ANESTHESIA SAFETY NEEDLE DEVICE

Needle covers having a clam-shell configuration configured to removably attach to a feature of a needle while the needle is inserted into the skin of a patient. The needle cover comprises a base having connecting feature, and a two-piece hinged cap connected to the base by two living hinges.

TECHNICAL FIELD

The present disclosure relates to safety needle device covers, and in particular the present disclosure relates to clam-shell needle sleeves and covers for needles and introducer needles.

BACKGROUND

It is estimated that 600,000 to 800,000 needlestick injuries occur per year in the United States. Vascular Access Devices (VAD) are used throughout the medical industry for the injection and withdrawal of a wide variety of fluids and solutions into and from the human body. Because of the numerous potential hazards associated with the handling and manipulation of bodily fluids, particularly blood, there are a number of known safety features that are frequently incorporated into various types of needle devices to protect the practitioner from accidental exposure to the needle. Needlesticks are a common occurrence in the health care profession.

Conventional vascular access devices are retrieved from a blister package, the needle shield is removed and then the plastic hub is attached to a luer lock or luer slip syringe. Drug from a vial is then retrieved and administered to the patient via injection. In spinal applications such as spinal anesthesia where there is an introducer needle and a spinal needle that are withdrawn together, once the anesthesia drug delivery is completed, the needle assembly is withdrawn from body and disposed without putting the needle shield back in place which can result in needlestick injury or cross contamination. The needle is then discarded either as is or after capping, both methods carrying their own risks of injury or contamination. On the other hand, a safety needle has an extra step wherein an additional component, the safety shield, is deployed to permanently “engulf” the needle thereby making it inaccessible. This ensures that the needle cannot be reused and also contributes to healthcare worker safety—by protecting them from contaminated needle stick injury. This extra step of safety needles are enabled by either a unique hub design that acts as a base for the safety mechanism to attach onto or a very complicated safety shield mechanism.

Thus, there is a need to provide a cover and needle shield for vascular access devices and spinal anesthesia needle assemblies incorporating features that reduce needle stick injuries while reducing manufacturing costs, including materials and molding complexity. Furthermore, there is a need to provide a method for removing a vascular access device and spinal anesthesia needle which reduces needle stick injuries.

SUMMARY

A first aspect of the present disclosure relates to a needle cover device having a base and a two-piece hinged cap. The base has a rectangular shape and a connecting feature, the connecting feature configured to removably interdigitate with a feature of a needle hub. The two-piece hinged cap is connected to the base by two living hinges, the two-piece hinged cap having a proximal surface and a distal surface, the two-piece hinged cap having a rectangular medial portion forming a cavity configured to enclose at least the needle hub within. Each of the two-piece hinged cap has a rectangular medial portion and a lateral portion, the medial portion having a rectangular cavity formed on the distal surface configured to accommodate the needle hub, and the lateral portion having a cavity configured to accommodate a needle cannula.

In some embodiments, the connecting feature of the base comprises a pair of teeth forming a channel, the pair of teeth and channel configured to interdigitate with a flange of the needle hub. In some embodiments, the pair of teeth have a u-shaped cross-section which can be sized and dimensioned to accommodate the flange of the needle hub.

In some embodiments, the two-piece hinged cap is configured to pivot at least 180 degrees around each of the two living hinges from an open position to a closed position, wherein each distal surface of each two-piece hinged cap is closed onto the other in the closed position.

In some embodiments, each of the living hinges extend an entire width of the rectangular shape of the medial portion.

In some embodiments, the medial portion is configured to cover and accommodate an assembled spinal anesthesia introducer needle hub and spinal needle hub. In some embodiments, the connecting feature connects to a flange of the spinal needle hub. In some embodiments, the rectangular cavity has a length LFextending from the flange of the spinal needle hub slightly past the distal end of the introducer needle hub such that the introducer needle hub and spinal needle hub are fully enclosed within the rectangular cavity.

In some embodiments, the connecting feature is configured to attach to a flange of the needle hub by sliding the foldable needle cover in a medial direction relative to the needle hub.

In some embodiments, the medial portion further includes a winged tab extending from the proximal surface configured to provide a surface area for manipulating and closing the two-piece hinged cap.

In some embodiments, distal edges of the lateral portion of each of the two-piece hinged cap are configured to interlock with one another in a snap-fit configuration.

In some embodiments, the foldable needle cover is injection molded forming a singular unitary body.

