NEEDLE MOUNTS AND FOLDING NEEDLE GUARD
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2022-08-16
- Publication Date
- 2026-06-12
AI Technical Summary
Existing needle assemblies face challenges in manufacturing efficiency due to the need for precise alignment of needle guards, leading to lower production rates and increased costs, while existing needle guards require both hands for operation, posing safety risks during medical procedures.
A hinged needle guard assembly with a cone connection portion, bridge portion, and protective portion, featuring a partially circular receiving ring and locking hooks, allowing one-handed operation and easy assembly, while maintaining cost-effectiveness and ease of manufacturing.
The hinged needle guard assembly enables efficient one-handed protection of needles after use, reducing safety risks and manufacturing complexities, while allowing flexibility in needle orientation for various medical procedures.
Smart Images

Figure MX434685B0 
Figure MX434685B1
Abstract
Description
NEEDLE MOUNTS AND FOLDING NEEDLE GUARD TECHNICAL FIELD This description refers, in general terms, to needle assemblies that have safety features and, more specifically, to a needle assembly that has a retractable needle guard assembly for use with a syringe. BACKGROUND Accidental needlestick injuries with a new, unused needle can cause injury and render the needle unusable. Accidental needlestick injuries with a used needle can transmit diseases. As a result, most previous technique (PT) needle assemblies include a needle shield. Some PT needle shields are rigid sleeves that can be manually folded over a needle cannula. This procedure requires a healthcare worker to hold the syringe barrel with one hand and the shield with the other. Some medical procedures require applying pressure to the insertion site after needle withdrawal. Therefore, healthcare workers often cannot use both hands to shield the needle cannula.In these situations, workers simply place the used medical device on a nearby surface with the intention of protecting it at a more convenient time. However, until the needle is protected or properly disposed of, it poses a potential hazard to others. A needle shield that folds down near the base of the needle has the advantage of allowing the needle to be reshielded with one hand, giving a clinician the opportunity to reshield it, in most circumstances, immediately after use. Various means have been provided for locking a fold-down needle shield in the closed, needle-shielding position. Deflecting elements have been provided in the needle shield to engage with the needle during shielding and prevent subsequent unshielding. These elements trap the needle within the shield. Locking has also been achieved by the locking engagement of the needle shield with a structure near the base of the needle. Syringes and flip-up needle shields are commonly packaged and manufactured together as a needle shield assembly or combination pack. However, because needle shield assemblies rely on the direct and specific mounting of the flip-up needle shield onto the needle assembly, the production rate (yield) is significantly lower than that of conventional needles (without a safety shield). This is because the manufacturing assembly must rotationally align the needle cannula so that the needle bevel is in the correct (user-friendly) orientation relative to the orientation of the safety shield. Furthermore, separate manufacturing lines for needle shields, compared to conventional needles, lead to higher production costs. There is still a need for an improved abatióle needle guard that is cost-effective and easy to manufacture. COMPENDIUM One aspect of the present description relates to a needle shield assembly for use with a needle assembly having a shield portion, a cone connecting 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, where the longitudinal walls are 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 are 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 receives a needle assembly cone, and the distal portion of the needle assembly receiving cavity receives a needle assembly cannula. The cone connecting portion includes a partially circular receiving ring that is substantially crescent-shaped. A crescent-shaped arc has a length greater than the length of a semicircle having the same radius as the arc. The partially circular receiving ring is deflected or elastically deformed outward by the advancement of a needle assembly receiving tongue. The partially circular receiving ring locks the needle assembly receiving tongue within it.In one or more embodiments, the bridge portion connects the protective portion and the cone-connecting portion, wherein the bridge portion comprises a cone-connecting portion, a bridge portion, and an integrated hinge. In one or more embodiments, the bridge portion joins the cone-connecting portion and the protective portion. In one or more embodiments, the cone-connecting portion includes the partially circular receiving ring having an inner diameter sized to frictionally receive and engage with the receiving tab of the needle assembly cone when the needle guard assembly advances against the