Hard-packaged safety needle device

Abstract

A hard-packaged safety needle device includes a needle hub having a distal portion and a proximal portion, a needle cannula extending from the distal portion of the needle hub, and a hard needle shell having a needle cover, an adapter, and a cap. The needle cover is configured to house the needle cannula, and the adapter has a tapered bore configured to form an interference fit and a sterile barrier with a tapered outer surface of the needle cover. The cap includes a distal opening defining a first cavity, the cap being configured to interlock with the adapter by receiving a proximal portion of the adapter through the first cavity of the cap.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a hard-packaged safety needle device. BACKGROUND

[0002] Clean or sterile articles, 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 thereby contaminating its contents. In most cases, the packaging is opened immediately prior to use of the article, such as a blister pack containing a needle, in order to minimize the period of time the article is exposed to non-sterile conditions. After use of the needle, the packaging is discarded separately from the needle.

[0003] Needle devices are used throughout the medical industry to inject various liquids and solutions into or withdraw from the human body. Due to the many potential hazards associated with handling and manipulating body fluids, particularly blood, there are many known safety features that are often incorporated into various types of needle devices to protect practitioners from accidental exposure to the needle.

[0004] A "conventional" hypodermic needle is removed from a blister pack, the needle guard is removed, and a plastic needle hub is attached to a luer lock or luer slip syringe. The medication is then removed from a vial and administered to the patient via injection. The needle is then discarded as is, or after being capped using a recommended capping method. On the other hand, safety needles have an additional step in which an additional component, a safety guard, is deployed to permanently "swallow" the needle, making it inaccessible. This ensures that the needle cannot be reused and also contributes to the safety of healthcare workers by protecting them from contaminated needle stick injuries.

[0005] This additional step is achieved through a unique needle hub design or a very complex safety guard mechanism, which acts as a base for the safety mechanism to attach to. This needle hub is larger in volume and more difficult to mold compared to a conventional needle hub. Similarly, the safety mechanism itself is also composed of components that are difficult to mold and are also large in volume. The needle guard is made of thick walled plastic to ensure that the needle is not damaged prior to use. Furthermore, the needle guard that protects the needle prior to use is found to be of no use after use and is discarded, thereby increasing the use of plastic.

[0006] Such features are limited in their purpose. The needle shield only serves a protective purpose during shipping and storage and does not contribute to the safety features of the device. The safety shield is a complex molded part and interfaces with the needle hub, the connection of the safety shield to the needle hub is also complex molded, resulting in higher cost of these two components. 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 complexity of molding. Further, there is a need to provide a hard needle housing or hard needle cover that provides needle sterility and eliminates the need for a blister pack. SUMMARY

[0007] A first aspect of the present disclosure is directed to a safety needle device comprising a needle hub, a needle cannula, a detachable collar, and a two-piece hinged cap having two elongated bodies in a clamshell configuration. The needle hub is configured to be coupled to a syringe, comprising a distal portion and a proximal portion, the needle hub having a substantially cylindrical shape. The needle cannula extends from the distal portion of the needle hub. The detachable collar has a substantially cylindrical body, a bore extending through the substantially cylindrical body, and two attachment sites disposed on an outer surface of the collar, the bore being sized and configured to receive the proximal portion of the needle hub; the two attachment sites being configured to attach to the two-piece hinged cap. The two-piece hinged cap has two elongated bodies in a clamshell configuration, the two elongated bodies being configured to close on each other, each elongated body 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 interdigitate with the two attachment sites of the collar.

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

[0009] In one or more embodiments of the first aspect, the bore of the collar is sized and configured to form a loose fit with the proximal portion of the needle hub. In one or more embodiments, the collar is free to rotate around the proximal portion of the needle hub. In one or more embodiments, the collar is configured to snap into the needle hub, forming an interference fit, the collar being configured to be free to rotate only when sufficient force is applied, thereby resisting free movement. In one or more embodiments, the two attachment sites are configured as hooks sized to receive the loop of the two-piece hinged cap. In one or more embodiments of the first aspect, the two attachment sites are sized and shaped to form a snap fit with the loop of the two-piece hinged cap.

[0010] In one or more embodiments of the first aspect, the two attachment sites form an interference fit with the ring configured to resist free movement. In one or more embodiments of the first aspect, the collar and the two-piece hinge cap are integrally formed. In one or more embodiments, the two attachment sites are configured as a living hinge. In one or more embodiments of the first aspect, the living hinge is configured to have a residual spring action, wherein the living hinge is in an open state at its rest position. In one or more embodiments of the first aspect, the open state of the living hinge resists movement of the two-piece hinge cap. In one or more embodiments of the first aspect, 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 aspect, in the open state of the safety needle device, the two-piece hinge cap is configured to move freely and the collar is configured to rotate freely around the needle hub.

[0011] In one or more embodiments of the first aspect, the two-piece hinge cap is configured to rotate such that the markings provided on the barrel of the syringe are clearly visible to the practitioner to ensure the correct dosage is being 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 such that the markings provided on the barrel of the syringe are clearly visible to the practitioner to ensure the correct dosage is being measured.

[0012] In one or more embodiments of the first aspect, each of the two-piece hinge caps is independently openable or closable freely. 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 caps are movable from 0 degrees relative to the cannula to at least several degrees relative to the needle cannula. In one or more embodiments of the first aspect, the two-piece hinge caps are closed on themselves in the closed state. In one or more embodiments, the safety needle device is packaged and supplied in the closed state. In one or more embodiments of the first aspect, the two-piece hinge caps are held closed by a disposable plastic seal or sleeve provided on the two-piece hinge caps.

[0013] In one or more embodiments of the first aspect, the closed distal end of the two-piece hinged cap is configured to be irreversibly locked when the two-piece hinged cap is closed. In one or more embodiments, the safety needle device further comprises a sleeve disposed on the two-piece hinged cap in the closed state, the sleeve being movable in a longitudinal direction on the two-piece hinged cap. In one or more embodiments, the closed distal end of the two-piece hinged cap is configured to be irreversibly locked when the two-piece hinged cap is closed, the closed distal end defining a final closed state. In one or more embodiments of the first aspect, the two-piece hinged cap further comprises a locking mechanism disposed at a distance from the closed distal end of the two-piece hinged cap.

[0014] In one or more embodiments of the first aspect, the locking mechanism comprises a hook tab protruding from an edge of one of the two-piece hinged caps and a corresponding hole disposed within a cavity of the other of the two-piece hinged caps. In one or more embodiments of the first aspect, the hole is configured to interdigitate and reversibly or irreversibly receive the hook tab in the closed state.

[0015] In one or more embodiments of the first aspect, the hole is configured to interdigitate and reversibly receive the hook tab in the closed state. In one or more embodiments of the first aspect, the hole is configured to interdigitate and irreversibly receive the hook tab in the closed state. In one or more embodiments, the locking mechanism comprises a hole disposed within a cavity of one of the two-piece hinged caps and a corresponding hook tab protruding from an edge of the other of the two-piece hinged caps. In one or more embodiments of the first aspect, the safety needle device further comprises a push feature disposed on the elongated body of the two-piece hinged cap.

[0016] In one or more embodiments of the first aspect, the push feature has a triangular shape with a hypotenuse face configured to abut a barrel surface of a syringe when the needle hub is connected to a luer connector of the syringe. In one or more embodiments, the hypotenuse face is configured to help push the two-piece hinged cap together. In one or more embodiments of the first aspect, a right angle face of the triangular shape is configured to help pull the two-piece hinged cap apart.

[0017] In one or more embodiments of the first aspect, the hole extending through the right angle face of the triangular shape forms an edge between the hole and the hypotenuse face, the hypotenuse face configured to assist in pulling the two-piece hinged cap apart. In one or more embodiments of the first aspect, the push feature is configured as a tab that protrudes from the elongated body of the two-piece hinged cap. In one or more embodiments of the first aspect, the tab includes a neck, a thumb press surface, and a barrel engagement surface, the barrel engagement surface configured to abut a barrel surface of a syringe when a needle hub is connected to a luer connector of the syringe. In one or more embodiments, the thumb press surface is configured to assist in pushing the two-piece hinged cap onto one another. In one or more embodiments of the first aspect, a distal edge of the thumb press surface is configured to allow a practitioner to pull the two-piece hinged cap apart.

[0018] In one or more embodiments of the first aspect, the thumb press surface is substantially parallel to the two-piece hinged cap. In one or more embodiments of the first aspect, the barrel engagement surface extends at an angle relative to the thumb press surface. In one or more embodiments of the first aspect, the barrel engagement surface extends at a right angle relative to the thumb press surface. In one or more embodiments, the thumb press surface is disposed on the neck, the thumb press surface is substantially at a right angle to the two-piece hinged cap, and the barrel engagement surface extends at a right angle to the thumb press surface.

