which the device 100 is used to deliver the medicament intranasally, the distally-facing contact surface 1171 of the patient contact member 117 may be configured to contact the nose of the patient to limit movement of the device 100 into the nasal cavity (e.g., to limit a penetration depth of an intranasal nozzle into the nasal cavity, if the intranasal nozzle extends distal to the distally-facing contact surface 1171). For example, the distally-facing contact surface 1171 may be configured to contact the alae and / or columella of the patient, to limit movement of the device 100 (e.g., limit movement of the medicament delivery member 250) into the nasal cavity.

[0236] In examples in which the device 100 is used to deliver the medicament orally, the distally-facing contact surface 1171 of the patient contact member 117 may be configured to contact the mouth of the patient to limit movement of the device 100 into the oral cavity (e.g., to limit a penetration depth of an oral nozzle into the oral cavity, if the oral nozzle extends distal to the distally-facing contact surface 1171).

[0237] In examples in which the device 100 is used to deliver the medicament parenterally, the distally-facing contact surface 1171 of the patient contact member 117 may be configured toAttorney Docket No.: 46567-1791 WO1

[0238] contact the skin of the patient to limit movement of the device 100 into the patient’s tissue (e.g., to limit a penetration depth of a hollow needle into the patient).

[0239] The housing 110 may comprise one or more cap retaining elements 118a, 118b configured to couple the cap 500 to the housing 110. The one or more cap retaining elements 118a, 118b are configured to engage one or more corresponding features of the cap 500 when the cap 500 is received on the housing 110 (e.g., when the device is in its initial state shown in Figs. 1 and 3A), to impede accidental removal of the cap 500 from the housing 110. Figs. 5 and 6 show the cap retaining elements 118a, 118b comprising a pair of recesses formed at the outer surface of the housing 110, adjacent and proximal to the patient contact member 117. The cap retaining elements 118a, 118b are arranged at opposing sides of the housing 110 about the device axis X-X.

[0240] As shown in Figs. 5 to 8, the cap retaining elements 118a, 118b may be formed in both the upper housing portion 110a and the lower housing portion 110b. That is, an upper part of each cap retaining element 118a, 118b (e.g., an upper part of a recess) may be formed at the upper housing portion 110a and a lower part of each cap retaining element 118a, 118b (e.g., a lower part of the recess) may be formed at the lower housing portion 110b such that, when the upper housing portion 110a and the lower housing portion 110b are joined to produce the assembled device 100 shown in Fig. 1 , respective upper parts and respective lower parts of each cap retaining element 118a, 118b are joined to provide the assembled cap retaining element 118a, 118b.

[0241] The upper housing portion 110a may comprise an upper housing coupling arrangement 120 for engaging with a corresponding lower housing coupling arrangement 130 of the lower housing portion 110b (as later described in relation to Fig. 7) when the device 100 is assembled (as shown in Fig. 1), to couple the upper housing portion 110a to the lower housing portion 110b. Fig. 6 shows such an upper housing coupling arrangement 120 comprising a plurality of upper housing connectors 121a, 121 b, 121c, 121 d spaced about a periphery of the upper housing portion 110a. Fig. 6 shows four upper housing connectors 121a, 121b, 121c, 121 d, each taking the form of a clip. However, it should be understood that this is not meant to be limiting. For instance, in other examples, the upper housing portion 110a may comprise a different number of upper housing connectors than four, for example only one upper housing connector, only two upper housing connectors, only three upper housing connectors, only five upper housing connectors, or more than five upper housing connectors. Additionally / alternatively, one or more of the upper housing connectorsAttorney Docket No.: 46567-1791 WO1

[0242] 121a, 121b, 121c, 121 d may take a different form to a clip (e.g., a magnetic connector, an adhesive connector, a friction-fit connector, etc.).

[0243] The upper housing portion 110a may comprise one or more upper housing alignment elements 122a, 122b configured to engage with one or more corresponding lower housing alignment elements 132a, 132b (as later described in relation to Fig. 7) to assist with alignment of the upper housing portion 110a and the lower housing portion 110b during assembly of the housing 110 and / or to inhibit relative movement between the upper housing portion 110a and the lower housing portion 110b when coupled together. As an example, the upper housing alignment elements 122a, 122b may comprise one or more recesses and / or projections configured to engage lower housing alignment elements 132a, 132b comprising one or more corresponding projections and / or recesses. Fig. 6 shows a pair of upper housing alignment elements 122a, 122b arranged at the distal end of the upper housing portion 110a, adjacent the cap retaining elements 118a, 118b, on opposing sides of the upper housing portion 110a about the device axis X-X. However, such an arrangement and / or number of upper housing alignment elements 122a, 122b is not meant to be limiting, and in other examples there may be fewer or greater than two upper housing alignment elements 122a, 122b, and / or they may be arranged at different locations on the upper housing portion 110a to those shown in Fig. 6.

[0244] The housing 110 comprises a cavity 140 formed between the upper housing portion 110a and the lower housing portion 110b when the upper housing portion 110a and the lower housing portion 110b are coupled together. The cavity 140 is configured to contain the plunger drive shuttle 320, as later described in relation to Fig. 10, such that the plunger drive shuttle 320 is axially movable within the cavity 140 in the distal direction A1 , substantially parallel to the device axis X-X, between an initial position, an intermediate position and a final position.

[0245] The plunger drive mechanism 300 of the device 100 comprises a drive shuttle hold arrangement 350 arranged within the housing 110. The drive shuttle hold arrangement 350 is configured to releasably hold the plunger drive shuttle 320 in the initial position relative to the housing 110 and, subsequently, hold the drive shuttle 320 in the intermediate position relative to the housing 110, as later described in relation to Figs. 12 to 17.

[0246] The drive shuttle hold arrangement 350 comprises a pair of axially-extending shuttle guide tracks 360a, 360b. The shuttle guide tracks 360a, 360b guide the plunger drive shuttle 320 and the holding members 330a, 330b as the plunger drive shuttle 320 moves from the initialAttorney Docket No.: 46567-1791 WO1

[0247] position to the intermediate position to dispense a first dose of medicament 230, and then from the intermediate position to the final position to dispense a second dose of the medicament 230.

[0248] As shown in Fig. 6, the pair of shuttle guide tracks 360a, 360b are arranged within the housing 110 such that they extend substantially parallel to the device axis X-X. The first shuttle guide track 360a and the second shuttle guide track 360b are symmetrically arranged about the device axis X-X. The first shuttle guide track 360a extends along an axis substantially parallel to the device axis X-X, between the medicament container 200 and a side wall of the housing 110 when the medicament container 200 is held within the housing 110. The second shuttle guide track 360b extends along a different axis that is also substantially parallel to the device axis X-X, between the medicament container 200 and an opposing side wall of the housing 110 when the medicament container 200 is held within the housing 110.

[0249] Each shuttle guide track 360a, 360b comprises a respective first track section 3601 a, 3601 b, second track section 3602a, 3602b, and third track section 3603a, 3603b, each of which extend substantially axially within the housing 110. The second track sections 3602a, 3602b are arranged distal to the corresponding first track sections 3601a, 3601 b. The third track sections 3602a, 3602b are arranged distal to the corresponding second track sections 3602a, 3602b.

[0250] The pair of second track sections 3602a, 3602b are offset from the pair of first track section 3601a, 3601b in the transverse direction A2. The pair of third stop elements 363a, 363b are offset from the pair of second stop elements 362a, 362b in the transverse direction A2.

[0251] The first track section 3601a of the first shuttle guide track 360a and the first track section 3601b of the second shuttle guide track 360b are symmetrically arranged about the device axis X-X. The second track section 3602a of the first shuttle guide track 360a and the second track section 3602b of the second shuttle guide track 360b are symmetrically arranged about the device axis X-X. The third track section 3603a of the first shuttle guide track 360a and the third track section 3603b of the second shuttle guide track 360b are symmetrically arranged about the device axis X-X.

[0252] The first track section 3601a, second track section 3602a and third track section 3603a of the first shuttle guide track 360a are configured to guide the first holding member 330a as the plunger drive shuttle 320 moves axially from its initial position, to its intermediateAttorney Docket No.: 46567-1791 WO1

[0253] position, to its final position. Similarly, the first track section 3601 b, second track section 3602b and third track section 3603b of the second shuttle guide track 360a are configured to guide the second holding member 330b as the plunger drive shuttle 320 moves axially from its initial position, to its intermediate position, to its final position.

[0254] Each shuttle guide track 360a, 360b may comprise a respective upper guide rail 3611 a, 3611b and a respective lower guide rail 3612a, 3612b. Fig. 6 shows the upper guide rails 3611a, 3611b arranged within the upper housing portion 110a. The lower guide rails 3612a, 3612b are arranged within the lower housing portion 110b, as later described with reference to Fig. 7. When the upper housing portion 110a and lower housing portion 110b are coupled together, the upper guide rail 3611a and respective lower guide rail 3612a together form the first shuttle guide track 360a, and the upper guide rail 3611 b and respective lower guide rail 3612b together form the second shuttle guide track 360b.

[0255] As shown in Fig. 6, the axially-extending upper guide rails 3611 a, 3611 b are arranged within the upper housing portion 110a such that they extend substantially parallel to the device axis X-X. The upper guide rails 3611 a, 3611 b are symmetrically arranged about the device axis X-X, such that the upper guide rails 3611 a, 3611 b are substantially parallel to each other and maintain a substantially equidistant spacing from the device axis X-X along their length. The first upper guide rail 3611 a extends along an axis substantially parallel to the device axis X-X, between the medicament container 200 and a side wall of the upper housing portion 110a when the medicament container 200 is held within the housing 110. The second upper guide rail 3611a extends along a different axis that is also substantially parallel to the device axis X-X, between the medicament container 200 and an opposing side wall of the upper housing portion 110a when the medicament container 200 is held within the housing 110.

[0256] As the plunger drive shuttle 320 travels distally along the shuttle guide tracks 360a, 360b, the shuttle guide surface 3322a of the first shuttle arm 324a may be configured to slide along an edge of the first upper guide rail 3611a, while the shuttle guide surface 3322b of the second shuttle arm 324b may be configured to slide along an edge of the second upper guide rail 3611 b. Furthermore, as the plunger drive shuttle 320 travels distally along the shuttle guide tracks 360a, 360b, the track guide element 336a of the first shuttle arm 324a may be configured to slide along a lateral surface of the first upper guide rail 3611a, while the track guide element 336b of the second shuttle arm 324b may be configured to slide along a lateral surface of the second upper guide rail 3611b.Attorney Docket No.: 46567-1791 WO1

[0257] Each shuttle guide track 360a, 360b comprises a respective first stop element 361a, 361b, a respective second stop element 362a, 362b and a respective third stop element 363a, 363b.

[0258] Each first stop element 361 a, 361 b is arranged between a corresponding first track section 3601a, 3601b and corresponding second track section 3602a, 3602b. Each second stop element 362a, 362b is arranged between the corresponding second track section 3601a, 3601b and a corresponding third track section 3603a, 3603b. Each third stop element 363a, 363b is arranged distal to the corresponding third track section 3603a, 3603b.

[0259] Each first stop element 361a, 361b is configured to releasably engage a corresponding holding member 330a, 330b of the plunger drive shuttle 320 to hold the plunger drive shuttle 320 in the initial position relative to the housing 110, as later described in relation to Fig. 10. That is, the first stop element 361a of the first shuttle guide track 360a is configured to releasably engage the corresponding first holding member 330a of the plunger drive shuttle 320, and the first stop element 361b of the second shuttle guide track 360b is configured to releasably engage the corresponding second holding member 330b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the initial position relative to the housing 110. More particularly, the first stop element 361a of the first shuttle guide track 360a is configured to releasably engage the first distally-facing engagement surface 3321a of the plunger drive shuttle 320, and the first stop element 361 b of the second shuttle guide track 360b is configured to releasably engage the second distally-facing engagement surface 3321 b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the initial position relative to the housing 110.

[0260] Each second stop element 362a, 362b is configured to releasably engage a corresponding holding member 330a, 330b of the plunger drive shuttle 320 to hold the plunger drive shuttle 320 in the intermediate position relative to the housing 110, as later described in relation to Fig. 15. That is, the second stop element 362a of the first shuttle guide track 360a is configured to releasably engage the corresponding first holding member 330a of the plunger drive shuttle 320, and the second stop element 362b of the second shuttle guide track 360b is configured to releasably engage the corresponding second holding member 330b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the intermediate position relative to the housing 110. More particularly, the second stop element 362a of the first shuttle guide track 360a is configured to releasably engage the first distally-facing engagement surface 3321a of the plunger drive shuttle 320, and the second stop element

[0261]

[0262] Attorney Docket No.: 46567-1791 WO1

[0263] distally-facing engagement surface 3321b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the initial position relative to the housing 110.

[0264] Each third stop element 363a, 363b is configured to releasably engage a corresponding holding member 330a, 330b of the plunger drive shuttle 320 to hold the plunger drive shuttle 320 in a final position relative to the housing 110, as later described in relation to Fig. 17. That is, the third stop element 363a of the first shuttle guide track 360a is configured to releasably engage the corresponding first holding member 330a of the plunger drive shuttle 320, and the third stop element 363b of the second shuttle guide track 360b is configured to releasably engage the corresponding second holding member 330b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the final position relative to the housing 110. More particularly, the third stop element 363a of the first shuttle guide track 360a is configured to releasably engage the first distally-facing engagement surface 3321a of the plunger drive shuttle 320, and the third stop element 363b of the second shuttle guide track 360b is configured to releasably engage the second distally-facing engagement surface 3321 b of the plunger drive shuttle 320, to hold the plunger drive shuttle 320 in the final position relative to the housing 110.

[0265] The holding members 330a, 330b are configured to engage the respective first stop elements 361a, 361b, second stop elements 362a, 362b and third stop elements 363a, 363b sequentially, in that order, as later described in relation to Figs. 12 to 17.

[0266] As shown in Fig. 6, the first stop element 361a, the second stop element 362a and the third stop element 363a of the first shuttle guide track 360a are aligned along an axis that is substantially parallel to the device axis X-X, with the second stop element 362a arranged distal to the first stop element 361a and the third stop element 362a arranged distal to the second stop element 362a. A distance between the first stop element 361a and the second stop element 362a parallel to the device axis X-X corresponds to the volume of the first dose of the medicament 230 that is to be dispensed from the device 100. A distance between the second stop element 362a and the third stop element 363a parallel to the device axis X-X corresponds to the volume of the second dose of the medicament 230 that is to be dispensed from the device 100.

[0267] As shown in Fig. 6, the first stop element 361b, the second stop element 362b and the third stop element 363b of the second shuttle guide track 360b are also aligned along an axis that is substantially parallel to the device axis X-X, with the second stop element 362b arranged distal to the first stop element 361 b and the third stop element 362b arranged distal to theAttorney Docket No.: 46567-1791 WO1

[0268] second stop element 362b. A distance between the first stop element 361b and the second stop element 362b parallel to the device axis X-X corresponds to the volume of the first dose of the medicament 230 that is to be dispensed from the device 100. A distance between the second stop element 362b and the third stop element 363b parallel to the device axis X-X corresponds to the volume of the second dose of the medicament 230 that is to be dispensed from the device 100.

