Needle shield remover, drug delivery device, and related methods

Abstract

A needle sheath remover, a drug delivery device, and an associated method are provided. The needle sheath remover includes a tubular body formed of a sheet and a closure having a plurality of teeth and a plurality of grooves. The teeth extend laterally outward from a longitudinal edge of the sheet, and the grooves extend laterally inward from a second longitudinal edge of the sheet into the sheet material. The teeth are frictionally received within the grooves to thereby hold the body in the tubular configuration. The needle sheath remover may further include a first plurality of barbs and a second plurality of barbs arranged around the circumference of the body adjacent to a first end of the body, and the second plurality of barbs arranged around the circumference of the body adjacent to a second end of the body.

Description

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 960,463, filed January 13, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to drug delivery devices, and more specifically to devices for automatically injecting drugs into patients. Background Technology

[0003] The widespread aversion to exposed needles, along with health and safety concerns, has spurred the development of drug delivery devices that conceal needles or other insertion components before use and automate various aspects of the injection process. Such devices offer several advantages compared to traditional forms of drug delivery, including, for example, delivery via conventional syringes.

[0004] Drug delivery devices can incorporate various mechanisms to achieve a range of automation features. These features include automatic needle covering before and / or after delivery, providing the user with an interface to enable the drive mechanism, and informing the user that drug delivery is complete. Typically, drug delivery devices combine individual or independently operable mechanisms to achieve each of their automation features. Therefore, with each additional function, the mechanical complexity of the device tends to increase. This can, in turn, increase the size of the device, potentially making it cumbersome for the user to handle, and increase manufacturing costs and time. With the growing demand for easier-to-use and safer drug delivery devices, finding ways to incorporate more automation features without unduly increasing the complexity of the drug delivery device presents various design and manufacturing challenges.

[0005] This disclosure describes a drug delivery device that embodies an advantageous alternative to existing drug delivery devices and can address one or more of the challenges or needs mentioned herein. Summary of the Invention

[0006] According to a first aspect, a needle shield remover is described, comprising a body having a tubular configuration having a first end and a second end, wherein the body is formed of a sheet of material having opposing first and second longitudinal edges. The needle shield remover further includes a closure configured to join the first and second longitudinal edges together to form the tubular configuration of the body. The closure includes a plurality of teeth extending laterally outward from the first longitudinal edge and a plurality of grooves extending laterally inward from the second longitudinal edge into the sheet of material.

[0007] In some forms, the needle shroud remover may include a first plurality of barbs and a second plurality of barbs arranged around the circumference of the body adjacent to a first end, and the second plurality of barbs arranged around the circumference of the body adjacent to a second end. In other forms, each of the first plurality of barbs and the second plurality of barbs may extend within an opening in the body and include a distal end with laterally spaced pointed tips, and / or the first plurality of barbs and the second plurality of barbs may extend inwardly into the body.

[0008] In some forms, the plurality of teeth may extend substantially perpendicularly away from the first longitudinal edge; and the plurality of grooves may extend along an axis at an angle relative to the second longitudinal edge, such that the plurality of teeth bend as each respective tooth enters a corresponding groove among the plurality of grooves. In other forms, each of the plurality of teeth may include an associated cut portion configured to release stress within the material caused by the bending of the plurality of teeth. In some examples, the cut portion may be located in the edge of each of the plurality of teeth or in the corner between each of the plurality of teeth and the first longitudinal edge. In other forms, the plurality of grooves may extend along an axis at an angle between 5 degrees and 20 degrees relative to the second longitudinal edge, and / or the axes of the plurality of grooves may be staggered to extend above and below a horizontal line extending between the first and second longitudinal edges.

[0009] According to a second aspect, an auto-injector drug delivery device is described, comprising: a housing; a drug container coupled to the housing, wherein the drug container includes a needle; a needle guard at least partially disposed over the distal end of the needle in the drug container; and a removable cap coupled to the housing. The auto-injector drug delivery device further includes a needle guard remover coupled to the removable cap and the needle guard, such that disconnection of the removable cap from the housing removes the needle guard from the needle in the drug container. The needle guard remover includes: a body having a tubular configuration having a first end and a second end, the body being formed of a sheet of material having opposite first and second longitudinal edges; and a closure connecting the first and second longitudinal edges together to form the tubular configuration of the body. The closure includes a plurality of teeth and a plurality of grooves, the plurality of teeth extending laterally outward from a first longitudinal edge and the plurality of grooves extending laterally inward from a second longitudinal edge into the sheet material, wherein the plurality of grooves receive the plurality of teeth to join the first longitudinal edge and the second longitudinal edge together.

[0010] In some forms, the needle shroud remover may include a first plurality of barbs and a second plurality of barbs arranged around the circumference of the body adjacent to a first end, and the second plurality of barbs arranged around the circumference of the body adjacent to a second end, wherein the first plurality of barbs grips the removable cap, and the second plurality of barbs grips the needle shroud. In other forms, each of the first plurality of barbs and the second plurality of barbs may extend within an opening in the body and include a distal end with laterally spaced pointed tips, and / or the first plurality of barbs and the second plurality of barbs may extend inwardly into the body.

[0011] In some forms, the removable cover may include a central wall configured to be gripped by a first plurality of barbs, and in other forms, the removable cover may include an annular wall spaced outward from the central wall, the annular wall being configured to engage the outer surface of a first end of the body.

[0012] These types of closures can have configurations according to any of the above configurations. Additionally, any of the above-described needle shield removers can be symmetrical about a horizontal plane extending through the midpoint of the body about a longitudinal axis perpendicular to the body.

[0013] According to a third aspect, a method for forming a needle shroud remover from a metal strip is described. The method includes: forming a sheet from the metal strip having a first longitudinal edge, a second longitudinal edge, and an end edge, wherein the sheet includes a closure for the needle shroud remover, the closure including a plurality of teeth and a plurality of grooves, the plurality of teeth extending laterally outward from the first longitudinal edge, and the plurality of grooves extending laterally inward from the second longitudinal edge into the sheet. The method further includes: forming a first plurality of barbs across the width of the metal strip; forming a second plurality of barbs across the width of the metal strip; and creating a tubular form from the sheet by forcing the plurality of teeth into the plurality of grooves.

[0014] In some forms, multiple toothed elements may extend substantially perpendicularly away from the first longitudinal edge, multiple grooves may extend along an axis at an angle relative to the second longitudinal edge, and the method may include producing a tubular form from a sheet by bending multiple toothed elements as each respective toothed element enters a corresponding groove in the multiple grooves.

[0015] In some forms, the method may include stamping guide holes in the metal travel to form a cut pattern of closure, a first plurality of barbs, and a second plurality of barbs. Attached Figure Description

[0016] Figure 1 This is a perspective view of a drug delivery device according to various embodiments of the present disclosure.

[0017] Figure 2yes Figure 1 A cross-sectional view of the drug delivery device in the image.

[0018] Figure 3 yes Figure 2 A disassembled and assembled view of the drug delivery device.

[0019] Figure 4 This is a side elevation view of an exemplary needle shield remover according to various embodiments of this disclosure.

[0020] Figure 5 yes Figure 4 Front elevation view of the needle guard remover.

[0021] Figure 6 This is a perspective view of a second exemplary needle shield remover according to various embodiments of the present disclosure, showing a closure holding the needle shield remover in a tubular configuration.

[0022] Figure 7 yes Figure 6 A perspective view of a needle shield remover, showing the closure in an open configuration.

[0023] Figure 8 yes Figure 6 A cross-sectional view of the first exemplary toothed configuration of the closure member.

[0024] Figure 9 yes Figure 6 A second exemplary toothed configuration of the closure and a cross-sectional view of the groove of the closure.

[0025] Figure 10 yes Figure 6 A cross-sectional view of a first exemplary barb configuration of a needle guard remover.

[0026] Figure 11 yes Figure 6 A cross-sectional view of a second exemplary barb configuration of the needle guard remover.

[0027] Figure 12 yes Figure 6 A cross-sectional view of a third exemplary barb configuration of a needle guard remover.

[0028] Figure 13 yes Figure 6 A cross-sectional view of a fourth exemplary barb configuration of a needle guard remover.

