Needle shield for syringes

Abstract

The syringe assembly includes a syringe having a barrel and a needle hub disposed at a distal end of the syringe, and a needle shield including an inner surface and a cavity for receiving the needle hub. The inner surface of the needle shield engages an outer surface of the needle hub to form a sealing interface between the inner surface and the outer surface when the needle shield is disposed on the syringe, removably coupling the needle hub and the needle shield. In some examples, the sealing interface includes at least one contoured feature configured to inhibit or reduce the amount of force required to remove the needle shield from the syringe.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 199,131, filed August 18, 2022, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure is directed 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 syringe assembly. The syringe assembly includes a syringe having a barrel and a needle hub disposed at a distal end of the syringe, and a needle shield including an inner surface and a cavity for receiving the needle hub. The inner surface of the needle shield engages with an outer surface of the needle hub when the needle shield is disposed on the syringe to form a sealing interface between the inner surface and the outer surface, removably coupling the needle hub and the needle shield. In some examples, the sealing interface includes at least one contoured feature configured to inhibit or reduce the amount of force required to remove the needle shield from the syringe.

[0006] In some variations, the at least one relief feature is defined by the needle hub. In some such variations, the at least one relief feature comprises at least one annular groove and / or at least one annular ridge defined in the needle hub surface. Alternatively, in other variations, the at least one relief feature comprises a plurality of dimples and / or a plurality of protrusions defined by the needle hub surface.

[0007] In other variations, the at least one contoured surface is defined by the needle shield. For example, the at least one contoured feature may comprise at least one annular groove and / or at least one annular ridge defined by the needle shield surface. Alternatively, the at least one contoured surface comprises a plurality of dimples and / or a plurality of protrusions defined by the needle shield surface.

[0008] Additionally, disclosed herein is a reduced-friction needle shield including a body having a proximal end and a distal end. The needle shield further includes an inner surface defining a cavity, the inner surface configured to contact an outer surface of the syringe to removably couple the needle shield to the syringe. The needle shield also includes an opening formed in the proximal end of the body that communicates with the cavity. Additionally, the inner surface includes at least one contoured feature configured to reduce or eliminate the amount of force required to remove the needle shield from the syringe.

[0009] In some variations, the cavity opening is a circular opening, and the cavity comprises a conical cavity portion and a cylindrical friction portion disposed between the opening and the conical cavity portion. In addition, the needle shield surface and the at least one relief feature may be disposed within the cylindrical friction portion of the cavity. For example, the at least one relief feature comprises at least one annular groove and / or at least one annular ridge. Alternatively, the at least one relief feature comprises a plurality of dimples and / or a plurality of protrusions. In some examples, the plurality of dimples and / or the plurality of protrusions are uniformly or non-uniformly distributed.

[0010] Also disclosed herein is a syringe including a barrel having a proximal end and a distal end. The syringe further includes a needle hub disposed at the distal end of the barrel, the needle hub having an outer surface configured to contact an inner surface of a needle shield to removably couple the needle shield to the syringe. Additionally, the outer surface of the needle hub includes at least one contoured feature configured to reduce or minimize a surface area of ​​the outer surface of the needle hub that contacts the inner surface of the needle shield.

[0011] In some variations, the needle hub further comprises a syringe bulb disposed on the distal end of the needle hub, hi some such variations, the syringe bulb defines a first radius and the needle hub neck defines a second radius, the first radius being greater than the second radius.

[0012] In other variations, the at least one relief feature is disposed on the syringe bulb. For example, the at least one relief feature may include an annular groove. Alternatively, the at least one relief feature may include a plurality of dimples and / or a plurality of protrusions. In some such examples, the plurality of dimples and / or the plurality of protrusions are uniformly or non-uniformly distributed.