[0269] Fig. 6 shows the pair of second stop elements 362a, 362b are offset from the pair of first stop elements 361a, 361b in the transverse direction A2. Fig. 6 shows the pair of third stop elements 363a, 363b are offset from the pair of second stop elements 362a, 362b in the transverse direction A2. When the housing 110 of the device 100 is assembled as shown in Fig.1 , the pair of third stop elements 363a, 363b are arranged nearer the lower housing portion 110b than the pair of second stop elements 362a, 362b, and the pair of second stop elements 362a, 362b are arranged nearer the lower housing portion 110b than the pair of first stop elements 361a, 361 b.

[0270] Fig. 6 shows the first stop elements 361a, 361b, the second stop elements 362a, 362b and the third stop elements 363a, 363b each taking the form of a respective proximally-facing surface of the upper guide rails 3611a, 3611b.

[0271] The housing 110 comprises a medicament container holding arrangement 150 for holding the barrel 210 of the medicament container 200 in a fixed axial position relative to the housing 110 when the device 100 is assembled. The medicament container holding arrangement 150 comprises a first medicament container holding feature 151 arranged within the upper housing portion 110a (as shown in Fig. 6) and a second medicament container holding feature 152 arranged within the lower housing portion 110b (as later described in relation to Fig. 7).

[0272] As shown in Fig. 6, the first medicament container holding feature 151 projects from an inner surface of the upper housing portion 110a and comprises a pair of retaining slots 1511a, 1511b configured to receive and retain the barrel flange 216 when the medicament container 200 is held within the device 100, as later described in relation to Fig. 10. However, it should be understood that this example of the first medicament container holding feature 151 is not meant to be limiting and that the first medicament container holding feature 151 may take any suitable form for holding the barrel 210 in a fixed axial position relative to the housing 110.Attorney Docket No.: 46567-1791 WO1

[0273] Figs. 5 and 6 show the button 400 arranged at the upper housing portion 110a. In some examples, the button 400 may be integrally formed with the upper housing portion 110a, however this is not meant to be limiting.

[0274] The button 400 configured to be moved by the user relative to the housing 110 with a substantially similar first actuation and second actuation action, in substantially the transverse direction A2, towards the device axis X-X and into the housing 110. The button 400 is coupled to the upper housing portion 110a to allow for such movement. For example, Figs. 5 and 6 show the button comprising a substantially planar hinge portion 410 that is pivotably coupled to the upper housing portion 110a at a proximal end 4101 of the hinge portion 410, such that the button 400 can pivot relative to the housing 110 about an axis substantially perpendicular to the device axis X-X. The button 400 is configured to pivot through an aperture 1102 in the upper housing portion 110a.

[0275] Figs. 5 and 6 further show the button 400 comprising a mount portion 420 and an actuation protrusion 430.

[0276] The actuation protrusion 430 is configured to be pushed by the finger or thumb of the user to actuate the button 400, to dispense the first and second doses of medicament 230. More particularly, the actuation protrusion 430 has an actuation surface 4301 configured to be directly contacted by the finger or thumb of the user such that the user may apply an actuation force to the button 400 via the actuation surface 4301 , for causing actuation of the button 400. The actuation surface 4301 faces substantially away from the device axis X-X.

[0277] Fig. 5 shows the actuation protrusion 430 projecting beyond the outer surface of the upper wall 1101a of the upper housing portion 110a, away from the device axis X-X, in a direction perpendicular to the device axis X-X, with the actuation surface 4301 outside of, and offset from, the housing 110. However, this is not meant to be limiting, and in one or more other examples the actuation protrusion 430 may not project beyond the upper wall 1101a of the upper housing portion 110a (e.g., the actuation protrusion 430 may be entirely within the housing 110, such that the actuation surface 4301 is substantially parallel to the outer surface of the upper wall 1101 a or is within the housing 110 but accessible to the user via the aperture 1102.

[0278] The actuation protrusion 430 is coupled to, and projects from, the mount portion 420. A distal end 4102 of the hinge portion 410 is coupled to the mount portion 420 such that the mount portion 420 and actuation protrusion 430 are pivotably coupled to the upper housing portionAttorney Docket No.: 46567-1791 WO1

[0279] 110a via the hinge portion 410, and pivot in substantially the transverse direction A2 when an actuation force is applied to the actuation surface 4301 of the actuation protrusion 430.

[0280] Fig. 5 shows the actuation protrusion 430 comprising a button engagement element 4302 configured to be engaged by the cap engagement element 530 of the cap 500 when the cap 500 is coupled to the housing 110, such that the button 400 is inhibited from being actuated relative to the housing 110. For example, Fig. 6 shows the button engagement element 4302 comprising a button recess 4303 configured to receive the tab 532 of the cap engagement element 530 when the cap 500 is coupled to the housing 110 as shown in Fig .1 . When the tab 532 is received in the button recess 4303, the actuation protrusion 430 is inhibited from being actuated in the transverse direction A2 due to engagement between the button recess 4303 and the tab 532, thereby inhibiting accidental actuation of the button 400 and dispensing of the medicament 230 when the cap 500 is coupled to the housing 110.

[0281] Uncoupling the cap 500 from the housing 110 removes the tab 532 from the button recess 4303, allowing the actuation protrusion 430 to be actuated by a user relative to the housing 110 to dispense the medicament 230.

[0282] As shown in Fig. 6, the button 400 further comprises a pair of first dose pins 451 a, 451 b and a pair of second dose pins 452a, 452b. The pair of first dose pins 451a, 451 b and pair of second dose pins 452a, 452b each project in substantially the transverse direction A2 from a lower surface of the mount portion 420, into the housing 110, and towards the lower housing portion 110b.

[0283] The first dose pins 451a, 451 b are arranged such that they engage a respective holding member 330a, 330b of the plunger drive shuttle 320 when the button 400 is actuated with the first actuation action in the transverse direction A2 and the plunger drive shuttle 320 is in its initial position relative to the housing 110. That is, when the plunger drive shuttle 320 is in its initial position and the button 400 is actuated with the first actuation action in the transverse direction A2, one of the first dose pins 451a engages the pin engagement surface 3341a of the first holding member 330a and the other of the first dose pins 451 b engages the pin engagement surface 3341 b of the second holding member 330b, to deflect the plunger drive shuttle 320 in the transverse direction A2, as later described in relation to Figs.

[0284] 12 to 14.

[0285] The second dose pins 452a, 452b are arranged distal to the first dose pins 451a, 451b, and are arranged such that they engage a respective holding member 330a, 330b of the plungerAttorney Docket No.: 46567-1791 WO1

[0286] drive shuttle 320 when the button 400 is actuated with the second actuation action in the transverse direction A2 and the plunger drive shuttle 320 is in its intermediate position relative to the housing 110. That is, when the plunger drive shuttle 320 is in its intermediate position and the button 400 is actuated with the second actuation action in the transverse direction A2, one of the second dose pins 452a engages the pin engagement surface 3341a of the first holding member 330a and the other of the second dose pins 452b engages the pin engagement surface 3341 b of the second holding member 330b, to deflect the plunger drive shuttle 320 in the transverse direction A2, as later described in relation to Figs. 15 and 16.

[0287] Fig. 6 shows the button 400 further comprising an actuation stop 460 that projects from the mount portion 420, towards the lower housing portion 110b when the device 100 is assembled as shown in Fig. 1. The actuation stop 460 of the button 400 is configured to limit actuation of the button 400 in the transverse direction A2 by being brought into engagement with a corresponding actuation stop 470 (shown in Fig. 7) projecting from the lower housing portion 110b, as later described in relation to Fig. 14.

[0288] Fig. 6 shows the device 100 comprising a first pair of proximal biasing member support surfaces 610a, 610b arranged at a proximal end of the cavity 140, for engaging and supporting a proximal end of the biasing member 380 when the biasing member 380 is received in the housing 110. Fig. 6 further shows the device 100 comprising a first pair of lateral biasing member guide surfaces 620a, 620b arranged to extend substantially parallel to the device axis X-X, and for guiding the biasing member 380 as it moves distally to dispense the medicament 230.

[0289] One or more aspects of the lower housing portion 110b will now be described with reference to Figs. 7 and 8.

[0290] Figs. 7 and 8 show perspective views of the lower housing portion 110b of the device 100. Fig. 7 shows a perspective view of the lower housing portion 110b when viewed from above, while Fig. 8 shows a perspective view of the lower housing portion 110b when viewed from below.

[0291] The lower housing portion 110b may be formed from one or more polymers including, but not limited to, polyethylene, polycarbonate, polypropylene, polyvinyl chloride and acrylonitrile butadiene styrene.Attorney Docket No.: 46567-1791 WO1

[0292] In some examples, the lower housing portion 110b may have been formed by one or more of injection moulding, blow moulding, thermoforming, three-dimensional (3D) printing, or the like, however this list is not exhaustive. In some examples, the lower housing portion 110b may be integrally formed from a single piece of material.

[0293] Figs. 7 and 8 show the lower housing portion 110b having a substantially elongate form that extends substantially parallel to the device axis X-X.

[0294] As shown in Figs. 7 and 8, the second window 112b is arranged at a lower wall 1101b of the lower housing portion 110b, such that a user may view the medicament container 200 through the second window 112b when the device 100 is assembled.

[0295] A distal end of the lower housing portion 110b forms, together with the distal end of the upper housing portion 110a when the housing 110 is assembled, the outlet 114 through which the medicament 230 is dispensed.

[0296] Figs 7 and 8 show part of the patient contact member 117 arranged at the distal end of the housing 110, such that the distally-facing contact surface 1171 of the patient contact member 117 may be configured to be brought into contact with the patient as previously described in relation to Figs. 5 and 6.

[0297] Fig. 7 shows the semicircular lower portion 1173 of the patient contact member 117 surrounding a lower half of the outlet 114. The semicircular lower portion 1173 is configured to be brought into alignment with the corresponding semicircular upper portion 1172 of the patient contact member 117 arranged at the upper housing portion 110a when the device 100 is assembled as shown in Fig. 1 and Figs. 3B to 3D.

[0298] As described previously in relation to Figs. 5 and 6, the housing 110 may comprise one or more cap retaining elements 118a, 118b configured to couple the cap 500 to the housing 110. Figs. 6 and 7 show a lower part of each cap retaining element 118a, 118b (e.g., a lower part of a recess) formed at the lower housing portion 110b that, when the upper housing portion 110a and the lower housing portion 110b are joined to produce the assembled device 100 shown in Fig. 1 , join with respective upper parts of each cap retaining element 118a, 118b formed in the upper housing portion 110a to provide fully-assembled cap retaining elements 118a, 118b.Attorney Docket No.: 46567-1791 WO1

[0299] The lower housing portion 110b may comprise a lower housing coupling arrangement 130 for engaging with a corresponding upper housing coupling arrangement 120 of the upper housing portion 110a (as previously described in relation to Fig. 6) when the device 100 is assembled (as shown in Fig. 1), to couple the lower housing portion 110b to the upper housing portion 110a. Fig. 7 shows such a lower housing coupling arrangement 130 comprising a plurality of lower housing connectors 131a, 131 b, 131c, 131 d spaced about a periphery of the lower housing portion 110b. Fig. 7 shows four lower housing connectors 131a, 131b, 131c, 131 d, each taking the form of a rib configured to be coupled to the corresponding upper housing connectors 121a, 121b, 121c, 121 d each taking the form of a clip. However, it should be understood that this is not meant to be limiting. For instance, in other examples, the lower housing portion 110b may comprise a different number of lower housing connectors than four, for example only one lower housing connector, only two lower housing connectors, only three lower housing connectors, only five lower housing connectors, or more than five lower housing connectors. Additionally / alternatively, one or more of the lower housing connectors 131a, 131b, 131c, 131 d may take a different form to a rib (e.g., a magnetic connector, an adhesive connector, a friction-fit connector, etc.).

[0300] The lower housing portion 110b may comprise one or more lower housing alignment elements 132a, 132b configured to engage with the one or more corresponding upper housing alignment elements 122a, 122b previously described in relation to Fig. 6, to assist with alignment of the upper housing portion 110a and the lower housing portion 110b during assembly of the housing 110 and / or to inhibit relative movement between the upper housing portion 110a and the lower housing portion 110b when coupled together. As described previously in relation to Fig. 6, the lower housing alignment elements 132a, 132b may comprise one or more projections and / or recesses configured to engage corresponding upper housing alignment elements 122a, 122b comprising one or more recesses and / or projections. Fig. 7 shows a pair of lower housing alignment elements 132a, 132b arranged at the distal end of the lower housing portion 110b, adjacent the cap retaining elements 118a, 118b, on opposing sides of the lower housing portion 110b about the device axis X-X.

[0301] However, such an arrangement and / or number of lower housing alignment elements 132a, 132b is not meant to be limiting, and in other examples there may be fewer or greater than two lower housing alignment elements 132a, 132b, and / or they may be arranged at different locations on the lower housing portion 110b to those shown in Fig. 7.

[0302] Fig. 7, shows the lower guide rails 3612a, 3612b of the shuttle guide tracks 360a, 360b arranged to extend axially within the lower housing portion 110b. The lower guide rails 3612a, 3612b are symmetrically arranged about the device axis X-X, such that the lowerAttorney Docket No.: 46567-1791 WO1

[0303] guide rails 3612a, 3612b are substantially parallel to each other and maintain a substantially equidistant spacing from the device axis X-X along their length.

[0304] Fig. 7 shows a second medicament container holding feature 152 of the medicament container holding arrangement 150 arranged within the lower housing portion 110b. The second medicament container holding feature 152 projects from an inner surface of the lower housing portion 110b and comprises a pair of proximally-facing retaining surfaces 1521a, 1521b configured to engage and retain the medicament container barrel flange 216 when the medicament container 200 is held within the device 100, as later described in relation to Fig. 10. However, it should be understood that this example of the second medicament container holding feature 152 is not meant to be limiting and that the second medicament container holding feature 152 may take any suitable form for holding the barrel 210 in a fixed axial position relative to the housing 110.

[0305] Fig. 7 shows the device 100 comprising a second pair of proximal biasing member support surfaces 610c, 61 Od arranged at a proximal end of the cavity 140, for engaging and supporting a proximal end of the biasing member 380 when the biasing member 380 is received in the housing 110. Fig. 7 further shows the device 100 comprising a second pair of lateral biasing member guide surfaces 620c, 620d arranged to extend substantially parallel to the device axis X-X, and for guiding the biasing member 380 as it moves distally to dispense the medicament 230.

[0306] Fig. 7 further shows an actuation stop 470 that projects from the inner surface of the lower housing portion 110b, towards the actuation stop 460 of the button 400 when the device 100 is assembled as shown in Fig. 1. The actuation stop 470 of the lower housing portion 110b is configured to be engaged by the actuation stop 460 of the button 400 after the button 400 has actuated in the transverse direction A2, to limit further actuation of the button 400 in the transverse direction A2, as later described in relation to Fig. 14.

[0307] Figs. 9A and 9B show perspective views of the cap 500. Fig. 9A shows the cap 500 when viewed substantially from above, while Fig. 9E3 shows the cap 500 when viewed substantially from below.

