Drug delivery device safety system

Abstract

The present invention discloses a drug delivery device, wherein the device comprises: a housing; a cap located at a proximal end of the housing, the cap including a first pair of deflectable arms and a second pair of deflectable arms; a product container disposed in the housing, and a needle coupled to a distal end of the product container; a plunger rod for dispensing product from the product container, wherein the plunger rod is slidably received within the cap and partially disposed within the product container; and a needle cap at least partially disposed in the housing, wherein the first pair of deflectable arms are configured to deflect radially inward toward the plunger rod, and the second pair of deflectable arms are configured to deflect radially outward away from the plunger rod.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 587,413, filed October 2, 2023, and incorporates by reference the entire contents of U.S. Patent Publication No. 2023 / 0233770A1, published January 25, 2023. Technical Field

[0002] This disclosure relates to a safety system for drug delivery devices (e.g., pre-filled syringes) and its use. Background Technology

[0003] Drug delivery devices (e.g., pre-filled syringes, auto-injectors, or other suitable drug delivery devices) are routinely used to deliver fluid pharmaceutical substances. Various safety issues can arise before, during, and after the use of a drug delivery device. To address these issues, conventional safety devices have been developed. Conventional safety devices may include active safety mechanisms. In such devices, the user needs to actively perform a specific action to trigger the safety mechanism. Users may have difficulty correctly activating the safety mechanism while simultaneously using the drug delivery device correctly to inject the pharmaceutical substance into themselves or another person. In contrast to these active safety devices, passive safety devices have been developed in which the user does not need to perform any additional and / or separate actions to trigger the safety mechanism during and / or after using the drug delivery device.

[0004] Even in passive safety systems, concerns may still exist regarding user safety and the proper use of the drug delivery device. For example, there may be premature fluid leakage, accidental needle pricks before and / or after injection, and / or premature locking before the end of administration. Passive safety mechanisms should be constructed to be used correctly and safely before, during, and after injection. Summary of the Invention

[0005] This disclosure describes a drug delivery device comprising: a housing; a cap located at a proximal end of the housing, the cap including a first pair of deflectable arms and a second pair of deflectable arms; a product vessel disposed within the housing, and a needle coupled to a distal end of the product vessel; a plunger rod for dispensing product from the product vessel, wherein the plunger rod is slidably received in the cap and partially disposed within the product vessel; and a needle cap at least partially disposed within the housing, wherein the first pair of deflectable arms are configured to deflect radially inward toward the plunger rod, and the second pair of deflectable arms are configured to deflect radially outward away from the plunger rod.

[0006] Various embodiments of the device may include one or more of the following aspects: The needle cap may include a pair of openings for receiving a first pair of deflectable arms. The plunger rod may include a first recess located at a distal portion of the plunger rod and a second recess located at a proximal portion of the plunger rod. The device may include a spring disposed within the housing, the spring being configured to restrict distal movement of the plunger rod. The device may be configured to transition from a first state to a second state, in which the first pair of deflectable arms are received in a portion of the needle cap; in the second state, in which the first pair of deflectable arms are radially inwardly deflected toward the plunger rod to be received in the second recess proximal to the plunger rod, wherein the spring is configured to move the plunger rod into the needle cap; and to a third state, in which the first pair of deflectable arms are in a relaxed position, wherein the first pair of deflectable arms restrict proximal movement of the needle cap in the third state, and the proximal end of the needle cap is located distal to the first pair of deflectable arms. The first pair of deflectable arms may be configured to generate audible feedback once the first pair of deflectable arms are in the relaxed position of the third state of the device. The device can be configured to transition from a first state (in which the second pair of deflectable arms abut against the proximal end of the product container and are aligned with the first notch) to a second state (in which the second pair of deflectable arms are radially deflected outward) and to a third state (in which the second pair of deflectable arms are aligned with the second notch within the plunger rod). In the first state, the second pair of deflectable arms restricts movement of the plunger rod in the distal direction and prevents movement of the plunger rod in the proximal direction, and in the second state, the deflected second pair of deflectable arms allow movement of the plunger rod. The transition from the second pair of deflectable arms to the third state can produce audible feedback.

[0007] This disclosure also describes a drug delivery device comprising: a housing including a cap and a flange, the cap including a plurality of deflectable arms configured to engage the cap to the flange; a product container disposed within the housing, and a needle engaged to a distal end of the product container; a plunger rod for dispensing product from the product container; and a needle cap at least partially disposed within the housing.

[0008] Various embodiments of the device may include one or more of the following aspects: Multiple deflectable arms may include a first pair of deflectable arms and a second pair of deflectable arms. The needle cap may include an indicator portion for signaling the end of dosing. The product container may have a deliverable volume ranging from about 1 mL to about 3 mL. The product container may include at least one of a pharmaceutical agent, an antibacterial agent, an anesthetic agent, or a combination thereof.

[0009] The device may include at least one acoustic feedback mechanism. This disclosure also describes a drug delivery device including a housing; a cap located at a proximal end of the housing, the cap including a first pair of deflectable arms and a second pair of deflectable arms; a product vessel disposed within the housing, and a needle extending from a distal end of the product vessel; a plunger rod for dispensing product from the product vessel, the plunger rod including at least one notch located on a distal portion of the plunger rod, wherein the at least one notch is configured to receive an arm of the second pair of deflectable arms; a needle cap at least partially disposed within the housing, the needle cap including at least one opening configured to receive an arm of the first pair of deflectable arms; and a tip cap removably coupled to and located at the distal end of the needle cap.

[0010] Various embodiments of the device may include one or more of the following aspects: a needle guard removably coupled to and located at the distal end of the needle cap, wherein a tip cap surrounds the needle guard. The tip cap may include multiple clips for attachment to a portion of the needle guard. The product container may have a volume ranging from about 2 mL to about 3 mL. The product container may include at least one of a pharmaceutical agent, an antibacterial agent, an anesthetic agent, or a combination thereof. Attached Figure Description

[0011] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate various examples and, together with the description, serve to explain the principles of the disclosed examples and embodiments.

[0012] Various aspects of this disclosure can be implemented in conjunction with the embodiments shown in the accompanying drawings. These drawings illustrate different aspects of this disclosure. Where appropriate, reference numerals illustrating the same structures, components, materials, and / or elements in different drawings are similarly labeled. It should be understood that various combinations of structures, components, and / or elements are contemplated and are within the scope of this disclosure, in addition to the structures, components, and / or elements specifically shown.

[0013] Furthermore, numerous embodiments are described and illustrated herein. This disclosure is neither limited to any single aspect or embodiment thereof, nor to any combination and / or arrangement of such aspects and / or embodiments. Moreover, each aspect of this disclosure and / or its embodiments may be used alone or in combination with other aspects of this disclosure and / or one or more of its embodiments. For the sake of brevity, certain arrangements and combinations are not discussed and / or illustrated separately herein. It is important to note that embodiments or specific implementations described herein as “exemplary” should not be construed as being more preferred or advantageous than other embodiments or specific implementations, for example; rather, they are intended to reflect or indicate that the embodiments are “example” embodiments.

[0014] Figures 1A to 1BExemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0015] Figures 2A to 2F Depicting Figures 1A to 1B Additional aspects and implementations of exemplary safety devices.

[0016] Figures 3A to 3B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0017] Figures 4A to 4D Depicting Figures 3A to 3B Additional aspects and implementations of exemplary safety devices.

[0018] Figures 5A to 5D Depicting Figures 3A to 3B Additional aspects and implementations of exemplary safety devices.

[0019] Figures 6A to 6B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0020] Figures 7A to 7F Depicting Figures 6A to 6B Additional aspects and implementations of exemplary safety devices.

[0021] Figures 8A to 8B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0022] Figures 9A to 9D Depicting Figures 8A to 8B Additional aspects and implementations of exemplary safety devices.

[0023] Figures 10A to 10B Depicting Figures 8A to 8B Additional aspects and implementations of exemplary safety devices.

[0024] Figure 11 Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0025] Figures 12A to 12C Depicting Figure 11 Additional aspects and implementations of exemplary safety devices.

[0026] Figures 13A to 13B Depicting Figure 11 Additional aspects and implementations of exemplary safety devices.

[0027] Figures 14A to 14C Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0028] Figures 15A to 15DDepicting Figures 14A to 14C Additional aspects and implementations of exemplary safety devices.

[0029] Figures 16A to 16B Depicting Figures 14A to 14C Additional aspects and implementations of exemplary safety devices.

[0030] Figures 17A to 17G Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0031] Figures 18A to 18B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0032] Figures 19A to 19B Depicting Figures 18A to 18B Additional aspects and implementations of exemplary safety devices.

[0033] Figures 20A to 20C Depicting Figures 18A to 18B Additional aspects and implementations of exemplary safety devices.

[0034] Figures 21A to 21C Depicting Figures 18A to 18B Additional aspects and implementations of exemplary safety devices.

[0035] Figures 22A to 22B Additional aspects and components of an exemplary security device according to embodiments of the present disclosure are described.

[0036] Figures 23A to 23B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0037] Figures 24A to 24C Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0038] Figure 25 Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0039] Figures 26A to 26B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0040] Figures 27A to 27B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0041] Figures 28A to 28B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0042] Figures 29A to 29BExemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0043] Figures 30A to 30D Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0044] Figure 31 Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0045] Figures 32A to 32F Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0046] Figures 33A to 33B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0047] Figure 34 Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0048] Figures 35A to 35B Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0049] Figures 36A to 36F Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0050] Figures 37A to 37D Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0051] Figures 38A to 38B Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0052] Figures 39A to 39C Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0053] Figures 40A to 40C Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0054] Figures 41A to 41B Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0055] Figures 42A to 42D Depicting Figures 33A to 33B Additional aspects and implementations of exemplary safety devices.

[0056] Figures 43A to 43B Exemplary safety devices and components thereof are depicted according to embodiments of the present disclosure.

[0057] Figures 44A to 44C Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0058] Figures 45A to 45C Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0059] Figure 46 Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0060] Figure 47 Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0061] Figures 48A to 48B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0062] Figures 49 to 51 Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0063] Figures 52A to 52B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0064] Figures 53A to 53C Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0065] Figures 54A to 54B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0066] Figures 55A to 55B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0067] Figures 56A to 56B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0068] Figures 57A to 57B Depicting Figures 43A to 43B Additional aspects and implementations of exemplary safety devices.

[0069] Figure 58 Depicting in the test environment Figures 43A to 43BAdditional aspects and implementations of exemplary safety devices.

[0070] As used herein, the term "comprising" or its other variations are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "or" is inclusive and is intended to indicate that a process, method, article, or apparatus that comprises a list of elements may include a combination or all of the elements. The term "exemplary" is used in the sense of "example" rather than in the sense of "ideal." Furthermore, the terms "first," "second," etc., used herein do not indicate any order, quantity, or importance, but are used to distinguish one element or structure from another. Additionally, the terms "an" and "a" used herein do not indicate a limitation of quantity but rather indicate the presence of one or more of the referenced items.

[0071] The term "distal end" or any variation thereof refers to the portion of the device that serves as the drug delivery end. Conversely, the term "proximal end" or any variation thereof refers to the portion of the device that serves as the actuating end. Furthermore, the terms "about," "substantially," and "approximately" as used herein generally indicate + / - 10% of the indicated value.

[0072] It is worth noting that, for simplicity and clarity, certain aspects of the accompanying drawings depict the general structure and / or construction of various embodiments. Descriptions and details of well-known features and technologies may be omitted to avoid unnecessarily obscuring other features. Elements in the drawings are not necessarily drawn to scale; the dimensions of some features may be exaggerated relative to other elements to better understand the exemplary embodiments. For example, those skilled in the art will understand that side views are not drawn to scale and should not be considered as representing proportional relationships between different components. Side views are provided to aid in illustrating the various components of the depicted assembly and to show their relative positioning to each other. Detailed Implementation

[0073] Reference will now be made in detail to examples of this disclosure shown in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.

[0074] With the use of drug delivery devices, various safety issues may arise. Safety concerns and anxieties may occur before, during, and / or after use (e.g., when injecting a product, such as a liquid medication, from a drug delivery device). For example, premature expulsion of the product may occur if components of the device are not secured and / or locked to the appropriate pre-injection site. Needle exposure can lead to accidental needle pricks during injection if the device is accidentally removed from the injection site, and / or if the device is removed from the injection site and discarded after injection. Needle exposure may also have adverse effects on users with needle phobia and / or needle-related anxiety. Furthermore, there may be concerns that users may insert the needle to an incorrect depth and / or inject it into the injection site.

[0075] To address these issues, conventional safety devices have been developed. These devices may include active safety mechanisms. Active safety mechanisms require the user to actively perform a specific action to trigger them. For ordinary users, such as those without medical training, it can be difficult to correctly activate an active safety mechanism and properly inject the medication into themselves or another person. Furthermore, if the user fails to activate the safety mechanism, it may be ineffective. Passive safety mechanisms have been developed to address these problems. Devices incorporating passive safety mechanisms do not require the user to perform any additional and / or separate actions before, during, and / or after use to trigger the mechanism. However, other problems may arise with passive drug delivery devices. For example, if the user accidentally removes the device from the injection site, the passive safety mechanism may automatically activate before the medication is complete. In this case, the user may not be able to complete the medication delivery and must obtain another device.

[0076] Embodiments of this disclosure relate to a drug delivery device, and more particularly to a device for passively activating a safety mechanism during and / or after injection of a drug from a product container (e.g., a syringe).

[0077] Figure 1A An external view of the device 10 is shown. The device 10 can be designed to hold any commercially known product container 12 (e.g., a syringe or other suitable drug delivery device). The device 10 may include a housing 14, a plunger rod 16, and a thumb pad 20. Figure 1B An internal view of the device 10 is shown, in which the housing 14 can be configured to accommodate the container 12. Figure 1B In the illustrated embodiment, container 12 may be a syringe, such as a pre-filled syringe. The outer casing 14 may include an inwardly projecting shoulder 28. Figure 1BAs shown, the shoulder 28 can be located in the proximal portion of the housing 14 and abuts against the proximal end of the container 12 when housed within the housing 14. The plunger rod 16 can be coupled to a stop 18 for discharging product from the container 12 and a flange 26 for coupling to the thumb pad 20. (Reference) Figure 1B The stop 18 can be positioned at the distal end of the plunger rod 16, and the flange 26 can be positioned at the proximal end of the plunger rod 16.

[0078] As will be described in detail below, the plunger rod 16 may abut and / or be releasably coupled to a portion of the syringe, such as the syringe piston, within the housing 14. In some embodiments, the plunger rod 16, thumb pad 20, and syringe may be locked together during injection, transmitting the force exerted by the user on the plunger rod 16 to the syringe piston. After injection is complete, the plunger rod 16 may be disengaged from the thumb pad 20. After the plunger rod 16 is disengaged from the thumb pad 20, the thumb pad 20 may be coupled to the housing 14, thereby preventing the thumb pad 20, plunger rod 16, and / or syringe from moving beyond the thumb pad position in the proximal direction (i.e., being removed from the housing). When the thumb pad 20 moves to the housing 14 in the distal direction, the spring 13 may cause the syringe and plunger rod 16 to move proximally into the housing 14 and thumb pad 20, respectively.

[0079] Various components can be used to move the plunger rod 16 and / or the syringe, and then lock the thumb pad 20, plunger rod 16, and / or syringe into the housing 14. In some embodiments, the thumb pad 20 may include a deflectable tab 22 and a distal extension 24. Figure 2B As shown, the deflectable tab 22 may include a recess 23. The recess 23 may be releasably coupled to the flange 26 of the plunger rod 16. In some embodiments, the deflectable tab 22 and the recess 23 may be formed continuously or around a large portion of the interior portion of the thumb pad 20. In other words, the deflectable tab 22 and the recess 23 may be formed in the thumb pad 20 to surround the flange 26. In other embodiments, the thumb pad 20 may include more than one deflectable tab 22 and recess 23. For example, the thumb pad 20 may include two, three, or four deflectable tabs, each tab having a recess 23. In configurations having more than one deflectable tab 22 and recess 23, the tabs may be equidistant from each other. For example, if the thumb pad 20 includes four deflectable tabs, then each of the tabs may be approximately 90 degrees to each other. Additionally, each deflectable tab may include a recess 23 for releasably engaging with a portion of the flange 26.

[0080] In some embodiments, the thumb pad 20 may include more than one distal extension 24. For example, the thumb pad 20 may include two, three, four, or more distal extensions 24. In configurations having more than one distal extension 24, the distal extensions may be equidistant from each other. For example, if the thumb pad 20 includes four distal extensions 24, each of the distal extensions may be approximately 90 degrees to each other. In some embodiments, a single distal extension may extend continuously or at least partially around the thumb pad 20.

[0081] Prior to injection, the plunger rod 16 can be fully extended from the proximal end of the housing 14. Figure 1B In this configuration, the container 12 (e.g., a filled syringe) and the plunger rod 16 may not be removed from the device 10. Various components can prevent the plunger rod 16 from being removed from the device 10. For example, the arm 36a of the thumb pad 20 can lock into the cutouts 34c, 34d of the housing 14 before injection and into the housing 14 to prevent the removal of the plunger rod 16, as... Figure 2E As shown. Reference Figures 2A to 2B To initiate product injection from container 12, the user can press down on the thumb pad 20 to move the thumb pad 20 and plunger rod 16 distally toward the housing 14. After the product has been completely expelled from container 12 at the end of the injection, the thumb pad 20 can abut against the proximal end of the housing 14. Figure 2B The proximal end of the housing 14 may include a collar 30 aligned with the deflectable tab 22. Figure 2B As shown, the collar 30 may have an inclined surface configured to abut against the deflectable tab 22 upon completion of injection and to cause the deflectable tab to flex outward in a direction away from the flange 26. The deflectable tab 22 may also include an inclined surface configured to abut against the inclined surface of the collar 30 to facilitate deflection of the deflectable tab 22. The thumb pad 20, tab 22, and recess 23 can be disengaged from the flange 26 and release the plunger rod 16. Figure 2A The arm 36a of the thumb pad 20 is also depicted, which will be described in more detail in the locking features of the reference device 10 below.

[0082] Similarly, Figure 2B As shown, once the thumb pad 20 abuts against the housing 14, at the end of the injection, the distal extension 24 of the thumb pad can contact the shoulder 28 of the housing 14 and deflect it in an outward direction away from the plunger rod 16. Figure 2C The distal extension 24 and shoulder 28 are depicted before they move to contact each other, and Figure 2DThe distal extension 24 of the thumb pad 20 is depicted when it begins to contact the shoulder 28. Once the shoulder 28 deflects outward in a proximal direction away from the plunger rod 16 and the container 12, the container 12 can be released, allowing the container 12 to move in a proximal direction. In some instances, a spring 13 (e.g., a spring guard) may abut a portion of the container 12 in the housing 14 to push the container 12 in a proximal direction once it is released from the shoulder 28. For example, at least partially compressed spring 13 may contact the distal surface of the flange of the container 12, and when the shoulder 28 deflects outward so that it no longer abuts the container 12, the spring may push the distal surface of the flange of the container 12 in a proximal direction, and thus push the entire container 12. Including a spring can provide a locking function for the device 10 to prevent reuse of the device. A spring may surround the container 12 in the housing 14, or one or more springs may be positioned adjacent to the container 12 and may abut a portion of the distal surface of the container 12.

[0083] Figure 2E The device 10 is depicted before it locks, when the thumb pad 20 initially abuts against the proximal end of the housing 14, and Figure 2F A locking device 10 is depicted, wherein a plunger rod 16 and a flange 26 are disposed in a thumb pad 20 such that the flange 26 abuts against the distal inner wall 32 of the thumb pad 20. Once the plunger rod 16 and the flange 26 are released from the recess 23 of the deflectable tab 22, and the distal end of the container 12 is released from the shoulder 28, the plunger rod 16, the flange 26, and the container 12 can move in the proximal direction toward the distal inner wall 32 of the thumb pad 20. Figure 2F ).

[0084] In some embodiments, the thumb pad 20 may include one or more arms, such as arms 36a and 36b, which extend distally into the housing 14 when the thumb pad 20 is pressed down. The distal ends of arms 36a, 36b may project radially outward away from the container 12, and arms 36a, 36b may be radially outward biased. The housing 14 may include a plurality of cuts 34a, 34b, 34c, 34d. Prior to injection, the distal ends of arms 36a, 36b may be aligned with cuts 34c, 34d to hold the thumb pad 20 in place before the user applies a pressing force to the plunger rod 16. When the thumb pad 20 abuts against the distal ends of the housing 14, the release flange 26, the plunger rod 16, and the container 12, protrusions on the distal ends of arms 36a, 36b may be aligned with cuts 34a, 34b and may be deflected outward to engage cuts 34a, 34b. Figure 2E The engagement of the distal ends of arms 36a and 36b with cutouts 34a and 34b can hold the thumb pad 20 in place when the flange 26 moves proximally to abut against the distal inner wall 32 of the thumb pad 20. Figure 2FThis is also used to lock the thumb pad 20 to the housing 14, thereby preventing the device 10 from being reused.

[0085] In some embodiments, multiple arms may extend distally from the thumb pad 20. For example, the thumb pad 20 may include two, three, four, or more arms 36a, 36b. In configurations with more than one arm, the arms may be equidistant from each other. For example, if the thumb pad 20 includes four arms, then each of these arms may be at approximately 90 degrees to each other. If the thumb pad 20 includes two arms, then these arms may be at approximately 180 degrees to each other. Furthermore, the housing 14 may include a complementary number of cuts aligned with a projection on the distal end of the arm when the thumb pad 20 is in its most distal position. In some embodiments, a single arm may extend from the thumb pad 20, and the housing 14 may include a single cut aligned with that arm. In some embodiments, the thumb pad 20 may include two arms, and the housing 14 may include two cuts, one aligned with each arm, and so on. Although the cuts 34a, 34b are depicted as extending through the wall of the housing 14, it is contemplated that the cuts 34a, 34b may be notches or grooves that may not extend completely through the housing 14. In an embodiment where the cutout is a groove, one or more grooves may be positioned in line with the arm on the thumb pad 20, or a single groove may extend around the inner wall of the housing 14.