[0019] A second aspect of the present disclosure is directed to a hard-packaged safety needle device including a needle hub, a needle cannula, and a hard needle housing including a needle cover and a cap. The needle hub is configured to be coupled to a syringe, includes a distal portion and a proximal portion, the needle hub having 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 and a closed distal end, a proximal portion having a cylindrical surface configured to mate with the cap, an intermediate portion defined by a flange extending from the elongated body, the elongated body further having an inner surface of the cavity having a proximal inner surface including a ribbed surface configured to form an interference fit with the proximal portion of the needle hub, and a distal inner surface. The cap includes a substantially cylindrical body having an open distal end, a closed proximal end, and a cavity defined by the open distal end and the closed proximal end, the open distal end of the cap abutting the open proximal end 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 comprises a plurality of protrusions extending from the intermediate surface, the plurality of protrusions 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, thereby preventing rotational movement of the needle hub. In one or more embodiments of the second aspect, a detachable interference fit is formed between the ribbed surface of the proximal inner surface and the proximal portion of the needle hub.

[0021] In one or more embodiments of the second aspect, the cap further comprises a plurality of protrusions extending from an inner surface of the cavity of the cap, the plurality of protrusions extending longitudinally from the inner surface. In one or more embodiments of the second aspect, the plurality of protrusions of the cap comprises a distal portion adjacent to the open distal end of the cap, the distal portion tapering inwardly from the open distal end, the taper configured to form an interference fit with the proximal portion of the needle cover when the cap is inserted onto the proximal portion of the needle cover. In one or more embodiments of the second aspect, a proximal portion of the plurality of protrusions of the cap further extends from the inner surface of the cap and is configured to abut the proximal portion of the needle hub when the cap is inserted onto the proximal portion of the needle cover. In one or more embodiments, the hard needle shell further comprises a sleeve formed in a cylindrical shape, the sleeve comprising an open proximal end, an open distal end, and a plurality of perforations disposed radially around the cylindrical shape, the plurality of perforations configured to break when the needle cover is separated from the cap.

[0022] In one or more embodiments of the second aspect, the sleeve further comprises a tab integrally formed with the sleeve. In one or more embodiments of the second aspect, the tab comprises a label or instructions. In one or more embodiments, the sleeve is heat sealed to the needle cover and the cap. In one or more embodiments of the second aspect, the sleeve is configured as a tamper-evident seal. In one or more embodiments of the second aspect, the sleeve completely covers the cap, and the proximal end of the needle cover. In one or more embodiments, when the hard needle shell is assembled, the plurality of perforations are proximate to or directly on the open distal end of the cap and the open proximal end of the needle cover.

[0023] A third aspect of the present disclosure relates to a hard-packaged safety needle device comprising a needle hub, a needle cannula, and a hard shell comprising a needle cover, an adapter, and a cap. The needle hub is configured to be coupled to a syringe, comprises a distal portion and a proximal portion, and has a substantially cylindrical shape. The needle cannula extends from the distal portion of the needle hub. The needle cover is configured to house the needle cannula and the distal portion of the needle hub, and has a tapered cylindrical outer surface. The adapter has a substantially cylindrical body comprising a proximal portion, a distal portion, and an outer cylindrical surface, the distal portion having a tapered bore configured to form an interference fit and a sterile barrier with the tapered cylindrical outer surface of the needle cover, the proximal portion having a second cavity in communication with the tapered bore. The cap has a substantially cylindrical shape comprising a distal opening defining a first cavity, and is configured to be cross-plugged with the adapter by receiving the proximal portion of the adapter through the first cavity of the cap.

[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 cap first cavity 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 cap first cavity are connected. In one or more embodiments of the third aspect, the outer cylindrical surface is adhesively detachably bonded to the inner surface of the first cavity. In one or more embodiments of the third aspect, the outer cylindrical surface is threadably connected to the inner surface of the first cavity.

[0025] In one or more embodiments of the third aspect, the tapered bore of the adapter is configured to be cross-plugged with a conventional needle or a commercially available needle. In one or more embodiments, the hard needle shell 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 hard needle shell is opened with one-handed operation 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 adhesively detachably bonded together.

[0026] In one or more embodiments of the third aspect, the hard needle shell further comprises a label disposed on the distal wall of the first cavity of the cap. In one or more embodiments of the third aspect, the label indicates that the hard needle shell has been opened or used. In one or more embodiments of the third aspect, the label comprises text, numbers, or symbols. In one or more embodiments, the label comprises a biohazard symbol.

[0027] In one or more embodiments of the third aspect, the cap further comprises a second cavity having an interior surface, the second cavity of the cap configured to interlock with the adapter. In one or more embodiments, the exterior cylindrical surface of the adapter creates or forms an interference fit and a sterile barrier with the interior surface of the first cavity when the adapter and the cap first cavity are connected. In one or more embodiments of the third aspect, the adapter further comprises a ledge having a triangular shape, wherein a right angle face of the ledge is positioned opposite a sloped surface of the ledge, the ledge of the adapter disposed on an exterior surface of the adapter.

[0028] In one or more embodiments of the third aspect, the cap comprises a retention tab disposed on the interior surface of the first cavity, the tab configured to releasably snap fit with the ledge 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 ledge comprising a locking surface disposed on the interior surface of the first cavity, the ledge of the cap having a triangular shape, wherein a right angle face of the ledge of the cap is positioned opposite a sloped surface of the ledge, the ledge of the cap configured to form a non-releasable snap fit with the ledge of the adapter when the adapter is inserted into the second cavity of the adapter. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 A perspective view of a safety needle device according to an exemplary first embodiment of the present disclosure is shown;

[0030] Figure 2 A perspective view of a needle hub of the safety needle device of the first embodiment is shown;

[0031] Figure 3 A perspective view of a collar of the safety needle device of the first embodiment is shown;

[0032] Figure 4 A perspective view of a cap of the safety needle device of the first embodiment is shown;

[0033] Figure 5 A perspective view of the safety needle device of the first embodiment in a closed state is shown;

[0034] Figure 6 A perspective view of the safety needle device of the first embodiment in an open state is shown;

[0035] Figure 7 A detailed view of a locking mechanism of the safety needle device of the second embodiment is shown.

[0036] Figure 8 A side view of the safety needle device of the second embodiment in an open state is shown;

[0037] Figure 9A side view of the safety needle device of the second embodiment is shown in the closed state;

[0038] Figure 10 A detailed side view of the safety needle device of the second embodiment is shown;

[0039] Figure 11A A side view of the safety needle device of the second embodiment is shown in the open state;

[0040] Figure 11B A side view of the safety needle device of the second embodiment is shown in the open state attached to a syringe barrel;

[0041] Figure 12 A side view of the safety needle device of the third embodiment is shown in the open state;

[0042] Figure 13 A side view of the safety needle device of the third embodiment is shown in the open state;

[0043] Figure 14 A side view of the safety needle device of the third embodiment is shown in the open state;

[0044] Figure 15 A side view of the safety needle device of the fourth embodiment is shown in the open state;

[0045] Figure 16 A side view of the safety needle device of the fourth embodiment is shown in the open state;

[0046] Figure 17 A side view of the safety needle device of the fourth embodiment is shown in the open state;

[0047] Figure 18 An exploded view of a hard needle hub according to the second embodiment of the present disclosure is shown;

[0048] Figure 19 An assembled view of a hard needle hub according to the second embodiment of the present disclosure is shown;

[0049] Figure 20 A perspective view of a needle hub of a hard needle hub according to the second embodiment of the present disclosure is shown;

[0050] Figure 21 A perspective view of a hard needle cover of a hard needle hub according to the second embodiment of the present disclosure is shown;

[0051] Figure 22 A cross-sectional view of a hard needle cover of a hard needle hub according to the second embodiment of the present disclosure is shown;

[0052] Figure 23A detailed side view of the hard needle housing according to a second embodiment of the present disclosure is shown;

[0053] Figure 24 A detailed cross-sectional view of a hard needle housing according to a second embodiment of the present disclosure is shown;

[0054] Figure 25 A perspective view of the cap of a hard needle housing according to a second embodiment of the present disclosure is shown;

[0055] Figure 26 A perspective cross-sectional view of the cap of a hard needle housing according to a second embodiment of the present disclosure is shown;

[0056] Figure 27 A perspective view of a removable sleeve of a rigid needle housing according to a second embodiment of the present disclosure is shown;

[0057] Figure 28 A perspective side view of a rigid needle housing according to a second embodiment of the present disclosure is shown;

[0058] Figure 29 A cross-sectional view of a rigid needle housing according to a second embodiment of the present disclosure is shown;

[0059] Figure 30 A cross-sectional view of a hard needle housing according to a third embodiment of the present disclosure is shown;

[0060] Figure 31 An exploded cross-sectional view of a hard needle housing according to a third embodiment of the present disclosure is shown;

[0061] Figure 32 A cross-sectional view of a hard needle housing according to a fourth embodiment of the present disclosure is shown;

[0062] Figure 33A A cross-sectional view of an adapter with a hard needle housing according to a fourth embodiment of the present disclosure is shown;

[0063] Figure 33B It shows that when a force F is applied Figure 33A The adapter for the hard needle housing shown;

[0064] Figure 34 A cross-sectional view of a hard needle housing according to a fifth embodiment of the present disclosure is shown;

[0065] Figure 35 A anatomical view of a rigid needle housing according to a sixth embodiment of the present disclosure is shown;

[0066] Figure 36 A anatomical view of a rigid needle housing according to a sixth embodiment of the present disclosure is shown;

[0067] Figure 37An exploded cross-sectional view illustrating a hard needle hub according to a sixth embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0068] Embodiments of the present disclosure are directed to a safety mechanism that combines features of both a needle shield and a safety guard mechanism, thereby reducing material costs, manufacturing complexity, and waste.