A second aspect of the present disclosure is directed to method of covering a spinal-introducer needle assembly. The method comprises the steps of sliding a foldable needle cover in a medial direction relative to a syringe assembly over a spinal-introducer needle assembly; withdrawing the spinal-introducer needle assembly and syringe assembly while the foldable needle cover is attached to the spinal-introducer needle assembly; and, closing the foldable needle cover over the spinal-introducer needle assembly.

In some embodiments, the foldable needle cover is slidable over the spinal-introducer needle assembly while the spinal-introducer needle assembly is still at least partially inserted within a patient.

In some embodiments, the foldable needle cover is closed over the spinal-introducer needle assembly by depressing winged tabs located on a two-piece hinged cap of the foldable needle cover, the two-piece hinged cap connected to a base of the foldable needle cover by two living hinges. In some embodiments, depressing the winged tabs causes the two-piece hinged cap to pivot on the two living hinges.

In some embodiments, the spinal-introducer needle assembly and syringe assembly90are withdrawn with one hand from the skin of a patient while the foldable needle cover is attached to the spinal-introducer needle assembly.

In some embodiments, the spinal-introducer needle assembly is withdrawn while closing the foldable needle cover over the spinal-introducer needle assembly simultaneously.

A second aspect of the present disclosure is directed to a safety needle devise assembly comprising an introducer needle, a two-piece hinged cap and a sliding block. The introducer needle has an introducer needle hub and an introducer needle cannula extending from a distal end of the introducer needle hub, the introducer needle hub having a pair of attachment points positioned at the distal end of the introducer needle hub. The two-piece hinged cap has an elongated body connected to the pair of attachment points a pair of corresponding attachment points located on a medial portion of the two-piece hinged cap, the two-piece hinged cap having a proximal surface and a distal surface, the distal surface having a cavity configured to enclose at least the introducer needle cannula within, each medial portion including a tab extending from the proximal surface. The sliding block is configured to open or close the two-piece hinged cap, the sliding block having a proximal wall, a distal wall and a sidewall therebetween defining a cavity, the distal wall configured to abut the tabs of the two-piece hinged cap.

In some embodiments, the assembly further comprises a spinal needle connected to the introducer needle.

In some embodiments, the attachment points of the introducer needle hub create a snap connection with the pair of corresponding attachment points of the two-piece hinged cap.

In some embodiments, introducer needle hub further comprising a pair of wings extending from an outside surface of the introducer needle hub, the pair of wings having a width greater than a width of an opening of the proximal wall of the sliding block.

In some embodiments, the pair of wings are configured to interdigitate with a channel formed on an inside surface of the side wall of the sliding block.

In some embodiments, the proximal wall of the sliding block is removable from the sliding block. In some embodiments, the distal wall is against the tabs of the two-piece hinged cap. In some embodiments, the distal wall of the sliding block is against the tabs of the two-piece hinged cap.

In some embodiments, movement of the sliding block in a proximal direction causes the two-piece hinged cap to pivot about the attachment points of the introducer needle hub causing the two-piece hinged cap to open from a closed position to an open position

DETAILED DESCRIPTION

As used herein, the use of “a,” “an,” and “the” includes the singular and plural.

As used herein, the term “Luer connector” refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of one or more interlocking tubes, slightly tapered to hold together with just a simple pressure/twist fit/friction fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. The Luer connector can interlock and connect to the end located on the vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe. As used herein, the term “Luer connector” refers to a male luer connector or a female luer connector.

As used herein, the term “medical device” refers to common medical devices having threaded or interlocking connections, the connections having corresponding mating elements. By way of example but not limitation, a syringe may have a threaded connection which releasably interlocks with a secondary medical device such as a needless connector of a catheter, an IV line and the like. The threaded connection may include a lumen defining a fluid path surrounded by a protruding wall having the threaded means for attaching to the secondary medical device.

As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “thread”, “taper”, “tab”, “wall”, “proximal”, “side”, “distal” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.

Embodiments of the present disclosure are directed to foldable needle sleeves and covers having a clam-shell configuration. The foldable needle cover of the embodiments described are configured to removably attach to a feature of a needle hub. By way of example but not limitation, the foldable needle cover can be configured to removably attach to a flange, ledge or taper of a needle hub. The needle hubs, needles and cannulas described herein can be conventional in the art or can include non-standard or novel features. In further embodiments described herein, a needle hub is configured to include pivot points for a two-piece hinged cap. In further embodiments, a slider is configured to cover at least part of the pivot points thereby preventing opening of the two-piece hinged cap.

