Subcutaneous safety needle

Abstract

A safety needle device for connection to a medical connector including a threaded connection. The safety needle includes a collar configured to interlock with a conventional needle hub, the collar having an attachment point for a hinged cap, the hinged cap being of two-piece construction. In a further embodiment, the safety needle device includes a removable rigid needle enclosure configured to cover a distal portion of the needle cannula and needle hub. The rigid needle enclosure further includes a cap configured to interlock with a needle cover and cover a proximal portion of the needle hub. The cap and at least a portion of the needle cover are covered by a removable sleeve, which holds the cap and needle cover together. A further embodiment includes a needle hub, a needle cover, an adapter, and a cap, the adapter configured to attach to a conventional needle cap.

Description

Technical Field

[0001] The present disclosure relates to a subcutaneous safety needle having a simplified design for reducing raw materials and speeding up the molding and manufacturing processes. The present disclosure relates to a passive safety needle device that combines the aspects of packaging and safety as a whole into a single design.

Background Art

[0002] Background Clean or sterile articles that are particularly useful for medical applications are packaged to maintain their sterility. The packaging of these articles is intended to provide a barrier to prevent microorganisms from entering the interior of the package and contaminating its contents. In most cases, the packaging is opened immediately before use of the article, such as a blister pack that houses a needle, to minimize the time the article is exposed to the sterile state. After use of the needle, the packaging is discarded separately from the needle.

[0003] Needle devices are used throughout the medical industry for the injection and withdrawal of a wide variety of liquids and solutions into and from the human body. Due to the numerous potential risks associated with the handling and manipulation of body 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.

Summary of the Invention

Problems to be Solved by the Invention

[0004] A "conventional" subcutaneous needle is removed from a blister package, the needle shield is removed, and then the plastic hub is attached to a Luer lock or Luer slip syringe. Thereafter, the drug is removed from the vial and administered to the patient by injection. The needle is either discarded as is or after capping in a recommended manner. On the other hand, a safety needle has an additional component, a safety shield, which is positioned to permanently "surround" the needle, thereby providing an extra step to prevent access to the needle. This contributes to the safety of healthcare workers by ensuring that the needle is not reused and by protecting them from contaminated needle stick injuries.

[0005] This extra step is made possible by either a unique hub design that functions as a base for attaching the safety mechanism or a very complex safety shield mechanism. This hub is bulkier and more difficult to mold compared to a conventional needle hub. Also, the safety mechanism itself is similarly composed of parts that are difficult to mold and bulky. The needle shield is made of thick plastic to ensure that the needle is not damaged before use. Furthermore, the needle shield that protects the needle before use has no usefulness after use and is discarded, increasing the amount of plastic used.

[0006] Such features are limited to their purpose. The needle shield only provides protection during transportation and storage and plays no role in the safety function of the device. The safety shield is a complex molded part and interfaces with the needle hub, and the connection of the safety shield to the needle hub is also complexly molded, increasing the cost of both parts. Therefore, there is a need to provide a safety needle device that incorporates the features of both the needle shield and the safety shield while reducing manufacturing costs, including material and molding complexity. Furthermore, there is a need to provide a rigid needle enclosure or rigid needle cover that provides needle sterility and eliminates the need for blister packs. Means for Solving the Problems

[0007] Summary A first aspect of the present disclosure relates to a safety needle device comprising a needle hub, a needle cannula, a removable collar, and a two-piece hinged cap having two elongated bodies in a clam shell configuration. The needle hub is configured to couple to a syringe having a distal portion and a proximal portion, and the needle hub has a substantially cylindrical shape. The needle cannula extends from the distal portion of the needle hub. The removable collar has a substantially cylindrical body, an opening extending through the substantially cylindrical body, and two attachment points disposed on an outer surface of the collar, the opening being dimensioned and configured to receive the proximal portion of the needle hub, and the two attachment points being configured for attachment to the two-piece hinged cap. The two-piece hinged cap has two elongated bodies in a clam shell configuration, the two elongated bodies being configured to close with each other, each of the elongated bodies having a semi-circular cross-section and a cavity defined by an open proximal end and a closed distal end, and a loop extending from the open proximal end, the loop being configured to interdigitate with the two attachment points of the collar.

[0008] In one or more embodiments of the first aspect, the proximal portion of the needle hub is tapered in the distal direction. In one or more embodiments, the needle hub further comprises at least one threaded portion included on an outer surface of the proximal portion of the needle hub, the at least one threaded portion being configured to engage a standard ISO-2 type luer fitting. In one or more embodiments of the first aspect, the opening of the collar is dimensioned and configured to create an interference fit with the proximal portion of the needle hub.

[0009] In one or more embodiments of the first aspect, the color aperture is sized and configured to create a loose fit with the proximal portion of the needle hub. In one or more embodiments, the collar rotates freely around the proximal portion of the needle hub. In one or more embodiments, the collar is configured to snap into the needle hub to create an interference fit, and the collar is configured to rotate freely only when sufficient force is applied, thereby resisting free movement. In one or more embodiments, the two attachment points are configured as hooks sized to receive the loop of the two-piece hinge cap. In one or more embodiments of the first aspect, the two attachment points are sized and shaped to create a snap fit with the loop of the two-piece hinge cap.

[0010] In one or more embodiments of the first aspect, the two attachment points create an interference fit with a loop configured to resist free movement. In one or more embodiments of the first side, the collar and the two-piece hinge cap are integrally formed. In one or more embodiments, the two attachment points are configured as a living hinge. In one or more embodiments of the first side, the living hinge is configured to have a residual spring action, and the living hinge is in an open state in its rest position. In one or more embodiments of the first side, the open state of the living hinge resists movement of the two-piece hinge cap. In one or more embodiments of the first side, the elongated body of the two-piece hinge cap is configured to snap together when fully closed. In one or more embodiments of the first side, the two-piece hinge cap is configured to move freely, and the collar is configured to rotate freely around the needle hub in the open state of the safety needle device.

[0011] In one or more embodiments of the first aspect, the two-piece hinge cap is configured to rotate, thereby enabling the operator to clearly view markings disposed on the barrel of the syringe and ensuring that the correct dosage is measured. In one or more embodiments of the first aspect, the two-piece hinge cap is configured to move away from the barrel of the syringe, thereby enabling the operator to clearly view markings disposed on the barrel of the syringe and ensuring that the correct dosage is measured.

[0012] In one or more embodiments of the first aspect, each of the two-piece hinge caps can be independently and freely opened or closed. In one or more embodiments of the first aspect, one of the two-piece hinge caps is movable independently of the other of the two-piece hinge caps. In one or more embodiments, the needle cannula is fully exposed in the open state. In one or more embodiments, the two-piece hinge cap is movable from 0 degrees relative to the cannula to at least a few degrees relative to the needle cannula. In one or more embodiments of the first aspect, the two-piece hinge cap is self-closing in the closed state. In one or more embodiments, the safety needle device is supplied packaged in the closed state. In one or more embodiments of the first aspect, the two-piece hinge cap is held in the closed state by a disposable plastic seal or sleeve disposed over the two-piece hinge cap.

[0013] In one or more embodiments of the first aspect, the closed end portion of the two-piece hinge cap is configured to lock non-removably when the two-piece hinge cap is closed. In one or more embodiments, the safety needle device further comprises a sleeve disposed over the two-piece hinge cap in the closed state, the sleeve being longitudinally movable over the two-piece hinge cap. In one or more embodiments, the closed end portion of the two-piece hinge cap is configured to lock non-removably when the two-piece hinge cap is closed, and the closed end portion defines a final closed state. In one or more embodiments of the first aspect, the two-piece hinge cap further comprises a locking mechanism disposed at a distance from the closed end portion of the two-piece hinge cap.

[0014] In one or more embodiments of the first aspect, the locking mechanism comprises a hook tab projecting from one edge of the two-piece hinge cap and a corresponding opening disposed within a cavity of the other side of the two-piece hinge cap. In one or more embodiments of the first aspect, the opening is configured to receive the hook tab in a mutually engaging and removable or non-removable manner.

[0015] In one or more embodiments of the first aspect, the opening is configured to receive the hook tab in a mutually engaging and removable manner in the closed state. In one or more embodiments of the first aspect, the opening is configured to receive the hook tab in a mutually engaging and non-removable manner in the closed state. In one or more embodiments, the locking mechanism comprises an opening disposed within a cavity of one side of the two-piece hinge cap and a corresponding hook tab projecting from the other edge of the two-piece hinge cap. In one or more embodiments of the first aspect, the safety needle device further comprises a pressing feature disposed on the elongate body of the two-piece hinge cap.

[0016] In one or more embodiments of the first aspect, the pressing feature has a triangular shape, and the triangular shape has a hypotenuse surface configured to abut against the barrel surface of the syringe when the needle hub is connected to the luer connector of the syringe. In one or more embodiments, the hypotenuse surface is configured to assist in pressing the two-piece hinge cap together. In one or more embodiments of the first aspect, the Upright triangular surface is configured to assist in separating the two-piece hinge cap.

