Improvements in medical needle cover devices

Abstract

The present invention relates to a medical needle shield apparatus having a safety device (8) with a needle shield (19) pivotally coupled to a carrier (18). The carrier (18) is configured to be secured to a syringe (20), and the needle shield (19) is configured to move outward from an initial shielding position to an unshielding position. A needle cover (23) protects a medical needle (11). In the initial shielding position, the needle cover (23) is positioned within the needle shield (19) in a first position, and a portion of the needle cover (23) and a portion of the needle shield (19) engage when the needle shield (19) is in the initial shielding position, releasably positioning the needle cover (23) within the needle shield (19) in the first position. The engagement of a portion of the needle cover (23) with a portion of the needle shield (19) prevents the needle cover (23) from moving away from the needle shield (19) from the first position until the needle shield (19) is moved to the unshielding position. The needle shield (19) is configured to move outwardly away from the needle cover (23), moving from an initial shielding position to an unshielded position, such that the movement of the needle shield (19) causes the needle shield (19) to detach from the needle cover (23), which then continues to detach, uncovering the medical needle (11).

Description

[Technical Field]

[0001] The present invention relates to a medical needle cover apparatus for use with a syringe having a forwardly extending medical needle. In a preferred aspect, the present invention relates to an improvement in a needle cover associated with a needle safety device configured to provide needlestick protection for a medical needle extending forwardly from a disposable syringe. [Background technology]

[0002] The syringes equipped with medical needles used in the present invention are intended for use in penetrating the human or animal body, or for other medical applications, such as penetration of a pierceable membrane of an intravenous administration system. In the following description, all medical applications of syringes and needles will be described simply as body penetration, even if specific embodiments are intended for other medical applications.

[0003] Syringes with a needle permanently affixed to them are often pre-filled with a liquid medication or liquid medicament and are used only once to administer an injection. After use, the syringe and needle must be disposed of in a safe manner. To protect users who must handle such syringes, it is becoming not only a requirement of health and safety legislation but also best practice to fit some type of safety device to the needle either before or after an injection is administered to minimize the risk of accidental needlestick injury.

[0004] Generally, such safety devices may be mounted on the syringe and include a shield that is axially slidable between a needle-protecting position and an unprotected position.

[0005] During the manufacturing process of disposable syringes with a needle permanently affixed to a needle hub at the forward end of the syringe barrel, it is common practice to place a needle cover over the needle prior to filling with a liquid medication or other substance and before packaging the syringe and sterilizing it for storage and transport. Such covers are typically made of a soft elastomer, such as rubber or TPE, and must meet drug compatibility and stability requirements. The rear end of the cover fits over the needle hub, and the sharp tip penetrates the cover material, forming a seal. However, the cover does not support a larger portion of the needle's length to prevent the removal of lubricants that typically coat the needle. This results in a gap around a larger portion of the needle from the syringe hub adjacent to the sharp tip. This portion of the needle must be maintained in a sterile environment before use. EP 1 502 617 and EP 1 964 586 describe embodiments of needle shields having a rigid outer shield covering a soft inner (elastomeric or rubber) needle cover, as outlined above.

[0006] A significant problem with disposable syringe manufacturing is the tendency of needle covers to pop off from their attached positions on the hub during packaging and sterilization, a phenomenon known as "pop-off." This is primarily due to pressure changes on the syringe and cover during sterilization, and the fact that a gap between the needle and cover actually exists within the sealed space. While this problem has been addressed by evacuating the space, the sterility of the needle may still be compromised. As a result, attempts have been made to enhance the secure attachment of needle covers to the syringe hub during the sterilization process, typically by providing at least one formation on the syringe hub and a corresponding formation on the rear end of the needle cover that interfaces with a formation on the hub to mechanically retain the needle cover on the syringe hub. For example, an upstanding rib may be formed around the hub, and a needle cover having an inwardly facing flange at its rear end may be mated to the rib to hold the cover on the syringe hub in a fixed position.

[0007] As mentioned above, needles must be sterilized and subsequently maintained within a cover to maintain sterility, and the cover must be removed prior to use. Thus, similar to needle covers with accompanying needle safety devices having a protective shield configured to provide needlestick protection, needle covers can be mounted within a protective shield, with the distal end portion of the cover extending beyond the distal end of the protective shield. In this case, the user first grasps the end portion and pulls the cover from within the shield before administering an injection. Illustratively, European Patent Application Publication No. 2533835 discloses a medical needle cover device used in the pharmaceutical industry. In this device, the distal end portion of the cover extends through an opening at the distal end of a telescoping needle shield. The needle shield is telescopically attached to a carrier, allowing the needle shield to be retracted proximally to expose the needle. To enable this telescopic proximal movement, the shield is mounted around the periphery of the distal end portion, which increases the overall diameter of the device relative to the diameter of the syringe. As noted above, the furthest distal end portion of the cover must extend beyond the furthest distal end of the needle shield, and of course the needle shield must be long enough to cover the entire needle, i.e., the length of the needle cover must be longer than the needle shield so that this distal extension of the cover extends beyond the end of the shield and allows the user to easily grasp the cover and pull it distally away from the rigid needle shield before administering the injection.

[0008] Thus, the overall diameter of the needle shield must be larger than the overall diameter of the syringe barrel, as described in EP 2533835. Furthermore, the needle cover must be significantly longer than the typical standard needle covers described in EP 1502617 and EP 1964586 in order for the user to grasp and remove the cover from inside the shield.

[0009] Automated methods and systems are used to fill prefillable medical syringes, often using tray (nest) / tab devices. These nest / tab devices utilize standard-sized trays (typically holding 160 ready-to-fill syringes per tray, each tray nested in a standard-depth tub) that lend themselves to automating standard, general-purpose syringe filling systems. It should be noted that the device described in EP 2533835 and many needle safety devices incorporated into prefillable syringes are not compatible with standard nest / tab systems without significant modifications to both the tray / nest and the tub. In fact, the bulkiness of some designs means that only 100 syringes can be placed in each tray, instead of the usual 160, creating problems within automated syringe filling systems and increasing the storage capacity of packaged syringes per pallet.

[0010] The present invention is suitable for incorporation into fully standard syringes, requiring no modifications to either the trays / nests or tubs used within these systems. The sterilization process can be performed while the syringes are packaged and contained within the pallet and box. Thus, a standard nest / tub system can be utilized rather than a custom modified system.

[0011] To enable incorporation into standard nest (tray) / tab systems, the primary objective of the present invention is to minimize the above-mentioned problems that arise when providing needle covers to disposable pre-filled syringes having needles fixed to their front ends, in particular to suppress the "pop-off" phenomenon associated with the production of conventional sterile ready-to-fill syringes, to provide a product that is suitable for corresponding automated equipment, filling and inspection lines, and to ensure that needle covers remain safely secured during storage of pre-filled syringes.