[0069] Embodiments of the present disclosure are directed to a safety needle device for connection to a medical connector, including a threaded connection. In one or more embodiments, the safety needle includes a collar configured to intermate with a conventional needle hub, the collar having an attachment site for a hinged cap, the hinged cap being a two-piece configuration. In further embodiments, the safety needle device includes a removable hard needle cover configured to cover a needle cannula, and a distal portion of a needle hub. The hard needle hub further includes a cap configured to intermate with the needle cover, and to cover a proximal portion of the needle hub. At least a portion of the cap, and the needle cover are covered by a removable sleeve that holds the cap and needle cover together. Even further embodiments include a needle hub, a needle cover, an adapter configured to attach to a conventional needle cap, and a cap. The present disclosure is directed to a safety mechanism that combines features of both a needle shield and a safety guard mechanism, thereby reducing material costs, manufacturing complexity, and waste.

[0070] Other embodiments of the present disclosure are directed to a hard-packaged needle device including a hard needle hub. In one or more embodiments, a blister-packaged needle is eliminated as the hard needle hub provides sterile packaging of the needle.

[0071] Before several exemplary embodiments of the present disclosure are described, it is to be understood that the present disclosure is not limited to the details of construction or processing steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

[0072] For the purposes of the description hereinafter, the terms "top", "bottom", "vertical", and derivatives thereof shall relate to the present disclosure as it is oriented in the drawing figures. However, it is to be understood that the present disclosure can assume alternative variations and step sequences, except where expressly

[0073] As used herein, the use of "a" or "an" includes singular and plural.

[0074] As used herein, the term "luer connector" refers to a connecting collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubing, etc. to each other. Luer connectors consist of one or more interlocking tubes that are slightly tapered to stay together with just a simple pressure / twist fit / friction fit. Luer connectors can optionally include an additional outer threaded rim, allowing them to be more secure. Luer connectors can interlock and connect with an end located on a vascular access device (VAD). Luer connectors include a distal end, a proximal end, an irregularly shaped outer wall, a shaped central passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. Luer connectors also have a distal channel that releasably attaches the luer connector to the distal end of the hub of a VAD, and a proximal channel that releasably attaches the luer connector to the barrel of a syringe. As used herein, the term "luer connector" refers to a male luer connector or a female luer connector.

[0075] As used herein, the term "medical device" refers to a common medical device with a threaded or interlocking connection that has a corresponding mating element. By way of example, but not by way of limitation, a syringe can have a threaded connection that releasably interlocks with a needleless connector of an ancillary medical device such as a catheter, IV line, etc. The threaded connection can include an internal cavity defining a fluid path that is surrounded by a protruding wall having a threaded device for attachment to the ancillary medical device.

[0076] As those skilled in the relevant art will readily appreciate, while descriptive terms such as "thread," "taper," "tab," "wall," "top," "side," "bottom," etc. are used throughout this specification to facilitate understanding, they are not intended to limit any components that can be used in combination or individually to achieve various aspects of embodiments of the present disclosure.

[0077] A first embodiment of a safety needle device includes a detachable collar configured to cross-fit with a conventional needle hub, the collar having an attachment site for a hinged cap, the hinged cap being a two-piece configuration that folds to cover a needle cannula of the needle hub. In one or more embodiments, the collar and two-piece hinged cap are configured as a shield assembly that can be assembled onto a conventional needle hub and can be packaged separately. In one or more embodiments, the two-piece hinged cap is configured as a mechanism to prevent reuse by irreversibly snapping together after needle use. In one or more embodiments, the collar is configured to freely rotate around the needle hub, allowing the practitioner to move the two-piece hinged cap out of view or away from the insertion site. In further embodiments, the safety needle device includes a detachable hard needle cover configured to cover a needle cannula, and a distal portion of the needle hub. The hard needle housing also includes a cap configured to cross-fit with the needle cover and to cover a proximal portion of the needle hub. At least a portion of the cap, and the needle cover are covered by a detachable sleeve that holds the cap and needle cover together. Even further embodiments include a needle hub, a needle cover, an adapter configured to attach to a conventional needle cap, and a cap. In exemplary implementations of embodiments of the present disclosure, the disinfecting cap includes an integrated thread or tab, and any and all combinations of other features that allow it to interface with threaded fittings of medical devices. In preferred embodiments, the disinfecting cap interfaces with a luer fitting. Exemplary configurations of couplings, fittings, ports, and adapters can include commercially available luer locks, luer slip ports, locking ports, threaded connections, interlocking connections, or generally other common medical device fittings known in the art.

[0078] Reference will now be made to the drawings wherein like numerals refer to like components throughout the several figures. Embodiments of the present disclosure are described as follows.

[0079] As Figure 1As depicted, the first embodiment of the safety needle device 100 includes a detachable collar 130 configured to cross-fit with a needle hub 110, the collar 130 having two attachment sites (132, 134) for a two-piece hinged cap (140, 142). The needle hub 110 is configured to be coupled to a syringe. The two-piece hinged cap (140, 142) is configured to fold over and cover a needle cannula 112 of the needle hub 110. In one or more embodiments, the two-piece hinged cap (140, 142) is configured as a mechanism to prevent reuse by irreversibly snapping together after use of the needle cannula 112. In one or more embodiments, the two-piece hinged cap (140, 142) is configured as a shield assembly that can fit onto a conventional needle hub and can be packaged separately. In one or more embodiments, the collar 130 is configured to freely rotate around the needle hub 110, allowing the practitioner to move the two-piece hinged cap (140, 142) out of view or away from the insertion site. In one or more embodiments, the collar 130 is configured to cross-fit with the needle hub 110 non-detachably to prevent removal of the collar 130.

[0080] As shown, Figure 2 The needle hub 110 includes a cylindrical body having a distal portion 114 and a proximal portion 116. The needle cannula 112 extends in a distal direction from the distal portion 114. 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 a distal direction. The proximal portion 116 further includes a cavity in fluid communication with the internal lumen, the cavity configured to receive a hub of a luer connector. In one or more embodiments, the cavity can be configured to facilitate a loose fit between the cavity and the hub of the luer connector, with the needle hub 110 being secured by at least one thread 118 or a set of tabs included on an outer surface of the proximal portion 116. The at least one thread 118 is sized and has a thread pattern that will engage with a standard ISO-2 type luer fitting. In further embodiments, the cavity can be configured as a luer slip fitting to facilitate an interference fit between the cavity and the hub of the luer connector. In one or more embodiments, the interference fit can be configured to be strong enough to not require a threaded connection or the at least one thread 118 to detachably secure the cavity to the luer connector. In one or more embodiments, the at least one thread 118 can include a tapered thread pattern. In one or more embodiments, the at least one thread 118 can include a helical thread pattern. Such connectors are commonly and generally used in medical applications as protective connectors for catheters and other fluid-tight connections. Further alternative embodiments are assembled non-detachably or detachably with threaded connections, press-fit connections, adhesive connections, or combinations thereof.

[0081] AsFigure 3 As shown, the removable collar 130 includes a substantially cylindrical body having a bore 136 extending therethrough. The bore 136 is sized and configured to receive the proximal portion 116 of the needle hub 110. In one or more embodiments, the bore 136 is sized and configured to form an interference fit with the proximal portion 116 of the needle hub 110. In one or more embodiments, the bore 136 is sized and configured to form a loose fit with the proximal portion 116 of the needle hub 110. In one or more embodiments, the collar 130 is free to rotate 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 is free to rotate, but cannot move in the longitudinal direction and thus cannot be removed from the needle hub 110. In one or more embodiments, the collar 130 can be removed with the application of sufficient force, greater than that typically exhibited on the device, thereby preventing inadvertent removal. In one or more embodiments, the collar 130 is configured to snap into the needle hub 110, forming an interference fit, whereby the collar 130 is free to rotate only when sufficient force is applied, thereby preventing free movement.

