Drug delivery device having a removable cap - Patents.com

Abstract

A drug delivery device is provided that includes a housing, a drug storage container, and a removable cap. The removable cap may be configured to be removably coupled to the housing such that the removable cap has a storage position in which the removable cap is coupled to the housing and at least partially covers an opening in the housing, and a removal position in which the removable cap is not coupled to the housing. The removable cap may include an outer portion, an inner portion, and a gap separating at least a portion of the inner portion and at least a portion of the outer portion such that when at least a portion of the outer portion is subjected to an external force, at least a portion of the outer portion can bend relative to at least a portion of the inner portion. Additionally or alternatively, the removable cap may be configured such that an external force applied to the removable cap induces at least one bending moment at a proximal end and / or a distal end of the removable cap.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 159,317, filed March 10, 2021, the entire contents of which are expressly incorporated by reference herein.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to devices for automatically injecting a drug into a patient. [Background technology]

[0003] General aversion to exposed needles and health and safety concerns have led to the development of drug delivery devices that hide the needle or other insertion member prior to use and automate various aspects of the injection process. Such devices offer various advantages over traditional forms of drug delivery, including, for example, delivery via a traditional syringe.

[0004] The drug delivery device can incorporate various mechanisms for implementing various automated or semi-automated features. Such features include, among other features, automatically covering the needle to a pre-delivery and / or post-delivery state, automatically inserting the needle and / or cannula into the user, automatically activating the drive mechanism, automatically indicating to the user that drug delivery is complete, and locking the guard into a needle-covering position after drug delivery is complete. Certain such features are activated, for example, by the application of an external force by the user. Such features may be susceptible to premature or inadvertent activation if the drug delivery device is subjected to sudden unintended forces or movements during manufacture, shipping, storage, and / or other handling of the device.

[0005] For example, if a drug delivery device is dropped from a height and impacts a stationary surface such as the ground, the drug delivery device may experience a significant impact force. This impact force has the potential to prematurely activate automated or semi-automated features and / or cause structural damage to the drug delivery device. The likelihood of such problems increases if the drug delivery device has recently been removed from cryogenic storage equipment required for the drug delivery device containing a particular drug. In cryogenic conditions, various components of the drug delivery device may be relatively fragile and therefore susceptible to destruction or damage as a result of a sudden impact.

[0006] The present disclosure describes a drug delivery device that embodies advantageous alternatives to existing drug delivery devices and removable cap features and may address one or more of the problems or needs set forth herein. Summary of the Invention [Means for solving the problem]

[0007] One aspect of the present disclosure provides a drug delivery device including a housing, a drug storage container, and a removable cap. The housing may have an opening. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The removable cap may include an outer portion and an inner portion. The outer portion may be configured to be removably coupled to the housing such that the removable cap has a storage position in which the removable cap is coupled to the housing and at least partially covers the opening, and a removal position in which the removable cap is not coupled to the housing. A gap may separate at least a portion of the inner portion and at least a portion of the outer portion to allow at least a portion of the outer portion to flex relative to at least a portion of the inner portion when at least a portion of the outer portion is subjected to an external force.

[0008] The outer portion may wholly or partially surround the inner portion. The removable cap may have a first axial opening configured to receive the housing and a second axial opening. The outer portion may partially or wholly surround the first axial opening and / or the second axial opening. The gap may be a radial gap.

[0009] The removable cap may include one or more support members disposed between the inner portion and the outer portion. The support member(s) may be coupled to the inner portion and / or the outer portion. When multiple support members are included, the support members may be disposed at respective circumferential positions about the inner portion.

[0010] One or more side openings may be formed in the outer portion and communicate with the gap. The side opening(s) may be partially or entirely formed in a distally directed end surface of the outer portion. The side opening(s) may be proximal to the distally directed end surface of the outer portion. If multiple side openings are included, the side openings may be disposed at respective circumferential positions around the outer portion.

[0011] The drug delivery device may include a removable sterile barrier configured to be removably coupled to the drug storage container such that the removable sterile barrier has a storage position in which the removable sterile barrier is coupled to the drug storage container and at least partially covers the insertion end of the delivery member, and a removal position in which the removable sterile barrier is not coupled to the drug storage container. The removable sterile barrier may be a rigid needle shield (RNS). An inner portion of the removable cap may be coupled to and / or define a gripper configured to engage the removable sterile barrier such that when the removable cap is removed from the housing, the gripper removes the removable sterile barrier from the drug storage container to expose the insertion end of the delivery member. The gripper may be configured to rotate relative to the removable sterile barrier, for example, during rotational movement of the removable cap relative to the housing.

[0012] The removable cap may be configured such that an external force induces at least one bending moment in at least one of the proximal end of the removable cap and the distal end of the removable cap.

[0013] Another aspect of the present disclosure provides a drug delivery device including a housing, a drug storage container, and a removable cap. The drug storage container may include a delivery member having an insertion end configured to extend at least partially through an opening during a delivery state. The removable cap may include a distal end and a proximal end. The proximal end may be configured to be removably coupled to the housing such that the removable cap has a storage position coupled to the housing and at least partially covering the opening, and a removal position in which the removable cap is not coupled to the housing. The removable cap may be configured such that an external force applied to the removable cap induces at least one bending moment at at least one of the proximal end of the removable cap and the distal end of the removable cap.

[0014] The at least one bending moment may include multiple distinct bending moments, including, for example, a first bending moment, a second bending moment, and / or a third bending moment. The first bending moment may be partially or entirely at a proximal end of the removable cap. The second bending moment may be partially or entirely at a distal end of the removable cap. The third bending moment may be partially or entirely at a gripper included as part of or coupled with the removable cap.

[0015] The first bending moment may be associated with a portion or all of the proximal end of the removable cap bending partially or entirely about a first bending axis. The second bending moment may be associated with a portion or all of the distal end of the removable cap bending partially or entirely about a second bending axis. The third bending moment may be associated with a portion or all of the gripper bending partially or entirely about a third bending axis. The first bending axis, the second bending axis, and / or the third bending axis may be generally perpendicular or otherwise non-parallel to the longitudinal axis of the housing and / or the removable cap.

[0016] The drug delivery device may include a removable sterile barrier configured to be removably coupled to the drug storage container such that the removable sterile barrier has a storage position in which the removable sterile barrier is coupled to the drug storage container to at least partially cover the insertion end of the delivery member and a removal position in which the removable sterile barrier is not coupled to the drug storage container. The removable sterile barrier may be a rigid needle shield (RNS). The gripper may be configured to engage the removable sterile barrier such that when the removable cap is removed from the housing, the gripper removes the removable sterile barrier from the drug storage container to expose the insertion end of the delivery member. The gripper may be configured to rotate relative to the removable sterile barrier, for example, during rotational movement of the removable cap relative to the housing.

[0017] The removable cap can include an outer portion and an inner portion. A gap can separate at least a portion of the inner portion and at least a portion of the outer portion to allow at least a portion of the outer portion to flex relative to at least a portion of the inner portion when at least a portion of the outer portion is subjected to an external force.

[0018] The external force may be applied to the housing and / or the removable cap in a direction generally parallel to a longitudinal axis of the removable cap.

[0019] The removable cap is made partially or entirely of an elastomeric material, which may include a polypropylene random copolymer.

[0020] All or a portion of the distal end of the removable cap may have a non-circular cross-section in a plane perpendicular to the longitudinal axis of the removable cap. The non-circular cross-section may be generally square-shaped. All or a portion of the proximal end of the removable cap may have a circular cross-section in a plane perpendicular to the longitudinal axis of the removable cap.

[0021] The housing may include a housing cam feature and the removable cap includes a cap cam feature. The cap cam feature and the housing cam feature may be configured to translate rotational motion into axial motion such that upon rotational movement of the removable cap relative to the housing, the cap cam feature and / or the housing cam feature urges the removable cap along a longitudinal axis of the housing and / or the removable cap.

[0022] The drug delivery device may include a plunger, a plunger biasing member, and / or a guard. The plunger may be movable in a distal direction relative to the drug storage container to release the drug from the drug storage container through the delivery member during a delivery state. The plunger biasing member may be configured to urge the plunger in a distal direction. The guard may be operatively coupled to the plunger biasing member to enable release of the plunger biasing member upon relative movement between the guard and the housing along a longitudinal axis of the housing and / or the removable cap.

