Hinged needle shield and needle assembly

Abstract

A needle shield assembly for use with a needle assembly is disclosed. The needle shield assembly includes an elongated needle shield having a shield portion, a hub connection portion, and a bridge portion including a living hinge having a thickness. The bridge portion joins the hub connection portion and the shield portion. The hub connection portion includes a partially circular receiving ring having a diameter sized to frictionally receive a flange of the hub of the needle assembly. The shield portion includes two longitudinal walls defining a cavity, and a needle assembly receiving cavity between the two longitudinal walls defining a recess. The shield portion is configured to pivot from an open position, in which the needle cannula is exposed, to a closed needle-shielding position, in which the distal end of the needle cannula is within the longitudinal opening of the shield.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to needle assemblies having safety features, and more particularly to needle assemblies having a hinged needle shield assembly for use with a syringe. [Background technology]

[0002] An accidental needlestick from a new, unused needle can cause injury and render the needle unsuitable for further use. An accidental needlestick from a used needle can transmit disease. As a result, prior art needle assemblies have needle shields. Some prior art needle shields define a rigid sleeve that can be manually nested over the needle cannula. This procedure requires the medical worker to hold the syringe barrel with one hand and the shield with the other. Some medical procedures require applying pressure to the penetration site after the needle is removed. As a result, medical workers often do not have both hands available to shield the needle cannula. In such situations, workers simply place the used medical instrument on a nearby surface with the intention of shielding it at a more convenient time. However, until the needle is shielded or properly disposed of, it poses a potential danger to others.

[0003] A needle shield that is hinged near the base of the needle has the advantage of allowing the needle to be reshielded with one hand, providing the opportunity for reshielding by the medical professional immediately after use under most circumstances.

[0004] Various means are provided for locking the hinged needle shield in the closed, needle-shielding position. A deflectable member is provided on the needle shield to engage the needle during shielding and prevent subsequent unshielding of the needle. Such a member can trap the needle within the needle shield. Locking has also been achieved by locking the engagement of the needle shield with structure near the base of the needle. Summary of the Invention [Problem to be solved by the invention]

[0005] The hinged needle shield and syringe are typically packaged and manufactured together as a needle shield assembly or composite package. However, because the needle shield assembly relies on a direct and specific fit of the hinged needle shield to the needle assembly, production rates (throughput) are significantly lower than for conventional (non-safety shield) needles. This is because the manufacturing assembly must rotate and align the needle cannula to ensure the needle bevel is in the correct (user-friendly) orientation relative to the orientation of the safety shield. Furthermore, separate manufacturing lines than conventional needles lead to higher production.

[0006] Thus, there remains a need for an improved hinged needle shield that is cost effective and easy to manufacture. [Means for solving the problem]

[0007] overview One aspect of the present disclosure relates to a needle shield assembly for use with a needle assembly having a shield portion, a hub connection portion, and a bridge portion. In one or more embodiments, the shield portion includes two longitudinal walls extending from a base of the shield portion, the two longitudinal walls being separated by a needle assembly receiving cavity. The needle assembly receiving cavity is defined by the base, the two longitudinal walls, and an open end opposite the base, the two longitudinal walls and the needle assembly receiving cavity being configured to receive a needle assembly. In one or more embodiments, a proximal portion of the needle assembly receiving cavity is wider than a distal portion of the needle assembly receiving cavity, the proximal portion of the needle assembly receiving cavity receiving a hub of the needle assembly, and the distal portion of the needle assembly receiving cavity receiving a cannula of the needle assembly. The hub connection portion includes a partially circular receiving ring having a substantially crescent shape, an arc of the crescent shape having a length greater than the length of a semicircle having the same radius as the arc, the partially circular receiving ring deflecting or elastically deforming outward when the receiving flange of the needle assembly advances, the partially circular receiving ring locking the receiving flange of the needle assembly therein. In one or more embodiments, a bridge portion connects the shield portion and the hub connection portion, the bridge portion comprising a hub connection portion, a bridge portion, and a living hinge. In one or more embodiments, the bridge portion joins the hub connection portion and the shield portion.

