Needle shield remover, drug delivery device, and related method

Abstract

The present invention provides a drug delivery device equipped with a needle shield remover for automatically injecting drugs into a patient, and related methods. [Solution] A needle shield remover 100 includes a tubular body 102 formed from a sheet having a closure 112 having a plurality of teeth 114 extending laterally outward from one longitudinal edge 106 of the sheet and a plurality of grooves 116 extending laterally inward into the sheet of material from a second longitudinal edge 108 of the sheet, wherein the plurality of teeth are received by friction in the plurality of grooves, thereby holding the body in a tubular configuration. The needle shield remover may further include a first plurality of barbs 118 arranged around the body adjacent to its first end and a second plurality of barbs 120 arranged around the body adjacent to its second end.

Description

Technical Field

[0001] 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.

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

Background Art

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

[0004] Drug delivery devices can incorporate various mechanisms for implementing various automated features. Such features include, among other things, automatically covering the needle in a pre-delivery and / or post-delivery state, providing the user with an interface for actuating a drive mechanism, and indicating to the user that drug delivery has been completed. Typically, drug delivery devices incorporate separate or independently operable mechanisms to effect each of their automated functions. As a result, the mechanical complexity of the device tends to increase with each additional function. This can increase the size of the device, complicate user handling, and in addition increase manufacturing costs and time frames. As the demand for more user-friendly and safer drug delivery devices grows, finding ways to incorporate more automated functions without adding excessive complexity to the drug delivery device presents various design and manufacturing challenges.

[0005] This disclosure describes a drug delivery device that embodies a favorable alternative to existing drug delivery devices and can address one or more of the challenges or needs described herein. [Overview of the project] [Means for solving the problem]

[0006] According to a first embodiment, a needle shield remover is described which includes a body having a tubular structure with first and second ends, the body being formed from a sheet of material having opposing first and second longitudinal edges. The needle shield remover further includes a closure configured to connect the first and second longitudinal edges to each other to form the tubular structure 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 into the material sheet from the second longitudinal edge.

[0007] In some embodiments, the needle shield remover may include a first plurality of barbs arranged around the body adjacent to a first end, and a second plurality of barbs arranged around the body adjacent to a second end. In further embodiments, each of the first plurality of barbs and the second plurality of barbs may extend into the opening of the body and include a distal end having laterally spaced pointed tips, and / or the first plurality of barbs and the second plurality of barbs may extend inward into the body.

[0008] In some embodiments, multiple teeth may extend substantially perpendicularly and spaced apart from the first longitudinal edge, and multiple grooves may extend along an axis at an angle to the second longitudinal edge, such that the multiple teeth bend as each tooth enters one of the multiple grooves. In further embodiments, each of the multiple teeth may include an associated notch configured to relieve stress within the material as a result of the bending of the multiple teeth. In some embodiments, the notch may be located on the edge of each of the multiple teeth, or at the corner between each of the multiple teeth and the first longitudinal edge. In additional embodiments, multiple grooves may extend along an axis at an angle between 5 and 20 degrees to the second longitudinal edge, and / or the axes of the multiple grooves may be staggered so as to extend above or below a horizontal line extending between the first and second longitudinal edges.

[0009] According to a second embodiment, an autoinjector drug delivery device is described, comprising a housing, a drug container coupled to the housing, the drug container including a needle, a needle shield disposed to at least partially cover the distal end of the needle of the drug container, and a removable cap coupled to the housing. The autoinjector drug delivery device further includes a needle shield remover coupled to the removable cap and the needle shield, such that the needle shield is removed from the needle of the drug container by separating the removable cap from the housing. The needle shield remover comprises a body having a tubular configuration with first and second ends, formed from a sheet of material having opposing first and second longitudinal edges, and a closure that connects the first and second longitudinal edges to each other to form a tubular configuration of the body. The closure includes a plurality of teeth extending laterally outward from a first longitudinal edge and a plurality of grooves extending laterally inward into the material sheet from a second longitudinal edge, the grooves receiving the plurality of teeth and connecting the first and second longitudinal edges to each other.

[0010] In some embodiments, the needle shield remover may include a first plurality of barbs arranged around the body adjacent to a first end, and a second plurality of barbs arranged around the body adjacent to a second end, the first plurality of barbs gripping a removable cap, and the second plurality of barbs gripping a needle shield. In further embodiments, each of the first plurality of barbs and the second plurality of barbs may extend into the opening of the body and may include a distal end having laterally spaced pointed tips, and / or the first plurality of barbs and the second plurality of barbs may extend inward into the body.

[0011] In some embodiments, the removable cap may include a central wall configured to be gripped by a first set of barbs, and in further embodiments, an annular wall spaced outward from the central wall and configured to engage with the outer surface of a first end of the body.

[0012] These forms of closures may have a configuration according to any of the above-described configurations. In addition, any of the above-described needle shield removers may be symmetrical with respect to a horizontal plane that passes through the midpoint of the body and extends perpendicular to its longitudinal axis.

[0013] According to a third aspect, a method for forming a needle shield remover from a metal strip is described as forming a sheet from a metal strip having first and second longitudinal edges and end edges, wherein the sheet includes a closure for a needle shield remover, which includes a plurality of teeth extending laterally outward from the first longitudinal edge and a plurality of grooves extending laterally inward into the material sheet from the second longitudinal edge. 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 shape from the sheet by pressing the plurality of teeth into the plurality of grooves.

[0014] In some forms, multiple teeth may extend substantially perpendicularly and spaced apart from a first longitudinal edge, and multiple grooves may extend along an axis at an angle to a second longitudinal edge, and the method may include creating a tubular form from a sheet, which involves bending the multiple teeth as each tooth enters one of the multiple grooves.

[0015] In some embodiments, the method may include drilling guide holes in a metal trip to form cutting patterns for a closure, a first plurality of barbs, and a second plurality of barbs. [Brief explanation of the drawing]

[0016] [Figure 1] This is a perspective view of drug delivery devices according to various embodiments of the present disclosure. [Figure 2] Figure 1 is a cross-sectional view of the drug delivery device. [Figure 3] Figure 2 is an exploded view of the drug delivery device. [Figure 4] This is a side view of an exemplary needle shield remover according to various embodiments of the present disclosure. [Figure 5] Figure 4 is a front view of the needle shield remover. [Figure 6] This is a perspective view of a second exemplary needle shield remover, showing a closure that holds the needle shield remover in a tubular configuration according to various embodiments of the present disclosure. [Figure 7] Figure 6 is a perspective view of the needle shield remover showing the closure in the opening configuration. [Figure 8] Figure 6 is a cross-sectional view of the configuration of the first exemplary teeth for the closure. [Figure 9] Figure 6 shows a cross-sectional view of the configuration of the second exemplary teeth for the closure, along with the grooves of the closure. [Figure 10] Figure 6 is a cross-sectional view of a first exemplary barb configuration for a needle shield remover. [Figure 11]Cross-sectional view of a second exemplary barb configuration for the needle shield remover of FIG. 6. [Figure 12] Cross-sectional view of a third exemplary barb configuration for the needle shield remover of FIG. 6. [Figure 13] Cross-sectional view of a fourth exemplary barb configuration for the needle shield remover of FIG. 6. [Figure 14] Cross-sectional view of a fifth exemplary barb configuration for the needle shield remover of FIG. 6. [Figure 15] Cross-sectional view of the needle shield remover of FIG. 6 attached to a removable cap for a drug delivery device, according to various embodiments of the present disclosure. [Figure 16] Cross-sectional view of the needle shield remover and removable cap of FIG. 15. [Figure 17] Exploded perspective view of a stamping tool for forming the needle shield remover of FIG. 6. [Figure 18] Perspective view of the stamping tool of FIG. 17. [Figure 19] Perspective view of a sheet of material having barbs in a first and second array and a closure formed therein for forming the needle shield remover of FIG. 6. [Figure 20] Perspective view of the sheet of material of FIG. 19 with barbs in the first and second arrays bent upward. [Figure 21] Perspective view of a tool station configured to bend the sheet of material of FIG. 19 into a tubular shape. [Figure 22] Perspective view of the bottom shape of the tool station of FIG. 21 showing the sheet of material formed into the needle shield remover of FIG. 6.

