Articulated needle shield and needle assembly

Abstract

A needle shield assembly includes 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 extending from the receiving ring, the diameter dimension of the receiving ring is suitable for frictionally receiving the outer surface of the hub when the needle assembly is inserted through the receiving ring, and the flange defines a top plane surface and a bottom surface. The ratio defined by the thickness of the flange divided by the thickness of the living hinge ranges from 1.1 to 6. The shield is configured to pivot from an open position in which the needle cannula is exposed to a closed needle protection position in which the distal end of the needle cannula is located within the longitudinal opening of the shield.

Description

[0001] Description of the case

[0002] This patent application is a divisional patent application.

[0003] The original application of this divisional patent application (i.e., the parent case, office file number IIM220369) is a patent application with an international application date of September 11, 2020, an international application number of PCT / US2020 / 050279, a Chinese national application number of 202080063739.0, and a subject name of "Articulated needle shield and needle assembly". Technical Field

[0004] The present disclosure relates generally to needle assemblies having safety features and, more particularly, to needle assemblies having hinged needle shield assemblies for use with syringes. Background Art

[0005] Accidental needle sticks with new, unused needles can cause injury and render the needle unsuitable for further use. Accidental needle sticks with used needles can spread disease. Therefore, most prior art needle assemblies have needle shields. Some prior art needle shields define a rigid sleeve that can be manually retracted and extended over the needle cannula. This procedure requires the healthcare worker to hold the syringe barrel in one hand and the shield in the other. Some medical procedures require that pressure be applied to the puncture site after the needle is removed. Therefore, healthcare workers often cannot shield the needle cannula with both hands. In these cases, workers simply place the used medical instrument on a nearby surface to shield it at a more convenient time. However, until the needle is shielded or properly disposed of, it is a potential hazard to others.

[0006] A needle shield hinged near the base of the needle has the advantage of allowing one-handed reshielding of the needle, providing the physician with the opportunity to reshield immediately after use in most cases.

[0007] Various means have been provided for locking an articulated needle shield in a closed needle protection position. A deflectable member is provided in the needle shield for engaging the needle when shielded and preventing subsequent unshielding of the needle. Such a member confines the needle within the needle shield. Locking is also accomplished by locking engagement of the needle shield with a structure proximate the needle base.

[0008] There remains a need for an improved hinged needle shield that is cost-effective and easy to manufacture. Summary of the invention

[0009] The first embodiment relates to a needle shield assembly for use with a needle assembly, the needle assembly comprising a needle cannula and a hub, the needle cannula having a proximal end, a distal end and a lumen extending through the needle cannula, the hub having an outer surface, an open proximal end and a distal end, the open proximal end comprising a lumen, the distal end of the hub being attached to the proximal end of the needle cannula so that the lumen communicates with the lumen fluid, the needle shield assembly comprising an elongated needle shield, the elongated needle shield comprising a shielding portion, a hub connecting portion and a bridging portion, the bridging portion comprising a living hinge having a certain thickness, the bridging portion coupling the hub connecting portion and the shielding portion, the hub connecting portion comprising a receiving ring and a flange, the receiving The ring has a diameter 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 certain thickness, and the ratio defined by the thickness of the flange divided by the thickness of the living hinge ranges from 1.1 to 6, the shield has two side walls defining a longitudinal opening and a rear wall between the side walls to define a recess having an inner surface, and the shield is configured to pivot from an open position to a closed needle protection position, in which the needle cannula is exposed, and in the closed needle protection position, the distal end of the needle cannula is located within the longitudinal opening of the shield.

