Activatable injection device for drug delivery

Abstract

To provide an injection device which can be safely and reliably activated for self-administering a drug.SOLUTION: An injection device 410 may include: a housing 412 having an opening 414; a drug storage container 420 including a delivery member 416 with an insertion end 428 configured to extend at least partially through the opening; and a plunger 426. A drive mechanism 430 may be included for expelling a drug from the drug storage container through the delivery member. The drive mechanism may be activated by: a guard member movably disposed in the opening in the housing; an activator member movable independently of the guard member and which may be movably disposed in the opening of the housing, and / or a portion of the housing that is moveable relative to another portion of the housing.SELECTED DRAWING: Figure 6

Description

Technical Field

[0001] Cross - Reference to Related Applications Priority is claimed to U.S. Provisional Patent Application No. 62 / 895,041, filed on September 3, 2019, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to injectors for drug delivery, and more specifically to the activation of such devices.

Background Art

[0003] Patients receive drugs to treat various medical conditions. Some drugs are administered via oral, topical, or inhalation routes, while other drugs are administered by injection. Injection involves piercing the patient's skin with a delivery member such as a needle or cannula and pumping the drug into the patient through the delivery member.

[0004] Conventionally, syringes have been used to administer injectable drugs. The use of a syringe requires manually inserting a needle into the skin and then manually pushing a plunger to expel the drug through the needle into the patient. Performing these steps requires dexterity and skill, and self - administration with a syringe can be difficult for certain individuals. Syringes also carry the risk of accidental needle sticks because the needle can be exposed before and after injection.

[0005] To facilitate self - administration, certain injectors automate various aspects of the injection process and include a drive mechanism that complies with these objectives. Generally, it is desirable for the activation of the drive mechanism to be intuitive for the patient and to involve relatively few steps. Also, it is desirable for any activation mechanism to be able to interact with the drive mechanism without adding excessive complexity or cost to the device. Achieving these and other objectives, such as providing an elongated pen - like shape in the case of an auto - injector, presents various design and manufacturing challenges.

[0006] The present disclosure describes an infusion device that embodies an advantageous alternative to existing infusion devices, can address one or more of the problems or needs described herein, and can provide other benefits and advantages. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] One aspect of the present disclosure provides an infusion device including a housing, a drug reservoir, a plunger, a biasing member, and a guard member. The housing may have an opening, and the drug reservoir may include a delivery member having an insertion end configured to at least partially extend through the opening of the housing. The biasing member is operatively coupled to the plunger and may initially be held in an excited state. Releasing the biasing member may drive the plunger by the biasing member to discharge the drug from the drug reservoir through the delivery member. The guard member may have a skin contact portion and an actuator portion. Further, the guard member may be movable relative to the housing, and may have an extended position where the guard member at least partially extends through the opening of the housing, and a retracted position where the guard member moves away from the extended position and is disposed toward the housing. Moving the guard member from the extended position to the retracted position may enable the actuator portion to release the biasing member, and the biasing member to drive the plunger to discharge the drug from the drug reservoir.

[0008] Another aspect of the present disclosure provides an injection device including a housing, a drug storage container, a plunger, a drive mechanism, a guard member, and an actuator member. The housing may have an opening, and the drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening of the housing. The drive mechanism may be operable to expel the drug from the drug storage container through the delivery member. The guard member may be movable relative to the housing and may have an extended position where the guard member extends at least partially through the opening of the housing and a retracted position where the guard member is spaced from the extended position and disposed toward the housing. The actuator member may be movable relative to the housing independently of the movement of the guard member.

[0009] A further aspect of the present disclosure provides an injection device including a distal housing, a drug storage container, a plunger, a drive mechanism, and a proximal housing. The distal housing may have an opening, and the drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening of the distal housing. The drive mechanism may be operable to drive the plunger in a distal direction to expel the drug from the drug storage container through the delivery member. The proximal housing may be operatively coupled to the drive mechanism and may be movable relative to the distal housing such that movement of the proximal housing in the distal direction causes the drive mechanism to operate.

[0010] The present disclosure is considered to be more fully understood by interpreting the following description in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. Such omissions of elements in some of the drawings do not necessarily represent the presence or absence of a particular element in any of the exemplary embodiments, except as explicitly described in the corresponding written description. Further, the drawings are not necessarily drawn to scale.

Brief Description of the Drawings

[0011]

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Mode for Carrying Out the Invention

[0012] The present disclosure generally relates to an infusion device that can be safely and reliably activated for a user to administer a drug or, if the patient is the user, for self - administration of a drug. Certain embodiments herein enable a user to activate or unlock a drive mechanism by pressing the infusion device against an infusion site. Thus, after placing the infusion device at the infusion site, the user does not need to change their grip and / or use a second hand to activate or unlock the drive mechanism. This simplifies the use of the device and reduces the likelihood of mis - infusion or sub - optimal infusion.

[0013] FIG. 1 is a schematic view of an infusion device 10 according to one embodiment of the present disclosure. The infusion device 10 may be configured as a single - use disposable injector or as a multi - use reusable injector. The infusion device 10 may be configured to inject any suitable drug or combination of drugs. The infusion device 10 may be for self - administration, but may also be used by a caregiver or a healthcare provider (e.g., a physician or a nurse) formally trained to manage the infusion. In some embodiments, the infusion device 10 may be configured as an auto - injector or a pen - type injector and may thus be held in the user's hand over the time required for drug delivery. In embodiments where drug delivery may be delayed or may take several minutes or hours, the infusion device 10 may be configured as a body - worn injector (e.g., a patch injector) that can be removably attached to the patient's skin, for example, via an adhesive.

[0014] As shown in FIG. 1, the injection device 10 includes an outer casing or housing 12. In some embodiments, the housing 12 may be sized and dimensioned to allow a person to grasp the injector 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylindrical shape extending along a longitudinal axis A between a proximal end and a distal end. An opening 14 may be formed at the distal end to allow the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window may be disposed in the wall of the housing 12 to allow a user to view the internal components of the injection device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window, the user can confirm that drug delivery is in progress and / or has been completed. A removable cap (not shown) may cover the opening 14 prior to use of the injection device 10 and, in certain embodiments, may be coupled to a sterilization barrier (e.g., a rigid needle shield) attached to the insertion end 28 of the delivery member 16 to assist in its removal.

[0015] The drug storage container 20 is disposed within the interior space of the housing 12 and is configured to contain a drug 22. The drug storage container 20 may be prefilled and delivered, for example, by a manufacturer, or alternatively, filled by a user prior to use of the injection device 10. The housing 12 may be preloaded with the drug storage container 20, for example, by a manufacturer, or alternatively, loaded by a user prior to use of the injection device 10. The drug storage container 20 may include a rigid wall defining an interior bore or reservoir. The wall may be made of glass or plastic. In some embodiments, the drug storage container 20 may have a flexible or deformable wall and may take the form of a collapsible pouch or bladder. In the illustrated embodiment, a stopper 24 is movably disposed within the drug storage container 20 such that the stopper 24 can move distally along the longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the interior surface of the drug reservoir 20 to prevent or inhibit leakage of the drug past the stopper 24 as the stopper 24 is being moved. When the stopper 24 is driven distally, the distal movement of the stopper 24 expels the drug 22 from the drug reservoir 20 through the delivery member 16. The proximal end of the drug reservoir 20 may be open to allow the plunger 26 to extend into the drug reservoir 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart, and the plunger 26 impacts the stopper 24 during operation of the injection device 10. In another embodiment, the stopper 24 and the plunger 26 may be coupled to one another, for example via a threaded connection, so that they move together from the initiation of movement of the plunger 26. In embodiments in which the drug storage container 20 is in the form of a collapsible pouch or bladder, the stopper 24 may be omitted and the plunger 26 may press against the outer surface of the wall of the drug storage container 20 to expel the drug 22 by deforming the wall and reducing the internal volume of the drug storage container 20.

[0016] The delivery member 16 is operably connected or connectable in fluid communication with the reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28 of the delivery member 16. The insertion end 28 can include a sharp tip of other pointed geometric shapes, enabling the insertion end 28 to pierce the patient's skin and / or subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 can be hollow and can have an internal passageway. One or more openings can be formed in the insertion end 28 to allow the drug to flow out from the delivery member 16 to the patient. In some embodiments, the delivery member 16 can be defined by a single structure such as a rigid needle or a flexible cannula, while in other embodiments, the delivery member 16 can be defined by a plurality of interdependent structures. Regarding the latter, in certain embodiments, the delivery member 16 may include a rigid metal needle and a flexible plastic cannula. In this case, the needle is used to insert the cannula into the patient, and then is partially or fully withdrawn from the cannula, with the cannula remaining in the patient for subcutaneous delivery. Such a configuration may be desirable from the perspective of safety and / or comfort, especially when the cannula remains in the patient's body for a significant period of time (e.g., several minutes, hours, days, etc.).

[0017] In the embodiment shown in FIG. 1, the drug storage container 20 is a prefilled syringe and has a fixed hollow metal needle that defines the delivery member 16. In this case, the needle is attached to the wall of the drug storage container 20 and is permanently in fluid communication with the reservoir of the drug storage container 20. In other embodiments, the drug storage container 20 may be a needleless cartridge and thus may not initially be in fluid communication with the delivery member 16. In such embodiments, during operation of the injection device 10, the drug storage container 20 may move towards or away from the proximal end of the delivery member 16 such that the proximal end of the delivery member 16 penetrates a septum covering the opening of the drug storage container 20, thereby establishing fluid communication with the reservoir of the drug storage container 20.

[0018] In some embodiments, the drug storage container 20 may be attached to the housing 12 so that it does not move relative to the housing 12 after being installed within the housing 12. In such embodiments, including those shown in FIG. 1, the insertion end 28 of the delivery member 16 may extend into the opening 14 of the housing 12 in both the initial or storage state and the post-delivery state. In another embodiment, the drug storage container 20 may be movably coupled to the housing 12 so that the drug storage container 20 can move relative to the housing 12 during operation of the injection device 10. In such a particular embodiment, the insertion end 28 of the delivery member 16 may be retracted into the opening 14 of the housing 12 in the initial or storage state. Thereafter, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be deployed through the opening 14 of the housing 12 for insertion into the patient. In some embodiments, this movement may be the result of the drug storage container 20 being driven distally relative to the housing 12.

