Patent ID: 12246170

DETAILED DESCRIPTION

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

Referring toFIGS.1-9, a needle shield assembly100for use with a needle assembly200including a needle cannula202having a proximal end203, a distal end205and a lumen206therethrough. The needle assembly200further comprises a hub208having an outer surface209, an open proximal end210including a cavity212therein and a distal end214attached to the proximal end203of the needle cannula202so that the lumen206is in fluid communication with the cavity212.

The needle shield assembly100comprises shield portion102, a hub connection portion104and a bridge portion106including a living hinge108having a thickness TH, the bridge portion106joining the hub connection portion104and the shield portion102. The hub connection portion104comprises a receiving ring112having a diameter D sized to frictionally receive the hub outer surface209when the needle assembly200is inserted through the receiving ring112and a flange114extending from the receiving ring112defining a top planar surface116and a bottom surface118. The distance between the top planar surface and the bottom surface118defines a flange thickness TF. In one or more embodiments, the thickness of the flange TF divided by the thickness of the living hinge TH defines a ratio of from 1.1 to 6. In one or more embodiments, the thickness of the flange TF divided by the thickness of the living hinge TH defines a ratio of 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.

If the thickness of the living hinge TH is too great, the living hinge will not be flexible enough, and the shield will not be easily closed over the needle cannula. On the other hand, if the thickness of the living hinge TH is too small, the living hinge will be prone to breaking. 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 above provided ranges. If the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is outside the defined ranges, 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 portion106and the hub connection portion104of the needle shield assembly100. In one or more embodiments, in addition to being within the ratios provided above, the living hinge108has a thickness TH in a range of from 0.1 mm to 0.3 mm, for example 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm or 0.3 mm) and the flange TF114has a thickness in a range of from 0.4 mm to 0.8 mm (for example 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 flange114is too small, the flange114will have insufficient structural integrity to withstand insertion of the hub208through the receiving ring112. However, if the thickness of the flange TF is outside the upper end of the ranges provided and not within the ratios provided above, it will be difficult to form the part by injection molding.

The shield portion102has two side walls, a first side wall120and a second sidewall122, defining a longitudinal opening124and a back wall126between the side walls120,122defining a recess127having an interior surface128. The shield portion102is configured to pivot from an open position in which the needle cannula is exposed (see e.g.,FIG.1andFIG.7) towards a closed protected position180(seeFIG.8) in which the distal end205of the needle cannula202is protected within the longitudinal opening124of the shield as shown inFIG.8. It will be appreciated for the purposes of illustration that inFIG.8, the protected position180is not in the fully closed position, but in a nearly closed position.

In one or more embodiments, the receiving ring112further comprises a cylindrical wall extension130which extends below the bottom surface118of the flange114to provide a cylindrical receiving structure130for the hub. In one or more embodiments, the needle shield assembly comprises a plurality of ribs132,134extending from the bottom surface118and radially extending from the cylindrical wall extension130. In some embodiments, the plurality of ribs comprises from 3 to 8 ribs. In some embodiments, the plurality of ribs132,134comprises from 3 to 5 ribs, for example 4 ribs. The ribs132,134provide additional structural integrity to the flange114, which also allows the thickness of the flange TF to be reduced.

In some embodiments, the bridge portion106comprising a first span142spaced apart from a second span144to provide a gap146between the first span142and the second span144, and the living hinge108having a first portion108ajoining the first span142to the shield portion102and a second portion108bjoining the second span144to the shield portion102. In one or more embodiments, the first span142and the second span144each comprise a width WS, and the gap146comprises a width WG such that the width of the gap WG is greater than the width WS of the first span and the width WS of the second span.

In one or more embodiments, the needle shield assembly100further comprises a leg150comprising a bend152connecting the shield portion102and the flange114. As shown inFIG.3andFIG.4, the leg150is disposed beneath the gap146. The leg provides additional stability to the living hinge108.