[0082] The collar 130 also includes two attachment sites (132, 134) disposed on the outer surface of the collar 130, each of the two attachment sites (132, 134) configured to attach to each of the two-piece hinged cap (140, 142). In one or more embodiments, the two attachment sites (132, 134) are disposed 180 degrees from each other. In one or more embodiments, the two attachment sites (132, 134) protrude from the outer surface of the collar 130 and are in the form of hooks, each hook configured such that the hook is configured to receive a hook of a loop portion (144, 146) of the two-piece hinged cap (140, 142). The two attachment sites (132, 134) are sized and shaped to form a snap fit with the loop portion (144, 146) of the two-piece hinged cap (140, 142). In one or more embodiments, the two attachment sites (132, 134) protrude from the outer surface of the collar 130 and are in the form of loop portions, each loop portion configured to interlock with a hook of the two-piece hinged cap (140, 142). In one or more embodiments, the two attachment sites (132, 134) and the loop portions (144, 146) also form an interference fit, whereby the two attachment sites (132, 134) are free to rotate only when sufficient force is applied, thereby preventing free movement.

[0083] In one or more embodiments, the collar 130 and the two-piece hinged caps (140, 142) are integrally formed. In one or more embodiments, the collar 130 and the two-piece hinged caps (140, 142) are integrally formed, and the two attachment points (132, 134) are configured as movable hinges. In one or more embodiments, the two attachment points (132, 134) are configured as movable hinges with residual spring action, wherein the movable hinges are in an open state in their rest position. The open state of the movable hinges resists movement of the two-piece hinged caps (140, 142), thereby moving the two two-piece hinged caps (140, 142) away from the insertion point.

[0084] like Figure 4 As shown, each of the two-piece hinged caps (140, 142) includes an elongated body with 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). A ring (144, 146) extends from the open proximal end (152, 154), the ring being configured to interlock with two attachment portions (132, 134) disposed on the outer surface of the collar 130. The two-piece hinged caps (140, 142) are configured in a clamshell configuration, wherein each elongated body is configured to close to each other, thereby providing a closed cavity in which the needle cannula 112 is protected. In one or more embodiments, the elongated bodies snap together when fully closed. In one or more embodiments, each of the two-piece hinged caps (140, 142) is identical to each other. In one or more embodiments, each of the two-piece hinged caps (140, 142) is configured to be manufactured or injected from the same mold, thereby reducing manufacturing costs due to simplified molding.

[0085] In one or more embodiments, such as Figure 5As shown, the safety needle device 100 is packaged and supplied to medical practitioners in a closed state. In one or more embodiments, the safety needle device 100 is packaged in a blister pack to maintain sterility. In the closed state, the two-piece hinged caps (140, 142) reversibly close to themselves. In one or more embodiments, the two-piece hinged caps (140, 142) are held closed by a disposable plastic seal or sleeve disposed on the two-piece hinged caps (140, 142). In one or more embodiments, the disposable seal or sleeve loosely fits on the two-piece hinged caps (140, 142). In one or more embodiments, the disposable plastic seal or sleeve has a perforation or break point configured to break when the two-piece hinged caps (140, 142) are pulled open. 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 force is applied away from the two-piece hinged caps (140, 142). In one or more embodiments, the disposable plastic seal or sleeve is sealed with an adhesive that is weak enough to separate when force is applied away from the two-piece hinged caps (140, 142).

[0086] like Figure 5 As shown, the assembled safety needle device 100 is in the open state, wherein the two-piece hinged caps (140, 142) are freely open, close, or move, and the collar 130 is freely rotatable about the needle hub 110. In the open state, the needle cannula 112 is fully exposed and can be inserted into the patient's skin. Due to the free movement of the two-piece hinged caps (140, 142) and the collar 130 relative to the needle hub 110, the practitioner can rotate or move the two-piece hinged caps (140, 142) away from the insertion site or out of the practitioner's field of vision. In the open state, the two-piece hinged caps (140, 142) can move 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 hinged caps (140, 142) can move 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 hinged caps (140, 142) are 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 hinged caps (140, 142) are movable from 0 degrees relative to the cannula 112 to approximately 170 degrees relative to the needle cannula 112.

[0087] Throughout its range of motion, the practitioner can rotate or move the two-piece hinged caps (140, 142) away from the syringe barrel, allowing the practitioner to clearly see the markings on the syringe barrel to ensure accurate dosage. In one or more embodiments, each of the two-piece hinged caps (140, 142) can be freely and independently opened or closed, wherein one of the two-piece hinged caps (140, 142) can move independently of the other.

[0088] like Figure 5 and Figure 6 As shown, after administering medical treatment, the practitioner can close the two-piece hinged caps (140, 142) onto themselves to bring the safety needle device 100 to a final closed state. This action can be performed using either the hand used to administer the medical treatment or the other hand. Since the two-piece hinged caps (140, 142) close in a snap-fit ​​manner, pressure on the caps (140, 142) is sufficient to close them. In one or more embodiments, the closed distal ends (156, 158) of the two-piece hinged caps (140, 142) are configured to be non-removably locked when the caps (140, 142) are closed in the final closed state, thereby preventing the reuse of the safety needle device 100. The safety needle device 100 in its final closed state can then be disposed of according to conventional biohazard waste practices.

[0089] In an alternative embodiment, the sleeve may be positioned in a closed state on the two-piece hinged caps (140, 142). The sleeve may move vertically along the longitudinal direction on the two-piece hinged caps (140, 142), and in doing so, push the two-piece hinged caps (140, 142) together or pull them apart, or alternatively, allow the two-piece hinged caps (140, 142) to separate. In one or more embodiments, the two-piece hinged caps (140, 142) are molded to have a movable hinge with residual spring action. In one or more embodiments, the sleeve locks the two-piece hinged caps (140, 142).

[0090] Figure 7 to Figure 9A second embodiment of the present disclosure is shown, which includes elements of the embodiments disclosed herein. The two-piece hinged caps (240, 242) of the safety pin device 200 further include a locking mechanism disposed at a distance from the closed distal ends (256, 258) of the two-piece hinged caps (240, 242). The locking mechanism includes a hook 264 projecting from an edge 265 of one of the two-piece hinged caps (240, 242) and a corresponding hole 268 disposed within a cavity 250 of the other of the two-piece hinged caps (240, 242), the hole 268 being configured to interlock and removably or non-removably receive the hook 264. In one or more embodiments, one of the two-piece hinged caps (240, 242) further includes a hole 266 disposed in a cavity 248 of one of the two-piece hinged caps (240, 242) and a corresponding hook 269 protruding from an edge 257 of the other of the two-piece hinged caps (240, 242), the hole 268 being configured to interlock and removably or non-removably receive the hook 269.

[0091] like Figure 9 As shown, hook 264 and hook 269, received in corresponding holes 268, detachably or nondetachably lock the two-piece hinged caps (240, 242) together. In one or more embodiments, the locking mechanism is configured to nondetachably lock the two-piece hinged caps (240, 242) when closed in their final closed state, thereby preventing the reuse of the safety pin device 200. The safety pin device 200 in its final closed state can then be disposed of as conventional biohazardous waste.

[0092] like Figure 8 to Figure 1 As shown in Figure 1, in one or more embodiments, each of the two-piece hinged caps (240, 242) of the safety needle device 200 further includes a push 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 is in the open state. The push feature (260, 262) is disposed on the elongated body of the two-piece hinged cap (240, 242). In one or more embodiments, the push feature (260, 262) has a triangular shape with a hypotenuse (270, 272) configured to abut against the barrel surface of the syringe when the needle hub 210 is connected to the Luer connector of the syringe in the open state, and a right-angled facet (274, 276) perpendicular to the surface of the elongated body of the two-piece hinged cap (240, 242). In one or more embodiments, the pushing features (260, 262) are configured to assist in manipulating the gripping features of the two-piece hinged cap (240, 242).

[0093] In one or more embodiments, such as Figure 10 As shown, the beveled surfaces (270, 272) also include a textured or shaded surface 273. The textured or shaded surface 273 facilitates manipulation of the two-piece hinged caps (240, 242). In one or more embodiments, the beveled surfaces (270, 272) facilitate pushing the two-piece hinged caps (240, 242) together. In one or more embodiments, the right-angled surfaces (274, 276) also include a hole 275 extending through the right-angled surfaces (274, 276). The edge 277 formed by the hole 275 and the beveled surfaces (270, 272) is configured to allow or assist a practitioner in pulling the two-piece hinged caps (240, 242) apart.

[0094] like Figure 11A As shown, the safety needle device 200 is in the fully open position, with the beveled surfaces (270, 272) abutting against the syringe barrel surface. In the fully open position, the two-piece hinged caps (240, 242) can be freely opened, closed, or moved, and the collar 230 can be freely rotated about the needle hub 210. In the fully open position, the two-piece hinged caps (240, 242) can be moved from 0 degrees relative to the cannula 212 to at least 175 degrees relative to the needle cannula 212. Throughout this range of motion, the practitioner can rotate or move the two-piece hinged caps (240, 242) away from the syringe barrel, allowing the practitioner to clearly see the markings on the syringe barrel to ensure accurate dosage.

