Improved restraining device in a safety needle device

Abstract

A safety needle assembly 10 includes a carrier 18 and a needle shield 19 pivotally connected to the carrier 18, the needle shield being movable outwardly from an initial shielded position to an unshielded position. The carrier 18 is configured to be secured to a needle hub. The safety needle assembly 10 further includes a needle cover 23 for protecting a needle 11. A restraining means provides a restraining force resisting pivotal movement of the needle shield 19 from the initial shielded position; a control means releasably retains the needle cover 23 within the needle shield 19. The restraining force is provided by a releasable interlock between the needle shield 19 and the carrier 18 which must be overcome to move the needle shield 19 outwardly from the initial shielded position to the unshielded position. The control means includes contact surfaces provided on the needle shield 19, the needle cover 23 and the carrier 18 for controlling axial displacement and / or angular misalignment of the respective longitudinal axes of the needle cover 23 and the carrier 18. The releasable interlock and the control means cooperate to maintain the carrier 18, the needle shield 19 and the needle cover 23 as an integral self-supporting safety needle assembly prior to securing the safety needle assembly to the needle hub.

Description

Technical Field

[0001] This invention relates to an improved restraint device in a safety needle device, which can be used with a syringe with a medical needle protruding from its tip. In a preferred aspect, the invention relates to an improved structure of the restraint mechanism between a pivotable protective shield and a carrier of the safety needle device, for providing puncture protection for the medical needle protruding from the tip of a disposable syringe. Background Technology

[0002] The syringe with a medical needle used in this invention is for piercing the human or animal body, or for other medical purposes, such as piercing the punctureable septum of an intravenous drug delivery system. Hereinafter, all medical uses of the syringe and needle will be referred to as "piercing the human body," even though some specific embodiments may be applicable to other medical scenarios.

[0003] Syringes with permanently fixed needles are typically pre-filled with liquid medication and intended for single injection only. After use, the syringe and needle must be disposed of safely. Equipping needles with safety devices to minimize the risk of accidental needlestick injuries and to protect personnel who may come into contact with such syringes before and after injection has become a mandatory requirement of health and safety regulations and industry best practices.

[0004] Typically, such safety devices may include a shield mounted on the syringe, which can slide or pivot axially, switching between a needle-protected position and a non-protected use position. With this invention, the shield will move to its final post-use position, where the needle is completely covered.

[0005] As described in WO2024 / 134197, the pivotable shield is mounted to pivot relative to the carrier, allowing the shield to move from an initial shielded position to an unshielded position; in the shielded position, the shield covers the needle cap. When the safety needle device is connected to a medical syringe, the syringe needle inserts and pierces the needle cap, which may be a flexible (soft) cap. The shield includes a snap-fit ​​mechanism for clamping and / or loosely securing the needle cap when the shield is in the shielded position. In use, the shield must be pivoted open so that the user can remove the needle cap from the needle; this movement requires overcoming the clamping force exerted by the shield on the needle cap. This movement inevitably causes the needle cap to deflect or move with the pivotable shield until the clamping force is overcome and the needle cap is released from the snap-fit ​​mechanism. Because the needle is located inside the needle cap, especially the soft end where the needle tip penetrates and pierces the inside of the cap, it is designed to protect the needle tip during storage. However, as the protective cover pivots outward, causing the cap to deflect, the needle is also at risk of deflection or bending. Without a snap-fit ​​mechanism, the needle cap would separate from the protective cover (and carrier), preventing the safety needle device from forming a self-supporting, integrated assembly, making it difficult to operate in the automated, high-speed assembly processes of the medical device industry.

[0006] Furthermore, the small size of these protective covers, even when made of rigid materials, means that when a user holds and squeezes the cover, moving it from a shielded position to an unshielded position, the cover is prone to inward deformation. Therefore, excessive inward pressure increases the inward clamping force between the cover and the needle cap, causing the needle cap and the needle inside to shift towards the unprotected position along with the cover, easily leading to deflection and damage to the precision needles in such devices.

[0007] Figure 1 and Figure 2 The above-mentioned problem is explained as follows: The safety needle assembly 2 includes a shield 3 pivotally connected to the carrier 5. The needle of the syringe 6 is located inside the shield 3, with the needle tip extending into and piercing the inner end of the needle cap 4. When the shield 3 moves from its initial shielded (protected) position to its unshielded (unprotected in use) position, the needle cap 4 and the needle inside will deflect outwards. This deflection is caused by the necessary clamping and / or holding force between the shield 3 and the needle cap 4; and the user must manually hold the shield 3 and pivot it to the unprotected position, inevitably resulting in "excessive" compression of the shield 3 during this process, which intensifies the clamping effect and thus amplifies the degree of deflection.

[0008] The object of this invention is to overcome at least one related problem in the prior art, whether or not such problem is mentioned herein. Summary of the Invention

[0009] According to a first aspect of the present invention, a medical needle cap device is provided, comprising: Needle hub, the needle hub also includes A medical needle having a longitudinal axis and a tip, the medical needle being mounted on a needle hub, the tip protruding distally from the needle hub; Safety pin assembly, including: The carrier has a longitudinal axis; A needle guard having a longitudinal axis and pivotally connected to a carrier, and configured to move outward from an initial shielded position to an unshielded position; the carrier is configured to be fixed to a needle holder; A needle cap is used to protect the needle tip, and when the needle shield is in the initial shielding position, the needle cap is located inside the needle shield; The needle cap includes, Longitudinal axis, A proximal profile is provided, which is configured to cover the outer side of the distal profile of the needle hub; when the needle guard is in the initial shielding position, the longitudinal axes of the carrier, the needle guard, and the needle cover are aligned with each other. The safety pin assembly also includes: Constraint devices are used to provide restraint force to prevent the needle guard from pivoting from its initial shielding position; and A control device for releasably retaining the needle cap inside the needle guard; Its features are: The restraining force is provided by a releasable interlocking device between the needle guard and the carrier; and this restraining force must be overcome to move the needle guard from its initial shielded position to an unshielded position; and The control device includes contact surfaces disposed on the needle guard, needle cap, and carrier, for controlling the axial offset and / or angular misalignment of the longitudinal axes of the needle cap and the carrier, respectively; and The releasable interlock device and control device are used to maintain the carrier, needle cover, and needle cap as an integrated self-supporting safety needle assembly before the safety needle assembly is fixed to the needle hub. An abutment surface on the needle guard releasably engages the needle cap, preventing (or resisting) distal movement of the needle cap relative to the needle guard when the safety needle assembly is secured to the needle hub, until the needle guard moves to an unshielded position; the needle guard is configured to be operable to pivot outward from an initial shielded position to an unshielded position. The needle sheath is configured to be operable to pivot outward from the initial shielded position to the unshielded position, and in particular, an outward forced operation is applied to the needle sheath to overcome the restraining force provided by the interlocking device, thereby disengaging the abutment surface from the needle cap to allow the needle cap to subsequently detach from the needle hub in a distal direction, thereby exposing the medical needle.

[0010] The needle cap may include a contour at its proximal end configured to engage with a contour on the distal end of the needle hub to form a substantially airtight seal between them, thereby maintaining the sterility of the medical needle housed within the needle cap when the needle cap is in the initial shielding position (within the sheath). In the initial shielding position, the tip of the needle can penetrate a soft portion / segment of the needle cap to prevent fluid from flowing out from the needle tip / end. Preferably, when the needle sheath is in the initial shielding position, a portion of the needle cap and a portion of the needle sheath are configured to engage with the needle cap to resist (and / or prevent) distal movement of the needle cap relative to the needle sheath, thereby releasably retaining the needle cap within the needle sheath when the needle sheath is in the initial shielding position to prevent drug leakage from the needle tip and to maintain the sterility of the medical needle during syringe storage.

[0011] The proximal contour of the needle cap can loosely fit over the distal contour of the needle hub. The needle hub can be accommodated or positioned on a (female) Luer connector. In use, the (female) Luer connector engages with a corresponding (male) Luer connector at the distal end of the syringe. The needle hub and Luer connector structure, together with the safety needle assembly, can constitute a sub-assembly or intermediate assembly. The sub-assembly can be provided in package form, specifically, the package may include a rigid outer packaging or shell. The package may include a front (distal) portion and a separate rear (proximal) portion. The two (separate) portions can be joined together to encapsulate the sub-assembly internally. The two portions can be secured together by a tamper-evident seal in the form of a label or other destructible seal, such as an easy-tear adhesive made of adhesive or heat-sealed welding, holding the two portions together until the tamper-evident seal is broken before using the needle safety device.

[0012] The proximal contour of the needle cap creates a substantially airtight seal between the needle cap and the needle hub, maintaining the sterility of the sealed medical needle when the needle cap covers the needle tip. The needle cap may have a soft area into which the tip of the needle can penetrate when the needle cap is releasably engaged by the needle guard in its initial shielding position. The needle hub may constitute the distal end of the syringe. The syringe may include a syringe barrel with a needle hub at its distal end. The syringe may also include a medical needle having a longitudinal axis and a tip, which is mounted on the needle hub with the tip projecting distally.