[0023] The drug delivery device may be, but is not limited to, an autoinjector.

[0024] 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 indicate the presence or absence of the particular element in any of the illustrative embodiments, unless expressly depicted in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0025] [Figure 1] 1A-1C are perspective views of an exemplary drug delivery device according to various embodiments with a removable cap present and coupled to the housing. [Diagram 2] 2 is a perspective view of a distal portion of the drug delivery device of FIG. 1 with the removable cap removed. FIG. [Diagram 3] FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1. [Figure 4] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Diagram 5] FIG. 5 is another perspective view of the removable cap of FIG. 4. [Figure 6] FIG. 5 is a side view of the removable cap of FIG. 4. [Figure 7] 5 is another perspective view of the distal end of the removable cap of FIG. 4. [Figure 8] FIG. 5 is a cross-sectional view of the removable cap of FIG. 4. [Figure 9] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Figure 10] 10 is another perspective view of the distal end of the removable cap of FIG. 9. [Figure 11] FIG. 10 is a cross-sectional view of the removable cap of FIG. [Figure 12] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Figure 13] 13 is another perspective view of the distal end of the removable cap of FIG. 12. [Figure 14] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Figure 15] 15 is another perspective view of the distal end of the removable cap of FIG. 14. [Figure 16] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Figure 17] 17 is another perspective view of the distal end of the removable cap of FIG. 16. [Figure 18] 1 is a perspective view of another exemplary removable cap according to various embodiments. [Figure 19] FIG. 19 is a cross-sectional view of the removable cap of FIG. 18. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] The present disclosure generally relates to a drug delivery device operable for a user to administer a drug or, if the patient is the user, for self-administration of a drug. The drug delivery device may include a housing having an opening and a drug storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state. The drug delivery device may also include a removable cap configured to be removably coupled to the housing such that the removable cap has a storage position in which the removable cap is coupled to the housing and at least partially covers the opening, and a removal position in which the removable cap is not coupled to the housing. In general, the removable cap may be configured to have one or more shock absorbing features to reduce or eliminate undesirable effects of sudden externally applied forces, including, for example, impact forces applied to the removable cap as a result of dropping the drug delivery device from a height onto a stationary surface such as the ground, floor, tabletop, countertop, etc. The presently disclosed shock absorbing features can allow the removable cap or a particular portion(s) thereof to flex (e.g., flex elastically) to reduce or attenuate at least a portion of the mechanical effects of an externally applied force, including, for example, reducing acceleration and / or deceleration caused by the externally applied force. Thus, the shock absorbing features can prevent or inhibit actuation of one or more automated or semi-automated features included in the drug delivery device, including, among others, for example, a drive mechanism for releasing the drug, a guard locking mechanism, and the like. Additionally, the presently disclosed shock absorbing features can prevent or inhibit damage to the drug delivery device, including the removable cap, that could otherwise result from an externally applied force. For example, the shock absorbing features can reduce the likelihood of breaks or cracks forming in the removable cap and / or other portions of the drug delivery device if a user accidentally drops the drug delivery device after removing it from a refrigerated storage unit. These and other advantages will be apparent to one of ordinary skill in the art upon consideration of this disclosure.

[0027] 1-3 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological agents such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the present disclosure is not limited to a particular condition.

[0028] Various implementations and configurations of the drug delivery device 10 are possible. This embodiment of the drug delivery device 10 is configured as a single-use, disposable injector. In other embodiments, the drug delivery device 10 may be configured as a multiple-use, reusable injector. The drug delivery device 10 is operable for self-administration by a patient or for administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). The exemplary drug delivery device shown in the figures may take the form of an auto-injector or pen injector and thus may be held in the hand of a user for the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and / or configurations.

[0029] The configuration of the various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a storage state, a pre-delivery state, a delivery or administration state, and a post-delivery state, although fewer or more states are possible. For example, each state may have several sub-states or stages. The storage state may correspond to the configuration of the drug delivery device 10 of FIGS. 1-3, where the delivery device includes a removable cap in a storage position. In some embodiments, the storage state may exist in the time between when the drug delivery device 10 leaves the manufacturing facility and when the patient or other user removes the removable cap. The pre-delivery stage may correspond to the configuration of the drug delivery device 10 after the removable cap has been removed, but before the actuation of the drive mechanism by the user. This may include the moment after the user removes the removable cap while the user is initially positioning the drug delivery device 10 relative to an injection site, but before administration begins. The delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as dosing, is ongoing. The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is placed in an end-of-dose position within the drug storage container.

[0030] 1-3, the drug delivery 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, and extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 (FIG. 3) may be formed at the distal end to allow an insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be disposed in a wall of the housing 12 to allow a user to view components within the drug delivery device 10, including a drug storage container 20. Viewing the drug storage container 20 through the window 17 allows a user to verify that drug delivery is in progress and / or is complete. At the distal end of the device, a removable cap 19 may cover the opening 14 prior to use of the drug delivery device 10 and may in some embodiments include a gripper 13 ( FIG. 3 ) configured to aid in the removal of a removable sterility barrier 21 (e.g., rigid needle shield (RNS), non-rigid needle shield (nRNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the removable sterility barrier 21 to pull the removable sterility barrier 21 along with the removable cap 19 when a user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the removable sterility barrier 21 from the delivery member 16.

[0031] In some embodiments, the housing 12 may include two separate interconnected structures, namely, a rear end cap 23 (e.g., a rear cover) at the proximal end of the drug delivery device 10 and a tubular housing 25 that extends substantially the entire length of the drug delivery device 10 and defines the opening 14. Additionally or alternatively, the housing 12 may include fewer or more components, e.g., a two-part tubular housing having a front portion and a rear portion. The tubular housing 25 may have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical or hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the tubular housing 25, as well as any components disposed therein, may be assembled together to define different subassemblies. In another embodiment, the housing 12 may be assembled in one piece such that the housing 12 is defined by a single monolithic structure that integrates the rear cap and the tubular housing into a single component.

[0032] The drug storage container 20 is disposed within the interior space of the housing 12 and is configured to contain a drug. The drug storage container 20 may be pre-filled and shipped, for example, by a manufacturer, to a location where the drug storage container 20 is combined with the remainder of the drug delivery device 10. For example, the drug 22 may be delivered and / or provided to a patient in more than one use case, such as as a pre-filled syringe or an auto-injector including a pre-filled syringe. By using the same or similar syringe components in both cases, at least some of the above steps, such as filling, labeling, packaging, shipping and distribution, may be streamlined or simplified for the two different use cases. As another example, when using some or all of the same syringe components in the multiple use cases, some regulatory pathways for trading and / or distributing the drug may be streamlined and / or simplified for at least one of the multiple use cases.

[0033] The drug storage container 20 may include a rigid wall that defines an internal bore, i.e., a reservoir. The wall may be made of glass or plastic. The stopper 24 may be movably disposed within the drug storage container 20 such that it 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 be in slidable and sealing contact with the inner surface 15 of the wall of the drug storage container 20 to prevent or inhibit leakage of the drug 22 past the stopper 24 while the stopper 24 is moving. Distal movement of the stopper 24 releases the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by the gap 18. Upon actuation of the drive mechanism 30, the plunger 26 moves distally to close the gap 18 and contact the stopper 24. Subsequent distal movement of the plunger 26 drives the stopper 24 distally to release the drug 22 from the drug storage container 20. In another embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or may be coupled to each other, for example via a threaded connection, so that they move together from the start of the movement of the plunger 26. Once moved, the stopper 24 may continue to move distally until it contacts a proximally facing portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 may be referred to as an end of administration or end of delivery position and may correspond to when delivery of the drug 22 to the patient is complete or substantially complete.