[0012] One object of the present invention is to solve at least one problem associated with the prior art, whether or not mentioned herein. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] European Patent Application Publication No. 2533835 [Patent Document 2] European Patent Application Publication No. 1502617 [Patent Document 3] European Patent Application Publication No. 1964586 [Patent Document 4] U.S. Patent No. 10,973,986 Summary of the Invention

[0014] A first aspect of the present invention provides a medical needle cover device, 1. A medical needle cover device, comprising: The medical needle cover device is a syringe having a syringe barrel with a needle hub at a distal end, the syringe having a medical needle having a longitudinal axis and a sharp tip mounted on the needle hub with the sharp tip protruding distally; a safety device having a needle shield pivotally coupled to a carrier, the carrier configured to be fixed to the syringe, the needle shield configured to move outwardly from an initial shielding position to a non-shielding position; a needle cover that covers the medical needle to protect it and prevents leakage of medicine from the sharp tip, The needle cover is The longitudinal axis and a profile at a proximal end configured to engage a profile at a distal end of the needle hub to form a substantially airtight seal therebetween when the needle cover is in a first position relative to the needle hub, thereby maintaining sterility of a medical needle enclosed within the needle cover; and, In the initial shielding position, the needle cover is positioned within the needle shield in the first position, with the longitudinal axis of the needle cover aligned with the longitudinal axis of the needle; the needle shield having fastener means for fastening and / or gripping, or loosely holding and restraining, the needle cover in the first position; the needle shield, the carrier, and the needle cover are maintained together as a unitary, self-contained safety needle device that is attached to the distal end of the syringe; a portion of the needle cover and a portion of the needle shield engage when the needle shield is in an initial shielding position to releasably maintain the needle cover within the needle shield in the first position, preventing drug leakage during storage of the syringe and maintaining sterility of the medical needle; when the safety needle device is attached to the distal end of the syringe, a portion of the needle shield engaging a portion of the needle cover prevents distal movement of the needle cover away from the first position relative to the needle hub until the needle shield moves to the unshielding position; The needle shield is configured to move outwardly away from the needle cover and away from the initial shielding position to the non-shielding position, and the movement of the needle shield away from the initial shielding disengages the needle shield from the needle cover, followed by disengaging the needle cover distally from the first position to remove the medical needle. The medical needle cover device is characterized by the above.

[0015] The fastener means includes a retention fastener having a shaped lug with an arcuate inner surface positioned around a portion of the outer periphery of the needle cover to grip or loosely hold the needle cover.

[0016] The clamping means preferably has a restraining force that must be overcome to move the needle shield outwardly from the initial shielding position to the non-shielding position.

[0017] The needle shield may have a longitudinally extending gap. The needle shield comprises a part-cylindrical shield with a longitudinal gap along the entire longitudinal length of the needle shield.

[0018] The clamping means includes one or more retention clamps located on or adjacent the edges of the longitudinal gap of the needle shield.

[0019] The one-piece, freestanding safety needle device may be configured to press fit onto the syringe.

[0020] Preferably, when the safety device is attached to the syringe, the needle shield and the needle cover engage, generating a distal axial compressive force on the needle cover between a rear end of the needle cover and a position where the needle shield engages the needle cover.

[0021] Preferably, when the needle shield is in the initial shielding position and the needle cover is in the first position, the farthest distal end of the needle cover is located within the needle shield.

[0022] Preferably, when the needle shield is in the initial shielding position and the needle cover is in the first position, the furthest distal end of the needle cover protrudes beyond the furthest distal end of the needle shield.

[0023] The needle shield is preferably pivotally coupled to the carrier.

[0024] Preferably, the needle shield is secured to the carrier by a hinge mechanism.

[0025] The hinge mechanism may define a fixed axis of rotation about which the needle shield can rotate relative to the carrier. The fixed axis of rotation may define a rotational joint between the needle shield and the carrier.

[0026] Preferably, the needle shield is configured to pivot from the initial shielding position to a non-shielding position.

[0027] The needle shield may have two pivot members that can engage with two pivot members on the carrier, the needle shield may have two stub shafts that can engage within two corresponding openings on the carrier, and the pivot members may form the pivot axes of the needle shield.

[0028] The carrier has two pivot members that can engage with two pivot members on the needle shield. The carrier has two stub shafts that can engage within two corresponding openings on the needle shield. The pivot members can form the pivot shafts of the needle shield.

[0029] The needle shield said initial shielding position; the non-shielding position; and Final shielding position, The structure may be such that the moving body moves in a swiveling manner between the above.

[0030] the needle shield The device may be configured to move, preferably rotate, and more preferably move continuously between the storage position (before use), the operating position (during use), and the safety position (after use).

[0031] The protective shield and the needle cover may form an interlock. Preferably, the interlock provides a mechanism for coordinating the functions of the protective shield and / or the needle cover. Preferably, the interlock coordinates the functions and / or relationships of the protective shield and / or the needle cover in each of the successive positions. Preferably, in the storage / initial shielding (pre-use) position, the interlock prevents access to distally remove the needle cover from within the protective shield.

[0032] In the final (safe) position, the sharp tip of the medical needle can be deflected away from the longitudinal axis of the syringe barrel. In the final shielding (safe) position, the medical needle can be deformed, preferably non-linear. This deformation preferably renders the medical needle non-reusable.

[0033] Preferably, while the needle shield is moving from the non-shielding position to the final shielding position, an inner surface of the needle shield abuts a portion of the medical needle, and this abutment and further movement of the needle shield causes the needle shield to deflect the medical needle.

[0034] The deformed medical needle can resiliently urge the needle shield back outward toward the non-shielding position.

[0035] The needle shield has an elastically deformable (elastomeric / resilient) fixation area, zone or portion that can fix the needle shield relative to the carrier in the final shielding position, which fixation area can consist of a proximal area, zone or portion of the needle shield.

[0036] The carrier may have a fixed abutment surface that secures the needle shield relative to the carrier in a final shielding position.

[0037] The contact surface may be provided on a part of the carrier.

[0038] The abutment surface may be provided on the carrier as a lug, preferably extending distally forward (outward) from the carrier.

[0039] A fixed portion or region of the needle shield may engage the abutment surface in a final shielding (safe) position. The sliding surface of the fixed portion may be configured to move over the sliding surface of the carrier or the lug when moving from the non-shielding position to the final shielding position. The fixed portion and / or lug may be elastically deformable while the fixed portion moves over the distal end of the fixed abutment surface of the lug. In the final shielding position, the fixed portion and the abutment surfaces of the lug are not deformed and are in a stress-free (relaxed) state / condition.

[0040] In the final shielding position, the fixed portion and the abutment surface can resiliently engage due to the deflection of the deformed medical needle caused by bending.

[0041] The needle cover may be constructed from a soft, one-piece component made of an elastomeric polymeric or rubber material. The needle cover may be constructed from a component having an inner soft portion that allows the sharp tip of the needle to penetrate the soft portion. The needle cover may also have a rigid portion. This rigid portion may have an outer rigid shell. This outer rigid shell may extend around part or substantially all of the outer surface of the inner soft portion. The inner soft portion may be constructed from one or more rigid portions affixed to the outer surface. The soft and rigid portions may be co-molded and / or bonded and adhered together, or may be constructed from separate pieces.

[0042] A portion of the needle cover may have a step, recess, outward protrusion, or annular flange that engages a portion of the needle shield, which may have a (rearward / proximally facing) shoulder or inward protrusion, to (releasably) engage and maintain and hold the needle cover on the needle in a first position. In this first position, this engagement preferably allows a proximal portion of the needle cover to compress and / or expand through engaging contact with a portion of the syringe hub. Preferably, the step or recess may be spaced from the proximal distal end of the needle cover. Preferably, the majority of the needle cover is surrounded by the needle shield in its initial shielding position when the needle cover is in the first position, preventing the user from accessing (touching) the cover and grasping and manipulating it with the user's finger(s). In some embodiments, the step or recess may be located at the furthest distal end, or may actually be formed by the distal end face of the needle cover. In other embodiments, these steps or recesses may not be provided and the needle shield may grip and hold the needle cover on the needle in the first position by friction.

[0043] The needle shield may (purely and solely) frictionally engage and / or grip the needle cover to maintain and hold the needle cover in the first position. The outer surface of the needle cover may be flattened (planarized) and / or substantially smooth, against which the needle shield may frictionally grip. The needle shield may present a corresponding (planar) and / or substantially smooth inner surface against which the needle cover may grip. Preferably, movement of the needle cover away from its initial shielding position disengages the needle shield from the needle cover.

[0044] The carrier may be comprised of an annular ring component. The carrier may comprise a securing member for securing the carrier (and the safety device) to the syringe. The securing member may comprise an internal rib or multiple external ribs capable of securing a (rearward-facing) shoulder on the syringe hub. The internal rib may comprise a circumferential rib on the inner surface of the carrier, extending around or partially around the inner periphery of the ring component and surrounding the needle hub. A portion of the internal rib, preferably an arc-shaped portion thereof, may resiliently move outward so that the (rearward-facing) shoulder of the needle hub passes through the internal rib, causing the internal rib to bend outward and then resiliently return to its original / initial state, preventing the syringe from being removed from the carrier.