[0013] The needle cover may include a fastening device for fastening and / or clamping, or loosely engaging, to retain and secure the needle cap when the needle cover is in its initial shielding position. Preferably, the fastening device includes a retaining latch with an irregularly shaped lug having an inner curved surface, surrounding a portion of the outer peripheral surface of the needle cap to clamp or loosely secure the needle cap. Preferably, in addition to the restraining force of the interlocking device, the fastening device provides an additional restraining force that must be overcome to move the needle cover outward from the initial shielding position to the unshielded position.

[0014] The fastening device may include one or more fasteners disposed on the inner surface of the needle guard. The fastening device may include one or more fasteners disposed on the needle guard and preferably disposed at the edge (or near the edge) of the longitudinal opening of the needle guard.

[0015] Preferably, the releasable interlocking device is formed directly between the needle guard and the carrier. Preferably, the releasable interlocking device is formed by the mating interface between the needle guard and the carrier. The releasable interlocking device can be formed in two locations, each location including the mating interface between the needle guard and the carrier.

[0016] The releasable interlocking device can be formed between a first interlocking member on the needle guard and a second interlocking member on the carrier. Preferably, the interlocking device is formed between a pair of first interlocking members on the needle guard and a corresponding pair of second interlocking members on the carrier.

[0017] Preferably, the carrier includes a first pair of second interlocking members and a second pair of second interlocking members. The first pair of interlocking members is arranged to prevent the needle shield from pivoting relative to the carrier from its initial shielded position during use, and the second pair of interlocking members is arranged to prevent the needle shield from pivoting relative to the carrier from its unshielded position during use.

[0018] The first and second interlocking components may include a pawl and a facet. The first interlocking component may include a pawl. The second interlocking component may include a facet.

[0019] The pawl may include a protrusion with an irregularly shaped / contoured outer surface, the shape / contour of which facilitates engagement and / or disengagement of the pawl with a corresponding facet. The pawl may include an arcuate or precisely shaped outer surface. The pawl may include a partially spherical component.

[0020] The facet is provided as a surface with an engaging edge. The engaging edge facilitates the engagement and disengagement of the corresponding pawl.

[0021] A first interlocking member may be disposed on a flexible portion of the needle sheath. Preferably, the flexible portion is elastic and / or deformable. Accordingly, the flexible portion may be configured to bend in use to facilitate disengagement of the first interlocking member from the second interlocking member. The flexible portion of the needle sheath may include support arms. The support arms, or each support arm, may be positioned proximal to the needle sheath. The support arms, or each support arm, may be positioned laterally to the needle sheath. A first support arm may be positioned on a first lateral side of the needle sheath, and a second support arm may be positioned on a second lateral side of the needle sheath.

[0022] Preferably, a pair of first interlocking members are provided, and each first interlocking member is disposed on a corresponding flexible portion of the needle sheath.

[0023] A pair of second interlocking members are disposed on the carrier to prevent the needle shield from pivoting to an unshielded position. Each second interlocking member may include at least a portion of a recess defined on the carrier. Each recess may include an elongated groove to allow a degree of pivoting movement between the needle shield and the carrier. Preferably, the elongated groove enables the first interlocking member to pivot and allows the needle shield (after use) to move past the initial shielded position to the final shielded position, i.e., allows the needle shield to pivot from the (in use) unshielded position to the final shielded position (preferably past the initial shielded position).

[0024] The constraint device may be formed between the pawl and the facet. The constraint device may consist of one or more (preferably two) pawls and one or more (preferably two) facets. The pawl may be disposed on one of the needle holder or the carrier, and the facet may be disposed on the other component of the needle holder or the carrier.

[0025] A portion of the needle cap may include a step, groove, outward protrusion, or annular flange, configured to engage with an abutment surface of the needle guard; said abutment surface may include a shoulder (facing rearward / proximal) or an inward protrusion for releasably engaging the needle cap before the safety needle assembly is secured to the needle hub, holding the needle cap within the needle guard and / or carrier. Preferably, this engagement allows the proximal portion of the needle cap to be pushed proximally within the safety device. Preferably, the step or groove may be located at the distal end of the needle cap and spaced at a distance from the distal end.

[0026] Preferably, before the safety needle assembly is secured to the needle hub, the contact surfaces control angular misalignment; a portion of the needle guard may be arranged to engage with a portion of the needle cap, and the proximal end face of the needle cap engages with a complementary surface or contour of the carrier. These surfaces may clamp, hold, press, or loosely fit to retain the proximal end of the needle cap, ensuring that the needle cap remains perpendicular to the longitudinal axis of the carrier (i.e., no angular misalignment).

[0027] Preferably, the contact surfaces also control offset (lateral) misalignment before the safety needle assembly is secured to the needle hub. The contact surfaces may include one or more (e.g., two) uprights at the distal end of the carrier. The proximal end of the needle cap is located between the uprights. Each upright may provide an inner surface for clamping a portion of the needle cap (proximal end) within the carrier during use. Each upright may abut a portion of the outer periphery of the needle cap. The uprights may be angularly offset along the outer periphery of the needle cap. The uprights may be offset by approximately 180 degrees. A single upright may also be provided that surrounds the outer periphery of the needle cap by more than 180 degrees. The uprights may even surround all or most of the outer periphery of the needle cap.

[0028] Before the safety needle assembly is secured to the needle hub, a portion of the inner side of the needle sheath may be arranged to prevent the needle cap from being misaligned laterally, sideways, or offset relative to the longitudinal axis of the carrier. Two opposing portions of the inner side of the needle sheath may be configured to prevent the needle cap from being misaligned laterally, sideways, or offset relative to the longitudinal axis of the carrier.

[0029] Preferably, the shield includes gripping areas positioned to prevent the user from squeezing the sides of the shield together. The gripping areas are preferably offset from the central longitudinal axis of the shield, and may be positioned along the upper part of the shield (off-center / offset position). Preferably, this arrangement allows the first and second gripping areas to be located on opposite sides of a continuous (solid linear) portion of the shield. Preferably, the gripping areas are located at both ends of the (basically) rigid / solid portion, so that the inner cavity of the shield where the needle cap initially resides is hardly or completely deformed by compression.

[0030] The distal end of the shield may be closed or partially closed (e.g., through the end wall). A basic solid portion extending between the two lateral gripping areas defines a channel for receiving the needle in its final position.

[0031] The gripping area can also be provided with flanges, edges, or small planes to make it easier for users to grip, thereby generating an outward pivoting force (initial outward lifting force).

[0032] The interlocking device may include a seal. The interlocking device may include a sealing device (component) providing a tamper-proof seal by heat sealing or adhesive bonding. The proximal portion of the shield may include support arms with pivoting members for pivotal engagement with a carrier. Each support arm is spaced apart from each other, forming a gap between them to bridging the carrier. Each support arm may provide a shear surface aligned with the longitudinal axis of the shield; as the shield moves from its initial shielded position to its unshielded position, the shear surface pivots outward about the pivot axis. When the shield is in its initial shielded position, the sealing member may cover the shear surface; the sealing member is secured to a safety device, covers the shear surface, and spans the gap between the support arms. During the movement of the shield from its initial shielded position to its unshielded position, the shear surface rotates outward, pressing against the upper sealing member, thereby irreversibly damaging, deforming, or cutting off a portion of the sealing member, disengaging the interlocking device.

[0033] Preferably, each shear surface is configured to impact and / or touch a portion of the sealing member during the movement of the protective sleeve from its initial shielded position before use to its unshielded position during use.

[0034] Preferably, each shear surface is configured to (push and) directly abut and / or contact a portion of the sealing member during the movement of the protective sleeve from its initial shielded position before use to its unshielded position during use.

[0035] Preferably, the sealing member includes an inner surface and an outer surface, the inner surface being arranged to cover and / or be fixed to one or both of the protective cover and / or the carrier. Preferably, each shear surface is configured to directly abut and / or contact or push against the inner surface of the sealing member during the movement of the protective sheath from its initial shielded position before use to its unshielded position during use.

[0036] The sealing component can cover the shear surface and at least a portion of the carrier.

[0037] Preferably, the sealing member is arranged to adhere to a portion of the protective cover and / or a portion of the carrier.

[0038] Preferably, the sealing member is arranged so that it can adhere only to a portion of the protective cover.

[0039] Preferably, the sealing member is arranged to adhere only to a portion of the carrier.

[0040] Preferably, the sealing member comprises a tubular ring or band arranged to cover and / or surround a portion of the protective shield and part or all of the carrier.

[0041] Preferably, the sealing member comprises a tubular shrink ring or strip, which is configured to cover and / or enclose a portion of the protective sheath and part or all of the carrier.

[0042] Preferably, the sealing member comprises a tubular ring or strip made of a heat-shrinkable material that is heat-shrinkable onto the safety device to cover the shear surface.