[0008] In one or more embodiments, the hub connecting portion includes a partially circular receiving ring having an inner diameter sized to frictionally receive and engage the receiving flange of the hub of the needle assembly when the needle shield assembly is advanced axially toward the needle assembly relative to the receiving flange, hi one or more embodiments, the receiving flange of the hub of the needle assembly and the hub connecting portion of the needle shield assembly engage with an interference fit.

[0009] In one or more embodiments, at least one locking hook is disposed within the proximal portion of the needle assembly receiving cavity, hi some embodiments, there are two locking hooks, a first locking hook and a second locking hook.

[0010] In one or more embodiments, a first of the at least one locking hook lies in a plane, a second of the at least one locking hook lies in a plane, and the at least one locking hook includes a protrusion extending from the base.

[0011] In one or more embodiments, the at least one locking hook is configured to deflect or resiliently deform upon engagement with the needle cannula, and the at least one locking hook has a pointed end that initially engages the needle cannula.

[0012] In one or more embodiments, the bridge portion includes a first portion and a second portion, each of the first portion and the second portion having a width, and the living hinge has a thickness sufficient to allow the living hinge to flex and bend.

[0013] In one or more embodiments, the shield portion pivots about a living hinge. In one or more embodiments, the shield portion pivots from an open position to a closed position. In one or more embodiments, the shield portion is in the closed position when the needle cannula of the needle assembly is fully disposed within the needle assembly receiving cavity.

[0014] In one or more embodiments, the partially circular receiving ring includes a recess.

[0015] In one or more embodiments, the recess forms a U-shaped cross section within the partially circular receiving ring of the hub connection portion. In one or more embodiments, the recess defines a first diameter and a second diameter that is smaller than the first diameter.

[0016] In one or more embodiments, the receiving flange of the needle assembly is received within a partially circular receiving ring of the needle shield assembly, the partially circular receiving ring deflecting or elastically deforming from an initial state as the receiving flange is advanced and snapping onto the receiving flange upon full advancement, causing the partially circular receiving ring to deflect or elastically deform back to its initial state.

[0017] In one or more embodiments, a snap-fit ​​fit between the receiving flange and the partial circular receiving ring allows for retention of the receiving flange within the partial circular receiving ring, hi one or more embodiments, the snap-fit ​​fit allows for torsional and angular movement of the partial circular receiving ring about the receiving flange.

[0018] In one or more embodiments, the partially circular receiving ring encompasses more than half of the contour of the receiving flange of the hub of the needle assembly, and the receiving flange is in the form of a circular protrusion extending from the outer surface of the needle assembly. In one or more embodiments, the circular protrusion of the hub of the needle assembly is received within a recess in the partially circular receiving ring. [Brief explanation of the drawings]