[0045] When the needle shield is in an initial shielding position that inhibits forward distal movement of the needle cover away from the syringe hub, a portion of the needle shield preferably engages the needle cover at a location spaced forward distally from the rear distal end, the needle shield surrounds a circumferential portion of the outer surface of the needle cover, extends along the entire longitudinal length of the needle cover, and can extend distally beyond the furthest distal point of the needle cover, thereby allowing the entire needle cover to be contained within the longitudinal length of the needle shield.

[0046] The needle cover may be constructed from a resilient material and is resiliently compressible and expandable in an axial direction and resiliently compressible and expandable in a radial direction.

[0047] The length of the needle cover from its proximal rearward surface to its engaged position within the needle shield is such that, when the carrier, needle shield, and needle cover are mated to the syringe, the rearward-facing proximal portion of the needle cover is subjected to an axial compressive force that causes the interior shape of the rearward-facing proximal portion of the needle cover to resiliently expand outward and engage the forward-facing distal portion of the syringe hub, thereby creating a substantially airtight seal between the resiliently biased proximal end surface of the needle cover and the syringe needle hub. This axial compressive force causes the shape of the rearward-facing proximal portion of the needle cover to strongly compress against the forward distal portion of the syringe hub, thereby creating a substantially airtight seal between the resiliently biased proximal end surface of the needle cover and the syringe needle hub.

[0048] Preferably, an axial force forms a substantially airtight seal between the rear proximal end of the needle cover and the front distal end of the syringe, pressing the safety device against the syringe hub when mated to the syringe and acting on a correspondingly shaped surface at the distal end of the syringe hub to resiliently expand the rear end of the needle cover. Preferably, as long as the safety device with the needle shield of the medical needle is mated to the syringe and the needle cover and the needle shield are engaged, the needle cover does not need to be held on the needle hub by mechanical interlocking of corresponding interlocking formations on the needle hub, such as inward flanges that engage behind ribs formed around the bulbous hub of the syringe used in standard needle covers described in EP 1 502 617 and EP 1 964 586. The present invention preferably eliminates the reliance on and need for mechanical interlocking formations currently utilized by standard needle covers currently used on the market. Alternatively, the seal of the present invention may be formed forward of a rib or other formation on the needle hub of the syringe. Preferably, engagement of the needle cover and the needle shield when in the initial shielding position prevents the cover from sliding distally forward and moving the syringe needle hub away from its first position during the manufacturing and sterilization processes, or subsequent storage of the syringe, due to the fact that the needle shield is inhibited from pivoting away from the initial shielding position.

[0049] The fastening means may comprise one or more fasteners on the needle shield, preferably at (or adjacent to) the edge of the longitudinal gap of the needle shield. The fastening means generates a restraining force that must be overcome to move the needle shield outward from the initial shielding position to the unshielding position. The fastening means may form a sub-assembly (preferably together with a pivotal coupling / hinge mechanism) comprising the carrier, needle shield and needle cover. The sub-assembly is preferably self-supporting in the sense that the fasteners generate a restraining force and support the needle cover by frictional engagement within the needle shield, maintaining and retaining it as a complete, integrated unit.

[0050] When the needle shield and needle cover are engaged during installation of the safety device onto the syringe, a distal axial compressive force is generated within the needle cover between the rear end of the needle cover and the location where the needle shield engages the needle cover. This force urges the resilient proximal region of the needle cover rearward and proximally against the syringe, ensuring a sterile seal is maintained between the rear end of the needle cover and the needle hub. The resilience of the needle cover allows it to sustain the distal axial compressive force applied to it during manufacturing, shipping, and storage of the syringe, thereby ensuring an effective seal is maintained even during the sterilization process, when the sealed void / space around the needle is normally subjected to different air pressures, creating an axial force that pulls the needle cover distally away from the needle hub.

[0051] Similar to conventional needle covers, the sharp tip of the medical needle can be received in the (elastic / soft / elastomeric) portion of the needle cover, thus allowing sterilization to be performed, which further protects the sharp tip of the medical syringe during each step of the syringe manufacturing, sterilization, packaging, unloading for filling, filling, and repackaging.

[0052] A second aspect of the present invention is 1. A method of protecting a medical needle comprising providing a medical needle cover device, the medical needle cover device comprising: a syringe having a syringe barrel with a needle hub at a distal end, the syringe having a medical needle having a longitudinal axis and a sharp tip mounted on the needle hub with the sharp tip protruding distally; a safety device having a needle shield pivotally coupled to a carrier, the carrier configured to be fixed to the syringe, the needle shield configured to move outward from an initial shielding position to a non-shielding position; a needle cover that covers the medical needle to protect it and prevents leakage of medicine from the sharp tip, The needle cover is The longitudinal axis and a profile at a proximal end configured to engage a profile at a distal end of the needle hub to form a substantially airtight seal therebetween when the needle cover is in a first position relative to the needle hub, thereby maintaining sterility of a medical needle enclosed within the needle cover; In the initial shielding position, the needle cover is positioned within the needle shield in the first position, with the longitudinal axis of the needle cover aligned with the longitudinal axis of the needle; the needle shield having fastener means for fastening and / or gripping, or loosely holding and restraining, the needle cover in the first position; the needle shield, the carrier, and the needle cover are maintained together as a unitary, self-contained safety needle device that is attached to the distal end of the syringe; a portion of the needle cover and a portion of the needle shield engage when the needle shield is in an initial shielding position to releasably maintain the needle cover within the needle shield in the first position, preventing drug leakage during storage of the syringe and maintaining sterility of the medical needle; engaging a portion of the needle shield with a portion of the needle cover to prevent the needle cover from moving distally from the first position relative to the needle hub until the needle shield moves to the unshielding position when the safety needle device is attached to the distal end of the syringe; The needle shield is configured to move outwardly away from the needle cover and away from the initial shielding position to the non-shielding position, and the movement of the needle shield away from the initial shielding disengages the needle shield from the needle cover, followed by disengaging the needle cover distally from the first position to remove the medical needle. The present invention relates to a method for protecting a medical needle.

[0053] In use, the needle shield is preferably initially moved outward with the needle enclosed within the needle cover, and once the needle shield is in the outward, unshielding position, the user preferably grasps the needle cover and moves it distally to remove it from the syringe, preparing for an injection. Thus, the needle shield prevents "user access" to the needle cover, preventing removal while the needle shield is in its initial shielding position and allowing removal in the unshielding position only immediately prior to injection. In this manner, the needle cover remains in its first position until the needle shield is moved to the unshielding position, at which point the user can decide when to grasp and remove the needle cover, thereby protecting the needle until ready for injection. For example, a fixed time period can be set between moving the needle shield to the unshielding position and removing the needle cover from the syringe. [Brief explanation of the drawings]

