CN214415381U

CN214415381U - Needle shield assembly and needle shield and needle assembly

Info

Publication number: CN214415381U
Application number: CN202021990142.4U
Authority: CN
Inventors: K·M·瑞安; A·怀恩福斯; T·A·皮克; R·阿拉佐; M·L·诺格卢比奥
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2019-09-13
Filing date: 2020-09-11
Publication date: 2021-10-19
Anticipated expiration: 2030-09-11

Abstract

Needle shield assemblies are disclosed herein as well as needle shields and needle assemblies. A needle shield assembly for use with a needle assembly is disclosed. The needle shield assembly includes an elongate needle shield including a shield portion, a hub connection portion, and a bridge portion including a living hinge having a thickness, the bridge portion coupling the hub connection portion and the shield portion, the hub connection portion including a receiving ring and a flange, the receiving ring having a diameter, the diameter is sized to frictionally receive the hub outer surface when the needle assembly is inserted through the receiving ring, the flange extends from the receiving ring to define a top planar surface and a bottom surface, the flange has a thickness, the ratio defined by the thickness of the flange divided by the thickness of the living hinge is 1.1 to 6, the shield portion has two sidewalls defining a longitudinal opening and a back wall defining a recess having an inner surface between the sidewalls, the shield portion is configured to pivot from an open position in which the needle cannula is exposed to a closed needle protecting position in which the distal end of the needle cannula is within the longitudinal opening of the shield.

Description

Needle shield assembly and needle shield and needle assembly

Technical Field

The present disclosure relates generally to needle assemblies having safety components and, more particularly, to needle assemblies having hinged needle shield assemblies for use with syringes.

Background

Accidental needle stick injuries with new unused needles can cause injury and render the needles unsuitable for further use. Accidental needle sticks with used needles can transmit disease. Therefore, most prior art needle assemblies have needle shields. Some prior art needle shields define a rigid sleeve that can be manually telescoped over a needle cannula. This procedure requires the healthcare worker to hold the syringe barrel in one hand and the guard in the other hand. Some medical procedures require that pressure be applied to the penetration site after the needle has been removed. Thus, a healthcare worker is typically unable to shield the needle cannula with both hands. In these cases, personnel simply place the used medical instrument on a nearby surface for protection at a more convenient time. However, until the needle is shielded or properly deployed, it can present a potential hazard to others.

A needle shield hinged near the base of the needle has the advantage of allowing re-shielding with a single handed needle, providing the opportunity to re-shield by the medical practitioner immediately after use (in most cases).

Various tools have been provided for locking an articulated needle guard in a closed needle protecting position. Deflectable members have been provided in needle shields to engage the needle during shielding and prevent subsequent unshielding of the needle. Such a member captures the needle within the needle guard. Locking has also been accomplished by locking the engagement of the needle guard with a structure near the base of the needle.

There remains a need for an improved articulated needle guard that is cost effective and easy to manufacture.

SUMMERY OF THE UTILITY MODEL

The first embodiment is directed to a needle shield assembly for use with a needle assembly including a needle cannula having a proximal end, a distal end, and a lumen therethrough, and a hub having an outer surface, an open proximal end including a cavity therein, and a distal end attached to the proximal end of the needle cannula such that the lumen is in fluid communication with the cavity, the needle shield assembly including an elongate needle shield including a shield portion, a hub connection portion, and a bridge portion, the bridge portion including a living hinge having a thickness, the bridge portion linking the hub connection portion and the shield portion, the hub connection portion including a receiving ring having a diameter sized to frictionally receive the hub outer surface when the needle assembly is inserted through the receiving ring, and a flange extending from the receiving ring defining a top planar surface and a bottom surface, the flange having a thickness, the ratio defined by the thickness of the flange divided by the thickness of the living hinge is 1.1 to 6, the shield portion has two sidewalls defining a longitudinal opening and a back wall defining a recess having an inner surface therebetween, the shield portion is configured to pivot from an open position in which the needle cannula is exposed to a closed needle protecting position in which the distal end of the needle cannula is within the longitudinal opening of the shield.