[0308] Figs. 9A and 9E3 show the cap 500 comprising a cover portion 510, grip element 520, and cap engagement element 530 comprising a tab 532, as previously described.Attorney Docket No.: 46567-1791 WO1

[0309] Fig. 9A shows the cap 500 may also comprise an instructional marking 540 formed at an outer surface of the cap 500, the instructional marking configured to instruct the user on how to remove the cap 500 from the housing 110. For instance, the instructional marking 540 may comprise a visual indication of the direction in which the cap 500 should be moved relative to the housing 110 to uncouple the cap 500 from the housing 110. Fig. 9A shows the instructional marking 540 comprising an arrow indicating the direction (e.g., the distal direction A1) in which the cap 500 should be moved relative to the housing 110 to uncouple the cap 500 from the housing 110. The instructional marking 540 could be applied to the outer surface of the cap 500 by printing, engraving, embossing, or any other suitable technique, or the instructional marking 540 could be integrally formed as part of the cap 500 during manufacture of the cap 500 by injection moulding or the like.

[0310] Fig. 9B shows the cap 500 further comprising a pair of shield engagement elements 560a, 560b, a pair of housing engagement elements 550a, 550b, and a window engagement element 570.

[0311] The shield engagement elements 560a, 560b are configured to hold the delivery member shield 260 such that the delivery member shield 260 is removed from the medicament delivery member 250 as the cap 500 is removed from the housing 110. In some examples, the shield engagement elements 560a, 560b are already engaged with the delivery member shield 260 when the cap 500 is coupled to the housing (i.e., when the device 100 is in its initial state shown in Fig. 1). In such examples, distal movement of the cap 500 to remove the cap 500 from the housing 110 causes the shield engagement elements 560a, 560b to also move the delivery member shield 260 distally such that it is removed from the medicament delivery member 250. In other examples, the shield engagement elements 560a, 560b and the delivery member shield 260 are not initially engaged, however the shield engagement elements 560a, 560b are configured to engage and remove the delivery member shield 260 the as the cap 500 is removed from the housing 110 (e.g., the delivery member shield 260 is ‘grabbed’ by the shield engagement elements 560a, 560b as the cap 500 is moved distally relative to the housing 110).

[0312] Fig. 9E3 shows the shield engagement elements 560a, 560b taking the form of teeth arranged to engage the delivery member shield 260, however this is not mean to be limiting and in other examples the shield engagement elements 560a, 560b may take a different form to teeth (e.g., as one or more adhesive elements, one or more friction surfaces, etc.). Additionally / alternatively, the shield engagement elements 560a, 560b may also differ inAttorney Docket No.: 46567-1791 WO1

[0313] number and / or arrangement to the number and / or arrangement of shield engagement elements 560a, 560b shown in Fig. 9B.

[0314] The housing engagement elements 550a, 550b are configured to couple the cap 500 to the housing 110. The housing engagement elements 550a, 550b are configured to engage the one or more cap retaining elements 118a, 118b of the housing 110 when the cap 500 is received on the housing 110 (e.g., when the device is in its initial state shown in Figs. 1 and 3A), to impede removal of the cap 500 from the housing 110. Fig. 9E3 shows the housing engagement elements 550a, 550b comprising a pair of clips configured to engage the pair of recesses forming the cap retaining elements 118a, previously described in relation to Figs. 5 and 6. The housing engagement elements 550a, 550b may be arranged within the cover portion 510 of the cap 500, at opposing sides of the inner surface of the cover portion 510. It should be understood that the example of the housing engagement elements 550a, 550b comprising a pair of clips is not meant to be limiting and that in other examples the engagement elements 550a, 550b may take forms other than clips, such as recesses, friction surfaces, adhesive surfaces, etc. Additionally / alternatively, the housing engagement elements 550a, 550b may also differ in number and / or arrangement to the number and / or arrangement of housing engagement elements 550a, 550b shown in Fig. 9E3.

[0315] The window engagement element 570 is configured to engage the window 112a when the cap 500 is coupled to the housing 110 such that rotation of the cap 500 relative to the housing 110 is inhibited. Fig. 9E3 shows the window engagement element 570 taking the form of a rib that projects from the cap engagement element 530. The window engagement element 570 is arranged at the cap engagement element 530 such that it is at least partially received within the window 112a and engages a pair of side walls of the window 112a when the cap 500 is coupled to the housing 110a, to inhibit rotation of the cap 500 relative to the housing 110. Additionally / alternatively, the window engagement element 570 may impede removal of the cap 500 from the housing 110, wherein, to remove the cap 500, the user must apply a force to the cap 500 in the distal direction A1 that is sufficient to overcome an engagement force between the window engagement element 570 and the window 112a.

[0316] Fig. 10 shows a perspective view of the upper housing portion 110a once the medicament container 200 and the plunger drive mechanism 300 have been inserted into the upper housing portion 110a.

[0317] Fig. 10 shows the medicament container 200 arranged within the upper body housing 110a such that it extends substantially along the device axis X-X. The medicament container 200Attorney Docket No.: 46567-1791 WO1

[0318] is held in position within the housing 110 by the medicament container holding arrangement 150. Engagement between the first medicament container holding feature 151 and the barrel 210 of the medicament container 200 inhibits axial movement of the medicament container barrel 210 within the housing 110, therefore the barrel 210 is fixed axially relative to the housing 110. Fig. 10 shows opposing sides of the barrel flange 216 received within the pair of retaining slots 1511a, 1511b such that engagement between the barrel flange 216 and the retaining slots 1511a, 1511b inhibits axial movement of the barrel 210 within the housing 110.

[0319] The barrel 210 extends substantially along the device axis X-X, with the medicament delivery member 250 arranged at the distal end of the cavity 140, to extend through the outlet 114. Fig. 10 shows the delivery member shield 260 coupled to the distal end of the delivery member 250 and also extending through the outlet 114. The cap 500 is coupled to the housing 110 via the housing engagement elements 550a, 550b. The cover portion 510 of the cap 500 at least partially surrounds the medicament delivery member 250 and the delivery member shield 260, with the shield engagement elements 560a, 560b engaging and holding the delivery member shield 260 such that removal of the cap 500 from the housing 110 by a user pulling the grip element 520 will also cause the delivery member shield 260 to be removed.

[0320] The plunger rod 240 of the medicament container 200 extends proximally from the barrel 210, substantially along the device axis X-X. The proximal end of the plunger rod 240 is adjacent to (and optionally engages) the plunger drive shuttle 320. For example, the proximal end of the plunger rod 240 plunger rod flange 242 is adjacent to (and optionally engages) the plunger rod engagement surface 328 of the shuttle body 322.

[0321] The shuttle body 322 is arranged within the upper housing portion 110a such that shuttle arms 324a, 324b each extend substantially parallel to the device axis X-X, at opposing sides of the plunger rod 240 and barrel 210. The shuttle crossmember 326 is arranged at the proximal end of each shuttle arm 324a, 324b and extends substantially perpendicular to the device axis X-X.

[0322] As shown in Fig. 10, the first holding member 330a engages the first stop element 361a and the second holding member 330b engages the second stop element 361 b.

[0323] As shown in Fig. 10, the biasing member 380 is arranged within the housing 110a, between the housing 110 and the shuttle body 322, such that it is proximal to the shuttle body 322Attorney Docket No.: 46567-1791 WO1

[0324] and the medicament container 200. Fig. 10 shows the biasing member 380 taking the form of a helical compression spring arranged along the device axis X-X. The support mandrel 327 of the plunger drive shuttle 320 extends through the biasing member 380 (e.g., through the helical spring), substantially along the device axis X-X, such that the biasing member 380 surrounds the support mandrel 327 and is supported by the support mandrel 327.

[0325] A proximal end of the biasing member 380 abuts the proximal biasing member support surfaces 610a, 610b, to inhibit proximal movement of the proximal end of the biasing member 380. A distal end of the biasing member 380 abuts the shuttle body 322, for example a proximally-facing surface of the shuttle body 322 (e.g., a proximally-facing surface of the shuttle crossmember 326).

[0326] Fig. 10 shows the biasing member 380 in a pretensioned state in which it has been loaded (e.g., stressed). The spring has been compressed between the proximal biasing member support surfaces 610a, 610b and the shuttle body 322 such that it is pretensioned. The potential energy stored in the biasing member 380 as a result of the pretensioning causes the biasing member 380 to attempt to expand, and therefore causes the biasing member 380 to exert a biasing force on the plunger drive shuttle 320 (e.g., the shuttle body 322 of the plunger drive shuttle 320) in the distal direction A1. However, the distal biasing force does not yet cause the plunger drive shuttle 320 and the shuttle body 322 to move distally, due to the aforementioned engagement between the holding members 330a, 330b and the corresponding first stop elements 361 a, 361 b. The plunger drive shuttle 320 therefore remains in its initial position relative to the housing 110.

[0327] Fig. 11 shows a perspective view of the system 1000 during assembly of the device 100, as the lower housing portion 110b is being coupled to the upper housing portion 110a.

[0328] The upper housing portion 110a contains the medicament container 200, the biasing member 380 and the plunger drive shuttle 320, and the cap 500 is coupled to the upper housing portion 110a, as previously described in relation to Fig. 10.

[0329] To finish assembly of the device 100, the lower housing portion 110b is brought into alignment with the upper housing portion 110a by aligning the upper house coupling arrangement 120 with the lower house coupling arrangement 130 (e.g., aligning each of the upper housing connectors 121a, 121b, 121c, 121 d with a corresponding lower housing connector 131a, 131 b, 131c, 131 d and, if present, aligning the upper housing alignment elements 122a, 122b with the corresponding lower housing alignment elements 132a, 132b.Attorney Docket No.: 46567-1791 WO1

[0330] The lower housing portion 110b is then moved towards the upper housing portion 110a until it engages and couples the upper housing portion 110a (e.g., until each of the upper housing connectors 121a, 121b, 121c, 121d engages and couples with a corresponding lower housing connector 131a, 131b, 131c, 131 d), resulting in the device 100 being fully assembled and in its initial state ready for medicament delivery, as shown in Fig. 1.

[0331] Operation of the system 1000 and the device 100 to deliver a first dose of medicament 230 and a second dose of medicament 230 is now described with reference to Figs. 12 to 18.

[0332] Fig. 12 is a sectional view of the system 1000 taken along the device axis X-X. Fig. 12 shows the device 100 in a first primed state, for example as previously described with respect to Fig. 3B. The first primed state follows the initial state of the device 100 as previously described in relation to Fig. 3A, but precedes the dispensing of any medicament. To move the device 100 from the initial state into the first primed state, the user may have removed a cap 500 from the housing 110 by moving the cap 500 in any manner as previously described.

[0333] Removal of the cap 500 uncovers the outlet 114 of the housing 110 and the medicament delivery member 250 (e.g., an intranasal nozzle). Fig. 12 shows a distal portion of the medicament delivery member 250 extending through the outlet 114, with a distal end of the medicament delivery member 250 distal to the distal end of the housing 110. However, it should be understood that this is not meant to be limiting and that in other examples the medicament delivery member 250 may not extend through the outlet 114, or a distal end of the medicament delivery member 250 may not be distal to the distal end of the housing 110.

[0334] A delivery member shield 260 (if present) may have been removed from the medicament delivery member 250 by the cap 500, for example in a manner as described previously.

[0335] As the cap 500 has been removed from the housing 110, a cap engagement element 530 (e.g., a tab 532 of the cap engagement element 530) has been moved out of engagement with the button engagement element 4302 of the button 400 such that the cap engagement element 530 no longer inhibits actuation of the button 400. As such, the user is now able to actuate the button 400 relative to the housing 110 in a substantially transverse direction A2 to dispense the medicament 230 contained within the medicament container 200.

[0336] When the device 100 is in the first primed state shown in Fig. 12, the plunger drive shuttle 320 is in its initial position relative to the housing 110, the first holding member 330a is withinAttorney Docket No.: 46567-1791 WO1

[0337] the first track section 3601a of the first shuttle guide track 360a, and the second holding member 330b is within the first track section 3601 b of the second shuttle guide track 360b. The biasing member 380 is pretensioned such that it biases the plunger drive shuttle 320 distally (i.e., in the distal direction A1) relative to the housing 110. However, when the device 100 is in the first primed state, axial movement of the plunger drive shuttle 320 in the distal direction A1 is inhibited by engagement between the plunger drive shuttle 320 and the drive shuttle hold arrangement 350. More particularly, axial movement of the plunger drive shuttle 320 in the distal direction A1 is inhibited by engagement between the holding members 330a, 330b of the shuttle arms 324a, 324b and the respective first stop elements 361a, 361b of the shuttle guide tracks 360a, 360b.

[0338] Fig. 12 shows the stop engagement element 332a (e.g., the distally-facing engagement surface 3321a of the stop engagement element 332a) of the first holding member 330a engaged with the first stop element 361a of the shuttle guide track 360a to inhibit movement of the plunger drive shuttle 320 in the distal direction A1. While not visible in Fig. 12, the stop engagement element 332b (e.g., the distally-facing engagement surface 3321 b of the stop engagement element 332b) of the second holding member 330b will similarly be engaged with the first stop element 361b of the shuttle guide track 360b to inhibit movement of the plunger drive shuttle 320 in the distal direction A.

[0339] Fig. 12 shows the button 400 axially aligned with the holding member 330a such that one of the first dose pins 451a of the button 400 is aligned with the first pin engagement element 334a, with the first pin engagement element 334a located below the particular first dose pin 451a in the transverse direction A2. Fig. 12 shows the first dose pin 451a abutting the pin engagement surface 3341a of the pin engagement element 334a, however it should be understood that this is not meant to be limiting and that in other examples the first dose pin 451 a does not yet abut the pin engagement surface 3341 a.

[0340] While not visible in Fig. 12, the other of the first dose pin 451 b of the button 400 will similarly be aligned with the second pin engagement element 334b, with the second pin engagement element 334b located below the other first dose pin 451 b in the transverse direction A2. The other first dose pin 451 b may in some examples abut the pin engagement surface 3341 b of the pin engagement element 334b, however it should be understood that this is not meant to be limiting and that in other examples the other first dose pin 451 b does not yet abut the pin engagement surface 3341 b.Attorney Docket No.: 46567-1791 WO1

[0341] As shown in Fig. 12, the actuation stop 460 of the button does not yet engage the actuation stop 470 of the housing 110 to limit movement of the button 400 in the transverse direction A2 relative to the housing 110.

[0342] Once the device 100 is in the first primed state, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250) to a medicament delivery site, for example as previously described in relation to Fig. 3B, in preparation for delivery of the first dose of the medicament 230.

[0343] Fig. 13 is a sectional view of the system 1000 taken along the device axis X-X after the device 100 has been moved from its first primed state to its first dose dispense state for dispensing the first dose of the medicament 230.

[0344] To move the device 100 from the first primed state to the first dose dispense state, the user has actuated the button 400 relative to the housing 110 a first time, thereby performing a first actuation of the button 400 relative to the housing 110. The user has performed the first actuation by applying a first actuation force F1 to the button 400 in substantially the transverse direction A2, for example by pushing the button 400 with a finger or thumb.

[0345] The first actuation force moves the button 400 in substantially the transverse direction A2 relative to the housing 110. The button 400 has pivoted relative to the housing 110 due to the pivotal coupling between the hinge portion 410 and the upper housing portion 110a, with the actuation protrusion 430, mount portion 420, first dose pins 451a, 451b and second dose pins 452a, 452b moving towards the medicament container 200 and the plunger drive shuttle 320 in substantially the transverse direction A2.