[0013] Also disclosed herein is a reduced-friction needle shield including an elongate body having a proximal end and a distal end, the elongate body being made from a needle shield material. Additionally, the reduced-friction needle shield includes an opening defined in the proximal end of the needle shield. The reduced-friction needle shield may further include a cavity disposed within the needle shield extending distally from the opening, the cavity being defined by a wall portion of the elongate body that defines a needle shield surface for sealing against a needle hub of a syringe during use. The needle shield material may include a material having a hardness greater than about 50 Shore A.

[0014] In some variations, the opening is a circular opening, and the cavity comprises a conical portion and a cylindrical portion disposed between the conical portion and the opening, at least a portion of the cylindrical portion defining a needle shield surface. Additionally, in some examples, the needle shield surface maintains a substantially constant diameter under a tensile load in the range of about 0 N to about 10 N applied to the elongate body.

[0015] 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]

[0016] [Figure 1] FIG. 1 is a side view of a first exemplary needle shield made in accordance with the present disclosure. [Figure 2] 2 is a side view of the first exemplary needle shield of FIG. 1 coupled to a syringe. [Figure 3] FIG. 1 is a side view of a first exemplary syringe made in accordance with the present disclosure. [Figure 4] FIG. 4 is a side view of the first exemplary syringe of FIG. 3 coupled to a needle shield. [Figure 5] FIG. 1 is a side view of a second exemplary syringe made in accordance with the present disclosure. [Figure 6] FIG. 6 is a side view of the second exemplary syringe of FIG. 5 coupled to a needle shield. [Figure 7] FIG. 10 is a side view of a second exemplary needle shield made in accordance with the present disclosure. [Figure 8] FIG. 8 is a side view of the second exemplary needle shield of FIG. 7 coupled to a syringe. [Figure 9] FIG. 10 is a side view of a third exemplary needle shield made in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] 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.

[0018] 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.

[0019] Needle shields or syringes made in accordance with the present disclosure are configured to provide a reduced or minimized friction interface between the needle shield and the syringe, without, for example, compromising the intended purpose of providing a needle shield that maintains the sterility of the syringe needle, protects the needle from damage, and / or prevents accidental needle sticks. As a result, the reduced friction interface reduces or reduces the amount of force required to remove the needle shield, thereby facilitating removal of the needle shield from the syringe compared to conventional configurations. As used herein, the term "reduced" may mean, for example, setting an upper threshold for removal force that should not be exceeded. For example, in at least some embodiments, the force required to remove the needle shield can be reduced to about 5 N or less or about 10 N or less. As used herein, the term "reduced" may mean minimizing the force required to remove the needle shield while still serving its intended purpose and / or providing a removal force that is less than that required for other conventional configurations. For example, in at least some embodiments, the needle shield or syringe of the present disclosure can reduce frictional forces between the needle shield and the syringe compared to conventional configurations by reducing the surface area of ​​contact between the syringe and the needle shield compared to conventional configurations.

[0020] 1, a needle shield 100 is constructed in accordance with the present disclosure. As shown, the needle shield 100 includes a body 102, a cavity 104, and a relief feature 106. As shown, the body 102 includes a diameter D and a length L, although in various examples, the diameter D and length L may be larger or smaller than those shown.

[0021] The body 102 is generally cylindrical and made of a thermoplastic material, although in other examples, the body 102 can be another shape or made of other natural or synthetic materials. As shown, the body 102 includes a proximal end 112 and a distal end 114. In this example, the body 102 includes a shoulder 116. The shoulder 116 can be an annular shoulder 116 that wraps around the body adjacent the proximal end 112. In other examples, the shoulder 116 may not wrap around the entire circumference of the body 102, or the shoulder 116 can be located elsewhere on the body, such as adjacent the distal end 114.

[0022] Needle shield 100 further includes a cavity 104 defined within proximal end 112 by an inner surface 105 (or needle shield face), the cavity 104 configured to receive a needle hub of a syringe. As shown, cavity 104 includes an opening 122, a contoured feature 106, and a conical cavity portion 124. In this example, opening 122 is a circular opening that opens into a cylindrical cavity portion 126. In other examples, opening 122 is an alternative cross-sectional shape. The contoured feature is disposed between opening 122 and conical cavity portion 124.