Embodiments of the foldable needle covers disclosed herein and shown inFIGS.1through6Dattach to a spinal-introducer needle assembly10. The foldable needle cover100is capable of attachment to the spinal-introducer needle assembly10while the spinal-introducer needle assembly10is still inserted into the skin of a patient. As the spinal-introducer needle assembly10is withdrawn, the foldable needle cover100can be closed and securely cover the spinal-introducer needle assembly10, thereby preventing needle stick injuries.

FIGS.1A and1Bshow an exemplary spinal-introducer needle assembly10comprising an introducer needle20and a spinal needle60.FIG.1Aillustrates a side view of the spinal-introducer needle assembly10andFIG.1Billustrates a cross-sectional view of the spinal-introducer needle assembly10. The introducer needle20comprises an introducer needle cannula22having a distal end24, the introducer needle cannula22extending from a distal end30of an introducer needle hub26. The needle hub26comprises a proximal end28and the distal end30. The spinal needle60comprises a spinal needle cannula62having a distal end64, the spinal needle cannula62extending from a distal end70of a spinal needle hub66. The spinal needle hub66comprises a proximal end68and the distal end70. In the embodiments described herein, the foldable needle cover100ofFIGS.1through6Dand the safety needle assembly200ofFIGS.7through12are configured to operate with the entire spinal-introducer needle assembly10, however in some embodiments, the foldable needle cover100and the safety needle assembly200can also be operable with only one of the introducer needle20or spinal needle60. In even further embodiments, the foldable needle cover100and the safety needle assembly200is operable with conventional needles and cannulas. As the drawings are not to scale, the foldable needle cover100and the safety needle assembly200can be sized and configured to cover or protect conventional needles and cannulas of any size or gauge.

The introducer needle cannula22has a length LINdefined by the distal end24of introducer needle cannula22to the distal end30of introducer needle hub26, and likewise the spinal needle cannula62has a length LSNdefined by distal end64of spinal needle cannula62to the distal end70of spinal needle hub66. The introducer needle cannula22has a needle gauge greater than a needle gauge of the spinal needle cannula62such that the spinal needle cannula62can be inserted through the introducer needle cannula22. As shown in the figures, the introducer needle20receives the spinal needle60such that the distal end70of spinal needle hub66fully abuts the proximal end28of introducer needle hub26. In such a configuration, the spinal-introducer needle assembly10has a total length LSIdefined by the proximal end68of spinal needle hub66to the distal end64of spinal needle cannula62. Furthermore, with the introducer needle hub26abutted against the, the two needle hubs (26,66) have a total length LHdefined by the proximal end68of spinal needle hub66to the distal end30of introducer needle hub26. The length LSNof the spinal needle cannula62is longer than the introducer needle hub26and the length LINof the introducer needle cannula22such that the distal end64of spinal needle cannula62extends beyond the distal end24of introducer needle cannula22.

In some embodiments, the distal end70of spinal needle hub66abuts the proximal end28of introducer needle hub26. In some embodiments, the distal end70of spinal needle hub66is at least partially inserted within the proximal end28of introducer needle hub26. In some embodiments, the distal end70of spinal needle hub66is releasably secured to the proximal end28of introducer needle hub26by way of a luer connector, a snap connection or an interference fit.

In operation, the introducer needle20can first be inserted into the skin of a patient and the spinal needle60can then be inserted into the proximal end28of introducer needle hub26of the introducer needle20. After completion of the medical procedure, the entire spinal-introducer needle assembly10is withdrawn together.

FIG.2illustrates a syringe assembly90attached to the spinal-introducer needle assembly10by way of a luer slip connection between the proximal end68of spinal needle hub66and a luer connector92extending from a distal end94of a barrel96of the syringe assembly90. In some embodiments, the syringe assembly90is attached to the spinal-introducer needle assembly10by way of a threaded connection or a snap connection.

A foldable needle cover100according to one or more embodiments is removably attached to the spinal needle hub66aa explained in further detail below.FIG.2illustrates the foldable needle cover100in a closed position andFIG.3illustrates the spinal-introducer needle assembly10attached to the foldable needle cover100in an open position.FIG.4illustrates a detailed view of the foldable needle cover100andFIGS.5A and5Billustrate cross-sectional views of the foldable needle cover100in the closed position with the spinal-introducer needle assembly10closed within.