[0029] Figure 14 yes Figure 6 A cross-sectional view of the fifth exemplary barb configuration of the needle guard remover.

[0030] Figure 15Various embodiments based on this disclosure Figure 6 A cross-sectional view of the needle guard remover installed on a removable cap for a drug delivery device.

[0031] Figure 16 yes Figure 15 A cross-sectional view of the needle shield remover and removable cap.

[0032] Figure 17 It is used to form Figure 6 An exploded perspective view of the punching tool for the needle guard remover.

[0033] Figure 18 yes Figure 17 A three-dimensional view of the stamping tool.

[0034] Figure 19 It is a material sheet having a first barb array and a second barb array, and formed therein to produce Figure 6 A perspective view of the closure of the needle guard remover;

[0035] Figure 20 yes Figure 19 A three-dimensional view of a sheet material, wherein the first barb array and the second barb array are bent upwards.

[0036] Figure 21 It is configured to make Figure 19 A three-dimensional diagram of a tool station for bending sheet material into a tubular shape.

[0037] Figure 22 yes Figure 21 A perspective view of the bottom mold of the tooling station, showing the material sheet being formed into... Figure 6 Needle sheath remover. Detailed Implementation

[0038] This disclosure generally relates to drug delivery devices that can be operated by a user to administer medication or, in the case of a patient, self-administer medication. Various features are disclosed to facilitate safe and proper manipulation of the drug delivery device, including manipulation of the device after it has been used to deliver its effective carrier. Such features include, but are not limited to, indicators signaling to the user that drug delivery is complete, and actuation mechanisms activated by pressing the drug delivery device against the injection site on the patient's skin. These and other features work together and / or interact with each other in a synergistic manner to limit the number and / or complexity of the moving parts of the drug delivery device. Furthermore, some features described herein are actuated using a biasing force applied by a plunger biasing member and / or a guard biasing member, thereby reducing any force that must be applied by the user and / or reducing the need for a dedicated energy source to implement the features. These and other advantages will be apparent to those skilled in the art upon review of this disclosure.

[0039] Figures 1 to 3 Several views are shown of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a pharmaceutical agent or drug product. The drug product may be, but is not limited to, various biological agents, such as peptides, peptide bodies, or antibodies. The drug product may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0040] Various implementations and configurations of the drug delivery device 10 are possible. This embodiment of the drug delivery device 10 is configured as a disposable syringe. In other embodiments, the drug delivery device 10 may be configured as a reusable syringe for multiple uses. The drug delivery device 10 is operable for self-administration by a patient or by a caregiver or a formally trained healthcare provider (e.g., a physician or nurse). This embodiment of the drug delivery device 10 takes the form of an auto-injector or a pen-type syringe and can therefore be held in the user's hand for the duration of drug delivery.

[0041] The configuration of the various components included in the drug delivery device 10 may depend on the operational state of the drug delivery device 10. The drug delivery device 10 may have a pre-delivery or storage state, a delivery or administration state, and a post-delivery state, but fewer or more states are also possible. The pre-delivery state may correspond to the configuration of the drug delivery device 10 after assembly and before it is activated by the user. In some embodiments, the pre-delivery state may exist between the time the drug delivery device 10 leaves the manufacturing facility and the time the patient or user activates the drive mechanism 30 of the drug delivery device 10. This includes the time after the user removes the drug delivery device 10 from any secondary packaging and before positioning the drug delivery device 10 against the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 during drug delivery (also referred to herein as administration). The post-delivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is completed and / or when the stopper is positioned at the end-of-administration position in the drug storage container.

[0042] The drug delivery device 10 includes a housing or casing 12. In some embodiments, the size and dimensions of the casing 12 may be determined to allow a person to hold the syringe 10 with one hand. The casing 12 may have a generally elongated shape, such as a cylindrical shape, and extend along a longitudinal axis A between the proximal and distal ends. An opening 14 may be formed in the distal end to allow the insertion end 28 of the delivery member 16 to extend outside the casing 12. A transparent or translucent inspection window 17 may be positioned in the wall of the casing 12 to allow the user to observe the internal components(s) of the drug delivery device 10, including the drug storage container 20. Observing the drug storage container 20 through the window 17 may allow the user to confirm that drug delivery is in progress and / or has been completed. A removable cap 19 may cover the opening 14 before the drug delivery device 10 is used, and in some embodiments, a gripper 13 may be included that is configured to assist in removing a sterile barrier 21 (e.g., a rigid needle shield (RNS) or a flexible needle shield (FNS)) mounted on the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting barbs or arms that frictionally or otherwise mechanically engage the sterile barrier 21 when the user separates the removable cover 19 from the housing 12, thereby pulling the sterile barrier 21 together with the removable cover 19. Thus, removing the removable cover 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0043] In this embodiment, the housing 12 is defined by three independent and interconnected structures: a rear end cap 23 at the proximal end of the drug delivery device 10; a front housing 25 at the distal end of the drug delivery device 10 and including an opening 14; and a rear housing 27 located between the rear end cap 23 and the front housing 25 and rigidly connecting the two. The front housing 25 and the rear housing 27 may each have a hollow and generally cylindrical or tubular shape, and the rear end cap 23 may have a generally hemispherical or hollow cylindrical shape, having an open end and a closed end. In some embodiments, the rear end cap 23, and the rear housing 27, and any components to be positioned therein, may be assembled together to define a rear subassembly. Simultaneously, the front housing 25 and any components to be positioned therein may be assembled together to define a front subassembly. In some embodiments, the rear subassembly and the front subassembly are assembled independently of each other and then combined with each other and with the drug storage container 20 to form a fully assembled drug delivery device 10. In some such embodiments, some or all of the above assembly stages may be performed in different manufacturing facilities or environments. In an alternative embodiment, the housing 12 may be constructed as a single piece, such that the housing 12 is defined by a single integral structure.

[0044] A drug storage container 20 is disposed within the internal space of the housing 12 and configured to contain a drug 22. The drug storage container 20 may be pre-filled and transported by the manufacturer, for example, to a location where it will be combined with the rest of the drug delivery device 10. The housing 12 may be pre-loaded with the drug storage container 20 by the manufacturer, or alternatively, by the user before using the drug delivery device 10. The drug storage container 20 may include a rigid wall defining an internal orifice or reservoir. This wall may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 such that the stopper is movable distally along a longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be constructed of rubber or any other suitable material. The stopper 24 may slidably and sealingly contact the internal surface 15 of the wall of the drug storage container 20 such that movement of the stopper 24 prevents or inhibits leakage of the drug 22 through the stopper 24. The distal movement of the stopper 24 displaces the drug 22 from the reservoir of the drug storage container 20 into the delivery member 16. The proximal end of the drug storage container 20 may be open to allow the plunger 26 to extend into the drug storage container 20 and push the stopper 24 distally. In this embodiment, the plunger 26 and the stopper 24 are initially spaced apart by a gap. When the drive mechanism 30 is activated, the plunger 26 moves distally to close the gap and contact the stopper 24. The subsequent distal movement of the plunger 26 drives the stopper 24 distally to displace the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially contact each other or be coupled to each other, for example via a threaded connection, such that they can move together from the moment the plunger 26 begins to move. Once the stopper 24 has moved, it may continue to move distally until it contacts the proximal portion of the inner surface 15 of the wall of the drug storage container 20. This position of the stopper 24 can be referred to as the end of administration or delivery end position, and can correspond to the time when the delivery of the drug 22 to the patient is completed or substantially completed.

[0045] In some embodiments, the volume of drug 22 contained in the reservoir of drug storage container 20 may be equal to 1 mL, or equal to about (e.g., ±10%) 1 mL, or equal to 2.5 mL, or equal to about (e.g., ±10%) 2.5 mL, or less than or equal to about (e.g., ±10%) 2 mL, or less than or equal to about (e.g., ±10%) 3 mL, or less than or equal to about (e.g., ±10%) 4 mL, or less than about (e.g., ±10%) 5 mL, or less than or equal to about (e.g., ±10%) 10 mL, or in the range of about (e.g., ±10%) 1-10 mL, or in the range of about (e.g., ±10%) 1-5 mL, or in the range of about (e.g., ±10%) 1-4 mL, or in the range of about (e.g., ±10%) 1-3 mL, or in the range of about (e.g., ±10%) 1-2.5 mL.