[0095] like Figure 11B As shown, the safety needle device 200 is in the fully open position and 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, the distal end defining a cavity for holding liquid. The cylindrical body 91 has an outer cylindrical surface 94, which in some embodiments has a mark or fluid volume indicator.

[0096] The proximal portion 216 of the needle hub 110 is inserted over an elongated tip (not shown) provided on the distal end 92 of the barrel 90, thereby securing the needle hub 110 on the elongated tip. In the fully open state, the beveled faces (270, 272) abut the outer cylindrical surface 94 of the syringe barrel 90, thereby creating a hard stop for the range of motion of the two-piece hinged cap (240, 242). As shown, the two-piece hinged cap (240, 242) is at a 170 degree angle relative to the cannula 212 in the fully open state, whereby the beveled faces (270, 272) abut 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, thereby allowing the practitioner to have full view of the needle cannula 212 being inserted into the insertion site of the patient’s skin.

[0097] In one or more embodiments, in the fully open state, the two-piece hinged 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 hinged 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 hinged cap (240, 242) is movable from 0 degrees relative to the cannula 212 to at least 160 degrees relative to the needle cannula 212.

[0098] As Figure 12 to Figure 14As shown, a third embodiment is described that incorporates elements of the embodiments disclosed herein. Each of the two-piece hinged caps (340, 342) of the safety needle device 300 further includes a push feature (360, 362) configured to abut against a barrel surface of a syringe when the needle hub 310 is connected to a luer connector of the syringe and in the open state. The push features (360, 362) are disposed on the elongated body of the two-piece hinged caps (340, 342). In one or more embodiments, the push features (360, 362) are configured as tabs that protrude from the elongated body of the two-piece hinged caps (340, 342). Each tab has a neck portion (370, 372), a thumb press surface (374, 376), and a barrel engagement surface (378, 380). The barrel engagement surfaces (378, 380) are configured to abut against a barrel surface of a syringe when the needle hub 310 is connected to a luer connector of the syringe in the open state. The thumb press surfaces (374, 376) are configured to aid in manipulation of the two-piece hinged caps (340, 342). In one or more embodiments, the thumb press surfaces (374, 376) are configured to aid in pushing the two-piece hinged caps (340, 342) onto one another. In one or more embodiments, the thumb press surfaces (374, 376) further include a textured or hatched patterned surface 373. The textured or hatched patterned surface 373 aids in manipulation of the two-piece hinged caps (240, 242). The distal edges (382, 384) of the thumb press surfaces (374, 376) are configured to aid in manipulation of the two-piece hinged caps (240, 242). In one or more embodiments, the distal edges (382, 384) are configured to allow a practitioner to pull the two-piece hinged caps (340, 342) apart.

[0099] As Figure 12 to Figure 14As shown, a third embodiment is described that incorporates elements of the embodiments disclosed herein. Each of the two-piece hinged cap (340, 342) of safety needle device 300 further comprises a push feature (360, 362) configured to abut against a barrel surface of a syringe when the needle hub 310 is connected to a luer connector of the syringe and in the open state. The push feature (360, 362) is disposed on the elongated body of the two-piece hinged cap (340, 342). In one or more embodiments, the push feature (360, 362) is configured as a tab that protrudes from the elongated body of the two-piece hinged cap (340, 342). Each tab has a neck (370, 372), a thumb press surface (374, 376), and a barrel engagement surface (378, 380). The thumb press surface (374, 376) is disposed on the neck (370, 372), the thumb press surface (374, 376) is substantially parallel to the two-piece hinged cap (340, 342), and the barrel engagement surface (378, 380) extends at an angle to the thumb press surface (374, 376). The barrel engagement surface (378, 380) is configured to abut against a barrel surface of a syringe when the needle hub 310 is connected to a luer connector of the syringe in the open state.

[0100] The thumb press surface (374, 376) is configured to aid in manipulation of the two-piece hinged cap (340, 342). In one or more embodiments, the thumb press surface (374, 376) is configured to aid in pushing the two-piece hinged cap (340, 342) onto each other. In one or more embodiments, the thumb press surface (374, 376) further comprises a textured or hatched patterned surface 373. The textured or hatched patterned surface 373 aids in manipulation of the two-piece hinged cap (340, 342). The distal edge (382, 384) of the thumb press surface (374, 376) is configured to aid in manipulation of the two-piece hinged cap (340, 342). In one or more embodiments, the distal edge (382, 384) is configured to allow a practitioner to pull the two-piece hinged cap (340, 342) apart.

[0101] As Figure 15 to Figure 17As shown, a fourth embodiment is described that incorporates elements of the embodiments disclosed herein. Each of the two-piece hinged cap (440, 442) of the safety needle device 400 further includes a push feature (460, 462) configured to abut against a barrel surface of a syringe when the needle hub 410 is connected to a luer connector of the syringe and in the open state. The push features (460, 462) are disposed on the elongated body of the two-piece hinged cap (440, 442). In one or more embodiments, the push features (460, 462) are configured as tabs that protrude from the elongated body of the two-piece hinged cap (440, 442). Each tab has a neck (470, 472), a thumb press surface (474, 476), and a barrel engagement surface (478, 480). The thumb press surface (474, 476) is disposed on the neck (470, 472), the thumb press surface (474, 476) is substantially at a right angle to the two-piece hinged cap (440, 442), and the barrel engagement surface (478, 480) extends at a right angle to the thumb press surface (474, 476). In one or more embodiments, the barrel engagement surface (478, 480) is substantially parallel to the two-piece hinged cap (440, 442). The barrel engagement surface (478, 480) is configured to abut against a barrel surface of a syringe when the needle hub 410 is connected to a luer connector of the syringe in the open state. The thumb press surface (474, 476) is configured to aid in manipulation of the two-piece hinged cap (440, 442).

[0102] In one or more embodiments, the thumb press surface (474, 476) is configured to aid in pushing the two-piece hinged cap (440, 442) onto each other. In one or more embodiments, the thumb press surface (474, 476) is configured to allow a practitioner to pull the two-piece hinged cap (440, 442) apart. In one or more embodiments, the thumb press surface (474, 476) further includes a textured or hatched patterned surface 473. The textured or hatched patterned surface 473 aids in manipulation of the two-piece hinged cap (440, 442).

[0103] As shown in FIGS. 1-3, a first embodiment of a safety needle device includes a hard needle housing 900. The hard needle housing 900 includes a needle hub 910, a needle cannula 912, and a needle cap 940. The needle hub 910 is configured to attach to a luer connector of a syringe. The needle cannula 912 is disposed within the needle hub 910. The needle cap 940 is configured to cover the needle cannula 912 and a distal portion 914 of the needle hub 910. The needle cap 940 is further configured to abut against a barrel surface of a syringe when the needle hub 910 is connected to a luer connector of the syringe and in an open state. Figure 18 and Figure 19 As shown, a second embodiment of a safety needle device including a hard needle housing 900 includes a detachable hard needle cover 940 configured to cover the needle cannula 912, and a distal portion 914 of the needle hub 910. The hard needle housing 900 further includes a cap 970 configured to interlock with the needle cover 940, and cover a 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 detachable sleeve 990 that holds the cap 970 and the needle cover 940 together.

[0104] like Figure 20 As shown, the needle hub 910 includes a cylindrical body having a distal portion 914 and a proximal portion 916. A needle cannula 912 extends from the distal portion 914 in a distal direction and is disposed within an inner cavity extending 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 generally cylindrical shape. In one or more embodiments, the proximal portion 916 tapers in a distal direction. In one or more embodiments, the proximal portion 916 has a tapered shape. This disclosure is not limited to the cylindrical shape shown in the exemplary embodiments. The proximal portion 916 also includes a cavity in fluid communication with the inner cavity, the cavity being configured to receive a sleeve of a Luer connector. In one or more embodiments, the cavity may be configured to facilitate a loose fit between the cavity and the sleeve of the Luer connector, wherein the needle hub 910 is secured by at least one thread 918 or a set of tabs included on the outer surface of the proximal portion 916. At least one thread 918 is sized and has a thread pattern that engages with a standard ISO-2 type Luer connector. In another embodiment, the cavity can be configured as a Luer sliding joint to facilitate an interference fit between the cavity and the sleeve of the Luer connector. In one or more embodiments, the interference fit can be configured strong enough to require no threaded connection or at least one thread 918 to detachably secure the cavity to the Luer connector. In one or more embodiments, at least one thread 918 may include a beveled thread pattern. In one or more embodiments, at least one thread 918 may include a helical thread pattern. Such connectors are generally and typically used in medical applications as protective connectors for catheters and other fluid-impermeable devices. Further alternative embodiments are assembled non-detachably or detachably using threaded connections, press-fit connections, adhesive connections, or combinations thereof.

