Safety device with foldable housing and trigger activation

Abstract

A drug delivery safety device having a trigger activation system activated by pressure applied to the skin of a patient and which automatically shields the needle after the needle is withdrawn from the skin of the patient.

Description

[0001] This application is a divisional application of a divisional patent application entitled "Security Device with Foldable Housing and Trigger Activation", filed on December 12, 2017, with National Application No. 202111259062.0. The original parent application is a Chinese patent application entitled "Security Device with Foldable Housing and Trigger Activation", with International Application No. PCT / US2017 / 065679, Chinese Application No. 201780076982.4, filed on December 12, 2017. Technical Field

[0002] This disclosure generally relates to a drug delivery safety device having a passive trigger activation system, i.e., a structure for trigger activation, which is engaged when using the drug delivery device to provide protection for the needle after injection without requiring additional user intervention. Background Technology

[0003] Accidental needlestick injuries from used needles can spread disease. As a result, most existing needle assemblies have needle guards. Some existing needle guards define a rigid sleeve that can be manually extended or retracted or rotated on the needle cannula after use. This procedure typically requires healthcare workers to hold the syringe barrel with one hand and the guard with the other. Because some medical procedures require applying pressure to the insertion site after needle removal, healthcare workers often cannot use both hands to apply needle cannula protection. In these situations, workers place the used medical instrument on a nearby surface, hoping to apply protection to the used needle when it is more convenient. However, the needle poses a potential hazard to other personnel until it is protected or properly disposed of.

[0004] As a further risk to healthcare workers, the additional post-injection action of manually applying protection to used needles (whether the procedure requires one or two hands) increases the likelihood of accidental needlestick injuries. Therefore, there is a need for a needle protection system and device that is automatically triggered when a needle is used to treat a patient, thereby eliminating the need for healthcare workers to take additional steps or further handle the medical device to ensure the safety of used needles. Such automatic protection devices and mechanisms are generally referred to as passive medical safety devices or passive protection systems. In particular, there is a need for passive needle safety devices that require less force to trigger the protection mechanism. Summary of the Invention

[0005] The first aspect relates to a drug delivery safety device comprising a body connected to a needle hub. The body encloses a rotating cam that engages in a slit passing through a sidewall of the body. The slit comprises three portions: a proximal inclined guide ramp, a boss at the distal end of the inclined guide ramp for accommodating the rotating cam, and an axial slit portion at the distal end of the boss. The needle hub includes a needle cannula surrounded by a flexible housing. The flexible housing connects the body to a locking clip near the distal end of the needle cannula, such that the needle cannula is substantially covered by the flexible housing but the distal tip of the needle cannula is exposed. A passive protection system is activated by a trigger mechanism comprising a first spring connecting the rotating cam to the locking clip and a second spring extending proximally from the rotating cam toward the needle hub within the body. The first spring biases the locking clip distally, and the second spring biases the rotating cam distally. The force applied to the rotating cam by the second spring is sufficient to position the rotating cam on the boss in the slit and maintain its position prior to injection using the cannula.

[0006] In one or more embodiments, the first spring may surround the needle cannula within a flexible housing.

[0007] In one or more embodiments, the locking clip may be housed in a cap attached to a flexible housing, the cap including a hole to allow a needle cannula to pass through.

[0008] When the drug delivery safety device is attached to the syringe and used for injection, a proximal force, greater than the distal force of the second spring, is applied to the locking clip. This compresses the first spring, causing the flexible housing to retract proximally. The proximal force also moves the locking clip proximally along the axis of the needle cannula. This proximal force is typically applied when administering the injection by inserting the exposed tip of the needle cannula into the patient's skin to the desired depth. This proximal force overcomes the biasing force of the second spring, causing the rotating cam to move proximally away from the boss and down the inclined guide ramp. The inclined surface of the inclined guide ramp causes the rotating cam to rotate as it moves to the proximal end of the inclined guide ramp. When the proximal force subsequently decreases (e.g., when the needle cannula is removed from the patient's skin after injection), the first spring decompresses, allowing the second spring to again apply sufficient distal force to the rotated cam to move it distally along the axial slit. This force causes the locking clamp to move in the distal direction through the distal tip of the needle tube to cover the distal tip.