[0019] [Figure 1A] FIG. 1A is an exploded side elevational view of a needle shield system according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is a side perspective view of a needle shield system according to the embodiment as shown in FIG. 1A. [Figure 2A] FIG. 2A is a top perspective view of a needle cap according to the embodiment as shown in FIG. 1A. [Figure 2B] 2B is a cross-sectional view of a needle cap according to the embodiment as shown in FIG. 1A taken along line 2A-2A of FIG. 2A. [Figure 3A] FIG. 3A is a side perspective view of a needle assembly according to the embodiment as shown in FIG. 1A. [Figure 3B] FIG. 3B is a side elevational view of a needle assembly according to the embodiment as shown in FIG. 1A. [Figure 3C] 3C is a cross-sectional view of a needle assembly according to the embodiment as shown in FIG. 1A taken along line 3B-3B of FIG. 3B. [Figure 4A] FIG. 4A is a side elevational view of a needle assembly disposed within a needle cap according to the embodiment as shown in FIG. 1A. [Figure 4B] 4B is a cross-sectional view of a needle assembly disposed within a needle cap according to the embodiment as shown in FIG. 1A taken along line 4B-4B of FIG. 4A. [Figure 5A] 5A is a top perspective view of a hub connection portion of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 5B] FIG. 5B is a top view of the hub connection portion of the needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 5C] 5C is a cross-sectional view of the hub connection portion of the needle shield assembly according to the embodiment as shown in FIG. 1A taken along line 5C-5C of FIG. 5A. [Figure 6A] FIG. 6A is a top perspective view of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 6B] FIG. 6B is a detailed top perspective view of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 6C] FIG. 6C is a detailed side perspective view of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 6D] FIG. 6D is a cross-sectional view of a needle shield assembly according to the embodiment as shown in FIG. 1A taken along line 6D-6D of FIG. 6B. [Figure 7A] FIG. 7A is a top perspective view of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 7B] 7B is a cross-sectional view of a needle shield assembly according to the embodiment as shown in FIG. 1A taken along line 7B-7B of FIG. 7A. [Figure 8] FIG. 8 is a detailed side perspective view of a needle shield assembly according to the embodiment as shown in FIG. 1A. [Figure 9] FIG. 9 is a side perspective view of a needle shield assembly in a closed position according to the embodiment as shown in FIG. 1A. [Figure 10] FIG. 10 is a top view of a needle shield assembly in a closed position according to the embodiment as shown in FIG. 1A. DETAILED DESCRIPTION OF THE INVENTION

[0020] Detailed Description While the present disclosure is susceptible to embodiments in many different forms, specific embodiments of the disclosure are illustrated in the drawings and described herein with the understanding that the disclosure is to be considered as an exemplification of the principles and is not intended to limit the disclosure to the illustrated embodiments, the scope of which is measured by the appended claims and their equivalents.

[0021] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0022] As used herein, the term "Luer connector" refers to a connecting collar, which is a standard method of attaching syringes, catheters, hub needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing, slightly tapered to allow for better retention with even a simple pressure / torsion fit. Luer connectors can optionally include an additional outer thread, making them more secure. The male end of the Luer connector is generally associated with a flush syringe and can interlock with a female end on a vascular access device (VAD). The Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.

[0023] As used herein, ISO 80369-7:2016 defines specifications for standard Luer connectors that include a 6% taper between the distal and proximal ends. Male standard Luer connectors increase in diameter from the open distal end to the proximal end. Female standard Luer connectors decrease in diameter from the open proximal end to the distal end. According to ISO 80369-7:2016, male standard Luer connectors have an outer cross-sectional diameter of 3.970 mm to 4.072 mm, measured 0.75 mm from the distal end. The length of the male standard Luer taper is 7.500 mm to 10.500 mm. The outer cross-sectional diameter, measured 7.500 mm from the distal end, is 4.376 mm to 4.476 mm. As used herein, the terms "male standard Luer connector" and "female standard Luer connector" refer to connectors having the dimensions set forth in ISO 80369-7, which is incorporated herein by reference in its entirety.

[0024] In embodiments of the present disclosure, the needleless assembly may include male threads sized and having a thread pattern that mates with a standard ISO 594-2 type female fitting, an example of which is a Q-style fitting.

[0025] According to yet further exemplary implementations of embodiments of the present disclosure, the collar or needleless connector as a whole may bend or elastically deform in order to allow for better interference fit compliance with the corresponding connector, i.e., needleless assembly.

[0026] In one or more embodiments, the female connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0027] In one or more embodiments, the male connector may be an intravenous tubing end or a stopcock.

[0028] As will be readily understood by one of ordinary skill in the relevant art, descriptive terms such as "lock," "hole," "tip," "hub," "thread," "point," "projection," "insert," "tab," "wall," "top," "side," "bottom," and the like are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0029] The matters illustrated in this specification are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Also, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0030] 1A and 1B, needle shield system 10 comprises needle shield assembly 100 for use with needle assembly 200 including hub 208 and needle cannula 202 disposed within a lumen of hub 208 and having a lumen extending therethrough. Hub 208 includes an open proximal end 203, a distal end 205, and an outer surface 209, with open proximal end 203 including a cavity (not shown) therein. The lumen of hub 208 is in fluid communication with cavity 212. A receiving flange 210 in the form of a radial protrusion is disposed a distance from open proximal end 203 on outer surface 209 of hub 208. In one or more embodiments, hub 208 is a conventional needle hub.