[0086] Figures 1A to 2F The implementation scheme describes a device with a passive safety mechanism that can be activated when the user is nearing the end of the administration, for example when a large amount of product has been completely discharged from container 12. Figures 1A to 2F The passive safety mechanism allows container 12 and injection needle 2 ( Figure 1B At the end of administration, the needle 2 is moved proximally into the housing 14 so that it can be fully retracted into the housing 14 to prevent accidental needle pricks after injection. The container 12 and needle 2 may not be moved proximally into the housing 14 until the injection is complete, and the thumb pad 20 presses against the proximal end of the housing 14 to release the flange 26 and the container 12. Figures 1A to 1B As shown, the user can only see a portion of the needle 2. This prevents needle phobia and needle-related anxiety compared to conventional drug delivery devices with exposed needles. Furthermore, exposing only a portion of the needle 2 allows the use of device 10 without any pre-injection steps, such as pinching the skin to change the injection depth to compensate for the longer needle length compared to the exposed needle 2 of device 10. The size of device 10 can be designed such that the initial position of container 12 within housing 14 is calibrated such that only a portion of the needle is exposed, and the length of the exposed portion of needle 2 represents the desired insertion depth of needle 2.

[0087] In some embodiments, device 10 may include a feedback mechanism. Device 10 may include a visual feedback mechanism, for example, where the thumb pad 20 and housing 14 are locked together and the needle 2 is retracted into housing 14, so that once device 10 is pulled away from the injection site, the user cannot see the needle 2. In some instances, device 10 may include an optional opening 40 (…). Figure 1B The device 10 is used to observe the movement of the container 12, the plunger rod 16, and the stop 18 within the container 12. In some aspects, the device 10 may include an audible "click" sound, such as when the thumb pad 20 and the housing 14 are connected and / or when the flange 26 abuts against the distal inner wall 32 of the thumb pad 20. In some aspects, the device 10 may include tactile feedback, such as a snapping or vibration when the thumb pad 20 and the housing 14 are connected and / or when the flange 26 abuts against the distal inner wall 32 of the thumb pad 20.

[0088] Device 10 may have any suitable size and shape to retain or partially retain product container 12, and / or support and retain plunger rod 16 and stop 18 within product container 12. Thumb pad 20 may have any suitable size and shape to abut and lock into device 10. Components of thumb pad 20, including deflectable tab 22 and recess 23, may have any suitable size and shape to receive flange 26. Cutouts 34a, 34b may have any suitable size and shape to receive arms 36a, 36b.

[0089] In other embodiments, device 10 may include a rear cap 163 ( Figure 17B ).like Figure 17B As shown, the rear cap 163 can be shaped and configured to fit into the proximal end of the housing 14. The rear cap 163 may have a substantially circular shape. The proximal end of the rear cap 163 may abut against the proximal end of the housing 14, such that the rear cap 163 can be secured within the housing 14. (Reference) Figure 17B The rear cap 163 may include a rear cap recess 165 for receiving a portion of the container 12. For example, a proximal portion of the container 12 may fit into the rear cap recess 165 of the rear cap 163. The thumb pad 20 of the device 10 may include a deflectable tab 22. In some instances, the thumb pad 20 may include multiple deflectable tabs 22. The deflectable tab 22 may include a recess 23 configured to receive a flange 26 of the plunger rod 16. The thumb pad 20 may also include a distal extension 24. Figure 17A As shown, in some instances, the thumb pad 20 may include a plurality of distal extensions 24. Figure 17C Depicting Figure 17B A rotated view of device 10. (Reference) Figure 17C The plunger rod 16 may include a plurality of ridges 16a, wherein a portion of the rear cap 163 may abut against a portion of the ridge 16a.

[0090] During use, the user can press the thumb pad 20 towards the outer casing 14 in a distal direction. (Similar to reference...) Figure 2A and Figure 2B The described institution, and reference Figure 17D and Figure 17E When the thumb pad 20 is pushed toward the housing 14, a portion of the proximal end of the housing 14 can abut against the deflectable tab 22. The deflectable tab 22 can deflect in a direction away from the flange 26, thereby allowing the plunger rod 16 and the thumb pad 20 to separate. Figure 17E Depicting Figure 17D A rotated view of device 10. (Reference) Figure 17F At the end of administration, the distal end of extension 24 can be engaged in housing 14. For example, housing 14 may include a notch 174 for receiving the distal end of extension 24. Once the distal end of extension 24 is engaged in notch 174, a portion of the rear cap 163 can be pressed inward toward the plunger rod 16, allowing the rear cap 163 to move proximally into the thumb pad 20. Device 10 may include an actuator, such as a spring (not shown), located below the rear cap 163. The actuator may be configured to push the rear cap 163 into the thumb pad 20 once a portion of the rear cap 163 is pressed inward toward the plunger rod 16. Figure 17G Depicting Figure 17F Rotational view of device 10 in the image.

[0091] Figure 18A and Figure 18B Alternative implementations of device 10 are described. Figure 18A A front exterior view of the device 10 is depicted, and Figure 18B A side external view of the device 10 is depicted. The housing 14 of the device 10 may include a finger-operated flange 15. The finger-operated flange 15 may be located at a proximal end of the housing 14 and extend in a direction away from the plunger rod 16. The finger-operated flange 15 may be shaped or configured to be properly gripped by a user and to operate correctly with the syringe. For example, the finger-operated flange 15 may be designed to meet safety requirements and necessary needle distance requirements. Reference Figure 18B The housing 14 may include a rear cap 190. In this embodiment, the rear cap 190 may be located at the proximal end of the housing 14. The rear cap 190 may include a hook portion 192 extending in the proximal direction. Figure 18B As shown, the rear cap 190 may include at least two hook portions 192. The hook portions 192 may abut against the recess 180 of the plunger rod 16 (in... Figure 19A and Figure 19B (As shown in detail). The hook portion 192 can hook onto the proximal surface of the recessed portion 180 (e.g., on top of it).

[0092] Figure 19A and Figure 19B Depicting Figure 18A and Figure 18B A cross-sectional view of device 10 in the diagram. Figure 19A This is a front sectional view of device 10, and Figure 19B This is a side sectional view of device 10. The thumb pad 20 may include a distal extension 24, and the housing 14 may include a finger-touch flange 15. As discussed above, the finger-touch flange 15 may include a rear cap 190, wherein the rear cap 190 may include a hook portion 192 that can hook onto a recess 180 of the plunger rod 16. Reference Figure 19A The outer shell 14 may also include a shoulder 28. Further details about the outer shell 14 and the rear cap 190 will be discussed below.

[0093] Figures 20A to 20C A view of the device 10 in its pre-injection state is depicted. Figure 20A A quarter-section view of device 10 is depicted. Figure 20B Depicting from Figure 20A Detailed view of the proximal end of the outer shell 14 and the rear cap 190, and Figure 20C Depicting from Figure 20A Detailed view of the thumb pad 20. (Reference) Figure 20B The rear cap 190 and the housing 14 may include attachment means for attaching the rear cap 190 to the housing 14. For example, the rear cap 190 may include a tab 201, and the housing 14 may include a housing hook 205. When the rear cap 190 and the housing 14 are attached ( Figure 20B The tab 203 may be located within a portion of the housing 14, and the housing hook 205 may hook onto a portion of the tab 201 (e.g., at its top). This configuration can serve as a pull-back prevention feature, thereby preventing the user from unintentionally pulling the plunger rod 16 out of the rear of the device 10. Such a configuration can also serve as a pre-discharge prevention feature to prevent loss of drug product before the needle is inserted into the skin. Figure 20C As shown, the thumb pad 20 may include a deflectable tab 22 and a distal extension 24. Figure 20C Depicting from Figure 20A A quarter-section view of the thumb pad 20. The thumb pad 20 may include a plurality of deflectable tabs 22 and a distal extension 24. Reference Figure 20C A portion of the flange 26 of the plunger rod 16 abuts against the distal surface of the notch 27 of the deflectable tab 22. Alternatively, a portion of the flange 26 may be located on top of the proximal surface of the flange 29 of the distal extension 24. Figures 21A to 21C Depicting Figures 18A to 20CThe device 10 is positioned after injection (e.g., at the end of administration). At the start of injection, the needle (not shown) of the container 12 extends distally from the housing 14. For example, approximately 6 mm of the needle may be exposed at the start of injection. When the user presses the thumb pad 20 distally toward the housing 14, the plunger rod 16 also extends distally into the container 12, allowing the recessed portion 180 to separate from the hook portion 192. (Reference) Figure 21B Once the thumb pad 20 abuts against the rear cap 190, the deflectable tab 22 can deflect outward in a direction away from the flange 26, thereby allowing the deflectable tab 22 to separate from the flange 26. Once the thumb pad 20 abuts against the rear cap 190, the distal extension 24 can abut against the shoulder 28, thereby pushing the shoulder 28 outward in a direction away from the container 12. Then, the container 12 and the plunger rod 16 can move in a proximal direction, such that the flange 26 of the plunger rod 16 abuts against the distal surface of the thumb pad 20. Figure 21C Then, the needle 70 of container 12 can be concealed within the outer casing 14. Figure 21A The passive dosing end locking mechanism can be activated by an actuator (e.g., spring 13) located around the proximal end of the container 12. Figure 1B ).

[0094] Figures 18A to 21C Embodiments of the device 10 depicted may include one or more additional features, such as features that lock the thumb pad 20 in place with the plunger rod 16 in the post-injection state; alignment features between the thumb pad 20 and the plunger rod 16 to reduce misalignment at the end of injection; ergonomic design to allow for two-handed operation, for example, one hand can hold the syringe at a 90-degree angle for needle insertion while the second hand pushes the plunger rod 16; optimal configuration and size of the deflectable tab 22, distal extension 24, plunger rod 16, and / or rear cap 190; an indicator of injection completion, such as a visual color change or an audible indicator; activation points that mitigate possible failure modes, such as pre-activation points or states; optimal configuration and size of the thumb pad 20 to fit the user's hand; the plunger rod 16 extending to be located within the piston of the device to improve alignment; and optimized design to reduce the required spring force, thereby minimizing plastic creep.

[0095] Figures 3A to 5D Another embodiment of this disclosure is depicted, in which the needle is covered in its pre-injection state. (Reference) Figures 3A to 3B The device 50 can be designed to hold any conventional product container 52, such as a syringe. The device 50 may include a housing 54, a plunger rod 56, a stop 60, a blocking member 62, and a needle cap 64. As shown, for example, in Figure 3BIn this configuration, the plunger rod 56 may include a first notch 58 in a distal region and a second notch 59 in a proximal region. The blocking member 62 may be located at the proximal end of the housing 54. The plunger rod 56 may be slidably coupled to the blocking member 62 such that the plunger rod 56 can slide through the blocking member 62 in a distal direction. The needle cap 64 may include the proximal end 66 of a deflectable arm 63 abutting against the blocking member 62. Figures 3A to 3B As shown, the blocking member 62 may include more than one deflectable arm 63. For example, the blocking member 62 may include two, three, four or more deflectable arms 63. In a configuration with more than one deflectable arm, the deflectable arms may be equidistant from each other. For example, if the blocking member 62 includes four deflectable arms 63, each of the deflectable arms may be about 90 degrees from each other. For example, the blocking member 62 may have a pair of deflectable arms 63 spaced apart from each other, for example, about 180 degrees. Therefore, the discussion herein is applicable to devices with different numbers of components. In some instances, the needle cap 64 may include a slot 55 ( Figures 3A to 4D The slot 55 is configured to receive a portion of the housing 54. The slot 55 will be described further below.

[0096] Figure 3A A device 50 is depicted before use, wherein a needle cap 64 can extend fully to the distal side of a housing 54 and cover a needle 70 in an initial starting position. Figure 3B The device 50 during use is depicted, specifically when the needle cap 64 can be pressed down and moved proximally to the housing 54 (e.g., by pressing the device 50 against the injection site). The detailed configuration and interaction of the needle cap 64 and the blocking member 62 will be further described when discussing the use of the device 50.

[0097] In the initial position before use, such as Figures 4A to 4B As shown, the distal end of the deflectable arm 63 can be fitted into a portion of the first recess 58 of the plunger rod 56. For example, the distal portion of the deflectable arm 63 can abut against a portion of the first recess 58 at contact point A. The distal end 66 of the needle cap 64 can also abut against a portion of the deflectable arm 63 at contact point B. In this initial position, significant movement of the plunger rod 56 in the proximal or distal direction can be prevented before use. For example, as Figures 4A to 4B As shown, if the plunger rod 56 is pushed into the housing 54 in the distal direction, the proximal end 66 of the needle cap 64 prevents the deflectable arm 63 from deflecting outward, thereby locking the deflectable arm 63 within the first recess 58 and preventing further movement of the plunger rod 56. Figures 4C to 4DAs shown, if the plunger rod 56 is pulled in a proximal direction away from the housing 54, the deflectable arm 63 is prevented from deflecting outward again by the proximal end 66 of the needle cap 64, thereby locking the deflectable arm 63 within the first recess 58 and preventing further movement of the plunger rod 56.

[0098] To initiate injection, the device 50 can be pressed against the injection site to depress the needle cap 64. Once the needle cap 64 moves distally, the proximal end 66 of the needle cap 64 moves proximally and disengages from the deflectable arm 63. This allows the plunger rod 56 to be pressed distally toward the housing 54 for injection. In other words, as the needle cap 64 moves proximally into the housing 54 and the proximal end 66 moves away from the contact point B, the plunger rod 56 can deflect the arm 63 of the blocking member 62, thereby allowing the first notch 58 to move through the deflectable arm 63. Figure 5A This allows the injection to be performed. For example... Figure 5A As shown, the proximal end 66 of the needle cap 64 moves proximal within the housing and can abut against a portion of the blocking member 62.

[0099] Once the injection is complete, the device 50 can be removed from the injection site, and the needle cap 64 can be pulled downwards in the distal direction. Figures 5B to 5C In some instances, device 50 may include spring guard 53. Figure 3A and 5A to Figure 5D To pull the needle cap 64 and bias the needle cap 64 in the proximal direction. For example... Figures 5B to 5C As shown, the plunger rod 56 is fully pressed into the housing 54. Figure 4A and Figure 4C As shown, the diameter of the portion of the plunger rod 56 at the second notch 59 can be smaller than the diameter of the portion of the plunger rod 56 at the first notch 58, thereby creating a second notch 59 that is larger than the first notch 58. Thus, once the plunger rod 56 is fully pressed into the housing 54 at the end of the injection, the area between the plunger rod 56 and the deflectable arm 63 at the second notch 59 increases. Figure 5B This space allows the distal end 66 of the needle cap 64 to flex the deflectable arm 63 inward toward the plunger rod 56, so that the proximal end 66 can move in the distal direction past the deflectable arm 63. Figure 5C In some instances, a spring-loaded shield 53 may be present around the needle cap 64, wherein the needle cap 64 can be moved via a deflectable arm 63 using spring force. (See reference) Figure 5DOnce the proximal end 66 has passed the deflectable arm 63, the deflectable arm 63 can return to the undeflected position and can again prevent further movement of the proximal end 66 in the proximal direction. The deflectable arm 63 can now function as a locking mechanism to prevent reuse of the device 50 or accidental needle puncture, as the needle cap 64 is no longer able to move proximally to expose the needle 70. In this final post-injection position of the device 50, the needle cap 64 can be in the locked position, and the proximal end 66 and the deflectable arm 63 can abut at contact point C. Figure 5D This prevents further movement of the needle cap 64 and the proximal end 66, wherein the proximal end 66 is held between the flange 72 of the housing 54 and the deflectable arm 63. Additionally, the device 50 may not be reused.

[0100] In some embodiments, the slot 55 of the needle cap 64 may be configured to slidably receive the flange 72. For example, the flange 72 may move within the slot 55 as the needle cap 64 moves. The flange 72 may move within the slot 55 in a distal and / or proximal direction. As described above, in the post-injection position of the device 50, the proximal end 66 may be held between the flange 72 of the housing 54 and the deflectable arm 63, wherein the flange 72 may be within the slot 55. Figure 3A As shown, the needle cap 64 may include a complementary number of slots aligned with the flange 72 of the housing 54. In some embodiments, the housing 54 may include a single flange, and the needle cap 64 may include a single slot aligned with that flange. In some embodiments, the housing 54 may include two flanges, and the needle cap 64 may include two slots, each slot aligned with one flange, and so on. The slot 55 may extend through the needle cap 64. In other embodiments, the slot 55 may be a notch or groove that may not extend completely through the needle cap 64.

[0101] Figures 3A to 5D The implementation of the invention describes a device with a passive safety mechanism that can be activated when the user is nearing the end of the administration, for example when a large amount of product has been completely discharged from container 52. Figures 3A to 5D The passive safety mechanism prevents accidental post-injection needle pricks because the needle cap 64 can remain unpressed before the device 50 is pressed against the injection site, and once the device 50 is removed from the injection site, the needle cap 64 springs back to extend from the distal end of the housing 54 to cover the needle 70.

[0102] in addition, Figures 3A to 5D Passive safety mechanisms can prevent premature locking. For example, some conventional drug delivery devices may automatically lock once the device is removed from the injection site, even if the product has not been completely expelled. (Reference) Figures 5C to 5DOnly when the plunger rod 56 is fully depressed into the housing 54 can the proximal end 66 of the needle cap 64 flex the deflectable arm 63 into the second recess 59, allowing the proximal end 66 to move distally past the deflectable arm 63 to a position adjacent to the flange 72 to abut the deflectable arm 63 at contact point C. The plunger rod 56 is fully depressed only at the end of administration, so locking does not occur until the complete dose of product in the container 52 is expelled. If the device 50 is removed from the injection site during injection (e.g., before the plunger rod 56 is fully depressed into the housing 54), the needle cap 64 may not be locked, and the device 50 may be returned to the injection site to continue injection.

[0103] Furthermore, since the needle 70 is contained within the needle cap 64 both before and after injection, the user cannot see the needle 70 at any point in time before, during, and / or after injection. Therefore, the needle cap 64 can reduce needle phobia and needle-related anxiety compared to conventional drug delivery devices with exposed needles. Additionally, exposing only a portion of the needle 70 allows the use of the device 50 without any pre-injection steps, such as pinching the skin to change the injection depth, to compensate for the longer needle length compared to the exposed needle 70 of the device 50. Figure 3B The device 50 may be configured such that, for example, the container 52 can be positioned within the housing 54 and / or the size of the needle cap 64 may be designed such that the retracted position of the needle cap 64 exposes only a portion of the needle 70, and the length of the exposed portion of the needle 70 represents the desired insertion depth of the needle 70.

[0104] In some embodiments, device 50 may include a feedback mechanism. Device 50 may include a visual feedback mechanism, such as a plunger 56 fully pressed into housing 54. Figure 5B The device 50 includes a needle cap 64 that extends proximally to the housing 54, covering the needle 70. In some instances, the device 50 may include an opening for observing the movement of the container 52 and the plunger rod 56 and stop 60 within the container 52. The device 50 may also include an audible feedback mechanism, such as an audible "click" sound once the proximal end of the plunger rod 56 engages with the housing 54. In some aspects, the device 50 may include tactile feedback, such as a snap or vibration as the needle cap 64 moves proximally and abuts against the flange 72 at the end of the injection.

[0105] Figures 6A to 6B Another embodiment of this disclosure is described, similar to the above reference. Figures 3A to 5D The described embodiment, however, involves a needle that extends beyond the needle cap in the pre-injection state. Where appropriate, features will be designated using reference numerals similar to those discussed above. Corresponding to Figures 3A to 5D Any feature and component of the features and components in [the document] can be understood as being constructed similarly. (Reference) Figures 6A to 6B The device 80 can be designed to hold any conventional product container 92, such as a syringe. The device 80 may include a housing 74, a plunger rod 76, a stop 90, a blocking member 82, and a needle cap 84. As shown, for example, in Figure 6B In this housing 74, the plunger rod 76 may include a first notch 78 in a distal region and a second notch 79 in a proximal region. The blocking member 82 may be located at the proximal end of the housing 74. The plunger rod 76 may be slidably coupled to the blocking member 82, such that the plunger rod 76 can slide through the blocking member 82. Figures 6A to 6B As shown, the blocking member 82 may include more than one deflectable arm 83. For example, the blocking member 82 may include two, three, four or more deflectable arms 83. In a configuration with more than one deflectable arm, the deflectable arms may be equidistant from each other. For example, if the blocking member 82 includes four deflectable arms 63, each of the deflectable arms may be about 90 degrees from each other. For example, the blocking member 82 may have a pair of deflectable arms 83 spaced apart from each other, for example, about 180 degrees. Therefore, the discussion herein is applicable to devices with different numbers of components.

[0106] Figure 6A A device 80 before use is depicted, wherein a needle 96 extends distally from a housing 74 and a needle cap 84. An optional removable needle shield 94 may be inserted into or onto the needle cap 84 and / or the housing 74 to cover the needle 96. Figure 6B The device 80 is depicted before use, once the needle guard 94 has been removed. (With) Figures 3A to 3B Compared to the previous implementation, since the needle 96 extends beyond the needle cap 84 in the initial state of the device, it may not be necessary to press down the needle cap 84 before use. Once the needle cap 94 is removed, the needle 96 is visible to the user before injection.

[0107] In the initial position before use, such as Figures 7A to 7BAs shown, the distal end of the deflectable arm 83 can be fitted into at least a portion of the first recess 78 of the plunger rod 76. For example, the distal portion of the deflectable arm 83 can abut a portion of the first recess 78 at contact point E. The proximal end 86 of the needle cap 84 can also abut a portion of the deflectable arm 83 at contact point D. In this initial position, significant movement of the plunger rod 76 in the proximal or distal direction can be prevented before use. For example, if the plunger rod 76 is pushed into the housing 74 in the distal direction using a loosening force, the contact between the deflectable arm 83 and the plunger rod 76 at contact point E, and the contact between the deflectable arm and the proximal end 86 of the needle cap 84, prevents the plunger rod 76 from moving proximally. The arrangement of the deflectable arm 83, the plunger rod 76 with the first notch 78, and the proximal end 86 of the needle cap 84 prevents movement of the plunger rod 76 in the distal direction unless an increased force is applied, such as a force higher than the typical release force. If the plunger rod 76 is pulled in the proximal direction away from the housing 74, the deflectable arm 83 can contact the edge of the first notch 78, thereby preventing movement of the plunger rod 76 in the distal direction.

