Needle shield assembly for syringe

Abstract

A 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 with at least the proximal end of the first needle shield. In addition, the second material of the second needle shield is harder than the first material of the first needle shield.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 399,146, filed on August 18, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to syringes and, more particularly, to needle shields for use with syringes. Background Art

[0004] The syringe may contain a medicament and include a needle for delivering the medicament, for example, into a patient's body. A needle shield may be provided to maintain the sterility of the needle, protect the needle from damage, and / or reduce the possibility of accidental needle sticks. In order to secure the needle shield to the syringe, the needle shield may be designed to be coupled to the syringe by friction. Before using the syringe to deliver the medicament, it may be necessary to remove the needle shield from the syringe. In at least some cases, the interface between the syringe and the needle shield may create substantial resistance to the force applied to remove the needle shield from the syringe.

[0005] To remove the needle shield, the user can grab the needle shield and pull it out with their hands and / or use a needle shield remover. Some needle shield removers grab the end of the needle shield, and the needle shield remover can be grasped by the user. Summary of the invention

[0006] A needle shield assembly is disclosed herein, comprising a first needle shield, the first needle shield being 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 comprises a cavity. The needle shield assembly further comprises a second needle shield being 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. In addition, the second material is harder than the first material.

[0007] 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 at least a portion of the annular shoulder of the first needle shield and / or is radially outward thereof. In some examples, the second needle shield is overmolded on the first needle shield.

[0008] In yet other variations, the second needle shield further comprises a tooth at least partially embedded in the first needle shield. Additionally, the tooth is embedded in the first needle shield at a substantially midpoint between the proximal and distal ends of the first needle shield. Alternatively, the tooth is embedded in the distal end of the first needle shield.

[0009] A needle shield assembly is disclosed herein, comprising a first needle shield having a proximal end and a distal end. The needle shield assembly further comprises a second needle shield having a flexible distal portion and a rigid proximal portion. Additionally, the needle shield assembly comprises 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 portion against the first needle shield.

[0010] In some variations, the second needle shield further includes a tooth coupled to the flexible distal portion. In some examples, the tooth is at least partially embedded in the first needle shield when the cap at least partially surrounds the second needle shield. Additionally, the tooth may be disposed at a distal end of the flexible distal portion of the second needle shield. Alternatively, the tooth may be disposed adjacent to a mechanical connection between the flexible distal portion of the second needle shield and the rigid portion.

[0011] In other variations, the first needle shield further comprises 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 disposed adjacent the proximal end of the first needle shield. Additionally or alternatively, the second needle shield abuts the proximal end of the first needle shield.

[0012] In yet other variations, the second needle shield includes an annular ridge, the cap includes an annular groove, and the annular ridge is 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 together. In some such examples, the second needle shield is overmolded on the first needle shield.

[0013] Also disclosed herein is an assembly method that includes providing a first needle shield that is at least partially made of a first material and has 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 a second material. In some examples, the second material is harder than the first material.

[0014] 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 to the second needle shield. In some examples, mechanically coupling the cap to the second needle shield includes disposing at least one annular ridge of the second needle shield in at least one annular groove formed in the cap.

[0015] In other variations, 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. Additionally, the flexible distal portion may include at least one tooth, and wherein mechanically coupling the cap to 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.

[0016] In still other variations, the method includes overmolding the second needle shield over 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 in a recess of the second needle shield. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present disclosure may be best understood by reference to the following description taken in conjunction with the accompanying drawings, in which:

[0018] Figure 1 is a side view of a first exemplary needle shield assembly made in accordance with the present disclosure.

[0019] Figure 2 yes Figure 1 Side view and cross-sectional view of a first example needle shield assembly.

[0020] Figure 3 is a perspective view of a second exemplary needle shield assembly made in accordance with the present disclosure.

[0021] Figure 4 Shown Figure 3 An exemplary first step in a manufacturing process of a second example needle shield assembly.

[0022] Figure 5 Shown Figure 3 An exemplary second step in a manufacturing process of a second exemplary needle shield assembly.

