Needle shield assembly for syringes

Abstract

The needle shield assembly includes a first needle shield at least partially made of a first material and having a proximal end and a distal end, the proximal end of the first needle shield including a cavity, and a second needle shield at least partially made of a second material, the second needle shield mechanically coupled to at least the proximal end of the first needle shield, and the second material of the second needle shield is harder than the first material of the first needle shield.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 399,146, filed August 18, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to syringes, and more particularly to needle shields for use with syringes. [Background technology]

[0003] A syringe may contain a needle for containing a medication and delivering the medication, for example, to a patient. A needle shield may be provided to maintain the sterility of the needle, protect the needle from damage, and / or reduce the possibility of an accidental needlestick injury. To secure the needle shield to the syringe, the needle shield may be designed to frictionally couple with the syringe. Before using the syringe to deliver the medication, the needle shield may need to be removed from the syringe. In at least some cases, the interface between the syringe and the needle shield may provide significant resistance to force applied to remove the needle shield from the syringe.

[0004] To remove the needle shield, the user can grasp the needle shield and pull it out by hand and / or use a needle shield remover. Certain needle shield removers grasp the end of the needle shield, which can provide a grip for the user. Summary of the Invention [Means for solving the problem]

[0005] Disclosed herein is a needle shield assembly including a first needle shield at least partially made of a first material and having a proximal end and a distal end. The proximal end of the first needle shield includes a cavity. The needle shield assembly further includes a second needle shield at least partially made of a second material, the second needle shield being mechanically coupled to at least the proximal end of the first needle shield. Additionally, the second material is harder than the first material.

[0006] In some variations, the first needle shield further includes an annular shoulder, and the second needle shield is mechanically coupled to the first needle shield by at least partially abutting the shoulder. Additionally or alternatively, the second needle shield further abuts the proximal end of the first needle shield. Furthermore, at least a portion of the second needle shield covers and / or is radially outward of at least a portion of the annular shoulder of the first needle shield. In some examples, the second needle shield is overmolded onto the first needle shield.

[0007] In yet another variation, the second needle shield further includes teeth at least partially embedded in the first needle shield. In addition, the teeth are embedded in the first needle shield approximately midway between the proximal and distal ends of the first needle shield. Alternatively, the teeth are embedded in the distal end of the first needle shield.

[0008] Disclosed herein is a needle shield assembly including a first needle shield having a proximal end and a distal end. The needle shield assembly further includes a second needle shield having a flexible distal portion and a rigid proximal portion. Additionally, the needle shield assembly includes a cap configured to at least partially surround at least one of the first and second needle shields and to press the flexible distal portion of the second needle shield against the first needle shield.

[0009] In some variations, the second needle shield further comprises teeth coupled with the flexible distal portion. In some examples, the teeth are at least partially embedded in the first needle shield when the cap at least partially surrounds the second needle shield. In addition, the teeth may be located at a distal end of the flexible distal portion of the second needle shield. Alternatively, the teeth may be located adjacent to the mechanical connection between the flexible distal portion and the rigid portion of the second needle shield.

[0010] In other variations, the first needle shield further includes an annular shoulder, and the second needle shield is mechanically coupled to the first needle by at least partially abutting the shoulder. For example, the annular shoulder may be located adjacent to the proximal end of the first needle shield. Additionally or alternatively, the second needle shield abuts the proximal end of the first needle shield.

[0011] In yet other variations, the second needle shield includes an annular ridge and the cap includes an annular groove, the annular ridge configured to engage the annular groove to mechanically couple the second needle shield and the cap. In some examples, the cap is configured to mechanically couple the first needle shield, the second needle shield, and the cap to one another. In some such examples, the second needle shield is overmolded onto the first needle shield.

[0012] Also disclosed herein is an assembly method that includes providing a first needle shield made of at least a first material and having a proximal end and a distal end. The method further includes mechanically coupling a second needle shield to the first needle shield, the second needle shield being at least partially made of the second material. In some examples, the second material is harder than the first material.

[0013] In some variations, the assembly method includes at least partially inserting the first needle shield and the second needle shield into the cap. Further, the method may include mechanically coupling the cap with the second needle shield. In some examples, mechanically coupling the cap with the second needle shield includes disposing at least one annular ridge of the second needle shield within at least one annular groove formed in the cap.