[0009] In one or more embodiments, the needle hub of the drug delivery safety device can be connected to the syringe barrel.

[0010] In one or more embodiments, the flexible housing may be a spring coil, disc spring, zigzag coil, or roll plate. In one or more embodiments, the flexible housing may have a slack portion in its extended position before injection, which allows the flexible housing to extend further after injection so that the locking clamp covers the distal tip of the needle cannula.

[0011] In one or more embodiments, instead of two separate springs, the first and second springs may be composed of a single spring configured to pass through a rotating cam.

[0012] In one or more embodiments, at least two slits are present in the body. In one or more embodiments, two slits are located in the body on opposite sides of the body.

[0013] In one or more embodiments, the locking clip may be a hook clip that contacts the axis of the needle cannula near its distal end and slides proximally along its length when the needle cannula is inserted into the patient's skin and the first spring is compressed. During passive protection of the procedure (after the needle cannula is removed from the patient's skin), the hook clip moves distally along the needle cannula and past the distal tip, such that the hook portion of the hook clip covers the distal tip.

[0014] In one or more embodiments, the locking clip may consist of two parts, one on each side of the needle cannula, with each part having a contact point with the surface of the needle cannula. Except that the two parts close together to cover the distal tip of the needle cannula as the two-part clip moves toward the distal end, this locking clip functions in the passive drug delivery safety device the same as the function discussed above regarding the hook clip.

[0015] In one or more embodiments, the drug delivery safety device may further include a removable sleeve mounted on the body to prevent triggering of the trigger mechanism. This feature allows the device to be used to fill the syringe before injection without activating the passive protection system. The removable sleeve is removed after the syringe is filled, allowing the passive protection system to be triggered when used to administer the injection. In one embodiment, the anti-trigger sleeve is mounted on the body and includes an inner surface with a protrusion (e.g., a ridge) that engages an axial slit portion of the slit, thereby preventing movement and rotation of the rotating cam.

[0016] The anti-trigger system may also include a cap, which is a removable filler cap covering the exposed tip of the needle cannula. Both the anti-trigger cap and the filler cap may be present on the device before filling. To fill the syringe, the filler cap is removed. Due to the presence of the anti-trigger sleeve, the syringe can be filled multiple times without triggering the passive safety mechanism. If it is desired to transport the filled syringe or delay injection, the filler cap can be selectively reattached. When injection is desired, the anti-trigger sleeve is removed (and the filler cap, if present), to allow the rotating cam to move and rotate.

[0017] The second aspect relates to a drug delivery safety device comprising a trigger mechanism for connecting a needle hub to a locking clip near the distal end of a needle cannula. A flexible housing surrounds the needle cannula and connects the needle hub to the locking clip, such that the needle cannula is substantially covered by the flexible housing but the distal tip of the needle cannula is exposed. A passive protection system is activated by the trigger mechanism, which includes a spring connecting the needle hub to the locking clip. The device also includes a body engaging the needle hub. The body has a cavity with a proximal and a distal end and a Y-shaped clip disposed within the cavity. The first and second arms of the Y-shaped clip are held open by engagement with first and second recesses at the distal end of the cavity and by a distal force applied by the spring biasing the first and second arms toward an "open" or "closed" position. The first and second arms of the Y-shaped clip have inclined surfaces such that an axial vector force is generated when they move toward each other (inward or toward a "closed" position). In one or more embodiments, the Y-shaped clip may include at least two protrusions that act as travel stops to prevent the Y-shaped clip from disengaging from the body, thereby setting the distal travel distance of the locking clip.

[0018] In one or more embodiments, the spring may surround the needle cannula within a flexible housing.

[0019] In one or more embodiments, the locking clip may be housed in a cap attached to a flexible housing, the cap including a hole to allow a needle cannula to pass through.

