A syringe that combines a Luer lock and a pen needle attachment function.

Abstract

A male needleless connector having a tapered elongated tip conforming to ISO standards and a collar, the collar having an outer wall surface with a plurality of threads for connection to corresponding internal threads of a pen needle. The male needleless connector has a taper between a distal end of the elongated tip and an inner wall of the elongated tip. The male needleless connector is configured to receive a pen needle.

Description

[Technical Field]

[0001] This disclosure is in the field of drug delivery devices, and in particular, is directed toward a male Luer connector having interoperability between a female Luer connector and a small-gauge pen needle.

[0002] background A medication pen is typically used to inject small amounts of medication into a patient. Individuals who need to self-inject medication regularly will typically carry a medication pen and several single-use needles. Medical practitioners can also utilize medication pens to dispense medication from vials and inject it using the pen and accompanying needles.

[0003] Pen needles are generally adapted to achieve injection to a specified target depth in the subcutaneous region (SC) and typically have shorter needle cannula lengths (such as 4mm and 5mm needles) and smaller needle cannula gauges (such as 32g). In applications where the practitioner must extract medication from a vial with a rubber stopper, pen needles often fail to fully penetrate the stopper due to their shorter needle cannula length. Furthermore, pen needles may bend, buckle, or break when penetrating the stopper due to their smaller needle cannula gauge. In applications where a larger volume of medication needs to be aspirated from the vial, pen needles often require significantly more time and greater withdrawal force due to their smaller needle cannula gauge.

[0004] Therefore, there is a need in the art to provide a drug delivery device compatible with a pen needle that can rapidly draw liquid from a vial for use in SC region injection.

[0005] overview A first aspect of the present disclosure is a collar having an elongated tip having a terminal end and a proximal base, a tapered outer surface and a lumen extending through the elongated tip, the proximal base having a diameter greater than the diameter of the terminal end, the lumen defining an inner wall and having a substantially cylindrical shape and a terminal end, the collar partially surrounding the elongated tip, the collar having a cavity forming an inner wall surface and an outer wall surface, the inner wall surface having a diameter greater than the proximal base of the elongated tip, and the outer wall surface including a plurality of threads for connection to a corresponding internal thread portion of a pen needle. The inner wall surface of the collar includes internal threads for connection to a corresponding thread portion of a female Luer connector.

[0006] In some embodiments, the female Luer connector is inserted between the elongated tip and the inner wall surface.

[0007] In some embodiments, the male pinless connector further comprises a taper between the inner wall of the elongated tip and the terminal end of the elongated tip. In some embodiments, the taper has a flat surface. In some embodiments, the taper has a flat surface with a rounded edge. In some embodiments, the taper has an angle θ with respect to the central axis Z of the male pinless connector. In some embodiments, the angle θ is in the range of 26 to 28.5 degrees. In some embodiments, the taper is configured to create a seal with the post of the pen needle.

[0008] In some embodiments, the male pinless connector conforms to the ISO-80369 standard for male Luer locks with fixed collars. In some embodiments, the projection distance G' of the elongated tip end from the proximal base is 7.5 mm, and the projection distance M' of the elongated tip end from the end of the collar is 2.1 mm. In some embodiments, the projection distance G' of the elongated tip end from the proximal base is 7.5 mm, and the projection distance M' of the elongated tip end from the end of the collar is in the range of 4.00 mm to 4.80 mm. In some embodiments, the projection distance G' of the elongated tip end from the proximal base is 7.5 mm, and the projection distance M' of the elongated tip end from the end of the collar is in the range of 2.1 mm to 4.80 mm. In some embodiments, multiple threads are configured to produce more than two rotations in the internal thread of a standard pen needle.

[0009] Further embodiments of the present disclosure are directed to a kit comprising a syringe having a barrel having an open proximal end, a terminal end and a cavity; a male needleless connector, the male needleless connector being integrally molded with the terminal end of the barrel; a pen needle hub having a double-ended cannula for coupling to a standard pen needle assembly, the pen needle having a body and a side wall forming an open end, the side wall having an internal thread for coupling to a standard pen needle assembly; and a standard female Luer needle having a needle hub and a cannula, the needle hub having a proximal end and a terminal end, the cannula extending through the terminal end.

[0010] In some embodiments, the body has a terminal surface with a periphery forming a shoulder, from which a tower extends away from the open end, and the shoulder has a shoulder side wall and a terminal end wall. In some embodiments, the post protrudes from the inner surface of the end wall of the pen needle to the proximal end to support a double-ended cannula, and the post has a conical base portion. In some embodiments, the taper between the inner wall of the elongated tip and the terminal end of the elongated tip is configured to create a seal with the conical base portion of the post. In some embodiments, the conical base portion of the post is at least partially inserted into the lumen of the elongated tip to create a seal.