[0014] In another variation, the second needle shield includes a flexible distal portion, and the cap presses the flexible distal portion of the second needle shield against the first needle shield. In addition, the flexible distal portion may include at least one tooth, and mechanically coupling the cap with the second needle shield includes pressing the flexible distal portion of the second needle shield against the first needle shield such that the at least one tooth is at least partially embedded within the first needle shield.

[0015] In yet other variations, the method includes overmolding a second needle shield onto the first needle shield. In some such examples, mechanically coupling the second needle shield to the first needle shield includes at least partially disposing an annular shoulder of the first needle shield within a pocket of the second needle shield.

[0016] The present disclosure may be best understood by referring to the following description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a side view of a first exemplary needle shield assembly made in accordance with the present disclosure. [Figure 2] 2A and 2B are side and cutaway views of the first exemplary needle shield assembly of FIG. 1. [Figure 3] FIG. 10 is a perspective view of a second exemplary needle shield assembly made in accordance with the present disclosure. [Figure 4]4 illustrates an exemplary first step in a manufacturing process for the second exemplary needle shield assembly of FIG. 3. [Figure 5] 4 illustrates an exemplary second step in the manufacturing process for the second exemplary needle shield assembly of FIG. 3. [Figure 6] 4 illustrates an exemplary third step in the manufacturing process for the second exemplary needle shield assembly of FIG. 3. [Figure 7] FIG. 10 is a perspective view of a third exemplary needle shield assembly made in accordance with the present disclosure. [Figure 8] 8 illustrates an exemplary first step in a manufacturing process for the third exemplary needle shield assembly of FIG. 7. [Figure 9] 8 illustrates an exemplary second step in the manufacturing process for the third exemplary needle shield assembly of FIG. 7. [Figure 10] 8 illustrates an exemplary third step in the manufacturing process for the third exemplary needle shield assembly of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0018] These figures depict preferred embodiments for illustrative purposes only and are not drawn to scale. Those skilled in the art will readily recognize from the following discussion that alternative embodiments of the systems and methods illustrated herein may be used without departing from the principles described herein.

[0019] In many cases, pre-filled syringes and other syringes loaded with drugs may be provided with a needle shield to maintain the sterility of the syringe needle, protect the needle from damage, and / or reduce the possibility of accidental needlestick injuries. The needle shield may be rigidly attached to the syringe, which may present challenges to at least some end users when removing the needle shield from the syringe. In some cases, removing the needle shield from the syringe may require the user to manually apply a force of about 45 Newtons (N) or more, which is beyond the capabilities of some users.

[0020] Needle shields or syringes made in accordance with the present disclosure are configured to provide a reduced-friction interface between the needle shield and the syringe, for example, without compromising the needle shield's ability to maintain the sterility of the syringe's needle, protect the needle from damage, and / or prevent accidental needle sticks. As a result, the reduced-friction interface can facilitate easier removal of the needle shield from the syringe compared to conventional configurations. In at least some embodiments, the force required to remove the needle shield is about 5 N or less, or about 10 N or less. Furthermore, in at least some embodiments, the needle shield or syringe of the present disclosure reduces friction between the needle shield and the syringe by reducing the surface area of ​​contact between the syringe and the needle shield.

[0021] Additionally, the needle shield tends to deform under the force applied to remove the needle shield from the syringe. For example, the needle shield may be narrow and elongated around the needle as it is pulled from the distal end. As a result, the deformed needle shield may pinch onto the needle, further increasing the force required to remove the needle shield from the syringe. According to the present disclosure, the needle shield is configured to distribute the removal force so that the needle shield does not or is less likely to deform relative to the needle and / or increases the force required to remove the needle shield from the syringe.

[0022] 1 and 2 show a first exemplary needle shield assembly 100 made in accordance with the present disclosure. The needle shield assembly 100 includes a first needle shield 102, a second needle shield 104, and a syringe 108. In the illustrated example of FIGS. 1 and 2, the second needle shield 104 is shorter than the first needle shield 102, but in various other examples, the second needle shield 104 is the same length as the first needle shield 102 or is longer than the first needle shield 102.

[0023] The first needle shield 102 is at least partially made of a first material and has a proximal end 112a and a distal end 112b, with the proximal end 112a of the first needle shield 102 including a cavity 114 extending from the proximal end 112a. In some examples, the first needle shield is made entirely of the first material. The cavity 114 is configured to receive and secure a needle, such as needle 202. Needle 202 is shown in FIG. 2 but may be omitted from other figures for clarity. The first needle shield 102 also includes an annular shoulder 116, and the second needle shield is mechanically coupled to the first needle shield by at least partially abutting the shoulder.