[0043] Preferably, each shear surface has an edge that can deform, damage, or cut off a portion of the sealing member.

[0044] Preferably, each shear surface provides a toothed or serrated edge that bites into and twists, damages, or cuts off a portion of the sealing member.

[0045] Preferably, each edge is arranged to push the sealing member outward in a direction away from the outer surface of the carrier and / or the protective cover, and at least initially creates a twisted, damaged or cut-off sealing area in at least two locations, extending from the location where the shear surface contacts the inner surface of the sealing member.

[0046] Each shear surface can create a deformed area or portion and / or a penetrated area or portion within a part of the sealing member.

[0047] Each shear surface can create a tear, cut, notch, break, or partial cut within a portion of the sealing member.

[0048] The sealing member may extend at least partially around the circumference of the safety device, preferably at least partially around the outer surface of the protective cover and the carrier.

[0049] The sealing member may extend at least partially around the circumference of the safety device, more preferably around the proximal outer surface of the protective cover including the support arm.

[0050] The sealing member may be configured to extend at least partially around the circumference of the safety device, and preferably around the proximal outer surface of the protective sleeve, the proximal outer surface including a support arm with a shear surface.

[0051] Preferably, the shearing member creates tears, cuts, and / or deformations at two spaced-apart locations or regions on the sealing member. The portion of the sealing member between the two locations may remain adhered to / connected to and / or secured to the carrier, and / or the portion of the sealing member extending between the two locations may remain adhered to / attached to the proximal outer surface of the protective sleeve, including the support arm.

[0052] According to a second aspect of the present invention, a method for protecting a medical needle is provided, wherein the medical needle cap device comprises: The needle hub further includes a medical needle having a longitudinal axis and a tip, the medical needle being mounted on the needle hub with the tip protruding distally from the needle hub; Safety pin assembly, including: The carrier has a longitudinal axis; A needle guard having a longitudinal axis and pivotally connected to a carrier, and configured to move outward from an initial shielded position to an unshielded position; the carrier is configured to be fixed to a needle holder; A needle cap is used to protect the needle tip, and when the needle shield is in the initial shielding position, the needle cap is located inside the needle shield; The needle cap includes, Longitudinal axis, A proximal profile is provided, which is configured to cover the outer side of the distal profile of the needle hub; when the needle guard is in the initial shielding position, the longitudinal axes of the carrier, the needle guard, and the needle cover are aligned with each other. The method includes: A restraint device is used to prevent the needle guard from pivoting from its initial shielding position, thereby providing a restraining force; The needle cap can be releasably held inside the needle guard by a control device; Its features are: The restraining force is provided by a releasable interlocking device between the needle guard and the carrier; and this restraining force must be overcome to move the needle guard from its initial shielded position to an unshielded position; and The control device includes contact surfaces disposed on the needle guard, needle cover, and carrier, for controlling the axial offset and / or angular misalignment of the longitudinal axis of the needle cover and the carrier, respectively. The releasable interlock device and control device are used to maintain the carrier, needle cover, and needle cap as an integrated self-supporting safety needle assembly before the safety needle assembly is fixed to the needle hub. An abutment surface provided on the needle guard releasably engages the needle cap, preventing (and / or resisting) distal movement of the needle cap relative to the needle guard when the safety needle assembly is secured to the needle hub, until the needle guard moves to an unshielded position; The needle cover is configured to be operable, pivoting outward from an initial shielded position to an unshielded position; specifically, forced outward operation of the needle cover overcomes the restraining force provided by the interlocking device, causing the abutment surface to detach from the needle cap, thereby allowing the needle cap to be removed distally from the needle hub to expose the medical needle.

[0053] This invention also provides an assembly method: first, the safety needle assembly is assembled, and then the safety needle assembly is introduced into the main assembly line, thereby simplifying and streamlining the main assembly line and process flow. Preferably, the safety needle assembly includes a carrier, a needle guard, and a needle cap. In short, the assembly line process provided by this invention is as follows: first, the needle tip is fixed in the needle holder, and then the safety needle assembly is installed onto the prepared needle holder in a single step. The needle holder may be equipped with a Luer connector structure. The needle holder may be located at the distal end of the syringe. Overall, the pre-assembled safety needle assembly significantly simplifies the process flow, reduces the inspection steps required on the assembly line, and improves the reliability and speed of the process; more importantly, the equipment and processes of existing assembly lines can be largely retained, requiring only minor modifications. Attached Figure Description

[0054] The invention will now be described by way of example only, in conjunction with the following figures, wherein: Figure 1 This is a perspective view of a prior art safety device, showing the state of the protective cover moving from an initial shielded (needle protection) position to an unshielded (no protection in use) position; Figure 2 This is a partial cross-sectional view of a prior art safety device, showing the state of the protective cover moving from an initial shielded position to an unshielded position; Figure 3 This is a perspective view of an embodiment of the safety device and syringe of the present invention before assembly; Figure 4 A perspective view of a safety device assembled to a syringe, with the protective shield in its initial (unlocked) shielding position before use; Figure 5 A perspective view of a safety device mounted on a syringe, with the protective shield in the unshielded position during use and the needle cap removed, ready for injection. Figure 6 A perspective view of a safety device mounted on a syringe, with the protective shield in its final (locked) shielded position after use; Figure 7 An exploded perspective view of a preferred embodiment of the safety device and syringe components; Figure 8 An exploded perspective view of a preferred embodiment of the safety device and syringe components; Figure 9 A side sectional view of an embodiment of the safety device; Figure 10 A bottom perspective view of an embodiment of a safety device; Figure 11 A top sectional view of an embodiment of the safety device; Figure 12 A perspective view of an embodiment of a carrier for a safety device; Figure 13A perspective view of an embodiment showing the needle cap engaged with the safety device carrier; Figure 14 A partial cross-sectional view of a safety device assembled to a syringe, with the protective shield in its initial (unlocked) shielding position before use; Figure 15 A partial cross-sectional view of a safety device assembled to a syringe, showing the protective shield in the unshielded position during use, the needle cap removed, and the syringe ready for injection. Figure 16 This is a schematic perspective view of the carrier and needle cap of the safety device, showing the axis of relative displacement; Figure 17 A partial cross-sectional view of the safety device (most of the protective shield structure has been removed for clarity). Figure 18 This is a detailed cross-sectional view of the safety device. Figure 19 This is a top perspective view of the safety device before it is assembled into the syringe; Figure 20 A partial detailed view of the safety device; Figure 21 This is a partial cross-sectional perspective view of the safety device, in which the protective cover is in the unshielded position during use, and the needle cap is still engaged; Figure 22 for Figure 21 A detailed partial view; Figure 23 A perspective view of another embodiment of a safety device assembled to a syringe, wherein the protective cover is in the initial (unlocked) shielding position before use; Figure 24 A side view of another embodiment of the safety device assembled to a syringe, wherein the protective cover is in the initial (unlocked) shielding position before use; Figure 25 Exploded view of another embodiment of a safety device adapted to a needle holder with a Luer connector structure; Figure 26 A perspective view of another embodiment of a safety device with a Luer connector structure pin seat, the device being housed within a rigid package; Figure 27 A perspective view of another embodiment of a safety device with a Luer connector structure needle hub, the device having been removed from the packaging but not yet installed on the tip of the syringe; Figure 28 A perspective view of another embodiment of a safety device adapted to a needle holder with a Luer connector structure, wherein the cover has been rotated outward and the needle cap has been removed; Figure 29 A perspective view of another embodiment of a safety device assembled to a syringe, wherein a sealing member provides interlocking between the needle guard and the carrier; Figure 30A perspective view of another embodiment of a safety device assembled to a syringe, wherein the sealing member has been destroyed and the needle guard is in an unshielded position during use. Detailed Implementation

[0055] Throughout this specification and in conjunction with the accompanying drawings, a safety needle assembly (or safety device) 8 is shown and described for shielding the tip of a syringe needle 11. In this document, the terms “distal” and “forward” and their derivatives generally refer to the direction towards the patient during use; the terms “proximal” and / or “rearward” / “posterior” and their derivatives are used to describe the direction away from the patient during use. As shown in the figures and described below, the proximal end of the safety needle assembly is connected to the distal end of the syringe (medical injection needle) 10.

[0056] First refer to Figures 3 to 6 The figure shows a syringe 10, with its needle 11 embedded in the nose 12 and secured by adhesive. A safety device 8 is used to protect the needle 11. The nose 12 of the syringe 10 serves as the needle seat of the needle 11 and defines a rearward-facing shoulder 14; the nose 12 in front of the shoulder 14 has a spherical profile, defining a mating surface 15. At the center of the nose 12, a small amount of adhesive 16 secures the needle 11 in a hole penetrating the nose 12. The safety device 8 includes an annular carrier 18 (a tubular body or sleeve with a longitudinal axis) for supporting a protective shield 19 (needle shield); the protective shield 19 is movable relative to the longitudinal axis of the carrier 18 and the needle 11 (specifically, it is pivotable / tiltable / rotatable). The carrier 18 has a through hole aligned with the axis of the carrier for the nose 12 of the syringe 10; an inward rib is formed inside the hole, which engages behind the shoulder 14 when the safety device 8 is installed on the syringe 10, thereby securing the safety device 8 to the syringe 10. This provides a secure, one-time snap-fit ​​permanent engagement between the safety device 8 and the syringe 10.