[0010] A second embodiment is directed to a needle shield and needle assembly, comprising: a needle assembly including a needle cannula and a hub, the needle cannula having a proximal end, a distal end, and a lumen extending therethrough, the hub having an outer surface, an open proximal end, and a distal end, the open proximal end including a lumen therein, the distal end of the hub being attached to the proximal end of the needle cannula so that the lumen is in fluid communication with the lumen,

[0011] An elongated needle shield, the elongated needle shield comprising a shield portion, a hub connection portion and a bridge portion, the bridge portion comprising a movable hinge having a certain thickness, the bridge portion coupling the hub connection portion and the shield portion, the hub connection portion comprising a receiving ring and a flange, the diameter of the receiving ring being suitable for frictionally receiving an outer surface of the hub when the needle assembly is inserted through the receiving ring, the flange extending from the receiving ring to define a top planar surface and a bottom surface, the flange having a certain thickness, the ratio defined by the thickness of the flange divided by the thickness of the movable hinge being in a range of 1.1 to 6, the shield portion having two side walls defining a longitudinal opening and a rear wall between the side walls to define a recess having an inner surface, the shield portion being configured to pivot from an open position to a closed needle protection position, in which the needle cannula is exposed, and in which the distal end of the needle cannula is located within the longitudinal opening of the shield portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a side elevation view of a needle assembly according to one embodiment of the present disclosure;

[0013] Figure 2 yes Figure 1 a top perspective view of the needle assembly shown;

[0014] Figure 3 yes Figure 1 a partial top perspective view of the needle assembly shown;

[0015] Figure 4 yes Figure 1 a partial side elevational view of the needle assembly shown;

[0016] Figure 5 yes Figure 1 An enlarged cross-sectional side elevation view of the distal end of the syringe assembly;

[0017] Fig. 6A yes Figure 1 a top partial perspective view of a portion of the needle assembly shown;

[0018] Figure 6B yes Figure 1 An enlarged perspective view of a bottom portion of a receiving ring of a needle assembly is shown;

[0019] Figure 6C is an enlarged perspective view of the hub of the needle assembly.

[0020] Figure 7 yes Figure 1 an exploded side elevation view of the needle assembly of the needle assembly shown;

[0021] Figure 8 yes Figure 1 a perspective view of the needle assembly shown with the shield in a partially folded position;

[0022] Fig. 9 is an exploded perspective view of the syringe and needle assembly. DETAILED DESCRIPTION

[0023] Although the present disclosure is satisfied by embodiments in many different forms, which are shown in the drawings and will be described in specific embodiments of the present disclosure, it should be understood that the present disclosure is considered to be an exemplary illustration of the principles and is not intended to limit the present disclosure to the embodiments shown. The scope of the present disclosure will be measured by the appended claims and their equivalents.

[0024] refer to Figure 1-9 , shows a needle shield assembly 100 for use with a needle assembly 200, which includes a needle cannula 202 having a proximal end 203, a distal end 205, and a lumen 206 extending through the needle cannula 202. The needle assembly 200 also includes a hub 208 having an outer surface 209, an open proximal end 210, and a distal end 214, including a lumen 212 therein, the distal end 214 of the hub 208 being attached to the proximal end 203 of the needle cannula 202 such that the lumen 206 is in fluid communication with the lumen 212.

[0025] Needle shield assembly 100 includes shield portion 102, hub connection portion 104 and bridge portion 106, bridge portion 106 includes living hinge 108 having thickness TH, bridge portion 106 coupling hub connection portion 104 and shield portion 102. Hub connection portion 104 includes receiving ring 112 and flange 114 extending from receiving ring 112, receiving ring 112 having diameter D sized to frictionally receive hub outer surface 209 when needle assembly 200 is inserted through receiving ring 112, flange 114 defining top planar surface 116 and bottom surface 118. The distance between top planar surface and bottom surface 118 defines flange thickness TF. In one or more embodiments, the ratio defined by flange thickness TF divided by living hinge thickness TH is in the range of 1.1 to 6. In one or more embodiments, the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH ranges from 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, 2.9 to 5, 3 to 5, 1.1 to 4, 1.2 to 4, 1.3 to 4, 1.4 to 4, 1.5 to 4, 1.6 to 4, 1.7 to 4, 1.8 to 4, 1.9 to 4, 2 to 4, 2.1 to 4, 2.2 to 4, 2.3 to 4, 2.4 to 4, 2.5 to 4, 2.6 to 4, 2.7 to 4, 2.8 to 4, 2.9 to 4, 3 to 4.