[0017] In one or more embodiments of the first aspect, an opening extending through the front elevation of the triangular shape forms an edge between the opening and the hypotenuse surface, and the hypotenuse surface is configured to assist in separating the two-piece hinge cap. In one or more embodiments of the first aspect, the pressing feature is configured as a tab protruding from the elongated body of the two-piece hinge cap. In one or more embodiments of the first side, the tab includes a neck, a thumb pressing surface, and a barrel engaging surface, and the barrel engaging surface is configured to abut against the barrel surface of the syringe when the needle hub is connected to the luer connector of the syringe. In one or more embodiments, the thumb pressing surface is configured to assist in pressing the two-piece hinge cap onto each other. In one or more embodiments of the first aspect, the distal end of the thumb pressing surface is configured to enable the operator to separate the two-piece hinge cap.

[0018] In one or more embodiments of the first aspect, the thumb pressing surface is substantially parallel to the two-piece hinge cap. In one or more embodiments of the first aspect, the barrel engaging surface extends at an angle with respect to the thumb pressing surface. In one or more embodiments of the first side, the barrel engaging surface extends perpendicular to the thumb pressing surface. In one or more embodiments, the thumb pressing surface is disposed on the neck, the thumb pressing surface is substantially perpendicular to the two-piece hinge cap, and the barrel engaging surface extends perpendicular to the thumb pressing surface.

[0019] A second aspect of the present disclosure relates to a rigid package safety needle device comprising a rigid needle enclosure including a needle hub, a needle cannula, a needle cover, and a cap. The needle hub is configured to couple to a syringe having a distal portion and a proximal portion, and the needle hub has a substantially cylindrical shape. The needle cannula extends from the distal portion of the needle hub. The needle cover has an elongated body, a cavity defined by an open proximal end portion and a closed distal end portion, a proximal portion, an intermediate portion, and a distal portion. The proximal portion has a cylindrical surface configured to mate with the cap. The intermediate portion is defined by a flange extending from the elongated body, and the elongated body further has an inner surface of a cavity having a proximal inner surface, an intermediate inner surface, and a distal inner surface. The proximal inner surface includes a ribbed surface configured to create an interference fit with the proximal portion of the hub. The cap includes a substantially cylindrical body having an open distal end portion, a closed proximal end portion, and a cavity defined by the open distal end portion and the closed proximal end portion. The open distal end portion of the cap abuts the open proximal end portion of the needle cover.

[0020] In one or more embodiments of the second aspect, the needle hub further comprises a plurality of longitudinal ribs extending from the distal portion of the needle hub. In one or more embodiments, the intermediate inner surface of the needle cover includes a plurality of protrusions extending from the intermediate surface, and the plurality of protrusions are configured to interlock with the plurality of longitudinal ribs of the needle hub. In one or more embodiments of the second aspect, each of the plurality of longitudinal ribs is nested between two of the plurality of protrusions to prevent rotational movement of the needle hub. In one or more embodiments of the second aspect, a removable interference fit is created between the proximal portion of the needle hub and the ribbed surface of the proximal inner surface.

[0021] In one or more embodiments of the second side, the cap further comprises a plurality of protrusions extending from the inner surface of the cavity of the cap, and the plurality of protrusions extend longitudinally from the inner surface. In one or more embodiments of the second aspect, the plurality of protrusions of the cap comprise a terminal portion adjacent to the open end end of the cap, and the terminal portion is tapered inwardly from the open end end, and the taper is configured to create an interference fit with the proximal portion of the needle cover when inserting the cap onto the proximal portion of the needle cover. In one or more embodiments of the second aspect, the proximal portion of the plurality of protrusions of the cap further extends from the inner surface of the cap and is configured to abut against the proximal portion of the needle hub when inserting the cap onto the proximal portion of the needle cover. In one or more embodiments, the rigid needle enclosure further comprises a sleeve formed within a cylindrical shape having an open proximal end, an open distal end, and a plurality of perforations radially disposed around the cylindrical shape, and the plurality of perforations are configured to break when separating the needle cover from the cap.

[0022] In one or more embodiments of the second aspect, the sleeve further comprises a tab formed integrally with the sleeve. In one or more embodiments of the second side, the tab includes labeling or instructions. In one or more embodiments, the sleeve is heat-sealed to the needle that covers the cap. In one or more embodiments of the second side, the sleeve is configured as a proof-of-opening seal. In one or more embodiments of the second side, the sleeve completely covers the proximal end portions of the cap and the needle cover. In one or more embodiments, the plurality of perforations are near or directly above the open distal end of the cap and the open proximal end of the needle cover when the rigid needle enclosure is assembled.

[0023] A third aspect of the present disclosure relates to a rigid-packaged safety needle device comprising a needle hub, a needle cannula, and a rigid enclosure including a needle cover, an adapter, and a cap. The needle hub is configured to couple to a syringe having a distal portion and a proximal portion, and the needle hub has a substantially cylindrical shape. The needle cannula extends from the distal portion of the needle hub. The needle cover is configured to receive the needle cannula and the distal portion of the needle hub, and the needle cover has a tapered cylindrical outer surface. The adapter has a substantially cylindrical body including a proximal portion, a distal portion, and an outer cylindrical surface, the distal portion having a tapered opening configured to create an interference fit and a sterile barrier with the tapered cylindrical outer surface of the needle cover, and the proximal portion having a second cavity in communication with the tapered opening. The cap has a substantially cylindrical shape including a distal opening defining a first cavity, and the cap is configured to engage with the adapter such that the first cavity of the cap receives the proximal portion of the adapter.

[0024] In one or more embodiments of the third aspect, the outer cylindrical surface creates or forms an interference fit and a sterile barrier with the inner surface of the first cavity when the adapter and the first cavity of the cap are connected. In one or more embodiments, the outer cylindrical surface creates or forms a snap fit and a sterile barrier with the inner surface of the first cavity when the adapter and the first cavity of the cap are connected. In one or more embodiments of the third aspect, the outer cylindrical surface is removably adhesively bonded onto the inner surface of the first cavity. In one or more embodiments of the third aspect, the outer cylindrical surface is threaded into the inner surface of the first cavity.

[0025] In one or more embodiments of the third aspect, the tapered opening of the adapter is configured to interlock with a conventional needle or a commercially available needle. In one or more embodiments, the rigid needle enclosure further comprises a hinge having a distal connection to the outer cylindrical surface of the adapter and a proximal connection to the outer cylindrical surface of the cap. In one or more embodiments of the third aspect, the rigid needle enclosure is released with one hand by applying a proximal force F to the outer cylindrical surface of the adapter opposite the hinge. In one or more embodiments of the third aspect, the proximal opening and the distal opening are removably bonded with an adhesive.

[0026] In one or more embodiments of the third aspect, the rigid needle enclosure further comprises a label disposed on the end wall of the first cavity of the cap. In one or more embodiments of the third aspect, the label indicates that the rigid needle enclosure has been opened or used. In one or more embodiments of the third aspect, the label includes words, numbers, or symbols. In one or more embodiments, the label includes a biological hazard symbol.

[0027] In one or more embodiments of the third aspect, the cap further comprises a second cavity having an inner surface, and the second cavity of the cap is configured to interlock with the adapter. In one or more embodiments, the outer cylindrical surface of the adapter creates or forms an interference fit and a sterile barrier with the inner surface of the first cavity when the first cavity of the adapter and the cap are connected. In one or more embodiments of the third aspect, the adapter further comprises a shelf portion having a triangular shape, the front elevation of the shelf portion is located on the side opposite the inclined surface of the shelf portion, and the shelf portion of the adapter is disposed on the outer surface of the adapter.

[0028] In one or more embodiments of the third aspect, the cap comprises a retaining tab disposed on the inner surface of the first cavity, and the tab is configured to removably snap fit with the shelf portion of the adapter when the adapter is inserted into the first cavity of the cap. In one or more embodiments of the third aspect, the cap further comprises a shelf portion including a locking surface disposed on the inner surface of the first cavity, the shelf portion of the cap has a triangular shape, the front elevation of the shelf portion of the cap is located on the opposite side of the inclined surface of the shelf portion, and the shelf portion of the cap is configured to generate a non-removable snap fit with the shelf portion of the adapter when the adapter is inserted into the second cavity of the adapter.

Brief Description of the Drawings

[0029]

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[0030] Detailed Description Embodiments of the present disclosure provide a safety mechanism incorporating features of both a needle shield and a safety shield mechanism, with the aim of reducing material costs, manufacturing complexity, and waste.

[0031] Embodiments of the present disclosure relate to a safety needle device for connection to a medical connector including a screw connection portion. In one or more embodiments, the safety needle comprises a collar configured to interengage with a conventional needle hub, the collar having an attachment point for a hinge cap, the hinge cap being of a two-piece construction. In further embodiments, the safety needle device comprises a removable rigid needle enclosure configured to cover the needle cannula and the distal portion of the needle hub. The rigid needle enclosure further comprises a cap configured to interengage with the needle cover to cover the proximal portion of the needle hub. The cap and at least a portion of the needle cover are covered by a removable sleeve that holds the cap and the needle cover together. Further embodiments comprise a needle hub, a needle cover, an adapter and a cap, the adapter being configured to attach to a conventional needle cap. The present disclosure provides a safety mechanism incorporating features of both a needle shield and a safety shield mechanism and is aimed at reducing material costs, manufacturing complexity, and waste.