[0011] In some embodiments, multiple threaded portions on the outer wall surface of the collar are configured to interlock with the internal threaded portions of the pen needle until the inner surface of the shoulder portion abuts against the end of the collar.

[0012] In some embodiments, the cannula of a standard female lure hook is a standard gauge needle, and the needle cannula of a double-ended pen hook is a small gauge needle.

[0013] Further embodiments are directed to a method of using the kit, which includes the steps of attaching the needle hub to the needleless connector, inserting the cannula into the stopper of the vial, aspirating the drug from the vial by pulling out the plunger rod of the barrel, removing the needle hub from the needleless connector, and attaching the pen needle to the needleless connector. Here, the pen needle is attached to the needleless connector by screwing the internal threaded portion of the pen needle into multiple threads on the outer wall surface of the collar of the needleless connector. [Brief explanation of the drawing]

[0014] [Figure 1] Figure 1 shows a standard ISO-compatible male Luer connector. [Figure 2] Figure 2 shows a standard ISO-compatible pen needle. [Figure 3]Figure 3 shows a syringe and a needleless male connector according to one or more embodiments of the present disclosure. [Figure 4] Figure 4 shows a detailed view of a needleless male connector according to one or more embodiments of the present disclosure. [Figure 5] Figure 5 shows a bottom perspective view of a pen needle according to one or more embodiments of the present disclosure. [Figure 6] Figure 6 shows a front perspective view of a pen needle according to one or more embodiments of the present disclosure. [Figure 7] Figure 7 shows a cross-sectional view of a pen needle according to one or more embodiments of the present disclosure. [Figure 8] Figure 8 shows a cross-sectional view of a male luer connector connected to a pen needle according to one or more embodiments of the present disclosure. [Figure 9] Figure 9 shows Detail A of the cross-sectional view of Figure 9 according to one or more embodiments of the present disclosure. [Figure 10] Figure 10 shows a cross-sectional view of an ISO-compatible pen needle and an ISO-compatible needleless male connector according to one or more embodiments of the present disclosure. [Figure 11] Figure 11 shows a kit having a pen needle, a standard female needle cannula, and a needleless male connector according to one or more embodiments of the present disclosure.

[0015] Detailed Description Before describing some exemplary embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of the structures or process steps described in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0016] For the purposes of the following description, the terms "proximal", "distal", "longitudinal", and their derivatives are with respect to this disclosure as oriented in the drawings. However, it is to be understood that this disclosure may contemplate alternative variations and step sequences, except where the contrary is expressly specified. Also, it is to be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of this disclosure. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein are not to be considered limiting.

[0017] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0018] As used herein, the term "medical device" refers to a general medical device having a screw or interlock connection, the connection having corresponding mating elements. By way of example and not limitation, a syringe may have a screw connection that releasably interfaces with secondary medical devices such as unnecessary connectors like catheters, drip lines, etc. The screw connection may include a lumen defining a fluid path surrounded by a protruding wall having screw means for attachment to the secondary medical device.

[0019] As will be readily understood by those skilled in the relevant art, descriptive terms such as "screw", "taper", "tab", "wall", "proximal", "side", "distal", etc. are used throughout this specification for ease of understanding, but are not intended to limit any of the components that may be used in combination or individually to implement the various aspects of the embodiments of this disclosure.

[0020] As used herein, the term “Luer connector” or “Luer lock connector” refers to a connecting collar, which is a standard method for connecting syringes, catheters, hub needles, IV tubes, etc. to one another. A Luer connector consists of one or more slightly tapered connecting tubes that are held together by simple press-fit / torsion-fit / friction-fit. Luer connectors optionally include an additional outer rim for the threaded portion, which allows them to be secured more securely. Luer connectors can be interlocked and connected to ends positioned on vascular access devices (VADs). A Luer connector comprises a profiled central passage for fluid communication extending terminally from the chamber of the syringe barrel to the hub of the VAD, a cylindrical outer wall surrounding the profiled central passage, a terminal end, and a proximal end. A Luer connector also has a terminal end channel for releasably attaching the Luer connector to the hub of the VAD and a proximal end channel for releasably attaching the Luer connector to the barrel of the syringe. As used herein, the term “Luer connector” refers to a male Luer connector or a female Luer connector.

[0021] As used herein, the term "male Luer connector" refers to a Luer connector having a central profile passage (a tapered, elongated end) and a cylindrical outer wall (collar).

[0022] As used herein, the term “standard” refers, when used in conjunction with one or more connectors described herein, to a connector that conforms to a specific International Organization for Standardization (ISO) standard relating to that connector.