[0046] The delivery member 16 is connected or operable to be connected in fluid communication with a reservoir of the drug storage container 20. The distal end of the delivery member 16 may define an insertion end 28. The insertion end 28 may include a sharp tip with other pointed geometries, thereby allowing the insertion end 28 to pierce the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and have internal passageways. One or more openings may be formed in the insertion end 28 to allow drug to flow from the delivery member 16 into the patient.

[0047] In this embodiment, the drug storage container 20 is a pre-filled syringe with a posted hollow metal needle for the delivery member 16. Here, the needle is fixed relative to the wall of the drug storage container 20 and is in permanent fluid communication with the reservoir of the drug storage container 20. In other embodiments, the drug storage container 20 may be a needleless cartridge, thus initially not in fluid communication with the delivery member 16. In such embodiments, during operation of the drug delivery device 10, the drug storage container 20 may be moved toward the proximal end of the delivery member 16, or vice versa, such that the proximal end of the delivery member 16 penetrates a diaphragm covering an opening in the drug storage container 20, thereby establishing fluid communication between the reservoir of the drug storage container 20 and the delivery member 16.

[0048] The drug storage container 20 can be fixed relative to the housing 12 such that once installed in the housing 12, it will not move relative to the housing 12. Thus, in the pre-delivery, delivery, and post-delivery states, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 in the housing 12. In this embodiment, a container holder 31 secures the position of the drug storage container 20 within the housing 12. The container holder 31 may be hollow and generally cylindrical or tubular in shape, and the drug storage container 20 may be partially or completely disposed within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33 abutting against the neck of the drug storage container 20 to prevent distal movement of the drug storage container 20. The container holder 31 can be fixedly attached to the housing 12 such that movement of the container holder 31 relative to the housing 12 is prevented during operation of the drug delivery device 10.

[0049] In alternative embodiments, the drug storage container 20 may be movably coupled to the housing 12, allowing the drug storage container 20 to move relative to the housing 12 during operation of the drug delivery device 10. In some such alternative embodiments, in a pre-delivery state, the insertion end 28 of the delivery member 16 may retract into the opening 14 in the housing 12. Subsequently, during operation of the injection device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 in the housing 12 for insertion into the patient. In some embodiments, this movement may result from the drug storage container 20 being driven distally relative to the housing 12.

[0050] The plunger 26 may be hollow and generally cylindrical or tubular in shape. The plunger 26 may include an annular wall 39 having an outer surface 41 and an inner surface 43. The inner surface 43 may define an internal space whose size is determined to accommodate the plunger biasing member 50 therein. It is generally desirable to minimize the thickness of the annular wall 39 to the extent possible, without compromising the integrity of the plunger 26, in order to maximize the inner diameter of the plunger 26. This allows a larger diameter plunger biasing member 50 to be fitted within the internal space of the plunger 26, which in turn allows for a more powerful plunger biasing member 50. As described in more detail below, the plunger 26 may be configured to selectively rotate relative to the housing 12 and translate linearly relative to the housing 12 during operation of the drug delivery device 10.

[0051] The plunger 26 may be constructed from multiple interconnected components or alternatively have a one-piece construction. In this embodiment, the plunger 26 is constructed from three separate and interconnected structures: a top ring 45 defining the proximal end of the plunger 26; a base 47 defining the distal end of the plunger 26; and a hollow rod 46 located between the top ring 45 and the base 47 and rigidly connecting the two. The positions of the top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other, such that these components are immovable relative to each other. The top ring 45, the hollow rod 46, and the base 47 may each have an annular construction centered on the longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a corresponding central opening extending from one end of the component to the other end to define an axial chamber; while the base 47 may have a central opening extending through the proximal end of the base 47 but closed at the distal end of the base 47. The closed end of the base 47 may define a base or abutment surface of the plunger biasing member 50. In an alternative embodiment, the central opening may extend through the base 47 from one end to the other. In such an alternative embodiment, the inner diameter of the central opening of the base 47 may be smaller than the outer diameter of the plunger biasing member 50, such that the base 47 retains the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is activated, the base 47 may be the portion of the plunger 46 that contacts the plug 24 to push the plug 24 distally.

[0052] The top ring 45 may include one or more flanges or protrusions 48 extending radially outward from a central portion of the top ring 45. Each of these protrusions 48 may include a distally facing cam surface 49. As described in more detail below, the distally facing cam surface 49 may interact with a mating cam surface on the plunger guide 60 to release the plunger biasing member 50. In some embodiments, the distally facing cam surface 49 may be arranged at an angle to or not parallel to an imaginary plane perpendicular to the longitudinal axis A.

[0053] In some embodiments, the top ring 45 and / or the base 47 may be made of a material different from that of the hollow rod 46. In some embodiments, the top ring 45 and / or the base 47 may be made of plastic, while the hollow rod 46 may be made of metal. This configuration allows the plastic material for the top ring 45 to facilitate the cam action described below by providing sliding friction, and the plastic material for the base 47 to help absorb or dampen any impacts or vibrations associated with the base 47 striking the plug 24. The metal material for the hollow rod 46 may provide sufficient stiffness to prevent buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, the hollow rod 46, and / or the base 47 may be made of the same material, including, for example, metal or plastic. In some such embodiments, the top ring 45, the hollow rod 46, and the base 47 may be integrally formed in one piece to define a single integral structure.

[0054] The drug delivery device 10 may further include a protective mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not used for injection. The protective mechanism may include a protective member 32 movably disposed at the distal end of the housing 12, adjacent to the opening 14. The protective member 32 may be hollow and generally cylindrical or tubular in shape centered on a longitudinal axis A, and may have a proximal end received within the housing 12. The protective member 32 may be configured to move relative to the housing 12 between an extended position and a retracted position, in which the distal end of the protective member 32 extends through the opening 14 in the housing 12, and in the retracted position, the distal end of the protective member 32 is fully or partially retracted into the opening 14 in the housing 12. Additionally or alternatively, the protective member 32 may be configured to move from the retracted position to the extended position. When moved from the extended position to the retracted position, the protective member 32 can be linearly translated proximally; and when moved from the retracted position to the extended position, the protective member 32 can be linearly translated distally. At least in the extended position, the protective member 32 can extend beyond and surround the insertion end 28 of the delivery member 16. In embodiments where the delivery member 16 protrudes from the opening 14 in the housing 12 in a pre-delivery or storage state, moving the protective member 32 from the extended position to the retracted position (e.g., by pressing the distal end of the protective member 32 against the injection site on the patient's skin) allows the insertion end 28 of the delivery member 16 to be inserted into the patient's skin.

[0055] For example, the delivery device 10 can utilize an inertial-driven design instead of a spring-driven design to insert the needle into the patient's subcutaneous tissue. As a more specific example, when the patient presses the distal end of the protective member 32 against the injection site on the patient's skin, the housing 12 of the delivery device 10 can advance toward the injection site. When the patient presses down a predetermined distance or with a predetermined force, the delivery device 10 achieves a rapid release to utilize energy stored in the patient's muscles, while compressing the needle sheath and its spring to a defined release point. The release mechanism is designed such that the achieved needle insertion speed exceeds the patient's reaction speed, and this speed, combined with the mass of the device, allows the needle to penetrate the skin quickly and completely to subcutaneous depth. Compared to known syringes where the entire main container moves forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing and thus provides a simplified and more robust design.

[0056] In some embodiments, the protective member 32 may be fixed in a rotational sense relative to the housing 12. Therefore, while the protective member 32 may be capable of linear translation relative to the housing 12, it can be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 61 may be formed in the wall of the protective member 32 and may be parallel to the longitudinal axis A. The dimensions of each longitudinal slot 61 may be determined to accommodate, either matingly or abuttingly, a protrusion or pin 63 extending radially inward from the front housing 25. When the protective member 32 translates linearly relative to the front housing 25 along the longitudinal axis A, each pin 63 may slidably engage the surface defining the corresponding slot in the longitudinal slot 61. However, the pin 63 abuts against this same surface to prevent rotation of the protective member 32 relative to the front housing 25 when any rotational force is applied to the protective member 32. In alternative embodiments, the pin and slot arrangement may be reversed, such that the protective member 32 has one or more radially outwardly extending pins, while the front housing 25 has one or more slots or other recesses to accommodate, either matingly or abuttingly, the one or more pins.