As shown inFIGS.2-4,5A and5B, the foldable needle cover comprises a rectangular base110which removably attaches to the spinal-introducer needle assembly10via a connecting feature112. In the embodiments depicted, the connecting feature112is in the form of a pair of teeth114which interdigitate with a flange78of the spinal needle hub66as best shown inFIGS.5A and5B. The pair of teeth114form a channel116between them in which the flange78of the spinal needle hub66slides into. As best shown inFIGS.5A and5B, in some embodiments, the pair of teeth114have a u-shaped cross-section which can be sized and dimensioned to accommodate the flange78of the spinal needle hub66. In some embodiments, the width between the pair of teeth114is configured to create an interference fit between the flange78of the spinal needle hub66and the pair of teeth114. In some embodiments, the u-shaped cross-section is configured to prevent longitudinal movement of the connecting feature112.

In some embodiments, the pair of teeth114and channel116are configured to interdigitate with a feature of the introducer needle hub26. In some embodiments, the pair of teeth114and channel116are configured to interdigitate with ridges, flanges or valleys of the introducer needle hub26and the spinal needle hub66. In some embodiments, the pair of teeth114and channel116are configured create an interference fit with the feature it removably attaches to.

The foldable needle cover100further comprises a two-piece hinged cap (120,122) connected to the base110by two living hinges (124.126), each living hinge of the two living hinges (124.126) corresponding to a hinged cap of the two-piece hinged cap (120,122). Each two-piece hinged cap (120,122) is configured to pivot at least 180 degrees around each of the two living hinges (124.126) from an open position as shown inFIG.3to a closed position as shown inFIG.2.

The foldable needle cover100, base110and two-piece hinged cap (120,122) have a proximal surface128and a distal surface130in the open position as shown inFIG.3. For purposes of clarity, said surfaces shall still be referred to as proximal and distal even when the foldable needle cover100is in the closed position as shown inFIG.2.

As shown in theFIG.3, the two-piece hinged cap (120,122) is initially in an open position with the distal surface130of each two-piece hinged cap (120,122) facing in a distal direction. As shown inFIG.2, in the closed position the distal surface130of each two-piece hinged cap (120,122) has rotated 90 degrees relative to the depicted initial position, closing each distal surface130of each two-piece hinged cap (120,122) onto the other, thereby enclosing the spinal-introducer needle assembly10within.

Each of the two-piece hinged cap (120,122) has a medial portion132and a lateral portion150relative to the base110. The medial portion132of some embodiments is rectangular in shape and has a rectangular cavity134formed on the distal surface130. As shown inFIGS.5A and5B, the medial portion132is configured to cover and accommodate the assembled introducer needle hub26and spinal needle hub66. As shown inFIG.4, the rectangular shape of the medial portion132of both of the two-piece hinged cap (120,122) is connected to the rectangular base110by the living hinge (124,126), the living hinge (124,126) extending the entire width of the rectangular shape of the medial portion132, thereby providing greater support for the living hinge (124,126).

As shown inFIG.5B, the rectangular cavity134has a length LFextending from the flange78of the spinal needle hub66(onto which the connecting feature112of the foldable needle cover100attaches to,) slightly past the distal end30of the introducer needle hub26such that the introducer needle hub26and spinal needle hub66are fully enclosed within the rectangular cavity134. “Slightly past” within the context of the length LFis a length LFwhich has sufficient clearance to accommodate the distal end30of the introducer needle hub26.

In some embodiments, the rectangular cavity134is configured to also cover and accommodate the entire length LSNof the spinal needle60, thereby completely covering the entire spinal-introducer needle assembly10from the flange78of the spinal needle hub66to the spinal needle60. In some embodiments, the medial portion132of each two-piece hinged cap (120,122) further includes a winged tab136extending from the proximal surface128. The winged tab136configured to provide a greater surface area for manipulating and closing the two-piece hinged cap (120,122).

In some embodiments, the foldable needle cover100disclosed herein is configured to interdigitate, slide onto or otherwise removably attach to one or more features of either of the introducer needle hub26or the spinal needle hub66. Such features can include ridges, flanges or valleys of either of the introducer needle hub26or the spinal needle hub66. In some embodiments, ridges can include a ridge32of introducer needle hub26or a ridge72of spinal needle hub66as shown inFIGS.1A and1B. Flanges can include a flange34of introducer needle hub26or a flange (74,78) of spinal needle hub66as shown inFIGS.1A,1B,5A and5B. Valleys can include a valley76of spinal needle hub66or a valley76of spinal needle hub66as shown inFIGS.1A and1B. Thus, whereFIG.5Billustrates the length LFof the rectangular cavity134extending from the flange78of the spinal needle hub66(onto which the connecting feature112of the foldable needle cover100attaches to,) slightly past the distal end30, the connecting feature112of the foldable needle cover100can interdigitate with a different feature, thereby changing the length of the rectangular cavity134. By way of example, but not limitation, in some embodiments, the connecting feature112of the foldable needle cover100can connect to the flange74of the spinal needle hub66as shown inFIG.1A. In such a configuration, the length of the rectangular cavity134can be less than the length LFdue to the connecting feature112being configured to connect to a different feature or element of the spinal-introducer needle assembly10.