[0023] Figure 6 Shown Figure 3 An exemplary third step in a manufacturing process of the second exemplary needle shield assembly.

[0024] Figure 7 is a perspective view of a third exemplary needle shield assembly made in accordance with the present disclosure.

[0025] Figure 8 Shown Figure 7 An exemplary first step in a manufacturing process of a third example needle shield assembly.

[0026] Fig. 9 Shown Figure 7 An exemplary second step in a manufacturing process of a third exemplary needle shield assembly.

[0027] Fig.10 Shown Figure 7 An exemplary third step in a manufacturing process of a third exemplary needle shield assembly.

[0028] These drawings depict preferred embodiments for purposes of illustration only and are not to scale. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the systems and methods presented herein may be employed without departing from the principles described herein. DETAILED DESCRIPTION

[0029] Prefilled syringes and other syringes filled with medication are often provided with a needle shield to maintain the sterility of the syringe's needle, protect the needle from damage, and / or reduce the possibility of accidental needle sticks. The needle shield may be tightly secured to the syringe, which may cause difficulty for at least some end users to remove 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 ability of some users.

[0030] A needle shield or syringe made according to the present disclosure is configured to provide a friction-reduced interface between the needle shield and the syringe without compromising the ability of the needle shield to, for example, maintain the sterility of the syringe needle, protect the needle from damage, and / or prevent accidental needle sticks. Thus, the friction-reduced interface can make it easier to remove the needle shield from the syringe compared to conventional arrangements. In at least some embodiments, the force required to remove the needle shield is less than or equal to about 5N or less than or equal to about 10N. In addition, in at least some embodiments, the needle shield or syringe of the present disclosure reduces the friction between the needle shield and the syringe by reducing the contact surface area between the syringe and the needle shield.

[0031] In addition, the needle shield tends to deform under the force applied to remove the needle shield from the syringe. For example, pulling the needle shield from the distal end may cause it to stretch and narrow around the needle. As a result, the deformed needle shield may clamp onto the needle and further increase 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 increase the force required to remove the needle shield from the syringe.

[0032] Figure 1 and Figure 2 A first exemplary needle shield assembly 100 made in accordance with the present disclosure is shown. The needle shield assembly 100 includes a first needle shield 102, a second needle shield 104, and a syringe 108. Figure 1 and Figure 2 In the illustrated example, the second needle shield 104 is shorter than the first needle shield 102 , however in various other examples, the second needle shield 104 is the same length as or longer than the first needle shield 102 .

[0033] The first needle shield 102 is at least partially made of the first material and has a proximal end 112a and a distal end 112b, wherein the proximal end 112a of the first needle shield 102 includes 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 the needle 202. The needle 202 is disposed in a Figure 2 The first needle shield 102 further comprises an annular shoulder 116, and the second needle shield is mechanically coupled to the first needle shield by at least partially abutting the shoulder.

[0034] 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 includes a recess 122 that covers the annular shoulder 116 and / or is radially outside at least a portion of the annular shoulder 116. In such an example, the second needle shield 104 transmits axial force to the first needle shield 102 via the recess 122 coupled to the annular shoulder 116. Figure 1 As shown, the annular shoulder 116 and the recess 122 are adjacent to the proximal end 112a of the first needle shield 102. In other examples, the shoulder 116 can be disposed approximately midway between the proximal end 112a and the distal end 112b, or the shoulder 116 can be disposed adjacent to the distal end 112b of the first shoulder 102. Additionally or alternatively, the second needle shield 104 can abut the proximal side of the first needle shield.

[0035] 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 a preferred example, the second material is harder than the first material. As a result, when a force is applied, the second needle shield 104 has limited deformation and can transfer the applied force to the first needle shield 102. By applying the force from the second needle shield 104 to the first needle shield 102 via the annular shoulder 116, the first needle shield 102 undergoes limited deformation and does not clamp onto the needle and increase 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 on the first needle shield 102. As used herein, overmolding 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 coupled thereto. Alternatively, the second needle shield 104 can be manufactured separately from the first needle shield 102 and then coupled thereto.