[0019] Continuing to refer to FIG. 1, the injection device 10 further includes a drive mechanism 30 mounted within the housing 12. The drive mechanism 30 stores energy and is configured to release or output that energy upon activation of the drive mechanism 30 by a user or in response to activation of the drive mechanism 30 by a user to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 to the patient. For example, the drive mechanism 30 may store mechanical, electrical, and / or chemical potential energy and be configured to convert that potential energy into kinetic energy or motion of the plunger 26 upon activation of the drive mechanism 30. The drive mechanism 30 may be disposed partially or entirely within the housing 12. The drive mechanism 30 may be directly coupled to the plunger 26 or may be coupled to the plunger 26 via an intervening mechanical or electromechanical linkage mechanism.

[0020] In some embodiments, the drive mechanism 30 may be powered by a biasing member, such as a spring, that is initially held in an excited state. In the excited state, the biasing member can be compressed, tensioned, torqued (e.g., twisted or wound), or any combination thereof, depending on the structure of the biasing member. In the excited state, the biasing member can exert a biasing force on the plunger 26, but the plunger 26 is prevented from moving by a holding mechanism as described below. When released, the biasing member returns to its natural length or shape and, as a result, can drive the plunger 26 to expel the drug 22 from the drug reservoir 20. In some embodiments, the biasing member may be a linear biasing member configured to exert a biasing force that produces linear motion, while in other embodiments, the biasing member may be a rotary biasing member configured to exert a biasing force that produces rotational motion. In embodiments where the biasing member includes a spring, the spring can be any one or combination of a compression coil spring, a tension coil spring, a torsion coil spring, a helical torsion spring, or any other suitable spring. In addition to or instead of the biasing member, the drive mechanism 30 can include an electromechanical mechanism including an electric motor and / or solenoid coupled to the plunger 26 and a drive train or transmission; or any one or combination of mechanisms that generate or release pressurized gas or fluid to propel the plunger 26 or act directly on the stopper 24 to move the stopper 24 within the drug reservoir 20 to expel the drug 22 within the drug reservoir 20. In embodiments where the drug reservoir 20 and / or the delivery member 16 are movable relative to the housing 12, the drive mechanism 30 can drive the drug reservoir 20 and / or the delivery member 16 distally to insert the insertion end 28 of the delivery member 16 into the patient upon activation. Thus, in certain embodiments, the drive mechanism 30 can provide the motive power necessary for both inserting the delivery member 16 into the patient and expelling the drug 22 from the drug reservoir 20.

[0021] Continuing to refer to FIG. 1, the injection device 10 includes a guard member 32 for preventing contact with the insertion end 28 of the delivery member 16 when the injection device 10 is not being used to administer an injection. The guard member 32 may have a proximal end received within the housing 12, and is configured to move relative to the housing 12 between an extended position in which the distal end of the guard member 32 extends through the opening 14 of the housing 12 and a retracted position in which the distal end of the guard member 32 is wholly or partially drawn into the opening 14 of the housing 12. At least in the extended position, the guard member 32 extends beyond the insertion end 28 of the delivery member 16 and may surround the insertion end 28 of the delivery member 16. In some embodiments, moving the guard member 32 toward the retracted position can expose the insertion end 28 of the delivery member 16. In some embodiments, the guard member 32 may be coupled to the housing 12 via, for example, a pin and slot mechanism such that the guard member 32 can translate linearly relative to the housing 12 but is prevented from rotating relative to the housing 12.

[0022] The proximal and distal ends of the guard member 32 may include an actuator portion 34 and a skin contact portion 36, respectively. In some embodiments, the actuator portion 34 and the skin contact portion 36 may be integrally formed to define a single monolithic structure. In other words, the actuator portion 34 and the skin contact portion 36 may be formed as a single piece. In other embodiments, the actuator portion 34 and the skin contact portion 36 may be physically separate structures that are fixedly attached to each other such that they do not move relative to each other and / or move together when moving. At least the skin contact portion 36 of the guard member 32 may have a tubular or cylindrical shape and, in some embodiments, may be centered about the longitudinal axis A of the injection device 10. Movement of the guard member 32 from the extended position to the retracted position may be effected by pressing the skin contact portion 36 against the patient's skin at the injection site. In embodiments where the delivery member 16 projects from the opening 14 of the housing 12 in an initial or storage state, this movement may cause the insertion end 28 of the delivery member 16 to be inserted into the patient's skin.

[0023] In some embodiments, the guard member 32 can be biased toward the extended position by a biasing member such as a spring. The user can overcome the biasing force provided by this biasing member by pressing the guard member 32 against the injection site. When the injection is complete and the injection device 10 is removed from the injection site, the biasing member may return the guard member 32 to the extended position, thereby covering the insertion end 28 of the delivery member 16. In some embodiments, the injection device 10 includes a lockout mechanism for locking the guard member 32 in the extended position to prevent reuse of the injection device 10 and / or reduce the likelihood of accidental needle sticks after the guard member 32 has moved from the retracted position to the extended position.

[0024] In some embodiments, the guard member 32 may be configured to interact with the drive mechanism 30 as the guard member 32 moves from the extended position to the retracted position. This interaction enables the drive mechanism 30 to output and / or deliver the energy necessary to drive the plunger 26 to expel the drug 22 from the drug reservoir 20 and / or insert the insertion end 28 of the delivery member 16 into the patient's skin. The interaction between the guard member 32 and the drive mechanism 30 can be achieved by directly coupling the guard member 32 to the drive mechanism 30 or indirectly coupling the guard member 32 to the drive mechanism 30 via, for example, a mechanical or electromechanical linkage mechanism. In embodiments where the drive mechanism 30 includes a biasing member such as a spring, the movement of the guard member 32 from the extended position to the retracted position can release the biasing member from the excited state, allowing the biasing member to drive and enabling the plunger 26 to expel the drug 22 from the drug reservoir 20. Additionally or alternatively, when the guard member 32 is disposed in the extended position, the guard member 32 may be configured to hold the biasing member in the excited state. In some embodiments, the guard member 32 may hold the biasing member by direct contact with the biasing member, the plunger 26, and / or an element firmly attached to the biasing member or the plunger 26. In embodiments where the biasing member exerts a biasing torque, the guard member 32 may hold the biasing member by preventing the rotation of the biasing member and / or a rotating element, such as the power sleeve 555 described below, that is rotated by the biasing member. In further embodiments where the guard member 32 is used to hold the biasing member in the excited state, the activator portion 34 of the guard member 32 may be deformable and may undergo deformation as a result of the guard member 32 moving from the extended position to the retracted position. This deformation releases the activator portion 34 of the guard member 32 from the biasing member or an element biased by the biasing member, thereby allowing the biasing member to be deactivated and enabling the plunger 26 to be driven to expel the drug 22 from the drug reservoir 20. In such specific embodiments, the activator portion 34 of the guard member 32 may include one or more deformable arms that deflect radially outward and release the biasing member when the guard member 32 moves from the extended position to the retracted position.In some embodiments, the deflection of the arm may occur by pressing the guard member 32 against a shelf or lip portion angled on the inner surface of the housing 12, thereby generating a torque that bends the deformable arm outwardly. In a variant of this embodiment, one or more elastic arms separate from the guard member 32 may be held in a first or compressed position that prevents movement of the elastic arms, the biasing member, the plunger 26, and / or an element firmly attached to the biasing member or plunger 26 by direct contact with the activator portion 34 of the guard member 32. When the guard member 32 moves from the extended position to the retracted position, the activator portion 34 of the guard member 32 no longer contacts the elastic arms, thereby releasing the elastic arms and allowing them to return to their original or natural shape and thus be moved to a second position. In the second position, the elastic arms no longer restrain the biasing member and thus may allow the biasing member to relax and drive the plunger 26 to expel the drug 22 from the drug reservoir 20.

[0025] In embodiments where the drive mechanism 30 includes an electromechanical mechanism including an electric motor and / or solenoid coupled to the plunger 46 and a drive train or transmission, or an energy source that generates or releases pressurized gas or fluid to propel the plunger 26 or acts directly on the stopper 424, when the guard member 32 moves from the extended position to the retracted position, the guard member 32 can act directly on (i.e., directly contact and apply force to) the drive mechanism 30 to activate the drive mechanism 30.

[0026] Referring now to FIGS. 2-3D, for example, an embodiment of a guard member that can be implemented in an injection device including the injection device 10 shown in FIG. 1 is shown. Elements in FIGS. 2-3D that are functionally and / or structurally similar to the elements in FIG. 1 are denoted by the same reference numerals incremented by 100 relative to the counterparts in FIG. 1. In this case, the guard member 132 is configured to interact with a retaining member 140, which is a separate structure from the guard member 132, as a result of the guard member 132 moving from an extended position to a retracted position. This interaction releases a biasing member included in the drive mechanism 30 such that the biasing member drives the plunger 26 and enables the drug 22 to be discharged from the drug reservoir 20. In some embodiments, the retaining member 140 may be part of the drive mechanism 30 shown in FIG. 1.

[0027] FIG. 2 shows that the skin contact portion 136 of the guard member 132 can have a tubular or cylindrical shape. Two longitudinally extending arms 142a and 142b extend in a proximal direction away from the skin contact portion 136. The skin contact portion 136 may be integrally formed with the longitudinally extending arm 142a and the longitudinally extending arm 142b to define a single monolithic structure. In other words, the skin contact portion 136 and the longitudinally extending arm 142a and the longitudinally extending arm 142b may be formed as a single piece. The longitudinally extending arm 142a and the longitudinally extending arm 142b may be parallel or substantially parallel to the longitudinal axis of the injection device 10 and may be arranged so as not to cover one or more windows formed in the housing 12 of the injection device 10.

[0028] One or both of the proximal ends of the longitudinally extending arm 142a and the longitudinally extending arm 142b may be defined in the actuator portion 134 of the guard member 132. In the embodiment shown in FIG. 2, the proximal ends of the longitudinally extending arm 142a and the longitudinally extending arm 142b each include a wall 144a and a wall 144b, and each of the walls 144a and 144b extends inwardly away from the remainder of the longitudinally extending arm. The walls 144a and 144b may be perpendicular or substantially perpendicular or otherwise non-parallel to the longitudinal axis A of the injection device 110.

