Needle shield for syringe

Abstract

A syringe assembly includes a syringe having a barrel and a needle hub disposed at a distal end of the syringe; and a needle shield comprising an inner surface and a cavity for receiving the needle hub. When the needle shield is disposed on the syringe, the inner surface of the needle shield engages the outer surface of the hub to form a sealed interface therebetween and removably couple the hub and the needle shield. In some examples, the sealing interface includes at least one profiled feature configured to limit or reduce an amount of force required to remove the needle shield from the syringe.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 199,131, 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 syringe assembly is disclosed herein. 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. When the needle shield is disposed on the syringe, the inner surface of the needle shield engages the outer surface of the needle hub to form a sealing interface therebetween and removably couple the needle hub and the needle shield. In some examples, the sealing interface includes at least one profiled feature configured to limit or reduce the amount of force required to remove the needle shield from the syringe.

[0007] In some variations, at least one profiled feature is defined by the needle hub. In some such variations, at least one profiled feature comprises at least one annular groove and / or at least one annular ridge defined in the needle hub surface. Alternatively, in other variations, at least one profiled feature comprises a plurality of dimples and / or a plurality of protrusions defined by the needle hub surface.

[0008] In other variations, at least one profiled surface is defined by the needle shield. For example, at least one profiled feature may include at least one annular groove and / or at least one annular ridge defined by the needle shield surface. Alternatively, at least one profiled surface includes a plurality of pits and / or a plurality of protrusions defined by the needle shield surface.

[0009] Additionally disclosed herein is a friction-reduced needle shield comprising a body having a proximal end and a distal end. The needle shield further comprises an inner surface defining a cavity and configured to contact an outer surface of a syringe to removably couple the needle shield and the syringe. The needle shield also comprises an orifice formed in the proximal end of the body and communicating with the cavity. Additionally, the inner surface comprises at least one profiled feature configured to limit or reduce the amount of force required to remove the needle shield from the syringe.

[0010] In some variations, the orifice of the cavity is a circular orifice, and the cavity defines a tapered cavity portion and a cylindrical friction portion disposed between the orifice and the tapered cavity portion. Additionally, the needle shield surface and at least one profiled feature can be disposed in the cylindrical friction portion of the cavity. For example, at least one profiled feature includes at least one annular groove and / or at least one annular ridge. Alternatively, at least one profiled feature includes a plurality of pits and / or a plurality of protrusions. In some examples, the plurality of pits and / or the plurality of protrusions are evenly distributed or unevenly distributed.

[0011] The present invention also discloses a syringe comprising a barrel having a proximal end and a distal end. The syringe further comprises a needle hub disposed at the distal end of the barrel and comprising an outer surface configured to contact an inner surface of a needle shield to removably couple the needle shield and the syringe. Additionally, the outer surface of the needle hub comprises at least one profiled feature configured to limit or reduce a surface area of ​​the outer surface of the needle hub in contact with the inner surface of the needle shield.

[0012] In some variations, the needle hub further comprises a syringe spherical body disposed on the distal end of the needle hub. In some such variations, the syringe spherical body defines a first radius, and the needle hub neck defines a second radius, the first radius being greater than the second radius.

[0013] In other variations, at least one profiled feature is disposed on the syringe spherical body. For example, at least one profiled feature may include an annular groove. Alternatively, at least one profiled 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 evenly distributed or unevenly distributed.

[0014] The present invention further discloses a friction-reduced needle shield, the needle shield comprising an elongated body having a proximal end and a distal end, the elongated body being composed of a needle shield material. Additionally, the friction-reduced needle shield comprises an orifice defined in the proximal end of the needle shield. Further, the friction-reduced needle shield may include a cavity disposed in the needle shield extending distally from the orifice, the cavity being defined by a wall portion of the elongated body, the wall portion defining a needle shield surface for sealing against a needle seat of a syringe during use. The needle shield material may comprise a material having a hardness greater than about 50 Shore A.

[0015] In some variations, the orifice is a circular orifice, and the cavity includes a conical portion and a cylindrical portion disposed between the conical portion and the orifice, at least a portion of the cylindrical portion defining a needle shield surface. Additionally, in some examples, under a tensile load in the range of about 0N to about 10N applied to the elongated body, the needle shield surface maintains a substantially constant diameter. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present disclosure may be best understood by reference to the following description taken in conjunction with the accompanying drawings, in which:

[0017] Figure 1 is a side view of a first exemplary needle shield made in accordance with the present disclosure.