[0108] To initiate the injection, the device 80 can be pressed against the injection site, allowing the needle 96 to pierce the injection site. The plunger rod 76 can then be pushed distally toward the housing 74 using a force greater than the normal release force. When the plunger rod 76 is pressed into the housing 74, under a force greater than the normal release force, the deflectable arm 83 can be radially deflected outwards in a direction away from the plunger rod 76 and the contact point E, thereby allowing the first notch 78 to move through the deflectable arm 83. Figure 7C A loosening force higher than normal can be, for example, a force higher than about 2 Newtons (N), such as about 3 N to about 20 N.

[0109] Once the injection is complete, the device 80 can be removed from the injection site, and as follows: Figure 7D As shown, the plunger rod 76 can be fully pressed into the housing 74, allowing the plunger rod 76 to abut against the housing 74. Once the device 80 is removed from the injection site, the needle cap 84 may include a spring guard 73. Figure 6A This causes the needle cap 84 to move downwards in the distal direction. For example... Figures 6A to 6B As shown, the diameter of the portion of the plunger rod 76 at the second notch 79 can be smaller than the diameter of the portion of the plunger rod 76 at the first notch 78, thereby creating a second notch 79 that is larger than the first notch 78. Thus, once the plunger rod 76 is fully pressed into the housing 74 at the end of injection, the area between the plunger rod 76 and the deflectable arm 83 at the second notch 79 increases. Figure 7D This space allows the proximal end 86 of the needle cap 84 to flex the deflectable arm 83 inward toward the plunger rod 76, such that the proximal end 86 can move in the distal direction past the deflectable arm 83. Figure 7EIn some instances, a spring guard (not shown) may be present around or at the end of the needle cap 84, wherein the needle cap 84 can be moved via the deflectable arm 83 using spring force. (See reference) Figure 7E Once the proximal end 86 has passed the deflectable arm 83, the deflectable arm 83 can flex back to its initial position, and the needle cap 84 can be prevented from moving further in the proximal direction by the deflectable arm 83. The deflectable arm 83 can now serve as a locking mechanism to prevent reuse of the device 80 or accidental needle puncture, because the needle cap 84 can extend further distally compared to its initial position covering the needle 96. At this final post-injection position of the device 80, the needle cap 84 can extend distally in the locked position, and the needle cap 84 can abut against the flange 98 at the contact point F, thereby preventing further movement of the needle cap 84 in the proximal direction. The proximal end 86 of the needle cap 84 can also abut against the distal end of the deflectable arm 83, thus preventing further proximal movement of the needle cap 84 and the proximal end 86.

[0110] In some instances, the pin cap 84 may include a slot 75 ( Figure 6A The slot 75 of the needle cap 84 is configured to receive a portion of the housing 74. In some embodiments, the slot 75 of the needle cap 84 may be configured to slidably receive a flange 98. For example, the flange 98 may move within the slot 75 as the needle cap 84 moves. The flange 98 may move within the slot 75 in a distal and / or proximal direction. As described above, in the post-injection position of the device 80, the proximal end 86 may be held between the flange 98 of the housing 74 and the deflectable arm 83, wherein the flange 98 may be within the slot 75. Figure 6A As shown, the needle cap 84 may include a complementary number of slots aligned with the flange 98 of the housing 74. In some embodiments, the housing 74 may include a single flange, and the needle cap 84 may include a single slot aligned with that flange. In some embodiments, the housing 74 may include two flanges, and the needle cap 84 may include two slots, each slot aligned with one flange, and so on. The slot 75 may extend through the needle cap 84. In other embodiments, the slot 75 may be a notch or groove that may not extend completely through the needle cap 84.

[0111] Figures 6A to 7F The implementation scheme describes a device with a passive safety mechanism that can be activated when the user is nearing the end of the administration, for example when a large amount of product has been completely discharged from container 92. Figures 6A to 7F Passive safety mechanisms can also prevent premature locking. For example, some conventional drug delivery devices may automatically lock once the device is removed from the injection site, even if the product has not been completely expelled. (Reference) Figures 7D to 7FOnly when the plunger rod 76 is fully depressed into the housing 74 can the proximal end 86 of the needle cap 84 allow the deflectable arm 83 to flex into the second recess 79, enabling the needle cap 84 to move distally past the deflectable arm 83 and then abut against the flange 98 at the contact point F. Once the plunger rod 76 is fully depressed, the complete dose of product in the container 92 can be expelled. If the device 80 can be removed from the injection site during injection (e.g., before the plunger rod 76 is fully depressed into the housing 74), the needle cap 84 can be left unlocked, and the device 80 can be returned to the injection site to continue injection.

[0112] Additionally, because a portion of the needle 96 is within the needle cap 84, the user can only see a portion of the needle 96 at any point before and / or during injection. Since the needle cap 84 extends from the proximal end of the housing 74 to cover the needle 96 after injection, the user may not see any part of the needle 96 at the end of administration. Therefore, the needle cap 84 can reduce needle phobia and needle-related anxiety compared to conventional drug delivery devices with exposed needles. Furthermore, exposing only a portion of the needle 96 allows the use of the device 80 without any pre-injection steps, such as pinching the skin to change the injection depth to compensate for the longer needle length compared to the exposed needle 96 of the device 80. Figure 6B The device 80 may be configured such that, for example, the container 92 can be positioned within the housing 74 and / or the size of the needle cap 84 may be designed such that the needle cap 84 exposes only a portion of the needle 96, and the length of the exposed portion of the needle 96 represents the desired insertion depth of the needle 96.

[0113] refer to Figure 7C The safety mechanism also prevents premature product ejection. As described above, the force applied to the plunger rod 76 by the deflectable arm 83 and the proximal end 86 of the needle cap 84 prevents the plunger rod 76 from moving until an initial “break-off” force (e.g., greater than the normal injection force) is generated to overcome the force between the deflectable arm 83, the proximal end 86, and the plunger rod 76. The “break-off” force can be adjusted according to the needs of a particular drug product, where the “break-off” force can be high enough to prevent premature ejection of the drug product, but low enough that the user may not find it difficult to initiate the injection.

[0114] In some embodiments, device 80 may include a feedback mechanism. Device 80 may include a visual feedback mechanism, for example, where plunger rod 76 is fully pressed into housing 74. Figure 7BThe needle cap 84 extends fully distally into the housing 74, covering the needle 96. In some instances, the device 80 may include an opening for observing the movement of the container 92 and the plunger rod 76 and stop 90 within the container 92. The device 80 may also include an audible feedback mechanism, such as an audible "click" sound once the proximal end of the plunger rod 76 abuts against the housing 74, or once the needle cap 84 is pushed distally from the housing 74. In some aspects, the device 80 may include tactile feedback, such as a snapping or vibration as the needle cap 84 moves distally and abuts against the flange 98 at the end of the injection.

[0115] Figures 14A to 14C Another embodiment of this disclosure is described, similar to the above reference. Figures 3A to 7F Those described. Where appropriate, features will be designated using reference numerals similar to those discussed above. Corresponding to Figures 3A to 7F Any feature and component in the structure can be understood as being constructed similarly. Figure 14A An external perspective view of the device 140 is shown. Figure 14B An external front view of the device 140 is shown, and Figure 14C An external side view of device 140 is shown. Device 140 may include a plunger rod 56, a housing 54, and a needle cap 232. Housing 54 may include a finger-operated flange 142 and a rear cap 144. The finger-operated flange 142 may have any suitable size and / or configuration that allows for proper use. For example, a user may operate device 140 using both hands. One hand may hold device 140 while the other hand pushes the plunger rod 56 toward the finger-operated flange 142 in a distal direction. Figures 14A to 14C As shown, the rear cap 144 may include a collar 146. The collar 146 may extend in a proximal direction away from the fingertip flange 142. The collar 146 may have any suitable size and / or configuration to surround a portion of the plunger rod 56. In some embodiments, the collar 146 may have a generally circular shape.

[0116] Figures 15A to 15D A cross-sectional view of the interior of device 140 is depicted. Figure 15A and Figure 15B A cross-sectional view depicting one-quarter of the device 140 is shown. (Reference) Figure 15A The device 140 may include a needle cap 64, a syringe 52, a spring guard 53, a needle cap 232, and a needle guard 94. This document will, for example, discuss... Figure 22A and Figure 22B The configuration of needle cap 232 and needle guard 94 is discussed in detail. (Reference) Figure 15BThe device 50 may include various features to engage the fingertip flange 142 and the rear cap 144. For example, the fingertip flange 142 may include a snap-fit ​​155, and the rear cap 144 may include an insert 156. The snap-fit ​​155 and the insert 156 may engage (e.g., snap together) to engage the rear cap 144 to the fingertip flange 142. The rear cap 144 may also include a rear cap hook 149 for abutting against the flange portion 158 of the housing 54.

[0117] refer to Figures 15B to 15D The device 50 is shown in a pre-injection state. The rear cap 144 may include a blocking member 62. The plunger rod 56 may include a notch 170 and may be slidably coupled to the blocking member 62, allowing the plunger rod 56 to slide in both distal and proximal directions. The blocking member 62 may include a deflectable arm 63 extending in the distal direction. Figure 15B As shown, the blocking member 62 may include more than one deflectable arm 63. For example, the blocking member 62 may include two, three, four or more deflectable arms 63. In a configuration with more than one deflectable arm 63, the deflectable arms 63 may be equidistant from each other. For example, if the blocking member 62 includes four deflectable arms 63, each of the deflectable arms 63 may be approximately 90 degrees to each other.

[0118] In the pre-injection state, one or more of the deflectable arms 63 can abut a portion of the plunger rod 56. For example, one or more of the deflectable arms 63 can abut a notch 170 of the plunger rod 56. Figure 15B The needle cap 64 may include an opening 172 for receiving a portion of one or more of the deflectable arms 63. In the pre-injection state, the first deflectable arm 63a may abut against the plunger rod 56, such that a portion of the first deflectable arm 63a can be fitted into the opening 172. Figure 15C The second deflectable arm 63 can abut against the notch 170. Figure 15D In this initial position, before use, significant movement of the plunger rod 56 in the proximal or distal direction can be prevented. For example, if the plunger rod 56 is pushed into the housing 54 in the distal direction, the first deflectable arm 63a is prevented from deflecting outward by the distal end of the needle cap 64, thereby locking the deflectable arm 63 within the opening 172 and preventing further movement of the plunger rod 56. If the plunger rod 56 is pulled in the proximal direction away from the housing 54, the second deflectable arm 63b is prevented from deflecting outward when it abuts against the recess 170.

[0119] To initiate injection, the device 140 can be pressed against the injection site to depress the needle cap 64. When the plunger rod 56 is pressed into the housing 54 in the distal direction, the plunger rod 56 can deflect the second deflectable arm 63b of the blocking member 62, thereby allowing the plunger rod 56 to move distally into the syringe 52, enabling injection. Once injection is complete, the device 140 can be removed from the injection site, and the needle cap 64 can be automatically pulled distally to cover the needle 70. Figure 16B In some instances, the spring guard 53 can pull the needle cap 64 distally. During injection, as the plunger rod 56 moves distally into the housing 54, the first deflectable arm 63a can deflect inward toward the plunger rod 56, thereby allowing the first deflectable arm 63a to disengage from the opening 172. (See reference) Figure 16A At the end of the injection, once the first deflectable arm 63a is proximal to the needle cap 64, it can return to its undeflected position and prevent the needle cap 64 from moving proximally. The first deflectable arm 63a can now function as a locking mechanism to prevent reuse of the device 140 or accidental needle puncture, as the needle cap 64 can no longer move distally to expose the needle 70. In this final post-injection position of the device 140, the needle cap 64 can be in a locked position, and the proximal end of the needle cap 64 and the first deflectable arm 63a can abut against each other. At this stage, the device 140 can be deprecated.

[0120] Figures 33A to 33B Another embodiment of this disclosure is described, similar to the above reference. Figures 14A to 16B Those described. Where appropriate, features will be designated using reference numerals similar to those discussed above. Corresponding to Figures 14A to 16B Any feature and component in the structure can be understood as being constructed similarly. Figure 33A An external perspective view of the device 140 is shown. Figure 33B An external front view of the device 140 is shown, and Figure 34 A perspective view of the exterior of the device 140 without the needle cap 232 is shown. The device 140 may include a plunger rod 56, a housing 54, and a needle cap 232. The housing 54 may include a finger-operated flange 142 and a rear cap 144. The rear cap 144 may also be referred to herein as a blocking member. The finger-operated flange 142 may have any suitable size and / or configuration that allows for proper use. The user may operate the device 140 using one or both hands. For example, the user may hold the device 140 with one hand while the user's other hand pushes the plunger rod 56 toward the finger-operated flange 142 in a distal direction. In other instances, the user may hold the device 140 with one hand and push the plunger rod 56 toward the finger-operated flange 142 in a distal direction. Figures 33A to 33BAs shown, the rear cap 144 may include a collar 146. The collar 146 may extend in a proximal direction away from the fingertip flange 142. The collar 146 may have any suitable size and / or configuration to surround a portion of the plunger rod 56. In some embodiments, the collar 146 may have a generally circular shape.

[0121] Figure 35A A front sectional view of the interior of device 140 is depicted, and Figure 35B A side sectional view of the interior of device 140 is depicted. (Reference) Figure 35A The device 140 may include a plunger rod 56, a housing 54, a needle cap 64, and a syringe 52. (Still referring to...) Figure 35A The device 140 may include various features to connect the fingertip flange 142 and the rear cap 144 together. The rear cap 144 may also include a plurality of deflectable arms 63a to 63b. (See reference) Figures 35A to 35B The rear cap 144 may include a first plurality of deflectable arms 63a and a second plurality of deflectable arms 63b. Such features will be discussed below regarding… Figures 36A to 38B Let's discuss this in detail. For example... Figures 35A to 35B As shown, the rear cap 144 may include a rear cap hook 149 for abutting against the flange portion 158 of the housing 54. In some embodiments, the rear cap 144 may include a plurality of rear cap hooks 149 for abutting against a plurality of flange portions 158 of the housing 54. For example, the rear cap 144 may include at least two rear cap hooks 149, at least three rear cap hooks 149, or at least four rear cap hooks 149. Figure 35B As shown, the housing 54 may include at least one flange portion 158, at least two flange portions 158, at least three flange portions 158, or at least four flange portions 158. In some embodiments, the plunger rod 56 may include a first portion 57a, a second portion 57b, and a third portion 57c. The first portion 57a ​​may have a first diameter, the second portion 57b may have a second diameter, and the third portion 57c may have a third diameter. In some embodiments, the first diameter and the third diameter may each be larger than the second diameter. In some embodiments, the third diameter of the third portion 57c may be larger than the first diameter of the first portion 57a. The second portion 57b may also be referred to herein as a recessed portion.

[0122] Figures 36A to 36F The device 140 is depicted in various states of use. (Reference) Figures 36A to 36B The device 140 is shown in a pre-injection state, such as the "ready to administer" stage. The spring shield 53 may be in a compression stage, wherein the spring shield 53 pushes the needle cap 64 in a distal direction, as... Figure 36C and Figure 36D The downward-pointing arrow indicates this. In some instances, the plunger rod 56 may include at least one notch 170. (See reference) Figure 36BThe notch 170 may have any suitable shape and / or configuration for receiving at least one of the second pair of deflectable arms 63b. For example, each notch 170 may have a wall that slopes radially inward in the distal direction and a wall facing proximal. In some embodiments, the plunger rod 56 may have a single notch 170 extending circumferentially around the plunger rod 56. In some instances, each arm of the second pair of deflectable arms 63b may abut against a corresponding notch 170 of the plunger rod 56. Still referring to Figure 36B Each of the second pair of deflectable arms 63b may include a radially inwardly extending ramp corresponding to the notch 170.

[0123] In some instances, the needle cap 64 may include at least one opening 172 for receiving a portion of one or more of the first pair of deflectable arms 63a. The opening 172 may extend through the outer wall of the needle cap 64. Figure 36A As shown, opening 172 may be located at the proximal portion of needle cap 64. In some embodiments, a portion of at least one of the first pair of deflectable arms 63a may be fitted into opening 172. Figure 36A In other instances, a portion of each of the first pair of deflectable arms 63a may be received into the corresponding opening 172. (e.g.) Figure 36B As shown, at least one of the second pair of deflectable arms 63b abuts against a portion of the plunger rod 56. In this pre-injection state, significant movement of the plunger rod 56 in the proximal or distal direction can be prevented or otherwise inhibited prior to use, and thus accidental initiation of drug administration and / or expulsion of the drug is prevented. For example, if the plunger rod 56 is pushed into the housing 54 distally with a force lower than the typical release force, the second pair of deflectable arms 63b may not bend, thereby preventing further movement of the plunger rod 56. Figure 36A If the plunger rod 56 is pulled in a proximal direction away from the housing 54, outward deflection of the second pair of deflectable arms 63b can be prevented because each of the second pair of deflectable arms 63b abuts against its corresponding notch 170. Figure 36B ).

[0124] To initiate the injection, remove the needle cap 232 from the device 140. Removing the needle cap 232 from the device 140 also removes the needle shield 430. The following will discuss... Figures 40A to 41BThe needle cap 232 and needle shield 430 are discussed in further detail. After removing the needle cap 232 and / or needle shield 430 from the device 140, the device 140 can be placed and / or pressed against the injection site. Pressing the device 140 against the injection site can depress the needle cap 64 in the proximal direction. In some instances, once the needle cap 232 and / or needle shield 430 are removed from the device 140, the distal end portion of the needle 70 can protrude from the distal end of the needle cap 64. In such instances, pressing the device 140 against the injection site can depress the needle cap 64 to a minimum in the proximal direction because the distal end portion of the needle 70 has already protruded from the distal end of the needle cap 64. In some instances, once the needle cap 232 and / or needle shield 430 are removed from the device 140, the needle 70 can be completely contained within the needle cap 64. In such instances, pressing the device 140 against the injection site can press down the needle cap 64 in the proximal direction to expose the distal end of the needle 70. The plunger rod 56 can then be pressed distally into the housing 54. As the plunger rod 56 is pressed distally into the housing 54, due to the increased diameter of the plunger rod 56, for example at the location where the third portion 57c of the plunger rod 56 interacts with the second pair of deflectable arms 63b, the plunger rod 56 can deflect the second pair of deflectable arms 63b away from the corresponding notch 170 of the plunger rod 56. This movement of the plunger rod 56 will initiate the injection (…). Figure 36C As the plunger rod 56 continues to move in the distal direction, it slides past the second pair of deflectable arms 63b. During this phase, the frictional force on the plunger rod 56 against the second pair of deflectable arms 63b can increase due to the radially inward tilt, which may require intentional movement / force from the user to continue the injection. During injection, as the diameter of the plunger rod 56 decreases, for example at the second portion 57b of the plunger rod 56, the first pair of deflectable arms 63a can deflect inward toward the plunger rod 56, thereby allowing each arm of the first pair of deflectable arms 63a to disengage from its corresponding opening 172. Figure 36D Once the injection is complete, the device 140 can be removed from the injection site, and the needle cap 64 can be automatically pulled in the distal direction so that the needle cap 64 covers a portion of the needle 70. Figures 35A to 35B In some instances, the spring guard 53 can pull the needle cap 64 distally, causing the needle cap 64 to cover a portion of the needle 70. In some instances, once injection is complete, the device 140 can be removed from the injection site, and the needle cap 64 can be automatically pulled distally, so that the entire needle 70 is contained within the needle cap 64. Figures 35A to 35B In some instances, the spring guard 53 can pull the needle cap 64 in the distal direction so that the entire needle 70 is contained within the needle cap 64.

[0125] At the end of the injection, such as in the dosing completion or locked state, refer to Figure 36ESince the plunger rod 56 is located distally within the syringe 52, the second pair of deflectable arms 63b can return to an undeflected position, such as a relaxed position, such that the second pair of deflectable arms 63b abuts against the second portion 57b of the plunger rod 56, wherein the diameter of the second portion 57b may be smaller than the diameter of the third portion 57c of the plunger rod 56. In some embodiments, the action of the second pair of deflectable arms 63b abutting against the second portion 57b can produce an audible sound, such as an audible click, which can be used as an end-of-dosing indicator. During this phase, the second pair of deflectable arms 63b may be located proximal to the needle cap 64, such as... Figure 36E As shown, this prevents the needle cap 64 from moving in the proximal direction. In the locked state, as... Figure 36F As shown, the first pair of deflectable arms 63a can be located proximally to the needle cap 64. The first pair of deflectable arms 63a can return to an undeflected (e.g., relaxed) position, thereby preventing the needle cap 64 from moving in the proximal direction. The first pair of deflectable arms 63a can now be used as a locking mechanism to prevent reuse of the device 140 or accidental needle puncture, as the needle cap 64 can no longer move distally to expose the needle 70. In this final post-injection position of the device 140, the needle cap 64 can be in a locked position, and the proximal end of the needle cap 64 and the first pair of deflectable arms 63a can abut against each other. Figure 36F During this phase, device 140 may not be reused. When the first pair of deflectable arms 63a relaxes back to their intermediate position, the first pair of deflectable arms 63a may abut against a portion of housing 54, thereby producing an audible sound, such as a click, which can be used as a dosing end indicator.