A second embodiment is directed to a needle guard and needle assembly comprising a needle cannula having a proximal end, a distal end and a lumen therethrough, and a hub having an outer surface, an open proximal end including a cavity therein, a distal end attached to the proximal end of the needle cannula such that the lumen is in fluid communication with the cavity; and an elongate needle shield including a shield portion, a hub connection portion, and a bridge portion, the bridge portion including a living hinge having a thickness, the bridge portion joining the hub connection portion and the shield portion, the hub connection portion including a receiving ring and a flange, the receiving ring having a diameter, the diameter is sized to frictionally receive the hub outer surface when the needle assembly is inserted through the receiving ring, the flange extends from the receiving ring to define a top planar surface and a bottom surface, the flange has a thickness, the ratio defined by the thickness of the flange divided by the thickness of the living hinge is 1.1 to 6, the shield portion has two sidewalls defining a longitudinal opening and a back wall defining a recess having an inner surface between the sidewalls, the shield portion is configured to pivot from an open position in which the needle cannula is exposed to a closed needle protecting position in which the distal end of the needle cannula is within the longitudinal opening of the shield.

Drawings

FIG. 1 is a side view of a needle assembly according to an embodiment of the present disclosure;

FIG. 2 is a top perspective view of the needle assembly shown in FIG. 1;

FIG. 3 is a partial top perspective view of the needle assembly shown in FIG. 1;

FIG. 4 is a partial side view of the needle assembly shown in FIG. 1;

FIG. 5 is an enlarged cross-sectional side view of the distal end of the syringe assembly of FIG. 1;

FIG. 6A is a top partial perspective view of the portion of the needle assembly shown in FIG. 1;

FIG. 6B is an enlarged, partial perspective view of the bottom of the receiving ring of the needle assembly shown in FIG. 1;

FIG. 6C is an enlarged perspective view of the hub of the needle assembly;

FIG. 7 is an exploded side view of the needle assembly shown in FIG. 1;

FIG. 8 is a perspective view of the needle assembly shown in FIG. 1 with the shield in a partially folded position; and

fig. 9 is an exploded perspective view of the syringe and needle assembly.

Detailed Description

While this disclosure is satisfied by embodiments in many different forms, there are shown in the drawings and will be described in detail specific embodiments of the disclosure with the understanding that the present disclosure is to be considered as an exemplification of the principles and is not intended to limit the disclosure to the embodiments illustrated. The scope of the disclosure is to be measured by the appended claims and their equivalents.

Referring to fig. 1-9, needle shield assembly 100 is for use with a needle assembly 200, needle assembly 200 including a needle cannula 202, needle cannula 202 having a proximal end 203, a distal end 205, and a lumen 206 therethrough. Needle assembly 200 further includes a hub 208, hub 208 having an outer surface 209, an open proximal end 210 including a cavity therein, and a distal end 214 attached to proximal end 203 of needle cannula 202 such that lumen 206 is in fluid communication with cavity 212.