[0031] The needle shield assembly 100 includes a shield portion 102, a hub connection portion 104, and a bridge portion 106 including a living hinge 108, with the bridge portion 106 joining the hub connection portion 104 and the shield portion 102. The hub connection portion 104 includes a partially circular receiving ring 112 that forms a U-shaped cross section 126 within the partially circular receiving ring 112 of the hub connection portion 104. The U-shaped cross section provides a structure having a first diameter 126D and a second diameter 124D. In one or more embodiments, the first diameter 126D is smaller than the second diameter 124D. As best seen in FIGS. 6C and 6D , the recess 124 is sized to frictionally receive and engage the receiving flange 210 of the hub 208 when the needle shield assembly 100 is advanced axially toward the needle assembly 200 relative to the receiving flange 210. The receiving flange 210 has a diameter 210D that is equal to or slightly smaller than the second diameter 124D of the recess 124, but larger than the first diameter 126D. In one or more embodiments, the partial circular receiving ring 112 defines a crescent shape with a pointed end 112P. According to one or more embodiments, "partial circular" refers to a component that defines a partial circular shape, rather than a complete circle. A partial circle comprises an arc that has a length that is less than the circumference of a full circle with the same radius of the arc. In one or more embodiments, the partial circular receiving ring 112 includes a radial or rotational locking feature that prevents significant rotational freedom between the needle shield assembly 100 and the needle assembly 200.

[0032] In one or more embodiments, the partial circular receiving ring 112 of the needle shield assembly 100 is sized such that a radial interference fit with the receiving flange 210 of the needle assembly 200 locks the partial circular receiving ring 112 onto the receiving flange 210.

[0033] In one or more embodiments, the partial circular receiving ring 112 has a crescent shape configured to attach to a hub 208 sized to the ISO standard for needle hubs.

[0034] In one or more embodiments, a needle cap 90 is disposed over the needle cannula 202 and hub 208. The needle cap 90 may be provided over the hub 208 during shipping and packaging and may be removed before use to prevent needle stick injuries. After use, the needle cap 90 may be disposed of according to appropriate medical waste procedures, while the needle shield assembly 100 is activated and folded over the needle cannula 202, after which the needle shield assembly 100 and needle assembly 200 may be discarded, with the needle shield assembly 100 providing needle stick protection. In one or more embodiments, the needle cap 90 includes a plurality of axially disposed ribs 92 on an outer surface of the needle cap 90, the plurality of axially disposed ribs 92 extending at least partially the length of the needle cap 90. The plurality of axially disposed ribs 92 aid in gripping and manipulating the needle cap 90. In one or more embodiments, the needle cap 90 includes an air vent 94 disposed at the distal end of the needle cap 90.

[0035] 2A and 2B, the open proximal end 95 of the needle cap 90 defines a cavity having an inner wall 96. The inner wall 96 comprises three adjacent portions: a first inner wall portion 97 adjacent and distal to the open proximal end 95; a second inner wall portion 98 adjacent and distal to the first inner wall portion 97; and a third inner wall portion 99 adjacent and distal to the second inner wall portion 98. The first inner wall portion 97 has a substantially cylindrical shape with a substantially constant diameter D1; the second inner wall portion 98 has a substantially cylindrical shape with a substantially constant diameter D2; and the third inner wall portion 99 has a frustum-shaped shape with a variable diameter D3. Diameter D1 is larger than diameters D2 and D3, and diameter D2 is larger than diameter D3. Diameter D3 is smallest at the distal end of the inner wall 96.