[0023] Where used herein, the term “pen injector” refers to a standard pen injector conforming to ISO 11608-1:2014. ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NIS) intended for use with injection needles and replaceable or non-replaceable containers. Where used herein, the term “pen needle” refers to a single-use, double-ended sterile needle for needle-based injection systems (NIS) that meets the specifications of ISO 11608-1. Unless otherwise stated, the pen needles described in this disclosure conform to ISO 11608-2:2012. ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended sterile needles for needle-based injection systems (NIS) that meet the specifications of ISO 11608-1.

[0024] Connectors used in drug delivery devices typically share ISO standard Luer connections. Standard male Luer tips or standard male connectors have specifications compliant with ISO 594-1:1986 and 594-2:1998 and the recently published ISO 80369-2021 standard. The standard male Luer connector is configured to interlock and connect with a standard female Luer connector commonly found on a Luer needle hub (such as the standard female Luer needle 70 shown in Figure 11). Conventional pen-type syringe needles are specified in ISO 11608-2:2012 to be compatible with pen-type syringes, particularly ISO 11608-1, but conventional pen-type syringe needles are not compatible with standard male Luer connectors.

[0025] Figure 1 shows a recently published standard male Luer lock connector 10 in accordance with ISO-80369-2021 for male Luer locks with fixed collar. The standard male Luer lock connector 10 comprises a tapered, elongated tip 12 extending from a base wall 14 and a collar 16 extending from the base wall 14 and partially surrounding the elongated tip 12.

[0026] The elongated tip 12 has a trapezoidal cross-section with a terminal end 18 and a proximal base 20. The proximal base 20 has a larger diameter than the diameter of the terminal end 18 of the elongated tip 12. The elongated tip 12 has a tapered outer surface whose diameter decreases from the proximal base portion 14 towards the terminal end 18. The elongated tip 12 further comprises a lumen 22 that extends through the elongated tip 12 and is in fluid communication with the cavity of the syringe barrel. The lumen 22 defines the inner wall surface 24 of the elongated tip 12, which extends from the terminal end 18 to the proximal base 20.

[0027] The collar 16 has a substantially cylindrical shape and extends from the base wall 14 to the terminal end 26 of the collar 16. The collar 16 has a length shorter than the length of the elongated tip 12. The collar 16 has an inner wall 28 and an outer wall 30, the inner wall 28 having a diameter larger than the diameter of the base 20 of the elongated tip 12, and the outer wall 30 having a diameter larger than the diameter of the inner wall 28. The inner wall 28 and the outer wall 30 define the thickness of the collar 16. The inner wall 28 includes an internal threaded portion 32 for connection to the corresponding threaded portion of the female Luer connector. In the standard male Luer lock connector 10 shown, the inner wall surface 24 defined by the lumen 22 is perpendicular to the terminal end 18 of the elongated tip 12.

[0028] Dimensional characteristics A (angle of the internal thread profile on the non-bearing surface), B (angle of the internal thread profile on the bearing surface), C (width of the thread profile at the top), E (nominal pitch), F (distance from the end of the elongated tip 18 to the bottom of the first complete thread profile of the internal thread section, which is an auxiliary dimension), J (width of the thread profile at the root), and K (small inner diameter) are defined in the Luer Slip and Luer Lock ISO-80369 standard, and the said dimensions have a specific range of values ​​(minimum, nominal, and maximum dimensions). In connection with this disclosure, the ISO-80369 standard also defines the diameter D of the inner wall 28. IS , outer wall 30 diameter D OS , diameter D of the lumen 22 LIn addition, there is a specific range of values ​​for the projection distance G of the terminal end 18 of the elongated tip 12 from the base wall 14, and for the projection distance M of the terminal end 18 of the elongated tip 12 from the terminal end 26 of the collar. In some embodiments, the aforementioned dimensions conform to the ISO-80369 standard. In the ISO-80369 standard, the projection distance G is in the range of 7.5 mm to 10.5 mm, the projection distance M has a minimum value of 2.1 mm, and the diameter D L It has a maximum value of 2.9 mm, and diameter D OS The diameter is in the range of 8.8 mm to 11.5 mm, and the elongated tip 130 has a 6% taper with a tip diameter of 3.97 mm to 4.72 mm at the terminal end 132 of the elongated tip 130, and a base diameter of 4.375 mm to 4.477 mm at the proximal base 134 of the elongated tip 130.