[0054] The invention will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1]FIG. 1 is a perspective view of a first preferred embodiment of a safety needle device and syringe prior to installation. [Figure 2] FIG. 2 is a perspective view of a first preferred embodiment of a safety needle device attached to a syringe. [Figure 3] FIG. 3 is a perspective view of the first preferred embodiment of the safety needle device attached to a syringe with the protective shield in the unshielded position and the cover removed. [Figure 4] FIG. 4 is a perspective view of the first preferred embodiment of the safety needle device attached to a syringe after an injection has been performed with the protective shield in the final shielding position. [Figure 5] FIG. 5 is a perspective view of the first preferred embodiment of the safety needle device prior to attachment to a syringe. [Figure 6] FIG. 6 is a side view of the first preferred embodiment of the safety needle device prior to attachment to a syringe. [Figure 7] FIG. 7 is a top plan view of the first preferred embodiment of the safety needle device prior to attachment to a syringe. [Figure 8] FIG. 8 is a side cross-sectional view of the first preferred embodiment of the safety needle device prior to installation, showing a side view of the syringe. [Figure 9] FIG. 9 is a side cross-sectional view of the first preferred embodiment of the installed safety needle device and a side view of the syringe. [Figure 10] FIG. 10 is a side cross-sectional view of the first preferred embodiment of the safety needle device installed with the protective shield moved toward the non-shielding position, showing a side view of the syringe. [Figure 11] FIG. 11 is a side cross-sectional view of the first preferred embodiment of the safety needle device with the protective shield in the non-shielding position and the cover removed from the syringe, and a side view of the syringe. [Figure 12]FIG. 12 is a side cross-sectional view of the first preferred embodiment of the safety needle device in an installed state with the protective shield moving toward the final shielding position, and a side view of the syringe. [Figure 13] FIG. 13 is a side cross-sectional view of the first preferred embodiment of the safety needle device with the protective shield installed in the final shielding position, showing a side view of the syringe. [Figure 14] FIG. 14 is a side cross-sectional view of the first preferred embodiment of the safety needle device installed, showing the proximal region of the protective shield in an unlocked position relative to the locked, protruding position, and a side view of the syringe. [Figure 15] FIG. 15 is a side cross-sectional view of the first preferred embodiment of the safety needle device loaded with the protective shield in the final shielding position showing the proximal region of the protective shield in a locked position relative to the locked protruding position, and a side view of the syringe. [Figure 16] FIG. 16 is a side cross-sectional view of another preferred embodiment of the safety needle device installed, showing a side view of a syringe. [Figure 17] FIG. 17 is a side cross-sectional view of the above alternative preferred embodiment of the safety needle device installed with the protective shield in the unshielding position and the syringe uncovered, and a side view of the syringe. DETAILED DESCRIPTION OF THE INVENTION

[0055] Throughout this specification, and with reference to the accompanying drawings, a safety needle device or safety device 8 is shown and described for shielding the tip of a sharp needle 11 of a syringe. As used herein, terms such as "distal," "forward-facing portion," or "forward direction" generally refer to directions toward the intended patient, and terms such as "proximal," "rear-facing portion," or "rear-direction" are used to describe directions away from the patient in use. As shown in the drawings and described below, the proximal end of the safety needle device is attached to the distal end of a syringe 10.

[0056] 1-13. The illustrated syringe 10 has a needle 11 connected to and adhesively secured to a tip 12 of the syringe 10, and a safety device 8 that protects the needle 11. The nose 12 of the syringe 8 serves as a hub for the needle 11 and defines a rearward-facing shoulder 14. Forward of the shoulder 14, the tip 12 is bulbous, providing an engagement surface 15. A small amount of adhesive 16 in the center of the tip 12 secures the needle 11 within a bore extending within the tip 12. The safety device 8 includes a carrier 18 in the form of a tubular body or sleeve portion for a protective shield 19 (needle shield), which is movable (e.g., swivelable, pivotable, tiltable, or rotatable) relative to the longitudinal axis of the needle 11 when an injection is administered. The carrier 18 has a bore 20 that faces the nose 12 of the syringe 10 and defines an inwardly directed rib 21 within the bore 20 that engages behind the shoulder 14 when the safety device 8 is attached to the syringe 10 and retains the safety device 8 on the syringe 10.

[0057] The rib 21 may comprise at least a portion of an outwardly facing flexible rib 21' (shown in FIG. 8) that curves outward upon insertion of the tip 12 into the bore 20. The flexible portion 21' has a sloped, inwardly facing abutment surface that engages the outer circumferential surface of the tip 12. Translation of the tip 12 into the bore 20 causes the outer surface of the flexible portion 21' to deflect outward until the shoulder 14 projects distally beyond the end of the flexible portion 21'. Once this position is reached, the flexible portion 21' momentarily returns inward, engaging the carrier 18 with the tip 12. The corresponding shapes of the shoulder 14 and the distal surfaces of the rib 21 and flexible portion 21' prevent the tip 12 from disengaging from the bore 20 in this engaged position. This allows for a secure, disposable, snap-lock mating of the safety device 8 to the syringe 10.

[0058] The protective shield 19 is configured to ensure that the (soft rubber) cover 23 remains in place within the safety device 8 .

[0059] In some of the illustrated embodiments, the needle cover 23 comprises a soft needle cover. The soft needle cover may be constructed entirely of a soft material, or may be constructed only partially / in part from a soft material. It should be understood that the needle cover 23 allows the sharp tip of the needle 11 to partially penetrate the soft interior surface, enabling the needle cover 23 to function. Other portions / surfaces of the needle cover 23 may not be soft and may, in fact, be harder than the soft portion. For example, as shown in FIGS. 16 and 17, the needle cover 23 may have a hard outer shell 92 positioned on or around the exterior surface of the soft interior portion 90, or one or more portions of this exterior surface. The soft interior portion 90, in some embodiments, may be combined with a hard shell 92, either entirely or partially, and may itself be defined as a soft needle cover. The hard outer shell 92 or similar hard component(s) may be secured around the soft interior portion 90 in any suitable configuration. Such combinations of portions 90, 92 are also within the scope of the definition of a soft needle cover. This is because a substantial interior portion of the needle cover is made of a soft material that allows the sharp tip of the needle 11 to penetrate. Therefore, the term "soft needle cover" can be used even when it is not a requirement that any portion of the needle cover 23 be soft.

[0060] Typically, the soft needle cover or component 90 can be press-fit into the outer shell 92 during the manufacturing process. Alternatively, the outer shell 92 and soft needle component 90 can be co-molded (also known as overmolding), and the two can be bonded together during the plastic injection molding process. The outer shell / cover can cover only a portion of the soft needle cover, for example, the rear proximal end. The harder the outer shell 92, the more slippery, low-friction surface it provides, making it easier for the clasp 44 of the needle shield 19 to disengage from the needle cover 23 when the shield 19 is pulled away from its initial shielding position.

[0061] As mentioned above, the needle shield cover can comprise an (elastic) soft needle cover with an outer (hard) shell and / or a soft needle cover without a shell. The outer shell can be co-molded, overmolded, or otherwise bonded to the inner soft needle cover. Furthermore, the outer shell can cover only a portion of the soft needle cover, for example, the proximal end area. The soft inner needle cover can be press-fit or friction-fit into the outer shell.

[0062] As shown in FIGS. 1-15, the needle cover 23 is a single (resilient) flexible component having a forward portion 24 (distal end) that does not extend beyond the distal end 50 of the protective shield 19. This provides significant advantages, as will be described below. The needle cover 23 has a single flexible component constructed from a resilient material, which may be an elastomeric polymer or rubber compound, allowing it to be penetrated by the sharp tip of a needle while being compatible with the medicament contained within the syringe 10. The rearward portion 25 (proximal end) of the cover 23 is located within the safety device 8. An opening / bore 26 extends into the cover 23 from the rearward proximal end 25, and the inner distal portion is penetrated by the tip of the needle 11 protruding from the tip 12 of the syringe 10. The outer surface of the cover 23 has a step 27 in the form of a flange distally forward of the end 25 that is adapted to engage the rearward-facing internal shoulder 42 of the protective shield 19. In this way, shoulder 42 engages step 27, thereby securely maintaining and retaining cover 23 within protective shield 19 when the latter is in its initial position (before use).

[0063] In some embodiments, the protective shield 19 solely and solely frictionally engages and / or grips and / or fastens the needle cover 23 to maintain and hold the needle cover 23 in the first position. In such embodiments, the outer surface of the needle cover 23 does not include any step, flange, or similar feature that physically and / or mechanically engages or abuts the needle cover 23 and the protective shield 19. The contours of the outer surface of the needle cover 23 are flat / planar and / or substantially smooth, and this outer surface frictionally grips or fastens the protective shield 19 when the needle cover is in the first position. Similarly, the protective shield 19 does not include any physical / mechanical features for needle cover engagement, but instead includes a corresponding flat and / or substantially smooth inner surface for frictionally gripping the needle cover 23.