[0029] Referring to FIGS. 3A-3D, a sequence for releasing the biasing member of the drive mechanism of the injection device 10 using the guard member 132 will now be described. FIG. 3A shows the initial state of the injection device 110 before activation. Here, the biasing member of the drive mechanism is held in an excited state by the holding member 140 disposed in the first position. In the excited state, the biasing member may exert a force that biases the plunger in the distal direction. As a result, a flange 146 extending radially outward from the plunger is pushed downward against the angled cam surface 148 of the sleeve 150 firmly attached to the housing 112. Due to the biasing force, the flange 146 is pushed and slid down the cam surface 148 towards the longitudinally extending slot 152 formed in the sleeve 150. Initially, the flange 146 is prevented from sliding down the cam surface 148 by the holding member 140 that abuts the flange 146 when the holding member 140 is in the first position. FIG. 3A shows that in the initial state, no portion of the guard member 132 is in contact with the holding member 140. However, in other embodiments, in the initial state, the actuator portion 134 of the guard member 132 may be in direct contact with the holding member 140. It should be noted that the flange 146 may be integrally formed with the plunger or a separate component firmly attached to the plunger such that the flange 146 moves together with the plunger.

[0030] Figure 3B shows the state of the injection device 110 after the skin contact portion 136 of the guard member 132 is pressed against the patient's skin and partially retracted into the opening 114 of the housing 112. Here, the wall 144a of the actuator portion 134 of the guard member 132 is in direct contact with the retaining member 140 and is pushing the retaining member 140 in the proximal direction. As a result, the retaining member 140 is moving from the first position to a second position where the flange 146 no longer restricts the retaining member 140 from sliding off the cam surface 148. As a result of this movement, the wall 144a instantaneously assumes the first position of the retaining member 140 and thus abuts against the flange 146, instantaneously holding the biasing member in an excited state by preventing the flange 146 from sliding off the cam surface 148. Although not shown, the wall 144b of the actuator portion 134 of the guard member 132 can perform a similar operation on the other side of the plunger.

[0031] As shown in Figure 3C, when the guard member 132 is further retracted, the wall 144a can slide out so as not to contact the flange 146. With nothing holding the flange 146, the flange 146 can slide off the cam surface 148 under the biasing force of the biasing member and then enter the longitudinally extending slot 152. In some embodiments, the plunger can rotate relative to the sleeve 150 as the flange 146 slides off the cam surface 148. When the flange 146 is within the longitudinally extending slot 152, the biasing member continues to be deactivated, thereby driving the plunger in the distal direction and discharging the drug 22 from the drug reservoir 20. When a certain dose of the drug 22 has been delivered to the patient, as shown in Figure 3D, the injection device 110 can be removed from the patient's skin and the guard member 132 can return to the extended position under the force of the needle guard biasing member.

[0032] In another embodiment, instead of the sleeve 150, the actuator portion 134 of the guard member 132 may include a cam surface. In such an embodiment, in the initial state, the flange 146 may initially rest on a stop surface that does not make an angle included in the sleeve 150 or other member so that the flange 146 is biased against rotation. When the guard member 132 moves from the extended position to the retracted position, the cam surface of the actuator portion 134 of the guard member 132 directly contacts the flange 146 and pushes the flange 146, thereby rotating the flange 146 to a position where it is aligned with the longitudinally extending slot 152 in the sleeve 150 or to another position where the flange 146 is no longer distally constrained by the stop surface of the sleeve 150.

[0033] In yet another embodiment, the holding member 140 may be moved from the first position to the second position by a non-physical interaction between the actuator portion 134 of the guard member 132 and the holding member 140. In such a particular embodiment, the actuator portion 134 of the guard member 132 and the holding member 140 may be magnetically repulsive or magnetically attracted to each other. The force associated with the magnetic repulsion or attraction may increase as the guard member 132 moves from the extended position to the retracted position. As a result, due to the magnetic repulsion or attraction between the actuator portion 134 of the guard member 132 and the holding member 140, the holding member 140 moves from the first position to the second position, thereby releasing the biasing member and driving the plunger 126 distally to expel the drug from the drug storage container.

[0034] In the foregoing embodiments, the holding member 140 is used to initially hold the biasing member in an excited state. However, in other embodiments, the holding member 140 may be omitted, and instead, a guard member may be used to initially hold the biasing member in an excited state. FIGS. 4A and 4B illustrate such an embodiment. Elements in FIGS. 4A and 4B that have functions and / or structures similar to those of the elements in FIGS. 2-3D are denoted by the same reference numerals incremented by 100 relative to the counterparts in FIGS. 2-3D. In the embodiments of FIGS. 4A and 4B, the injection device may include a releaser member 250. The releaser member 250 may have a tubular or cylindrical shape and may be disposed around a plunger (not shown in FIGS. 4A and 4B). The releaser member 250 may be biased to rotate under the force exerted by the biasing member. When the releaser member 250 rotates freely, the releaser member 250 may rotate from a first rotational position to a second rotational position. In the first rotational position, the releaser member 250 may directly or indirectly engage the plunger to prevent the plunger from moving distally. In the second rotational position, the releaser member 250 may release the plunger and allow the plunger to move distally under the biasing force of the biasing member to enable the drug 22 to be discharged from the drug storage container 20.

[0035] FIG. 4A shows the guard member 232 in the extended position and the releaser member 250 in the first rotational position. Here, the walls 244a and 244b of the activator portion 234 of the guard member 232 are received within and in direct contact with respective grooves 252a and 252b formed in the outer peripheral surface of the releaser member 250. As a result of this mating engagement, the activator portion 234 of the guard member 232 prevents the releaser member 250 from rotating and, thus, holds the biasing member in the energized state. When the guard member 232 is pressed against the patient's skin and drawn into the opening 14 of the housing 12, the walls 244a and 244b can slide out of their corresponding grooves 252a and 252b, as shown in FIG. 4B. As a result, the releaser member 250 is free to rotate from the first rotational position to the second rotational position under the biasing force of the biasing member. This movement further aligns a groove formed in the inner surface of the releaser member 250 with a flange extending from the plunger, thereby enabling the plunger to move distally under the biasing force of the biasing member and expel the drug from the drug reservoir.

[0036] Referring to FIGS. 5A and 5B, the embodiments shown herein generally combine the embodiments of FIGS. 2-3D and the embodiments of FIGS. 4A and 4B. The injection devices of FIGS. 5A and 5B may each include a flange 346, a cam surface 348, a sleeve 350, and a longitudinally extending slot 352 that are functionally and structurally similar to the flange 146, the cam surface 148, the sleeve 150, and the longitudinally extending slot 152 of the embodiments of FIGS. 3A-3D. Similar to the embodiments of FIGS. 4A and 4B, the guard member 332 of the embodiments of FIGS. 5A and 5B is configured to hold the biasing member in an excited state when the guard member 332 is in the extended position (FIG. 5B). To achieve this, the activation portion 334 of the guard member 332 generally takes the form of a U-shaped hook. More specifically, referring to FIGS. 5A and 5B, the proximal ends of the longitudinally extending arm 342a and the longitudinally extending arm 342b may each include a wall 354a and a wall 354b. The walls 354a and 354b each extend in a generally circumferential direction with respect to the longitudinal axis A of the injection device and away laterally from the remainder of the longitudinally extending arm. A notch or groove 356a and a notch or groove 356b are formed at the distal ends of the wall 354a and the wall 354b, respectively. As shown in FIG. 5B, when the guard member 332 is in the extended position, the flange 346 extending radially outward from the plunger is received within the groove 356a of the wall 354a. As a result, the wall 354a directly contacts the flange 346 extending outward from the plunger, preventing the flange 346 from sliding off the cam surface 348. This further prevents the biasing member from de-energizing and pushing the plunger in the distal direction. The wall 354b can perform a similar holding function on the opposite side of the injection device. When the guard member 332 is pressed against the patient's skin and drawn into the opening of the housing, the wall 354a can slide out so as not to engage the flange 346. This releases the flange 346 so that it can slide off the cam surface 358 under the biasing force of the biasing member and enter the longitudinally extending slot 352.When the flange 346 is within the longitudinally extending slot 352, the biasing member continues to bias, thereby driving the plunger in the distal direction and enabling the drug to be discharged from the drug storage container.

[0037] While each of the foregoing embodiments uses a guard member to release the biasing member of the drive mechanism, the scope of the present disclosure is not limited to this configuration. Another embodiment, as will be apparent from what is described below, may use an activator member configured to move independently of the guard member to release, activate, and / or unlock the drive mechanism. This activator member, together with the guard member, may be pressed against the patient's skin at the injection site, or alternatively, the activator member may preferably be actuated by the user with their own hand without the user having to change the way they hold the injection device.

[0038] FIG. 6 is a schematic view of an injection device 410 similar to the injection device 10 of FIG. 1, except that the injection device 410 incorporates an activator member 440 that is movable independently of the guard member 432. Elements of FIG. 6 that have functions and / or structures similar to those of the elements of FIG. 1 are indicated by the same reference numerals incremented by 400 relative to the counterparts of FIG. 1. The descriptions of many of these elements are simplified or even omitted for brevity.

[0039] Referring to FIG. 6, in certain embodiments, the actuator member 440 can be disposed adjacent to and / or coaxial with the guard member 432. The actuator member 440 may have a proximal end received within the housing 412, and be configured to move relative to the housing 412 between an extended position where the distal end of the actuator member 440 extends through the opening 414 of the housing 412 and a retracted position where the distal end of the actuator member 440 is wholly or partially drawn into the opening 414 of the housing 412. In the extended position, the actuator member 440 can extend beyond and / or surround the insertion end 428 of the delivery member 416. In some embodiments, moving the actuator member 440 toward the retracted position can expose the insertion end 428 of the delivery member 416. In such embodiments, the actuator member 440 can serve as a second needle guard. In another embodiment, the configuration of the actuator member 440 can provide little or no protection against inadvertent needlesticks. In some embodiments, the actuator member 440 can translate linearly relative to the housing 412, but is prevented from rotating relative to the housing 412, and can be coupled to the housing 412 via, for example, a pin and slot mechanism or a similar mechanism.