[0023] As shown in FIG. 1 , the inner surface 105 is designed to engage the needle hub outer surface 205 (described in more detail in connection with FIG. 2 ). More specifically, the contoured feature 106 includes an annular ridge 132 defined by the inner surface 105. The annular ridge 132 is defined in part by an adjacent annular groove 134. As a result, the contoured feature 106 is designed to contact the syringe bulb along the annular ridge 132. The reduced contact surface area is designed to reduce frictional forces when the needle shield 100 is removed from the syringe.

[0024] The needle shield 100 further includes a conical cavity portion 124. The conical cavity portion 124 includes a beveled surface 142 configured to guide the needle into the needle receiving portion 144. The needle receiving portion 144 receives the needle and ensures sterility of the needle during shipping and storage of the syringe. The beveled surface 142 of the conical cavity portion includes an angle 146 of approximately 10 degrees (°). However, in various other examples, the angle 146 can be greater or less than 10°; for example, the angle 146 can be as small as 2° or as large as 30°.

[0025] FIG. 2 shows a syringe assembly 250 including a needle shield 100 disposed on a syringe 200. In this example, the syringe 200 includes a syringe barrel 202, a needle hub 204, and a syringe bulb 206 disposed on the needle hub 204. The syringe barrel 202 includes a reservoir volume 222, and the needle hub 204 includes a needle passageway 212. As shown in FIG. 2, the needle hub 204 is disposed on a distal end 214b of the syringe 200, opposite a proximal end 214a. In various examples, the syringe 200 may include alternative configurations or dimensions other than those shown in FIG. 2.

[0026] 2 , the syringe 200 contacts the outer surface 205 of the needle shield 100 at the contoured feature 106. More specifically, the syringe bulb 206 and the annular ridge 132 of the needle hub 204 define a sealing interface 242. In accordance with the present disclosure, the sealing interface 242 provides enough friction to prevent the needle shield 100 from falling off the syringe 200 during shipping, but not so much friction that it is difficult for an end user to remove the needle shield 100 from the syringe 200. To provide the desired amount of friction, the sealing interface 242 may constitute the only physical contact between the syringe 200 and the needle shield 100.

[0027] FIG. 3 illustrates a syringe 300 constructed in accordance with the present disclosure. The exemplary syringe 300 includes a syringe barrel 302, a needle hub 304, and a syringe bulb 306. The syringe barrel 302 includes a reservoir volume 322, and the needle hub 304 includes a needle 324 disposed within a needle passageway 312. In other figures, the needle 324 is omitted for clarity. As shown in FIG. 3, the needle hub 304 is disposed on a distal end 314b of the syringe 300, opposite the proximal end 314a. In various examples, the syringe 300 may include alternative configurations or dimensions other than those illustrated in FIG. 3.

[0028] Syringe bulb 306 includes a contoured feature 332. In this example, contoured feature 332 includes an annular groove 334. In this example, annular groove 334 circumscribes syringe bulb 306. However, in other examples, annular groove 334 may include multiple grooves. Additionally, although annular groove 334 is shown as having a semicircular cross-sectional shape, annular groove 334 may have any cross-sectional shape, including semi-elliptical, rectangular, triangular, etc.

[0029] 4, the syringe 300 is mechanically coupled to the needle shield 402 to form a syringe assembly 450. The syringe is frictionally coupled to the needle shield 402 at the syringe bulb 306. Specifically, sealing interfaces 442a, 442b are on either side of the annular groove 334. The annular groove 334 therefore reduces the contact surface area between the syringe 300 and the needle shield 402. By reducing the contact surface area between the syringe 300 and the needle shield 402, friction between the needle shield 402 and the syringe bulb 306 is reduced.