[0126] Figures 37A to 37D The details of the back cap 144 are depicted, and Figures 38A to 38B Details of the housing 54 are depicted. The rear cap 144 may include a proximal surface 141, a distal surface 143, a collar 146 surrounding the opening 147, and a plurality of rear cap hooks 149. As described throughout this disclosure, the collar 146 may extend in a proximal direction away from the proximal surface 141. The collar 146 may have any suitable size and / or configuration to surround a portion of the plunger rod 56. In some embodiments, the collar 146 may have a generally circular shape. Figure 37A As shown, the collar 146 may surround the opening 147. The opening 147 may be configured to receive a portion of the plunger rod 56. In some instances, the opening 147 may have a generally circular shape. The plurality of rear cap hooks 149 may be of any suitable size and / or configuration to securely engage and / or permanently attach the rear cap 144 to the housing 54. For example, the plurality of rear cap hooks 149 may be tabs attached to corresponding portions (e.g., recesses 384) of the housing 54. In some instances, the rear cap 144 may include a plurality of protrusions 145a, 145b. Figures 37C to 37DAs shown, a plurality of protrusions 145a, 145b may extend in a distal direction away from the distal surface 143. The plurality of protrusions 145a, 145b may have any suitable size, shape, and / or configuration such that the plurality of protrusions 145a, 145b can be securely joined and / or permanently attached to the housing 54. For example, the first plurality of protrusions 145a may have a generally triangular, rectangular, or cubic shape. The shape of the first plurality of protrusions 145a may correspond to the recess 380 in the housing 54. Figure 38A In other instances, the second plurality of protrusions 145b may be fitted into and / or abut against the corresponding edge 386 of the housing 54. (See reference) Figures 38A to 38B The housing 54 may include a fingertip flange 142 as described in detail throughout this disclosure and an opening 388 configured to receive the syringe 52. The opening 388 may have a generally circular shape. In some embodiments, the housing 54 may include a plurality of ribs 382. Each of the plurality of ribs 382 may have a generally rectangular shape to retain the position of the syringe 52 within the housing 54.

[0127] The first pair of deflectable arms 63a and the second pair of deflectable arms 63b are described in detail above. Figures 37A to 37D Exemplary configurations of a first pair of deflectable arms 63a and a second pair of deflectable arms 63b are depicted. For example, the first arm of the first pair of deflectable arms 63a may be positioned relative to the second arm of the first pair of deflectable arms 63a. Furthermore, the first arm of the second pair of deflectable arms 63b may be positioned relative to the second arm of the second pair of deflectable arms 63b. In embodiments with four deflectable arms, each deflectable arm may be approximately 90 degrees to each other. In some embodiments, the arms of the first pair of deflectable arms 63a may alternate with the arms of the second pair of deflectable arms 63b around the circumference of the opening 147.

[0128] Figures 39A to 39C Details of the needle cap 64 are depicted. The needle cap 64 may include at least one opening 172, as described above regarding Figures 36A to 36D The subject of discussion. For example... Figure 39B As shown, the needle cap 64 may include at least two openings 172. The openings 172 may have any suitable size, shape, and / or configuration for receiving a portion of the first pair of deflectable arms 63a. In some instances, the openings 172 may have a generally rectangular shape, but other suitable shapes are contemplated. In some instances, the needle cap 64 may include a proximal portion 390, an indicator portion 391, a shaft 392, and a neck 394. The diameter of the needle cap 64 may vary at different sections. For example, see reference... Figure 39AThe outer diameter of the proximal portion 390 may be greater than each of the outer diameters of the indicator portion 391, the shaft 392, and the neck 394. In some embodiments, the outer diameter of the indicator portion 391 may be smaller than the outer diameter of the proximal end portion 390, but larger than the outer diameters of the shaft 392 and the neck 394. In other embodiments, the outer diameter of the shaft 392 may be smaller than each of the outer diameters of the proximal portion 390 and the indicator portion 391, but larger than the outer diameter of the neck 394. The inner diameter may also vary in different regions. For example, refer to... Figure 39B The inner diameter of the proximal portion 390 may be larger than each of the outer diameter of the indicator portion 391, the outer diameter of the shaft 392, and the inner diameter of the neck 394. In some embodiments, the inner diameter of the indicator portion 391 may be smaller than the inner diameter of the proximal end portion 390, but larger than the inner diameters of the shaft 392 and the neck 394. In other embodiments, the inner diameter of the shaft 392 may be smaller than each of the inner diameters of the proximal portion 390 and the indicator portion 391, but larger than the inner diameter of the neck 394. Still referring to... Figure 39B The proximal portion 390 may include at least one proximal flange 398. In some instances, the flange 398 may support a portion of the syringe 52, such as the proximal end portion of the syringe 52. In some instances, the distal portion of the shaft 392 may include at least one angled flange 399.

[0129] At the end of administration, the indicator portion 391 can be pushed distally out of the housing 54, making a portion of the indicator portion 391 visible to the user. The indicator portion 391 may include a different color and / or a design visible to the user than other parts of the needle cap 64 and / or the device 140. Such an indicator portion 391 can indicate the end of administration, such as the completion of an injection procedure. The needle cap 64 may also include at least one protrusion 396. Figures 39B to 39C As shown, the needle cap 64 may include at least one protrusion 396 located on the inner surface of the needle cap 64, the length of the protrusion being the same as the length of the needle cap 64 in the extending direction. In some instances, the needle cap 64 may include multiple protrusions 396. For example, the needle cap 64 may include at least one protrusion 396, at least two protrusions 396, at least three protrusions 396, or at least four protrusions 396. The protrusions 396 may have any suitable size, shape, and / or configuration to secure the syringe 52. For example, the protrusions 396 may be circumferentially spaced, wherein each of the protrusions 396 extends in the same orientation. Figure 39C As shown, the needle cap 64 forms a periphery around the inner cavity 374, which is configured to receive the syringe 52.

[0130] Figures 40A to 40C A needle cap 232 is depicted. The needle cap 232 can be attached to the distal end of the device 140. Figures 33A to 33BIn some instances, the cap 232 may include a cap loop 421, a neck 423, and a skirt 422. For example... Figure 40A As shown, the cap skirt 422 may surround the distal end 420 of the needle cap 232. The distal end 420 may include a plurality of openings 424. For example, the distal end 420 may include at least one opening 424, at least two openings 424, at least three openings 424, or at least four openings 424. The openings 424 may serve as anti-clogging holes. In some instances, the openings 424 may be fabricated during manufacturing to produce clips 426a, 426b, 426c, 426d. Figures 40B to 40C A cross-sectional view of the needle cap 232 is depicted, and Figures 41A to 41B A needle cap 232 is depicted attached to the device disclosed herein, wherein the needle cap 232 can be attached to the needle guard 430. Figure 41A A front cross-sectional view of the needle cap 232 is depicted, and Figure 41B A side cross-sectional view of the needle cap 232 is depicted. The needle shield 430 may extend in a distal direction to completely enclose the needle 70 and / or abut a portion of the needle cap 232. In some instances, the needle cap 232 may include a plurality of clips 426a, 426b, 426c, 426d. In some instances, the needle cap 232 may include at least one clip, at least two clips, at least three clips, or at least four clips. Each clip 426a, 426b, 426c, 426d may be shaped and / or configured to attach (e.g., latch to) a corresponding flange 428a, 428b, 428c, 428d of the needle shield 430. For example, clip 426a can be latched onto flange 428a, clip 426b can be latched onto flange 428b, clip 426c can be latched onto flange 428c, and clip 426d can be latched onto flange 428d. Figures 41A to 41B As shown, the needle guard 430 may include multiple arms 432a, 432b, 432c, and 432d. The needle guard 430 may include at least one arm, at least two arms, at least three arms, or at least four arms. In some embodiments, the needle guard 430 may include multiple arms 432a, 432b, 432c, and 432d and a gap 434 between each arm. When the user pulls down the needle cap 232 in a direction distal to the housing 54, the needle guard 430 may also be simultaneously pulled out from the housing 54 to expose the needle 70.

[0131] Figures 42A to 42D Details of the plunger rod 56 are depicted. The plunger rod 56 may include a thumb pad 492 for a user to press the plunger rod 56 in a distal direction. In some embodiments, and as referenced above... Figures 35A to 35B The plunger rod 56 discussed may include a first portion 494a having a first diameter, a second portion 494b having a second diameter, and a third portion 494c having a third diameter. For example... Figure 42A As shown, the first diameter of the first portion 494a and the third diameter of the third portion 494c may each be larger than the second diameter of the second portion 494b. The plunger rod 56 may include a notch 497, which may correspond to the notch referenced above. Figure 36B The notch 170 is described. The plunger rod 56 can have various configurations, for example, such as... Figures 42B to 42D As shown. For example, a portion of the plunger rod 56 may be hollowed out to form a plurality of ribs 495 and / or grooves 496. The plurality of ribs 495 and / or grooves 496 may form a location for placing an ejector pin (498). The placement of the ejector pin 498 may affect the injection force as the plunger rod 56 slides through components of the device discussed herein (e.g., cap 144). To reduce the injection force, the ejector pin 498 may be placed in an area of ​​the device other than the outer surface of the plunger rod 56. For example, the ejector pin 498 may be placed in the inner surface of the plunger rod 56. Figure 42D Another exemplary plunger rod 56 is depicted, which includes a first portion 602a having a first diameter and a second portion 602b having a second diameter. In some instances, the second diameter of the second portion 602b may be larger than the first diameter of the first portion 602a. Figure 42D The plunger rod 56 shown may include multiple ribs 495 and / or grooves 496.

[0132] Figures 14A to 16B and Figures 33A to 42D Implementations of the device 140 and components depicted may include one or more additional features, such as optimal configuration and size of the deflectable arms 63a, 63b; ergonomic design to enable two-handed operation, for example, one hand can hold the syringe at a 90-degree angle for needle insertion while the second hand pushes the plunger rod 56; an indicator of injection completion, such as a visual color change or an audible indicator; activation points to mitigate possible failure modes, such as pre-activation points or states; the plunger rod 56 extending to be located within the piston of the device to improve the alignment of the plunger rod 56 before and / or during use; and optimized design to reduce the required spring force, thereby minimizing plastic creep.

[0133] exist Figures 8A to 10B Another embodiment of this disclosure is shown in the figure. Figure 8A An external view of the device 100 is shown, while Figure 8B A cross-section of the device is shown. Device 100 can be designed to hold any suitable commercially known product container 104 (e.g., a syringe or other suitable drug delivery device). Reference Figure 8B The device 100 may include a housing 106, a needle cap 108, a plunger rod 110, a stop 112, and a rotating component 114, such as a cam.

[0134] Before injection, the needle cap 108 can extend distally from the housing 106 to cover the needle 118. To initiate injection, the device 100 can be pressed against the injection site. The device 100 may include a spring (not shown), for example, around or at the end of the needle cap 108. For the purposes of discussion, Figures 9A to 9D An exemplary actuator, such as spring 124, is schematically shown. Figures 9A to 9D The upper region of each figure depicts a cross-section of the plunger rod 110, the rotating component 114, and the protrusion 116 of the needle cap 108 that interacts with the track 120 of the rotating component 114. Figures 9A to 9D The bottom area of ​​each figure depicts a side view of the protrusion 116 of the needle cap 108 moving along the track 120 of the rotating member 114, which corresponds to the sectional view of the figure.

[0135] like Figures 9A to 9D As shown, the rotating component 114 may include a track 120, such as a groove, for receiving the protrusion 116 of the needle cap 108. In the initial position ( Figure 9A The actuator 124 may be uncompressed, the needle cap 108 may extend distally over the needle 118, and the plunger rod 110 may be locked in place relative to the rotating member 114. This prevents the plunger rod 110 from being pushed distally into the housing 106 until the needle cap 108 is pushed proximally to expose the needle 118. To initiate an injection, the plunger rod 110 may be twisted relative to the rotating member 114, allowing the plunger rod 110 to move from the locked position to the unlocked position. The needle cap 108 may be pushed proximally into the housing 106, for example, by the user pressing the device 100 against the injection site, which may cause the rotating member 114 to rotate and the actuator 124 to compress during injection. Figure 9B The plunger rod 110 can be locked in place, for example, preventing movement of the plunger rod 110 until the needle cap 108 retracts proximally into the housing 106. This configuration prevents premature product ejection. During injection, the needle cap 108 can be held in the retracted position due to the position of the protrusion 116 on the needle cap 108 within the track 120 of the rotating component 114. Figure 9B This can serve as a signal to the user that the device 100 is still in use. In this retracted position, the needle cap 108 also controls the insertion depth of the needle 118, because once the distal end of the needle cap 108 contacts the injection site, the distal end of the needle cap 108 prevents the needle 118 from being inserted further. Once the injection is complete, the plunger rod 110 can rotate the rotating component 114 to release the needle cap 108. Figure 9C Furthermore, actuator 124 can push needle cap 108 downwards back to the locked position, wherein once injection is complete, needle cap 108 extends distally from housing 106. Figure 9D (Use cover needle 118.) Figure 9D As shown, in the locked position, at the end of the injection, the protrusion 116 on the needle cap 108 can engage the notch at the end of the track 120 on the rotating component 114, thereby preventing the needle cap 108 from being pushed into the housing 106 again to prevent reuse of the device 100.

[0136] In some implementations, in the locked position, the pin cap 108 can be pushed further distally than its initial position. For example, Figure 10A The initial position of the needle cap 108 before injection is depicted, and Figure 10B The locked position of the needle cap 108 at the end of drug administration is depicted. Part 122 represents an additional portion of the needle cap 108 that can be exposed at the end of injection but not at the beginning of injection. In some embodiments, the height of the rotating component 114 of the track 120 may be greater at the end position compared to the starting position of the track 120. For example, the starting position of the track 120 (at...) Figures 9A to 9D (The left side of the rotating component 114 is shown) can begin in the central region of the rotating component 114, continue to the upper region of the rotating component 114, and then end at the end of the track 120 (in Figures 9A to 9D The rotating component 114 (shown on the right) can be located in the lower region of the rotating component 114. Therefore, the height of the end of the track 120 can be greater than the height of the initial portion of the track 120. This increased height at the end of the track 120 allows the needle cap 108 to be in its locked position compared to its original position. Figure 10B It extends further.

[0137] Figures 8A to 10B The implementation scheme describes a device with a passive safety mechanism that can be activated when the user is nearing the end of the administration, for example when a large amount of product has been completely discharged from container 104. Figures 8A to 10BThe passive safety mechanism allows the plunger rod 110 to rotate the rotating component 114 near the end of administration, which pushes the needle cap 108 proximally into an extended locked position. In the locked position, the needle cap 108 may not retract into the housing 106. In this locked position, and prior to injection, the needle cap 108 can cover the needle 118 to prevent accidental needle pricks after injection. This can also reduce needle phobia and needle-related anxiety compared to conventional drug delivery devices with exposed needles. Furthermore, the needle cap 108 can allow for controlled needle insertion depth. In other words, exposing only a portion of the needle 118 during injection allows the use of the device 100 without any pre-injection steps, such as pinching the skin to change the injection depth to compensate for the longer needle length compared to the exposed needle 118 of the device 100. The device 100 may be configured such that, for example, the container 104 may be positioned within the housing 106 and / or the size of the needle cap 108 may be designed such that the needle cap 108 exposes only a portion of the needle 118, and the length of the exposed portion of the needle 118 represents the desired insertion depth of the needle 118. As discussed above, during injection, the needle cap 108 may be held in a retracted position due to the position of the protrusion 116 on the needle cap 108 in the track 120 of the rotating member 114. Figure 9B This prevents the passive safety mechanism from activating before the administration is completed. Additionally, if the device 100 is accidentally or intentionally removed from the injection site, the passive safety mechanism may not activate because the needle cap 108 remains in the track 120. Injection can be resumed once the device 100 is reapplied to the injection site and the plunger lever 110 can be depressed.

[0138] In some embodiments, device 100 may include a feedback mechanism. Device 100 may include a visual feedback mechanism, such as a plunger rod 110 abutting against housing 106, a needle cap 108 extending fully distally from housing 106, and / or an extension 122 distally to housing 106. Figure 10B In some instances, the needle cap 108 may have, for example, a first color, pattern, or texture, and the extension 122 may have a second color, pattern, or texture to indicate that the device 100 is in the locked position and that the device has been used and the dose has been dispensed. In some instances, the device 100 may include an opening 102 for observing the movement of the container 104 and the plunger rod 110 and / or stop 112 within the container 104. The device 100 may also include an audible feedback mechanism, such as an audible “click” sound once the plunger rod 110 abuts against the housing 106 and / or the needle cap 108 moves distally at the end of administration. In some aspects, the device 100 may include tactile feedback, such as a snapping or vibration when the needle cap 108 moves distally at the end of injection.

[0139] Device 100 may have any suitable size and shape to hold or partially hold container 104, and / or support and hold any components described herein. Any component of device 100 may have a suitable size and / or shape to be configured to mate with other components designed for use. For example, rotating component 114 may have any suitable size and / or shape to be slidably coupled to plunger rod 110. In another example, needle cap 108 and / or protrusion 116 may have any suitable size and / or shape to fit into track 120 of rotating component 114.

[0140] exist Figures 11 to 13B Another embodiment of this disclosure is shown in the figure. Figure 11 An external view of device 200 is shown. Device 200 can be designed to hold any suitable commercial product container 202 (e.g., syringe or other suitable drug delivery device). Reference Figure 11 The device 200 may include a housing 204, a plunger rod 206, a needle cap 208, and a stop 230. The proximal region of the housing 204 may include one or more deflectable housing tabs 212. The housing 204 may also include a housing cap 210 located within the proximal portion of the housing 204. The device 200 may include a locking ring 214 slidably coupled to the proximal end of the container 202. In some embodiments, the housing 204 may include more than one deflectable housing tab 212. For example, the housing 204 may include two, three, four, or more deflectable housing tabs 212. In configurations having more than one deflectable housing tab 212, the deflectable housing tabs 212 may be equidistant from each other. For example, if the housing 204 includes four deflectable housing tabs 212, each of the deflectable housing tabs 212 may be approximately 90 degrees to each other. If the housing 204 includes two deflectable housing tabs 212, each of the deflectable housing tabs 212 can be approximately 180 degrees apart from each other.

[0141] like Figure 11 As shown, the needle cap 208 can extend and cover the needle 220 before use. In the initial position ( Figure 12A At the location, the deflectable housing tab 212 can abut against a portion of the locking ring 214, and the locking ring 214 can be located proximal to the proximal end 216 of the needle cap 208. The needle cap can be biased distally, for example by a spring, but can be pushed proximally back within the housing 204 for use. To initiate injection, the needle cap 208 can be pushed proximally into the housing 204, for example, by pushing the device 200 against the injection site. As the needle cap 208 moves proximally, the proximal end 216 of the needle cap 208 can hook onto the flange 224 of the locking ring 214. Figure 12B ).exist Figures 13A to 13BThe movement of the proximal end 216 of the needle cap 208 relative to the locking ring 214 is shown in more detail. In some instances, the proximal end 216 may include a slit 222 for engaging with a flange 224. In some instances, the needle cap 208 may include more than one slit 222, such as a pair of slits, and the locking ring 214 may include more than one flange 224, such as a pair of flanges. The number of flanges and slits may correspond to each other, such that each flange can engage with each slit. Although the locking ring 214 is depicted as including one or more flanges 224, and the proximal end 216 of the needle cap 208 is depicted as including one or more slits 222, the two mating regions may be reversed; for example, the locking ring 214 may include one or more slits 222, and the needle cap 208 may include one or more flanges 224. Furthermore, the flanges 224 and slits 222 may represent any suitable mating portion.

[0142] In cases where, for example, the needle cap 208 is pushed proximally into the housing 204 by pressing the device 200 against the injection site, the plunger rod 206 can be pushed distally into the housing 204 to discharge the product from the container 202 into the injection site.

[0143] Moving the proximal end 216 of the needle cap 108 into the housing 204 allows the deflectable tab 212 to flex outwards away from the plunger rod 206 during injection, such as... Figure 12B As indicated by the radially outward-pointing arrow. Once the device 200 is removed from the injection site, for example, when the injection is complete, the needle cap 208, together with the locking ring 214, can be biased downward to return to its initial position (e.g., via the spring force of a spring guard (not shown) surrounding the needle cap 208). The needle cap 208 and the locking ring 214, connected to each other via the notch 222 and the flange 224, can move downward past the deflectable tab 212, thereby allowing the deflectable tab 212 to flex back to its initial position. Figure 12C ).like Figure 12C As shown, the proximal end of the locking ring 214 can abut the distal end of the deflectable tab 212. At this final end-of-dose position, the needle cap 208 can be in a locked position, in which the deflectable tab 212 prevents the needle cap 208 from moving proximally back into the housing 204, blocking the path of the needle cap.

[0144] Figures 11 to 13BThe embodiment describes a device with a passive safety mechanism that can be activated at any point when the device 200 is removed from the injection site, regardless of whether a full dose has been dispensed from the container 202. The passive safety mechanism can be activated once the needle cap 208 has been pushed proximally into the housing 204 to initiate injection. Because the needle cap 208 is biased distally, the safety mechanism can be activated once the force that pushed the needle cap 208 into the housing 204 (e.g., by removing the device 200 from the user's skin) is removed. Such a passive safety mechanism can be helpful for users who may be concerned about needle safety. For example, if the user accidentally drops the device 200 during use, the passive safety mechanism can push out the needle cap 208 to prevent accidental needle pricks. Additionally, the needle 220 can be covered by the needle cap 208 and concealed from view before, during, and after injection. This can reduce needle phobia and needle-related anxiety compared to conventional drug delivery devices with exposed needles. Furthermore, the needle cap 108 allows for controlled needle insertion depth. In other words, exposing only a portion of the needle 220 during injection allows the use of device 200 without any pre-injection steps, such as pinching the skin to change the injection depth to compensate for a longer needle length compared to the exposed needle 220 of device 200. Device 200 may be configured such that, for example, container 202 may be positioned within housing 204 and / or the size of needle cap 208 may be designed such that needle cap 208 exposes only a portion of needle 220, and the length of the exposed portion of needle 220 represents the desired insertion depth of needle 220.

[0145] In some embodiments, device 200 may include a feedback mechanism. Device 200 may include a visual feedback mechanism, such as a plunger rod 206 abutting against housing 204 and a needle cap 208 extending fully distally from housing 204. In some instances, device 100 may include openings for observing the movement of container 202 and plunger rod 206 and / or stop 230 within container 202. Device 200 may also include an audible feedback mechanism, such as when plunger rod 206 abuts against housing 204, when needle cap 208 extends distally, and / or when deflectable tab 212 relaxes back to its initial neutral position. Figure 12C An audible "click" sound is emitted when the needle cap 208 moves distally. In some aspects, the device 200 may include tactile feedback, such as a snapping or vibration.