[0018] Figure 2 is connected to the syringe Figure 1 Side view of a first exemplary needle shield.

[0019] Figure 3 is a side view of a first exemplary syringe made in accordance with the present disclosure.

[0020] Figure 4 is connected to the needle shield Figure 3 Side view of a first exemplary syringe.

[0021] Figure 5 is a side view of a second exemplary syringe made in accordance with the present disclosure.

[0022] Figure 6 is connected to the needle shield Figure 5 Side view of a second exemplary syringe.

[0023] Figure 7 is a side view of a second exemplary needle shield made in accordance with the present disclosure.

[0024] Figure 8 is connected to the syringe Figure 7 Side view of a second exemplary needle shield.

[0025] Fig. 9 is a side view of a third exemplary needle shield made in accordance with the present disclosure.

[0026] 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

[0027] 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.

[0028] The needle shield or syringe made according to the present disclosure is configured to provide a friction-reduced or restricted interface between the needle shield and the syringe without compromising the purpose of setting the needle shield, such as maintaining the sterility of the syringe needle, protecting the needle from damage, and / or preventing accidental needle sticks. Therefore, the friction-reduced interface limits or reduces the amount of force required to remove the needle shield, thereby making it easier to remove the needle shield from the syringe compared to the conventional arrangement. As used herein, the term "limit" may mean setting an upper threshold of the removal force that will not be exceeded. For example, in at least some embodiments, the force required to remove the needle shield may be limited to less than or equal to about 5N or less than or equal to about 10N. As used herein, the term "reduction" may mean minimizing the force required to remove the needle shield, while still serving the intended purpose and / or providing a removal force less than the removal force required for other conventional arrangements. For example, in at least some embodiments, the needle shield or syringe of the present disclosure can reduce the friction between the needle shield and the syringe when compared to the conventional arrangement by reducing the contact surface area between the syringe and the needle shield when compared to the conventional arrangement.

[0029] Go to Figure 1 , a needle shield 100 is made according to the present disclosure. As shown, the needle shield 100 includes a body 102, a cavity 104, and a profiled feature 106. As shown, the body 102 includes a diameter D and a length L, however, in various examples, the diameter D and the length L can be greater or less than that shown.

[0030] The body 102 is generally cylindrical and made of a thermoplastic material, but in other examples, the body 102 may be another shape or may be 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 may be an annular shoulder 116 that wraps around the body near 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 may be arranged elsewhere on the body, such as near the distal end 114.

[0031] The needle shield 100 further includes a cavity 104 defined by an inner surface 105 (or needle shield surface) in the proximal end 112 and configured to receive a needle hub of a syringe. As shown, the cavity 104 includes an orifice 122, a profiled feature 106, and a tapered cavity portion 124. In this example, the orifice 122 is a circular orifice and leads to a cylindrical cavity portion 126. In other examples, the orifice 122 is an alternative cross-sectional shape. The profiled feature is disposed between the orifice 122 and the tapered cavity portion 124.

[0032] like Figure 1 As shown in FIG. 1 , the inner surface 105 is designed to engage the outer surface 205 of the needle hub (combined with Figure 2 106 is discussed in more detail). More specifically, the profiled feature 106 includes an annular ridge 132 defined by the inner surface 105. The annular ridge 132 is partially defined by an adjacent annular groove 134. As a result, the profiled feature 106 is designed to contact the syringe ball along the annular ridge 132. The reduced contact surface area is designed to reduce friction when the needle shield 100 is removed from the syringe.

[0033] The needle shield 100 further includes a tapered cavity portion 124. The tapered cavity portion 124 includes an angled surface 142 configured to guide the needle into a needle receiving portion 144. The needle receiving portion 144 receives the needle and ensures the sterility of the needle during transport and storage of the syringe. The angled surface 142 of the tapered cavity portion includes an angle 146 of approximately 10 degrees (°). However, in a number of different 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 high as 30°.