[0040] The actuator member 440 is configured to move independently of the guard member 432, at least during retraction of the actuator member 440. Thus, the guard member 432 does not push or otherwise act on the actuator member 440 to move the actuator member 440 to the retracted position. The guard member 432 may be configured to move relative to the actuator member 440, and vice versa. In some embodiments, the guard members 432 may slide relative to each other during this relative movement, but this is not necessarily required.

[0041] The proximal and distal ends of the actuator member 440 may include an actuator portion 444 and a skin contact portion 446, respectively. In some embodiments, the actuator portion 444 and the skin contact portion 446 may be integrally formed to define a single monolithic structure. In other words, the actuator portion 444 and the skin contact portion 446 may be formed as a single piece. In other embodiments, the actuator portion 444 and the skin contact portion 446 may be physically separate structures that are fixedly attached to each other so as not to move relative to each other and / or to move together when moving. In some embodiments, the actuator portion 444 may initially be separated from the skin contact portion 446 by a gap, and when the skin contact portion 446 is pulled proximally, the skin contact portion 446 closes the gap and pushes on the actuator portion 444 or otherwise acts on the actuator portion 444 to move the actuator portion 444 relative to the housing 412. At least the skin contact portion 446 of the actuator member 440 may have a tubular or cylindrical shape and, in some embodiments, may be centered about the longitudinal axis A of the injection device 410. In some embodiments, the movement of the actuator member 440 from the extended position to the retracted position may be effected by pressing the skin contact portion 446 against the patient's skin at the injection site. In embodiments where the delivery member 416 protrudes from the opening 414 of the housing 412 in the initial or storage state, this movement may cause the insertion end 428 of the delivery member 416 to be inserted into the patient's skin.

[0042] In some embodiments, the actuator member 440 can be biased toward the extended position by a biasing member such as a spring. The user can overcome the biasing force provided by this biasing member, for example, by pressing the actuator member 440 against the injection site. When the injection is complete and the injection device 410 is removed from the injection site, the biasing member may return the actuator member 440 to the extended position, thereby covering the insertion end 428 of the delivery member 416. In some embodiments, the injection device 410 may include a lockout mechanism for locking the actuator member 440 in the extended position to prevent reuse of the injection device 410 after the actuator member 440 has moved from the retracted position to the extended position. In some embodiments, only the actuator member 440 may return to the extended position after delivery, and the guard member 432 may not return to the extended position, or vice versa. In yet another embodiment, both the actuator member 440 and the guard member 432 may return to the extended position after delivery.

[0043] The actuator member 440 may be configured to interact with the drive mechanism 430 when the actuator member 440 moves from the extended position to the retracted position. Due to this interaction, the drive mechanism 430 can drive the plunger 426 and output and / or deliver the energy necessary to discharge the drug 422 from the drug storage container 420, and / or insert the insertion end 428 of the delivery member 416 into the patient's skin. The interaction between the actuator member 440 and the drive mechanism 430 can be achieved by directly coupling the actuator member 440 to the drive mechanism 430 or indirectly coupling the actuator member 440 to the drive mechanism 430 via, for example, a mechanical or electromechanical linkage mechanism. In embodiments where the drive mechanism 430 includes a biasing member such as a spring, the movement of the actuator member 440 from the extended position to the retracted position can release the biasing member from the excited state, allowing the biasing member to drive and the plunger 426 to discharge the drug 422 from the drug storage container 420. Further or alternatively, when the actuator member 440 is disposed in the extended position, the actuator member 440 can be configured to hold the biasing member in the excited state. In some embodiments, the actuator member 440 may hold the biasing member by direct contact with the biasing member, the plunger 426, and / or an element firmly attached to the biasing member or the plunger 426.

[0044] In embodiments where the drive mechanism 430 includes an electromechanical mechanism including an electric motor and / or solenoid coupled to the plunger 426 and a drive train or transmission, or a mechanism that generates or releases pressurized gas or fluid to propel the plunger 426 or acts directly on the stopper 424, when the actuator member 440 moves from the extended position to the retracted position, the actuator member 440 can act directly on the drive mechanism 430 (i.e., make direct contact and apply force) to activate the drive mechanism 430.

[0045] In some embodiments, the guard member 332 may not interact with the drive mechanism 430, and only the actuation of the actuator member 440 may be responsible for activating the drive mechanism 430. In another embodiment, the guard member 332 may play a role in activating the drive mechanism 430. In certain such other embodiments, pulling in the guard member 332 may unlock the drive mechanism 430, which by itself cannot output the energy necessary to drive the plunger 436, but then allows the actuator member 440 to interact with the drive mechanism 430 so as to cause the drive mechanism 430 to output the energy necessary to drive the plunger 436 and discharge the drug 422 from the drug reservoir 420.

[0046] Referring to FIGS. 7-8D, for example, one embodiment of an actuator member that may be implemented in an injection device including the injection device shown in FIG. 6 is shown. Elements in FIGS. 7-8D that have functions and / or structures similar to the elements of FIG. 6 are denoted by the same reference numerals with 100 added to the counterparts in FIG. 6. In this case, the actuator member 540 is configured to interact with a retaining member 541, which is a structure separate from the actuator member 540, as a result of the actuator member 540 moving from the extended position to the retracted position. This interaction releases a biasing member included in the drive mechanism 430 so as to enable the biasing member to drive the plunger 526 and discharge the drug 422 from the drug reservoir 420. In some embodiments, the retaining member 541 may be part of the drive mechanism 430 shown in FIG. 6.

[0047] FIG. 7 shows that the skin contact portion 546 of the activator member 540 may have a tubular or cylindrical shape. Two longitudinally extending arms 552a and 552b extend in a proximal direction away from the skin contact portion 546. The skin contact portion 546 may be integrally formed with the longitudinally extending arms 552a and 552b and may define a single monolithic structure. In other words, the skin contact portion 546 and the longitudinally extending arms 552a and the longitudinally extending arms 552b may be formed as an integral part. The longitudinally extending arms 552a and the longitudinally extending arms 552b may be parallel or substantially parallel to the longitudinal axis A of the injection device 510 and may be arranged so as not to cover one or more windows formed in the housing 412 of the injection device 510.

[0048] One or both of the proximal ends of the longitudinally extending arm 552a and the longitudinally extending arm 552b may be defined in the activator portion 544 of the activator member 540. In the embodiment shown in FIG. 7, the proximal ends of the longitudinally extending arm 552a and the longitudinally extending arm 552b each include a wall 554a and a wall 554b, and each of the walls 554a and 554b extends inwardly away from the remaining portion of the longitudinally extending arm. The walls 554a and 554b may be perpendicular or substantially perpendicular or otherwise non-parallel to the longitudinal axis A of the injection device 510.

[0049] When assembled within the injection device, the skin contact portion 546 of the activator member 540 may be coaxial with the guard member 530 and may be disposed radially inward of the guard member 530. In an initial state, the skin contact portion 536 of the guard member 530 may surround the skin contact portion 546 of the activator member 540, as shown in FIG. 8A. In another embodiment, it may be the skin contact portion 546 of the activator member 540 that surrounds the skin contact portion 536 of the guard member 530.

[0050] Referring to FIGS. 8A-8D, a sequence for releasing a rotational biasing member of a drive mechanism of an injection device, for example the injection device 410 of FIG. 6, using the activator member 540 will now be described. FIG. 8A shows the initial state of the injection device 510 before activation. Here, the rotational biasing member of the drive mechanism is held in an excited state by a holding member 541 disposed in a first position. In the excited state, the rotational biasing member can act to bias and rotate the power sleeve 555. However, initially, the power sleeve 555 is prevented from rotating by an inner surface of the holding member 541 that engages lockingly with an outer surface of the power sleeve 555. In some embodiments, this interface may include a longitudinally extending slot in one of the power sleeve 555 and the holding member 541 that receives a protrusion formed on the other of the power sleeve 555 and the holding member 541. FIG. 8A shows that in the initial state, no portion of the activator member 540 is in contact with the holding member 541. However, in other embodiments, in the initial state, the activator portion 544 of the activator member 540 may be in direct contact with the holding member 541.

[0051] FIG. 8B shows the state of the injection device 510 after the skin contact portion 546 of the activator member 540 has been pressed against the patient's skin and partially drawn into the opening 514 of the housing 512. Here, the walls 554a and 554b of the activator portion 544 of the activator member 540 are in direct contact with the holding member 541 and are pushing the holding member 541 in the proximal direction. As a result, the holding member 541 is moving from the first position to a second position where the holding member 541 no longer contacts the power sleeve 555 or restricts the rotational movement of the power sleeve 555. As a result of this operation, the walls 554a and 554b instantaneously assume the first position of the holding member 541 and thus instantaneously hold the rotational biasing member in an excited state by engaging and rotatably locking the power sleeve 555. This may involve the walls 554a and 554b sliding into longitudinally extending grooves formed in the outer surface of the power sleeve 555 (previously occupied by inwardly extending protrusions of the holding member 541).

[0052] In the illustrated embodiment, the guard member 530 is pressed against the patient's skin simultaneously with the actuator member 540. However, in other embodiments, the guard member 530 may contact the patient's skin before the actuator member 540, or vice versa.

[0053] As shown in FIG. 8C, when the actuator member 540 is further retracted, the walls 554a and 554b can slide out so as not to contact the power sleeve 555. In the absence of anything restraining the power sleeve 555, the power sleeve 555 can rotate under the rotational biasing force of a rotational biasing member (which may include, for example, a torsion spring (such as a torsion coil spring, helical torsion spring, etc.)). The threaded inner surface of the power sleeve 555 can engage the threaded outer surface of the plunger 526. Thus, rotation of the power sleeve 555 can drive the plunger 526 in the distal direction to eject the drug from the drug reservoir. When a certain dose of the drug has been delivered to the patient, as shown in FIG. 8D, the injection device 510 can be removed from the patient's skin and the actuator member 540 can return to the extended position under the force of the biasing member.