[0057] As described below, the present invention can also provide a safety device 8 adapted to a needle holder with a Luer lock needle head structure (see below). Figure 25-28 In this configuration, the needle 11 is mounted on a needle hub 100 with a Luer connector. Specifically, the needle hub has a female Luer connector for connecting a male Luer cone. The Luer connector of the needle hub is ultimately secured to the syringe by a complementary Luer-type structure (e.g., a male Luer nose / cone). In this embodiment, the Luer connector constitutes the mounting needle hub for the needle 11. Products with this configuration can be packaged in conventional aseptic tear-off packaging or rigid packaging, with the rigid packaging comprising a front (distal) packaging portion 110 and a rear (proximal) packaging portion 112, such as... Figure 26As shown. Both parts are made of rigid materials, forming a complete hard package. The front and rear parts can also be secured and sealed with tamper-evident sealing strips, allowing users to easily identify whether the packaging has been opened and whether the sterility of the safety pin has been compromised. In use, separating packaging parts 110 and 112 allows the removal of the safety device 8, as shown. Figure 27 As shown. In this arrangement, the safety device 8 is secured to the needle hub via a Luer connector 100. The Luer connector 100 has a joint structure in the form of a cross rib 114 that engages with the proximal end of the needle cap 23 to prevent the needle cap from detaching from the distal end of the needle tip. However, it may be more advantageous not to secure the needle cap to the needle hub: as... Figure 27 As shown, first rotate the cover outward to the use position, then tilt the safety device downward to detach the needle cap from the needle hub, thus fully exposing the needle. The safety device 8 constitutes an integrated self-supporting assembly; furthermore, the safety device 8, combined with the needle hub with Luer connector 100, forms an additional (self-supporting) sub-assembly for connection to a syringe without needle 11—since needle 11 is pre-installed on the needle hub of Luer connector 100. The combined safety device 8 and Luer connector 100 can be easily connected to a syringe equipped with a complementary Luer connector; simply attach the safety device 8 (along with the needle / needle hub) to the syringe for use. It should be understood in the following description that the needle hub can be directly disposed at the distal end of the syringe, integrally formed with the syringe, or provided by the needle hub of Luer connector 100 and subsequently fixed to the appropriate syringe. The invention will now be further described with reference to an embodiment in which the needle hub is integrally disposed at the distal end of the syringe and directly disposed thereon, rather than disposed on a needle hub with Luer connector 100.

[0058] In a needle hub with a Luer connector structure, the proximal profile of the needle cap 23 can be designed to loosely fit over the outer profile of the distal profile of the needle hub. When the needle hub is formed by the distal end of the syringe, the proximal profile of the needle cap 23 can form a substantially airtight seal between the needle cap 23 and the needle hub (formed by the syringe nose), maintaining the sterility of the sealed medical needle 11 when the needle cap 23 covers the needle tip 11 and preventing subsequent drug leakage from the needle tip.

[0059] The needle cap 23 may include a soft, one-piece component containing an elastic plastic polymer or rubber material. The needle cap 23 may include a component with an internal soft portion allowing the tip of the needle 11 to penetrate. The needle cap 23 may also include a rigid portion. The needle cap may include an external rigid housing. The external rigid housing may extend to cover part or substantially all of the outer surface of the internal soft portion. The internal soft portion may include one or more rigid portions fixed to the outer surface. The soft portion and the rigid portion may be co-molded and / or bonded together, or they may be separate, mechanically connected components.

[0060] The protective cover 19 and the carrier 18 are configured to secure and position the needle cap 23 (made of, for example, soft rubber) inside the safety device 8 before the safety device 8 is installed onto the syringe 10. The needle cap may be made entirely of soft material or only partially soft. It is readily understood that, compared to a standard needle cap, the needle cap 23 allows the needle tip to penetrate the internal soft area to achieve the intended function; other parts / surfaces of the needle cap 23 may not be soft, and in fact may be harder than the soft parts.

[0061] Initial position before use (e.g.) Figure 4 As shown), the protective cover 19 prevents the user from touching the needle cap 23. Only when the protective cover 19 is moved outward to a non-shielded position during use (e.g.) Figure 5 As shown), the user can then access the needle cap 23. During this movement, the engagement structure between the needle cap 23 and the protective shield 19, which prevents (or blocks) the needle cap from moving distally relative to the needle shield, disengages, and any tendency to push the needle cap proximally by the blocking engagement between the shield and the needle cap is eliminated. Figure 5 As shown in the outward pivoting position, needle cap 23 is exposed, allowing the user to manually grasp and pull it distally from the needle tip, exposing the needle tip in preparation for injection. Needle cap 23 can be... Figure 5 The item shown is removed, discarded, or set aside for further processing. At this point, the syringe and safety device are ready for injection.

[0062] Therefore, before using the syringe 10 and safety device 8, the protective cover 19 must be moved to the unshielded (unprotected) position to contact the needle cap 23. After injection, the protective cover 19 is moved to the final locked shielded (needle protection) position to (permanently) protect the needle (e.g., Figure 6 (As shown). During this movement, the protective cover 19 first returns to the initial shielding position, and then rotates further inward to the final locked shielding position after use.

[0063] like Figure 7 and Figure 8 As shown, the protective cover 19 includes a pair of inwardly projecting short shafts 40. The carrier 18 includes a corresponding pair of holes 41 for rotatably engaging with the short shafts 40. The carrier 18 includes two sidewalls 36, 37, on which the holes 41 are disposed (see...). Figure 12These sidewalls 36, 37 are provided with recesses / cuts / openings to provide a flat surface. Sidewalls 36, 37 extend from the proximal portion 33 of the carrier 18 to the distal end of the carrier 18. The carrier 18 is also provided with an opening 35, longitudinally aligned with the carrier axis, extending from the proximal end to the distal end, for engagement and fixation of the needle hub therein. Thus, the protective shield 19 is rotatably or pivotally connected to the carrier 18 and is movable relative to the axis of the carrier 18. Specifically, when the carrier 18 (and consequently the safety device 8) is connected to the syringe 10, the protective shield 19 is pivotally movable inward and outward relative to the longitudinal axes of the carrier 18 and the needle 11. When the safety device 8 is connected to the syringe 10, the initial position of the protective shield 19 is such that the longitudinal axis 21 is substantially parallel and aligned with the longitudinal axes of the carrier 18 and the needle 11, i.e., the initial supply state before use, such as... Figures 9 to 11 As shown. It can be understood that any form of pivoting connection can be used between the shield and the carrier, such as a "live hinge" structure—the pivoting connection between the shield and the carrier is provided by a thin-film hinge, which typically requires the shield and the carrier to be molded as a single plastic assembly.

[0064] The protective cover 19 is a partially or incomplete longitudinal tubular sleeve structure extending circumferentially along most of the outer surface of the needle cap 23. This forms a longitudinal opening, allowing the semi-tubular sleeve portion of the protective cover 19 to accommodate and hold the needle cap in its initial shielding position before use, and then move outward away from the sealed needle 11. The protective cover 19 has a distal end 50, which constitutes the outermost or furthest boundary of the safety device 8. Specifically, the distal end 50 of the protective cover 19 extends distally by a distance at least level with, and preferably beyond, the distal end 24 of the cap 23; the distal end can be a completely closed, partially closed, or open structure.

[0065] This invention provides a control device for releasably retaining the needle cap 23 within the needle guard 19 before the safety needle assembly is fitted onto the needle tip and during storage before the needle tip is used. Specifically, before the safety needle assembly 8 is secured or fitted onto the needle tip of the syringe 10, the control device maintains the needle guard 19, needle cap 23, and carrier 18 as an integrated self-supporting safety needle assembly 8. This integrated self-supporting safety needle assembly 8, as... Figure 9-11 As shown.

[0066] The control device includes contact surfaces respectively disposed on the needle guard 19, the needle cap 23, and the carrier 18. These contact surfaces control and prevent relative axial displacement between the longitudinal axes of the needle cap 23 and the carrier 18, such as... Figure 16 As shown in the diagram. Furthermore, the contact surface also controls and prevents angular misalignment (relative angular displacement) between the longitudinal axes of the needle cap 23 and the carrier 18, similarly as... Figure 16 As shown.