In some embodiments, the medial portion132of each of the two-piece hinged cap (120,122) as shown inFIGS.2-4, further includes snap locks (138,140) which are configured to lock with one another upon closure of the two-piece hinged cap (120,122). In some embodiments, the snap locks (138,140) are configured to non-removably lock with one another upon closure of the two-piece hinged cap (120,122). In some embodiments, one of the snap locks140is configured as a set of tabs projecting from the medial portion132and the other of the snap locks138is configured as a set of hooks which can elastically deform and engage with the set of tabs. In some embodiments, the snap locks (138,140) are located at a lateral end142of the medial portion132.

Adjacent and lateral to the lateral end142of the medial portion132, a lateral portion150extends therefrom. The lateral portion150is configured to envelop the introducer needle cannula22and the introducer needle hub26. In some embodiments, distal edges (152,154) of the lateral portion150of each of the two-piece hinged cap (120,122) are configured to interlock with one another in a snap-fit configuration. In some embodiments, edges (152,154) of the lateral portion150of each of the two-piece hinged cap (120,122) are configured to non-removably interlock with one another in a snap-fit configuration.

Due to the live-hinge configuration of the foldable needle cover100, the foldable needle cover100can be injection molded forming a singular unitary body. Thus, the foldable needle cover100can be cheap to manufacture from a single mold and can be included in a kit for an anesthesia needle assembly. Furthermore, as explained in further detail below, the foldable needle cover100, (due to its connecting feature112being slidable onto a hub of the spinal-introducer needle assembly10) can be attached to the spinal-introducer needle assembly10while the spinal-introducer needle assembly10is still inserted within the skin of a patient. Thus, in operation, a practitioner can attach the foldable needle cover100onto the spinal-introducer needle assembly10, and upon removal of the spinal-introducer needle assembly10, the foldable needle cover100can be non-removably closed together as the spinal-introducer needle assembly10is removed from the skin of a patient. Thus, the step of re-inserting the introducer needle hub26or the spinal needle hub66back into a needle-sleeve is not required as the foldable needle cover100fully envelops the entire spinal-introducer needle assembly10.

FIGS.6A through6Dillustrate a method of covering a spinal-introducer needle assembly10within a foldable needle cover100in accordance with one or more embodiments of the present disclosure. As shown inFIG.6A, the method includes the steps of holding the syringe assembly90and spinal-introducer needle assembly10with one hand and the foldable needle cover100with the other hand. As shown inFIG.6B, the method further includes the steps of sliding the foldable needle cover100in a medial direction relative to the syringe assembly90over the spinal-introducer needle assembly10as previously described. In some embodiments, the foldable needle cover100is slidable over the spinal-introducer needle assembly10while the spinal-introducer needle assembly10is still at least partially inserted within the skin of a patient. As shown inFIG.6C, the method further includes the step of withdrawing the spinal-introducer needle assembly10and syringe assembly90with one hand from the skin of a patient while the foldable needle cover100is still attached to the spinal-introducer needle assembly10. As shown inFIG.6D, the method further includes the step of closing the foldable needle cover100over the spinal-introducer needle assembly10by depressing the winged tabs136, thereby causing the two-piece hinged cap (120,122) to pivot on the two living hinges (124.126). In some embodiments, the steps ofFIGS.6C and6Dcan be completed simultaneously, where a practitioner performs the steps of withdrawing the spinal-introducer needle assembly10while simultaneously closing the foldable needle cover100over the spinal-introducer needle assembly10by depressing the winged tabs136. In some embodiments, the closed foldable needle cover100in the closed position along with the spinal-introducer needle assembly10can be safely disposed of.

As shown inFIGS.7-12, embodiments of the present disclosure are further directed to a safety needle assembly200comprising the introducer needle20as previously described, a two-piece hinged cap (220,222) and a sliding block260configured to open or close the two-piece hinged cap (220,222). In some embodiments, the safety needle assembly200further comprises the spinal needle60connected to the introducer needle20as previously described. The sliding block260is configured to open or close the two-piece hinged cap (220,222) as the sliding block260is translated from a proximal to distal direction without having to further manipulate the safety needle assembly200or the two-piece hinged cap (220,222) as explained in further detail below.