[0346] Fig. 14 is a detailed view of a portion of the device 100 of Fig. 13, with the medicament container 200 removed such that interactions between the button 400 and the plunger drive shuttle 320 can be more clearly seen.

[0347] As shown in Fig. 14, the movement of the button 400 in the transverse direction A2 has engaged the first dose pin 451a with the pin engagement surface 3341a of the pin engagement element 334a, if they were not previously engaged. Once the first dose pin 451a is engaged with the pin engagement surface 3341a, continued movement of the button 400 during the first actuation transfers the first actuation force F1 from the first dose pin 451a to the pin engagement surface 3341a of the pin engagement element 334a, deflecting the plunger drive shuttle 320 (e.g., the first holding member 330a and first shuttle arm 324a ofAttorney Docket No.: 46567-1791 WO1

[0348] the plunger drive shuttle 320) in substantially the transverse direction A2 such that the first holding member 330a moves in the transverse direction A2, as indicted by arrow K1. In some examples, the first shuttle arm 324a may flex in the transverse direction A2 to allow the first holding member 330a to move in the transverse direction A2.

[0349] While hidden in Fig. 14, the movement of the button 400 in the transverse direction A2 has also engaged the first dose pin 451 b with the pin engagement surface 3341 b of the pin engagement element 334b, if they were not previously engaged, with continued movement of the button 400 during the first actuation transferring the first actuation force F1 from the first dose pin 451 b to the pin engagement surface 3341 b of the pin engagement element 334b, deflecting the plunger drive shuttle 320 (e.g., the second holding member 330b and second shuttle arm 324b of the plunger drive shuttle 320) in substantially the transverse direction A2 such that the second holding member 330b moves in the transverse direction A2. In some examples, the second shuttle arm 324b may flex in the transverse direction A2 to allow the second holding member 330b to move in the transverse direction A2.

[0350] The movement of the first holding member 330a by the first dose pin 451a deflects the plunger drive shuttle 320 to disengage the first holding member 330a from the first stop element 361a. More particularly, the movement of the first holding member 330a by the first dose pin 451a disengages the distally-facing engagement surface 3321a of the first stop engagement element 332a from the first stop element 361a, by sliding the distally-facing engagement surface 3321a across the proximally-facing surface of the first stop element 361a in the transverse direction A2. Fig. 14 shows the distally-facing engagement surface 3321a of the first stop engagement element 332a and the first stop element 361a no longer in abutment. The first holding member 330a has moved from the first track section 3601a into the second track section 3602a as it has moved in the transverse direction A2 during the first actuation.

[0351] Similarly, while not visible in Fig. 14, the movement of the second holding member 330b by the first dose pin 451 b deflects the plunger drive shuttle 320 to disengage the second holding member 330b from the first stop element 361b. More particularly, the movement of the second holding member 330b by the first dose pin 451b disengages the distally-facing engagement surface 3321 b of the second stop engagement element 332b from the first stop element 361b, by sliding the distally-facing engagement surface 3321b across the proximally-facing surface of the first stop element 361b in the transverse direction A2. The second holding member 330b will have moved from the first track section 3601 b into theAttorney Docket No.: 46567-1791 WO1

[0352] second track section 3602b as it has moved in the transverse direction A2 during the first actuation.

[0353] As shown in Fig. 14, the actuation stop 460 of the button 400 may have been moved into engagement with the actuation stop 470 of the housing 110 as the button 400 has moved in the transverse direction A2, to inhibit further movement of the button 400 in the transverse direction A2. The actuation stop 460 and the actuation stop 470 may be arranged such that they engage to inhibit further movement shortly after the first holding member 330a has disengaged the first stop element 361a.

[0354] Since the first holding member 330a and the second holding member 330b are no longer in abutment with the first stop element 361a and first stop element 361 b respectively, the first stop elements 361a, 361 b no longer inhibit the plunger drive shuttle 320 from being moved in the distal direction A1 by the biasing member 380. The first actuation of the button 400 has therefore deflected the plunger drive shuttle 320 to release the plunger drive shuttle 320 from the drive shuttle hold arrangement 350, such that the plunger drive shuttle 320 can move distally from the initial position to the intermediate position relative to the housing 110.

[0355] Once the first holding member 330a and the first stop element 361a are disengaged and the second holding member 330b and the first stop element 361 b are disengaged, the plunger drive shuttle 320 is moved axially in the distal direction A1 by the biasing member 380, from the initial position relative to the housing 110 to an intermediate position relative to the housing 110, to dispense a first dose of the medicament 230 from the medicament container 200. More specifically, the biasing member 380 is no longer inhibited from moving in the distal direction A1 by engagement between the holding members 330a, 330b and the respective first stop elements 361a, 361b, therefore the distal biasing force applied by the biasing member 380 to the plunger drive shuttle 320 moves the plunger drive shuttle 320 in the distal direction A1. Movement of the plunger drive shuttle 320 in the distal direction A1 also causes the plunger rod 240 of the medicament container 200 to move in the distal direction A1 , due to engagement between the plunger drive shuttle 320 and the plunger rod 240. Distal movement of the plunger rod 240 relative to the barrel 210 causes the first dose of the medicament 230 to be dispensed from the barrel 210, via the medicament delivery member 250, to the patient.

[0356] As the plunger drive shuttle 320 is moved distally, the holding members 330a, 330b move distally along their respective second track sections 3602a, 3602b of the respective shuttle guide tracks 360a, 360b until they engage the second stop elements 362a arranged at theAttorney Docket No.: 46567-1791 WO1

[0357] distal ends of the second track sections 3602a, 3602b. This engagement inhibits further distal movement of the plunger drive shuttle 320 by the biasing member 380. More particularly, the distally-facing engagement surface 3321a of the stop engagement element 332a engages a proximally-facing surface of the second stop element 362a and the distally-facing engagement surface 3321b of the stop engagement element 332b engages a proximally-facing surface of the second stop element 362b, to inhibit further movement of the plunger drive shuttle 320 in the distal direction A1. The plunger drive shuttle 320 engages the second stop elements 362a , 362b when it reaches the intermediate position relative to the housing, which corresponds to the first dose of medicament 230 having been dispensed from the medicament container 200.

[0358] Fig. 15 is a detailed view of the same portion of the device 100 of Fig. 14, again with the medicament container 200 removed, but once the plunger drive shuttle 320 has moved to its intermediate position. The user has also stopped applying a first actuation force F1 to the button 430, thereby causing the button 430 to pivot back towards its original position relative to the housing 110, in a direction substantially opposite to the transverse direction A2. This has moved the device 100 from its first dose dispense state shown in Fig. 14 to its second primed state shown in Fig. 15. The button 400 may have automatically moved back, away from plunger drive shuttle 320, due to a resilient force, for example provided by the hinge portion 410.

[0359] Fig. 15 shows that the first holding member 330a has been moved distally with respect to the housing 110 by the biasing member 380, until the distally-facing engagement surface 3321 a of the stop engagement element 332a has engaged the second stop element 362a, inhibiting further distal movement. The distal movement of the holding member 330a has moved the pin engagement surface 3341a of the pin engagement element 334a out of alignment with the first dose pin 451 a and into alignment with the second dose pin 452a of the button 400, such that the second dose pin 452a is now adjacent to (and optionally abuts) the pin engagement surface 3341 a when the plunger drive shuttle 320 is in the intermediate position.

[0360] Similarly, while hidden in Fig. 15, the distal movement of the holding member 330b has moved the pin engagement surface 3341b of the pin engagement element 334b out of alignment with the first dose pin 451 b and into alignment with the second dose pin 452b of the button 400, such that the second dose pin 452b is now adjacent to (and optionally abuts) the pin engagement surface 3341 b when the plunger drive shuttle 320 is in the intermediate position.Attorney Docket No.: 46567-1791 WO1

[0361] With the device 100 in the second primed state, it may now be used to deliver a second dose of the medicament.

[0362] Prior to dispensing the second dose, the user may move the distal end of the device 100 (e.g., the distal end of the medicament delivery member 250) to a new medicament delivery site, for example as previously described in relation to Fig. 3D, in preparation for delivery of the second dose of the medicament 230.

[0363] Fig. 16 shows the device in its second dose dispense state, which follows its second primed state. To move the device 100 from the second primed state to the second dose dispense state, the user actuates the button 400 relative to the housing 110 a second time, thereby performing a second actuation of the button 400 relative to the housing 110. The user performs the second actuation by applying a second actuation force F2 to the button 400 in substantially the transverse direction A2, for example by pushing the button 400 with a finger or thumb, as shown in Fig. 16.

[0364] The second actuation force moves the button 400 in substantially the transverse direction A2 relative to the housing 110. As shown in Fig. 16, the button 400 has again pivoted relative to the housing 110 about the pivotal coupling between the hinge portion 410 and the upper housing portion 110a, with the actuation protrusion 430, mount portion 420, first dose pins 451a, 451b and second dose pins 452a, 452b again moving towards the medicament container 200 and the plunger drive shuttle 320 in substantially the transverse direction A2, in a similar manner as during the first actuation.

[0365] As shown in Fig. 16, the movement of the button 400 in the transverse direction A2 has engaged the second dose pin 452a with the pin engagement surface 3341a of the pin engagement element 334a, if they were not previously engaged. Once the second dose pin 452a is engaged with the pin engagement surface 3341a, continued movement of the button 400 during the second actuation transfers the second actuation force F2 from the second dose pin 452a to the pin engagement surface 3341a of the pin engagement element 334a, deflecting the plunger drive shuttle 320 (e.g., the first shuttle arm 324a of the plunger drive shuttle 320) in substantially the transverse direction A2 such that the first holding member 330a moves in the transverse direction A2, as indicted by arrow K2. In some examples, the first shuttle arm 324a may flex in the transverse direction A2 to allow the first holding member 330a to move in the transverse direction A2.Attorney Docket No.: 46567-1791 WO1

[0366] Similarly, while hidden in Fig. 16, the movement of the button 400 in the transverse direction A2 has engaged the second dose pin 452b with the pin engagement surface 3341 b of the pin engagement element 334b, if they were not previously engaged, with continued movement of the button 400 during the second actuation transferring the second actuation force F2 from the second dose pin 452b to the pin engagement surface 3341 b of the pin engagement element 334b, deflecting the plunger drive shuttle 320 (e.g., the second shuttle arm 324b of the plunger drive shuttle 320) in substantially the transverse direction A2 such that the second holding member 330b moves in the transverse direction A2. In some examples, the second shuttle arm 324b may flex in the transverse direction A2 to allow the second holding member 330b to move in the transverse direction A2.

[0367] The movement of the first holding member 330a by the second dose pin 452a deflects the plunger drive shuttle 320 to disengage the first holding member 330a from the second stop element 362a. More particularly, the movement of the first holding member 330a by the second dose pin 452a disengages the distally-facing engagement surface 3321a of the first stop engagement element 332a from the second stop element 362a, by sliding the distally-facing engagement surface 3321a across the proximally-facing surface of the second stop element 362a in the transverse direction A2. Fig. 16 shows the distally-facing engagement surface 3321a of the first stop engagement element 332a and the second stop element 362a no longer in abutment. The first holding member 330a has moved from the second track section 3602a into the third track section 3603a as it has moved in the transverse direction A2 during the second actuation.

[0368] Similarly, while hidden in Fig. 16, the movement of the second holding member 330b by the second dose pin 452b deflects the plunger drive shuttle 320 to disengage the second holding member 330b from the second stop element 362b. More particularly, the movement of the second holding member 330b by the second dose pin 452b disengages the distally-facing engagement surface 3321b of the second stop engagement element 332b from the second stop element 362b, by sliding the distally-facing engagement surface 3321b across the proximally-facing surface of the second stop element 362b in the transverse direction A2. The second holding member 330b will have moved from the second track section 3602b into the third track section 3603b as it has moved in the transverse direction A2 during the second actuation.

[0369] As shown in Fig. 16, the actuation stop 460 of the button 400 may again have been moved into engagement with the actuation stop 470 of the housing 110 as the button 400 has moved in the transverse direction A2, to inhibit further movement of the button 400 in theAttorney Docket No.: 46567-1791 WO1

[0370] transverse direction A2. The actuation stop 460 and the actuation stop 470 may be arranged such that they engage to inhibit further movement shortly after the first holding member 330a has disengaged the second stop element 362a.

[0371] Since the holding members 330a, 330b and the second stop elements 362a, 362b are no longer in engagement, the second stop elements 362a, 362b no longer inhibit the plunger drive shuttle 320 from being moved in the distal direction A1 by the biasing member 380. The second actuation of the button 400 has therefore deflected the plunger drive shuttle 320 to release the plunger drive shuttle 320 from the drive shuttle hold arrangement 350, such that the plunger drive shuttle 320 can move distally from the intermediate position to the final position relative to the housing 110.

[0372] Once the holding members 330a, 330b and the second stop elements 362a, 362b are disengaged, the plunger drive shuttle 320 is moved axially in the distal direction A1 by the biasing member 380, from the intermediate position relative to the housing 110 to the final position relative to the housing 110, to dispense the second dose of the medicament 230 from the medicament container 200. More specifically, the biasing member 380 is no longer inhibited from moving in the distal direction A1 by engagement between the holding members 330a, 330b and the second stop elements 362a, 362b, therefore the distal biasing force applied by the biasing member 380 to the plunger drive shuttle 320 moves the plunger drive shuttle 320 in the distal direction A1. Movement of the plunger drive shuttle 320 in the distal direction A1 also causes the plunger rod 240 of the medicament container 200 to move in the distal direction A1 , due to engagement between the plunger drive shuttle 320 and the plunger rod 240. Distal movement of the plunger rod 240 relative to the barrel 210 causes the second dose of the medicament 230 to be dispensed from the barrel 210, via the medicament delivery member 250, to the patient.

[0373] As the plunger drive shuttle 320 is moved distally, the holding members 330a, 330b move distally along their respective third track sections 3603a, 3603b of their respective shuttle guide tracks 360a, 360b until they engage the respective third stop elements 363a, 363b arranged at the distal ends of the third track sections 3603a, 3603b, as shown in Fig. 17. Engagement between the holding members 330a, 330b and the third stop elements 363a, 363b inhibits further distal movement of the plunger drive shuttle 320 by the biasing member 380. More particularly, the distally-facing engagement surfaces 3321a, 3321b of the stop engagement elements 332a, 332b engage respective proximally-facing surfaces of the third stop elements 363a, 363b to inhibit further movement of the plunger drive shuttle 320 in the distal direction A1. The plunger drive shuttle 320 engages the third stop elements 363a,Attorney Docket No.: 46567-1791 WO1

[0374] 363b when it reaches the final position relative to the housing, which corresponds to the second dose of medicament 230 having been dispensed from the medicament container 200.

[0375] Fig. 17 shows the device 100 in a final state, which follows the second dose dispense state. The user has moved the device 100 from the second dose dispense state to the final state by releasing the button 400. The user has removed the second actuation force F2 from the button 400, causing the button 400 to pivot back towards its initial position relative to the housing 110, for example in a similar manner as described in relation to Fig. 15. The plunger drive shuttle 320 has moved to its final position relative to the housing 110 to dispense the second dose of medicament 230.