[0057] The protective mechanism may further include a protective member biasing member 35 and a protective member extension 37. The protective member extension 37 may be positioned proximal to the protective member 32; and the protective member biasing member 35 may be positioned proximal to the protective member extension 37. The protective member extension 37 may have a hollow, generally cylindrical or tubular shape centered on a longitudinal axis A. Furthermore, the protective member extension 37 may be linearly movable relative to the housing 12 along the longitudinal axis A. In this embodiment, the protective member extension 37 is a separate structure from the protective member 32. However, in alternative embodiments, the protective member extension 37 and the protective member 32 may be integrally formed to define a single, unified structure. In such alternative embodiments, the proximal end of the protective member 32 may correspond to the protective member extension 37.

[0058] Similar to the protective member 32, the protective extension 37 can be fixed in a rotational sense relative to the housing 12. Therefore, while the protective extension 37 may be able to translate linearly relative to the housing 12, it can be prevented from rotating relative to the housing 12. To achieve this effect, in some embodiments, one or more longitudinal slots 71 may be formed in the wall of the protective extension 37 and may be parallel to the longitudinal axis A. The dimensions of each longitudinal slot 71 may be determined to accommodate, either matingly or abuttingly, a protrusion or pin (not shown) extending radially inward from the housing 12 (e.g., the rear housing 23 and / or the front housing 25). When the protective extension 37 translates linearly relative to the housing 12 along the longitudinal axis A, each pin may slidably engage the surface defining the corresponding longitudinal slot 71. However, the pin abuts against this same surface to prevent rotation of the protective extension 37 relative to the housing 12 when any rotational force is applied to the protective extension 37. In an alternative embodiment, the pin and slot arrangement may be reversed, such that the protective extension 37 has one or more radially outwardly extending pins, while the housing 12 has one or more slots or other recesses to receive the one or more pins in a mating or close-fitting manner.

[0059] A protective biasing member 35 may be positioned between and in contact with the protective extension 37 and the release member 52. The protective biasing member 35 may be configured to bias or push the protective extension 37 distally and the release member 52 proximally. The protective biasing member 35 may initially be in a stored (e.g., compressed) state, such that, in a pre-delivery state, the protective biasing member applies a biasing force to the protective extension 37 and a biasing force to the release member 52. In some embodiments, the distal end of the protective extension 37 initially contacts the proximal end of the protective member 32, as in... Figure 2As can be seen from this, the protective extension 37 transmits the biasing force of the protective biasing member 35 to the protective member 32, causing the protective biasing member 35 to bias or push the protective member 32 toward the extended position. The user can overcome the biasing force by pressing the protective member 32 against the injection site. In doing so, the protective member 32 and the protective extension 37 move together in the proximal direction until, for example, the protective member 32 reaches the retracted position. When the injection is completed and the drug delivery device 10 is lifted from the injection site, the protective biasing member 35 can push the protective extension 37, causing the protective extension 37 and the protective member 32 to move together in the distal direction. This movement returns the protective member 32 to the extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the protective biasing member 35 may include a compression spring (e.g., a helical compression spring). Furthermore, in embodiments where the plunger biasing member 50 also includes a compression spring, the protective biasing member 35 may be positioned around the plunger biasing member 50 and / or have a larger diameter than the plunger biasing member.

[0060] In an alternative embodiment, the distal end of the protective member extension 37 may initially be spaced apart from the proximal end of the protective member 32 in the proximal direction. Therefore, in the pre-delivery state, the protective member biasing member 35 cannot bias the protective member 32 toward the extended position. Only when the protective member 32 is retracted proximally and contacts the protective member extension 37 can the protective member biasing member 35 apply a biasing force to push it toward the extended position. In such an alternative embodiment, in the pre-delivery state, only the locking ring biasing member 51 described below can be used to bias the protective member 32 toward the extended position.

[0061] After drug delivery is complete and the protective member 32 has been re-extended to the extended position, it may be desirable to lock the protective member 32 in the extended position to prevent the user from subsequently accessing the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. According to these purposes, some embodiments of the drug delivery device 10 may include a locking ring 40 configured to selectively rotate depending on the axial position of the protective member 32, so as to lock the protective member 32 in the extended position once it has been moved from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered on and rotates about a longitudinal axis A. Figure 2As shown, the proximal end of the locking ring 40 can contact the container holder 31, and the distal end of the locking ring 40 can be at least partially disposed within the protective member 32. A locking ring biasing member 51 can be positioned axially between the distally facing surface of the locking ring 40 and the proximal facing surface of the protective member 32. The locking ring biasing member 51 can initially be in a compressed or stored state, such that it biases the locking ring 40 and the protective member 32 away from each other. Thus, the locking ring biasing member 51 can apply a biasing force to push the protective member 32 toward an extended position and apply a biasing force to press the proximal end of the locking ring 40 against the container holder 31. In some embodiments, the locking ring biasing member 51 may include a compression spring (e.g., a helical compression spring).

[0062] Rotation of the locking ring 40 can be achieved via a cam arrangement between the locking ring 40 and the container holder 31. In some embodiments, the proximal end of the locking ring 40 may include one or more cam surfaces 53 configured to slidably engage with one or more corresponding cam surfaces 55 included on the annular inner wall 57 of the front housing 25. The annular inner wall 57 of the front housing 25 may be centered on the longitudinal axis A and may be a radially inward cantilever of the annular outer wall 59 of the front housing 25, such that an annular gap exists between the annular inner wall 57 and the annular outer wall 59 of the front housing 25. This configuration allows the protective member 32 to slide into the annular gap between the inner wall 57 and the outer wall 59 during retraction. In some embodiments, the cam surfaces 53 of the locking ring 40 may have a generally serrated appearance when viewed radially from the longitudinal axis A. Furthermore, the cam surfaces 53 may be arranged around the longitudinal axis A such that each cam surface 53 is located at a different angular position around the longitudinal axis A. Similarly, when viewed radially from the longitudinal axis A, the cam surface 55 on the container holder 31 can have a generally serrated appearance. Furthermore, the cam surfaces 55 can be positioned around the longitudinal axis A such that each cam surface 55 is located at a different angular position around the longitudinal axis A.

[0063] When pressed against each other, cam surfaces 53 and 55 can convert linear motion into a combination of rotational and linear motion. More specifically, as the locking ring 40 moves proximally along the longitudinal axis A, each cam surface in cam surface 53 can slide against a corresponding cam surface in cam surface 55. This interaction converts the proximal linear movement of the locking ring 40 into a combination of rotational movement of the locking ring 40 about the longitudinal axis A and proximal linear movement of the locking ring 40 along the longitudinal axis A. Throughout the movement of the locking ring 40, the annular inner wall 57 of the front housing 25 remains stationary relative to the rest of the front housing 25. This configuration allows the annular inner wall 57 of the front housing 25 to function as a cam, while the locking ring 40 functions as a cam follower.

[0064] The biasing force of the biasing member 35 of the protective member can continuously press the cam surface 53 of the locking ring 40 against the cam surface 55 of the annular inner wall 57. Therefore, the locking ring 40 is continuously advanced to rotate about the longitudinal axis A. However, depending on the relative positions of the various cooperating abutment structures included on the exterior of the locking ring 40 and the interior of the protective member 32, the locking ring 40 may not rotate. Depending on the axial position of the protective member 32, these cooperating abutment structures can engage and / or disengage with each other to allow the locking ring 40 to rotate. In some embodiments, the locking ring 40 can rotate to a final rotated position as the protective member 32 moves from a retracted position to an extended position. In the final rotated position, the distally facing surfaces of one or more abutment structures included on the locking ring 40 can be rotatably aligned with and arranged opposite to the proximal facing surfaces of one or more mating abutment structures included on the protective member 32. Therefore, by means of the distal surface engagement of the plurality of abutment structures included on the locking ring 40 and the proximal surface engagement of the plurality of abutment structures included on the protective member 32, any subsequent movement of the protective member 32 in the proximal direction can be prevented.