[0067] Specifically, before the safety needle assembly is fitted onto the needle tip, the contact surfaces control angular misalignment. For example, the portion where the needle guard 19 engages with the needle cap 23 is complementary to the plane of the carrier 18. These surfaces can actually clamp, tighten / press, or loosely hold the proximal end 72 of the needle cap 23, ensuring that the cap 23 remains vertical, i.e., does not angularly misalign with the longitudinal axis of the carrier 18.

[0068] The contact surface can also control the offset (lateral) misalignment of the needle cap, for example, provided by the uprights 60, 74 at the distal end of the carrier 18, with the proximal end 72 of the needle cap 23 located between the uprights; at the same time, a portion 79 inside the needle guard 19 (see...) Figure 11 This prevents the needle cap 23 from being misaligned laterally, sideways, or offset relative to the longitudinal axis of the carrier 18.

[0069] like Figure 12 and Figure 13 As shown, the carrier 18 provides contact control surfaces to retain the needle cap 23 in a mating position. The contact surfaces provide a gripping structure that grips and holds the proximal end 72 of the needle cap 23, or loosely holds the proximal end of the needle cap. The proximal end 72 of the needle cap 23 is widened to form a step or shoulder. The outer surface (or one or more portions) of the outer peripheral surface of this step or shoulder provides a contact surface that engages with one or more contact surfaces provided by the carrier 18. The control structure includes inner surfaces 70, 71 on the carrier 18, including a first inner surface 70 and an opposing second inner surface 71. The first surface 70 includes the inner surface of a lug 60, and the second surface 71 may be disposed on an opposing second lug 74. The two surfaces are spaced apart to clamp and / or loosely hold, and / or elastically deform a portion of the proximal end 72 of the needle cap 23. The two inner surfaces 70, 71 may be partially arcuate, arranged to partially surround the circumference of the proximal end 72 of the needle cap 23 in the clamping and holding position—for example, when the shroud 19, cap 23, and carrier 18 together constitute a self-supporting assembly, or when the assembly is in a pre-use shielded position after being fitted onto the needle 11. In some embodiments, the carrier 18 may be provided with a groove and configured to provide a circular contact surface to contact the entire periphery / circumference of the shoulder / step of the needle cap 23.

[0070] The orientation of surfaces 70 and 71 keeps the needle cap 23 along the longitudinal axis of the safety device 8 (specifically, the carrier 18) (ultimately aligned with the longitudinal axis of the needle tip 11). This holding force maintains both the longitudinal (translational) position of the needle cap 23 and the angular direction of the needle cap 23 relative to the longitudinal axis of the carrier 18 (see...). Figure 16 ).

[0071] like Figure 12As shown, the carrier 18 provides an abutment structure in the form of two opposing, distally facing abutment surfaces 76. These abutment surfaces 76 are disposed on the inner surfaces of the two lugs 60, 74. These abutment surfaces are arranged to contact the proximal end of the cap 23 when the safety device is in an assembled state without the needle and in the initial shielded position before use after being attached to the needle. Therefore, before the safety device 8 is attached to the syringe 10, the cap 23 (particularly the proximal end of the cap 23) is held, clamped, or loosely engaged. For example, the proximal end of the cap is held radially inward by the two inner surfaces 70, 71, and the step of the cap 23 is sandwiched between the distal abutment surface 76 of the carrier 18 and the internal proximal rib / shoulder 20 on the protective cover 19. The abutment surfaces 76 are located near (preferably directly adjacent to) the inner surfaces 70, 71. The proximal end of the cap 23 thus (directly) abuts the internal region on the carrier adjacent to the inner surfaces 70, 71.

[0072] The needle cap 23 is held in place by the inner surfaces 70 and 71 on one hand, and is also held in place by the engagement of the inner shoulder 20 (or rib) of the protective cover 19 with the upper step of the needle cap 23, either by clamping or loosening.

[0073] As described above and as Figures 9 to 11 As shown, the control device also includes a contact surface 22 of the protective cover 19 (provided by the inner shoulder 20), which engages with the needle cap 23. During and before the assembly of the device 8 into the syringe 10 needle seat, the needle cap 23 is prevented from moving distally away from the first position, instead pushing the cap 23 towards the syringe 10 in its initial position. The needle cap 23 has a corresponding contact surface 25. Specifically, the shoulder 72 of the needle cap 23 provides the corresponding contact surface towards the distal surface 25.

[0074] In use, the user first manually moves and rotates the protective cover 19 outwards to the non-shielded position for use, such as... Figure 5 As shown. This movement disengages the shoulder 20 from the step 72 on the needle cap 23, and also releases and / or relaxes any pushing or compressive forces acting on the cap 23 that would otherwise push the cap proximally towards the engagement surface 15 of the syringe 10. When the protective shield 19 is in the outer pivot position, the user can manually grasp the needle cap 23 and pull it distally forward, disengaging it from its holding position between the inner surfaces 70, 71. This releases the contact between the inner surfaces 70, 71 and the outer periphery of the step 72 on the needle cap 23.

[0075] Overall, the control structure maintains the needle guard 19, needle cap 23, and carrier 18 as a single integral assembly before the components are attached or fixed to the needle tip, in order to control / prevent relative axial offset / misalignment and / or relative angular offset / misalignment of the needle cap 23 and carrier 18, respectively, along with their respective longitudinal axes.

[0076] The present invention also provides a restraining device that provides a restraining force to prevent undesirable and / or accidental unintended pivoting movement of the needle guard relative to the carrier before the safety needle assembly is placed onto the needle tip, and also to resist pivoting movement of the needle guard 19 from its initial shielded position during storage and before use of the needle tip. The restraining force is provided by a releasable interlocking device between the needle guard 19 and the carrier 18. This restraining force must be overcome to move the needle guard 19 outward from its initial shielded position to an unshielded position. Importantly, this interlocking structure acts directly between the needle guard 19 and the carrier 18, unlike the prior art WO2024 / 134197, without any interaction between the guard and the needle cap, thereby avoiding unnecessary damage to the precision needle tip 11 that could occur when the needle cap 23 pivots outward with the guard 19 to the unshielded position—as described above. Figure 1 , Figure 2 As shown. For example, existing devices use a shield 19 to fasten the needle cap 23, helping to hold the shield 19 and needle cap 23 in their initial shielded position. However, as mentioned above, this fastening force combined with the gripping force may create a tendency for the needle cap 23 to move outward along with the shield 19 when the shield 19 is held and manually pivoted to an unshielded position. This tendency for the cap 23 to move outward only stops when it is released from the shield 19; however, during this movement, the needle 11 may have been damaged. As previously mentioned, the tip of the needle 11 can extend into the inner wall of the needle cap 23, such as... Figure 14 As shown. The needle 11 may therefore pivot about the needle seat, and such deflection of the needle 11 could subsequently damage the delicate needle 11. The present invention prevents any such deflection, or at least minimizes the possibility of it occurring.

[0077] Nevertheless, in some embodiments, the needle cover 19 may include a fastening device for fastening and / or clamping, or loosening, retaining the needle cap in the initial shielded position. The fastening device may be in the form of a retaining latch, including a shaped lug with an inwardly curved surface surrounding a portion of the outer peripheral surface of the cover 23 to clamp or loosen the needle cap 23. The latch may be located on the inner surface of the needle cover 19, or at the edge (or near the edge) of the longitudinal opening of the needle cover 19. Therefore, in addition to the restraining force of the interlocking mechanism, the fastening device provides an additional restraining force that must be overcome to move the needle cover 19 outward from the initial shielded position to the unshielded position; naturally, the two forces can be adjusted and balanced accordingly to optimize the normal operation of the releaseable interlocking mechanism.

[0078] The needle shield 19 is configured to be operable from its initial shielding position (see...). Figure 14The needle guard 19 is pivoted outwards to an unshielded position; specifically, the forced outward operation of the needle guard 19 overcomes the restraining force provided by the releasable interlocking device. As described above, this movement also disengages the abutment surface 22 inside the guard from the needle cap 23, thereby allowing the needle cap 23 to be removed distally from the needle hub, exposing the medical needle tip 11 (see...). Figure 15 ).

[0079] The releasable interlock mechanism includes corresponding engagement structures on the protective cover 19 and the carrier 18. As described above, this releasable interlock relies solely on the resistance between the protective cover 19 and the carrier 18. This prevents force from being transmitted through the needle cap 23 and subsequently to the needle 11. Therefore, the interlock mechanism prevents unnecessary or unintended force from being applied to the needle 11 during the release of the protective cover from its initial shielded position to its unprotected use position, thus avoiding damage to the needle 11.

[0080] Interlocking devices ensure that the shield 19 and the carrier 18 are engaged to prevent unnecessary / unintended relative pivoting movements. In some preferred embodiments, the shield 19 is held / maintained in its unshielded position during use and / or its initial position before use by pure friction engagement or by corresponding interlocking members in the form of pawls / facets provided between the shield 19 and the carrier 18. Specifically, the shield 19 can be selectively held in its initial position and its position during use by a first pair of interlocking members (pawls) on the shield 19 and two pairs of second interlocking members (facets) on the carrier 18.