[0026] If the thickness of the living hinge TH is too large, the flexibility of the living hinge is insufficient, and the shield is not easy to close on the needle cannula. On the other hand, if the thickness of the living hinge TH is too small, the living hinge will be easy to break. In one or more embodiments, the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is within the range provided above. If the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is outside the defined range, the needle shield will be difficult to manufacture by injection molding because when the ratio is too low, insufficient material will flow to form the bridge portion 106 and the hub connection portion 104 of the needle shield assembly 100. In one or more embodiments, in addition to being within the ratios provided above, the thickness TH of the living hinge 108 is in a range from 0.1 mm to 0.3 mm (e.g., 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, or 0.3 mm), and the thickness of the flange TF 114 is in a range from 0.4 mm to 0.8 mm (e.g., 0.4 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.70 mm, 0.75 mm, or 0.80 mm). In addition, if the thickness of the flange 114 is too small, the flange 114 will not have sufficient structural integrity to withstand the insertion of the hub 208 through the receiving ring 112. However, if the thickness of the flange TF is outside the upper limit of the provided range and is not within the ratios provided above, it is difficult to form the component by injection molding.

[0027] The shield 102 has two side walls and a rear wall, the two side walls are a first side wall 120 and a second side wall 122, defining a longitudinal opening 124, and a rear wall 126 between the side walls 120 and 122, defining a recess 127 having an inner surface 128. The shield 102 is configured to be opened from an open position (see, e.g., Figure 1 and Figure 7 ) to the closed protection position 180 (see Figure 8 ) pivots, in the open position, the needle cannula is exposed, and in the closed protective position, the distal end 205 of the needle cannula 202 is protected in the longitudinal opening 124 of the shielding member, such as Figure 8 It should be understood that for the purpose of illustration, Figure 8 In the embodiment, the protection position 180 is not in a fully closed position, but in a nearly closed position.

[0028] In one or more embodiments, the receiving ring 112 further comprises a cylindrical wall extension 130 extending below the bottom surface 118 of the flange 114, providing a cylindrical receiving structure 130 for the hub. In one or more embodiments, the needle shield assembly comprises a plurality of ribs 132, 134 extending from the bottom surface 118 and radially extending 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 comprises 3 to 5 ribs, for example 4 ribs. The ribs 132, 134 provide additional structural integrity to the flange 114, which also allows the thickness of the flange TF to be reduced.

[0029] In some embodiments, bridge portion 106 includes a first span portion 142 spaced apart from a second span portion 144 to provide a gap 146 between first span portion 142 and second span portion 144, living hinge 108 has a first portion 108a coupling first span portion 142 to shield 10 and a second portion 108b coupling second span portion 144 to shield 102. In one or more embodiments, first span portion 142 and second span portion 144 each include a width WS, and gap 146 includes a width WG, such that the width of gap WG is greater than the width WS of the first span portion and the width WS of the second span portion.

[0030] In one or more embodiments, the needle shield assembly 100 further includes a leg 150 including a bent portion 152 connecting the shield portion 102 and the flange 114. Figure 3 and Figure 4 As shown, a leg 150 is disposed below the gap 146. The leg provides additional stability to the living hinge 108.