receiving tab in an axial direction toward the needle assembly. In one or more embodiments, the receiving tab of the needle assembly cone and the cone-connecting portion of the needle guard assembly engage in an interference fit. In one or more configurations, at least one locking hook is disposed within the proximal portion of the needle assembly's receiving cavity. In some configurations, there are two locking hooks: a first locking hook and a second locking hook. 7t ΠΩ ίη / 77Π7 / Ε / ΥΙΛΙ In one or more embodiments, the first locking hook is in a plane, and the second locking hook is in the plane, where the locking hook comprises a projection extending from the base. In one or more embodiments, at least one locking hook is configured to deflect or elastically deform upon engagement with the needle cannula; the locking hook has a pointed end that first engages with the needle cannula. In one or more embodiments, the bridge portion includes a first part and a second part, each of the first part and second part comprising a width and the incorporated hinge comprising a thickness, where the thickness is sufficient to allow the incorporated hinge to flex and fold. In one or more configurations, the protective portion pivots against the integrated hinge. In one or more configurations, the protective portion pivots from an open to a closed position. In one or more configurations, the protective portion is in the closed position when the needle cannula of the needle assembly is fully inserted into the needle assembly's receiving cavity. In one or more forms, the partially circular receiving ring includes a recess. In one or more embodiments, the recess forms a U-shaped cross-section within the partially circular receiving ring of the cone-shaped connecting portion. In one or more embodiments, the recess defines a first diameter and a second diameter that is smaller than the first diameter. In one or more embodiments, the receiving tongue of the needle assembly is received within the partially circular receiving ring of the needle guard assembly; the partially circular receiving ring is deflected or elastically deformed from an initial state as the receiving tongue advances and snaps into place with the receiving tongue after full advance, where the partially circular receiving ring is deflected or elastically deformed back to the initial state. In one or more embodiments, a snap-fit fitting between the receiving tongue and the partially circular receiving ring allows the receiving tongue to be retained within the partially circular receiving ring. In one or more embodiments, the snap-fit fitting allows rotation and angular movement of the partially circular receiving ring around the receiving tongue. In one or more embodiments, the partially circular receiving ring envelops more than half of a profile of the receiving tongue of the needle assembly cone, where the receiving tongue is in the form of a circular projection extending from the outer surface of the needle assembly. In one or more embodiments, the circular projection of the needle assembly cone seats within the recess of the partially circular receiving ring. nn Ln / zznz / E / YiAi BRIEF DESCRIPTION OF THE FIGURES Figure 1A is an exploded side elevation view of a needle protection system according to one modality of the present description; Figure 1B is a perspective side view of the needle protection system according to the modality shown in Figure 1A; Figure 2A is a top perspective view of a needle case according to the modality shown in Figure 1A; Figure 2B is a cross-sectional view of the needle sheath according to the modality shown in Figure 1A taken along line 2A-2A of Figure 2A; Figure 3A is a perspective side view of a needle assembly according to the modality shown in Figure 1A; Figure 3B is a side elevation view of the needle assembly according to the modality shown in Figure 1A; Figure 3C is a cross-sectional view of the needle assembly according to the modality shown in Figure 1A taken along line 3B-3B of Figure 3B; Figure 4A is a side elevation view of the needle assembly arranged within the needle sheath according to the modality shown in Figure 1A; Figure 4B is a cross-sectional view of the needle assembly arranged within the needle sheath according to the modality shown in Figure 1A taken along line 4B-4B of Figure 4A; Figure 5A is a top perspective view of a cone connecting portion of a needle guard assembly according to the modality shown in Figure 1A; Figure 5B is a top view of the cone connection portion of the needle guard assembly according to the modality shown in Figure 1A; Figure 5C is a cross-sectional view of the cone connection portion of the needle guard assembly according to the modality shown in Figure 1A taken along line 5C-5C of Figure 5A; Figure 6A is a top perspective view of the needle guard assembly according to the modality shown in Figure 1A; Figure 6B is a detailed top perspective view of the needle guard assembly according to the modality shown in Figure 1A; Figure 6C is a detailed side perspective view of the needle guard assembly according to the modality shown in Figure 1A; Figure 6D is a cross-sectional view of the needle guard assembly according