[0105] like Figure 21 The removable hard needle cap 940, as depicted, includes an elongated body having a cavity 942 defined by an open proximal end 944 and a closed distal end 946, the cavity 942 extending from the open proximal end 944 to the closed distal end 946. The elongated body also includes a proximal portion 950, a middle portion 952, and a distal portion 945. The proximal portion 950 has a cylindrical surface configured to mate with a cap 970. The middle portion 952 is adjacent to the proximal portion 950 and is defined by a flange 956 extending from the elongated body of the removable hard needle cap 940. The distal portion 945 is adjacent to the middle portion 952 and includes a plurality of gripping members 948 extending from the closed distal end 946 along a surface of the elongated body.

[0106] like Figure 22As shown, the inner surface 960 of the cavity 942 includes 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, each of the plurality of longitudinal ribs 915 being nested between two of the plurality of protrusions 965, thereby preventing 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.

[0107] like Figure 23 and Figure 24 As shown, the needle hub 910 is partially disposed within the 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, thereby 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. Multiple protrusions 965 of the intermediate surface 964 interlock with multiple longitudinal ribs 915 of the distal portion 914 of the needle hub 910. In this configuration, the needle hub 910 cannot rotate due to the interlocking of the multiple protrusions 965 of the intermediate surface 964 and the multiple longitudinal ribs 915, and the needle hub 910 cannot be accidentally removed from the rigid needle cover 940 due to 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 the creation of a vacuum due to changes in the atmosphere, which would otherwise require a greater force than breaking the interference fit to remove.

[0108] like Figure 25 and Figure 26 As shown, the cap 970 includes a generally cylindrical body having an open distal end 972 and a closed proximal end 974, which define a cavity 976. A plurality of protrusions 980 extend from an 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 972 and a proximal portion 984 adjacent to the proximal end 974. The distal portions 982 of the plurality of protrusions 980 taper inward from the open distal end 972 to the proximal portion 984, the taper being configured to form an interference fit with the proximal portion 950 of the needle cap 940 when the cap 970 is inserted onto the proximal portion 950 of the needle cap 940. The proximal portions 984 of the plurality of protrusions 980 extend further from the inner surface 978 of the cap 970 and are configured to abut against the proximal portions 916 of the needle hub 910 when the cap 970 is inserted onto the proximal portion 950 of the needle cover 940.

[0109] As shown in Figure 27 , the sleeve 990 can be formed in a cylindrical shape that includes an open distal end 992 and an open proximal end 994. A plurality of perforations 996 are disposed radially around the cylindrical shape, 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 that is integrally formed with the sleeve 990. In one or more embodiments, the tab 997 can include a label or instructions. In one or more embodiments, the sleeve 990 is heat or induction sealed to the needle cover 940 and the cap 970. In one or more embodiments, the sleeve 990 is configured as a tamper-evident seal.

[0110] As shown in Figure 28 and Figure 29 , when fully assembled, the sleeve 990 covers both the cap 970 and the proximal end 944 of the needle cover 940. The open distal end 972 of the cap 970 is in abutment with the flange 956 of the needle cover 940. The open distal end 972 fully covers the open proximal end 944 of the needle cover 940. The plurality of perforations 996 are proximate or directly on the open distal end 972 of the cap 970 and the open proximal end 944 of the needle cover 940. As shown in Figure 29 , the proximal portion 984 of the plurality of protrusions 980 of the cap 970 restricts movement of the needle hub 910.

[0111] As shown in Figure 30 and Figure 31 , a third embodiment of a safety needle device including a hard needle housing 1000 includes a needle hub 1010, a needle cover 1020, an adapter 1030, and a cap 1040, wherein Figure 19 an assembled view of the hard needle housing 1000 is shown, and Figure 20 an exploded view of the hard needle housing is shown.

[0112] Figure 30 and Figure 31 are cross-sectional views of a substantially cylindrical body. The needle cover 1020 covers a needle cannula 1012 that is disposed within an inner lumen of the needle hub 1010. The needle cover 1020 has a tapered cylindrical outer surface 1022 that creates or forms an interference fit and a sterile barrier with a tapered bore 1032 of the adapter 1030 when connected to the adapter.

[0113] The adapter 1030 includes 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 a tapered bore 1032 of the distal portion 1036. The tapered bore 1032 is configured to form 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 defining a distal cavity 1044. The cap 1040 is configured to be crosswise mated with the adapter 1030 by way of the distal cavity 1044 of the cap 1040 receiving the proximal portion 1034 of the adapter 1030. When the two portions are connected, the outer cylindrical surface 1038 creates or forms an interference fit and a sterile barrier with an inner surface 1046 of the distal cavity 1044. In one or more embodiments, the outer cylindrical surface 1038 creates or forms a snap fit and a sterile barrier with the inner surface 1046 of the distal cavity 1044 when the two portions are connected. Because the sterile barrier is provided by the fit between the outer cylindrical surface 1038 and the inner surface 1046, the need for a blister pack to provide the sterile barrier is eliminated, thereby reducing the packaging cost of the needle device as compared to conventional needle devices that require a blister pack to provide the sterile barrier. In one or more embodiments, the outer cylindrical surface 1038 is removably adhered to the inner surface 1046 of the distal cavity 1044 with an adhesive. In one or more embodiments, the outer cylindrical surface 1038 is threadably connected to the inner surface 1046 of the distal cavity 1044. In one or more embodiments, the cap 1040 fits within the distal cavity 1044 of the adapter 1030. In one or more embodiments, a sticker label can be provided on the cap to allow for indicia relating to the contents of the hard needle case 1000. In one or more embodiments, a label 1049 is placed on the distal end of the cap 1040. In one or more embodiments, the label 1049 indicates that the hard needle case 1000 has been opened or used. In one or more embodiments, the label 1049 includes text, numbers, or symbols. In one or more embodiments, the label 1049 includes a biohazard symbol. In one or more embodiments, as shown, a tamper-evident seal 1050 is incorporated where the cap 1040 and the adapter 1030 are joined to indicate when the cap 1040 and the adapter 1030 have been separated. In some embodiments, the tamper-evident seal 1050 is a sticker or peel-off label or tear-off label. The present disclosure is not limited to the cylindrical shape of the exemplary embodiments shown. Figure 30

[0114] ​The needle device including the hard needle hub 1000 is shipped and stored fully assembled. In operation, the practitioner first removes the cap 1040 from the adapter 1030, and then removes the needle hub 1010 and the needle cover 1020 from the adapter 1030. In one or more embodiments, the tapered bore 1032 of the adapter 1030 is configured to cross-fit with a conventional needle or a commercially available needle.

[0115] As Figure 32 and FIG. 33, a fourth embodiment of a hard needle hub 1100 includes a needle hub 1110, a needle cover 1120, an adapter 1130, and a cap 1140, wherein Figure 21 shows an assembled view of the hard needle hub 1100, and Figure 22 shows an exploded view of the hard needle hub. Figure 32 and FIG. 33 is a cross-sectional view of a substantially cylindrical body. The needle cover 1120 covers a needle cannula 1112 disposed within an inner cavity of the needle hub 1110. The needle cover 1120 has a tapered cylindrical surface 1122 that creates or forms an interference fit and a sterile barrier with the tapered bore 1132 of the adapter 1130 when the two parts are connected.

[0116] The adapter 1130 includes a substantially cylindrical body having a proximal portion 1134, a distal portion 1136, and a hinge 1139 disposed on an outer cylindrical surface 1138 of the adapter 1130. The proximal portion 1134 has a proximal cavity 1135 in communication with the tapered bore 1132 of the distal portion 1136. The tapered bore 1132 is configured to form an interference fit with the tapered cylindrical surface 1122 of the needle cover 1120. The cap 1140 has a substantially cylindrical shape with a distal opening 1142 defining a distal cavity 1144. The cap 1140 is configured to cross-fit with the adapter 1130 by way of the distal cavity 1144 of the cap 1140 receiving the proximal portion 1134 of the adapter 1130. The hinge 1139 has a distal connection with the outer cylindrical surface 1138 of the adapter 1130 and a proximal connection with an outer cylindrical surface 1150 of the cap 1140.