[0031] In some embodiments, the shield 102 further includes a locking member 160, which includes two locking protrusions, a first locking protrusion 162 and a second locking protrusion 164, facing each other, protruding from the side walls 120, 122, and configured to engage with the locking tab 170. The locking tab 170 includes a first tab 172 and a ramp 173 cooperating with the first locking protrusion ramp 163 of the locking member 160, and a second tab 174 and a ramp cooperating with the second locking protrusion ramp 165 of the locking member 160. The first tab 172 and the second tab 174 of the locking tab 170 push the first locking protrusion 162 and the second locking protrusion 164 outward, respectively. The first locking protrusion ramp 163 engages with the ramp 173 of the first tab 172, and the second locking protrusion ramp 165 engages with the ramp 173 of the second tab 174. After the first locking protrusion ramp 163 and the second locking protrusion ramp 165 move beyond the ramp 173 of the first tab 172 and the ramp 175 of the second tab 174, the locking protrusions 162, 164 snap lock to the locking tab 170 to secure the shield 102 in the protective position 180. In this position, when the shield 102 is in the protective position 180 over the needle cover 240, the device is in a ready-to-use position. A medical professional can grasp the shield 102 and rotate the shield 102 away from the needle cover 240, for example, Figure 1 When the medical staff is ready to give the patient an injection, the needle cover 240 is removed to expose the needle cannula 202. After the patient is injected, the shield portion is rotated so that the shield portion 102 is in the protective position 180 on the needle cannula 202.

[0032] In one or more embodiments, the shield portion 102 , the bridge portion 106 , the hub connection portion 104 , and the living hinge 108 comprise a unitary structure integrally molded from a thermoplastic material.

[0033] Another aspect of the present disclosure is directed to a needle shield and needle assembly, including the needle assembly 100 shown and described herein, the needle assembly including a needle cannula 202 and a hub 208, the needle cannula having a proximal end 203, a distal end 205, and a lumen 206 extending therethrough, the hub 208 having an outer surface 209, an open proximal end 210, and a distal end 214, including a cavity 212 in the open proximal end 210, the distal end 214 of the hub being attached to the proximal end of the needle cannula 202 such that the lumen 206 is in fluid communication with the cavity 212. The needle shield and needle assembly includes an elongated needle shield 100 including a shield portion 102, a hub connecting portion 104, and a bridge portion 106 including a living hinge 108 having a thickness TH, the bridge portion 106 coupling the hub connecting portion 104 and the shield portion 102. The hub connection portion includes a receiving ring 112 having a diameter D sized to frictionally receive the hub outer surface 209 when the needle assembly 200 is inserted through the receiving ring 112, and a flange 114 extending from the receiving ring 112, the flange 114 defining a top planar surface 116 and a bottom surface 118. The flange 114 has a thickness TF, and the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH ranges from 1.1 to 6.

[0034] In one or more embodiments, the ratio defined by the flange thickness TF divided by the living hinge thickness TH ranges from 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, 2.9 to 5, 3 to 5, 1.1 to 4, 1.2 to 4, 1.3 to 4, 1.4 to 4, 1.5 to 4, 1.6 to 4, 1.7 to 4, 1.8 to 4, 1.9 to 4, 2 to 4, 2.1 to 4, 2.2 to 4, 2.3 to 4, 2.4 to 4, 2.5 to 4, 2.6 to 4, 2.7 to 4, 2.8 to 4, 2.9 to 4, 3 to 4.

[0035] If the thickness of the living hinge TH is too large, the flexibility of the living hinge is insufficient, and the shield is not easy to close on the needle cannula. On the other hand, if the thickness of the living hinge TH is too small, the living hinge will be easy to break. In one or more embodiments, the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is within the range provided above. If the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is outside the defined range, the needle shield will be difficult to manufacture by injection molding because when the ratio is too low, the material flowing to form the bridge portion 106 and the hub connection portion 104 of the needle shield assembly 100 will be insufficient. In one or more embodiments, in addition to within the ratios provided above, the thickness TH of the living hinge 108 is in the range from 0.1 mm to 0.3 mm (e.g., 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, or 0.3 mm), and the thickness TF of the flange 114 is in the range from 0.4 mm to 0.8 mm (e.g., 0.4 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.75 mm, or 0.80 mm).