[0146] The device 200 may have any suitable size and shape to retain or partially retain the product container 202, and / or support and retain any components described herein. Any component of the device 200 may have a suitable size and / or shape and be configured to mate with other components designed to do so. For example, the needle cap 208, proximal ends 216, 222, locking ring 214, and flange 224 may have any suitable size and / or shape that allows the cutout 222 to lock onto the flange 224.

[0147] Figure 22A and Figure 22B An embodiment of a needle shield 94 and a needle cap 232 that can be used with any of the devices disclosed herein is depicted. The needle shield 94 may be attached to a needle cap (not shown) and may extend in the distal direction to completely enclose the needle 96. Figure 22A and Figure 22B As shown, the needle guard 94 may extend in a distal direction such that the needle guard 94 may abut a portion of the needle cap 232. The needle cap 232 may include clips 221. In other embodiments, the needle cap 232 may include a plurality of clips 221. The clips 221 may be shaped or configured to attach (e.g., latch to) a flange 223 of the needle guard 94. Figure 22A and 22B The needle cap 232 depicted shows an arm 95 of a needle guard 94. In other embodiments, the needle guard 94 may include a plurality of arms 95 and a gap between each arm 95. In some instances, the needle cap 232 may include at least two clips, at least three clips, or at least four clips. Reference Figure 22B The first clip 221a can be attached to the first flange 223a and abut against the first arm 95 of the needle guard 94. The second clip 221b can be attached to the second flange 223b. When the user pulls down the needle cap 232 in a direction away from the housing 14, the needle guard 94 can also be pulled out from the housing 14 at the same time to expose the needle 86.

[0148] The following will discuss additional concepts and features that may be used with or in any apparatus disclosed herein. These concepts and features may correspond to those discussed throughout this disclosure.

[0149] Figure 23A and Figure 23B A plunger rod 235 is depicted that can be used in any of the embodiments discussed herein. The plunger rod 235 may include a first portion 236 and a second portion 237. For example... Figure 23A As shown, the width of the second part 237 can be smaller than the width of the first part 236. (See reference) Figure 23BAs the plunger rod 235 moves distally toward the housing 238, dispensing agent from the container 12, the second portion 237 can collapse into (e.g., insert into) the first portion 236. In other embodiments, the width of the first portion 236 may be smaller than the width of the second portion 237, such that when the plunger rod 235 moves distally toward the housing 238, the first portion 236 can collapse into the second portion 237. The plunger rod 235 may be referred to as a telescopic plunger rod. Figure 23A and 23B As shown, when the plunger rod 235 collapses, the length of the plunger rod 235 changes from the first length ( Figure 23A It is reduced to the second length (23B).

[0150] Figures 24A to 24C Embodiments of this disclosure are depicted. Device 240 may include a thumb pad 241, a plunger rod 242, a housing 243, a syringe 244, a spring guard 245, a rotator 246, and a needle 249. In the pre-injection state, such as... Figure 24A As depicted, the rotator 246 can be located proximal to the proximal end of the syringe 244. (Reference) Figure 24C The rotator 246 may include an opening 246a shaped and configured to surround a portion of the plunger rod 242. In some instances, the opening 246a may have a circular shape, allowing a portion of the plunger rod 242 to slide through the rotator 246 in a distal direction. The rotator 246 may also include a plurality of slits 246b. The slits 246b may have a shape, size, and configuration corresponding to the proximal end of the syringe 244. For example, the slits 246b may correspond to the flange 247 of the syringe 244. In a pre-injection state, the rotator 246 may be located proximal to the proximal end of the container 12, such that the slits 246b are displaced from the flange 247. A spring shield 245 may surround the proximal end of the syringe 244, such that the syringe 244 may be spring-loaded and held in place by the rotator 246. Figure 24A To initiate injection, the user can press the thumb pad 241 toward the housing 243 in the distal direction. During injection, as the plunger rod 242 moves distally into the housing 243 and syringe 244, the plunger rod 242 can rotate, causing the incision 246b to rotate toward the flange 247. At the end of administration, as... Figure 24B As shown, syringe 244 can move proximally into housing 243 and rotator 246, and needle 249 can be accommodated within the distal end of housing 243. In some embodiments, rotator 246 and syringe 244 may not be coupled together, and can then be moved proximally toward the proximal end of housing 243. Any suitable syringe 244 can be used with device 240. For example, syringe 244 may be a cycloolefin polymer syringe or a glass-cut flange syringe.

[0151] Figure 25 Embodiments of this disclosure are depicted. Device 250 may include a housing 251, a syringe 252, and a thumb pad 253. Device 250 may also include a telescopic plunger rod comprising a first portion 254 and a second portion 255. The telescopic plunger rod may correspond to... Figure 23A and Figure 23B The plunger rod 235 is depicted in the image. (Example) Figure 25 As shown, the first portion 254 may include a plurality of flanges 254a, and the second portion 255 may include a plurality of cutouts 255a. The flanges 254a may fit into the cutouts 255a, thereby connecting the first portion 254 to the second portion 255. At the end of administration, the thumb pad 253 may abut against the flange portion 251b of the housing 251. The housing 251 may include a distal extension 251a. (Reference) Figure 25 At the end of administration, once the thumb pad 253 abuts against the flange portion 251b, the first portion 254 and the second portion 255 may also abut against the distal extension 251a. When the first portion 254 and the second portion 255 abut against the distal extension 251a, the flange 254a may push the distal extension 251a, thereby deflecting the distal extension 251a outward and away from the syringe 252. The spring shield 258 may then pull the syringe 252 and / or the first portion 254 proximally into the thumb pad 253, thereby pulling the needle (not shown) at the distal end of the syringe into the housing 251. In some embodiments, the thumb pad 253 and the housing 251 may include attachment features for locking the thumb pad 253 and the housing 251 together at the end of administration.

[0152] Figure 26A and Figure 26B Embodiments of this disclosure are depicted. Device 260 may include a housing 261, a syringe 262, and a plunger rod 263. Device 260 may also include an inner rod 264 extending through the plunger rod 263. Figure 26A As shown, the inner rod 264 may include a button 264a extending proximally from the thumb pad 263a of the plunger rod 263. In the pre-injection state, the deflectable arm 263b of the plunger rod 263 may abut against the distal portion of the inner rod 264, thereby preventing movement of the plunger rod 263 and thus preventing pre-ejection of the contents of the syringe 262. A spring 269 may be included in the plunger rod 263. To initiate injection, the user may press the button 264a while simultaneously pushing the thumb pad 263a distally toward the housing 261 and against the spring 269. Pressing the button 264a causes the inner rod 264 to move distally toward the housing 261. (Reference) Figure 26BWhen the inner rod 264 moves distally into the housing 261, the deflectable arm 263b can then deflect inward into the recess 264b. Once the deflectable arm 263b is deflected into the recess 264b, the plunger rod 263 can move freely in the distal direction to dispense the contents of the syringe 262.

[0153] Figure 27A and Figure 27B Depicting and Figure 26A and Figure 26B The device 260 is similar to the device 270. Device 270 may include a housing 271, a syringe 272, and a plunger rod 273. Device 270 may also include an inner rod 274. (As...) Figure 27A As shown, the inner rod 274 may include a button 274a extending proximally from the thumb pad 273a of the plunger rod 273. In the pre-injection state, the deflectable arm 273b of the plunger rod 273 may abut against the distal portion of the inner rod 274, thereby preventing movement of the plunger rod 273 and thus preventing pre-ejection of the contents of the syringe 272. A spring 279 may be included in the plunger rod 273. To initiate injection, the user may press the button 274a while simultaneously pushing the thumb pad 273a distally toward the housing 271 and against the spring 279. Pressing the button 274a causes the inner rod 274 to move distally toward the housing 271. (Reference) Figure 27B When the inner rod 274 moves distally into the housing 271, the deflectable arm 273b can then deflect inward into the recess 274b. Once the deflectable arm 273b is deflected into the recess 274b, the plunger rod 273 can move freely in the distal direction to dispense the contents of the syringe 272.

[0154] Figure 28A and Figure 28B Another embodiment according to this disclosure is depicted. Device 280 may include a housing 281, a syringe 282, and a plunger rod 283. (As...) Figure 28A and Figure 28B As shown, housing 281 may include flange 281a. Housing 281 may also include trigger 284. Figure 28A and Figure 28B An internal view of the device 280 is shown. The trigger 284 may extend through an internal portion of the housing 281, such as a flange 281a. (Reference) Figure 28A A portion of the trigger 284 may extend distally from the flange 281a. The flange 281a may include a plurality of slots 284a. The slots 284a allow the trigger 284 to move within the flange 281a. In the pre-injection state, as Figure 28AAs shown, a portion of the trigger 284 abuts against the plunger rod 283, thereby preventing the contents of the syringe 282 from being prematurely ejected. To initiate injection, the user can push the thumb pad 283a distally toward the housing 281 while simultaneously squeezing the portion of the trigger 284 extending distally from the flange 281a. For example, the user can squeeze a portion of the trigger 284 into the flange 281a in the proximal direction. When a portion of the trigger 284 is squeezed, the slot 284a guides the trigger 284 in a direction away from the plunger rod 283, thereby allowing the plunger rod 283 to move distally into the housing 281. Figure 28B ).

[0155] Figure 29A and Figure 29B Another embodiment according to this disclosure is depicted. Device 290 may include a housing 291, a syringe 292, a plunger rod 293, and an inner rod 294. (As...) Figure 29A As shown, device 290 may include a blocking member 300. The blocking member 300 may correspond to blocking members 62 and 82 as described herein. The blocking member 300 may include a deflectable arm 302. The deflectable arm 302 may correspond to deflectable arms 63 and 83 as described herein. The inner rod 294 may include a button 294a extending proximally from the thumb pad 293a of the plunger rod 293. The inner rod 294 may also include a distal end block 294b. In the pre-injection state, as... Figure 29A As shown, the distal block 294b can be positioned above the spring 295 and within the flexible portion 293b of the plunger rod 293. The distal block 294b can abut against the flexible portion 293b, thereby preventing movement of the deflectable arm 302. This pre-injection state prevents contents from being pre-emptively expelled from the syringe 292. To initiate injection, the user can press the button 294a distally into the plunger rod 293. Pressing the button 294a causes the inner rod 294 and the distal block 294b to move distally toward the syringe 292 and against the spring 295. Figure 29B As shown, the distal block 294b can move in a distal direction away from the flexible portion 293b of the plunger rod 293. The deflectable arm 302 can then be deflected inward toward the flexible portion 293b, which then allows the plunger rod 293 to move distally into the housing 291 and the syringe 292 to expel the contents of the syringe 292.

[0156] Figures 30A to 30D Another embodiment according to this disclosure is depicted. Device 400 may include a housing 402, a syringe 404, a plunger rod 406, a finger-access flange 408, and a spring 410 surrounding the proximal portion of the syringe 404. Figure 30AAs shown, the proximal portion of the housing 402 may include a plurality of recesses 403a, 403b, and the fingertip flange 408 may include a plurality of distal arms 409a, 409b. The recesses 403, 403b may be configured to receive the distal arms 409a, 409b. To engage the fingertip flange 408 with the housing 402, a first distal arm 409a may hook into a recess 403a, and a second distal arm 409b may hook into a recess 403b. The syringe 404 may also include a syringe flange 405. Figure 30A As shown, the syringe flange 405 may be located between a portion of the finger-access flange 408 and a portion of the housing 402. For example, the proximal end of the syringe flange 405 may abut against the distal inner surface of the finger-access flange 408, and the distal end of the syringe flange 405 may abut against the proximal end of the housing 402. (Refer to...) Figure 30A and Figure 30C The plunger rod 406 may include a first portion 407a and a second portion 407b. The first portion 407a may have a first diameter, and the second portion 407b may have a second diameter. The first diameter may be larger than the second diameter. In other embodiments, the first diameter may be smaller than the second diameter. In some embodiments, the plunger rod may have a first width and a second width, wherein the first width may be larger than the second width. In other embodiments, the first width may be smaller than the second width. Figure 30C As shown, the plunger rod 406 may include a third portion 407c, wherein the diameter of the third portion 407c is larger than the diameter of the second portion 407b. The finger-operated flange 408 may be any suitable size, shape, and / or configuration to surround a portion of the plunger rod 406.

[0157] refer to Figure 30B The fingertip flange 408 may include a first component 412a and a second component 412b. The first component 412a may include a first hook 414a, and the second component 412b may include a second hook 414b. Figure 30B As shown, the first hook 414a and the second hook 414b can abut and / or surround a portion of the plunger rod 406. In the pre-injection state, as... Figure 30A and Figure 30B As shown, the fingertip flange 408 may surround the first portion 407a of the plunger rod 406. The fingertip flange 408 may also include a spring (not shown) configured to separate the first component 412a and the second component 412b. Figure 30BMovement of the fingertip flange 408 can be prevented by a spring and engagement of the first hook 414a and the second hook 414b with the first portion 407a of the plunger rod 406. To initiate injection, the user can press the thumb pad (not shown) of the plunger rod 406 toward the housing 402 in a distal direction. During injection, the plunger rod 406 may be positioned within the housing 402 such that the second portion 407b of the plunger rod 406 is received within the fingertip flange 408. In embodiments where the diameter of the second portion 407b is smaller than the diameter of the first portion 407a, the hooks 414a, 414b may no longer abut against a portion of the plunger rod 406. For example, as Figure 30D As shown, a space may exist between the finger-shaped flange 408 and the plunger rod 406, allowing the plunger rod 406 to move distally into the housing 402 and the syringe 404 to expel the contents from the syringe 404. At the end of administration, as... Figure 30A As shown, the user can keep the thumb pad pressed down, allowing a portion of the plunger rod 406 to retract backward, for example, proximally away from the housing 402. The spring 410 can then be released, allowing the syringe 404 to move proximally toward the distal surface of the finger-touch flange 408.

[0158] Figure 31 and Figures 32A to 32F Another embodiment according to this disclosure is described. Regarding Figure 31 and Figures 32a to Figure 32F The features and institutions discussed can be utilized and are consistent with those described above and Figure 30A The feature combination of the device 400 shown in Figure 3D. Figure 31 , Figure 32A , Figure 32B , Figure 32E and Figure 32F A top view of device 500 is depicted. Device 500 may include a housing (not shown), a fingertip flange 503, a thumb pad 504, and a slider 506. The thumb pad 504 may include a plurality of clips 508a, 508b. The slider 506 may include an opening 510 for receiving a plunger rod (not shown). The clips 508a, 508b may engage the thumb pad 504 and the plunger rod in the opening 510. The plunger rod used in device 500 and having the characteristics of device 500 discussed herein may include various geometric features, such as... Figure 19B The recessed portion shown. (Reference) Figure 31 , Figure 32A , Figure 32B , Figure 32E and Figure 32F To initiate the injection, the user can press the plunger rod in the distal direction. During injection, when the geometry of the plunger rod changes, for example in its diameter and / or width, as mentioned above... Figures 30A to 30DAs described in device 400, a spring can, for example, push a slider 506 in a rightward direction. When the slider 506 shifts, the ramps 512a and 512b of the slider 506 can press against clips 508a and 508b. The width of the ramps 512a and 512b can be greater than the portion of the slider 506 initially located between the clips 508a and 508b. The ramps 512a and 512b can press against the clips 508a and 508b, causing the clips 508a and 508b to deflect in an outward direction. This unlocks the thumb pad 504 from the plunger rod, while allowing the syringe (not shown) to move in a proximal direction and deflecting the clips 508a and 508b outward to lock them into the housing, locking them into the locked position. Figure 31 This is a top view of device 500 at the end of drug administration. Figures 32A to 32D A slider 506 including a recess 520 is depicted. The recess 520 may be formed as a C-shaped block, for example, having a C-shape. The recess 520 may interact with portions of the housing to prevent movement of the slider and / or the syringe in the proximal direction. These features eliminate the need for the user to apply additional force at the end of injection to activate a safety mechanism for locking the syringe. A spring 514 may be located on the side of the slider 506 including ramps 512a, 512b. The spring 514 may release its stored energy to push the syringe in the proximal direction while disengaging the thumb pad 504 and the plunger rod from each other.

[0159] Figures 43A to 43B Another embodiment of this disclosure is described, similar to the above reference. Figures 33A to 35B Those described. Where appropriate, features will be designated using reference numerals similar to those discussed above. Corresponding to Figures 33A to 35B Any feature and component in the structure can be understood as being constructed similarly. Figure 43A A perspective view of the exterior of device 150 is shown, and Figure 43B A perspective view of the exterior of the device 150 without the needle cap 232 is provided. The device 150 may include a plunger rod 56, a housing 54, and the needle cap 232, among other components. The housing 54 may include a finger-operated flange 142 and a rear cap 144. The rear cap 144 may also be referred to herein as a blocking member. The finger-operated flange 142 may have any suitable size and / or configuration that allows for proper use. The user may operate the device 150 with one or two hands. For example, the user may hold the device 150 with one hand while pushing the plunger rod 56 distally toward the finger-operated flange 142 with the other hand. In other instances, the user may hold the device 150 with one hand and push the plunger rod 56 distally toward the finger-operated flange 142. Figure 43AAs shown, the rear cap 144 may include a collar 146. The collar 146 may extend in a proximal direction away from the fingertip flange 142 and contact the proximal surface of the thumb pad 492 upon completion of the injection dose. The collar 146 may have any suitable size and / or configuration to surround a portion of the plunger rod 56. In some embodiments, the collar 146 may have a generally circular shape.

[0160] Figures 44A to 44C The needle cap 232 is depicted, similar to the reference above. Figures 40A to 40C The described implementation scheme. The needle cap 232 can be attached to the distal end of the device 150, such as... Figure 43A As shown in the diagram. In some instances, the cap 232 may include a neck 423 and a skirt 422. For example... Figure 43A and Figure 44C As shown, the cap skirt 422 may surround the distal end 420 of the needle cap 232. The distal end 420 may include a plurality of openings 424. For example, the distal end 420 may include at least one opening 424, at least two openings 424, at least three openings 424, at least four openings 424, or more than four openings 424. The openings 424 may serve as anti-clogging holes. In some instances, during manufacturing, when four openings 424 are present, the openings 424 may be manufactured to produce clips 426a, 426b, 426c, 426d (not shown). In some instances, the needle cap 232 may include a plurality of clips 426a, 426b, 426c, 426d. In some instances, the needle cap 232 may include at least one clip, at least two clips, at least three clips, or at least four clips. Each clip 426a, 426b, 426c, 426d may be shaped and / or configured to attach (e.g., latch to) to the corresponding flange 428a, 428b, 428c, 428d of the needle guard 430, such as Figures 41A to 41B As shown. For example, clip 426a can latch onto flange 428a, clip 426b can latch onto flange 428b, clip 426c can latch onto flange 428c, and clip 426d can latch onto flange 428d. In some instances, needle cap 232 may include two, three, four, or more ridges 427. Ribs 427 may be configured to restrict the movement of the restraining device 150 proximally within needle cap 232. Ribs 427 may be deflectable and / or deformable. Ribs 427 may be rigid.

[0161] Figures 45A to 45C The needle cap 232 is depicted, similar to the reference above. Figures 40A to 40C and Figures 44A to 44C The described needle cap 232. The needle cap 232 can be attached to the distal end of the device 150. In some embodiments, the needle cap 232 may include a cap loop 421, a neck 423, and a skirt 422. For example... Figure 43A and Figure 44C As shown, the skirt portion 422 may surround the distal end 420 of the needle cap 232. In some embodiments, the needle cap 232 may include a plurality of clips 426a, 426b. In some embodiments, the needle cap 232 may include at least one clip or at least two clips. Each clip 426a, 426b may be shaped and / or configured to attach (e.g., latch to) a corresponding flange 428a, 428b of the needle guard 430, such as Figures 41A to 41B As shown. For example, clip 426a can be latched onto flange 428a, and clip 426b can be latched onto flange 428b, as shown. Figures 41A to 41B As shown.

[0162] Figure 46 A perspective view of the exterior of the device 150 without the needle cap 232 is shown, similar to that referenced above. Figure 34 The described embodiment. Device 150 may include a plunger rod 56, a housing 54, a needle cap 64, and a needle nut 232. Housing 54 may include a fingertip flange 142 having a recess 384. The fingertip flange 142 may have any suitable size and / or configuration that allows for proper use. The plunger rod 56 may include a thumb pad 492 for the user to press the plunger rod 56 in a distal direction. The user may operate device 150 with one or two hands. For example, the user may hold device 150 with one hand while the user's other hand pushes the thumb pad 492 of the plunger rod 56 toward the fingertip flange 142 in a distal direction. In other instances, the user may hold device 150 with one hand and push the plunger rod 56 toward the fingertip flange 142 in a distal direction. In some embodiments, and as referenced above. Figures 42A to 42D The plunger rod 56 discussed may include a first portion 494a having a first diameter, a second portion 494b having a second diameter, and a third portion 494c having a third diameter. The first diameter of the first portion 494a and the third diameter of the third portion 494c may each be larger than the second diameter of the second portion 494b. Portions of the plunger rod 56 may be hollowed out to form a plurality of ribs 495 and / or grooves 496. The needle cap 232 may cover the needle 70, as... Figure 43B As shown, it may include a cap loop 421, a cap neck 423, and a cap skirt 422. The needle cap 323 may include at least one clip 426a, which may be shaped and / or configured to attach (e.g., latch to) a corresponding flange 428a of the needle guard 430, as shown. Figures 41A to 41B As shown.

[0163] Figure 47Details of the housing 54 are depicted. The housing 54 may include a fingertip flange 142, as described in detail throughout this disclosure. In some instances, the housing 54 may include a plurality of ribs 382. Each of the plurality of ribs 382 may each have any suitable size, shape, and / or configuration to hold the syringe 52 in position within the housing 54. For example, each of the plurality of ribs 382 may have a generally rectangular shape to hold the syringe 52 in position within the housing 54. Each of the plurality of ribs 382 may have a generally trapezoidal shape to guide into and hold the syringe 52 in position within the housing. The housing 54 may include a plurality of flange portions 158 configured to receive a rear cap hook 149, such as... Figures 57A to 57B As shown, the flange portion 158 and the edge 386 may each have any suitable size, shape and / or configuration, such that the rear cap hook 149 can be securely attached and / or permanently attached to the housing 54.

