Devices and methods for delivering medicaments

Abstract

Systems and methods are provided for delivering a medicament. The medicament delivery device includes a base movably coupled to a housing, a case at least partially surrounding the base and the housing, an initialization assembly, an actuator assembly, a retraction assembly, and a medicament container assembly containing a medicament. The case is separated from the housing to initialize the medicament via the initialization assembly. The actuator assembly is then actuated by moving the base relative to the housing in a first direction to deliver the medicament. Following the delivery of the medicament, the retraction assembly is actuated by moving the base in a second direction relative to the housing.

Description

DEVICES AND METHODS FOR DELIVERING MEDICAMENTSCross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 664,144, entitled ’‘Devices and Methods for Delivering Reconstituted Medicaments,” filed June 25, 2024, which is incorporated herein by reference in its entirety.Statement Regarding Federally Sponsored Research or Development

[0002] This invention was made with government support under Other Transaction Authority for Prototype Agreement No. W911 SR2390013. The government has certain rights in the invention.Background

[0003] The embodiments described herein relate generally to a medicament delivery device for preparing a medicament and delivering the medicament into a body of a patient.

[0004] Exposure to certain substances, such as, for example, peanuts, shellfish, bee venom, certain drugs, toxins, and the like, can cause allergic reactions in some individuals. Such allergic reactions can, at times, lead to anaphylactic shock, which can cause a sharp drop in blood pressure, hives, and / or severe airway constriction. Accordingly, responding rapidly to mitigate the effects from such exposures can prevent injury and / or death. For example, in certain situations, an injection of epinephrine (i.e. , adrenaline) can provide substantial and / or complete relief from the allergic reaction. In other situations, for example, an injection of an antidote to a toxin can greatly reduce and / or eliminate the harm potentially caused by the exposure. Similarly, an injection of glucagon can reduce and / or eliminate the harm potentially caused by reduced blood glucose levels in individuals who suffer from diabetes.

[0005] Because emergency medical facilities are not always available when an individual is suffering from a medical condition, some individuals cany' an auto-injector to rapidly self-administer a medicament in response to such medical conditions. Some known auto-injectors include a vial containing a medicament in a deliverable state and a spring loaded needle to automatically penetrate the user’s skin and inject the medicament. The storage of certain medicaments in a deliverable state, however, can result in a shorter shelf life and / or anunstable medicament. Accordingly, some known auto-injectors include a vial containing a first medicament that is separated from a second medicament. Such auto-injectors are often referred to as ‘‘wet / dry” auto-injectors, because one medicament is often a liquid (e.g., water or another diluent) and the other medicament can be substantially solid or dry (e.g., glucagon powder). In use, the first medicament and the second medicament must be mixed prior to injection.

[0006] Some known wet / dry injectors, however, require that the user manually actuate a mixing mechanism prior to injection (e.g., by twisting a portion of the device to complete the mixing step). Such configurations can, however, result in incomplete mixing and / or an injection occurring without mixing. In addition, the operation of some known wet / dry delivery systems includes manually inserting the needle into the skin prior to activation and subsequent medicament delivery. The operation of such configurations may also include separately attaching a needle to prepare the device for injection, resulting in a delay in deli ven’ of the medicament. Moreover, such configurations can be complicated, making them difficult for a user to operate during an emergency situation or by an individual without medical training.

[0007] Some known injectors employ a single mechanism to automatically mix and inject the medicaments contained therein. Because the mixing operation is not independent from the injection operation in such configurations, however, the medicament can be injected prior to the completion of the mixing operation and / or prior to the injector being properly positioned for the injection operation.

[0008] Thus, a need exists for an improved auto-injector that can prepare and inject the medicaments in distinct operations.Summary

[0009] This summary introduces certain aspects of the embodiments described herein to provide a basic understanding. This summary is not an extensive overview' of the inventive subject matter, and it is not intended to identify key or critical elements or to delineate the scope of the inventive subject matter.

[0010] In some embodiments, the present disclosure is directed to an apparatus for preparing and delivering a medicament. The apparatus includes a housing and a medicament container assembly movably disposed within the housing. A positioning spring is disposed within the housing and operably coupled to the medicament container assembly. Aninitialization spring is also disposed within the housing and operably coupled to the medicament container assembly. The initialization spring is configured to produce an initialization force to initialize the medicament container assembly on a condition that the medicament container assembly is at a first container position. The positioning spring is configured to produce a positioning force to move the medicament container assembly within the housing from the first container position to a second container position following the initialization of the medicament container assembly. The positioning spring is configured to produce a first dispensing force that causes a first portion of a medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position. The initialization spring is configured to produce a second dispensing force that causes a second portion of the medicament within the medicament container assembly to be conveyed out of the medicament container assembly on the condition that the medicament container assembly is at the second container position.

[0011] In some embodiments, the apparatus includes an initialization assembly operably coupled to the medicament container assembly. The initialization assembly includes a rod carrier, a rod, and the initialization spring. The rod carrier is movable along a longitudinal housing axis in response to the positioning force and the first dispensing force. The rod carrier defines a bore sized to receive the initialization spring and at least a portion of the rod. The rod is movable along the longitudinal housing axis relative to the rod carrier in response to the initialization force and the second dispensing force. Movement of the rod in response to the initialization force initializes the medicament container assembly.

[0012] In some embodiments, the medicament container assembly includes a container body. The initialization assembly is positioned at least partially within a proximal end portion of the container body.

[0013] In some embodiments, the initialization spring is in a first compressed state having a first spring length prior to an initialization of the apparatus. The initialization spring is configured to transition from the first compressed state to a first extended state having a second spring length to produce the initialization force on a condition that an initialization assembly is in a released state. The initialization spring is configured to transition from the first extended state to a second compressed state having a third spring length in response to the movement ofthe medicament container assembly within the housing from the first container position to the second container position in response to the positioning force. The initialization spring is configured to transition from the second compressed state to a second extended state having a fourth spring length to produce the second dispensing force.

[0014] In some embodiments, the transition of the initialization spring from the first extended state to the second compressed state absorbs a shock load resulting from the movement of the medicament container assembly from the first container position to the second container position via the positioning force.

[0015] In some embodiments, the medicament container assembly includes a first elastomeric member, a second elastomeric member, and a third elastomeric member disposed within a container body. The first elastomeric member is disposed within a proximal end portion of the container body. The second elastomeric member is disposed between the first elastomeric member and the third elastomeric member and member is spaced apart from the first elastomeric member and the third elastomeric member. The third elastomeric member is disposed within a distal end portion of the container body and seals the distal end portion of the container body. The first elastomeric member, a first portion of the container body, and the second elastomeric member collectively define, at least in part, a first medicament containing portion containing a first substance on a condition that the medicament is in a stored state. The second elastomeric member, a second portion of the container body, and the third elastomeric member collectively define, at least in part, a second medicament containing portion containing a second substance on the condition that the medicament is in the stored state. The initialization force is configured to move the first elastomeric member toward the second elastomeric member within the container body to place the first substance in contact with the second substance to transition the medicament to a deliverable state. The first elastomeric member is at an initialized position defined by a compressibility of the medicament within the second medicament containing portion on a condition that the medicament is in the deliverable state. The compressibility of the medicament within the second medicament containing portion precluding a distal movement of the first elastomeric member on a condition that the distal end portion of the container body is sealed by the third elastomeric member.

[0016] In some embodiments, the first elastomeric member is configured to receive the positioning force on the condition that the distal end portion of the container body is sealed bythe third elastomeric member to move the medicament container assembly from the first container position to the second container position. The first elastomeric member is configured to receive the first dispensing force and the second dispensing force on the condition that the medicament container assembly is at the second container position and the second medicament containing portion is fluidically coupled to a needle through the third elastomeric member.

[0017] In some embodiments, the second substance is selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine, etanercept, exenatide, glucagon, haloperidol, hydroxyzine, insulin, ketorolac, lixisenatide, lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

[0018] In some embodiments, the apparatus includes a carrier movably disposed within the housing. The medicament container assembly includes a container body. The container body is slidably coupled to the carrier. The carrier is in a first carrier configuration on the condition that the medicament container assembly is at the first container position and the carrier is at a first carrier position. The container body is fixed relative to the carrier on a condition that the carrier is in the first carrier configuration. The container body and the carrier are configured to move in unison from the first container position and the first carrier position toward the second container position and a second carrier position in response to exertion of the positioning force on the medicament container assembly. The carrier is configured to transition to a second carrier configuration at the second carrier position. The container body is movable in a distal direction relative to the carrier in response to the positioning force on a condition that the earner is in the second carrier configuration.

[0019] In some embodiments, the distal movement of the container body relative to the carrier couples the container body to a needle supported by the carrier and positions the container body at the second container position.

[0020] In some embodiments, the carrier defines a needle hub. A needle is supported by the needle hub. A sealing member surrounds the needle hub. A distal end portion of the container body includes a neck. The sealing member is positioned within the neck on a condition that the container body and the carrier are at the first container position and the first carrier position. The sealing member is at least partially positioned proximal to the neck following the distal movement of the container body relative to the carrier.

[0021] In some embodiments, the carrier includes at least one container-release leg. The container-release leg(s) includes a container-engagement protrusion. The first carrier configuration includes a first position of the container-engagement protrusion. The second carrier configuration includes a second position of the container-engagement protrusion. The movement of the container body in the distal direction is precluded by the containerengagement protrusion at the first position.

[0022] In some embodiments, the container-engagement protrusion is at the first position on a condition that the container-release leg(s) is in a compressed configuration. The housing defines at least one carrier guide wall positioned to maintain the container-release leg(s) in the compressed configuration on a condition that the carrier is at the first carrier position. The container-engagement protrusion is at the second position on a condition that the containerrelease leg is in a released configuration. The carrier guide wall(s) is angled away from a longitudinal axis of the housing to facilitate a transition of the container-release leg(s) from the compressed configuration to the released configuration on a condition that the carrier is moved in a distal direction from the first carrier position to the second carrier position.

[0023] In some embodiments, the present disclosure is directed to an apparatus for preparing and delivering a medicament. The apparatus includes a housing and a medicament container assembly movably disposed within the housing. A base is movably coupled to the housing. The base is movable relative to the housing between a first base position and a second base position. A positioning spring is disposed within the housing. The positioning spring is configured at least to produce a positioning force to move the medicament container assembly from a first container position to a second container position on a condition that the base is moved from the first base position to the second base position. An initialization spring is also disposed within the housing. The initialization spring is configured to produce an initialization force and a dispensing force. The dispensing force causes at least a portion of a medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position. A base spring is positioned between the housing and the base. The base spring is configured to produce a base-return force to bias the base away from the housing toward the first base position. A retraction spring is disposed within the housing. The retraction spring is configured to produce a retraction force to move the medicament container assembly from thesecond container position to the first container position on a condition that the base is moved from the second base position toward the first base position in response to the base-return force.

[0024] In some embodiments, the initialization spring is axially aligned with a longitudinal axis of the medicament container assembly. The positioning spring and the retraction spring are parallel to the longitudinal axis of the medicament container assembly. The positioning spring is separated laterally from the initialization spring.

[0025] In some embodiments, the retraction spring is separated laterally from the initialization spring. The initialization spring is between the retraction spring and the positioning spring.

[0026] In some embodiments, the base spring is axially aligned with the retraction spring.

[0027] In some embodiments, the base spring is one of a coil spring or a leaf spring.

[0028] In some embodiments, the base spring is axially aligned with a longitudinal axis of the medicament container assembly.

[0029] In some embodiments, the base spring and the retraction spring are monolithically formed.

[0030] In some embodiments, the base spring defines an internal volume sized to receive a distal end portion of the housing. The base spring is positioned outside the housing and within the internal volume defined by the base. The retraction spring and the base spring are components of a retraction assembly configured to move the medicament container assembly from the second container position to the first container position following the delivery of a medicament from the medicament container assembly.

[0031] In some embodiments, the retraction assembly includes at least one blocking protrusion coupled to the base and extending longitudinally within the internal volume defined by the base. The blocking protrusion(s) is positioned to preclude an operable decoupling of the positioning spring from the medicament container assembly on a condition that the base is at the second base position.

[0032] In some embodiments, the apparatus includes an initialization assembly operably coupled to a proximal end portion of the medicament container assembly. The initialization assembly includes a rod carrier, a rod, and the initialization spring. The rod carrier is movable along a longitudinal housing axis in response to the positioning force. The rod carrier defines a bore sized to receive the initialization spring and at least a portion of the rod. The rod is movable along the longitudinal housing axis relative to the rod carrier in response to the initialization force and the dispensing force.

[0033] In some embodiments, the initialization spring is in a first compressed state having a first spring length prior to an initialization of the apparatus. The initialization spring is configured to transition from the first compressed state to a first extended state having a second spring length to produce the initialization force on a condition that an initialization assembly is in a released state. The initialization spring is configured to transition from the first extended state to a second compressed state having a third spring length in response to the movement of the medicament container assembly within the housing from the first container position to the second container position via the positioning force. The initialization spring is configured to transition from the second compressed state to a second extended state having a fourth spring length to produce the dispensing force.

[0034] In some embodiments, the transition of the initialization spring from the first extended state to the second compressed state absorbs a shock load resulting from the movement of the medicament container assembly from the first container position to the second container position via the positioning force.

[0035] In some embodiments, the positioning spring is configured to produce a first dispensing force that causes a first portion of the medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position. The dispensing force produced by the initialization spring is a second dispensing force and the portion of the medicament is a second portion of the medicament.

[0036] In some embodiments, the apparatus includes a carrier movably disposed within the housing and slidingly coupled to the medicament container assembly. The medicament container assembly is configured to transmit a portion of the positioning force to the carrier to move the carrier from a first carrier position to a second carrier position. The medicamentcontainer assembly is operably coupled to a needle extending at least partially beyond the base on a condition that the carrier is at the second carrier position and the medicament container assembly is at the second container position.

[0037] In some embodiments, the retraction spring is operably coupled between the housing and the carrier to move the carrier from the second carrier position to the first carrier position on a condition that the positioning spring is operably decoupled from the carrier and the medicament container assembly. The needle is positioned within the housing on a condition that the carrier is at the first carrier position.

[0038] In some embodiments, the present disclosure is directed to an apparatus for preparing and delivering a medicament. The apparatus includes a housing and a medicament container assembly disposed within the housing. The medicament container assembly is movable between a first container position and a second container position in which a container body of the medicament container assembly is coupled to a needle and a distal end portion of the needle is outside the housing. The apparatus includes a base movably coupled to the housing. The base is movable relative to the housing between a first base position and a second base position. The apparatus also includes a retraction assembly configured to position the distal end portion of the needle within the housing following a delivery of a medicament from the medicament container assembly. The retraction assembly includes a base spring positioned between the housing and the base. The base spring is configured to produce a base-return force to bias the base away from the housing toward the first base position. The retraction assembly also includes a retraction spring disposed within the housing. The retraction spring is configured to produce a retraction force to move the medicament container assembly from the second container position to the first container position on a condition that the base is moved from the second base position toward the first base position in response to the base-return force.

[0039] In some embodiments, the retraction assembly includes at least one blocking protrusion coupled to the base and extending longitudinally within an internal volume defined by the base. The blocking protrusion(s) is positioned to facilitate a decoupling of the medicament container assembly from a positioning force on a condition that the base is at the first base position following the delivery of the medicament.

[0040] In some embodiments, the positioning force is configured to bias the medicament container assembly toward the base. The retraction force is configured to bias the medicamentcontainer assembly away from the base. A magnitude of the positioning force is greater than a magnitude of the retraction force.

[0041] In some embodiments, the medicant delivery device includes a carrier movably disposed within the housing and slidingly coupled to the container. The retraction spring is operably coupled between the housing and the carrier to move the carrier from a second carrier position to a first carrier position on a condition that the base is at the first base position following the delivery of the medicament.

[0042] In some embodiments, the base spring is axially aligned with the retraction spring.

[0043] In some embodiments, the base spring is one of a coil spring or a leaf spring.

[0044] In some embodiments, the base spring is axially aligned with a longitudinal axis of the medicament container assembly.

[0045] In some embodiments, the base spring and the retraction spring are monolithically formed.

[0046] In some embodiments, the present disclosure is directed to a method for delivering a medicament via a medicament delivery apparatus. The apparatus includes a base movably coupled to a housing, a case at least partially surrounding the base and the housing, an initialization assembly, an actuator assembly, and a retraction assembly. The method includes applying a separation force to one of the case or an exposed portion of the housing to separate the housing and the case and transition the initialization assembly from a loaded state to a released state. The method also includes actuating the actuator assembly by causing a reduction in a separation distance between the base and the housing, actuating the actuator assembly transitions the medicament delivery apparatus to an actuated state and causes a medicament container assembly to move from a first container position to a second container position in which a container body of the medicament container assembly is coupled to a needle and a distal end portion of the needle is at least partially outside the housing. Additionally, the method includes actuating the retraction assembly by permitting the base to move relative to the housing in response to a base-return force from a base spring positioned between the housing and the base, the movement of the base reversing the reduction in the separation distance. Reversing the reduction of the separation distance permits the medicament containerassembly to return to the first container position in response to a retraction force produced by a retraction spring. The return of the medicament container assembly to the first container position positions the distal end portion of the needle within the housing. The method also includes following the return of the medicament container assembly to the first container position, coupling the medicament delivery apparatus to an article of clothing of a patient via a hook defined by the housing.

[0047] In some embodiments, the separation force is a longitudinal force.

[0048] In some embodiments, separating the housing and the case exposes a distal face of the base, and the distal face of the base is configured to contact a portion of a patient’s body.

[0049] In some embodiments, the method includes positioning the base against a portion of a patient’s body following the separation of the housing and the case.

[0050] In some embodiments, actuating the actuator assembly includes applying a longitudinal force to the housing to move the housing toward the base and the patient’s body.

[0051] In some embodiments, the method includes maintaining the reduction in the separation distance throughout the dispensing of the medicament from the medicament container assembly.

[0052] In some embodiments, permitting the base to move relative to the housing in response to the base-return force includes separating the medicament delivery apparatus from a portion of a patient’s body following a dispensing of the medicament.

[0053] In some embodiments, the apparatus includes a housing and a case shaped to receive the housing. The case is removable from the housing. The apparatus also includes an initialization assembly positioned within the housing and operably coupled to a medicament container. The initialization assembly is configured to transition a medicament within the medicament container from a stored state to a deliverable state. The apparatus also includes an initialization actuator assembly operably coupled to the initialization assembly to transition the initialization assembly from a loaded state to a released state. The initialization actuator assembly includes a release strap and a trigger protrusion. The release strap contains a first end portion removably coupled to the initialization assembly and a second end portion shapedto engage the trigger protrusion. The trigger protrusion is coupled to the case and positioned at least partially within the housing on a condition that the initialization assembly is in the loaded state.

[0054] In some embodiments, the case includes a wall portion surrounding a longitudinal case axis. The wall portion and a base portion define a cavity sized to receive a distal portion of the housing. The trigger protrusion extends from the base portion into the cavity.

[0055] In some embodiments, at least 50 percent of a surface area of the housing is surrounded by the wall portion on a condition that the housing is received by the case.

[0056] In some embodiments, the case and the housing have an absence of a removable safety’ lock.

[0057] In some embodiments, the case defines a longitudinal case axis. A longitudinal axis of the trigger protrusion has an angle relative to the longitudinal case axis on a range of one to five degrees.

[0058] In some embodiments, the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis. The second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth. The engagement tooth develops a first force vector component parallel to the longitudinal case axis and a second force vector component parallel to the lateral case axis relative to the engagement surface on a condition that a separation force is applied in a longitudinal direction to the case. A movement of the engagement tooth along the lateral case axis in response to the second force vector component is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at a first longitudinal position. On a condition that the second end portion of the release strap is moved to a second longitudinal position in response to the first force vector component, the engagement tooth moves along the lateral case axis in response to the second force vector component away from the second end portion of the release strap to disengage the trigger protrusion from the release strap.

[0059] In some embodiments, the trigger protrusion includes an engagement tooth extending along a lateral case axis. The lateral case axis is orthogonal to the longitudinal caseaxis. A distal face of the engagement tooth has an angle relative to the lateral case axis in a range of -0.5 to -2.0 degrees.

[0060] In some embodiments, the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth. The trigger protrusion has a length that establishes a separation distance between a distal face of the engagement tooth and the engagement surface of the engagement pocket on a condition that the housing is received within the case.

[0061] In some embodiments, a proximal portion of the trigger protrusion includes at least one guide facet extending parallel to a first lateral case axis. The guide facet(s) is positioned to engage a distal most face of the release strap to move the proximal portion of the trigger protrusion along a second lateral case axis during an assembly of the apparatus.

[0062] In some embodiments, the guide facet(s) is a first guide facet. The proximal portion of the trigger protrusion includes a second guide facet extending parallel to the second lateral case axis. The second guide facet is positioned to engage a trigger guide defined by the housing to move the proximal portion of the trigger protrusion along the first lateral case axis during the assembly of the apparatus.

[0063] In some embodiments, the trigger protrusion is tapered such that a proximal portion of the trigger protrusion has a length along a lateral case axis that is less than a length along the lateral case axis of a distal portion of the trigger protrusion.

[0064] In some embodiments, the release strap has a fixed length. The release strap has a set shape that is elastically deformable.

[0065] In some embodiments, the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto. The second end portion of the release strap is movable distally from a first longitudinal position to a second longitudinal position to move the first end portion of the release strap from a first lateral position to a second lateral position to transition the initialization assembly from the loaded state to a released state.

[0066] In some embodiments, a travel distance of the second end portion has a ratio of 1 : 1 to a travel distance of the first end portion.

[0067] In some embodiments, the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto. The release strap includes a middle portion between the first end portion and the second end portion. The release strap defines a force transfer plane extending parallel to the longitudinal housing axis. The second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

[0068] In some embodiments, the second end portion of the release strap includes a travellimit notch positioned between the engagement pocket and the middle portion of the release strap. The travel-limit notch is sized to receive a travel -limit protrusion of the housing.

[0069] In some embodiments, the engagement pocket includes an engagement surface. The engagement surface is a cylinder sector. The trigger protrusion includes an engagement tooth sized to be received by the engagement pocket. A distal face of the engagement tooth is a cylinder sector with a radius that corresponds to a radius of the engagement surface.

[0070] In some embodiments, the first end portion of the release strap is movable relative to the initialization assembly in a first lateral direction. The first end portion of the release strap includes a retention portion. The retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on the condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at a first lateral position. The retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion in a second lateral direction that is orthogonal to the first lateral direction. The retention portion includes a plurality of notches. The plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is at a second lateral position.

[0071] In some embodiments, the housing includes a curv ed guide surface and an arcuate guide surface. The curved guide surface and the arcuate guide surface at least partially define a curved guide path for the release strap.

[0072] In some embodiments, the curved guide surface is positioned proximally to the arcuate guide surface. The arcuate guide surface is positioned laterally between a first lateral portion of the curv ed guide surface and a second lateral portion of the curved guide surface.

[0073] In some embodiments, the curved guide surface defines a first radius of curvature of the curved guide path. The arcuate guide surface defines a second radius of curvature of the curved guide path. The second radius of curvature is in a range of 0.5 to 1.5 times the first radius of curvature.

[0074] In some embodiments, the initialization assembly includes a rod carrier, a rod, and a spring. The rod carrier is movable along a longitudinal housing axis. The rod carrier defines a bore sized to receive the spring and at least a portion of the rod. The rod is movable along the longitudinal housing axis relative to the rod carrier. The rod extends at least partially from the rod carrier on a condition that the initialization assembly is in a released state. The spring is in a compressed state on a condition that the initialization assembly is in the loaded state. A proximal portion of the rod includes a plurality of retention protrusions positioned to engage the first end portion of the release strap to preclude the movement of the rod relative to the rod carrier. The spring is in an extended state on a condition that the initialization assembly is in the released state.

[0075] In some embodiments, the apparatus includes a first elastomeric member disposed within a proximal end portion of the medicament container. The apparatus also includes a second elastomeric member disposed within the medicament container and spaced apart from the first elastomeric member. The first elastomeric member, a portion of the medicament container, and the second elastomeric member collectively define, at least in part, a first medicament containing portion containing a first substance on a condition that the medicament is in the stored state. The second elastomeric member and a distal end portion of the medicament container collectively define, at least in part, a second medicament containing portion containing a second substance on the condition that the medicament is in the stored state. The rod is configured to move the first elastomeric member toward the second elastomeric member on a condition that the case is separated from the housing to transition the initialization assembly to a released state. The movement of the first elastomeric member toward the second elastomeric member is configured to place the first substance in contact with the second substance to transition the medicament to the deliverable state.

[0076] In some embodiments, the second substance is selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine, etanercept, exenatide, glucagon, haloperidol, hydroxyzine,insulin, ketorolac, lixisenatide, lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

[0077] In some embodiments, the apparatus includes a housing including a curved guide surface and an arcuate guide surface. The apparatus also includes a release strap positioned within the housing, the release strap being movable within a curved guide path at least partially defined by the curved guide surface and the arcuate guide surface, the curved guide path having a first radius of curvature and a second radius of curvature of that is in a range of 0.5 to 1.5 times the first radius of curvature. The apparatus also includes a case shaped to receive a portion of the housing, the case being operably coupled to the release strap such that when the case is removed from the portion of housing the release strap is moved within the curved guide path to transition an initialization assembly positioned within the housing from a loaded state to a released state, the initialization assembly being configured to transition a medicament within the housing from a stored state to a deliverable state.

[0078] In some embodiments, the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto. The release strap has a first end portion removably coupled to the initialization assembly and a second end portion operably coupled to the case. The second end portion of the release strap is movable distally from a first longitudinal position to a second longitudinal position to move the first end portion of the release strap from a first lateral position to a second lateral position to transition the initialization assembly from the loaded state to a released state.

[0079] In some embodiments, the curved guide path defines a travel distance of the second end portion relative to a travel distance of the first end portion at a ratio of 1 : 1.

[0080] In some embodiments, the curved guide surface is positioned proximally to the arcuate guide surface. The arcuate guide surface is positioned laterally between a first lateral portion of the curved guide surface and a second lateral portion of the curved guide surface.

[0081] In some embodiments, the arcuate guide surface partially defines a retention hook of the housing.

[0082] In some embodiments, the release strap has a fixed length. The release strap has a set shape that is elastically deformable within the curved guide path.

[0083] In some embodiments, the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto. The release strap defines a force transfer plane extending parallel to the longitudinal housing axis. A second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

[0084] In some embodiments, the curved guide path is further defined by a travel-limit protrusion of the housing. The second end portion of the release strap includes a travel-limit notch positioned between the engagement pocket and a middle portion of the release strap. The travel-limit notch is sized to receive the travel-limit protrusion to limit a movement of the release strap within the curved guide path.

[0085] In some embodiments, the engagement pocket includes an engagement surface. The engagement surface is a cylinder sector shaped to receive an engagement tooth of a trigger protrusion coupled to the case.

[0086] In some embodiments, a first end portion of the release strap is movable within the curved guide path in a first lateral direction. The first end portion of the release strap includes a retention portion. The retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on a condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at a first lateral position. The retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion from the curved guide path. The retention portion includes a plurality of notches. The plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is at a second lateral position.

[0087] In some embodiments, the case includes a wall portion surrounding a longitudinal case axis. The wall portion and a base portion define a cavity sized to receive a distal portion of the housing. A trigger protrusion extends from the base portion into the cavity.

[0088] In some embodiments, at least 50 percent of a surface area of the housing is surrounded by the wall portion on a condition that the housing is received by the case.

[0089] In some embodiments, the case and the housing have an absence of a removable safety lock.

[0090] In some embodiments, a longitudinal axis of the trigger protrusion has an angle relative to the longitudinal case axis in a range of one to five degrees.

[0091] In some embodiments, the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis. A second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth. The engagement tooth develops a first vector component parallel to the longitudinal case axis and a second vector component parallel to the lateral case axis relative to the engagement surface on a condition that a separation force is applied to the case. A movement of the engagement tooth along the lateral case axis in response to the second vector component is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at a first longitudinal position. On a condition that the second end portion of the release strap is moved to a second longitudinal position in response to the first vector component, the engagement tooth moves along the lateral case axis in response to the second vector component away from the second end portion of the release strap to disengage the trigger protrusion from the release strap.

[0092] In some embodiments, the trigger protrusion includes an engagement tooth extending along a lateral case axis. The lateral case axis is orthogonal to the longitudinal case axis. A distal face of the engagement tooth has an angle relative to the lateral case axis in a range of -0.5 to -2.0 degrees.

[0093] In some embodiments, the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth. The trigger protrusion has a length that establishes a separation distance between a distal face of the engagement tooth and the engagement surface of the engagement pocket on a condition that the apparatus is in a stored state.

[0094] In some embodiments, a proximal portion of the trigger protrusion includes at least one guide facet extending parallel to a first lateral case axis. The guide facet(s) is positioned to engage a distal most face of the release strap to move the proximal portion of the trigger protrusion along a second lateral case axis during an assembly of the apparatus.

[0095] In some embodiments, the guide facet(s) is a first guide facet. The proximal portion of the trigger protrusion including a second guide facet extending parallel to the second lateral case axis. The second guide facet is positioned to engage a trigger guide defined by the housing to move the proximal portion of the trigger protrusion along the first lateral case axis during the assembly of the apparatus.

[0096] In some embodiments, the trigger protrusion is tapered such that a proximal portion of the trigger protrusion has a length along a lateral case axis that is less than a length along the lateral case axis of a distal portion of the trigger protrusion.

[0097] In some embodiments, the present disclosure is directed to a release strap of a medicament delivery apparatus. The release strap includes a first end portion removably coupled to an initialization assembly of the medicament delivery apparatus, the first end portion being shaped to preclude a transition of the initialization assembly from a loaded state to a released state on a condition that the first end portion is at a first lateral position within a housing of the medicament delivery apparatus. The release strap also includes a second end portion shaped to engage a trigger protrusion of a case of the medicament delivery apparatus.

[0098] In some embodiments, the release strap has a fixed length. The release strap has a set shape that is elastically deformable within a curved guide path defined by the housing.

[0099] In some embodiments, the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto. The release strap defines a force transfer plane extending parallel to the longitudinal housing axis. The second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

[0100] In some embodiments, the second end portion of the release strap includes a travellimit notch positioned between the engagement pocket and a middle portion of the release strap. The travel-limit notch is sized to receive a travel-limit protrusion of the housing.

[0101] In some embodiments, the engagement pocket includes an engagement surface. The engagement surface is a cylinder sector shaped to receive an engagement tooth of a trigger protrusion coupled to the case.

[0102] In some embodiments, the first end portion of the release strap includes a retention portion. The retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on the condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at the first lateral position. The retention portion includes a plurality of notches. The plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is moved from in a first lateral direction from the first lateral position to a second lateral position. The retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion in a second lateral direction orthogonal to the first lateral direction.

[0103] In some embodiments, a movement of the release strap within the housing is within a curved guide path. The housing includes a curved guide surface and an arcuate guide surface. The curved guide surface and the arcuate guide surface at least partially define the curved guide path for the release strap. The curved guide surface defines a first radius of curvature of the curved guide path. The arcuate guide surface defines a second radius of curvature of the curved guide path. The second radius of curvature is in a range of 0.5 to 1.5 times the first radius of curvature.

[0104] In some embodiments, the present disclosure is directed to an apparatus for a method for initializing a medicament delivery apparatus. The medicament delivery' apparatus includes a housing at least partially surrounded by a case, an initialization assembly positioned within the housing, and an initialization actuator assembly operably coupled to the initialization assembly. The initialization assembly includes a trigger protrusion of the case and a release strap. The method includes applying a first separation force to one of the case or an exposed portion of the housing to move the case a first distance relative to the housing, the movement of the case the first distance positioning the trigger protrusion in contact with a release strap. The method also includes applying a second separation force to one of the case or the exposed portion of the housing to move the case a second distance relative to the housing, a portion of the second separation force being transmitted to the release strap via the trigger protrusion, the portion of the second separation force causing the release strap to move within the housing to transition the initialization assembly from a loaded state to a released state. The method also includes separating the case from the housing.

[0105] In some embodiments, the movement of the case the first distance provides a haptic indication to an operator of the medicament delivery' apparatus. A position of the release strap within the housing is unaffected by the movement of the case the first distance.

[0106] In some embodiments, the second separation force has a magnitude in a range of between 0.9 kilograms and 2.3 kilograms.