[0036] As shown in FIGS. 3A-3C , needle assembly 200 includes a hub 208 having a proximal end 203 and a distal end 205. A lumen of hub 208 extends through needle assembly 200 and is in fluid communication with a cavity 212. Needle cannula 202 is permanently disposed within the lumen of hub 208. Cavity 212 is defined by an open proximal end, a proximal frusto-conical portion, and a distal frusto-conical portion, the proximal frusto-conical portion being configured to mate with a female Luer connector, the proximal frusto-conical portion including a 6% taper between the distal and proximal ends in accordance with the ISO 80369-7:2016 standard. Male Luer connector threads 216 are disposed on the proximal portion 218 of the exterior surface of hub 208, and include two partial flanges. In one or more embodiments, the two partial flanges are helical. The male luer connector threads 216 are configured to connect to a female luer connector of a syringe according to the ISO 80369-7:2016 standard.

[0037] The outer surface of the hub 208 includes a proximal portion 218, a receiving flange 210, and a distal portion 220. The receiving flange 210 is proximally adjacent to the proximal portion 218, and the distal portion 220 is distally adjacent to the receiving flange 210. The proximal portion 218 has a frustoconical shape. The receiving flange 210 in the depicted embodiment is configured as a radial protrusion. In one or more embodiments, the receiving flange 210 includes two flanges separated by a gap.

[0038] Distal portion 220 has at least two radially disposed ribs 222, which have an upper portion 224 and a lower portion 226. Upper portion 224 has a diameter DU, and lower portion 226 has a diameter DL. Diameter DU is smaller than diameter DL. The transition from upper portion 224 to lower portion 226 may be rounded or chamfered.

[0039] 4A and 4B, needle assembly 200 is disposed within needle cap 90. Lower portions 226 of at least two radially disposed ribs 222 of needle assembly 200 are received within first inner wall portion 97 of needle cap 90. Upper portions 224 of at least two radially disposed ribs 222 of needle assembly 200 are received within second inner wall portion 98.

[0040] A diameter D1 of the first inner wall portion 97 of the needle cap 90 and a diameter DL of the lower portions 226 of the at least two radially disposed ribs 222 of the needle assembly 200 are substantially equal, or the diameter DL is slightly larger than the diameter D1 to create an interference fit. Similarly, a diameter D2 of the second inner wall portion 98 of the needle cap 90 and a diameter DU of the upper portions 224 of the at least two radially disposed ribs 222 of the needle assembly 200 are substantially equal, or the diameter DU is slightly larger than the diameter D2 to create an interference fit.

[0041] As shown in FIGS. 5A-5C , in one or more embodiments, the hub connection portion 104 includes a partially circular receiving ring 112 that is circular and defines a partial circle. In one or more embodiments, the partially circular receiving ring 112 defines an arc A of the circle C having an arc length L that is less than the circumference of the circle C defined by the receiving ring 112. In one or more embodiments, the arc A is greater than 50%, less than 90%, less than 80%, or less than 70% of the circumference of the circle C defined by the receiving ring 112. In some embodiments, the receiving ring 112 defines a crescent shape having a pointed end 112P and an arc A with a length L that is greater than the circumference of a semicircle having the same radius as the arc A and less than the circumference of a full circle having the same radius as the arc A. In some embodiments, the partially circular receiving ring 112 deflects or elastically deforms outward when the receiving flange 210 of the needle assembly 200 is advanced thereover. The crescent shape acts similar to a pair of hooks that removably lock the receiving flange 210 of the needle assembly 200 therein. In one or more embodiments, the partial circular receiving ring 112 further includes a recess 124 that forms a U-shaped cross section 126 within the partial circular receiving ring 112 of the hub connection portion 104. The recess 124 defines a first diameter 126D that is smaller than the second diameter 124D such that the receiving flange 210 of the needle assembly 200 fits snugly within the recess 124 and is held in place by the recess 124.