[0029] Figure 2 shows a standard pen needle 40 in accordance with the ISO 11608-2:2012 standard for pen needles. The standard pen needle 40 comprises a needle hub 42 having an open proximal end 44, a terminal wall 46, and a double-ended needle cannula 48 having a proximal end 50 in a cavity 52 of the needle hub 42 and a terminal end 54 extending terminally from the terminal wall 46 of the needle hub 42. The needle hub 42 further comprises a threaded portion 56 located on the inner wall of the needle hub 42. The standard pen needle 40 in accordance with ISO 11608-2:2012 may further include a needle container 58 for completely enclosing the needle, the needle container 58 having an open proximal end 60.

[0030] As shown in Figure 2, the dimensional characteristics N (length of the needle cannula from the terminal end 54), O (length of the needle cannula to the terminal wall 46 in the cavity 52), P(), Q (distance from the base end 62 of the threaded portion 56 to the opening base end 60 of the needle container 58) and S (post projection distance in the cavity) are defined in the ISO 11608-2:2012 standard for pen needles, and the said dimensions have a range of specific values ​​(minimum, nominal, and maximum dimensions). In connection with this disclosure, the ISO 11608-2:2012 standard defines the length L of the base end 62 of the threaded portion 56 from the terminal wall 46. TThe length Q from the base end 62 of the threaded portion 56 to the opening base end 60 of the needle container 58, and the length T from the inner surface of the end wall 46 to the opening base end 44 also have a specific range of values. In some embodiments, the above dimensions conform to the ISO 11608-2:2012 standard. The ISO 11608-2:2012 standard specifies the length L T The length is less than 3.7 mm, the length Q is less than 6.0 mm, and the length T is less than 7.5 mm.

[0031] Compliance with the ISO-80369 standard ensures that the corresponding standard female connector (such as the standard female luer hook 70 shown in Figure 11) can be connected to the male pinless connector 10 by creating an interference fit with the elongated tip 12, or by screwing it onto the internal threaded portion 32, or both. However, as shown in Figure 10 and as will be discussed in more detail below, the standard hook pen 40 cannot be fully locked to the standard male luer lock connector 10.

[0032] Embodiments of this disclosure are directed toward a modified male Luer lock connector 120 that is compatible with a preceding pen needle (such as the pen needle 200 in Figures 5 to 7) while still maintaining compatibility with a standard female Luer lock connector under ISO standards (such as the standard female Luer lock needle 70 shown in Figure 11). In some embodiments, the pen needle is compatible with ISO 11608 standards. In some embodiments, the pen needle is the BD NANO® PRO 4MM PEN NEEDLE from Becton Dickinson Company. In some embodiments, the male Luer lock connector 120 is molded onto a preceding syringe.

[0033] As previously described, Figures 1 and 2 show prior art equipment based on ISO standards. Figures 3 and 4 show embodiments of syringe 100 having a male needleless connector 120 that conforms to and complies with ISO 80369-7:2021 standard and thus incorporates all the dimensions of a standard male Luer lock connector 10. The male needleless connector 120 is configured to accept not only standard female Luer lock connectors such as needle hubs and cannulas (such as the standard female Luer needle 70 shown in Figure 11), but also pen needles 200 as described herein.

[0034] The syringe 100 comprises a barrel 102 and a plunger rod 110. The barrel 102 has an open base end 104, a terminal end 106 and a cavity 108. The plunger rod 110 has a thumb rest 112 located at its end. As shown in Figure 3 and in more detail in Figure 4, the needleless connector 120 comprises a tapered elongated tip 130 extending from the terminal end 106 of the barrel 102 and a collar 140 extending from the terminal end 160 of the barrel 102 and partially surrounding the elongated tip 130.

[0035] The elongated tip 130 has a trapezoidal cross-section with a terminal end 132 and a proximal base 134. As shown in the figure, the proximal base 134 is integral with the terminal end 106 of the barrel 102. The proximal base 134 has a diameter larger than the diameter of the terminal end 132 of the elongated tip 130. The elongated tip 130 has a tapered outer surface whose diameter decreases from the proximal base 134 towards the terminal end 132. The elongated tip 130 further comprises a lumen 136 that extends through the elongated tip 130 and is in fluid communication with the cavity 108 of the barrel 102. The lumen 136 defines the inner wall 138 of the elongated tip 130, which extends from the terminal end 132 to the proximal base 134.

[0036] The collar 140 has a substantially cylindrical shape and extends from the end end 106 of the barrel 102 to the end end 142 of the collar 140. The collar 140 has a length shorter than the length of the elongated tip 130. The collar 142 has cavities forming an inner wall surface 144 and an outer wall surface 146, the inner wall surface 144 having a diameter larger than the diameter of the proximal base 134 of the elongated tip 130, and the outer wall surface 146 having a diameter larger than the diameter of the inner wall surface 144. The inner wall surface 144 and the outer wall surface 146 define the thickness of the collar 140. The inner wall surface 144 includes an internal threaded portion 145 for connection to the corresponding threaded portion of a female Luer connector. In some embodiments, the female Luer connector is a standard female Luer needle 70 shown in Figure 11.