[0064] In the preferred embodiment shown, the protective shield 19 mates with the needle cover 23. In particular, the present invention provides a mechanism for connecting and / or coordinating the functions of different components. Specifically, the protective shield 19 and the needle cover 23 form an interlock that coordinates a specific, predetermined sequence of operations during operation of the protective shield between (1) a first, retracted / initial position (before use), (2) an activated / non-shielding position (during use), and (3) a safe / final shielding position (after use).

[0065] The protective shield 19 and the needle cover 23 form a cooperative arrangement, and this relationship defines the functionality of the components and procedures. In an initial step, the protective shield 19 must be moved outward by the cooperative arrangement. This is because in its initial position, the needle cover 23 is inaccessible and cannot be removed, requiring the user to remove it. In this initial position, the protective shield 19 surrounds the needle cover 23 and resiliently presses it toward the syringe 10. This prevents access to the needle cover 23 and prevents the user from manually grasping and / or manually removing it. In a second step, the needle cover 23 becomes accessible and can be removed because the protective shield 19 does not prevent access to the needle cover 23. In this position, the needle cover 23 is accessible and can be removed by the user. The protective shield 19 therefore acts as an effective barrier, preventing and / or prohibiting access to the needle cover 23 in its initial position, thereby preserving the integrity of the drug contained in the syringe. Finally, upon completion of the injection, the protective shield 19 assumes an irreversible safety position around the needle 11 in its final shielding position after use.

[0066] As described above, the protective shield 19 denies access to the needle cover 23 in the initial position, ensuring that the needle cover remains in the initial position until the user is ready to perform an injection, at which point the user only gains access to the needle cover 23 after the protective shield 19 has been moved to the non-shielding position, which disengages the needle cover 23 from the protective shield 19 and relieves any compressive force applied to the needle cover in the proximal direction.

[0067] The present invention therefore provides a series of pre-defined and oriented procedures capable of coordinating the functions of differently positioned components, which must be adhered to and which will guide the user through the correct operation of the invention.

[0068] Additionally, the protective shield 19 provides a visual indicator, in the form of an arrow 45, showing how to initially initiate a pre-set operating sequence. As shown in FIG. 6, one or two arrows 45 may be provided on the protective shield 19 to indicate to the user how to initiate the injection device ready for a precise injection sequence. While the user's instinct is to locate and remove the needle cover 23, the present invention denies access to the needle cover 23 in its initial position. Thus, the arrows 45 provide a simple visual cue or cue to first move the protective shield outward to initiate the injection sequence, and then ensure that the protective shield 19 and needle cover 23 interlock with each other. In this manner, the arrows 45 provide an initial cue to first move the protective shield 19, and then for the user to "instinctively grasp" the needle cover 23 and pull it away from the syringe, thereby exposing the needle 11 and preparing the device for injection.

[0069] Collectively, the protective shield 19 and needle cover 23 together with the carrier and syringe form a linkage in which the components are essentially linked and connected to coordinate the function of these components in a predefined sequence of steps during use of the present invention.

[0070] The needle cover can be loosely held within the protective shield, and the portion of the needle shield that contacts the needle cover (when the cover is in the first position) can be stuck and / or adhered to a portion of the needle cover. This causes the adhesive to break / tear / detach when the shield is moved to the unshielding position. This results in a permanent separation of the two parts, allowing the shield to move freely to the unshielding position, notifying the user that the "tamper-evident seal" has been broken. This provides confirmatory evidence that the protective shield has not moved from its initial shielding position (before use).

[0071] As the protective shield 19 moves away from the initial shielding position, it frictionally disengages from the needle cover 23. Note that in some further embodiments, a frictional engagement element may be used in conjunction with the physical / mechanical element such as the step / shoulder of the preferred embodiment.

[0072] The rearward surface 28 of the cover 23 within the bore 26 has a shape complementary to the (bulb-shaped) engagement surface 15 of the tip 12 of the syringe 10. The length of the cover 23, and specifically the position of the rearward surface 28 relative to the step 27, is such that, during press-fit of the safety device 8 onto the syringe 10, the rearward surface 28 engages the syringe tip engagement surface 15 and resiliently expands outward by forcing the carrier of the safety device 8 directly onto the nose 12 of the syringe 10, as shown in Figures 2 and 9. Thus, with the internal ribs of carriers 21 and 21' secured to rearwardly facing shoulder 14 of the syringe hub, attachment of safety device 8 to syringe 10 subjects rearward portion 25 of the cover to an axial compressive force that causes rearward surface 28 to expand radially outward against mating surface 15 of nose 12 of the syringe, ensuring or establishing a substantially airtight seal between cover 23 and nose 12 of syringe 10, as shown in Figures 2 and 9. Figure 2 shows syringe 8 filled with medication and attached piston and plunger.

[0073] At the nose 12 of the syringe 10, the engagement surface 15 may be generally rounded, bulbous, or chamfered (and / or other suitable shape), and the rearward surface 28 of the cover 23 may have a corresponding, complementary internal shape. These corresponding shapes allow for a substantially airtight seal to be formed between the cover 23 and the syringe 10. When the safety device 8 is attached to the syringe 25, an axial compressive force is applied to the rearward portion 25 of the cover 23 while the internal engagement of the step 27 with the internal rearward-facing shoulder 42 of the protective shield 19 holds the cover in the first position. Other safety device 8 designs may be utilized, so long as the cover 23 is appropriately modified so that when the safety shield is in the initial position and the cover is in the first position, a compressive force is applied to the rearward portion 25 of the cover 23, ensuring that its rearward end surface 28 sealingly engages the corresponding engagement surface 15 of the syringe 10. When the cover is in the first position, a design that generates a compressive force within the flexible region of the needle cover causes the engagement surface 15 of the syringe to expand the rearward end surface 28 (of the flexible / flexible portion) of the needle cover outward, or alternatively, causes the end surface (e.g., the flexible / flexible end surface) of the needle cover to compressively engage a portion of the nose / hub end of the syringe, establishing and maintaining a substantially airtight seal therebetween. In this latter configuration, the substantially planar or flat surface (e.g., the flexible / flexible surface) of the needle cover 23 seals against the substantially planar or flat surface of the syringe 10, maintaining a constant, permanent compressive force therebetween to maintain an airtight seal therebetween. Similarly, other cooperating shapes that are configured to undergo a compressive force (when the safety device 8 is engaged with the syringe) can also establish and maintain an airtight seal therebetween.

[0074] In this position, the sharp tip of needle 11 is sealed and penetrates, albeit shallowly, rubber cover 23, thereby preventing leakage of medication. Specifically, the sharp tip penetrates the soft portion of needle cover 23. This eliminates the possibility of medication leakage from needle 11, and by placing only the tip of needle 11 within cover 23, the silicone lubricant that is applied to the shaft of needle 11 and that facilitates penetration of the needle into the skin is not wiped away by cover 23. Furthermore, the internal engagement between cover end surface 28 and syringe nose engaging surface 15 also effectively acts as a seal, ensuring that needle 11 remains sterile.

[0075] When using the syringe 10 and safety device 8, the protective shield 19 must first be moved to the unshielding position to allow access to the needle cover.

[0076] The protective shield 19 has a pair of inwardly protruding stub shafts 40. Correspondingly, the carrier 18 has a pair of holes 41 that rotatably engage the stub shafts 40. Thus, the protective shield 19 is rotatable or pivotable relative to the carrier 18. Specifically, when the carrier 18 (and thus the safety device 8) is attached to the syringe 10, the protective shield 19 is pivotably movable relative to the longitudinal axis of the needle 11. The protective shield 19 is initially positioned with its longitudinal axis generally parallel to the longitudinal axis of the needle 11, aligning the protective shield 19 with the needle 11 in its initial dispensing configuration prior to use.