[0032] Other embodiments of the present disclosure relate to a rigid packaged needle device including a rigid needle enclosure. In one or more embodiments, the rigid needle enclosure provides a sterile package for the needle, eliminating the need for blister packaging of the needle.

[0033] Before describing some exemplary embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of the structures or process steps defined in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0034] For the following description, the terms "top," "bottom," "longitudinal," and derivatives thereof shall relate to this disclosure as oriented in the drawing figures. However, it is understood that this disclosure may contemplate alternative variations and step sequences, except as expressly specified to the contrary. Also, it should be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of this disclosure. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0035] As used herein, the use of "a," "an," and "the" includes both singular and plural.

[0036] As used herein, the term "luer connector" refers to a connection collar, which is a standard way of attaching syringes, catheters, hub needles, IV tubes, etc. to each other. A luer connector consists of one or more interlocking tubes that are slightly tapered to hold together by simple pressure / twist fit / friction fit. Optionally, the luer connector may further be threaded on the outer edge to allow for increased safety. A luer connector can be connected in an interlocking manner to an end located on a vascular access device (VAD). The luer connector comprises a central passage contoured to provide fluid communication from a chamber of a barrel of a syringe to a hub of a VAD. The luer connector also has a distal end channel for releasably attaching the luer connector to the hub of the VAD and a proximal end channel for releasably attaching the luer connector to the barrel of the syringe. As used herein, the term "luer connector" refers to a male luer connector or a female luer connector.

[0037] As used herein, the term "medical device" refers to a general medical device having a threaded connection or an interlocking connection, the connection having corresponding mating elements. By way of example, and not limitation, a syringe may have a threaded connection that releasably interlocks with a secondary medical device such as a needle connector for a catheter, IV line, etc. The threaded connection may include a lumen defining a fluid path surrounded by a protruding wall having screw means for attaching to the secondary medical device.

[0038] As will be readily understood by those of ordinary skill in the relevant art, descriptive terms such as "thread", "taper", "tab", "wall", "top", "side", "bottom", etc. are used throughout this specification to facilitate understanding, but are not intended to limit any of the components that may be used in combination or individually to implement the various aspects of the present disclosure.

[0039] The first embodiment of the safety needle device includes a removable collar configured to engage with a conventional needle hub. The collar has an attachment point for a hinge cap, and the hinge cap is a two-piece construction that folds to cover the needle cannula of the needle hub. In one or more embodiments, the collar and the two-piece hinge cap are configured as a shield assembly that can be attached to a conventional needle hub and may be packaged separately. In one or more embodiments, the two-piece hinge cap is configured as a reuse prevention mechanism by irreversibly snapping after use of the needle. In one or more embodiments, the collar is configured to rotate freely around the needle hub, whereby the operator can move the two-piece hinge cap out of sight or away from the insertion site. In a further embodiment, the safety needle device includes a removable rigid needle cover configured to cover the needle cannula and the distal portion of the needle hub. The rigid needle enclosure further includes a cap configured to engage with the needle cover to cover the proximal portion of the needle hub. The cap and at least a portion of the needle cover are covered by a removable sleeve that holds the cap and the needle cover together. A further embodiment includes a needle hub, a needle cover, an adapter, and a cap, and the adapter is configured to attach to a conventional needle cap. In an exemplary embodiment of the embodiments of the present disclosure, the sterilization cap includes an integrated screw or tab and any and all other features in any combination that enable it to interface with a threaded joint of a medical device. In a preferred embodiment, the sterilization cap interfaces with a luer fitting. Exemplary configurations of couplers, joints, ports, and adapters may include commercially available luer locks, luer slip ports, lock ports, screw connections, interlocking connections, or other common medical device joints known in the art.

[0040] Referring now to the drawings, like reference numerals indicate identical or corresponding parts throughout several views, and embodiments of the present disclosure are described as follows.

[0041] As depicted in FIG. 1, the first embodiment of the safety needle device 100 includes a removable collar 130 configured to engage with the needle hub 110. The collar 130 has two attachment points (132, 134) for the two-piece hinge cap (140, 142). The hub 110 is configured to couple to a syringe. The two-piece hinge cap (140, 142) is configured to fold over and cover the needle cannula 112 of the needle hub 110. In one or more embodiments, the two-piece hinge cap (140, 142) is configured as a reuse prevention mechanism by irreversibly snapping after use of the needle cannula 112. In one or more embodiments, the two-piece hinge cap (140, 142) is configured as a shield assembly that may be fitted onto a conventional needle hub or packaged separately. In one or more embodiments, the collar 130 is configured to rotate freely around the needle hub 110, whereby the practitioner can move the two-piece hinge cap (140, 142) out of the field of view or away from the insertion site. In one or more embodiments, the collar 130 is configured to engage non-removably with the needle hub 110 to prevent removal of the collar 130.

[0042] As shown in FIG. 2, the needle hub 110 comprises a cylindrical body having a distal portion 114 and a proximal portion 116. From the distal portion 114, a needle cannula 112 extends in the distal direction. In one or more embodiments, the distal portion 114 further includes a plurality of longitudinal ribs 115. The proximal portion 116 has a substantially cylindrical shape. In one or more embodiments, the proximal portion 116 is tapered in the distal direction. The proximal portion 116 further comprises a cavity in fluid communication with the lumen, the cavity being configured to receive the hub of a luer connector. In one or more embodiments, the cavity may be configured to facilitate a loose fit between the cavity and the hub of the luer connector, and the needle hub 110 is secured by a set of at least one threaded portion 118 or tabs included on the outer surface of the proximal portion 116. The at least one threaded portion 118 is sized to have a thread pattern that engages a standard ISO-2 type luer fitting. In a further embodiment, the cavity may be configured to facilitate an interference fit between the cavity and the hub of the luer connector in a luer slip fitting. In one or more embodiments, the interference fit may be configured to be strong enough such that a screw connection or at least one threaded portion 118 is not required when removably securing the cavity to the luer connector. In one or more embodiments, the at least one threaded portion 118 can include an inclined thread pattern. In one or more embodiments, the at least one threaded portion 118 can include a helical thread pattern. Such connectors are commonly used as catheters and other fluid tight protection connectors in medical applications. Further alternative embodiments are non-removably or removably assembled with screw connections, press fit connections, adhesive connections, or combinations thereof.

[0043] As shown in FIG. 3, the removable collar 130 comprises a substantially cylindrical body having an opening 136 extending therethrough. The opening 136 is sized to receive the proximal portion 116 of the needle hub 110. In one or more embodiments, the opening 136 is sized and configured to create an interference fit with the proximal portion 116 of the needle hub 110. In one or more embodiments, the opening 136 is sized and configured to create a loose fit with the proximal portion 116 of the needle hub 110. In one or more embodiments, the collar 130 rotates freely about the proximal portion 116 of the needle hub 110. In one or more embodiments, the collar 130 is configured to snap into the needle hub 110, whereby the collar 130 can rotate freely but cannot move longitudinally and is thus not removable from the needle hub 110. In one or more embodiments, the collar 130 can be removed upon application of sufficient force, which is greater than the force normally exhibited by the device, thereby preventing inadvertent removal. In one or more embodiments, the collar 130 is configured to snap into the needle hub 110 to create an interference fit, whereby the collar 130 can rotate freely only upon application of sufficient force, thereby resisting free movement.

[0044] Color 130 further includes two attachment points (132, 134) disposed on the outer surface of Color 130, and each of the two attachment points (132, 134) is configured to attach to each of the two-piece hinge caps (140, 142). In one or more embodiments, the two attachment points (132, 134) are disposed 180 degrees apart from each other. In one or more embodiments, the two attachment points (132, 134) protrude from the outer surface of Color 130 in the form of hooks, and each hook is configured such that the hook receives loops (144, 146) of the two-piece hinge caps (140, 142). The two attachment points (132, 134) are dimensioned and shaped to snap-fit with the loops (144, 146) of the two-piece hinge caps (140, 142). In one or more embodiments, the two attachment points (132, 134) protrude from the outer surface of Color 130 in the form of loops, and each loop is configured to interlock with a hook of the two-piece hinge caps (140, 142). In one or more embodiments, the two attachment points (132, 134) and the loops (144, 146) also create an interference fit, whereby the two attachment points (132, 134) can rotate freely only when sufficient force is applied, thereby resisting free movement.

[0045] In one or more embodiments, Color 130 and the two-piece hinge caps (140, 142) are integrally formed. In one or more embodiments, Color 130 and the two-piece hinge caps (140, 142) are integrally formed, and the two attachment points (132, 134) are configured as a living hinge. In one or more embodiments, the two attachment points (132, 134) are configured as a living hinge having a residual spring action, and the living hinge is in an open state in its rest position. The open state of the living hinge resists movement of the two-piece hinge caps (140, 142) and keeps the two-piece hinge caps (140, 142) away from the insertion site.

[0046] As shown in FIG. 4, each piece of the two-piece hinge cap (140, 142) comprises an elongated body having a semi-circular cross-section. Each of the two elongated bodies has a cavity (148, 150) defined by an open proximal end (152, 154) and a closed distal end (156, 158). From the open proximal ends (152, 154), loops (144, 146) extend that are configured to engage with two attachment points (132, 134) disposed on the outer surface of the collar 130. The two-piece hinge cap (140, 142) is configured as a clam shell configuration, and each of the elongated bodies is configured to close with each other, providing a closed cavity that protects the needle cannula 112. In one or more embodiments, the elongated bodies snap together when fully closed. In one or more embodiments, each of the two-piece hinge caps (140, 142) is identical to each other. In one or more embodiments, each of the two-piece hinge caps (140, 142) is configured to be manufactured or injected from the same mold, thus reducing manufacturing costs through simplification of molding.