[0034] In some embodiments, the volume of drug 22 contained within the reservoir of drug storage container 20 may be equal to 1 mL, or may be equal to about (e.g., ±10%) 1 mL, or may be equal to 2.5 mL, or may be equal to about (e.g., ±10%) 2.5 mL, or may be equal to 3 mL, or may be equal to about (e.g., ±10%) 3 mL, or may be equal to about (e.g., ±10%) 1 mL or less, or may be equal to about (e.g., ±10%) 2 mL or less, or may be equal to about (e.g., ±10%) 3 mL or less. or may be about (e.g., ±10%) 4 mL or less, or may be about (e.g., ±10%) less than 5 mL, or may be about (e.g., ±10%) 10 mL or less, or may be in the range of about (e.g., ±10%) 1 to 10 mL, or may be in the range of about (e.g., ±10%) 1 to 5 mL, or may be in the range of about (e.g., ±10%) 1 to 4 mL, or may be in the range of about (e.g., ±10%) 1 to 3 mL, or may be in the range of about (e.g., ±10%) 1 to 2.5 mL.

[0035] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. A 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 shapes to allow the insertion end 28 to pierce the skin and 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 are formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 and into the patient.

[0036] In one embodiment, the drug storage container 20 may be a pre-filled syringe with a fixed hollow metal needle for the delivery member 16. In this case, the needle may be attached to the wall of the drug storage container 20 and may be in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the needle may be coupled to the drug storage container 20 via a luer lock or other suitable connection. In yet other embodiments, the drug storage container 20 may be a needleless cartridge and thus may not initially be in fluid communication with the delivery member 16. In such an embodiment, during operation of the drug delivery device 10, the drug storage container 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 storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0037] The device may also include a container holder 33 configured to secure the medication storage container 20 relative to the housing 12, such as by preventing distal movement of the medication storage container 20 during actuation of the plunger. The container holder 33 may include a plurality of flanges 33c, each including an arcuate inclined surface 33a that substantially matches the arcuate shape of a shoulder of the medication storage container 20. As a more specific example, when the medication storage container 20 is inserted into the container holder 33, the flanges 33c cooperate to support the shoulder and limit distal movement of the medication storage container 20. The housing 12 may include a plurality of locking slots 12c, each of which receives a respective flange 33c of the container holder 33 to prevent and / or limit relative movement between the respective components 12, 33. As a result, when fully assembled, the storage container 20, the container holder 33, and the housing 12 are all substantially or completely secured relative to one another.

[0038] The drug delivery device 10 may further include a guard mechanism for preventing contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a guard member 32 movably disposed at a distal end of the housing 12 adjacent the opening 14. The guard member 32 may have a hollow, generally cylindrical or tubular shape generally centered about the longitudinal axis A and may have a proximal end that is received within the housing 12. The guard member 32 may be 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 in the housing 12 and a retracted position in which the distal end of the guard member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the guard member 32 may be configured to move from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 may translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 may translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond and surround the insertion end 28 of the delivery member 16. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 prior to delivery or in a storage state, moving the guard member 32 from the extended position to the retracted position may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin, for example, by pressing the distal end of the guard member 32 against the patient's skin at the injection site.

[0039] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be disposed proximal to the guard member 32, and the guard biasing member 35 may be disposed proximal to the guard extension 37. The guard extension 37 may have a hollow generally cylindrical or tubular shape centered about a longitudinal axis A. Furthermore, the guard extension 37 may be movable in a linear direction along the longitudinal axis A relative to the housing 12. In this embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in alternative embodiments, the guard extension 37 and the guard member 32 may be integrally formed as one piece to define a single monolithic structure. In such alternative embodiments, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0040] The guard bias member 35 may be disposed between and in contact with the guard extension 37 and the release member 52. The guard bias member 35 may be configured to bias or urge the guard extension 37 in a distal direction and to bias or urge the release member 52 in a proximal direction. The guard bias member 35 may be initially in a biased (e.g., compressed) state to apply a biasing force to the guard extension 37 and a biasing force to the release member 52 in a pre-delivery state. In some embodiments, the distal end of the guard extension 37 is initially in contact with the proximal end of the guard member 32, as seen in FIG. 3. As a result, the guard extension 37 transmits the biasing force of the guard bias member 35 to the guard member 32, such that the guard bias member 35 biases or urges the guard member 32 toward the extended position. A user can overcome the biasing force by pressing the guard member 32 against the injection site. In doing so, the guard member 32 and the guard extension 37 move together in a proximal direction, for example, until the guard member 32 reaches a retracted position. Once the injection is completed and the drug delivery device 10 is lifted from the injection site, the guard biasing member 35 may press against the guard extension 37, causing the guard extension 37 and the guard member 32 to move together in a distal direction. This action returns the guard member 32 to the extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the guard biasing member 35 may include a compression spring (e.g., a helical compression spring). Further, in embodiments in which the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be disposed around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0041] After drug delivery is completed and the guard member 32 is repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent subsequent user contact with the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. In accordance with these objectives, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the guard member 32 to lock the guard member 32 in the extended position once the guard member 32 has moved from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered and rotates about the longitudinal axis A. As shown in FIG. 3, a proximal end of the locking ring 40 may contact the container holder 33 and a distal end of the locking ring 40 may be at least partially disposed within the guard member 32. A locking ring biasing member 51 may be axially disposed between a distally facing surface of the locking ring 40 and a proximally facing surface of the guard member 32. The lock ring biasing member 51 may be initially in a compressed or biased state to bias the lock ring 40 and the guard member 32 away from one another. As such, the lock ring biasing member 51 may apply a biasing force that urges the guard member 32 toward the extended position as well as a biasing force that urges the proximal end of the lock ring 40 against the container holder 33. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a helical compression spring). In some embodiments, rotation of the lock ring 40 may be accomplished by a cam arrangement between the lock ring 40 and the container holder 33.

[0042] The drug delivery device 10 may further include a drive mechanism 30 disposed partially or completely within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and upon or in response to actuation of the drive mechanism 30 by a user, release or output the energy to drive the plunger 26 to release the drug 22 from the drug storage container 20 through the delivery member 16 and into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy, although alternative embodiments of the drive mechanism 30 may be configured in different forms, for example, such that the drive mechanism 30 stores electrical or chemical potential energy. Generally, upon actuation of the drive mechanism 30, the drive mechanism 30 may convert potential energy into kinetic energy for moving the plunger 26.

[0043] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member seat 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 may be compressed such that its axial length is shorter than in a natural or unbiased state. When released, the plunger biasing member 50 attempts to expand to its natural axial length such that a biasing force may be applied to urge the plunger 26 distally.

[0044] The plunger biasing member 50 may be at least partially disposed within the plunger 26, may have a distal end abutting the proximally-facing inner surface of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. The outer diameter or other dimension of the plunger biasing member 50 may be equal to or smaller than the inner diameter of the ring 45 and / or the inner diameter of the hollow rod 46 so that the plunger biasing member 50 can be received within the plunger 26. In some embodiments, the distal end of the plunger biasing member 50 may abut the proximally-facing inner surface of the base 47 of the plunger 26. Additionally, the proximal end of the plunger biasing member 50 may abut the distally-facing surface of the plunger biasing member seat 38. The plunger biasing member seat 38 may be fixedly attached to the tubular housing 25 such that the plunger biasing member seat 38 provides a stationary surface against which the plunger biasing member 50 is urged. So configured, when released from a biased state, the plunger biasing member 50 may expand in length by causing a distal end of the plunger biasing member 50 to move distally away from a stationary proximal end of the plunger biasing member 50. This action may push the plunger 26 distally, which may in turn push the stopper 24 distally, releasing the drug 22 from the drug storage container 20 into the delivery member 16 and subsequently into the patient.

[0045] The release member 52 may have a hollow generally cylindrical or tubular shape and may be centered about the longitudinal axis A. As shown in FIG. 3, the release member 52 may be radially disposed between the distal end of the plunger guide 60 and the proximal end of the guard extension 37. Additionally, the release member 52 may be disposed radially inward of the guard biasing member 35. In general, the release member 52 is configured to operatively couple the guard member 32 and the plunger 26 in an actuation sequence and to generate an audible signal indicating the end of drug delivery. So configured, the release member 52 is utilized to perform two separate functions, thus reducing the number of moving parts required by the drug delivery device 10.