to the modality shown in Figure 1A taken along line 6D-6D of Figure 6B; Figure 7A is a top perspective view of the needle guard assembly according to the nn Ln / zznz / E / YiAi modality shown in Figure 1A; Figure 7B is a cross-sectional view of the needle guard assembly according to the modality shown in Figure 1A taken along line 7B-7B of Figure 7A; Figure 8 is a detailed side perspective view of the needle guard assembly according to the modality shown in Figure 1A; Figure 9 is a side perspective view of the needle guard assembly in a closed position according to the modality shown in Figure 1A; and Figure 10 is a top view of the needle guard assembly in a closed position according to the modality shown in Figure 1A. DETAILED DESCRIPTION Although the description is presented in various forms, it is shown in the figures and will be described below in some specific forms, with the understanding that this description should be considered illustrative of the principles and is not intended to limit the description to the illustrated forms. The scope of the description will be measured by the appended claims and their equivalents. As used herein, the use of “a”, “one” and “the” includes both singular and plural. As used herein, the term “Luer connector” refers to a connecting collar that is the standard way to join syringes, catheters, hub needles, IV tubing, etc., together. The Luer connector consists of interlocking male and female tubes, slightly tapered to ensure a secure fit, even with a simple push-pull / twist adjustment. Luer connectors may optionally include an additional external threaded rim for added security. The male end of the Luer connector is typically associated with a flush syringe and can be locked onto and connected to the female end located on the vascular access device (VAD). A Luer connector also has a distal end channel that loosely connects the Luer connector to the center of a VAD, and a proximal end channel that loosely connects the Luer connector to the barrel of a syringe. As used herein, ISO 80369-7:2016 defines a specification for standard Luer connectors that includes a 6% taper between the distal and proximal ends. A standard male Luer connector increases in size from the open distal end to the proximal end. A standard female Luer connector decreases in size from the open proximal end to the distal end. According to ISO 80369-7:2016, a standard male Luer connector has an outside cross-sectional diameter, measured 0.75 mm from the distal end of the tip, of between 3.970 mm and 4.072 mm. The taper length of the standard male Luer connector is between 7.500 mm and 10.500 mm. The diameter of the outer cross section measured ζ / ηηιη / ζζηζ / E / γίΛΐ of 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm.As used herein, the phrases “standard male Luer connector” and “standard female Luer connector” shall refer to connectors having the dimensions described in ISO 80369-7, which is incorporated herein by reference in its entirety. In the embodiments of the present description, the needleless monk may comprise male threads having a size and thread pattern that will mate with a female fitting of the ISO 594-2 type. An example of an ISO 594-2 fitting type is a Q-style fitting. According to further illustrative implementations of the modalities described herein, a collar or a needleless connector can generally be folded or elastically deformed to allow better compliance with the interference fit with the corresponding connectors, i.e., needleless assembly. In one or more configurations, the male connector can be selected from the group consisting essentially of needleless connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors. In one or more configurations, the needleless connector is selected from a Q-Syte, 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, or other connector. In one or more of the configurations, the male connector is either an end of the intravenous tubing or a stopcock. As experts in the relevant technique will readily understand, while descriptive terms such as “block”, “hole”, “tip”, “center”, “thread”, “tooth”, “protrusion”, “insertion”, “tongue”, “wall”, “top”, “side”, “bottom”, and others are used throughout this descriptive memorandum to facilitate understanding, it is not intended to limit any component that may be used in combinations or individually to implement various aspects of the modalities described herein. The examples provided herein are intended to aid a comprehensive understanding of the illustrative modalities described. Accordingly, those skilled in the art will recognize that various changes and modifications can be made to the modalities described herein without departing from the scope and spirit of the description. Furthermore, descriptions of known functions and constructions are omitted for the sake of clarity and conciseness. Referring to Figs. 1A and 1B, a needle protection system 10 comprises a needle protection assembly 100 for use with a needle assembly 200, which includes a cone 208 and a needle cannula 202 disposed within a lumen of the cone 208, the lumen extending through it. The cone 208 includes an open proximal end 203, a distal end 205, and a 7f ΠΩ ίη / 77Π7 / E / YΙΛΙ outer surface 209, wherein the open proximal end 203 includes a cavity (not shown) therein. The lumen of the cone 208 has fluid communication with the cavity 212. A radially projecting receiving tongue 210 is disposed some distance from the open proximal end 203 on the outer surface 209 of the cone 208. In one or more embodiments, the cone 208 is a conventional needle cone. The needle guard assembly 100 comprises a guard portion 102, a cone connecting portion 104, and a bridge portion 106 including an integrated hinge 108, wherein the bridge portion 106 connects the cone connecting portion 104 and the guard portion 102. The cone connecting portion 104 comprises a partially circular receiving ring 112 forming a U-shaped cross-section 126 within the partially circular receiving ring 112 of the cone connecting 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 can be seen more clearly in Fig.In 6C and 6D, a recess 124 is sized to receive by friction and engage with the receiving tongue 210 of the cone 208 when the needle guard assembly 100 advances against the receiving tongue 210 in an axial direction toward the needle assembly 200. The receiving tongue 210 has a diameter 210D that is equal to or slightly less than the second diameter 124D of the recess 124 but greater than the first diameter 126D. In one or more embodiments, the partially circular receiving ring 112 defines a crescent shape having pointed ends 112P. According to one or more embodiments, “partially circular” refers to a component that defines the shape of a partial circle, but not a full circle. A partial circle comprises an arc having a length less than the circumference of a full circle having the same radius as the arc.In one or more embodiments, the partially circular receiving ring 112 includes a radial or rotational locking element, where the locking element prevents a significant degree of rotational freedom between the needle guard assembly 100 and the needle assembly 200. In one or more embodiments, the partially circular receiving ring 112 of the stylus guard assembly 100 is sized such that a radial interference fit with the receiving tab 210 of the stylus assembly 200 is locked with the partially circular receiving ring 112, so that the partially circular receiving ring 112 is locked into the receiving tab 210. In one or more embodiments, the partially circular receiving ring 112 has a crescent shape configured to join the cone 208, with a size according to ISO standards for a stylus cone. In one or more configurations, a needle sheath 90 is positioned over the needle cannula 202 and the cone 208. The needle sheath 90 may be provided over the cone 208 during shipping and packaging and may be removed prior to use to prevent needlestick injuries. After use, the needle sheath 90 may be disposed of through appropriate medical waste disposal procedures, while the needle protective assembly 100 is activated and folded over the needle cannula 202, after which both the needle protective assembly 100 and the needle protective assembly 200 may be disposed of, with the needle protective assembly 100 preventing needlestick injuries. In one or more embodiments, the needle sheath 90 includes a plurality of axially arranged ribs 92 on an outer surface of the needle sheath 90, wherein the plurality of axially arranged ribs 92 extend at least partially along the length of the needle sheath 90.The plurality of axially arranged ribs 92 help to hold and manipulate the needle sheath 90. In one or more embodiments, the needle sheath 90 includes a vent hole 94 disposed at a distal end of the needle sheath 90. As shown in Figures 2A and 2B, an open proximal end 95 of the needle sheath 90 defines a cavity having an internal lateral wall 96. The internal lateral wall 96 comprises three adjacent parts: a first internal lateral wall part 97 adjacent to and distal to the open proximal end 95, a second internal lateral wall part 98 adjacent to and distal to the first internal lateral wall part 97, and a third lateral wall part 99 adjacent to and distal to the second internal lateral wall part 98. The first internal lateral wall part 97 has a substantially cylindrical shape with a substantially constant diameter D1, the second internal lateral wall part 98 has a substantially cylindrical shape with a substantially constant diameter D2, and the third internal lateral wall part 99 has a truncated conical 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 the smallest at a distal end of the inner lateral wall 96. As shown in Figures 3A to 3C, the needle assembly 200 comprises a cone 208 having a proximal end 203 and a distal end 205. The lumen of the cone 208 extends through the needle assembly 200 and has fluid communication with a cavity 212. The needle cannula 202 is non-removably arranged within the lumen of the cone 208. The cavity 212 is defined by an open proximal end, a proximal truncated cone portion, and a distal conical portion, where the proximal truncated cone portion is configured to mate with a female Luer connector, and the proximal truncated cone portion includes a 6% taper between the distal and proximal ends according to ISO 80369-7:2016. A male Luer connector