[0034] Figure 2 A syringe assembly 250 is shown that includes 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 ball 206 disposed on the needle hub 204. The syringe barrel 202 includes a container volume 222, and the needle hub 204 includes a needle channel 212. Figure 2 As shown in FIG. 2 , the needle hub 204 is disposed at the distal end 214 b of the syringe 200, opposite the proximal end 214 a. In various examples, the syringe 200 may include a syringe 200 having a distal end 214 b and a proximal end 214 a. Figure 2 Different alternative structures or dimensions are shown in .

[0035] like Figure 2 , the syringe 200 contacts the outer surface 205 of the needle shield 100 at the profiled feature 106. More specifically, the syringe ball 206 and the annular ridge 132 of the needle hub 204 define a sealing interface 242. According to 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 does not provide so much friction that it is difficult for an end user to remove the needle shield 100 from the syringe 200. In order to provide the desired amount of friction, the sealing interface 242 can constitute the only physical contact between the syringe 200 and the needle shield 100.

[0036] Figure 3 A syringe 300 made in accordance with the present disclosure is shown. The exemplary syringe 300 includes a syringe barrel 302, a needle hub 304, and a syringe ball 306. The syringe barrel 302 includes a container volume 322, and the needle hub 304 includes a needle 324 disposed in a needle channel 312. In other figures, the needle 324 is omitted for clarity. Figure 3 As shown in FIG. 3 , the needle hub 304 is disposed at the distal end 314 b of the syringe 300, opposite the proximal end 314 a. In various examples, the syringe 300 may include a syringe 300 having a distal end 314 b and a proximal end 314 a. Figure 3 Different alternative structures or dimensions are shown in .

[0037] The syringe spherical body 306 includes a profiled feature 332. In this example, the profiled feature 332 includes an annular groove 334. In this example, the annular groove 334 surrounds the syringe spherical body 306. However, in other examples, the annular groove 334 may include multiple grooves. Additionally, the annular groove 334 is shown as having a semicircular cross-sectional shape, but the annular groove 334 can have any cross-sectional shape, including semi-elliptical, rectangular, triangular, etc.

[0038] exist Figure 4, the syringe 300 is mechanically connected to the needle shield 402 and forms a syringe assembly 450. The syringe is frictionally coupled to the needle shield 402 at the syringe ball 306. Specifically, the sealing interfaces 442a, 442b are on either side of the annular groove 334. Therefore, the annular groove 334 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, the friction between the needle shield 402 and the syringe ball 306 is reduced.

[0039] Figure 5 An alternative embodiment of the present disclosure is shown in which a syringe 500 includes an alternative configuration. The syringe 500 includes a syringe barrel 502, a needle seat 504, and a syringe ball 506. As shown, the syringe barrel 502 includes a container volume 522 and a needle channel 512. Figure 5 As shown in FIG, the needle hub 504 is disposed on the distal end 514b of the syringe 500, opposite the proximal end 514a. In a number of different alternative examples, the syringe 500 may have alternative sizes or configurations.

[0040] The syringe ball 506 of the present embodiment includes a profiled surface 532 having a plurality of dimples and / or protrusions. In the illustrated example, the profiled surface 532 covers substantially the entire surface of the syringe ball 506. In other examples, the profiled surface 532 may cover less of the syringe ball 506 (e.g., covering approximately 50% of the surface, 25% of the surface, etc.). Further, the size and distribution of the dimples may be greater or less than Figure 5 For example, profiled surface 532 may include more or fewer dimples per square inch. Additionally, the dimples may be larger or smaller than shown.

[0041] Figure 6 A syringe assembly 650 is shown that includes 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 ball 506. Specifically, the sealing interface 642 surrounds the profiled surface 532. The profiled 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, the friction between the needle shield 602 and the syringe ball 506 is reduced.

[0042] Figure 7 A needle shield 700 made in accordance with the present disclosure is shown. Needle shield 700 includes a body 702, a cavity 704, and a contoured surface 706.

[0043] The body 702 is generally cylindrical and made of a thermoplastic material, but in other examples, the body 702 may be another shape or may be 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 may be an annular shoulder 716 that wraps around the body near 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 may be arranged elsewhere on the body, such as near the distal end 714.

[0044] The needle shield 700 further includes a cavity 704 defined by an inner surface 705, which is configured to receive a syringe. As shown, the cavity 704 includes an orifice 722, a profiled feature 706, and a tapered cavity portion 724. In this example, the orifice 722 leads to a cylindrical cavity portion 726. The profiled feature is arranged between the orifice 722 and the tapered cavity portion 724.