[0042] 6A-6D , the receiving flange 210 of the needle assembly 200 is received within the partially circular receiving ring 112 of the needle shield assembly 100. The partially circular receiving ring 112 deflects or elastically deforms from an initial state as the receiving flange 210 is advanced, and upon full advancement, it snaps into the receiving flange 210, causing the partially circular receiving ring 112 to deflect or elastically deform back to its initial state. The snap-fit ​​engagement allows for retention of the receiving flange 210 within the partially circular receiving ring 112, while still allowing for twisting and angular movement of the partially circular receiving ring 112 around the receiving flange 210. Thus, the practitioner may position the partially circular receiving ring 112 and needle shield assembly 100 at any angle relative to the insertion site on the patient's skin. The practitioner may also position the partially circular receiving ring 112 and needle shield assembly 100 at any angle relative to the practitioner's line of sight, thereby allowing an unobstructed view of the fluid being drawn from the vial container or an unobstructed view of the insertion site on the patient's skin.

[0043] This configuration allows the appropriate or preferred orientation of the needle bevel on the needle cannula 202 to be varied depending on the particular medical procedure. For example, subcutaneous, intravenous, or intradermal-type injections typically require the needle to be inserted at various angles relative to the patient's skin (e.g., 45 degrees, 25 degrees, and 10 degrees, respectively), with the needle bevel typically in the up position (pointing away from the skin surface) so that the needle bevel is visible to the practitioner. Thus, it is advantageous to rotate the needle assembly 200 relative to the needle shield assembly 100 to a position where the needle bevel does not obstruct the practitioner's view. For intramuscular injections, the bevel is typically at 90 degrees relative to the patient's skin.

[0044] 6D, partially circular receiving ring 112 encompasses more than half the contour of receiving flange 210, which is in the form of a circular protrusion extending from outer surface 209 of needle assembly 200. The circular protrusion fits within recess 124 of partially circular receiving ring 112, with U-shaped cross section 126 of recess 124 having a height and width slightly greater than that of receiving flange 210.

[0045] 7A and 7B , the shield portion 102 includes two longitudinal walls 128A and 128B extending from a base 134, the two longitudinal walls 128A and 128B separated by a needle assembly receiving cavity 130 defined by the base 134, the two longitudinal walls 128A and 128B, and an opposite open end of the base 134. The two longitudinal walls 128A and 128B and the needle assembly receiving cavity 130 are configured to receive the needle assembly 200, with the proximal portion of the needle assembly receiving cavity 130 being wider than the distal portion of the needle assembly receiving cavity 130. The proximal portion of the needle assembly receiving cavity 130 is wide enough to receive the hub 208 of the needle assembly 200. The distal portion of the needle assembly receiving cavity 130 is wide enough to receive the needle cannula 202. Disposed within the proximal portion of the needle assembly receiving cavity 130 is at least one locking hook 132. The at least one locking hook 132 is coplanar with the second of the at least one locking hook 132. The at least one locking hook 132 is a protrusion extending from the base 134. The at least one locking hook 132 is configured to deflect or elastically deform upon engagement with the needle cannula 202. The at least one locking hook 132 has a pointed end that initially engages the needle cannula 202.

[0046] As shown in FIG. 8 , the bridge portion 106 includes a first portion 136 that joins the bridge portion 106 to the shield portion 102 of the needle shield assembly 100 and a second portion 138 that joins the bridge portion 106 to the partially circular receiving ring 112. The first portion 136 and the second portion 138 are separated by a living hinge 108. In one or more embodiments, the first portion 136 and the second portion 138 each have a width WS, and the living hinge 108 has a thickness TH. If the thickness TH of the living hinge 108 is too large, the living hinge 108 will not be sufficiently flexible, and the shield portion 102 will not easily close over the needle assembly 200. On the other hand, if the thickness TH of the living hinge 108 is too small, the living hinge 108 will be prone to breaking or shearing.

[0047] A medical practitioner can grasp shield portion 102 and pivot shield portion 102 toward needle assembly 200 from an open position, as shown in Figure 6A, to a closed position, as shown in Figures 9 and 10. As shown in Figure 10, at least one locking hook 132 locks needle cannula 202, thereby preventing opening of shield portion 102.