Best Mode for Carrying Out the Invention

[0017] This disclosure relates, in general, to a drug delivery device that can be operated by a user to administer a drug, or, if the user is a patient, to self-administer a drug. Various features are disclosed to facilitate the safe and proper handling of the drug delivery device, including handling of the drug delivery device after it has been used to deliver its payload. Such features include, but are not limited to, an indicator for notifying the user that drug delivery is complete, and a drive mechanism that can be operated by pressing the drug delivery device against the patient's skin at the injection site. These and other features work together and / or interact with each other in a synergistic way to limit the number of moving parts and / or the complexity of the drug delivery device. Furthermore, certain features described herein reduce any force that must be applied by the user and / or reduce the need to incorporate a dedicated energy source to implement the feature by utilizing the biasing force applied by a plunger biasing member and / or a guard biasing member for the purpose of operation. These and other advantages will become apparent to those skilled in the art who consider this disclosure.

[0018] Figures 1 to 3 illustrate several embodiments of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological formulations such as peptides, peptide bodies, or antibodies. The drug may be in fluid or liquid form, but this disclosure is not limited to any particular state.

[0019] Various realizations and configurations are possible for the drug delivery device 10. In this embodiment, the drug delivery device 10 is configured as a single-use 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 the patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a doctor or nurse). This embodiment of the drug delivery device 10 takes the form of a self-injector or a pen-type injector and can therefore be held in the user's hand throughout the period of drug delivery.

[0020] The configuration of the various components included in the drug delivery device 10 may depend on the operating state of the drug delivery device 10. The drug delivery device 10 may have pre-delivery or storage state, delivery or administration state, and 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 operation by the user. In some embodiments, the pre-delivery state may exist in the time from when the drug delivery device 10 leaves the manufacturing facility until when the patient or user operates the drive mechanism 30 of the drug delivery device 10. This includes the time from when the user removes the drug delivery device 10 from some secondary package until the drug delivery device 10 is placed at the injection site. The delivery state may correspond to the configuration of the drug delivery device 10 during drug delivery, which is 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 complete and / or when the stopper is placed at the end of administration position in the drug storage container.

[0021] The drug delivery device 10 includes an external casing or housing 12. In some embodiments, the housing 12 may be sized and configured to allow a person to grasp the syringe 10 with one hand. The housing 12 may have a generally elongated shape, such as a cylinder, and may extend along a longitudinal axis A between a proximal end and a distal end. An opening 14 may be formed at the distal end to allow the insertion end 28 of the delivery member 16 to extend outside the housing 12. A transparent or translucent inspection window 17 may be placed in the wall of the housing 12 to allow the user to see the components inside the drug delivery device 10, including the drug storage container 20. By viewing the drug storage container 20 through the window 17, the user can confirm that drug delivery is in progress and / or completed. Before use of the drug delivery device 10, a removable cap 19 may cover the opening 14, and in some embodiments, a gripper 13 may be included, configured to assist in the removal of a sterile barrier 21 (e.g., a rigid needle shield (RNS), a flexible needle shield (FNS), etc.) attached to the insertion end 28 of the delivery member 16. The gripper 13 may include one or more inwardly projecting return portions or arms that frictionally or mechanically engage with the sterile barrier 21 to pull the sterile barrier 21 together with the removable cap 19 when the user separates the removable cap 19 from the housing 12. Thus, removing the removable cap 19 has the effect of removing the sterile barrier 21 from the delivery member 16.

[0022] In this embodiment, the housing 12 is defined by three separate 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, including an opening 14; and a rear housing 27 positioned between the rear end cap 23 and the front housing 25, and rigidly connecting them. The front housing 25 and the rear housing 27 may each have a hollow, substantially cylindrical or tubular shape, and the rear end cap 23 may have a substantially hemispherical shape or a hollow cylindrical shape with an open end and a closed end. In some embodiments, the rear end cap 23 and the rear housing 27, and any components placed therein, may be assembled together to define a rear subassembly. Alternatively, the front housing 25 and any components placed therein may be assembled together to define a front subassembly. In some embodiments, the rear and front subassemblies 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 certain such embodiments, some or all of the assembly steps described above may be carried out in different manufacturing facilities or environments. In alternative embodiments, the housing 12 may be constructed as a single unit such that the housing 12 is defined by a single monolithic structure.

[0023] The drug storage container 20 is disposed within the internal space of the housing 12 and is configured to contain the drug 22. The drug storage container 20 may be pre-filled and transported, for example, by the manufacturer to a location where the drug storage container 20 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, for example, or the drug storage container 20 may be loaded by the user before use of the drug delivery device 10. The drug storage container 20 may include rigid walls that define an internal bore, i.e., a reservoir. The walls may be made of glass or plastic. A stopper 24 may be movably disposed within the drug storage container 20 so as to move distally along the longitudinal axis A between the proximal and distal ends of the drug storage container 20. The stopper 24 may be made of rubber or any other suitable material. To prevent or stop the drug 22 from leaking over the stopper 24 while the stopper 24 is moving, the stopper 24 may be in slidable and airtight contact with the inner surface 15 of the wall of the drug storage container 20. Distal movement of the stopper 24 releases the drug 22 from the reservoir of the drug storage container 20 to 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. Subsequently, as the plunger 26 moves distally, the stopper 24 is driven distally, releasing the drug 22 from the drug storage container 20. In an alternative embodiment, the stopper 24 and the plunger 26 may initially be in contact with each other or connected to each other, for example, via a screw coupling, so that they move together from the start of the plunger 26's movement. Once the stopper 24 is in a moving state, it can 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 on the stopper 24 may be called the end-of-dose position or end-of-delivery position, and may correspond to when the delivery of the drug 22 to the patient is complete or substantially complete.

[0024] In some embodiments, the volume of drug 22 contained in the reservoir of the drug storage container 20 may be equal to 1 mL, or approximately (e.g., ±10%) equal to 1 mL, or equal to 2.5 mL, or approximately (e.g., ±10%) equal to 2.5 mL, or approximately (e.g., ±10%) less than or equal to 2 mL, or approximately (e.g., ±10%) less than or equal to 3 mL, or approximately (e.g., ±10%) less than or equal to 4 mL, or approximately (e.g., ±10%) less than or equal to 5 mL, or approximately (e.g., ±10%) less than or equal to 10 mL, or approximately (e.g., ±10%) within the range of 1 to 10 mL, or approximately (e.g., ±10%) within the range of 1 to 5 mL, or approximately (e.g., ±10%) within the range of 1 to 4 mL, or approximately (e.g., ±10%) within the range of 1 to 3 mL, or approximately (e.g., ±10%) within the range of 1 to 2.5 mL.

[0025] The delivery member 16 is fluidly connected to or operable to be connected to the reservoir of the drug storage container 20. The distal end of the delivery member 16 may define the insertion end 28 of the delivery member 16. The insertion end 28 may include other pointed sharp tips to allow the insertion end 28 to puncture the patient's skin 5 and subcutaneous tissue during insertion of the delivery member 16. The delivery member 16 may be hollow and may have an internal pathway. One or more openings may be formed in the insertion end 28 to allow the drug to flow out of the delivery member 16 and into the patient.