FIG.7illustrates a perspective view of the safety needle assembly200in a closed position.FIG.8illustrates a perspective view of the safety needle assembly200with one of the two-piece hinged cap (220,222) separated from the safety needle assembly200.FIG.9illustrates the illustrates a perspective view of the safety needle assembly200with both of the two-piece hinged cap (220,222) separated from the safety needle assembly200.FIG.10illustrates a cross-sectional view of the sliding block260.FIG.11Aillustrates a cross-sectional view of the safety needle assembly200andFIG.11Billustrates a detailed cross-sectional view of the safety needle assembly200.FIG.12illustrates a cross-sectional view of the safety needle assembly200in an open position.

As shown inFIGS.7through9, the introducer needle20further includes a pair of wings212extending longitudinally from an outside surface210of the introducer needle hub26. The introducer needle20further includes attachment points (214,216) on the outside surface210of the introducer needle hub26for connecting the two-piece hinged cap (220,222) to the introducer needle hub26as explained in further detail below. In some embodiments, the introducer needle hub26is a rectangular elongated body. In some embodiments, the introducer needle hub26is a circular or oval elongated body. In some embodiments, the introducer needle hub26is a rectangular elongated body with opposing flat faces. In some embodiments, as shown inFIG.8, the attachment points (214,216) are located on opposing flat faces211of the introducer needle hub26.

The attachment points (214,216) in the depicted embodiments consist of two pairs of apertures partially extending into the outside surface210of introducer needle hub26and are located on opposite sides on the introducer needle hub26. Each of the two pairs of apertures and the attachment points (214,216) are configured to create a snap connection with a pair of corresponding attachment points (224,226) of the two-piece hinged cap (220,222). In some embodiments, the attachment points (214,216) of the introducer needle hub26are positioned at a right angle relative to the pair of wings212of the introducer needle hub26. Stated differently and as best shown inFIG.8, in some embodiments the attachment points (214,216) are located on opposing flat faces211of the introducer needle hub26and the pair of wings212extend from faces213which is at a right angle with the opposing flat faces211of the attachment points (214,216). In some embodiments, the faces213are also flat.

In some embodiments, the attachment points (214,216) of the introducer needle hub26are positioned at the distal end30of the introducer needle hub26. In some embodiments, as shown inFIG.11A, a distal edge213the pair of wings212is positioned a distance DWfrom the distal end30of introducer needle hub26, and the pair of wings212have a longitudinal length LW. Furthermore, as shown inFIG.11B, the pair of wings212have a total width WWdefined by the distance between the pair of wings212.

Referring back toFIGS.7through9, each of the two-piece hinged cap (220,222) has a proximal surface228and a distal surface230, the distal surfaces of the two-piece hinged cap (220,222) configured to close on each other. The two-piece hinged cap (220,222) has an elongated body with a cavity within the distal surface230. As shown inFIG.12, the two-piece hinged cap (220,222) is initially in an open position with the distal surface230of each two-piece hinged cap (220,222) are facing in a distal direction. As shown inFIG.7, in the closed position the distal surface230of each two-piece hinged cap (220,222) has closed relative to the depicted initial position, thereby closing each distal surface130of each two-piece hinged cap (120,122) onto the other and enclosing the introducer needle cannula22and spinal needle cannula62within.

Each of the two-piece hinged cap (220,222) has a medial portion232and a lateral portion250. Each of the medial portion232comprises a tab236extending from the proximal surface228in a proximal direction relative to the proximal surface228and the pair of corresponding attachment points (224,226). In the depicted embodiments, the pair of corresponding attachment points (224,226) are in the form of tabs or protrusions positioned on the distal surface230and extend inwardly such that the tabs or protrusions are opposite each other. The tabs or protrusions are configured to interrogate in a snap-lock configuration with the apertures of the attachment points (214,216) of the introducer needle hub26.