[0164] Figures 48A to 48B Details of the needle cap 64 are depicted. The needle cap 64 may include at least one opening 172, as described above regarding Figures 36A to 36D The subject of discussion. For example... Figure 48A As shown, the needle cap 64 may include at least two openings 172. The openings 172 may have any suitable size, shape, and / or configuration for receiving a portion of the first pair of deflectable arms 63a of the blocking member 62, such as... Figures 15B to 15B As shown. In some instances, the opening 172 may have a generally rectangular shape, but other suitable shapes are conceivable. In some instances, the needle cap 64 may include a proximal portion 390, a shaft 392, and a neck 394. The diameter of the needle cap 64 may vary in different sections. For example, see reference... Figure 48A The outer diameter of the proximal portion 390 may be greater than each of the outer diameters of the shaft 392 and / or the neck 394. In some instances, the outer diameter of the shaft 392 may be smaller than the outer diameter of the proximal portion 390, but larger than the outer diameter of the neck 394. The inner diameter may also vary in different regions. As mentioned above regarding... Figures 39B to 39C As described, the needle cap 64 may also include at least one protrusion 396. (As...) Figure 48B As shown, the needle cap 64 may include at least one protrusion 396 located on the inner surface of the needle cap 64, the length of the protrusion being the same as the length of the needle cap 64 in the extending direction. In some instances, the needle cap 64 may include multiple protrusions 396. For example, the needle cap 64 may include at least one protrusion 396, at least two protrusions 396, at least three protrusions 396, or at least four protrusions 396. The protrusions 396 may have any suitable size, shape, and / or configuration to secure the syringe 52. For example, the protrusions 396 may be circumferentially spaced, wherein each of the protrusions 396 extends in the same orientation. Figure 48BAs shown, the needle cap 64 forms a periphery around the inner cavity 374, which is configured to receive the syringe 52.

[0165] Figures 49 to 52B Alternative implementations of the plunger rod 56 are described. (See above reference.) Figure 36A As shown, the plunger rod 56 may include a thumb pad 492 for a user to press the plunger rod 56 in a distal direction. In some embodiments, and as referenced above... Figures 35A to 35B and Figure 46 The plunger rod 56 discussed may include a first portion 494a having a first diameter, a second portion 494b having a second diameter, and a third portion 494c having a third diameter. The first diameter of the first portion 494a and the third diameter of the third portion 494c may each be larger than the second diameter of the second portion 494b. The plunger rod 56 may include a notch 497, which may correspond to the notch referenced above. Figure 36B The notch 170 is described. The plunger rod 56 can have various configurations, for example, such as... Figures 49 to 52B As shown. For example, a portion of the plunger rod 56 can be hollowed out to form multiple ribs 495 and / or grooves 496. (See diagram) Figure 52A and Figure 52B As shown, the multiple ribs 495 and / or grooves 496 can be symmetrical or asymmetrical. For example... Figures 51 to 52B As shown, a plurality of ribs 495 may extend longitudinally along the length of the plunger rod 56 and / or laterally along the width of the plunger rod 56. In some embodiments, the plurality of ribs 495 may extend longitudinally along the length of a third portion 494c of the plunger rod 56. The plurality of ribs 495 and / or grooves 496 may form a location for placing an ejector pin 498. The placement of the ejector pin 498 may affect the injection force as the plunger rod 56 slides through components of the device discussed herein (e.g., cap 144). To reduce the injection force, the ejector pin 498 may be placed in an area of ​​the device other than the outer surface of the plunger rod 56. For example, the ejector pin 498 may be placed in the inner surface of the plunger rod 56. The grooves 496 may have any suitable size, shape, and / or configuration to correspond to the plurality of ribs 382, ​​thereby holding the syringe 52 in position within the housing 54. The distal end of the plunger rod 56 may also include a spike 499. The spike 499 may have any suitable size, shape and / or configuration to be advanced within the pin cap 64.

[0166] Figures 53A to 53C Alternative implementations of the plunger rod 56 are described. For example... Figure 53A As shown, multiple ribs 495 may extend longitudinally along the length of the plunger rod 56 and / or laterally along the width of the plunger rod 56. Figures 53B to 53C As shown, the plunger rod 56 may include a notch 497, which may correspond to the notch mentioned above. Figure 36BThe notch 170 is described and can be slidably connected to the blocking member 62, so that the plunger rod 56 can slide in the distal and proximal directions. Figure 54A A cross-sectional view depicting a quarter portion of the interior of device 150 is shown. Device 150 may include a needle cap 64, a plunger rod 56, a fingertip flange 142, and a rear cap 144. Device 150 may include various features to engage the fingertip flange 142 and the rear cap 144 together. For example, the fingertip flange 142 may include a snap 155, and the rear cap 144 may include an insert 156. The snap 155 and the insert 156 may engage (e.g., snap together) to engage the rear cap 144 to the fingertip flange 142. The rear cap 144 may also include a ridge 148. The ridge 148 may extend from the underside of the rear cap 144 to prevent the rear cap 144 from deflecting when the plunger rod 56 is used. The plunger rod 56 may include a notch 497, which may correspond to the reference above. Figure 15B The notch 170 is described and can be slidably coupled to the blocking member 62, allowing the plunger rod 56 to slide in both distal and proximal directions. The blocking member 62 may include a deflectable arm 63 extending in the distal direction. The blocking member 62 may include more than one deflectable arm 63. For example, the blocking member 62 may include two, three, four, or more deflectable arms 63. In configurations with more than one deflectable arm 63, the deflectable arms 63 may be equidistant from each other. For example, if the blocking member 62 includes four deflectable arms 63, each of the deflectable arms 63 may be approximately 90 degrees to each other. The notch 497 may be configured to receive the deflectable arms 63.

[0167] Figure 54B Alternative embodiments of the posterior cap 144 are depicted. The posterior cap 144 may include a collar 146. The collar 146 may extend proximally from 144 in a proximal direction and contact the proximal surface of the thumb pad 492 upon completion of injection administration. In some instances, the posterior cap 144 may include a plurality of protrusions 145a, 145b that may extend distally from the distal surface 143. The plurality of protrusions 145a, 145b may have any suitable size, shape, and / or configuration such that the plurality of protrusions 145a, 145b can be securely coupled and / or permanently attached to the housing 54. The posterior cap 144 may include a plurality of recesses 384 corresponding to the needle cap 64.

[0168] Figures 55A to 55B The details of the outer casing 54 are depicted, as described above regarding... Figure 47As described herein, housing 54 may include a fingertip flange 142 as described in detail throughout this disclosure and an opening 388 configured to receive syringe 52. The opening 388 may have a generally circular shape. In some instances, housing 54 may include a plurality of ribs 382. Each of the plurality of ribs 382 may have any suitable size, shape, and / or configuration to retain the syringe 52 within housing 54.

[0169] Each of the plurality of ribs 382 may have a generally rectangular shape to hold the syringe 52 in position within the housing 54. The plurality of ribs 382 may be arranged symmetrically or asymmetrically with respect to the opening 388. The housing 54 may include a plurality of flange portions 158 configured to receive a rear cap hook 149, such as... Figures 37C to 37D As shown. The flange portion 158 and the edge 386 may each have any suitable size, shape and / or configuration, such that the rear cap hook 149 can be securely engaged and / or permanently attached to the housing 54.

[0170] Figures 56A to 57B The details of the back cap 144 are depicted, similar to the reference above. Figures 14A to 16B and Figures 37A to 37B Those described. For example... Figures 56A to 56B As shown, the collar 146 may surround the opening 147. The opening 147 may be configured to receive a portion of the plunger rod 56. In some embodiments, the opening 147 may have a generally circular shape. Figure 57A As shown, the opening 147 may have a cross-shaped form. In some instances, the rear cap 144 may include a hole 135 extending from the proximal surface 141 to the distal surface 143. In some instances, the rear cap 144 may include a plurality of protrusions 145a, 145b that may extend in a distal direction away from the distal surface 143. The plurality of protrusions 145a, 145b may have any suitable size, shape, and / or configuration such that the plurality of protrusions 145a, 145b can be securely coupled and / or permanently attached to the housing 54. For example, the first plurality of protrusions 145a may have a generally triangular, circular, semi-circular, rectangular, or cubic shape. The shape of the first plurality of protrusions 145a may correspond to the recess 380 in the housing 54 ( Figure 55A and Figure 55B In other instances, a second plurality of protrusions 145b may be fitted into and / or abut against the corresponding edge 386 of the housing 54.

[0171] The first pair of deflectable arms 63a and the second pair of deflectable arms 63b are referenced above. Figures 37A to 37D Detailed description. Figures 56A to 57BExemplary configurations of a first pair of deflectable arms 63a and a second pair of deflectable arms 63b are depicted. For example, the first arm of the first pair of deflectable arms 63a may be positioned relative to the second arm of the first pair of deflectable arms 63a. Furthermore, the first arm of the second pair of deflectable arms 63b may be positioned relative to the second arm of the second pair of deflectable arms 63b. In embodiments with four deflectable arms, each deflectable arm may be approximately 90 degrees to each other. In some embodiments, the arms of the first pair of deflectable arms 63a may alternate with the arms of the second pair of deflectable arms 63b around the circumference of the opening 147. Figure 57B As shown, the rear cap 144 may include a flange portion 158 for abutting against the housing 54. Figure 35B The rear cap 144 may include a plurality of rear cap hooks 149 for abutting against a plurality of flange portions 158 of the housing 54. For example, the rear cap 144 may include at least two, at least three, or at least four rear cap hooks 149.

[0172] Figure 58 A device 150 in a test system 501 is depicted. Device 150 may include a plunger rod 56, a housing 54, and a pin cap 64. The housing 54 may include a finger-touch flange 142 configured to engage with a rear cap 144. The rear cap 144 may include a collar 146. The collar 146 may extend in a proximal direction away from the finger-touch flange 142. The collar 146 may have any suitable size and / or configuration to surround a portion of the plunger rod 56. In some embodiments, the collar 146 may have a generally circular shape. A portion of the plunger rod 56 may be hollowed out to form a plurality of ribs 495 and / or grooves 496. The plurality of ribs 495 and / or grooves 496 may form a location for placing an ejector pin 498. In some embodiments, the rear cap 144 may include a hole 135 extending from a proximal surface 141 to a distal surface 143. When the rear cap 144 and the fingertip flange 142 are engaged, the hole 135 extends from the distal side of the fingertip flange 142 to the proximal surface of 141. A screw 502 may extend through the hole 135. The hole 135 may have any suitable size and / or be configured to surround a portion of the screw 502. The screw 502 secures the device 150 in a test system 501. The test system 501 can test the functionality of the device 150, such as the force required to depress the plunger 56 and / or the dose delivered when the plunger is depressed.

[0173] The embodiments described herein can be used in conjunction with the administration of various agents, drugs, and / or pharmaceutical preparations to a patient. Exemplary agents, drugs, and / or pharmaceutical preparations that can be used with the embodiments described herein are described in U.S. Patent Nos. 8,945,559 B2, 9,987,500 B2, and 11,603,407 B2, the entire contents of which are incorporated herein by reference. Agents, drugs, and / or pharmaceutical preparations that can be used with embodiments of this disclosure are further described in detail below.

[0174] First, exemplary pharmaceutical preparations, drugs, and / or pharmaceutical formulations conforming to U.S. Patent No. 8,945,559 B2 are described. As used herein, the term "pharmaceutical formulation" means a combination of at least one active ingredient (e.g., a small molecule, macromolecule, compound, etc., capable of exerting biological effects in a human or non-human animal) and at least one inactive ingredient suitable for therapeutic administration to a human or non-human animal when combined with the active ingredient or one or more additional inactive ingredients. As used herein, unless otherwise specifically stated, the term "formulation" means "pharmaceutical formulation".

[0175] This disclosure provides pharmaceutical formulations comprising at least one therapeutic polypeptide. According to certain embodiments of this disclosure, the therapeutic polypeptide is an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor α (hIL-4Rα). More specifically, this disclosure includes pharmaceutical formulations comprising: (i) a human antibody that specifically binds to hIL-4Rα; (ii) an acetate / histidine buffer system; (iii) an organic cosolvent that is a nonionic surfactant; (iv) a heat stabilizer for carbohydrates; and (v) a viscosity reducer. Specific exemplary components and formulations included in this disclosure are described in detail below.

[0176] The pharmaceutical formulations disclosed herein may comprise a human antibody or antigen-binding fragment thereof that specifically binds to hIL-4Rα. As used herein, the term "hIL-4Rα" refers to a human cytokine receptor that specifically binds to interleukin-4 (IL-4). In some embodiments, the antibody contained in the pharmaceutical formulations of this disclosure specifically binds to the extracellular domain of hIL-4Rα. An exemplary amino acid sequence of human IL-4 receptor α (hIL-4Rα) is described in SEQ ID NO:25. Antibodies against hIL-4Rα are described in U.S. Patent Nos. 7,605,237 and 7,608,693. The extracellular domain of hIL-4Rα is represented by the amino acid sequence of SEQ ID NO:26.

[0177] As used herein, the term "antibody" generally refers to an immunoglobulin molecule comprising four polypeptide chains (two heavy (H) chains and two light (L) chains) linked together by disulfide bonds, as well as its polymers (e.g., IgM); however, immunoglobulin molecules consisting only of heavy chains (e.g., lacking light chains) are also included within the definition of the term "antibody." Each heavy chain contains a heavy chain variable region (abbreviated herein as HCVR or V). H The heavy chain constant region contains three domains: CH1, CH2, and CH3. Each light chain contains a light chain variable region (abbreviated as LCVR or V in this paper). L The light chain constant region contains a structural domain (CL1). H District and V L The region can be further subdivided into highly variable regions (called complementary determinant regions (CDRs)) and more conservative regions scattered between them (called frame regions (FRs)). Each V H and V L It consists of three CDRs and four FRs, arranged in the following order from the amino terminus to the carboxyl terminus: FR1, CDR1, FR2, CDR2, FR3, CDR3, FR4.

[0178] Unless otherwise specified, as used herein, the term “antibody” should be understood to encompass the complete antibody molecule and its antigen-binding fragment. As used herein, the term “antigen-binding portion” or “antigen-binding fragment” (or simply “antibody portion” or “antibody fragment”) of an antibody refers to one or more fragments of an antibody that retain the ability to specifically bind to hIL-4Rα or its epitopes.

[0179] As used herein, “isolated antibody” is intended to refer to an antibody that is substantially free of other antibodies that have different antigen specificities (e.g., an isolated antibody that specifically binds to hIL-4Rα is substantially free of antibodies that specifically bind to antigens other than hIL-4Rα).

[0180] The term "specific binding" refers to the formation of a relatively stable complex between an antibody or its antigen-binding fragment and the antigen under physiological conditions. Specific binding can be achieved by a dissociation constant of at least approximately 1 × 10⁻⁶. -6 M or larger is used for characterization. Methods for determining whether two molecules specifically bind are well known in the art and include, for example, equilibrium dialysis, surface plasmon resonance, etc. However, isolates that specifically bind hIL-4Rα may cross-react with other antigens, such as IL-4R molecules (orthologs) from other species. In the context of this disclosure, multispecific (e.g., bispecific) antibodies that bind hIL-4Rα and one or more additional antigens are considered to "specifically bind" hIL-4Rα. Furthermore, isolates may be substantially free of other cellular material or chemicals.

[0181] Exemplary anti-hIL-4Rα antibodies that may be included in the pharmaceutical formulations disclosed herein are described in U.S. Patent Nos. 7,605,237 and 7,608,693, the disclosure of which is incorporated herein by reference in its entirety.

[0182] According to certain embodiments of this disclosure, the anti-hIL-4Rα antibody is human IgG1 comprising the heavy chain variable region of the IGHV3-9 subtype and the light chain variable region of the IGKV2-28 subtype (see Barbie and Lefranc, The Human Immunoglobulin Kappa Variable (IGKV) Genes and Joining (IGKJ) Segments, Exp. Clin. Immunogenet. 1998; 15:171-183; and Scaviner, D. et al., Protein Displays of the Human Immunoglobulin Heavy, Kappa and Lambda Variable and Joining Regions, Exp. Clin. Immunogenet., 1999; 16:234-240).

[0183] In some embodiments, the anti-hIL-4Rα contains at least one amino acid substitution that results in a charge change at the exposed surface of the antibody relative to the germline IGHV3-9 or germline IGKV2-28 sequence. The germline IGHV3-9 and IGKV2-28 sequences and amino acid position assignments provided herein conform to the International Immunogenetics (IMGT) Information System, as described in Lefranc, M.-P. et al., IMGT®, Nucl. Acids Res, 37, D1006-D1012 (2009). In some embodiments, the exposed surface contains a complementarity-determining region (CDR). In some embodiments, one or more amino acid substitutions are selected from the group consisting of: (a) basic amino acid substitutions for neutral amino acids within CDR2 (e.g., position 58) of IGHV3-9; (b) neutral amino acid substitutions for acidic amino acids within CDR3 (e.g., position 107) of IGHV3-9; and (c) neutral amino acid substitutions for basic amino acids within CDR1 (e.g., position 33) of IGKV2-28. The unique arrangement of the antibody's charge distribution, particularly at the environmental interface (e.g., in the CDR), is expected to create unpredictable conditions for the antibody's stability in solution.

[0184] In some embodiments, the anti-hIL-4Rα antibody comprises at least one amino acid substitution that produces a torsional strain change relative to the germline IGHV3-9 sequence or the germline IGKV2-28 sequence within the frame region of the antibody's variable region. In some embodiments, one or more amino acid substitutions are selected from the group consisting of: (a) proline substitution for a non-proline amino acid in frame region 3 (FR3) (e.g., position 96) of IGHV3-9; and (b) non-proline substitution for a proline in frame region 2 (FR2) (e.g., position 46) of IGKV2-28. Changes in peptide chain rotation capability, particularly within the frame region, affect the interface between the CDR and the solvent, and are expected to create unpredictable conditions for the antibody's stability in solution.

[0185] According to certain embodiments of this disclosure, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises the heavy chain complementarity-determining region (HCDR) 1 of SEQ ID NO:2, HCDR2 of SEQ ID NO:3, and HCDR3 of SEQ ID NO:4. In some embodiments, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises HCVD of SEQ ID NO:1.

[0186] According to certain embodiments of this disclosure, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises the light (κ) chain complementarity-determining region (LCDR) 1 of SEQ ID NO: 6, the LCDR2 of SEQ ID NO: 7, and the LCDR3 of SEQ ID NO: 8. In some embodiments, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises the LCVD of SEQ ID NO: 5.

[0187] According to certain other embodiments of this disclosure, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises HCDR1 of SEQ ID NO: 10, HCDR2 of SEQ ID NO: 11, HCDR3 of SEQ ID NO: 12, LCDR1 of SEQ ID NO: 14, LCDR2 of SEQ ID NO: 15, and LCDR3 of SEQ ID NO: 16. In some embodiments, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises HCVD of SEQ ID NO: 9 and LCVD of SEQ ID NO: 13.

[0188] According to certain other embodiments of this disclosure, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises HCDR1 of SEQ ID NO: 18, HCDR2 of SEQ ID NO: 19, HCDR3 of SEQ ID NO: 20, LCDR1 of SEQ ID NO: 22, LCDR2 of SEQ ID NO: 23, and LCDR3 of SEQ ID NO: 24. In some embodiments, the anti-hIL-4Rα antibody or its antigen-binding fragment comprises HCVD of SEQ ID NO: 17 and LCVD of SEQ ID NO: 21.

[0189] Another non-limiting exemplary antibody that can be used in practice with this disclosure is called “mAb2”. This antibody is also referred to as H4H083P in U.S. Patent No. 7,608,693. mAb2 (H4H083P) comprises the HCVR / LCVR amino acid sequence pair having SEQ ID NO:9 / 13 and the HCDR1-HCDR2-HCDR3 / LCDR1-LCDR2-LCDR3 domain represented by SEQ ID NO:10-11-12 / SEQ ID NO:14-15-16.

[0190] Another non-limiting exemplary antibody that can be used in practice with this disclosure is called “mAb3”. This antibody is also referred to as H4H095P in U.S. Patent No. 7,608,693. mAb3 (H4H095P) comprises the HCVR / LCVR amino acid sequence pair having SEQ ID NO:17 / 21 and the HCDR1-HCDR2-HCDR3 / LCDR1-LCDR2-LCDR3 domain represented by SEQ ID NO:18-19-20 / SEQ ID NO:22-23-24.

[0191] The amount of antibody or antigen-binding fragment thereof contained in the pharmaceutical formulations disclosed herein may vary depending on the specific properties required by the formulation and the specific circumstances and purpose for which the formulation is intended to be used. In some embodiments, the pharmaceutical formulation is a liquid formulation, which may contain about 100±10 mg / mL to about 200±20 mg / mL of antibody, about 110±11 mg / mL to about 190±19 mg / mL of antibody, about 120±12 mg / mL to about 180±18 mg / mL of antibody, about 130±13 mg / mL to about 170±17 mg / mL of antibody, about 140±14 mg / mL to about 160±16 mg / mL of antibody, or about 150±15 mg / mL of antibody. For example, the formulations disclosed herein may comprise an antibody or an antigen-binding fragment thereof that specifically binds to hIL-4Rα at concentrations of about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 131 mg / mL, about 132 mg / mL, about 133 mg / mL, about 134 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, or about 200 mg / mL.

[0192] The pharmaceutical formulations disclosed herein comprise one or more excipients. As used herein, the term "excipient" means any non-therapeutic agent added to the formulation to provide a desired consistency, viscosity, or stabilizing effect.

[0193] In some embodiments, the pharmaceutical formulation of this disclosure comprises at least one organic cosolvent, the type and amount of which stabilizes the hIL-4Rα antibody under rough treatment (e.g., vortexing). In some embodiments, "stabilize" means preventing the formation of aggregated antibodies exceeding 2% (in moles per liter) of the total antibody volume during rough treatment. In some embodiments, rough treatment involves vortexing the solution containing the antibody and the organic cosolvent for approximately 120 minutes.