Needle shield assembly 100 includes a shield portion 102, a hub connection portion 104, and a bridge portion 106, bridge portion 106 including a thickness T_HThe bridge portion 106 joins the hub connection portion 104 and the shield portion 102. Hub connection portion 104 includes a receiving ring 112 and a flange 114, receiving ring 112 having a diameter D sized to frictionally receive a hub outer surface 209 when needle assembly 200 is inserted through receiving ring 112, flange 114 extending from receiving ring 112 defining a top planar surface 116 and a bottom surface 118. The distance between the top planar surface and the bottom surface 118 defines a flange thickness T_F. In one or more embodiments, the thickness T of the flange_FDivided by the thickness T of the living hinge_HThe defined ratio is 1.1 to 6. In one or more embodiments, the thickness T of the flange_FDivided by the thickness T of the living hinge_HDefined ratios are 1.2 to 6, 1.3 to 6, 1.4 to 6, 1.5 to 6, 1.6 to 6, 1.7 to 6, 1.8 to 6, 1.9 to 6, 2 to 6, 2.1 to 6, 2.2 to 6, 2.3 to 6, 2.4 to 6, 2.5 to 6, 2.6 to 6, 2.7 to 6, 2.8 to 6, 2.9 to 6, 3 to 6, 1.1 to 5, 1.2 to 5, 1.3 to 5, 1.4 to 5, 1.5 to 5, 1.6 to 5, 1.7 to 5, 1.8 to 5, 1.9 to 5, 2 to 5, 2.1 to 5, 2.2 to 5, 2.3 to 5, 2.4 to 5, 2.5 to 5, 2.6 to 5, 2.7 to 5, 2.8 to 5, 2.1 to 5, 2.4 to 4, 1.4 to 5, 2.4 to 4, 2.4 to 5, 2.6 to 5, 2.7 to 5, 2.4 to 4, 2.4 to 5, 1.4 to 4, 2.4 to 4, 4 to 5, 2.4 to 4, 4 to 4, 2.6 to 5, 1.4 to 5, 2.6 to 5, 4, 2.4, 4 to 4, 2.4 to 4 to 5, 4, 2.6 to 5, 2.4 to 4, 4 to 5, 4, 2.4 to 5, 4, 2.6, 4 to 5, 4, 2.6, 4, 2, 4 to 5, 4, 2.6, 4, 2, 4, 2, 4, 2, 4, 2, 4 to 5, 4 to 5, 2, 4, 2, 4, 2, 2.6, 4 to 5, 4 to 5, 2, 2.6, 4, 2, 4, 2, 4, 2, 6, 2, 6, 2, 4, 2, 6, 2, 6, 2.

If thickness T of living hinge_HToo large, the living hinge will not be flexible enough and the shield will not easily cover over the needle cannula. On the contrary, ifThickness T of living hinge_HToo small, the living hinge is easily broken. In one or more embodiments, the thickness T of the flange is determined by the thickness T of the flange_FDivided by the thickness T of the living hinge_HThe ratios defined are within the ranges provided above. If it is determined by the thickness T of the flange_FDivided by the thickness T of the living hinge_HThe defined ratio is outside the defined range, then the needle shield would be difficult to manufacture by injection molding because when the ratio is too low, there is not enough material flow to form the bridge portion 106 and hub connection portion 104 of the needle shield assembly 100. In one or more embodiments, living hinge 108 has a thickness T, other than within the ratios provided above_HIn the range of 0.1mm to 0.3mm (e.g., 0.1mm, 0.15mm, 0.2mm, 0.25mm, or 0.3mm) and the flange 114 has a thickness T_FIn the range of 0.4mm to 0.8mm (e.g. 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm or 0.80 mm). Furthermore, if the thickness of the flange 114 is too small, the flange 114 will have insufficient structural integrity to withstand insertion of the hub 208 through the receiving ring 112. However, if the thickness T of the flange is_FOutside the upper end of the provided range and not within the ratios provided above, it would be difficult to form parts by injection molding.

The guard portion 102 has two side walls (a first side wall 120 and a second side wall 122) defining the longitudinal opening 104, and a rear wall 126 defining a recess 127 having an inner surface 128 between the

side walls

120, 122. The shield portion 102 is configured to pivot from an open position (see, e.g., fig. 1 and 7) in which the needle cannula is exposed toward a closed shield position 180 (see fig. 8) in which the distal end 205 of the needle cannula 202 is shielded within the longitudinal opening 124 of the shield shown in fig. 8. For purposes of example, it will be understood that in fig. 8, the protection position 180 is not in a fully closed position, but is in a nearly closed position.