thread 216 is disposed on a proximal portion 218 of an outer surface of the cone 208, wherein the male Luer connector thread 216 comprises two partial tabs. In one or more embodiments, the two partial tabs are helically shaped.The 216 male Luer connector thread is configured to connect to a female Luer connector of a syringe according to ISO 80369-7:2016 standards. The outer surface of cone 208 comprises the proximal part 218, the receiving tongue 210 and 7¡ nn Ln / zznz / E / YiAi a distal portion 220. The receiving tongue 210 is proximally adjacent to the proximal portion 218, and the distal portion 220 is distally adjacent to the receiving tongue 210. The proximal portion 218 is truncated cone-shaped. The receiving tongue 210 in the depicted modality is configured as a radial projection. In one or more modalities, the receiving tongue 210 includes two tongues separated by a space. The distal portion 220 has at least two radially arranged ribs 222, the two radially arranged ribs 222 having an upper portion 224 and a lower portion 226. The upper portion 224 has a diameter DU and the lower portion 226 has a diameter DL. The DU diameter is smaller than the DL diameter. The transition from the upper portion 224 to the lower portion 226 may be rounded or chamfered. As shown in Figures 4A and 4B, the needle assembly 200 is arranged inside the needle sheath 90. The lower portion 226 of the two radially arranged ribs 222 of the needle assembly 200 sits within the first inner side wall portion 97 of the needle sheath 90. The upper portion 224 of the two radially arranged ribs 222 of the needle assembly 200 sits within the second inner side wall portion 98. The diameter D1 of the first part of the inner side wall 97 of the needle sleeve 90 and the diameter DL of the lower part 226 of the two radially arranged 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, the diameter D2 of the second part of the inner side wall 98 of the needle sleeve 90 and the diameter DU of the upper part 224 of the two radially arranged 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. As shown in Figures 5A-5C, in one or more embodiments, the cone-shaped connecting portion 104 comprises a partially circular receiving ring 112 that is circular in shape and defines a partial circle. In one or more embodiments, the partially circular receiving ring 112 defines an arc A of a 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, arc A is greater than 50% and less than 90%, less than 80%, or less than 70% of the circle C defined by the receiving ring 112. In some embodiments, the receiving ring 112 defines a crescent shape having pointed ends 112P and an arc A having a length L that is greater than the circumference of a semicircle having the same radius as arc A and less than the circumference of a full circle having the same radius as arc A.In some forms, the partially circular receiving ring 112 is deflected or elastically deformed outwards as the receiving tongue 210 of the needle assembly 200 advances. The crescent shape behaves similarly to a pair of hooks that removably lock the receiving tongue 210 of the needle assembly 200 into its interior. In one or more embodiments, the partially circular receiving ring 112 further includes a recess 124, wherein the recess 124 forms a U-shaped cross-section 126 within the partially circular receiving ring 112 of the cone connecting portion 104. The recess 124 defines the first diameter 126D, which is smaller than the second diameter 124D, so that the receiving tongue 210 of the needle assembly 200 fits snugly into the recess 124 and is held in place by the recess 124. As shown in Figures 6A-6D, the receiving tab 210 of the needle assembly 200 is received within the partially circular receiving ring 112 of the needle guard assembly 100. The partially circular receiving ring 112 is deflected or elastically deformed from an initial state as the receiving tab 210 advances and presses into place with the receiving tab 210 as it is fully advanced, where the partially circular receiving ring 112 is deflected or elastically deformed back to the initial state. The snap-fit attachment allows the receiving tab 210 to be retained within the partially circular receiving ring 112, but still permits rotation and angular movement of the partially circular receiving ring 112 around the receiving tab 210. Therefore, a clinician can position the partially circular receiving ring 112 and the needle guard assembly 100 at any angle with respect to an insertion site in a patient's skin.The physician can also position the partially circular receiving ring 112 and the needle protective assembly 100 at any angle with respect to the physician's line of sight; thereby enabling unobstructed viewing of the extraction of fluid from a container vial or unobstructed viewing of the insertion site in a patient's skin. This configuration allows for varying the appropriate or preferred bevel orientation on the 202 needle cannula depending on the specific medical procedure. For example, subcutaneous, intravenous, or intradermal injections generally require the needle to be inserted at various angles relative to the patient's skin (e.g., 45 degrees, 25 degrees, 