[0194] In some embodiments, the organic cosolvent is a nonionic surfactant, such as alkyl poly(ethylene oxide). Specific nonionic surfactants that may be included in the formulations disclosed herein include, for example, polysorbates, such as polysorbate 20, polysorbate 28, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 81, and polysorbate 85; poloxamers, such as poloxamer 181, poloxamer 188, and poloxamer 407; or polyethylene glycol (PEG). Polysorbate 20 is also known as TWEEN 20, dehydrated sorbitan monolaurate, and polyoxyethylene dehydrated sorbitan monolaurate. Poloxamer 181 is also known as PLURONIC F68.

[0195] The amount of organic cosolvent contained in the pharmaceutical formulations of this disclosure can vary depending on the specific properties required by the formulation and the specific circumstances and purpose for which the formulation is intended to be used. In some embodiments, the formulation may contain about 0.1% ± 0.01% to about 2% ± 0.2% of a surfactant. For example, the formulations of this disclosure may contain about 0.09%, about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.20%, about 0.21%, about 0.22%, about 0.23%, about 0.24%, about 0.25%, about 0.26%, about 0.27%, about 0.28%, about 0.29%, or about 0.30% of polysorbate 20 or poloxamer 181. For example, the formulation disclosed herein may contain about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, or about 2.0% of PEG 3350.

[0196] Exemplary organic cosolvents for stabilizing hIL-4Rα antibodies include 0.2% ± 0.02% polysorbate 20, 0.2% ± 0.02% poloxamer 181, or 1% ± 0.1% PEG 3350.

[0197] The pharmaceutical formulation disclosed herein may also comprise one or more heat stabilizers, the type and amount of which stabilize the hIL-4Rα antibody under thermal stress conditions. In some embodiments, "stable" means that when the solution containing the antibody and the heat stabilizer is maintained at about 45°C for up to about 28 days, greater than about 92% of the antibody remains in its native conformation. In some embodiments, "stable" means that when the solution containing the antibody and the heat stabilizer is maintained at about 45°C for up to about 28 days, less than about 5% of the antibody aggregates.

[0198] In some embodiments, the heat stabilizer is a sugar or sugar alcohol selected from sucrose, trehalose, and mannitol, or any combination thereof, and the amount of such sugar or sugar alcohol contained in the formulation may vary depending on the specific circumstances of using the formulation and its intended use. In some embodiments, the formulation may contain about 2.5% to about 10% sugar or sugar alcohol, about 3% to about 9.5% sugar or sugar alcohol, about 3.5% to about 9% sugar or sugar alcohol, about 4% to about 8.5% sugar or sugar alcohol, about 4.5% to about 8% sugar or sugar alcohol, about 5% to about 7.5% sugar or sugar alcohol, about 5.5% to about 7% sugar or sugar alcohol, or about 6.0% to about 6.5% sugar or sugar alcohol. For example, the pharmaceutical formulations disclosed herein may contain about 2.5% ± 0.375%, about 3% ± 0.45%, about 3.5% ± 0.525%, about 4.0% ± 0.6%, about 4.5% ± 0.675%, about 5.0% ± 0.75%, about 5.5% ± 0.825%, about 6.0% ± 0.9%, about 6.5% ± 0.975%, about 7.0% ± 1.05%, about 7.5% ± 1.125%, about 8.0% ± 1.2%, 8.5% ± 1.275%, about 9.0% ± 1.35%, or about 10.0% ± 1.5% of sugars or sugar alcohols (e.g., sucrose, trehalose, or mannitol).

[0199] The pharmaceutical formulation disclosed herein may also comprise a buffer or buffer system for maintaining a stable pH and aiding in the stabilization of the hIL-4Rα antibody. In some embodiments, "stable" means that less than 3.0% ± 0.5% of the antibody aggregates when the solution containing the antibody and buffer is maintained at about 45°C for up to about 14 days. In some embodiments, "stable" means that less than 3.7% ± 0.5% of the antibody aggregates when the solution containing the antibody and buffer is maintained at about 25°C for up to about 6 months. In some embodiments, "stable" means that at least 95% ± 0.5% of the antibody remains in its native conformation when the solution containing the antibody and buffer is maintained at about 45°C for up to about 14 days, as determined by size exclusion chromatography. In some embodiments, "stable" means that at least 96% ± 0.5% of the antibody remains in its native conformation when the solution containing the antibody and buffer is maintained at about 25°C for up to about 6 months, as determined by size exclusion chromatography. In some embodiments, "stable" means that when the solution containing antibody and buffer is maintained at about 45°C for up to about 14 days, at least 62% ± 0.5% of the antibody is in a neutral conformation, as determined by cation exchange chromatography. In some embodiments, "stable" means that when the solution containing antibody and buffer is maintained at about 25°C for up to about 6 months, at least 54% ± 0.5% of the antibody is in a neutral conformation, as determined by cation exchange chromatography. The term "neutral conformation" means that the antibody fraction eluted from the ion exchange resin typically has a more "basic" peak on one side and a more "acidic" peak on the other.

[0200] The pharmaceutical formulations disclosed herein can have a pH of about 5.2 to about 6.4. For example, the formulations disclosed herein can have a pH of about 5.2, about 5.3, about 5.4, about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6.0, about 6.1, about 6.2, about 6.3, or about 6.4. In some embodiments, the pH is about 5.3 ± 0.2, about 5.9 ± 0.2, or about 6.0 ± 0.2.

[0201] In some embodiments, the buffer solution or buffer system comprises at least one buffer having a buffering range that fully or partially overlaps with the pH range of 5.2-6.4. In one embodiment, the buffer solution or buffer system comprises two buffers, with the first buffer having an effective pH range of 3.6-5.6 and the second buffer having an effective pH range of 5.5-7.4. In one embodiment, the first buffer has a pKa of about 4.8 ± 0.3, and the second buffer has a pKa of about 6.0 ± 0.3. In some embodiments, the buffer system comprises an acetate buffer and a histidine buffer. In some embodiments, histidine is present at about 1.3-1.9 parts per part acetate (in moles). In some embodiments, histidine is present at about 1.6 ± 0.25 parts to 1 part acetate (in moles). In some embodiments, the acetate is expressed in amounts from about 2.5 mM to about 22.5 mM, from about 3.0 mM to about 22 mM, from about 3.5 mM to about 21.5 mM, from about 4.0 mM to about 21.0 mM, from about 4.5 mM to about 20.5 mM, from about 5.0 mM to about 20 mM, from about 5.5 mM to about 19.5 mM, from about 6.0 mM to about 19.0 mM, from about 6.5 mM to about 18.5 mM, from about 7.0 mM to about 18.0 mM, and from about 7.5 mM to... Concentrations of about 17.5 mM, about 8.0 mM to about 17 mM, about 8.5 mM to about 16.5 mM, about 9.0 mM to about 16.0 mM, about 9.5 mM to about 15.5 mM, about 10.0 mM to about 15.0 mM, about 10.5 mM to about 14.5 mM, about 12.5 mM ± 1.875 mM, about 11.0 mM to about 14.0 mM, about 11.5 mM to about 13.5 mM, or about 12.0 mM to about 13.0 mM are present. In some embodiments, histidine is present at concentrations of about 10 mM to about 30 mM, about 11 mM to about 29 mM, about 12 mM to about 28 mM, about 13 mM to about 27 mM, about 14 mM to about 26 mM, about 15 mM to about 25 mM, about 16 mM to about 24 mM, about 17 mM to about 23 mM, about 18 mM to about 22 mM, or about 19 mM to about 21 mM. In some embodiments, the buffer system comprises about 12.5 mM of acetate and about 20 mM of histidine at a pH of about 5.9.

[0202] The pharmaceutical formulations disclosed herein may also comprise one or more excipients for maintaining reduced viscosity or reducing the viscosity of formulations containing high concentrations of protein (e.g., typically >100 mg / ml protein). In some embodiments, the formulation comprises arginine in an amount sufficient to maintain the viscosity of the liquid formulation at less than about 35 cPoise, less than about 30 cPoise, less than about 25 cPoise, less than about 20 cPoise, less than about 15 cPoise, less than about 14 cPoise, less than about 13 cPoise, less than about 12 cPoise, less than about 10 cPoise, or less than about 9 cPoise.

[0203] In some embodiments, the pharmaceutical formulation of this disclosure contains arginine at a concentration of about 25 mM ± 3.75 mM, about 50 mM ± 7.5 mM, or about 100 mM ± 15 mM, preferably L-arginine hydrochloride. In some embodiments, the arginine is about 20 mM to about 30 mM, about 21 mM to about 29 mM, about 21.25 mM to about 28.75 mM, about 22 mM to about 28 mM, about 23 mM to about 27 mM, or about 24 mM to about 26 mM.

[0204] According to one aspect of this disclosure, the pharmaceutical formulation is a low-viscosity, generally physiologically isotonic liquid formulation comprising: (i) a human antibody (e.g., mAb1, mAb2, or mAb3 [as above]) that specifically binds to hIL-4Rα at a concentration of about 100 mg / ml or higher; (ii) a buffer system that provides adequate buffering at about 5.9 ± 0.6; (iii) a sugar, particularly used as a heat stabilizer; (iv) an organic cosolvent that protects the structural integrity of the antibody; and (v) an amino acid for maintaining manageable viscosity for subcutaneous injection.

[0205] According to one embodiment, the pharmaceutical formulation comprises: (i) a human IgG1 antibody at a concentration of about 100 mg / ml to about 200 mg / ml, which specifically binds to hIL-4Rα and comprises a substituted IGHV3-9 type heavy chain variable region and a substituted IGHV2-28 type light chain variable region (e.g., mAb1); (ii) a buffer system comprising acetate and histidine, which effectively buffers at about pH 5.9 ± 0.6; (iii) sucrose as a heat stabilizer; (iv) polysorbate as an organic cosolvent; and (v) arginine as a viscosity reducer.

[0206] According to one embodiment, the pharmaceutical formulation comprises: (i) a human IgG1 antibody at a concentration of about 150 mg / ml ± 25 mg / ml, which specifically binds to hIL-4Rα, and comprising HCDR1 of SEQ ID NO:2, HCDR2 of SEQ ID NO:3, HCDR3 of SEQ ID NO:4, LCDR1 of SEQ ID NO:6, LCDR2 of SEQ ID NO:7, and LCDR3 of SEQ ID NO:8; (ii) about 12.5 mM ± 1.9 mM of acetate and about 20 mM ± 3 mM of histidine, which are effectively buffered at about pH 5.9 ± 0.3; (iii) about 5% w / v ± 0.75% w / v of sucrose; (iv) about 0.2% w / v ± 0.03% w / v of polysorbate 20; and (v) about 25 mM ± 3.75 mM of arginine in the form of L-arginine hydrochloride.

[0207] The pharmaceutical formulations disclosed herein generally exhibit a high level of stability. As used herein, the term "stable" with respect to a pharmaceutical formulation means that the antibody within the pharmaceutical formulation retains an acceptable degree of chemical structure or biological function after storage under defined conditions. A formulation may be stable even if the antibody contained therein does not retain 100% of its chemical structure or biological function after a defined storage time. In some cases, retention of approximately 90%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, or approximately 99% of the antibody's structure or function after a defined storage time may be considered "stable."

[0208] Stability can be measured, in particular, by determining the percentage of natural antibodies retained in the formulation after storage at a defined temperature for a defined time. The percentage of natural antibodies can be determined, in particular, by size exclusion chromatography (e.g., size exclusion high-performance liquid chromatography [SE-HPLC]). As used herein, the phrase “acceptable level of stability” means that at least 90% of the natural form of antibody can be detected in the formulation after storage at a given temperature for a defined time. In some embodiments, at least about 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% of the natural form of antibody can be detected in the formulation after storage at a defined temperature for a defined time. The defined time for measuring stability can be at least 2 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, at least 18 months, at least 24 months, or longer. When assessing stability, the permitted storage temperature for a pharmaceutical preparation can be any temperature from about -80°C to about 45°C, such as storage at about -30°C, about -20°C, about 0°C, about 4°C–8°C, about 5°C, about 25°C, or about 45°C. For example, if after 3 months of storage at 5°C, greater than about 90%, 95%, 96%, 97%, or 98% of natural antibodies are detected by SE-HPLC, the pharmaceutical preparation can be considered stable. If after 6 months of storage at 5°C, greater than about 90%, 95%, 96%, 97%, or 98% of natural antibodies are detected by SE-HPLC, the pharmaceutical preparation can also be considered stable. If after 9 months of storage at 5°C, greater than about 90%, 95%, 96%, 97%, or 98% of natural antibodies are detected by SE-HPLC, the pharmaceutical preparation can also be considered stable. If after 3 months of storage at 25°C, greater than about 90%, 95%, 96%, or 97% of natural antibodies are detected by SE-HPLC, the pharmaceutical preparation can also be considered stable. A pharmaceutical preparation can also be considered stable if, after being stored at 25°C for 6 months, greater than approximately 90%, 95%, 96%, or 97% of natural antibodies are detected by SE-HPLC. Similarly, a pharmaceutical preparation can be considered stable if, after being stored at 25°C for 9 months, greater than approximately 90%, 95%, 96%, or 97% of natural antibodies are detected by SE-HPLC.

[0209] Stability can be measured, in particular, by determining the percentage of antibodies formed in aggregates within the formulation after storage at a defined temperature for a defined time, wherein stability is inversely proportional to the percentage of aggregates formed. The percentage of aggregated antibodies can be determined, in particular, by size exclusion chromatography (e.g., size exclusion high-performance liquid chromatography [SE-HPLC]). As used herein, the phrase “acceptable level of stability” means that after storage at a defined temperature for a defined time, up to 5% of the antibody is detected in aggregate form in the formulation. In some embodiments, acceptable level of stability means that after storage at a defined temperature for a defined time, up to about 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of the antibody can be detected in aggregates within the formulation after storage at a defined temperature for a defined time. The defined time for measuring stability can be at least 2 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, at least 18 months, at least 24 months, or longer. When assessing stability, the pharmaceutical preparation can be stored at any temperature from about -80°C to about 45°C, such as at about -30°C, about -20°C, about 0°C, about 4°C-8°C, about 5°C, about 25°C, or about 45°C. For example, if less than about 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected after 3 months of storage at 5°C, the pharmaceutical preparation can be considered stable. If less than about 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected after 6 months of storage at 5°C, the pharmaceutical preparation can also be considered stable. If less than about 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected after 9 months of storage at 5°C, the pharmaceutical preparation can also be considered stable. The pharmaceutical preparation can also be considered stable if, after storage at 25°C for 3 months, less than approximately 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected. Similarly, the pharmaceutical preparation can be considered stable if, after storage at 25°C for 6 months, less than approximately 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected. Finally, the pharmaceutical preparation can be considered stable if, after storage at 25°C for 9 months, less than approximately 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in aggregated form are detected.

[0210] Stability can be measured, in particular, by determining the percentage of antibody that migrates during ion exchange in a more acidic fraction (“acidic form”) rather than in the majority fraction (“neutral conformation”), where stability is inversely proportional to the fraction of antibody in the acidic form. While not wishing to be bound by theory, deamidation of antibodies can result in antibodies carrying a greater negative charge and thus being more acidic relative to undeamidated antibodies (see, for example, Robinson, N., Protein Deamidation, PNAS, April 16, 2002, 99(8):5283-5288). The percentage of “acidified” or “deamidized” antibodies can be determined, in particular, by ion exchange chromatography (e.g., cation exchange high-performance liquid chromatography [CEX-HPLC]). As used herein, the phrase “acceptable level of stability” means that, after storage at a defined temperature for a defined time, up to 45% of the antibody is detected in the formulation in a more acidic form. In some embodiments, acceptable stability means that after storage at a given temperature for a specified period of time, up to about 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of the antibody in its acidic form can be detectable in the formulation. The specified period for measuring stability can be at least 2 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, at least 18 months, at least 24 months, or longer. When assessing stability, the pharmaceutical formulation can be stored at any temperature from about -80°C to about 45°C, for example, at about -30°C, about -20°C, about 0°C, about 4°C–8°C, about 5°C, about 25°C, or about 45°C. For example, if after 3 months of storage at 5°C, less than approximately 15%, 14%, 13%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies are in a more acidic form, the pharmaceutical preparation can be considered stable. Similarly, if after 3 months of storage at 25°C, less than approximately 18%, 17%, 16%, 15%, 14%, 13%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies are in a more acidic form, the pharmaceutical preparation can also be considered stable. Furthermore, if after 8 weeks of storage at 45°C, less than approximately 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies are in a more acidic form, the pharmaceutical preparation can also be considered stable.If, after storage at 40°C for 2 weeks, less than approximately 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.1% of antibodies in a more acidic form can be detected, the pharmaceutical preparation can also be considered stable.

[0211] Other methods can be used to assess the stability of the formulations disclosed herein, such as using differential scanning calorimetry (DSC) to determine thermal stability, using controlled stirring to determine mechanical stability, and using absorbance at about 350 nm or about 405 nm to determine solution turbidity. For example, if the OD405 of the formulation changes by less than about 0.05 (e.g., 0.04, 0.03, 0.02, 0.01, or less) after being stored at about 5°C to about 25°C for 6 or more months, the formulation disclosed herein can be considered stable.

[0212] Stability can also be assessed by measuring the biological activity or binding affinity of the antibody to its target. For example, a formulation of this disclosure can be considered stable if, after storage for a defined period of time (e.g., 1 to 12 months) at, for example, 5°C, 25°C, 45°C, etc., the anti-IL-4Rα antibody contained in the formulation binds IL-4Rα with at least 90%, 95%, or higher affinity than the antibody before storage. Binding affinity can be determined by, for example, ELISA or plasma resonance. Biological activity can be determined by an IL-4Rα activity assay, for example, by contacting cells expressing IL-4Rα with a formulation containing an anti-IL-4Rα antibody. The binding of the antibody to such cells can be measured directly, for example, by FACS analysis. Alternatively, downstream activity of the IL-4Rα system can be measured in the presence of the antibody and an IL-4Rα agonist and compared with the activity of the IL-4Rα system in the absence of the antibody. In some embodiments, IL-4Rα can be endogenous in cells. In other embodiments, IL-4Rα can be ectopically expressed in cells.

[0213] In some embodiments, the liquid pharmaceutical formulations of this disclosure may exhibit low to moderate levels of viscosity. As used herein, “viscosity” can be “kinematic viscosity” or “absolute viscosity.” Kinematic viscosity is a measure of the resistance to flow of a fluid under gravity. When two fluids of equal volume are placed in the same capillary viscometer and allowed to flow under gravity, the viscous fluid takes longer to flow through the capillary than the less viscous fluid. For example, if one fluid takes 200 seconds to complete its flow and another takes 400 seconds, the second fluid has twice the viscosity of the first fluid on the kinematic viscosity scale. Absolute viscosity, sometimes called dynamic viscosity or simple viscosity, is the product of kinematic viscosity and fluid density (absolute viscosity = kinematic viscosity × density). The dimension of kinematic viscosity is L² / T, where L is length and T is time. Typically, kinematic viscosity is expressed in centistokes (cSt). The SI unit of kinematic viscosity is mm² / s, or 1 cSt. Absolute viscosity is expressed in centipoises (cP). The SI unit for absolute viscosity is millipascal-second (mPa-s), where 1 cP = 1 mPa-s.

[0214] As used herein, with respect to the fluid formulations of this disclosure, low levels of viscosity will exhibit an absolute viscosity of less than about 15 cPoise (cP). For example, if a fluid formulation of this disclosure exhibits an absolute viscosity of about 15 cP, about 14 cP, about 13 cP, about 12 cP, about 11 cP, about 10 cP, about 9 cP, about 8 cP, or lower when measured using standard viscosity measurement techniques, the formulation will be considered to have “low viscosity.” As used herein, with respect to the fluid formulations of this disclosure, medium levels of viscosity will exhibit an absolute viscosity between about 35 cP and about 15 cP. For example, if the fluid formulation of this disclosure exhibits an absolute viscosity of about 34 cP, about 33 cP, about 32 cP, about 31 cP, about 30 cP, about 29 cP, about 28 cP, about 27 cP, about 26 cP, about 25 cP, about 24 cP, about 23 cP, about 22 cP, about 21 cP, about 20 cP, about 19 cP, 18 cP, about 17 cP, about 16 cP, or about 15.1 cP when measured using standard viscosity measurement techniques, then the formulation will be considered to have “medium viscosity”.

[0215] The pharmaceutical formulations disclosed herein are particularly useful for treating, preventing, or improving any disease or condition associated with IL-4 activity, including those mediated by IL-4Rα activation. Exemplary non-limiting diseases and conditions that can be treated or prevented by administration of the pharmaceutical formulations disclosed herein include various atopic diseases, such as atopic dermatitis, allergic conjunctivitis, allergic rhinitis, asthma, and other IgE / Th2-mediated diseases.

[0216] Therefore, this disclosure includes methods for treating, preventing, or improving any disease or condition (including any of the exemplary diseases, conditions, and illnesses described above) associated with IL-4 activity or IL-4Rα activation. Treatment methods of this disclosure include administering to a subject any formulation comprising an anti-hIL-4Rα antibody disclosed herein. The subject administering the pharmaceutical formulation may be, for example, any person or non-human animal requiring such treatment, prevention, or improvement, or any person or non-human animal that would otherwise benefit from inhibiting or attenuating IL-4 or IL-4Rα-mediated activity. For example, the subject may be an individual diagnosed with any of the aforementioned diseases or conditions or considered to be at risk of developing any of the aforementioned diseases or conditions. This disclosure also includes the use of any pharmaceutical formulation disclosed herein in the preparation of a medicament for treating, preventing, or improving any disease or condition (including any of the exemplary diseases, conditions, and illnesses described above) associated with IL-4 activity or IL-4Rα activation.