[0117] When the two parts are connected, the outer cylindrical surface 1138 creates or forms an interference fit and a sterile barrier with the inner surface 1146 of the distal cavity 1144. In one or more embodiments, when the two parts are connected, the outer cylindrical surface 1138 creates or forms a snap fit and a sterile barrier with the inner surface 1146 of the distal cavity 1144. In one or more embodiments, the outer cylindrical surface 1138 is adhesively detachably bonded to the inner surface 1146 of the distal cavity 1144. In one or more embodiments, the outer cylindrical surface 1138 is threadably connected to the inner surface 1146 of the distal cavity 1144. In one or more embodiments, the cap 1140 fits within the distal cavity 1144 of the adapter 1130. In one or more embodiments, an adhesive label can be provided on the cap to allow for labeling of the contents of the hard needle shell 1100. In one or more embodiments, a label 1149 is placed on the distal end of the cap 1140. In one or more embodiments, the label 1149 indicates that the hard needle shell 1100 has been opened or used. In one or more embodiments, the label 1149 comprises text, numbers, or symbols. In one or more embodiments, the label 1149 comprises a biohazard symbol. In one or more embodiments, a tamper-evident seal (not shown) similar to the tamper-evident seal 1050 shown is incorporated where the cap 1140 and the adapter 1130 join to indicate when the cap 1140 and the adapter 1130 have been separated. In some embodiments, the tamper-evident seal is a sticker or peel-off or tear-off label. The present disclosure is not limited to the cylindrical shape of the exemplary embodiments shown. Figure 30

[0118] The needle device including the hard needle shell 1100 is shipped and stored fully assembled. 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 Figure 33A and Figure 33B , the hard needle shell is opened with one-handed operation by applying a proximal force F to the outer cylindrical surface 1138 of the adapter 1130 opposite the hinge 1139, as shown in Figure 33B In one or more embodiments, the tapered bore 1132 of the adapter 1130 is configured to cross-fit with a conventional needle or a commercially available needle. The present disclosure is not limited to the cylindrical shape of the exemplary embodiments shown.

[0119] As shown in Figure 34 , a fifth embodiment of a hard needle shell 1200 includes a needle hub, a needle cover, an adapter 1230, and a cap 1240. Figure 34 ​This is a cross-sectional view of the basic cylindrical body. The needle cap covers the needle cannula, which is disposed within the inner cavity of the needle hub. The needle cap has a tapered cylindrical surface that, when the two parts are connected, creates or forms an interference fit and sterile barrier with the tapered orifice of the adapter 1230.

[0120] The adapter 1230 includes a generally cylindrical body having a proximal portion 1234 and a distal portion 1236, the proximal portion having a cavity 1238 defined by a proximal opening 1239. The cap 1240 has a generally cylindrical shape, with its distal opening 1232 defining the distal cavity 1244. In full assembly, the proximal opening 1239 and the distal opening 1232 abut against each other. The proximal opening 1239 and the distal opening 1232 are detachably bonded together with an adhesive 1242. In one or more embodiments, a label 1249 is placed on the distal end of the cap 1240. In one or more embodiments, the label 1249 indicates that the hard needle housing 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 biohazard symbol. In one or more embodiments, a symbol similar to […] is incorporated at the junction of the cap 1240 and the adapter 1230. Figure 30 The tamper-evident seal 1050 shown has a tamper-evident seal (not shown) to indicate when the cap 1240 and adapter 1230 have been separated. In some embodiments, the tamper-evident seal is a sticker, peel label, or torn label. This disclosure is not limited to the cylindrical shape of the exemplary embodiments shown.

[0121] like Figure 35 As shown, the sixth embodiment of the hard needle housing 1300 includes a needle hub 1310, a needle cover 1320, an adapter 1330, and a cap 1340, wherein... Figure 24 An exploded view of the hard needle housing 1300 is shown. Figure 35 This is a cross-sectional view of the basic cylindrical body. A needle cap 1320 covers a needle cannula 1312, which is disposed within the inner cavity of the needle hub 1310. The needle cap 1320 has a tapered cylindrical surface 1322, which, when the two parts are connected, creates or forms an interference fit and sterile barrier with the tapered orifice 1332 of the adapter 1330.

[0122] The adapter 1330 includes a substantially cylindrical body having a proximal portion 1334, a distal portion 1336, and an exterior surface 1338. The proximal portion 1334 has a proximal cavity 1335 that communicates with a tapered bore 1332 of the distal portion 1336. The tapered bore 1332 is configured to form 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 defining a first cavity 1344. In one or more embodiments, the first cavity 1344 forms a distal wall 1365 on which a label 1349 is placed. In one or more embodiments, the label 1349 indicates that the hard needle shell 1300 has been opened or used. In one or more embodiments, the label 1349 includes text, numbers, or symbols. In one or more embodiments, the label 1349 includes a biohazard symbol.

[0123] The cap 1340 is configured to interfit with the adapter 1330 by way of the first cavity 1344 of the cap 1340 receiving the proximal portion 1334 of the adapter 1330. When the two portions are connected, the exterior surface 1338 creates or forms an interference fit and a sterile barrier with the interior surface 1346 of the first cavity 1344. In one or more embodiments, when the two portions are connected, the exterior surface 1338 creates or forms a snap fit and a sterile barrier with the interior surface 1346 of the first cavity 1344. In one or more embodiments, the exterior surface 1338 is removably adhered to the interior surface 1346 of the first cavity 1344 with an adhesive. In one or more embodiments, the exterior surface 1338 is threadably connected to the interior surface 1346 of the first cavity 1344. In one or more embodiments, the cap 1340 fits within the first cavity 1344 of the adapter 1330. In one or more embodiments, a sticker label can be provided on the cap to allow for marking related to the contents of the hard needle shell 1300. In one or more embodiments, the label 1349 is placed on the distal end of the cap 1340. In one or more embodiments, the label 1349 indicates that the hard needle shell 1300 has been opened or used. In one or more embodiments, the label 1349 includes text, numbers, or symbols. In one or more embodiments, the label 1349 includes a biohazard symbol. In one or more embodiments, a tamper-evident seal (not shown) similar to the tamper-evident seal 1050 shown is incorporated where the cap 1340 and the adapter 1330 are joined to indicate when the cap 1340 and the adapter 1330 have been separated. In some embodiments, the tamper-evident seal is a sticker or peel or tear label. Figure 30

[0124] ​The cap also includes a second cavity 1350 having an inner surface 1352. The second cavity 1350 is configured to interlock with the adapter 1330. When the two parts are connected, the outer surface 1338 of the adapter 1330 and the inner surface 1352 of the first cavity 1344 create or form an interference fit and a sterile barrier. This disclosure is not limited to the cylindrical shape of the exemplary embodiments shown.

[0125] like Figure 36 to Figure 37 As shown, in one or more embodiments, adapter 1330 and cap 1340 each include a tab configured to snap into each other removably or non-removably. More specifically, adapter 1330 includes an adapter tab or adapter protrusion 1339 having a locking surface 1339a and a ramp surface 1339b. In the illustrated embodiment, the adapter tab or adapter protrusion 1339 has a triangular shape, wherein the locking surface 1339a is located on the right-angled face of the adapter tab or adapter protrusion 1339, which is positioned opposite to the ramp surface 1339b of the adapter tab or adapter protrusion 1339. Figure 36 and Figure 37 As shown, the right-angled surface is substantially perpendicular to the outer surface 1338 of the adapter 1330. The adapter tab or adapter protrusion 1339 may be a single continuous feature located on the proximal end of the adapter 1330, or there may be multiple (e.g., two, three, four or more) discrete adapter tabs or adapter protrusions 1339 disposed on the outer surface 1338 of the adapter 1330 and spaced apart.

[0126] The cap 1340 includes a retaining tab or protrusion 1354 disposed on the inner surface 1346 of the first cavity 1344. The retaining tab or protrusion 1354 is configured to removably or releasably engage with the adapter tab or adapter protrusion 1339 of the adapter 1330 when the adapter 1330 is inserted into the first cavity 1344 of the cap 1340. The retaining tab or protrusion includes a first ramp surface 1354a and a second ramp surface 1354b, which slidably engage the locking surface 1339a and ramp surface 1339b of the adapter tab or adapter protrusion 1339. The retaining tab or protrusion 1354 may be a single continuous feature, or there may be multiple (e.g., two, three, four or more) discrete retaining tabs or protrusions disposed on the inner surface 1346 of the first cavity 1344 and spaced apart. When the hard needle housing encapsulates the new needle cannula 1312, the first cavity 1344 faces the distal direction.

[0127] The cap 1340 also includes a locking tab or cap ledge 1358 disposed on the interior surface 1352 of the second cavity 1350. The locking tab or cap ledge 1358 of the second cavity 1350 has a triangular shape with a locking surface 1358a present on the right angle face of the locking tab or cap ledge 1358 that is positioned opposite the angled surface 1358b of the locking tab or cap ledge 1358 when the cap 1340 is installed onto the newly packaged needle cannula 1312. As shown in Figure 36 and Figure 37 the right angle face is substantially perpendicular to the interior surface 1352 of the second cavity 1350. The locking surface 1358a of the first cavity 1344 is configured to form a non-detachable or irreversible snap fit with the locking 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 locking tab or cap ledge 1358 can be a single continuous feature or there can be multiple (e.g., two, three, four, or more) discrete locking tabs or cap ledges that are disposed on the interior surface 1352 of the second cavity 1350 and spaced apart. In Figure 37 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.