[0036] Figure 3 300 is a perspective view of a second exemplary needle shield assembly 300 made according to the present disclosure. The needle shield assembly 300 includes a first needle shield 302, a second needle shield 304, a cap 410 (combined with Figure 4 , Figure 5 and Figure 6 ), and syringe 308. Figure 3 In the example shown, the second needle shield 304 is transparent, however, in other examples, the second needle shield 304 can be made of an opaque material (e.g., Figure 4 , Figure 5 and Figure 6 shown).

[0037] The first needle shield 302 includes a proximal end 312a and a distal end 312b. Although the first needle shield 302 is generally cylindrical, the first needle shield further includes an annular shoulder 314. Therefore, the first needle shield 302 is substantially similar to Figure 1 and Figure 2 The first needle shield 102. In various examples, the first needle shield 302 is made of a flexible and pliable first thermoplastic material.

[0038] 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 (hereinafter combined with Figure 4 , Figure 5 and Figure 6324 ), these teeth are carried or coupled by the flexible distal portion 324. In some examples, the second needle shield 304 is manufactured and overmolded on the first needle shield 302. As used herein, overmolding 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 subsequently coupled thereto. Alternatively, the second needle shield 304 can be manufactured separately from the first needle shield 302 and later coupled thereto.

[0039] In addition, 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 recess 326. The shoulder 316 and the recess 326 couple the first needle shield 302 to the second needle shield 304 and inhibit axial movement of the first needle shield 302 relative to the second needle shield 304. Moreover, the annular shoulder 316 is disposed adjacent to 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.

[0040] The second needle shield 304 further includes at least a first flexible arm 328a and a second flexible arm 328b. In the illustrated example, the second needle shield 304 includes only two flexible arms 328a, 328b. In various other examples, the second needle shield 304 may include more than one flexible arm. Figure 3 More or fewer flexible arms are shown.

[0041] Figure 4 Shown Figure 3 FIG. 4 is an exemplary first step of a manufacturing process of a second exemplary needle shield assembly 300. In the illustrated example, the syringe 308 includes a first needle shield 302, a second needle shield 304, and a cap 410 disposed separately from the first needle shield 302 and the second needle shield 304. As indicated by arrows F1, F2, and F3, the cap 410 moves toward the first needle shield 302 and the second needle shield 304. In some examples, the cap 410 may be assembled to the first needle shield 302 and the second needle shield 304 before the first needle shield 302 and the second needle shield 304 are disposed on the syringe 308.

[0042] The cap 410 includes a rim 412, a cavity 414, a sealing surface 416, and a first annular groove 418a and a second annular groove 418b. In this example, the cavity 414 passes through the cap 410, but in other examples, the cavity 414 may only partially pass through the cap 410. In addition, the cap 410 includes a rim 412, and the rim is configured to help the end user pull the cap off the syringe.

[0043] In addition, if Figure 4 As shown, the teeth 422 are disposed adjacent to the rigid portion 322. In some examples, the teeth 422 can be disposed adjacent to or abutting 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 disposed adjacent to the distal end 312b of the first needle shield 302, but in other examples, the mechanical connection 424 can be disposed elsewhere on the second needle shield 304.

[0044] Figure 5 Shown Figure 3 The second example second step of the manufacturing process of the second example needle shield assembly 300. According to the present disclosure, the cap 410 is configured to partially or completely surround the first needle shield 302 and / or the second needle shield 304. As an example, the cap 410 can at least partially surround the first needle shield 302 and / or the second needle shield 304. Figure 5 As shown, the cap 410 will press the flexible distal portion 324 of the second needle part against the first needle shield. Specifically, the sealing surface 416 will contact the flexible distal portion 324.

[0045] Figure 6 Shown Figure 3 The third exemplary step of the manufacturing process of the second exemplary needle shield assembly 300 is shown in FIG. Figure 6 As shown, the tooth 422 is at least partially embedded in the first needle shield 302 after the cap 410 has surrounded (e.g., enclosed) the second needle shield 304. In this example, the tooth 422 embedded in the first needle shield 302 is embedded at a substantially midpoint between the proximal end 312a and the distal end 312b of the first needle shield 302. In various other examples, the tooth 422 can be configured to be embedded elsewhere in the first needle shield 302, including adjacent to the proximal end 312a or the distal end 312b.