[0047] In one or more embodiments, as shown in FIG. 5, the safety needle device 100 is packaged and supplied to a healthcare provider in a closed state. In one or more embodiments, the safety needle device 100 is packaged within a blister package to maintain sterility. In the closed state, the two-piece hinge cap (140, 142) is reversibly closed over itself. In one or more embodiments, the two-piece hinge cap (140, 142) is held in the closed state by a disposable plastic seal or sleeve disposed over the two-piece hinge cap (140, 142). In one or more embodiments, the disposable seal or sleeve is loosely fitted over the two-piece hinge cap (140, 142). In one or more embodiments, the disposable plastic seal or sleeve has a perforation or break point configured to break when separating the two-piece hinge cap (140, 142). In one or more embodiments, the disposable plastic seal or sleeve has a pull tab configured to separate the disposable plastic seal or sleeve when a force away from the two-piece hinge cap (140, 142) is applied. In one or more embodiments, the disposable plastic seal or sleeve is sealed with an adhesive that is weak enough to separate when a force is applied to move it away from the two-piece hinge cap (140, 142).

[0048] As shown in FIG. 5, the assembled safety needle device 100 is in an open state, in which state the two-piece hinge cap (140, 142) can be freely opened or closed or moved, and the collar 130 can rotate freely around the needle hub 110. In the open state, the needle cannula 112 is fully exposed and may be inserted into the patient's skin. For the free movement of the two-piece hinge cap (140, 142) and the collar 130 relative to the needle hub 110, the operator can move the two-piece hinge cap (140, 142) away from the insertion site or rotate or move it out of the operator's field of view. In the open state, the two-piece hinge cap (140, 142) is movable from 0 degrees relative to the cannula 112 to at least 170 degrees relative to the needle cannula 112. In one or more embodiments, the two-piece hinge cap (140, 142) is movable from 0 degrees relative to the cannula 112 to at least 150 degrees relative to the needle cannula 112. In one or more embodiments, the two-piece hinge cap (140, 142) is movable from 0 degrees relative to the cannula 112 to at least 125 degrees relative to the needle cannula 112. In one or more embodiments, the two-piece hinge cap (140, 142) is movable from 0 degrees relative to the cannula 112 to about 170 degrees relative to the needle cannula 112.

[0049] Throughout the entire region of operation, the operator can rotate or move the two-piece hinge cap (140, 142) away from the barrel of the syringe, thereby ensuring that the correct dosage is measured with a clear view of the markings located on the barrel of the syringe. In one or more embodiments, each of the two-piece hinge caps (140, 142) can be freely opened or closed independently, and one of the two-piece hinge caps (140, 142) is movable independently of the other of the two-piece hinge caps (140, 142).

[0050] As shown in FIGS. 5 and 6, during the administration of a medical treatment, the operator may close the two-piece hinge cap (140, 142) over itself to place the safety needle device 100 in its final closed state. This operation may be performed with the same hand used to perform the medical treatment or with the opposite hand. Since the two-piece hinge cap (140, 142) closes by snap fit, the pressure on the two-piece hinge cap (140, 142) is sufficient to close the two-piece hinge cap (140, 142). In one or more embodiments, the closing end portions (156, 158) of the two-piece hinge cap (140, 142) are configured to lock non-removably when the two-piece hinge cap (140, 142) is closed in its final closed state, thereby preventing reuse of the safety needle device 100. The safety needle device 100 in its final closed state may then be discarded in accordance with conventional biological hazardous waste practices.

[0051] In an alternative embodiment, a sleeve may be disposed over the two-piece hinge cap (140, 142) in its closed state. The sleeve can move longitudinally up and down over the two-piece hinge cap (140, 142), in which case it presses the two-piece hinge cap (140, 142) together or pulls the two-piece hinge cap (140, 142) apart, or alternatively allows the two-piece hinge cap (140, 142) to separate. In one or more embodiments, the two-piece hinge cap (140, 142) is molded with a living hinge having a residual spring action. In one or more embodiments, the sleeve locks the two-piece hinge cap (140, 142).

[0052] The second embodiment of the present disclosure is shown in FIGS. 7-9, and the second embodiment incorporates elements of the embodiments disclosed herein. The two-piece hinge cap (240, 242) of the safety needle device 200 further comprises a locking mechanism disposed at a distance from the closed end portions (256, 258) of the two-piece hinge cap (240, 242). The locking mechanism comprises a hook tab 264 projecting from one edge 265 of the two-piece hinge cap (240, 242) and a corresponding opening 268 disposed within the other cavity 250 of the two-piece hinge cap (240, 242), the opening 268 being configured to receive the hook tab 264 removably or non-removably in engagement with each other. In one or more embodiments, one of the two-piece hinge caps (240, 242) further comprises an opening 266 disposed within one cavity 248 of the two-piece hinge cap (240, 242) and a corresponding hook tab 269 projecting from the other edge 257 of the two-piece hinge cap (240, 242), the opening 268 being configured to receive the hook tab 269 removably or non-removably in engagement with each other.

[0053] As shown in FIG. 9, the hook tab 264 is received within the corresponding opening 268 and the hook tab 269 is received within the corresponding opening 268, locking the two-piece hinge cap (240, 242) together removably or non-removably. In one or more embodiments, the locking mechanism is configured to lock non-removably upon closure of the two-piece hinge cap (240, 242) in its final closed state, thereby preventing reuse of the safety needle device 200. The safety needle device 200 in its final closed state may then be discarded in accordance with conventional biological hazardous waste practices.

[0054] As shown in FIGS. 8 - 11, in one or more embodiments, each of the two - piece hinge caps (240, 242) of the safety needle device 200 further includes a pressing feature (260, 262) configured to abut against the barrel surface of the syringe when the needle hub 210 is connected to the luer connector of the syringe and in an open state. The pressing features (260, 262) are disposed on the elongate body of the two - piece hinge caps (240, 242). In one or more embodiments, the pressing features (260, 262) have a triangular shape, and the triangular shape includes a hypotenuse surface (270, 272) configured to contact the barrel surface of the syringe when the needle hub 210 is connected to the luer connector of the syringe while in an open state, and an upright surface (274, 276), and the upright surface (274, 276) is perpendicular to the surface of the elongate body of the two - piece hinge caps (240, 242). In one or more embodiments, the pressing features (260, 262) are configured as grip features to assist in the operation of the two - piece hinge caps (240, 242).

[0055] In one or more embodiments, as shown in FIG. 10, the hypotenuse surface (270, 272) further includes a textured or hatched surface 273. The textured or hatched surface 273 assists in the operation of the two - piece hinge caps (240, 242). In one or more embodiments, the hypotenuse surface (270, 272) assists in pressing the two - piece hinge caps (240, 242) together. In one or more embodiments, the upright surface (274, 276) further includes an opening 275 extending therethrough. The edge 277 formed by the opening 275 and the hypotenuse surface (270, 272) is configured to enable or assist an operator in separating the two - piece hinge caps (240, 242).

[0056] As shown in FIG. 11A, the safety needle device 200 is in a fully open state, and the beveled surfaces (270, 272) abut against the barrel surface of the syringe. In the fully open state, the two-piece hinge cap (240, 242) can be freely opened, closed, or moved, and the collar 230 can rotate freely around the needle hub 210. In the fully open state, the two-piece hinge cap (240, 242) is movable from 0 degrees with respect to the cannula 212 to at least 175 degrees with respect to the needle cannula 212. Throughout the entire range of motion, the operator can rotate or move the two-piece hinge cap (240, 242) away from the barrel of the syringe, thereby enabling the operator to have a clear view of the markings disposed on the barrel of the syringe and ensuring that the correct dosage is measured.

[0057] As shown in FIG. 11B, the safety needle device 200 is in a fully open state and is attached to the syringe barrel 90. The syringe barrel 90 includes an elongated cylindrical body 91 having an open proximal end (not shown) and a distal end 92 that defines a cavity for holding fluid. The cylindrical body 91 has an outer cylindrical surface 94, which, in some embodiments, has markings or fluid volume indicators.

[0058] The proximal portion 216 of the needle hub 110 is inserted over an elongated tip (not shown) disposed on the distal end 92 of the barrel 90 to secure the needle hub 110 over the elongated tip. In the fully open state, the beveled surfaces (270, 272) abut against the outer cylindrical surface 94 of the syringe barrel 90 to form a rigid stop for the range of motion of the two-piece hinge cap (240, 242). As shown, the two-piece hinge cap (240, 242) in the fully open state is at an angle of 170 degrees with respect to the cannula 212, whereby the beveled surfaces (270, 272) abut against the outer cylindrical surface 94 of the syringe barrel 90. As shown, in the fully open state, the needle cannula 212 is fully exposed and unobstructed, so that the operator can fully view the insertion of the needle cannula 212 into the insertion site of the patient's skin.