[0081] The interlocking device forms an anti-pivot constraint structure on the carrier 18 and / or the protective cover 19 to maintain the rotational alignment of the protective cover 19 relative to the carrier 18. In some embodiments, one or more pawls 90 (first interlocking members) are provided on one of the carrier 18 or the protective cover 19 to engage with grooves 92, 96 (second interlocking members) on the other component to prevent accidental pivoting movement. Figures 17 to 20 A preferred embodiment of the interlocking mechanism between the shield 19 and the carrier 18 is shown. Engaging groove 92 is used to releasably retain alignment in the pre-use shielded position. This anti-pivot structure requires the user to overcome initial holding resistance to remove (pivot) the shield 19 from the pre-use shielded position. The restraint device may also provide an anti-pivot or holding structure to hold the shield 19 in the unshielded position during use.

[0082] In a preferred embodiment, the shield 19 is provided with a pawl 90. The carrier 18 is provided with a corresponding engagement groove 92, within which the pawl 90 is held in an initial position. The groove 92 has an upper retaining surface or facet 95 to prevent accidental displacement of the pawl 90, i.e., a predetermined force is required to disengage the pawl 90 from the groove 92. These upper retaining surfaces or facets 95 may include smooth or curved edges to allow and / or assist in disengagement of the pawl 90. The pawl 90 includes an irregular profile to effectively provide a sliding surface. For example, the pawl 90 includes an arcuate or curved engagement / protrusion surface that engages with the upper surface of the groove 92. The pawl 90 may be a partially spherical component. This shaped surface allows the user to disengage the pawl 90 by applying the required force, thereby deflecting and / or deforming the shield 19 and causing relevant parts of the shield 19 (e.g., support arms 26, 27) to flex outward, thus moving the pawl 90 out of the groove 92 and subsequently moving upward along the contoured surface 94 provided by the carrier 18. Therefore, this interlocking device requires the user to consciously disengage the pawl 90, and this movement provides tactile feedback to the user. This feedback confirms that the pawl 90 has disengaged, indicating that the shield 19 has left its initial shielding position. In this position, the shield 19 can rotate relatively freely on the carrier 18.

[0083] The carrier 18 also includes a retaining groove 96 for holding the cover 19 in an external use position. The retaining groove 96 includes a slot 96 defined in the carrier 18, which engages and holds the pawl 90 in the open use position, such as... Figure 21 and Figure 22 As shown. This maintains the angularly open position of the shield 19 relative to the carrier 18. Specifically, on the one hand, it helps to initially expose the needle cap 23, making it convenient for the user to manually grasp and remove the needle cap 23. On the other hand, keeping the shield 19 in the open position after removing the needle cap 23 also prevents the shield 19 from swinging freely, avoiding obstruction when the needle pierces the skin.

[0084] The retaining groove 96 is positioned at one or more locations on the carrier 18 to hold and secure the protective shield 19 in an outward pivoting position. Similarly, the user must overcome resistance to move the protective shield 19 inward. This structure helps hold the protective shield 19 in the external position, preventing it from interfering with the actual injection procedure. Both the initial and external anti-pivot structures require the user to consciously and actively move the protective shield 19, and the user receives feedback as these movements and actions begin.

[0085] After use, the shape of the outer surface of the pawl 90 helps the user to separate the pawl from the groove 96. During this process, the support arms 26, 27 can bend elastically (outward). Similarly, this separation action provides tactile feedback to the user, indicating that the shield 19 can now pivot freely.

[0086] In general, the control device includes contact surfaces arranged on the needle guard 19, needle cover 23 and carrier 18 for controlling the axial offset and / or angular misalignment of the longitudinal axes of the needle cover 23 and carrier 18, especially in the pre-use configuration.

[0087] Safety device 8 provides a retaining structure, forming a sub-assembly including carrier 18, protective cover 19, and needle cap 23; this sub-assembly is held and secured together to form a complete integral assembly, and is preferably self-supporting. This allows the sub-assembly to be securely finalized using a high-speed assembly machine, or connected to a separate needle and needle hub, or mounted to a syringe already equipped with a needle.

[0088] When the protective cover 19 is in its initial shielding position before use, the retaining structure aligns the longitudinal axis of the carrier 18 with the longitudinal axis of the protective cover 19. Furthermore, this ensures that the protective cover 19, carrier 18, and needle cap 23 remain together, forming a single, self-supporting safety needle assembly for attachment to the distal end of the syringe 10 or a single Luer sliding / locking needle.

[0089] The protective cover 19 and the carrier 18 can also engage with each other to prevent accidental relative pivoting movement. In a preferred embodiment, the protective cover 19 is held / maintained in an unshielded use position and / or an initial use position by the interlocking of corresponding pawls / facets between it and the carrier 18 (interlocking mechanism) or by pure frictional engagement. Specifically, the protective cover 19 is held in the initial position and / or the use position.

[0090] After injection, the tip of needle 11 needs to be protected. This is achieved by rotating the protective shield 19 inward to a locked (post-use) final shielding position. In a preferred embodiment, this movement is performed manually by the user, providing so-called "active needle prick protection" to protect the tip of needle 11 from punctures. The user manually rotates the protective shield 19 inward to the initial pre-use shielding position, and then further inward; if the total needle length is sufficient, the inner surface of the protective shield 19 abuts against and contacts the distal region of needle 11. Continuing the inward pivoting movement, the protective shield 19 deflects / bends the needle shaft of needle 11. In this position, the longitudinal axis of the protective shield 19 is at an angle to the longitudinal axes of syringe 10 and carrier 18. This both protects and shields the tip of needle 11 and prevents reuse of needle 11. It should be noted (provided the needle is long enough) that although the elastic properties of the metal medical needle may resist the inward movement of the shield, this reaction force is very small and can be easily overcome when the user moves the shield to the post-use final shielding position.

[0091] exist Figure 6As shown in the final shielded position after use, the shield 19 is securely locked relative to the carrier 18 and syringe 10. Furthermore, the pawl 90 is repositioned in the initial groove 92. These grooves are slots or extended grooves that allow the pawl to move further beyond the initial position where the longitudinal axis of the shield 19 is aligned with the longitudinal axis of the carrier 18. In the final shielded position after use, the pivot angle of the shield 19 will exceed that of the initial pre-use position. In some embodiments, this allows the needle to be deformed or deflected by the inner surface of the shield 19. In other embodiments, the needle 11 is not deformed by the inner surface of the shield 19. For example, the shield 19 may provide an internal channel in which the needle 11 can be positioned in the final shielded position after use. This channel allows the needle 11 to be shielded for a longer distance, which is not possible otherwise. The channel is defined on the inner surface of the shield 19 and extends longitudinally along the inner surface. The position of the channel allows it to accommodate the needle 11, or at least a portion (distal portion) of the needle 11 in its final position.

[0092] It should be understood that in some examples of the invention, the distal end of the protective cover 19 may be open and not closed by the end wall 50. In some cases, using an open-end protective cover 19 may be more advantageous.

[0093] As described above, one object of the present invention is to minimize the inward clamping force on the needle cap 23 when the shield 19 is moved from the initial shielded position to the unshielded position. This clamping force can cause the needle cap 23 to move outward when the shield 19 is rotated to the use position, thereby damaging the needle tip 11. To aid in achieving this object, the shield 19 may include a gripping area positioned to prevent or reduce user pressure on the sides of the shield 19. Inevitably, when a user grips the shield 19 with their fingers, a compressive force is generated, which is necessary for the user to grip the shield 19. In the present invention, the gripping area 80 is positioned offset from the longitudinal axis of the shield 19 and is disposed along the upper part of the shield, such as... Figure 23 and Figure 24 As shown. Furthermore, this positioning positions the first and second gripping areas 80 on either side of the continuous (solid line) portion of the protective cover 19. Because the gripping areas 80 are located at both ends of the (basically) rigid / solid portion, the inner cavity of the protective cover 19, where the needle cap 23 is initially located, is hardly or completely squeezed together. Therefore, the gripping force applied by the user does not translate into a disproportionate gripping / pressing force applied to the needle cap 23. Thus, the present invention reduces the problem of the protective cover 19 being excessively squeezed inward onto the needle cap 23 during the movement of the protective cover from its initial shielded position to its unshielded position in use.

[0094] The distal end of the shield 19 may also be closed or partially closed (e.g., through end wall 50), which further strengthens the internal cavity of the shield 19 and prevents the shield 19 from being squeezed against the needle cap 23. As described above, the substantially solid portion extending between the two lateral gripping areas 80 defines a channel for receiving the needle 11 in its final position. While this channel may prevent the connecting / reinforcing portion from maintaining a strictly solid continuity, this relatively small area does not significantly weaken the gripping reinforcement area because the gripping areas are offset from the central or lower regions of the sides of the shield 19. It is understood that these lower regions are the weakest gripping points and are more prone to causing the sides of the shield 19 to be squeezed together.

