ACTIVABLE INFUSION DEVICE FOR DRUG DELIVERY - Patent application

Abstract

An injection device for drug delivery is disclosed. The injection device may include a housing having an opening, a drug reservoir including a delivery member having an insertion end configured to extend at least partially through the opening, and a plunger. A drive mechanism may be included for expelling the drug from the drug reservoir through the delivery member. The drive mechanism may be actuated by a guard member movably disposed within the opening of the housing, an activator member that may be movable independently of the guard member and movably disposed within the opening of the housing, and / or a portion of the housing that is movable relative to another portion of the housing.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 62 / 895,041, filed September 3, 2019, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to injectors for drug delivery, and more particularly to actuation of such devices. [Background technology]

[0003] Patients receive medications to treat a variety of medical conditions. Some medications are administered orally, topically, or by inhalation routes, while others are administered by injection. Injection involves piercing the patient's skin with a delivery member, such as a needle or cannula, and forcing the drug through the delivery member and into the patient.

[0004] Traditionally, syringes have been used to administer injectable medications. Use of a syringe requires manually inserting a needle into the skin and then manually depressing a plunger to force the medication through the needle and into the patient. Performing these steps requires dexterity and skill, making self-administration with a syringe difficult for certain individuals. Syringes also carry the risk of accidental needle sticks, as the needle may be exposed before and after injection.

[0005] To facilitate self-administration, certain injectors automate various aspects of the injection process and include actuation mechanisms according to these objectives. In general, it is desirable that actuation of the actuation mechanism be intuitive for the patient and involve relatively few steps. It is also desirable that any actuation mechanism be able to interact with the actuation mechanism without adding undue complexity or cost to the device. Achieving these and other objectives, such as providing an elongated, pen-like shape in the case of an autoinjector, presents a variety of design and manufacturing challenges.

[0006] The present disclosure describes an infusion device that embodies an advantageous alternative to existing infusion devices and that may address one or more of the problems or needs set forth herein, as well as provide other benefits and advantages. Summary of the Invention [Means for solving the problem]

[0007] One aspect of the present disclosure provides an injection 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 extend at least partially through the opening of the housing. The biasing member may be operatively coupled to the plunger and may be initially held in an excited state. Releasing the biasing member may drive the plunger to expel the drug from the drug reservoir through the delivery member. The guard member may have a skin contact portion and an activator portion. Furthermore, the guard member may be movable relative to the housing and may have 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 disposed away from the extended position and toward the housing. Moving the guard member from the extended position to the retracted position may cause the activator portion to release the biasing member, allowing the biasing member to drive the plunger to expel the drug from the drug reservoir.

[0008] Another aspect of the present disclosure provides an injection device including a housing, a drug reservoir, a plunger, a drive mechanism, a guard member, and an activator member. The housing may have an opening, and the drug reservoir 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 reservoir through the delivery member. The guard member may be movable relative to the housing and may have 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 disposed away from the extended position and toward the housing. The activator member may be movable relative to the housing independent of movement of the guard member.

[0009] A further aspect of the present disclosure provides an injection device including a distal housing, a drug reservoir, a plunger, a drive mechanism, and a proximal housing. The distal housing may have an opening, and the drug reservoir 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 reservoir through the delivery member. The proximal housing may be operatively coupled to the drive mechanism and movable relative to the distal housing such that moving the proximal housing in a distal direction actuates the drive mechanism.

[0010] The present disclosure will be more fully understood when the following description is taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily represent the presence or absence of the particular element in any of the illustrative embodiments, unless expressly described in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0011] [Figure 1] 1 is a schematic cross-sectional view of an injection device according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of a guard member according to one embodiment of the present disclosure. [Figure 3A] 3 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 2. [Figure 3B] 3 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 2. [Figure 3C] 3 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 2. [Figure 3D] 3 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 2. [Figure 4A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 4B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 5A] 13 is a perspective view of a guard member according to another embodiment of the present disclosure. FIG. [Figure 5B] 13 is a perspective view of a guard member according to another embodiment of the present disclosure. FIG. [Figure 6] 1 is a schematic cross-sectional view of an injection device according to another embodiment of the present disclosure. [Figure 7] 13 is a perspective view of a guard member according to another embodiment of the present disclosure. FIG. [Figure 8A] 8 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 7. [Figure 8B] 8 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 7. [Figure 8C] 8 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 7. [Figure 8D] 8 illustrates an actuation sequence of an embodiment of an injection device incorporating the guard member of FIG. 7. [Figure 9A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 9B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 9C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 10A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 10B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 10C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11D] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11E] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 11F] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 12A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 12B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 12C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 13] 1 shows an injection device according to another embodiment of the present disclosure. [Figure 14] 1 is a schematic cross-sectional view of an injection device according to an embodiment of the present disclosure. [Figure 15A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 15B]13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 15C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 15D] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 16] 1 is a schematic cross-sectional view of an injection device according to an embodiment of the present disclosure. [Figure 17A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 17B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 17C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 18A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 18B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 18C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 19] 1 is a schematic cross-sectional view of an injection device according to an embodiment of the present disclosure. [Figure 20A] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 20B] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 20C] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. [Figure 20D] 13 illustrates an actuation sequence of an injection device according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0013] FIG. 1 is a schematic diagram of an injection device 10 according to one embodiment of the present disclosure. The injection device 10 may be configured as a single-use disposable injector or as a multiple-use reusable injector. The injection device 10 may be configured to inject any suitable drug or combination of drugs. The injection device 10 may be for self-administration, but may also be used by a caregiver or a health care provider formally trained to administer injections (e.g., a doctor or nurse). In some embodiments, the injection device 10 may be configured as an autoinjector or pen injector and thus may be held in the user's hand for the duration of drug delivery. In embodiments where drug delivery may be delayed or may take minutes or hours, the injection device 10 may be configured as an on-body injector (e.g., a patch injector) that may 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 semi-transparent inspection window may be disposed in a wall of the housing 12 to allow a user to view the internal components of the injection device 10, including the drug reservoir 20. Viewing the drug reservoir 20 through the window may allow a user to verify that drug delivery is in progress and / or 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 sterility barrier (e.g., a rigid needle shield) attached to the insertion end 28 of the delivery member 16 to aid in this 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 with the drug storage container 20 by a user prior to use of the injection device 10. The drug storage container 20 may include a rigid wall defining an internal 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 an inner surface of the drug reservoir 20 to prevent or inhibit leakage of the drug past the stopper 24 as the stopper 24 is moving. 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 from each other, 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 each other, for example via a threaded connection, to move together from the start of the 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 connected or operable to be connected in fluid communication with a 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 may include a sharp tip of other pointed geometric shapes to allow the insertion end 28 to pierce the skin and / or subcutaneous tissue of a patient during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal passageway. One or more openings may be formed in the insertion end 28 to allow drug to flow from the delivery member 16 to the patient. In some embodiments, the delivery member 16 may be defined by a single structure, such as a rigid needle or flexible cannula, while in other embodiments, the delivery member 16 may be defined by multiple interdependent structures. Regarding the latter, in certain embodiments, the delivery member 16 may include a rigid metal needle and a flexible plastic cannula, where the needle is used to insert the cannula into the patient and then partially or fully retracted from the cannula, which remains within the patient for subcutaneous delivery. Such a configuration may be desirable from a safety and / or comfort standpoint, especially if the cannula will be left within the patient for a significant period of time (e.g., minutes, hours, days, etc.).