In one or more embodiments, the receiving ring 112 further includes a cylindrical wall extension 130, the cylindrical wall extension 130 extending below the bottom surface 118 of the flange 114 to provide a cylindrical receiving structure 130 for the hub. In one or more embodiments, the needle shield assembly includes a needle extending from the bottom surface 118 and fromA plurality of

ribs

132, 134 extending radially from the cylindrical wall extension 130. In some embodiments, the plurality of ribs comprises 3 to 8 ribs. In some embodiments, the plurality of

ribs

132, 134 includes 3 to 5 ribs, such as 4 ribs. The

ribs

132, 134 provide additional structural integrity to the flange 114, which also allows for the thickness T of the flange_FIs reduced.

In some embodiments, bridge portion 106 includes a first span 142 and a living hinge 108, first span 142 being spaced apart from second span 144 to provide a gap 146 between first span 142 and second span 144, and living hinge 108 having a first portion 108a coupling first span 142 to shield portion 102 and a second portion 108b coupling second span 144 to shield portion 102. In one or more embodiments, first span 142 and second span 144 each include a width W_SAnd gap 146 includes a width W_GSo that the gap W_GIs greater than the width W of the first span_SAnd a width W of the second span_S。

In one or more embodiments, needle shield assembly 100 further includes legs 150, legs 150 including a bend 152 connecting shield portion 102 and flange 114. As shown in fig. 3 and 4, the leg 150 is disposed below the gap 146. The legs provide additional stability to living hinge 108.

In some embodiments, the guard portion 102 further includes a locking member 160, the locking member 160 including two locking projections (a first locking projection 162 and a second locking projection 164), the first and

second locking projections

162, 164 facing each other and projecting from the

side walls

120, 122 and configured to engage with a locking tab 170. The locking tab 170 includes a first tab 172 and ramp 173 that cooperate with the first locking tab ramp 163 of the locking member 160, and a second tab 174 and ramp that cooperate with the second locking tab ramp 165 of the locking member 160. The first and

second tabs

172 and 174 of the locking tab 170 push the first and

second locking projections

162 and 164, respectively, outward. The first locking protrusion ramp 163 engages the ramp 173 of the first tab 172 and the second locking protrusion ramp 165 engages the ramp 173 of the second tab 174. After the first and second locking tab ramps 163, 165 are moved beyond the

ramps

173, 175 of the first and

second tabs

172, 174, the locking

tabs

162, 164 snap lock to the locking tabs 170 to secure the protective portion 102 in the protected position 180. In this position, the device is in a ready-to-use position when the shield portion 102 is in the protective position 180 on the needle cover 240. The practitioner can grasp shield portion 102 and rotate shield portion 102 away from needle cover 240, e.g., as shown in the position shown in fig. 1. When the practitioner is ready to inject a patient, the needle cover 240 is removed to expose the needle cannula 202. After injecting the patient, the shield portion is rotated such that the shield portion 102 is in the shielding position 180 on the needle cannula 202.

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

Another aspect of the present disclosure relates to a needle guard and needle assembly including the needle assembly 100 shown and described herein, the needle assembly 100 including a needle cannula 202 and a hub 208, the needle cannula 202 having a proximal end 203, a distal end 205 and a lumen 206 therethrough, the hub 208 having an outer surface 209, an open proximal end 210 including a cavity 212 therein and a distal end 214 attached to the proximal end of the needle cannula 202 such that the lumen 206 is in fluid communication with the cavity 212. Needle shield and needle assembly includes elongate needle shield 100, elongate needle shield 100 including a shield portion 102, a hub connection portion 104 and a bridge portion 106, bridge portion 106 including a thickness T_HThe bridge portion 106 joins the hub connection portion 104 and the shield portion 102. The hub connection portion includes a receiving ring 112 and a flange 114, the receiving ring 112 having a diameter D sized to frictionally receive a hub outer surface 209 when the needle assembly 200 is inserted through the receiving ring 112, the flange 114 extending from the receiving ring 112 defining a top planar surface 116 and a bottom surface 118. The flange 114 has a thickness T_FThickness T of the flange_FDivided by the thickness T of the living hinge_HThe defined ratio is 1.1 to 6.