[0046] like Figure 6 As shown, the cap 410 mechanically couples the first needle shield 302, the second needle shield 304, and the cap 410 together. When the annular grooves 418a, 418b provided in the cap 410 receive the annular ridges 428a, 428b provided on the second needle shield 304, the cap 410 is mechanically coupled to the second needle shield 304. In addition, the second needle shield 304 is coupled to the first needle shield 304 because the teeth 422 are embedded in the first needle shield 302 and the annular shoulder 316 is coupled to the recess 326. Therefore, the first needle shield 302, the second needle shield 304, and the cap 410 are mechanically coupled together.

[0047] When the first needle shield 302, the second needle shield 304, and the cap 410 are coupled together, the force applied to the rim 412 is distributed at least at the annular shoulder 316 and through the first needle shield 304 via the teeth 422. As a result, the uniform 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 low (e.g., about 5N-10N or less).

[0048] Figure 7 700 is a perspective view of a third exemplary needle shield assembly 700 made according to the present disclosure. The needle shield assembly 700 includes a first needle shield 702, a second needle shield 704, a cap 810 (hereinafter referred to as Figure 8 , Fig. 9 and Fig.10 ), and syringe 708. Figure 7 In the illustrated example, the second needle shield 704 is transparent, however, in other examples, the second needle shield 704 is made of an opaque material (e.g., Figure 8 , Fig. 9 and Fig.10 shown).

[0049] The first needle shield 702 includes a proximal end 712a and a distal end 712b. Although the first needle shield 702 is generally cylindrical, the first needle shield further includes an annular shoulder 714. Therefore, the first needle shield 702 is substantially similar to Figure 1 and Figure 2 The first needle shield 102 and Figure 3 , Figure 4 , Figure 5 and Figure 6 The first needle shield 302. In various examples, the first needle shield 702 is made of a flexible and pliable first thermoplastic material.

[0050] 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 (combined with Figure 8 , Fig. 9 and Fig.10 ), these teeth are carried or coupled by the flexible distal portion 724. In some examples, the second needle shield 704 is manufactured and overmolded on the first needle shield 702. Alternatively, the second needle shield 704 can be manufactured separately from the first needle shield 702 and coupled to the first needle shield 702 at a later time.

[0051] In addition, 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 recess 726. The shoulder 716 and the recess 726 couple the first needle shield 702 to the second needle shield 704 and inhibit axial movement of the first needle shield 702 relative to the second needle shield 704. Moreover, the annular shoulder 716 is disposed adjacent to the proximal end 712a of the first needle shield 702. Additionally or alternatively, the second needle shield 704 can abut the proximal end 712a of the first needle shield 702.

[0052] The second needle shield 704 further includes at least a first flexible arm 728a and a second flexible arm 728b. In the illustrated example, the second needle shield 704 includes only two flexible arms 728a, 728b. In various other examples, the second needle shield 704 may include more than one flexible arm. Figure 7 More or fewer flexible arms are shown.

[0053] Figure 8 Shown Figure 7 700. In the illustrated example, the syringe 708 includes a first needle shield 702, a second needle shield 704, and a cap 810 that is disposed separately from the first needle shield 702 and the second needle shield 704. As indicated by arrows F1, F2, and F3, the cap 810 moves toward the first needle shield 702 and the second needle shield 704. In some examples, the cap 810 can be assembled onto the first needle shield 702 and the second needle shield 704 before the first needle shield 702 and the second needle shield 704 are disposed on the syringe 708.

[0054] The cap 810 includes a rim 812, a cavity 814, a sealing surface 816, and a first annular groove 818a and a second annular groove 818b. In this example, the cavity 814 passes through the cap 810, however, in some examples, the cavity 814 may only partially pass through the cap 810. In addition, the cap 810 includes a rim 812, and the rim is configured to help the end user pull the cap off the syringe.