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

[0018] In some embodiments, the drug reservoir 20 may be attached to the housing 12 such that the drug reservoir 20 does not move relative to the housing 12 after being placed therein. In such embodiments, including the one 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 reservoir 20 may be movably coupled to the housing 12 such that the drug reservoir 20 can move relative to the housing 12 during operation of the injection device 10. In certain such embodiments, 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 a patient. In some embodiments, this movement may be the result of the drug reservoir 20 being driven distally relative to the housing 12.

[0019] With continued reference to FIG. 1 , the injection device 10 further includes a drive mechanism 30 mounted within the housing 12. The drive mechanism 30 may be configured to store energy and upon or in response to activation of the drive mechanism 30 by a user, release or output the energy to drive the plunger 26 to expel the drug 22 from the drug reservoir 20 through the delivery member 16 and into the patient. For example, the drive mechanism 30 may be configured to store mechanical, electrical, and / or chemical potential energy and convert the potential energy into kinetic energy or motion of the plunger 26 upon activation of the drive mechanism 30. The drive mechanism 30 may be partially or entirely disposed 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.

[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 energized state. In the energized state, the biasing member may be compressed, tensioned, torqued (e.g., twisted or wound), or any combination thereof, depending on the configuration of the biasing member. In the energized state, the biasing member may exert a biasing force on the plunger 26, but the plunger 26 is prevented from moving by a retention mechanism, as described below. Upon release, the biasing member may return to its natural length or shape, thereby driving 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 in which the biasing member includes a spring, the spring may be any one or combination of a compression spring, an extension spring, a torsion spring, a helical torsion spring, or any other suitable spring. In addition to or in lieu of a biasing member, the drive mechanism 30 may include any one or combination of an electromechanical mechanism including an electric motor and / or a solenoid coupled to the plunger 26 and a drive train or transmission; or a mechanism that generates or releases a pressurized gas or fluid to propel the plunger 26, or that directly acts on the stopper 24 to move the stopper 24 within the drug reservoir 20 and expel the drug 22 within the drug reservoir 20. In embodiments in which the drug reservoir 20 and / or the delivery member 16 are movable relative to the housing 12, the drive mechanism 30, when actuated, may drive the drug reservoir 20 and / or the delivery member 16 in a distal direction to insert the insertion end 28 of the delivery member 16 into the patient. Thus, in certain embodiments, the drive mechanism 30 can provide the motive force necessary to both insert the delivery member 16 into the patient and expel the drug 22 from the drug reservoir 20 .

[0021] 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 fully or partially retracted within the opening 14 of the housing 12. At least in the extended position, the guard member 32 may extend beyond and enclose the insertion end 28 of the delivery member 16. In some embodiments, the guard member 32 may be moved toward the retracted position to 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 may 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 activator portion 34 and a skin-contacting portion 36, respectively. In some embodiments, the activator portion 34 and the skin-contacting portion 36 may be integrally formed to define a single monolithic structure. In other words, the activator portion 34 and the skin-contacting portion 36 may be formed of a single piece. In other embodiments, the activator portion 34 and the skin-contacting portion 36 may be physically separate structures that are fixedly attached to one another to prevent them from moving and / or to move together when moving. At least the skin-contacting 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 infusion device 10. Movement of the guard member 32 from the extended position to the retracted position may be performed by pressing the skin-contacting portion 36 against the patient's skin at the injection site. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 in the initial or storage state, this movement may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin.

[0023] In some embodiments, the guard member 32 may be biased towards the extended position by a biasing member, such as a spring. A user may overcome the biasing force provided by the biasing member by pressing the guard member 32 against the injection site. Once the injection is completed and the injection device 10 is moved away 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 may include a lockout mechanism to lock the guard member 32 in the extended position after the guard member 32 has been moved from the retracted position to the extended position to prevent reuse of the injection device 10 and / or to reduce the possibility of a needle stick.

[0024] In some embodiments, the guard member 32 may be configured to interact with the drive mechanism 30 when the guard member 32 moves from the extended position to the retracted position. This interaction may enable the drive mechanism 30 to output the energy required to drive the plunger 26 and 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 may be achieved by directly coupling the guard member 32 to the drive mechanism 30 or by indirectly coupling the guard member 32 to the drive mechanism 30, for example, via a mechanical or electromechanical linkage. In embodiments in which the drive mechanism 30 includes a biasing member, such as a spring, movement of the guard member 32 from the extended position to the retracted position may release the biasing member from an energized state, allowing the biasing member to drive and cause the plunger 26 to expel the drug 22 from the drug reservoir 20. Additionally or alternatively, the guard member 32 may be configured to hold the biasing member in an energized state when the guard member 32 is disposed in the extended position. In some embodiments, the guard member 32 may retain the biasing member by direct contact with the biasing member, the plunger 26, and / or an element rigidly attached to the biasing member or the plunger 26. In embodiments in which the biasing member exerts a biasing torque, the guard member 32 may retain the biasing member by preventing rotation of the biasing member and / or a rotating element biased to rotate by the biasing member, such as the power sleeve 555 described below. In further embodiments in which the guard member 32 is used to retain the biasing member in an energized 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 causes the activator portion 34 to release the biasing member or an element biased by the biasing member, thereby deactivating the biasing member and allowing the plunger 26 to drive the drug 22 from the drug reservoir 20. In certain such embodiments, the activator portion 34 of the guard member 32 may include one or more deformable arms that deflect radially outwardly and release the biasing member when the guard member 32 moves from the extended position to the retracted position.In some embodiments, deflection of the arms may occur by forcing the guard member 32 against an angled ledge or lip formed on the interior surface of the housing 12, which creates a torque that bends the deformable arms outward. In a variation of this embodiment, one or more resilient arms separate from the guard member 32 may be held in a first or compressed position in which the resilient arms prevent movement of the biasing member, the plunger 26, and / or elements rigidly attached to the biasing member or the 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 is no longer in contact with the resilient arms, thereby releasing the resilient arms to return to their original or natural shape and thus to the second position. In the second position, the resilient arms no longer restrain the biasing member, thus allowing the biasing member to de-energize and drive the plunger 26 to expel the drug 22 from the drug reservoir 20.