In one or more of the embodiments described herein,thickness T of flange_FDivided by the thickness T of the living hinge_HDefined ratios are 1.2 to 6, 1.3 to 6, 1.4 to 6, 1.5 to 6, 1.6 to 6, 1.7 to 6, 1.8 to 6, 1.9 to 6, 2 to 6, 2.1 to 6, 2.2 to 6, 2.3 to 6, 2.4 to 6, 2.5 to 6, 2.6 to 6, 2.7 to 6, 2.8 to 6, 2.9 to 6, 3 to 6, 1.1 to 5, 1.2 to 5, 1.3 to 5, 1.4 to 5, 1.5 to 5, 1.6 to 5, 1.7 to 5, 1.8 to 5, 1.9 to 5, 2 to 5, 2.1 to 5, 2.2 to 5, 2.3 to 5, 2.4 to 5, 2.5 to 5, 2.6 to 5, 2.7 to 5, 2.8 to 5, 2.1 to 5, 2.4 to 4, 1.4 to 5, 2.4 to 4, 2.4 to 5, 2.6 to 5, 2.7 to 5, 2.4 to 4, 2.4 to 5, 1.4 to 4, 2.4 to 4, 4 to 5, 2.4 to 4, 4 to 4, 2.6 to 5, 1.4 to 5, 2.6 to 5, 4, 2.4, 4 to 4, 2.4 to 4 to 5, 4, 2.6 to 5, 2.4 to 4, 4 to 5, 4, 2.4 to 5, 4, 2.6, 4 to 5, 4, 2.6, 4, 2, 4 to 5, 4, 2.6, 4, 2, 4, 2, 4, 2, 4, 2, 4 to 5, 4 to 5, 2, 4, 2, 4, 2, 2.6, 4 to 5, 4 to 5, 2, 2.6, 4, 2, 4, 2, 4, 2, 6, 2, 6, 2, 4, 2, 6, 2, 6, 2.

If thickness T of living hinge_HToo large, the living hinge will not be flexible enough and the shield will not easily close over the needle cannula. On the other hand, if the thickness T of the living hinge is_HToo small, the living hinge is easily broken. In one or more embodiments, the thickness T of the flange is determined by the thickness T of the flange_FDivided by the thickness T of the living hinge_HThe ratios defined are within the ranges provided above. If it is determined by the thickness T of the flange_FDivided by the thickness T of the living hinge_HThe defined ratio is outside the defined range, then the needle shield would be difficult to manufacture by injection molding because when the ratio is too low, there is not enough material flow to form the bridge portion 106 and hub connection portion 104 of the needle shield assembly 100. In one or more embodiments, thickness T of living hinge 108 is within the ratios provided above_HIn the range of 0.1mm to 0.3mm (e.g., 0.1mm, 0.15mm, 0.2mm, 0.25mm, or 0.3mm) and the thickness T of the flange 114_FIn the range of 0.4mm to 0.8mm (e.g. 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm or 0.80 mm).

side walls

120, 122. The shield portion 102 is configured to pivot from an open position in which the needle cannula is exposed (see, e.g., fig. 1 and 7) to a closed, shielded position 180 in which the distal end 205 of the needle cannula 202 is shielded within the longitudinal opening 124 of the shield.

In one or more embodiments, the needle guard and needle assembly further includes a plurality of radial projections 220 extending from the needle hub, the radial projections 220 being spaced from the open proximal end 210 such that the hub 208 remains seated in the receiving ring 112 when the needle assembly 200 has been inserted through the receiving ring. As best shown in fig. 6A, the radial projections 220 engage the periphery of the receiving ring 112 to prevent the hub 208 from moving past the flange. The radial projections 220 are configured to prevent the hub 208 from moving in a proximal direction to be pushed through the receiving ring 112.