[0376] If the device 100 is single-use, it may be disposed of after the second dose of the medicament 230 has been dispensed. On the other hand, if the device 200 is reusable, the medicament container 200 within the device 100 may be replaced with a new medicament container 200 containing a medicament 230, the plunger drive shuttle 320 may be manually moved back to its initial position within the housing 110, and the biasing member 380 may be recompressed, such that the device 100 is returned to a state similar to its initial state or first primed state.

[0377] It has been assumed in the discussion regarding Figs. 14 and 15 that the user has released the button 400 quickly after performing the first actuation, such that the button 400 has pivoted back to its initial position shown in Fig. 15 before the biasing member 380 has been able to drive the first holding member 330a distally into engagement with the second dose pin 451a. If the user were to have instead held the button 400 in its position shown in Fig. 14 for an excessive amount of time, the biasing member 380 may have driven the first holding member 330a distally into engagement with the second dose pin 451a, which in some examples could inhibit the plunger drive shuttle 320 from reaching its intermediate position until the user releases the button 400. To address this, in some examples the second dose pins 452a, 452b may be resiliency deformable such that they can be flexed by the holding members 330a, 330b, as now described with reference to Fig. 18.

[0378] Fig. 18 shows a cross-sectional view of the device 100 when in its first actuation state shown in Fig. 14, when the user is performing the first actuation to the button 400. The cross-sectional view is taken along the axis A-A shown in Fig. 14. The medicament container 200 is again hidden from view.Attorney Docket No.: 46567-1791 WO1

[0379] As shown in Fig. 18, when the button 400 is pivoted towards the medicament container 200, the second dose pins 452a, 452b are axially aligned with the respective pin flexing surfaces 335a, 335b of the holding members 330a, 330b. If the user holds the button 400 in the pivoted position shown in Fig. 18 for the duration of the plunger drive shuttle 320 moving from its initial position to its intermediate position, the pin flexing surfaces 335a, 335b will eventually engage the second dose pins 452a, 452b. The pin flexing surfaces 335a, 335b are ramped such that, once the pin flexing surfaces 335a, 335b engage the second dose pins 452a, 452b, continued distal movement of the pin flexing surfaces 335a, 335b causes the second dose pins 452a, 452b to be deflected towards the device axis X-X, as indicated by arrows S1 and S2, thereby allowing the plunger drive shuttle 320 to continue moving distally to its intermediate position. Once the user removes the first actuation force F1 from the button 400 and the button pivots back to its initial position as shown in Fig. 15, the second dose pins 452a, 452b, are disengaged from the respective pin flexing surfaces 335a, 335b, allowing the second dose pins 452a, 452b to flex back to their original configurations as shown in Fig. 15 due to their resiliency.

[0380] In the present example, the medicament delivery system 1000 may be an intranasal medicament delivery system 1000. The intranasal medicament delivery system 1000 may be an intranasal atomization delivery system 1000.

[0381] The intranasal medicament delivery system 1000 may be configured to deliver about % of a dose to each nostril.

[0382] The intranasal medicament delivery system 1000 may be configured to deliver about 0.2mL, wherein about 0.1 mL is delivered to each nostril.

[0383] The medicament delivery member 250 may be in the form of an intranasal nozzle that may be configured to deliver an average droplet size Dv50 of about 10-120 pm.

[0384] The intranasal nozzle may deliver an average droplet size Dv50 delivered to each nostril that may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm.

[0385] The intranasal medicament delivery system 1000 may be configured so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.Attorney Docket No.: 46567-1791 WO1

[0386] In some embodiments, the intranasal medicament delivery system 1000 is configured to deliver in the range of 20 to 2000 microlitres (0.02 to 2 ml) volume of medicament and, preferably, in the range of 100 to 400 microlitres (0.1 to 0.4 ml) and, preferably, in the range of 10 to 300 microlitres (0.1 to 0.3 ml) and, preferably, about 200 microlitres (0.2 ml).

[0387] In some embodiments, the intranasal medicament delivery system 1000 is configured to deliver in the range of 10 to 1000 microlitres (0.01 to 1 ml) volume of medicament to each nostril of the user and, preferably, in the range of 50 to 200 microlitres (0.05 to 0.2 ml) and, preferably, in the range of 50 to 150 microlitres (0.05 to 0.1 ml) and, preferably, about 100 microlitres (0.1 ml) of medicament to each nostril of the user.

[0388] A second embodiment of a medicament delivery system 1000’ according to one or more aspects of the present disclosure shall now be described with reference to Figs. 19A to 30. One or more aspects of the medicament delivery system 1000’ may be similar or identical to one or more aspects of the medicament delivery system 1000 previously described with reference to Figs. 1 to 18.

[0389] The system 1000’ comprises a medicament delivery device 100’ and a medicament container 200’. One or more aspects of the device 100’ may be similar or identical to one or more aspects of the device 100 previously described with reference to Figs. 1 to 18. One or more aspects of the medicament container 200’ may be similar or identical to one or more aspects of the medicament container 200 previously described with reference to Figs. 1 to 18.

[0390] Fig. 19A is a top-view of the system 1000’. Fig. 19B is a side-view of the system 1000’. As shown in Figs. 19A and 19E3, the device 100’ extends along a longitudinal device axis X’-X’.

[0391] An elongate housing 110’ is arranged along the device axis X’-X’ and is configured to contain a medicament container 200’, the medicament container 200’ later described in relation to Figs. 23 and 24. The housing 110’ comprises a front housing portion 161 for containing the medicament container 200’ and a rear housing portion 162 coupled to a proximal end of the front housing portion 161. The rear housing portion 162 may be couplable to the front housing portion 161 using any suitable coupling arrangement, for example in a similar manner as the upper housing portion 110a and lower housing portion 110b previously described in relation to Figs. 6 and 7 (e.g., similar to the upper housing coupling arrangement 120 and / or lower housing coupling arrangement 130).Attorney Docket No.: 46567-1791 WO1

[0392] A window 112’ may be arranged at the front housing portion 161 such that a user may view at least a portion of the medicament container 200’. One or more aspects of the window 112’ may be similar to the window 112a and / or window 112b. The window 112’ may allow the user to view a medicament level remaining in the medicament container 200’.

[0393] An outlet 114’ is arranged at a distal end of the front housing portion 161 , through which medicament from the medicament container 200’ can be dispensed to a patient. An annular patient contact member 117’, which may be similar or identical to the patient contact member 117, may surround the outlet 114’.

[0394] Figs. 19A and 19B show a delivery member shield 260’ coupled to the medicament container 200’, extending distal to the housing 110’. The delivery member shield 260’ may be similar or identical to the delivery member shield 260 previously described. The delivery member shield 260’ is coupled to a medicament delivery member 250’, as later described in relation to Figs. 23 and 24.

[0395] The device 100’ comprises a button 400’ arranged at an outer surface of the housing 110’, wherein the button 400’ may be similar or identical to the button 400. Fig. 19A shows the button 400’ pivotably coupled to the rear housing portion 162 by a hinge portion 410’ of the button 400’.

[0396] A drive assembly 700 of the device 100’ shall now be described with reference to Figs. 20 to 22.

[0397] The drive assembly 700 is couplable to the front housing portion 161 and is operable to drive a piston 710 of the medicament container 200’ (shown in Fig. 23) to dispense a first and second dose of medicament.

[0398] Fig. 20 is a schematic side view of the drive assembly 700 prior to assembly of the components of the drive assembly 700. Fig. 22 is a schematic side view of the drive mechanism 700 after assembly of the components of the drive assembly 700.

[0399] As shown in Fig. 20, the drive assembly 700 comprises a plunger drive mechanism 300’ comprising a plunger drive shuttle 320’ and a biasing member 380’.

[0400] The plunger drive shuttle 320’ comprises a hollow plunger rod 720 that is configured to move the piston 710 of the medicament container 200’ to dispense the medicament. The elongateAttorney Docket No.: 46567-1791 WO1

[0401] plunger rod 720 has a substantially constant diameter along its length. A piston engagement feature 722 (such as a projection) may be arranged at a distal end of the plunger rod 720 for engaging a corresponding engagement feature 724 (e.g., recess) of the piston 710 (as shown in Fig. 24).

[0402] The plunger rod 720 comprises an elongate cavity 725 extending along a substantial portion of its length, for receiving at least a portion of the biasing member 380’. The plunger rod 720 is open at its proximal end so that the biasing member 380’ may extend into the cavity 725 through the open proximal end.

[0403] The biasing member 380’ may be similar or identical to the biasing member 380 previously described in relation to Figs. 1 to 18. For example, Figs. 20 and 22 show the biasing member 380’ comprising a helical compression spring.

[0404] The drive assembly 700 comprises a plunger rod retaining arrangement 730 for retaining the plunger rod 720. The plunger rod retaining arrangement 730 inhibits lateral movement of the plunger rod 720 in radial directions from the device axis X’-X’, but permits axial displacement of the plunger rod 720 parallel to the device axis X’-X’ and rotation of the plunger rod 720 about the longitudinal axis of the plunger rod 720. Figs. 20 and 22 show the plunger rod retaining arrangement 730 comprising a bore through at least a proximal portion of the plunger rod 720 may extend and be retained. As shown in Figs. 20 and 22, the drive assembly 700 may comprise a support mandrel 327’ configured to be received within the biasing member 380’ to support the biasing member 380’. Figs. 20 and 22 show the support mandrel 327 extending distally from the rear housing portion 162, through the bore of the plunger rod retaining arrangement 730.

[0405] As shown in Figs. 20 and 22, the drive assembly 700 comprises the button 400 and the rear housing portion 162 to which it is coupled. The button comprises a hinge portion 410’, mount portion 420’ and actuation protrusion 430’, which may be similar or identical to the hinge portion 410, mount portion 420 and actuation protrusion 430 previously described in relation to Figs. 1 to 18. The actuation protrusion 430’ is pivotably coupled to the rear housing portion 162 by the hinge portion 410’. The actuation protrusion 430’ has an actuation surface 4301 ’ arranged to be directly pushed by the finger or thumb of a user, in the same or similar manner as the actuation surface 4301.

[0406] Fig. 21 is a schematic sectional view taken along the axis C-C of Fig. 20, showing the button 400’ from below.Attorney Docket No.: 46567-1791 WO1

[0407] As shown in Figs. 20 to 22, the button 400’ comprises a first dose pin 451’ and a second dose pin 452’, which may be similar to the first dose pins 451 a, 451 b and the second dose pins 452a, 452b previously described in relation to Figs. 1 to 18, respectively. The first dose pin 451’ and second dose pin 452’ project from the mount portion 420’ of the button 400, towards the plunger rod 720 when the plunger rod 720 is held in the plunger rod retaining arrangement 730. The first dose pin 451 ’ and second dose pin 452’ are aligned along an axis that is substantially parallel to, but offset from, the device axis X’-X’. The first dose pin 451 ’ and second dose pin 452 are separated from one another along the axis, such that the second dose pin 452’ is distal to the first dose pin 451 ’. The button 400 may further comprise an insertion ramp 770 arranged at a distal end of the mount portion 430’.

[0408] The drive assembly 700 further comprises a drive shuttle hold arrangement 350’, which may share one or more similarities with the drive shuttle hold arrangement 350 previously described with reference to Figs. 1 to 18. The drive shuttle hold arrangement 350 comprises a first shuttle guide track 360a’ and a second shuttle guide track 360b’, for guiding movement of the plunger drive shuttle 320’. The second shuttle guide track 360b’ is hidden from view in Figs. 20 and 22, but the first shuttle guide track 360a’ and the second shuttle guide track 360b’ are shown together in Fig. 27, as described later.

[0409] The first shuttle guide track 360a’ and the second shuttle guide track 360b’ each comprise respective first track sections 3601a’, 3601 b’, second track sections 3602a’, 3602b’ and third track sections 3603a’, 3603b’, each of which extend axially. The first track section 3601a’, second track section 3602a’ and third track section 3603a’ of the first shuttle guide track 360a’ are substantially aligned along a same axis, which is substantially parallel to the device axis X’-X’. Similarly, the first track section 3601b’, second track section 3602b’ and third track section 3603b’ of the second shuttle guide track 360b’ are substantially aligned along a same axis, which is also substantially parallel to the device axis X’-X’. As shown in Fig. 20, the first track sections 3601 a’, 3601 b’, second track sections 3602a’, 3602b’ and third track sections 3603a’, 3603b’ are offset from each other in a transverse direction perpendicular to the device axis X’-X’.

[0410] The shuttle guide tracks 360a’, 360b’ each comprise a respective first stop element 361a’, 361 b’, second stop element 362a’, 362b’, and third stop elements 363a’, 363b’. The first stop elements 361a’, 361b’ are arranged between the respective first track sections 3601a’, 3601b’ and second track sections 3602a’, 3602b’. The second stop elements 362a’, 362b’ are arranged between the respective second track sections 3602a’, 3602b’ and third trackAttorney Docket No.: 46567-1791 WO1

[0411] sections 3603a’, 3603b’. The third stop elements 363a’, 363b’ are arranged distal to the third track sections 3603a’, 3603b’.

[0412] To fully assemble the drive assembly 700, the biasing member 380’ (e.g., helical spring) is inserted into the cavity 725 within the plunger rod 720, and the plunger rod 720 and biasing member 380’ are inserted into the plunger rod retaining arrangement 730 (e.g., bore), as shown in Fig. 22. The support mandrel 327’ is shown extending within the biasing member 380’. The biasing member 380’ is loaded (e.g., compressed) between the plunger rod 720 and the rear housing portion 161 as the plunger rod 720 is inserted into the plunger rod retaining arrangement 730, pretensioning the biasing member 380’ such that it is ready for dose delivery. Once the plunger rod 720 is fully inserted into the plunger rod retaining arrangement 730 as shown in Fig. 22, it may become axially locked relative to the rear housing portion 162 due to engagement between the plunger drive shuttle 320’ and the drive shuttle hold arrangement 350’, as later described.

[0413] Once the drive assembly 700 is fully assembled as shown in Fig. 22, it may now be coupled to the front housing portion 161 of the device 100’.

[0414] Figs. 23 and 24 show sectional views of the assembled device 100‘ and system 1000’ taken along the device axis X’-X’, after the drive assembly 700 has been coupled to the front housing portion 161. Fig. 23 shows a sectional top-view.

[0415] Prior to coupling the drive assembly 700 to the front housing portion 161 , the user may have inserted a medicament container 200’ through an open proximal end of the front housing portion 161 such that the medicament container 200’ is at least partially held within the front housing portion 161 , as shown in Figs. 23 and 24.

[0416] As shown in Figs. 23 and 24, the medicament container 200’ may be similar to the medicament container 200 previously described in relation to Figs. 1 to 18, having a barrel 210’ containing a medicament 230’, and a medicament delivery member 250’ coupled to a distal end of the barrel 210’, wherein a distal end of the medicament delivery member 250’ may extend through the outlet 114’ such that it is distal to the housing 110. However, the function of the plunger rod 240 previously described in relation to the medicament container 200 has been replaced in the medicament container 200’ by the plunger rod 720 of the drive assembly 700, which may act on a piston 710 axially movable within the barrel 210’ to dispense the medicament via the medicament delivery member 250’.Attorney Docket No.: 46567-1791 WO1

[0417] The medicament container 200’ is held within the front housing portion 161 by a medicament container holding arrangement 150’, which may inhibit lateral movement of the barrel 210’ relative to the housing 110. Distal movement of the barrel 210’ relative to the front housing portion 161 may be inhibited by engagement between a barrel flange 216’ and a proximally-facing surface of the medicament container holding arrangement 150, as shown in Fig. 23.