[0036] The shield 102 has two side walls, a first side wall 120 and a second side wall 122, defining a longitudinal opening 124, and a rear wall 126 between the side walls 120 and 122, defining a recess 127 having an inner surface 128. The shield 102 is configured to be opened from an open position (see, e.g., Figure 1 and Figure 7 ) is pivoted to a closed, protected position 180, in which the needle cannula is exposed in the open position and in which the distal end 205 of the needle cannula 202 is protected within the longitudinal opening 124 of the shield.

[0037] In one or more embodiments, the needle shield and needle assembly further include a plurality of radial projections 220 extending from the needle hub, the radial projections 220 being spaced apart from the open proximal end 210 so that the hub 208 remains seated in the receiving ring 112 when the needle assembly 200 is inserted through the receiving ring. Fig. 6A As best shown, radial projections 220 engage the periphery of receiving ring 112 to prevent hub 208 from moving through the flange. Radial projections 220 are configured to prevent hub 208 from moving in a proximal direction to be pushed through receiving ring 112.

[0038] In one exemplary application of the present disclosure, a medical professional unpacks the needle shield assembly 100 from the packaging in the open position 190. The medical professional 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 performed. The medical professional removes the needle cannula 202 from the patient. Regardless of whether the syringe 310 is secured to the hub 208 of the needle assembly 200, the medical professional 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 protective position 180. In the protective position 180, the locking tab 170 is fully engaged with the locking member 160, thereby shielding the needle cannula 202 from an accidental post-injection needle stick.

[0039] Reference Figure 6B The cylindrical wall extension extends below the bottom surface 118 of the flange 114 to provide a cylindrical receiving structure 130 for the hub 208 , and the cylindrical wall extension includes an inner surface 135 and splines 136 . Figure 6C The hub is shown having complementary hub splines 224 that are configured to engage splines 136 on the inner surface 135 of the cylindrical receiving structure 130. In the illustrated embodiment, the splines 136 are hollow sections on the inner surface 135 and the hub splines 224 are elongated radial protrusions that are complementary to the splines 136 and configured to be seated within the splines 136. Thus, the splines 136 are female splines and the hub splines 224 are male splines. It should be understood that this configuration can 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 individual splines are spaced 15 degrees around the circumference of the cylindrical receiving structure 130. It should be understood that the number of splines can be varied so 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). Figure 6C Four hub splines 224 are shown in FIG. 8 , and this number may vary and include one, two, three, four, five, six, seven, eight, nine, or more hub splines 224 .

[0040] The hub splines 224 and splines 136 are configured to cooperate to allow the hub 208 to rotate relative to the shield 102. In some embodiments, the hub splines 224 and splines 136 are configured to produce a tactile or perceptible click during each rotation as the hub splines 224 and splines 136 engage and disengage one another as the hub 208 rotates relative to the shield.

[0041] In one or more embodiments, the needle shield assembly 100 can be switched from the open position 190 to the protective position 180 in a variety of ways. During an injection, it may be necessary for the medical staff to use one hand to hold a sanitary cloth or pad to press against the injection site during or after the injection. The medical staff can remove the needle cannula 202 from the skin and switch the needle shield assembly 100 with one hand by turning the syringe, thereby folding over the hub connection 104 with the weight of the shield 102 and fully engaging the protective position 180. In addition, for example, the medical staff can use a flat surface such as a patient table to rotate the shield 102 about the bridge 106 to engage the protective position 180.

[0042] In one or more embodiments, a needle cannula clip (not shown) may be disposed within the longitudinal opening 124 of the shield portion 102 that is configured to receive the needle cannula 202 to enhance shielding when the needle shield assembly 100 is in the protecting position 180 .

[0043] In one or more embodiments, after performing an injection, a medical professional can remove the needle assembly 200 from the receiving ring 112 of the hub connection 104 while the needle shield assembly 100 is engaged in the protecting position 180 .