[0128] The embodiments shown and described in relation to Figure 36 and Figure 37 According to embodiments of the present disclosure, the adapter includes an adapter locking feature, illustrated as the adapter tab or adapter ledge 1339, that interacts with a reversible or releasable retention feature, illustrated as the retention tab or ledge 1354 in the first cavity 1344, the locking tab or cap ledge 1358 in the second cavity 1350 of the cap 1340. However, according to one or more embodiments, the adapter can include adapter retention and locking features different than those shown in Figure 36 and Figure 37 the adapter retention and locking features shown in Figs. 13A-13C interact with cap retention features in the first cavity 1344 to provide a releasable or reversible attachment of the cap 1340 to the adapter 1330 and with cap locking features in the second cavity 1350 of the cap 1340. Thus, in one or more embodiments, the adapter and first cavity are configured to releasably connect and the adapter and second cavity are configured to connect in a locked configuration, where the cap and adapter cannot be released once locked.

[0129] According to one or more embodiments, the first cavity 1344 includes a first indicium 1349a on the inside and visible and / or tactilely discernible by a person that indicates that the hard-packaged safety needle device including the needle cannula 1312 has been used and the device should be discarded. In some embodiments, the first indicium 1349a includes a symbol, such as a biohazard symbol, a word such as "used" or "do not use," or other suitable visual or tactile indicium that indicates that the used device should be discarded and cannot be reused. It will be appreciated that when the cap 1340 is in the configuration shown in FIG. 13A, the first indicium 1349a is not visible or tactilely discernible when the first indicium indicating the hard-packaged safety needle device including the needle cannula 1312 has not been used. The second cavity 1350 of the cap 1340 can also include a second indicium 1349b that indicates that the hard-packaged safety needle device is ready for use. In some embodiments, the second indicium 1349 includes a symbol or words such as "ready for use," or information about the device such as the needle gauge and length. In some embodiments, the symbol can include a corporate logo. Figure 36 It will be appreciated that when the cap 1340 is in the configuration shown in FIG. 13A, the first indicium 1349a is not visible or tactilely discernible when the first indicium indicating the hard-packaged safety needle device including the needle cannula 1312 has not been used. The second cavity 1350 of the cap 1340 can also include a second indicium 1349b that indicates that the hard-packaged safety needle device is ready for use. In some embodiments, the second indicium 1349 includes a symbol or words such as "ready for use," or information about the device such as the needle gauge and length. In some embodiments, the symbol can include a corporate logo.

[0130] After the hard-packaged safety needle device has been used, and the cap 1340 is inverted and slidably inserted onto the adapter 1330 such that the cap 1340 is locked onto the adapter as shown in FIG. 13B, the first indicium 1349a is now visible and / or tactilely discernible by a person. Figure 36 It will be appreciated that when the cap 1340 is in the configuration shown in FIG. 13A, the first indicium 1349a is not visible or tactilely discernible when the first indicium indicating the hard-packaged safety needle device including the needle cannula 1312 has not been used. The second cavity 1350 of the cap 1340 can also include a second indicium 1349b that indicates that the hard-packaged safety needle device is ready for use. In some embodiments, the second indicium 1349 includes a symbol or words such as "ready for use," or information about the device such as the needle gauge and length. In some embodiments, the symbol can include a corporate logo. Figure 37 It will be appreciated that when the cap 1340 is in the configuration shown in FIG. 13A, the first indicium 1349a is not visible or tactilely discernible when the first indicium indicating the hard-packaged safety needle device including the needle cannula 1312 has not been used. The second cavity 1350 of the cap 1340 can also include a second indicium 1349b that indicates that the hard-packaged safety needle device is ready for use. In some embodiments, the second indicium 1349 includes a symbol or words such as "ready for use," or information about the device such as the needle gauge and length. In some embodiments, the symbol can include a corporate logo.

[0131] While the present disclosure has been illustrated and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Additionally, the inner and / or outer housing of the sterilization cap can be single-shot molded or made by other suitable processes. Furthermore, any feature or element of any exemplary implementation of the embodiments of the present disclosure as described above and illustrated in the drawings can be implemented alone or in any combination as readily understood by the skilled artisan without departing from the spirit and scope of the embodiments of the present disclosure.

[0132] Furthermore, the included drawings further describe and illustrate some non-limiting examples of the implementations of certain exemplary embodiments of the present disclosure and can be useful in describing the associated technology. Any specific or relative dimensions or measurements provided in the drawings, as described above, are exemplary only and are not intended to limit the scope or content of the design or method of the present invention as understood by one of ordinary skill in the relevant art.

[0133] References throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments" or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrases such as "in one or more embodiments," "in certain embodiments," "in one embodiment," or "in an embodiment" throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments.

[0134] While the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will thus 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 disclosure. Such modifications and variations are intended to fall within the scope of the present disclosure as defined by the appended claims and their equivalents.

Claims

1. A hard-packaged safety needle device comprising: a needle hub configured to be coupled to a syringe, including a distal portion and a proximal portion; a needle cannula extending from the distal portion of the needle hub; and a hard needle housing including a needle cover, an adapter, and a cap, the needle cover configured to house the needle cannula and the distal portion of the needle hub, the needle cover having a tapered outer surface, the adapter having a body including a proximal portion, a distal portion, and an outer surface, the distal portion having a tapered bore configured to form an interference fit and a sterile barrier with the tapered outer surface of the needle cover, the proximal portion having a proximal cavity in communication with the tapered bore, and the cap having a first cavity, the cap configured to be cross-fitted with the adapter by receiving the proximal portion of the adapter through the first cavity of the cap, and the cap further including a second cavity having an inner surface, the second cavity of the cap configured to be cross-fitted with the adapter, the adapter and the first cavity configured to be releasably connected, and the adapter and the second cavity configured to be connected in a locked configuration, the adapter further including a ledge having a triangular shape, wherein a right angle face of the ledge is positioned opposite a sloped surface of the ledge, the ledge of the adapter disposed on the outer surface of the adapter, wherein the first cavity of the cap includes a retention tab configured to releasably snap-fit with a locking surface of the ledge of the adapter when the adapter is inserted into the first cavity of the cap, and the cap further including a ledge, the ledge of the cap including a locking surface disposed on the inner surface of the second cavity, the ledge of the cap having a triangular shape, wherein a right angle face of the ledge of the cap is positioned opposite a sloped surface of the ledge of the cap, the ledge of the cap configured to form a non-releasable snap-fit with the ledge of the adapter when the adapter is inserted into the second cavity of the adapter.

2. The hard-packaged safety needle device of claim 1, wherein the outer surface forms an interference fit and a sterile barrier with the inner surface of the first cavity when the adapter is connected with the first cavity.

3. The hard-packaged safety needle device of claim 1, wherein the outer surface forms a snap fit and a sterile barrier with the inner surface of the first cavity when the adapter is connected with the first cavity.

4. The hard-packaged safety needle device of claim 1, wherein the outer surface is releasably adhered to the inner surface of the first cavity with an adhesive.

5. The hard-packaged safety needle device of claim 1, wherein the outer surface is threadably connected to the inner surface of the first cavity.

6. The hard-packaged safety needle device of claim 1, wherein the tapered bore of the adapter is configured to be cross-fitted with a conventional needle. ​ 7. The hard-packaged safety needle device of claim 1, further comprising a hinge having a distal connection to an outer surface of the adapter and a proximal connection to an outer surface of the cap.

8. The hard-packaged safety needle device of claim 7, wherein the hard needle housing is opened with a single hand by applying a proximal force F to the outer surface of the adapter opposite the hinge.

9. The hard-packaged safety needle device of claim 1, wherein the proximal opening and the distal opening are removably adhered together with an adhesive.

10. The hard-packaged safety needle device of claim 1, further comprising a label disposed on a wall of the first cavity of the cap.

11. The hard-packaged safety needle device of claim 10, wherein the label indicates that the hard needle housing has been opened.

12. The hard-packaged safety needle device of claim 10, the label comprising indicia.

13. The hard-packaged safety needle device of claim 10, the label comprising a biohazard symbol.

14. The hard-packaged safety needle device of claim 1, wherein the first cavity comprises indicia indicating that the safety needle device has been used.

15. The hard-packaged safety needle device of claim 14, wherein the second cavity comprises indicia indicating that the safety needle device is ready for use.

16. The hard-packaged safety needle device of claim 1, wherein the adapter's tapered bore is configured to cross-fit with a commercially available needle.

17. The hard-packaged safety needle device of claim 10, wherein the label indicates that the hard needle housing has been used.

18. The hard-packaged safety needle device of claim 10, the label comprising text.

19. The hard-packaged safety needle device of claim 10, the label comprising a number.

20. The hard-packaged safety needle device of claim 10, the label comprising a symbol.

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