[0026] In this embodiment, the drug storage container 20 is a pre-filled syringe having a fixed, hollow metal needle for the delivery member 16. Here, the needle is fixed 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 cartridge without a needle and therefore may not be in fluid communication with the delivery member 16 initially. In such embodiments, during operation of the drug delivery device 10, the drug storage container 20 may move toward or toward the proximal end of the delivery member 16, so 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.

[0027] Once the drug storage container 20 is installed in the housing 12, it may be fixed to the housing 12 so that it does not move relative to the housing 12. Therefore, the insertion end 28 of the delivery member 16 permanently extends through the opening 14 of the housing 12 in the pre-delivery, during-delivery, and post-delivery states. In this embodiment, a container holder 31 fixes the position of the drug storage container 20 within the housing 12. The container holder 31 may have a hollow, substantially cylindrical or tubular shape, and the drug storage container 20 may be partially or entirely disposed within the container holder 31. The distal end of the container holder 31 may include an inwardly projecting flange 33 that abuts against the neck of the drug storage container 20, thereby preventing distal movement of the drug storage container 20. The container holder 31 may be fixedly attached to the housing 12 so that it is prevented from moving relative to the housing 12 during operation of the drug delivery device 10.

[0028] In an alternative embodiment, the drug storage container 20 may be movably coupled to the housing 12 so that the drug storage container 20 can move relative to the housing 12 during the operation of the drug delivery device 10. In certain such alternative embodiments, the insertion end 28 of the delivery member 16 may be retracted inward into the opening 14 of the housing 12 in the pre-delivery state. Subsequently, during the operation of the injection device 10, the insertion end 28 of the delivery member 16 may be extended through the opening 14 of 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.

[0029] The plunger 26 may have a hollow, substantially cylindrical or tubular 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 dimensioned to accommodate the plunger biasing member 50 therein. It is generally desirable to minimize the thickness of the annular wall 39 as much as possible without compromising the integrity of the plunger 26, in order to maximize the inner diameter of the plunger 26. This makes it possible to fit a plunger biasing member 50 of a larger diameter into the internal space of the plunger 26, thereby making the plunger biasing member 50 stronger. As will be described in more detail below, the plunger 26 may be configured to selectively rotate relative to the housing 12 and to translate linearly relative to the housing 12 during operation of the drug delivery device 10.

[0030] The plunger 26 may consist of multiple interconnected parts, or it may have an integrated structure. In this embodiment, the plunger 26 consists of three separate 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 positioned between the top ring 45 and the base 47 and rigidly connecting them. The positions of the top ring 45, the hollow rod 46, and the base 47 may be fixed relative to each other so that these components do not move relative to each other. The top ring 45, the hollow rod 46, and the base 47 may each have an annular structure and may be centered around a longitudinal axis A. The top ring 45 and the hollow rod 46 may each have a central opening that extends from end to end of the component and defines an axial chamber, while the base 47 may have a central opening that extends through the proximal end of the base 47 but is closed at the distal end of the base 47. The closed end of the base 47 may define a seating or contact surface for the plunger biasing member 50. In an alternative embodiment, the central opening may extend from end to end through the base 47. 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 so that the base 47 holds the distal end of the plunger biasing member 50 within the plunger 26. When the drive mechanism 30 is actuated, the base 47 may be a portion of the plunger 46 that contacts the stopper 24 and pushes the stopper 24 distally.

[0031] The top ring 45 may include one or more flanges or projections 48 extending radially outward from the central portion of the top ring 45. Each of the projections 48 may include a distally facing cam surface 49. As will be described in more detail below, the distally facing cam surface 49 may interact with a corresponding 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 configured at an angle to a virtual plane perpendicular to the longitudinal axis A, or non-parallel to this virtual plane.

[0032] In some embodiments, the top ring 45 and / or base 47 may be made of a different material than the hollow rod 46. In some embodiments, the top ring 45 and / or base 47 may be made of plastic, while the hollow rod 46 may be made of metal. By such configuration, the plastic material used for the top ring 45 may facilitate the cam action described below by providing sliding friction, and the plastic material used for the base 47 may help absorb or dampen shocks or vibrations associated with the base 47 striking the stopper 24. The metal material used for the hollow rod 46 can provide sufficient rigidity to avoid buckling under the biasing force applied by the plunger biasing member 50. In alternative embodiments, the top ring 45, hollow rod 46, and / or base 47 may be made of the same material, including, for example, metal or plastic. In certain such embodiments, the top ring 45, hollow rod 46, and base 47 may be integrally formed as a single piece to define a single monolithic structure.

[0033] The drug delivery device 10 may further include a guard mechanism to prevent contact with the insertion end 28 of the delivery member 16 when the drug delivery device 10 is not being used to administer an injection. The guard mechanism may include a guard member 32 movably disposed at the distal end of the housing 12 adjacent to the opening 14. The guard member 32 may have a hollow, substantially cylindrical or tubular shape centered about a longitudinal axis A, and may have a proximal end housed within the housing 12. The guard member 32 may be configured to move relative to the housing 12 between an extended position in which the distal end of the guard member 32 extends through the opening 14 in the housing 12, and a retracted position in which the distal end of the guard member 32 is fully or partially retracted into the opening 14 in the housing 12. In addition or alternatively, the guard member 32 may be configured to move from the retracted position to the extended position. When moving from the extended position to the retracted position, the guard member 32 may translate linearly in the proximal direction, and when moving from the retracted position to the extended position, the guard member 32 may translate linearly in the distal direction. At least in the extended position, the guard member 32 may extend beyond and surround the insertion end 28 of the delivery member 16. In embodiments in which the delivery member 16 protrudes from the opening 14 of the housing 12 before delivery or in storage, moving the guard member 32 from the extended position to the retracted position by pressing the distal end of the guard member 32 against the patient's skin at the injection site may result in the insertion end 28 of the delivery member 16 being inserted into the patient's skin.

[0034] For example, the delivery device 10 may utilize an inertial design rather than a spring-driven design to insert the needle into the patient's subcutaneous tissue. In a more specific example, when the patient presses the distal end of the guard member 32 against the patient's skin at the injection site, the housing 12 of the delivery device 10 may advance toward the injection site. When the patient pushes down a predetermined distance or with a predetermined force, the delivery device 10 is rapidly released using the energy stored in the patient's muscles, while compressing the needle cover and its spring to a predetermined release point. The release mechanism is designed such that the resulting 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 and reach subcutaneous depth quickly and completely. Compared to known syringes in which the entire primary container moves forward relative to the housing, this embodiment prevents relative movement between the drug storage container 20 and the housing, thus providing a simplified, more robust design.

[0035] In some embodiments, the guard member 32 may be fixed from rotation relative to the housing 12. Therefore, the guard member 32 may be able to translate linearly relative to the housing 12, but rotation relative to the housing 12 may be prevented. To achieve this effect, in some embodiments, one or more longitudinal slots 61 may be formed in the wall of the guard member 32 and may be parallel to the longitudinal axis A. Each longitudinal slot 61 may be dimensioned to engage with or snugly accommodate projections or pins 63 extending radially inward from the front housing 25. Each pin 63 may slidably engage with a surface defining a corresponding one of the longitudinal slots 61 when the guard member 32 translates linearly along the longitudinal axis A relative to the front housing 25. However, the pins 63 abut against the same surface to prevent rotation of the guard member 32 relative to the front housing 25 when some rotational force is applied to the guard member 32. In an alternative embodiment, the pin and slot configuration may be reversed, with the guard member 32 having one or more radially outwardly extending pins, and the front housing 25 having one or more slots or other recesses for mating or snugly accommodating one or more pins.