[0418] After the medicament container 200’ has been inserted into the front housing portion 161, the drive assembly may be coupled to the front housing portion 161. This is performed by inserting at least a distal portion of the drive assembly 700 into the front housing portion 161 via the open proximal end of the front housing portion 161. More particularly, at least a distal end of the plunger rod 720 is inserted distally into the front housing portion 720 such that it is coaxial with, and in some instances partially inserted into, the barrel 210’ of the medicament container 200’. The drive assembly 700 is inserted into the front housing portion 161 until the rear housing portion 162 engages and couples with the front housing portion 161 , as shown in Figs. 23 and 24.

[0419] As shown in Fig. 24, the plunger drive shuttle 320’ comprises a pair of plunger arms 810, 820 extending radially from the plunger rod 720. The first plunger arm 810 and second plunger arm 820 extend from the outer circumferential surface of the plunger rod, in opposing directions from the plunger rod 720 and device axis X’-X’.

[0420] The plunger arms 810, 820 comprise holding members 330a’, 330b’ at respective free ends. As shown in Fig. 24, the first holding member 330a’ is configured to be received in, and guided by, the first shuttle guide track 360a’, while the second holding member 330b’ is configured to be received in, and guided by, the second shuttle guide track 360b’.

[0421] Figs. 23 and 24 show the device 100’ in a first primed state prior to medicament dispensing, with the plunger drive shuttle 320’ at an initial axial position within the housing 110. The plunger drive shuttle 320’ is axially movable in the distal direction A1 by the biasing member 380’ from the initial position relative to the housing to an intermediate position relative to the housing to dispense a first dose of the medicament 230’, and then from the intermediate position relative to a final position relative to the housing to dispense a second dose of the medicament 230’. However, the plunger drive shuttle 320’ is initially held in its initial position and inhibited from moving distally by engagement between the holding members 330a’, 330b’ and the shuttle guide tracks 360a’, 360b’. More particularly, the plunger drive shuttle 320’ is initially held in its initial position and inhibited from moving distally by engagement between the holding members 330a’, 330b’ and the respective first stop elements 361a’, 361b’ of the shuttle guide tracks 360a’, 360b’.Attorney Docket No.: 46567-1791 WO1

[0422] As shown in Fig. 24, when the device 100’ is in its first primed state, the first dose pin 451’ is aligned with the first plunger arm 810.

[0423] To dispense a first dose of the medicament 230’, the user performs a first actuation of the button 400’ relative to the housing 110’, by pushing the actuation surface 430a’ of the button 400’ in a substantially transverse direction A2 that is substantially perpendicular to the distal direction A1 , for example in a similar manner as described in relation to Figs. 1 to 18. The first actuation deflects the plunger drive shuttle 720 to cause the plunger drive shuttle 720 to move from the initial position to the intermediate position to dispense the first dose of medicament. More particularly, movement of the button 400’ in the transverse direction A2 engages the first dose pin 45T with the first plunger arm 810 (if not already engaged) and then moves the first plunger arm 810 in the transverse direction A2, causing the first plunger arm 810 to rotate the plunger rod 720 about the device axis X’-X’ with a first rotation in a first rotational direction.

[0424] Fig. 25 shows a side-view of the plunger rod 720, the first and second dose pins 45T, 452’ and the first plunger arm 810 of the device 100’ when the device 100’ is in its first primed state, prior to the button 400 being actuated. Fig. 26 is a sectional view of the plunger rod 720, the first and second plunger arms 810, 820 and the first dose pin 451 ’ of the device 100’ when the device 100’ is in its first primed state, taken in a plane that is normal to the device axis X’X’, and when viewing from the proximal end of the device 100’ towards the distal end of the device 100’.

[0425] Fig. 28 shows a side-view of the plunger rod 720, the first and second dose pins 45T, 452’ and the first plunger arm 810 of the device 100’, after the device 100’ has been moved from its first primed state to a first dose dispense state by the user moving the button 400 in the transverse direction A2 with the first actuation. Fig. 29 is a sectional view of the plunger rod 720, the first and second plunger arms 810, 820 and the first dose pin 451 ’ of the device 100’ when the device 100’ is in its first dose dispense state, taken along the axis D-D shown in Fig. 28, when viewing from the proximal end of the device 100’ towards the distal end of the device 100’. Fig. 30 is a sectional view of the plunger rod 720, the first and second plunger arms 810, 820 and the second dose pin 452’ of the device 100’ when the device 100’ is in its first dose dispense state, taken along the axis E-E shown in Fig. 28, when viewing from the distal end of the device 100’ towards the proximal end of the device 100’.Attorney Docket No.: 46567-1791 WO1

[0426] As shown in Figs. 28 to 30, the first actuation has moved the first and second dose pins 451 452’ in the transverse direction A2, causing the first dose pin 451 ’ to engage the first plunger arm 810 (if not already engaged) and then move the first plunger arm 810 in the transverse direction A2, causing the first plunger arm 810 to rotate the plunger rod 720 about the device axis X’-X’ with the first rotation in the first rotational direction. As shown in Figs.

[0427] 29 and 30, the first rotation of the plunger rod 720 causes the second plunger arm 820 to also rotate about the device axis X’X’ in the same rotational direction as the first plunger arm 810. The rotation of the second plunger arm 820 disengages the holding member 330b’ of the second plunger arm 820 from the corresponding first stop element 361 b’ of the second shuttle guide track 360b’ such that the plunger drive shuttle 320’ moves from the initial position to the intermediate position due to the biasing force applied to the plunger rod 720 in the distal direction A1.

[0428] It should be noted that the first rotation of the plunger rod 720 may also disengage the holding member 330a’ of the first plunger arm 810 from the corresponding first stop element 361 a’ of the first shuttle guide track 360a’ such that the plunger drive shuttle 320’ moves from the initial position to the intermediate position due to the biasing force applied to the plunger rod 720 in the distal direction A1.

[0429] The distal movement of the plunger drive shuttle 320’ and plunger rod 720 causes a first dose of the medicament 230’ to be dispensed from the medicament container 200’ as the plunger rod 720 moves the piston 710 distally within the barrel 210’. As the plunger drive shuttle 320’ moves distally, the holding members 330a’, 330b’ of the plunger arms 810, 820 move distally along the respective second track sections 3602a’, 3602b’ until they engage the respective second stop elements 362a’, 362b’, inhibiting further distal movement of the plunger drive shuttle 320’.

[0430] The second dose pin 452’ may be flexible such that it can be flexed by the first plunger arm 810 as the plunger drive shuttle 320’ moves from its initial position to its intermediate position, should the user maintain the button 400’ in its actuated state for an extended period of time. Once the user releases the button 400’, the button 400’ may move back towards its initial position relative to the housing 110’, in a direction substantially opposite to the transverse direction A2. The button 400’ may move back automatically due to a resilient force, for example provided by a resilient coupling between the button 400’ and the housing 110’.Attorney Docket No.: 46567-1791 WO1

[0431] Once the plunger drive shuttle 320’ has reached its intermediate position, the first plunger arm 810 will now be aligned with the second dose pin 452’. To dispense a second dose of the medicament 230’, the user performs a second actuation of the button 400’ relative to the housing 110’, by pushing the actuation surface 430a’ of the button 400’ in a substantially transverse direction A2 that is substantially perpendicular to the distal direction A1 , for example in a similar manner as described in relation to Figs. 1 to 18. The second actuation deflects the plunger drive shuttle 720 to cause the plunger drive shuttle 720 to move from the intermediate position to a final position to dispense the second dose of medicament. More particularly, movement of the button 400’ in the transverse direction A2 engages the second dose pin 452’ with the first plunger arm 810 (if not already engaged) and then moves the first plunger arm 810 in the transverse direction A2, causing the first plunger arm 810 to further rotate the plunger rod 720 about the device axis X’-X’ with a second rotation in the first rotational direction.

[0432] The second rotation of the plunger rod 720 causes the second plunger arm 820 to also further rotate about the device axis X’X’ in the same rotational direction as the first plunger arm 810. The further rotation of the second plunger arm 820 disengages the holding member 330b’ of the second plunger arm 820 from the corresponding second stop element 362b’ of the second shuttle guide track 360b’ such that the plunger drive shuttle 320’ moves from the intermediate position to the final position due to the biasing force applied to the plunger rod 720 in the distal direction A1.

[0433] It should be noted that the second rotation of the plunger rod 720 may also disengage the holding member 330a’ of the first plunger arm 810 from the corresponding second stop element 361b’ of the first shuttle guide track 360a’ such that the plunger drive shuttle 320’ moves from the intermediate position to the final position due to the biasing force applied to the plunger rod 720 in the distal direction A1.

[0434] The distal movement of the plunger drive shuttle 320’ and plunger rod 720 causes a second dose of the medicament 230’ to be dispensed from the medicament container 200’ as the plunger rod 720 moves the piston 710 distally within the barrel 210’. As the plunger drive shuttle 320’ moves distally, the holding members 330a’, 330b’ of the plunger arms 810, 820 move distally along the respective third track sections 3603a’, 3603b’ until they engage the respective third stop elements 363a’, 363b’ (if present), inhibiting further distal movement of the plunger drive shuttle 320’.Attorney Docket No.: 46567-1791 WO1

[0435] In the present example, the medicament delivery system 1000’ may be an intranasal medicament delivery system 1000’. The intranasal medicament delivery system 1000’ may be an intranasal atomization delivery system 1000’.

[0436] The intranasal medicament delivery system 1000’ may be configured to deliver about % of a dose to each nostril.

[0437] The intranasal medicament delivery system 1000’ may be configured to deliver about 0.2mL, wherein about 0.1 mL is delivered to each nostril.

[0438] The medicament delivery member 250’ may be in the form of an intranasal nozzle that may be configured to deliver an average droplet size Dv50 of about 10-120 pm.

[0439] The intranasal nozzle may deliver an average droplet size Dv50 delivered to each nostril that may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm.

[0440] The intranasal medicament delivery system 1000’ may be configured so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.

[0441] In some embodiments, the intranasal medicament delivery system 1000’ is configured to deliver in the range of 20 to 2000 microlitres (0.02 to 2 ml) volume of medicament and, preferably, in the range of 100 to 400 microlitres (0.1 to 0.4 ml) and, preferably, in the range of 10 to 300 microlitres (0.1 to 0.3 ml) and, preferably, about 200 microlitres (0.2 ml).

[0442] In some embodiments, the intranasal medicament delivery system 1000’ is configured to deliver in the range of 10 to 1000 microlitres (0.01 to 1 ml) volume of medicament to each nostril of the user and, preferably, in the range of 50 to 200 microlitres (0.05 to 0.2 ml) and, preferably, in the range of 50 to 150 microlitres (0.05 to 0.1 ml) and, preferably, about 100 microlitres (0.1 ml) of medicament to each nostril of the user.

[0443] A third embodiment of a medicament delivery system 1000” according to one or more aspects of the present disclosure shall now be described with reference to Figs. 31 to 33. The medicament delivery system 1000” is substantially the same as the medicament delivery system 1000’ previously described with reference to Figs. 19A to 30, but differs inAttorney Docket No.: 46567-1791 WO1

[0444] the plunger drive shuttle 320”, the dose pins 452a’, 451a’, and shuttle guide tracks 360a”, 360b” as described below.

[0445] Fig. 31 is a side-view of the plunger drive shuttle 320” and first and second dose pins 451a’, 452a’ according to the third embodiment, when the device 100” is in a first primed state (e.g., similarto the first primed state of the second embodiment). A second pair of first and second dose pins 451b’ and 452b’ is hidden behind the first pair of first and second dose pins 451a’, 452a’ (i.e., a first dose pin 451b’ is hidden directly behind the first dose pin 451a’, and a second dose pin 452b’ is hidden directly behind the second dose pin 452a’). The dose pins 451 a’, 451 b’, 452a’, 452b’ therefore have a similar arrangement to the dose pins 451a, 451b, 452a, 452b previously described in relation to Figs. 1 to 18.

[0446] Fig. 32 is a cross-sectional view of the plunger drive shuttle 320” and first dose pins 451a’, 451 b’, when viewing from a proximal end towards the distal end.

[0447] In a similar manner to the plunger drive shuttle 320’ of the second embodiment, the plunger drive shuttle 320” of the second embodiment also comprises a hollow plunger rod 720 configured to retain at least a distal end of the biasing member 380’, and first and second plunger arms 810, 820 arranged to extend radially from an outer surface of the plunger rod 720. However, in the third embodiment, the first and second plunger arms 810, 820 are flexibly coupled to the plunger rod 720 such that they may be deflected relative to the plunger rod 720 in substantially the transverse direction A2. For example, the plunger rod 720 may have a pair of opposing slots 900a, 900b extending through and along the plunger rod 720, the pair of slots 900a, 900b arranged substantially parallel to each other and separated by a flexible elongate member 920 from which the first plunger arm 810 extends radially.

[0448] The flexible elongate member 920 is sufficiently thin such that it allows the first and second plunger arms 810, 820 to which it is coupled to flex relative to the plunger rod 720 (e.g., pivot about the longitudinal axis of the plunger rod 720, or move in the transverse direction A2 relative to the plunger rod 720).

[0449] As shown in Figs. 31 and 32, when the device 100” is in its first primed state prior to dispensing the medicament, the first dose pins 451a’, 451b’ are aligned with the respective plunger arms 810, 820. A first actuation of the button 400’ by the user causes the pair of first dose pins 451 a’, 451 b’ to move in substantially the transverse direction A2 to engage the respective plunger arms 810, 820 (if not already engaged), with further transverseAttorney Docket No.: 46567-1791 WO1

[0450] movement of the first dose pins 451a’, 451b’ deflecting the plunger drive shuttle 320” by flexing the respective plunger arms 810, 820 relative to the plunger rod (e.g., in a substantially transverse direction A2). The flexing of the plunger arms 810, 810 disengages the holding member 330a’ of the first plunger arm 810 from a corresponding first stop element 361a” of a first shuttle guide track 360a” (e.g., shown in Fig. 33) and disengages the holding member 330b’ of the second plunger arm 820 from a corresponding first stop element 361 b” of a second shuttle guide track 360b” (e.g., shown in Fig. 33), such that the plunger drive shuttle 320” is released to move distally from the initial position to the intermediate position to dispense a first dose of medicament 230. As the plunger drive shuttle 320” moves distally, the first dose pins 451 a’, 451 b’ are brought out of engagement with the plunger arms 810, 820, causing the plunger arms 810, 820 to flex back towards their initial positions with respect to the plunger rod 720, due to their resilient coupling to the plunger rod 720.