[0030] 5 illustrates an alternative embodiment of the present disclosure in which a syringe 500 includes an alternative configuration. The syringe 500 includes a syringe barrel 502, a needle hub 504, and a syringe bulb 506. As shown, the syringe barrel 502 includes a reservoir volume 522 and a needle passageway 512. As shown in FIG. 5, the needle hub 504 is located on a distal end 514b of the syringe 500, opposite the proximal end 514a. In various alternatives, the syringe 500 can have alternative dimensions or configurations.

[0031] Syringe bulb 506 in this embodiment includes a contoured surface 532 that includes a plurality of dimples and / or protrusions. In the illustrated example, contoured surface 532 covers substantially the entire surface of syringe bulb 506. In other examples, contoured surface 532 may cover less of syringe bulb 506 (e.g., covering approximately 50% of the surface, 25% of the surface, etc.). Furthermore, the size and distribution of the dimples may be larger or smaller than that shown in FIG. 5. For example, contoured surface 532 may include more or fewer dimples per square inch. Additionally, the dimples may be larger or smaller than those shown.

[0032] 6 illustrates a syringe assembly 650 including a syringe 500 mechanically coupled to a needle shield 602. The syringe 500 is mechanically coupled to the needle shield 602. The syringe 500 is frictionally coupled to the needle shield 602 at the syringe bulb 506. Specifically, the sealing interface 642 around the contoured surface 532. The contoured surface 532 reduces the contact surface area between the syringe 500 and the needle shield 602. By reducing the contact surface area between the syringe 500 and the needle shield 602, friction between the needle shield 602 and the syringe bulb 506 is reduced.

[0033] 7 illustrates a needle shield 700 made in accordance with the present disclosure. Needle shield 700 includes a body 702, a cavity 704, and a contoured surface 706.

[0034] The body 702 is generally cylindrical and made of a thermoplastic material, although in other examples, the body 702 can be another shape or made of other natural or synthetic materials. As shown, the body 702 includes a proximal end 712 and a distal end 714. In this example, the body 702 includes a shoulder 716. The shoulder 716 can be an annular shoulder 716 that wraps around the body adjacent the proximal end 712. In other examples, the shoulder 716 may not wrap around the entire circumference of the body 702, or the shoulder 716 can be located elsewhere on the body, such as adjacent the distal end 714.

[0035] Needle shield 700 further includes a cavity 704 defined by an inner surface 705 configured to receive a syringe. As shown, cavity 704 includes an opening 722, a contoured feature 706, and a conical cavity portion 724. In this example, opening 722 opens into a cylindrical cavity portion 726. The contoured feature is disposed between opening 722 and conical cavity portion 724.

[0036] As shown in FIG. 7, the inner surface 705 is designed to engage the needle hub outer surface 805 (described in more detail in connection with FIG. 8). More specifically, the contoured feature 706 includes a protrusion array 732. The protrusion array 732 includes a plurality of rigid or semi-rigid protrusions 734. In some examples, the protrusion array 732 may alternatively be made of a plurality of dimples. The contoured feature 706 is configured to contact a syringe bulb at each of the protrusions 734, thereby reducing the surface area of ​​contact between the needle shield 700 and the syringe.

[0037] The needle shield 700 further includes a conical cavity portion 724. The conical cavity portion 724 includes a sloped surface 742 configured to guide the needle into a needle receiving portion 744. The needle receiving portion 744 receives the needle and ensures sterility of the needle during shipping and storage of the syringe. The sloped surface 742 of the conical cavity portion includes an angle 746 of approximately 10 degrees (°). However, in various other examples, the angle 746 can be greater or less than 10°; for example, the angle 746 can be as small as 2° or as large as 30°.

[0038] As shown in FIG. 8 , the needle shield 700 is placed onto a syringe 800, thereby forming a syringe assembly 850. In this example, the syringe 800 includes a syringe barrel 802, a needle hub 804, and a syringe bulb 806. The syringe barrel 802 includes a reservoir volume 822, and the needle hub 804 includes a needle passageway 812. As shown in FIG. 8 , the needle hub 804, including an outer surface 805, is located on a distal end 814b of the syringe 800, opposite a proximal end 814a. In various examples, the syringe 800 may include alternative configurations or dimensions other than those shown in FIG. 2 .