[0036] The guard mechanism may further include a guard biasing member 35 and a guard extension 37. The guard extension 37 may be positioned proximal to the guard member 32, and the guard biasing member 35 may be positioned proximal to the guard extension 37. The guard extension 37 may have a hollow, substantially cylindrical or tubular shape centered about the longitudinal axis A. Furthermore, the guard extension 37 may be movable linearly along the longitudinal axis A relative to the housing 12. In this embodiment, the guard extension 37 is a separate structure from the guard member 32. However, in another embodiment, the guard extension 37 and the guard member 32 may be integrally formed in a single part to define a single monolithic structure. In such another embodiment, the proximal end of the guard member 32 may correspond to the guard extension 37.

[0037] Similar to the guard member 32, the guard extension 37 may be rotatably fixed to the housing 12. Thus, although the guard extension 37 may be able to translate linearly relative to the housing 12, it may 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 guard extension 37 and may be parallel to the longitudinal axis A. Each longitudinal slot 71 may be dimensioned to fit or snugly accommodate projections or pins (not shown) extending radially inward from the housing 12, for example, from the rear housing 23 and / or the front housing 25. Each pin may slidably engage with a surface defining the corresponding longitudinal slot 71 when the guard extension 37 moves linearly relative to the housing 12 along the longitudinal axis A. However, the pins abut the same surface to prevent the guard extension 37 from rotating relative to the housing 12 when any rotational force is applied to it. In an alternative embodiment, the pin and slot configuration may be reversed so that the guard extension 37 has one or more radially outwardly extending pins, and the housing 12 has one or more slots or other recesses to fit or snugly accommodate one or more pins.

[0038] The guard biasing member 35 may be positioned between the guard extension 37 and the release member 52, in contact with them. The guard biasing member 35 may be configured to bias or press the guard extension 37 distally and bias or press the release member 52 proximal. The guard biasing member 35 may initially be in a biased (e.g., compressed) state so as to apply a biasing force to the guard extension 37 and the release member 52 in the pre-delivery state. In some embodiments, the distal end of the guard extension 37 is initially in contact with the proximal end of the guard member 32, as shown in Figure 2. As a result, the guard extension 37 transmits the biasing force of the guard biasing member 35 to the guard member 32 so that the guard biasing member 35 biases or presses the guard member 32 toward the extended position. The user can overcome the biasing force by pressing the guard member 32 against the injection site. In this manner, the guard member 32 and the guard extension 37 move together proximal to a position, for example, until the guard member 32 reaches a retracted position. When the injection is complete and the drug delivery device 10 is lifted from the injection site, the guard biasing member 35 may press against the guard extension 37, thereby causing the guard extension 37 and the guard member 32 to move together distally. This movement returns the guard member 32 to an extended position, which has the effect of covering the insertion end 28 of the delivery member 16. In some embodiments, the guard biasing member 35 may include a compression spring (e.g., a helical compression spring). Furthermore, in embodiments in which the plunger biasing member 50 also includes a compression spring, the guard biasing member 35 may be arranged around the plunger biasing member 50 and / or may have a larger diameter than the plunger biasing member 50.

[0039] In an alternative embodiment, the distal end of the guard extension 37 may initially be positioned with a gap that separates it from the proximal end of the guard member 32. As a result, the guard biasing member 35 may not bias the guard member 32 toward the extended position in the pre-delivery state. Only when the guard member 32 retracts proximal and contacts the guard extension 37 can the guard biasing member 35 apply a biasing force to the guard member 32, pressing it toward the extended position. In such an alternative embodiment, biasing the guard member 32 toward the extended position in the pre-delivery state can only be achieved by relying on the lock ring biasing member 51, which is described below.

[0040] After drug delivery is complete and the guard member 32 has been repositioned to the extended position, it may be desirable to lock the guard member 32 in the extended position to prevent further user contact with the insertion end 28 of the delivery member 16 and / or to prevent reuse of the drug delivery device 10. 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 guard member 32 in order to lock the guard member 32 in the extended position once the guard member 32 has moved from the retracted position to the extended position. In this embodiment, the locking ring 40 is centered and rotates about a longitudinal axis A. As shown in Figure 2, the proximal end of the locking ring 40 may be in contact with the container holder 31, and the distal end of the locking ring 40 may be disposed at least partially within the guard member 32. A locking ring biasing member 51 may be axially positioned between the distal opposing surface of the locking ring 40 and the proximal opposing surface of the guard member 32. The lock ring biasing member 51 may initially be in a compressed or biased state so as to bias the lock ring 40 and the guard member 32 away from each other. Thus, the lock ring biasing member 51 may apply a biasing force that pushes the guard member 32 toward the extended position, and may also apply a biasing force that pushes the proximal end of the lock ring 40 toward the container holder 31. In some embodiments, the lock ring biasing member 51 may include a compression spring (e.g., a helical compression spring).

[0041] The rotation of the lock ring 40 can be achieved by a cam configuration between the lock ring 40 and the container holder 31. In some embodiments, the proximal end of the lock ring 40 may include one or more cam surfaces 53 configured to slidably engage with one or more corresponding cam surfaces 55 included in the inner annular wall 57 of the front housing 25. The inner annular wall 57 of the front housing 25 may be centered about the longitudinal axis A and may be supported by a cantilever radially inward from the outer annular wall 59 of the front housing 25 such that an annular gap exists between the inner annular wall 57 and the outer annular wall 59 of the front housing 25. This configuration may allow the guard 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 lock 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 positioned at a different angular position with respect to the longitudinal axis A. Similarly, the cam surfaces 55 on the container holder 31 may have a generally sawtooth appearance when viewed radially from the longitudinal axis A. Furthermore, the cam surfaces 55 may be arranged around the longitudinal axis A such that each cam surface 55 is positioned at a different angular position with respect to the longitudinal axis A.

[0042] The cam surfaces 53 and 55, when pressed against each other, can convert linear motion into a combination of rotational and linear motion. More specifically, as the lock ring 40 moves proximal along the longitudinal axis A, each of the cam surfaces 53 can slide relative to each of the cam surfaces 55. This interaction can convert the proximal linear motion of the lock ring 40 into a combination of rotational motion of the lock ring 40 about the longitudinal axis A and proximal linear motion of the lock ring 40 along the longitudinal axis A. Throughout the entire movement of the lock ring 40, the inner annular wall 57 of the front housing 25 remains stationary relative to the rest of the front housing 25. In this configuration, the inner annular wall 57 of the front housing 25 functions as a cam, and the lock ring 40 functions as a cam follower.

[0043] The biasing force of the guard biasing member 35 can continuously press the cam surface 53 of the lock ring 40 against the cam surface 55 of the inner annular wall 57. As a result, the lock ring 40 is continuously promoted to rotate about the longitudinal axis A. However, the lock ring 40 may not rotate depending on the relative positions of the various cooperating contact structures contained outside the lock ring 40 and inside the guard member 32. Depending on the axial position of the guard member 32, these cooperating contact structures may engage and / or disengage from each other to enable the rotation of the lock ring 40. In some embodiments, the lock ring 40 may rotate to a final rotation position when the guard member 32 moves from a retracted position to an extended position. In the final rotation position, the distally facing surfaces of one or more contact structures contained in the lock ring 40 may be aligned in the rotational direction with and facing the proximal facing surfaces of one or more corresponding contact structures contained in the guard member 32. As a result, any subsequent proximal movement of the guard member 32 can be prevented by the distal surface of the contact structure included in the lock ring 40, which engages with the proximal surface of the contact structure included in the guard member 32.