[0048] In one or more embodiments, the shield portion 102, bridge portion 106, hub connection portion 104, and living hinge 108 comprise a unitary structure molded integrally from a thermoplastic material.

[0049] In an exemplary use of the present disclosure, a practitioner removes the needle shield assembly 100 from its packaging to the open position. The practitioner assembles and secures a syringe to the hub 208 of the needle assembly 200. Once the syringe 310 is engaged with the hub 208, the needle cap 90 is removed from the needle assembly 200 and an injection is administered. The practitioner removes the needle cannula 202 from the patient. With or without the syringe 310 secured to the hub 208 of the needle assembly 200, the practitioner rotates the hub connection portion 104 relative to the bridge portion 106 to toggle the needle shield assembly 100 from the open position to the closed position. In the closed position, at least one locking hook 132 is fully engaged, thus shielding the needle cannula 202 from an accidental needlestick injury after an injection.

[0050] In one or more embodiments, toggling the needle shield assembly 100 from the open position to the closed position may be accomplished in a variety of ways. During an injection, the practitioner may be required to use one hand to apply pressure to the injection site with a sanitary cloth or pad during or after the injection. The practitioner can rotate the needle shield assembly 100 about the hub 208 of the needle assembly 200 to remove the needle cannula 202 from the skin and toggle the needle shield assembly 100 with one hand.

[0051] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the disclosure. Therefore, it is intended that the disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A needle shield assembly for use with a needle assembly comprising: a shield portion having two longitudinal walls extending from a base thereof, the two longitudinal walls being separated by a needle assembly receiving cavity, the needle assembly receiving cavity being defined by the base, the two longitudinal walls, and an open end opposite the base, the two longitudinal walls and the needle assembly receiving cavity being configured to receive a needle assembly, a proximal portion of the needle assembly receiving cavity being wider than a distal portion of the needle assembly receiving cavity, the proximal portion of the needle assembly receiving cavity receiving a hub of the needle assembly, and the distal portion of the needle assembly receiving cavity receiving a needle cannula of the needle assembly; a removable needle cap disposed on the needle cannula of the needle assembly and the hub of the needle assembly, the removable needle cap having an open proximal end defining a cavity, the cavity having an inner wall including a first inner wall portion distal to the open proximal end of the cavity, a second inner wall portion distal to the first inner wall portion, and a third inner wall portion distal to the second inner wall portion, the first inner wall portion having a constant first diameter; the second inner wall portion is substantially cylindrical in shape with a constant second diameter and the third inner wall portion is frustum-shaped with a variable third diameter, the first diameter of the first inner wall portion being greater than both the second diameter of the second inner wall portion and the third diameter of the third inner wall portion, the second diameter of the second inner wall portion being greater than the third diameter of the third inner wall portion, and the third diameter of the third inner wall portion being smallest at a distal end of the inner wall of the cavity. a hub connection portion including a partially circular receiving ring defining an arc and having a length greater than the length of an arc of a semicircle having the same radius as the arc, the partially circular receiving ring deflecting or elastically deforming outward when the receiving flange of the needle assembly advances thereover, the partially circular receiving ring having a recess, a first diameter of the recess being smaller than a second diameter of the recess, the recess being crescent-shaped with a pointed end, the receiving flange of the needle assembly configured to be received in the partially circular receiving ring of the needle shield assembly, a cross section of the recess in the partially circular receiving ring being smaller than a cross section of the receiving flange of the needle assembly a hub connection portion sized to have a height and width greater than the receiving flange of the needle assembly, allowing the partial circular receiving ring torsionally and angularly move about the receiving flange, and the receiving flange of the needle assembly has a diameter equal to or slightly less than the second diameter of the recess in the partial circular receiving ring but greater than the first diameter of the recess in the partial circular receiving ring, such that the partial circular receiving ring locks the receiving flange of the needle assembly therein and allows the partial circular receiving ring torsionally and angularly move about the receiving flange; two locking hooks disposed within the proximal portion of the needle assembly receiving cavity, each of the two locking hooks being a protrusion extending from the base; a bridge portion including a living hinge, the bridge portion joining the hub connection portion and the shield portion; Equipped with A needle shield assembly, wherein the partially circular receiving ring of the hub connection portion is configured to snap onto the receiving flange to allow a practitioner to toggle the needle shield assembly with one hand.