In an exemplary use of the present disclosure, a practitioner detaches the needle shield assembly 100 from the packaging in the open position 190. The practitioner assembles and secures the syringe 310 to the hub 208 of the needle assembly 200. Once the syringe 310 has been engaged with the hub 208, the needle cover 240 is removed from the needle assembly 200 and an injection is administered. The practitioner removes the needle cannula 202 from the patient. With the syringe 310 secured to the hub 208 of the needle assembly 200 or without the syringe 310 secured to the hub 208 of the needle assembly 200, the practitioner rotates the hub connection portion 104 about the bridge portion 106 to switch the needle shield assembly 100 from the open position 190 to the protected position 180. In the protecting position 180, the locking adapter 170 and locking member 160 are fully engaged, thereby protecting the needle cannula 202 from accidental post-injection needle stick injuries.

Referring now to fig. 6B, the cylindrical wall extension that extends below the bottom surface 118 of the flange 114 and provides the cylindrical receiving structure 130 for the hub 208 includes an inner surface 135 and splines 136. Fig. 6C shows a hub having complementary hub splines 224, the complementary hub splines 224 configured to engage with the splines 136 on the inner surface 135 of the cylindrical receiving structure 130. In the illustrated embodiment, splines 136 are hollow portions on inner surface 135, and hub splines 224 are elongated radial projections complementary to splines 136 and configured to be located within splines 136. Thus, the splines 136 are female splines and the hub splines 224 are male splines. It will be appreciated that this profile may be reversed. In the illustrated embodiment, 24 splines 136 are shown on the inner surface 135 of the cylindrical receiving structure 130. In this configuration, the splines are spaced 15 degrees around the circumference of the cylindrical receiving structure 130. It will be appreciated that the number of splines may vary such that the splines are spaced 10 degrees (36 splines), 15 degrees (24 splines), 20 degrees (18 splines), 30 degrees (12 splines), 40 degrees (9 splines), 45 degrees (8 splines), 60 degrees (6 splines), 72 degrees (5 splines) or 90 degrees (4 splines). Four hub splines 224 are shown in fig. 6C, and the number may vary and include one, two, three, four, five, six, seven, eight, nine, or ten hub splines 224.

Hub splines 224 and splines 136 are configured to cooperate to allow hub 208 to rotate relative to shield portion 102. In some embodiments, as hub 208 rotates relative to the shield portion, hub splines 224 and splines 136 are configured to generate a tactile or perceptible clicking sound (click) during each rotation as hub splines 224 and splines 136 engage and disengage one another.

In one or more embodiments, switching needle shield assembly 100 from open position 190 to protected position 180 may be accomplished in a variety of ways. During an injection, the practitioner may need to press the injection site with a sanitary cloth or pad with one hand during or after the injection. The practitioner may remove the needle cannula 202 from the skin and switch the needle shield assembly 100 one-handed by rotating the syringe, thereby folding the hub connection portion 104 and fully engaging (engage) the shield position 180 with the weight of the shield portion 102. Further, the practitioner may use a flat surface like a patient table, for example, to rotate the protective portion 102 around the bridge portion 106 to engage the protective position 180.

In one or more embodiments, a needle clip (not shown) may be disposed within longitudinal opening 124 of shield portion 102, longitudinal opening 124 being configured to receive needle cannula 202 to increase shielding when needle shield assembly 100 is in the shielding position 180.

In one or more embodiments, after performing an injection, the practitioner may remove the needle assembly 200 from the receiving ring 112 of the hub connection portion 104 while the needle shield assembly 100 is engaged in the protective position 180.