[0055] In addition, if Figure 8 As shown, the tooth 822 is disposed adjacent to the distal end 712b of the first needle shield 702. In some examples, the tooth 822 can be disposed adjacent to or adjacent to a 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 disposed between the proximal end 826a and the distal end 826b of the second needle shield. In other examples, the mechanical connection 824 can be disposed elsewhere on the second needle shield 704.

[0056] Fig. 9 Shown Figure 7 The third example of the second step of the manufacturing process of the needle shield assembly 700. According to the present disclosure, the cap 810 is configured to partially or completely surround the first needle shield 702 and / or the second needle shield 704. As an example, the cap 810 can at least partially surround the first needle shield 702 and / or the second needle shield 704. Fig. 9 As shown, the cap 810 is about to press the flexible distal portion 724 of the second needle portion against the first needle shield 700. Specifically, the sealing surface 816 is about to contact the flexible distal portion 724.

[0057] Fig.10 Shown Figure 7 The third exemplary step of the manufacturing process of the third exemplary needle shield assembly 700 is shown in FIG. Fig.10 As shown, the tooth 822 is embedded in the first needle shield 702 after the cap 810 has surrounded the second needle shield 704. In this example, the tooth 822 embedded in the first needle shield 702 is embedded at a substantially midpoint between the proximal end 712a and the distal end 712b of the first needle shield 702. In various other examples, the tooth 822 can be configured to be embedded elsewhere in the first needle shield 702, including adjacent to the proximal end 712a or the distal end 712b.

[0058] like Fig.10 As shown, the cap 810 mechanically couples the first needle shield 702, the second needle shield 704, and the cap 810 together. When the annular grooves 818a, 818b provided in the cap 810 receive the annular ridges 828a, 828b provided on the second needle shield 704, the cap 810 is mechanically coupled to the second needle shield 704. In addition, the second needle shield 704 is coupled to the first needle shield 704 because the teeth 822 are embedded in the first needle shield 702 and the annular shoulder 716 is coupled to the recess 726. Therefore, the first needle shield 702, the second needle shield 704, and the cap 810 are mechanically coupled together.

[0059] When the first needle shield 702, the second needle shield 704, and the cap 810 are coupled together, the force applied to the rim 812 is distributed at least at the annular shoulder 716 and to the first needle shield 704 via the teeth 822. As a result, the uniform distribution of force reduces deformation in the first needle shield 702. Since the first needle shield 702 does not deform, the force required to remove the needle shield remains low (e.g., approximately 5N-10N).

[0060] In at least some embodiments of the needle shield assembly described herein, the combination of the first needle shield and the second needle shield and, in addition, in some cases, the cap can inhibit deformation of the first needle shield during removal of the needle shield assembly from the syringe and / or at other times. Therefore, the first needle shield may be less likely to deform in a manner that increases the friction between the first needle shield and the needle of the syringe. Therefore, at least some of the disclosed embodiments can reduce the force required to remove the needle shield assembly from the syringe. In addition, in at least some examples, the feature(s) described herein in conjunction with one embodiment can be combined with the feature(s) of one or more other embodiments described herein.

[0061] The above description describes various devices, assemblies, parts, subsystems and methods used in relation to drug delivery devices. Devices, assemblies, parts, subsystems, methods or drug delivery devices may further include drugs or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of medicament or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also covered. The drug can be in liquid form, in lyophilized form or in a form reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0062] The drug will be 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, a cartridge, or a pre-filled syringe.

[0063] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor (such as granulocyte colony stimulating factor (G-CSF)), or the device can be used with a colony stimulating factor. Such G-CSF agents include, but are not limited to (Pegfilgrastim, Pegylated filgrastim, Pegylated G-CSF, Pegylated hu-Met-G-CSF) and (filgrastim, G-CSF, hu-MetG-CSF), (Pegfilgrastim-cbqv), (LA-EP2006; pegfilgrastim-bmez) or FULPHILA (pegfilgrastim-bmez).