[0107] In some embodiments, the movement of the release strap within the housing in response to the second separation force includes a movement of a first end portion of the release strap from a first lateral position to a lateral position, and a movement of a second end portion of the release strap from a first longitudinal position to a second longitudinal position.

[0108] In some embodiments, the portion of the second separation force transmitted to the release strap via the trigger protrusion includes a longitudinal force vector and a lateral force vector. The longitudinal force vector causes a movement of a portion of the release strap from a first longitudinal position to a second longitudinal position. The lateral force vector causes a separation of the trigger protrusion from the release strap on a condition that the second end portion is at the second longitudinal position.

[0109] In some embodiments, a longitudinal axis of the trigger protrusion has an angle relative to a longitudinal case axis in a range of one to five degrees.

[0110] In some embodiments, the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis. The second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth. The engagement tooth develops the longitudinal force vector parallel to the longitudinal case axis and the lateral force vector parallel to the lateral case axis relative to the engagement surface in response to the application of the second separation force. A movement of the engagement tooth along the lateral case axis in response to the lateral force vector is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at the first longitudinal position. The engagement tooth moves along the lateral case axis in response to the lateral force away from the second end portion of the release strap to disengage the trigger protrusion from the release strap as the second end portion is moved to the second longitudinal position.

[0111] In some embodiments, the housing defines a curved guide path. The movement of the release strap within the housing in response to the second separation force includes a movement within the curved guide path. The curved guide path defines a travel distance of a second end portion of the release strap relative to a travel distance of a first end portion of the release strap at a ratio of 1 : 1.

[0112] In some embodiments, the movement of the release strap within the curved guide path includes a movement along a curved guide surface defining a first radius of curvature and an arcuate guide surface defining a second radius of curvature that is in a range of 0.5 to 1.5 times the first radius of curvature.

[0113] In some embodiments, the movement of the release strap within the curved guide path has a travel length that is defined by a travel-limit protrusion of the housing that is received by a travel-limit notch of the release strap.

[0114] In some embodiments, the transition of the initialization assembly from the loaded state to the released state transitions a medicament within a medicament container within the housing from a stored state to a deliverable state.

[0115] In some embodiments, the initialization assembly includes a rod carrier, a rod, and a spring. The rod carrier is movable along a longitudinal housing axis. The rod carrier defines a bore sized to receive the spring and at least a portion of the rod. The rod is movable along the longitudinal housing axis relative to the rod carrier. The spring is in a compressed state on a condition that the initialization assembly is in the loaded state prior to the application of the second separation force. A proximal portion of the rod includes a plurality of retention protrusions positioned to engage a first end portion of the release strap to preclude the movement of the rod relative to the rod carrier prior to the application of the second separation force. The transition of the initialization assembly from the loaded state to the released state in response to the movement of the release strap causes the rod to extend at least partially from the rod carrier in response to a force applied by the spring.

[0116] In some embodiments, the medicament delivery apparatus includes a medicament container positioned within the housing, a first substance of a medicament positioned within the medicament container, a second substance of the medicament positioned within the medicament container, a first elastomeric member disposed within a proximal end portion ofthe medicament container, and a second elastomeric member disposed within the medicament container and spaced apart from the first elastomeric member, the second elastomeric member separating the first substance from the second substance on a condition that the medicament is in a stored state. The extension of the rod moves the first elastomeric member toward the second elastomeric member to place the first substance in contact with the second substance to transition the medicament to a deliverable state.

[0117] In some embodiments, the present disclosure is directed to an apparatus for preparing and delivering a medicament. The apparatus includes a housing that defines a positioning notch having an engagement surface. The apparatus also includes a rod carrier positioned within the housing. The rod carrier is movable from a first longitudinal position to a second longitudinal position on a condition that the apparatus is transitioned to an actuated state. The apparatus also includes an actuator assembly positioned at least partially within the housing. The actuator assembly is configured to transition the apparatus to the actuated state. The actuator assembly includes a positioning arm coupled to the rod carrier, a spring, a transfer arm operably coupled between the positioning arm and the spring, and an activator. An engagement between a latch protrusion of the positioning arm and the positioning notch maintains the rod carrier at the first longitudinal position prior to the transition of the apparatus to the actuated state. An angle of at least the engagement surface biases the latch protrusion out of the positioning notch. The activator is positioned at a first longitudinal position in contact with the positioning arm to maintain the engagement between the latch protrusion and the positioning notch prior to the transition of the apparatus to the actuated state. The activator is movable to a second longitudinal position apart from the positioning arm to allow the apparatus to transition to the actuated state.

[0118] In some embodiments, the housing defines an axial midline extending longitudinally between a proximal end portion of the housing and a distal end portion of the housing. The housing defines an actuator-assembly guide wall that extends longitudinally between the positioning arm and the spring. The actuator-assembly guide wall defines the positioning notch. An opening of the positioning notch is oriented toward the axial midline.

[0119] In some embodiments, the latch protrusion is biased in a lateral direction toward the axial midline and away from the spring.

[0120] In some embodiments, a force transfer from the spring to the positioning arm via the transfer arm develops a lateral force vector acting on the latch protrusion. The lateral force vector is oriented toward the axial midline and away from the positioning notch. The lateral force vector is countered by the activator at the first longitudinal position.

[0121] In some embodiments, the angle of the engagement surface is in a range of 100 degrees to 150 degrees relative to the actuator-assembly guide wall.

[0122] In some embodiments, the latch protrusion includes a distal face. The distal face is positioned to contact the engagement surface on a condition that the latch protrusion is received by the positioning notch. The distal face is positioned at an angle in a range of 60 degrees to 80 degrees relative to the axial midline.

[0123] In some embodiments, the positioning arm includes a receiving portion and a latch arm. The receiving portion is configured to receive a force transferred from the spring via the transfer arm. The latch arm extends distally from the receiving portion. The latch protrusion extends from a distal end portion of the latch arm.

[0124] In some embodiments, the latch arm has a width that is in a range of 10 percent to 20 percent of a width of the receiving portion.

[0125] In some embodiments, the latch arm is in a neutral posture on a condition that the latch protrusion is received by the positioning notch. The latch arm is in a flexed posture on a condition that the apparatus is in the actuated state. A transition from the neutral posture to the flexed posture moves the latch protrusion toward an axial midline defined by the housing.

[0126] In some embodiments, the latch protrusion has a thickness that is greater than a thickness of the latch arm. A radially outer portion of the latch protrusion is shaped to be received by the positioning notch. A radially inner portion of the latch protrusion is shaped to contact the activator on a condition that the activator is at the first longitudinal position.

[0127] In some embodiments, a proximal face of the radially inner portion has an angle in a range of 110 degrees to 130 degrees relative to the latch arm. The proximal face is positioned to engage the activator on the condition that the activator is at the first longitudinal position. The engagement between the proximal face and the activator facilitates the maintenance of theengagement between the latch protrusion and the positioning notch prior to the transition of the apparatus to the actuated state.

[0128] In some embodiments, a proximal end portion of the positioning arm defines a coupling location with the rod carrier. The positioning arm extends in a distal direction from the coupling location.

[0129] In some embodiments, the positioning arm and the rod carrier are monolithically formed.

[0130] In some embodiments, a proximal end portion of the activator includes a holding face positioned to contact a radially inner portion of the latch protrusion on a condition that the activator is at the first longitudinal position. The holding face has an angle in a range of two degrees to 6 degrees relative to a longitudinal axis of the activator.

[0131] In some embodiments, the proximal end portion includes a proximal guide facet. The proximal guide facet facilitates a positioning of the activator during assembly of the apparatus. The proximal guide facet maintains a clearance between the activator and the positioning arm on a condition that the activator is at the second longitudinal position.

[0132] In some embodiments, the activator defines a channel that extends distally from the proximal end portion. The channel has a depth sized to receive the latch protrusion on a condition that the activator is at the second longitudinal position.

[0133] In some embodiments, the depth of the channel defines a clearance relative to an actuator-assembly guide wall of the housing. The clearance is in a range of 105 percent to 125 percent of a thickness of the latch protrusion.

[0134] In some embodiments, the apparatus includes a base defining an internal volume sized to receive a distal end portion of the housing. A distal end portion of the activator is coupled to the base within the internal volume. The activator extends in a longitudinal direction from the base into the housing. The base is movable relative to the housing to move the activator from the first longitudinal position to the second longitudinal position to transition the apparatus to the actuated state.

[0135] In some embodiments, the base and the activator are monolithically formed.

[0136] In some embodiments, the base is configured to move proximally relative to the housing to transition the apparatus to the actuated state. The second longitudinal position of the activator is proximal to the first longitudinal position of the activator.

[0137] In some embodiments, a proximal end portion of the activator has a first thickness that is greater than a second thickness that extends distally from the first thickness. The first thickness is positioned to contact a radially inner portion of the latch protrusion to maintain the engagement between the latch protrusion of the positioning arm and the positioning notch prior to the transition of the apparatus to the actuated state. The base is configured to move proximally relative to the housing to move the first thickness proximally aw ay from the radially inner portion of the latch protrusion to transition the apparatus to the actuated state.

[0138] In some embodiments, the transfer arm includes a first end portion and a second end portion. The first end portion is configured to be received by the positioning arm. The second end portion is configured to receive a force from the spring.

[0139] In some embodiments, the transfer arm includes a guide rod extending from the second end portion. The guide rod is sized to be received within the spring.

[0140] In some embodiments, the second end portion includes a plurality of guide protrusions positioned to engage the housing. The guide rod defines a longitudinal axis of the transfer arm. The engagement between the plurality of guide protrusions and the housing precludes a rotation of the transfer arm about the longitudinal axis while facilitating an axial movement of the transfer arm along the longitudinal axis.

[0141] In some embodiments, the first end portion is separated from the second end portion by a bendable portion. The bendable portion extends radially from the second end portion toward an axial midline of the apparatus defined by the housing. The bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion. The bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees.

[0142] In some embodiments, the first end portion includes a transfer latch sized to be received by a receiving notch defined by the positioning arm. A radially inner face of thetransfer latch forms a blended angle with a radially inner face of the bendable portion that is in a range of 165 degrees to 175 degrees.

[0143] In some embodiments, the transfer latch has a lateral width that is in a range of 1 .5 to 2.0 times a lateral width of the bendable portion. A portion of the lateral width of the transfer latch extends laterally beyond a first lateral face of the bendable portion and beyond a second lateral face of the bendable portion opposite the first lateral face.

[0144] In some embodiments, the transfer latch includes a distal face. The distal face has an angle relative to a longitudinal axis of the transfer arm in a range of 80 degrees to 85 degrees.

[0145] In some embodiments, the positioning arm defines a receiving notch. The receiving notch is sized to receive a transfer latch of the transfer arm.

[0146] In some embodiments, the receiving notch is defined in part by a first receiving protrusion and a second receiving protrusion. The first receiving protrusion is separated from the second receiving protrusion in a lateral direction.

[0147] In some embodiments, the first receiving protrusion has a proximal surface. The proximal surface of the first receiving protrusion has an angle relative to an axial midline of the apparatus that is in a range of 90.5 degrees to 93 degrees.

[0148] In some embodiments, the apparatus includes a medicament container positioned within the housing coaxially with an axial midline of the apparatus. The medicament container contains a medicament. The apparatus also includes a rod carrier. The rod carrier is coupled to a proximal end portion of the medicament container. The medicament container is movable within the housing from a first longitudinal container position to a second longitudinal container position in response to a force transferred from the spring to the rod carrier via the transfer arm on the actuation of the apparatus. The medicament container is configured to dispense the medicament in the second longitudinal container position.

[0149] In some embodiments, the movement of the medicament container places the medicament in fluid communication with a needle. The force transferred from the spring is an injection force.

[0150] In some embodiments, the transfer arm is decoupled from the rod carrier on a condition that the rod carrier is at the second longitudinal container position. The medicament container is retracted to the first longitudinal container position via a retraction force applied by a retraction spring on a condition that the transfer arm is decoupled from the rod carrier.

[0151] In some embodiments, the housing defines an actuator-assembly guide wall that is between the positioning arm and the spring. The actuator-assembly guide wall is positioned to contact a transfer latch of the transfer arm to fix a position of the transfer latch relative to the positioning arm during a movement of the rod carrier from the first longitudinal position to the second longitudinal position. The actuator-assembly guide wall defines at least in part a release passage sized to permit the transit of the transfer latch on the condition that the rod carrier is at the second longitudinal position. The transit of the transfer latch at least partially through the release passage decouples the transfer arm from the rod carrier.

[0152] In some embodiments, the apparatus includes a base defining an internal volume sized to receive a distal end portion of the housing. The base is movable longitudinally relative to the housing between a first base position and a second base position. The base includes at least one blocking protrusion extending longitudinally within the internal volume. The second base position is proximal to the first base position. A proximal end portion of the blocking protrusion(s) occludes the release passage on a condition that the base is at the second base position. The proximal end portion is positioned distal to the release passage on a condition that the base is at the first base position.

[0153] In some embodiments, a force applied by the spring on the transfer arm develops a longitudinal force vector and a lateral force vector acting on the transfer latch. The transfer latch is moved radially away from the axial midline in response to the lateral force vector on a condition that the transfer latch is longitudinally aligned with the release passage and the base is at the first base position.

[0154] In some embodiments, the present disclosure is directed to an apparatus for preparing and delivering a medicament. The apparatus includes a housing and a medicament container assembly disposed within the housing. The medicament container assembly includes a container body and an elastomeric member disposed within the container body. An axial centerline of the container body is coaxial with an axial midline of the housing. The apparatus also includes a spring of an actuator assembly positioned within the housing. The spring isconfigured to move the container body from a proximal position to a distal position within the housing on a condition that the apparatus is transitioned to an actuated state. An axial centerline of the spring is separated from the axial centerline of the container body. The apparatus also includes a transfer arm of the actuator assembly operably coupled between the spring and the medicament container assembly. The transfer arm is configured to transfer a force from the spring to move the container body in a distal direction on a condition that the transfer arm is in a first configuration at a proximal position within the housing. The transfer arm is configured to preclude the transfer of the force from the spring to the container body on a condition that the transfer arm is in a second configuration at a distal position within the housing.

[0155] In some embodiments, the housing defines an actuator-assembly guide wall that is positioned between the container body and the spring. The actuator-assembly guide wall is positioned to maintain the transfer arm in the first configuration during a movement of the transfer arm from the proximal position within the housing to the distal position within the housing.

[0156] In some embodiments, the actuator-assembly guide wall defines at least in part a release passage sized to permit the transit of a portion of the transfer arm in a direction radially away from the axial midline of the container body to transition the transfer arm from the first configuration to the second configuration on a condition that the transfer arm is at the distal position within the housing.

[0157] In some embodiments, the apparatus includes a base defining an internal volume sized to receive a distal end portion of the housing. The base is movable longitudinally relative to the housing between a first base position and a second base position. The base includes at least one blocking protrusion extending longitudinally within the internal volume. The second base position is proximal to the first base position. A proximal end portion of the blocking protrusion(s) occludes the release passage on a condition that the base is at the second base position. The transfer arm is maintained in the first configuration on a condition that the blocking protrusion(s) includes the release passage. The proximal end portion is positioned distal to the release passage on a condition that the base is at the first base position.

[0158] In some embodiments, the actuator assembly includes a positioning arm operably coupled between the transfer arm and the container body. A first end portion of the transfer arm includes a transfer latch. The transfer latch is received by a receiving notch definedpositioning arm on a condition that the transfer arm is in the first configuration. A force applied by the spring on the transfer arm develops a longitudinal force vector and a lateral force vector acting on the transfer latch. The transfer latch is moved radially away from the axial midline of the container body in response to the lateral force vector on a condition that the transfer latch is longitudinally aligned with the release passage and the base is at the first base position.

[0159] In some embodiments, the apparatus includes a rod carrier positioned within the housing and coupled to a proximal portion of the container body. The rod carrier is operably positioned between the transfer arm and the container body.

[0160] In some embodiments, the actuator assembly includes a positioning arm coupled to the rod carrier. A first end portion of the transfer arm is removably coupled to the positioning arm on the condition that the transfer arm is in the first configuration.

[0161] In some embodiments, the transfer arm includes a second end portion separated from the first end portion by a bendable portion. The bendable portion extends radially from the second end portion toward the axial midline of the container body. The bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion. The bendable portion is in a deflected pose relative to the second end portion on the condition that the transfer arm is in the second configuration.

[0162] In some embodiments, the transfer arm includes a guide rod extending from the second end portion. The guide rod is sized to be received within the spring. The guide rod defines a longitudinal axis of the transfer arm. The bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees on the condition that the transfer arm is in the first configuration.

[0163] In some embodiments, the present disclosure is directed to an actuator assembly for a medicament delivery' device. The actuator assembly includes a spring having a first length on a condition that the actuator assembly is in a ready configuration and a second length that is greater than the first length on a condition that the actuator assembly is in an actuated configuration. The actuator assembly also includes a positioning arm operably coupled to a container body of a medicament container assembly within a housing of the medicament delivery device. The positioning arm is configured to maintain the container body' at a first longitudinal container position on the condition that the actuator assembly is in the readyconfiguration. The actuator assembly also includes a transfer arm operably coupled between the positioning arm and the spring. The transfer arm is configured to transfer a force from the spring to the positioning arm to move in a distal direction the container body within the housing on the condition that the actuator assembly is in the actuated configuration. The actuator assembly also includes an activator. The activator is positioned at a first longitudinal position in contact with the positioning arm to preclude a movement of the positioning arm on the condition that the actuator assembly is in the ready configuration. The activator is movable to a second longitudinal position to transition the actuator assembly to the actuated configuration.

[0164] In some embodiments, the housing defines a positioning notch. An engagement between a latch protrusion of the positioning arm and the positioning notch maintains the container body at the first longitudinal container position prior to the transition of the actuator assembly to the actuated configuration.

[0165] In some embodiments, the latch protrusion is biased in a lateral direction toward an axial midline of the container body and away from the spring.

[0166] In some embodiments, a force transfer from the spring to the positioning arm via the transfer arm develops a lateral force vector acting on the latch protrusion. The lateral force vector is oriented toward an axial midline of the container body and away from the positioning notch. The lateral force vector is countered by the activator at the first longitudinal position.

[0167] In some embodiments, the latch protrusion includes a distal face. The distal face is positioned to contact an engagement surface of the positioning notch on a condition that the latch protrusion is received by the positioning notch. The distal face is positioned at an angle in a range of 60 degrees to 80 degrees relative to an axial midline of the container body.

[0168] In some embodiments, the positioning arm includes a receiving portion and a latch arm. The receiving portion is configured to receive a force transferred from the spring via the transfer arm. The latch arm extends distally from the receiving portion. A latch protrusion extends from a distal end portion of the latch arm.

[0169] In some embodiments, the latch arm has a width that is in a range of 10 percent to 20 percent of a width of the receiving portion.

[0170] In some embodiments, the latch arm is in a neutral posture on a condition that the latch protrusion is received by a positioning notch of the positioning arm. The latch arm is in a flexed posture on a condition that the actuator assembly is in the actuated configuration. A transition from the neutral posture to the flexed posture moves the latch protrusion toward an axial midline defined by the container body.

[0171] In some embodiments, the latch protrusion has a thickness that is greater than a thickness of the latch arm. A radially outer portion of the latch protrusion is shaped to be received by a positioning notch of the positioning arm. A radially inner portion of the latch protrusion is shaped to contact the activator on a condition that the activator is at the first longitudinal position.

[0172] In some embodiments, a proximal face of the radially inner portion has an angle in a range of 110 degrees to 130 degrees relative to the latch arm. The proximal face is positioned to engage the activator on the condition that the activator is at the first longitudinal position. The engagement between the proximal face and the activator facilitates the maintenance of the engagement between the latch protrusion and the positioning notch prior to the transition of the actuator assembly to the actuated configuration.

[0173] In some embodiments, a rod carrier is coupled to a proximal end portion of the container body. A proximal end portion of the positioning arm defines a coupling location with the rod carrier. The positioning arm extends in a distal direction from the coupling location.

[0174] In some embodiments, a proximal end portion of the activator includes a holding face positioned to contact a radially inner portion of a latch protrusion of the positioning arm on a condition that the activator is at the first longitudinal position. The holding face has an angle in a range of two degrees to 6 degrees relative to a longitudinal axis of the activator.

[0175] In some embodiments, the activator defines a channel that extends distally from the proximal end portion. The channel has a depth sized to receive the latch protrusion on a condition that the activator is at the second longitudinal position.

[0176] In some embodiments, the apparatus includes a distal end portion of the activators coupled to a base within an internal volume defined by the base. The internal volume is sizedto receive a distal end portion of the housing. The activator extends in a longitudinal direction from the base into the housing. The base is movable relative to the housing to move the activator from the first longitudinal position to the second longitudinal position to transition the actuator assembly to the actuated configuration.

[0177] In some embodiments, a proximal end portion of the activator has a first thickness that is greater than a second thickness that extends distally from the first thickness. The first thickness is positioned to contact the radially inner portion of the latch protrusion to maintain an engagement between the latch protrusion of the positioning arm and a positioning notch of the housing prior to the transition of the actuator assembly to the actuated configuration. The base is configured to move proximally relative to the housing to move the first thickness proximally away from the radially inner portion of the latch protrusion to transition the actuator assembly to the actuated configuration.

[0178] In some embodiments, the transfer arm includes a first end portion and a second end portion. The first end portion is configured to be received by the positioning arm. The second end portion is configured to receive a force from the spring.

[0179] In some embodiments, the transfer arm includes a guide rod extending from the second end portion. The guide rod is sized to be received within the spring.

[0180] In some embodiments, the second end portion includes a plurality of guide protrusions positioned to engage the housing. The guide rod defines a longitudinal axis of the transfer arm. The engagement between the plurality of guide protrusions and the housing precludes a rotation of the transfer arm about the longitudinal axis while facilitating an axial movement of the transfer arm along the longitudinal axis.

[0181] In some embodiments, the first end portion is separated from the second end portion by a bendable portion. The bendable portion extends radially from the second end portion toward an axial midline of the container body defined by the housing. The bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion. The bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees.

[0182] In some embodiments, the first end portion includes a transfer latch sized to be received by a receiving notch defined by the positioning arm. A radially inner face of the transfer latch forms a blended angle with a radially inner face of the bendable portion that is in a range of 165 degrees to 175 degrees.

[0183] In some embodiments, the transfer latch has a lateral width that is in a range of 1.5 to 2.0 times a lateral width of the bendable portion. A portion of the lateral width of the transfer latch extends laterally beyond a first lateral face of the bendable portion and beyond a second lateral face of the bendable portion opposite the first lateral face.

[0184] In some embodiments, the transfer latch includes a distal face. The distal face has an angle relative to a longitudinal axis of the transfer arm in a range of 80 degrees to 85 degrees.

[0185] In some embodiments, the positioning arm defines a receiving notch. The receiving notch is sized to receive a transfer latch of the transfer arm.

[0186] In some embodiments, the receiving notch is defined in part by a first receiving protrusion and a second receiving protrusion. The first receiving protrusion is separated from the second receiving protrusion in a lateral direction.

[0187] In some embodiments, the first receiving protrusion has a proximal surface. The proximal surface of the first receiving protrusion has an angle relative to an axial midline of the container body that is in a range of 90.5 degrees to 93 degrees.Brief Description of the Drawings

[0188] FIG. 1 is a schematic illustration of a medicament delivery device according to an embodiment in a stored state.

[0189] FIG. 2 is a schematic illustration of the medicament delivery device of FIG. 1 in an initialized state.

[0190] FIG. 3 is a schematic illustration of the medicament delivery device of FIG. 1 in an actuated state.

[0191] FIG. 4 is a schematic illustration of the medicament delivery device of FIG. 1 in a delivery state.

[0192] FIG. 5 is a schematic illustration of the medicament delivery device of FIG. 1 in a retracted state.

[0193] FIG. 6 is a schematic illustration of a medicament delivery device according to an embodiment in a stored state.

[0194] FIG. 7 is a schematic illustration of the medicament delivery device of FIG. 6 in an intermediate state.

[0195] FIG. 8 is a schematic illustration of the medicament delivers’ device of FIG. 6 in another intermediate state.

[0196] FIG. 9 is a schematic illustration of the medicament delivers’ device of FIG. 6 in an initialized state.

[0197] FIG. 10 is a schematic illustration of a medicament delivery device prior to actuation according to an embodiment.

[0198] FIG. 11 is a schematic illustration of the medicament delivery device of FIG. 10 in an actuated state.

[0199] FIG. 12 is a perspective view of a medicament delivery device according to an embodiment in a stored state.

[0200] FIG. 13 is an exploded view of the medicament deliver}' device of FIG. 12.

[0201] FIG. 14 is a partial perspective view the medicament delivery device of FIG. 12 with a case and a portion of the housing removed depicting the medicament delivery device in a stored state.

[0202] FIG. 15 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x, with the medicament delivery device being in a stored state.

[0203] FIG. 16 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x, with the medicament delivery device being in an intermediate state.

[0204] FIG. 17 is a perspective view of the medicament delivery device of FIG. 12 with the case separated from the housing.

[0205] FIG. 18 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case to transition an initialization assembly from a loaded state to a released state.

[0206] FIG. 19 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting an initiation of transition a medicament within a medicament container from a stored state to a deliverable state.

[0207] FIG. 20 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting the medicament delivery device in an initialized state.

[0208] FIG. 21 is a front view of the medicament delivery device of FIG. 12 follow ing the removal of the case and depicting the medicament delivery device in an actuated state.

[0209] FIG. 22 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting the medicament delivery device in the actuated state.

[0210] FIG. 23 is a front view of the medicament delivery device of FIG. 12 following the removal of the case and depicting the medicament delivery device in a delivery7state.

[0211] FIG. 24 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting the medicament delivery device in the delivery' state.

[0212] FIG. 25 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting the medicament delivery device in the delivery state following the delivery of the medicament.

[0213] FIG. 26 is a front view of the medicament delivery device of FIG. 12 following the removal of the case and depicting the medicament delivery device in a retracted state.

[0214] FIG. 27 is a cross-sectional view of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting the medicament delivery device in the retracted state.

[0215] FIG. 28 is a perspective view of a portion of the medicament delivery device of FIG. 12 in the stored state with the case and the housing removed for clarity.

[0216] FIG. 29 is a front view of the portion of the medicament delivery device of FIG. 28.

[0217] FIG. 30 is a rear view of the portion of the medicament delivery device of FIG. 28.

[0218] FIG. 31 is a perspective view of an initialization assembly of the medicament deliver}' device of FIG. 13 in a loaded state according to an embodiment.

[0219] FIG. 32 is a cross-sectional view of the initialization assembly of FIG. 31 taken at line xi-xi.

[0220] FIG. 33 is an exploded view of the initialization assembly of FIG 31.

[0221] FIG. 34 is a cross-sectional view of a rod carrier of the initialization assembly of FIG. 31 taken at line xi-xi.

[0222] FIG. 35 is a cross-sectional view of the initialization assembly of FIG. 31 with a release strap coupled thereto taken at line xi-xi.

[0223] FIG. 36 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 15.

[0224] FIG. 37 is a cross-sectional view of a portion of the medicament delivery device of FIG. 12 taken at line X2-X2.

[0225] FIG. 38 is a cross-sectional view of the case of FIG. 17 taken at line xa-xs

[0226] FIG. 39 is a cross-sectional view of the case of FIG. 17 taken at line X4-X4.

[0227] FIG. 40 is an enlarged view of a trigger protrusion of an initialization actuator assembly according to an embodiment.

[0228] FIG. 41 is a perspective view of a release strap of an initialization actuator assembly according to an embodiment.

[0229] FIG. 42 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 15.

[0230] FIG. 43 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 15 taken at line xs-xs of FIG. 12.

[0231] FIG. 44 is a rear perspective view of an external face of a housing portion of FIG. 13.

[0232] FIG. 45 is a front view of an internal face of the housing portion of FIG. 44.

[0233] FIG. 46 is a perspective view of the internal face of the housing portion of FIG. 44.

[0234] FIG. 47 is a front perspective view of an external face of a housing portion ofFIG. 13.

[0235] FIG. 48 is a rear view of an internal face of the housing portion of FIG. 47.

[0236] FIG. 49 is a perspective view of the internal face of the housing portion of FIG. 47.

[0237] FIG. 50 is a bottom perspective view of the medicament delivery device of FIG. 12 with the case and a base removed.

[0238] FIG. 51 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 16.

[0239] FIG. 52 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 16.

[0240] FIG. 53 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 16 taken at line xs-xs of FIG. 12.

[0241] FIG. 54 is a simplified, enlarged cross-sectional view of a portion of the medicament delivery' device of FIG. 16.

[0242] FIG. 55 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 16 following the separation of the case from the housing.

[0243] FIG. 56 is a cross-sectional view taken at line X2-X2 of FIG. 12 of a portion of the medicament delivery' device of FIG. 16 following the initiation of a case separation but before the case is fully separated from the housing.

[0244] FIG. 57 is a perspective view of an initialization assembly of FIG. 31 with the release strap of FIG. 41 operably coupled thereto in a released state according to an embodiment.

[0245] FIG. 58 is a cross-sectional view of the initialization assembly of FIG. 57 taken at line xe-xe.

[0246] FIG. 59 is a perspective view of initialization assembly of FIG. 57 in the released state and coupled to a medicament container assembly of the medicament delivery device of FIG. 13.

[0247] FIG. 60 is a front perspective view of an actuator assembly’ of the medicament delivery device of FIG. 13 prior to actuation according to an embodiment.

[0248] FIG. 61 is a front view of the actuator assembly of FIG. 60.

[0249] FIG. 62 is a side view of the actuator assembly of FIG. 60.

[0250] FIG. 63 is a rear perspective view of the actuator assembly of FIG. 60 with a spring removed for clarity.

[0251] FIG. 64 is an enlarged portion of the actuator assembly of FIG. 63 prior to actuation of the medicament delivery device.

[0252] FIGS 65A-65C are simplified cross-sectional views of the medicament delivery device of FIG. 13 depicting a transition of the medicament delivery device to an actuated state.

[0253] FIG. 66 is a side view of a positioning notch of the actuator assembly of FIG. 61 .

[0254] FIG. 67 is an enlarged cross-sectional view of a portion of the housing of FIG. 45.

[0255] FIG. 68 is a rear perspective view of an activator of the actuator assembly of FIG. 60 and a base of the medicament delivery device of FIG. 13.

[0256] FIG. 69 is a rear perspective view of an activator of the actuator assembly ofFIG. 60 and a base of the medicament delivery device of FIG. 13.

[0257] FIG. 70 is a perspective view of a transfer arm of the actuator assembly of FIG. 60.

[0258] FIG. 71 is a side view of the transfer arm of FIG. 70.

[0259] FIG. 72 is a top view of the transfer arm of FIG. 70.

[0260] FIG. 73 is an enlarged front view of a portion of the transfer arm of FIG. 70.

[0261] FIG. 74 is a cross-sectional view of the transfer arm and spring of the actuator assembly of FIG. 60.

[0262] FIG. 75 is an enlarged portion of the actuator assembly of FIG. 63 upon actuation of the medicament delivery device.

[0263] FIG. 76 is a front perspective view of a portion of the internal components of the medicament delivery device of FIG. 13 in a deliver}' state according to an embodiment.

[0264] FIG. 77 is a rear perspective view of a portion of the internal components of FIG. 76.

[0265] FIG. 78 is an enlarged rear perspective view of a portion of the internal components of the medicament delivery device of FIG. 13 upon the initiation of a transition for a deli venstate to a retracted state according to an embodiment.

[0266] FIG. 79 is a rear perspective view of a portion of the internal components of the medicament delivery device of FIG. 13 in the retracted state with the positioning spring being operably decoupled from the rod carrier according to an embodiment.

[0267] FIG. 80A is a simplified enlarged perspective view of a portion of the medicament delivery device of FIG. 13 in the delivery state.

[0268] FIG. 80B is a simplified enlarged perspective view of a portion of the medicament delivery device of FIG. 13 depicting a transition to the retracted state.

[0269] FIG. 81 is an enlarged cross-sectional view of a portion of the medicament delivery device of FIG. 12 taken at line x-x following the removal of the case and depicting a transition of the medicament delivery device from a delivery state to a retracted state.

[0270] FIG. 82 is a front view of a medicament container assembly of the medicament delivery device of FIG. 13 in a first configuration according to an embodiment.