[0054] In the embodiments of FIGS. 7 to 8D, the holding member 541 is used to initially hold the rotational biasing member in the excited state. However, in other embodiments, the holding member 541 may be omitted, and instead, the actuator member 540 may be used to initially hold the rotational biasing member in the excited state. For example, in the initial state, when the actuator member 540 is in the extended position, the walls 554a and 554b of the actuator portion 544 of the actuator member 540 are received in the respective grooves formed on the outer surface of the power sleeve 555, and the rotation of the power sleeve 555 can be prevented. When the actuator member 540 moves from the extended position to the retracted position, the walls 554a and 554b slide out so as not to contact the power sleeve 555, thereby releasing the power sleeve 555. Therefore, the power sleeve 555 can rotate under the rotational biasing force of the rotational biasing member, thereby advancing the plunger 526 in a screw-like manner in the distal direction and discharging the drug 422.

[0055] FIGS. 9A to 13 show some deformed forms of the actuator member that can move independently of the guard member and can be implemented in any of the injection devices shown in FIGS. 6 to 8D and other injection devices. Also, similar to the embodiments of FIGS. 6 to 8D, the guard member of the embodiments of FIGS. 9A to 13 may not be operatively coupled to or interact with the drive mechanism of the injection device in other ways to activate, release, and / or unlock the drive mechanism.

[0056] Figures 9A - 9C show an embodiment where the actuator member 610 has a skin contact portion 612, the skin contact portion 612 has a tubular or cylindrical shape, and surrounds the skin contact portion 616 of the guard member 614. Further, in an initial state, before contacting the patient's skin, the guard member 614 can extend distally beyond the actuator member 610 such that the skin contact portion 616 of the guard member 614 is exposed (Figure 9A). As a result, the skin contact portion 616 of the guard member 614 contacts the patient's skin at the injection site before the skin contact portion 612 of the actuator member 610. Upon contact with the skin, first, the guard member 614 is drawn into the housing of the injection device while the actuator member 610 remains stationary relative to the housing of the injection device. When the skin contact portion 616 of the guard member 614 is drawn to a position where it is at the same height as the skin contact portion 612 of the actuator member 610 (Figure 9B), the skin contact portion 612 of the actuator member 610 contacts the patient's skin and begins to be drawn into the housing. Thereafter, both the actuator member 610 and the guard member 614 are pushed to their respective retracted positions (Figure 9C). As described above in connection with Figures 6 - 8D, when the actuator member 610 is drawn in, the actuator member 610 can interact directly or indirectly with the drive mechanism to release, activate, and / or unlock the drive mechanism, which further causes the drive mechanism to output energy to drive a plunger to discharge drug from the drug reservoir to the patient and / or to insert the insertion end of the delivery member into the patient's skin. In some embodiments, after drug delivery is complete and the injection device is removed from the patient's skin, the guard member 614 can be redeployed to its extended position for needle stick prevention while the actuator member 610 can be locked in its retracted position.

[0057] Figures 10A - 10C show an embodiment similar to the embodiment of Figures 9A - 9C, except that in the initial state, the actuator member 620 extends distally beyond the guard member 624 such that the skin - contacting portion 626 of the guard member 624 is covered by the skin - contacting portion 622 of the actuator member 620 (Figure 10A). As a result, the skin - contacting portion 622 of the actuator member 620 contacts the patient's skin at the injection site before the skin - contacting portion 626 of the guard member 624. Upon contact with the skin, initially, the actuator member 620 is drawn into the housing of the injection device while the guard member 624 remains stationary relative to the housing of the injection device. When the skin - contacting portion 622 of the actuator member 620 is drawn to a position where it is at the same height as the skin - contacting portion 626 of the guard member 624, the skin - contacting portion 626 of the guard member 624 contacts the patient's skin and begins to be drawn into the housing together with the actuator member 620. Thereafter, both the actuator member 610 and the guard member 614 are pushed to their respective retracted positions (Figure 10B). As described above in connection with Figures 6 - 8D, drawing in the actuator member 620 can cause the actuator member 620 to directly or indirectly interact with the drive mechanism to release, activate, and / or unlock the drive mechanism, which in turn causes the drive mechanism to output energy to drive the plunger for discharging the drug from the drug reservoir to the patient and / or for inserting the insertion end of the delivery member into the patient's skin. After drug delivery is complete and the injection device is removed from the patient's skin, the guard member 624 can be redeployed to its extended position while the actuator member 620 can be locked in its retracted position (Figure 10C). Thus, after injection, it is the guard member 624, not the actuator member 620, that provides protection against inadvertent needle sticks. In a variant of the embodiment of Figures 10A - 10C, the guard member 624 may initially be held in the retracted position and not be deployed to the extended position until after drug delivery. In such an alternative embodiment, the guard member 624 may not contact the patient's skin at the injection site during the drawing in of the actuator member 620.

[0058] Figures 11A - 11F show an embodiment similar to the embodiment of Figures 9A - 9C, except that the actuator member 630 is constantly surrounded by the guard member 634. Here, the skin contact portion 632 of the actuator member 630 may have a diameter or width smaller than that of the actuator portion 633 of the actuator member 630. Further, the diameter of the skin contact portion 632 may be smaller than the opening 637 of the skin contact portion 636 of the guard member 634. Configured in this way, the skin contact portion 632 of the actuator member 630 can fit within the opening 637 and contact the patient's skin when the guard member 634 is retracted. Thereby, the actuator member 630 can be pushed to the retracted position shown in Figures 11C and 11D. Increasing the diameter or width of the actuator portion 633 of the actuator member 630 can enable the actuator portion 633 to accommodate the barrel of the drug reservoir. After drug delivery is completed and the injection device is removed from the patient's skin, the guard member 634 is redeployed to its extended position, while the actuator member 630 can be locked in its retracted position (Figure 11F).

[0059] Figures 12A - 12C show an embodiment similar to the embodiment of Figures 9A - 9C, except that the activator member 640 has a different shape. Similar to its counterpart in the embodiment of Figures 9A - 9C, the distal end of the activator member 640 is disposed around the guard member 644 and has a generally tubular or cylindrical shape. Different from its counterpart in the aforementioned embodiment, the tubular portion of the activator member 640, which can be regarded as a ring, does not extend over the entire distance between the housing of the injection device and the skin - contacting portion 642 of the activator member 640. As a result, in the initial state of Figure 12A, a portion of the guard member 644 that is axially located between the housing and the skin - contacting portion 642 of the activator member 640 is not covered by the activator member 640. A longitudinally extending arm or rod 643, which may define the activation portion of the activator member 640, extends laterally to the guard member 644 and away from the skin - contacting portion 642 of the activator member 640. As seen in Figure 12A, in the initial state, a portion of the rod 643 is disposed outside the opening of the housing of the injection device. Similar to its counterpart in the embodiment of Figures 9A - 9C, the activator member 640 releases, activates, and / or unlocks the drive mechanism of the injection device when the activator member 640 moves from its extended position (Figure 12A) to its retracted position (Figure 12B). After drug delivery is completed and the injection device is removed from the patient's skin, while the guard member 644 is redeployed to its extended position again, the activator member 640 can be locked in its retracted position (Figure 12C).

[0060] Figure 13 shows a variant of the embodiment of Figures 12A - 12C. Here, the activator member 650 does not have a tubular portion, and a longitudinally extending arm or rod 653 defines both the skin - contacting portion of the activator member 650 and the activation portion of the activator member 650. Figure 13 shows that the rod 653 is disposed within a groove or slot in the wall of the guard member 654. In another embodiment, the rod 653 may be disposed laterally to the guard member 654, either radially inside or radially outside the guard member 654.

[0061] In any of the embodiments described in connection with FIGS. 6-13, the infusion device may include one or more mechanisms for positioning the actuator member and the guard member according to any of the following methods. According to one method, in an initial state (e.g., before placing the infusion device on the patient's skin at the infusion site), the guard member may be held in a retracted position or otherwise positioned, and the actuator member may be biased to an extended position or otherwise positioned. Later, in a post-delivery state (e.g., after the drug has been delivered to the patient and the infusion device has been removed from the infusion site), the guard member may automatically deploy to an extended position, and the actuator member may be held in a retracted position or automatically deployed to an extended position. According to another method, in the initial state, the actuator member may be held in a retracted position or otherwise positioned, and the guard member may be biased to an extended position or otherwise positioned. Later, in the post-delivery state, the actuator member may automatically deploy to an extended position, and the guard member may be held in a retracted position or automatically deploy to an extended position.

[0062] In embodiments of the actuator member described in connection with FIGS. 6-13, it is necessary for the actuator member to extend within the same opening of the housing as the guard member, although alternative embodiments may be configured differently. FIG. 14 shows one embodiment of an actuator member that is disposed at the proximal end of the housing of the infusion device and does not contact the patient's skin at the infusion site. Rather, the actuator member can be manually actuated by the user with their hand while the distal end of the infusion device is pressed against the patient's skin at the infusion site.

[0063] With particular reference to FIG. 14, elements in FIG. 14 that have a similar function and / or structure to the elements in FIG. 6 are denoted by the same reference numerals incremented by 300 with respect to the counterparts in FIG. 6. The descriptions of many of these elements are simplified or even omitted for the sake of brevity. FIG. 14 shows an actuator member 740 slidably received within an opening 760 formed in the proximal end of the housing 712. The actuator member 740 is movable relative to the housing 712 through the opening 760 unless restricted by the locks mentioned below. Movement of the actuator member 740 relative to the housing 712 causes the actuator member 740 to interact directly or indirectly with the drive mechanism 730 to release, activate, and / or unlock the drive mechanism 730, which in turn causes the drive mechanism 730 to output energy to drive the plunger 726 to expel the drug 722 from the drug reservoir 720 and / or to insert the insertion end 728 of the delivery member 716 into the patient's skin. To this end, the actuator member 740 is operatively coupled to the drive mechanism 730.

[0064] As shown in FIG. 14, the actuator member 740 may take the form of a push button sized and dimensioned for operation by the user's thumb or other finger. The user can grip the peripheral surface of the housing 712 in the palm of their hand and operate the actuator member 740 using their thumb without having to change their grip. In the illustrated embodiment, the actuator member 740 may be configured to move in a direction parallel or substantially parallel to the longitudinal axis A of the injection device 710. In other embodiments, the actuator member 740 may be configured to move in a direction perpendicular, substantially perpendicular, or non-parallel to the longitudinal axis A of the injection device 710. In some embodiments, the movement of the actuator member 740 may follow an arcuate path, for example, a path centered about the longitudinal axis A.