[0064] 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. ESA is any molecule that stimulates erythropoiesis. In some embodiments, ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes erythropoietin receptor activation (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate erythropoietin receptors; antibodies that bind to and activate erythropoietin receptors; or peptides that bind to and activate erythropoietin receptors. Erythropoiesis stimulating proteins include but are not limited to (Epoetin α), (darbepoetin alfa), (Epoetine δ), (methoxy polyethylene glycol-epoetin beta), MRK-2578, INS-22, (Epoetin ζ), (Epoetin β), (Epoetin ζ), (Epoetin α), Epoetin α Hexal, (Epoetin α), (Epoetine θ), (Epoetine θ), (Epoetin theta), Epoetin alpha, 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.

[0065] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies 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., particularly those that inhibit activity mediated by binding of IL-4 and / or IL-13 to the receptor; interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; An g2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., especially human CD22-specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, especially including but not limited to human CD22-specific IgG antibodies, such as a dimer of a human-mouse monoclonal hLL2γ-chain and a human-mouse monoclonal hLL2κ chain connected by a disulfide, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS registration number 501423-23-0; IGF-1 receptor-specific antibodies, peptibodies and related proteins, including Including but not limited to anti-IGF-1R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins, etc. ("B7RP-1", also known as B7H2, ICOSL, B7h and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as 145c7; IFNγ-specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersant (HGF / SF);TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of OX40 receptors; (alteplase, tPA); (Darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); (epoetin alfa, or erythropoietin); GLP-1, (interferon beta-1a); (tositumomab, anti-CD22 monoclonal antibody); (interferon-β); (alemtuzumab, anti-CD52 monoclonal antibody); (Epoetin delta); (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); (etanercept, TNF receptor / Fc fusion protein, TNF blocker); (Epoetin alpha); (cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Somatropin, human growth hormone); (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti TM (Trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of trastuzumab, or another product containing trastuzumab for the treatment of breast or gastric cancer; (Somatropin, human growth hormone); (adalimumab); (panitumumab), (Dinosutumab), (Dinosutumab), RANK ligand immunoglobulin G2 human monoclonal antibody, (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; (interferon alfacon-1); (Nesiritide; recombinant human B-type natriuretic peptide (hBNP)); (Anakinra); (sargramostim, rhuGM-CSF); (epatuzumab, anti-CD22 mAb); Benlysta TM (lymphostat B, belimumab, anti-BlyS mAb); (tenecteplase, a t-PA analog); (methoxypolyethylene glycol-epoetin beta); (gemtuzumab ozogamicin); (efalizumab); (certolizumab pegol, CDP 870); Soliris TM (eculizumab); pexelizumab (anti-C5 complement); (MEDI-524); (ranibizumab); (17-1A, edrecolomab); (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); (IDM-1); (B43.13); (viciluzumab); cantuzumab mertansine (huC242-DM1); (Epoetin beta); (Opreleukin, human interleukin-11); Orthoclone (Muromonab-CD3, anti-CD3 monoclonal antibody); (Epoetin alpha); (infliximab, anti-TNFα monoclonal antibody); (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); (anti-IL6 receptor mAb); (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi TM (bevacizumab-awwb); (rituximab, anti-CD20 mAb); (erlotinib); (interferon alfa-2a); (basiliximab); (lumiracoxib); (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); (natalizumab, anti-α4 integrin mAb); (MDX-1303, anti-anthrax protective antigen mAb); ABthrax TM ; (omalizumab); ETI211 (anti-MRSA mAb); IL-1trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); (daclizumab); (daclizumab, anti-IL-2Rα mAb); (ibritumomab tiuxetan); (ezetimibe); (atacicept, TACI-Ig); anti-CD80 mAb (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (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-mesothelin dsFv-PE38 conjugate (CAT-5001);Anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3). ;