[0046] The release member 52 may be configured to rotate relative to the housing 12 and / or to translate linearly relative to the housing 12 depending on the operational stage of the drug delivery device 10. While the initial rotation of the release member 52 associated with actuation may be powered by the plunger biasing member 50 and / or the guard biasing member 35, subsequent rotation of the release member 52 associated with generating an end-of-dose signal may be powered solely by the guard biasing member 35. Any linear translational movement of the release member 52 that does not involve rotation may be powered solely by the guard biasing member 35. In some embodiments, the release member 52 may translate linearly only in the proximal direction, although alternative embodiments may permit linear translational movement of the release member 52 in both the proximal and distal directions.

[0047] The ability of the release member 52 to rotate about the longitudinal axis A may be regulated by the interaction between an outer portion of the annular wall of the release member 52 and an inner portion of the guard extension 37. The guard extension 37 may be prevented from rotating about the longitudinal axis A as a result of being coupled to the housing 12. This has the effect of preventing rotation of the release member 52 about the longitudinal axis A when an abutment structure (e.g., an outwardly extending protrusion) included on the outer portion of the release member 52 engages a cooperating abutment structure (e.g., an inwardly extending protrusion) included on the inner portion of the guard extension 37. If the release member 52 cannot rotate, then the outwardly extending protrusion of the plunger 26, which is received in a recess formed in the inner surface of the release member 52, cannot rotate either. If this protrusion of the plunger 26 cannot rotate, then the protrusion cannot slide into the longitudinal opening of the plunger guide 60. If the protrusion cannot move in this way, then the plunger 26 cannot move either. If the plunger 26 cannot move, the plunger biasing member 50 cannot extend to release the bias. Thus, the release member 52 holds the plunger biasing member 50 in a biased state until the guard extension 37 moves to an axial position in which the cooperating abutment structures on the outer portion of the release member 52 and the inner portion of the guard extension 37 disengage from one another, thereby allowing the release member 52 to rotate relative to the guard extension 37.

[0048] As mentioned above, the removable cap 19 may have a storage position (FIGS. 1 and 3) in which the removable cap 19 is coupled to the housing 12, and a removal position (FIG. 2) in which the removable cap 19 is removed from and not coupled to the housing 12. As also mentioned above, the device 10 may include a removable sterility barrier 21 that is removed from the delivery member 16 when the removable cap 19 is removed from the housing 12. The removable sterility barrier 21 may have a relatively snug or relatively high friction fit with the drug storage container 20 to maintain sterility of the delivery member 16 and / or to prevent air from entering the drug storage container 20. It may be desirable to prevent or reduce the possibility of air entering the drug storage container and / or the delivery member 16, for example, to reduce the possibility of contamination and / or blocked or evaporated drug. Additionally or alternatively, it may be desirable to have a relatively snug or relatively high friction fit between the sterility barrier 21 and the drug storage container 20 to prevent or reduce the possibility of an inadvertent needle stick. For these or other reasons, or alternatively, it may be desirable to have a relatively snug or relatively high friction fit between the removable cap 19 and the housing 12. The sterility barrier 21 and removable cap 19 may also be coupled to their respective components (e.g., the medication storage container 20 and the housing 12) via other suitable features, such as mating tab / slot connections, breakable connections such as pierce seals, threaded connections, or other features that achieve a relatively secure, yet removable connection between the respective components.

[0049] As a result of these binding forces, features, and / or other factors, some device users may experience difficulty or discomfort in removing the removable cap 19. As an example, some device users may have difficulty removing the cap 19 via axial force (along the longitudinal axis A) alone. In other words, some device users may have difficulty pulling the cap 19 off / away from the housing 12. The cap 19 shown in Figures 1-3 includes a number of ribs 19d to help the user grip the surface of the cap 19 when removing it.

[0050] The device 10 shown in Figures 1-3 also includes cam features for translating rotational motion into axial motion such that upon rotational movement of the removable cap 19, the removable cap 19 is biased away from the housing 12, thereby facilitating and / or facilitating removal of the cap 19. For example, the housing 12 includes a housing cam feature 12a and a cap cam feature 19c. As a more specific example, to remove the removable cap 19 from the housing 12 via axial force / movement only (e.g., a "straight pull"), a user may require a force of 45 Newtons or less, about 40-45 Newtons, about 35-40 Newtons, about 30-35 Newtons, about 25-30 Newtons, about 20-25 Newtons, about 15-20 Newtons, about 10-15 Newtons, about 5-10 Newtons, or less than about 5 Newtons. For device 10 shown in Figures 1-3, removal of removable cap 19 requires a straight pull force of approximately 10-15 Newtons.

[0051] The cap cam feature 19c shown in Figures 1-3 defines a wave shape, such as an arcuate surface. As a more specific example, the removable cap 19 shown in the figures includes a generally cylindrical body portion 19d and an end wall 19e that is generally perpendicular to the body portion 19d at a distal end of the cap 19. The body portion 19d defines a generally annular leading rim 19f at a proximal end of the cap 19. The leading rim 19f defines a wave-shaped cap cam feature 19c. As a more specific example, the leading rim 19f shown in the figures defines two wave-shaped cam surfaces 19c and two relatively flat surfaces 19c' extending between the wave-shaped cam surfaces 19c. In other words, the two wave-shaped cam surfaces 19c and the two relatively flat surfaces 19c' cooperate to define the leading rim 19f. Alternatively, the leading rim 19f may define a continuous waveform, such as a continuous sine wave or another continuous waveform. For purposes of this application, the term "continuous" should be interpreted to mean that the waveform continues around the entire circumference of the leading edge, rather than alternating between corrugated and flat surfaces.

[0052] Housing cam ring feature 12a shown in Figures 1-3 defines a wave shape, such as an arcuate protrusion that extends away from exterior surface 25 of housing 12. As a more specific example, housing cam ring feature 12a is a protrusion having a shape not unlike a "smile" or "crescent" shape. As an even more specific example, housing 12 shown in the figures defines two wave-shaped cam features 12a.

[0053] When the removable cap 19 is in the storage position 19a shown in Figures 1-3, the cap cam feature 19c engages or abuts the housing cam feature 12a. In addition, the respective cam features 12a, 19c shown in the figures have matching or mirrored shapes such that the respective surfaces 12a, 19c slide smoothly / easily across one another. For example, when the removable cap 19 is rotated (either clockwise or counterclockwise) relative to the housing 12, the housing cam features 12a, 19c rotate relative to one another and urge the removable cap 19 away from the housing 12 along the axis A. In other words, the cam features 12a, 19c convert the rotational motion into an axial motion to remove or aid in the removal of the cap 19. In some embodiments, even a relatively small rotation can promote and / or facilitate removal of the cap 19.

[0054] Having described the general configuration of the drug delivery device 10, a general method of using the drug delivery device 10 to perform an injection will now be described. As a preliminary step, the user may remove the drug delivery device 10 from any secondary packaging, such as a plastic bag and / or a cardboard box. Also as a preliminary step, the user may prepare the injection site, for example by wiping the patient's skin with an alcohol wipe. The user may then pull and remove the removable cap 19 from the housing 12, as will be described in more detail below. As a result of this action, the gripper 13 may pull and remove the removable sterility barrier 21 from the drug storage container 20. This may expose the insertion end 28 of the delivery member 16. Nevertheless, at this stage, the insertion end 28 of the delivery member 16 remains enclosed by the guard member 32, since the guard member 32 is located in the extended position. The user may then place the drug delivery device 10 over the injection site and thereafter press the distal end of the guard member 32 against the injection site. The force applied by the user will overcome the biasing force of the guard bias member 35 and the biasing force of the lock ring bias member 51, causing the guard member 32 to move proximally from the extended position to the retracted position and retract into the opening 14. The delivery member 16 remains stationary relative to the housing 12 during the retraction movement of the guard member 32.

[0055] The movement of the guard member 32 from the extended position to the retracted position may result in several actions. Because the delivery member 16 remains stationary relative to the housing 12 during retraction of the guard member 32, the insertion end 28 of the delivery member 16 extends through an opening at the distal end of the guard member 32, thereby piercing the patient's skin at the injection site and penetrating into the patient's subcutaneous tissue. In addition, retraction of the guard member 32 may also actuate the drive mechanism 30 to expel the drug 22 from the drug storage container 20.

[0056] As the guard member 32 moves from the extended position to the retracted position, it can press against the guard extension 37 in a proximal direction. During the proximal movement of the guard extension 37, the cooperating abutment structures on the outer portion of the release member 52 and the inner portion of the guard extension 37 can slide past each other until they no longer contact each other. When that happens, the release member 52 can freely rotate about the longitudinal axis A. Rotation of the release member 52 at this stage is caused by the plunger biasing member 50 extending, pushing against a distally facing cam surface included in the plunger 26 and sliding along a proximally facing cam surface of the plunger guide 60. The resulting cam action can rotate the plunger 26, which in turn can co-rotate the release member 52.

[0057] The co-rotation of the release member 52 and the plunger 26 may continue until the distally facing cam surface included in the plunger 26 reaches the end of the proximally facing cam surface on the plunger guide 60 and moves into the longitudinal slot formed in the plunger guide 60. The longitudinal slot does not inhibit the linear motion of the plunger 26. As a result, the plunger 26 is driven to translate linearly in the distal direction by the expanding plunger biasing member 50. As a result, the plunger 26 contacts the stopper 24 (if it is not already contacting the stopper 24) and then pushes the stopper 24 distally to expel the drug 22 from the drug storage container 20, through the delivery member 16, out the insertion end and into the patient's tissue 28. Drug delivery may continue until the stopper 24 reaches an end-of-dosage position, at which point the stopper 24 may abut against a proximally facing portion of the inner surface 15 of the wall of the drug storage container 20. As a result, the plunger 26 stops moving in the distal direction.

[0058] After delivery is complete, the user may then lift the drug delivery device 10 from the injection site. With nothing resisting the guard bias member 35, it may push the guard member 32 from the retracted position to the extended position to cover the insertion end 28 of the delivery member 16. In some embodiments, this movement of the guard member 32 may rotate the locking ring 40 into a position that prevents further retraction of the guard member 32.

[0059] These and other aspects of exemplary drug delivery devices are discussed in more detail in U.S. Patent Application No. 17 / 036,690, filed September 29, 2020, U.S. Patent Application No. 17 / 035,851, filed September 29, 2020, U.S. Patent Application No. 17 / 035,927, filed September 29, 2020, U.S. Patent Application No. 17 / 036,129, filed September 29, 2020, U.S. Patent Application No. 17 / 036,217, filed September 29, 2020, and a U.S. provisional patent application entitled "DRUG DELIVERY DEVICE" filed on the same day herewith by the applicant of the present application, the entire contents of each of which are incorporated by reference.

[0060] The embodiments of the removable cap described above will now be described with reference to Figures 4-19. Various elements of the removable cap 119 shown in Figures 4-19 may be similar or identical in structure, configuration, and / or function to the elements of the removable cap 19 described above in conjunction with Figures 1-3. Such elements are assigned the same reference numerals used in Figures 1-3, except increased by 100 or multiples thereof. Descriptions of some of these elements have been simplified or omitted for the sake of brevity. Details of structure, configuration, and / or function that distinguish the embodiments of the removable cap 119 shown in Figures 4-19 from the embodiments of the removable cap 19 of Figures 1-3 are the focus of the following discussion.

[0061] As mentioned above, it may be advantageous to incorporate one or more shock absorbing features within the removable cap. If the drug delivery device 10 is accidentally dropped from a height such that the removable cap contacts the ground at a substantial speed, or if the removable cap otherwise impacts or is impacted by an external object at a substantial speed, the removable cap may experience substantial impact force(s). Such force(s) may have the potential to trigger the actuation of automated or semi-automated features included in the drug delivery device 10 and / or cause damage to the drug delivery device 10. As an example, if the drug delivery device 10 is dropped with the longitudinal axis A parallel or substantially parallel to the direction of gravity and the removable cap facing generally downward, the deceleration associated with the drug delivery device 10 impacting the ground may cause the guard member 32 to retract into the housing, thereby triggering the drive mechanism 30. Additionally or alternatively, the deceleration may cause the locking ring 40 to rotate or otherwise move to a position that prevents further retraction of the guard member 32. This may then prematurely lock out the guard member 32, thereby preventing a user from using the drug delivery device 10 to perform an injection. If the drug delivery device 10 has recently been removed from cold storage (e.g., temperatures below 10° C., below 5° C., or below 0° C.) before being dropped, there may be a risk that components of the drug delivery device 10 will break or crack, for example due to reduced elasticity of certain materials at low temperatures. Such breaks or cracks may impair the proper operation of the drug delivery device 10, and even if not, if they are visible to the user, may cause the user to assume that the drug delivery device 10 is defective, and thus to discard the drug delivery device 10, whether or not this is necessary.

[0062] 4-8 illustrate an embodiment of a removable cap 119 having shock absorbing properties that reduce or eliminate the undesirable effects of sudden externally applied forces, as well as other advantageous properties. The cap 119 may have a generally elongated shape extending along a longitudinal axis A between a proximal end 162 and a distal end 164. As an example, the cap 119 may have a longitudinal axis that is parallel to the longitudinal axis A and / or coaxial with the longitudinal axis A. The removable cap 119 may further include an outer portion 166 and an inner portion 168, with the outer portion 166 being further from the longitudinal axis A than the inner portion 168. As an example, the outer portion 166 may partially or entirely surround the inner portion 168. As a more specific example, the outer portion 166 and / or the inner portion 168 may be centered about the longitudinal axis A. Outer portion 166 may include at least a portion of proximal end 162 and at least a portion of distal end 164. Outer portion 166 may extend between and include at least a portion of proximal end 162 and at least a portion of distal end 164. Inner portion 168 may be disposed at distal end 164, or alternatively may extend between and include at least a portion of proximal end 162 and at least a portion of distal end 164.

[0063] The proximal end 162 may include a first axial opening 170 (FIG. 6) and the distal end 164 may include a second axial opening 172 (FIG. 4). The outer portion 166 may partially or entirely surround the first axial opening 170 and / or the second axial opening 172. The inner portion 168 may be axially aligned with the first axial opening 170 and / or the second axial opening 172.

[0064] The proximal end 162 and / or outer portion 166 of the removable cap 119 may be configured to be releasably coupled to a housing of a drug delivery device (e.g., the housing 12 of the drug delivery device 10 described above) such that the removable cap 119 has a storage position in which the removable cap 119 is coupled to the housing and at least partially covers an opening (e.g., the opening 14 described above) and a removal position in which the removable cap 119 is not coupled to the housing. As an example, the first axial opening 170 may be sized to receive a distal end of the housing of the drug delivery device such that a relatively snug or relatively high friction fit is formed between the proximal end 162 and / or outer portion 166 of the removable cap 119 and the distal end of the housing when the removable cap 119 is in the storage position. Additionally or alternatively, the proximal end 162 and / or outer portion 166 of the removable cap 119 may include one or more connector members configured to releasably couple with one or more connector members included on the distal end of the housing of the drug delivery device.

[0065] The outer portion 166 of the removable cap 119 may include a wall 174 having a generally annular shape (e.g., a tubular shape). As an example, the wall 174 may have a proximal end having a generally circular cross-section in a plane perpendicular to the longitudinal axis A and a distal end having a non-circular cross-section in a plane perpendicular to the longitudinal axis A. As a more specific example, the distal end of the wall 174 may have a generally square-shaped cross-section. As an even more specific example, as seen in FIGS. 4-8 , the square-shaped cross-section of the distal end of the wall 174 may have rounded corners. The cross-section of the wall 174 may gradually transition from a circular cross-section to a square cross-section moving in a direction along the longitudinal axis A. The circular cross-section of the proximal end of the wall 174 may have an inner diameter sized to facilitate a relatively snug or relatively high friction fit between the removable cap 119 and a housing of the drug delivery device. The square or other non-circular cross-section of the distal end of wall 174 can inhibit or prevent removable cap 119 from rolling across a flat surface, such as a tabletop or countertop, when removable cap 119 and / or drug delivery device (if removable cap 119 is attached) are placed on their side on a flat surface.