As used herein, the term “attachment points (214,216) of the introducer needle hub26” refer to a pair of attachment points (214,216) positioned on opposing faces of the introducer needle hub26as previously described. Thus, a first pair of attachment points214comprises two apertures on opposing faces213of the of the introducer needle hub26and a second pair of attachment points216adjacent to the first pair of attachment points214. Thus, the introducer needle hub26has a total of four apertures which each interdigitate with the corresponding attachment points (224,226). In the figures, only two apertures are shown, however it is to be understood that the two unshown apertures are positioned opposite the face presented in the figures. Likewise, as used herein the term “pair of corresponding attachment points (224,226)” refer to two tabs or protrusions for each of the two-piece hinged cap (220,222). Thus, a first pair of the corresponding attachment points224interdigitates with the first pair of attachment points214of the introducer needle hub26and a second pair of the corresponding attachment points226interdigitates with the first pair of attachment points216. The tabs and apertures described form snap-fit configurations in which a tab is seated within an aperture by elastically deforming the two-piece hinged cap (220,222) over the introducer needle hub26.

As shown inFIG.8, the tab236extends in a perpendicular plane relative to the pair of corresponding attachment points (224,226) of the two-piece hinged cap (220,222). As shown inFIGS.8and11Bwhere the two-piece hinged cap (220,222) is in the closed position, the tabs236of the two-piece hinged cap (220,222) are on the same plane as the pair of wings212, and are on a perpendicular plane to the attachment points (214,216) of the introducer needle hub26and the corresponding attachment points (224,226) of the two-piece hinged cap (220,222). As shown inFIG.11B, the tabs236have a total width WTas defined by the length between proximal edges of the tabs236. The two-piece hinged cap (220,222) in some embodiments has a greater cross-sectional width than the lateral portion250and further comprises a medially-located cut-out234to permit a wider range of motion when opening the two-piece hinged cap (220,222) relative to the introducer needle hub26. As shown inFIGS.5A and5B, the lateral portion250is configured to cover and accommodate the introducer needle cannula22and the spinal needle cannula62.

As shown inFIGS.7and10-12, the safety needle assembly200further comprises a sliding block260having an elongated body having a substantially cylindrical cross-sectional shape. In some embodiments, the sliding block260is rectangular in shape. In some embodiments, the sliding block260is oval in shape. In some embodiments, the sliding block260is rectangular in shape with two flat faces and two rounded faces. In some embodiments, the sliding block260comprises gripping features264at least partially covering the outside surface262of one or more faces of the sliding block260. As shown inFIG.7, in some embodiments the gripping features264are a plurality of ribs.

As shown inFIGS.10and11A-11B, the sliding block260is hollow having a cavity266, a proximal wall268having a proximal wall opening270, and a distal wall272and a distal wall opening284. Between the proximal wall268and distal wall272extends a side wall276having an inside surface278. From the inside surface278of the side wall276a set of protrusions280extend in a medial direction away from the inside surface278. The set of protrusions280in some embodiments also extend longitudinally from the proximal wall268to the distal wall272. The set of protrusions280in some embodiments also extend longitudinally from the proximal wall268to a distance towards the distal wall272. The set of protrusions280in some embodiments also extend longitudinally a distance from the proximal wall268to a distance towards the distal wall272. The set of protrusions280define a channel282in which the pair of wings212of the introducer needle hub26can slide proximally or distally between the proximal wall268and distal wall272of the sliding block260. The channel282is configured to limit rotational movement of the introducer needle hub26.

In some embodiments, the proximal wall268is separable from the sliding block260. In some embodiments, the proximal wall268is a unitary body with the sliding block260. In some embodiments, the proximal wall268is removably or non-removably threaded or snap-fit onto the sliding block260. In some embodiments, the proximal wall268is non-removably adhered, welded, sonic welded or otherwise non-removably attached onto the sliding block260.

As shown inFIG.11B, the proximal wall opening270has a width WTwhich is less than the total width WWof the pair of wings212but greater than the width of the introducer needle hub26such that the introducer needle hub26can slide through the proximal wall opening270. Likewise, the distal wall distal wall opening274has a width WBwhich is less than the total width WTof the tabs236but greater than the width of the introducer needle hub26such that the introducer needle hub26can slide through the distal wall opening274. In some embodiments, a distance DBdefined by the proximal wall268to the distal wall272can be configured to have the proximal wall268abutting the pair of wings212and the distal wall272abutting the tabs236of the two-piece hinged cap (220,222) in the closed position.

In such a configuration, the sliding block260can longitudinally travel relative to the introducer needle hub26in a distal direction until the pair of wings212abuts against the proximal wall268, and in a proximal direction until the two-piece hinged cap (220,222) are opened 180 degrees relative to each other as explained in further detail below.