[0066] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody for the treatment of postmenopausal osteoporosis and / or fracture healing, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity TM (Lomosozumab-aqqg), another product comprising lomosozumab, and in other embodiments, comprising a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to (evolocumab) and (alirocumab). In other embodiments, the drug delivery device may contain or be used with: rituximab, bixalomer, trebananib, ganitazumab, canatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with a drug for treating melanoma or other cancers. (talimogene laherparepvec) or another oncolytic HSV, or the device can be used with it, the other oncolytic HSV includes but is not limited to OncoVEXGALV / CD; OrienX010; G207,1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device can include or be used with endogenous tissue metalloproteinase inhibitors (TIMPs), such as but not limited to TIMP-3. In some embodiments, the drug delivery device can include or be used with: for the treatment of migraine (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptor (such as but not limited to, erenumab) and bispecific antibody molecules targeting CGRP receptor and other headache targets can also be delivered using the drug delivery device of the present disclosure. Additionally, bispecific T cell engagers Molecules (such as but not limited to (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 with an APJ macromolecular agonist, such as but not limited to apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device can contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), anti-TNFα monoclonal antibody, In some embodiments, the drug delivery device may include a biosimilar of infliximab (Janssen Biotech, Inc.) or another product containing infliximab or used together with it. (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-phenylbutyramido)-4-methylpentanamide, or another product comprising or for use with carfilzomib. In some embodiments, the drug delivery device may comprise a drug for treating various inflammatory diseases. (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 or used together with it. In some embodiments, the drug delivery device can contain Parsabiv for treating secondary hyperparathyroidism (sHPT) in chronic kidney disease (KD) dialysis patients. TM (Vicositriptyline HCl, KAI-4169) or another product comprising Vicositriptyline HCl or used together with it. In some embodiments, the drug delivery device may comprise ABP 798 (rituximab), / MabThera TM In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate of, or another product comprising an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)). In some embodiments, the drug delivery device may contain ABP 959 (eculizumab), In some embodiments, the drug delivery device may contain or be used with a biosimilar drug candidate, or another product comprising a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafuspalfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecadimecarb (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile mechanism, or another product comprising a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with sotolacib (formerly AMG 510), KRAS G12C Small molecule inhibitors, or KRAS G12C In some embodiments, the drug delivery device may contain or be used with another product that is a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product that contains a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product that contains a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein (a) (also known as Lp(a)), or another product that contains a small interfering RNA (siRNA) that lowers lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1κ antibody), In some embodiments, the drug delivery device may contain Amjevita TM or Amgevita TM (formerly ABP501) (mab anti-TNF human IgG1), In some embodiments, the drug delivery device may contain AMG 160, or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 (bispecific T cell engager) construct or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 119 or another product containing delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy or use it together. In some embodiments, the drug delivery device may include AMG 133 or another product containing gastric inhibitory peptide receptor (GIPR) antagonists and GLP-1R agonists or use it together. In some embodiments, the drug delivery device may include AMG 171 or another product containing growth differentiation factor 15 (GDF15) analogs or use it together. In some embodiments, the drug delivery device may include AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) or use it together. In some embodiments, the drug delivery device may comprise AMG 199 or a bispecific T cell engager construct comprising a half-life extended (HLE) In some embodiments, the drug delivery device may contain or be used with another product of the invention. In some embodiments, the drug delivery device may contain or be used with AMG256 or another product (comprising anti-PD-1 x IL21 mutant protein and / or IL-21 receptor agonist) designed to selectively turn on the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain AMG 330 or a product comprising anti-CD33 x anti-CD3 In some embodiments, the drug delivery device may contain or be used with another product of a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product (comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody) being studied for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG427 or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 In some embodiments, the drug delivery device may contain AMG430 or another product containing an anti-Jagged-1 monoclonal antibody or be used with it. In some embodiments, the drug delivery device may contain AMG 506 or another product (containing a multispecific FAP x4-1BB-targeting In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager, and the use 2+1 technology design. In some embodiments, the drug delivery device may contain AMG 562 or contain half-life extended (HLE) CD19 x CD3 In some embodiments, the drug delivery device may contain or be used with another product comprising a (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product comprising Efavaleukin alpha (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product comprising a CD3 x epidermal growth factor receptor vIII (EGFRvIII) In some embodiments, the drug delivery device may comprise AMG 673 or comprise half-life extended (HLE) anti-CD33 x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 701 or comprise half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 757 or comprise half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 In some embodiments, the drug delivery device may comprise AMG 910 or comprise a half-life extended (HLE) epithelial cell tight junction protein (claudin) 18.2x CD3 Another product of the (bispecific T cell engager) construct is used together with it.