[0077] The protective shield 19 has a partial or incomplete longitudinal tubular sleeve portion that extends circumferentially around a majority of the outer circumferential surface of the needle cover 23. This configuration creates a longitudinal gap that allows the semi-tubular sleeve portion of the protective shield 19, which receives and retains the needle cover in its initial shielding position prior to use, to move outward from the enclosed needle 11. The protective shield 19 has a distal end 50 that defines the outermost, or distal-most, region of the safety device 8. Specifically, the distal end 50 of the protective shield 19 extends at least as far as, but preferably beyond, the distal end 24 of the cover 23. This provides the shield's forward extent with an ideal distal dimension for use in standard nest-and-tab packaging systems. This eliminates the need to manually grasp the cover 23 for removal, which is required with prior devices using telescoping protective shields and requires an excessively long needle cover that protrudes beyond the distal end of the protective shield. The distal dimensions of the protective needle shield (with enclosed needle cover) of the present invention are designed and constructed to be smaller than or equal to standard needle covers used in existing nest / tab systems. Therefore, no modifications are required to any of the existing packaging components used in these standard syringe processing assembly lines to accommodate the safety device 8. As described below, another reason this is achievable is because the overall diameter of the safety device 8 of the present invention is compatible with existing standard tray / nest and tab systems. The ability to use needle shield / carriers (safety device 8) with diameters no larger than, equal to, or less than the diameter of the syringe 10, combined with the ability to use the most distal portion of the needle cover 23 on the most distal portion of the protective shield 19 or within the length of the shield 19, results in an overall assembled length of the safety device 8 no larger than the non-safety standard needle covers disclosed in U.S. Pat. No. 10,973,986 and currently used in existing nest / tab systems.

[0078] As mentioned above, the protective shield 19 has an internal shoulder 42 that prevents distal movement of the needle cover 23 away from the first position during assembly of the device 8 onto the syringe 10, but instead urges the cover 23 toward the syringe 10 in its initial position. An advantageous effect of the present invention is that it limits the length of the cover 23 so that its most distal point is defined by the end 50 of the protective shield 19. This limitation precludes manual grasping of the needle cover 23 to remove it as needed to perform an injection. Therefore, the protective shield 19 is first manually moved outward toward the non-shielding position, as shown in FIG. 10 . This movement disengages the shoulder 42 from the front face 29 of the step 27, and this movement also relieves or relieves the pushing or compressive force urging the cover proximally toward the syringe 10.

[0079] In the outward pivoted position shown in Figures 3 and 11, cover 23 is exposed and ready for a user to grasp, manipulate, and pull distally from the syringe and needle to administer an injection. With the protective shield in the unshielding position, the outer surface of cover 23 is grasped and pulled distally from syringe 10. Shoulder 42 of protective shield 19 disengages from step 27 of cover 23, allowing cover 23 to move freely distally. Cover 23 can then be removed, as shown in Figures 3 and 11, and discarded or set aside for later disposal, and the syringe and safety device are ready to administer an injection.

[0080] After an injection is performed, the sharp tip of the needle 11 must be protected. This is accomplished by moving the protective shield 19 inward (after use) to a fixed, final, shielding position. In a preferred embodiment, this movement is accomplished manually through user intervention, which is referred to as "active protection" of the sharp tip of the needle 11. When the protective shield 19 is pivoted inward (manually by the user), the inner surface of the protective shield 19 abuts and contacts the end region of the needle 11, as shown in FIG. 12. Further pivoting causes the protective shield 19 to distort / bend the axis of the needle 11, as shown in FIGS. 4 and 13. In this position, the longitudinal axis of the protective shield 19 is angled relative to the longitudinal axes of the syringe 10 and carrier 18. This not only protects and shields the sharp tip of the needle 11, but also prevents the needle 11 from being reused. Although the metallic medical needle resists the inward movement of the shield due to its elastic properties, this reaction force is very small and can be easily suppressed by the user while the shield is moving to the final shielding position.

[0081] In the final shielding position shown in Figure 13, the protective shield 19 is secured in its final shielding position relative to the carrier 18 and syringe 10. During the inward pivoting movement of the protective shield, the proximal region 52 of the protective shield 19 elastically deforms over the distal edge of the carrier 18 defined by the carrier's lugs 54, as shown in Figure 12. The proximal region 52 moves over the lugs 54 and eventually overcomes the edges of the lugs 54. At this point, the elastic properties of the material comprising the proximal region 52 cause the proximal region 52 to return to its original, stress-free, relaxed state, releasing any deformation in the proximal (abutment) region 52.

[0082] The forward-facing (distal) abutment surfaces 55 of the protruding lugs 54 can be angled to maintain the protective shield 19 in a fixed position. Specifically, the forward-facing surfaces 55 can be angled rearward from the outer surface to the inner surface. The angled surfaces thereby prevent the resiliently deformable proximal region 52 from moving past the protruding lugs 54 back to a non-shielding position, thereby preventing any subsequent attempts to pull the shield away from its final shielding position. In some embodiments, the rearward-facing abutment surfaces 53 of the proximal region 52 of the protective shield 19 can be angled to maintain the protective shield 19 in a fixed position. In some embodiments, both the forward-facing surfaces 55 of the protruding lugs 54 and the rearward-facing abutment surfaces 53 of the protective shield 19 are angled to maintain the protective shield 19 in a fixed position.

[0083] When the protective shield 19 is secured in the final shielding position, it protects the sharp tip of the needle, and the angle of the protective shield 19 provides a visual indication that the safety device 8 has been used. Additionally, if the shaft of the needle 11 is deformed, this can also be a visual indication that the needle 11 should not be reused.

[0084] 14 and 15 are diagrams showing the shield fixing configuration in detail. The outer surface of the lug 54 has a sliding surface 57, over which a portion of the protective shield 19 moves when the shield is moved to the fixed position. The inner surface of the protective shield 19 forms a sliding surface 56, which assists the sliding movement of the protective shield 19 to the fixed, final shielding position. Specifically, the inner sliding surface 56 of the protective shield 19 slides over the outer sliding surface 57 of the lug 54. To move to the fixed position, the protective shield 19 pivots relative to the carrier 18, and this pivoting causes the sliding surfaces 56, 57 to move relative to each other, causing the sliding surface 56 of the protective shield 19 to slide over the sliding surface 57 of the lug 54. Next, the sliding surface 56 of the protective shield 19 (sliding over the sliding surface 57 of the lug 54) reaches the distal edge of the projection (lug) 54, and the rotational force applied by the user to move the shield into the protective position causes the zone in the proximal region 52 of the protective shield 19 to deform outward relative to the adjacent zone in the proximal region 52 of the protective shield 19. The deformable zone and the adjacent zone are provided in a continuous (and homogenous) portion of the protective shield 19.

[0085] The proximal region 52 of the protective shield 19 provides a deformable zone and is resilient / elastic. In some embodiments, this zone or region of the proximal region 52 may be thin or thick (i.e., a relatively thin or thick zone / region) or may have a tapered cross-sectional thickness to provide the necessary deformability. Typically, the protective shield 19 is constructed from a molded plastic or polymeric material that provides the necessary resilience / elasticity. This material can be a thermoplastic material with resilient, deformable plasticity, allowing the proximal region 52 to deform or fold outward as the protective shield 19 moves to its locked position, and the lugs 54 can be shaped to induce this outward deformation or fold of the region 52. The material and / or dimensions within this zone allow for elastic deformation to allow the protective shield 19 to move to its locked, final position. As shown in FIG. 15 , in the locked, final shielding position, any previously occurring deformation of the proximal region 52 is eliminated, and the proximal region 52 returns to its original, stress-free, relaxed state or condition. Specifically, in this locked position, as shown in FIG. 15 , a gap or space 59 can be formed between the contact or abutment surfaces 53, 55 of the protective shield 19 and the lugs 54. This indicates that the deformation of the proximal region 52 has been eliminated, and the proximal region 52 and the associated adjacent zones have returned to their original, stress-free, relaxed state or condition. Furthermore, the (complementary angled) end abutment surfaces 53, 55 of the protective shield 19 and the lugs 54 engage, preventing pivotal movement of the protective shield 19 back toward a position that would expose and jeopardize the needle 11.