[0020] When this drug delivery safety device is used to administer an injection, the force applied to the locking clip proximally compresses the spring distally. This spring compression causes the flexible housing to retract proximally and also moves the locking clip proximally along the needle cannula to expose more of the distal end of the cannula. This proximal force is typically applied at the desired depth of insertion of the exposed tip of the needle cannula into the patient's skin for the purpose of administering the injection. The proximal force compressing the spring creates relaxation within the flexible housing, allowing the Y-shaped clip to move proximally within the body to release the first and second arms from the first and second recesses of the body and to move the first and second arms inward toward each other, thereby generating an axial vector force. When the proximal force subsequently decreases (e.g., when the needle cannula is removed from the patient's skin after the injection), the spring decompresses, and the axial vector force moves the locking clip distally through the distal tip of the needle cannula to cover it.

[0021] In one or more embodiments, the needle hub of the drug delivery safety device can be connected to the syringe barrel.

[0022] In one or more embodiments, the flexible housing may be a spring coil, disc spring, zigzag coil, or roll plate. In one or more embodiments, the flexible housing may have a slack portion in its extended position before injection, which allows the flexible housing to extend further after injection so that the locking clamp covers the distal tip of the needle cannula.

[0023] In one or more embodiments, the locking clip may be a hook clip that contacts the needle cannula near its distal end and slides proximally along its length when the needle cannula is inserted into the patient's skin, causing the spring to be compressed. During passive protection of the procedure (after the needle cannula is removed from the patient's skin), the hook clip moves distally along the needle cannula and past the distal tip, such that the hook covers the distal tip.

[0024] In one or more embodiments, the locking clip may consist of two parts, one on each side of the needle cannula, and each part having a contact point with the axis of the needle cannula. Except that the two parts close together to cover the distal tip of the needle cannula as the two-part clip moves toward the distal end, this locking clip functions in the passive drug delivery safety device the same as the function discussed above regarding the hook clip.

[0025] In one or more embodiments, the drug delivery safety device may further include a removable anti-trigger cap mounted on the body and preventing triggering of the trigger mechanism. This feature allows the device to be used to fill the syringe before injection without activating the passive protection system. The removable anti-trigger cap is removed after the syringe is filled, allowing the passive protection system to be triggered when used to administer the injection. In one embodiment, the anti-trigger cap may have an outer wall mounted on the outer wall of the body and an inner wall located between the first and second legs of the Y-clamp when the cap is placed on the body. The inner wall is positioned between the first and second arms such that the arms are held “open” or “spread” even when the spring is compressed, thereby preventing the first and second arms from being released from the first and second recesses when a proximal force is applied.

[0026] The anti-trigger system may also include a second cap, which is a removable filler cap that covers the exposed tip of the needle cannula. Both the anti-trigger cap and the filler cap are present on the device before filling. To fill the syringe, the filler cap is removed. Due to the presence of the anti-trigger cap, the syringe can be filled multiple times without triggering the passive safety mechanism. If it is desired to transport the filled syringe or delay injection, the filler cap can be selectively reattached. When injection is desired, the anti-trigger cap is removed (and the filler cap, if present), to allow movement of the Y-clamp arm.

[0027] The third aspect relates to a drug delivery safety device comprising a needle hub having a needle cannula and at least two flexible arms axially adjacent to the needle cannula, the flexible arms connecting a trigger housing near the distal end of the cannula to the needle hub. The trigger housing includes a hole in its distal wall allowing the needle cannula to pass through. A trigger mechanism within the trigger housing consists of a spring connecting the trigger housing to the flexible arms and a double-leaf spring locking clip. The locking clip is located near the distal end of the needle cannula such that the tip of the needle cannula protrudes through a hole in the locking clip. A first leaf spring of the locking clip removably engages the flexible arm, and a second leaf spring of the locking clip engages the trigger housing. The second leaf spring of the locking clip includes a distal needle tip cap that contacts the needle cannula near its distal end before triggering, thereby preventing the needle tip cap from aligning with the holes in the trigger housing and the locking clip. Before injection, the spring biases the trigger housing and locking clip in the distal direction to prevent the trigger housing and locking clip from moving proximally along the axis of the needle tube and to keep the first spring of the locking clip engaged with the flexible arm.

[0028] In one or more embodiments, the needle hub of the drug delivery safety device can be connected to the syringe barrel via a neck ring that connects the needle hub to the syringe barrel.

[0029] In one or more embodiments, the spring may be a coil spring or a leaf spring.