[0271] FIG. 83 is a front view of the medicament container assembly of FIG. 82 in asecond configuration according to an embodiment.

[0272] FIG. 84 is a perspective view of a carrier of the medicament delivery device of FIG. 13 according to an embodiment.

[0273] FIG. 85 is a front view of the carrier of FIG. 84 in a first carrier configuration.

[0274] FIG. 86 is a cross-sectional view of the carrier of FIG. 84 and the medicament container assembly of FIG. 82.

[0275] FIG. 87 is a cross-sectional view of the carrier of FIG. 84 and the medicament container assembly of FIG. 83.

[0276] FIG. 88 is a front view of the carrier of FIG. 84 in a second carrier configuration.

[0277] FIG. 89 is a cross-sectional view of the carrier of FIG. 84 in the second carrier configuration and the medicament container assembly of FIG. 83 fluidically coupled to a needle according to an embodiment.Detailed Description

[0278] Generally, the present disclosure is directed to systems and methods for delivering a medicament. The medicament delivery device can, for example, be an auto-injector that delivers the medicament via a needle. In some embodiments, the medicament delivery devices disclosed herein can prepare (e.g.. mix, compress, crush, hydrate, or prime) a medicament for delivery in response to a first action by the user. With the medicament being thus prepared, the user can perform a second action that actuates the medicament delivery device to deliver the medicament, such as via a needle. In some embodiments, following the delivery, the user can perform or otherwise permit a third action that transitions the medicament delivery device to a retracted state (e.g., with the needle being retracted within the housing of the medicament delivery device). Accordingly, the medicament delivery device can ensure that a fully prepared (e.g., properly mixed) medicament can be delivered by the user without significant training in an emergency situation and that the used medicament delivery' device does not present a sharp hazard following its use.

[0279] As used herein, the term “about” when used in connection with a referenced numeric indication means the referenced numeric indication plus or minus up to 10 percent of that referenced numeric indication. For example, the language “about 50” covers the range of 45 to 55. Similarly, the language “about 5” covers the range of 4.5 to 5.5.

[0280] Further, specific words chosen to describe one or more embodiments and optional elements or features are not intended to limit the invention. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — may be used to describe the relationship of one element or feature to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., translational placements) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the term “below” can encompass both positions and orientations of above andbelow. A device may be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along (translation) and around (rotation) various axes includes various spatial device positions and orientations.

[0281] Similarly, geometric terms, such as '‘parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as '‘round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0282] In addition, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. The terms “comprises”, '‘includes”, “has”, and the like specify the presence of stated features, steps, operations, elements, components, etc. but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, or groups.

[0283] As used herein, the w ords “proximal” and “distal” refer to direction closer to and away from, respectively, an operator of the medical device. Thus, for example, the end of the medicament delivery device contacting the patient’s body would be the distal end of the medicament delivery7device, while the end opposite the distal end would be the proximal end of the medicament delivery device.

[0284] As used in herein, the term “medicament” includes any constituent of a therapeutic substance. A medicament can include such constituents regardless of their state of matter (e.g., solid, liquid or gas). Moreover, a medicament can include the multiple constituents that can be included in a therapeutic substance in a mixed state, in an unmixed state and / or in a partially mixed state. A medicament can include both the active constituents and inert constituents of a therapeutic substance. Accordingly, as used herein, a medicament can include non-active constituents such as, w ater, colorant or the like.

[0285] FIGS. 1-5 are schematic illustrations of an apparatus 1000 for the delivery of a medicament 1240. The apparatus 1000 (e.g., the medicament delivery device) can, for example, be an auto-injector, a pen injector, an inhaler, a nasal delivery system or the like.FIG. 1 depicts the apparatus 1000 in a stored state. FIG. 2 depicts the apparatus 1000 in an initialized state in which the medicament 1240 has been transitioned from a stored state to a deliverable state. FIG. 3 depicts the apparatus 1000 in an actuated state. FIG. 4 depicts the apparatus 1000 in a delivery state from which the medicament has been delivered. FIG. 5 depicts the apparatus 1000 in a retracted state following the delivery of the medicament.

[0286] In some embodiments, the apparatus 1000 includes a housing 1100 and a base 1510 movably coupled to the housing 1100. The base 1510 and at least a portion of the housing 1100 can be surrounded (or partially surrounded) by a case 1190 on a condition that the apparatus 1000 is in a stored state as depicted in FIG. 1. The base 1510 is movable relative to the housing 1100 between a first base position BPi (FIGS. 2 and 5) and a second base position BP2(FIGS. 3 and 4) on a condition that the case 1190 is separated from the housing 1100. A medicament container assembly 1200 can also be movably disposed within the housing 1100. The medicament container assembly 1200 can define a longitudinal axis AXCL (e.g., an axial midline, an axial centerline) that can be coaxial with a longitudinal axis HALO of the housing 1100.

[0287] A medicament 1240 can be contained within the medicament container assembly 1200. The apparatus 1000 can be configured to transition the medicament 1240 from a stored state SSTO (as depicted in FIG. 1) to a deliverable state SDEL (as depicted in FIG. 2). For example, the apparatus 1000 can be configured to maintain a liquid component of the medicament separate from a dry component of the medicament in the stored state SSTO and to mix the liquid and dry components to initialize the medicament and transition the medicament to the deliverable state SDEL.

[0288] In some embodiments, the apparatus 1000 can, as depicted in FIGS. 1-5, include a first spring 1520, a second spring 1702, a third spring 1420, and a fourth spring 1440. In some embodiments, the second spring 1702 is axially aligned with the longitudinal axis AXCL of the medicament container assembly 1200. The first spring 1520 and / or the fourth spring 1440 can be parallel to the longitudinal axis AXCL and separated laterally from the second spring. For example, in some embodiments, the fourth spring is separated laterally from the second spring and the second spring is between the fourth spring and the first spring. Additionally, in some embodiments, the third spring can be axially aligned with the fourth spring. Accordingly, in some embodiments, the third spring and the fourth spring can be monolithically formed. Alternatively, in some embodiments, the third spring, which can be a coil spring or leaf spring.can be axially aligned with the longitudinal axis AXCL of the medicament container assembly 1200.

[0289] The first spring 1520 can, for example, function as a positioning spring. The first spring 1520 can be disposed within the housing and configured to at least produce a positioning force Fp. The positioning force Fp produced by the first spring 1520 can, in some embodiments, move the medicament container assembly 1200 from a first container position MCLOI (FIGS. 1 and 2) to a second container position MCLO2 (FIG. 4) (e.g., a delivery position). The positioning force Fp can move the medicament container assembly 1200 on a condition that the base 1510 is moved from the first base position BPi to the second base position BP2 to actuate the apparatus following the initialization of the medicament 1240. Although the first spring 1520 (which functions as a positioning spring) is shown and described as producing a force to move the medicament container assembly 1200 within the housing 1100, in other embodiments, the first spring 1520 can produce a force that moves a needle (not shown) from a position within the housing to a position outside of the housing 1100. In other embodiments, the first spring 1520 need not function to move the medicament container assembly 1200 or the needle but may only produce a force (referred to as a first dispensing force) to convey the medicament 1240 from the medicament container assembly 1200 as described herein.

[0290] In some embodiments, the second spring 1702 can function as an initialization spring. Accordingly, the second spring 1702 can be configured to produce at least an initialization force Fi (FIG. 2). The second spring 1702 can be disposed within the housing 1100 and can be a component of an initialization assembly 1700. The initialization assembly 1700 can be operably coupled to the medicament container assembly 1200 (e.g., to a proximal end portion of the medicament container assembly 1200) and can be triggered (e.g., actuated) by the separation of the case 1190 from the housing 1100. The initialization assembly 1700 can include a rod carrier 1710, a rod 1730 (e.g., a piston), and the second spring 1702. As depicted in FIGS. 3 and 4, the rod carrier 1710 is movable along the longitudinal axis HALO of the housing 1100 in response to the positioning force Fp. The rod carrier 1710 defines a bore sized to receive the second spring 1702 and at least a portion of the rod 1730. The second spring 1702 can be positioned between the rod carrier 1710 and the rod 1730 such that the second spring 1702 can act off of the rod carrier 1710 to move the rod 1730 relative to the rod carrier 1710. Said another way, the rod 1730 is movable along the longitudinal axis HALOrelative to the rod carrier 1710 in response to the initialization force Fi (FIG. 2) and the dispensing force FD (FIG. 4).

[0291] As depicted in FIG. 1, the second spring 1702 is in a first compressed state SSci with a first spring length prior to an initialization of the apparatus 1000. Said another way, the second spring 1702 has a stored energy on a condition that the apparatus 1000 is in the stored state as depicted in FIG. 1. The removal of the housing 1100 from the case 1190 can cause the second spring 1702 to transition from the first compressed state SSci to a first extended state SSEI that has a second spring length as depicted in FIG. 2. The transition of the second spring 1702 from the first compressed state SSci to the first extended state SSEI can produce the initialization force Fi. Said another way, the removal of the housing 1100 from the case 1190 can trigger a transition of the initialization assembly 1700 from a stored state to a released state to transition the medicament 1240 from the stored state SSTO to the deliverable state SDEL. In some embodiments, the second spring length is greater than the first spring length.

[0292] As depicted in FIGS. 2 and 3, in some embodiments, the second spring 1702 is configured to transition from the first extended state SSEI to a second compressed state SSc2. The second compressed state SSc.2 can have a third spring length, which can be greater than or equal to the first spring length. The transition from the first extended state SSEI to the second compressed state SSc2 can be in response to (e.g., concurrent with) the movement of the medicament container assembly 1200 within the housing 1100 from the first container position MCLOI toward the second container position MCLO2 via the positioning force Fp (i.e., the force produced by the first spring 1520). The transition from the first extended state SSEI to the second compressed state SSc2 can absorb a shock load resulting from the movement of the medicament container assembly 1200 from the first container position MCLOI to the second container position MCLO2 via the positioning force Fp. For example, the second container position MCLO2 can correspond to a travel limit hard-stop at which the medicament container assembly 1200 is rapidly decelerated. This deceleration can result in a shock load that would otherwise negatively affect the operation and / or structural integrity of the medicament container assembly 1200 if not absorbed or otherwise dissipated. Therefore, the rod 1730 is movable both longitudinally and distally relative to the rod carrier 1710 such that the second spring 1702 can be at least partially re-compressed to absorb at least a portion of the shock load to mitigate or preclude the negative effects of such a preload on the medicament container assembly 1200 and / or the operation of the apparatus 1000.

[0293] Additionally, the second spring 1702 can, as depicted in FIGS. 3 and 4, be configured to transition from the second compressed state SSc2 to a second extended state SSE2. The second extended state SSE2 can have a fourth spring length, which can be greater than or equal to the second spring length. The transition from the second compressed state SSc2 to the second extended state SSE2 can produce the dispensing force FD to deliver at least a portion of the medicament 1240 from the medicament container assembly 1200. Said another way, in addition to the initialization force Fi, the second spring 1702 is also configured to produce a dispensing force FD. The dispensing force FD causes at least a portion of the medicament 1240 within the medicament container assembly 1200 in the deliverable state SDEL to be conveyed out of the medicament container assembly 1200 on a condition that the medicament container assembly 1200 is at the second container position MCLO2 as depicted in FIG. 4. In some embodiments, however, both the first spring 1520 in the second spring 1702 can produce portions of the dispensing force FD such that portions of the medicament 1240 are dispensed (e.g., delivered) via a corresponding portions of the dispensing force produced by each of the first spring 1520 and the second spring 1702.

[0294] In some embodiments, the third spring 1420 can function as a base spring. Accordingly, the third spring 1420 can be positioned functionally and / or physically between the housing 1100 and at least a portion of the base 1510. As depicted in FIG. 5, the third spring 1420 can be configured to produce a base-return force FBR. The base-return force FBR can bias the base 1510 away (e.g., distally) from the housing 1100. Said another way, on a condition that the base 1510 is in the second base position BP2, the base-return force FBR can bias the base 1510 toward the first base position BPi. Accordingly, moving the base 1510 from the first base position BPi to the second base position BP2 to actuate the apparatus 1000 requires a force magnitude that is greater than the base-return force FBR. Returning the base 1510 to the first base position BPi from the second base position BP2 can facilitate a movement of the medicament container assembly 1200 from the second container position MCLO2 toward the first container position MCLOI (e.g., in a proximal direction).

[0295] In some embodiments, the fourth spring 1440 can function as a retraction spring. Accordingly, as depicted in FIG. 5, the fourth spring 1440 can be positioned within the housing 1100 and configured to produce a retraction force FR. The reaction force FR can move the medicament container assembly 1200 from the second container position MCLO2 toward the first container position MCLOI on a condition that the base 1510 is moved from the second baseposition BP2 toward the first base position BPi, such as in response to the base-return force FBR. In order to produce the retraction force FR, the fourth spring 1440 can be placed into an energy storage state (e.g., compressed) by a movement of the medicament container assembly 1200 in response to the positioning force Fp. Said another way. a portion of the kinetic energy resulting from a release of the first spring 1520 can be absorbed by the fourth spring 1440 as potential energy. The stored potential energy of the fourth spring 1440 can then be discharged following the delivery of the medicament 1240, with the discharge being triggered by the movement of the base 1510 from the second base position BP2 toward the first base position BPi.

[0296] As described with reference to the apparatus 1000, the medicament deli very devices disclosed herein can be configured to initialize a medicament to transition the medicament from a stored state to a deliverable state. Accordingly, FIGS. 6-9 are schematic illustrations of an apparatus 2000 configured to initialize a medicament prior to delivery. As depicted in FIG. 6, the apparatus 2000 (e.g., the medicament delivery' device) includes a housing 2100 and a removable case 2190. The case 2190 is configured to receive (e.g., surround) at least a portion (e.g., a distal end portion) the housing 2100. For example, in some embodiments, at least 50% of a surface area of the housing 2100 is surrounded by the case 2190. The case 2190 and the housing 2100 have an absence of a removable safety lock. The absence of a removable safety lock beneficially reduces a part count of the apparatus 2000 while still maintaining desirable protections against inadvertent triggering of the apparatus 2000.

[0297] As depicted in FIGS. 6-9, the apparatus 2000 includes an initialization assembly 2700 and an initialization actuator assembly 2800. The initialization assembly 2700 is positioned within the housing 2100 and operably coupled to a medicament container 2210. The initialization assembly 2700 is configured, upon triggering, to transition a medicament 2240 within the medicament container 2210 from a stored state SSTO to a deliverable state SDEL. In some embodiments, the initialization assembly 2700 can include a rod carrier 2710, arod 2730 (e.g., a piston), and an initialization spring (not shown). Upon triggering, the initialization assembly 2700 is transitioned from a loaded state SLOA, such as depicted in FIG. 6, to a released state SRF.L, such as depicted in FIGS. 8 and 9, to effectuate the transition of the medicament 2240. Accordingly, the rod 2730 is movable along the longitudinal housing axis HALO relative to the rod carrier 2710 and extends at least partially from the rod carrier 2710 on a condition that the initialization assembly 2700 is in the released state SREL. The extension of the rod 2730in response to an initialization force produced by the initialization spring can, for example, cause portions of the medicament 2240 to mix thereby transitioning the medicament from the stored state SSTO to the deliverable state SDEL.

[0298] The initialization actuator assembly 2800 is operably coupled to the initialization assembly 2700. Being thus operably coupled, the initialization actuator assembly 2800 can transition the initialization assembly 2700 from a first state (e.g., the loaded state SLOA) as depicted in FIG. 6 to a state (e.g., the released state SREL) as depicted in FIGS. 8 and 9. Said another way, the initialization actuator assembly 2800 can trigger the initialization assembly 2700.

[0299] The initialization actuator assembly 2800 includes a release strap 2810 (e.g., a release member) and a trigger protrusion 2830 (e.g.. a trigger member). The release strap 2810 has a first end portion 2811 that is removably coupled to the initialization assembly 2700. The first end portion 2811 functions as a restraining member (e.g., a pin or a latch) that maintains the initialization assembly in the first state on a condition that the apparatus 2000 is in a stored state, such as depicted in FIG. 6. The first end portion 2811 is movable in a lateral direction relative to the initialization assembly 2700 to trigger (e g., release) the initialization assembly 2700 such that the rod 2730 moves in the distal direction in response to an initialization force produced by the initialization spring.

[0300] In some embodiments, the release strap 2810 includes a second end portion 2820. The second end portion 2820 can be movable longitudinally within the housing 2100. The second end portion 2820 can be shaped to engage a trigger protrusion 2830 to receive a force therefrom. The force transferred to the second end portion 2820 by the trigger protrusion 2830 can move the first end portion 2811 radially away from the initialization assembly 2700 to trigger the initialization assembly 2700. Said another way, the first end portion 2811 of the release strap 2810 can be pulled free from the initialization assembly 2700 by a force applied to the second end portion 2820 by the trigger protrusion 2830. In some embodiments, however, the force can be applied directly to the second end portion 2820 by a user of the apparatus 2000.

[0301] As depicted in FIGS. 6-9, in some embodiments, the trigger protrusion 2830 is coupled to the case 2190 and is positioned at least partially within the housing 2100 on a condition that the initialization assembly 2700 is in the loaded state SLO . In some embodiments, the trigger protrusion 2830 has a length that establishes a separation distance SD(FIG. 6) between an engagement portion (e.g., an engagement tooth) of the trigger protrusion 2830 and a corresponding engagement surface (e.g., an engagement surface of an engagement pocket) of the second end portion 2820 on a condition that the housing 2100 is seated within the case 2190. As depicted in FIG. 7, the application of a first separation force Fsi to the case 2190 or an exposed portion of the housing 2100 closes the separation distance and positions the trigger protrusion 2830 in operable contact with the release strap 2810. Said another way, the application of the first separation force Fsi can move the case 2190 a first distance relative to the housing 2100, or vice versa. This movement provides a haptic indication to an operator of the apparatus 2000 that the first separation force is being applied in a proper direction and that the case 2190 is designed to be separated from the housing 2100. However, the position of the release strap 2810 within the housing is unaffected by the movement in response to the first separation force Fsi.

[0302] As depicted in FIG. 8, a second separation force Fs2 can be applied to the case 2190 or an exposed portion of the housing 2100 in a longitudinal direction. The second separation force FS2 can cause the case 2190 to move a second distance relative to the housing 2100 or vice versa. A portion of the second separation force Fs2 is transmitted to the release strap 2810 via the trigger protrusion 2830. The portion of the second separation force Fs2 that is transmitted to the release strap 2810 can cause the release strap 2810 to move within the housing 2100 to transition the initialization assembly 2700 from the loaded state SLOA (FIGS. 6 and 7) to the released state SREL (FIGS. 8 and 9). The continued application of the second separation force Fs2 can cause the case 2190 to be separated from the housing 2100. as depicted in FIG. 9. The separation of the case 2190 and the housing 2100 can prepare the housing 2100 for further actuation to deliver the medicament 2240, which has been transitioned to the deliverable state SDEL in response to the transition of the initialization assembly 2700 to the released state SREL.

[0303] Referring to FIGS. 8 and 9, the case 2190 defines a longitudinal case axis CALO. A longitudinal axis TPLO of the trigger protrusion 2830 is not parallel with the longitudinal case axis CALO. More specifically, the longitudinal axis TPLO of the trigger protrusion 2830 can have an angle relative to the longitudinal case axis CALO with an absolute value that is in a range of one to five degrees. Due, at least in part, to the angle betw een the longitudinal axis TPLO of the trigger protrusion 2830 and the longitudinal case axis CALO, the second separation force Fs2 develops a first vector component VCi and a second vector component VC2 at thepoint of operable contact between the release strap 2810 and the trigger protrusion 2830. The first vector component VCi can be parallel to the longitudinal case axis CALO and, thus, corresponds to the portion of the second separation force Fs2 that causes the release strap 2810 to move within the housing 2100. The second vector component VC2 is parallel to the lateral case axis CALA. The second vector component VC2 biases the engagement portion of the trigger protrusion 2830 away from corresponding engagement surface of the second end portion 2820 of the release strap 2810. Accordingly, in response to the second vector component VC2 the trigger protrusion 2030 can be decoupled from the release strap 2810 such that the case 2190 can be separated from the housing 2100 while the release strap 2810 remains positioned within the housing. This arrangement allows for repeatable actuation of the release strap 2810 and removal of the case 2190 via one single application of the second separation force FS2. The angled arrangement of the trigger protrusion 2830 (and the vector components that result) limit the likelihood that the case 2190 will inadvertently be retained by the release strap after the second separation force Fs2 is applied.

[0304] As described with reference to the apparatus 1000 and the apparatus 2000, the medicament delivery devices disclosed herein can be configured to initialize a medicament to transition the medicament from a stored state to a deliverable state. Following the transition of the medicament from the stored state to the deliverable state, the medicament is maintained within the medicament delivery7device until the device is separately actuated, and the medicament is delivered. Accordingly, FIGS. 10 and 11 are schematic illustrations of an apparatus 3000 configured to deliver the medicament in the deliverable state.

[0305] As depicted in FIGS. 10 and 11, the apparatus 3000 (e.g., the medicament delivery7device) includes a housing 3100 and an actuator assembly 3500. The actuator assembly 3500 is positioned at least partially within the housing 3100 and is configured to transition the apparatus 3000 to the actuated state, which is depicted in FIG. 1 1. The apparatus 3000 can also include a rod carrier 3710, which can be a component of an initialization assembly 3700, that is operably coupled to a medicament container assembly 3200. The rod carrier 3710 can be positioned within the housing 3100 and be movable from a first longitudinal position RCLOI (FIG. 10) to a second longitudinal position RC1.02 (FIG. 11) on a condition that the apparatus 3000 is transitioned to the actuated state of FIG. 11.

[0306] In some embodiments, the actuator assembly 3500 includes a positioning arm 3550 (coupled to the rod carrier 3710), a spring 3520 (e.g., a positioning spring), a transfer arm 3600(operably coupled between the positioning arm 3550 and the spring 3520), and an activator 3530. The spring 3520 is in a compressed state (e.g., an energy storage state) on a condition that the rod carrier 3710 is at the first longitudinal position RCLOI. In the compressed state, the spring 3520 exerts a force in the distal direction on the transfer arm 3600. The transfer arm 3600, in turn, transfers the force to the positioning arm 3550 via the operable coupling therebetween. However, the positioning arm 3550 engages with a portion of the housing 3100 to maintain the rod carrier 3710 at the first longitudinal position RCLOI prior to actuation of the apparatus 3000. Said another way, the engagement between the positioning arm 3550 and the portion of the housing 3100 precludes a movement of the rod carrier 3710 in the distal direction that would otherwise occur in response to the force (e.g., a positioning force) developed by the spring 3520.

[0307] The portion of the positioning arm 3550 (e.g., a latch protrusion) and / or the portion (e.g., a positioning notch) of the housing 3100 to which the positioning arm 3550 is engaged is shaped such that the portion of the positioning arm 3550 is biased toward a disengaged position. Said another way, the portion of the positioning arm 3550 can be biased away from the portion of the housing 3100 and toward and axial midline ML of the housing 3100. However, the activator 3530 is positioned to counteract the bias and maintain the engagement between the positioning arm 3550 and the housing 3100 prior to the actuation of the apparatus 3000. More specifically , the activator 3530 is positioned at a first longitudinal position AVLOI (FIG. 10) in contact with the positioning arm 3550 to maintain the engagement between the portion of the positioning arm 3550 and the portion of the housing 3100 prior to the transition of the apparatus 3000 to the actuated state. The activator 3530 is movable (e.g. proximally) to a second longitudinal position AVLO2 (FIG. 11) that is spaced apart from the positioning arm 3550. This movement of the activator 3530 permits the disengagement of the positioning arm 3550 from the housing 3100 in response to the force developed by the spring 3520. Upon the disengagement, the force developed by the spring 3520 is transmitted via the transfer arm 3600 to the positioning arm 3550 and on to the medicament container assembly 3200 via the rod carrier 3710 to move the rod carrier 3710 (the medicament container assembly 3200) to the second longitudinal position RCLO2 (FIG. 11). The apparatus 3000 can be configured to deliver the medicament from the medicament container assembly 3200 on a condition that the rod carrier 3710 is at the second longitudinal position RCLC>2.

[0308] As described with reference to the apparatus 1000, the apparatus 2000, and the apparatus 3000, the medicament delivery devices disclosed herein can be configured to initialize a medicament to transition the medicament from a stored state to a deliverable state. Following the transition of the medicament from the stored state to the deliverable state, the medicament is maintained within the medicament delivery devices until the device is separately actuated, and the medicament is delivered. Accordingly, FIGS. 12-89 depict elements and features of embodiments of an apparatus 4000 (e.g., a medicament delivery device) to automatically initialize a medicament in response to a first user action and deliver the initialize the medicament in response to a second user action. FIGS. 12-89 also show various views of the apparatus 4000 according to an embodiment in various different configurations (or stages of operations). A discussion of the operation of the apparatus 4000 is followed herein by a discussion focused on the components, functions and assemblies, and functions thereof of the apparatus 4000.

[0309] The apparatus 4000 can include any of the features and special elements described herein with reference to the apparatus 1000, the apparatus 2000, and / or the apparatus 3000. The apparatus 4000 can, as depicted configured as an auto-injector having a needle through which the medicament is delivered. However, in other embodiments, the apparatus 4000 can be configured as a pen injector, an inhaler, a nasal delivery system or the like.

[0310] FIGS. 12 and 13 are a perspective view and an exploded view of the apparatus 4000 in a stored state. FIG. 14 is a perspective view of the apparatus 4000 in a stored state but with a case 4190 and a portion of a housing 4100 removed to more clearly show the internal components and assemblies of the apparatus 4000 and their positioning within the apparatus. Reference is made herein to FIGS. 12-14 for orientation purposes though it is recognized that the relative positioning of the various components can change in accordance with the operating state of the apparatus 4000. As depicted, in some embodiments, the apparatus 4000 can include the housing 4100 and the case 4190. Additionally, in some embodiments, the apparatus 4000 can include any of a medicament container assembly 4200, an initialization assembly 4700, an initialization actuator assembly 4800, an actuator assembly 4500. and / or a retraction assembly 4400.

[0311] In some embodiments, on a condition that the apparatus 4000 is in a stored state, such as depicted in FIGS. 12 and 14, the initialization assembly 4700 is in a loaded state SLOA and the medicament 4240 contained within the medicament container assembly 4200 is in astored state SSTO. Additionally, the medicament container assembly 4200 is at a first container position MCLOI. In the stored state (e.g., a first operating condition), at least a distal end portion 4102 of the housing 4100 is positioned within a cavity 4196 defined by the case 4190 (FIG. 17).

[0312] As depicted in FIG. 16, a longitudinal separation force Fs can be applied to one of the case 4190 or an exposed portion of the housing 4100 to move the case 4190 relative to the housing 4100 or vice versa. The separation force Fs can for example have a magnitude in a range of between 0.9 kg and 2.3 kg. A portion of the separation force Fs can be transmitted to a release strap 4810 of the initialization actuator assembly 4800 via the trigger protrusion 4830 of the initialization actuator assembly 4800 thereby causing the release strap 4810 to move within the housing and transition the initialization assembly 4700 from the loaded state SLOA to a released state SREL, such as depicted in FIG. 16. The transition of the initialization assembly 4700 from the loaded state SLOA to the released state SREL can correspond to a transition of the apparatus 4000 to an initialized state (e.g., a second operating condition), such as depicted in FIG. 20. A continued application of the separation force Fs can, as depicted in FIG. 17, separate the case 4190 housing 4100.

[0313] FIGS. 18 and 19 are sequential cross-sectional views of the apparatus 4000 at the outset (e.g., the commencement) of the transition of the apparatus 4000 from the stored state to the initialized state following the separation of the case 4190. Said another way, the removal of the case triggers an automatic transition of the apparatus 4000 to an intermediate state (e.g., an intermediate operating condition) as depicted in FIGS. 18 and 19. FIG. 20 is a cross-sectional view of the apparatus in the initialized state in which the medicament 4240 has been transitioned from the stored state SSTO (FIG. 15) to the deliverable state SDEL. In some embodiments, the transition of the medicament from the stored state SSTO to the deliverable state SDEL can include the initialization assembly 4700 causing a first component (e.g., a first substance) of the medicament 4240 to contact a second component (e g., a second substance) of the medicament 4240. For example, once triggered by the movement of the release strap 4810 in response to the portion of the separation force Fs, the initialization assembly 4700 can mix a dry component (e.g., a lyophilized, micronized, or general powder component) of the medicament 4240 with a liquid component (e.g., a solvent) of the medicament to transition the medicament 4240 to the deliverable state SDEL. However, in some embodiments, the transition of the medicament 4240 to the deliverable state SDEL can include any of compressing, crushing, hydrating, or priming the medicament 4240.

[0314] Following the transition of the medicament 4240 from the stored state SSTO to the deliverable state SDEL, the medicament 4240 is maintained within the apparatus 4000 until the apparatus 4000 is separately actuated to transition the apparatus 4000 to an actuated state (e.g., a third operating condition), such as depicted in FIGS. 21 and 22. To transition the apparatus 4000 to the actuated state, a base 4510 is moved relative to the housing 4100 from a first base position BPi (FIGS. 18-20) to a second base position BP2 (FIG. 21 and 22). For example, as depicted in FIG. 21, a distal face 4512 of the base 4510, which was exposed by the removal of the case 4190, can be placed in contact a portion of a patient’s body PB. With the apparatus 4000 thus positioned, a longitudinal actuation force FA can be applied in a distal direction to move the housing 4100 toward the base 4510 while the base 4510 remains stationary due to the contact with the patient’s body PB. This movement causes a reduction in the separation distance between the base 4510 and the housing 4100 (e.g., a distal face 4107 (FIG. 50) of the housing 4100 that is positioned within an internal volume 4515 (FIG. 28) defined by the base 4510).

[0315] With the actuator assembly 4500 thus actuated by the movement of the base 4510 relative to the housing 4100, the actuator assembly 4500 transitions the apparatus 4000 from the actuated state to delivery / inj ection state (e.g., a fourth operating state), such as depicted in FIGS. 23 and 24. To transition the apparatus 4000 to the deliver}' state, the actuator assembly 4500 causes the medicament container assembly 4200 to move from the first container position MCLOI to a second container position MCLO2. AS depicted in FIG. 24. in some embodiments in which the apparatus 4000 is configured as an auto-injector, moving the medicament container assembly 4200 to the second container position MCLO2 can couple a container body 4210 of the medicament container assembly 4200 to a needle 4216. However, in some embodiments, the needle and the container body are coupled prior to installation within the housing 4100. In inj ector embodiments, a distal end portion 4218 of the needle 4216 is at least outside the housing 4100 upon the transition of the apparatus 4000 to the injection state. The distal end portion 4218 of the needle 4216 can, for example, be positioned within the patient’s body PB such that the medicament 4240 in the deliverable state SDEL can be injected via the needle 4216. It should be appreciated that in some embodiments, to transition the apparatus 4000 to the delivery state, the actuator assembly 4500 can cause the needle 4216 to be positioned outside the housing 4100 while the position of the container body 4210 is unchanged.

[0316] As depicted in FIG. 25, during the delivery of the medicament 4240 (e.g., the timeframe required for the medicament 4240 to be dispensed from the medicament container assembly 4200), the position of the base 4510 relative to the housing 4100 is maintained. Said another way. the reduction in the separation distance between the base 4510 and the housing 4100 that actuated the actuator assembly 4500 is maintained throughout the deliver}' of the medicament 4240. In the operating state depicted in FIG. 25, the medicament 4240 has been dispensed from the medicament container assembly 4200 and the medicament container assembly 4200 is maintained at the second container position MCL02 by a positioning force Fp developed by a positioning spring 4520 of the actuator assembly 4500.