[0086] As shown in FIGS. 5, 6, and 7, the protective shield 19 may have gripping portions 46, 47 on its outer surface (shown next to arrow 45) to facilitate manual manipulation of the protective shield 19. These gripping portions 46, 47 may comprise ribs extending along the outer surface. The protective shield 19 may have a pair of front or distal ribs 46 and a pair of rear or proximal ribs 47. Each pair of ribs, i.e., the two ribs 46, 47, are offset approximately 180 degrees around the circumference of the protective shield 19. The protective shield 19 also has retaining means in the form of retaining clasps 44 for maintaining the protective shield 19 in an initial position, as shown in FIGS. 5 and 6. These retaining clasps 44 comprise shaped lugs with arcuate inner surfaces that are positioned around a portion of the outer periphery of the cover 23 to grip or loosely hold the cover 23. As shown in FIG. 5, the two clasps 44 are spaced apart to form a release gap between them. The distance between the release gaps is less than the outer diameter of the cover 23. Note that if cover 23 is constructed from an elastically deformable material, cover 23 in this area may be deformed sufficiently to allow cover 23 to pass through the release gap during use and / or the sides of the needle shield to bend outward, allowing the clasp to move over the needle shield. The amount of force is controlled by the size of the release gap and the materials from which cover 23 and the shield are constructed. Specifically, the release force is sufficient to prevent accidental, inadvertent, or unwanted movement of protective shield 19 from its initial position, yet is controllable enough to allow the user to move protective shield 19 to the open position despite some tactile resistance.

[0087] The clasp 44, together with the pivotable coupling / hinge mechanism and shield arrangement, forms a sub-assembly with the carrier 18, protective shield 19, and needle cover 23, which is a unitary, preferably self-supporting, unit that facilitates manipulation and mating of the device to a syringe during manufacture.

[0088] Overall, the present invention provides a needle safety device 8 whose dimensions (length and diameter) allow it to be used with standard prefillable syringes in a standard nest / tab system, replacing typical non-safe needle cover systems; importantly, device 8 provides a safer method of attaching and retaining needle covers on fully standard prefillable syringes. Protective shield 19 is pivotable onto syringe 10 from an initial position in which cover 23 has a proximal portion that axially compresses upon assembly of device 8, thereby providing a secure and durable seal against nose 12 of syringe 10. In this position, cover 23 is protected and cannot be accessed (touched), grasped, or removed by a user unless the user first pivots protective shield 19 outward, exposing cover 23, which the user then grasps and pulls to expose needle 11 and prepares for injection. After the injection is completed, the protective shield 19 is pivoted inward until it contacts the sharp tip of the needle 11 and bends away from the central longitudinal axis (the needle is still long enough to contact the shield), and the protective shield 19 continues to move inward until the fixing means in the final shielding position engages the needle 11 and maintains the protective shield 19 at an angle offset from the longitudinal axis of the syringe 10.

[0089] The present invention can be used with prefilled or prefillable glass or plastic syringes. In summary, the present invention provides a needle safety device that can be used in place of unsafe standard needle covers and can be integrated into full-standard tray / nest and tub packaging systems without requiring custom or modified nest / tray and tub designs. The present invention also provides an improved method for safely attaching needle covers to full-standard syringes and preventing unwanted detachment of the needle covers due to changes in air pressure during sterilization of the syringes prior to filling with injectable medication.

[0090] The shape (profile) of the proximal end of the device 8 is configured (shaped) to engage the distal end of the needle hub and form a substantially airtight seal therebetween, maintaining sterility of the medical needle and preventing leakage of medication from the syringe through the needle. The needle cover is positioned within the protective shield / needle shield, so that the axis of the cover as a whole is coaxial with the axis of the medical needle when the needle shield is in the initial shielding position. A portion of the needle cover and a portion of the needle shield engage (or resist distal movement of the needle cover relative to the protective shield) when the shield is in the initial shielding position, maintaining the needle cover in a first position within the shield to prevent medication leakage and maintain sterility of the needle during syringe storage. The portion of the needle shield that engages with a portion of the needle cover blocks / prevents distal movement of the needle cover relative to the needle hub away from the first position until the needle shield is moved to the unshielding position. The needle shield is configured to pivot outward (relative to the axis of the syringe body) and is configured to be actuated (by the user) to move the needle shield away from the initial shielding position to the unshielding position. This actuation of the needle shield outward from the initial shielding position disengages the needle shield in an arcuate radially outward direction from the needle cover, and continued movement of the shield to the unshielding position then completely disengages the needle cover from the syringe and needle. After the injection is completed and the medication has been delivered, the needle shield is actuated to move the needle shield to the fixed final needle shielding position.

[0091] The needlestick safety of the present invention has a soft inner needle cover and a plastic outer shell, using only one extra plastic component compared to existing non-safety standard needle covers commonly used with existing nest-and-tab systems (e.g., as disclosed in U.S. Pat. No. 10,973,986). The use of a fully standard, pre-fillable glass syringe with a typical spherical needle hub shape is of great benefit / importance. The present invention utilizes a "resilient engagement" that can have the soft cover, or at least the soft portion of the needle cover, resiliently abut the end of the syringe nose (needle hub). [Explanation of symbols]

[0092] 8 Safety device, syringe filled with drug 10 syringes 11 needles 12 Nose, tip 14, 42 Shoulder 15 Engagement surface 16 Adhesive 18, 21, 21´ Carrier 19 Protective Shield 20, 26 bore 21, 46, 47 Ribs 21´ Flexible ribs, flexible parts 23 Needle cover 24 Anterior portion (distal end) 25 Posterior part (proximal end) 27 steps 28 Rear surface, end surface 29 Front 40 stub shaft 44 Clasp 45 Arrow 46, 47 Grip part 50 distal end 52 Proximal region 53, 55 Contact surface 54 Protrusions, lugs 56, 57 Sliding surface 90 Soft needle cover or component, soft needle component, soft part 92 outer shell

Claims

1. 1. A medical needle cover device, comprising: The medical needle cover device is a syringe having a syringe barrel with a needle hub at a distal end, the syringe having a medical needle having a longitudinal axis and a sharp tip mounted on the needle hub with the sharp tip protruding distally; a safety device having a needle shield pivotally coupled to a carrier, the carrier configured to be fixed to the syringe, the needle shield configured to move outward from an initial shielding position to a non-shielding position; a needle cover that covers the medical needle to protect it and prevents leakage of medicine from the sharp tip, The needle cover is The longitudinal axis and a profile at a proximal end configured to engage a profile at a distal end of the needle hub to form a substantially airtight seal therebetween when the needle cover is in a first position relative to the needle hub, thereby maintaining sterility of a medical needle enclosed within the needle cover; and, In the initial shielding position, the needle cover is positioned within the needle shield in the first position, with the longitudinal axis of the needle cover aligned with the longitudinal axis of the needle; the needle shield having fastener means for fastening and / or gripping, or loosely holding and restraining, the needle cover in the first position; the needle shield, the carrier, and the needle cover are maintained together as a unitary, self-contained safety needle device that is attached to the distal end of the syringe; a portion of the needle cover and a portion of the needle shield engage when the needle shield is in an initial shielding position to releasably maintain the needle cover within the needle shield in the first position, preventing drug leakage during storage of the syringe and maintaining sterility of the medical needle; when the safety needle device is attached to the distal end of the syringe, a portion of the needle shield engaging a portion of the needle cover prevents distal movement of the needle cover away from the first position relative to the needle hub until the needle shield moves to the unshielding position; The needle shield is configured to move outwardly away from the needle cover and away from the initial shielding position to the non-shielding position, the movement of the needle shield away from the initial shielding disengaging the needle shield from the needle cover and subsequently disengaging the needle cover distally from the first position to remove the medical needle. A medical needle cover device.