[0065] The drug delivery device 10 may further include a drive mechanism 30, partially or completely disposed within the housing 12. Typically, the drive mechanism 30 may be configured to store energy and, when or in response to user activation of the drive mechanism 30, release or output that energy to drive the plunger 26 to expel the drug 22 from the drug storage container 20 through the delivery member 16 into the patient. In this embodiment, the drive mechanism 30 is configured to store mechanical potential energy; however, alternative embodiments of the drive mechanism 30 may be configured differently, for example, wherein the drive mechanism 30 stores electrical or chemical potential energy. Typically, when the drive mechanism 30 is activated, the drive mechanism 30 can convert potential energy into kinetic energy to move the plunger 26.

[0066] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member base 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) initially held in a stored state. In the stored state, the plunger biasing member 50 can be compressed such that its axial length is shorter than in its natural or deactivated state. When released, the plunger biasing member 50 may attempt to extend to its natural axial length, and thus apply a biasing force that pushes the plunger 26 distally.

[0067] A plunger biasing member 50 may be at least partially disposed within the plunger 26 and may have a distal end abutting against the proximal inner surface of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. Such that the plunger biasing member 50 can be received within the plunger 26, the outer diameter or other dimensions of the plunger biasing member 50 may be equal to or less than the inner diameter of the top ring 45 and / or equal to or less than the inner diameter of the hollow rod 46. In some embodiments, the distal end of the plunger biasing member 50 may abut against the proximal inner surface of the base 47 of the plunger 26. Furthermore, the proximal end of the plunger biasing member 50 may abut against the distal surface of the plunger biasing member base 38. The plunger biasing member base 38 may be fixedly attached to the rear housing 27 such that the plunger biasing member base 38 provides a resting surface for pushing the plunger biasing member 50 away. This configuration allows the plunger biasing member 50 to extend in length when released from its stored state by moving its distal end toward a direction distal to the stationary proximal end of the plunger biasing member 50. This movement can push the plunger 26 distally, which in turn can push the stopper 24 distally to expel the drug 22 from the drug storage container 20 into the delivery member 16 and then into the patient.

[0068] The plunger guide 60 can be fixedly attached to the rear housing 27 such that the plunger guide 60 is immovable relative to the rear housing 27. The plunger guide 60 can have a hollow and generally cylindrical or tubular shape, and can be centered on the longitudinal axis A. The outer diameter or other outer dimension of the proximal end of the plunger guide 60 can be larger than the outer diameter or other outer dimension of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 can be radially positioned between the plunger 26 and the release member 52. Thus, the plunger 26 can be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 can be at least partially disposed within the release member 52, such as... Figure 2 As shown.

[0069] exist Figures 4 to 22 An exemplary gripper or needle sheath remover 100 is shown. In each of the exemplary forms, the remover 100 includes a body 102 having a tubular configuration. The body 102 is made of a rectangular sheet 104 of material having a first longitudinal side edge 106 and a second longitudinal side edge 108 and an end edge 110 extending between the side edges 106, 108. Figure 19The tubular configuration of the body 102 is formed by bringing the side edges 106, 108 together and securing the edges 106, 108 together by a closure 112. As shown, the closure 112 includes a plurality of teeth 114 extending outward from the first side edge 106 and a plurality of grooves 116 extending inward from the second side edge 108, wherein the tabs 114 are configured to be inserted into the grooves 116 to thereby hold the sheet 104 in the tubular configuration of the remover 100.

[0070] like Figure 5 and Figure 6 As shown, the remover 100 includes a first barb array 118 extending circumferentially around the body 102, adjacent to a first end edge in the end edge 110, and a second barb array 120 extending circumferentially around the body 102, adjacent to a second end edge in the end edge 110. The first barb array 118 and the second barb array 120 are configured to grip a sterile barrier 21 disposed on the delivery member 16 of the syringe 20, and a removable cap 19, respectively, such that removal of the cap 19 from the device 10 also removes the sterile barrier 21 from the delivery member 16. The first barb array 118 and the second barb array 120 may each be disposed in a plane substantially perpendicular to the longitudinal axis L of the body 102. In one form, the remover 100 may be symmetrical about a central plane extending perpendicular to the longitudinal axis L through the midpoint of the body 102, which advantageously allows the remover 100 to be mounted within the device 10 in any orientation, and the barbs 118, 120 can effectively grip the cap 19 and the sterile barrier 21, respectively. In one manner, the barbs 118, 120 can be formed by creating an opening 122 within the material sheet 104, which shapes the individual barbs 118, 120. The barbs 118, 120 can then be bent radially relative to the longitudinal axis L, such that the barbs 118, 120 grip structures adjacent to the remover 100. As shown, the two arrays of barbs 118, 120 can be bent to extend radially inward into the body 102 of the remover 100, which advantageously prevents the barbs 118, 120 from becoming entangled with each other or wrapped around other structures. This, combined with the symmetrical configuration, allows the remover 100 to be efficiently and effectively assembled into the device 10.

[0071] exist Figure 6 and Figure 7Details of an exemplary configuration for the toothed member 114 and the recess 116 are shown. As illustrated, in this configuration, the toothed member 114 extends perpendicularly away from the first side edge 106, while the recess 116 extends inwardly relative to the second side edge 108 at an angle away from that second side edge. With this configuration, the toothed member 114 bends and flexes as it is forced into the angled configuration of the recess 116. This bending action effectively holds the toothed member 114 within the recess 116, thereby holding the body 102 in a tubular configuration without welding the edges 106, 108 together or otherwise securing them together. In some examples, the recess 116 may extend at an angle between 5 and 20 degrees, between 10 and 20 degrees, or between 15 and 20 degrees relative to the second side edge 108. In the illustrated form, the grooves 116 have an interlaced configuration, such that the grooves 116 extend successively above and below a plane extending vertically through the longitudinal axis L of the body 102 or a horizontal line extending between the first side edge 106 and the second side edge 108. As shown, the toothed member 118 may have a tab-like configuration with generally parallel side edges 124 and rounded ends 126, and the groove 120 may have an opening with a complementary configuration having generally parallel side edges 128 and rounded ends 130, the size of which is determined to frictionally receive one of the teeth of the toothed member 118. Other configurations include all grooves angled in the same direction, and repeating patterns of two or three grooves extending in the same or random directions.

[0072] If expected, such as Figure 8 and Figure 9 As shown, each tooth in the toothed members 118 may include an associated cutout portion 132 on one side of the individual toothed member 118 facing the angled groove 120. This cutout portion is configured to release stress caused by bending and deflection resulting from the insertion of the toothed member 118 into the angled groove 120. In a first embodiment, the cutout portion 132 may be located in the side edge 124 of the toothed member 118, adjacent to the second side edge 108 of the sheet 104, such that the cutout portion 132 extends into the toothed member 118. In a second embodiment, the cutout portion 132 may be located in the corner between the side edge 124 of the toothed member 118 and the second side edge 108 of the sheet 104, such that the cutout portion 132 extends inwardly into both the toothed member 118 and the sheet 104. The cutout portion 132 may have a curved shape, for example, formed by a circular or elliptical punch.