[0317] As depicted in FIG. 26 and 27, following the deliver}' of the medicament 4240 (e.g., the dispensing of a dose of the medicament 4240. such as via injection) the apparatus 4000 is transitioned from the delivery / injection state to a retracted state (e.g., a fifth operating state). To transition the apparatus 4000 to the retracted state, the retraction assembly 4400 is actuated. To actuate the retraction assembly 4400, the base 4510 is permitted to move relative to the housing 4100 toward the first base position FBi. Said another way, to trigger the retraction assembly 4400, the base 4510 can be permitted to reverse the reduction in the separation distance that previously triggered the actuator assembly 4500. Reversing the reduction of the separation distance permits the medicament container assembly 4200 to move toward and / or to the first container position MCLOI (e.g. to move in the proximal direction) in response to a retraction force FR produced by a retraction spring 4440 of the retraction assembly 4400. The movement of the medicament container assembly 4200 toward the first container position MCLOI positions the distal end portion 4218 of the needle 4216 within the housing 4100. Said another way, the needle 4216 can be retracted within the housing 4100 to mitigate or eliminate a sharps-hazard that would otherwise be present in the absence of needle retraction. Accordingly, the retraction of the needle 4216 can facilitate the safe handling of the apparatus 4000 following the delivery of the medicament 4240.

[0318] The movement of the base 4510 relative to the housing 4100 can be in response to a base-return force FBR produced by a base spring 4420 positioned between a portion of the base 4510 and a portion of the housing 4100. The base spring 4420 can be oriented to bias the base 4510 away from the housing 4100 and toward the first base position BPi. The base spring 4420 is compressed by the application of the longitudinal actuation force FA on a condition that the base 4510 is in contact with the patient's body PB. Accordingly, ceasing the applicationof the longitudinal actuation force FA and / or moving the base 4510 out of contact with the patient's body PB (e.g., separating the apparatus 4000 from the portion of the patient’s body PB) following the dispensing of the medicament 4240 permits the base 4510 to move from the second base position BP2 toward the first base position BPi in response to a release of potential energy from the base spring 4420. As depicted in FIG. 27, in some embodiments, the base spring 4420 and the retraction spring 4440 can be monolithically formed.

[0319] In some embodiments, following the retraction of the needle 4216 (e.g., via the return of the medicament container assembly 4200 to the first container position MCLOI), the apparatus 4000 can be coupled to an article of clothing of the patient. For example, in some embodiments, the housing 4100 defines a retention hook 4185. The retention hook can be shaped to provide a secure coupling between the now-empty (e.g., discharged or used) apparatus 4000 and a visible location of article of clothing / equipment (e.g., a strap, a loop, a pocket, a band, a collar, or other suitable location). Coupling the used apparatus 4000 to the visible location via the retention hook 4185, provides a visible indication to medical personnel that the patient has received a dose of the medicament 4240. Additionally, more than one apparatus 4000 can be coupled to the article of clothing to provide a rapid visual indication of the number of doses of the medicament that have been delivered to the patient. The visible indications provided by coupling the used apparatus 4000 to the article of clothing can be particularly beneficial in emergency response situations in which the patient and / or the provider of the initial care that delivered the dose may not be available or otherwise able to convey the delivery information to the subsequent medical providers. Accordingly, the visible indications provided by the coupling of the used apparatus 4000 to the article of clothing can facilitate the provision of appropriate follow-on medical care.

[0320] The operating states and functions of the apparatus 4000 discussed above with reference to FIGS. 15-27 are facilitated in part by the components and assemblies depicted in FIGS. 28-89. In FIGS. 28-30, for example, a portion of the components of the apparatus 4000 are depicted on a condition that the apparatus 4000 is in a stored state (e.g., prior to the initialization, actuation, medicament delivery, and retraction). For purposes of illustration, FIG. 28 is a perspective view of the portion of the apparatus 4000 in the stored state with the case 4190 (FIG. 13) and the housing 4100 (FIG. 12) removed for clarity. FIG. 29 is a front view and FIG. 30 is a rear view of the same portion of the apparatus 4000 as FIG. 28.

[0321] As described herein, to transition the medicament 4240 from the stored state SSTO (FIG. 15) to the deliverable state SDEL (FIG. 20), the apparatus 4000 includes the initialization assembly 4700. Referring to FIGS. 31-34 and 57-59, in some embodiments, the initialization assembly 4700 includes a rod carrier 4710, a rod 4730. and an initialization spring 4702. As depicted in FIGS. 24, 25, and 27, the rod carrier 4710 is movable along a longitudinal housing axis HALO (FIG. 15) relative to the housing 4100. The rod carrier 4710 defines a bore 4712 that is sized to receive the initialization spring 4702 and at least a portion of the rod 4730. In some embodiments, however, the rod 4730 can define a bore sized that is sized to receive the initialization spring 4702 and at least a portion of the rod carrier 4710. As depicted in FIG. 32. in embodiments wherein at least a portion of the rod is received by the bore 4712, substantially an entire length of the rod 4730 can be positioned within the bore 4712 on a condition that the initialization assembly 4700 is in a loaded state SLOA. In some embodiments, the rod 4730 and the initialization spring can be coaxial with the bore 4712. In some embodiments, the rod 4730 can surround the initialization spring 4702. However, in some embodiments, the initialization spring 4702 can surround a portion of the rod 4730.

[0322] As depicted, for example, in FIGS. 19, 20, and 22, the rod 4730 is movable along the longitudinal housing axis HALO relative to the rod carrier 4710. Being that the rod carrier 4710 is movable along the longitudinal housing axis HALO relative to the housing 4100, the rod 4730 is, thus, also movable along the longitudinal housing axis HALO relative to the housing 4100. As depicted at least in FIGS. 19, 20, 57, and 58, the rod 4730 extends at least partially from the rod carrier 4710 on a condition that the initialization assembly 4700 is in the released state SREL. The portion of the rod 4730 extending from the rod carrier 4710 can, in some embodiments, extend within a container body 4210 (FIG. 82) of the medicament container assembly 4200. As described more fully below, the movement / extension of the rod 4730 is configured to move a first elastomeric member 4221 (FIG. 82) of the medicament container assembly 4200 toward a second elastomeric member 4225 (FIG. 82) as depicted in FIG. 83 on a condition that the initialization assembly 4700 is triggered to transition the apparatus 4000 from the stored state to the initialized state. For example, the rod 4730 can be configured to move the first elastomeric member 4221 on a condition that the case 4190 is separated from the housing 4100 to transition the initialization assembly 4700 to a released state SREL. The movement of the first elastomeric member 4221 toward the second elastomeric member 4225 is configured to place the first substance in contact with the second substance to transition the medicament 4240 to the deliverable state SDEL (FIG. 83).

[0323] Referring again to FIG. 31-33, in some embodiments, rod 4730 includes a proximal portion 4732 and a distal end portion 4733. The distal end portion 4733 includes a rod base 4735. A proximal surface of the rod base 4735 defines a spring seat that receives a distal end portion of the initialization spring 4702. A distal surface of the rod base 4735 is configured to engage the first elastomeric member 4221, as described above. The rod 4730 further includes at least one rod wall 4736 that extend in the proximal direction from the rod base 4735. In some embodiments, the proximal portion 4732 of the rod 4730 includes a set of retention protrusions 4734. The set of retention protrusions 4734 are positioned to pass through openings defined by the rod carrier 4710 and engage a first end portion 4811 (FIG. 35) of the release strap 4810 to preclude the movement of the rod 4730 relative to the rod carrier 4710 prior to the initialization of the apparatus 4000, as described herein with reference to FIGS. 16-18. The proximal portion 4732 can also include alignment grooves 4737 positioned to receive alignment protrusions of the rod carrier 4710 on the condition that the initialization assembly is in the loaded state SLOA.

[0324] In some embodiments, the initialization spring 4702 is in a first compressed state SSci on a condition that the initialization assembly 4700 is in the loaded state SLOA. Upon the triggering of the initialization assembly 4700, the first end portion 4811 of the release strap 4810 is moved out of engagement with the set of retention protrusions 4734, and the rod 4730 is released to move longitudinally away from the rod carrier 4710 in response to a force produced by the initialization spring 4702. Said another way, upon the release of the rod 4730, the initialization spring 4702 can extend to produce an initialization force Fi that is transmitted to the first elastomeric member 4221 via the movement of the rod 4730 in the distal direction. Accordingly, the initialization spring 4702 can transition from the first compressed state SSci to a first extended state SSEI upon the triggering of the initialization assembly 4700 but prior to the triggering of the actuator assembly 4500. Said yet another way, the initialization spring 4702 expands to move the rod 4730 in the distal direction. The expansion of the initialization spring 4702 is such that the initialization spring 4072 exerts the initialization force Fi on the rod 4730.

[0325] To trigger or otherwise release the initialization assembly 4700 from the loaded state SLOA, the apparatus 4000 includes an initialization actuator assembly 4800. Said another way, the initialization actuator assembly 4800 is operably coupled to the initialization assembly 4700 (as depicted in FIG. 35) to first maintain the initialization assembly 4700 in the loadedstate SLOA and then to transition the initialization assembly 4700 from the loaded state SLOA to the released state SREL in response to a user action. The initialization actuator assembly 4800 includes a release strap 4810 and a trigger protrusion 4830. The trigger protrusion 4830 is configured to transmit a user-produced separation force Fs (FIG. 16) to the release strap 4810 to move the release strap within the housing 4100 and trigger the initialization assembly 4700.

[0326] In some embodiments, the release strap 4810 has a first end portion 4811 that is removably coupled to the initialization assembly 4700. as depicted in FIG. 35, and a second end portion 4820 that is shaped to engage the trigger protrusion 4830. In some embodiments, the trigger protrusion 4830 is coupled to the case 4190 and positioned at least partially within the housing 4100 on a condition that the initialization assembly 4700 is in the loaded state SLOA.

[0327] As depicted in FIGS. 38 and 39. the case 4190 includes a wall portion 4193 and a base portion 4194. The wall portion 4193 surrounds a longitudinal case axis CALO. The wall portion 4193 and the base portion 4194 define a cavity 4196 sized to receive a distal end portion 4102 of the housing 4100. For example, in some embodiments, the wall portion 4193 extends from the base portion 4194 a sufficient distance that at least 50% and less than 100% (e.g., 55% to 75%, 60% to 80%, 65% to 85%, 70% to 90%, 75% to 95%, 80% to 95%, 90% to 98%, or other suitable ranges) of the surface are of the housing 4100 is surrounded by the wall portion 4193 when the housing 4100 is positioned within the cavity 4196. The longitudinal case axis CALO is coaxial with the longitudinal housing axis HALO and an axial centerline AXCL of the medicament container assembly 4200 on a condition that the housing 4100 is received (e.g., surrounded) within the cavity. The trigger protrusion 4830 extends from the base portion 4194 into the cavity 4196. For example, in some embodiments, the trigger protrusion 4830 and the case 4190 are monolithically formed. Being that the trigger protrusion 4830 extends from the base portion 4194. the case 4190 and the housing 4100 have an absence of a removable safety lock.

[0328] As depicted in FIG. 38, a longitudinal axis TPLO of the trigger protrusion 4830 has an angle Al relative to the longitudinal case axis CALO. The angle Al has an absolute value that is in a range of 1.0 to 5.0 degrees (e.g., 1.5 to 4.5 degrees, 2.0 to 4.0 degrees, 2.0 to 3.0 degrees, 3.0 to 4.0 degrees or other suitable ranges). As depicted in FIG. 54, the lack of parallelism between the longitudinal axis TPLO of the trigger protrusion 4830 and the longitudinal case axis CALO facilitates the development of orthogonal first and second force vector components VCi, VC2 when a longitudinal separation force Fs is applied by the user tothe case 4190 or an exposed portion of the housing 4100. The second force vector component VC2, in turn, facilitates the disengagement of the trigger protrusion 4830 from the second end portion 4820 of the release strap 4810 such that the case 4190 and the housing 4100 can be separated. Being that the trigger protrusion 4830 is coupled to the case 4190 at an angle relative to the longitudinal case axis CALO, the trigger protrusion 4830 is in a neutral position rather than a flexed or deflected position on a condition that the apparatus 4000 is in the stored state. Having the trigger protrusion 4030 in a neutral position in the stored state eliminates material fatigue that could otherwise result if the trigger protrusion were maintained in a flexed or deflected position. This, in turn, increases the functional reliability of the initialization actuator assembly 4800 and facilitates the consistent removal of the case 4190 such that the apparatus 4000 can be used to respond to an emergency medical situation.

[0329] In some embodiments, the trigger protrusion 4830 includes an engagement tooth 4832. The engagement tooth 4832 can extend along a lateral case axis CALAI (e.g., a first lateral case axis) that is orthogonal to the longitudinal case axis CALO. The engagement tooth 4832 can be positioned, sized, and shaped to engage the release strap 4810 to transfer a portion of the longitudinal separation force Fs to the release strap 4810 and, thereby, release the initialization assembly 4700. For example, in some embodiments, the second end portion 4820 of the release strap 4810 can include an engagement pocket 4824 (FIG. 41) that is sized to receive the engagement tooth 4832. The engagement pocket 4824 can include an engagement surface 4822. The engagement surface 4822 can. for example, extend laterally relative to the longitudinal housing axis HALO and face in the proximal direction.

[0330] Upon the application of the longitudinal separation force Fs, the engagement tooth 4832 develops the first and second force vector components VCi, VC2 relative to the engagement surface 4822. The first force vector component VCi is parallel to the longitudinal case axis CALO. The first force vector component VCi moves the second end portion 4820 of the release strap 4810 in the distal direction and the first end portion 4811 laterally within the housing 4100 to transition the initialization assembly 4700 from the loaded state SLOA to the released state SREL. At the same time, the second force vector component VC2 is parallel to the lateral case axis CALAI . The second force vector component VC2 biases the engagement tooth 4832 out of the engagement pocket 4824. For example, the second force vector component VC2 can drive the engagement tooth 4832 radially inward toward the longitudinal case axis CALO.

[0331] Although the engagement tooth 4832 is biased away from the release strap 4810 by the second force vector component VC2 the radial movement is initially prevented by a trigger guide 4119 (FIG. 42) defined by the housing 4100. Similarly, a radial movement of the second end portion 4820 of the release strap is precluded by a blocking protrusion 4136 defined by the housing 4100. The trigger guide 41 19 can be positioned between the trigger protrusion 4830 and the longitudinal case axis C ALO. Said another way, a portion of the trigger protrusion 4830 can be positioned laterally between the trigger guide 4119 and the engagement pocket 4824 and the release strap 4810 can be positioned laterally between trigger guide 4119 and the blocking protrusion 4136. Accordingly, on a condition that the second end portion 4820 of the release strap 4810 is at a first longitudinal position RSLPI (FIG. 42), the trigger guide 4119 precludes a radially inward movement of the engagement tooth 4832 along the lateral case axis CALAI, while the blocking protrusion 4136 precludes a radially outward movement of the second end portion 4820 of the release strap 4810. However, as the second end portion 4820 is moved in the distal direction by the first force vector component VCi toward a second longitudinal position RSLP2 (FIG 18), a proximal -most portion of the trigger protrusion 4830 is moved to a position that is distal to the trigger guide 4119. Upon achieving the position that is distal to the trigger guide 4119, the radially inward movement of the engagement tooth 4832 is no longer precluded (e.g.. obstructed) by the trigger guide 4119. Said another way. upon moving the case 4190 a sufficient distance distally relative to the housing 4100 in response to the separation force Fs, the trigger guide 4119 is cleared and the engagement tooth 4832 moves radially inward in response to the second force vector component VC2 to disengage the trigger protrusion 4830 from the release strap 4810 such that the case 4190 can be separated from the housing 4100. Said yet another way, on a condition that the second end portion 4820 of the release strap 4810 is moved to the second longitudinal position RSLP2 in response to the first force vector component VCi, the engagement tooth 4832 moves along the lateral case axis CALAI in response to the second force vector component VC2 away from the second end portion 4820 of the release strap 4810 to disengage the trigger protrusion 4830 from the release strap 4810.

[0332] To facilitate the development of the first and second force vector components VCi, VC2, in some embodiments, a distal face 4833, which lies on a plane DLi as depicted in FIG. 54, has an angle relative to the lateral case axis CALAI that has an absolute value in a range of 0.5 to 2.0 degrees (e.g., 0.75 to 1.75 degrees, 1.0 to 1.5 degrees, 1.25 to 2.0 degrees). For example, the plane DLi can be rotated such that a radially inner portion is -0.5 degrees to -2.0degrees beyond orthogonal to the longitudinal case axis CALO. In contrast, the engagement surface 4822 can lie on a plane that is parallel to the lateral case axis CALAI such that the angle of the distal face 4833 facilitates the movement of the engagement tooth 4832 away from the engagement pocket 4824 when not precluded by the trigger guide 4119. In other embodiments, the engagement surface 4822 can be angled while the distal face 4833 can lie on a plane that is parallel to the lateral case axis CALAI.

[0333] As depicted, in FIGS. 42 and 43 for example, in some embodiments, the trigger protrusion 4830 has a length that establishes a separation distance SD between the distal face 4833 of the engagement tooth 4832 and the engagement surface 4822 of the engagement pocket 4824 on a condition that the housing 4100 is received within the case 4190 (e.g., that the apparatus 4000 is in the stored state). As depicted in FIG. 54, an initial application of the separation force Fs (e.g., a first separation force as described herein with reference to FIG. 7 and the apparatus 2000) closes the separation distance SD and places the distal face 4833 in contact with the engagement surface 4822. Said another way, the initial application of the separation force Fs can move the case 4190 a first distance relative to the housing 4100, or vice versa. This movement provides a haptic indication to an operator of the apparatus 4000 that the longitudinal separation force Fs is being applied in aproper direction and that the case 4190 is designed to be separated from the housing 4100. However, the position of the release strap 4810 within the housing is unaffected by the initial movement in response to the separation force Fs. FIGS. 51-53 depict the movement of the second end portion 4820 toward the second longitudinal position RSLP2 in response to the continued application of the separation force Fs following the initial closure of the separation distance SD but prior to achieving the second longitudinal position RSLP2 from which the engagement tooth 4832 is decoupled from the release strap 4810 via the second force vector component VC2.

[0334] As depicted in FIG. 40, in some embodiments, a proximal portion 4834 of the trigger protrusion 4830 includes a first guide facet 4835. The first guide facet 4835 extends parallel to a first lateral case axis CALAI (extending out of the page in FIG. 40). The first guide facet 4835 is positioned to engage a distal-most face 4828 (FIG. 41) of the release strap 4810 during an assembly of the apparatus 4000. The distal-most face 4828 can be angled relative to a second lateral case axis CALA2 (FIGS. 39 and 42) that is orthogonal to the first lateral case axis CAL I and the longitudinal case axis CALO. The engagement between the first guide facet 4835 and the distal-most face 4828 moves the proximal portion 4834 of the trigger protrusion4830 along the second lateral case axis CALA2 during the assembly operation. Said another way, the engagement between the first guide facet 4835 and the distal-most face 4828 temporarily deflects the trigger protrusion 4830 as the case 4190 is moved proximally during a positioning of the housing 4100 within the case 4190. Further proximal movement of the trigger protrusion 4830 (e.g., upon the seating of the housing 4100 fully within the cavity 4196) moves the engagement tooth 4832 beyond the distal-most face 4828 and into the engagement pocket 4824. Once moved beyond the distal-most face 4828 and into the engagement pocket, the trigger protrusion 4830 returns to a neutral position. The return to the neutral position reduces or eliminates material fatigue that could negatively affect the removal of the case 4190 if the trigger protrusion 4830 were otherwise maintained in a deflected position while the apparatus 4000 is in the stored state.

[0335] In some embodiments, the proximal portion 4834 of the trigger protrusion 4830 includes a second guide facet 4836, as depicted in FIG. 42. The second guide facet 4836 extends parallel to the second lateral case axis CALA2. Accordingly, the second guide facet4836 can intersect with the first guide facet 4835. The second guide facet 4836 is positioned to engage the trigger guide 4119 during the assembly operation of the apparatus 4000. More specifically, the second guide facet 4836 can contact a distal-most chamfered portion 4137 of the trigger guide 4119. The engagement between the second guide facet 4836 and the trigger guide 4119 can move the proximal portion 4834 of the trigger protrusion 4030 along the first lateral case axis CALAI during the assembly operation. Said another way, the contact between the second guide facet 4836 and the distal-most chamfered portion 4137 can facilitate the positioning of the trigger guide 4119 at a lateral position that is radially inward of the trigger protrusion 4830 on a condition that the housing 4100 is fully seated within the cavity 4196.

[0336] As depicted in FIGS. 42 and 43, the trigger protrusion 4830 is, in some embodiments, tapered in a proximal direction from the case 4190. For example, the trigger protrusion 4830 can be tapered such that the proximal portion 4834 has a length along the first lateral case axis CALAI that is less than a length of a distal portion 4837 along the same axis. Similarly, the trigger protrusion 4830 can be tapered such that the proximal portion 4834 has a length along the second lateral case axis CAI,A2 that is less than a length of the distal portion4837 along the same axis. In some embodiments, the trigger protrusion 4830 can be tapered along both the lateral case axis CALAI and the second lateral case axis CALA2. The tapering of the trigger protrusion 4030 can facilitate the assembly of the apparatus 4000 withoutnecessitating a plastic deformation of the trigger protrusion 4830 that could negatively affect the operation of the initialization actuator assembly 4800 and, by extension, the initialization assembly 4700.

[0337] In order for the movement of the case 4190 relative to the housing 4100 in response to the separation force Fs to actuate the initialization assembly 4700, the apparatus 4000 includes the release strap 4810 that is operably coupled between the case 4190 and the initialization assembly 4700. In some embodiments, the release strap 4810 includes the first end portion 4811 and a second end portion 4820 separated by a middle portion 4829 (FIG. 41). The first end portion 4811 is removably coupled to the initialization assembly 4700 and is shaped to preclude a transition of the initialization assembly 4700 from the loaded state SLOA to the released state SREL on a condition that the first end portion 4811 is at a first lateral position RSLAPI (FIG. 36) within the housing 4100 along the lateral housing axis HALA. The second end portion 4820 is, as previously described, shaped to engage the trigger protrusion 4830 of the case 4190 to transmit a portion of a longitudinal separation force Fs to the release strap 4810. In some embodiments, the release strap 4810 has a fixed length. Additionally, the release strap 4810 has a set shape that is elastically deformable in response to the application of first force vector component VCi.

[0338] In some embodiments, the release strap 4810 is positioned within the housing 4100 such that the first end portion 4811 is at the first lateral position RSLAPI and the second end portion 4820 is at the first longitudinal position RSLPI on a condition that the apparatus 4000 is in the stored state as depicted in FIG. 15. The second end portion 4820 is movable distally from the first longitudinal position RSLPI to a second longitudinal position RSLP2 (FIG. 18). Being that the release strap 4810 has a fixed length, the distal movement of the second end portion 4820 moves the first end portion 4811 from the first lateral position RSLAPI to a second lateral position RSLAP2. A travel distance of the second end portion 4820 has a ratio of 1 :1 to a travel distance of the first end portion 4811 except that the travel direction of the second end portion 4820 is a longitudinal direction while the travel direction of the first end portion 4011 is a lateral direction. The movement from the first lateral position RSLAPI to the second lateral position RSLAP2 is a radially outw ard movement that moves the first end portion 4811 laterally away from the longitudinal housing axis HALO. The movement of the first end portion 4811 transitions the initialization assembly 4700 from the loaded state SLOA to the released state SREL. Said another way. the movement of the first end portion 4811 releases theinitialization assembly 4700 such that the rod 4730 moves distally in response to an initialization force Fi produced by the initialization spring 4702.

[0339] In some embodiments, the release strap 4810 (FIG. 41) defines a force transfer plane FTP. As depicted in FIG. 29, the force transfer plane FTP extends parallel to the longitudinal housing axis HALO. The force transfer plane FTP is the plane along which the first force vector component VCi is transmitted from the second end portion 4820 to the first end portion 4811 of the release strap 4810. The middle portion 4829 of the release strap 4810 can, for example, extend along the force transfer plane FTP. In some embodiments, the engagement pocket 4824 of the second end portion 4820 extends laterally from the force transfer plane FTP away from the longitudinal housing axis HALO. Accordingly, the first force vector component VC i acting on the engagement surface 4822 can develop a moment at a point of coupling between the second end portion 4820 and the middle portion 4829. The resultant moment is precluded from developing a lateral motion of the second end portion 4820 by the blocking protrusion 4136.

[0340] In some embodiments, the second end portion 4820 of the release strap 4810 also includes a travel-limit notch 4827 (FIG. 41). The travel-limit notch 4827 can be positioned between the engagement pocket 4824 and the middle portion 4829 of the release strap 4810. The travel-limit notch 4827 is sized to receive a travel-limit protrusion 4135 (FIG. 46) of the housing 4100. A length of the travel-limit notch 4827 establishes a maximal amount of travel of the release strap 4810 in the distal direction. The engagement between the travel-limit notch 4827 and the travel-limit protrusion 4135 precludes the extension of even a portion of the release strap 4810 beyond the housing 4100. Said another way, the engagement between the travel-limit notch 4827 and a travel-limit protrusion 4135 maintains the release strap 4810 entirely within the housing 4100. Containing the release strap 4810 entirely within the housing precludes an interference with the operation of the apparatus 4000 that could otherw ise occur if a portion of the release strap 4810 were improperly positioned outside of the housing 4100 following the separation of the case 4190. Such a portion extending beyond the housing 4100 could, for example interfere with the proper movement of the base 4510. Therefore, maintaining the release strap 4810 entirely within the housing 4100 facilitates the desired operation of the apparatus 4000.

[0341] Referring now to FIGS. 40 and 43, in some embodiments, the engagement surface 4822 of the engagement pocket 4824 is a cylinder sector. Said another way, the engagementsurface 4822 can have a concave shape defined about an axis extending parallel to the lateral housing axis HALA. Similarly, the distal face 4833 of the engagement tooth 4832 is a cylinder sector with a radius that corresponds to a radius of the cylinder sector of the engagement surface 4822. Said another way, the distal face 4833 can have a convex shape defined about an axis extending parallel to the lateral case axis CALAL The concave shape of the engagement surface 4822 is configured to receive the convex shape of the distal face 4833. The matching concave and convex shapes of the engagement surface 4822 and the distal face 4833 can maintain the relative position of the engagement tooth 4032 within the engagement pocket 4824 along the second lateral case axis CALA2 on a condition that the distal face 4833 is in contact with the engagement surface 4822.

[0342] Returning now to the first end portion 4811 of the release strap 4810. in some embodiments, the first end portion 4811 includes a retention portion 4812. The retention portion 4812 includes a lock surface 4813. The lock surface 4813 is positioned to engage the retention protrusion 4734 (e.g., at least one of the four retention protrusions depicted in FIG. 37) of the rod 4730 of the initialization assembly 4700. The lock surface 4813 is engaged with the retention protrusions 4734 on a condition that the initialization assembly 4700 is in the loaded state SLOA and the first end portion 481 1 is at the first lateral position RSLAPI as depicted in FIG. 37. The retention portion 4812 also includes at least one notch 4814. The notch 4814 is positioned to allow a longitudinal movement of the retention protrusion 4734, and thus the rod 4730, on a condition that the first end portion 4811 is at the second lateral position RSLAP2 as depicted in FIG. 56. Said another ay, the notch 4814 and the lock surface 4813 are arranged such that the movement of the first end portion 4811 toward the second lateral position RSLAP2 (e.g., away from the longitudinal housing axis HALO) moves the lock surface 4813 out of longitudinal alignment while simultaneously moving the notch 4814 into longitudinal alignment with the retention protrusion 4734. The longitudinal alignment of the retention protrusion 4734 with the notch 4814 permits the rod 4730 to move longitudinally in response to the initialization force Fi produced by the initialization spring 4702.

[0343] In some embodiments, the retention portion 4812 also includes a guide ridge 4815. The guide ridge 4815 is positioned to contact the retention protrusion 4734 to preclude a movement of the first end portion 4811 and a lateral direction that is orthogonal to the lateral housing axis HALA. Said another way, the engagement between the guide ridge 4815 and the retention protrusion 4734 can permit movement of the first end portion 4811 only along thelateral housing axis HALA away from the longitudinal housing axis HALO. The engagement between the guide ridge 4815 and the retention protrusion 4734 also precludes a rotational movement of the first end portion 4011 and / or the rod 4730. In some embodiments, such as depicted in FIG. 37, the guide ridge 4815 can be positioned between a pair of notches 4814.

[0344] As depicted in FIG. 36 for example, in some embodiments, the movement of the release strap 4810 within the housing 4100 is within a curved guide path 4125 defined by the housing 4100. To that end, the housing 4100 includes a curved guide surface 4123. The housing 4100 also includes an arcuate guide surface 4124. The curved guide surface 4123 and / or the arcuate guide surface 4124 at least partially define the curved guide path 4125 for the release strap 4810. As depicted, the curved guide surface 4123 is positioned proximally to the arcuate guide surface 4124. Additionally, the arcuate guide surface 4124 is positioned laterally between a first lateral portion of the curved guide surface 4123 and a second lateral portion of the curved guide surface 4123. The second lateral portion of the curved guide surface 4123 can be positioned laterally between the first lateral portion and the longitudinal housing axis HALO. In some embodiments, the arcuate guide surface 4124 can at least partially define the retention hook 4185 of the housing 4100.

[0345] In some embodiments, the curved guide surface 4123 defines a first radius of curvature of the curved guide path 4125. The arcuate guide surface 4124 can define a second radius of curvature of the curved guide path 4125. The second radius of curvature can be in a range of 0.5 to 1.5 times (e.g., 0.75 to 1.25, 0.8 to 1.2, or 0.9 to 1.1) times the first radius of curvature. The first radius of curvature can be concave relative to the longitudinal housing axis HALO while the second radius of curvature currently convex. Accordingly, the curved guide surface 4123 can define a point of maximal separation laterally from the longitudinal housing axis HALO of the curved guide path 4125. Moving longitudinally from the curved guide surface 4123 toward the arcuate guide surface 4124, the curved guide path 4125 reduces a separation distance between the release strap 4810 and the longitudinal housing axis HALO. It should be appreciated that the curved guide path 4125 defines a travel distance of the second end portion 4820 of the release strap 4810 relative to the travel distance of the first end portion 4811 at a ratio of 1: 1.

[0346] Referring now to FIGS. 44-50, in some embodiments the housing 4100 can include a first housing member 4110 (FIGS. 44-46) and a second housing member 4140 (FIG. 47-49). The first housing member 4110 and the second housing member 4140 coupled together to formthe housing 4100. The housing 4100 has a proximal end portion 4101 at a distal end portion 4102. In some embodiments, the league first housing member4110 and / or the second housing member 4140 can define a status indicator aperture 4130. The status indicator aperture(s) 4130 can allow a patient to monitor the status and / or the contents of the medicament container assembly 4200 contained within the housing 4100. For example, by visually inspecting the status indicator aperture 4130, a patient or a medical provider can determine whether the medicament container assembly 4200 contains a medicament, whether the medicament is in the deliverable state and / or whether the medicament has been delivered (e.g.. by the apparatus 4000 has been used).

[0347] As depicted in FIG. 44, the first housing member 4110 includes an outer surface 4113 and an inner surface 4116, and a proximal end portion 4111 and a distal end portion 4112. The outer surface 4113 defines a base retention recess 4134 and base rail groove 4114, at the distal end portion 4112 of the first housing member 4110. The base retention recess 4134 is configured to receive a portion of the base 4510 to establish a travel range of the base 4510 relative to the housing 4100. The base rail groove 4114 is configured to receive a portion of the base 4510 to allow the base 4510 to move only longitudinally relative to the housing 4100. Said another way, the base 4510 engages the base rail groove 4114 in a way that allows the base 4510 to slide in a proximal and / or distal direction while limiting lateral movement of the base 4510 with respect to the housing 4100.

[0348] In some embodiments, the first housing member 4110 further includes a set of latches 4128. The latches 4128 extend from portions of an inner surface 4116 of the first housing member 4110. The first housing member 4110 can include any number of latches 4128 that can have any suitable shape or size. For example, in some embodiments, the latches 4128 vary in size. The latches 4128 are configured to engage portions of the second housing member 4140 to couple the first housing member 41 10 to the second housing member 4140, as described in further detail herein.

[0349] As depicted in FIGS. 45 and 46. the first housing member 4110 includes an inner surface 411 . The inner surface 41 16 is shaped to receive, support and / or guide the movement of the various components and assemblies of the apparatus 4000 described herein. For example, as described herein various guide walls, guide surfaces, plates, and protrusions extend from the inner surface 4116 and define notches and / or passages within the housing 4100. Thevarious guide walls, guide services, protrusions, notches, and / or passages are positioned to affect the operation of the various assemblies described herein.