10 degrees, respectively), with the needle bevel typically facing upward (away from the skin surface) and visible to the clinician. It is advantageous to rotate the 200 needle assembly relative to the 100 needle assembly to a position where the needle bevel does not obstruct the clinician's view. In intermuscular injection, the bevel is typically at a 90-degree angle to the patient's skin. As shown in Figure 6D, the partially circular receiving ring 112 encloses more than half of a profile of the receiving tongue 210, where the receiving tongue 210 is in the form of a circular projection extending from the outer surface 209 of the needle assembly 200. The circular projection sits within the recess 124 of the partially circular receiving ring 112, where the U-shaped cross-section 126 of the recess 124 has a height and width slightly greater than the receiving tongue 210. 7}nn ίη / 77Ω7 / E / YΙΛΙ As shown in Figures 7A and 7B, the protective portion 102 comprises two longitudinal walls 128A and 128B extending from a base 134, where the two longitudinal walls 128A and 128B are separated by a needle assembly receiving cavity 130, where the needle assembly receiving cavity 130 is defined by the base 134, the two longitudinal walls 128A and 128B, and an open end opposite 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, where a proximal portion of the needle assembly receiving cavity 130 is wider than a 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 cone. 208 of the needle assembly 200.The distal portion of the receiving cavity of needle assembly 130 is wide enough to receive needle cannula 202. Disposed within the proximal portion of the receiving cavity of needle assembly 130 is at least one locking hook 132. Locking hook 132 is in the same plane as a second locking hook 132. Locking hook 132 is a projection extending from base 134. Locking hook 132 is configured to deflect or elastically deform upon engagement with needle cannula 202. Locking hook 132 has a pointed end that first engages with needle cannula 202. As shown in Figure 8, the bridge portion 106 comprises a first part 136 that connects the bridge portion 106 to the protective portion 102 of the needle guard assembly 100 and a second part 138 that connects the bridge portion 106 to the partially circular receiving ring 112. The first part 136 and the second part 138 are separated by the incorporated hinge 108. In one or more embodiments, the first part 136 and the second part 138 each comprise a width WS, and the incorporated hinge 108 comprises a thickness TH. If the thickness of the built-in hinge 108 TH is too large, the built-in hinge 108 will not be flexible enough and the protective part 102 will not close easily over the needle cannula 200. On the other hand, if the thickness of the built-in hinge 108 TH is too small, the built-in hinge 108 will be prone to breaking or cracking. A physician can grasp the protective part 102 and rotate it toward the 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, the locking hook 132 locks the needle cannula 202, thereby preventing the protective part 102 from opening. In one or more embodiments, the protective part 102, the bridge part 106, the cone connection part 104, and the built-in hinge 108 comprise a unitary structure integrally molded from thermoplastic material. zt nn Ln / zznz / E / YiAi In an illustrative use of the description, a physician unpacks the needle guard assembly 100 from the packaging in an open position. The physician assembles and secures the syringe to the cone 208 of the needle guard assembly 200. Once the syringe 310 is attached to the cone 208, the needle sheath 90 is removed from the needle guard assembly 200, and the injection is performed. The physician removes the needle cannula 202 from the patient. With or without the syringe 310 attached to the cone 208 of the needle guard assembly 200, the physician rotates the cone connecting portion 104 over the bridge portion 106 to toggle the needle guard assembly 100 from the open to the closed position. In the closed position, the locking hook 132 is fully engaged, thereby protecting the needle cannula 202 from accidental needlestick injuries after injection. In one or more of the following methods, changing the needle shield assembly 100 from the open to the closed position can be accomplished in various ways. During the injection, the clinician may be required to use one hand to apply pressure to the injection site with a hygienic drape or pad during or after the injection. The clinician can remove the needle cannula 202 from the skin and, with one hand, toggle the needle shield assembly 100 by rotating it around the cone 208 of the needle assembly 200. Although the description herein has been given with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the description herein. It will be evident to those skilled in the art that various modifications and variations of the method and apparatus of the description herein may be made without departing from the spirit or scope of the description. Therefore, the description herein is intended to include modifications and variations that fall within the scope of the appended claims and their equivalents.