[0059] In one or more embodiments, in the fully open state, the two-piece hinge cap (240, 242) is movable from 0 degrees relative to the cannula 212 to at least 175 degrees relative to the needle cannula 212. In one or more embodiments, in the fully open state, the two-piece hinge cap (240, 242) is movable from 0 degrees relative to the cannula 212 to at least 165 degrees relative to the needle cannula 212. In one or more embodiments, in the fully open state, the two-piece hinge cap (240, 242) is movable from 0 degrees relative to the cannula 212 to at least 160 degrees relative to the needle cannula 212.

[0060] As shown in FIGS. 12 - 14, the third embodiment is described, which incorporates elements of the embodiments disclosed herein. Each of the two - piece hinge caps (340, 342) of the safety needle device 300 further comprises a pressing feature (360, 362) configured to contact the barrel surface of the syringe when the needle hub 310 is connected to the luer connector of the syringe and in an open state. The pressing features (360, 362) are disposed on the elongated body of the two - piece hinge caps (340, 342). In one or more embodiments, the pressing features (360, 362) are configured as tabs protruding from the elongated body of the two - piece hinge caps (340, 342). Each tab has a neck portion (370, 372), a thumb - pressing surface (374, 376), and a barrel - engaging surface (378, 380). The barrel - engaging surfaces (378, 380) are configured to contact the barrel surface of the syringe when the needle hub 310 is connected to the luer connector of the syringe while in an open state. The thumb - pressing surfaces (374, 376) are configured to assist in operating the two - piece hinge caps (340, 342). In one or more embodiments, the thumb - pressing surfaces (374, 376) are configured to assist in pressing the two - piece hinge caps (340, 342) onto each other. In one or more embodiments, the thumb - pressing surfaces (374, 376) further include a textured or hatched surface 373. The textured or hatched surface 373 assists in the operation of the two - piece hinge caps (240, 242). The end edges (382, 384) of the thumb - pressing surfaces (374, 376) are configured to assist in the operation of the two - piece hinge caps (240, 242). In one or more embodiments, the end edges (382, 384) are configured to enable the practitioner to pull apart the two - piece hinge caps (340, 342).

[0061] As shown in FIGS. 12 - 14, the third embodiment is described, which incorporates elements of the embodiments disclosed herein. Each of the two - piece hinge caps (340, 342) of the safety needle device 300 further includes pressing features (360, 362) configured to contact the barrel surface of the syringe when the needle hub 310 is connected to the luer connector of the syringe and in an open state. The pressing features (360, 362) are disposed on the elongated body of the two - piece hinge caps (340, 342). In one or more embodiments, the pressing features (360, 362) are configured as tabs protruding from the elongated body of the two - piece hinge caps (340, 342). Each of the tabs has a neck (370, 372), a thumb - pressing surface (374, 376), and a barrel - engaging surface (378, 380). The thumb - pressing surfaces (374, 376) are disposed on the necks (370, 372), the thumb - pressing surfaces (374, 376) are substantially parallel to the two - piece hinge caps (340, 342), and the barrel - engaging surfaces (378, 380) extend at an angle from the thumb - pressing surfaces (374, 376). The barrel - engaging surfaces (378, 380) are configured to contact the barrel surface of the syringe when the needle hub 310 is connected to the luer connector of the syringe while in an open state.

[0062] The thumb - pressing surfaces (374, 376) are configured to assist in operating the two - piece hinge caps (340, 342). In one or more embodiments, the thumb - pressing surfaces (374, 376) are configured to assist in pressing the two - piece hinge caps (340, 342) onto each other. In one or more embodiments, the thumb - pressing surfaces (374, 376) further include a textured or hatched surface 373. The textured or hatched surface 373 assists in the operation of the two - piece hinge caps (340, 342). The end edges (382, 384) of the thumb - pressing surfaces (374, 376) are configured to assist in the operation of the two - piece hinge caps (340, 342). In one or more embodiments, the end edges (382, 384) are configured to enable the operator to pull the two - piece hinge caps (340, 342) apart.

[0063] As shown in FIGS. 15-17, a fourth embodiment is described, which incorporates elements of the embodiments disclosed herein. Each of the two-piece hinge caps (440, 442) of the safety needle device 400 further includes pressing features (460, 462) configured to contact the barrel surface of the syringe when the needle hub 410 is connected to the luer connector of the syringe and in an open state. The pressing features (460, 462) are disposed on the elongated body of the two-piece hinge caps (440, 442). In one or more embodiments, the pressing features (460, 462) are configured as tabs protruding from the elongated body of the two-piece hinge caps (440, 442). Each of the tabs has a neck (470, 472), a thumb pressing surface (474, 476), and a barrel engaging surface (478, 480). The thumb pressing surfaces (474, 476) are disposed on the necks (470, 472), the thumb pressing surfaces (474, 476) are substantially perpendicular to the two-piece hinge caps (440, 442), and the barrel engaging surfaces (478, 480) extend perpendicularly from the thumb pressing surfaces (474, 476). In one or more embodiments, the barrel engaging surfaces (478, 480) are substantially parallel to the two-piece hinge caps (440, 442). The barrel engaging surfaces (478, 480) are configured to contact the barrel surface of the syringe when the needle hub 410 is connected to the luer connector of the syringe while in an open state. The thumb pressing surfaces (474, 476) are configured to assist in operating the two-piece hinge caps (440, 442).

[0064] In one or more embodiments, the thumb pressing surfaces (474, 476) are configured to assist in pressing the two-piece hinge caps (440, 442) onto each other. In one or more embodiments, the thumb pressing surfaces (474, 476) are configured to enable an operator to pull apart the two-piece hinge caps (440, 442). In one or more embodiments, the thumb pressing surfaces (474, 476) further include a textured or hatched surface 473. The textured or hatched surface 473 assists in the operation of the two-piece hinge caps (440, 242).

[0065] As shown in FIGS. 18 and 19, a second embodiment of a safety needle device including a rigid needle enclosure 900 comprises a removable rigid needle cover 940 configured to cover the distal portions 914 of the needle cannula 912 and the needle hub 910. The rigid needle enclosure 900 further comprises a cap 970 configured to engage with the needle cover 940 to cover the proximal portion 916 of the needle hub 910. At least a portion of the cap 970 and the needle cover 940 are covered by a removable sleeve 990 that holds the cap 970 and the needle cover 940 together.

[0066] As shown in FIG. 20, the needle hub 910 comprises a cylindrical body having a distal portion 914 and a proximal portion 916. A needle cannula 912 extends in the distal direction from the distal portion 914, and the needle cannula 912 is disposed in a lumen extending along the length of the cylindrical body. In one or more embodiments, the distal portion 914 further includes a plurality of longitudinal ribs 915. The proximal portion 916 has a substantially cylindrical shape. In one or more embodiments, the proximal portion 916 is tapered in the distal direction. In one or more embodiments, the proximal portion 916 has a conical shape. The present disclosure is not limited to the cylindrical shape shown in the exemplary embodiments. The proximal portion 916 further comprises a cavity in fluid communication with the lumen, and the cavity is configured to receive the hub of a luer connector. In one or more embodiments, the cavity may be configured to facilitate a loose fit between the cavity and the hub of the luer connector, and the needle hub 910 is secured by at least one set of threads 918 or tabs included on the outer surface of the proximal portion 916. The at least one thread 918 is sized to have a thread pattern that engages a standard ISO-2 type luer fitting. In a further embodiment, the cavity may be configured to facilitate an interference fit between the cavity and the hub of the luer connector in a luer slip fitting. In one or more embodiments, the interference fit may be configured to be strong enough such that a screw connection or at least one thread 918 is not required when removably securing the cavity to the luer connector. In one or more embodiments, the at least one thread 918 can include an angled thread pattern. In one or more embodiments, the at least one thread 918 can include a helical thread pattern. Such connections are commonly used as catheters and other fluid tight protective connectors in medical applications. Further alternative embodiments are assembled non-removably or removably with a screw connection, a press fit connection, an adhesive connection, or combinations thereof.

[0067] As depicted in FIG. 21, the removable rigid needle cover 940 comprises an elongated body having a cavity 942 defined by an open proximal end portion 944 and a closed distal end portion 946, and the cavity 942 extends from the open proximal end portion 944 to the closed distal end portion 946. The elongated body further comprises a proximal portion 950, an intermediate portion 952 and a distal portion 945. The proximal portion 950 has a cylindrical surface configured to mate with a cap 970. The intermediate portion 952 is adjacent to the proximal portion 950 and is defined by a flange 956 extending from the elongated body of the removable rigid needle cover 940. The distal portion 945 is adjacent to the intermediate portion 952, and the distal portion comprises a plurality of grip members 948 extending from the closed distal end portion 946 along the surface of the elongated body.

[0068] As shown in FIG. 22, the inner surface 960 of the cavity 942 comprises a proximal inner surface 962, an intermediate inner surface 964, and a distal inner surface 968. The proximal inner surface 962 includes a ribbed surface 963. The intermediate inner surface 964 includes a plurality of protrusions 965 extending from the intermediate surface 964. The plurality of protrusions 965 are configured to interlock with a plurality of longitudinal ribs 915 of the needle hub 910, and each of the plurality of longitudinal ribs 915 is nested between two of the plurality of protrusions 965 to prevent rotational movement of the needle hub 910. The distal portion 945 is adjacent to the intermediate surface 964 and is configured to receive the needle cannula 912 of the needle hub 910.