[0066] The inner portion 168 of the removable cap 119 may generally be configured to aid in the removal of a removable sterility barrier (e.g., the removable sterility barrier 21 described above) mounted over an insertion end of a delivery member (e.g., a needle) of a drug storage container included in a drug delivery device. As an example, the inner portion 168 of the removable cap 119 may define or be coupled with a gripper (e.g., the gripper 13 described above) configured to engage the removable sterility barrier such that when the removable cap 119 is removed from the housing of the drug delivery device, the gripper removes the removable sterility barrier from the drug storage container to expose the insertion end of the delivery member. As a more specific example, when a user rotates the removable cap 119 relative to the housing of the drug delivery device, the inner portion 168 and / or the gripper can rotate relative to (i.e., rotate independently of) the removable sterile barrier, and as the removable cap 119 moves distally, the gripper can frictionally or otherwise mechanically engage the removable sterile barrier to pull it out of the drug storage container and expose the insertion end of the delivery member.

[0067] 4, 7, and 8, the inner portion 168 of the removable cap 119 can include a sidewall 176 generally parallel to the longitudinal axis A and a transverse wall 178 generally perpendicular to the longitudinal axis A. By way of example, the sidewall 176 can have a generally annular shape defining a cavity 180 for receiving at least the distal end of the removable sterility barrier. The sidewall 176 can be defined by a single annular structure, or alternatively, by a plurality of spaced apart structures in a generally circular or other annular shape. An inner surface of the sidewall 176 can define a gripper as described above, or alternatively, the gripper can be a separate structure coupled to and / or disposed on the interior side of the sidewall 176. The transverse wall 178 can be coupled to a distal end of the sidewall 176. As an example, the transverse wall 178 may be coupled with the side wall 176 to define a closed distal end of the inner portion 168 .

[0068] The inner portion 168 of the removable cap 119 may be coupled to the outer portion 166 of the removable cap 119. As an example, the inner portion 168 may include a flange 182 extending radially outward from and fixedly coupled to the proximal end of the sidewall 176 and fixedly coupled to the wall 174 of the outer portion 166, as seen in Figures 7 and 8. As a more specific example, the flange 182 may be a wall that is generally perpendicular to the longitudinal axis A and covers the radial distance between the outer surface of the sidewall 176 of the inner portion 168 and the inner surface of the wall 174 of the outer portion 166, whereby the flange 182 provides a barrier that prevents physical access to the interior of the proximal end of the removable cap 119 when the removable cap 119 is removably coupled with the housing of the drug delivery device. In some embodiments, the wall 174, the sidewall 176, the transverse wall 178, and / or the flange 182 may be integrally formed together to define a single, unitary structure, although this is not required.

[0069] As discussed above, the flange 182 may be disposed radially between the proximal end of the inner portion 168 and the proximal or distal end of the outer portion 166. Distal to the flange 182, a gap 184 may separate the inner portion 168 and the outer portion 166, as seen in FIGS. 4, 7, and 8. As an example, the gap 184 may separate the distal end of the inner portion 168 and the distal end of the outer portion 166. As a more specific example, the gap 184 may be a radial gap such that there is an empty space located radially between the distal end of the inner portion 168 and the distal end of the outer portion 166. The gap 184 may partially or entirely surround the circumference or periphery of the inner portion 168. Gap 184 may be in communication with second axial opening 172 and, in some embodiments, may be blocked from first axial opening 170 by flange 182 such that gap 184 is not in communication with first axial opening 170. As a more specific example, gap 184 may surround the entire circumference or periphery of inner portion 168 such that a distal end of wall 174 of outer portion 166 defines a skirt-like structure that surrounds inner portion 168.

[0070] When an external force is applied to the outer portion 166, the outer portion 166 can bend relative to the inner portion 168, at least in part due to the gap 184. As an example, the gap 184 may provide space and / or freedom for at least a portion of the outer portion 166 to bend radially inward toward the longitudinal axis A, radially outward away from the longitudinal axis A, proximally, and / or distally. The term "bend" as used herein is a broad term and is to be given its ordinary and accustomed meaning by those skilled in the art (and is not limited to any special or customized meaning), and further refers, without limitation, to any elastic and / or inelastic deformation, deflection, and / or bending that an object may undergo when subjected to an external force or load.

[0071] As an example, the removable cap 119 may be subjected to an external force as a result of the drug delivery device including the removable cap 119 being dropped from a height onto a stationary surface, such as the ground, a floor, a tabletop, a countertop, etc. As a more specific example, the drug delivery device may be dropped with the longitudinal axis A generally parallel or otherwise non-perpendicular to the direction of gravity, and with the distally directed end surface of the removable cap 119 facing generally downward. In such a scenario, the ground or other external surface may exert a reaction force on the removable cap 119 in a direction generally parallel or otherwise non-perpendicular to the longitudinal axis A. In comparison, if the drug delivery device is dropped with the longitudinal axis A generally perpendicular or otherwise non-parallel to the direction of gravity, the ground or other external surface may exert a reaction force on the removable cap 119 in a direction perpendicular or otherwise non-parallel to the longitudinal axis A.

[0072] The recoil force described above, when applied to the outer portion 166 of the removable cap 119, may cause the outer portion 166 of the removable cap 119 to bend relative to the inner portion 168 of the removable cap 119. In at least some scenarios, the bending of the outer portion 166 of the removable cap 119 may convert kinetic energy into another form of energy, such as thermal energy (e.g., heat), and / or spread out the time of the impulse. This, in turn, may reduce the likelihood that the impact event will cause actuation of automated or semi-automated features included in the drug delivery device, including, for example, a drive mechanism for releasing the drug and / or a guard locking mechanism, and / or may reduce the likelihood of structural damage to components of the drug delivery device, including, for example, the removable cap 119. In at least some scenarios, the outer portion 166 of the removable cap 119 due to bending during an impact event may function as a spring and damper system and / or a shock absorber.

[0073] As seen in FIG. 6 , the distal-most portion of the outer portion 166 may extend beyond the distal end of the inner portion 168 in the distal direction. In at least some scenarios, this may increase the likelihood that the outer portion 166 (but not the inner portion 168) will contact the ground or other external surface if the drug delivery device is dropped with the removable cap 119 facing generally downward. In some embodiments, one or more corners of the distal end of the outer portion 166 may define the distal-most portion of the removable cap 119, such that if the drug delivery device is dropped with the removable cap 119 facing generally downward, one or more of the corners will contact the ground or other external surface first. In alternative embodiments, the distally directed end surface of the outer portion 166 may be generally level with the distally directed end surface of the inner portion 168 in the direction along the longitudinal axis A. In further alternative embodiments, the distal-most portion of the inner portion 168 may extend beyond the distal-most portion of the outer portion 166 in the distal direction.

[0074] The removable cap 119, or at least the outer portion 166 of the removable cap 119, and / or the distal end 164 of the removable cap 119, may be made partially or entirely of an elastic (e.g., stretchable) material. The elastic material may allow the removable cap 119 to deform from its original shape when subjected to an external force and to fully or at least partially regain its original shape when the external force is removed. By way of example, the entire removable cap 119, or at least the outer portion 166 of the removable cap 119, and / or at least the distal end 164 of the removable cap 119 may be made partially or entirely of a polypropylene material, a polypropylene random copolymer material, Bormed™ RF830MO, or any other suitable material. The removable cap 119, or at least the outer portion 166 of the removable cap 119, and / or at least the distal end 164 of the removable cap 119, may be partially or entirely constructed of an elastic material to facilitate the above-mentioned bending and / or shock absorbing properties of the removable cap 119.

[0075] Referring now to Figures 9-11, another embodiment of a removable cap will be described. The removable cap 219 shown in Figures 9-11 includes many elements similar or identical to those shown in Figures 4-8 and described above. Elements of the removable cap 219 not described in more detail below may have a similar or identical structure, configuration, and / or function to the correspondingly numbered elements described above with respect to the removable cap 119 shown in Figures 4-8.