[0065] In some embodiments, the injection device 710 may include a lock 762 that is operatively coupled to the actuator member 740 and configured to selectively permit movement of the actuator member 740 relative to the housing 712. The lock 762 may have a locked state in which the lock 762 prevents movement of the actuator member 740 and an unlocked state in which the lock 762 permits movement of the actuator member 740. Further, the lock 762 may be operatively coupled to the guard member 732 such that when the guard member 732 is moved from the extended position to the retracted position when the guard member 732 is pressed against the injection site, the lock 762 changes from the locked state to the unlocked state. Thus, the actuator member 740 can move and thus activate, release, and / or unlock the drive mechanism 730 only when the guard member 732 has moved from the extended position to the retracted position. This helps to reduce the likelihood of premature activation of the drive mechanism 730 that could result in the drug 722 being expelled into the atmosphere. In another embodiment, the lock 762 may be omitted. In such an embodiment, the actuator member 740 can move freely and activate, release, and / or unlock the drive mechanism 730 regardless of the position of the guard member 732.

[0066] Figures 15A - 15D show a sequence of performing an injection using the injection device 710. Figure 15A shows the initial state before activation. Here, the guard member 732 is biased to its extended position and the lock 762 is in the locked state. Thus, in this state, the lock 762 prevents the movement of the actuator member 740 relative to the housing 712. Thereafter, in Figure 15B, the guard member 732 is pressed against the patient's skin at the injection site, moving the guard member 732 from the extended position to the retracted position. This movement causes the guard member 732 to interact with the lock 762, changing the lock 762 from the locked state to the unlocked state. Next, the user can press the actuator member 740 distally with their thumb into the opening 760 of the housing 712 (Figure 15C). As a result, the actuator member 740 interacts with the drive mechanism 730 to release, activate, and / or unlock the drive mechanism 730, thereby further causing the drive mechanism 730 to output energy to drive the plunger 726 to discharge the drug 722 from the drug reservoir 720, and if the insertion end 728 of the delivery member 716 has not been previously inserted into the patient during the retraction of the guard member 732, inserting the insertion end 728 of the delivery member 716 into the patient's skin. When a certain dose of the drug 722 has been delivered to the patient, as shown in Figure 15D, the injection device 710 can be removed from the patient's skin and the guard member 732 can return to the extended position under the force of the needle guard biasing member.

[0067] In each of the foregoing embodiments, the actuator member is a structure separate from the housing of the injection device. Alternative embodiments, such as the embodiment of Figure 16, may be configured such that the housing or a portion thereof functions as the actuator member. The injection device of Figure 16 includes many elements that are structurally and / or functionally similar to elements of the injection device of Figure 14. Such elements are identified with the same reference numbers incremented by 100 relative to the counterparts in Figure 14.

[0068] FIG. 16 shows that the injection device 810 has a proximal housing 812a and a distal housing 812b. The proximal housing 812a and the distal housing 812b may each have a generally tubular or cylindrical shape and may be centered about the longitudinal axis A of the injection device 810. The proximal housing 812a may be sized and dimensioned such that it can be gripped by a user's palm. Thus, the proximal housing 812a may define a tubular handgrip. The drive mechanism 830 may be disposed wholly or partially within the internal space of the proximal housing 812a. The distal end of the proximal housing 812a, which may have a diameter or width smaller than that of the proximal end of the proximal housing 812a, may be slidably received within an opening 813 formed in the proximal end of the distal housing 812b. The proximal housing 812a is movable relative to the distal housing 812b, and the distal end of the proximal housing 812a is inserted into the opening 813 when the proximal housing 812a moves distally. Further, as the proximal housing 812a moves distally relative to the distal housing 812b, the proximal housing 812a directly or indirectly interacts with the drive mechanism 830 to release, activate, and / or unlock the drive mechanism 830, and this further causes the drive mechanism 830 to output energy for driving the plunger 826 to discharge the drug 822 from the drug reservoir 820 and / or to insert the insertion end 828 of the delivery member 816 into the patient's skin. The proximal housing 812a is operatively coupled to the drive mechanism 830.

[0069] As shown in FIG. 16, in an initial state, the distal opposing surface 815 of the proximal housing 812a may be spaced apart from the proximal opposing surface 817 of the distal housing 812b by an axial distance or gap. A biasing member 819, such as a spring, may be disposed between the proximal housing 812a and the distal housing 812b and may be configured to act with a biasing force against closing the gap between the distal opposing surface 815 of the proximal housing 812a and the proximal opposing surface 817 of the distal housing 812b. Further, in the initial state, the guard member 832 may be disposed in a retracted position, as shown in FIG. 16.

[0070] Referring now to FIGS. 17A - 17C, a sequence for performing an injection using injection device 810 is shown. FIG. 17A shows the initial state of injection device 810 before activation. Here, in the absence of an external force pushing the proximal housing 812a and the distal housing 812b towards each other, the biasing force of the biasing member 819 maintains a gap between the distal opposing surface 815 of the proximal housing 812a and the proximal opposing surface 817 of the distal housing 812b. Thereafter, the user can grip the proximal housing 812a in their hand and press the distal housing 812b against the patient's skin at the injection site (FIG. 17B). The force applied by the hand overcomes the biasing force of the biasing member 819, and the proximal housing 812a moves distally along the longitudinal axis A towards the distal housing 812b until the distal opposing surface 815 of the proximal housing 812a abuts the proximal opposing surface 817 of the distal housing 812b. This distal movement of the proximal housing 812a causes the proximal housing 812a to interact with the drive mechanism, and as a result, activates, releases, and / or unlocks the drive mechanism, which in turn outputs energy to drive the delivery member 816 distally such that the insertion end 828 of the delivery member 816 pierces the patient's skin, drives the plunger 826 distally, and discharges the drug from the drug reservoir 820 through the delivery member 816 to the patient. When a certain dose of the drug has been delivered to the patient, the injection device 810 can be removed from the patient's skin, the biasing member is released, the guard member 832 is moved from the retracted position to the extended position, and can cover the insertion end 828 of the delivery member 816 (FIG. 17C).

[0071] Figs. 18A - 18C show a modified form of the embodiment of Figs. 16 - 17C. Here, the proximal housing 912a is divided into two separate structures, namely, an actuating sleeve 970 and an end cap 972. The end cap 972 may be attached to the distal housing 912b such that the end cap 972 does not move relative to the distal housing 912b. The actuating sleeve 970 may have a proximal opening that slidably receives the distal end of the end cap 927 and a distal opening that slidably receives the proximal end of the distal housing 912b. Further, the actuating sleeve 970 may be axially disposed between the end cap 972 and the distal housing 912b and may be movable relative to the end cap 972 and the distal housing 912b. Movement of the actuating sleeve 970 in the distal direction causes the actuating sleeve 970 to directly or indirectly interact with the drive mechanism to release, activate, and / or unlock the drive mechanism, which in turn causes the drive mechanism to output energy to drive the plunger to discharge the drug from the drug storage container and / or to insert the insertion end of the delivery member into the patient's skin, so that the actuating sleeve 970 may be operatively coupled to the drive mechanism.

[0072] FIG. 18A shows the initial state of the injection device 910 before activation. Here, the guard member 932 is in the retracted state, and the actuating sleeve 970 is biased proximally, for example via a biasing member 819, such that the proximal opposing end face of the actuating sleeve 970 abuts the distal opposing surface of the end cap 972. In this configuration, a gap is maintained between the distal opposing end face of the actuating sleeve 970 and the proximal opposing surface of the distal housing 912b by the biasing force of the biasing member. Thereafter, the user can grip the actuating sleeve 970 in his or her hand and press the distal housing 912b against the patient's skin at the injection site (FIG. 18B). The force applied by the hand overcomes the biasing force, and the actuating sleeve 970 moves distally along the longitudinal axis A toward the distal housing 912b (i.e., away from the end cap 972) until the distal opposing end face of the actuating sleeve 970 abuts the proximal opposing surface of the distal housing 912b. This distal movement of the actuating sleeve 970 causes the actuating sleeve 970 to interact with the drive mechanism, and as a result, activates, releases, and / or unlocks the drive mechanism, which in turn outputs energy to drive the delivery member 916 distally such that the insertion end 928 of the delivery member 916 pierces the patient's skin, drives the plunger distally, and discharges the drug from the drug reservoir to the patient through the delivery member 916. After a certain dose of the drug has been delivered to the patient, the injection device 910 can be removed from the patient's skin, the biasing member is released, the guard member 932 is moved from the retracted position to the extended position, and the insertion end 928 of the delivery member 916 can be covered (FIG. 18C).

[0073] FIG. nineteen shows an embodiment of an injection device that is similar in certain respects to the injection device of FIG. 16, except that, among other differences, the guard member is disposed in the extended position in the initial state. The injection device of FIG. 19 includes many elements that are structurally and / or functionally similar to elements of the injection device of FIG. 16. Such elements are identified by the same reference numbers incremented by 200 relative to the counterparts in FIG. 16.

[0074] FIG. 19 shows that the injection device 1010 has a proximal housing 1012a and a distal housing 1012b. The proximal housing 1012a and the distal housing 1012b may each have a generally tubular or cylindrical shape and may be centered about the longitudinal axis A of the injection device 1010. The proximal housing 1012a may be sized and dimensioned such that a user can grasp it with the palm of his or her hand. Thus, the proximal housing 1012a may define a tubular handgrip. The drive mechanism 1030 may be disposed wholly or partially within the internal space of the proximal housing 1012a. An opening 1019 may be formed at the distal end of the proximal housing 1012a and may be slidably received at the proximal end of the distal housing 1012b. The proximal housing 1012a may be movable relative to the distal housing 1012b, and the proximal end of the distal housing 1012b is inserted into the opening 1019 when the proximal housing 1012a moves distally. Further, the proximal housing 1012a directly or indirectly interacts with the drive mechanism 1030 by the distal movement of the proximal housing 1012a relative to the distal housing 1012b to release, activate, and / or unlock the drive mechanism 1030, and this further causes the drive mechanism 1030 to output energy for driving the plunger 1026 to discharge the drug 1022 from the drug reservoir 1020 and / or to insert the insertion end 1028 of the delivery member 1016 into the patient's skin, so the proximal housing 1012a may be operatively coupled to the drive mechanism 1030.