[0350] As depicted in FIG. 47. the second housing member 4140 the second housing member 4140 includes an outer surface 4143 and an inner surface 4146 and a proximal end portion 4141, a proximal cap 4103, and a distal end portion 4142. The second housing member 4140 further includes a set of tabs 4158. The second housing member 4140 can include any number of tabs 4158 such that the number of tabs 4158 corresponds to the number of latches 4128 of the first housing member 4110. Collectively, the latches 4128 of the first housing member 4110 and the tabs 4158 of the second housing member 4140 couple the first housing member 4110 to the second housing member 4140. Similarly stated, the latches 4128 are configured to engage the tabs 4158 to define a lock fit. Moreover, a surface of each of the latches 4128 is in contact with a surface of the corresponding tab 4158 to define a lock fit such that the first housing member 4110 and the second housing member 4140 collectively define the housing 4100.

[0351] The outer surface 4143 defines a base retention recess 4134 and a base rail groove 4114, at the distal end portion 4142 of the second housing member 4140. The base retention recess 4134 is configured to receive a portion ofthe base 4510 to establish a travel range ofthe base 4510 relative to the housing 4100. The base rail groove 4114 is configured to receive a portion of the base 4510 to allow the base 4510 to move only longitudinally relative to the housing 4100. Said another way, the base 4510 engages the base rail groove 4114 in a way that allows the base 4510 to slide in a proximal and / or distal direction while limiting lateral movement of the base 4510 with respect to the housing 4100.

[0352] The proximal cap 4103 extends from the proximal end portion 4141 of the second housing member 4140 and encloses the proximal end portion 4101 of the housing 4100 when the first housing member 4110 is coupled to the second housing member 4140.

[0353] As depicted in FIGS. 48 and 49, the second housing member 4140 includes an inner surface 4146. The inner surface 4146 is shaped to receive, support and / or guide the movement of the various components and assemblies of the apparatus 4000 described herein. For example, as described herein various guide walls, guide surfaces, plates, and protrusions extend from the inner surface 4146 and define notches and / or passages within the housing 4100. Thevarious guide walls, guide services, protrusions, notches, and / or passages are positioned to affect the operation of the various assemblies described herein.

[0354] As shown in FIG. 50, when the first housing member 4110 and the second housing member 4140 are assembled, the distal end portion 4102 of the housing 4100 defines a needle aperture 4108 through a distal face 4107 of the housing 4100. Similarly stated, the first housing member 4110 and the second housing member 4140 collectively define the needle aperture 4108. The needle aperture 4108 is configured to allow a needle 4216 (FIG. 23) to exit the housing 4100 when the apparatus 4000 is actuated by moving the base 4510 from the first base position BPi toward the second base position BP2 as described herein. Additionally, the needle 4216 can be retracted back into the housing 4100 through the needle aperture 4108 upon completion of the injection, as described in further detail herein.

[0355] In some embodiments, the needle aperture 4108 can also be sized to receive and / or permit the passage of a needle sheath 4250. The needle sheath 4250 is configured to surround and seal the needle 4216 prior to the separation of the case 4190 from the housing 4100. The needle sheath 4250 defines a bore within which to receive the needle 4216. In some embodiments, a needle plug (not shown) can be positioned within the bore to isolate the needle from a surrounding environment. The needle plug can be any suitable material configured to engage a distal end portion 4218 of the needle 4216. For example, in some embodiments, the needle plug can be a cork material or any other suitable porous material (e.g.. any suitable Porex™ material) to allow for exposure to ethylene oxide during a sterilization operation.

[0356] In some embodiments, the needle sheath 4250 includes a rib 4252. The rib 4252 is positioned to be engaged by removal tabs 4195 (FIG. 51) of the case 4190. Being thus engaged, the needle sheath 4250 is removed from around the needle 4216 concurrent with the separation of the case 4190 and the housing 4100. Said another way, the needle sheath 4250 is extracted through the needle aperture 4108 via the separation force Fs applied to the case 4190 and / or an exposed portion of the housing 4100.

[0357] Following the transition of the medicament 4240 from the stored state SSTO to the deliverable state SDEL via the initialization assembly 4700, the medicament 4240 is maintained within the apparatus 4000 until the apparatus 4000 is separately actuated to transition the apparatus 4000 to an actuated state See, FIGS. 21 and 22). To transition the apparatus 4000 to the actuated state, an actuator assembly 4500 is released by a user-supplied force.Specifically, the base 4510 is moved relative to the housing 4100 from a first base position BPi (See, FIGS. 18-20) to a second base position BP2 (See, FIG. 21 and 22). For example, as described herein with reference to FIG. 21, a distal face 4512 of the base 4510, which was exposed by the removal of the case 4190, can be placed in contact a portion of a patient's body PB. With the apparatus 4000 thus positioned, a longitudinal actuation force FA can be applied in a distal direction to move the housing 4100 toward the base 4510 while the base 4510 remains stationary due to the contact with the patient’s body PB. This movement causes a reduction in the separation distance between the base 4510 and the housing 4100 (e.g., a distal face 4107 of the housing 4100 that is positioned within an internal volume 4515 (FIG. 28) defined by the base 4510).

[0358] The actuator assembly 4500 is positioned at least partially within the housing 4100 and is configured to transition the apparatus 4000 to the actuated state from the initialized state. FIGS. 60-77 depict components of the actuator assembly 4500 and their positional and / or functional arrangements with the housing 4100 removed in some views for clarity. In some embodiments, the actuator assembly 4500 includes an activator 4530 and a positioning arm 4550 that is coupled to the rod carrier 4710 of the initialization assembly 4700. The actuator assembly 4500 also includes a positioning spring 4520, which is also referred to herein as a “first spring.” The positioning spring 4520 can be positioned to react from an upper spring plate 4122 (FIG. 46) defined by the housing 4100. Additionally, the actuator assembly 4500 includes a transfer arm 4600 that is operably coupled between the positioning arm 4550 and the positioning spring 4520.

[0359] The actuator assembly 4500 is configured such that upon actuation, the positioning spring 4520 extends to produce a positioning force Fp (FIG. 76) (e.g.. an injection force). The positioning force Fp is transmitted to the positioning arm 4550 via the transfer arm 4600. The positioning force Fp is then transmitted to the rod carrier 4710 via the positioning arm 45500 to move the rod carrier 4710 within the housing 4100 from a first longitudinal position RCLOI (See, FIG. 20) to a second longitudinal position RCLO2 (See, FIG. 24) to position the medicament container assembly 4200 at a position from which the medicament 4240 is dispensed. For example, the movement of the rod carrier 4710 from the first longitudinal position RCLOI to the second longitudinal position RCLO2 can position a distal end portion 4218 of the needle 4216 within the patient’s body BP.

[0360] As depicted in FIGS. 60-62, the positioning spring 4520 is in a compressed state (e.g., an energy' storage state) on a condition that the rod carrier 4710 is at the first longitudinal position RCLOI. In the compressed state, the positioning spring 4520 continuously exerts a force in the distal direction on the positioning arm 4550 via the transfer arm 4600. However, the positioning arm 4550 engages with a portion of the housing 4100 to maintain the rod carrier 4710 at the first longitudinal position RCLOI prior to actuation of the apparatus 4000 (including when the apparatus 4000 is in the stored state and in the initialized state as described herein). Said another way, the engagement between the positioning arm 4550 and the portion of the housing 4100 precludes a movement of the rod carrier 4710 in the distal direction that would otherwise occur in response to the force (e.g., the positioning force) developed by the positioning spring 4520.

[0361] In some embodiments, the positioning arm 4550 includes a latch protrusion 4552 (FIG. 66). The latch protrusion 4552 is sized to engage (e g., be received by) a positioning notch 4120 (FIG. 67) defined by the housing 4100. The positioning notch 4120 can, for example, be defined by the first housing member 4110. The engagement between the latch protrusion 4552 of the positioning arm 4550 and the positioning notch 4120 maintains the rod carrier 4710 at the first longitudinal position RCLOI prior to the transition of the apparatus 4000 to the actuated state. Said another way, the force produced by the positioning spring 4520 is resisted on a condition that the latch protrusion 4552 is positioned within the positioning notch 4120 such that the rod carrier 4710 cannot move distally within the housing 4100. Said yet another way. the engagement between the latch protrusion 4552 and the positioning notch 4120 develops a holding force in opposition to the positioning force Fp.

[0362] In some embodiments, the positioning notch 4120 is, as depicted in FIG. 46, defined by an actuator-assembly guide wall 4117 of the housing 4100 (e.g., the first housing member 41 10). The actuator-assembly guide wall 4117 can extend longitudinally between the positioning arm 4550 and the positioning spring 4520 as depicted, for example, in FIG. 22. In opening of the positioning notch 4120 can be oriented toward an axial midline MLA (See, FIG. 46) of the housing 4100. The axial midline MLA can be defined by the housing 4100 and extend longitudinally between the proximal end portion 4101 and the distal end portion 4102 of the housing 4100.

[0363] To facilitate the reliable actuation of the apparatus 4000, the latch protrusion 4552 can, in some embodiments, be biased to disengage from the positioning notch 4120. The latchprotrusion 4552 can, for example, be biased in a lateral direction toward the axial midline MLA and away from the positioning spring 4520.

[0364] To bias the latch protrusion 4552 out of the positioning notch 4120, in some embodiments, a force transfer (e.g., the positioning force Fp) from the positioning spring 4520 to the positioning arm 4550, via the transfer arm 4600, develops a lateral force vector FVLA (FIGS. 65A and 65B) that acts on the latch protrusion 4552. The lateral force vector FVLA is oriented toward the axial midline MLA and away from the positioning notch 4120. In some embodiments, to facilitate the development of the lateral force vector FELA and, therefore, bias the latch protrusion 4552 out of the positioning notch 4120, at least an engagement surface 4121 of the positioning notch 4120 can be angled. The engagement surface 4121 can be the distal-most face of the positioning notch 4120. The engagement surface 4121 can. for example, be sloped toward the MLA moving distally. Said another way. a radially inner edge of the engagement surface 4121 can be at a longitudinal position that is distal to a radially outer edge of the engagement surface 4121 with the radially inner edge being positioned between the axial midline MLA and the radially outer edge. In some embodiments, the engagement surface 4121 can have an angle A3 that is in a range of 100 degrees to 150 degrees (e.g., 100 to 140 degrees, 105 to 1 15 degrees, 105 to 110 degrees, 110 to 120 degrees) relative a portion of the actuator-assembly guide wall 4117 that extends distally from the positioning notch 4120.

[0365] As depicted in FIG. 66, in some embodiments, a radially outer portion 4554 of the latch protrusion 4552 can include a distal face 4553. The distal face 4553 can be oriented to contact the engagement surface 4121 on a condition that the latch protrusion 4552 is received by the positioning notch 4120. In some embodiments, the distal face 4553 can have an angle in a range of 60 to 80 degrees (e.g., 62 to 72 degrees, 65 to 75 degrees, 70 to 80 degrees) relative to a reference line RL that is parallel to the axial midline MLA. In some embodiments, the angle A4 of the distal face 4553 can be a supplementary angle with angle A3 of the engagement surface 4121. In some embodiments, however, only one of the engagement surface 4121 or the distal face 4553 may be angled to facilitate the development of the lateral force vector FVLA.

[0366] Being that the latch protrusion 4552 is biased to disengage from the positioning notch 4120, the activator 4530 is positioned at a first longitudinal position AVLOI (FIG. 65 A) in contact with the positioning arm 4550 to maintain the engagement prior to the actuation of the apparatus 4000. Said another way, as depicted in FIG. 65 A, the lateral force vector FVLAis countered by the activator 4530 at the first longitudinal position AVLOI. Therefore, absent a resistive force provided by the activator 4530, the latch protrusion 4552 would, by default, move out of the positioning notch 4120 in response to the positioning force that is constantly exerted by the positioning spring 4520. This default towards moving away from the positioning notch, thereby allowing the rod earner 4710 to move distally, improves the reliability of the apparatus 4000 over known alternative apparatuses that requires the activator to exert a force to dislodge a holding member for actuation.

[0367] As depicted in FIGS. 65B and 65C, the activator 4530 is, in some embodiments, movable to a second longitudinal position AVLO2. At the second longitudinal position AVLO2, the activator 4530 is spaced apart from the positioning arm 4550. For example, the activator 4530 can move longitudinally in a proximal direction as depicted by arrow Pl in FIG. 75 (for clarity, the positioning spring 4520 is not shown in FIG. 75). This movement can be in response to a movement of the base 4510 from the first base position BPi toward the second base position BP2. The movement of the activator 4530 from first longitudinal position AVLOI toward the second longitudinal position AVLO2 (e g., the longitudinal movement in the proximal direction) removes the resistive force (e.g., a blocking force) provided by the activator 4530 that had previously maintained the latch protrusion 4552 within the positioning notch 4120. The removal of the resistive force allows the latch protrusion 4552 to move out of the positioning notch 4120 in response to the positioning force Fp exerted by the positioning spring 4520. Being no longer countered by the holding force developed by the engagement between the latch protrusion 4552 and the positioning notch 4120, the positioning force Fp moves the rod carrier 4710 toward the second longitudinal position RCLO2 of the rod carrier 4710.

[0368] As depicted in FIG. 68, a proximal end portion 4531 the activator 4530 includes a holding face 4535. The holding face 4535 is positioned to contact a radially inner portion 4556 (FIG. 66) of the latch protrusion 4552 on a condition that the activator 4530 is at the first longitudinal position AVLOI. The radially inner portion 4556 can, for example, be a surface that faces the axial midline MLA of the housing 4100. In some embodiments, the holding face 4535 has an angle in a range of 2.0 to 6.0 degrees (e.g.. 2.5 to 5.5 degrees. 3.0 to 5.0 degrees, 3.5 to 4.5 degrees) relative to a longitudinal axis AV1.0 of the activator 4530. The angle of the holding face 4535 facilitates the development of the resistive force that is directed radially outward to maintain the engagement between the latch protrusion 4552 and the positioning notch 4120.

[0369] Referring still to FIG. 68, the activator 4530 defines a channel 4533. The channel 4533 extends distally from the proximal end portion 4531. For example, the channel 4533 can extend distally from the holding face 4535. The channel 4533 has a depth sized to receive the latch protrusion 4552 on a condition that the activator 4530 is at the second longitudinal position AVLO2. The depth of the channel 4533 defines a clearance relative to the actuator-assembly guide wall 4117. The clearance is sufficient to permit the longitudinal movement of the positioning arm 4550 and response to the positioning force Fp in the distal direction. The clearance can, for example, be in a range of 105 percent to 125 percent (e.g., 105 to 120 percent, 110 to 115 percent) of a thickness LPr (FIG. 66) of the latch protrusion 4552.

[0370] In some embodiments, the proximal end portion 4531 of the activator 4530 has a first thickness AVTI that is greater than a second thickness AVT2 that extends distally from a first thickness AVTI. The first thickness AVTI can be positioned to contact the radially inner portion 4556 of the latch protrusion 4552. The contact between the first thickness AVTI and the radially inner portion 4556 can maintain the engagement between the latch protrusion 4552 and the positioning notch 4120 prior to the transition of the apparatus 4000 to the actuated state. The activator 4530 can be configured to move proximally relative to the housing 4100. This proximal movement can move the first thickness AVTI away from the radially inner portion 4556 of the latch protrusion 4552 and position the second thickness AVT2 in line therewith to transition the apparatus 4000 to the actuated state. In some embodiments, the proximal movement can correspond to a proximal movement of the base 4510 relative to the housing 4100.

[0371] As further depicted in FIG. 68, in some embodiments, the proximal end portion 4531 of the activator 4530 includes a proximal guide facet 4536. The proximal guide facet 4536 facilitates the lateral positioning of the activator 4530 between the medicament container assembly 4200 and the latch protrusion 4552 during assembly of the apparatus 4000. Additionally, the proximal guide facet 4536 facilitates the maintenance of a clearance between the activator 4530 and the positioning arm 4550 on a condition that the activator 4530 is at the second longitudinal position AV1.02.

[0372] As depicted in FIG. 68 and 69, in some embodiments, the activator 4530 extends in a longitudinal direction from the base 4510. For example, the activator 4530 can extend from the base 4510 to within the housing 4100 to maintain the engagement between the latchprotrusion 4552 and the positioning notch 4120 on a condition that the base 4510 is at the first base position BPi (FIG. 20). The base 4510 can define an internal volume 4515. The internal volume 4515 can be sized to receive the distal end portion 4102 of the housing 4100; though in some embodiments, this can be reversed such that a portion of the base 4510 can be received by the distal end portion 4102 of the housing 4100. A distal end portion 4532 of the activator 4530 can be coupled to the base 4510 within the internal volume 4515 as depicted in FIG. 69. In some embodiments, the base 4510 and activator 4530 can be monolithically formed Being thus coupled / formed, a movement of the base 4510 relative to the housing 4100 from the first base position BPi toward the second base position BP2 moves the activator 4530 (e.g., the proximal end portion 4531) from the first longitudinal position AVLOI toward the second longitudinal position AVLO2. Such a proximal movement of the activator 4530 removes the resistive force thereby permitting the disengagement of the latch protrusion 4552 from the positioning notch 4120 such that the positioning force Fp moves the rod carrier 4710 in the distal direction. Said another way, the base 4510 is movable relative to the housing 4100 to move the activator 4530 from the first longitudinal position AVLOI toward the second longitudinal position AVLO2, which can be proximal to the first longitudinal position AVLOI to transition the apparatus 4000 to the actuated state.

[0373] In some embodiments, a proximal end portion 4572 of the positioning arm 4550 defines a coupling location 4573 (FIG. 59) with the rod carrier 4710, with the positioning arm 4550 extending in a distal direction from the coupling location 4573. In some embodiments, the positioning arm 4550 can be monolithically formed with the rod carrier 4710. As depicted, for example, in FIGS. 63 and 64, the positioning arm 4550, in some embodiments, includes a receiving portion 4570 and a latch arm 4560. The receiving portion 4570 is configured to receive a force (e.g., the positioning force Fp) transferred from the positioning spring 4520 via the transfer arm 4600. As depicted, the latch arm 4560 extends distally from the receiving portion 4570. The latch protrusion 4552 extends from a distal end portion 4562 of the latch arm 4560. The latch arm 4560 has a width LAw that is less than a width RPw of the receiving portion 4570 for example, the width LAw of the latch arm 4560 can be in a range of 10 percent to 20 percent of the width RPw of the receiving portion 4570. The reduced width of the latch arm 4560 can facilitate the disengagement of the latch protrusion 4552 from the positioning notch 4120 in response to the lateral force vector FVLA.

[0374] As depicted in FIG. 65A, in some embodiments, the latch arm 4560 is in a neutral posture on a condition that the latch protrusion 4552 is received by the positioning notch 4120. Therefore, latch arm 4560 is in the neutral posture on a condition that the apparatus 4000 is in the stored state. As depicted in FIG. 65C, the latch arm 4560 is in a flexed posture on a condition that the apparatus 4000 is in the actuated state. Said another way, the 4560 is flexed radially inward toward the axial midline MLA as the latch protrusion 4552 is driven away from the positioning notch 4120 by the lateral force vector FVLA. Maintaining the latch arm 4560 in neutral posture when the apparatus 4000 is in the stored state reduces the potential for material fatigue that could negatively affect the actuation of the apparatus 4000 when desired if the latch arm 4560 were maintain in a flexed position.

[0375] As depicted in FIG. 66, in some embodiments, the thickness LPT of the latch protrusion 4552 is greater than a thickness LAT of the latch arm 4560. The reduced thickness LAT of the latch arm 4560 permits the latch arm 4560 to pass (e.g., move distally) between the proximal end portion 4531 of the activator 4530 and the actuator-assembly guide wall 4117 on a condition that the activator 4530 is at the second longitudinal position AVLO2 and the latch protrusion 4552 is positioned within the channel 4533.

[0376] The positioning arm 4550 is configured to receive the positioning force Fp from the positioning spring 4520 via the transfer arm 4600. Accordingly, the positioning arm 4550, and more specifically the receiving portion 4570, is operably coupled to the transfer arm 4600 on a condition that the rod carrier 4710 is at the first longitudinal position RCLOI (e.g., when the apparatus 4000 is in the stored state and in the initialized state). As depicted in FIG. 70, the transfer arm 4600 includes a first end portion 4610 coupled to a second end portion 4630 via a bendable portion 4660. The first end portion 4610 is configured to be received by the positioning arm 4550 (e.g.. the receiving portion 4570). The second end portion 4630 is configured to receive a force from the positioning spring 4520. To facilitate the operable coupling with the receiving portion 4570, the first end portion 4610 includes a transfer latch 4620. The transfer latch 4620 is sized to be received by a receiving notch 4575 defined by the receiving portion 4570 as depicted in FIG. 64.

[0377] As depicted in FIG. 73, in some embodiments, a radially inner face 4622 of the transfer latch 4620 forms a blended angle A8 with a radially inner face 4661 of the bendable portion 4660. The angle A8 can be in a range of 165 degrees to 175 degrees. As depicted in FIG. 72, in some embodiments, the transfer latch 4620 has a lateral width TLLW that is in arange of 1.5 to 2.0 times a lateral width BPLW of the bendable portion 4660. A portion of the lateral width TLLW of the transfer latch 4620 extends laterally beyond a first lateral face 4662 of the bendable portion 4660 and beyond a second lateral face 4663 of the bendable portion 4660 opposite the first lateral face 4662.

[0378] In some embodiments, the transfer latch 4620 includes a distal face 4621. The distal face 4621 has an angle A9 relative to a longitudinal axis TALO of the transfer arm 4600, which is defined by a guide rod 4650 extending longitudinally from the second end portion 4630. The angle A9 is in a range of 80 degrees to 85 degrees. The angle A9 of the distal face 4621 can bias the transfer latch 4620 out of the receiving notch 4575 (e.g., away from the axial midline MLA) to decouple the transfer and 4600 from the positioning arm 4550. During a longitudinal movement of the rod carrier 4710 from the first longitudinal position RCLOI toward the second longitudinal position RCLO2. the movement of the transfer latch 4620 away from the receiving notch 4575 is precluded by the actuator-assembly guide wall 41 17. Said another way, the actuator-assembly guide wall 4117 is positioned to contact the transfer latch 4620 to fix a position of the transfer latch 4620 relative to the positioning arm 4550 during the movement of the rod carrier 4710 in the distal direction. However, at the second longitudinal position RCLO2, the movement of the transfer latch 4620 away from the receiving notch 4575 is precluded by a blocking protrusion 4410 (FIG. 68) on a condition that the base 4510 is at the second base position BP2 and is permitted from the second longitudinal position on a condition that the base 4510 is at the first base position BPi. The decoupling of the transfer arm 4600 from the positioning arm 4550 operably decouples the positioning spring 4520 from the rod carrier 4710 and, thus, the medicament container assembly 4200. The decoupling, therefore, facilitates the operation of the retraction assembly 4400 as further described herein.

[0379] In some embodiments, the receiving notch 4575 is defined in part by a first receiving protrusion 4576 and a second receiving protrusion 4578, as depicted in FIG. 64. The first receiving protrusion 4576 is separated and a lateral direction from the second protrusion 4578 to define a notch / channel therebetween. The notch / channel has a width that is in a range of 1.05 to 1.15 times the width BPLW of the bendable portion 4660 such that a portion of the bendable portion 4660 is received within the notch / channel on a condition that the transfer latch 4620 is positioned within the receiving notch 4575. Additionally, in some embodiments, at least the first receiving protrusion 4576 includes a proximal surface 4577. The proximal surface 4577 has an angle relative to the axial midline MLA that is in a range of 90.5 degreesto 93 degrees. Said another way, the proximal surface 4577 is sloped toward the transfer arm 4600. Similar to the angle of the distal face 4621, the angle of the proximal surface 4577 can bias the transfer latch 4620 out of the receiving notch 4575 to decouple the transfer and 4600 from the positioning arm 4550 to achieve the same benefits as described.

[0380] Referring to FIG. 70-74, in some embodiments, the transfer arm 4600 includes the guide rod 4650. The guide rod 4650 extends longitudinally from the second end portion 4630 and defines the longitudinal axis TALO of the transfer arm 4600. The guide rod 4650 is sized to be received within the positioning spring 4520 as depicted in FIG. 74. The length of the guide rod 4650 can be at least 80 percent of a compressed length of the positioning spring 4520. Accordingly, the guide rod 4650 can preclude misalignments, such as bulges, of the positioning spring 4520 in a compressed state.

[0381] As depicted in FIG. 72, in some embodiments, the second end portion 4630 of the transfer arm 4600 includes a set of guide protrusions 4632. The guide protrusions 4632 are positioned to engage the housing 4100. The engagement between the guide protrusions 4632 and the housing 4100 precludes a rotation of the transfer arm 4600 about the longitudinal axis TALO of the transfer arm 4600. Additionally, the guide protrusions 4632 facilitate an axial movement of the transfer arm 4600 along the longitudinal axis TALO in response to the force produced by the positioning spring 4520.

[0382] As depicted in FIG. 73, the bendable portion 4660 extends radially from the second end portion 4630 toward the axial midline MLA. The bendable portion 4660 also extends longitudinally from the second end portion 4630 in a proximal direction. Accordingly, the second end portion 4630 is distal to the first end portion 4610. Said another way, the second end portion 4630 is at the distal most portion of the transfer arm 4600. In some embodiments, the bendable portion 4660 defines an angle A7 relative to the longitudinal axis TALO of the transfer arm 4600 that is in a range of 6.0 degrees to 10 degrees.

[0383] The first end portion 4610 of the transfer arm 4600 being separated from the second end portion 4630 by the bendable portion 4660 facilitates the transfer arm 4600 having a first configuration (See FIG. 77) and a second configuration (See FIG 78). The transfer arm 4600 is operably coupled between the positioning spring 4520 and the medicament container assembly 4200 and configured to transfer a force from the positioning spring 4520 to move a container body 4210 of the medicament container assembly 4200 and a distal direction on acondition that the transfer arm 4600 is in the first configuration. The transfer arm 4600 is in the first configuration at a proximal position TALOI (FIG. 20) within the housing 4100. The bendable portion 4660 is in a neutral posture on a condition that the transfer arm 4600 is in the first configuration. The transfer arm 4600 is configured to preclude a transfer of the force from the positioning spring 4520 to the container body 4210 on a condition that the transfer arm 4600 is in a second configuration at a distal position TALO2 (FIG. 27) within the housing 4100. In the second configuration, the bendable portion 4660 is in a flexed posture. By transitioning the bendable portion 4660 from a neutral posture and the first configuration toward the flexed posture in lieu of transferring from a flexed posture to a neutral posture, negative effects of material fatigue are mitigated or precluded and the reliable operable decoupling of the positioning spring 4520 from the medicament container assembly 4200 is beneficially increased.

[0384] Upon the longitudinal movement of the activator 4530, the apparatus 4000 is transitioned to the actuated state from which the apparatus 4000 is automatically further transitioned to the delivery' state (FIG. 76) from which the medicament 4240 is automatically delivered. In some embodiments, the positioning spring 4520 and the initialization spring 4702 operate together to deliver the medicament 4240 from the initialized and actuated apparatus 4000.

[0385] As described above with reference to the initialization assembly 4700. in some embodiments, the initialization spring 4702 is configured to produce the initialization force Fi (FIG. 59) in response to the separation of the case 4190 from the housing 4100. The initialization force Fi drives the of the medicament container assembly 4200 on a condition that the medicament container assembly 4200 is at the first container position MCLOI. AS described above with reference to the actuator assembly 4500, the positioning spring 4520 is configured to produce a positioning force Fp (FIG. 76) in response to the triggering of the actuator assembly, such as via a movement of the base 4510 from the first base position BPi toward the second base position BP2. The positioning force Fp is configured to move the initialized medicament container assembly 4200 within the housing 4100 from the first container position MC1.01 to a second container position MC1.02.

[0386] To deliver from the medicament container assembly 4200 at the second container position MCLO2, in some embodiments, the positioning spring 4520 is configured to produce a first dispensing force FDI (FIG. 24) (e.g., a first portion of a consolidated dispensing force FD(FIG. 77)) that causes a first portion of the medicament 4240 within the medicament container assembly 4200 to be conveyed out of the medicament container assembly 4200. In such embodiments, the initialization spring 4702 is also configured to produce a second dispensing force FD2 (e.g.. a second portion of a consolidated dispensing force FD) that causes a second portion of the medicament 4240 within the medicament container assembly 4200 to be conveyed out of the medicament container assembly 4200. Accordingly, each of the positioning spring 4520 and the initialization spring 4702 perform at least two distinct functions of the operation the of the apparatus 4000.

[0387] In embodiments wherein each of the positioning spring 4520 and the initialization spring 4702 perform more than one function that together ultimately result in the delivery of the initialized medicament, the rod carrier 4710 is movable along the longitudinal housing axis HALO in response to the positioning force Fp and the first dispensing force FDI. The rod 4730 is movable along the longitudinal housing axis HALO relative to the rod carrier 4710 in response to the initialization force Fi and the second dispensing force FD2.

[0388] In some embodiments, the initialization spring 4702 is in a first compressed state SSci (FIG. 16) with a first spring length prior to an initialization of the apparatus 4000. Said another way, the initialization spring 4702 has a stored energy on a condition that the apparatus 4000 is in the stored state as depicted in FIG. 16. The removal of the housing 4100 from the case 4190 can cause the initialization spring 4702 to transition from the first compressed state SSci to a first extended state SSEI that has a second spring length as depicted in FIG. 20. The transition of the initialization spring 4702 from the first compressed state SSci to the first extended state SSEI can produce the initialization force Fi. Said another way, the removal of the housing 4100 from the case 4190 can trigger a transition of the initialization assembly 4700 from the loaded state SLOA to the released state SREL to transition the medicament 4240 from the stored state SSTO to the deliverable state SDEL. In some embodiments, the second spring length is greater than the first spring length.

[0389] As depicted in FIG. 24, in some embodiments, the initialization spring 4702 is configured to transition from the first extended state SSEI to a second compressed state SSc2. The second compressed state SSc2 can have a third spring length, which can be greater than or equal to the first spring length. The transition from the first extended state SSEI to the second compressed state SSc2 can be in response to (e.g., concurrent with) the movement of the medicament container assembly 4200 within the housing 4100 from the first container positionMCLOI toward the second container position MCLO2 via the positioning force Fp. The transition from the first extended state SSEI to the second compressed state SSc2 can absorb a shock load resulting from the movement of the medicament container assembly 4200 from the first container position MCLOI to the second container position MCLO2 via the positioning force Fp. For example, the second container position MCLO2 can correspond to a travel limit hard-stop at which the medicament container assembly 4200 is rapidly decelerated. This deceleration can result in a shock load that would otherwise negatively affect the operation and / or structural integrity of the medicament container assembly 4200 if not absorbed or otherwise dissipated. Therefore, the rod 4730 is movable both longitudinally and distally relative to the rod carrier 4710 such that the initialization spring 4702 can be at least partially re-compressed to absorb at least a portion of the shock load to mitigate or preclude the negative effects of such a preload on the medicament container assembly 4200 and / or the operation of the apparatus 4000.

[0390] Additionally, the initialization spring 4702 can, as depicted in FIG. 25, be configured to transition from the second compressed state SSc2 to a second extended state SSE2. The second extended state SSE2 can have a fourth spring length, which can be greater than or equal to the second spring length. The transition from the second compressed state SSc2 to the second extended state SSE2 can produce the second dispensing force FD2 to deliver a portion of the medicament 4240 from the medicament container assembly 4200. Said another way, in addition to the initialization force Fi, the initialization spring 4702 is also configured to produce the second dispensing force FD2. The second dispensing force FD2 causes a portion of the medicament 4240 within the medicament container assembly 4200 in the deliverable state SDEL to be conveyed out of the medicament container assembly 4200 on a condition that the medicament container assembly 4200 is at the second container position MCLO2 as depicted in FIG. 25.

[0391] As depicted in FIGS. 82 and 83, in some embodiments, the medicament container assembly 4200 includes a first elastomeric member 4221, a second elastomeric member 4225, and a third elastomeric member 4229. Each elastomeric member is positioned within a container body 4210. The container body 4210 includes a proximal end portion 4212, a distal end portion 4213, and a bypass 4220. The bypass 4220 can be a singular channel bypass or can define multiple channels. Although the bypass 4220 is shown in FIGS. 82 and 83 as an external bypass, in other embodiments, the bypass 4220 can be internal to the medicament container and / or a part of the elastomeric member 4225. Said another way, in someembodiments the bypass can be configured such that the outer diameter of the container body 4210 is substantially constant. The bypass 4220 is configured to facilitate the mixing and / or injection of a medicament contained within the container body 4210, as described in further detail herein. In particular, the bypass 4220 is configured to place various volumes within the container body 4210 in fluid communication with each other. In some embodiments, the distal end portion 4213 of the container body 4210 includes a neck 4215. The neck 4215 is configured to engage at least a portion of the carrier 4260 and the needle 4216, as described below.