[0039] 8 , the syringe 800 contacts the inner surface 705 of the needle shield 700 at the contoured feature 706. More specifically, the syringe bulb 806 and the protrusion array 732 of the needle hub 804 define a sealing interface 842. In accordance with the present disclosure, the sealing interface 842 provides enough friction to prevent the needle shield 700 from falling off the syringe 800 during shipping, but not so much friction that it is difficult for an end user to remove the needle shield 700 from the syringe 800. To provide the desired amount of friction, the sealing interface 842 may constitute the only physical contact between the syringe 800 and the needle shield 700.

[0040] 9 illustrates yet another alternative syringe assembly 950 including a needle shield 900 made in accordance with the present disclosure. The alternative needle shield 900 is made of a harder material than typical needle shields. In some examples, the needle shield 900 is made of a harder material than the needle shields 100, 400, 600, and 700 of the present disclosure. As shown, the needle shield 100 includes a body 102, a cavity 104, and a relief feature 106.

[0041] The body 902 is generally cylindrical and made of a thermoplastic material, although in other examples, the body 902 can be another shape or made of other natural or synthetic materials. As shown, the body 902 includes a proximal end 912 and a distal end 914. In this example, the body 902 includes a shoulder 916. The shoulder 916 can be an annular shoulder 916 that wraps around the body adjacent the proximal end 912. In other examples, the shoulder 916 may not wrap around the entire circumference of the body 902, or the shoulder 916 can be located elsewhere on the body, such as adjacent the distal end 914.

[0042] The needle shield 900 further includes a cavity 904 configured to receive a syringe. As shown, the cavity 904 includes an opening 922 and a conical cavity portion 924. In this example, the opening 922 opens into a cylindrical cavity portion 926. In other examples, the opening 922 has an alternative cross-sectional shape. In this example, the needle shield 900 is made of a stiffer material that exhibits reduced deformation under axial load, thereby reducing friction between the needle shield 900 and the syringe 950. As a result, the opening 922 does not deform and does not increase friction with the syringe 950. In some such examples, the needle shield 900 is made of a material having a hardness greater than about 50 Shore A. Such a material allows the cavity 904 and the needle shield surface 905 to maintain a substantially constant diameter under a tensile load ranging from about 0 N to about 20 N. As used herein, a diameter is substantially deformed if it decreases by more than 5% from its undeformed state.

[0043] The needle shield 900 further includes a conical cavity portion 924. The conical cavity portion 924 includes a sloped surface 942 configured to guide the needle into a needle receiving portion 944. The needle receiving portion 944 receives the needle and ensures sterility of the needle during shipping and storage of the syringe. The sloped surface 942 of the conical cavity portion includes an angle 946 of approximately 10 degrees (°). However, in various other examples, the angle 946 can be greater or less than 10°; for example, the angle 946 can be as small as 2° or as large as 30°.

[0044] In each of the foregoing embodiments, the needle shield and the needle hub of the syringe are manufactured to reduce the friction that must be overcome to remove the needle shield from the syringe. Friction is reduced because the contact surface area between the needle shield and the syringe is reduced. In at least some embodiments, friction can be reduced to a level where the force required to remove the needle shield from the syringe can be about 5 N or less, or 10 N or less. Additionally, friction-reducing features described herein can be added to one or both of the needle shield and the syringe and / or combined to further improve friction-reducing effectiveness in accordance with the present disclosure.

[0045] 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.

[0046] 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.

[0047] 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).

[0048] 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.

[0049] 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 I 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); .

[0050] 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.

[0051] 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.