[0075] The injection device 1010 may include a first biasing member 1080 disposed between the distal housing 1012b and the guard member 1032, and a second biasing member 1082 disposed between the proximal housing 1012a and the distal housing 1012b. In some embodiments, the first biasing member 1080 and the second biasing member 1082 may each include respective springs, such as compression springs for example. As shown in FIG. 19, in certain embodiments, these springs may be operatively arranged in series with each other. The first biasing member 1080 may be configured to exert a first biasing force that pushes the guard member 1032 towards the extended position. The second biasing member 1082 may be configured to exert a second biasing force that pushes the proximal housing away from the distal housing. Further, the second biasing force may be greater than the first biasing force. In embodiments where the first biasing member 1080 and the second biasing member 1082 are springs, this may be achieved by the second biasing member 1082 having a spring constant greater than that of the first biasing member 1080. Configured in this way, when the guard member 1032 is pressed against the patient's skin at the injection site, the guard member 1032 first moves from the extended position to the retracted position, and then the proximal housing 1012a moves towards the distal housing 1012b. This sequence can ensure that the insertion end 1028 of the delivery member 1016 is inserted into the patient before activating the drive mechanism 1030 and discharging the drug 1022 from the drug reservoir 1020.

[0076] In addition to or instead of the series arrangement of the first biasing member 1080 and the second biasing member 1082, some embodiments may incorporate a lock that is operatively coupled to the proximal housing 1012a and configured to selectively permit movement of the proximal housing 1012a relative to the distal housing 1012b. This lock may be similar to the lock described above in connection with FIG. 14 at certain points. The lock may have a locked state in which the lock prevents movement of the proximal housing 1012a relative to the distal housing 1012b and an unlocked state in which the lock permits movement of the proximal housing 1012a relative to the distal housing 1012b. Further, the lock may be operatively coupled to the guard member 1032 such that when the guard member 1032 is moved from the extended position to the retracted position when the guard member 1032 is pressed against the injection site, the lock changes from the locked state to the unlocked state. As a result, the proximal housing 1012a can move distally relative to the distal housing 1012b only when the guard member 1032 is moved from the extended position to the retracted position, thereby activating, releasing, and / or unlocking the drive mechanism 1030.

[0077] Referring to FIGS. 20A - 20D, a sequence of performing an injection using an injection device 1010 is shown. FIG. 20A shows the initial state of the injection device 1010 before activation. Here, in a state where there is no external force pushing and moving the guard member 1032 and the proximal housing 1012a towards each other, the guard member 1032 is disposed at the extended position and biased towards the extended position by the first biasing member 1080. Also, in the initial state, the proximal housing 1012a is disposed at a first position relative to the distal housing 1012b and biased towards this first position by the second biasing member 1082. In use, the user can grip the proximal housing 1012a in his or her hand and press the guard member 1032 against the patient's skin at the injection site (FIG. 20B). The force applied by the hand overcomes the first biasing force of the first biasing member 1080 and moves the guard member 1032 proximally until it reaches its retracted position. As a result, the insertion end 1028 of the delivery member 1016 can be inserted into the patient's skin. As shown in FIG. 20B, the retracted position of the guard member 1032 may correspond to the guard member 1032 being fully drawn into the distal housing 1012b, but this does not necessarily have to occur as long as the guard member 1032 is drawn into a position where it can no longer be drawn further into the distal housing 1012b. Thus, the user continues to apply a force distally such that the proximal housing 1012a moves distally along the longitudinal axis A towards the distal housing 1012b in order to overcome the second biasing force of the second biasing member 1082 (FIG. 20C). The force required to cause this movement is greater than the minimum force required to retract the needle guard 1032. The distal movement of the proximal housing 1012a causes the proximal housing 1012a to interact with the drive mechanism 1030, and as a result, activates, releases, and / or unlocks the drive mechanism 1030. Further, by this, the drive mechanism 1030 drives the plunger distally and outputs energy to discharge the drug from the drug reservoir through the delivery member to the patient.When a dose of drug 1022 is delivered to a patient, the infusion device 1010 can be detached from the patient's skin, and the first biasing member 1080 can move the guard member 1032 from a retracted position to an extended position to cover the insertion end 1028 of the delivery member 1016 (FIG. 20D).

[0078] Of course, the devices and methods according to the present disclosure can have one or more advantages over the prior art, and any one or more of them can exist according to the features of the present disclosure included in the specific embodiments in the specific embodiments. The same may be understood for other advantages not specifically mentioned herein.

[0079] In the above description, various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices are described. The devices, assemblies, components, subsystems, methods, or drug delivery devices can further include or be used with drugs including, but not limited to, the drugs specified below, as well as their generic and biosimilar equivalents. As used herein, the term drug can be used interchangeably with other similar terms and refers to any kind of agent or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biological agents, biologically active agents and compositions, macromolecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic pharmaceuticals. Non-therapeutic injectable materials are also included. The drug can be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary agents should not be considered exhaustive or limiting.

[0080] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the agent for treatment. The primary container can be a vial, a cartridge, or a pre-filled syringe.

[0081] In some embodiments, the reservoir of the drug delivery device may be filled with a colony stimulating factor such as granulocyte colony stimulating factor (G-CSF), or the device can be used with them. Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastrim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF).

[0082] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA) formulation, which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means, for example, any protein that binds to a receptor and directly or indirectly causes activation of the erythropoietin receptor by causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include Epogen® (epoetin alpha), Aranesp® (darbepoetin alpha), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogs, but are not limited thereto.

[0083] Among certain exemplary proteins are the following specific proteins, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully human monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that suppress activities mediated by binding to the receptors for IL-4 and / or IL-13; interleukin 1-receptor 1 (「IL1-R1」)-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly humanized and fully human monoclonal antibodies, including but not limited to humanized and fully human antibodies, such as human CD22-specific IgG antibodies, including in particular the dimer of human-mouse monoclonal hLL2γ chain disulfide bound to the human-mouse monoclonal hLL2κ chain, for example, the fully humanized antibody of human CD22, epratuzumab (CAS registration number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, etc., including but not limited to anti-IGF-1R antibodies; B7-related protein 1-specific antibodies, peptibodies, related proteins, etc. (also referred to as 「B7RP-1」, B7H2, ICOS-L, B7h, and CD275), including but not limited to those that suppress the interaction between B7RP-1 and ICOS, the natural receptor for B7RP-1 on activated T cells, including but not limited to fully human monoclonal IgG2 antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; IL-15-specific antibodies, peptibodies, related proteins, etc., including but not limited to HuMax IL-15 antibodies and related proteins, such as 146B7, particularly humanized monoclonal antibodies; human IFNIFN-γ specific antibodies, peptibodies, related proteins, etc. including but not limited to γ-specific antibodies and fully human anti-IFN-γ antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., and other TALL specific binding proteins; parathyroid hormone (「PTH」) specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor (「TPO-R」) specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor (「HGF」) specific antibodies, peptibodies, related proteins, etc. including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met) such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, related proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc. including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc. including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon β-1a), Bexxar® (tositumomab, anti-CD22 monoclonal antibody), Betaseron® (interferon-β), Campath® (alemtuzumab, anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-α4β7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb), Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP)), Kineret® (anakinra), Leukine® (sargramostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lynphosphostat B, belimumab, anti-BlyS mAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCimhR3 (Nimotuzumab), Omnitarg (Pertuzumab, 2C4), Osidem (registered trademark) (IDM-1), OvaRex (registered trademark) (B43.13), Nuvion (registered trademark) (Visilizumab), Cantuzumab mertansine (huC242-DM1), NeoRecormon (registered trademark) (Epoetin beta), Neumega (registered trademark) (Oprelvekin, human interleukin-11), Orthoclone OKT3 (registered trademark) (Muromonab-CD3, anti-CD3 monoclonal antibody), Procrit (registered trademark) (Epoetin alpha), Remicade (registered trademark) (Infliximab, anti-TNFα monoclonal antibody), Reopro (registered trademark) (Abciximab, anti-GP lIb / Ilia receptor monoclonal antibody), Actemra (registered trademark) (anti-IL6 receptor mAb), Avastin (registered trademark) (Bevacizumab), HuMax-CD4 (Zanolimumab), Rituxan (registered trademark) (Rituximab, anti-CD20 mAb), Tarceva (registered trademark) (Erlotinib), Roferon-A (registered trademark) (Interferon α-2a), Simulect (registered trademark) (Basiliximab), Prexige (registered trademark) (Lumiracoxib), Synagis (registered trademark) (Palivizumab), 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507), Tysabri (registered trademark) (Natalizumab, anti-α4 integrin mAb), Valortim (registered trademark) (MDX-1303, anti-anthrax protective antigen mAb), ABthrax (trademark), Xolair (registered trademark) (Omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc), Zenapax (registered trademark) (Daclizumab), Zenapax (registered trademark) (Daclizumab, anti-IL-2Rα mAb), Zevalin (registered trademark) (Ibritumomab tiuxetan), Zetia (registered trademark) (Ezetimibe), Orencia (registered trademark) (Abatacept, TACI-Ig), anti-CD80 monoclonal antibody (Galiximab), anti-CD23mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO 148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatumumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (cetuximab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-Clostridium difficile toxin A and toxin B C mAbs MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMax CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF idiopathic pulmonary fibrosis phase 1 fibrinogen (FG-3019), anti-CTLA4 mAb, anti-eotaxin-1 mAb (CAT-213), anti-FGF8 mAb, anti-ganglioside GD2 mAb, anti-ganglioside GM2 mAb, anti-GDF-8 human mAb (MYO-029), anti-GM-CSF receptor mAb (CAM-3001), anti-HepC mAb (HuMax HepC), anti-IFNα mAb (MEDI-545, MDX-1103), anti-IGF1R mAb, anti-IGF-1R mAb (HuMax-Inflam), anti-IL12 mAb (ABT-874), anti-IL12 / IL23 mAb (CNTO 1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-integrin receptor mAb (MDX-018, CNTO 95), anti-IP10 ulcerative colitis mAb (MDX-mAb (GC-1008), anti-TRAIL receptor-2 human mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, and anti-ZP3 mAb (HuMax-ZP3).