[0044] The drug delivery device 10 may further include a drive mechanism 30 partially or completely disposed within the housing 12. Generally, the drive mechanism 30 may be configured to store energy and, at the time of or in response to activation of the drive mechanism 30 by the user, release or output that energy to drive the plunger 26 to release 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, but alternative embodiments of the drive mechanism 30 may be configured in a different form, for example, so that the drive mechanism 30 stores electrical or chemical potential energy. Generally, at the time of activation of the drive mechanism 30, the drive mechanism 30 may convert the potential energy into kinetic energy to move the plunger 26.

[0045] In this embodiment, the drive mechanism 30 includes a plunger biasing member 50, a plunger biasing member seating surface 38, a release member 52, and a plunger guide 60. The plunger biasing member 50 may include a compression spring (e.g., a helical compression spring) that is initially held in a biased state. In the biased state, the plunger biasing member 50 can be compressed such that its axial length is shorter than that in the natural or unbiased state. When released, the plunger biasing member 50 attempts to extend to its natural axial length, thereby applying a biasing force to press the plunger 26 distally.

[0046] The plunger biasing member 50 may be at least partially disposed within the plunger 26, and may have a distal end that abuts against the proximal inner surface of the plunger 26, and / or may be fixedly attached to the inner surface of the plunger 26. The outer diameter or other dimensions of the plunger biasing member 50 may be less than or equal to the inner diameter of the top ring 45 and / or the inner diameter of the hollow rod 46 so that the plunger biasing member 50 can be housed within the plunger 26. 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 seating surface 38. The plunger biasing member seating surface 38 may be fixedly attached to the rear housing 27 so that it provides a stationary surface against which the plunger biasing member 50 presses as it extends. With this configuration, the plunger biasing member 50 may extend in length when released from the biased state, by moving distally so that the distal end of the plunger biasing member 50 moves away from the stationary proximal end of the plunger biasing member 50. This movement pushes the plunger 26 distally, thereby pushing the stopper 24 distally, allowing the drug 22 to be released from the drug storage container 20 into the delivery member 16 and then into the patient.

[0047] The plunger guide 60 may be fixedly attached to the rear housing 27 so as not to move relative to the rear housing 27. The plunger guide 60 may have a hollow, substantially cylindrical or tubular shape and may be centered around the longitudinal axis A. The outer diameter or other external dimensions of the proximal end of the plunger guide 60 may be larger than the outer diameter or other external dimensions of the distal end of the plunger guide 60. At least a portion of the distal end of the plunger guide 60 may be radially positioned between the plunger 26 and the release member 52. Thus, as shown in Figure 2, the plunger 26 may be at least partially disposed within the distal end of the plunger guide 60, and the distal end of the plunger guide 60 may be at least partially disposed within the release member 52.

[0048] Examples of the gripper or needle shield remover 100 are shown in Figures 4 to 22. In each of the embodiments, the remover 100 includes a body 102 having a tubular structure. The body 102 is formed from a rectangular sheet 104 (Figure 19) of material having first and second longitudinal side edges 106, 108 and an end edge 110 extending between the side edges 106, 108. The tubular structure of the body 102 is created by joining the side edges 106, 108 together and fixing the edges 106, 108 together with a closure 112. As shown in the figure, the closure 112 includes a plurality of teeth 114 extending outward from a first side edge 106 and a plurality of grooves 116 extending inward from a second side edge 108, where the tab 114 is inserted into the grooves 116 and thereby configured to hold the sheet 104 within the tubular structure of the remover 100.

[0049] As shown in Figures 5 and 6, the remover 100 includes a first array of barbs 118 extending around the body 102 adjacent to a first edge of the edge portion 110, and a second array of barbs 120 extending around the body 102 adjacent to a second edge of the edge portion 110. The first and second arrays of barbs 118 and 120 are configured to grip the sterile barrier 21 and the removable cap 19, respectively, which are disposed on the delivery member 16 of the syringe 20, so that when the cap 19 is removed from the device 10, the sterile barrier 21 is also removed from the delivery member 16. The first and second arrays of barbs 118 and 120 can each be arranged in a plane substantially perpendicular to the longitudinal axis L of the body 102. In one embodiment, the remover 100 can be symmetrical with respect to a central plane extending perpendicular to the longitudinal axis L through the midpoint of the main body 102, which is advantageous as it allows the remover 100 to be installed inside the device 10 in either orientation, and the barbs 118, 120 can effectively grasp the cap 19 and the sterile barrier 21, respectively. By one approach, the barbs 118, 120 can be formed by creating openings 122 inside a sheet 104 of material that forms the shape of the individual barbs 118, 120. The barbs 118, 120 can then be bent radially with respect to the longitudinal axis L so that they grasp a structure disposed adjacent to the remover 100. As shown in the figure, the barbs 118 and 120 of both arrays can be bent radially inward into the body 102 of the remover 100, which advantageously prevents the barbs 118 and 120 from getting tangled in the remover 100 together with or into other structures. This, combined with the symmetrical configuration, allows for efficient and effective assembly of the remover 100 into the device 10.

[0050] Details of one configuration example for the teeth 114 and groove 116 are shown in Figures 6 and 7. As shown, in this configuration, the teeth 114 extend perpendicularly away from the first lateral edge 106, while the groove 116 extends inward at an angle away from the second lateral edge 108. This configuration causes the teeth 114 to bend and flex so as to be pressed into the angled configuration of the groove 116. This bending action effectively holds the teeth 114 within the groove 116, thereby holding the body 102 in a tubular configuration without using welding or other methods to fix the edges 106 and 108 together. In some embodiments, the groove 116 can extend at an angle between 5 and 20 degrees, between 10 and 20 degrees, or between 15 and 20 degrees relative to the second lateral edge 108. In the illustrated configuration, the grooves 116 have a staggered configuration such that they extend continuously above and below a plane that extends perpendicularly through the longitudinal axis L of the body 102, or above a horizontal line that extends between the first and second side edges 106, 108. As shown in the illustration, the teeth 118 may have a tab-like configuration with substantially parallel side edges 124 and a rounded end 126, and the grooves 120 may have an opening with a complementary configuration having substantially parallel side edges 128 and a rounded end 130, large enough to receive one of the teeth 118 by friction. Other configurations are also possible, such as all grooves being angled in the same direction, or repeating patterns of two or three grooves extending in the same or random directions.

[0051] If desired, as shown in Figures 8 and 9, each tooth 118 may include a notch 132 associated with the side of the individual tooth 118 facing the angle of the associated groove 120, configured to relieve stress resulting from bending and deflection caused by the tooth 118 being inserted into the angled groove 120. In a first embodiment, the notch 132 may be positioned on the side edge 124 of the tooth 118 adjacent to the second side edge 108 of the seat 104, such that the notch 132 extends into the tooth 118. In a second embodiment, the notch 132 may be positioned at the corner between the side edge 124 of the tooth 118 and the second side edge 108 of the seat 104, such that the notch 132 extends inward into the tooth 118 and the seat 104. The notch 132 may have a curved shape, for example, formed by a circular or elliptical punch.