[0030] In one or more embodiments, the trigger housing may be configured to mount on an end cap connecting the at least two flexible arms. The end cap includes holes aligned with the holes in the trigger housing and the locking clip, thereby allowing a needle cannula to pass through. In one or more embodiments, the end cap may be integrally molded with the at least two flexible arms.

[0031] In one or more embodiments, the spring may surround the end cap and be biased against the distal inner wall of the trigger housing before use, thereby pushing the trigger housing and the locking clip toward the distal end to maintain engagement of the first leaflet of the locking clip with the at least two flexible arms.

[0032] In one or more embodiments, the first spring of the locking clip is removably engaged with the at least two arms by means of a removable engagement with the end cap (e.g., by means of a proximal hook on the first spring of the engagement end cap with a partition).

[0033] When an injection is administered using the drug delivery safety device, a force applied to the distal end of the trigger housing compresses the spring, causing the trigger housing and locking clamp to move proximally toward the at least two flexible arms. This movement disengages the first spring of the locking clamp from its end cap. The tension released from the first spring of the locking clamp bends it to an unloaded state, thus maintaining the disengaged position as the trigger housing continues to move proximally. After disengagement, the needle can be inserted to the desired depth with the at least two flexible arms bent outwards. After the needle cannula is removed from the skin (i.e., after injection), the spring is fully decompressed, and the trigger housing moves axially distally along the needle cannula past its distal tip. At this point, the needle tip cap of the second spring of the locking clamp is no longer in contact with the needle cannula and bends to a needle tip-covered position. Generally, the force required to move the trigger housing and release the first spring of the locking clamp is less than the force required to bend the two or more flexible arms, thus triggering the passive protection mechanism over a short distance during injection.

[0034] In one or more embodiments, the drug delivery safety device may further include a structure for preventing the passive safety mechanism from being triggered prior to injection. This feature allows the device to be used to fill the syringe before injection without activating the passive protection system. Removing or disabling the anti-trigger structure after filling the syringe allows the passive protection system to be triggered during injection. In one or more embodiments, the anti-trigger structure may include a removable cap or sleeve with ribs to hold a first spring of the locking clip in an engaged position and restrain proximal movement of the trigger housing during filling. After filling the syringe, the cap is removed to allow the trigger housing to move proximally and provide passive protection during injection. In some embodiments, the anti-trigger element includes a removable filling cap that covers the needle cannula exposed at the distal end of the removable cap or sleeve before filling the syringe.

[0035] In an alternative embodiment, the anti-trigger element may include a support and a pull pin. The support (e.g., a "U"-shaped support) engages a drug delivery safety device on either side of the trigger housing to restrain movement of the trigger housing during syringe filling. The pull pin facilitates the removal of the support by pulling it to the side. This allows the trigger housing to move proximally after injection and provides passive protection. This embodiment may also include a removable filler cap to cover any exposed needle cannula before filling the syringe. The filler cap may include a slit adapted for mounting on the pull pin on the side.

[0036] The user first removes the filler cap to fill the syringe. Due to the trigger-resistant constraint of the removable sleeve or cap, the syringe can be filled multiple times. When the user wants to administer the injection, the second element of the trigger-resistant mechanism (e.g., sleeve / cap or support / pin) is removed from the drug delivery safety device to allow the passive safety feature to be triggered during injection. If the user wants to delay administering the injection using the filled syringe, the filler cap can be reapplied until the desired injection time. In this case, both the filler cap and the second element are removed before injection to allow for triggering.

[0037] In any of these three aspects, it should be understood that the needle tip may protrude through the distal end of the housing of the locking mechanism, or if the needle tip protrudes through the distal end of the locking clamp, then the housing may cover the needle tip. Attached Figure Description

[0038] Figure 1 An embodiment of a drug delivery device is shown.

[0039] Figure 2 An embodiment of the body and rotating cam assembly of a drug delivery device is shown.

[0040] Figure 3An embodiment of a drug delivery device is shown.

[0041] Figure 4 An embodiment of a rotating cam is shown.

[0042] Figure 5 A second embodiment of the drug delivery device is shown.

[0043] Figure 6 A second embodiment of the drug delivery device is shown.