[0045] like Figure 7 As shown in FIG. 1 , the inner surface 705 is designed to engage the outer surface 805 of the needle hub (combined with Figure 8 706. In some examples, the protrusion array 732 may alternatively be made of a plurality of dimples. The profiled feature 706 is configured to contact the syringe ball at each protrusion 734, thereby reducing the contact surface area between the needle shield 700 and the syringe.

[0046] The needle shield 700 further includes a tapered cavity portion 724. The tapered cavity portion 724 includes an angled surface 742 configured to guide the needle into a needle receiving portion 744. The needle receiving portion 744 receives the needle and ensures the sterility of the needle during transport and storage of the syringe. The angled surface 742 of the tapered cavity portion includes an angle 746 of approximately 10 degrees (°). However, in a number of different 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 high as 30°.

[0047] like Figure 8 As shown in , the needle shield 700 is arranged on the syringe 800 to form a syringe assembly 850. In this example, the syringe 800 includes a syringe barrel 802, a needle seat 804, and a syringe ball 806. The syringe barrel 802 includes a container volume 822, and the needle seat 804 includes a needle channel 812. Figure 8As shown in FIG. 8 , a needle hub 804 including an outer surface 805 is disposed at a distal end 814 b of the syringe 800, opposite the proximal end 814 a. In various examples, the syringe 800 may include a needle hub 804 having an outer surface 805. Figure 2 Different alternative structures or dimensions are shown in .

[0048] like Figure 8 , the syringe 800 contacts the outer surface 805 of the needle shield 800 at the profiled feature 706. More specifically, the syringe ball 806 and the protrusion array 732 of the needle hub 804 define a sealing interface 842. According to 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 does not provide so much friction that it is difficult for an end user to remove the needle shield 700 from the syringe 800. In order to provide the desired amount of friction, the sealing interface 842 can constitute the only physical contact between the syringe 800 and the needle shield 700.

[0049] Fig. 9 Yet another alternative syringe assembly 950 made according to the present disclosure is shown, the syringe assembly including a needle shield 900. The alternative needle shield 900 is made of a harder material than a typical needle shield. 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 profiled feature 106.

[0050] The body 902 is generally cylindrical and made of a thermoplastic material, but in other examples, the body 902 may be another shape or may be 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 may be an annular shoulder 916 that wraps around the body near 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 may be arranged elsewhere on the body, such as near the distal end 914.

[0051] The needle shield 900 further includes a cavity 904 configured to receive a syringe. As shown, the cavity 904 includes an orifice 922 and a tapered cavity portion 924. In this example, the orifice 922 leads to a cylindrical cavity portion 926. In other examples, the orifice 122 is an alternative cross-sectional shape. In this example, the needle shield 900 reduces the friction between the needle shield 900 and the syringe 950 because the needle shield 900 is made of a more rigid material with reduced deformation under axial load. As a result, the orifice 922 does not deform and increase the friction on 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. With this material, the cavity 904 and the needle shield surface 905 maintain a substantially constant diameter under a tensile load in the range of about 0N to about 20N. As used herein, if the diameter is reduced by more than 5% from the undeformed state, the diameter has been significantly deformed.

[0052] The needle shield 900 further includes a tapered cavity portion 924. The tapered cavity portion 924 includes an angled surface 942 that is configured to guide the needle into a needle receiving portion 944. The needle receiving portion 944 receives the needle and ensures the sterility of the needle during transport and storage of the syringe. The angled surface 942 of the tapered cavity portion includes an angle 946 of approximately 10 degrees (°). However, in a number of different 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 high as 30°.

[0053] In each of the foregoing embodiments, the needle shield and syringe needle hub are manufactured to reduce the friction that must be overcome in order to remove the needle shield from the syringe. The friction is reduced because the contact surface area between the needle shield and the syringe is reduced. In at least some embodiments, the friction can be reduced to a level such that the force required to remove the needle shield from the syringe can be less than or equal to about 5N or less than or equal to 10N. Additionally, according to the present disclosure, one or more friction reduction features described herein can be added to one or both of the needle shield and the syringe and / or combined to further improve the friction reduction effect.

[0054] 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.