2. 2. The needle shield assembly of claim 1, wherein the hub connection portion comprises the partially circular receiving ring having a diameter sized to frictionally receive the receiving flange of the hub of the needle assembly when the needle shield assembly is advanced axially toward the needle assembly relative to the receiving flange.

3. The needle shield assembly of claim 2 , wherein the receiving flange of the hub of the needle assembly and the hub connecting portion of the needle shield assembly engage with an interference fit.

4. 2. The needle shield assembly of claim 1, wherein the two locking hooks are configured to deflect or resiliently deform upon engagement with the needle cannula, and the two locking hooks have pointed ends that initially engage the needle cannula.

5. 2. The needle shield assembly of claim 1, wherein the bridge portion includes a first portion and a second portion separated by the living hinge, the first portion and the second portion each having a width, and the living hinge having a thickness, the thickness being sufficient to allow the living hinge to flex and bend.

6. The needle shield assembly of claim 1 , wherein the shield portion pivots about the living hinge.

7. The needle shield assembly of claim 6 , wherein the shield portion pivots from an open position to a closed position.

8. The needle shield assembly of claim 7, wherein the shield portion is in the closed position when the needle cannula of the needle assembly is fully disposed within the needle assembly receiving cavity.

9. The needle shield assembly of claim 1 , wherein the partially circular receiving ring further includes a recess, the recess forming a U-shaped cross section within the partially circular receiving ring of the hub connection portion.

10. A needle shield assembly as described in claim 1, wherein the partially circular receiving ring distorts or elastically deforms from its initial state as the receiving flange advances, and snaps onto the receiving flange when fully advanced, causing the partially circular receiving ring to distort or elastically deform and return to its initial state.

11. The needle shield assembly of claim 10, wherein the snap-fit ​​engagement allows torsional and angular movement of the part-circular receiving ring about the receiving flange.

12. 10. The needle shield assembly of claim 9, wherein the partially circular receiving ring encompasses more than half of the contour of the receiving flange of the hub of the needle assembly, the receiving flange comprising a circular protrusion extending from an outer surface of the needle assembly.

13. The needle shield assembly of claim 12, wherein the circular protrusion of the hub of the needle assembly fits within the recess of the partially circular receiving ring.

14. 2. The needle shield assembly of claim 1, wherein the partially circular receiving ring includes radial or rotational locking features that prevent significant rotational freedom between the needle shield assembly and the needle assembly.

15. 2. The needle shield assembly of claim 1, wherein the distal portion of the hub has at least two radially disposed ribs, the at least two radially disposed ribs having an upper portion and a lower portion, the upper portion having a diameter smaller than a diameter of the lower portion.

16. 16. The needle shield assembly of claim 15, wherein the needle assembly is disposed within the needle cap, the lower portions of the at least two radially disposed ribs of the needle assembly nesting within the first inner wall portion of the needle cap, and the upper portions of the at least two radially disposed ribs of the needle assembly nesting within the second inner wall portion.

17. 16. The needle shield assembly of claim 15, wherein a diameter of the lower portion of the at least two radially disposed ribs of the needle assembly is slightly larger than a diameter of the first inner wall portion of the needle cap to create an interference fit, and a diameter of the upper portion of the at least two radially disposed ribs of the needle assembly is slightly larger than a diameter of the second inner wall portion of the needle cap to create an interference fit.

18. The needle shield assembly of claim 15, wherein two locking hooks extending from the base each engage the upper portion of the at least two radially disposed ribs of the needle assembly.

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