[0076] The removable cap 219 may include one or more support members 286a-d radially disposed between the outer portion 266 and the inner portion 268. Each of the support members 286a-d may be coupled to the outer portion 266 and / or the inner portion 268. As an example, each of the support members 286a-d may be coupled to the sidewall 276 of the inner portion 268, the flange 282 of the inner portion 268, and / or the wall 274 of the outer portion 266. As a more specific example, each of the support members 286a-d may be defined by a wall or rib extending generally radially relative to the longitudinal axis A. Furthermore, each of the support members 286a-d may span all or a portion of the radial distance between the outer portion 266 and the inner portion 268. In an axial direction, the support members 286a-d may be disposed distal to the flange 282. In the circumferential direction, the support members 286 a - d may be disposed at respective circumferential positions about the sidewall 276 of the inner portion 268 .

[0077] In some embodiments, the support members 286a-d may be configured to limit and / or control bending of the outer portion 266 of the removable cap 219 relative to the inner portion 268 of the removable cap 219 when the outer portion 266 of the removable cap 219 is subjected to an external force, such as a recoil force applied by the ground in a drop scenario as described above. By limiting and / or controlling bending of the outer portion 266, the support members 286a-d can reduce the likelihood that the external force will cause structural damage, such as cracks or breaks, to the outer portion 266 and / or other portions of the removable cap 219.

[0078] Referring now to Figures 12-17, additional embodiments of removable caps are described. The removable caps 319, 419, 519 shown in Figures 12-17 include many elements similar or identical to those shown in Figures 4-11 and described above. Elements of the removable caps 319, 419, and 519 not described in more detail below may have similar or identical structure, configuration, and / or function to the correspondingly numbered elements described above with respect to the removable caps shown in Figures 4-11.

[0079] 12 and 13 show an embodiment of the removable cap 319 including one or more side openings 388a-d formed in the wall 374 of the outer portion 366. Each of the side openings 388a-d can be in communication with the gap 384. Additionally, each of the side openings 388a-d can be in communication with the second axial opening 372 and can be at least partially formed in a distally directed end surface of the wall 374 of the outer portion 366. In the axial direction, the side openings 388a-d can be partially or entirely distal to the flange 382 of the inner portion 382. In the circumferential direction, the side openings 388a-d can be disposed at respective circumferential positions around the wall 374 of the outer portion 366. For example, as seen in FIGS. 12 and 13, each of the side openings 388a-d can be located approximately midway between two adjacent corners of each of the distal end portions 364 of the removable cap 319. Each of the side openings 388a-d may have a generally elongated shape such that the longest dimension or length of each of the side openings 388a-d is generally parallel to the longitudinal axis A. As an example, each of the side openings 388a-d may have an elongated oval or elliptical shape as seen in Figures 12 and 13. Alternatively, each of the openings 388a-d may have a circular, square, rectangular, or any other suitable shape.

[0080] In some embodiments, the side openings 388a-d may be configured to facilitate bending of the outer portion 366 of the removable cap 319 relative to the inner portion 368 of the removable cap 319 when the outer portion 366 of the removable cap 319 is subjected to an external force, such as a recoil force applied by the ground in a drop scenario as described above. For example, the side openings 388a-d may allow portions of the outer portion 366 of the removable cap 319 to move independently of one another and / or provide additional bending modes compared to when the side openings 388a-d are omitted. Additionally or alternatively, the side openings 388a-d may limit and / or focus stress concentrations to desired or predetermined portions of the outer portion 366, e.g., portions of the outer portion 366 that have thinner and / or more compliant or flexible walls compared to other portions of the outer portion 366.

[0081] 14 and 15 show an alternative embodiment of the removable cap shown in FIGS. 12 and 13. The removable cap 419 includes side openings 488a-d similar to the side openings 388a-d of the removable cap 319, except for in terms of their shape, for example. Each of the side openings 488a-d has a width W that gradually decreases as it begins at the distally directed end surface of the wall 474 and moves in a proximal direction. As an example, each of the side openings 488a-d may be generally V-shaped or U-shaped when viewed from the side, as shown in FIG. 14. The shape and / or location of the openings 488a-d may facilitate bending of the outer portion 466 of the removable cap 419 relative to the inner portion 468 of the removable cap 419 when the outer portion 466 of the removable cap 419 is subjected to an external force, such as a recoil force applied by the ground in a drop scenario as described above. For example, the side openings 488a-d may allow portions of the outer portion 466 of the removable cap 419 to move independently of one another and / or provide additional bending modes compared to if the side openings 488a-d were omitted. Additionally or alternatively, the side openings 488a-d may limit and / or focus stress concentrations to desired or predetermined portions of the outer portion 466, e.g., portions of the outer portion 466 that have thinner and / or more compliant or flexible walls compared to other portions of the outer portion 466.

[0082] 16 and 17 show another embodiment of the removable cap 519 including one or more side openings 588a-d formed in the wall 574 of the outer portion 566. Each of the side openings 588a-d can be in communication with the gap 584. In an axial direction, the side openings 588a-d can be partially or entirely distal to the flange 582 of the inner portion 582 and / or proximal to a distally directed end surface of the wall 574 of the outer portion 566. In a circumferential direction, the side openings 588a-d can be disposed at respective circumferential positions around the wall 574 of the outer portion 566. For example, as seen in FIGS. 16 and 17, each of the side openings 588a-d can be disposed at a respective corner of the distal end 564 of the removable cap 519. As a more specific example, each of the side openings 588a-d may be disposed at a respective corner of the distal end 564 of the removable cap 519 such that one half of each respective side opening is disposed on one side of the respective corner and the other half of each respective side opening is disposed on the other side of the respective corner. The shape and / or location of the openings 588a-d may facilitate bending of the outer portion 566 of the removable cap 519 relative to the inner portion 568 of the removable cap 519 when the outer portion 566 of the removable cap 519 is subjected to an external force, such as a recoil force applied by the ground in a drop scenario described above. For example, the side openings 588a-d may enable portions of the outer portion 566 of the removable cap 519 to move independently of one another and / or provide additional bending modes compared to when the side openings 588a-d are omitted. Additionally or alternatively, side openings 588a-d can limit and / or focus stress concentrations to desired or predetermined portions of outer portion 566, such as portions of outer portion 566 that have thinner and / or more compliant or flexible walls compared to other portions of outer portion 566.

[0083] 18 and 19, another embodiment of a removable cap is described. The removable cap 619 in FIGS. 18 and 19 includes many elements similar or identical to those shown in FIGS. 4-17 and described above. Elements of the removable cap 619 not described in more detail below may have similar or identical structure, configuration, and / or function to the correspondingly numbered elements described above with respect to the removable cap shown in FIGS. 4-17. In terms of structure, the difference between the removable cap 619 and the removable cap described in connection with FIGS. 4-17 is that the flange 682 of the inner portion 668 of the removable cap 619 extends radially outward from the distal end (as opposed to the proximal end) of the sidewall 676 of the inner removable cap 619 such that there is no second axial opening at the distal end 664 of the removable cap 619.

[0084] The removable cap 619 is configured such that an external force applied to the removable cap 619, such as a recoil force applied by the ground in a drop scenario as described above, induces at least one bending moment in the removable cap 619. By way of example, an external force applied to the removable cap 619 may induce one or more bending moments in at least one of the following, or in any combination: (a) the proximal end 662 of the removable cap 619, (b) the distal end 664 of the removable cap 619, (c) the outer portion 666 of the removable cap 619, (d) the inner portion 668 of the removable cap 619, (e) the wall 674 of the outer portion 666 of the removable cap 619, (f) the side wall 676 of the inner portion 668 of the removable cap 619, (g) the lateral wall 678 of the inner portion 668 of the removable cap 619, (h) the flange 682 of the inner portion 668 of the removable cap 619, and (i) a gripper (e.g., the gripper 13 described above) configured to remove a removable sterile barrier (e.g., the removable sterile barrier 21 described above). As a more specific example, referring to FIG. 19 , an external force applied to the removable cap 619 can induce a first bending moment 690a in the proximal end 662 of the removable cap 619, induce a second bending moment 690b in the distal end 664 of the removable cap 619, and / or induce a third bending moment in the side wall 676 of the inner portion 668 and / or in a gripper (e.g., gripper 13, described above) configured to remove the removable sterile barrier (e.g., removable sterile barrier 21, described above).As a more specific example, in a drop scenario in which the drug delivery device is dropped with the longitudinal axis A generally parallel or otherwise non-perpendicular to the direction of gravity and the distally directed end surface of the removable cap 619 facing generally downward, the ground or other external surface striking the removable cap 619 can exert a reaction force on the removable cap 619 in a direction generally parallel or otherwise non-perpendicular to the longitudinal axis A, inducing a first bending moment 690a on the proximal end 662 of the removable cap 619, inducing a second bending moment 690b on the distal end 664 of the removable cap 619, and / or inducing a third bending moment on the side wall 676 of the inner portion 668 and / or a gripper (e.g., gripper 13 described above) configured to remove the removable sterile barrier (e.g., removable sterile barrier 21 described above). In at least some scenarios, the bending moment(s) induced in the respective portions of the removable cap 619 may cause one or more of the respective portions to impact bend and / or act like leaf spring shock absorbers.