[0025] In embodiments in which the drive mechanism 30 includes an energy source that is an electromechanical mechanism including an electric motor and / or solenoid coupled to the plunger 46 and a drive train or transmission, or a mechanism that generates or releases pressurized gas or fluid to propel the plunger 26, or that 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 exert a force on) the drive mechanism 30 to activate the drive mechanism 30.

[0026] 2-3D, an embodiment of a guard member is shown that may be implemented in an injection device, including, for example, the injection device 10 shown in FIG. 1. Elements in FIGS. 2-3D that are similar in function and / or structure to elements in FIG. 1 are indicated by the same reference numerals, increased by 100 relative to their counterparts in FIG. 1. The guard member 132 in this case 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 allows the expulsion of the drug 22 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] 2 shows that the skin contacting portion 136 of the guard member 132 may have a tubular or cylindrical shape. Two longitudinally extending arms 142a and 142b extend in a proximal direction away from the skin contacting portion 136. The skin contacting portion 136 may be integrally formed with the longitudinally extending arms 142a and 142b to define a single monolithic structure. In other words, the skin contacting portion 136 and the longitudinally extending arms 142a and 142b may be formed in one piece. The longitudinally extending arms 142a and 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 arms 142a and 142b may be defined in the activator portion 134 of the guard member 132. In the embodiment shown in FIG. 2, the proximal ends of the longitudinally extending arms 142a and 142b include walls 144a and 144b, respectively, each of which extends inwardly away from the remainder of the longitudinally extending arms. The walls 144a and 144b may be perpendicular or substantially perpendicular or otherwise non-parallel to the longitudinal axis A of the infusion device 110.

[0029] 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 an initial state of the injection device 110 prior to activation. Here, the biasing member of the drive mechanism is held in an energized state by a retaining member 140 disposed in a first position. In the energized state, the biasing member may exert a force that biases the plunger in a distal direction. As a result, a flange 146 extending radially outward from the plunger is pressed downward against an angled cam surface 148 of a sleeve 150 that is rigidly attached to the housing 112. The biasing force urges the flange 146 down the cam surface 148 towards a longitudinally extending slot 152 formed in the sleeve 150. Initially, the flange 146 is prevented from sliding down the cam surface 148 by the retaining member 140 abutting the flange 146 when the retaining member 140 is disposed in the first position. 3A shows that in the initial state, no portion of the guard member 132 is in contact with the retaining member 140. However, in other embodiments, in the initial state, the activator portion 134 of the guard member 132 may be in direct contact with the retaining member 140. It should be noted that the flange 146 may be integrally formed with the plunger or may be a separate component fixedly attached to the plunger such that the flange 146 moves therewith.

[0030] 3B shows the state of the injection device 110 after the skin-contacting portion 136 of the guard member 132 has been pressed against the patient's skin and partially retracted into the opening 114 of the housing 112. Here, the wall 144a of the activator portion 134 of the guard member 132 is in direct contact with the retaining member 140, pushing it in a proximal direction. As a result, the retaining member 140 moves from the first position to a second position in which the retaining member 140 no longer restricts the flange 146 from sliding down the cam surface 148. As a result of this action, the wall 144a momentarily assumes the first position of the retaining member 140, thus momentarily holding the biasing member in the excited state by abutting the flange 146 and preventing the flange 146 from sliding down the cam surface 148. Although not shown, the wall 144b of the activator portion 134 of the guard member 132 may perform a similar action on the other side of the plunger.

[0031] Further retraction of the guard member 132 allows the wall 144a to slide out of contact with the flange 146, as shown in FIG. 3C. With nothing to hold the flange 146, it can slide down the cam surface 148 under the biasing force of the biasing member and then into the longitudinally extending slot 152. In some embodiments, the plunger can rotate relative to the sleeve 150 as the flange 146 slides down the cam surface 148. When the flange 146 is within the longitudinally extending slot 152, the biasing member continues to be de-energized, thereby driving the plunger distally and expelling the drug 22 from the drug reservoir 20. Once a dose of the drug 22 has been delivered to the patient, the injection device 110 can be moved away 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, as shown in FIG. 3D.

[0032] In another embodiment, instead of the sleeve 150, the activator portion 134 of the guard member 132 may include a cam surface. In such an embodiment, the flange 146 may initially rest against a non-angled stop surface included in the sleeve 150 or other member such that the flange 146 is initially biased against rotation. As the guard member 132 moves from the extended position to the retracted position, the cam surface of the activator portion 134 of the guard member 132 directly contacts the flange 146 and urges the flange 146 against rotation, thereby permitting the flange 146 to rotate to a position where the flange 146 is aligned with a longitudinally extending slot 152 in the sleeve 150 or another position where the flange 146 is no longer constrained distally by the stop surface of the sleeve 150.

[0033] In yet another embodiment, the retention member 140 may be moved from the first position to the second position by a non-physical interaction between the activator portion 134 of the guard member 132 and the retention member 140. In certain such embodiments, the activator portion 134 of the guard member 132 and the retention member 140 may be magnetically repelled from one another or may be magnetically attracted to one another. 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, the magnetic repulsion or attraction between the activator portion 134 of the guard member 132 and the retention member 140 may move the retention member 140 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 reservoir.

[0034] While the above-described embodiment uses a retaining member 140 to initially hold the biasing member in an energized state, other embodiments may omit the retaining member 140 and instead use a guard member to initially hold the biasing member in an energized state. Figures 4A and 4B illustrate such an embodiment. Elements in Figures 4A and 4B that are similar in function and / or structure to elements in Figures 2-3D are indicated by the same reference numbers, increased by 100, relative to their counterparts in Figures 2-3D. In the embodiment of Figures 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 Figures 4A and 4B). The releaser member 250 may be biased to rotate under a force exerted by a biasing member. When the releaser member 250 is free to rotate, 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 in a distal direction, and in the second rotational position, the releaser member 250 may release the plunger to allow the plunger to move in a distal direction under the biasing force of the biasing member to expel the drug 22 from the drug reservoir 20.

[0035] FIG. 4A shows the guard member 232 in an extended position and the releaser member 250 in a first rotational position, where 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, thus holding the biasing member in an excited 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 can freely rotate from the first rotational position to the second rotational position under the biasing force of the biasing member. This movement may also cause a groove formed on the inner surface of the releaser member 250 to align with a flange extending from the plunger, thereby allowing the plunger to move distally under the biasing force of the biasing member to expel the drug from the drug storage container.