[0069] As shown in FIGS. 23 and 24, the needle hub 910 is partially disposed within a removable rigid needle cover 940. The proximal portion 916 of the needle hub 910 is partially disposed within the proximal inner surface 962 of the cavity 942 of the rigid needle cover 940, forming a removable interference fit between the proximal portion 916 of the needle hub 910 and the ribbed surface 963 of the proximal inner surface 962. A plurality of protrusions 965 on the intermediate surface 964 engage with a plurality of longitudinal ribs 915 on the distal portion 914 of the needle hub 910. In this configuration, the needle hub 910 cannot rotate due to the engagement of the plurality of protrusions 965 on the intermediate surface 964 with the plurality of longitudinal ribs 915, and the needle hub 910 cannot be inadvertently removed from the rigid needle cover 940 by the interference fit between the proximal portion 916 of the needle hub 910 and the ribbed surface 963 of the proximal inner surface 962. The ribbed surface 963 of the proximal inner surface 962 is further configured to allow air to flow around the needle hub 910, thereby preventing a vacuum due to changes in the atmosphere, which would otherwise require a large force to remove beyond breaking the interference fit.

[0070] As shown in FIGS. 25 and 26, the cap 970 includes a substantially cylindrical body having an open distal end portion 972 and a closed proximal end portion 974, and the open distal end portion 972 and the closed proximal end portion 974 define a cavity 976. A plurality of protrusions 980 extend from the inner surface 978 of the cavity. The plurality of protrusions 980 extend longitudinally from the inner surface 978 and include a distal portion 982 adjacent to the open distal end portion 972 and a proximal portion 984 adjacent to the proximal end portion 974. The distal portion 982 of the plurality of protrusions 980 is tapered inwardly from the open distal end portion 972 toward the proximal portion 984, and the taper is configured to create an interference fit with the proximal portion 950 of the needle cover 940 when the cap 970 is inserted over the proximal portion 950 of the needle cover 940. The proximal portion 984 of the plurality of protrusions 980 extends further from the inner surface 978 of the cap 970 and is configured to abut against the proximal portion 916 of the needle hub 910 when the cap 970 is inserted over the proximal portion 950 of the needle cover 940.

[0071] As shown in FIG. 27, the sleeve 990 can be formed in a cylindrical shape having an open distal end portion 992 and an open proximal end portion 994. A plurality of perforations 996 are radially arranged around the cylindrical shape, and the plurality of perforations 996 are configured to break when the needle cover 940 is separated from the cap 970. In one or more embodiments, the sleeve 990 further includes a tab 997 integrally formed with the sleeve 990. In one or more embodiments, the tab 997 may include a label or indicator. In one or more embodiments, the sleeve 990 is heat sealed or induction sealed to the needle cover 940 and the cap 970. In one or more embodiments, the sleeve 990 is configured as a proof-of-opening seal.

[0072] As shown in FIGS. 28 and 29, when fully assembled, the sleeve 990 covers both the cap 970 and the proximal end portion 944 of the needle cover 940. The open distal end portion 972 of the cap 970 abuts against the flange 956 of the needle cover 940. The open distal end portion 972 completely covers the open proximal end portion 944 of the needle cover 940. The plurality of perforations 996 are near or directly above the open distal end portion 972 of the cap 970 and the open proximal end portion 944 of the needle cover 940. As shown in FIG. 29, the proximal portions 984 of the plurality of protrusions 980 of the cap 970 limit the movement of the needle hub 910.

[0073] As shown in FIGS. 30 and 31, a third embodiment of a safety needle device including a rigid needle enclosure 1000 includes a needle hub 1010, a needle cover 1020, an adapter 1030, and a cap 1040. FIG. 19 shows an assembled view of the rigid needle enclosure 1000 and FIG. 20 shows an exploded view. FIGS. 30 and 31 are cross-sectional views of a substantially cylindrical body. The needle cover 1020 covers the needle cannula 1012, and the needle cannula 1012 is disposed within the lumen of the needle hub 1010. The needle cover 1020 has a tapered cylindrical outer surface 1022 which, when connected to the adapter, creates an interference fit and a sterile barrier with the tapered opening 1032 of the adapter 1030.

[0074] The adapter 1030 comprises a substantially cylindrical body having a proximal portion 1034, a distal portion 1036, and an outer cylindrical surface 1038. The proximal portion 1034 has a proximal cavity 1035 that communicates with the tapered opening 1032 of the distal portion 1036. The tapered opening 1032 is configured to produce an interference fit with the tapered cylindrical surface 1022 of the needle cover 1020. The cap 1040 has a substantially cylindrical shape with a distal opening 1042 that defines a distal cavity 1044. The cap 1040 is configured to interengage with the adapter 1030 such that the distal cavity 1044 of the cap 1040 receives the proximal portion 1034 of the adapter 1030. The outer cylindrical surface 1038 produces or forms an interference fit and a sterile barrier with the inner surface 1046 of the distal cavity 1044 when the two components are connected. In one or more embodiments, the outer cylindrical surface 1038 produces or forms a snap fit and a sterile barrier with the inner surface 1046 of the distal cavity 1044 when the two components are connected. Since the sterile barrier is provided by the fit between the outer cylindrical surface 1038 and the inner surface 1046, there is no need for a blister pack, reducing the cost of packaging the needle device compared to conventional needle devices that require a blister pack to provide a sterile barrier. In one or more embodiments, the outer cylindrical surface 1038 is removably bonded with an adhesive onto the inner surface 1046 of the distal cavity 1044. In one or more embodiments, the outer cylindrical surface 1038 is screwed into the inner surface 1046 of the distal cavity 1044. In one or more embodiments, the cap 1040 fits into the distal cavity 1044 of the adapter 1030. In one or more embodiments, a sticker label can be placed on the cap, enabling markings related to the contents of the rigid needle enclosure 1000. In one or more embodiments, the label 1049 is placed at the distal end of the cap 1040. In one or more embodiments, the label 1049 indicates that the rigid needle enclosure 1000 has been opened or used. In one or more embodiments, the label 1049 includes words, numbers, or symbols.In one or more embodiments, label 1049 includes a biological hazard symbol. In one or more embodiments, as shown in FIG. 30, at the junction of cap 1040 and adapter 1030, an unsealing proof seal 1050 is incorporated to indicate when cap 1040 and adapter 1030 are separated. In some embodiments, the unsealing proof seal 1050 is a seal or a peel label or a tear-away label. The present disclosure is not limited to the cylinder shape of the illustrated exemplary embodiments.

[0075] A needle device including a rigid needle enclosure 1000 is shipped and stored in a fully assembled state. In operation, the operator first removes cap 1040 from adapter 1030 and then removes needle hub 1010 and needle cover 1020 from adapter 1030. In one or more embodiments, the tapered opening 1032 of adapter 1030 is configured to interengage with a conventional needle or a commercially available needle.

[0076] As shown in FIGS. 32 and 33, a fourth embodiment of the rigid needle enclosure 1100 includes a needle hub 1110, a needle cover 1120, an adapter 1130, and a cap 1140. FIG. 21 is an assembly view of the rigid needle enclosure 1100, and FIG. 22 is an exploded view. FIGS. 32 and 33 are cross-sectional views of a substantially cylindrical body. The needle cover 1120 covers the needle cannula 1112, and the needle cannula 1112 is disposed within the lumen of the needle hub 1110. The needle cover 1120 has a tapered cylindrical surface 1122, which interference fits with and forms a sterile barrier with the tapered opening 1132 of the adapter 1130 when the two parts are connected.

[0077] The adapter 1130 comprises a substantially cylindrical body having a proximal portion 1134, a distal portion 1136, and a hinge 1139 disposed on the outer cylindrical surface 1138 of the adapter 1130. The proximal portion 1134 has a proximal cavity 1135 that communicates with the tapered opening 1132 of the distal portion 1136. The tapered opening 1132 is configured to produce an interference fit with the tapered cylindrical surface 1122 of the needle cover 1120. The cap 1140 has a substantially cylindrical shape having a distal opening 1142 that defines a distal cavity 1144. The cap 1140 is configured to interengage with the adapter 1130 such that the distal cavity 1144 of the cap 1140 receives the proximal portion 1134 of the adapter 1130. The hinge 1139 has a distal connection to the outer cylindrical surface 1138 of the adapter 1130 and a proximal connection to the outer cylindrical surface 1150 of the cap 1140.