[0073] exist Figures 10 to 14 Exemplary configurations for barbs 118 and 120 are shown. Figure 10 and Figure 11 In the first form shown, the barbs 118, 120 have a pointed configuration with side edges 134 extending to the pointed end 136. In this form, the barbs 118, 120 can be connected along their bottom edges 138 (at which point the barbs 118, 120 are connected to the remainder of the body 102). Figure 10 And / or bend radially inward along the middle edge of the barbs 118, 120 (which extends between the ends of the adjacent pointed ends 136 of the side edges 134) into the interior of the body 102, thereby angled the ends 136 inward. Figure 11 The opening 122 may have a complementary configuration extending around and defining the barbs 118, 120, the complementary configuration having a side portion 142 extending along the side edges 134 of the barbs 118, 120 and a pointed end portion 144 extending around the pointed ends 136 of the barbs 118, 120. Figure 12 In the second form shown, as... Figure 10 and Figure 11 Unlike the pointed end 136 shown, the barbs 118 and 120 can have rounded ends 146, wherein the barbs 118 and 120 are curved inward along the bottom edge 138. Figure 13 In the third form shown, the barbs 118, 120 can have a forked configuration with side edges 148 extending to forked ends 150 including two laterally spaced pointed ends 152. In the shown form, the pointed ends 152 are defined by the side edges 148 and concave curved end edges 154 of the barbs 118, 120, but other configurations of the end edges 154, such as angled portions, can be utilized. Alternatively, the pointed ends 152 can extend outward from the end edges 154. The barbs 118, 120 can be curved inward along the bottom edges 155 of these barbs. The opening 122 of this form can have a complementary configuration extending around and defining the barbs 118, 120, having side portions 156 extending along the side edges 148 of the barbs 118, 120 and rounded end portions 158 defining the curved end edges 154 of the barbs 118, 120. In other versions, barbs 118 and 120 may be configured with ends having three or more pointed tips. In each of the first to third forms, barbs 118 and 120 extend longitudinally along axis L and are oriented inward toward the longitudinal center of body 102. Figure 14In the fourth form shown, the barbs 118, 120 extend at an angle relative to the longitudinal axis L of the body 102 and have a pointed configuration with side edges 160 extending to pointed ends 162. Unlike the symmetrical ends shown in the previous forms, the pointed ends 162 of the barbs 118, 120 in this form are offset in the direction of the midpoint of the body 102, such that the ends 162 are oriented toward the midpoint, and the barbs 118, 120 extend at an angle relative to this midpoint. Due to this configuration, the opening 122 in this form includes side portions 164 of different lengths (i.e., a smaller top portion and a larger bottom portion) and end portions 166 extending at an angle between the ends of the side portions 164.

[0074] exist Figure 15 and Figure 16 An exemplary removable cover 170 is shown, adapted for use as the cover 19 described above. As shown, cover 170 includes an upright annular sidewall 172 and an end wall 174. Sidewall 172 may include an inwardly projecting lip 176 and a boss 178 for engaging with housing 12 of device 10. Cover 170 further includes concentrically disposed annular walls 180, 182 extending upward from end wall 174. Inner wall 180 includes an outwardly projecting lip 184 at its distal end 186 and (if desired) may include an inwardly tapering portion 188 adjacent to lip 184 to provide passage to underside of lip 184. Inner wall 180 is sized to have a radius that fits within cylindrical body 102 of remover 100, such that body 102 can be mounted around inner wall. Advantageously, the lip 184 may project radially outward a distance sufficient to allow the barbs 120 of the remover 100 to protrude beneath the lip, thereby mounting the remover 100 to the cover 170. The outer wall 182 and the inner wall 180 are radially outwardly spaced sufficient to accommodate the body 102 within the distance between the outer and inner walls. With this configuration, the outer wall 182 can support the outer surface of the end of the body 102 and prevent the end of the body 102 from radially deflecting outward, which could occur, for example, when tension is applied to the remover 100 by pulling the cover 170 away from the device 10. Although the depicted cover 170 includes both the inner wall 180 and the outer wall 182, alternative variations include only the inner wall 180 but not the outer wall 182.

[0075] The remover 100 described above can be advantageously used as... Figure 17 and Figure 18The high-speed stamping tool 200 shown is mass-produced. In operation, a metal strip 202 is fed into the tool 200, and the tool 200 performs sequential operations to form features on individual portions of the strip 202 to transform it into a sheet 104, and subsequently forms a body 102 by engaging the teeth 114 and grooves 116 of the closure 112. Accordingly, the tool 200 may include multiple stations 204, and the strip 202 can be fed through the tool 200 such that the stations 204 sequentially operate on the strip 202 to ultimately form an extractor 100. The stations 204 of the tool 200 may be located on three blocks 206, 208, and 210 as shown. Station 204 in the first block 206 uses a punch 212 to create guide holes in the strip 202 to form the following pattern: edges 106, 108, 110 of the sheet 104, toothed elements 114, grooves 116, a first barb array 118 and a second barb array 120, and associated openings 122. Then, subsequent stations 204 in the first block 206 and stations 204 in the second block 208 use the punch 214 to cut the strip 202 to form the sheet 104. Figure 19 The sheet includes toothed members 114, grooves 116, and barbs 118, 120. Guide holes formed in the first block 206 allow the sheet 104 to be formed without substantially deforming the thin metal of the strip 202. Stations 204 in the second block 208 allow the barbs 118, 120 to bend further inward at a desired angle along the bottom edge and / or middle edge as discussed above (e.g., Figure 20 (As shown), then the bending process begins to continue forming a cylindrical shape from the sheet 104. Then, station 204 in the third block 210 fully forms the tubular shape of the body 102 by forcefully forcing the toothed member 114 into the groove 116 to interlock the edges 106, 108. (As shown) Figure 21 and Figure 22 As shown, the station 204, which is configured to bend the body 102 into a cylindrical shape, includes a lower concave mold 216 and an upper convex mold 218, which are configured to be pressed together to thereby bend the sheet 104.

[0076] The cold forming process and the force applied to the sheet 104 to interlock the teeth 114 and grooves 116 can slightly elongate the body 102. For example, the body 102 can be extended by about 0.15 during the forming process. In the form shown, the tool 200 is about 3 feet long and 1.25 feet wide. The tool 200 is configured to receive a supply of a 3-inch wide, 0.078-inch thick metal strip 202. Each time the tool 200 is closed and opened (which corresponds to one stroke), the strip 202 can be moved forward by about 1 inch to align a portion of the strip 202 with the next station 204 in the tool 200. The tool 200 shown includes a total of twenty-two stations 204. However, it should be understood that the tool 204 can have any desired layout and configuration to produce a remover 100 with the features described herein.

[0077] It will be understood that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figures may be enlarged relative to other elements to aid in understanding the various embodiments of the invention. Furthermore, commonly used but easily understood elements that are available or necessary in commercially viable embodiments are generally not drawn to facilitate viewing these various embodiments with less obstruction. The same reference numerals may be used to describe the same or similar parts. Further, while several examples have been disclosed herein, any feature from any example may be combined with or replaced by other features from other examples. Moreover, while several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0078] The above description describes various devices, components, parts, subsystems, and methods used in connection with drug delivery devices. Devices, components, parts, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to those drugs identified below and their class counterparts and biosimilar counterparts. As used herein, the term "drug" is used interchangeably with other similar terms and can be used to refer to any type of pharmaceutical agent or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, tonics, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, peptides, proteins, small molecules, and classifiers. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or in a form that can be reconstructed from lyophilized form. The following exemplary list of drugs should not be considered as all-encompassing or restrictive.

[0079] The medication will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or prefilled with the medication for treatment. This master container can be a vial, cartridge, or prefilled syringe.

[0080] In some embodiments, the reservoir of the drug delivery device may be filled with colony-stimulating factors (such as granulocyte colony-stimulating factor (G-CSF)), or the device may be used in conjunction with colony-stimulating factors. Such G-CSF agents include, but are not limited to, Neulasta® (pefragiltin, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pefragiltin-cbqv), Ziextenzo® (LA-EP2006; pefragiltin-bmez) or FULPHILA (pefragiltin-bmez).

[0081] In other embodiments, the drug delivery device may include or be used with an erythropoiesis stimulant (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis-stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin-stimulating proteins include, but are not limited to, Epogen® (epogen α), Aranesp® (dabepoetin α), Dynepo® (epogen δ), Mircera® (methoxy-polyethylene glycol-epogen β), Hematide®, MRK-2578, INS-22, Retacrit® (epogen ζ), Neorecormon® (epogen β), Silapo® (epogen ζ), Binocrit® (epogen α), epogen α Hexal, Abseamed® (epogen α), Ratioepo® (epogen θ), Eporatio® (epogen θ), Biopoin® (epogen θ), epogen α, epogen β, epogen ι, epogen ω, epogen δ, epogen ζ, epogen θ and epogen δ, pegylated erythropoietin, carbamylated erythropoietin, and their molecules or variants or analogues.