[0044] 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 so that there is a friction fit between the hub 208 and the receiving ring 112, allowing the medical staff to set the rotation of the hub 208, but not too loose to allow free rotation. This configuration allows the correct or preferred orientation of the bevel on the needle cannula 202 to vary depending on the specific 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, 10 degrees, respectively), and the needle bevel is typically in an upward position (away from the skin surface) and the bevel is visible to the clinician. In this way, it is advantageous to rotate the hub 208 to a position where the needle bevel does not obstruct the clinician's observation of the needle bevel. In intramuscular injections, the bevel is typically 90 degrees to the patient's skin. In this way, the rotational orientation of the needle bevel relative to the safety needle cover is not important because the clinician does not need to see the bevel orientation.

[0045] In one or more embodiments, the open proximal end 210 of the hub 208 includes a lug 222 configured to engage a threaded collar 315 of a syringe 310, such that the needle shield and needle assembly can be connected to the syringe 310, which has a distal end 312 and a proximal end 313. Fig. 9 As shown, the syringe 310 may also include a plunger 320 having a distal end 322 and a proximal end 323. The distal end 322 may include a stopper 324 having a distal tip 325. In use, Fig. 9 The illustrated hub 208 may be inserted into the receiving ring 112 of the needle shield assembly 100 , and the syringe 310 may be connected to the hub by engaging the lugs 222 with the threaded collar 314 of the syringe 310 .

[0046] The plunger 320 may be positioned in fluid-tight engagement with the inner surface of the syringe barrel to draw fluid into and expel fluid from the barrel chamber by movement of the plunger relative to the barrel. An elongated body portion extends outwardly from the open end of the barrel.

[0047] Although the present disclosure has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrations of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments without departing from the scope or spirit of the present disclosure. Therefore, it is intended that the present disclosure covers such modifications and variations as fall within the scope of the appended claims and their equivalents.

Claims

1. A needle shield assembly, comprising: a shield portion configured to pivot from an open position in which a needle cannula of a needle assembly is exposed to a closed needle protection position in which at least a distal end of the needle cannula is received in the shield portion; Hub connection portion; as well as a bridge portion, the bridge portion including a living hinge, the bridge portion coupling the hub connection portion and the shielding portion, The hub connection portion comprises: a receiving ring having a diameter sized to frictionally receive the hub of the needle assembly when the needle assembly is received by the receiving ring; and a flange extending from the receiving ring to define a top planar surface and a bottom surface, The receiving ring is rotatable relative to the hub, and the cylindrical wall extension provides a cylindrical receiving structure having 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, wherein the splines are configured to engage and disengage with the hub splines when the hub is rotated to a fixed position relative to the shield. 2 . The needle shield assembly of claim 1 , said receiving ring further comprising said cylindrical wall extension extending below a bottom surface of said flange. 3 . The needle shield assembly of claim 2 , further comprising a plurality of ribs extending from the bottom surface and extending radially from the cylindrical wall extension.

4. The needle shield assembly of claim 1 , wherein the bridging portion comprises a first span portion and a second span portion, wherein the first span portion is spaced apart from the second span portion to provide a gap between the first span portion and the second span portion, and wherein the movable hinge has a first portion and a second portion, wherein the first portion couples the first span portion to the shield portion, and the second portion couples the second span portion to the shield portion.

5. The shield assembly of claim 6, the first span portion and the second span portion each comprising a width, the gap comprising a width such that the width of the gap is greater than the width of the first span portion and the width of the second span portion. 6 . The needle shield assembly of claim 7 , further comprising a leg including a bend connecting the shield portion and the flange.

7. The needle shield assembly of claim 1, wherein the thickness of the living hinge is in the range of 0.1 mm to 0.3 mm, and the thickness of the flange is in the range of 0.4 mm to 0.8 mm.

8. The needle shield assembly of claim 1 , wherein the shield portion further comprises a locking member comprising two locking protrusions facing each other and protruding from the side wall and configured to engage with locking tabs extending from the flange when the shield is in the closed position with the needle cover placed on the needle cannula.