[0392] In some embodiments, the first elastomeric member 4221 is disposed within a proximal end portion 4212 of the container body 4210. The first elastomeric member 4221 can, therefore, be configured to receive a force (e.g., the initialization force Fi and the dispensing force FD) applied directly thereto by the rod 4730. The second elastomeric member 4225 is disposed between the first elastomeric member 4221 and the third elastomeric member 4229. The second elastomeric member 4225 is spaced apart from the first elastomeric member 4221 on a condition that the medicament 4240 is in the stored state SSTO and is in contact with the first elastomeric member 4221 on a condition that the medicament 4240 is transitioned to the deliverable state SDEL. The third elastomeric member 4229 is disposed within a distal end portion 4213 of the container body 4210. The third elastomeric member 4229 seals the distal end portion 4213 of the container body 4210.

[0393] In some embodiments, the first elastomeric member 4221, a first portion of the container body 4210, and the second elastomeric member 4225 collectively define, at least in part, a first medicament containing portion 4236. The first medicament containing portion 4236 contains a first substance of the medicament on a condition that the medicament is in the stored state SSTO. In some embodiments, the first medicament containing portion 4236 can define a diluent volume. For example, the first medicament containing portion 4236 can contain a medicament diluent, such as, for example, water

[0394] The second elastomeric member 4225. a second portion of the container body 4210, and the third elastomeric member 4229 collectively define, at least in part, a second medicament containing portion 4237. The second medicament containing portion 4237 contains a second substance of the medicament on the condition that the medicament is in the stored state SSTO. In some embodiments, the second medicament containing portion 4237 can define a dry medicament volume. For example, the second medicament containing portion4237 can contain a lyophilized medicament (e.g., any suitable medicament produced via any suitable lyophilizing process).

[0395] The first elastomeric member 4221, the second elastomeric member 4225, and the third elastomeric member 4229 can be of any design or formulation suitable for contact with the medicament (e.g., the diluent contained in the first medicament containing portion 4236 and / or a lyophilized medicament contained in the second medicament containing portion 4237). For example, the elastomeric members 4221, 4225, and 4229 can be formulated to minimize any reduction in the efficacy of the medicament that may result from contact (either direct or indirect) between the elastomeric members 4221, 4225, and 4229 and the medicament. For example, in some embodiments, the first elastomeric member 4221, the second elastomeric member 4225, and the third elastomeric member 4229 can be formulated to minimize any leaching or out-gassing of compositions that may have an undesired effect on the medicament. In other embodiments, the elastomeric members 4221, 4225, and 4229 can be formulated to maintain its chemical stability, flexibility' and / or sealing properties when in contact (either direct or indirect) with the medicament over a long period of time (e.g., for up to six months, one year, two years, five years or longer).

[0396] The initialization force Fi is configured to move the first elastomeric member 4221 toward the second elastomeric member 4225 within the container body 4210 to place the first substance in contact with the second substance to transition the medicament 4240 to the deliverable state SDEL. The first elastomeric member 4221 is at an initialized position EMPI defined in part by a compressibility of the medicament 4240 within the second medicament containing portion 4237 on a condition that the medicament 4240 is in the deliverable state SDEL. The compressibility of the medicament 4240 within the second medicament containing portion 4237 precludes a distal movement of the first elastomeric member 4221 on a condition that the distal end portion 4213 of the container body 4210 is sealed by the third elastomeric member 4229.

[0397] With the third elastomeric member 4229 remaining in a sealed state, the first elastomeric member 4221 can receive the positioning force Fp to move the medicament container assembly 4200 from the first container position MCLOI the second container position MCLO2. Said another way, the positioning force Fp is transmitted to the first elastomeric member 4221 via the rod 4730, in lieu of the force being applied directly to the container body 4210 or a carrier 4260, to move the medicament container assembly 4200 in the distal direction.However, at the second container position MCLO2, the second medicament containing portion 4237 is fluidically coupled to the needle 4216 via a portion of the needle 4216 that is passed through the third elastomeric member 4229 as depicted in FIG. 89. Therefore, the dispensing force FD (e.g., the first dispensing force FDI and the second dispensing force FD2) applied to the first elastomeric member 4221 is no longer resisted by the compressibility of the medicament 4240 within the second medicament containing portion 4237. As a result, the first elastomeric member 4221 (and the second elastomeric member 4225) moves distally from the initialized position EMpi to a delivery position EMP2 (FIG. 83) to dispense the medicament 4240 from the container body 4210.

[0398] Referring to FIGS. 84-89, in some embodiments the container body 4210 is slidably coupled to the carrier 4260. The carrier 4260 is in a first carrier configuration CCi on a condition that the medicament container assembly 4200 is at the first container position MCLOI and the carrier is at a first carrier position CCLOI as depicted in FIG. 15. When the carrier 4260 is in the first carrier configuration CCi, the container body 4210 is fixed relative to the carrier 4260. Said another way. in the first carrier configuration CCi, the carrier 4260 securely holds the container body 4210 such that the container body 4210 is precluded from sliding relative to the carrier 4260. When the carrier 4260 is in the first carrier configuration CCi, the carrier 4260 and the container body 4210 are configured to move in unison in response to the positioning force Fp. For example, the container body 4210 and the carrier 4260 can be configured to move in unison from the first container position MCLOI and the first carrier position CCLOI toward the second container position MCLO2 and a second carrier position CCLO2 in response to the exertion of the positioning force Fp on the first elastomeric member 4221 at the initialized position EMPI.

[0399] The carrier 4260 is configured to transition to a second carrier configuration CC2 at a second carrier position CCLO2 (FIG. 24). The second carrier position CCLO2 can, for example, be a position at which a distal portion 4262 of the carrier 4260 is in contact with a distal end portion 4102 of the housing 4100 such that further longitudinal movement in the distal direction is blocked. With the carrier 4260 transitioned to the second carrier configuration CC2, the container body 4210 is movable in a distal direction relative to the carrier 4260 in response to the positioning force Fp. Said another way, being that in the first carrier configuration CCi the container body 4210 is fixed relative to the carrier 4260, during a longitudinal movement in the distal direction, upon the carrier 4260 first contacting the second carrier position CCLO2,the container body 4210 will be proximal to the second container position MCLO2. Therefore, the transition of the carrier 4260 to the second carrier configuration CC2 slidingly releases the container body 4210 such that the container body 4210 can continue the longitudinal movement to achieve the second container position MCLO2. Additionally, the continued distal movement of the container body 4210 relative to the carrier 4260 couples the container body 4210 to a needle 4216 support by the carrier 4260.

[0400] In some embodiments, the carrier 4260 includes at least one container-release leg 4271. The first carrier configuration CCi and the second carrier configuration CC2 can be defined by a configuration / position of the container-release leg 4271. The container-release leg 4271 includes a container-engagement protrusion 4272. The container-engagement protrusion 4272 is positioned to engage a distal portion of the container body 4210 and preclude a distal movement thereof relative to the carrier 4260 on a condition that the carrier 4260 is in the first carrier configuration CCi. In the second carrier configuration CC2, the container-engagement protrusion 4272 is spaced apart from the container body 4210 such that the container body 4210 is slidable in the distal direction relative to the carrier 4260. Accordingly, as depicted in FIG. 86. the first carrier configuration CCi includes a first position of the container-engagement protrusion 4272 in which the container-engagement protrusion 4272 is in contact with the container body 4210. Therefore, the movement of the container body 4210 in the distal direction is precluded by the container-engagement protrusion 4272 at the first position. As depicted in FIG. 89, the second carrier configuration CC2 includes the second position of the container-engagement protrusion 4272 in which the container-engagement protrusion 4272 is spaced apart from the container body 4210. Therefore, the movement of the container body 4210 in the distal direction is not blocked by the container-engagement protrusion 4272 at the second position. The second position can be radially outward of the first position relative to an axial centerline AXCL of the medicament container assembly 4200.

[0401] In some embodiments, the container-engagement protrusion 4272 is movable from the first position to the second position in response to a transition of the container-release leg 4271 from a holding configuration, as depicted in FIG. 85, to a released configuration as depicted in FIG. 88. The container-release leg 4271 can be splayed radially outward in the released configuration. Therefore, the container-engagement protrusion 4272 is at the first position on a condition that the container-release leg 4271 is in the holding configuration andis at the second position on a condition that the container-release leg 4271 is in the released configuration.

[0402] In some embodiments, the housing 4100 (e.g., the first housing member 4110) defines at least one carrier guide wall 4131 (FIG. 46). The housing 4100 can define a number of carrier guide walls 4131 that matches the number of container-release legs 4271 of the carrier 4260. For example, in some embodiments, the carrier 4260 can include a pair of container-release legs 4271 on either side of the axial centerline AXCL and the housing 4100 can define a pair of carrier guide walls 4131 on either side of the longitudinal housing axis HALO.

[0403] In some embodiments, the earner guide wall 4131 can be angled / flared away from the longitudinal housing axis HALO (e.g.. the axial centerline AXCL of the medicament container assembly 4200) such that a distal end portion of the carrier guide wall 4131 is separated from the longitudinal housing axis HALO by a greater lateral distance than a proximal end portion of the carrier guide wall 4131. The carrier guide wall 4131 is, for example as depicted in FIG. 20, positioned to maintain the container-release leg 4271 in a neutral position on a condition that the carrier 4260 is at the first carrier position CCLOI. A distal movement of the carrier 4260 places the container-release leg 4271 in contact with an orthogonal portion of the housing 4100. Being that the contact halts a further distal movement of the container-release leg 4271. the continued application of the position Fp causes the container-release leg 4271 to move radially outward away from the axial centerline AXCL of the medicament container assembly 4200. Said another way, portions of the carrier guide wall 4131 that are spaced at increasingly greater distances from the longitudinal housing axis HALO facilitate a transition of the container-release leg 4271 to the released configuration.

[0404] In some embodiments, the container-release leg 4271 can be formed such that the released configuration is the default configuration of the carrier 4260 prior to assembly of the apparatus 4000. Said another way, the container-release leg 4271 can be biased toward the released configuration. In such embodiments, the carrier guide wall 4131 can. for example as depicted in FIG. 20, be positioned to maintain the container-release leg 4271 in a compressed configuration on a condition that the carrier 4260 is at the first carrier position CCLOI. A distal movement of the carrier 4260 places the container-release leg 4271 in contact with portions of the carrier guide wall 4131 that are spaced at increasingly greater distances from the longitudinal housing axis HALO, which facilitates a transition of the container-release leg 4271from the compressed configuration to the released configuration. Said another way, during the distal movement from the first carrier position CCLOI toward the second carrier position CCLO2 the container-release leg 4271 returns to the default splayed configuration thereby moving the container-engagement protrusion 4272 away from the container body 4210. The transition from the compressed configuration to the released configuration can correspond to a release of energy stored within the container-engagement protrusion 4272 during the assembly of the apparatus 4000.

[0405] As further depicted in FIG. 84, in some embodiments, the carrier 4260 defines a needle hub 4264. The needle hub 4264 can support the needle 4216. On a condition that the apparatus 4000 is in the stored state or the initialized state, the needle 4216 is fluidically isolated from the medicament 4240 within the container body 4210, while the needle 4216 is fluidically coupled to the medicament 4240 on a condition that the apparatus is in the delivery state. As depicted, the needle hub 4264 is surrounded by a sealing member 4278. The sealing member 4278 can be any suitable member, such as, for example, an O-ring, a set of O-rings, a ridged elastomeric member, a cup seal, a lip seal, a V-ring seal and / or a double-acting seal. The sealing member 4278 can be configured to engage an inner surface of the container body 4210 and a portion of a needle hub 4264 to define a fluidic seal. Said another way, the sealing member 4278 can surround the needle hub 4264 and be surrounded in turn by the container body 4210.

[0406] As depicted in FIG. 86, in some embodiments, the sealing member 4278 is initially positioned within the neck 4215 of the container body 4210. For example, the sealing member 4278 can be positioned longitudinally within the neck 4215 of the container body 4210 on a condition that the container body 4210 is at the first container position MCLOI and the carrier 4260 is at the first carrier position CCLOI. A distal movement of the container body 4210 relative to the carrier 4260 moves the sealing member 4278 proximally within the container body 4210 to aposition that is proximal to the neck 4215. Additionally, in some embodiments, the sealing member 4278 is positioned in contact with the third elastomeric member 4229 following the distal movement of the container body 4210 relative to the carrier 4260. On a condition that the sealing member 4278 is in contact with the third elastomeric member 4229, a portion of the needle 4216 is passed through the third elastomeric member 4229 and into the second medicament containing portion 4237. At which point, medicament container assembly 4200 is fluidically coupled to the needle 4216 such that the medicament 4240 can be deliveredto the patient via the needle 4216. Being that a proximal portion of the needle hub 4264 extends proximally beyond the sealing member 4278, the third elastomeric member 4229 can be configured to receive a portion of the proximal portion of the needle hub 4229 to at least partially absorb a shock load associated with the distal movement of the container body 4210 relative to the carrier 4260.

[0407] Following the delivery of the medicament 4240, the needle 4216 can be withdrawn from the patient's body and retracted within the housing 4100. To that end, the apparatus 4000 includes the retraction assembly 4400 (FIG. 13). The retraction assembly 4400 is configured to position the distal end portion 4218 of the needle 4216 within the housing 4100 following the delivery' of the medicament 4240. The retraction assembly 4400 is configured to mitigate or eliminate a sharps hazard that would otherwise exist if the distal end portion 4218 of the needle 4216 were maintained in an exposed position following the delivery of the medicament 4240.

[0408] In some embodiments, the retraction assembly 4400 includes a retraction spring 4440 positioned within the housing 4100. The retraction spring 4440 can, for example, be a coil spring configured to produce a retraction force FR (FIG. 27). The retraction force FR is configured to move the medicament container assembly 4200 from the second container position MCLO2 toward the first container position MCLOI on a condition that the base 4510 is moved from the second base position BP2 toward the first base position BPi following the delivery of medicament 4240. The return of the base 4510 toward the first base position BPi reverses a previous movement of the base 4510 from the first base position BPi to the second base position BP2 to initiate the injection and subsequent delivery of the dose of the medicament 4240.

[0409] As depicted in FIG. 20, prior to the actuation of the initialized apparatus 4000, the retraction spring 4440 is in a default extended state. A proximal end portion of the retraction spring 4440 is coupled to the carrier 4260. Accordingly, a longitudinal movement of the carrier 4260 in the distal direction in response to the positioning force Fp produced by the positioning spring 4520, compresses the retraction spring 4440. Said another way, a portion of the positioning force Fp is stored by the retraction spring 4440 as potential energy as the retraction spring 4440 is transitioned from the default extended state to a compressed state, such as depicted in FIG. 24. Being that the retraction spring 4440 stores only a portion of the positioning force Fp, the spring constant of the retraction spring 4440 is less than the springconstat of the positioning spring 4520. Said another way, the positioning force Fp produced by the positioning spring 4520 has a magnitude that is greater than the retraction force FR produced by the retraction spring 4440. Therefore, the retraction force FR has insufficient magnitude to affect the longitudinal position of the carrier 4260 while the positioning spring 4520 remains operably coupled thereto via a kinematic chain that includes the transfer arm 4600.

[0410] Being that the retraction force FR has insufficient magnitude to overcome the positioning force Fp, the actuator assembly 4500 is configured to operably decouple the positioning spring 4520 from the positioning arm 4550, and thus, the carrier 4260, following the delivery of the dose of the medicament. Said another way, the transfer arm 4600 is configured to decouple from the rod carrier 4710 on a condition that the rod carrier 4710 is at the second longitudinal position MCLO2 and the base 4510 is moved toward the first base position BPi.

[0411] As previously described, the transfer latch 4620 is biased to disengage from the receiving notch 4575. More specifically, the force (e.g., the positioning force Fp) applied by the positioning spring 4520 on the transfer arm 4600 develops a longitudinal force vector and a lateral force vector acting on the transfer latch 4620. The development of the longitudinal force vector and the lateral force vector is due, at least in part, to the angle A9 (FIG. 73) of the distal face 4621. But for contact with the actuator-assembly guide wall 4117, the transfer latch 4620 would move radially away from the axial midline MLA in response to the lateral force vector as depicted by arrow R1 of FIG. 78.

[0412] To facilitate the operable decoupling of the positioning spring 4520 from the positioning arm 4550, in some embodiments, the actuator-assembly guide wall 4117 defines, at least in part, a release passage 4118 as depicted in FIGS 80A-81. The release passage 4118 is sized to permit the transit of the transfer latch 4620 on the condition that the rod carrier 4017 is at the second longitudinal position RCLO2. When not prevented as described herein, the transit of the transfer latch 4620 at least partially through the release passage 4118 operably decouples the transfer arm 4600 from the rod carrier 4710 as depicted in FIGS. 79. 80B and 81.

[0413] If the operable decoupling were to occur automatically upon achieving the second longitudinal position RCLO2, the needle 4216 could be retracted prior to the delivery of the entirety of the intended dose of the medicament. Therefore, as depicted in FIGS. 80A and 80B,the retraction assembly 4400 includes at least one blocking protrusion 4410 that blocks the release passage 4118 until moved in response to a user action to permit the operable decoupling and subsequent retraction of the needle 4216. In some embodiments, the retraction assembly 4400 can include a pair of blocking protrusion 4410 that are positioned on either side of the bendable portion 4660 of the transfer arm 4600.

[0414] In some embodiments, the blocking protrusion 4410 extends longitudinally within the internal volume 4515 defined by the base 4510. In some embodiments, the blocking protrusion 4410 can be coupled to the base 4510. In some embodiments, the blocking protrusion 4410 and the base 4510 can be monolithically formed. Being thus coupled / formed, the blocking protrusion 4410 is movable in a longitudinal direction concurrent with the base 4510. Accordingly, a proximal end portion 4412 of the blocking protrusion 4410 is positioned to occlude the release passage 4118 on a condition that the base 4510 is at the second base position BP2. Following the injection, the base 4510 is permitted to move away from the housing 4100. This movement positions the proximal end portion 4412 at a longitudinal position that is distal to the release passage 4118. Said another way, the movement of the base 4510 from the second base position BP2 toward the first base position moves the proximal end portion 4412 of the blocking protrusion 4410 out of the release passage 4118 thereby permitting the passage of the transfer latch 4620 at least partially through the release passage 4118 in response to the lateral force vector, which is directed away from the axial midline MLA.

[0415] As depicted in FIG. 14, in some embodiments, the retraction assembly 4400 includes a base spring 4420. The base spring 4420 can, for example, be one of a coil spring (as depicted) or a leaf spring. In some embodiments, the base spring 4420 is axial aligned with the retraction spring 4440. Further, in some embodiments the base spring 4420 and the retraction spring 4440 are monolithically formed. In such an embodiment, the functions of the base spring 4420 can be performed by a distal end portion of a unitary spring member, and the functions of the retraction spring 4440 can be performed by a proximal end portion of the same unitary spring member. In some embodiments, the unitary spring member can extend from a coupling with the carrier 4260, outside of the housing 4100 to a coupling with the base 4510.

[0416] In some embodiments, the base spring 4420 is positioned between a portion of the housing 4100 (e.g., the distal face 4107 (FIG. 50) of the housing 4100) and a portion of the base 4510. The base spring 4420 can, for example, be positioned within the internal volume 4515 defined by the base 4510. The base spring 4420 is configured to produce a base-returnforce FBR (FIG. 27) to bias the base 4510 away from the housing 4100 and toward the first base position BPi. Accordingly, the base spring 4420 can be in an extended state on a condition that the base 4510 is at the first base position BPi and can be transitioned to a compressed state by the movement of the base 4510 toward the second base position BP2 in response to the actuation force FA (FIG. 21). Further, the removal of the actuation force FA and / or the removal of the base 4510 from contact with the patient’s body PB removes the resistance to the extension of the base spring 4420 and, therefore, permits the base 4510 to move toward the first base position BPi. This movement toward the first base position BPi clears the blocking protrusion 4410 from the release passage 4118 to permit the operable decoupling of the positioning spring 4520 from the positioning arm 4550 and the subsequent movement of the carrier 4260 in the proximal direction in response to the retraction force FR produced by the retraction spring 4440.

[0417] As described herein with reference to apparatus 1000 depicted in FIGS. 1-5, the functions of the apparatus 4000 can be driven by the forces produced by a set of four springs. In some embodiments, the apparatus 4000 can, as described herein, include the positioning spring 4520 (e.g., a first spring), the initialization spring 4702 (e.g.. a second spring), the base spring 4420 (e.g., a third spring), and the retraction spring 4440 (e.g., a fourth spring). In some embodiments, the initialization spring 4702 is axially aligned with the longitudinal axis AXCL of the medicament container assembly 4200. The positioning spring 4520 and / or the retraction spring 4440 can be parallel to the longitudinal axis AXCL and separated laterally from the second spring. For example, in some embodiments, the retraction spring 4440 is separated laterally from the initialization spring 4702 and the initialization spring 4702 is between the retraction spring 4440 and the positioning spring 4520. Additionally, in some embodiments, the base spring 4420 can be axially aligned with the retraction spring 4440. Accordingly, in some embodiments, the base spring 4420 and the retraction spring 4440 can be monolithically formed. Alternatively, in some embodiments, the base spring 4420 can be axially aligned with the longitudinal axis AXCL of the medicament container assembly 4200.

[0418] As described herein, the positioning spring 4520 can be disposed within the housing and configured to at least produce a positioning force Fp. The positioning force Fp produced by the positioning spring 4520 can, in some embodiments, move the medicament container assembly 4200 from a first container position MCLOI to a second container position MCLO2 (e.g., a delivery position). The positioning force Fp can move the medicament containerassembly 4200 on a condition that the base 4510 is moved from the first base position BPi to the second base position BP2 to actuate the apparatus following the initialization of the medicament 4240. Although the positioning spring 4520 (which functions as a positioning spring) is shown and described as producing a force to move the medicament container assembly 4200 within the housing 4100, in other embodiments, the positioning spring 4520 can produce a force that moves a needle 4216 from a position within the housing to a position outside of the housing 4100. In other embodiments, the positioning spring 4520 need not function to move the medicament container assembly 4200 or the needle but may only produce a force (referred to as a first dispensing force) to convey the medicament 4240 from the medicament container assembly 4200 as described herein.

[0419] As described herein, the initialization spring 4702 can be configured to produce at least an initialization force Fi. The initialization spring 4702 can be disposed within the housing 4100 and can be a component of an initialization assembly 4700. The initialization assembly 4700 can be operably coupled to the medicament container assembly 4200 (e.g., to a proximal end portion of the medicament container assembly 4200) and can be triggered (e.g., actuated) by the separation of the case 4190 from the housing 4100. The initialization assembly 4700 can include a rod carrier 4710, a rod 4730 (e.g., a piston), and the initialization spring 4702. The rod carrier 4710 is movable along the longitudinal axis HALO of the housing 4100 in response to the positioning force Fp. The rod carrier 4710 defines a bore sized to receive the initialization spring 4702 and at least a portion of the rod 4730. The initialization spring 4702 can be positioned between the rod carrier 4710 and the rod 4730 such that the initialization spring 4702 can act off of the rod carrier 4710 to move the rod 4730 relative to the rod carrier 4710. Said another way, the rod 4730 is movable along the longitudinal axis HALO relative to the rod carrier 4710 in response to the initialization force Fi and the dispensing force FD.

[0420] The initialization spring 4702 is in a first compressed state SSci with a first spring length prior to an initialization of the apparatus 4000. Said another way, the initialization spring 4702 has a stored energy on a condition that the apparatus 4000 is in the stored state. The removal of the housing 4100 from the case 4190 can cause the initialization spring 4702 to transition from the first compressed state SSci to a first extended state SSF.I that has a second spring length. The transition of the initialization spring 4702 from the first compressed state SSci to the first extended state SSEI can produce the initialization force Fi. Said another way, the removal of the housing 4100 from the case 4190 can trigger a transition of the initializationassembly 4700 from a stored state to a released state to transition the medicament 4240 from the stored state SSTO to the deliverable state SDEL. In some embodiments, the second spring length is greater than the first spring length.

[0421] The initialization spring 4702 is configured to transition from the first extended state SSEI to a second compressed state SSc2. The second compressed state SSc2 can have a third spring length, which can be greater than or equal to the first spring length. The transition from the first extended state SSEI to the second compressed state SSc2 can be in response to (e.g., concurrent with) the movement of the medicament container assembly 4200 within the housing 4100 from the first container position MCLOI toward the second container position MCLO2 via the positioning force Fp (i.e., the force produced by the positioning spring 4520). The transition from the first extended state SSEI to the second compressed state SSc2 can absorb a shock load resulting from the movement of the medicament container assembly 4200 from the first container position MCLOI to the second container position MCLO2 via the positioning force Fp. For example, the second container position MCLO2 can correspond to a travel limit hard-stop at which the medicament container assembly 4200 is rapidly decelerated. This deceleration can result in a shock load that would otherwise negatively affect the operation and / or structural integrity of the medicament container assembly 4200 if not absorbed or otherwise dissipated. Therefore, the rod 4730 is movable both longitudinally and distally relative to the rod carrier 4710 such that the initialization spring 4702 can be at least partially re-compressed to absorb at least a portion of the shock load to mitigate or preclude the negative effects of such a preload on the medicament container assembly 4200 and / or the operation of the apparatus 4000.

[0422] Additionally, the initialization spring 4702 can be configured to transition from the second compressed state SSc2 to a second extended state SSE2. The second extended state SSE2 can have a fourth spring length, which can be greater than or equal to the second spring length. The transition from the second compressed state SSc2 to the second extended state SSE2 can produce the dispensing force FD to deliver at least a portion of the medicament 4240 from the medicament container assembly 4200. Said another way. in addition to the initialization force Ft, the initialization spring 4702 is also configured to produce a dispensing force FD. The dispensing force FD causes at least a portion of the medicament 4240 within the medicament container assembly 4200 in the deliverable state SDEL to be conveyed out of the medicament container assembly 4200 on a condition that the medicament container assembly 4200 is at thesecond container position MCLO2. In some embodiments, however, both the positioning spring 4520 in the initialization spring 4702 can produce portions of the dispensing force FD such that portions of the medicament 4240 are dispensed (e.g., delivered) via a corresponding portions of the dispensing force produced by each of the positioning spring 4520 and the initialization spring 4702.

[0423] As described herein, the base spring 4420 can be positioned functionally and / or physically between the housing 4100 and at least a portion of the base 4510. The base spring 4420 can be configured to produce a base-return force FBR. The base-return force FBR can bias the base 4510 away (e.g., distally) from the housing 4100. Said another way, on a condition that the base 4510 is in the second base position BP2, the base-return force FBR can bias the base 4510 toward the first base position BPi. Accordingly, moving the base 4510 from the first base position BPi to the second base position BP2 to actuate the apparatus 4000 requires a force magnitude that is greater than the base-return force FBR. Returning the base 4510 to the first base position BPi from the second base position BP2 can facilitate a movement of the medicament container assembly 4200 from the second container position MCLO2 toward the first container position MCLOI (e.g., in a proximal direction).

[0424] As described herein, the retraction spring 4440 can be positioned within the housing 4100 and configured to produce a retraction force FR. The reaction force FR can move the medicament container assembly 4200 from the second container position MCLO2 toward the first container position MCLOI on a condition that the base 4510 is moved from the second base position BP2 toward the first base position BPi, such as in response to the base-return force FBR. In order to produce the retraction force FR, the retraction spring 4440 can be placed into an energy storage state (e.g., compressed) by a movement of the medicament container assembly 4200 in response to the positioning force Fp. Said another way. a portion of the kinetic energy resulting from a release of the positioning spring 4520 can be absorbed by the retraction spring 4440 as potential energy. The stored potential energy of the retraction spring 4440 can then be discharged following the deliver}' of the medicament 4240, with the discharge being triggered by the movement of the base 4510 from the second base position BP2 toward the first base position BPi.

[0425] Although various embodiments have been described as having particular features and / or combinations of components, other embodiments are possible having a combination of any features and / or components from any of embodiments as discussed above.

[0426] While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

[0427] Although the components and methods described herein are shown and described as being included in device that include a medicament, in other embodiments, any of the components and / or methods described herein can be used in either an actual medicament delivery device or a simulated medicament delivery7device. A simulated medicament delivery7device can. for example, correspond to an actual medicament delivery device and can be used, for example, to train a user in the operation of the corresponding actual medicament delivery device. A simulated medicament delivery device or trainer can be similar to the simulated medicament delivery devices or trainers described in U.S. Patent Publication Number 2008 / 0059133, entitled "Medical Injector Simulation Device,” filed February 27. 2007, which is incorporated herein by reference in its entirety.

[0428] In such embodiments, the simulated medicament delivery7device can simulate the actual medicament delivery7device in any number of ways. For example, in some embodiments, the simulated medicament delivery device can have a shape corresponding to a shape of the actual medicament delivery device, a size corresponding to a size of the actual medicament delivery device and / or a weight corresponding to a weight of the actual medicament delivery7device. Moreover, in some embodiments, the simulated medicament delivery device can include components that correspond to the components of the actual medicament delivery device. In this manner, the simulated medicament delivery device can simulate the look, feel and sounds of the actual medicament delivery device. For example, in some embodiments, the simulated medicament delivery7device can include external components (e g., a housing, a needle guard, a case, or the like) that correspond to external components of the actual medicament delivery device. In some embodiments, the simulated medicament delivery device can include internal components or assemblies that correspond to internal components of the actual medicament delivery device.

[0429] In some embodiments, however, the simulated medicament delivery device can be devoid of a medicament and / or those components that cause the medicament to be delivered(e.g., a needle, a nozzle or the like). In this manner, the simulated medicament delivery device can be used to train a user in the use of the actual medicament delivery' device without exposing the user to a needle and / or a medicament. Moreover, the simulated medicament delivery device can have features to identify it as a training device to prevent a user from mistakenly believing that the simulated medicament delivery device can be used to deliver a medicament. For example, in some embodiments, the simulated medicament delivery device can be of a different color than a corresponding actual medicament delivery device. Similarly, in some embodiments, the simulated medicament delivery device can include a label clearly identifying it as a training device.

[0430] Any of the medicament container assemblies described herein can be any container suitable for storing the compositions disclosed herein. In some embodiments, the medicament container can be a pre-fdled syringe, a pre-filled cartridge, a vial, an ampule or the like. In some embodiments, for example, any of the devices shown and described herein can include components and / or mechanisms to accommodate a pre-filled syringe, similar to the embodiments shown and described in U.S. Patent Application No. 13 / 357,935 (Attorney Docket No. INTJ-009 / 00US 306456-2116). entitled '’Medicament Delivery Devices for Administration of Medicament within a Prefilled Syringe,” filed on the same date herewith, which is incorporated herein by reference in its entirety . In other embodiments, the medicament container can be a container having a flexible wall, such as, for example, a bladder or a blister pack.

[0431] Any of the devices and / or medicament containers show n and described herein can be constructed from any suitable material. Such materials include glass, plastic (including thermoplastics such as cyclic olefin copolymers), or any other material used in the manufacture of prefilled syringes containing medications.