[0084] In some embodiments, the drug delivery device contains a sclerostin antibody such as, but not limited to, romosozumab, blosozumab, or BPS 804 (Novartis). In other embodiments, the drug delivery device may contain or be used with a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, vismodegib, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042, or the device may be used with these. In some embodiments, the drug delivery device may contain or be used with an endogenous tissue inhibitor of metalloproteinase (TIMP) such as, but not limited to, TIMP-3. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered using the drug delivery devices of the present disclosure. Additionally, bispecific T cell engager (BiTE®) antibodies such as, but not limited to, BLINCYTO® (blinatumomab) can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist such as, but not limited to, apelin or an analog thereof.In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery devices of the present disclosure.

[0085] Drug delivery devices, assemblies, components, subsystems, and methods have been described from the perspective of exemplary embodiments, but are not limited thereto. This detailed description should be construed as illustrative only and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, yet such embodiments are still within the scope of the claims that define the invention disclosed herein.

[0086] Those skilled in the art will appreciate that various modifications, changes, and combinations can be made to the above embodiments without departing from the spirit and scope of the invention disclosed herein, and such modifications, changes, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. A housing having an opening, A drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening of the housing, A plunger, A biasing member operatively coupled to the plunger and initially held in an excited state, wherein when the biasing member is released, the plunger is driven to discharge a drug from the drug storage container through the delivery member, A guard member having a skin contact portion and an actuator portion, the guard member being movable relative to the housing and having an extended position in which the guard member extends at least partially through the opening of the housing and a retracted position in which the guard member is spaced away from the extended position and disposed toward the housing, comprising, Moving the guard member from the extended position to the retracted position enables the actuator portion to release the biasing member, and the biasing member drives the plunger to discharge the drug from the drug storage container. An injection device.

2. Including a holding member having a first position in which the holding member holds the biasing member in the excited state and a second position in which the holding member is released from holding the biasing member, and when the guard member moves from the extended position to the retracted position, the actuator portion acts on the holding member to move the holding member from the first position to the second position. The injection device according to Claim 1.

3. The injection device according to Claim 2, wherein the actuator portion directly contacts the holding member to move the holding member from the first position to the second position.

4. The guard member has a partially retracted position between the retracted position and the extended position, and when the actuator portion is in the partially retracted position, the actuator portion is configured to hold the biasing member in the excited state. The injection device according to Claim 2 or 3.

5. The injection device according to Claim 1, wherein when the guard member is in the extended position, the actuator portion is configured to hold the biasing member in the excited state.

6. Including a release member configured to rotate under a biasing force applied by the biasing member, wherein when the guard member is in the extended position, the actuator portion is configured to prevent rotation of the release member, the injection device according to claim 5.

7. When the guard member is in the extended position, the actuator portion is in direct contact with the release member, and when the guard member is in the retracted position, the actuator portion is spaced from the release member, the injection device according to claim 6.

8. The release member is attached to the plunger or integrally formed with the plunger, the injection device according to claim 6 or 7.

9. The skin contact portion and the actuator portion translate linearly together between the extended position and the retracted position, the injection device according to any one of claims 1 to 8.

10. The skin contact portion and the actuator portion are integrally formed and define a single monolithic structure, the injection device according to any one of claims 1 to 9.

11. The guard member includes a tubular portion and at least one longitudinally extending arm extending away from the tubular portion, and an end face of the tubular portion defines the skin contact portion, the injection device according to any one of claims 1 to 10.

12. The actuator portion is at least partially defined by a wall extending inwardly from the at least one longitudinally extending arm, the injection device according to claim 11.

13. The biasing member includes a spring, the injection device according to any one of claims 1 to 12.

14. When the guard member is in the extended position, the insertion end portion of the delivery member is surrounded by the guard member, and when the guard member is in the retracted position, the insertion end portion of the delivery member protrudes outside the guard member, the injection device according to any one of claims 1 to 13.

15. A housing having an opening, A drug storage container including a delivery member having an insertion end portion configured to extend at least partially through the opening of the housing, A plunger, A drive mechanism operable to discharge a drug from the drug storage container through the delivery member, A guard member movable relative to the housing, the guard member having a guard member extended position in which the guard member extends at least partially through the opening of the housing, and a guard member retracted position in which the guard member is spaced from the guard member extended position and disposed toward the housing, the guard member; An actuator member movable relative to the housing independently of the movement of the guard member; An injection device comprising the same.

16. The injection device according to claim 15, wherein the actuator member is movable relative to the housing, the actuator member having an actuator member extended position in which the actuator member extends into the opening of the housing, and an actuator member retracted position in which the actuator member is spaced from the actuator member extended position and disposed toward the housing.

17. The drive mechanism including a rotation biasing member; A holding member having a first position in which the holding member holds the rotation biasing member in an excited state, and a second position in which the holding member releases the rotation biasing member and allows the rotation biasing member to rotate, wherein when the actuator member moves from the actuator member extended position to the actuator member retracted position, the actuator member acts on the holding member and moves the holding member from the first position to the second position, the holding member; The injection device according to claim 16, comprising the same.

18. The injection device according to claim 16, wherein the actuator member is operatively coupled to the drive mechanism such that the drive mechanism is actuated when the actuator member moves from the actuator member extended position to the actuator member retracted position.

19. The injection device according to claim 18, wherein the actuator member directly contacts and interacts with the drive mechanism when moving from the actuator member extended position to the actuator member retracted position, thereby actuating the drive mechanism.

20. The injection device according to claim 18, wherein the actuator member releases the biasing member of the drive mechanism when moving from the actuator member extended position to the actuator member retracted position.

21. The injection device according to any one of claims 16 to 20, wherein the guard member in the guard member extended position extends beyond the actuator member in the actuator member extended position.

22. The injection device according to any one of claims 15 or 16, wherein the actuator member includes a skin contact portion and surrounds at least a portion of the guard member.

23. The injection device according to any one of claims 15 or 16, wherein the guard member surrounds at least a portion of the actuator member, and the actuator member has a skin contact portion.

24. The injection device according to claim 16, wherein the guard member includes a tubular skin contact portion, and the actuator member includes an arm extending in a longitudinal direction that is disposed through the opening of the housing when the actuator member is in the actuator member extended position.

25. The injection device according to claim 15, wherein the actuator member includes a push button.

26. The injection device according to claim 25, wherein the push button is operatively coupled to the drive mechanism such that the drive mechanism is actuated when the push button is pressed.

27. Including a lock, the lock having a locked state in which the lock prevents movement of the push button and an unlocked state in which the lock allows movement of the push button, the lock being operatively coupled to the guard member such that when the guard member is moved from the guard member extended position to the guard member retracted position, the lock changes from the locked state to the unlocked state. The injection device according to any one of claims 25 or 26.

28. The injection device according to any one of claims 16 to 24, wherein in an initial state, the guard member is in the guard member retracted position and the actuator member is in the actuator member extended position.

29. The injection device according to claim 28, wherein in a post-delivery state, the guard member is in the guard member extended position and the actuator member is in the actuator member extended position or the actuator member retracted position.

30. In an initial state, the actuator member is in the actuator member retracted position, and the guard member is in the guard member extended position, the injection device according to any one of claims 16 to 24.

31. In a post-delivery state, the actuator member is in the actuator member extended position, and the guard member is in the guard member retracted position or the guard member extended position, the injection device according to claim 30.

32. When the guard member is in the extended position, the insertion end portion of the delivery member is surrounded by the guard member, and when the guard member is in the retracted position, the insertion end portion of the delivery member projects outside the guard member, the injection device according to any one of claims 15 to 31.

33. A distal housing having an opening, A drug storage container including a delivery member having an insertion end portion at least partially disposed within the distal housing and configured to extend at least partially through the opening of the distal housing, A plunger, A drive mechanism operable to drive the plunger in a distal direction to discharge a drug from the drug storage container through the delivery member, A proximal housing operatively coupled to the drive mechanism and movable relative to the distal housing such that the drive mechanism is actuated when the proximal housing is moved in the distal direction, An injection device including.

34. Including a guard member movable relative to the distal housing, the guard member having an extended position in which the guard member extends at least partially through the opening of the distal housing and a retracted position in which the guard member moves away from the extended position and is disposed toward the distal housing, the injection device according to claim 33.

35. The proximal housing is cylindrical and sized and dimensioned to be gripped by a user's hand, the injection device according to claim 33 or 34.

36. At least a portion of the drive mechanism is disposed within the proximal housing, the injection device according to any one of claims 33 to 35.

37. The proximal housing has an initial position in which a distal opposing surface of the proximal housing is spaced from a proximal opposing surface of the distal housing, and an operative position in which the distal opposing surface of the proximal housing abuts the proximal opposing surface of the distal housing. The injection device according to any one of claims 33 to 36.

38. The distal end of the proximal housing is received in a second opening in the proximal end of the distal housing. The injection device according to any one of claims 33 to 37.

39. The proximal end of the distal housing is received in an opening in the distal end of the proximal housing. The injection device according to any one of claims 33 to 37.

40. Including an end cap, the proximal housing is movable between the end cap and the distal housing. The injection device according to claim 39.

41. The guard member is initially in the retracted position. The injection device according to any one of claims 34 to 40.

42. The guard member is initially in the extended position. The injection device according to claim 34.

43. A first biasing member configured to act on a first biasing force and push the guard member toward the extended position; A second biasing member configured to act on a second biasing force and push the proximal housing away from the distal housing, the second biasing force being greater than the first biasing force. A second biasing member; Including. The injection device according to any one of claims 33 to 36 or 42.

44. The first biasing member includes a first spring, the second biasing member includes a second spring, and the first spring and the second spring are operatively arranged in series. The injection device according to claim 43.

45. Including a lock, the lock has a locked state in which the lock prevents movement of the proximal housing relative to the distal housing, and an unlocked state in which the lock allows movement of the proximal housing relative to the distal housing. The lock is operatively coupled to the guard member such that when the guard member is moved from the guard member extended position to the guard member retracted position, the lock changes from the locked state to the unlocked state. The injection device according to claim 42.

46. When the guard member is in the extended position, the insertion end portion of the delivery member is surrounded by the guard member, and when the guard member is in the retracted position, the insertion end portion of the delivery member protrudes outside the guard member. The injection device according to any one of claims 34 to 45.

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