As shown inFIG.8, the two-piece hinged cap (220,222) can be attached to the attachment points (214,216) of the introducer needle hub26by way of the pair of corresponding attachment points (224,226) of the two-piece hinged cap (220,222). In such a configuration, each of the two-piece hinged cap (220,222) can freely pivot around the attachment points (214,216) of the introducer needle hub26. In some embodiments, the two-piece hinged cap (220,222) can freely pivot between 0 degrees at the closed position as shown inFIG.7to 90 degrees from the fully closed position to an open position. Stated differently, each of the two-piece hinged cap (220,222) opens 90 degrees relative to the closed position, and each of the two-piece hinged cap (220,222) are 180 degrees from each other. In some embodiments, each of the two-piece hinged cap (220,222) can open more than 90 degrees.

As shown inFIG.11A, after the two-piece hinged cap (220,222) is attached to the introducer needle hub26, the sliding block260can be slid onto the introducer needle hub26. The proximal wall268can be slid from a proximal to distal direction and the sliding block260absent the proximal wall268can be slid from a distal to proximal direction until the proximal wall268and the sliding block260can be removably or non-removably attached to one another as previously described. Thus, the initial and fully closed position is defined by the proximal wall268abutting the proximal surface of the pair of wings212of the introducer needle hub26and the distal wall272abutting the bottom surface of the tabs236of the two-piece hinged cap (220,222), and the two-piece hinged cap (220,222) is closed.

As shown inFIG.12, and as illustrated by the arrow indicating motion, the sliding block260is pulled by one hand in a proximal direction as indicated by arrow A. Proximal sliding motion of the sliding block260then causes the distal wall272to pull the tabs236of the two-piece hinged cap (220,222) which causes the two-piece hinged cap (220,222) to pivot about the attachment points (214,216) of the introducer needle hub26as indicated by arrows B and B′. The sliding block260can advance until the two-piece hinged cap (220,222) pivots 90 degrees relative to the closed position or until a medial surface238of the tabs236abuts against the outside surface210of the introducer needle hub26, thereby serving as a hard stop. A fully open position as shown inFIG.12is defined by the medial surface238of the tabs236abutting against the outside surface210of the introducer needle hub26.

In operation, a practitioner can pull the safety needle assembly200out of a package or kit, grasp the sliding block260and pull the sliding block260in a proximal direction until the safety needle assembly200is either in a fully open position or an intermediate position anywhere between the fully open and fully closed position. The safety needle assembly200can then be inserted into the skin of a patient and the desired medical procedure can be performed. Upon removal of the safety needle assembly200, the safety needle assembly200can be withdrawn while simultaneously pulling the sliding block260in a proximal direction, thereby closing the two-piece hinged cap (220,222).

As shown inFIG.11A, the longitudinal length LWof the pair of wings212, the distance DW(the distance between the distal edge213the pair of wings212and the distal end30of introducer needle hub26) and the distance DB(the distance between the proximal wall268to the distal wall272) can all be configured to limit the range of motion of the two-piece hinged cap (220,222) as shown by arrows A, B and B′ ofFIG.12.

Further embodiments are directed to a method of assembling a safety needle assembly200comprising the steps of attaching the two-piece hinged cap (220,222) to the attachment points (214,216) of the introducer needle hub26, closing the two-piece hinged cap (220,222), sliding the sliding block260absent the proximal wall268over the two-piece hinged cap (220,222) until the distal wall272abuts the bottom surface of the tabs236of the two-piece hinged cap (220,222), sliding the proximal wall268over the introducer needle hub26and securing or adhering the proximal wall268to the sliding block260. In some embodiments, the method further comprises abutting the spinal needle hub66against the introducer needle hub26as previously explained.

Further embodiments are directed to a method of use of a safety needle assembly200comprising the steps of can pulling the safety needle assembly200out of a package or kit, grasping the sliding block260and pulling the sliding block260in a proximal direction until the safety needle assembly200is either in a fully open position or an intermediate position anywhere between the fully open and fully closed position. In some embodiments, the method further comprises the step of inserting the safety needle assembly200into the skin of a patient. In some embodiments, the method further comprises the steps of removing of the safety needle assembly200from the skin of a patient. In some embodiments the method further comprises the steps of pulling the sliding block260in a proximal direction, thereby closing the two-piece hinged cap (220,222). In some embodiments, the method further comprises the steps of removing of the safety needle assembly200from the skin of a patient while simultaneously pulling the sliding block260in a proximal direction, thereby closing the two-piece hinged cap (220,222).

While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and/or the outer housing of the disinfection cap can be single shot molded, or made by other suitable process. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the spirit and scope of the embodiments of the present disclosure.

In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans skilled in the relevant field of invention.