[0432] Any of the devices and / or medicament containers show n and described herein can include any suitable medicament or therapeutic agent. For example, although the medical injectors described above are shown and described is including a multi-chamber medicament container that includes a substantially dry medicament and a diluent, in other embodiments, any of the medicament delivery' devices disclosed herein can include a multi-chamber container that is filled with any suitable substances. For example, in some embodiments, any of the medicament delivery’ devices disclosed herein can include a medicament container (e.g., a cartridge) that separately stores and mixes, upon actuation, two liquid substances. For examplein some embodiments, any of the devices shown and described herein can include a medicament container filled with (in separate chambers) epinephrine and at least one antihistamine (e.g., epinephrine and diphenhydramine, epinephrine and hydroxyzine, epinephrine and cetirizine); an antipsychotic medicament and a benzodiazepine (e.g. haloperidol and diazepam, haloperidol and midazolam, haloperidol and lorazepam); insulin and a GLP-1 analog or incretin mimetic (e.g. insulin and exenatide, insulin and lixisenatide); an NSAID and an opiode (e.g., ketorolac and buprenorphine). Other suitable compositions that can be included in any of the medicament containers and / or devices described herein include pralidoxime chloride and atropine; obidoxime chloride and atropine; epinephrine and atropine; methotrexate and etanercept; methotrexate and adalimumab; and methotrexate and certolizumab. For example, in some embodiments any of the medicament containers and / or devices described herein can include any of the atropine formulations shown and described in PCT application WO 2024 / 243149 “Devices and Methods for Delivering Reconstituted Medicaments,” filed May 20, 2024, which is incorporated herein by reference in its entirety.Glucagon Formulation

[0433] In some embodiments, a composition can include glucagon and / or any pharmaceutically acceptable constituents for use in the medicament delivery' devices disclosed herein. A composition according to an embodiment can be formulated such that the target concentration of glucagon in the solution, either before and / or after being reconstituted upon actuation of the device, is approximately Img / mL. In other embodiments, the target concentration of glucagon in the solution, either before lyophilization and / or after being reconstituted, can be approximately 2 mg / rnL, approximately 1.5 mg / mL, approximately 0.5 mg / mL (e.g., a pediatric dose) or approximately 0.25 mg / mL. In other embodiments a composition can be formulated such that the target concentration of glucagon in the solution, either before lyophilization and / or after being reconstituted upon actuation of the device, is between approximately 0.25 mg / mL and 2 mg / mL, between approximately 0.5 mg / mL and 1 mg / mL, or between approximately 0.8 mg / mL and 1.2 mg / mL.

[0434] In certain embodiments, the concentration (either before lyophilization or upon reconstitution) of glucagon in a glucagon formulation is about Img / mL and the total solute concentration is about 50 mg / mL. For example, in some embodiments, a composition can include glucagon and any suitable bulking agents to increase the total solute concentration inthe glucagon formulation. In this manner, the glucagon formulation can be more effectively lyophilized and / or reconstituted. For example, in some embodiments, as described below, certain bulking agents can be used to improve the stability , solubility and / or efficacy of the composition when reconstituted in any of the devices shown and described herein. In some embodiments, certain bulking agents can be used to produce a visual indicia when the composition is reconstituted (e.g., such agents can allow the reconstituted medicament to be more easily detected by the user).

[0435] In some embodiments, a composition can include a peptide, such as, for example, glucagon and a carbohydrate. In this manner, the stability of the peptide (e.g., glucagon) can be increased during lyophilization and subsequent storage. In particular, the stability' of peptides, such as glucagon, can be increased in an amorphous (i.e. non-crystalline) environment. It is believed that carbohydrates undergoing dehydration create a solid-state environment that is amorphous and exhibits high viscosity when maintained below the glass transition temperature. In addition, carbohydrates contain multiple hydroxyl groups that may form hydrogen bonds with polar groups on a protein or peptide surface in an amorphous solid-state environment. Without being bound by any particular mechanism, when water is removed during lyophilization, such carbohydrates may maintain the hydrogen bonds and preserve the native-like solid state of the polypeptide structure. In certain embodiments, therefore, the glucagon formulations include other excipients, such as, but not limited to carbohydrates. Suitable carbohydrates include, but are not limited to, lactose, trehalose, mannitol, and combinations thereof.

[0436] Additionally, the solubility' of glucagon increases below a pH of 4. In certain embodiments, the glucagon formulations, prior to lyophilization and / or after reconstitution, have a pH of less than about pH 5.0, including less than about pH 4.5, less than about pH 4.0, less than about pH 3.5, less than about pH 3.0, less than about pH 2.5, less than about pH 2.0. In other embodiments of the invention, the glucagon formulations, prior to lyophilization and / or after reconstitution, have a pH range of about pH 1.5 to about pH 5.0, inclusive of all ranges and subranges therebetween, e.g., about pH 2.0 to about pH 4.5, about pH 2.0 to about pH 4.0, about pH 2.0 to about pH 3.5, about pH 2.0 to about pH 3.0, about pH 2.0 to about pH 2.5, about pH 2.5 to about pH 4.5, about pH 2.5 to about pH 4.0, about pH 2.5 to about pH 3.5, about pH 2.5 to about pH 3.0, about pH 3.0 to about pH 4.5, about pH 3.0 to about pH 4.0, about pH 3.0 to about pH 3.5, about pH 3.5 to about pH 4.5. and about pH 3.5 to about pH 4.0.In certain embodiments, the pH of the glucagon formulation is adjusted prior to lyophilization by the addition of a suitable acid, such as hydrochloric acid or citric acid.

[0437] The lyophilized formulations of the present invention may be reconstituted by any suitable diluent or combination of diluent, including, but not limited to, water, sterile water, glycerin, or hydrochloric acid.

[0438] As described above, in some embodiments, a glucagon formulation can include any suitable bulking agents and / or excipients. Table 1 lists the formulations investigated for lyophilization. The formulations set for the below include a concentration of glucagon in the solution, either before lyophilization and / or after being reconstituted, of approximately Img / mL.Table 1:

[0439] Formulation 1 included lactose, which is a known animal-derived excipient. Lactose, which is used in the commercially available glucagon formulations, is a reducing sugar that may destabilize glucagon. Accordingly, Formulations 2 through 5 are lactose-free formulations. Formulation 2 utilized trehalose and mannitol as carbohydrate bulking agents. Formulation 3 included a buffer system of citric acid and sodium citrate, in addition to the carbohydrate bulking agents. Formulation 4 was carbohydrate free, containing only glycine asthe bulking agent. Formulation 5 utilized only mannitol as a bulking agent and included ascorbic acid. All formulations except Formulation 3 employed hydrochloric acid to reduce the solution pH to approximately 3 before lyophilization.

[0440] Trehalose, however, is a non-reducing sugar, and without being bound by any particular mechanism, may potentially increase the stability' of glucagon, prior to lyophilization, during lyophilization, in storage, and / or after reconstitution. In addition to the improved properties of Formulation 3, the absence of any animal-based excipients, such as lactose, make it particularly appealing from a regulatory standpoint, as the FDA has strict guidelines regarding animal-based excipients.

[0441] All five formulations listed in Table 1 were successfully reconstituted with water and resulted in solutions suitable for use in the multi-chambered container closure system of the present invention.

[0442] In some embodiments, the medicament contained within any of the medicament containers shown herein can be a vaccine, such as, for example, an influenza A vaccine, an influenza B vaccine, an influenza A (H1N1) vaccine, a hepatitis A vaccine, a hepatitis B vaccine, a haemophilus influenza Type B (HiB) vaccine, a measles vaccine, a mumps vaccine, a rubella vaccine, a polio vaccine, a human papilloma virus (HPV) vaccine, a tetanus vaccine, a diphtheria vaccine, a pertussis vaccine, a bubonic plague vaccine, a yellow fever vaccine, a cholera vaccine, a malaria vaccine, a smallpox vaccine, a pneumococcal vaccine, a rotavirus vaccine, a varicella vaccine and / or a meningococcus vaccine. In other embodiments, the medicament contained within any of the medicament containers shown herein can be epinephrine. In other embodiments, the medicament contained within any of the medicament containers shown herein can be naloxone, including any of the naloxone formulations described in U.S. Patent Application No. 13 / 036,720, entitled “Medicament Delivery Device for Administration of Opioid Antagonists Including Formulation for Naloxone,” fded on February 28, 2011.

[0443] In other embodiments, the medicament contained within any of the medicament containers shown herein can include insulin, glucagon, human growth hormone (HGH), erythropoiesis-stimulating agents (ESA), DeMab, Interferon and other chronic therapies, or the like. Such formulations can be produced using a general lyophilization process with glucagon (of recombinant origin) using bulking agents, stabilizers, buffers, acidifying agents or otherexcipients comprising of, but not limited to, one or more of the following combinations: lactose, hydrochloric acid; glucose, histidine, hydrochloric acid; trehalose, mannitol, citrate; trehalose, mannitol, hydrochloric acid; trehalose, glycine, hydrochloric acid; Mannitol, ascorbic acid; and Glycine, hydrochloric acid.

[0444] In other embodiments any of the injectors described herein can be filled with and / or used to inject medicament formulations, including lyophilized biologies and / or biopharmaceuticals, such as, for example, canakinumab, certolizumab, golimumab, and / or interleukins, for the treatment of crypyrin associated periodic syndromes, hereditary andioedema, and other auto-immune diseases. In yet other embodiments any of the injectors described herein can be filled with and / or used to inject intranasal biologies, such as glucagon or human growth hormone, formulated for use in an auto injector, for the treatment of musculoskeletal diseases, growth disorders, diabetes & treatment related disorders.

[0445] In other embodiments, any of the injectors described herein can be filled with and / or used to inject an anti-thrombotics, such as LMWH, ULMWH, Xa Inhibitors, biotinylated idraparinux, etc., for either the acute management and / or surgical prophylaxis of deep vein thrombosis and / or pulmonary embolism or for the management of other conditions w hich may require anticoagulation to prevent thromboembolism, such as its use in cardiovascular diseases including atrial fibrillation and ischemic stroke. In another example, in some embodiments an injector according to an embodiment can be filled with and / or used to inject formulations for the treatment of asthma and / or chronic obstructive pulmonary disease.

[0446] In other embodiments, any of the injectors described herein can be filled with and / or used to inject recombinant hyaluronidase.

[0447] In other embodiments, any of the injectors described herein can be filled with and / or used to inject depot medroxyprogesterone acetate for the treatment of infertility .

[0448] In other embodiments, any of the injectors described herein can be filled with and / or used to inject environmental, food, and household allergen formulations for the treatment of allergic disease, specifically for use in immunotherapy.

[0449] In still other embodiments, the medicament contained within any of the medicament containers shown herein can be a placebo substance (i.e., a substance with no active ingredients), such as water.

[0450] The medicament containers and / or medicament delivery devices disclosed herein can contain any suitable amount of any medicament. For example, in some embodiments, a medicament delivery device as shown herein can be a single-dose device containing an amount medicament to be delivered of approximately 0.4 mg. 0.8 mg, 1 mg. 1.6 mg or 2 mg. As described above, the fill volume can be such that the ratio of the delivery volume to the fill volume is any suitable value (e.g., 0.4, 0.6 or the like).

Claims

ClaimsWhat is claimed is:1 . An apparatus, comprising: a housing; a medicament container assembly movably disposed within the housing; a positioning spring disposed within the housing and operably coupled to the medicament container assembly; and an initialization spring disposed within the housing and operably coupled to the medicament container assembly, wherein: the initialization spring is configured to produce an initialization force to initialize the medicament container assembly on a condition that the medicament container assembly is at a first container position, the positioning spring is configured to produce a positioning force to move the medicament container assembly within the housing from the first container position to a second container position following the initialization of the medicament container assembly, the positioning spring is configured to produce a first dispensing force that causes a first portion of a medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position, and the initialization spring is configured to produce a second dispensing force that causes a second portion of the medicament within the medicament container assembly to be conveyed out of the medicament container assembly on the condition that the medicament container assembly is at the second container position.

2. The apparatus of claim 1, further comprising: an initialization assembly operably coupled to the medicament container assembly, the initialization assembly including a rod carrier, a rod, and the initialization spring. wherein: the rod carrier is movable along a longitudinal housing axis in response to the positioning force and the first dispensing force, the rod carrier defines a bore sized to receive the initialization spring and at least a portion of the rod.the rod is movable along the longitudinal housing axis relative to the rod carrier in response to the initialization force and the second dispensing force, and movement of the rod in response to the initialization force initializes the medicament container assembly.

3. The apparatus of claim 2, wherein: the medicament container assembly includes a container body; and the initialization assembly is positioned at least partially within a proximal end portion of the container body.

4. The apparatus of claim 1, wherein: the initialization spring is in a first compressed state having a first spring length prior to an initialization of the apparatus; the initialization spring is configured to transition from the first compressed state to a first extended state having a second spring length to produce the initialization force on a condition that an initialization assembly is in a released state; the initialization spring is configured to transition from the first extended state to a second compressed state having a third spnng length in response to the movement of the medicament container assembly within the housing from the first container position to the second container position in response to the positioning force; and the initialization spring is configured to transition from the second compressed state to a second extended state having a fourth spring length to produce the second dispensing force.

5. The apparatus of claim 4, wherein: the transition of the initialization spring from the first extended state to the second compressed state absorbs a shock load resulting from the movement of the medicament container assembly from the first container position to the second container position via the positioning force.

6. The apparatus of claim 1, wherein: the medicament container assembly includes a first elastomeric member, a second elastomeric member, and a third elastomeric member disposed within a container body, wherein:the first elastomeric member is disposed within a proximal end portion of the container body, the second elastomeric member is disposed between the first elastomeric member and the third elastomeric member and member is spaced apart from the first elastomeric member and the third elastomeric member, the third elastomeric member is disposed within a distal end portion of the container body and seals the distal end portion of the container body, the first elastomeric member, a first portion of the container body, and the second elastomeric member collectively define, at least in part, a first medicament containing portion containing a first substance on a condition that the medicament is in a stored state, the second elastomeric member, a second portion of the container body, and the third elastomeric member collectively define, at least in part, a second medicament containing portion containing a second substance on the condition that the medicament is in the stored state, the initialization force is configured to move the first elastomeric member toward the second elastomeric member within the container body to place the first substance in contact with the second substance to transition the medicament to a deliverable state, the first elastomeric member is at an initialized position defined by a compressibility of the medicament within the second medicament containing portion on a condition that the medicament is in the deliverable state, and the compressibility of the medicament within the second medicament containing portion precluding a distal movement of the first elastomeric member on a condition that the distal end portion of the container body is sealed by the third elastomeric member.

7. The apparatus of claim 6, further comprising: the first elastomeric member is configured to receive the positioning force on the condition that the distal end portion of the container body is sealed by the third elastomeric member to move the medicament container assembly from the first container position to the second container position; andthe first elastomeric member is configured to receive the first dispensing force and the second dispensing force on the condition that the medicament container assembly is at the second container position and the second medicament containing portion is fl radically coupled to a needle through the third elastomeric member.

8. The apparatus of claim 6, wherein: the second substance is selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine, etanercept, exenatide, glucagon, haloperidol, hydroxyzine, insulin, ketorolac, lixisenatide, lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

9. The apparatus of claim 1, further comprising: a carrier movably disposed within the housing, wherein: the medicament container assembly includes a container body, the container body is slidably coupled to the carrier, the carrier is in a first carrier configuration on the condition that the medicament container assembly is at the first container position and the carrier is at a first carrier position, the container body is fixed relative to the carrier on a condition that the carrier is in the first carrier configuration, the container body and the carrier are configured to move in unison from the first container position and the first carrier position toward the second container position and a second carrier position in response to exertion of the positioning force on the medicament container assembly, the carrier is configured to transition to a second carrier configuration at the second carrier position, and the container body is movable in a distal direction relative to the carrier in response to the positioning force on a condition that the carrier is in the second carrier configuration.

10. The apparatus of claim 9, wherein: the distal movement of the container body relative to the carrier couples the container body to a needle supported by the carrier and positions the container body at the second container position.

11. The apparatus of claim 9, wherein: the carrier defines a needle hub; a needle is supported by the needle hub; a sealing member surrounds the needle hub; a distal end portion of the container body includes a neck; the sealing member is positioned within the neck on a condition that the container body and the carrier are at the first container position and the first carrier position; and the sealing member is at least partially positioned proximal to the neck following the distal movement of the container body relative to the carrier.

12. The apparatus of claim 9, wherein: the carrier includes at least one container-release leg; the at least one container-release leg includes a container-engagement protrusion; the first carrier configuration includes a first position of the container-engagement protrusion; the second carrier configuration includes a second position of the containerengagement protrusion; and the movement of the container body in the distal direction is precluded by the container-engagement protrusion at the first position.

13. The apparatus of claim 12. wherein: the container-engagement protrusion is at the first position on a condition that the at least one container-release leg is in a compressed configuration; the housing defines at least one carrier guide wall positioned to maintain the at least one container-release leg in the compressed configuration on a condition that the carrier is at the first carrier position; the container-engagement protrusion is at the second position on a condition that the container-release leg is in a released configuration; andthe at least one carrier guide wall is angled away from a longitudinal axis of the housing to facilitate a transition of the at least one container-release leg from the compressed configuration to the released configuration on a condition that the carrier is moved in a distal direction from the first carrier position to the second carrier position.

14. An apparatus, comprising: a housing; a medicament container assembly movably disposed within the housing; a base movably coupled to the housing, the base being movable relative to the housing between a first base position and a second base position; a positioning spring disposed within the housing, the positioning spring being configured at least to produce a positioning force to move the medicament container assembly from a first container position to a second container position on a condition that the base is moved from the first base position to the second base position; an initialization spring disposed within the housing, the initialization spring being configured to produce an initialization force and a dispensing force, the dispensing force causing at least a portion of a medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position; a base spring positioned between the housing and the base, the base spring being configured to produce a base-return force to bias the base away from the housing toward the first base position; and a retraction spring disposed within the housing, the retraction spring being configured to produce a retraction force to move the medicament container assembly from the second container position to the first container position on a condition that the base is moved from the second base position toward the first base position in response to the base-return force.

15. The apparatus of claim 14, wherein: the initialization spring is axially aligned with a longitudinal axis of the medicament container assembly; the positioning spring and the retraction spring are parallel to the longitudinal axis of the medicament container assembly; and the positioning spring is separated laterally from the initialization spring.

16. The apparatus of claim 15, wherein: the retraction spring is separated laterally from the initialization spring; and the initialization spring is between the retraction spring and the positioning spring.

17. The apparatus of claim 15, wherein: the base spring is axially aligned with the retraction spring.

18. The apparatus of claim 14. wherein: the base spring is one of a coil spring or a leaf spring.

19. The apparatus of claim 14, wherein: the base spring is axially aligned with a longitudinal axis of the medicament container assembly.

20. The apparatus of claim 14, wherein: the base spring and the retraction spring are monolithically formed.

21. The apparatus of claim 14, wherein: the base defines an internal volume sized to receive a distal end portion of the housing; the base spring is positioned outside the housing and within the internal volume defined by the base; and the retraction spring and the base spring are components of a retraction assembly configured to move the medicament container assembly from the second container position to the first container position following the delivery of a medicament from the medicament container assembly.

22. The apparatus of claim 21, wherein: the retraction assembly includes at least one blocking protrusion coupled to the base and extending longitudinally within the internal volume defined by the base; andIl lthe at least one blocking protrusion is positioned to preclude an operable decoupling of the positioning spring from the medicament container assembly on a condition that the base is at the second base position.

23. The apparatus of claim 14, further comprising: an initialization assembly operably coupled to a proximal end portion of the medicament container assembly, the initialization assembly including a rod carrier, a rod, and the initialization spring, wherein: the rod carrier is movable along a longitudinal housing axis in response to the positioning force, the rod carrier defines a bore sized to receive the initialization spring and at least a portion of the rod. and the rod is movable along the longitudinal housing axis relative to the rod earner in response to the initialization force and the dispensing force.

24. The apparatus of claim 23, wherein: the initialization spring is in a first compressed state having a first spring length prior to an initialization of the apparatus; the initialization spring is configured to transition from the first compressed state to a first extended state having a second spring length to produce the initialization force on a condition that an initialization assembly is in a released state; the initialization spring is configured to transition from the first extended state to a second compressed state having a third spring length in response to the movement of the medicament container assembly within the housing from the first container position to the second container position via the positioning force; and the initialization spring is configured to transition from the second compressed state to a second extended state having a fourth spring length to produce the dispensing force.

25. The apparatus of claim 24, wherein: the transition of the initialization spring from the first extended state to the second compressed state absorbs a shock load resulting from the movement of the medicament container assembly from the first container position to the second container position via the positioning force.

26. The apparatus of claim 14, wherein: the positioning spring is configured to produce a first dispensing force that causes a first portion of the medicament within the medicament container assembly to be conveyed out of the medicament container assembly on a condition that the medicament container assembly is at the second container position; and the dispensing force produced by the initialization spring is a second dispensing force and the portion of the medicament is a second portion of the medicament.

27. The apparatus of claim 14, further comprising: a carrier movably disposed within the housing and slidingly coupled to the medicament container assembly, wherein: the medicament container assembly is configured to transmit a portion of the positioning force to the carrier to move the carrier from a first carrier position to a second carrier position, and the medicament container assembly is operably coupled to a needle extending at least partially beyond the base on a condition that the carrier is at the second carrier position and the medicament container assembly is at the second container position.

28. The apparatus of claim 27, wherein: the retraction spring is operably coupled between the housing and the carrier to move the carrier from the second carrier position to the first carrier position on a condition that the positioning spring is operably decoupled from the carrier and the medicament container assembly; and the needle is positioned within the housing on a condition that the carrier is at the first carrier position.

29. A medicament delivery device, comprising: a housing; a medicament container assembly disposed within the housing, the medicament container assembly being movable between a first container position and a second container position in which a container body of the medicament container assembly is coupled to a needle and a distal end portion of the needle is outside the housing;a base movably coupled to the housing, the base being movable relative to the housing between a first base position and a second base position; and a retraction assembly configured to position the distal end portion of the needle within the housing following a delivery of a medicament from the medicament container assembly, the retraction assembly including: a base spring positioned between the housing and the base, the base spring being configured to produce a base-return force to bias the base away from the housing toward the first base position, and a retraction spring disposed within the housing, the retraction spring being configured to produce a retraction force to move the medicament container assembly from the second container position to the first container position on a condition that the base is moved from the second base position toward the first base position in response to the base-return force.

30. The medicament delivery device of claim 29, wherein: the retraction assembly includes at least one blocking protrusion coupled to the base and extending longitudinally within an internal volume defined by the base; and the at least one blocking protrusion is positioned to facilitate a decoupling of the medicament container assembly from a positioning force on a condition that the base is at the first base position following the delivery of the medicament.

31. The medicament delivery device of claim 30, wherein: the positioning force is configured to bias the medicament container assembly toward the base; the retraction force is configured to bias the medicament container assembly away from the base; and a magnitude of the positioning force is greater than a magnitude of the retraction force.

32. The medicament delivery device of claim 29, further comprising: a carrier movably disposed within the housing and shdingly coupled to the container body, wherein the retraction spring is operably coupled between the housing and the carrierto move the carrier from a second carrier position to a first carrier position on a condition that the base is at the first base position following the delivery' of the medicament.

33. The medicament delivery’ device of claim 29, wherein: the base spring is axially aligned with the retraction spring.

34. The medicament delivery' device of claim 29, wherein: the base spring is one of a coil spring or a leaf spring.

35. The medicament delivery' device of claim 29, wherein: the base spring is axially aligned with a longitudinal axis of the medicament container assembly.

36. The medicament delivery' device of claim 29, wherein: the base spring and the retraction spring are monolithically formed.

37. A method for delivering a medicament via a medicament delivery apparatus, the medicament delivery apparatus including a base movably coupled to a housing, a case at least partially surrounding the base and the housing, an initialization assembly, an actuator assembly, and a retraction assembly, the method comprising: applying a separation force to one of the case or an exposed portion of the housing to separate the housing and the case and transition the initialization assembly from a loaded state to a released state; actuating the actuator assembly by causing a reduction in a separation distance between the base and the housing, actuating the actuator assembly transitions the medicament delivery apparatus to an actuated state and causes a medicament container assembly to move from a first container position to a second container position in which a container body of the medicament container assembly is coupled to a needle and a distal end portion of the needle is at least partially outside the housing; actuating the retraction assembly by permitting the base to move relative to the housing in response to a base-return force from a base spring positioned between the housing and the base, the movement of the base reversing the reduction in the separation distance, reversing the reduction of the separation distance permits the medicament container assemblyto return to the first container position in response to a retraction force produced by a retraction spring, the return of the medicament container assembly to the first container position positions the distal end portion of the needle within the housing; and following the return of the medicament container assembly to the first container position, coupling the medicament delivery apparatus to an article of clothing of a patient via a hook defined by the housing.

38. The method of claim 37, wherein: the separation force is a longitudinal force.

39. The method of claim 37, wherein: separating the housing and the case exposes a distal face of the base, and the distal face of the base is configured to contact a portion of a patient’s body.

40. The method of claim 37, further comprising: positioning the base against a portion of a patient’s body following the separation of the housing and the case.

41. The method of claim 40, wherein: actuating the actuator assembly includes applying a longitudinal force to the housing to move the housing toward the base and the patient’s body.

42. The method of claim 37, further comprising: maintaining the reduction in the separation distance throughout the dispensing of the medicament from the medicament container assembly.

43. The method of claim 37, wherein: permitting the base to move relative to the housing in response to the base-return force includes separating the medicament delivery apparatus from a portion of a patient’s body following a dispensing of the medicament.

44. An apparatus, comprising: a housing;a case shaped to receive the housing, the case being removable from the housing; an initialization assembly positioned within the housing and operably coupled to a medicament container, the initialization assembly being configured to transition a medicament within the medicament container from a stored state to a deliverable state; and an initialization actuator assembly operably coupled to the initialization assembly to transition the initialization assembly from a loaded state to a released state, the initialization actuator assembly including a release strap and a trigger protrusion, the release strap having a first end portion removably coupled to the initialization assembly and a second end portion shaped to engage the trigger protrusion, the trigger protrusion being coupled to the case and positioned at least partially within the housing on a condition that the initialization assembly is in the loaded state.

45. The apparatus of claim 44. wherein: the case includes a wall portion surrounding a longitudinal case axis; the wall portion and a base portion define a cavity sized to receive a distal portion of the housing; and the trigger protrusion extends from the base portion into the cavity.

46. The apparatus of claim 45, wherein: at least 50 percent of a surface area of the housing is surrounded by the wall portion on a condition that the housing is received by the case.

47. The apparatus of claim 45, wherein: the case and the housing have an absence of a removable safety7lock.

48. The apparatus of claim 44, wherein: the case defines a longitudinal case axis ; and a longitudinal axis of the trigger protrusion has an angle relative to the longitudinal case axis in a range of one to five degrees.

49. The apparatus of claim 48. wherein: the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis;the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth; the engagement tooth develops a first force vector component parallel to the longitudinal case axis and a second force vector component parallel to the lateral case axis relative to the engagement surface on a condition that a separation force is applied in a longitudinal direction to the case; a movement of the engagement tooth along the lateral case axis in response to the second force vector component is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at a first longitudinal position; and on a condition that the second end portion of the release strap is moved to a second longitudinal position in response to the first force vector component, the engagement tooth moves along the lateral case axis in response to the second force vector component away from the second end portion of the release strap to disengage the trigger protrusion from the release strap.

50. The apparatus of claim 48, wherein: the trigger protrusion includes an engagement tooth extending along a lateral case axis; the lateral case axis is orthogonal to the longitudinal case axis; and a distal face of the engagement tooth has an angle relative to the lateral case axis in a range of -0.5 to -2.0 degrees.

51. The apparatus of claim 50, wherein: the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth; and the trigger protrusion has a length that establishes a separation distance between a distal face of the engagement tooth and the engagement surface of the engagement pocket on a condition that the housing is received within the case.

52. The apparatus of claim 45, wherein: a proximal portion of the trigger protrusion includes at least one guide facet extending parallel to a first lateral case axis; andthe at least one guide facet is positioned to engage a distal most face of the release strap to move the proximal portion of the trigger protrusion along a second lateral case axis during an assembly of the apparatus.

53. The apparatus of claim 52, wherein: the at least one guide facet is a first guide facet; the proximal portion of the trigger protrusion including a second guide facet extending parallel to the second lateral case axis; and the second guide facet is positioned to engage a trigger guide defined by the housing to move the proximal portion of the trigger protrusion along the first lateral case axis during the assembly of the apparatus.

54. The apparatus of claim 45. wherein: the trigger protrusion is tapered such that a proximal portion of the trigger protrusion has a length along a lateral case axis that is less than a length along the lateral case axis of a distal portion of the trigger protrusion.

55. The apparatus of claim 44. wherein: the release strap has a fixed length; and the release strap has a set shape that is elastically deformable.

56. The apparatus of claim 44. wherein: the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto; and the second end portion of the release strap is movable distally from a first longitudinal position to a second longitudinal position to move the first end portion of the release strap from a first lateral position to a second lateral position to transition the initialization assembly from the loaded state to a released state.

57. The apparatus of claim 56, wherein: a travel distance of the second end portion has a ratio of 1 : 1 to a travel distance of the first end portion.

58. The apparatus of claim 44, wherein: the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto: the release strap includes a middle portion between the first end portion and the second end portion; the release strap defines a force transfer plane extending parallel to the longitudinal housing axis; and the second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

59. The apparatus of claim 58, wherein: the second end portion of the release strap includes a travel-limit notch positioned between the engagement pocket and the middle portion of the release strap; and the travel-limit notch is sized to receive a travel-limit protrusion of the housing.

60. The apparatus of claim 58, wherein: the engagement pocket includes an engagement surface; the engagement surface is a cylinder sector; the trigger protrusion includes an engagement tooth sized to be received by the engagement pocket; and a distal face of the engagement tooth is a cylinder sector with a radius that corresponds to a radius of the engagement surface.

61. The apparatus of claim 44, wherein: the first end portion of the release strap is movable relative to the initialization assembly in a first lateral direction; the first end portion of the release strap includes a retention portion; the retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on the condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at a first lateral position;the retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion in a second lateral direction that is orthogonal to the first lateral direction; the retention portion includes a plurality of notches; and the plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is at a second lateral position.

62. The apparatus of claim 44. wherein: the housing includes a curved guide surface and an arcuate guide surface; and the curved guide surface and the arcuate guide surface at least partially define a curved guide path for the release strap.

63. The apparatus of claim 62, wherein: the curved guide surface is positioned proximally to the arcuate guide surface; and the arcuate guide surface is positioned laterally between a first lateral portion of the curved guide surface and a second lateral portion of the curved guide surface.

64. The apparatus of claim 62, wherein: the curved guide surface defines a first radius of curvature of the curved guide path; the arcuate guide surface defines a second radius of curvature of the curved guide path; and the second radius of curvature is in a range of 0.5 to 1.5 times the first radius of curvature.

65. The apparatus of claim 44, wherein: the initialization assembly includes a rod carrier, a rod, and a spring; the rod carrier is movable along a longitudinal housing axis; the rod carrier defines a bore sized to receive the spring and at least a portion of the rod; the rod is movable along the longitudinal housing axis relative to the rod carrier; the rod extends at least partially from the rod carrier on a condition that the initialization assembly is in a released state;the spring is in a compressed state on a condition that the initialization assembly is in the loaded state; a proximal portion of the rod includes a plurality of retention protrusions positioned to engage the first end portion of the release strap to preclude the movement of the rod relative to the rod carrier; and the spring is in an extended state on a condition that the initialization assembly is in the released state.

66. The apparatus of claim 65. further comprising: a first elastomeric member disposed within a proximal end portion of the medicament container; and a second elastomeric member disposed within the medicament container and spaced apart from the first elastomeric member, wherein: the first elastomeric member, a portion of the medicament container, and the second elastomeric member collectively define, at least in part, a first medicament containing portion containing a first substance on a condition that the medicament is in the stored state, the second elastomeric member and a distal end portion of the medicament container collectively define, at least in part, a second medicament containing portion containing a second substance on the condition that the medicament is in the stored state, the rod is configured to move the first elastomeric member toward the second elastomeric member on a condition that the case is separated from the housing to transition the initialization assembly to a released state, and the movement of the first elastomeric member toward the second elastomeric member is configured to place the first substance in contact with the second substance to transition the medicament to the deliverable state.

67. The apparatus of claim 66, wherein: the second substance is selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine. etanercept, exenatide, glucagon, haloperidol, hydroxyzine, insulin, ketorolac, lixisenatide,lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

68. An apparatus, comprising: a housing including a curved guide surface and an arcuate guide surface; a release strap positioned within the housing, the release strap being movable within a curved guide path at least partially defined by the curved guide surface and the arcuate guide surface, the curved guide path having a first radius of curvature and a second radius of curvature of that is in a range of 0.5 to 1.5 times the first radius of curvature; and a case shaped to receive a portion of the housing, the case being operably coupled to the release strap such that when the case is removed from the portion of housing the release strap is moved within the curved guide path to transition an initialization assembly positioned within the housing from a loaded state to a released state, the initialization assembly being configured to transition a medicament within the housing from a stored state to a deliverable state.