[0055] 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, cartridge, or pre-filled syringe.

[0056] 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).

[0057] 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.

[0058] 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). ;

[0059] 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 AMG 427 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 AMG673 or comprise anti-CD33 x anti-CD3 with extended half-life (HLE). 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.

[0060] 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.

[0061] 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 syringe assembly comprising: a syringe comprising a barrel and a needle hub disposed at a distal end of the syringe; a needle shield comprising an inner surface and a cavity for receiving the needle hub, the inner surface of the needle shield engaging the outer surface of the needle hub to form a sealing interface therebetween and removably coupling the needle hub and the needle shield when the needle shield is disposed on the syringe; and Wherein the sealing interface includes at least one profiled feature configured to limit or reduce the amount of force required to remove the needle shield from the syringe.

2. The syringe assembly of claim 1, wherein: The at least one profiled feature is defined by the hub.

3. The syringe assembly according to any one of claims 1 to 2, wherein: The at least one profiled feature includes at least one annular groove and / or at least one annular ridge defined in the hub surface.

4. The syringe assembly according to any one of claims 1 to 2, wherein: The at least one profiled feature includes a plurality of dimples and / or a plurality of protrusions defined by the hub surface.

5. The syringe assembly of claim 1, wherein: The at least one contoured surface is defined by the needle shield.

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

7. The syringe assembly of claim 1 or 5, wherein: The at least one profiled surface includes a plurality of dimples and / or a plurality of protrusions defined by the needle shield surface.

8. A needle shield, comprising: a body, the body comprising a proximal end and a distal end; an inner surface defining a cavity and configured to contact an outer surface of a syringe to removably couple the needle shield and the syringe; an orifice formed in a proximal end of the body and communicating with the cavity; and Wherein the inner surface includes at least one profiled feature configured to limit or reduce an amount of force required to remove the needle shield from the syringe.

9. The needle shield of claim 8, wherein: The orifice of the cavity is a circular orifice, and the cavity includes a tapered cavity portion and a cylindrical friction portion disposed between the orifice and the tapered cavity portion.

10. The needle shield of claim 9, wherein: The needle shield surface and at least one profiled feature are disposed in a cylindrical friction portion of the cavity.

11. The needle shield according to any one of claims 8 to 10, wherein: The at least one profiled feature 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, wherein: The at least one profiled feature comprises a plurality of dimples and / or a plurality of protrusions.

13. The needle shield of claim 12, wherein: The plurality of recesses and / or the plurality of protrusions are evenly distributed or unevenly distributed.

14. A syringe comprising: a barrel, the barrel comprising a proximal end and a distal end; a needle hub disposed at a distal end of the barrel and comprising an outer surface configured to contact an inner surface of a needle shield to removably couple the needle shield and the syringe; and The outer surface of the needle seat includes at least one profiled feature, and the at least one profiled feature is configured to limit or reduce the surface area of ​​the outer surface of the needle seat in contact with the inner surface of the needle shield.

15. The syringe of claim 14, wherein: The distal end of the hub includes a syringe ball defining a first radius, and the hub neck defines a second radius, the first radius being greater than the second radius.

16. The syringe of claim 15, wherein: The syringe ball includes the at least one profiled feature.

17. The syringe according to any one of claims 15 to 16, wherein The at least one profiled feature comprises an annular groove.

18. The syringe according to any one of claims 15 to 16, wherein The at least one profiled feature comprises a plurality of dimples and / or a plurality of protrusions.

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

20. A needle shield, comprising: an elongated body including a proximal end and a distal end, the elongated body being constructed of a needle shield material; an orifice formed in a proximal end of the needle shield; as well as a cavity extending distally from the orifice, the cavity being defined by a wall portion of the elongated body, the wall portion defining a needle shield surface for sealing against a needle hub of a syringe during use; and Wherein, the needle shield material comprises a material having a hardness greater than about 50 Shore A.

21. The needle shield of claim 20, wherein: The aperture is a circular aperture, and the cavity includes a conical portion and a cylindrical portion disposed between the conical portion and the aperture, at least a portion of the cylindrical portion defining the needle shield surface.

22. The needle shield of claim 20 or 21, wherein: The needle shield surface maintains at least a substantially constant diameter under a tensile load in the range of about 0 N to about 10 N applied to the elongated body.

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