[0037] Referring back to Figure 1, both the standard male Luer lock connector 10 and the male pinless connector 120 in Figure 1 are compatible with and compliant with ISO standard 80369-7:202, so the dimensions described earlier apply to the male pinless connector 120.

[0038] As shown in Figure 4, the outer wall surface 146 includes a plurality of threaded portions 147. In some embodiments, the plurality of threaded portions 147 have a pitch of 0.8 mm, a thread angle of 60 degrees, and a root-to-top distance of 0.293 mm, in accordance with the ISO 11608 standard. Furthermore, in some embodiments, the plurality of threaded portions 147 have a root diameter of 0.2 mm and a top diameter of 0.2 mm. Since the ISO Luer standard requires that the corresponding connector be inserted between the elongated tip 130 and the inner wall surface 144 of the collar, having a plurality of threaded portions 147 on the outer wall surface 146 of the collar does not hinder the connection of the corresponding connector. Furthermore, in some embodiments, the terminal end 132 of the elongated tip 130 has a taper 139 between the inner wall 138 of the elongated tip 130 and the terminal end 132 of the elongated tip 130. In some embodiments, as best shown in Figure 9, the taper 139 has a flat surface 149 with a rounded edge. In some embodiments, the taper 139 has an angle 9 with respect to the central axis Z of the syringe 100. In some embodiments, the flat surface 149 has an angle θ with respect to the central axis Z of the syringe 100. In some embodiments, the angle θ is in the range of 26 to 28.5 degrees. As will be described in more detail below, the flat surface 149 and the taper 139 are configured to create a seal with the post 244 of the pen needle 200. The female Luer connector creates an interference fit and a fluid-tight seal with the elongated tip 130, but the female Luer connector does not interact with the inner wall 138 of the elongated tip 130 and does not create a seal with the terminal end 132 of the elongated tip 130, so having the taper 139 on the inner wall 138 of the elongated tip 130 does not interfere with the connection of the corresponding connector. In other words, the seal created between the taper 138 and the post 244 of the pen needle 200 (described in more detail below) does not affect the compatibility of standard female luer connectors.

[0039] Referring to Figures 3 and 5-7, the pen needle hub 200 includes a double-ended cannula 220 that is chamfered and sharpened at both ends for coupling with a standard pen needle assembly and for penetrating the patient's skin. The pen needle hub 200 has a body 222 having side walls 224 that form an open end 226. In the shown embodiment, the body 222 has a substantially cylindrical shape. The open end 226 forms an internal cavity having an internal threaded portion 230 located on the inner surface of the side walls 224 for coupling with a pen needle delivery device.

[0040] The body 222 of the needle hub 200 has an end surface 260 having a periphery 232 that forms a shoulder 234. The shoulder 234 may be oriented in a plane substantially perpendicular to the central axis of the needle hub 200. The tower 236 that forms the upper end portion of the needle hub 200 extends from the shoulder 234 in the direction of the central axis away from the open end 226. The tower 236 has a shoulder side wall 238 that extends substantially parallel to the side wall 224 of the body 222 of the needle hub 200. The tower 236 has an end end wall 240 having an axial surface 242 that forms a skin contact surface. The end wall 240 may be substantially convex. The end surface 242 may have a diameter of about 5 to 7 mm. The shoulder has a width that receives the inner shield and is about 1 to 4 mm wide from the periphery of the body 222 and the side wall 238 of the tower 236. The cavity 286 of the main body 222 is defined by the main body side wall 238, the shoulder portion 234, the shoulder portion side wall 238, the end surface 260, and the base end opening portion 226. The cavity 286 is wider at the base end opening portion 226 than at the shoulder portion 234.

[0041] A post 244 for supporting the cannula extends inward from the inner surface 246 of the end wall 240 of the tower 236, as shown. The post 244 protrudes inward and close to the central axis to support the cannula 220. The post 244 has an axial passage extending through the pen needle hub 200 to receive the cannula and a conical end 249. A well 248 is formed at the end wall 240 of the terminal face 242 to receive the adhesive that connects the cannula 220 to the pen needle hub 200. In the shown embodiment, the cannula 220 extends inward for a distance to connect the delivery device and outward from the terminal face 242 for a distance to puncture the patient's skin.