[0024] The needle shield assembly 100 further includes a second needle shield 104 made of a second material. The second needle shield 104 is mechanically coupled to the first needle shield 102. In this example, the second needle shield 104 covers the annular shoulder 116 and / or includes a pocket 122 radially outward of at least a portion of the annular shoulder 116. In such an example, the second needle shield 104 transmits axial forces to the first needle shield 102 through the pocket 122 coupled to the annular shoulder 116. As shown in FIG. 1 , the annular shoulder 116 and the pocket 122 are proximate the proximal end 112 a of the first needle shield 102. In other examples, the shoulder 116 can be located approximately midway between the proximal end 112 a and the distal end 112 b, or the shoulder 116 can be located proximate the distal end 112 b of the first needle shield 102. Additionally or alternatively, the second needle shield 104 can abut the proximal face of the first needle shield.

[0025] According to the present disclosure, the second needle shield 104 is at least partially made of a second material, and the first needle shield 102 is made of a first material. In some examples, the second needle shield 104 is made entirely of the second material. In preferred examples, the second material is harder than the first material. As a result, when a force is applied, the second needle shield 104 is limited in deformation and can transfer the applied force to the first needle shield 102. By applying a force from the second needle shield 104 to the first needle shield 102 through the annular shoulder 116, the first needle shield 102 is limited in deformation and does not pinch onto the needle, increasing the force required to remove the needle shield 102 from the syringe 108. In some examples, the second needle shield 104 is manufactured and overmolded onto the first needle shield 102. As used herein, overmolded means that the second needle shield 104 is formed and molded onto the first needle shield 102, rather than being manufactured separately from the first needle shield 102 and then bonded to the first needle shield 102. Alternatively, the second needle shield 104 can be manufactured separately from the first needle shield 102 and then bonded to the first needle shield 102.

[0026] Figure 3 is a perspective view of a second exemplary needle shield assembly 300 made in accordance with the present disclosure. The needle shield assembly 300 includes a first needle shield 302, a second needle shield 304, a cap 410 (described in more detail in connection with Figures 4, 5, and 6), and a syringe 308. In the example shown in Figure 3, the second needle shield 304 is transparent, although in other examples, the second needle shield 304 may be made of an opaque material (e.g., as shown in Figures 4, 5, and 6).

[0027] The first needle shield 302 includes a proximal end 312a and a distal end 312b. The first needle shield 302 is generally cylindrical, but the first needle shield further includes an annular shoulder 314. As a result, the first needle shield 302 is substantially similar to the first needle shield 102 of Figures 1 and 2. In various examples, the first needle shield 302 is made of a first thermoplastic material that is flexible and pliable.

[0028] The second needle shield 304 includes a rigid proximal portion 322 and a flexible distal portion 324. The second needle shield further includes teeth 422 (described in more detail below in connection with FIGS. 4, 5, and 6) supported by or coupled to the flexible distal portion 324. In some examples, the second needle shield 304 is manufactured and overmolded onto the first needle shield 302. As used herein, overmolded means that the second needle shield 304 is formed and molded onto the first needle shield 302, rather than being manufactured separately from the first needle shield 302 and then coupled to the first needle shield 302. Alternatively, the second needle shield 304 can be manufactured separately from the first needle shield 302 and then coupled to the first needle shield 302.

[0029] Additionally, the first needle shield 302 and the second needle shield 304 are mechanically coupled. As shown, the first needle shield 302 includes a shoulder 316, and the second needle shield 304 includes a pocket 326. The shoulder 316 and the pocket 326 couple the first needle shield 302 to the second needle shield 304 and prevent axial movement of the first needle shield 302 relative to the second needle shield 304. The annular shoulder 316 is also disposed adjacent the proximal end 312a of the first needle shield 302. Additionally or alternatively, the second needle shield 304 may abut the proximal end 312a of the first needle shield 302.

[0030] The second needle shield 304 further includes at least a first flexible arm 328 a and a second flexible arm 328 b. In the illustrated example, the second needle shield 304 includes only two flexible arms 328 a, 328 b. In various other examples, the second needle shield 304 can include more or fewer flexible arms than those shown in FIG. 3 .