[0451] The holding members 330a’, 330b’ engage respective second stop elements 362a”, 362b” of the shuttle guide tracks 360a”, 360b” once the plunger drive shuttle 320” has reached its intermediate position, inhibiting further distal movement of the plunger drive shuttle 320”. The pair of second dose pins 452a’, 452b’ will now be aligned with the first and second plunger arms 810, 820 respectively. The pair of second dose pins 452a’, 452b’ may be flexible, such that they are flexed by the plunger arms 810, 820 during movement of the plunger drive shuttle 320” from the initial position to the intermediate position, should the user maintain the button 400’ in its actuated state for too long.

[0452] Once the user releases the button 400’ the button will return towards its initial position relative to the housing 110, for example due to a resilient coupling with the housing 110.

[0453] To dispense a second dose of medicament, the user may perform a second actuation of the button 400’ of the device 100”, causing the pair of second dose pins 452a’, 452b’ to flex the first and second plunger arms 810, 820 in a similar manner to the flexing of the plunger arms 810, 820 by the first dose pins 451a’, 451b’. The flexing of the plunger arms 810, 810 disengages the holding member 330a’ of the first plunger arm 810 from the corresponding second stop element 362a” of a first shuttle guide track 360a” (e.g., shown in Fig. 33) and disengages the holding member 330b’ of the second plunger arm 820 from a corresponding second stop element 362b” of a second shuttle guide track 360b” (e.g., shown in Fig. 33), such that the plunger drive shuttle 320” is released to move distally from the intermediate position to the final position to dispense the second dose of medicament 230.Attorney Docket No.: 46567-1791 WO1

[0454] In the present example, the medicament delivery system 1000” may be an intranasal medicament delivery system 1000”. The intranasal medicament delivery system 1000” may be an intranasal atomization delivery system 1000”.

[0455] The intranasal medicament delivery system 1000” may be configured to deliver about % of a dose to each nostril.

[0456] The intranasal medicament delivery system 1000” may be configured to deliver about 0.2mL, wherein about 0.1 mL is delivered to each nostril.

[0457] The medicament delivery member 250’ may be in the form of an intranasal nozzle that may be configured to deliver an average droplet size Dv50 of about 10-120 pm.

[0458] The intranasal nozzle may deliver an average droplet size Dv50 delivered to each nostril that may be about 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm.

[0459] The intranasal medicament delivery system 1000” may be configured so that an average shot volume to each nostril is between about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.

[0460] In some embodiments, the intranasal medicament delivery system 1000” is configured to deliver in the range of 20 to 2000 microlitres (0.02 to 2 ml) volume of medicament and, preferably, in the range of 100 to 400 microlitres (0.1 to 0.4 ml) and, preferably, in the range of 10 to 300 microlitres (0.1 to 0.3 ml) and, preferably, about 200 microlitres (0.2 ml).

[0461] In some embodiments, the intranasal medicament delivery system 1000” is configured to deliver in the range of 10 to 1000 microlitres (0.01 to 1 ml) volume of medicament to each nostril of the user and, preferably, in the range of 50 to 200 microlitres (0.05 to 0.2 ml) and, preferably, in the range of 50 to 150 microlitres (0.05 to 0.1 ml) and, preferably, about 100 microlitres (0.1 ml) of medicament to each nostril of the user.

[0462] A method 3400 of using a medicament delivery device according to one or more aspects of the present disclosure shall now be described with reference to Fig. 34. the method 3400 is performed to dispense a first dose of a medicament and a second dose of the medicament from the medicament delivery device. The medicament delivery device may be anyAttorney Docket No.: 46567-1791 WO1

[0463] medicament delivery device disclosed herein, for example the medicament delivery device 100, the medicament delivery device 100’, or the medicament delivery device 100”.

[0464] As shown in Fig. 34, the method 3400 comprises a first method step 3410 followed by a second method step 3420.

[0465] In the first method step 3410, a first actuation of the button of the medicament delivery device relative to the housing is performed, as described previously. The first actuation causes the plunger drive shuttle to move from the initial position to the intermediate position to dispense the first dose of medicament to a patient, as described previously.

[0466] In the second method step 3420, subsequent to performing the first actuation, a second actuation of the button relative to the housing is performed, as described previously. The second actuation causes the plunger drive shuttle to move from the intermediate position to the final position to dispense the second dose of medicament, as described previously.

[0467] Prior to the first method step 3410, a medicament container 200 containing the medicament 230 to be dispensed is inserted into the medicament delivery device, if the medicament delivery device does not already contain a medicament container 200.

[0468] Prior to the first method step 3410, the user may move the medicament delivery device to a first medicament delivery site of the patient (e.g., a first nostril of the patient), as previously described.

[0469] Subsequent to the first method step 3410 but prior to the second method step 3420, the user may move the medicament delivery device to a second medicament delivery site of the patient other than the first medicament delivery site (e.g., a second nostril of the patient), as previously described.

[0470] While it has generally been described herein that that the first and second doses of medicament are to be administered to one or more patients, it should be understood that this is not meant to be limiting and that in one or more examples at least one of the first dose or the second dose may be dispensed without being administered to a patient. For instance, in such examples, at least one of the first dose or the second dose may be a priming dose of medicament that is not to be administered to a patient. As such, one or more devices, systems and / or methods disclosed herein may be used to dispense a first priming dose of medicament and / or a second priming dose of medicament during a priming operation of theAttorney Docket No.: 46567-1791 WO1

[0471] device, without actually administering medicament to a patient. For example, method step 3410 and / or method step 3420 of method 3400 may be performed during a priming operation of a medicament delivery system, prior to administering medicament to a patient.

[0472] While it has generally been contemplated that the user of any of the systems, devices, components, and methods disclosed herein is a different person to the patient to whom one or more doses of medicament is administered, it should be understood that this is not meant to be limiting and that in one or more examples a user may also be the patient (e.g., during self-administration).

[0473] The medicament delivered by any of the embodiments described above may be any medicament described herein. The medicament may be a vaccine adapted for nasal administration. The vaccine may be an RSV vaccine.

[0474] Described herein are systems, devices, components, and methods that may be associated with delivering a respiratory syncytial virus (RSV) vaccine using an intranasal atomization delivery device.

[0475] As used herein, “RSV ANS2 / A1313 / I1314L” refers to an RSV ANS2 / A1313 / I1314L (NIH) or an RSV ANS2 / A1313 / I1314L (Sanofi). Each of the ANS2 / A1313 / I1314L (NIH) and the RSV ANS2 / A1313 / I1314L (Sanofi) comprise a live-attenuated RSV with (i) a 523 nucleotide (nt) deletion of the NS2 gene (ANS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stabilizing mutation in the L gene. The live-attenuated RSV of the RSV ANS2 / A1313 / I1314L (Sanofi) also includes a nucleotide modification at position 14456 that represents a change from a thymine (T) to an adenine (A) in a non-coding region.

[0476] As used herein, “RSV ANS2 / A1313 / 11314L vaccine” refers to an “RSV ANS2 / A1313 / I1314L (NIH) vaccine” or an “RSV ANS2 / A1313 / I1314L (Sanofi) vaccine.” An RSV ANS2 / A1313 / I1314L (NIH) vaccine comprises an effective amount of RSV ANS2 / A1313 / I1314L (NIH). An RSV ANS2 / A1313 / I1314L (Sanofi) vaccine comprises an effective amount of RSV ANS2 / A1313 / I1314L (Sanofi).

[0477] Exemplary Methods and Uses

[0478] In some embodiments, provided are methods of delivering a dose of an RSV vaccine using an intranasal atomization delivery device.Attorney Docket No.: 46567-1791 WO1

[0479] In some embodiments, the methods of administering a dose of an RSV vaccine that comprises a live attenuated RSV use an intranasal atomization delivery device. In some embodiments, provided are methods of administering a dose of an RSV vaccine using an intranasal atomization delivery device, the RSV vaccine comprising an effective amount of a live-attenuated RSV with (i) a 523 nucleotide (nt) deletion of the NS2 gene (ANS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stabilizing mutation in the L gene (RSVA NS2 / A1313 / I1314L (NIH) vaccine) or RSVA NS2 / A1313 / I1314L (Sanofi) vaccine that further comprises a nucleotide modification in a non-coding region that represents a change from a thymine (T) to an adenine (A). In some embodiments, a codon that encodes a serine at position 1313 of the L protein is deleted resulting in the deletion of the amino acid in the L protein (A1313). In some embodiments, an amino acid residue substitution of leucine for isoleucine at position 1314 results in a genetically stabilizing mutation in the L gene (I1314L).

[0480] In some embodiments, provided are methods of administering a dose of an RSV vaccine using an intranasal atomization delivery device. In some embodiments, the paediatric subject may be 6 to 18 months of age.

[0481] In some embodiments, the RSV vaccine is delivered intranasally using the intranasal atomization delivery device to deliver about % dose to each nostril. In some embodiments, the RSV vaccine is delivered intranasally so that the whole dose is delivered to one nostril. In some embodiments, the RSV vaccine is delivered intranasally with % dose delivered to one nostril and the other % dose is delivered to the same nostril after the first % dose is absorbed. In some embodiments, the RSV vaccine is delivered intranasally using the intranasal atomization delivery device to deliver a dose in unequal amounts to one or both nostrils.

[0482] In some embodiments, the RSV vaccine is delivered intranasally using the intranasal atomization delivery device in a liquid formulation. In some embodiments, the RSV vaccine dose is delivered intranasally using the intranasal atomization delivery device in about 0.2 mL. In some embodiments, the 0.2 mL dose is delivered intranasally wherein about 0.1 mL is delivered to each nostril. In some embodiments, the RSV vaccine dose is delivered intranasally using the intranasal atomization delivery device in about 0.01 mL, 0.02 mL, 0.05 mL, 0.1 mL, 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL or 1.5 mL. As described above, the dose may be divided evenly between two nostrils, divided unevenly between two nostrils, or delivered all to one nostril in one or more deliveries.Attorney Docket No.: 46567-1791 WO1

[0483] In some embodiments, provided are methods of administering a first dose of an RSV vaccine using an intranasal atomization delivery device and administering a second dose of the RSV vaccine using an intranasal atomization delivery device.

[0484] In some embodiments, provided are methods of administering a first dose of an RSV vaccine using an intranasal atomization delivery device wherein the intranasal atomization delivery device comprises a spray nozzle to atomize the RSV vaccine and direct a spray plume toward a top of a nasal passageway into a nasal cavity. In some embodiments, provided are methods of administering a dose of an RSV vaccine using an intranasal atomization delivery device wherein the intranasal atomization delivery device comprises a spray nozzle to atomize the RSV vaccine and direct a spray plume toward a top of a nasal passageway into a nasal cavity. In some embodiments, the intranasal atomization delivery device comprises a barrel operably connected to the spray nozzle and a plunger movable within the barrel to advance the RSV vaccine through the spray nozzle. In some embodiments, the intranasal atomization delivery device further includes a dose divider for splitting the dose of the RSV vaccine into two or more deliveries. In some embodiments, the dose divider may divide the dose of the RSV vaccine in about half of a volume to be delivered to a subject. In some embodiments the dose divider is used to deliver % dose to each nostril of the subject.

[0485] In some embodiments, the intranasal atomization delivery device delivers an average droplet size DV5O of 10-120 pm. In some embodiments, the intranasal atomization delivery device delivers an average droplet size DV5o of 10-120 pm, about 30-110 pm, about 50-110 pm, about 70-110 pm, or about 80-110 pm. In some embodiments, the intranasal atomization delivery device delivers an average shot weight between about 95 mg to about 135 mg, between about 100 mg to about 130 mg, or between about 100 mg to about 130 mg or between about 105 mg to about 130. In some embodiments, the intranasal atomization delivery device delivers an average shot volume of about 85 pL to about 120 pL, about 90 pL to about 115 pL, or about 95 pL to about 115 pL.

[0486] In some embodiments, use of an intranasal atomization delivery device described herein for administering a dose of an RSV vaccine to a subject is provided wherein the RSV vaccine comprises an effective amount of a live-attenuated RSV. In some embodiments, the use includes a live-attenuated RSV with (i) a 523 nucleotide (nt) deletion of the NS2 gene (ANS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stabilizing mutation in the L gene (RSVA NS2 / A1313 / 11314L) (NIH) vaccine or RSVA NS2 / A1313 / I1314L (Sanofi)Attorney Docket No.: 46567-1791 WO1

[0487] vaccine that further comprises a nucleotide modification in a non-coding region that represents a change from a thymine (T) to an adenine (A).

[0488]

[0489] Approximately seventy percent (70%) of vaccine recipients attained a 4-fold response in neutralizing antibody titer following the second vaccine dose in both low and high dose groups, compared to 61 and 47% following one vaccine dose in low and high dose RSV naive participants. This increase in the percentage of participants attaining a 4-fold response following a second administration supports the use of a second vaccine administration in this population. The 70% attaining this fold rise post second vaccine administration aligns with the expected clinical efficacy goal of 70% for the candidate. After one or two vaccinations, 75% attained a 4-fold rise in serum neutralizing antibody titers. The percentage of RSV experienced participants (36% and 22% in the low and high dose groups respectively) also attaining a 4 -fold response in neutralizing antibody titers post vaccination 1 suggests potential benefit for this sub-group as well. It must be noted that this comes from a modest sample of participants (n = 20 of 97 vaccine recipients) at this point of interim analysis.

[0490] Taken together, these data strongly support the use of RSV ANS2 / A1313 / I1314L (Sanofi) vaccine at an operative range study for the candidate including doses at 5.6 and 6.2 log PFU / dose.

[0491] Vaccine virus shedding and Infectivity

[0492] Following each vaccine administration, the shedding of vaccine virus was considered in addition to the fold rise in neutralizing antibody titers or serum IgG as vaccine infectivity. The high level of vaccine infectivity (over 80% and 70% in RSV naive following the first and second vaccine administration respectively) is supportive of a promising vaccine candidate associated with good vaccine take. When infectivity was considered after either vaccine administration, over 90% of participants had evidence of infection. In the small cohort of RSV experienced participants, relatively high infectivity (80% and 33.3% in low and high dose recipients following one vaccine administration and 60 and 50% following a second vaccine administration) was found, implicating promise for this group. In addition, the marked drop in the percentage of vaccine virus shedders in RSV naive participants after the second vaccine administration (roughly 20%) compared to the first vaccine administration (over 70%) is as previously documented with other efficacious live-attenuated mucosal viral vaccines where subsequent ‘challenge’ in the form of a second vaccine dose is characterized by a markedAttorney Docket No.: 46567-1791 WO1

[0493] reduction in vaccine virus shedding. Of note, the shedding data available for this cohort was from data at a single timepoint following each vaccination (seven days post vaccination). While this coincides with the point of peak viral shedding documented in other RSV live-attenuated vaccine (LAV) trials, it is likely that some shedders may have been missed. This limitation in the available shedding data makes the results obtained particularly encouraging.

[0494] Interim analysis results showed a promising safety, immunogenicity and infectivity profile of the RSV ANS2 / A1313 / I1314L (Sanofi) candidate.

[0495] No safety concerns were identified after 1- and 2-dose administrations of either dose level of the investigational RSV ANS2 / A1313 / I1314L (Sanofi) vaccine or by baseline serostatus.

[0496] The vaccine virus shedding, and immunogenicity conclusions based on the IgA serostatus at baseline show marked vaccine take demonstrated at both dose levels, and 70% of vaccine RSV-naTve recipients attained a 4-fold response in serum neutralizing antibody responses post the second vaccine administration for both dose levels in RSV-naTve participants.