[0042] The pen needle hub 200 deforms the skin by insertion force during insertion and penetration of the cannula by the insertion force typically applied by the patient. In the shown embodiment, the pen needle hub 200 has an inner ring 250 extending from the end face 242 of the tower 236. The inner ring 250 has a well 248 with an inner surface 254 and an axially facing end face 252 surrounding the cannula 220. An outer ring 256 is formed on the outer periphery of the tower 236, forming a recess 258 between the inner ring 250 and the outer ring 256. The outer ring 256 has an axially facing end face 260 with an inner surface 262 facing the inner surface 254. In the shown embodiment, the surface of the recess 258 and the axial faces of the inner ring 250 and the outer ring 256 have substantially continuous concentric radii of curvature, defining the skin contact surface of the pen needle hub 200. The recess 258 has a depth such that the patient's skin flexes into the recess and contacts the bottom surface of the recess during needle insertion, deforming the skin in a controlled manner. In one embodiment, the radial width of the recess is substantially equal to the combined radial width of the inner ring 250 and the outer ring 256. The axial surface of the end face of the tower 236 has a convex dome shape that is axially outwardly spaced from the surfaces that the inner ring 250 faces axially with respect to the outer ring 256 and the recess 258.

[0043] The initial penetration of the cannula 220 by contact of the inner ring protruding from the tower 236 with the patient's skin forms a depression in the skin, establishing the initial cannula penetration depth. The skin surface then relaxes so that it substantially conforms to the shape of the contact surface formed by the outer ring 256 and the depression 258, limiting the penetration depth of the cannula 220. The shape, surface area, and height of the contact surface provide control over the penetration depth of the cannula during insertion and penetration forces applied to the infusion device.

[0044] The side wall 224 of the main body 222 has an inner surface 266 at the base end open end 226 of the pen needle hub 200. In the shown embodiment, a recess 268 is formed in the inner surface 266. In one embodiment, the recess 268 surrounds the perimeter of the needle hub, forming a continuous recess. The recess 268 extends the distance of the side wall and terminates with an inclined chamfered edge 270. The recess 268 can provide a larger open end to assist in assembling the pen needle hub 200 into a delivery device.

[0045] The outer surface 272 of the side wall 224 includes a plurality of recesses 274 at its upper end that form a scalloped shape. Each recess 274 has a substantially V-shape formed by an inclined side surface 276 and an opening top end 278. The recesses 274 can provide increased flexibility to the upper part of the side wall compared to a surface without recesses. Recesses 268 at the bottom end of the side surface can provide reduced thickness and flexibility, similar to the flexibility provided by the recesses 274.

[0046] The surface 246 of the end wall 240 has a substantially conical shape corresponding to the shape of the outer end surface 242. In the shown embodiment, the end wall 240 has a substantially uniform thickness. The post 244 has a conical base portion 284 on its inner surface 246 that converges to the cylindrical surface of the post 244. The conical base 284 also provides the end wall 240 with rigidity that resists inward deflection during use.

[0047] As shown in FIGS. 8 and 9, the pen needle 200 is configured to engage with the male needleless connector 120. As shown, the cavity 286 is configured to receive the elongate tip 130 and the collar 140, and the cavity 286 completely surrounds the collar 140. A plurality of screw threads 147 outside the outer wall surface 146 of the collar 140 are configured to engage with the internal screw threads 230 of the pen needle 200 until the inner surface of the shoulder 234 abuts the end end 142 of the collar 140. The conical base portion 284 of the post 244 is at least partially inserted into the lumen 136 of the elongate tip, and the conical base portion 284 forms a first fluid tight seal 202 with the taper 139 of the elongate tip 130. The end end 132 of the elongate tip 130 forms a second fluid tight seal 204 with the inner surface of the end face 260 of the pen needle 200.

[0048] Referring to FIGS. 1 and 7, the diameter Ds of the side wall 224 of the pen needle 200 is the diameter D of the outer wall surface 146 of the collar 140 OS configured to accommodate, and the length L from the end face 260 of the pen needle 200 to the shoulder 234 of the pen needle 200 SF is configured to accommodate the protruding distance M of the end end 18 of the elongate tip 12 from the end end 26 of the collar, and the length L from the shoulder 234 of the pen needle 200 to the open end 226 of the pen needle 200 TP is the length L SF and in conjunction with, is configured to accommodate the protruding distance G of the end end 18 of the elongate tip 12 from the base end wall 14. As shown, the external screw threads 147 of the collar 140 and the internal screw threads 230 of the pen needle 200 generate sufficient turns to satisfy an ISO11608-2-2012 torque value of from 0.060 Nm to 0.080 Nm. In some embodiments, the external screw threads 147 of the collar 140 and the internal screw threads 230 of the pen needle 200 generate more than 2 rotations. In some embodiments, the external screw threads 147 of the collar 140 and the internal screw threads 230 of the pen needle 200 generate more than 3 rotations.