69. The apparatus of claim 68, wherein: the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto; the release strap has a first end portion removably coupled to the initialization assembly and a second end portion operably coupled to the case; and the second end portion of the release strap is movable distally from a first longitudinal position to a second longitudinal position to move the first end portion of the release strap from a first lateral position to a second lateral position to transition the initialization assembly from the loaded state to a released state.

70. The apparatus of claim 69, wherein: the curved guide path defines a travel distance of the second end portion relative to a travel distance of the first end portion at a ratio of 1 : 1.

71. The apparatus of claim 68, wherein: the curved guide surface is positioned proximally to the arcuate guide surface; andthe arcuate guide surface is positioned laterally between a first lateral portion of the curved guide surface and a second lateral portion of the curved guide surface.

72. The apparatus of claim 68, wherein: the arcuate guide surface partially defines a retention hook of the housing.

73. The apparatus of claim 68, wherein: the release strap has a fixed length; and the release strap has a set shape that is elastically deformable within the curved guide path.

74. The apparatus of claim 68, wherein: the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto; the release strap defines a force transfer plane extending parallel to the longitudinal housing axis; and a second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

75. The apparatus of claim 74, wherein: the curved guide path is further defined by a travel-limit protrusion of the housing; the second end portion of the release strap includes a travel-limit notch positioned between the engagement pocket and a middle portion of the release strap; and the travel-limit notch is sized to receive the travel-limit protrusion to limit a movement of the release strap within the curved guide path.

76. The apparatus of claim 74, wherein: the engagement pocket includes an engagement surface; and the engagement surface is a cylinder sector shaped to receive an engagement tooth of a trigger protrusion coupled to the case.

77. The apparatus of claim 68, wherein: a first end portion of the release strap is movable within the curved guide path in a first lateral direction; the first end portion of the release strap includes a retention portion; the retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on a condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at a first lateral position; the retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion from the curved guide path; the retention portion includes a plurality of notches; and the plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is at a second lateral position.

78. The apparatus of claim 68, wherein: the case includes a wall portion surrounding a longitudinal case axis; the wall portion and a base portion define a cavity sized to receive a distal portion of the housing; and a trigger protrusion extends from the base portion into the cavity.

79. The apparatus of claim 78, wherein: at least 50 percent of a surface area of the housing is surrounded by the wall portion on a condition that the housing is received by the case.

80. The apparatus of claim 78, wherein: the case and the housing have an absence of a removable safety lock.

81. The apparatus of claim 78, wherein: a longitudinal axis of the trigger protrusion has an angle relative to the longitudinal case axis in a range of one to five degrees.

82. The apparatus of claim 81, wherein: the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis; a second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth; the engagement tooth develops a first vector component parallel to the longitudinal case axis and a second vector component parallel to the lateral case axis relative to the engagement surface on a condition that a separation force is applied to the case; a movement of the engagement tooth along the lateral case axis in response to the second vector component is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at a first longitudinal position; and on a condition that the second end portion of the release strap is moved to a second longitudinal position in response to the first vector component, the engagement tooth moves along the lateral case axis in response to the second vector component away from the second end portion of the release strap to disengage the trigger protrusion from the release strap.

83. The apparatus of claim 82, wherein: the trigger protrusion includes an engagement tooth extending along a lateral case axis; the lateral case axis is orthogonal to the longitudinal case axis; and a distal face of the engagement tooth has an angle relative to the lateral case axis in a range of -0.5 to -2.0 degrees.

84. The apparatus of claim 83, wherein: the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth; and the trigger protrusion has a length that establishes a separation distance between a distal face of the engagement tooth and the engagement surface of the engagement pocket on a condition that the apparatus is in a stored state.

85. The apparatus of claim 78. wherein: a proximal portion of the trigger protrusion includes at least one guide facet extending parallel to a first lateral case axis; andthe at least one guide facet is positioned to engage a distal most face of the release strap to move the proximal portion of the trigger protrusion along a second lateral case axis during an assembly of the apparatus.

86. The apparatus of claim 85, wherein: the at least one guide facet is a first guide facet; the proximal portion of the trigger protrusion including a second guide facet extending parallel to the second lateral case axis; and the second guide facet is positioned to engage a trigger guide defined by the housing to move the proximal portion of the trigger protrusion along the first lateral case axis during the assembly of the apparatus.

87. The apparatus of claim 78. wherein: the trigger protrusion is tapered such that a proximal portion of the trigger protrusion has a length along a lateral case axis that is less than a length along the lateral case axis of a distal portion of the trigger protrusion.

88. A release strap of a medicament delivery apparatus, the release strap comprising: a first end portion removably coupled to an initialization assembly of the medicament delivery apparatus, the first end portion being shaped to preclude a transition of the initialization assembly from a loaded state to a released state on a condition that the first end portion is at a first lateral position within a housing of the medicament delivery apparatus; and a second end portion shaped to engage a trigger protrusion of a case of the medicament delivery apparatus.

89. The release strap of claim 88, wherein: the release strap has a fixed length; and the release strap has a set shape that is elastically deformable within a curved guide path defined by the housing.

90. The release strap of claim 88, wherein: the housing defines a longitudinal housing axis and a lateral housing axis extending orthogonal thereto: the release strap defines a force transfer plane extending parallel to the longitudinal housing axis; and the second end portion of the release strap includes an engagement pocket extending from the force transfer plane in a lateral direction.

91. The release strap of claim 90, wherein: the second end portion of the release strap includes a travel-limit notch positioned between the engagement pocket and a middle portion of the release strap; and the travel-limit notch is sized to receive a travel-limit protrusion of the housing.

92. The release strap of claim 90, wherein: the engagement pocket includes an engagement surface; and the engagement surface is a cylinder sector shaped to receive an engagement tooth of a trigger protrusion coupled to the case.

93. The release strap of claim 88, wherein: the first end portion of the release strap includes a retention portion; the retention portion includes a lock surface positioned to engage a plurality of retention protrusions of the initialization assembly on the condition that the initialization assembly is in the loaded state and the first end portion of the release strap is at the first lateral position; the retention portion includes a plurality of notches; the plurality of notches are positioned to allow a longitudinal movement of the retention protrusions on a condition that the first end portion of the release strap is moved from in a first lateral direction from the first lateral position to a second lateral position; and the retention portion includes a guide ridge positioned to contact at least one retention protrusion of the plurality of retention protrusions to preclude a movement of the first end portion in a second lateral direction orthogonal to the first lateral direction.

94. The release strap of claim 88, wherein: a movement of the release strap within the housing is within a curved guide path; the housing includes a curved guide surface and an arcuate guide surface; and the curv ed guide surface and the arcuate guide surface at least partially define the curved guide path for the release strap; the curved guide surface defines a first radius of curvature of the curved guide path; the arcuate guide surface defines a second radius of curv ature of the curved guide path; and the second radius of curvature is in a range of 0.5 to 1.5 times the first radius of curvature.

95. A method for initializing a medicament delivery apparatus, the medicament delivery apparatus including a housing at least partially surrounded by a case, an initialization assembly positioned within the housing, and an initialization actuator assembly operably coupled to the initialization assembly, the initialization assembly including a trigger protrusion of the case and a release strap, the method comprising: applying a first separation force to one of the case or an exposed portion of the housing to move the case a first distance relative to the housing, the movement of the case the first distance positioning the trigger protrusion in contact with a release strap; applying a second separation force to one of the case or the exposed portion of the housing to move the case a second distance relative to the housing, a portion of the second separation force being transmitted to the release strap via the trigger protrusion, the portion of the second separation force causing the release strap to move within the housing to transition the initialization assembly from a loaded state to a released state; and separating the case from the housing.

96. The method of claim 95, wherein: the movement of the case the first distance provides a haptic indication to an operator of the medicament delivery' apparatus; and a position of the release strap within the housing is unaffected by the movement of the case the first distance.

97. The method of claim 95, wherein: the second separation force has a magnitude in a range of between 0.9 kilograms and2.3 kilograms.

98. The method of claim 95, wherein: the movement of the release strap within the housing in response to the second separation force includes: a movement of a first end portion of the release strap from a first lateral position to a lateral position, and a movement of a second end portion of the release strap from a first longitudinal position to a second longitudinal position.

99. The method of claim 98, wherein: the portion of the second separation force transmitted to the release strap via the trigger protrusion includes a longitudinal force vector and a lateral force vector; the longitudinal force vector causing a movement of a portion of the release strap from a first longitudinal position to a second longitudinal position; and the lateral force vector causing a separation of the trigger protrusion from the release strap on a condition that the second end portion is at the second longitudinal position.

100. The method of claim 99, wherein: a longitudinal axis of the trigger protrusion has an angle relative to a longitudinal case axis in a range of one to five degrees.

101. The method of claim 100, wherein: the trigger protrusion includes an engagement tooth extending along a lateral case axis that is orthogonal to the longitudinal case axis; the second end portion of the release strap includes an engagement surface of an engagement pocket sized to receive the engagement tooth; the engagement tooth develops the longitudinal force vector parallel to the longitudinal case axis and the lateral force vector parallel to the lateral case axis relative to the engagement surface in response to the application of the second separation force;a movement of the engagement tooth along the lateral case axis in response to the lateral force vector is precluded by a trigger guide defined by the housing on a condition that the second end portion of the release strap is at the first longitudinal position; and the engagement tooth moves along the lateral case axis in response to the lateral force away from the second end portion of the release strap to disengage the trigger protrusion from the release strap as the second end portion is moved to the second longitudinal position.

102. The method of claim 95, wherein: the housing defines a curved guide path; the movement of the release strap within the housing in response to the second separation force includes a movement within the curved guide path; and the curv ed guide path defines a travel distance of a second end portion of the release strap relative to a travel distance of a first end portion of the release strap at a ratio of 1 : 1.

103. The method of claim 102, wherein: the movement of the release strap within the curved guide path includes a movement along a curved guide surface defining a first radius of curvature and an arcuate guide surface defining a second radius of curvature that is in a range of 0.5 to 1.5 times the first radius of curvature.

104. The method of claim 102, wherein: the movement of the release strap within the curved guide path has a travel length that is defined by a travel-limit protrusion of the housing that is received by a travel -limit notch of the release strap.

105. The method of claim 95, wherein: the transition of the initialization assembly from the loaded state to the released state transitions a medicament within a medicament container within the housing from a stored state to a deliverable state.

106. The method of claim 105, wherein: the initialization assembly includes a rod carrier, a rod, and a spring; the rod carrier is movable along a longitudinal housing axis;the rod carrier defines a bore sized to receive the spring and at least a portion of the rod; the rod is movable along the longitudinal housing axis relative to the rod carrier; the spring is in a compressed state on a condition that the initialization assembly is in the loaded state prior to the application of the second separation force; a proximal portion of the rod includes a plurality of retention protrusions positioned to engage a first end portion of the release strap to preclude the movement of the rod relative to the rod carrier prior to the application of the second separation force; and the transition of the initialization assembly from the loaded state to the released state in response to the movement of the release strap causes the rod to extend at least partially from the rod carrier in response to a force applied by the spring.

107. The method of claim 106, wherein: the medicament delivery apparatus includes: a medicament container positioned within the housing, a first substance of a medicament positioned within the medicament container, a second substance of the medicament positioned within the medicament container, a first elastomeric member disposed within a proximal end portion of the medicament container, and a second elastomeric member disposed within the medicament container and spaced apart from the first elastomeric member, the second elastomeric member separating the first substance from the second substance on a condition that the medicament is in a stored state; and the extension of the rod moves the first elastomeric member tow ard the second elastomeric member to place the first substance in contact with the second substance to transition the medicament to a deliverable state.

108. An apparatus, comprising: a housing defining a positioning notch having an engagement surface; a rod carrier positioned within the housing, the rod carrier being movable from a first longitudinal position to a second longitudinal position on a condition that the apparatus is transitioned to an actuated state; andan actuator assembly positioned at least partially within the housing, the actuator assembly being configured to transition the apparatus to the actuated state, the actuator assembly including a positioning arm coupled to the rod carrier, a spring, a transfer arm operably coupled between the positioning arm and the spring, and an activator, wherein: an engagement between a latch protrusion of the positioning arm and the positioning notch maintains the rod carrier at the first longitudinal position prior to the transition of the apparatus to the actuated state, an angle of at least the engagement surface biases the latch protrusion out of the positioning notch, the activator is positioned at a first longitudinal position in contact with the positioning arm to maintain the engagement between the latch protrusion and the positioning notch prior to the transition of the apparatus to the actuated state, and the activator is movable to a second longitudinal position apart from the positioning arm to allow the apparatus to transition to the actuated state.

109. The apparatus of claim 108, wherein: the housing defines an axial midline extending longitudinally between a proximal end portion of the housing and a distal end portion of the housing; the housing defines an actuator-assembly guide wall that extends longitudinally between the positioning arm and the spring; the actuator-assembly guide wall defines the positioning notch; and an opening of the positioning notch is oriented toward the axial midline.

110. The apparatus of claim 109, wherein: the latch protrusion is biased in a lateral direction toward the axial midline and away from the spring.

111. The apparatus of claim 109, wherein: a force transfer from the spring to the positioning arm via the transfer arm develops a lateral force vector acting on the latch protrusion; the lateral force vector is oriented toward the axial midline and away from the positioning notch; and the lateral force vector is countered by the activator at the first longitudinal position.

112. The apparatus of claim 109, wherein: the angle of the engagement surface is in a range of 100 degrees to 150 degrees relative to the actuator-assembly guide wall.

113. The apparatus of claim 109, wherein: the latch protrusion includes a distal face; the distal face is positioned to contact the engagement surface on a condition that the latch protrusion is received by the positioning notch; and the distal face is positioned at an angle in a range of 60 degrees to 80 degrees relative to the axial midline.

114. The apparatus of claim 108, wherein: the positioning arm includes a receiving portion and a latch arm; the receiving portion is configured to receive a force transferred from the spring via the transfer arm; the latch arm extends distally from the receiving portion; and the latch protrusion extends from a distal end portion of the latch arm.

115. The apparatus of claim 114, wherein: the latch arm has a width that is in a range of 10 percent to 20 percent of a width of the receiving portion.

116. The apparatus of claim 114, wherein: the latch arm is in a neutral posture on a condition that the latch protrusion is received by the positioning notch: the latch arm is in a flexed posture on a condition that the apparatus is in the actuated state; and a transition from the neutral posture to the flexed posture moves the latch protrusion toward an axial midline defined by the housing.

117. The apparatus of claim 114, wherein: the latch protrusion has a thickness that is greater than a thickness of the latch arm;a radially outer portion of the latch protrusion is shaped to be received by the positioning notch; and a radially inner portion of the latch protrusion is shaped to contact the activator on a condition that the activator is at the first longitudinal position.

118. The apparatus of claim 117, wherein: a proximal face of the radially inner portion has an angle in a range of 110 degrees to 130 degrees relative to the latch arm; the proximal face is positioned to engage the activator on the condition that the activator is at the first longitudinal position; and the engagement between the proximal face and the activator facilitates the maintenance of the engagement betw een the latch protrusion and the positioning notch prior to the transition of the apparatus to the actuated state.

119. The apparatus of claim 108, wherein: a proximal end portion of the positioning arm defines a coupling location with the rod carrier; and the positioning arm extends in a distal direction from the coupling location.

120. The apparatus of claim 108, wherein: the positioning arm and the rod carrier are monolithically formed.

121. The apparatus of claim 108, wherein: a proximal end portion of the activator includes a holding face positioned to contact a radially inner portion of the latch protrusion on a condition that the activator is at the first longitudinal position; and the holding face has an angle in a range of two degrees to 6 degrees relative to a longitudinal axis of the activator.

122. The apparatus of claim 121, wherein: the proximal end portion includes a proximal guide facet; the proximal guide facet facilitates a positioning of the activator during assembly of the apparatus; andthe proximal guide facet maintains a clearance between the activator and the positioning arm on a condition that the activator is at the second longitudinal position.

123. The apparatus of claim 121, wherein: the activator defines a channel that extends distally from the proximal end portion; and the channel has a depth sized to receive the latch protrusion on a condition that the activator is at the second longitudinal position.

124. The apparatus of claim 123, wherein: the depth of the channel defines a clearance relative to an actuator-assembly guide wall of the housing; and the clearance is in a range of 105 percent to 125 percent of a thickness of the latch protrusion.

125. The apparatus of claim 108, further comprising: a base defining an internal volume sized to receive a distal end portion of the housing, wherein: a distal end portion of the activator is coupled to the base within the internal volume, the activator extends in a longitudinal direction from the base into the housing, and the base is movable relative to the housing to move the activator from the first longitudinal position to the second longitudinal position to transition the apparatus to the actuated state.

126. The apparatus of claim 125, wherein: the base and the activator are monolithically formed.

127. The apparatus of claim 125, wherein: the base is configured to move proximally relative to the housing to transition the apparatus to the actuated state; andthe second longitudinal position of the activator is proximal to the first longitudinal position of the activator.

128. The apparatus of claim 125, wherein: a proximal end portion of the activator has a first thickness that is greater than a second thickness that extends distally from the first thickness; the first thickness is positioned to contact a radially inner portion of the latch protrusion to maintain the engagement between the latch protrusion of the positioning arm and the positioning notch prior to the transition of the apparatus to the actuated state; and the base is configured to move proximally relative to the housing to move the first thickness proximally away from the radially inner portion of the latch protrusion to transition the apparatus to the actuated state.

129. The apparatus of claim 108, wherein: the transfer arm includes a first end portion and a second end portion; the first end portion is configured to be received by the positioning arm; and the second end portion is configured to receive a force from the spring.

130. The apparatus of claim 129, wherein: the transfer arm includes a guide rod extending from the second end portion; and the guide rod is sized to be received within the spring.

131. The apparatus of claim 130, wherein: the second end portion includes a plurality of guide protrusions positioned to engage the housing; and the guide rod defines a longitudinal axis of the transfer arm; and the engagement between the plurality of guide protrusions and the housing precludes a rotation of the transfer arm about the longitudinal axis while facilitating an axial movement of the transfer arm along the longitudinal axis.

132. The apparatus of claim 129, wherein the first end portion is separated from the second end portion by a bendable portion;the bendable portion extends radially from the second end portion toward an axial midline of the apparatus defined by the housing; the bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion; and the bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees.

133. The apparatus of claim 132, wherein: the first end portion includes a transfer latch sized to be received by a receiving notch defined by the positioning arm; and a radially inner face of the transfer latch forms a blended angle with a radially inner face of the bendable portion that is in a range of 165 degrees to 175 degrees.

134. The apparatus of claim 133, wherein: the transfer latch has a lateral width that is in a range of 1.5 to 2.0 times a lateral width of the bendable portion; and a portion of the lateral width of the transfer latch extends laterally beyond a first lateral face of the bendable portion and beyond a second lateral face of the bendable portion opposite the first lateral face.

135. The apparatus of claim 133, wherein: the transfer latch includes a distal face; and the distal face has an angle relative to a longitudinal axis of the transfer arm in a range of 80 degrees to 85 degrees.

136. The apparatus of claim 108, wherein: the positioning arm defines a receiving notch; and the receiving notch is sized to receive a transfer latch of the transfer arm.

137. The apparatus of claim 136, wherein: the receiving notch is defined in part by a first receiving protrusion and a second receiving protrusion; andthe first receiving protrusion is separated from the second receiving protrusion in a lateral direction.

138. The apparatus of claim 137, wherein: the first receiving protrusion includes a proximal surface; and the proximal surface of the first receiving protrusion has an angle relative to an axial midline of the apparatus that is in a range of 90.5 degrees to 93 degrees.

139. The apparatus of claim 108, further comprising: a medicament container positioned within the housing coaxially with an axial midline of the apparatus, the medicament container containing a medicament, wherein: the rod carrier is coupled to a proximal end portion of the medicament container, the medicament container is movable within the housing from a first longitudinal container position to a second longitudinal container position in response to a force transferred from the spring to the rod carrier via the transfer arm on the actuation of the apparatus, and the medicament container is configured to dispense the medicament in the second longitudinal container position.

140. The apparatus of claim 139, wherein: the movement of the medicament container places the medicament in fluid communication with a needle; and the force transferred from the spring is an injection force.

141. The apparatus of claim 139, wherein: the transfer arm is decoupled from the rod carrier on a condition that the rod carrier is at the second longitudinal container position; and the medicament container is retracted to the first longitudinal container position via a retraction force applied by a retraction spring on a condition that the transfer arm is decoupled from the rod carrier.

142. The apparatus of claim 141, wherein: the housing defines an actuator-assembly guide wall that is between the positioning arm and the spring; the actuator-assembly guide wall is positioned to contact a transfer latch of the transfer arm to fix a position of the transfer latch relative to the positioning arm during a movement of the rod carrier from the first longitudinal position to the second longitudinal position; the actuator-assembly guide wall defines at least in part a release passage sized to permit the transit of the transfer latch on the condition that the rod carrier is at the second longitudinal position; and the transit of the transfer latch at least partially through the release passage decouples the transfer arm from the rod carrier.

143. The apparatus of claim 142, further comprising: a base defining an internal volume sized to receive a distal end portion of the housing, the base being movable longitudinally relative to the housing between a first base position and a second base position, the base including at least one blocking protrusion extending longitudinally within the internal volume, wherein: the second base position is proximal to the first base position, a proximal end portion of the at least one blocking protrusion occludes the release passage on a condition that the base is at the second base position, and the proximal end portion is positioned distal to the release passage on a condition that the base is at the first base position.

144. The apparatus of claim 143, wherein: a force applied by the spring on the transfer arm develops a longitudinal force vector and a lateral force vector acting on the transfer latch; and the transfer latch is moved radially away from the axial midline in response to the lateral force vector on a condition that the transfer latch is longitudinally aligned with the release passage and the base is at the first base position.

145. An apparatus comprising: a housing;a medicament container assembly disposed within the housing, the medicament container assembly including a container body and an elastomeric member disposed within the container body, an axial centerline of the container body being coaxial with an axial midline of the housing; a spring of an actuator assembly positioned within the housing, the spring being configured to move the container body from a proximal position to a distal position within the housing on a condition that the apparatus is transitioned to an actuated state, an axial centerline of the spring being separated from the axial centerline of the container body; and a transfer arm of the actuator assembly operably coupled between the spring and the medicament container assembly, the transfer arm being configured to transfer a force from the spring to move the container body in a distal direction on a condition that the transfer arm is in a first configuration at a proximal position within the housing, the transfer arm being configured to preclude the transfer of the force from the spring to the container body on a condition that the transfer arm is in a second configuration at a distal position within the housing.

146. The apparatus of claim 145, wherein: the housing defines an actuator-assembly guide wall that is positioned between the container body and the spring; and the actuator-assembly guide wall is positioned to maintain the transfer arm in the first configuration during a movement of the transfer arm from the proximal position within the housing to the distal position within the housing.

147. The apparatus of claim 146, wherein: the actuator-assembly guide wall defines at least in part a release passage sized to permit the transit of a portion of the transfer arm in a direction radially away from the axial midline of the container body to transition the transfer arm from the first configuration to the second configuration on a condition that the transfer arm is at the distal position within the housing.

148. The apparatus of claim 147, further comprising: a base defining an internal volume sized to receive a distal end portion of the housing, the base being movable longitudinally relative to the housing between a first base positionand a second base position, the base including at least one blocking protrusion extending longitudinally within the internal volume, wherein: the second base position is proximal to the first base position, a proximal end portion of the at least one blocking protrusion occludes the release passage on a condition that the base is at the second base position, the transfer arm is maintained in the first configuration on a condition that the at least one blocking protrusion includes the release passage, and the proximal end portion is positioned distal to the release passage on a condition that the base is at the first base position.

149. The apparatus of claim 148, wherein: the actuator assembly includes a positioning arm operably coupled between the transfer arm and the container body; a first end portion of the transfer arm includes a transfer latch; the transfer latch is received by a receiving notch defined positioning arm on a condition that the transfer arm is in the first configuration; a force applied by the spring on the transfer arm develops a longitudinal force vector and a lateral force vector acting on the transfer latch; and the transfer latch is moved radially away from the axial midline of the container body in response to the lateral force vector on a condition that the transfer latch is longitudinally aligned with the release passage and the base is at the first base position.

150. The apparatus of claim 145, further comprising: a rod carrier positioned within the housing and coupled to a proximal portion of the container body, the rod carrier being operably positioned between the transfer arm and the container body.

151. The apparatus of claim 150, wherein: the actuator assembly includes a positioning arm coupled to the rod carrier; and a first end portion of the transfer arm is removably coupled to the positioning arm on the condition that the transfer arm is in the first configuration.

152. The apparatus of claim 151, wherein: the transfer arm includes a second end portion separated from the first end portion by a bendable portion; the bendable portion extends radially from the second end portion toward the axial midline of the container body; the bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion; and the bendable portion is in a deflected pose relative to the second end portion on the condition that the transfer arm is in the second configuration.

153. The apparatus of claim 152, wherein: the transfer arm includes a guide rod extending from the second end portion; the guide rod is sized to be received within the spring; the guide rod defines a longitudinal axis of the transfer arm; and the bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees on the condition that the transfer arm is in the first configuration.

154. An actuator assembly for a medicament delivery device, the actuator assembly comprising: a spring having a first length on a condition that the actuator assembly is in a ready configuration and a second length that is greater than the first length on a condition that the actuator assembly is in an actuated configuration; a positioning arm operably coupled to a container body of a medicament container assembly within a housing of the medicament delivery device, the positioning arm being configured to maintain the container body at a first longitudinal container position on the condition that the actuator assembly is in the ready configuration; a transfer arm operably coupled between the positioning arm and the spring, the transfer arm being configured to transfer a force from the spring to the positioning arm to move in a distal direction the container body within the housing on the condition that the actuator assembly is in the actuated configuration; and an activator, the activator being positioned at a first longitudinal position in contact with the positioning arm to preclude a movement of the positioning arm on the condition thatthe actuator assembly is in the ready configuration, the activator being movable to a second longitudinal position to transition the actuator assembly to the actuated configuration.

155. The actuator assembly of claim 154, wherein: the housing defines a positioning notch; and an engagement between a latch protrusion of the positioning arm and the positioning notch maintains the container body at the first longitudinal container position prior to the transition of the actuator assembly to the actuated configuration.

156. The actuator assembly of claim 155, wherein: the latch protrusion is biased in a lateral direction toward an axial midline of the container body and away from the spring.

157. The actuator assembly of claim 155, wherein: a force transfer from the spring to the positioning arm via the transfer arm develops a lateral force vector acting on the latch protrusion; the lateral force vector is oriented toward an axial midline of the container body and away from the positioning notch; and the lateral force vector is countered by the activator at the first longitudinal position.

158. The actuator assembly of claim 155, wherein: the latch protrusion includes a distal face; the distal face is positioned to contact an engagement surface of the positioning notch on a condition that the latch protrusion is received by the positioning notch; and the distal face is positioned at an angle in a range of 60 degrees to 80 degrees relative to an axial midline of the container body.

159. The actuator assembly of claim 154, wherein: the positioning arm includes a receiving portion and a latch arm; the receiving portion is configured to receive a force transferred from the spring via the transfer arm; the latch arm extends distally from the receiving portion; and a latch protrusion extends from a distal end portion of the latch arm.

160. The actuator assembly of claim 159, wherein: the latch arm has a width that is in a range of 10 percent to 20 percent of a width of the receiving portion.

161. The actuator assembly of claim 159, wherein: the latch arm is in a neutral posture on a condition that the latch protrusion is received by a positioning notch of the positioning arm; the latch arm is in a flexed posture on a condition that the actuator assembly is in the actuated configuration; and a transition from the neutral posture to the flexed posture moves the latch protrusion toward an axial midline defined by the container body.

162. The actuator assembly of claim 159, wherein: the latch protrusion has a thickness that is greater than a thickness of the latch arm; a radially outer portion of the latch protrusion is shaped to be received by a positioning notch of the positioning arm; and a radially inner portion of the latch protrusion is shaped to contact the activator on a condition that the activator is at the first longitudinal position.

163. The actuator assembly of claim 162, wherein: a proximal face of the radially inner portion has an angle in a range of 110 degrees to 130 degrees relative to the latch arm; the proximal face is positioned to engage the activator on the condition that the activator is at the first longitudinal position; and the engagement between the proximal face and the activator facilitates the maintenance of the engagement between the latch protrusion and the positioning notch prior to the transition of the actuator assembly to the actuated configuration.

164. The actuator assembly of claim 154, wherein: a rod carrier is coupled to a proximal end portion of the container body;a proximal end portion of the positioning arm defines a coupling location with the rod carrier; and the positioning arm extends in a distal direction from the coupling location.

165. The actuator assembly of claim 154, wherein: a proximal end portion of the activator includes a holding face positioned to contact a radially inner portion of a latch protrusion of the positioning arm on a condition that the activator is at the first longitudinal position; and the holding face has an angle in a range of two degrees to 6 degrees relative to a longitudinal axis of the activator.

166. The actuator assembly of claim 165, wherein: the activator defines a channel that extends distally from the proximal end portion; and the channel has a depth sized to receive the latch protrusion on a condition that the activator is at the second longitudinal position.

167. The actuator assembly of claim 165. wherein: a distal end portion of the activators coupled to a base within an internal volume defined by the base; the internal volume sized to receive a distal end portion of the housing; the activator extends in a longitudinal direction from the base into the housing; and the base is movable relative to the housing to move the activator from the first longitudinal position to the second longitudinal position to transition the actuator assembly to the actuated configuration.

168. The actuator assembly of claim 167, wherein: a proximal end portion of the activator has a first thickness that is greater than a second thickness that extends distally from the first thickness; the first thickness is positioned to contact the radially inner portion of the latch protrusion to maintain an engagement between the latch protrusion of the positioning arm and a positioning notch of the housing prior to the transition of the actuator assembly to the actuated configuration; andthe base is configured to move proximally relative to the housing to move the first thickness proximally away from the radially inner portion of the latch protrusion to transition the actuator assembly to the actuated configuration.

169. The actuator assembly of claim 154, wherein: the transfer arm includes a first end portion and a second end portion; the first end portion is configured to be received by the positioning arm; and the second end portion is configured to receive a force from the spring.

170. The actuator assembly of claim 169, wherein: the transfer arm includes a guide rod extending from the second end portion; and the guide rod is sized to be received within the spring.

171. The actuator assembly of claim 170, wherein: the second end portion includes a plurality of guide protrusions positioned to engage the housing; and the guide rod defines a longitudinal axis of the transfer arm; and the engagement between the plurality of guide protrusions and the housing precludes a rotation of the transfer arm about the longitudinal axis while facilitating an axial movement of the transfer arm along the longitudinal axis.

172. The actuator assembly of claim 169. wherein the first end portion is separated from the second end portion by a bendable portion; the bendable portion extends radially from the second end portion toward an axial midline of the container body defined by the housing; the bendable portion extends longitudinally from the second end portion in a proximal direction such that the second end portion is distal to the first end portion; and the bendable portion defines an angle relative to a longitudinal axis of the transfer arm that is in a range of 6 degrees to 10 degrees.

173. The actuator assembly of claim 172. wherein: the first end portion includes a transfer latch sized to be received by a receiving notch defined by the positioning arm; anda radially inner face of the transfer latch forms a blended angle with a radially inner face of the bendable portion that is in a range of 165 degrees to 175 degrees.

174. The actuator assembly of claim 173, wherein: the transfer latch has a lateral width that is in a range of 1.5 to 2.0 times a lateral width of the bendable portion; and a portion of the lateral width of the transfer latch extends laterally beyond a first lateral face of the bendable portion and beyond a second lateral face of the bendable portion opposite the first lateral face.

175. The actuator assembly of claim 173, wherein: the transfer latch includes a distal face; and the distal face has an angle relative to a longitudinal axis of the transfer arm in a range of 80 degrees to 85 degrees.

176. The actuator assembly of claim 154, wherein: the positioning arm defines a receiving notch; and the receiving notch is sized to receive a transfer latch of the transfer arm.

177. The actuator assembly of claim 176, wherein: the receiving notch is defined in part by a first receiving protrusion and a second receiving protrusion; and the first receiving protrusion is separated from the second receiving protrusion in a lateral direction.

178. The actuator assembly of claim 177, wherein: the first receiving protrusion includes a proximal surface; and the proximal surface of the first receiving protrusion has an angle relative to an axial midline of the container body that is in a range of 90.5 degrees to 93 degrees.

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