[0036] 5A and 5B, the embodiment shown generally combines the embodiment of FIGS. 2-3D with the embodiment of FIGS. 4A and 4B. The injection device of FIGS. 5A and 5B may include a flange 346, a cam surface 348, a sleeve 350, and a longitudinally extending slot 352, which are similar in function and structure to the flange 146, the cam surface 148, the sleeve 150, and the longitudinally extending slot 152 of the embodiment of FIGS. 3A-3D, respectively. Similar to the embodiment of FIGS. 4A and 4B, the guard member 332 of the embodiment 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 actuation portion 334 of the guard member 332 takes the form of a generally U-shaped hook. More specifically, and with reference to FIG. 5A, the proximal ends of the longitudinally extending arms 342a and 342b may include walls 354a and 354b, respectively. The walls 354a and 354b each extend generally circumferentially relative to the longitudinal axis A of the injection device and laterally away from the remainder of the longitudinally extending arms. A notch or groove 356a and a notch or groove 356b are formed in the distal ends of the walls 354a and 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 in the groove 356a of the wall 354a. As a result, wall 354a directly contacts flange 346 extending outwardly from the plunger, preventing flange 346 from sliding down cam surface 348. This further prevents the biasing member from being de-energized to urge the plunger in a distal direction. Wall 354b can perform a similar retention function on the opposite side of the injection device. When guard member 332 is pressed against the patient's skin and retracted into the housing opening, wall 354a can slide out of engagement with flange 346. This releases flange 346 to slide down cam surface 358 and into longitudinally extending slot 352 under the biasing force of the biasing member.When the flange 346 is within the longitudinally extending slot 352, the biasing member continues to be de-energized, thereby driving the plunger distally and allowing the drug to be expelled from the drug reservoir.

[0037] While each of the foregoing embodiments utilize a guard member to release the biasing member of the drive mechanism, the scope of the disclosure is not limited to this configuration. Alternative embodiments, as will become apparent from the following description, may utilize 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 be actuated by the user's hand, preferably without the user having to change how they grip the injection device.

[0038] Figure 6 is a schematic diagram of an injection device 410 similar to the injection device 10 of Figure 1, except that the injection device 410 incorporates an activator member 440 that is movable independently of the guard member 432. Elements of Figure 6 that are similar in function and / or structure to elements of Figure 1 are designated by the same reference numerals, increased by 400 relative to their counterparts in Figure 1. The description of many of these elements has been simplified or even omitted for the sake of brevity.

[0039] 6, the activator member 440 may be disposed adjacent to and / or coaxial with the guard member 432 in certain embodiments. The activator member 440 may have a proximal end received within the housing 412 and may be configured to move relative to the housing 412 between an extended position in which a distal end of the activator member 440 extends through the opening 414 of the housing 412 and a retracted position in which the distal end of the activator member 440 is fully or partially retracted within the opening 414 of the housing 412. In the extended position, the activator member 440 may extend beyond and / or surround the insertion end 428 of the delivery member 416. In some embodiments, moving the activator member 440 toward the retracted position may expose the insertion end 428 of the delivery member 416. In such embodiments, the activator member 440 may act as a second needle guard. In another embodiment, the configuration of the activator member 440 may be such that it offers little or no protection against inadvertent needle sticks. In some embodiments, the activator member 440 may be coupled to the housing 412 via, for example, a pin-and-slot mechanism or similar mechanism such that the activator member 440 can translate in a linear direction relative to the housing 412, but is prevented from rotating relative to the housing 412.

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

[0041] The proximal and distal ends of the activator member 440 may include an activator portion 444 and a skin-contacting portion 446, respectively. In some embodiments, the activator portion 444 and the skin-contacting portion 446 may be integrally formed to define a single monolithic structure. In other words, the activator portion 444 and the skin-contacting portion 446 may be formed of a single piece. In other embodiments, the activator portion 444 and the skin-contacting portion 446 may be physically separate structures that are fixedly attached to one another to prevent them from moving and / or to move together when they do. In some embodiments, the activator portion 444 may initially be separated from the skin-contacting portion 446 by a gap, and when the skin-contacting portion 446 is retracted proximally, the skin-contacting portion 446 may close the gap and push or otherwise act on the activator portion 444, causing the activator portion 444 to move relative to the housing 412. At least the skin contacting portion 446 of the activator 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, movement of the activator member 440 from the extended position to the retracted position may be performed by pressing the skin contacting portion 446 against the patient's skin at the injection site. In embodiments in which the delivery member 416 protrudes from the opening 414 of the housing 412 in the initial or stored state, this movement may result in the insertion end 428 of the delivery member 416 being inserted into the patient's skin.

[0042] In some embodiments, the activator member 440 may be biased toward the extended position by a biasing member, such as a spring. A user may overcome the biasing force provided by the biasing member, for example, by pressing the activator member 440 against the injection site. Once the injection is completed and the injection device 410 is moved away from the injection site, the biasing member may return the activator 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 to lock the activator member 440 in the extended position to prevent reuse of the injection device 410 after the activator member 440 has moved from the retracted position to the extended position. In some embodiments, after delivery, only the activator member 440 may return to the extended position and the guard member 432 may not return to the extended position, or vice versa. In yet another embodiment, after delivery, both the activator member 440 and the guard member 432 may return to the extended position.

[0043] The activator member 440 may be configured to interact with the drive mechanism 430 when the activator member 440 moves from the extended position to the retracted position. This interaction may enable the drive mechanism 430 to output the energy required to drive the plunger 426 and expel the drug 422 from the drug reservoir 420 and / or insert the insertion end 428 of the delivery member 416 into the patient's skin. The interaction between the activator member 440 and the drive mechanism 430 may be achieved by directly coupling the activator member 440 to the drive mechanism 430 or by indirectly coupling the activator member 440 to the drive mechanism 430, for example, via a mechanical or electromechanical linkage. In embodiments in which the drive mechanism 430 includes a biasing member, such as a spring, movement of the activator member 440 from the extended position to the retracted position may release the biasing member from an excited state, allowing the biasing member to drive and cause the plunger 426 to expel the drug 422 from the drug reservoir 420. Additionally or alternatively, the activator member 440 may be configured to hold the biasing member in an excited state when the activator member 440 is disposed in the extended position. In some embodiments, the activator member 440 may hold the biasing member by direct contact with the biasing member, the plunger 426, and / or an element fixedly attached to the biasing member or the plunger 426.

[0044] In embodiments in which 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 activator member 440 moves from the extended position to the retracted position, the activator member 440 can act directly on (i.e., directly contact and exert a force on) the drive mechanism 430 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 activator member 440 may be responsible for activating the drive mechanism 430. In other embodiments, the guard member 332 may be responsible for activating the drive mechanism 430. In certain such other embodiments, retraction of the guard member 332 may unlock the drive mechanism 430, which in itself does not allow the drive mechanism 430 to output the energy required to drive the plunger 436, but subsequently allows the activator member 440 to interact with the drive mechanism 430 to output the energy required to drive the plunger 436 and expel the drug 422 from the drug reservoir 420.