[0082] The specific illustrative proteins are those described below, including their fusions, fragments, analogs, variants, or derivatives: OPGL-specific antibodies, peptides, related proteins, etc. (also known as RANKL-specific antibodies, peptides, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, especially fully humanized monoclonal antibodies; myostatin-binding proteins, peptides, related proteins, etc., including myostatin-specific peptides; IL-4 receptor-specific antibodies, peptides, related proteins, etc., particularly those inhibiting the activity of IL-4 and / or IL-4 receptors. -13-mediated activities involving receptor binding; interleukin-1 receptor 1 ("IL1-R1") specific antibodies, peptides, and related proteins; Ang2 specific antibodies, peptides, and related proteins; NGF specific antibodies, peptides, and related proteins; CD22 specific antibodies, peptides, and related proteins, especially human CD22 specific antibodies, such as, but not limited to, humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2. Dimers of the γ-chain linked to the human-mouse monoclonal hLL2 κ chain by disulfide, such as the fully humanized human CD22-specific antibody in epazuzumab (CAS Registry No. 501423-23-0); IGF-1 receptor-specific antibodies, peptides, and related proteins, including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptides, and related proteins (“B7RP-1”, also known as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies binding to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those inhibiting the interaction of B7RP-1 with its native receptor ICOS on activated T cells; IL-15-specific antibodies, peptides, and related proteins, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as 145c7; IFN. γ-specific antibodies, peptides, and related proteins, including but not limited to human IFN γ-specific antibodies, and including but not limited to fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptides, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone (“PTH”) specific antibodies, peptides, and related proteins; thrombopoietin receptor (“TPO-R”) specific antibodies, peptides, and related proteins;Hepatocyte growth factor (“HGF”) specific antibodies, peptides, and related proteins, including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF); TRAIL-R2 specific antibodies, peptides, and related proteins; activin A specific antibodies, peptides, and proteins; TGF-β specific antibodies, peptides, and related proteins; amyloid-β protein specific antibodies, peptides, and related proteins; c-Kit specific antibodies, peptides, and related proteins, including but not limited to proteins binding to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptides, and related proteins, including but not limited to those binding to OX40L and / or OX40 receptors. Other ligand proteins; Activase® (alteplase, tPA); Aranesp® (dabepoetin α) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], dabepoetin α, novel erythropoiesis-stimulating protein (NESP); Epogen® (epogenetin α, or erythropoietin); GLP-1, Avonex® (interferon β-1a); Bexxar® (tosimomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-β); Camppath® (alemumab, anti-CD52 monoclonal antibody); Dynepo® (epogenetin δ); Velcade® (bortezomib); MLN0002 (anti-α4β7) mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (ebertin α); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (growth hormone, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns), an anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (growth hormone, human growth hormone); Humira® (adalimumab).Vectibix® (panitumumab), Xgeva® (dinosumab), Prolia® (dinosumab), RANK ligand immunoglobulin G2 human monoclonal antibody, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romistamine), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon-1 interferon); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)); Kineret® (anaspirin); Leukine® (saxaglastine, rhuGM-CSF); LymphoCide® (epazolizumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS) mAb); Metalyse® (tenectiplase, t-PA analog); Mircera® (methoxy-polyethylene glycol-ebertheline beta); Mylotarg® (gem-tuzumab-ozomicin); Raptiva® (efalizumab); Cimzia® (sertozumab, CDP 870); Soliris™ (eculizumab); Pexazumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibumab); Panorex® (17-1A, ezolomide); Trabio® (lerdelimumab); TheraCim hR3 (Nimotuzumab); Omnitarg (Pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (Vencizumab); Cantuzumab Mertansine (huC242-DM1); NeoRecormon® (Ibertin β); Neumega® (Interleukin-11); Orthoclone OKT3® (Moromab-CD3, anti-CD3 monoclonal antibody); Procrit® (Ibertin α); Remicade® (Infliximab, anti-TNFα monoclonal antibody); Reopro® (Abciximab, anti-GP IIb / Ilia receptor monoclonal antibody); Actemra® (Anti-IL6 receptor mAb); Avastin® (Bevacizumab); HuMax-CD4 (Zanolimuab); Mvasi; TM(Bevacizumab - awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (baliximab); Prexige® (romexicob); Synagis® (palizumab); 145c7-CHO (anti-IL15 antibody, see US Patent No. 7,153,507); Tysabri® (natelizumab, anti-alpha4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domain of the Fc portion of human IgG1 and IL-1 receptor components (type I receptor and receptor accessory proteins)); VEGF trap (with IgG1) Fc fusion of VEGFR1 Ig domain); Zenapax® (dalizumab); Zenapax® (dalizumab, anti-IL-2Rα mAb); Zevalin® (teimomab); Zetia® (ezetimibe); Orencia® (asceticipeptide, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipramab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1 and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb;Anti-CTGF fibrinogen for stage I idiopathic pulmonary fibrosis (FG-3019); Anti-CTLA4 mAb; Anti-eosinophil chemokine 1 mAb (CAT-213); Anti-FGF8 mAb; Anti-ganglioside GD2 mAb; Anti-ganglioside GM2 mAb; Anti-GDF-8 human mAb (MYO-029); Anti-GM-CSF receptor mAb (CAM-3001); Anti-HepC mAb (HuMax HepC); Anti-IFNα mAb (MEDI-545, MDX-198); Anti-IGF1R mAb; Anti-IGF-1R mAb (HuMax-Inflam); Anti-IL12 mAb (ABT-874); Anti-IL12 / IL23 mAb (CNTO 1275); Anti-IL13 mAb (CAT-354); Anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0083] In some embodiments, the drug delivery device may comprise or be used with sclerosing protein antibodies, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to the human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may comprise or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumab, or similar drugs. In some embodiments, the reservoir of the drug delivery device may be filled with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, or the device may be used with such other oncolytic HSV, including but not limited to OncoVEX GALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may include or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may include Aimovig® (anovisumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for the treatment of migraine containing or being used with anovisumab. Needle-antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor (such as, but not limited to, anovisumab) and bispecific antibody molecules targeting the CGRP receptor and other headache targets may also be delivered using the drug delivery device of this disclosure. Additionally, bispecific T-cell binding agent (BiTE®) antibodies (such as, but not limited to, BLINCYTO® (bonatumab)) may be used in or with the drug delivery device of this disclosure.In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), an anti-TNF α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab, or used therewith. In some embodiments, the drug delivery device may contain Kyprolis® (carfilzomib) for the treatment of multiple myeloma, (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methylethyleneoxy-2-yl)-1-oxopentane-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamyl)-4-phenylbutamido)-4-methylpentanamide, or another product containing carfilzomib, or used therewith. In some embodiments, the drug delivery device may comprise or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory conditions. In some embodiments, the drug delivery device may comprise Parsabiv for the treatment of, for example, secondary hyperparathyroidism (sHPT) in dialysis patients with chronic kidney disease (KD). TM(Vicocineptide HCl, KAI-4169) or another product containing vecocineptide HCl or used therewith. In some embodiments, the drug delivery device may contain ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody or used therewith. In some embodiments, the drug delivery device may contain a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (a fusion of the Ig domain 2 of VEGFR1 and the Ig domain 3 of VEGFR2 with the Fc domain of IgG1)) or used therewith. In some embodiments, the drug delivery device may contain ABP959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5 or used therewith. In some embodiments, the drug delivery device may comprise or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks the activity of ICOSL and BAFF. In some embodiments, the drug delivery device may comprise or be used with omeprazole (a small molecule selective cardiac myosin activator), or myotrope which directly targets the cardiac contractile mechanism, or another product comprising or being used with a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may comprise sotoraraciab (formerly AMG 510), KRAS G12C Small molecule inhibitors, or those containing KRAS G12CAnother product containing or used with a small molecule inhibitor. In some embodiments, the drug delivery device may comprise tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing or used with a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may comprise AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing or used with a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may comprise AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a) (also known as Lp(a)), or another product containing or used with a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may comprise or be used with ABP 654 (human IgG1κ antibody), a biosimilar candidate of Stelara®, or another product comprising or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may comprise Amjevita. TM Or Amgevita TM(Previously ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing or used with a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product containing a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T-cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may comprise or be used with AMG171 or another product comprising a growth differentiation factor 15 (GDF15) analogue. In some embodiments, the drug delivery device may comprise or be used with AMG 176 or another product comprising a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may comprise or be used with AMG 199 or another product comprising a bispecific T-cell conjugate with extended half-life (HLE) (BiTE®). In some embodiments, the drug delivery device may comprise or be used with AMG 256 or another product (comprising an anti-PD-1 x IL21 mutant protein and / or an IL-21 receptor agonist) designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may comprise or be used with AMG 330 or another product comprising an anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, which is being investigated for the treatment of patients with solid tumors, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing or being used with an extended-life (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell binder) construct.In some embodiments, the drug delivery device may comprise or be used with AMG 430 or another product comprising an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with AMG 506, which is being investigated for the treatment of solid tumors, or another product comprising a multispecific FAP x 4-1BB-targeting DARPin® biologic. In some embodiments, the drug delivery device may comprise or be used with AMG 509 or another product comprising a bivalent T-cell conjugate and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may comprise or be used with AMG 562 or another product comprising an extended half-life (HLE) CD19 x CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with Efavaleukin α (formerly AMG 592) or another product comprising an IL-2 mutant Fc fusion protein. In some embodiments, the drug delivery device may comprise or be used with AMG 596 or another product comprising or using with a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T-cell conjugate) molecule. In some embodiments, the drug delivery device may comprise or be used with AMG 673 or another product comprising or using with a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 701 or another product comprising or using with a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 757 or another product comprising or using with a half-life extended (HLE) anti-δ-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell conjugate) construct. In some embodiments, the drug delivery device may be used with AMG 910 or another product containing an extended-life (HLE) epithelial cell tight junction protein (claudin) 18.2 xCD3 BiTE® (bispecific T-cell binder) construct.