[0031] 4 illustrates an exemplary first step in the manufacturing process for the second exemplary needle shield assembly 300 of FIG. 3. In the illustrated example, a syringe 308 includes a first needle shield 302, a second needle shield 304, and a cap 410 positioned away from the first and second needle shields 302, 304. The cap 410 has been moved toward the first and second needle shields 302, 304, as indicated by arrows F1, F2, and F3. In some examples, the cap 410 may be assembled onto the first and second needle shields 302, 304 before the first and second needle shields 302, 304 are placed on the syringe 308.

[0032] Cap 410 includes a rim 412, a cavity 414, a sealing surface 416, and first and second annular grooves 418a, 418b. In this example, cavity 414 passes through cap 410, although in other examples, cavity 414 may only partially pass through cap 410. Additionally, cap 410 includes rim 412, which is configured to assist an end user in withdrawing the cap from the syringe.

[0033] 4, the teeth 422 are located proximate to the rigid portion 322. In some examples, the teeth 422 may be located proximate or adjacent to a mechanical connection 424 between the flexible distal portion 324 and the rigid portion 322 of the second needle shield 304. In this example, the mechanical connection 424 is located proximate to the distal end 312b of the first needle shield 302, but in other examples, the mechanical connection 424 may be located elsewhere on the second needle shield 304.

[0034] 5 illustrates an exemplary second step in the manufacturing process of the second exemplary needle shield assembly 300 of FIG. 3. In accordance with the present disclosure, a cap 410 is configured to partially or completely surround the first needle shield 302 and / or the second needle shield 304. By way of example, the cap 410 may at least partially surround the first needle shield 302 and / or the second needle shield 304. As shown in FIG. 5, the cap 410 is about to press the flexible distal portion 324 of the second needle shield against the first needle shield. Specifically, the sealing surface 416 is about to connect to the flexible distal portion 324.

[0035] 6 illustrates an exemplary third step in the manufacturing process of the second exemplary needle shield assembly 300 of FIG. 3. As shown in FIG. 6, the teeth 422 are at least partially embedded in the first needle shield 302 after the cap 410 surrounds (e.g., encloses) the second needle shield 304. In this example, the teeth 422 are embedded in the first needle shield 302 approximately midway between the proximal end 312 a and the distal end 312 b of the first needle shield 302. In various other examples, the teeth 422 may be configured to be embedded in other locations on the first needle shield 302, including near the proximal end 312 a or the distal end 312 b.

[0036] 6, the cap 410 mechanically couples the first needle shield 302, the second needle shield 304, and the cap 410 to one another. The cap 410 is mechanically coupled to the second needle shield 304 when the annular grooves 418a, 418b located in the cap 410 receive the annular ridges 428a, 428b located on the second needle shield 304. In addition, the second needle shield 304 is coupled to the first needle shield 302 because the teeth 422 are embedded in the first needle shield 302 and the annular shoulder 316 is coupled to the pocket 326. Thus, the first needle shield 302, the second needle shield 304, and the cap 410 are mechanically coupled to one another.

[0037] When the first needle shield 302, the second needle shield 304, and the cap 410 are coupled together, the force exerted on the rim 412 is distributed at least at the annular shoulder 316 through the first needle shield 302 and via the teeth 422. As a result, the even distribution of force reduces deformation in the first needle shield 302. Because the first needle shield 302 does not deform, the force required to remove the needle shield remains relatively small (e.g., less than about 5-10 N).

[0038] Figure 7 is a perspective view of a third exemplary needle shield assembly 700 made in accordance with the present disclosure. The needle shield assembly 700 includes a first needle shield 702, a second needle shield 704, a cap 810 (described in more detail below in connection with Figures 8, 9, and 10), and a syringe 708. In the illustrated example of Figure 7, the second needle shield 704 is transparent, although in other examples, the second needle shield 704 is made of an opaque material (e.g., as shown in Figures 8, 9, and 10).

[0039] The first needle shield 702 includes a proximal end 712a and a distal end 712b. The first needle shield 702 is generally cylindrical, but the first needle shield further includes an annular shoulder 714. As a result, the first needle shield 702 is substantially similar to the first needle shield 102 of Figures 1 and 2 and the first needle shield 302 of Figures 3, 4, 5, and 6. In various examples, the first needle shield 702 is made of a first thermoplastic material that is flexible and pliable.