In some embodiments, the shield portion102further comprises a locking member160including two locking projections, a first locking projection162and a second locking projection164, facing each other and projecting from the side walls120,122and configured to engage with a locking tab170. The locking tab170includes a first tab172and ramp173which cooperates with the first locking projection ramp163of the locking member160and a second tab174and ramp which cooperate with the second locking projection ramp165of the locking member160. The first tab172and the second tab174of the locking tab170respectively push the first locking projection162and second locking projection164outwards. The first locking projection ramp163engages with the ramp173of the first tab172and the second locking projection ramp165engages with the ramp173of the second tab174. After the first locking projection ramp163and the second locking projection ramp165are moved beyond the ramp173of the first tab172and the ramp175of the second tab174, the locking projections162,164snap locks to the locking tab170to secure the shield portion102in a protecting position180. In this position, when the shield portion102is in the protected position180over the needle cover240, the device is in the ready to use position. A medical practitioner can grip the shield portion102and rotate the shield portion102away from the needle cover240, for example, as in the position shown inFIG.1. When the practitioner is ready to inject a patient, the needle cover240is removed to expose the needle cannula202. After injection of the patient, the shield portion is rotated so that the shield portion102is in a protected position180over the needle cannula202.

In one or more embodiments, the shield portion102, the bridge portion106, the hub connection portion104and the living hinge108comprise a unitary structure integrally molded of thermoplastic material.

Another aspect of the disclosure pertains to a needle shield and needle assembly comprising the needle assembly100shown and described herein including the needle cannula202having a proximal end203, a distal end205and a lumen206therethrough, and a hub208having an outer surface209, an open proximal end210including a cavity212therein and a distal end214attached to the proximal end of the needle cannula202so that the lumen206is in fluid communication with the cavity212. The needle shield and needle assembly comprise the elongate needle shield100comprising a shield portion102, a hub connection portion104and a bridge portion106including a living hinge108having a thickness TH, the bridge portion106joining the hub connection104portion and the shield portion102. The hub connection portion comprises a receiving ring112having a diameter D sized to frictionally receive the hub outer surface209when the needle assembly200is inserted through the receiving ring112and a flange114extending from the receiving ring112defining a top planar surface116and a bottom surface118. The flange114has a thickness TF, the thickness of the flange TF divided by the thickness of the living hinge TH defining a ratio of from 1.1 to 6.

In one or more embodiments, the thickness of the flange TF divided by the thickness of the living hinge TH defines a ratio of 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.

If the thickness of the living hinge TH is too great, the living hinge will not be flexible enough, and the shield will not be easily closed over the needle cannula. On the other hand, if the thickness of the living hinge TH is too small, the living hinge will be prone to breaking. 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 above provided ranges. If the ratio defined by the thickness of the flange TF divided by the thickness of the living hinge TH is outside the defined ranges, 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 portion106and the hub connection portion104of the needle shield assembly100. In one or more embodiments, in addition to being within the ratios provided above, the living hinge108has a thickness TH in a range of from 0.1 mm to 0.3 mm, for example 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm or 0.3 mm) and the flange TF114has a thickness in a range of from 0.4 mm to 0.8 mm (for example 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).

The shield portion102has two side walls, a first side wall120and a second sidewall122, defining a longitudinal opening124and a back wall126between the side walls120,122defining a recess127having an interior surface128. The shield portion102is configured to pivot from an open position in which the needle cannula is exposed (see e.g.,FIG.1andFIG.7), to a closed protected position180in which the distal end205of the needle cannula202is protected within the longitudinal opening124of the shield.

In one or more embodiments, the needle shield and needle assembly further comprises a plurality of radial projections220extending from the needle hub, the radial projections220spaced from the open proximal end210so that the hub208remains seated in the receiving ring112when the needle assembly200has been inserted through the receiving ring. As best shown inFIG.6A, the radial projections220are engaged with the periphery of the receiving ring112to prevent the hub208from being moved through the flange. The radial projections220are configured to prevent the hub208from being moved in a proximal direction to be pushed through the receiving ring112.

In an exemplary use of the disclosure, a practitioner unpacks needle shield assembly100from packaging in an open position190. The practitioner assembles and secures syringe310to hub208of needle assembly200. Once syringe310has been engaged with the hub208, the needle cover240is removed from the needle assembly200and injection occurs. The practitioner removes the needle cannula202from the patient. Either with or without the syringe310secured to the hub208of the needle assembly200, practitioner rotates the hub connection portion104about the bridge portion106to toggle the needle shield assembly100from the open position190to the protected position180. In the protected position180, the locking tab170and the locking member160are fully engaged, thus shielding the needle cannula202from accidental post-injection needle sticks.