[0052] Examples of the configuration of barbs 118 and 120 are shown in Figures 10 to 14. In the first embodiment shown in Figures 10 and 11, barbs 118 and 120 have a pointed configuration with a side edge portion 134 that extends to a pointed tip 136. In this embodiment, barbs 118 and 120 can be bent radially inward into the body 102 along the bottom edge portion 138 of barbs 118 and 120 where they connect to the rest of the body 102 (Figure 10), and / or along the intermediate edge portion of barbs 118 and 120 that extends between the ends of the side edge portion 134 adjacent to the pointed tip 136, thereby angling the tip 136 inward (Figure 11). The opening 122 may extend around the barbs 118 and 120 and have a complementary configuration defining them, the side portion 142 may extend along the side edge portion 134 of the barbs 118 and 120, and the pointed end portion 144 may extend around the pointed tip portion 136 of the barbs 118 and 120. In the second embodiment shown in Figure 12, the barbs 118 and 120 may have a rounded tip portion 146 instead of the pointed tip portion 136 as shown in Figures 10 and 11, and the barbs 118 and 120 may be bent inward along the bottom edge portion 138. In the third embodiment shown in Figure 13, the barbs 118 and 120 may have a forked configuration in which the side edge portion 148 extends to a forked end portion 150 including two laterally spaced pointed tips portion 152. In the illustrated configuration, the pointed tip 152 is defined by the lateral edges 148 of the barbs 118 and 120 and the concavely curved end edge 154, although other configurations for the end edge 154, such as an angled portion, can be used. Alternatively, the pointed tip 152 may extend outward from the end edge 154. The barbs 118 and 120 may be curved inward along their bottom edge 155. The opening 122 in this configuration may extend around the barbs 118 and 120 and have complementary configurations that define them, with the side portion 156 extending along the lateral edges 148 of the barbs 118 and 120, and the circular end portion 158 defining the curved end edge 154 of the barbs 118 and 120. In other versions, the barbs 118 and 120 may be composed of ends having three or more pointed tips. In each of the first to third forms, the barbs 118 and 120 extend longitudinally along axis L and are oriented inward toward the longitudinal center of the body 102.In the fourth embodiment, as shown in Figure 14, the barbs 118 and 120 have a pointed configuration with a side edge portion 160 that extends at an angle with respect to the longitudinal axis L of the body 102 and extends to a pointed tip 162. Unlike the symmetrical tip shown in the previous embodiment, the pointed tip 162 of the barbs 118 and 120 in this embodiment is offset in the direction of the midpoint of the body 102 such that the tip 162 is oriented toward the midpoint, while the barbs 118 and 120 extend at an angle thereto. With this configuration, the opening 122 in this embodiment includes side portions 164 having different lengths, i.e., a smaller top and a larger bottom, and an end portion 166 that extends at an angle between the ends of the side portions 164.

[0053] Figures 15 and 16 show an exemplary removable cap 170 suitable for use as the cap 19 described above. As shown, the cap 170 includes an upright annular side wall 172 and an end wall 174. The side wall 172 may include a lip 176 and a ledge 178 projecting inward to engage with the housing 12 of the device 10. The cap 170 further includes concentrically arranged annular walls 180, 182 extending upward from the end wall 174. The inner wall 180 includes a lip 184 projecting outward at its distal end 186 and may optionally include an inwardly tapered portion 188 adjacent to the lip 184 to provide access to the underside of the lip 184. The inner wall 180 is made to have a radius that fits inside the cylindrical body 102 of the remover 100 so that the body 102 can be mounted around it. Advantageously, the lip 184 can project radially outward to a distance sufficient to allow the barb 120 of the remover 100 to protrude below it, thereby attaching the remover 100 to the cap 170. The outer wall 182 is spaced radially outward from the inner wall 180 to a distance sufficient to accommodate the body 102 between them. This configuration allows the outer wall 182 to reinforce the outer surface of the end of the body 102 and prevent the end of the body 102 from deflecting radially outward, which could occur if a tensile force is applied to the remover 100 by pulling the cap 170 away from the device 10. The illustrated cap 170 includes both the inner wall 180 and the outer wall 182, while an alternative modification includes only the inner wall 180 and does not include the outer wall 182.

[0054] The remover 100 described above can, advantageously, be mass-produced in a high-speed stamping tool 200 as shown in Figures 17 and 18. In operation, a metal strip 202 is fed into the tool 200, and the tool 200 performs a series of operations to deform the strip 202 into a sheet 104 by forming features on individual parts of the strip 202, and then to form the 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 so that the stations 204 perform sequential operations on the strip 202 to finally form the remover 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 punch 212 to create guide holes in the strip 202, patterning the edges 106, 108, 110, teeth 114, grooves 116, and the first and second arrays of barbs 118, 120, as well as the associated openings 122 of the sheet 104. Station 204 in the first block 206 and Station 204 in the second block 208 then cut the strip 202 with punch 214 to form the sheet 104 (Figure 19), including its teeth 114, grooves 116, and barbs 118, 120. The guide holes formed in the first block 206 allow the sheet 104 to be formed without substantially distorting the thin metal of the strip 202. The station 204 in the second block 208 can further bend the barbs 118, 120 inward along the bottom and / or middle edges at a desired angle, as shown in Figure 20, as discussed above, initiating the bending process to continuously form a cylindrical shape from the sheet 104. The station 204 in the third block 210 then completes the tubular shape of the body 102 by pushing the teeth 114 into the groove 116 and connecting the edges 106, 108 with strong force.As shown in Figures 21 and 22, the station 204, configured to bend the main body 102 into a cylindrical shape, includes a lower concave shape 216 and an upper convex shape 218 that are pressed together to bend the sheet 104.

[0055] The cold forming process and the force applied to the sheet 104 to engage the teeth 114 and grooves 116 may cause a slight elongation of the body 102. For example, the body 102 may elongate by about 0.15 during the forming process. In the illustrated embodiment, the tool 200 is about 3 feet long and about 1.25 feet wide. The tool 200 is configured to receive a metal strip 202 that is 3 inches wide and 0.078 inches thick. Each time the tool 200 opens and closes in a stroke, the strip 202 is moved forward by about 1 inch, allowing a portion of the strip 202 to align with the next station 204 in the tool 200. The tool 200 as illustrated includes a total of 22 stations 204. However, it will be understood that the tool 204 can have any desired layout and configuration for creating the remover 100 having the features described herein.

[0056] Those skilled in the art will understand that the elements in the figures are drawn for simplification and clarity and are not necessarily drawn to a consistent scale. For example, the dimensions and / or relative positions of some elements in the figures may be exaggerated relative to others to improve the understanding of various embodiments of the invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often omitted so as not to interfere too much with the illustrations of these various embodiments. The same reference numerals may be used to describe similar or analogous parts. Furthermore, although several examples have been disclosed herein, any feature of any example may be combined with or substituted for other features of other examples. Furthermore, although several examples have been disclosed herein, modifications may be made to the disclosed examples without departing from the scope of the claims.

[0057] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used in conjunction with, the drugs specified below, and their generic and biosimilar equivalents, but not limited to those drugs. As used herein, the term "drug" is interchangeable with other similar terms and may be used to refer to any type of drug or therapeutic substance, including traditional and non-traditional medicines, dietary supplements, supplements, biological preparations, biological activators and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or restrictive.

[0058] The drug is contained within a reservoir. Depending on the case, the reservoir is a primary container, which may be either filled with the drug for treatment or pre-filled. The primary container may be a vial, cartridge, or pre-filled syringe.