[0040] The second needle shield 704 includes a rigid proximal portion 722 and a flexible distal portion 724. The second needle shield further includes teeth 822 (described in more detail in connection with FIGS. 8, 9, and 10) supported by or coupled to the flexible distal portion 724. In some examples, the second needle shield 704 is manufactured and overmolded onto the first needle shield 702. Alternatively, the second needle shield 704 can be manufactured separately from the first needle shield 702 and then coupled to the first needle shield 702.

[0041] Additionally, the first needle shield 702 and the second needle shield 704 are mechanically coupled. As shown, the first needle shield 702 includes a shoulder 716, and the second needle shield 704 includes a pocket 726. The shoulder 716 and the pocket 726 couple the first needle shield 702 to the second needle shield 704 and prevent axial movement of the first needle shield 702 relative to the second needle shield 704. Additionally, the annular shoulder 716 is disposed adjacent the proximal end 712a of the first needle shield 702. Additionally or alternatively, the second needle shield 704 may abut the proximal end 712a of the first needle shield 702.

[0042] The second needle shield 704 further includes at least a first flexible arm 728 a and a second flexible arm 728 b. In the illustrated example, the second needle shield 704 includes only two flexible arms 728 a, 728 b. In various other examples, the second needle shield 704 can include more or fewer flexible arms than those shown in FIG. 7.

[0043] 8 illustrates an exemplary first step in a manufacturing process for the third exemplary needle shield assembly 700 of FIG. 7. In the illustrated example, a syringe 708 includes a first needle shield 702, a second needle shield 704, and a cap 810 positioned away from the first needle shield 702 and the second needle shield 704. The cap 810 has been moved toward the first needle shield 702 and the second needle shield 704, as indicated by arrows F1, F2, and F3. In some examples, the cap 810 may be assembled onto the first and second needle shields 702, 704 before the first and second needle shields 702, 704 are placed on the syringe 708.

[0044] Cap 810 includes a rim 812, a cavity 814, a sealing surface 816, and first and second annular grooves 818a, 818b. In this example, cavity 814 passes through cap 810, although in some examples, cavity 814 may only partially pass through cap 810. Additionally, cap 810 includes rim 812, which is configured to assist an end user in withdrawing the cap from the syringe.

[0045] 8, the teeth 822 are positioned proximate to the distal end 712b of the first needle shield 702. In some examples, the teeth 822 may be positioned proximate to or adjacent to the mechanical connection 824 between the flexible distal portion 724 and the rigid portion 722 of the second needle shield 704. In this example, the mechanical connection 824 is positioned between the proximal end 826a and the distal end 826b of the second needle shield. In other examples, the mechanical connection 824 may be positioned elsewhere on the second needle shield 704.

[0046] 9 illustrates an exemplary second step in the manufacturing process of the third exemplary needle shield assembly 700 of FIG. 7. According to the present disclosure, a cap 810 is configured to partially or completely surround the first needle shield 702 and / or the second needle shield 704. By way of example, the cap 810 may at least partially surround the first needle shield 702 and / or the second needle shield 704. As shown in FIG. 9, the cap 810 is about to press the flexible distal portion 724 of the second needle shield against the first needle shield 702. Specifically, the sealing surface 816 is about to connect to the flexible distal portion 724.

[0047] 10 illustrates an exemplary third step in the manufacturing process of the third exemplary needle shield assembly 700 of FIG. 7. As shown in FIG. 10, the teeth 822 are embedded in the first needle shield 702 after the cap 810 surrounds the second needle shield 704. In this example, the teeth 822 are embedded in the first needle shield 702 approximately midway between the proximal end 712 a and the distal end 712 b of the first needle shield 702. In various other examples, the teeth 822 may be configured to be embedded in other locations on the first needle shield 702, including near the proximal end 712 a or the distal end 712 b.

[0048] 10 , the cap 810 mechanically couples the first needle shield 702, the second needle shield 704, and the cap 810 to one another. The cap 810 is mechanically coupled to the second needle shield 704 when the annular grooves 818a, 818b located in the cap 810 receive the annular ridges 828a, 828b located on the second needle shield 704. In addition, the second needle shield 704 is coupled to the first needle shield 702 because the teeth 822 are embedded in the first needle shield 702 and the annular shoulder 716 is coupled with the pocket 726. Thus, the first needle shield 702, the second needle shield 704, and the cap 810 are mechanically coupled to one another.