[0078] The outer cylindrical surface 1138 interferes and fits with the inner surface 1146 of the end cavity 1144 and creates or forms a sterile barrier when the two parts are connected. In one or more embodiments, the outer cylindrical surface 1138 snap-fits with the inner surface 1146 of the end cavity 1144 and creates or forms a sterile barrier when the two parts are connected. In one or more embodiments, the outer cylindrical surface 1138 is removably bonded with an adhesive onto the inner surface 1146 of the end cavity 1144. In one or more embodiments, the outer cylindrical surface 1138 is screwed into the inner surface 1146 of the end cavity 1144. In one or more embodiments, the cap 1140 fits into the end cavity 1144 of the adapter 1130. In one or more embodiments, a sticker label may be disposed on the cap to enable markings related to the contents of the rigid needle enclosure 1100. In one or more embodiments, the label 1149 is disposed at the end end of the cap 1140. In one or more embodiments, the label 1149 indicates that the rigid needle enclosure 1100 has been opened or used. In one or more embodiments, the label 1149 includes words, numbers, or symbols. In one or more embodiments, the label 1149 includes a biological hazard symbol. In one or more embodiments, a proof-of-opening seal (not shown) similar to the proof-of-opening seal 1050 shown in FIG. 30 is incorporated at the location where the cap 1140 and the adapter 1130 are joined to indicate that the cap 1140 and the adapter 1130 have been separated. In some embodiments, the proof-of-opening seal is a sticker or a peel-away label or a tear-away label. The present disclosure is not limited to the cylindrical shape of the illustrated exemplary embodiments.

[0079] A needle device including a rigid needle enclosure 1100 is shipped and stored in a fully assembled state. In operation, the practitioner first removes the cap 1140 from the adapter 1130 and then removes the needle hub 1110 and the needle cover 1120 from the adapter 1130. Referring to FIGS. 33A and 33B, the rigid needle enclosure is opened with one hand by applying a proximal force F to the outer cylindrical surface 1138 of the adapter 1130 on the side opposite the hinge 1139, as shown in FIG. 33B. In one or more embodiments, the tapered opening 1132 of the adapter 1130 is configured to interlock with a conventional or commercially available needle. The present disclosure is not limited to the cylinder shape of the exemplary embodiments shown.

[0080] As shown in FIG. 34, a fifth embodiment of the rigid needle enclosure 1200 includes a needle hub, a needle cover, an adapter 1230, and a cap 1240. FIG. 34 is a cross-sectional view of a substantially cylindrical body. The needle cover covers the needle cannula, and the needle cannula is disposed within the lumen of the needle hub. The needle cover has a tapered cylindrical surface that interference fits with the tapered opening of the adapter 1230 and creates or forms a sterile barrier when the two parts are connected.

[0081] The adapter 1230 comprises a substantially cylindrical body having a proximal portion 1234 with a cavity 1238 defined by a proximal opening 1239 and a distal portion 1236. The cap 1240 has a substantially cylindrical shape with a distal opening 1232 that defines a distal cavity 1244. When fully assembled, the proximal opening 1239 and the distal opening 1232 abut each other. The proximal opening 1239 and the distal opening 1232 are removably bonded with an adhesive 1242. In one or more embodiments, a label 1249 is disposed at the distal end of the cap 1240. In one or more embodiments, the label 1249 indicates that the rigid needle enclosure 1200 has been opened or used. In one or more embodiments, the label 1249 includes words, numbers, or symbols. In one or more embodiments, the label 1249 includes a biological hazard symbol. In one or more embodiments, a proof-of-opening seal (not shown) similar to the proof-of-opening seal 1050 shown in FIG. 30 is incorporated at the location where the cap 1240 and the adapter 1230 are joined to indicate when the cap 1240 and the adapter 1230 are separated. In some embodiments, the proof-of-opening seal is a sticker or a peel-away label or a tear-away label. The present disclosure is not limited to the cylindrical shape of the illustrated exemplary embodiments.

[0082] As shown in FIG. 35, a sixth embodiment of the rigid needle enclosure 1300 includes a needle hub 1310, a needle cover 1320, an adapter 1330, and a cap 1340, and FIG. 24 shows an exploded view of the rigid needle enclosure 1300. FIG. 35 is a cross-sectional view of a substantially cylindrical body. The needle cover 1320 covers the needle cannula 1312, and the needle cannula 1312 is disposed within the lumen of the needle hub 1310. The needle cover 1320 has a tapered cylindrical surface 1322 that interference fits with and forms a sterile barrier with a tapered opening 1332 of the adapter 1330 when the two parts are connected.

[0083] The adapter 1330 comprises a substantially cylindrical body having a proximal portion 1334, a distal portion 1336, and an outer surface 338. The proximal portion 1334 has a proximal cavity 1335 that communicates with the tapered opening 1332 of the distal portion 1336. The tapered opening 1332 is configured to provide an interference fit with the tapered cylindrical surface 1322 of the needle cover 1320. The cap 1340 has a substantially cylindrical shape with a distal opening 1342 that defines a first cavity 1344. In one or more embodiments, the first cavity 1344 forms a distal wall 1365 on which the label 1349 is disposed. In one or more embodiments, the label 1349 indicates that the rigid needle enclosure 1300 has been opened or used. In one or more embodiments, the label 1349 includes words, numbers, or symbols. In one or more embodiments, the label 1349 includes a biological hazard symbol.

[0084] The cap 1340 is configured to engage with the adapter 1330 by the first cavity 1344 of the cap 1340 receiving the proximal portion 1334 of the adapter 1330. The outer surface 1338 creates or forms an interference fit and a sterile barrier with the inner surface 1346 of the first cavity 1344 when the two parts are connected. In one or more embodiments, the outer surface 1338 creates or forms a snap fit and a sterile barrier with the inner surface 1346 of the first cavity 1344 when the two parts are connected. In one or more embodiments, the outer surface 1338 is removably adhered with an adhesive onto the inner surface 1346 of the first cavity 1344. In one or more embodiments, the outer surface 338 is screwed onto the inner surface 1346 of the first cavity 1344. In one or more embodiments, the cap 1340 fits into the first cavity 1344 of the adapter 1330. In one or more embodiments, a sticker label can be placed on the cap, enabling markings related to the contents of the rigid needle enclosure 1300. In one or more embodiments, the label 1349 is placed at the distal end of the cap 1340. In one or more embodiments, the label 1349 indicates that the rigid needle enclosure 1300 has been opened or used. In one or more embodiments, the label 1349 includes words, numbers, or symbols. In one or more embodiments, the label 1349 includes a biological hazard symbol. In one or more embodiments, a proof-of-opening seal (not shown) similar to the proof-of-opening seal 1050 shown in FIG. 30 is incorporated at the location where the cap 1340 and the adapter 1330 are joined to indicate when the cap 1340 and the adapter 1330 are separated. In some embodiments, the proof-of-opening seal is a sticker or a peel-away label or a tear-away label.

[0085] The cap further includes a second cavity 1350 having an inner surface 1352. The second cavity 1350 is configured to engage with the adapter 1330. The outer surface 338 of the adapter 1330 interferentially fits with and generates or forms a sterile barrier with the inner surface 1352 of the first cavity 1344 when the two components are connected. The present disclosure is not limited to the cylindrical shape of the illustrated exemplary embodiments.

[0086] As shown in FIGS. 36-37, in one or more embodiments, the adapter 1330 and the cap 1340 each include tabs that are configured to snap removably or non-removably into each other. More specifically, the adapter 1330 includes an adapter tab or adapter ledge 1339 having a locking surface 1339a and an inclined surface 1339b. In the illustrated embodiment, the adapter tab or adapter ledge 1339 has a triangular shape, and the locking surface 1339a on the right-angled surface of the adapter tab or adapter ledge 1339 is located on the side opposite to the inclined surface 1339b of the adapter tab or adapter ledge 1339. As shown in FIGS. 36 and 37, the right-angled surface is substantially perpendicular to the outer surface 1338 of the adapter 1330. The adapter tab or adapter ledge 1339 can be a single continuous feature located at the proximal end of the adapter 1330, or there can be a plurality (e.g., 2, 3, 4 or more) of individual adapter tabs or adapter ledges 1339 spaced apart and disposed on the outer surface 1338 of the adapter 1330.

[0087] The cap 1340 includes a retaining tab or bump 1354 disposed on the inner surface 1346 of the first cavity 1344. The retaining tab or bump 1354 is configured to snap removably or releasably with the adapter tab or adapter ledge 1339 of the adapter 1330 when the adapter 1330 is inserted into the first cavity 1344 of the cap 1340. The retaining tab or bump includes a first inclined surface 1354a and a second inclined surface 1354b, which slidably engage with the locking surface 1339a and the inclined surface 1339b of the adapter tab or adapter ledge 1339. The retaining tab or bump 1354 can be a single continuous feature or there can be a plurality (e.g., 2, 3, 4 or more) of individual retaining tabs or bumps spaced apart and disposed on the inner surface 1346 of the first cavity 1344. The first cavity 1344 faces in the distal direction when the hard needle enclosure packages the new needle cannula 1312.

[0088] The cap 1340 further includes a lock tab or cap ledge 1358 disposed on the inner surface 1352 of the second cavity 1350. The lock tab or cap ledge 1358 of the second cavity 1350 has a triangular shape, and has a lock surface 1358a on the right-angled surface of the lock tab or cap ledge 1358, which is disposed opposite to the inclined surface 1358b of the lock tab or cap ledge 1358 when the cap 1340 is mounted on the newly packaged needle cannula 1312. As shown in FIGS. 36 and 37, the right-angled surface is substantially perpendicular to the inner surface 1352 of the second cavity 1350. The lock surface 1358a of the first cavity 1344 is configured to produce a non-removable or irreversible snap fit with the lock surface 1339a of the adapter tab or adapter ledge 1339 of the adapter 1330 when the adapter 1330 is inserted into the second cavity 1350 of the cap 1340. The lock tab or cap ledge 1358 can be a single continuous feature, or there can be a plurality (e.g., 2, 3, 4 or more) of individual lock tabs or cap ledges spaced apart and disposed on the inner surface 1352 of the second cavity 1350. In FIG. 37, when the cap 1340 is in the locked position, the second cavity 1350 faces in the distal direction and the first cavity 1344 faces in the proximal direction.