[0046] 7-8D, an embodiment of an activator member is shown that may be implemented in an injection device, including, for example, the injection device shown in FIG. 6. Elements in FIG. 7-8D that are similar in function and / or structure to elements in FIG. 6 are indicated by the same reference numbers, increased by 100 with respect to their counterparts in FIG. 6. The activator member 540 in this case is configured to interact with a retaining member 541, which is a separate structure from the activator member 540, as a result of the activator member 540 moving from an extended position to a retracted position. This interaction releases a biasing member included in the drive mechanism 430 such that the biasing member drives the plunger 526 and allows the expulsion of 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] 7 shows that the skin contacting 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 contacting portion 546. The skin contacting portion 546 may be integrally formed with the longitudinally extending arms 552a and 552b to define a single monolithic structure. In other words, the skin contacting portion 546 and the longitudinally extending arms 552a and 552b may be formed in one piece. The longitudinally extending arms 552a and 552b may be parallel or substantially parallel to the longitudinal axis A of the infusion device 510 and may be arranged so as not to cover one or more windows formed in the housing 412 of the infusion device 510.

[0048] One or both of the proximal ends of the longitudinally extending arms 552a and 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 arms 552a and 552b include walls 554a and 554b, respectively, each of which extends inwardly away from the remainder of the longitudinally extending arms. The walls 554a and 554b may be perpendicular or substantially perpendicular or otherwise non-parallel to the longitudinal axis A of the infusion device 510.

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

[0050] 8A-8D, a sequence for using an activator member 540 to release a rotational biasing member of a drive mechanism of an injection device, including, for example, the injection device 410 of FIG. 6, will now be described. FIG. 8A shows an initial state of the injection device 510 prior to activation, where the rotational biasing member of the drive mechanism is held in an energized state by a retaining member 541 disposed in a first position. In the energized state, the rotational biasing member may exert a force that biases the power sleeve 555 to rotate. However, initially, the power sleeve 555 is prevented from rotating by an inner surface of the retaining member 541 that lockingly engages 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 retaining member 541 that receives a protrusion formed in the other of the power sleeve 555 and the retaining member 541. FIG. 8A shows that in the initial state, no portion of the activator member 540 is in contact with the retaining 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 retaining member 541 .

[0051] 8B shows the state of the infusion device 510 after the skin contacting portion 546 of the activator member 540 has been pressed against the patient's skin and partially retracted 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 retaining member 541, pushing it in a proximal direction. As a result, the retaining member 541 has moved from the first position to a second position where the retaining member 541 is no longer in contact with or restricting the rotational movement of the power sleeve 555. As a result of this action, the walls 554a and 554b momentarily assume the first position of the retaining member 541, thus momentarily holding the rotational biasing member in an excited state by engaging and rotatably locking the power sleeve 555. This may involve walls 554a and 554b sliding into respective longitudinally extending grooves formed in the outer surface of power sleeve 555 (previously occupied by inwardly extending protrusions of retaining member 541).

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

[0053] Further retraction of the activator member 540 allows the walls 554a and 554b to slide out of contact with the power sleeve 555, as shown in FIG. 8C. With nothing 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 (e.g., a torsion coil spring, a helical torsion spring, etc.). A threaded inner surface of the power sleeve 555 can engage a threaded outer surface of the plunger 526. Thus, rotation of the power sleeve 555 can drive the plunger 526 in a distal direction to expel the drug from the drug reservoir. Once a dose of drug has been delivered to the patient, the injection device 510 can be moved away from the patient's skin and the activator member 540 can return to the extended position under the force of the biasing member, as shown in FIG. 8D.

[0054] 7-8D, a retaining member 541 is used to initially hold the rotational biasing member in an energized state, but in other embodiments, the retaining member 541 may be omitted and instead an activator member 540 may be used to initially hold the rotational biasing member in an energized state. For example, in an initial state, when the activator member 540 is in an extended position, the walls 554a and 554b of the activator portion 544 of the activator member 540 may be received within respective grooves formed in an outer surface of the power sleeve 555 to prevent the power sleeve 555 from rotating. When the activator member 540 moves from the extended position to the retracted position, the walls 554a and 554b may slide out of contact with the power sleeve 555, thereby releasing the power sleeve 555 so that the power sleeve 555 may rotate under the rotational biasing force of the rotational biasing member, thereby threadably advancing the plunger 526 distally and expelling the drug 422.

[0055] Figures 9A-13 show several variations of activator members that are movable independently of the guard member and that may be implemented in any of the injection devices shown in Figures 6-8D and other injection devices. Also, similar to the embodiments of Figures 6-8D, the guard members of the embodiments of Figures 9A-13 may not be operatively coupled to or otherwise interact with the drive mechanism of the injection device to activate, release, and / or unlock the drive mechanism.

[0056] 9A-9C show an embodiment in which the activator member 610 has a skin contacting portion 612 that has a tubular or cylindrical shape and surrounds the skin contacting portion 616 of the guard member 614. Additionally, in an initial state, the guard member 614 can extend distally beyond the activator member 610 such that the skin contacting portion 616 of the guard member 614 is exposed prior to contacting the patient's skin (FIG. 9A). As a result, the skin contacting portion 616 of the guard member 614 contacts the patient's skin at the injection site before the skin contacting portion 612 of the activator member 610. Upon contacting the skin, initially, the guard member 614 retracts into the housing of the injection device while the activator member 610 remains stationary relative to the housing of the injection device. When the skin-contacting portion 616 of the guard member 614 is retracted to a position where it is flush with the skin-contacting portion 612 of the activator member 610 (FIG. 9B), the skin-contacting portion 612 of the activator member 610 contacts the patient's skin and begins to retract into the housing. Both the activator member 610 and the guard member 614 are then pushed to their respective retracted positions (FIG. 9C). As discussed above in connection with FIGS. 6-8D, retraction of the activator member 610 can cause the activator member 610 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 a plunger to expel a 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 completed and the injection device is removed from the patient's skin, the activator member 610 can be locked in its retracted position while the guard member 614 is redeployed to its extended position to prevent needle sticks.