[0497] In other embodiments, one or more vaccines directed to one or more of the following viruses or bacteria may be delivered using components, devices, or systems described herein. The viruses may include severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1), severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), influenza virus, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), human parainfluenza viruses (i.e., HPIV-1, HPIV-2, HPIV-3, and HPIV 4), rhinovirus, human papillomavirus (HPV), or human immunodeficiency virus (HIV). The bacteria may include Porphyromonas gingivalis, Streptococcus pneumoniae, Bordetella pertussis, Neisseria meningitidis, Chlamydia trachomatis, or Neisseria gonorrhoeae. The vaccines may be compositions that generate a protective immune response in a subject. For example, the protective immune response may be an immune response that protects a subject from infection (prevents infection or prevents the development of disease associated with infection) or reduces the symptoms of infection (for instance an infection by a virus or bacterium as provided above). Vaccines may elicit both prophylactic (preventative) and therapeutic responses.

[0498] Additional Exemplary Methods and Uses

[0499] The terms “drug” or “medicament” are used synonymously herein and may describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceuticallyAttorney Docket No.: 46567-1791 WO1

[0500] 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.

[0501] As described below, a drug or medicament suitable for use in one or more embodiments disclosed herein 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.

[0502] 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 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0503] 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, ora 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, ora 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 occurringAttorney Docket No.: 46567-1791 WO1

[0504] 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.

[0505] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(E332) human insulin (insulin glargine); Lys(E33), Glu(E329) human insulin (insulin glulisine); Lys(E328), Pro(E329) human insulin (insulin lispro); Asp(E328) human insulin (insulin aspart); human insulin, wherein proline in position E328 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position E329 Lys may be replaced by Pro; Ala(E326) human insulin; Des(B28-E330) human insulin;

[0506] Des(B27) human insulin and Des(B30) human insulin.

[0507] 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-(oj-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(OJ-carboxyheptadecanoyl) human insulin.

[0508] 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 I HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, GRMD-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,Attorney Docket No.: 46567-1791 WO1

[0509] DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0510] 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.

[0511] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0512] 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.

[0513] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin ora 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.

[0514] 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).

[0515] 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 notAttorney Docket No.: 46567-1791 WO1

[0516] comprise a full-length antibody polypeptide, butthat 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.

[0517] 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.

[0518] 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).

[0519] 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.

[0520] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the 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.Attorney Docket No.: 46567-1791 WO1

[0521] List of Reference Numbers

[0522] 100, 100’, 100” - medicament delivery device

[0523] 110, 110’ - housing

[0524] 110a - upper housing portion

[0525] 1101a - upper wall (of upper housing portion)

[0526] 1102 - aperture (in upper housing portion)

[0527] 110b- lower housing portion

[0528] 1101b- lower wall (lower housing portion)

[0529] 112a, b, 112’ - windows

[0530] 114, 114’ - outlet (of housing)

[0531] 115a, b - indicator elements

[0532] 116 - label

[0533] 117, 117’ - patient contact member

[0534] 1171 - distally-facing contact surface (of patient contact member) 1172 - upper portion (of patient contact member)

[0535] 1173 - lower portion (of patient contact member)

[0536] 118a, b - cap retaining elements

[0537] 120 - upper housing coupling arrangement

[0538] 121a,b,c,d - upper housing connectors

[0539] 122a,b - upper housing alignment elements

[0540] 130 - lower housing coupling arrangement

[0541] 131 a,b,c,d - lower housing connectors

[0542] 132a,b - lower housing alignment elements

[0543] 140 - cavity

[0544] 150, 150’ - medicament container holding arrangement

[0545] 151 - first medicament container holding feature

[0546] 1511 a,b - retaining slots

[0547] 152 - second medicament container holding feature

[0548] 1521a,b - retaining surfaces

[0549] 161 - front housing portion

[0550] 162 - rear housing portion

[0551] 200 - medicament container

[0552] 210 - barrelAttorney Docket No.: 46567-1791 WO1

[0553] 212 - proximal opening (of barrel)

[0554] 214 - outlet (of barrel)

[0555] 216, 216’ - barrel flange

[0556] 220 - reservoir

[0557] 230 - medicament

[0558] 240 - plunger rod

[0559] 242 - plunger rod flange

[0560] 250, 250’, 250” - medicament delivery member

[0561] 2501 , 2501 ’ - medicament delivery conduit

[0562] 2501A, 2501A’ - nozzle outlet

[0563] 2502 - needle

[0564] 260, 260’ - delivery member shield

[0565] 300, 300’ - plunger drive mechanism

[0566] 320, 320’ - plunger drive shuttle

[0567] 322 - shuttle body (of plunger drive shuttle)

[0568] 324a, b - shuttle arms

[0569] 3241 a, b - outer lateral surface (of shuttle arm)

[0570] 326 - shuttle crossmember

[0571] 327, 327’ - support mandrel

[0572] 328 - plunger rod engagement surface

[0573] 330a, b, a’, b’ - holding member

[0574] 332a, b - stop engagement element

[0575] 3321 a, b - distally-facing engagement surface (of stop engagement element) 3322a, b - shuttle guide surface

[0576] 3323a, b - chamfered surface (of stop engagement element)

[0577] 334a, b - pin engagement element

[0578] 3341 a, b - pin engagement surface

[0579] 3342a, b - chamfered surface (of pin engagement element)

[0580] 335a, b - pin flexing surface

[0581] 336a, b - track guide element

[0582] 337a, b - first lateral guide element

[0583] 338a, b - second lateral guide element

[0584] 350, 350’ - drive shuttle hold arrangementAttorney Docket No.: 46567-1791 WO1

[0585] 360a,b,a’,b’,a”,b” - shuttle guide track

[0586] 3601 a, b, a’, b’ - first track section (of shuttle guide track) 3602a, b, a’, b’ - second track section (of shuttle guide track) 3603a, b, a’, b’ - third track section (of shuttle guide track)

[0587] 3611 a,b - upper guide rail (of shuttle guide track)

[0588] 3612a, b - lower guide rail (of shuttle guide track)

[0589] 361 a,b,a’,b’,a”,b” - first stop element (of shuttle guide track) 362a,b,a’,b’,a”,b” - second stop element (of shuttle guide track) 363a, b, a’, b’ - third stop element (of shuttle guide track)

[0590] 380, 380’ - biasing member

[0591] 400, 400’ - button

[0592] 410, 410’ - hinge portion (of button)

[0593] 4101 - proximal end (of hinge portion)

[0594] 4102 - distal end (of hinge portion)

[0595] 420, 420’ - mount portion (of button)

[0596] 430, 430’ - actuation protrusion (of button)

[0597] 4301 , 4301 ’ - actuation surface (of button)

[0598] 4302 - button engagement element (of button)

[0599] 4303 - button recess (of button)

[0600] 451 a,b - first dose pins

[0601] 451 ’ - first dose pin

[0602] 452a, b - second dose pins

[0603] 452’ - second dose pin

[0604] 460 -actuation stop (of button)

[0605] 470 -actuation stop (of housing)

[0606] 500 - cap

[0607] 510 - cover portion (of cap

[0608] 520 - grip element (of cap)

[0609] 530 - cap engagement element

[0610] 532 - tab (of cap engagement element)

[0611] 540 - instructional marking (of cap)

[0612] 550a, b -housing engagement elements

[0613] 560a, b - shield engagement elements

[0614] 570 - window engagement elementAttorney Docket No.: 46567-1791 WO1

[0615] 610a,b,c,d - proximal biasing member support surfaces 620a,b,c,d - lateral biasing member guide surfaces

[0616] 700 - drive assembly

[0617] 710 - piston

[0618] 720 - plunger rod

[0619] 722 - piston engagement feature

[0620] 725 - cavity (of plunger rod)

[0621] 730 - plunger rod retaining arrangement

[0622] 770 - insertion ramp

[0623] 810 - first plunger arm

[0624] 820 - second plunger arm

[0625] 900a, b - slots

[0626] 920 - flexible elongate members

[0627] 1000, 1000’, 1000” - medicament delivery system

[0628] 3400 - method

[0629] 3410 - first method step

[0630] 3420 - second method step

Claims

Attorney Docket No.: 46567-1791 WO1Claims1. A medicament delivery device (100, 100’, 100”) comprising:a housing (110, 110’) configured to contain a medicament container (200, 200’); a button (400, 400’); anda plunger drive mechanism (300, 300’) comprising a plunger drive shuttle (320, 320’, 320”) and a biasing member (380, 380’) configured to bias the plunger drive shuttle in a distal direction (A1) relative to the housing;wherein the plunger drive shuttle is movable in the distal direction by the biasing member from an initial position relative to the housing to an intermediate position relative to the housing, to dispense a first dose of medicament (230, 230’) from the medicament container,wherein the plunger drive shuttle is movable in the distal direction by the biasing member from the intermediate position to a final position relative to the housing, to dispense a second dose of medicament from the medicament container,wherein a first actuation of the button relative to the housing deflects the plunger drive shuttle to cause the plunger drive shuttle to move from the initial position to the intermediate position to dispense the first dose of medicament, andwherein a second actuation of the button relative to the housing deflects the plunger drive shuttle to cause the plunger drive shuttle to move from the intermediate position to the final position to dispense the second dose of medicament.

2. The medicament delivery device according to any preceding claim, wherein the button comprises a first dose pin (451a, 451b, 45T, 451a’, 451b’), and a second dose pin (452a, 452b, 452’, 452a’, 452b’), wherein the button is arranged such that:the first actuation of the button relative to the housing causes the first dose pin to deflect the plunger drive shuttle such that the plunger drive shuttle moves from the initial position to the intermediate position, andthe second actuation of the button relative to the housing causes the second dose pin to deflect the plunger drive shuttle such that the plunger drive shuttle moves from the intermediate position to the final position.

3. The medicament delivery device according to claim 1 or 2, wherein the plunger drive mechanism comprises a drive shuttle hold arrangement (350, 350’) configured to releasably hold the plunger drive shuttle in the initial position and the intermediate position, wherein the button and the drive shuttle hold arrangement are configured such that:Attorney Docket No.: 46567-1791 WO1the first actuation of the button deflects the plunger drive shuttle to release the plunger drive shuttle from the drive shuttle hold arrangement, such that the plunger drive shuttle moves from the initial position to an intermediate position, andthe second actuation of the button deflects the plunger drive shuttle to releases the plunger drive shuttle from the drive shuttle hold arrangement, such that the plunger drive shuttle moves from the intermediate position to the final position.

4. The medicament delivery device according to claim 3, wherein the drive shuttle hold arrangement comprises:a first stop element (361 a, 361 b, 361 a’, 361 b’, 361 a”, 361 b”) configured to engage a holding member (330a, 330b, 330a’, 330b’) of the plunger drive shuttle when the plunger drive shuttle is in the initial position, to hold the plunger drive shuttle in the initial position; anda second stop element (362a, 362b, 362a’, 362b’, 362a”, 362b”) configured to engage the holding member of the plunger drive shuttle when the plunger drive shuttle is in the intermediate position, to hold the plunger drive shuttle in the intermediate position, wherein the holding member is configured to engage the first stop element and the second stop element sequentially.

5. The medicament delivery device according to claim 3 or 4, wherein the drive shuttle hold arrangement comprises a shuttle guide track (360a, 360b, 360a’, 360b’, 360a”, 360b”) for guiding the holding member as the plunger drive shuttle moves from the initial position to the intermediate position and from the intermediate position to the final position, wherein the shuttle guide track comprises the first stop element and the second stop element.

6. The medicament delivery device according to claim 4 or 5, wherein the holding member is arranged on an axially-extending shuttle arm (324a, 324b) of the plunger drive shuttle,wherein the first actuation deflects the shuttle arm to disengage the holding member from the first stop element, andwherein the second actuation deflects the shuttle arm to disengage the holding member from the second stop element.

7. The medicament delivery device according to claim 4 or 5, wherein the plunger drive shuttle comprises a plunger rod (720), a first plunger arm (810) extending from the plunger rod and a second plunger arm (820) extending from the plunger rod,wherein the second plunger arm comprises the holding member,Attorney Docket No.: 46567-1791 WO1wherein the first actuation causes the button to move the first plunger arm to rotate the plunger rod with a first rotation, andwherein the first rotation disengages the holding member from the first stop element such that the plunger drive shuttle moves from the initial position to the intermediate position.

8. The medicament delivery device according to claim 7, wherein the second actuation causes the button to move the first plunger arm to rotate the plunger rod with a second rotation, andwherein the second rotation disengages the holding member from the second stop element such that the plunger drive shuttle moves from the intermediate position to the final position.

9. The medicament delivery device according to claim 4 or 5, wherein the plunger drive shuttle comprises a plunger rod (720) and a first plunger arm (810) flexibly coupled to the plunger rod and extending radially from the plunger rod,wherein the first plunger arm comprises the holding member, andwherein first actuation causes the button to flex the first plunger arm relative to the plunger rod to disengage the holding member from the first stop element, such that the plunger drive shuttle moves from the initial position to the intermediate position, optionally wherein the second actuation causes the button to flex the first plunger arm relative to the plunger rod to disengage the holding member from the second stop element, such that the plunger drive shuttle moves from the intermediate position to the final position.

10. The medicament delivery device according to any of claims 4 to 9, wherein the button is configured such that the first actuation of the button deflects the plunger drive shuttle in a transverse direction (A2) that is substantially transverse to the distal direction, to disengage the holding member from the first stop element,optionally wherein the button is configured such that the second actuation of the button deflects the plunger drive shuttle in the transverse direction to disengage the holding member from the second stop element.

11. The medicament delivery device according to any preceding claim, further comprising a cap (500) that is removably coupled to the housing, wherein the cap comprises a cap engagement element (530) configured to:inhibit the first actuation and the second actuation of the button relative to the housing when the cap is coupled to the housing; andAttorney Docket No.: 46567-1791 WO1allow the first actuation and the second actuation of the button relative to the housing when the cap is uncoupled from the housing.

12. The medicament delivery device according to any preceding claim, wherein the biasing member comprises a spring arranged between the housing and the plunger drive shuttle and configured to apply a biasing force to the plunger drive shuttle, optionally wherein the spring is pretensioned.

13. The medicament delivery device according to any preceding claim, wherein the medicament delivery device is an intranasal medicament delivery device.

14. A medicament delivery system (1000) comprising:a medicament delivery device according to any of claims 1 to 13; anda medicament container (200), optionally wherein the medicament container contains a medicament (230), the medicament preferably being a vaccine.

15. A method (3400) of using a medicament delivery device according to any preceding claim, the method comprising:performing (3410) a first actuation of the button relative to the housing to cause the plunger drive shuttle to move from the initial position to the intermediate position to dispense the first dose of medicament.

16. The method according to claim 15, wherein the method is during a priming operation of the device and wherein the first dose of medicament is a first priming dose of medicament that is not administered to a patient.

17. The method according to claim 15 or 16, further comprising:subsequent to performing the first actuation, performing (3420) a second actuation of the button relative to the housing to cause the plunger drive shuttle to move from the intermediate position to the final position to dispense the second dose of medicament.

18. The method according to claim 17, wherein the method is during a priming operation of the device and wherein the second dose of medicament is a second priming dose of medicament that is not administered to a patient.

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