9. The needle shield assembly of claim 1, the shield portion, the bridge portion, the hub connection portion, and the living hinge comprising a unitary structure integrally molded from a thermoplastic material.

10. A needle shield and needle assembly, comprising: a needle assembly comprising a needle cannula and a hub, the needle cannula having a proximal end, a distal end and a lumen extending therethrough, the hub having an outer surface, an open proximal end and a distal end, the outer surface of the hub further comprising a plurality of hub splines and a plurality of radial projections extending radially from the hub, the open proximal end being spaced apart from the hub splines and radial projections, the open proximal end comprising a lumen therein, the distal end of the hub being attached to the proximal end of the needle cannula such that the lumen is in fluid communication with the lumen; as well as An elongated needle shield, the elongated needle shield comprising a shield portion, a hub connecting portion and a bridge portion, the bridge portion comprising a living hinge having a certain thickness, the bridge portion coupling the hub connecting portion and the shield portion, the hub connecting portion comprising a receiving ring and a flange, the receiving ring having a diameter sized to frictionally receive an outer surface of the hub when the needle assembly is inserted through the receiving ring, the flange extending from the receiving ring to define a top planar surface and a bottom surface, the hub being rotatable within the receiving ring, the outer diameter of the hub at the hub spline being configured to allow the hub to be rotated relative to the hub when the needle assembly is inserted through the receiving ring, A friction fit exists between the receiving rings to allow rotation of the hub to be set to a fixed position, the flange has a certain thickness, and the ratio defined by the thickness of the flange divided by the thickness of the living hinge ranges from 1.1 to 6, the shield portion has two side walls defining a longitudinal opening and a rear wall between the two side walls to define a recess having an inner surface, and the shield portion is configured to pivot from an open position to a closed needle protection position, in which the needle cannula is exposed, and in the closed needle protection position, the distal end of the needle cannula is located within the longitudinal opening of the shield.

11. The needle shield and needle assembly of claim 10, said receiving ring further comprising a cylindrical wall extension extending below a bottom surface of said flange to provide a cylindrical receiving structure.

12. The needle shield and needle assembly of claim 11 further comprising a plurality of ribs extending from the bottom surface and extending radially from the cylindrical wall extension.

13. The needle shield and needle assembly of claim 10, wherein the bridging portion comprises a first wing span portion and a second wing span portion, wherein the first wing span portion is spaced apart from the second wing span portion to provide a gap between the first wing span portion and the second wing span portion, and wherein the movable hinge has a first portion and a second portion, wherein the first portion couples the first wing span portion to the shield portion, and the second portion couples the second wing span portion to the shield portion.

14. The needle shield and needle assembly of claim 13, the first span portion and the second span portion each comprising a width, and the gap comprising a width such that the width of the gap is greater than the width of the first span portion and the width of the second span portion.

15. The needle shield and needle assembly of claim 14, further comprising a leg including a bend connecting the shield portion to the flange.

16. A needle shield and needle assembly according to claim 10, wherein the shield further comprises a locking member, wherein the locking member comprises two locking protrusions facing each other and protruding from the side wall and configured to engage with locking tabs extending from the flange when the shield is in the closed position with the needle cover placed on the needle cannula.

17. The needle shield and needle assembly of claim 10, said radial projection being spaced apart from said proximal end such that said hub remains seated in said receiving ring.

18. The needle shield and needle assembly of claim 17, the proximal end of the hub comprising a lug configured to engage a threaded collar of a syringe such that the needle shield and needle assembly can be connected to the syringe.

19. The needle shield and needle assembly of claim 10, wherein: The splines are hollow sections on the inner surface and the hub splines are elongated radial protrusions that are complementary to the splines and are configured to seat within the splines.

20. The needle shield and needle assembly of claim 19, wherein: The hub splines and the splines are configured to cooperate to allow the hub to rotate relative to the shield.

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