[0084] Although drug delivery devices, components, parts, subsystems, and methods have been described with reference to exemplary embodiments, they are not limited thereto. This detailed description is to be interpreted as exemplary only and does not describe every possible embodiment of this disclosure. Many alternative embodiments can be implemented using current technology or technology developed after the date of this patent application, and these embodiments still fall within the scope of the claims defining the invention disclosed herein.

[0085] Those skilled in the art will understand that various modifications, alterations, and combinations can be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations can be considered to be within the scope of the inventive concept.

Claims

1. A needle sheath remover, comprising: The body has a tubular configuration having a first end and a second end, and the body is formed of a sheet of material having opposite first longitudinal edges and second longitudinal edges; as well as A closure configured to join the first longitudinal edge and the second longitudinal edge together to form a tubular configuration of the body, the closure comprising: Multiple toothed members extending laterally outward from the first longitudinal edge; Multiple grooves extend laterally and inwardly from the second longitudinal edge into the material sheet; A plurality of barbs, arranged around the circumference of the body and adjacent to the first end, gripping a removable cover; and The second plurality of barbs are arranged around the circumference of the body and adjacent to the second end; The removable cover includes a central wall and an annular wall. The central wall is configured to be gripped by the first plurality of barbs, and the annular wall is spaced outward from the central wall and configured to engage the outer surface of a first end of the body.

2. The needle sheath remover as described in claim 1, wherein, The plurality of teeth extend substantially perpendicularly away from the first longitudinal edge; and the plurality of grooves extend along an axis at a non-perpendicular angle relative to the second longitudinal edge, such that the plurality of teeth bend as each respective tooth enters a respective groove in the plurality of grooves.

3. The needle sheath remover as described in claim 2, wherein, Each of the plurality of teeth includes an associated cut portion configured to release stress within the material caused by bending of the plurality of teeth.

4. The needle sheath remover as described in claim 3, wherein, The cut portion is located in the edge of each of the plurality of toothed members or in the corner between each of the plurality of toothed members and the first longitudinal edge.

5. The needle sheath remover as described in any one of claims 2 to 4, wherein, The plurality of grooves extend along the axis at an angle between 5 and 20 degrees relative to the second longitudinal edge.

6. The needle sheath remover as described in any one of claims 1 to 4, wherein, The axes of the plurality of grooves include the axis of each of the plurality of grooves, and the axes of the plurality of grooves are interlaced to extend above or below a horizontal line extending between the first longitudinal edge and the second longitudinal edge.

7. The needle sheath remover as described in any one of claims 2 to 4, wherein, Each of the first plurality of barbs and the second plurality of barbs includes a member extending within an opening in the body, the distal end of which has laterally spaced pointed tips.

8. The needle sheath remover as described in any one of claims 2 to 4, wherein, The first plurality of barbs and the second plurality of barbs extend inward into the body.

9. The needle sheath remover as described in any one of claims 2 to 4, wherein, The needle shield remover is symmetrical about a horizontal plane that extends through the midpoint of the body about a longitudinal axis perpendicular to the body.

10. A drug delivery device, comprising: case; A drug container, which is attached to the housing, includes a needle; A needle guard, which is at least partially disposed above the distal end of the needle of the drug container; A removable cover is attached to the housing; as well as A needle shield remover, connected to a removable cap and a needle shield, such that disconnection of the removable cap from the housing removes the needle shield from the needle of the drug container. The needle shield remover includes: The body has a tubular configuration having a first end and a second end, and the body is formed of a sheet of material having opposite first longitudinal edges and second longitudinal edges; as well as A closure member that connects the first longitudinal edge and the second longitudinal edge to form a tubular configuration of the body, the closure member comprising: Multiple toothed members extending laterally outward from the first longitudinal edge; Multiple grooves extend laterally inward from the second longitudinal edge into the material sheet, and the multiple grooves receive the multiple toothed members to join the first longitudinal edge and the second longitudinal edge together; A plurality of barbs, arranged around the circumference of the body and adjacent to the first end, grip the removable cover; and The second plurality of barbs are arranged around the circumference of the body and adjacent to the second end, and the second plurality of barbs grip the needle guard; The removable cover includes a central wall and an annular wall. The central wall is configured to be gripped by the first plurality of barbs, and the annular wall is spaced outward from the central wall and configured to engage the outer surface of a first end of the body.

11. The drug delivery device of claim 10, wherein, The plurality of toothed members extend substantially perpendicularly away from the first longitudinal edge; and the plurality of grooves extend along an axis at a non-perpendicular angle relative to the second longitudinal edge, such that the plurality of toothed members bend as each corresponding tab enters the corresponding groove in the plurality of grooves.

12. The drug delivery device according to any one of claims 10 to 11, wherein, The axes of the plurality of grooves include the axis of each of the plurality of grooves, and the axes of the plurality of grooves are interlaced to extend above or below a horizontal line extending between the first longitudinal edge and the second longitudinal edge.

13. The drug delivery device according to any one of claims 10 to 11, wherein, Each of the first plurality of barbs and the second plurality of barbs extends within the opening of the body and includes a distal end with a pointed tip having lateral spacing.

14. The drug delivery device according to any one of claims 10 to 11, wherein, The first plurality of barbs and the second plurality of barbs extend inward into the body.

15. The drug delivery device according to any one of claims 10 to 11, wherein, The needle shield remover is symmetrical about a horizontal plane that extends through the midpoint of the body about a longitudinal axis perpendicular to the body.

16. The drug delivery device according to any one of claims 10 to 11, wherein, The drug container is filled or pre-filled with a drug, and said drug includes one of the following: a drug containing a human IgG1κ antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), efavaleukin α, evolocumab, and a drug containing a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist.

17. The drug delivery device of claim 11, wherein, Each of the plurality of teeth includes an associated cut portion configured to release stress generated within the metal as the plurality of teeth bend as each respective tooth enters a corresponding groove in the plurality of grooves.

18. The drug delivery device of claim 17, wherein, The associated cutout is provided on one side of each corresponding toothed member, facing the corresponding groove at a non-perpendicular angle.

19. The drug delivery device according to any one of claims 10 to 11, wherein, The central wall includes an outwardly projecting lip at its distal end, and the first plurality of barbs are configured to grip the removable cap below the outwardly projecting lip.

20. The drug delivery device of claim 19, wherein, The central wall also includes an inwardly tapering portion adjacent to the lip margin to provide access to the underside of the outwardly projecting lip margin for the first plurality of barbs.

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