[0089] The embodiments shown and described with respect to FIGS. 36 and 37 are merely exemplary. According to embodiments of the present disclosure, the adapter includes an adapter lock feature exemplified as an adapter tab or adapter shelf portion 1339, which interacts with a reversible or releasable retention feature exemplified as a retention tab or bump 1354 within the first cavity 1344, and includes a lock tab or cap shelf portion 1358 within the second cavity 1354 of the cap 1340. However, according to one or more embodiments, the adapter can include adapter retention and lock features different from those shown in FIGS. 36 and 37, which interact with a cap retention feature within the first cavity 1344 to provide a releasable or reversible attachment of the cap 1340 to the adapter 1330 and a cap lock feature within the second cavity 1350 of the cap 1340. Thus, in one or more embodiments, the adapter and the first cavity are configured to be releasably connected, and the adapter and the second cavity are configured to be connected in a lock configuration such that the cap and the adapter cannot be released once they are locked.

[0090] According to one or more embodiments, the first cavity 1344 includes a first display portion 1349a therein, which is visible and / or tactilely releasable by a person, and the first display portion 1349a indicates that a rigidly packaged safety needle device including the needle cannula 1312 has been used and that the device should be discarded. This first display portion 1349a in some embodiments is composed of a symbol such as a biological hazard symbol, words such as "used" or "not for use", or other suitable visual or tactile display portions indicating a used device that should be discarded and not reused. When the cap 1340 is in the configuration shown in FIG. 36, it will be understood that the first display portion 1349a indicating that a rigidly packaged safety needle device including the needle cannula 1312 has not been used is not visibly or tactilely distinguishable. The second cavity 1350 of the cap 1340 may further include a second display portion 1349b indicating that the rigidly packaged safety needle device is available for use. The second display portion 1349 in some embodiments comprises a symbol or words such as "ready for use", or information about the device such as the gauge and length of the needle. The symbol in some embodiments may include a corporate logo.

[0091] When the rigidly packaged safety needle device is used and the cap 1340 is inverted from the configuration shown in FIG. 36 and slidably inserted onto the adapter 1330 such that the cap 1340 is locked onto the adapter as shown in FIG. 37, the cap 1340 is in a position slidably engaged with the adapter 1330. In this position, the first display portion 1349a is now visible and / or tactilely releasable by a person. When a person views or touches the first display portion 1349a, they will be informed that the device has been used and that the device should be discarded without being reused.

[0092] Although the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and / or outer housing of the disinfection cap can be single-shot molded or manufactured by other suitable processes. Further, the features or elements of any exemplary implementation of the embodiments of the present disclosure as described above and shown in the figures of the drawings can be individually or implemented in any combination(s) that can be readily understood by those skilled in the art without departing from the spirit and scope of the embodiments of the present disclosure.

[0093] In addition, the included drawing figures further illustrate non-limiting examples of the implementation of specific exemplary embodiments of the present disclosure and assist in the description of the related art. Any specific or relative dimensions or measurements provided in the drawings other than those described above are exemplary and are not intended to limit the scope or content of the design or methodology of the present invention as understood by those skilled in the relevant art of the invention.

[0094] Reference throughout this specification to "one embodiment", "a particular embodiment", "one or more embodiments" or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases "in one or more embodiments", "in a particular embodiment", "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Further, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0095] Although the disclosure herein has provided a description with reference to specific embodiments, it should be understood that these embodiments merely illustrate 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 methods and apparatuses of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

1. A safety needle device comprising a needle hub configured to be coupled to a syringe having a distal end portion and a proximal end portion, the needle hub having a substantially cylindrical shape, a needle cannula extending from the distal end portion of the needle hub, a removable collar having a substantially cylindrical body, an opening extending through the substantially cylindrical body, and two attachment points disposed on an outer surface of the collar, the opening being dimensioned and configured to receive the proximal end portion of the needle hub, the two attachment points being configured to be attached to a two-piece hinge cap, a two-piece hinge cap having two elongated bodies in a clam shell configuration, the two elongated bodies being configured to close against each other, each of the elongated bodies having a semi-circular cross-section and a cavity defined by an open proximal end and a closed distal end, a loop extending from the open proximal end, the loop being configured to engage the two attachment points of the collar with each other, and comprising further comprising a pressing feature disposed on the elongated body of the two-piece hinge cap, the pressing feature having a triangular shape, the triangular shape having a hypotenuse configured to contact an outer cylindrical surface of a barrel of the syringe when the needle hub is connected to a luer connector of the syringe, and in a fully open state, the hypotenuse being able to contact the outer cylindrical surface of the barrel of the syringe to form a firm stop against the range of motion of the two-piece hinge cap. A safety needle device.

2. The safety needle device according to claim 1, wherein the proximal end portion of the needle hub is tapered in the distal direction.

3. The safety needle device according to claim 1, wherein the opening of the collar is dimensioned and configured to create an interference fit with the proximal portion of the needle hub.

4. The safety needle device according to claim 1, wherein the opening of the collar is dimensioned and configured to create a loose fit with the proximal portion of the needle hub.

5. The safety needle device according to claim 1, wherein the collar rotates freely around the proximal portion of the needle hub.

6. The safety needle device according to claim 1, wherein the collar is configured to snap into the needle hub to create an interference fit, and the collar is configured to rotate freely only when sufficient force is applied, thereby resisting free movement.

7. The safety needle device according to claim 1, wherein the two attachment points are configured as hooks sized to receive the loop of the two-piece hinge cap, and the two attachment points are dimensioned and shaped to create a snap fit or interference fit with the loop of the two-piece hinge cap.

8. The safety needle device according to claim 1, wherein the two attachment points are configured as a living hinge having a residual spring action, the living hinge being in an open state in its rest position, and the open state of the living hinge resisting movement of the two-piece hinge cap.

9. The safety needle device according to claim 1, wherein the elongated body of the two-piece hinge cap is configured to snap together when fully closed.

10. The safety needle device according to claim 1, wherein the two-piece hinge cap is configured to move freely, and the collar is configured to rotate freely around the needle hub in the open state of the safety needle device.

11. The safety needle device according to claim 10, wherein each of the two-piece hinge caps is independently and freely openable or closable.

12. The safety needle device according to claim 10, wherein the two-piece hinge cap is movable from 0 degrees with respect to the needle cannula to at least 125 degrees with respect to the needle cannula.

13. The safety needle device according to claim 1, wherein the two-piece hinge cap is held in a closed state by a disposable plastic seal or sleeve disposed on the two-piece hinge cap.

14. The safety needle device according to claim 1, further comprising a sleeve disposed on the two-piece hinge cap in a closed state, the sleeve being longitudinally movable on the two-piece hinge cap.

15. The safety needle device according to claim 1, wherein the closed end portion of the two-piece hinge cap is configured to be non-removably locked when the two-piece hinge cap is closed, and the closed end portion defines a final closed state.

16. The safety needle device according to claim 1, wherein the two-piece hinge cap further comprises a locking mechanism disposed at a distance from the closed end portion of the two-piece hinge cap.

17. The safety needle device according to claim 16, wherein the locking mechanism comprises a hook tab protruding from one edge of the two-piece hinge cap and a corresponding opening disposed in the other cavity of the two-piece hinge cap.

18. The safety needle device according to claim 17, wherein the opening is configured to be removably or non-removably received in engagement with the hook tab.

19. The safety needle device according to claim 18, wherein the opening is configured to be removably received in engagement with the hook tab in a closed state.

20. The safety needle device according to claim 18, wherein the opening is configured to be non-removably received by engaging with the hook tab in a closed state.

21. The safety needle device according to claim 16, wherein the locking mechanism includes an opening disposed in one of the cavities of the two-piece hinge cap and a corresponding hook tab protruding from the other edge of the two-piece hinge cap.

22. The safety needle device according to claim 1, wherein the beveled surface is configured to assist in pressing the two-piece hinge cap together.

23. The safety needle device according to claim 22, wherein the triangular-shaped front elevation is configured to assist in pulling the two-piece hinge cap apart.

24. The safety needle device according to claim 22, wherein an opening extending through the triangular-shaped front elevation forms an edge between the opening and the beveled surface, and the beveled surface is configured to assist in pulling the two-piece hinge cap apart.

25. The safety needle device according to claim 1, wherein the pressing feature is configured as a tab protruding from the elongated body of the two-piece hinge cap.

26. The tab includes a neck portion, a thumb pressing surface, and a barrel engaging surface, and the barrel engaging surface is configured to contact the outer cylindrical surface of the barrel of the syringe when the needle hub is connected to the luer connector of the syringe. The safety needle device according to claim 25.

27. The safety needle device according to claim 26, wherein the thumb pressing surface is configured to assist in pressing the two-piece hinge cap onto each other.

28. The safety needle device according to claim 26, wherein the distal end portion of the thumb pressing surface is configured to enable an operator to pull apart the two-piece hinge cap.

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