[0059] 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 with such factors. Examples of such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastrim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0060] In other embodiments, the drug delivery device may contain, or be used with, an erythropoiesis-stimulating agent (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 activates the erythropoietin receptor, for example, by binding to the receptor and causing its dimerization. Examples of 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. Examples of red blood cell production stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0061] Among certain exemplary proteins, there are specific proteins described below, including their fusions, fragments, analogues, variants, or derivatives: fully humanized and human OPGL-specific antibodies, in particular fully humanized monoclonal antibodies, OPGL-specific antibodies, peptide bodies, and related proteins (also referred to as RANKL-specific antibodies, peptide bodies, etc.); myostatin-specific peptide bodies, myostatin-binding proteins, peptide bodies, and related proteins; in particular, those targeting IL-4 and / or IL-13 receptors. IL-4 receptor-specific antibodies, peptide bodies, and related proteins that inhibit binding-mediated activity; interleukin-1 receptor 1 ("IL1-R1")-specific antibodies, peptide bodies, and related proteins; Ang2-specific antibodies, peptide bodies, and related proteins; NGF-specific antibodies, peptide bodies, and related proteins; CD22-specific antibodies, peptide bodies, and related proteins, particularly dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain. Human CD22-specific antibodies, including but not limited to human CD22-specific IgG antibodies such as epratuzumab (CAS registry number 501423-23-0), human CD22-specific fully humanized antibodies, humanized and fully human monoclonal antibodies, humanized and fully human antibodies, etc.; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins, including but not limited to anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 This includes, but is not limited to, antibodies, including, but not limited to, fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; and antibodies that inhibit the interaction between B7RP-1 and its native receptor ICOS on activated T cells, such as B-7-related protein 1-specific antibodies, peptide bodies, and related proteins (also referred to as "B7RP-1" as well as B7H2, ICOSL, B7h, and CD275); and includes, but is not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7, particularly humanized monoclonal antibodies, such as IL-15-specific antibodies, peptide bodies, and related proteins;IFN-gamma specific antibodies, peptide bodies, and related proteins, including but not limited to human IFN-gamma specific antibodies, and fully human anti-IFN-gamma antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; and fully human hepatocyte growth factor / dispersion factor (HGF / SF) neutralizers. This includes hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as clonal antibodies; TRAIL-R2-specific antibodies, peptide bodies, and related proteins; activin A-specific antibodies, peptide bodies, and proteins; TGF-beta-specific antibodies, peptide bodies, and related proteins; amyloid-beta protein-specific antibodies, peptide bodies, and related proteins; and proteins that bind to c-Kit and / or other stem cell factor receptors. c-Kit-specific antibodies, peptide bodies, and related proteins, etc., not limited to those; OX40L-specific antibodies, peptide bodies, and related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel hematopoietic stimulating proteins NESP; Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (aremtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti® (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar of Herceptin®, or other products containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (Trademark) (Panitumumab), Xgeva (Registered Trademark) (Denosumab), Prolia (Registered Trademark) (Denosumab), Immunoglobulin G2 Human Monoclonal Antibody against RANK Ligand, Enbrel (Registered Trademark) (Etanercept, TNF-receptor / Fc Fusion Protein, TNF Blocker), Nplate (Registered Trademark) (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution; Infergen (Registered Trademark) (Interferon Alphacon-1); Natrecor (Registered Trademark) (Nesiritide; Recombinant Human Type B Natriuretic Peptide (hBNP); Kineret (Registered Trademark) (Anakinra); Leukine (Registered Trademark) (Sargamostim, rhuGM-CSF); LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb); Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb); Metalyse (registered trademark) (tenecteplase, t-PA analog); Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta); Mylotarg (registered trademark) (gemtuzumab ozogamicin); Raptiva (registered trademark) (efalizumab); Cimzia (registered trademark) (certolizumab pegol, CDP 870); Soliris (trademark) (eculizumab); pexerizumab (anti-complement C5); Numax (registered trademark) (MEDI-524); Lucentis (registered trademark) (ranibizumab);Panorex(registered trademark) (17-1A, edrecolomab); Trabio(registered trademark) (reldelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem(registered trademark) (IDM-1); OvaRex(registered trademark) (B43.13); Nuvion(registered trademark) (vizilizumab); Cantuzumab meltansine (huC242-DM1); NeoRecormon(registered trademark) (epoetin beta); Neumega(registered trademark) (oprelbequin, human interleukin-11); Orthoclone OKT3(registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit(registered trademark) (epoetin alfa); Remicade(registered trademark) (infliximab, anti-TNFα monoclonal antibody); Reopro(registered trademark) (absiximab, anti-GP) Ib / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanorimumab); Mvasi® (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva(registered trademark) (erlotinib); Roferon-A(registered trademark) (interferon alpha-2a); Simulect(registered trademark) (basiliximab); Prexige(registered trademark) (lumiracoxib); Synagis(registered trademark) (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri(registered trademark) (natalizumab, anti-α4 integrin mAb); Valortim(registered trademark) (MDX-1303, anti-anthrax (B. anthracis) protective antigen mAb); ABthrax(trademark); Xolair(registered trademark) (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (extracellular domains of the Fc portion of human IgG1 and both IL-1 receptor components (type I receptor and receptor co-protein)); VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimabe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (saltumumab); M200 (boroxiximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1)); anti-BR3 mAb; Anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388); Anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015); Anti-CD25 mAb (HuMax-TAC); Anti-CD3 mAb (NI-0401); Adekatumumab; Anti-CD30 mAb (MDX-060); MDX-1333 (Anti-IFNAR); Anti-CD38 mAb (HuMax CD38); Anti-CD40L mAb; Anti-Cripto mAb; Anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); Anti-CTLA4 mAb; Anti-eotaxin 1 mAb (CAT-213); Anti-FGF8 mAb; Anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;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-mesoterin 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).

[0062] In some embodiments, the drug delivery device may contain, or be used in conjunction with, sclerostin antibodies such as romosozumab, brosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), and other products containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, as well as, in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain, or be used in conjunction with, rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with IMLYGIC® (Tarimogene Laharpa Lepbec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042, or the device may be used in conjunction with them. In some embodiments, the drug delivery device may contain or be used in conjunction with endogenous tissue inhibitors (TIMPs) of metalloproteinases, including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used in conjunction with Aimovig® (Erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to erenumab and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery device of this disclosure.In addition, bispecific T-cell engager (BiTE®) antibodies, such as but not limited to BLINCYTO® (blinatumomab), 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 macromolecule agonist, such as, but not limited to, apelin or its analogues. In some embodiments, a therapeutically effective amount of anti-thymoid-interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibody 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, Avsola® (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamide)-4-phenylbutanamide)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindole-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain, or be used in conjunction with, Parsabiv® (ethelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain, or be used in conjunction with, another product containing ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera®, or an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used in conjunction with, a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (VEGFR1-derived Ig domain 2 and VEGFR2-derived Ig domain 3 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain, or be used in conjunction with, rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain, or be used in conjunction with, omecamutib mecarbil, small molecule selective cardiac myosin activator, or myotrope, or another product containing small molecule selective cardiac myosin activator that directly targets the cardiac contractile mechanism. In some embodiments, the drug delivery device may contain, or be used in conjunction with, sotrasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor.In some embodiments, the drug delivery device may contain, or be used in conjunction with, tezeperumab, a human monoclonal antibody, or another product containing a human monoclonal antibody that inhibits the action of thymic interstitial lymphocyte necrotizing factor (TSLP). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 714, a human monoclonal antibody, or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 890, a small interfering RNA (siRNA), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a). In some embodiments, the drug delivery device may contain, or be used in conjunction with, ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stellara®, or another product containing human IgG1 kappa antibody and / or binding to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Amjevita® or Amgevita® (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product containing human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 160, or another product containing the half-life extension (HLE) anti-prostate-specific membrane antigen (PSMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 119 or another product containing delta-like ligand 3 (DLL3)CAR T (chimeric antigen receptor T cell) therapy.In some embodiments, the drug delivery device may contain, or be used in conjunction 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 in conjunction with, AMG 133, or another product containing a gastric suppressor polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 171, or another product containing a growth and differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 176, or another product containing a small molecule inhibitor of myeloid leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 199, or another product containing a half-life extension (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 256, or another product containing anti-PD-1 × IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 330, or another product containing the anti-CD33 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 427, or another product containing the half-life extension (HLE) anti-fms-like tyrosine kinase 3 (FLT3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 430, or another product containing the anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 506, or another product containing the multispecific FAP × 4-1 BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 562, or another product containing the half-life extension (HLE) CD19 × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, efavavalukin alfa (formerly AMG 592), or another product containing the IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 596, or another product containing the CD3 × epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 673, or another product containing the half-life extension (HLE) anti-human CD33 × anti-anti-human CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 701, or another product containing the HLE (Hyperlife-Extended Epithelial) anti-B cell maturation antigen (BCMA) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 757, or another product containing the HLE (Hyperlife-Extended Epithelial) anti-delta-like ligand 3 (DLL3) × anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain, or be used in conjunction with, AMG 910, or another product containing the HLE (Hyperlife-Extended Epithelial Cell Tight Junction Constituent Protein Claudin 18.2 × anti-CD3 BiTE® (bispecific T cell engager) construct.