[0217] According to one aspect of this disclosure, the pharmaceutical formulation is a stable, low-viscosity, generally physiologically isotonic liquid formulation comprising: (i) a human antibody (e.g., H4H7798N) specifically binding to human PD-1 at a concentration up to 250 mg / mL ± 45 mg / mL; (ii) a histidine buffer system providing adequate buffering at about pH 6.0 ± 0.3; (iii) an organic cosolvent protecting the structural integrity of the antibody; (iv) a heat stabilizer for the sugar; and (iv) a viscosity modifier for the amino acid, which is used to maintain a manageable viscosity for convenient subcutaneous volumetric injection.

[0218] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising SEQ ID NO: 3 HCDR1, SEQ ID NO: 4 HCDR2, SEQ ID NO: 5 HCDR3, SEQ ID NO: 6 LCDR1, SEQ ID NO: 7 LCDR2 and SEQ ID NO: 8 LCDR3 at concentrations up to 200 mg / ml ± 30 mg / mL; (ii) 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 0.2% w / v ± 0.1% w / v polysorbate 80; (iv) 5% ± 1% w / v sucrose; and (v) 1.5% (w / v) ± 0.3% L-proline.

[0219] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising HCDR1 of SEQ ID NO: 3, HCDR2 of SEQ ID NO: 4, HCDR3 of SEQ ID NO: 5, LCDR1 of SEQ ID NO: 6, LCDR2 of SEQ ID NO: 7, and LCDR3 of SEQ ID NO: 8 at a concentration of 175 mg / ml ± 26.25 mg / mL; (ii) a 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 0.2% w / v ± 0.1% w / v polysorbate 80; (iv) 5% ± 1% w / v sucrose; and (v) 1.5% (w / v) ± 0.3% L-proline.

[0220] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising HCDR1 of SEQ ID NO: 3, HCDR2 of SEQ ID NO: 4, HCDR3 of SEQ ID NO: 5, LCDR1 of SEQ ID NO: 6, LCDR2 of SEQ ID NO: 7, and LCDR3 of SEQ ID NO: 8 at a concentration of 150 mg / ml ± 22.5 mg / mL; (ii) a 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 0.2% w / v ± 0.1% w / v polysorbate 80; (iv) 5% ± 1% w / v sucrose; and (v) 1.5% (w / v) ± 0.3% L-proline.

[0221] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising SEQ ID NO: 3 HCDR1, SEQ ID NO: 4 HCDR2, SEQ ID NO: 5 HCDR3, SEQ ID NO: 6 LCDR1, SEQ ID NO: 7 LCDR2 and SEQ ID NO: 8 LCDR3 at a concentration of 100 mg / mL ± 15 mg / mL; (ii) 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 5% w / v ± 1% w / v sucrose; (iv) 0.2% w / v ± 0.1% polysorbate 80; and 1.5% (w / v) ± 0.3% L-proline.

[0222] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising HCDR1 of SEQ ID NO: 3, HCDR2 of SEQ ID NO: 4, HCDR3 of SEQ ID NO: 5, LCDR1 of SEQ ID NO: 6, LCDR2 of SEQ ID NO: 7, and LCDR3 of SEQ ID NO: 8 at a concentration of 50 mg / mL ± 7.5 mg / mL; (ii) a 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 5% w / v ± 1% w / v sucrose; (iv) 0.2% w / v ± 0.1% polysorbate 80; and 1.5% (w / v) ± 0.3% L-proline.

[0223] According to one embodiment, a stable, low-viscosity pharmaceutical formulation comprises: (i) a human IgG4 antibody that specifically binds to human PD-1, and comprising HCDR1 of SEQ ID NO: 3, HCDR2 of SEQ ID NO: 4, HCDR3 of SEQ ID NO: 5, LCDR1 of SEQ ID NO: 6, LCDR2 of SEQ ID NO: 7, and LCDR3 of SEQ ID NO: 8 at a concentration of 25 mg / mL ± 3.75 mg / mL; (ii) a 10 mM ± 2 mM histidine buffer with a buffer pH of 6.0 ± 0.3; (iii) 5% w / v ± 1% w / v sucrose; (iv) 0.2% w / v ± 0.1% polysorbate 80; and 1.5% (w / v) ± 0.3% L-proline.

[0224] Additional exemplary agents, drugs, and / or drug formulations include: drugs targeting activin A and GDF8 (e.g., gatoxumab and trogolumab as described in US 9,718,881, which is incorporated herein by reference); drugs targeting C5 (e.g., parzelimab and cemdisiran as described in US Publication 2021 / 0046182, which is incorporated herein by reference); drugs targeting LEPR (e.g., mibavademab as described in US 10,023,644, which is incorporated herein by reference); drugs targeting LAG3 (e.g., as described in US 10,023,644, which is incorporated herein by reference); and drugs targeting LAG3 (e.g., gatoxumab and trogolumab as described in US 9,718,881, which is incorporated herein by reference). The following are examples of drugs targeted by US patents: 10,358,495 (e.g., the antibody disclosed in US Patent 10,793,624, which is incorporated herein by reference); 10,358,495 (e.g., the antibody disclosed in US Patent 10,793,624, which is incorporated herein by reference); 10,793,624 (e.g., the antibody disclosed in US Patent 8,795,669, which is incorporated herein by reference); 10,793,624 (e.g., the antibody disclosed in US Patent Publication 2020 / 0369760, which is incorporated herein by reference); 10,358,495 (e.g., the antibody disclosed in US Patent 8,795,669, which is incorporated herein by reference); 10,793,624 ... The salinomycin bacterium disclosed in 9,173,880 (which is incorporated herein by reference).

[0225] Additional exemplary agents, drugs, and / or drug formulations include: an RNAi therapy targeting APP for early-onset Alzheimer's disease (ALN-APP1); an RNAi therapy targeting HSD17B13 for non-alcoholic steatohepatitis (“NASH”) (ALN-HSD); an RNAi therapy targeting PNPLA3 for NASH (ALN-PNP1); a PD-1 antibody (cimiprimab) in combination with BNT116 for first-line NSCLC; and a BCMA-targeting RNAi for multiple myeloma. Bispecific antibodies targeting CD3 (Rinozazumab); TTR gene knockout using CRISPR / Cas9 for transthyretin (“ATTR”) amyloidosis; bispecific antibodies targeting CD20 and CD3 for certain B-cell malignancies (Onitomab); bispecific antibodies targeting PSMA and CD3 for prostate cancer; bispecific antibodies targeting two different MET epitopes for advanced NSCLC with MET alterations; and bispecific antibodies targeting two different MET epitopes for advanced cancers with MET overexpression. Bispecific antibody-drug conjugates; NPR1 agonist antibody / REGN5381 reversal agent for reversal in healthy volunteers; bispecific antibody targeting BCMA and CD3 for transplant desensitization in patients with chronic kidney disease; bispecific antibody targeting MUC16 and CD28 for platinum-resistant ovarian cancer; bispecific antibody targeting PSMA and CD28 for prostate cancer; bispecific antibody targeting CD22 and CD28 for B-NHL; GITR antibody for solid tumors; EG-targeting antibody for solid tumors. Bispecific antibodies against FR and CD28; IL2Rg antibody against aplastic anemia; factor XI antibody against thrombosis; TMPRSS6 antibody against transfusion-dependent iron overload; factor XI antibody against thrombosis; RNAi therapy targeting HSD17B13 (ALN-HSD) for non-alcoholic steatohepatitis (“NASH”); PD-1 antibody for neoadjuvant CSCC; ISA101b combination (cimipril) for second-line cervical cancer; IL-4R for ulcerative colitis. Antibodies targeting the alpha subunit; eosinophilic gastroenteritis (stage 2 / 3) (duprilumab); LAG-3 antibody (furanlimab) for first-line advanced NSCLC (stage 2 / 3) (pivotal study); bispecific antibody (linezolizumab) targeting BCMA and CD3 for multiple myeloma (pivotal study); leptin receptor (“LEPR”) agonist antibody for systemic lipodystrophy; partial lipodystrophy (mibavarimab); bispecific antibody (onituzumab) targeting CD20 and CD3 for B-cell non-Hodgkin lymphoma (“B-NHL”) (pivotal study); C5 antibody;Studies of monotherapy and in combination with sedixyl for CD55-deficient protein-losing bowel disease (“CHAPLE”) include: monotherapy (potential pivotal study) (parzelimumab); NPR1 agonist antibody / REGN5381 reversal agent for heart failure; IL-6R antibody for polyarticular juvenile idiopathic arthritis (“pcJIA”) (pivotal study); systemic juvenile idiopathic arthritis (“sJIA”) (pivotal study) (salilumab); bispecific antibody targeting MUC16 and CD3 for platinum-resistant ovarian cancer (urbutumab); immune activator targeting TLR9 for solid tumors (virduribitimod); VEGF-Trap for wet AMD and DME (aflibercept); PCSK9 antibody for pediatric HeFH (alixilumab); PD-1 antibody for adjuvant CSCC (cimiprimab); and IL-4R for pediatric EoE. Alpha subunit antibody; chronic obstructive pulmonary disease (“COPD”); bullous pemphigoid; chronic spontaneous urticaria (“CSU”); chronic pruritus of unknown cause (duprilumab); LAG-3 antibody for first-line metastatic melanoma; first-line helper melanoma (furanlimab); activin A antibody for progressive ossifying fibrosis dysplasia (“FOP”) (gatoxomab); IL-33 antibody for COPD (etagerumab); C5 antibody; sentipril combination therapy as monotherapy and in combination with sentipril for myasthenia gravis; paroxysmal nocturnal hemoglobinuria (“PNH”), sentipril combination therapy (pazelimab); Bet v1 multi-antibody therapy for birch allergy; antibody that binds to and inhibits vascular endothelial growth factor (VEGF)-F and angiopoietin-2 (Ang-2) (faricimab-svoa; VABYSMO).

[0226] Depending on the drug to be delivered, the product container (e.g., syringe) described herein may have any suitable volume. For example, the volume of the product container (e.g., syringe) may range from about 1 mL to about 50 mL, from about 2 mL to about 10 mL, from about 3 mL to about 6 mL, or from about 2 mL to about 5 mL. In other instances, the volume of the product container (e.g., syringe) may be greater than or equal to about 1 mL, greater than or equal to about 1.25 mL, greater than or equal to about 1.5 mL, greater than or equal to about 1.75 mL, greater than or equal to about 2 mL, greater than or equal to about 2.25 mL, greater than or equal to about 2.5 mL, greater than or equal to about 2.75 mL, greater than or equal to about 3 mL, greater than or equal to about 3.25 mL, greater than or equal to about 3.5 mL, greater than or equal to about 3.75 mL, or greater than or equal to about 4 mL. In some instances, the product container (e.g., syringe) may have a volume greater than or equal to about 10 mL or greater than or equal to about 15 mL.

[0227] The device disclosed herein can also be configured to deliver additional components to and / or around a patient's injection site. For example, the additional components may include at least one of a membrane (e.g., a liquid bandage or surgical adhesive), an antibacterial agent, or an anesthetic. In some instances, a liquid bandage may be applied to and / or around a patient's injection site. The liquid bandage may include a polymer dissolved in a solvent carrier (e.g., water or alcohol). When the solvent carrier evaporates, the liquid bandage can protect the skin at and / or around the injection site by forming a polymer film on and / or around the injection site. In some instances, a membrane (e.g., a liquid bandage or surgical adhesive) may be combined with at least one of an antibacterial agent and an anesthetic agent and applied to and / or around a patient's injection site. Such components described above may be delivered to and / or around a patient's injection site before and / or after drug delivery. In other instances, such components may be delivered to and / or around a patient's injection site after drug delivery and before the locking configuration of the device. In some embodiments, the device disclosed herein may deliver a membrane to and / or around a patient's injection site after drug delivery and before the locking configuration of the device. Such additional components may be stored in the product container of the device disclosed herein, such as a syringe. In other instances, any additional components may be stored in cap 232. In some instances, the device disclosed herein may include at least one additional compartment, such as a chamber, to accommodate any additional components.

[0228] The components of the device described herein can be made of any suitable material, and each component can be made of the same or different material as the other components. For example, one or more components can be made of materials including polymers, such as plastics. In some embodiments, one or more components can include a variety of different materials, such as glass, plexiglass, any other suitable polymer or copolymer, plastic, or rubber. In some embodiments, a portion of a product container configured to contain a formulated pharmaceutical substance can be made of a transparent or translucent material. In some embodiments, the components of the device can be made of materials each having similar or different hardness. In some embodiments, the components can include elastic materials. For example, a deflectable or flexible component can be made of a material having some degree of flexibility to allow deflection, for example. One or more of the materials listed above (e.g., plastics, rubber, polymers, or copolymers) can have such properties.

[0229] The above descriptions and examples are illustrative and not intended to be limiting. Many modifications and / or alterations can be made by those skilled in the art without departing from the overall scope of the invention. For example, and as already referenced, aspects of the above embodiments can be used with each other in any suitable combination. Furthermore, portions of the above embodiments can be removed without departing from the scope of the invention. Additionally, modifications can be made without departing from its scope to adapt particular situations or aspects to the teachings of various embodiments. Many other embodiments will also be apparent to those skilled in the art upon reading the above description.

[0230] The embodiments of this disclosure may include the following features:

[0231] Item 1. A drug delivery device, the device comprising: shell; A cap located at the proximal end of the housing, the cap comprising a first pair of deflectable arms and a second pair of deflectable arms; A product container arranged in the housing, and a needle attached to the distal end of the product container; A plunger rod for dispensing product from the product container, wherein the plunger rod is slidably received within the cap and partially disposed within the product container; and A needle cap, at least partially disposed within the housing, The first pair of deflectable arms is configured to deflect radially inward toward the plunger rod, and the second pair of deflectable arms is configured to deflect radially outward away from the plunger rod.

[0232] Item 2. The device as described in Item 1, wherein the needle cap includes a pair of openings for receiving the first pair of deflectable arms.

[0233] Item 3. The device as described in Item 1, wherein the needle cap includes a pair of openings for receiving the first pair of deflectable arms.

[0234] Item 4. The device as described in Item 1, wherein the needle cap includes a pair of openings for receiving the first pair of deflectable arms.

[0235] Item 5. The item as claimed in claim 4, wherein the device is configured to The system transitions from a first state to a second state, in which the first pair of deflectable arms are received within a portion of the needle cap. In the second state, the first pair of deflectable arms are radially inwardly deflected toward the plunger rod to be received in the first recess, wherein the spring is configured to move the plunger rod into the needle cap and to... In the third state, the first pair of deflectable arms are in a relaxed position, wherein the first pair of deflectable arms restrict the proximal movement of the needle cap in the third state, and the proximal end of the needle cap is located distal to the first pair of deflectable arms.

[0236] Item 6. The device as described in Item 5, wherein the first pair of deflectable arms is configured to generate audible feedback once the first pair of deflectable arms are in the relaxed position of the third state of the device.

[0237] Item 7. The apparatus as described in Item 4, wherein the apparatus is configured to The transition from the first state to the second state occurs when, in the first state, the second pair of deflectable arms abut against the proximal end of the product vessel and are aligned with the first notch. In the second state, the second pair of deflectable arms deflect radially outward, and transform to... In the third state, the second pair of deflectable arms are aligned with the second notch within the plunger rod.

[0238] Item 8. The apparatus of Item 7, wherein, in the first state, the second pair of deflectable arms restricts the movement of the plunger rod in the distal direction and prevents the movement of the plunger rod in the proximal direction, and wherein, in the second state, the deflected second pair of deflectable arms allows the movement of the plunger rod.

[0239] Item 9. The apparatus of Item 7, wherein the transition of the second pair of deflectable arms to the third state generates audible feedback.

[0240] Item 10. A drug delivery device, the device comprising: A housing including a cap and a flange, the cap including a plurality of deflectable arms configured to attach the cap to the flange; A product container arranged in the housing, and a needle attached to the distal end of the product container; A plunger rod for dispensing product from the product container; and The needle cap is at least partially disposed within the housing.

[0241] Item 11. The apparatus of Item 10, wherein the plurality of deflectable arms includes a first pair of deflectable arms and a second pair of deflectable arms.

[0242] Item 12. The device as described in Item 10, wherein the needle cap includes an indicator portion for signaling the end of drug administration.

[0243] Item 13. The apparatus of Item 10, wherein the product vessel has a deliverable volume in the range of about 1 mL to about 3 mL.

[0244] Item 14. The apparatus of Item 10, wherein the product vessel comprises at least one of a pharmaceutical agent, an antimicrobial agent, an anesthetic agent, or a combination thereof.

[0245] Item 15. The apparatus as described in Item 10 further includes at least one acoustic feedback mechanism.

[0246] Item 16. A drug delivery device, the device comprising: shell; A cap located at the proximal end of the housing, the cap comprising a first pair of deflectable arms and a second pair of deflectable arms; A product container arranged in the housing, and a needle extending from the distal end of the product container; A plunger rod for dispensing product from the product vessel, the plunger rod including at least one notch located on a distal portion of the plunger rod, wherein the at least one notch is configured to receive one of the second pair of deflectable arms; A needle cap, at least partially disposed within the housing, includes at least one opening configured to receive one of the first pair of deflectable arms; and A tip cap that is removably attached to the distal end of the needle cap and located at the distal end of the needle cap.

[0247] Item 17. The device of Item 16 further includes a needle guard removably coupled to and located at the distal end of the needle cap, wherein the tip cap surrounds the needle guard.

[0248] Item 18. The device as described in Item 17, wherein the tip cap includes a plurality of clips for attaching to a portion of the needle guard.

[0249] Item 19. The apparatus as described in Item 16, wherein the product vessel has a range of about 2 mL to about 3 mL.

[0250] Item 20. The apparatus of Item 16, wherein the product vessel comprises at least one of a pharmaceutical agent, an antimicrobial agent, an anesthetic agent, or a combination thereof.

Claims

1. A drug delivery device, the device comprising: shell; A cap located at the proximal end of the housing, the cap comprising a first pair of deflectable arms and a second pair of deflectable arms; A product container arranged in the housing, and a needle attached to the distal end of the product container; A plunger rod for dispensing product from the product container, wherein the plunger rod is slidably received within the cap and partially disposed within the product container; and A needle cap, at least partially disposed within the housing, The first pair of deflectable arms is configured to deflect radially inward toward the plunger rod, and the second pair of deflectable arms is configured to deflect radially outward away from the plunger rod.

2. The device of claim 1, wherein the needle cap includes a pair of openings for receiving the first pair of deflectable arms.

3. The apparatus of claim 1, wherein the plunger rod includes a first notch located at a distal portion of the plunger rod and a second notch located at a proximal portion of the plunger rod.

4. The device of claim 3, wherein the device includes a spring disposed within the housing to facilitate distal movement of the needle cap.

5. The apparatus of claim 4, wherein the apparatus is configured to The system transitions from a first state to a second state. In the first state, the first pair of deflectable arms are received within a portion of the needle cap, wherein the first pair of deflectable arms restrict distal movement of the needle cap in the first state. In the second state, the first pair of deflectable arms are radially inwardly deflected toward the plunger rod to be received in the first recess, wherein the spring is configured to move the needle cap distally and to... In the third state, the first pair of deflectable arms are in a relaxed position, such that the first pair of deflectable arms restrict the proximal movement of the needle cap, and the proximal end of the needle cap is located distal to the first pair of deflectable arms.

6. The apparatus of claim 5, wherein the first pair of deflectable arms is configured to generate audible feedback once the first pair of deflectable arms are in the relaxed position of the third state of the apparatus.

7. The apparatus of claim 3, wherein the apparatus is configured to The transition from the first state to the second state occurs when, in the first state, the second pair of deflectable arms abut against the proximal end of the product vessel and are aligned with the first notch. In the second state, the second pair of deflectable arms deflect radially outward, and transform to... In the third state, the second pair of deflectable arms are aligned with the second notch within the plunger rod.

8. The apparatus of claim 7, wherein, In the first state, the second pair of deflectable arms restricts the movement of the plunger rod in the distal direction and prevents the movement of the plunger rod in the proximal direction, and in the second state, the deflected second pair of deflectable arms allows the movement of the plunger rod.

9. The apparatus of claim 7, wherein the transition of the second pair of deflectable arms to the third state generates audible feedback.

10. A drug delivery device, the device comprising: A housing including a cap and a flange, the cap including a plurality of deflectable arms configured to attach the cap to the flange; A product container arranged in the housing, and a needle attached to the distal end of the product container; A plunger rod for dispensing product from the product container; and The needle cap is at least partially disposed within the housing.

11. The apparatus of claim 10, wherein the plurality of deflectable arms comprises a first pair of deflectable arms and a second pair of deflectable arms.

12. The device of claim 10, wherein the needle cap includes an indicator portion for signaling the end of drug administration.

13. The apparatus of claim 10, wherein the product vessel has a deliverable volume in the range of about 1 mL to about 3 mL.

14. The apparatus of claim 10, wherein the product container comprises at least one of a pharmaceutical agent, an antibacterial agent, an anesthetic agent, or a combination thereof.

15. The apparatus of claim 10, further comprising at least one acoustic feedback mechanism.

16. A drug delivery device, the device comprising: shell; A cap located at the proximal end of the housing, the cap comprising a first pair of deflectable arms and a second pair of deflectable arms; A product container arranged in the housing, and a needle extending from the distal end of the product container; A plunger rod for dispensing product from the product vessel, the plunger rod including at least one notch located on a distal portion of the plunger rod, wherein the at least one notch is configured to receive one of the second pair of deflectable arms; A needle cap, at least partially disposed in the housing, includes at least one opening configured to receive one of the first pair of deflectable arms; and A tip cap that is removably attached to the distal end of the needle cap and located at the distal end of the needle cap.

17. The apparatus of claim 16, further comprising a needle guard removably coupled to and located at the distal end of the needle cap, wherein the tip cap surrounds the needle guard.

18. The device of claim 17, wherein the tip cap includes a plurality of clips for attaching to a portion of the needle guard.

19. The apparatus of claim 16, wherein the product vessel has a volume in the range of about 2 mL to about 3 mL.

20. The apparatus of claim 16, wherein the product container comprises at least one of a pharmaceutical agent, an antibacterial agent, an anesthetic agent, or a combination thereof.

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