2. 2. The medical needle cover device of claim 1, wherein the fastener means includes a retention fastener having shaped lugs with arcuate inner surfaces positioned around a portion of the outer periphery of the needle cover to grip or loosely hold the needle cover.

3. 3. The medical needle covering device of claim 1 or claim 2, wherein the clamping means provides a restraining force that must be relieved to move the needle shield outward from the initial shielding position to the non-shielding position.

4. The medical needle covering apparatus of any one of claims 1 to 3, wherein the needle shield comprises a partially cylindrical shield with a longitudinal gap along the entire longitudinal length of the needle shield.

5. 5. The medical needle cover apparatus of claim 4, wherein said fastening means comprises one or more retention fasteners located on or adjacent an edge of said longitudinal gap of said needle shield.

6. The medical needle cover device of any one of claims 1 to 5, wherein the integral, freestanding safety needle device is configured to press fit onto the syringe.

7. 7. The medical needle cover device according to claim 1, wherein the needle shield and the needle cover engage when the safety device is attached to the syringe, generating an axial compressive force in the distal direction on the needle cover between the rear end of the needle cover and the position where the needle shield engages with the needle cover.

8. 8. The medical needle cover device of claim 1, wherein the farthest distal end of the needle cover is located within the needle shield when the needle shield is in the initial shielding position and the needle cover is in the first position.

9. 8. The medical needle cover device of claim 1, wherein when the needle shield is in the initial shielding position and the needle cover is in the first position, the farthest distal end of the needle cover protrudes beyond the farthest distal end of the needle shield.

10. The medical needle cover apparatus of any one of claims 1 to 9, wherein the needle shield is secured to the carrier by a hinge mechanism.

11. 11. The medical needle cover apparatus of claim 10, wherein the hinge mechanism defines a fixed axis of rotation about which the needle shield rotates relative to the carrier.

12. The medical needle covering device of any one of claims 1 to 11, wherein the needle shield is configured to pivot from the initial shielding position to a non-shielding position.

13. 13. The medical needle cover device of any one of claims 1 to 12, wherein one of the needle shield or the carrier has two pivot members that engage within two pivot members of the other of the needle shield or carrier.

14. The needle shield said initial shielding position; the non-shielding position; and Final shielding position, The medical needle cover device according to any one of claims 1 to 13, which is configured to pivotally move between

15. The medical needle cover device of any one of claims 1 to 14, wherein in the final shielding position, the sharp tip of the medical needle is deflected away from the longitudinal axis of the syringe barrel.

16. 16. The medical needle cover device of claim 1, wherein an inner surface of the needle shield abuts a portion of the medical needle while the needle shield is moving from the non-shielding position to the final shielding position, and this abutment and further movement of the needle shield causes the needle shield to deflect the medical needle.

17. The medical needle covering device according to any one of claims 1 to 16, wherein the needle shield has a resiliently deformable fixing feature that fixes the needle shield in the final shielding position relative to the carrier.

18. 18. The medical needle cover apparatus of claim 17, wherein the securing feature comprises a proximal region of the needle shield.

19. 19. The medical needle cover device of claim 17 or claim 18, wherein the carrier has a locking abutment surface on a distally extending protrusion that locks the needle shield in the final shielding position relative to the carrier.

20. 20. The medical needle cover device of claim 19, wherein the securing portion is configured to transition over a portion of the securing surface when moving from the non-shielding position to the final shielding position, and wherein the securing portion elastically deforms while moving over the securing surface.

21. The medical needle cover device according to any one of claims 17 to 20, wherein in the final shielding position, the fixing action portion is in a non-deformed relaxed state.

22. The medical needle cover device of any one of claims 1 to 21, wherein a portion of the needle cover has a step or an outer protrusion or an annular flange.

23. The medical needle covering device of any one of claims 1 to 22, wherein a portion of the needle shield has a rearward facing shoulder for maintaining and retaining the needle covering on the needle in the first position.

24. A medical needle cover device according to any one of claims 1 to 23, wherein the needle cover is maintained and held in the first position by frictionally engaging and gripping the needle shield, the outer surface of the needle cover being substantially smooth, the outer surface being frictionally gripped by the needle shield, and movement of the needle shield from the initial shielding position frictionally detaches the needle shield from the needle cover.

25. 25. The medical needle cover device of claim 24, wherein said engagement compresses and / or expands a proximal portion of said needle cover.

26. 26. The medical needle cover device of claim 1, wherein when the needle shield is in the initial shielding position, the portion of the needle shield engages the needle cover at a position spaced forward from its rear proximal end to restrict movement of the needle cover forward and distally away from the syringe hub.

27. 27. The medical needle cover apparatus of any one of claims 1 to 26, wherein the needle shield surrounds a circumferential portion of the outer surface of the needle cover and extends along the entire longitudinal length of the needle cover.

28. 28. The medical needle cover device of any one of claims 1 to 27, wherein the needle shield extends distally to a position beyond the furthest distal point of the needle cover, and the entirety of the needle cover is contained within the longitudinal length of the needle shield.

29. 29. The medical needle cover device of claim 1, wherein the length of the needle cover from the rear proximal face to the engagement position with the needle shield is such that, when the carrier, the needle shield and the needle cover are mated to the syringe, a portion of the needle cover is subjected to an axial compressive force such that the inner profile of the rear proximal portion expands radially outward on the forward distal portion of the syringe hub, thereby ensuring a substantially airtight seal between the resiliently pressed proximal end face of the needle cover and the needle hub of the syringe.

30. 30. The medical needle cover device of any one of claims 1 to 29, wherein the axial force and corresponding shaped surfaces on the distal ends of the syringe and needle cover form a seal between the rear proximal end of the needle cover and the front distal end of the syringe.

31. 1. A method of protecting a medical needle comprising providing a medical needle cover device, the medical needle cover device comprising: a syringe having a syringe barrel with a needle hub at a distal end, the syringe having a medical needle having a longitudinal axis and a sharp tip mounted on the needle hub with the sharp tip protruding distally; a safety device having a needle shield pivotally coupled to a carrier, the carrier configured to be fixed to the syringe, the needle shield configured to move outward from an initial shielding position to a non-shielding position; a needle cover that covers the medical needle to protect it and prevents leakage of medicine from the sharp tip, The needle cover is The longitudinal axis and a profile at a proximal end configured to engage a profile at a distal end of the needle hub to form a substantially airtight seal therebetween when the needle cover is in a first position relative to the needle hub, thereby maintaining sterility of a medical needle enclosed within the needle cover; In the initial shielding position, the needle cover is positioned within the needle shield in the first position, with the longitudinal axis of the needle cover aligned with the longitudinal axis of the needle; the needle shield having fastener means for fastening and / or gripping, or loosely holding and restraining, the needle cover in the first position; the needle shield, the carrier, and the needle cover are maintained together as a unitary, self-contained safety needle device that is attached to the distal end of the syringe; a portion of the needle cover and a portion of the needle shield engage when the needle shield is in an initial shielding position to releasably maintain the needle cover within the needle shield in the first position, preventing drug leakage during storage of the syringe and maintaining sterility of the medical needle; engaging a portion of the needle shield with a portion of the needle cover to prevent distal movement of the needle cover from the first position relative to the needle hub until the needle shield moves to the unshielding position when the safety needle device is attached to the distal end of the syringe; The needle shield is configured to move outwardly away from the needle cover and away from the initial shielding position to the non-shielding position, the movement of the needle shield away from the initial shielding disengaging the needle shield from the needle cover and subsequently disengaging the needle cover distally from the first position to remove the medical needle. A method for protecting a medical needle.

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