[0044] Figure 7 An embodiment of a Y-shaped clamp for a safe drug delivery device is shown.

[0045] Figure 8 An embodiment of an anti-trigger device for use with a drug safety delivery system is shown.

[0046] Figure 9 A third embodiment of a drug delivery device is shown.

[0047] Figure 10 A third embodiment of a drug delivery device is shown.

[0048] Figure 11A -C illustrates one embodiment of a trigger housing that can be used with a drug delivery device. Figure 11A Details of the trigger housing before injection are shown. Figure 11B Details of the trigger housing when the passive safety mechanism is activated during injection are shown. Figure 11C Details of the trigger housing in the needle protection locked position after injection are shown.

[0049] Figure 12 An embodiment of the double leaf spring locking clamp is shown. Detailed Implementation

[0050] When used herein, the terms “proximal,” “pointing proximal,” and related terms for a drug safety delivery device refer to the direction toward the needle hub or toward the syringe when the drug safety delivery device is attached to the syringe.

[0051] When used herein, the terms “distal,” “pointing distal,” and related terms for a drug delivery device refer to the direction toward the needle tip or toward the patient’s skin when the device is used to administer an injection.

[0052] Before describing several exemplary embodiments, it should be understood that this disclosure is not limited to the details of the structures or method steps set forth in the following description. This disclosure can have other embodiments and can be implemented or performed in various ways.

[0053] In general, a safety device is provided for passive protection of the distal tip of a needle cannula after it has been administered for injection. The safety device includes a foldable or flexible structure that connects the needle hub directly or indirectly to a locking clip located at the distal end of the needle cannula. Initially, before use, the needle tip is exposed through the locking clip. The foldable or flexible structure is longitudinally oriented between the needle hub and the locking clip and extends around or near the needle cannula. Before use, energy in the form of tension is stored in the safety device, preventing it from being triggered and keeping the needle tip exposed for use. When the needle tip is inserted into the patient's skin, the stored energy is released, and the safety device is activated or triggered. However, once activated, the safety device does not protect the needle as long as it remains in the skin. This allows the user to continue inserting the needle to the desired depth. Only after the needle is removed from the skin does the activated safety device automatically advance the locking clip forward to cover the needle tip, thus automatically and passively preventing needlestick injury immediately after injection. In some embodiments, the safety device includes additional elements that allow the syringe to be filled prior to injection without triggering the passive safety mechanism.

[0054] These features can be achieved through various embodiments of the safety device. In addition to the advantage of automatically and immediately protecting used needles, these embodiments offer the advantage of requiring less force against the patient's skin during injection to trigger the passive safety mechanism. Various aspects and embodiments also provide a passive mechanism for applying protection to the needle, which activates over a shorter travel distance during injection.

[0055] Rotational trigger

[0056] exist Figure 1 One embodiment, generally shown, is referred to herein as a "rotational force trigger." The rotational force trigger drug delivery safety device 10 includes a needle hub 12 for connecting the drug delivery safety device 10 to a syringe, the needle hub 12 having an attached needle cannula 14. A body 16 engaging the needle hub 12 covers a rotating cam 18. The rotating cam 18 engages the body 16 through a slit in the sidewall 20 of the body 16. As shown in... Figure 2 As shown in more detail, the slit comprises three parts: a proximal inclined guide ramp 22, a boss 24 at the distal end of the inclined guide ramp for mounting a rotating cam, and an axial slit portion 26 at the distal end of the boss.

[0057] like Figure 3As shown, the needle cannula 14 is surrounded by a flexible housing 28, which connects a rotating cam 18 to a locking clip 30 near the distal end of the needle cannula 14, such that the needle cannula 14 is substantially covered by the flexible housing, but the distal tip 32 of the cannula is exposed. The passive protection system includes a trigger mechanism comprising a first spring 34 connecting the rotating cam 18 to the locking clip 30 and a second spring 36 extending proximally from the rotating cam 18 toward the needle seat 12 within the body 16. The first spring 34 biases the locking clip 30 toward the distal end, and the second spring 36 biases the rotating cam 18 toward the distal end. The locking clip 30 may be accommodated in a cap 38, which is connected to the flexible housing 28.