[0095] The gripping area 80 may also be provided with flanges, edges, or small facets 82 to allow the user to grip more easily, generate pivoting force (initial outward lifting force) without "over-squeezing," and eliminate the risk of squeezing the shield. These small facets 82 allow the user to place part of their thumb and fingers under the flange, thereby moving the shield 19 outward and disengaging the pawl 90 from its position on the irregular surface 94 of the carrier 18.

[0096] In the pre-use shielding position, the present invention may also define a gap 30 (cavity) or void between the needle cap 23 and the needle shield 19, such as... Figure 9 and Figure 11 As shown. The gap 30 is designed to prevent the needle cap 23 from being accidentally clamped and to pivot together with the needle guard 19 to the unshielded position. Therefore, the gap or opening 30 can accommodate a certain degree of squeezing movement without causing the needle cap 23 to be clamped by the inner surface of the needle guard 19.

[0097] As described above, the restraint mechanism provided by the releasable interlock includes friction and / or pawl structures disposed on one or both of the needle guard 19 and the carrier 18 to resist and / or restrain pivoting movement of the needle guard 19 from its initial position. The restraint / retention mechanism may include modifications to the pivot member or the area adjacent to the pivot member to provide the desired friction interface between the carrier and the guard, thereby resisting undesired rotational movement of the guard relative to the carrier. The restraint / retention mechanism includes a friction or pawl arrangement disposed between the needle guard 19 and the carrier 18 for interlocking the needle guard 19 with the carrier 18 when the needle guard 19 is in its initial shielded position. In some further embodiments, a releasable mechanical interlock is provided around a seal (e.g., a sealing member / label or diaphragm) attached / wrapped around a portion of the guard 19 and the carrier 18, which needs to be broken or torn before the guard 19 can be moved outward from its initial pre-use position.

[0098] like Figure 29 and Figure 30As shown, the sealing member 120 can be secured around the safety device 8, forming an interlock between the shield 19 and the carrier 18, and helping to maintain this self-supporting sub-assembly configuration—for example, the sealing member 120 acts as an adhesive tape, helping to maintain this configuration. Specifically, this complete integral assembly is suitable for mechanical operations within an automated assembly machine. When the shield 19 is in its initial shielding position before use, attaching the sealing member 120 to the safety device 8 aligns the longitudinal axis of the carrier 18 with the longitudinal axis of the shield 19. In a preferred embodiment, the sealing member 120 comprises a strip or band of material, at least partially surrounding the circumference of the shield 19. The sealing member 120 can be secured around the entire perimeter of the shield 19, such as... Figure 29 As shown.

[0099] The sealing member 120 may be attached to a suitable location around the protective cover 19 after the safety device 8 is attached to the needle hub, or during the assembly of the safety device 8. The safety device 8 (or safety needle assembly) is provided as a sub-assembly component, fixed to the needle hub, and provides shielding for the needle 11 of the syringe 10.

[0100] The sealing member 120 comprises a strip or loop made of a tearable / tearable or damageable material. For example, the strip may comprise a paper-based material. In this example, the sealing member 120 adheres to the entire periphery of the safety device 8, covering the longitudinally extending interface between the protective shield 19 and the carrier 18. Specifically, the sealing member 120 covers or overlaps at least a portion of the longitudinally upper outer surfaces of the support arms 26, 27. These longitudinal upper surfaces form shear surfaces 126, 127. The support arms 26, 27 are spaced apart from each other, forming a gap therebetween to bridging the carrier 18. For example, one support arm 26 is located on one side of the carrier 18, and the other support arm 27 is located on the other side of the carrier 18. Each shear surface 126, 127 may have a serrated or jagged profile edge to bite, twist, indent, damage, or cut off a portion of the sealing member 120.

[0101] The sealing member 120 is stacked above and positioned relative to the shear surfaces 126 and 127, such that movement of the protective cover 19 relative to the carrier 18 causes the shear surfaces to impact the sealing member 120. The sealing member 120 includes a distal edge 122 and a proximal edge 123. The sealing member 120 is positioned such that the shear surfaces 126 and 127 are located below the distal edge 122 and the proximal edge 123, and at least partially between the distal edge 122 and the proximal edge 123.

[0102] Each shear surface 126, 127 includes its own distal and proximal ends. In a preferred embodiment, the pivoting structure is positioned proximal to the distal end along the safety device 8. When the protective cover 19 pivots outward from its initial position to its use position, the shear surfaces 126, 127 rotate outward accordingly, pivoting about the pivot axis. Specifically, the distal and distal ends of the shear surfaces pivot upward and outward (from...) Figure 29 Viewed clockwise, the shear surfaces 126 and 127 move towards the sealing member 120, thereby cutting into or tearing into the sealing member 120. During this movement, at least a portion of the shear surfaces 126 and 127 will come into contact with the inner surface of the sealing member 120. Continued movement will force the shear surfaces 126 and 127 to break / tear / sever and damage the sealing member 120. Specifically, the distal ends of the shear surfaces 126 and 127 effectively form an edge (or blade), initiating a tear from the distal edge 122 of the sealing member 120. As the pivoting movement continues into the unshielded position in use, the shear surfaces 126 and 127 will continue to widen and prolong the tear, extending proximally towards the proximal edge 123 of the sealing member, thereby overcoming the interlocking and restraining forces provided by the sealing member 120.

[0103] In a preferred embodiment, each shear surface 126, 127 creates and forms a damaged area, including a tear or crease indentation extending from the distal edge 122 to the proximal edge 123 of the sealing member 120 into the longitudinal length of the sealing member 120. Outward movement of the protective cover from its storage position (before use) may result in complete breakage of the sealing member 120, causing the sealing member 120 or a portion thereof to separate from the safety device 8. The specific arrangement depends on the type of sealing member, the material of manufacture, and the manner in which the sealing member 120 is attached to the safety device 8. For example, the inner surface of the sealing member 120 may be substantially completely covered with an adhesive (e.g., a self-adhesive surface) to keep the entire sealing member 120 attached to the safety device. Alternatively, the inner surface of the sealing member 120 may be only partially covered (dotted) or partially covered with an adhesive (self-adhesive) to allow a portion of the sealing member 120 to separate from the carrier 18 after operation.

[0104] In general, the main objective of this invention is to prevent unnecessary or unintended accidental pivoting of the needle guard 19 relative to the carrier 18 before the safety needle assembly 8 is fitted onto the needle tip 11; and to prevent the needle guard 19 from pivoting from its initial shielding position during storage before use. Furthermore, the retaining device not only keeps the guard 19 rotationally stable relative to the carrier 18, but also simultaneously retains and positions the needle cap 23—because there is no needle seat inside the safety needle assembly for mounting the needle cap 23, it must be held within the assembly in some way before being assembled onto the needle seat. All other prior art safety needle assemblies require a needle cap mounted on the needle seat, and the needle tip is pre-mounted on the needle seat.

[0105] This invention can be used with existing (mature and reliable) assembly lines. Specifically, the size of the safety needle assembly is particularly well-suited for integration into existing production lines. For example, in its initial position, the needle guard extends along the longitudinal axis of the carrier (and needle), and the guard does not tilt outward, avoiding the problem of increased external dimensions causing the device to be unsuitable for existing production lines. In particular, this invention is applicable to existing manufacturing / production / assembly lines related to Luer lock needles, as well as existing manufacturing / production / assembly lines related to pre-filled syringes with pre-embedded needles—the nose of such syringes serves as the needle hub. In this invention, the safety needle assembly effectively replaces the standard / ordinary needle cap (hard or soft) traditionally used to cover the Luer lock needle hub needle, and also replaces the rigid (or soft) needle cap used to protect the needle of a pre-filled syringe.

[0106] The safety needle device 8 provided by this invention is sized (length and diameter) to fit standard pre-filled syringes supplied by standard nest-canister packaging systems, replacing the common non-safety needle sheath devices currently used in the pharmaceutical industry. More importantly, this device 8 provides a safer way to install and secure the needle cap onto a fully standard pre-filled syringe. After injection, the protective cover 19 pivots inward until the locking mechanism engages with the needle 11 in its final shielding position after use, with the protective cover 19 held at an angle offset from the longitudinal axis of the syringe 10. In the final position, the protective cover 19 can contact the tip of the needle 11 and bend the needle 11 away from its central longitudinal axis. In some embodiments, the protective cover 19 may not contact or deform the needle in the final position. Especially for shorter needles, the final position protects the needle after use without deforming the needle 11. In other embodiments, the inner surface of the protective cover 19 may contact the needle 11, or the contact may be minimal. In still other embodiments, the protective cover 19 can cause significant deformation of the needle.

[0107] This invention can be used with pre-filled or pre-fillable glass or plastic polymer syringes. Furthermore, it can be used with needle hubs featuring Luer locks and Luer sliding couplings. In summary, this invention provides a safety needle device for syringes that can replace non-safety standard needle caps, requiring no customization or modification of nest / pallet and drum packaging designs, and can be integrated into fully standard pallet / nest and drum packaging systems.