In one or more embodiments, the hub 208 is rotatable within the receiving ring 112. The outer diameter of the hub 208 at the complementary hub splines 224 is configured such that there is a friction fit between the hub 208 and the receiving ring 112, allowing rotation of the hub 208 to be set by the practitioner, but not so loose as to allow free rotation. This configuration permits the appropriate or preferred orientation of the bevel on needle cannula 202 to vary depending on the particular medical procedure. For example, injections of the subcutaneous, intravenous, or intradermal type typically require the needle to be inserted at various angles (e.g., 45 degrees, 25 degrees, 10 degrees, respectively) relative to the patient's skin, with the needle bevel typically in an upward position (facing away from the skin surface) and the bevel visible to the clinician. Thus, it is beneficial for the hub 208 to be rotated into position so that the needle bevel does not interfere with the clinician's view of the needle bevel. In an intramuscular injection, the bevel is typically 90 degrees to the patient's skin. As such, the rotational orientation of the needle bevel relative to the safety needle cover is not critical, as the clinician does not need to view the bevel orientation.

In one or more embodiments, the open proximal end 210 of the hub 208 includes a tab (lug)222, the tab 222 configured to engage a threaded collar 315 of a syringe 310 having a distal end 312 and a proximal end 313 such that a needle shield and needle assembly may be connected to the syringe 310. As shown in fig. 9, the syringe 310 may further include a plunger 320 having a distal end 322 and a proximal end 323. Distal end 322 may include a plug 324 having a distal tip 325. In use, hub 208 shown in fig. 9 may be inserted into receiving ring 112 of needle shield assembly 100 and syringe 310 may be connected to the hub by engaging tabs 222 with threaded collar 314 of syringe 310.

Plunger 320 may be positioned in fluid-tight engagement with the inside surface of the barrel of the syringe for drawing fluid into the barrel chamber and driving fluid out of the barrel chamber by movement of the stopper relative to the barrel. An elongate body portion extends outwardly from the open end of the barrel.

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 present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made in the method and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Therefore, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

1. A needle shield assembly for use with a needle assembly including a needle cannula having a proximal end, a distal end and a lumen therethrough, and a hub having an outer surface, an open proximal end including a cavity therein and a distal end attached to the proximal end of the needle cannula such that the lumen is in fluid communication with the cavity, the needle shield assembly comprising:

an elongate needle shield comprising a shield portion, a hub connection portion and a bridge portion, the bridge portion comprising a living hinge having a thickness, the bridge portion joining the hub connection portion and the shield portion, the hub connection portion comprising a receiving ring having a diameter sized to frictionally receive the hub outer surface when the needle assembly is inserted through the receiving ring, and a flange extending from the receiving ring defining a top planar surface and a bottom surface, the flange having a thickness, characterized in that the ratio defined by the thickness of the flange divided by the thickness of the living hinge is 1.1 to 6, the shield portion having two sidewalls defining a longitudinal opening and a back wall defining a recess having an inner surface between the sidewalls, the shield portion being configured to pivot from an exposed open position of the needle cannula to a distal end of the needle cannula A closed needle protecting position within the longitudinal opening of the guard.

2. The needle shield assembly of claim 1 wherein said receiving ring further comprises a cylindrical wall extension extending below a bottom surface of said flange to provide a cylindrical receiving structure.

3. The needle shield assembly of claim 2 further including a plurality of ribs extending from said bottom surface and extending radially from said cylindrical wall extension.

4. The needle shield assembly of claim 3 wherein said plurality of ribs comprises between 3 and 8 ribs.

5. The needle shield assembly of claim 4 wherein said plurality of ribs comprises between 3 and 5 ribs.

6. The needle shield assembly of claim 1 wherein said bridge portion includes a first span spaced from a second span to provide a gap between said first span and said second span, and said living hinge has a first portion coupling said first span to said shield portion and a second portion coupling said second span to said shield portion.

7. The needle shield assembly of claim 6 wherein said first span and said second span each include a width and said gap includes a width such that said gap width is greater than said first span width and said second span width.

8. The needle shield assembly of claim 7 further comprising a leg, said leg including a bend connecting said shield portion and said flange.

9. The needle shield assembly of claim 1 wherein said living hinge has a thickness in the range of 0.1mm to 0.3mm and said flange has a thickness in the range of 0.4mm to 0.8 mm.