[0052] 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. Syringe assembly, A syringe comprising a barrel and a needle hub located at the distal end of the syringe, A needle shield comprising an inner surface and a cavity for receiving the needle hub, wherein the inner surface of the needle shield engages with the outer surface of the needle hub to form a sealing interface between the inner surface and the outer surface when the needle shield is placed on the syringe, thereby removably connecting the needle hub and the needle shield. Equipped with, The sealing interface comprises at least one undulating feature configured to suppress or reduce the amount of force required to remove the needle shield from the syringe. Syringe assembly.

2. The syringe assembly according to claim 1, wherein the at least one undulating feature is defined by the needle hub.

3. The syringe assembly according to claim 1 or 2, wherein the at least one undulating feature comprises at least one annular groove and / or at least one annular ridge defined by the outer surface of the needle hub.

4. The syringe assembly according to claim 1 or 2, wherein the at least one undulating feature portion comprises a plurality of dimples and / or a plurality of protrusions defined by the outer surface of the needle hub.

5. The syringe assembly according to claim 1, wherein the at least one undulating feature is defined by the needle shield.

6. The syringe assembly according to claim 1 or 5, wherein the at least one undulating feature comprises at least one annular groove and / or at least one annular ridge defined by the inner surface of the needle shield.

7. The syringe assembly according to claim 1 or 5, wherein the at least one undulating feature portion comprises a plurality of dimples and / or a plurality of protrusions defined by the inner surface of the needle shield.

8. It is a needle shield, A main body including a proximal end and a distal end, An inner surface defining a cavity, configured to contact the outer surface of the syringe and to removably connect the needle shield and the syringe, An opening formed at the proximal end of the main body and communicating with the cavity, Equipped with, (a) The inner surface is provided with at least one undulating feature configured to suppress or reduce the amount of force required to remove the needle shield from the syringe, (b) The material of the needle shield includes a material having a hardness greater than about 50 Shore A. A needle shield, which is one of the following.

9. The needle shield according to claim 8, wherein the opening is a circular opening, and the cavity comprises a conical cavity portion and a cylindrical portion disposed between the opening and the conical cavity portion.

10. The needle shield according to claim 9, comprising (a), wherein the inner surface of the needle shield and the at least one undulating feature portion are located within the cylindrical portion of the cavity.

11. The needle shield according to any one of claims 8 to 10, comprising (a), wherein the at least one undulating feature portion comprises at least one annular groove and / or at least one annular ridge.

12. The needle shield according to any one of claims 8 to 10, comprising (a), wherein the at least one undulating feature portion comprises a plurality of dimples and / or a plurality of protrusions.

13. The needle shield according to claim 12, wherein the plurality of dimples and / or the plurality of protrusions are distributed uniformly or non-uniformly.

14. It is a syringe, A barrel including a proximal end and a distal end, A needle hub disposed at the distal end of the barrel, the needle hub having an outer surface configured to contact the inner surface of the needle shield and to removably connect the needle shield and the syringe, Equipped with, The outer surface of the needle hub is provided with at least one undulating feature configured to suppress or reduce the surface area of ​​the outer surface of the needle hub that contacts the inner surface of the needle shield. Syringe.

15. The syringe according to claim 14, wherein the distal end of the needle hub is a syringe spherical portion comprising a syringe spherical portion defining a first radius and a needle hub neck portion defining a second radius, the first radius being greater than the second radius.

16. The syringe according to claim 15, wherein the spherical portion of the syringe comprises the at least one undulating feature portion.

17. The syringe according to claim 15 or 16, wherein at least one of the undulating features is provided with an annular groove.

18. The syringe according to claim 15 or 16, wherein the at least one textured feature portion comprises a plurality of dimples and / or a plurality of protrusions.

19. The syringe according to claim 18, wherein the plurality of dimples and / or the plurality of protrusions are distributed uniformly or non-uniformly.

20. The needle shield according to claim 8, comprising (b), wherein the inner surface of the needle shield maintains at least a substantially constant diameter under a tensile load applied to the body in the range of about 0 N to about 10 N.

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