[0049] Figure 10 shows an example of improper mating between the male pinless connector 120 and the standard pen pin 40 due to ISO dimensional limitations of the male pinless connector 120 and the standard pen pin 40. Figure 10 is drawn to a proportional scale, and the dimensional projection distance G' of the end end 132 of the elongated tip 130 from the base 134 is 7.5 mm, the projection distance M' of the end end 132 of the elongated tip 130 from the end end 142 of the collar 140 is 2.1 mm, and the length L of the base end 62 of the threaded portion 56 from the end wall 46 is 2.1 mm. T The diameter is 3.7 mm. As shown, only two turns of thread engagement of the threaded portion 56 of the standard needle pen 40 can engage with the multiple threaded portions 147 of the outer wall surface 146 of the male needleless connector 120.

[0050] In particular, the screw engagement length W of the standard needle pen 40 and the male needleless connector 120 is only 1.2 mm, which is insufficient to meet the ISO torque requirements. As shown, increasing the projection distance M' (the distance from the end end 142 of the collar 140 to the end end 132 of the elongated tip 130) results in even less screw engagement. Decreasing the projection distance M' will cause the projection distance M' to fall out of compliance with the ISO standard. Furthermore, length L T (The base end portion 62 of the threaded portion 56 from the end wall 46) has a length L T Since ISO compliance must be maintained at less than 3.7 mm, it cannot be made any longer. Even if the length T (from the inner surface of the end wall 46) is made longer, the length L T It must be less than 3.7 mm and maintain ISO compliance.

[0051] Figure 11 shows a kit 300 comprising a syringe 100 having a needleless connector 120 integrally molded to the end 106 of the syringe barrel 102, a pen needle 200, and a standard female Luer needle 70. In some embodiments, each of the syringe 100, pen needle 200, and standard female Luer needle 70 is placed in separate pouches 302, 304, and 306, respectively. In some embodiments, the separate pouches 302, 304, and 306 form a single pouch with multiple compartments for each of the syringe 100, pen needle 200, and standard female Luer needle 70.

[0052] A standard female luer hook 70 comprises a hook hub 72 and a cannula 78. The hook hub 72 has a proximal end 74 and a distal end 76, and the cannula 78 extends through the distal end 76 of the hook hub. In some embodiments, the proximal end 74 further comprises a flange 80 configured to screw-couple to an internal threaded portion 145 of a collar 140 of a male pinless connector 120. In some embodiments, the proximal end 74 of the hook hub 72 has a conical cavity (not shown) configured to interlock with an elongated tip 130 of the male pinless connector 120.

[0053] In some embodiments, the double-ended needle cannula 48 of the pen needle 40 is a small-gauge needle common to the pen needle. In some embodiments, the double-ended needle cannula 48 of the pen needle 40 is a small-gauge needle such as a 32g needle. In some embodiments, the cannula 78 of the standard female Luer needle 70 is a standard-gauge needle. In some embodiments, the cannula 78 of the standard female Luer needle 70 is a 25g needle. Because the standard female Luer needle 70 has a larger diameter gauge than the pen needle 40, the standard female Luer needle 70 is better suited for drawing drugs from vials with stoppers, allowing the standard female Luer needle to draw faster.

[0054] The method of using Kit 300 includes the following steps: attaching the needle hub 72 to the male needleless connector 120; inserting the cannula 78 into the stopper of the vial; aspirating the drug from the vial by pulling out the plunger rod 110 of the barrel 102; removing the cannula 78 from the vial; removing the needle hub 72 from the male needleless connector 120; attaching the pen needle 40 to the male needleless connector 120; and discharging the drug by pushing down the plunger rod 110.

[0055] While this disclosure has been shown and described with reference to certain exemplary embodiments, those skilled in the art will understand that various modifications in form and detail can be made therein without departing from the spirit and scope of the embodiments of this disclosure. Furthermore, the inner and / or outer housing of the disinfectant cap may be molded in a single piece or manufactured by other suitable processes. Moreover, any feature or element of any exemplary embodiment of the embodiments of this disclosure, as described above and shown in the drawings, may be implemented individually or in any combination(s) without departing from the spirit and scope of the embodiments of this disclosure, as will be readily understood by those skilled in the art.

[0056] Furthermore, the included drawings further illustrate non-limiting examples of implementations of specific exemplary embodiments of the present disclosure and aid in describing the related technology. Specific or relative dimensions or measurements described in the drawings other than those stated above are illustrative and are not intended to limit the scope or content of the design or methodology of the present invention as understood by those skilled in the art of the relevant invention.