10. The needle shield assembly of claim 1 wherein said shield portion further comprises a locking member comprising two locking tabs facing each other and projecting from said sidewall and configured to engage a locking tab extending from said flange when said shield is in a closed position with a needle cap placed on said needle cannula.

11. The needle shield assembly of claim 1 wherein said shield portion, said bridge portion, said hub connection portion and said living hinge comprise a unitary structure integrally molded from a thermoplastic material.

12. The needle shield assembly of claim 2 wherein said cylindrical wall extension has an inner surface with splines configured to cooperate with hub splines on a needle hub when the needle hub is engaged with said cylindrical wall extension.

13. A needle guard and needle assembly, comprising:

a needle assembly comprising a needle cannula having a proximal end, a distal end, and a lumen therethrough, and a hub having an outer surface, an open proximal end including a cavity therein, and a distal end attached to the proximal end of the needle cannula such that the lumen is in fluid communication with the cavity; and

14. The needle guard and needle assembly of claim 13, wherein the receiving ring further includes a cylindrical wall extension extending below a bottom surface of the flange to provide a cylindrical receiving structure.

15. The needle guard and needle assembly of claim 14, further comprising a plurality of ribs extending from the bottom surface and extending radially from the cylindrical wall extension.

16. The needle guard and needle assembly of claim 15, wherein said plurality of ribs includes between 3 and 8 ribs.

17. The needle guard and needle assembly of claim 15, wherein said plurality of ribs includes between 3 and 5 ribs.

18. The needle shield and needle assembly of claim 13 wherein said bridge portion includes a first span spaced from a second span to provide a gap between said first span and said second span, and said living hinge has a first portion coupling said first span to said shield portion and a second portion coupling said second span to said shield portion.

19. The needle guard and needle assembly of claim 18, wherein the first span and the second span each include a width and the gap includes a width such that the width of the gap is greater than the width of the first span and the width of the second span.

20. The needle guard and needle assembly of claim 19, further comprising a leg including a bend connecting the guard portion and the flange.

21. The needle guard and needle assembly of claim 13, wherein the thickness of the living hinge is in the range of 0.1mm to 0.3mm and the thickness of the flange is in the range of 0.4mm to 0.8 mm.

22. The needle shield and needle assembly of claim 13, wherein the shield portion further comprises a locking member comprising two locking projections facing each other and projecting from the sidewall and configured to engage with a locking tab extending from the flange when the shield is in the closed position with a needle cap placed on the needle cannula.

23. The needle guard and needle assembly of claim 13, wherein the guard portion, the bridge portion, the hub connection portion, and the living hinge comprise a unitary structure integrally molded from a thermoplastic material.

24. The needle guard and needle assembly of claim 13, further comprising a plurality of radial projections extending from the hub, the projections being spaced from the proximal end such that the hub remains seated in the receiving ring.

25. The needle guard and needle assembly of claim 14, wherein said hub is rotatable within said receiving ring.

26. The needle guard and needle assembly of claim 25, wherein the proximal end of the hub includes a tab configured to engage a threaded collar of a syringe such that the needle guard and needle assembly can be connected to the syringe.

27. The needle guard and needle assembly of claim 25, wherein the cylindrical wall extension has an inner surface with splines configured to cooperate with hub splines on the needle hub when the needle hub is engaged with the cylindrical wall extension.

28. The needle guard and needle assembly of claim 27, wherein the splines are hollow portions on the inner surface and the hub splines are elongated radial projections complementary to the splines and configured to be located within the splines.

29. The needle guard and needle assembly of claim 28, wherein said hub splines and said splines 136 are configured to cooperate to allow said hub to rotate relative to said guard portion.

30. The needle guard and needle assembly of claim 28, wherein the hub splines and the splines are configured to produce tactile or perceptible clicks during each rotation as the hub splines and the splines engage and disengage each other as the hub rotates relative to the guard portion.