Referring now toFIG.6B, the cylindrical wall extension which extends below the bottom surface118of the flange114and provides a cylindrical receiving structure130for the hub208comprises an inner surface135and splines136.FIG.6Cshows the hub as having complementary hub splines224which are configured to engage the spline136on the inner surface135of the cylindrical receiving structure130. In the embodiment shown, the splines136are hollow sections on the inner surface135, and the hub splines224are elongate radial protrusions that are complementary to and configured to seat within the splines136. Thus, the splines136are female splines and the hub splines224are male splines. It will be understood that this figuration could be reversed. In the embodiment shown, twenty-four splines136are shown on the inner surface135of the cylindrical receiving structure130. In this configuration, the splines are space apart by 15 degrees around the periphery of the cylindrical receiving structure130. It will be understood that the number of splines can be varied so that the splines are spaced apart by 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). There are four hub splines224shown inFIG.6C, and this number can vary and include one, two, three, four, five, six, seven, eight, nine or then hub splines224.

The hub splines224and the splines136are configured to cooperate to allow rotation of the hub208with respect to the shield portion102. The hub splines224and the splines136in some embodiments are configured to create a tactile or perceptible click during each rotation as the hub splines224and the splines136engage and disengage each other as the hub208is rotated with respect to the shield portion.

In one or more embodiments, toggling the needle shield assembly100from open position190to protected position180may be completed in a variety of ways. During injection, the practitioner may be required to use one hand to press the injection site with a sanity cloth or pad during or after injection. The practitioner can remove the needle cannula202from the skin and single-handedly toggle the needle shield assembly100by rotating the syringe, thus using the weight of the shield portion102to fold over the hub connection portion104and fully engage the protected position180. Additionally, a practitioner may use a flat surface like a patient table, for example, to rotate the shield portion102about the bridge portion106to engage the protected position180.

In one or more embodiments, a needle cannula clip (not shown) may be disposed within the longitudinal opening124of the shield portion102configured to receive the needle cannula202to increase shielding while the needle shield assembly100is in the protected position180.

In one or more embodiments, after an injection is performed, a practitioner can remove the needle assembly200from the receiving ring112of the hub connection portion104while the needle shield assembly100is engaged in the protected position180.

In one or more embodiments, the hub208is rotatable within the receiving ring112. The outside diameter of the hub208at the complementary hub splines224is configured so that there is a friction fit between the hub208and the receiving ring112, allowing rotation of the hub208to be set by the practitioner, but not too loose to allow free rotation. This configuration permits a proper or a preferred orientation of a bevel on the needle cannula202to be varied depending on a particular medical procedure. For example, subcutaneous, intravenous or intradermal types of injections typically require the needle to be inserted at various angles in relation to the patient's skin (e.g., 45 degrees, 25 degrees, 10 degrees respectively), with the needle bevel typically in the up position (facing away from the skin surface) and the bevel visible to the clinician. As such, it is advantageous for the hub208to be rotated to a position such that the needle bevel is not obstructing the clinician's view of the needle bevel. In intermuscular injection, the bevel is typically 90 degrees to the patient's skin. As such, the needle bevel rotational orientation in relation to the safety needle cover does not matter because the clinician does not need to see the bevel orientation.

In one or more embodiments, the open proximal end210of the hub208comprises lugs222that are configured to be engaged with a threaded collar315of a syringe310having a distal end312and a proximal end313so that the needle shield and needle assembly connectable to the syringe310. As shown inFIG.9, the syringe310may further comprise a plunger320having a distal end322and a proximal end323. The distal end322may include a stopper324having a distal tip325. In use the hub208shown inFIG.9can be inserted in the receiving ring112of the needle shield assembly100, and the syringe310can be connected to the hub by engaging the lugs222with threaded collar314of the syringe310.

The plunger320can be positioned in fluid-tight engagement with the inside surface of the barrel of the syringe for drawing fluid into and driving fluid out of the barrel chamber by movement of the stopper relative to the barrel. The 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 to the method and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.