[0057] 10A-10C show an embodiment similar to that of FIGS. 9A-9C, except that in an initial state, the activator member 620 extends distally beyond the guard member 624 (FIG. 10A) such that the skin-contacting portion 626 of the guard member 624 is covered by the skin-contacting portion 622 of the activator member 620. As a result, the skin-contacting portion 622 of the activator member 620 contacts the patient's skin at the injection site before the skin-contacting portion 626 of the guard member 624. Upon contacting the skin, initially, the activator member 620 is retracted into the housing of the injection device while the guard member 624 remains stationary relative to the housing of the injection device. Once the skin-contacting portion 622 of the activator member 620 is retracted to a position where it is flush with 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 retracted into the housing together with the activator member 620. Thereafter, both the activator member 610 and the guard member 614 are pushed to their respective retracted positions (FIG. 10B). As described above in connection with FIGS. 6-8D, retracting the activator member 620 can cause the activator 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 to expel the drug from the drug reservoir to the patient and / or to insert the insertion end of the delivery member into the patient's skin. After drug delivery is completed and the injection device is removed from the patient's skin, the activator member 620 can be locked in its retracted position while the guard member 624 is redeployed to its extended position (FIG. 10C). Thus, after injection, the guard member 624, rather than the activator member 620, provides protection against inadvertent needle sticks. 10A-10C, the guard member 624 may be initially held in a retracted position and not deployed to the extended position until after drug delivery. In such alternative embodiments, the guard member 624 may not contact the patient's skin at the injection site during retraction of the activator member 620.

[0058] 11A-11F show an embodiment similar to that of FIGS. 9A-9C, except that the activator member 630 is surrounded by a guard member 634 at all times. Here, the skin contacting portion 632 of the activator member 630 may have a smaller diameter or width than the activator portion 633 of the activator member 630. Additionally, the diameter of the skin contacting portion 632 may be smaller than the opening 637 of the skin contacting portion 636 of the guard member 634. So configured, the skin contacting portion 632 of the activator member 630 may fit within the opening 637 and contact the patient's skin when the guard member 634 is retracted. This allows the activator member 630 to be pushed into the retracted position shown in FIGS. 11C and 11D. Increasing the diameter or width of the activator portion 633 of the activator member 630 may allow the activator portion 633 to accommodate the barrel of a drug reservoir. After drug delivery is completed and the infusion device is removed from the patient's skin, the activator member 630 may be locked in its retracted position while the guard member 634 is redeployed to its extended position (FIG. 11F).

[0059] 12A-12C show an embodiment similar to that of FIGS. 9A-9C, except that the activator member 640 has a different shape. Like its counterpart in the embodiment of FIGS. 9A-9C, the distal end of the activator member 640 is disposed around a guard member 644 and has a generally tubular or cylindrical shape. Unlike its counterpart in the previous embodiment, the tubular portion of the activator member 640, which may be considered a ring, does not extend the entire distance between the housing of the infusion device and the skin-contacting portion 642 of the activator member 640. As a result, in the initial state of FIG. 12A, a portion of the guard member 644 located axially 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 actuation portion of the activator member 640, extends alongside the guard member 644 in a direction away from the skin-contacting portion 642 of the activator member 640. As seen in Figure 12A, in an 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 as 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, the activator member 640 can be locked in its retracted position while the guard member 644 is redeployed to its extended position (Figure 12C).

[0060] Figure 13 shows a variation of the embodiment of Figures 12A-12C, where activator member 650 lacks a tubular portion, and a longitudinally extending arm or rod 653 defines both the skin contacting portion of activator member 650 and the actuation portion of activator member 650. Although Figure 13 shows rod 653 disposed within a groove or slot in the wall of guard member 654, in alternative embodiments rod 653 may be disposed alongside guard member 654, either radially inward or radially outward of guard member 654.

[0061] In any of the embodiments described in connection with Figures 6-13, the injection device may include one or more mechanisms for deploying the activator member and the guard member according to any of the following approaches. According to one approach, in an initial state (e.g., prior to placing the injection device on the patient's skin at the injection site), the guard member may be retained or otherwise deployed in the retracted position and the activator member may be biased or otherwise deployed in the extended position. Later, in a post-delivery state (e.g., after the drug has been delivered to the patient and the injection device has been removed from the injection site), the guard member may be automatically deployed to the extended position and the activator member may be retained in the retracted position or automatically deployed in the extended position. According to another approach, in an initial state, the activator member may be retained or otherwise deployed in the retracted position and the guard member may be biased or otherwise deployed in the extended position. Later, in a post-delivery state, the activator member may be automatically deployed to the extended position and the guard member may be retained in the retracted position or automatically deployed in the extended position.

[0062] While the embodiment of the activator member described in connection with Figures 6-13 requires that the activator member extend into the same opening in the housing as the guard member, alternative embodiments may be configured differently. Figure 14 illustrates one embodiment of an activator member that is located at the proximal end of the injection device housing and does not contact the patient's skin at the injection site. Rather, the activator member can be manually activated by a user with their own hand while the distal end of the injection device is pressed against the patient's skin at the injection site.

[0063] With particular reference to Figure 14, elements similar in function and / or structure to elements in Figure 6 are designated by the same reference numerals, increased by 300 relative to their counterparts in Figure 6. Descriptions of many of these elements have been simplified or even omitted for brevity. Figure 14 shows activator member 740 slidably received within an opening 760 formed in the proximal end of housing 712. Activator member 740 is movable relative to housing 712 through opening 760 unless restricted by a lock, as described below. The activator member 740 is operatively coupled to the drive mechanism 730 such that movement of the activator member 740 relative to the housing 712 causes the activator member 740 to directly or indirectly interact 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 storage container 720 and / or to insert the insertion end 728 of the delivery member 716 into the patient's skin.

[0064] As shown in FIG. 14, the activator member 740 may take the form of a push button sized and dimensioned for operation by a user's thumb or other finger. A user can grasp the peripheral surface of the housing 712 in the palm of their hand and use their thumb to activate the activator member 740 without having to change their grip. In the illustrated embodiment, the activator 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 activator 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 activator member 740 may follow an arcuate path, including, for example, a path centered about the longitudinal axis A.

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

[0066] 15A-15D show a sequence for performing an injection using the injection device 710. FIG. 15A shows an initial state before activation, where the guard member 732 is biased to its extended position and the lock 762 is in a locked state. Thus, in this state, the lock 762 prevents movement of the activator member 740 relative to the housing 712. Then, in FIG. 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 a locked state to an unlocked state. The user can then push the activator member 740 distally with his or her thumb into the opening 760 in the housing 712 (FIG. 15C). 15D, the injection device 710 may be moved away from the patient's skin and the guard member 732 may return to the extended position under the force of the needle guard biasing member.

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

[0068] 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 a longitudinal axis A of the injection device 810. The proximal housing 812a may be sized and dimensioned so that a user can grasp it in the palm of his or her hand. Thus, the proximal housing 812a may define a tubular hand grip. The drive mechanism 830 may be disposed entirely or partially within an interior space of the proximal housing 812a. The distal end of the proximal housing 812a, which may have a smaller diameter or width than the proximal end of the proximal housing 812a, may be slidably received in 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 a distal end of the proximal housing 812a is inserted into the opening 813 when the proximal housing 812a moves distally. Furthermore, the proximal housing 812a is operatively coupled to the drive mechanism 830 such that distal movement of the proximal housing 812a relative to the distal housing 812b causes the proximal housing 812a to directly or indirectly interact with the drive mechanism 830 to release, activate, and / or unlock the drive mechanism 830, which in turn causes the drive mechanism 830 to output energy to drive the plunger 826 to expel 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.