Claims
1. A needle protective assembly for use in a needle assembly comprising: a protective part comprising two longitudinal walls extending from a base of the protective part, where the two longitudinal walls are separated by a needle assembly receiving cavity, where the needle assembly receiving cavity is defined by the base, the two longitudinal walls and an open end opposite the base, where the two longitudinal walls and the needle assembly receiving cavity are configured to receive a needle assembly, where 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 receives a cone of the needle assembly and the distal portion of the needle assembly receiving cavity receives a needle cannula of the needle assembly;a cone-connecting portion comprising a partially circular receiving ring defining an arc having a length greater than the length of a semicircle having the same radius as the arc, wherein the partially circular receiving ring is deflected or elastically deformed outwards by the advancement of a receiving tab of the needle assembly, the partially circular receiving ring locking the receiving tab of the needle assembly inside it; and a bridge portion, wherein the bridge portion connects the protective portion and the cone-connecting portion, wherein the bridge portion comprises a cone-connecting portion and a bridge portion and an incorporated hinge, wherein the bridge portion joins the cone-connecting portion and the protective portion.
2. The needle guard assembly of claim 1, wherein the cone-connecting portion comprises the partially circular receiving ring having a diameter sized to frictionally receive the receiving tongue of the needle guard assembly when the needle guard assembly advances against the receiving tongue in an axial direction toward the needle guard assembly.
3. The needle shield assembly of claim 2, wherein the receiving tab of the needle shield assembly cone and the connecting portion of the needle shield assembly cone are engaged in an interference fit.
4. The needle protective assembly of claim 1, wherein at least one locking hook is disposed within the proximal portion of the receiving cavity of the needle assembly.
5. The needle guard assembly of claim 4, wherein the locking hook comprises a projection extending from the base.
6. The needle protective assembly of claim 5, wherein at least one locking hook is configured to deflect or elastically deform upon engagement with the needle cannula, the locking hook having a pointed end that first engages with the needle cannula.
7. The needle protector assembly of claim 1, wherein the bridge portion includes a first part and a second part separated by the incorporated hinge, each of the first and second parts comprising a width and the incorporated hinge comprising a thickness, wherein the thickness is sufficient to permit the incorporated hinge to flex and fold.
8. The needle guard assembly of claim 1, wherein the guard portion pivots against the built-in hinge.
9. The needle guard assembly of claim 8, wherein the guard pivots from an open position to a closed position.
10. The needle protective assembly of claim 9, wherein the protective portion is in the closed position when the needle cannula of the needle assembly is fully disposed within the receiving cavity of the needle assembly.
11. The needle protective assembly of claim 1, wherein the partially circular receiving ring further includes a recess.
12. The needle protective assembly of claim 11, wherein the recess forms a U-shaped cross-section within the partially circular receiving ring of the cone connecting portion.
13. The needle protective assembly of claim 12, wherein the recess defines a first diameter and a second diameter which is smaller than the first diameter.
14. The needle guard assembly of claim 1, wherein the receiving tab of the needle guard assembly is received within the partially circular receiving ring of the needle guard assembly, the partially circular receiving ring being deflected or elastically deformed from an initial state upon advancement of the receiving tab and snapping into place with the receiving tab after full advancement, wherein the partially circular receiving ring is deflected or elastically deformed back to the initial state.
15. The needle protective assembly of claim 1, wherein a snap-fit fitting between the receiving tongue and the partially circular receiving ring allows the receiving tongue to be retained within the partially circular receiving ring.
16. The needle guard assembly of claim 15, wherein the snap-fit fitting permits rotation and angular movement of the partially circular receiver ring around the receiver tongue.
17. The needle protective assembly of claim 11, wherein the partially circular receiving ring encloses more than half of a profile of the receiving tab of the needle assembly cone, wherein the receiving tab comprises a circular projection extending from an outer surface of the needle assembly.
18. The needle protector assembly of claim 17, wherein the circular projection of the needle assembly cone seats within the recess of the partially circular receiving ring.