[0049] When the first needle shield 702, the second needle shield 704, and the cap 810 are coupled together, the force exerted on the rim 812 is distributed at least at the annular shoulder 716 to the first needle shield 702 and through the teeth 822. As a result, the even distribution of force reduces deformation in the first needle shield 702. Because the first needle shield 702 does not deform, the force required to remove the needle shield remains small (e.g., approximately 5-10 N).

[0050] In at least some of the embodiments of the needle shield assembly described herein, the combination of the first and second needle shields, and in certain cases, the cap, may prevent deformation of the first needle shield during removal of the needle shield assembly from the syringe and / or at other times. As a result, the first needle shield may be less likely to deform in a way that increases frictional forces between the first needle shield and the syringe needle. Thus, at least some of the disclosed embodiments may reduce the force required to remove the needle shield assembly from the syringe. Furthermore, in at least some cases, features described herein in connection with one embodiment may be combined with features of one or more other embodiments described herein.

[0051] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. The term drug, as used herein, can be used interchangeably with other similar terms and can refer to any type of drug or therapeutic material, including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following exemplary list of drugs should not be considered exhaustive or limiting.

[0052] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0053] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0054] 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" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alfa, Epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0055] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which particularly inhibit activities mediated by binding of IL-4 and / or IL-13 to its receptor; Interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide linked to human-mouse monoclonal hLL2 kappa chain, e.g., epratuzumab (CAS Registry Number 501423-23-0). human CD22-specific antibodies, such as, but not limited to, humanized and fully human monoclonal antibodies, particularly including, but not limited to, human CD22-specific IgG antibodies, such as the human CD22-specific fully humanized antibody of; IGF-1 receptor-specific antibodies, peptibodies and related proteins, including, but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, including, but not limited to, those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including, but not limited to, a B7RP-specific fully human monoclonal IgG2 antibody; e.g., 145c7, HuMax IL-15 specific antibodies, such as humanized monoclonal antibodies, peptibodies, related proteins, and the like, including but not limited to IL-15 antibodies and related proteins;IFN gamma-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, human IFN gamma-specific antibodies, and including, but not limited to, fully human anti-IFN gamma antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., as well as other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF). Hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as monoclonal antibodies; TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-β-specific antibodies, peptibodies, related proteins, etc.; amyloid β protein-specific antibodies, peptibodies, related proteins, etc.; including, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors. including, but not limited to, c-Kit-specific antibodies, peptibodies, related proteins, etc.; OX40L-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, de novo erythropoiesis stimulation Protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-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, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® trademark) (panitumumab); Xgeva® (denosumab); Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide); recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP IL6 / IL6 receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri® (natalizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG1 and the extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb); Zevalin® (ibritumomab tiuxetan);Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-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 (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficile toxin A and toxin BC 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); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; 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-metameric dsFv-PE38 antibody (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3); .

[0056] In some embodiments, the drug delivery device may contain or be used in conjunction with sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device can be loaded with, or the device can be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device can contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device can contain, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) molecules, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device can contain or be used in conjunction with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNF-alpha monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune disease. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)—N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide hydrochloride, KAI-4169) or another product containing etelcalcetide hydrochloride for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1), such as aflibercept. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 959 (eculizumab), a biosimilar candidate for 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 rozivacsp 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 omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the cardiac contractile machinery, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS inhibitor. G12C Small molecule inhibitors, or KRAS G12CThe drug delivery device may contain or be used in conjunction with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 714, a human monoclonal antibody that binds interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds 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) that reduces lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used in conjunction with Amjevita™ or Amgevita™ (formerly ABP 501) (a mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product containing a 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 a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133 or a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171 or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176 or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199 or a half-life extended (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 an anti-PD-1 x IL21 mutein and / or 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 an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 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 house or be used in conjunction with another product containing AMG 427 or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell engager) construct.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 506 or another product containing a multispecific FAPx4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used 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 a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with efavalukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device is administered with AMG 596 or CD3× epidermal growth factor. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecules. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 673 or a half-life extended (HLE) anti-human CD33 x 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 another product containing AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 757 or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 910 or another product containing the half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0057] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of, but are not limited to, exemplary embodiments, the detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure, and many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0058] Those skilled in the art will understand that various modifications, variations and combinations can be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and that such modifications, variations and combinations are to be construed as being within the scope of the present invention.