[0069] 16, in the initial state, the distal facing surface 815 of the proximal housing 812a may be spaced apart from the proximal facing 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 configured to exert a biasing force against closing the gap between the distal facing surface 815 of the proximal housing 812a and the proximal facing 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.

[0070] 17A-17C, a sequence for performing an injection using the injection device 810 is shown. FIG. 17A shows an initial state of the injection device 810 before activation. Here, in the absence of any external force pushing the proximal and distal housings 812a, 812b towards each other, the biasing force of the biasing member 819 maintains a gap between the distal facing surface 815 of the proximal housing 812a and the proximal facing surface 817 of the distal housing 812b. The user can then grasp the proximal housing 812a in his / her 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 facing surface 815 of the proximal housing 812a abuts the proximal facing surface 817 of the distal housing 812b. This distal movement of the proximal housing 812a causes the proximal housing 812a to interact with, and consequently activate, release, and / or unlock, the drive mechanism, which in turn causes the drive mechanism to output energy to drive the delivery member 816 distally such that the insertion end 828 of the delivery member 816 pierces the patient's skin, driving the plunger 826 distally and expelling the drug from the drug reservoir 820 through the delivery member 816 and into the patient. Once a dose of drug has been delivered to the patient, the injection device 810 may be moved away from the patient's skin and the biasing member may be released to move the guard member 832 from a retracted position to an extended position to cover the insertion end 828 of the delivery member 816 ( FIG. 17C ).

[0071] 18A-18C show a variation of the embodiment of FIGS. 16-17C. Here, the proximal housing 912a is split into two separate structures, an actuation 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 actuation 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. Additionally, the actuation 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. The actuating sleeve 970 may be operatively coupled to the drive mechanism such that distal movement of the actuating sleeve 970 directly or indirectly interacts 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 a plunger to expel drug from the drug storage container and / or to insert the insertion end of the delivery member into the patient's skin.

[0072] FIG. 18A shows an initial state of the injection device 910 before activation. Here, the guard member 932 is in a retracted state, and the actuation sleeve 970 is biased in a proximal direction, e.g., via the biasing member 819, such that the proximal-facing end face of the actuation sleeve 970 abuts the distal-facing surface of the end cap 972. In this configuration, the biasing force of the biasing member maintains a gap between the distal-facing end face of the actuation sleeve 970 and the proximal-facing surface of the distal housing 912b. The user can then grasp the actuation 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 actuation 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-facing end face of the actuation sleeve 970 abuts the proximal-facing surface of the distal housing 912b. This distal movement of the actuation sleeve 970 causes the actuation sleeve 970 to interact with, and consequently activate, release, and / or unlock, the drive mechanism, which in turn causes the drive mechanism to output energy to drive the delivery member 916 distally such that the insertion end 928 of the delivery member 916 pierces the patient's skin, driving the plunger distally and expelling the drug from the drug reservoir through the delivery member 916 and into the patient. After a dose of drug has been delivered to the patient, the injection device 910 may be moved away from the patient's skin and the biasing member may be released to move the guard member 932 from the retracted position to the extended position to cover the insertion end 928 of the delivery member 916 (FIG. 18C).

[0073] Figure 19 illustrates an embodiment of an injection device similar in certain respects to the injection device of Figure 16, except that, among other differences, the guard member is initially disposed in an extended position. The injection device of Figure 19 includes many elements that are structurally and / or functionally similar to the injection device of Figure 16. Such elements are identified with the same reference numerals as their counterparts in Figure 16, increased by 200.

[0074] 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 a longitudinal axis A of the injection device 1010. The proximal housing 1012a may be sized and dimensioned so that a user can hold it in the palm of his or her hand. Thus, the proximal housing 1012a may define a tubular hand grip. The drive mechanism 1030 may be disposed entirely or partially within an interior space of the proximal housing 1012a. An opening 1019 may be formed in a distal end of the proximal housing 1012a and slidably received in a proximal end of the distal housing 1012b. The proximal housing 1012a may be movable relative to the distal housing 1012b, with the proximal end of the distal housing 1012b being inserted into the opening 1019 as the proximal housing 1012a moves distally. Additionally, the proximal housing 1012a may be operatively coupled to the drive mechanism 1030 such that distal movement of the proximal housing 1012a relative to the distal housing 1012b causes the proximal housing 1012a to directly or indirectly interact with the drive mechanism 1030 to release, activate, and / or unlock the drive mechanism 1030, which in turn causes the drive mechanism 1030 to output energy to drive the plunger 1026 to expel 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.

[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 a respective spring, such as, for example, a compression spring. As shown in FIG. 19, in certain embodiments, the springs may be operatively arranged in series with one another. The first biasing member 1080 may be configured to exert a first biasing force urging the guard member 1032 toward the extended position. The second biasing member 1082 may be configured to exert a second biasing force urging the proximal housing away from the distal housing. Furthermore, the second biasing force may be greater than the first biasing force. In embodiments in which the first biasing member 1080 and the second biasing member 1082 are springs, this may be accomplished by the second biasing member 1082 having a spring constant greater than the spring constant of the first biasing member 1080. Configured in this manner, 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 toward the distal housing 1012b. This sequence may ensure that the insertion end 1028 of the delivery member 1016 is inserted into the patient before actuating the drive mechanism 1030 to expel the drug 1022 from the drug reservoir 1020.

[0076] In addition to or as an alternative to the series arrangement of the first biasing member 1080 and the second biasing member 1082, some embodiments may incorporate a lock operatively coupled to the proximal housing 1012a and configured to selectively allow movement of the proximal housing 1012a relative to the distal housing 1012b. The lock may be similar in certain respects to the lock described above in connection with FIG. 14. 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 allows 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 moving the guard member 1032 from the extended position to the retracted position when the guard member 1032 is pressed against the infusion site changes the lock from the locked state to the unlocked state. As a result, only when the guard member 1032 moves from the extended position to the retracted position can the proximal housing 1012a move distally relative to the distal housing 1012b, thereby activating, releasing, and / or unlocking the drive mechanism 1030.