[0063] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. This detailed description should be construed as illustrative only and does not describe all possible embodiments of the disclosure. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments would still fall within the scope of the claims defining the invention disclosed herein.

[0064] Those skilled in the art will understand that various modifications, changes, and combinations of the above embodiments can be made without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations should be interpreted as falling within the scope of the concept of the invention.

Claims

1. It is a needle shield remover, A body having a tubular structure with first and second ends, the body being formed from a sheet of material having opposing first and second longitudinal edges, A closure configured such that the first and second longitudinal edges are joined together to form the tubular structure of the main body, Multiple teeth extending laterally outward from the first longitudinal edge, A closure comprising: a plurality of grooves extending laterally inward from the second longitudinal edge into the material sheet; Needle shield remover.

2. The needle shield remover according to claim 1, wherein the plurality of teeth extend substantially perpendicularly to the first longitudinal edge, spaced apart from the first longitudinal edge, and the plurality of grooves extend along an axis at a certain angle to the second longitudinal edge, and the plurality of teeth bend when each tooth enters one of the plurality of grooves.

3. The needle shield remover according to claim 2, wherein each of the plurality of teeth includes an associated notch configured to relieve stress within the material as a result of the plurality of teeth bending.

4. The needle shield remover according to claim 3, wherein the notched portion is disposed at the edge of each of the plurality of teeth, or at the corner between each of the plurality of teeth and the first longitudinal edge.

5. The needle shield remover according to any one of claims 2 to 4, wherein the plurality of grooves extend along the axis at an angle between 5 and 20 degrees with respect to the second longitudinal edge.

6. The needle shield remover according to any one of claims 2 to 5, wherein the axes of the plurality of grooves are arranged alternately so as to extend above or below a horizontal line extending between the first and second longitudinal edges.

7. A plurality of first barbs arranged around the body adjacent to the first end, A plurality of second barbs arranged around the body adjacent to the second end, Furthermore, Each of the first plurality of barbs and the second plurality of barbs comprises a member extending into the opening of the main body, the distal end of the member having a pointed tip spaced laterally apart. A needle shield remover according to any one of claims 1 to 6.

8. A plurality of first barbs arranged around the body adjacent to the first end, A plurality of second barbs arranged around the body adjacent to the second end, Furthermore, The first plurality of barbs and the second plurality of barbs extend inward within the main body. A needle shield remover according to any one of claims 1 to 7.

9. The needle shield remover according to any one of claims 1 to 8, wherein the needle shield remover is symmetrical with respect to a horizontal plane that passes through the midpoint of the body and extends perpendicularly to its longitudinal axis.

10. A self-injecting drug delivery device, Housing and A drug container coupled to the housing, comprising a drug container including a needle, A needle shield is provided to at least partially cover the distal end of the needle of the drug container, A removable cap is coupled to the housing, A needle shield remover is coupled to the removable cap and the needle shield such that the needle shield is removed from the needle of the drug container by separating the removable cap from the housing, A body having a tubular structure with first and second ends, the body being formed from a sheet of material having opposing first and second longitudinal edges, A closure that connects the first and second longitudinal edges of the main body to each other to form the tubular structure, Multiple teeth extending laterally outward from the first longitudinal edge, A closure comprising: a plurality of grooves extending laterally inward from the second longitudinal edge within the material sheet, the plurality of grooves receiving the plurality of teeth and connecting the first and second longitudinal edges to each other; A needle shield remover equipped with, Auto-injector drug delivery device.

11. The autoinjector drug delivery device according to claim 10, wherein the plurality of teeth extend substantially perpendicularly to the first longitudinal edge, spaced apart from the first longitudinal edge, and the plurality of grooves extend along an axis at an angle to the second longitudinal edge, and the plurality of teeth bend when each tab enters one of the plurality of grooves.

12. The auto-injector drug delivery device according to claim 11, wherein the axes of the plurality of grooves are arranged alternately so as to extend above or below a horizontal line extending between the first and second longitudinal edges.

13. The aforementioned needle shield remover is A plurality of first barbs arranged around the body adjacent to the first end, the plurality of first barbs that grip the removable cap, The present invention further comprises a plurality of second barbs arranged around the body adjacent to the second end, the plurality of second barbs for gripping the needle shield, A self-injecting drug delivery device according to any one of claims 10 to 12.

14. The auto-injector drug delivery device according to claim 13, wherein each of the first plurality of barbs and the second plurality of barbs extends into the opening of the body and includes a distal end having a laterally spaced pointed tip.

15. The auto-injector drug delivery device according to claim 13 or 14, wherein the first plurality of barbs and the second plurality of barbs extend inward within the main body.

16. The self-injector drug delivery device according to claim 15, wherein the removable cap comprises a central wall configured to be gripped by a plurality of first barbs and an annular wall spaced outward from the central wall and configured to engage with the outer surface of the first end of the body.

17. The self-injector drug delivery device according to any one of claims 10 to 16, wherein the needle shield remover is symmetrical with respect to a horizontal plane that passes through the midpoint of the main body and extends perpendicular to its longitudinal axis.

18. A method for forming a needle shield remover from a metal strip, A sheet is formed from the metal strip having first and second longitudinal edges and end edges, wherein the sheet includes a closure for the needle shield remover, comprising a plurality of teeth extending laterally outward from the first longitudinal edge and a plurality of grooves extending laterally inward into the material sheet from the second longitudinal edge. To form a plurality of first barbs across the width of the metal strip, To form a second set of barbs across the width of the metal strip, This includes creating a tubular shape from the sheet by pressing the plurality of teeth into the plurality of grooves, method.

19. The method of claim 18, wherein the plurality of teeth extend substantially perpendicularly to the first longitudinal edge, spaced apart from the first longitudinal edge, the plurality of grooves extend along an axis at an angle to the second longitudinal edge, and creating the tubular shape from the sheet involves bending the plurality of teeth as each tooth enters each of the plurality of grooves.

20. The method according to claim 18 or 19, further comprising drilling guide holes in the metal strip to form cutting patterns for the closure, the first plurality of barbs, and the second plurality of barbs.

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