[0067] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, and these embodiments will still fall within the scope of the claims defining the invention(s) disclosed herein.

[0068] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes and combinations are deemed to be within the scope of the inventive concept.

Claims

1. A needle shield assembly, comprising: 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 comprising a cavity; and a second needle shield at least partially made of a second material, the second needle shield being mechanically coupled to at least a proximal end of the first needle shield, Wherein, the second material is harder than the first material.

2. The needle shield assembly of claim 1, wherein: The first needle shield includes an annular shoulder, and the second needle shield is mechanically coupled to the first needle shield by at least partially abutting the shoulder.

3. The needle shield assembly according to any one of claims 1 to 2, wherein: The second needle shield abuts against the proximal end of the first needle shield.

4. The needle shield assembly according to any one of claims 2 to 3, 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 outside thereof.

5. The needle shield assembly according to any one of claims 1 to 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 to 5, wherein: The second needle shield comprises teeth, wherein the teeth are at least partially embedded in the first needle shield.

7. The needle shield assembly of claim 6, wherein: The teeth are embedded in the first needle shield approximately midway between the proximal and distal ends of the first needle shield.

8. The needle shield assembly of claim 6, wherein: The teeth are embedded in the distal end of the first needle shield.

9. A needle shield assembly, comprising: 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; as well as A cap is 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 portion against the first needle shield.

10. The needle shield assembly of claim 9, wherein: The second needle shield further includes teeth coupled to the flexible distal portion.

11. The needle shield assembly of claim 10, wherein: The teeth are at least partially embedded in the first needle shield when the cap at least partially surrounds the second needle shield.

12. The needle shield assembly of claim 11, wherein: The teeth are provided at the distal end of the flexible distal portion of the second needle shield.

13. The needle shield assembly of claim 11, wherein: The teeth are disposed adjacent to the mechanical connection between the flexible distal portion and the rigid portion of the second needle shield.

14. The needle shield assembly according to any one of claims 9 to 13, 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.

15. The needle shield assembly of claim 14, wherein: The annular shoulder is disposed adjacent the proximal end of the first needle shield.

16. The needle shield assembly of any one of claims 9 to 15, wherein: The second needle shield abuts against the proximal end of the first needle shield.

17. The needle shield assembly of any one of claims 9 to 16, wherein: The second needle shield includes an annular ridge, the cap includes an annular groove, and the annular ridge is configured to engage the annular groove to mechanically couple the second needle shield and the cap.

18. The needle shield assembly of any one of claims 9 to 17, wherein: The cap is configured to mechanically couple the first needle shield, the second needle shield, and the cap together.

19. The needle shield assembly of any one of claims 9 to 18, wherein: The second needle shield is overmolded onto the first needle shield.

20. An assembly method, comprising: providing a first needle shield at least partially made of a first material and having a proximal end and a distal end; as well as A second needle shield is mechanically coupled to the first needle shield, the second needle shield being at least partially made of a second material that is harder than the first material.

21. The method of assembling a component as claimed in claim 20, further comprising: The first needle shield and the second needle shield are at least partially inserted into the cap.

22. The assembly method of claim 21, further comprising: The cap is mechanically coupled to the second needle shield.

23. The assembly method according to claim 22, wherein: Mechanically coupling the cap with the second needle shield includes disposing at least one annular ridge of the second needle shield in at least one annular groove formed in the cap.

24. The assembly method according to any one of claims 21 to 23, wherein: 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.

25. The assembly method according to claim 24, wherein: The flexible distal portion comprises at least one tooth, and wherein mechanically coupling the cap to the second needle shield comprises 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.

26. The assembly method according to any one of claims 20 to 25, further comprising: The second needle shield is overmolded onto the first needle shield.

27. The assembly method according to any one of claims 20 to 25, wherein: Mechanically coupling the second needle shield to the first needle shield includes at least partially disposing an annular shoulder of the first needle shield in a recess of the second needle shield.

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