Claims

1. A medical needle cap device, comprising: The needle hub further includes a medical needle having a longitudinal axis and a tip, the medical needle being mounted on the needle hub with the tip protruding distally from the needle hub; Safety pin assembly, including: A carrier, wherein the carrier has a longitudinal axis; A needle guard having a longitudinal axis and pivotally connected to a carrier and configured to move outward from an initial shielded position to an unshielded position; the carrier is configured to be fixed to a needle hub. A needle cap is used to protect the needle tip, and when the needle shield is in the initial shielding position, the needle cap is located inside the needle shield; The needle cap includes, Longitudinal axis, A proximal profile is provided, which is configured to be positioned on a distal profile of the needle hub; when the needle guard is in the initial shielding position, the longitudinal axes of the carrier, the needle guard, and the needle cap are aligned with each other. The safety pin assembly also includes: A restraint device is used to provide a restraining force to prevent the needle shield from pivoting from its initial shielding position; A control device for releasably retaining the needle cap inside the needle guard; Its features are: The restraint is provided by a releasable interlock between the needle guard and the carrier; and this restraint must be overcome in order to move the needle guard from the initial shielded position to the unshielded position. The control device includes contact surfaces disposed on the needle guard, needle cover, and carrier, for controlling the axial offset and / or angular misalignment of the longitudinal axis of the needle cover and the carrier, respectively. The releasable interlock device and control device are used to maintain the carrier, needle cover, and needle cap as an integrated self-supporting safety needle assembly before the safety needle assembly is fixed to the needle hub. An abutment surface provided on the needle guard releasably engages the needle cap, preventing the needle cap from moving distally relative to the needle guard when the safety needle assembly is secured to the needle hub, until the needle guard moves to the unshielded position; The needle cover is configured to be operable, pivoting outward from an initial shielded position to an unshielded position; specifically, the outward forced operation of the needle cover overcomes the restraint provided by the interlocking mechanism, causing the contact surface to disengage from the needle cover, thereby allowing the needle cover to be subsequently removed distally from the needle hub to expose the medical needle.

2. The medical needle cap device according to claim 1, characterized in that, The needle cap includes a proximal profile configured to engage with a distal profile of the needle hub, forming a substantially airtight seal between them, thereby maintaining the sterility of the sealed medical needle inside the needle cap when the needle cap is in its initial shielded position within the shield.

3. The medical needle cap device according to claim 1 or 2, characterized in that, A portion of the needle cap and a portion of the needle shield are configured to engage with each other when the needle shield is in its initial shielding position, releasably retaining the needle cap within the needle shield, preventing distal movement of the needle cap relative to the needle shield to prevent drug leakage, and maintaining the sterility of the medical needle during syringe storage.

4. The medical needle cap device according to any one of the preceding claims, characterized in that, The releasable interlocking device is formed directly between the needle guard and the carrier.

5. The medical needle cap device according to claim 4, characterized in that, The releasable interlocking device is formed by the mating interface between the needle guard and the carrier.

6. The medical needle cap device according to claim 5, characterized in that, The releasable interlocking device is formed in two positions, each of which includes a mating interface between the needle guard and the carrier.

7. The medical needle cap device according to any one of the preceding claims, characterized in that, The releasable interlocking device is formed between a first interlocking member on the needle guard and a second interlocking member on the carrier.

8. The medical needle cap device according to claim 7, characterized in that, An interlocking device is formed between a pair of first interlocking components on the needle guard and a corresponding pair of second interlocking components on the carrier.

9. The medical needle cap device according to claim 8, characterized in that, The carrier includes a first pair of second interlocking components and a second pair of second interlocking components.

10. The medical needle cap device according to claim 9, characterized in that, The first pair of interlocking components is arranged to prevent the needle shield from pivoting relative to the carrier from its initial shielded position during use, and the second pair of interlocking components is arranged to prevent the needle shield from pivoting relative to the carrier from its unshielded position during use.

11. The medical needle cap device according to any one of claims 7 to 10, characterized in that, The first interlocking component and the second interlocking component include a pawl and a facet.

12. The medical needle cap device according to claim 11, characterized in that, The pawl includes a protrusion with an irregularly shaped outer surface, and the contour of the surface facilitates engagement and disengagement of the pawl with the corresponding facet.

13. The medical needle cap device according to claim 11 or 12, characterized in that, The facet provides a surface with an engaging edge, which facilitates the engagement and disengagement of the corresponding pawl.

14. The medical needle cap device according to any one of claims 7 to 13, characterized in that, The first interlocking component is disposed on the flexible portion of the needle guard, and the flexible portion is elastic.

15. The medical needle cap device according to claim 14, characterized in that, The flexible portion is arranged to bend during use, assisting in the disengagement of the first interlocking member from the second interlocking member.

16. The medical needle cap device according to any one of claims 8 to 15, characterized in that, A pair of second interlocking components are provided on the carrier to prevent the needle guard from pivoting to the unshielded position.

17. The medical needle cap device according to any one of the preceding claims, characterized in that, A portion of the needle cap includes a step configured to engage with an abutment surface of the needle guard; the abutment surface includes a shoulder facing proximal to releasably engage with the needle cap before the safety needle assembly is secured to the needle hub, thereby holding the needle cap within the needle guard and carrier.

18. The medical needle cap device according to claim 17, characterized in that, The engagement causes the proximal portion of the needle cap to be pushed proximally within the safety needle assembly.

19. The medical needle cap device according to any one of the preceding claims, characterized in that, Before the safety needle assembly is fixed to the needle hub, the contact surface control angle is misaligned; a portion of the needle guard is arranged to engage with a portion of the needle cap, and the proximal end face of the needle cap engages with the complementary surface of the carrier.

20. The medical needle cap device according to any one of the preceding claims, characterized in that, Before the safety needle assembly is fixed to the needle holder, the contact surface controls lateral offset misalignment; and the contact surface includes one or more upright members at the distal end of the carrier.

21. The medical needle cap device according to claim 20, characterized in that, The proximal end of the needle cap is located between two upright members, each of which has an inner surface arranged to hold part of the proximal end of the needle cap within the carrier during use.

22. The medical needle cap device according to any one of the preceding claims, characterized in that, Before the safety needle assembly is fixed to the needle holder, a portion of the inner side of the needle guard is arranged to prevent the needle cap from being misaligned laterally, sideways, or offset relative to the longitudinal axis of the carrier; and two opposing portions of the inner side of the needle guard are used to prevent the needle cap from being misaligned laterally, sideways, or offset relative to the longitudinal axis of the carrier.

23. The medical needle cap device according to any one of the preceding claims, characterized in that, The interlocking device includes a sealing component.

24. The medical needle cap device according to claim 23, characterized in that, The sealing member is a tubular shrinkable band arranged to cover and surround part of the protective shield and part of the carrier.

25. A method for protecting a medical needle, wherein the medical needle cap device comprises: The needle hub further includes a medical needle having a longitudinal axis and a tip, the medical needle being mounted on the needle hub with the tip protruding distally from the needle hub; Safety pin assembly, including: A carrier, wherein the carrier has a longitudinal axis; A needle guard having a longitudinal axis and pivotally connected to a carrier and configured to move outward from an initial shielded position to an unshielded position; the carrier is configured to be fixed to a needle hub. A needle cap is used to protect the needle tip, and when the needle shield is in the initial shielding position, the needle cap is located inside the needle shield; The needle cap includes, Longitudinal axis, A proximal profile is provided, which is configured to be positioned outside the profile at the distal end of the needle hub; when the needle guard is in the initial shielding position, the longitudinal axes of the carrier, needle guard, and needle cap are aligned with each other. The method includes: A restraint device is used to prevent the needle guard from pivoting from its initial shielding position, thereby providing a restraining force; The needle cap can be releasably held inside the needle guard by a control device; Its features are: The restraint is provided by a releasable interlock between the needle guard and the carrier; and this restraint must be overcome in order to move the needle guard from the initial shielded position to the unshielded position. The control device includes contact surfaces disposed on the needle guard, needle cover, and carrier, for controlling the axial offset and / or angular misalignment of the longitudinal axis of the needle cover and the carrier, respectively. The releasable interlock device and control device are used to maintain the carrier, needle cover, and needle cap as an integrated self-supporting safety needle assembly before the safety needle assembly is fixed to the needle hub. An abutment surface provided on the needle guard releasably engages the needle cap, preventing the needle cap from moving distally relative to the needle guard when the safety needle assembly is secured to the needle hub, until the needle guard moves to the unshielded position; The needle cover is configured to be operable, pivoting outward from an initial shielded position to an unshielded position; specifically, the outward forced operation of the needle cover overcomes the restraint provided by the interlocking mechanism, causing the contact surface to disengage from the needle cover, thereby allowing the needle cover to be subsequently removed distally from the needle hub to expose the medical needle.

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