[0057] Throughout this specification, any reference to “one embodiment,” “a particular embodiment,” “one or more embodiments,” or “a certain embodiment” means that any particular feature, structure, material, or property described in relation to an embodiment is included in at least one embodiment of this disclosure. Therefore, expressions such as “in one or more embodiments,” “a particular embodiment,” “in one embodiment,” or “in a certain embodiment” appearing in various places throughout this specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, any particular feature, structure, material, or property may be combined in any preferred manner in one or more embodiments.

[0058] While the disclosure herein provides explanations with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. Those skilled in the art will see that various modifications and variations can be made to the methods and apparatus of the disclosure without departing from the spirit and scope of the disclosure. Accordingly, the disclosure is intended to include modifications and variations that fall within the scope of the appended claims and their equivalents.

Claims

1. A connector without male pins, An elongated tip having a terminal end and a proximal base, having a tapered outer surface and a lumen extending through the elongated tip, the proximal base having a diameter larger than the diameter of the terminal end, and the lumen defining an inner wall, the elongated tip, A collar having a substantially cylindrical shape and an end portion, wherein the collar partially surrounds the elongated tip, the collar has cavities forming an inner wall surface and an outer wall surface, the inner wall surface having a diameter larger than the base end of the elongated tip, and the outer wall surface includes an outer thread for connection to the corresponding internal thread portion of a pen needle, A male pinless connector wherein the inner wall surface of the collar includes an internal thread for connection to a corresponding threaded portion of a female luer connector, and further comprises a taper between the inner wall of the elongated tip and the terminal end of the elongated tip, the taper being configured to produce a seal with the post of a pen needle.

2. The male pinless connector according to claim 1, wherein a female luer connector is inserted between the elongated tip and the inner wall surface.

3. The male pinless connector according to claim 1, wherein the taper has a flat surface.

4. The male pinless connector according to claim 1, wherein the taper has a flat surface with a rounded edge.

5. The male pinless connector according to claim 1, wherein the taper has an angle θ with respect to the central axis Z of the male pinless connector.

6. The male pinless connector according to claim 5, wherein the angle θ is in the range of 26 degrees to 28.5 degrees.

7. The male pinless connector according to claim 1, wherein the male pinless connector conforms to the ISO-80369 standard for male luer locks with fixed collars.

8. The male pinless connector according to claim 1, wherein the protrusion distance G' of the terminal end of the elongated tip from the base is 7.5 mm, and the protrusion distance M' of the terminal end of the elongated tip from the terminal end of the collar is 2.1 mm.

9. The male pinless connector according to claim 1, wherein the protrusion distance G' of the terminal end of the elongated tip from the base is 7.5 mm, and the protrusion distance M' of the terminal end of the elongated tip from the terminal end of the collar is in the range of 4.00 mm to 4.80 mm.

10. A kit comprising a male needleless connector according to claim 8, wherein the external thread portion is configured to generate more than two turns with the internal thread portion of a standard pen needle.

11. It's a kit, A syringe having a barrel with an open base end, a terminal end and a cavity, wherein the needleless connector according to claim 1 is integrally molded with the terminal end of the barrel, A pen needle hub having a double-ended cannula for connection to a standard pen needle assembly, wherein the pen needle hub has a body and side walls forming an open end, and the side walls have internal threads for connection to a standard pen needle assembly, and A standard female lure hook having a needle hub and a cannula, wherein the needle hub has a proximal end and a distal end, the cannula extends through the distal end, and a post protrudes inward and proximal from the body of the pen needle hub to support the double-ended cannula, the post has a conical base portion, and the taper between the inner wall of the elongated tip and the distal end of the elongated tip is configured to create a seal between the post and the conical base portion, A kit that includes the following:

12. The kit according to claim 11, wherein the main body has an end surface having a periphery forming a shoulder portion, a tower extends from the shoulder portion away from the open end, the shoulder portion has a shoulder side wall, and the tower has a terminal end wall.

13. The kit according to claim 11, wherein the conical base portion of the post is at least partially inserted into the lumen of the elongated tip to form a seal.

14. The kit according to claim 12, wherein the external thread portion of the outer wall surface of the collar is configured to interlock with the internal thread portion of the pen needle until the inner surface of the shoulder portion abuts against the end end of the collar.

15. The kit according to claim 11, wherein the cannula of the standard female lure hook is a standard gauge needle, and the double-ended needle cannula of the pen hook is a small gauge needle.

16. A method of using the kit according to claim 11, Steps include attaching the aforementioned needle hub to the male connector without needles, The step of inserting the cannula into the stopper of the vial, The step of aspirating the drug from the vial by withdrawing the plunger rod of the barrel, The steps of removing the needle hub from the male pinless connector, The step includes attaching the pen needle to the male pinless connector, A method for attaching the pen needle to the male pinless connector by screwing the internal threaded portion of the pen needle into the external threaded portion of the outer wall surface of the collar of the male pinless connector.

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