[0077] 20A-20D, a sequence for performing an injection using the injection device 1010 is shown. FIG. 20A shows an initial state of the injection device 1010 before activation. Here, the guard member 1032 is disposed in an extended position and is biased toward the extended position by a first biasing member 1080, in the absence of an external force urging the guard member 1032 and the proximal housing 1012a toward each other. Also in the initial state, the proximal housing 1012a is disposed in a first position relative to the distal housing 1012b and is biased toward this first position by a second biasing member 1082. In use, a user can grasp the proximal housing 1012a in his / 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 in a proximal direction until it reaches its retracted position. As a result, the insertion end 1028 of the delivery member 1016 may 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 retracted into the distal housing 1012b, although this need not necessarily occur as long as the guard member 1032 is retracted to a position where it can no longer be retracted further relative to the distal housing 1012b. Thus, the user continues to apply a force in the distal direction such that the proximal housing 1012a moves distally along the longitudinal axis A toward the distal housing 1012b 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. Distal movement of the proximal housing 1012a causes the proximal housing 1012a to interact with the drive mechanism 1030, thereby activating, disengaging, and / or unlocking the drive mechanism 1030, which in turn causes the drive mechanism 1030 to output energy to drive the plunger distally and expel the drug from the drug storage container through the delivery member and into the patient.Once a dose of drug 1022 has been delivered to the patient, the injection device 1010 can be moved away from the patient's skin and the first biasing member 1080 can move the guard member 1032 from the retracted position to the extended position, covering the insertion end 1028 of the delivery member 1016 (FIG. 20D).

[0078] It will be appreciated that devices and methods according to the present disclosure may have one or more advantages over the prior art, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment, and other advantages not specifically recited herein may be understood as well.

[0079] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to the drugs identified below, and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs 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 into which the drug is filled or pre-filled for treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0081] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). 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 erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin 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 alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0083] Among the specific exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: 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 humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, including myostatin-specific peptibodies; and myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; and myostatin-binding proteins, particularly those directed against the receptors for IL-4 and / or IL-13. which inhibit activity mediated by the binding of; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc.; 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 dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g. human CD22-specific antibodies, including but not limited to, humanized and fully human monoclonal antibodies, including but not limited to, human CD22-specific IgG antibodies, particularly including but not limited to, the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; and B7RP-specific fully human monoclonal IgG2 antibodies. B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (also referred to as "B7RP-1", B7H2, ICOSL, B7h, and CD275), including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, which inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells; IL-15 specific antibodies, peptibodies, related proteins and the like, particularly humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as 146B7; human IFNIFN gamma specific antibodies, peptibodies, related proteins, etc., including but not limited to, anti-IFN gamma antibodies, and fully human anti-IFN gamma 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 / scatter factor (HGF / SF):cMet axis (HGF / SF): such as fully human monoclonal antibodies that neutralize HGF / SF hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including those that target 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.; proteins that bind to c-Kit and / or other stem cell factor receptors. c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind OX40L and / or other ligands of the OX40 receptor; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7mAb), 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® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat 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® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IL6 / IL6 receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Rituxan® (rituximab, anti-CD20 mAb), Tarceva® (erlotinib), Roferon-A® (interferon alpha-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 146B7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-alpha4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory proteins)), VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, 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 (mapatuzumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (zalutumumab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-C. difficile toxin A and toxin BC 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 stage 1 fibrogen (FG-3019), anti-CTLA4 mAb, anti-eotaxin 1 mAb (CAT-213), anti-FGF8 mAb, anti-ganglioside GD2 mAb, anti-ganglioside GM2 mAb 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-1100), BMS-66513, anti-mannose receptor / hCGβ mAb (MDX-1307), anti-mesothelin dsFv-PE38 conjugate (CAT-5001), anti-PD1 mAb (MDX-1106(ONO-4538)), anti-PDGFRα antibody (IMC-3G3), anti-TGFβmAb(GC-1008), TRAIL-2 mAb (HGS-ETR2), TWEAK mAb, VEGFR / Flt-1 mAb, ZP3 mAb (HuMax-ZP3)

[0084] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, or BPS 804 (Novartis), or in other embodiments, 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 in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction 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. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinase (TIMP), such as but not limited to TIMP-3. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as but not limited to erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery device of the present disclosure. Additionally, bispecific T cell engaging (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), may be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery devices may contain or be used with APJ large molecule agonists, such as, but not limited to, apelin or analogs 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 device of the present disclosure.

[0085] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. This detailed description should be construed as exemplary 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, and such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0086] Those skilled in the art will appreciate that numerous modifications, alterations, and combinations may be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations are to be construed as falling within the scope of the inventive concept.

Claims

1. 1. An injection device comprising: a housing having an opening; a drug reservoir including a delivery member having an insertion end configured to extend at least partially through the opening in the housing; A plunger; a biasing member operatively coupled to the plunger and initially held in an excited state, wherein release of the biasing member actuates the plunger to expel drug from the drug reservoir through the delivery member; a guard member having a skin contact portion and an activator 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 in the housing and a retracted position in which the guard member is positioned away from the extended position toward the housing; a retaining member having a first position in which the retaining member retains the biasing member in the excited state and a second position in which the retaining member is released from retaining the biasing member; Including, moving the guard member from the extended position to the retracted position causes the activator portion to release the biasing member, allowing the biasing member to actuate the plunger to expel the drug from the drug reservoir; When the guard member moves from the extended position to the retracted position, the activator portion acts on the retention member to move the retention member proximally from the first position to the second position.

2. The injection device of claim 1 , wherein the activator portion directly contacts the retaining member to move the retaining member from the first position to the second position.

3. 3. The injection device of claim 1, wherein the guard member has a partially retracted position between the retracted position and the extended position, and the activator portion is configured to maintain the biasing member in the excited state when the activator portion is in the partially retracted position.

4. 2. The injection device of claim 1, wherein the activator portion is configured to maintain the biasing member in the excited state when the guard member is in the extended position.

5. 5. The injection device of claim 4, comprising a releaser member configured to rotate under a biasing force exerted by the biasing member, the activator portion configured to prevent rotation of the releaser member when the guard member is in the extended position.

6. 6. The injection device of claim 5, wherein the activator portion directly contacts the releaser member when the guard member is in the extended position and the activator portion is spaced from the releaser member when the guard member is in the retracted position.

7. An injection device according to claim 5 or 6, wherein the releaser member is attached to or formed integrally with the plunger.

8. An injection device according to any preceding claim, wherein the skin contact portion and the activator portion translate together in a linear direction between the extended and retracted positions.

9. An infusion device according to any preceding claim, wherein the skin contact portion and the activator portion are integrally formed and define a single monolithic structure.

10. 10. An injection device according to any one of the preceding claims, wherein the guard member comprises a tubular portion and at least one longitudinally extending arm extending away from the tubular portion, an end face of the tubular portion defining the skin contact portion.

11. 11. The injection device of claim 10, wherein the activator portion is defined at least in part by a wall extending inwardly from the at least one longitudinally extending arm.

12. An injection device according to any preceding claim, wherein the biasing member comprises a spring.

13. 13. An injection device according to any one of claims 1 to 12, wherein an insertion end of the delivery member is surrounded by the guard member when the guard member is in the extended position, and wherein the insertion end of the delivery member protrudes outside the guard member when the guard member is in the retracted position.

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