Claims

1. A needle shield assembly, A first needle shield, at least partially made of a first material and having a proximal end and a distal end, wherein the proximal end of the first needle shield is provided with a cavity, A second needle shield made at least partially of a second material, wherein the second needle shield is mechanically coupled to at least the proximal end of the first needle shield. Equipped with, The second material is harder than the first material. Needle shield assembly.

2. The needle shield assembly according to claim 1, wherein the first needle shield comprises an annular shoulder, and the second needle shield is mechanically coupled to the first needle shield by at least partially contacting the annular shoulder.

3. The needle shield assembly according to claim 1 or 2, wherein the second needle shield abuts against the proximal end of the first needle shield.

4. The needle shield assembly according to claim 2, wherein at least a portion of the second needle shield covers at least a portion of the annular shoulder of the first needle shield and / or is radially outward of at least a portion of the annular shoulder of the first needle shield.

5. The needle shield assembly according to any one of claims 1, 2, or 4, wherein the second needle shield is overmolded onto the first needle shield.

6. The needle shield assembly according to any one of claims 1, 2, or 4, wherein the second needle shield comprises teeth, the teeth being at least partially embedded in the first needle shield.

7. The needle shield assembly according to claim 6, wherein the tooth is either (a) embedded in the first needle shield at a point substantially midway between the proximal end and the distal end of the first needle shield, or (b) embedded in the distal end of the first needle shield.

8. A needle shield assembly, A first needle shield having a proximal end and a distal end, A second needle shield having a flexible distal portion and a rigid proximal portion, A cap configured to at least partially surround at least one of the first needle shield and the second needle shield, and to press the flexible distal portion of the second needle shield against the first needle shield. A needle shield assembly comprising:

9. The needle shield assembly according to claim 8, wherein the second needle shield further comprises a tooth coupled to the flexible distal portion.

10. The needle shield assembly according to claim 9, wherein the teeth are at least partially embedded in the first needle shield when the cap at least partially surrounds the second needle shield.

11. The needle shield assembly according to claim 10, wherein the teeth are either (a) located at the distal end of the flexible distal portion of the second needle shield, or (b) located adjacent to the mechanical connection between the flexible distal portion and the rigid portion of the second needle shield.

12. The needle shield assembly according to any one of claims 8 to 11, wherein the first needle shield further includes an annular shoulder, and the second needle shield is mechanically coupled to the first needle by at least partially abutting the shoulder.

13. The needle shield assembly according to claim 12, wherein the annular shoulder portion is positioned close to the proximal end of the first needle shield.

14. (a) The second needle shield abuts against the proximal end of the first needle shield and / or (b) The second needle shield is provided with an annular protrusion, the cap is provided with an annular groove, and the annular protrusion is configured to engage with the annular groove to mechanically connect the second needle shield and the cap, and / or (c) The cap is configured to mechanically connect the first needle shield, the second needle shield, and the cap to each other, and / or (d) The second needle shield is overmolded on the first needle shield. The needle shield assembly according to any one of claims 8 to 11.

15. This is an assembly method, To prepare a first needle shield that is made at least partially of the first material and has a proximal end and a distal end, The method involves mechanically bonding a second needle shield to the first needle shield, wherein the second needle shield is at least partially made of a second material, and the second material is harder than the first material. Assembly method, including the assembly method.

16. The assembly method according to claim 15, further comprising inserting the first needle shield and the second needle shield at least partially into the cap.

17. The cap is further mechanically coupled to the second needle shield, The assembly method according to claim 16, wherein mechanically coupling the cap with the second needle shield includes positioning at least one annular protrusion of the second needle shield within at least one annular groove formed in the cap.

18. The second needle shield includes a flexible distal portion, and the cap presses the flexible distal portion of the second needle shield against the first needle shield. The assembly method according to claim 16 or 17, wherein the flexible distal portion comprises at least one tooth, and mechanically coupling the cap with the second needle shield includes pressing the flexible distal portion of the second needle shield against the first needle shield such that the at least one tooth is at least partially embedded in the first needle shield.

19. The assembly method according to any one of claims 15 to 17, further comprising overmolding the second needle shield onto the first needle shield.

20. The assembly method according to any one of claims 15 to 17, wherein mechanically coupling the second needle shield to the first needle shield includes positioning at least partially the annular shoulder portion of the first needle shield within the pocket of the second needle shield.

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