[0085] In some embodiments, the first bending moment 690a may be centered about or otherwise associated with a first bending axis, the second bending moment 690b may be centered about or otherwise associated with a second bending axis, and the third bending moment 690a may be centered about or otherwise associated with a third bending axis. As an example, the first bending moment 690a may correspond to or otherwise be associated with the proximal end 662 of the removable cap 619 bending partially or entirely about a first bending axis, the second bending moment 690b may correspond to or otherwise be associated with the distal end 664 of the removable cap 619 bending partially or entirely about a second bending axis, and / or the third bending moment 690c may correspond to or otherwise be associated with the sidewall 676 of the inner portion 668 and / or a gripper (e.g., gripper 13 described above) bending partially or entirely about a third bending axis. As a more specific example, any one or any combination of the first bending axis, the second bending axis, and the third bending axis may be generally perpendicular or otherwise non-parallel to the longitudinal axis A and / or offset a distance (e.g., a radial distance) from the longitudinal axis A.

[0086] All features disclosed herein with respect to any of the removable cap embodiments may be combined in any combination, except combinations in which at least some of such features are mutually exclusive.

[0087] As will be appreciated, the 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 and in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically recited herein may be appreciated as well.

[0088] 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 drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, 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 lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0089] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for the treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0090] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, pegfilgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0091] 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. Erythropoietin 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 alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, 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.

[0092] 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. IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which inhibit activity mediated by binding; 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, including but not limited to those that 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 145c7; human IFNIFN gamma specific antibodies, peptibodies, related proteins, etc., including but not limited to, IFN gamma specific antibodies, and including but not limited to, fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; those that target the hepatocyte growth factor / scatter factor (HGF / SF:c-Met) axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize HGF / SF. including, hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc.; TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to X40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis stimulating protein (NESP), 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-α4β7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), (panitumumab), Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, 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-BlySmAb), 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), TheraCim hR3 (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 IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Mvasi™ (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon alpha-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 145c7-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 protein)), VEGF trap (VEGFR1 Ig domain fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatumumab, 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-Clostridium 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 (HuMaxCD38), 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-Gan GD2 mAb, anti-Gan GGM2 mAb, anti-GDF-8 Hit mAb (MYO-029), anti-GM-CSF receptor mAb (CAM-3001), anti-HepC mAb (HuMax HepC), anti-IFNα mAb (MEDI-545, MDX-198), anti-IGF1R mAb, anti-IGF-1R mAb (HuMax-Inflam), anti-IL12 mAb (ABT-874), anti-IL12 / IL23 mAb (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-integrin receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), BMS-66513, anti-mannos 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-TGFβ mAb (GC-1008), anti-TRAIL receptor-2 mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, and anti-ZP3 mAb (HuMax-ZP3).

[0093] 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, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and 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 niphosphate, 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 metalloproteinases (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies to 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 devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as but not limited to apelin or an analogue 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 disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotorasibe (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor.In some embodiments, the drug delivery device may contain or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that includes the human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or a product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multispecific FAPx4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain efavalukin alfa (formerly known as efavarukin alfa). The drug delivery device may contain or be used with another product containing AMG 592 or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 596 or a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0094] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be construed as merely exemplary 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.

[0095] Those skilled in the art will understand that numerous modifications, alterations, and combinations can 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. A drug delivery device comprising: a housing having an opening; a medication storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; a removable cap including an outer portion and an inner portion, the outer portion configured to be removably coupled to the housing such that the removable cap has a storage position in which the removable cap is coupled to the housing and at least partially covers the opening, and a removal position in which the removable cap is not coupled to the housing; Equipped with a gap separating at least a portion of the inner portion and at least a portion of the outer portion such that at least a portion of the outer portion can flex relative to at least a portion of the inner portion when at least a portion of the outer portion is subjected to an external force. Drug delivery devices.

2. The drug delivery device of claim 1 , wherein the outer portion at least partially surrounds the inner portion.

3. The drug delivery device of claim 1 or 2, wherein the removable cap has a first axial opening configured to receive the housing and a second axial opening.

4. The drug delivery device of claim 3 , wherein the outer portion at least partially surrounds the first axial opening and the second axial opening.

5. The drug delivery device according to any one of claims 1 to 4, wherein the gap is a radial gap.

6. The drug delivery device of any one of claims 1 to 5, wherein the removable cap includes at least one support member disposed between the inner portion and the outer portion, the at least one support member being coupled to at least one of the inner portion and the outer portion.

7. The drug delivery device of claim 6 , wherein the at least one support member is coupled to the inner portion and the outer portion.

8. The drug delivery device of claim 6 or 7, wherein the at least one support member comprises a plurality of support members arranged at respective circumferential positions around the inner portion.

9. A drug delivery device according to any one of claims 1 to 8, comprising at least one side opening formed in the outer portion and in communication with the gap.

10. The drug delivery device of claim 9 , wherein the at least one side opening is at least partially formed in a distally directed end surface of the outer portion.

11. The drug delivery device of claim 9 , wherein the at least one side opening is proximal to a distally directed end surface of the outer portion.

12. The drug delivery device according to any one of claims 9 to 11, wherein the at least one side opening comprises a plurality of side openings arranged at respective circumferential positions around the outer portion.

13. the external force is applied to the removable cap in a direction generally parallel to a longitudinal axis of the removable cap and / or housing; and / or The drug delivery device of any one of claims 1 to 12, wherein the removable cap is configured such that the external force induces at least one bending moment at at least one of a proximal end of the removable cap or a distal end of the removable cap.

14. 1. A drug delivery device comprising: a housing having an opening; a medication storage container including a delivery member having an insertion end configured to extend at least partially through the opening during a delivery state; a removable cap including a proximal end and a distal end, the proximal end configured to be removably coupled to the housing such that the removable cap has a storage position in which the removable cap is coupled to the housing and at least partially covers the opening, and a removal position in which the removable cap is not coupled to the housing; Equipped with the removable cap is configured such that an external force applied to the removable cap induces at least one bending moment at at least one of the proximal end of the removable cap and the distal end of the removable cap. Drug delivery devices.

15. 15. The drug delivery device of claim 14, wherein the at least one bending moment includes a first bending moment at the proximal end of the removable cap and a second bending moment at the distal end of the removable cap.

16. 16. The drug delivery device of claim 14 or 15, wherein the at least one bending moment is associated with at least a portion of the proximal end of the removable cap bending at least partially about a first bending axis.

17. The drug delivery device of claim 16 , wherein the at least a portion of the proximal end of the removable cap includes an annular wall.

18. 18. The drug delivery device of claim 16 or 17, wherein the at least one bending moment is associated with at least a portion of the distal end of the removable cap bending at least partially about a second bending axis.

19. The drug delivery device of any one of claims 14 to 18, wherein the external force is applied to the removable cap in a direction generally parallel to a longitudinal axis of the removable cap and / or housing.

20. 20. The drug delivery device of any one of claims 14 to 19, wherein the removable cap includes an outer portion and an inner portion, and a gap separates the at least a portion of the inner portion from the at least a portion of the outer portion such that the at least a portion of the outer portion can bend relative to the at least a portion of the inner portion when the at least a portion of the outer portion is subjected to the external force.

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