[0058] Figure 4 An embodiment of a rotating cam 18 configured to engage two opposing slits in the body 16 is shown in more detail. A tongue 40 is configured to engage the slits in the body 16. A wing 42 may be present on the outer periphery of the rotating cam 18 for engagement with threads or grooves on the inner wall of the body 16 to facilitate smooth rotation in only one direction. The wing 42 is in an unbent state and can ride over ribs on the inner surface of the housing 16 as the rotating cam 18 rotates. The heads of the ribs and the wing 42 have offset ramps, forming ratchet teeth. This prevents the tongue 40 from re-engaging with the boss 24 of the body 16 during travel toward the distal end. The tongues 40 may be cylindrical to achieve a line contact area with the inclined guide ramp 22; or they may have matching helices to increase the contact area, thereby reducing constraint and resistance to movement.

[0059] exist Figure 1 The diagram also shows an anti-trigger element that can be used with a drug delivery safety device. The anti-trigger element is a removable anti-trigger sleeve 44, which is hollow and configured to be mounted on the drug delivery safety device 10 to engage the body 16. The inner surface 46 of the anti-trigger sleeve 44 includes ribs 48 configured to engage the axial slit 26 and prevent rotation of the rotating cam 18 when the sleeve 44 is in place. A removable filler cap 50 covers the distal opening of the anti-trigger sleeve 44 to prevent access to the needle cannula 14 until the syringe is about to be filled, at which point the removable filler cap is removed and the ribs 48 of the sleeve 44, engaged in the axial slit 26, prevent rotation of the rotating cam 18 during filling. When the syringe is filled and injection is about to be administered, the removable anti-trigger sleeve 44 is removed from the drug delivery safety device 10. This anti-trigger structure also allows for triggering with very little force during use because the anti-trigger ribs prevent triggering during transport and storage.

[0060] Linear distance trigger

[0061] exist Figure 5 and 6One embodiment, generally shown, is referred to herein as a "linear distance trigger." The drug delivery safety device 60 includes a spring 62 that connects a needle hub 12 to a locking clip 30 near the distal end of a needle cannula 14. The needle hub 12 provides connection between the drug delivery safety device 60 and the syringe 94. A flexible housing 28 surrounds the needle cannula 14 and connects a Y-clamp 72 to the locking clip 30, such that the needle cannula 14 is substantially covered by the flexible housing 28, but the distal tip 32 of the needle cannula 14 is exposed.

[0062] The body 64 adaptably engages with the needle seat 12. The body 64 has an inner cavity 66 with a proximal end 68 and a distal end 70, and a Y-shaped clip 72 disposed within the inner cavity 66. The first arm 74 and the second arm 76 of the Y-shaped clip 72 are held open by engaging with a first recess 78 and a second recess 80 at the distal end of the inner cavity, respectively, and by the force of a spring 62 biasing the first and second arms toward an "open" or "closed" position. The first and second arms 74, 76 of the Y-shaped clip 72 have inclined surfaces 73, as shown in... Figure 7 As shown in more detail below. The locking clip 30 is housed in a cap 86, which is connected to the flexible housing 28.

[0063] Figure 7 The Y-clamp 72 is shown in more detail, which includes a sleeve 82 that adaptably engages with the needle seat 12 and includes a hole 84 that allows the needle cannula 14 to pass through. The travel stop 85 is a protruding member that engages with a lip on the inside of the body 64 to limit the travel of the Y-clamp toward the distal end.

[0064] Figure 8 An anti-trigger element for use with the drug delivery safety device 60 is shown. A removable anti-trigger cap 86 includes an outer wall 88 configured to mount on the outside of the body 64. The anti-trigger cap 86 also includes an inner wall 90 located between the first and second arms 74, 76 of the Y-clamp 72 when the anti-trigger cap 86 is in place. Therefore, the inner wall 90 prevents the first and second arms 74, 76 from being released from the first and second recesses 78, 80. A removable filling cap 92 covers the distal end of the drug delivery safety device 60 to prevent access to the needle cannula 14 until the syringe 94 is to be filled, at which point the removable filling cap is removed and the Y-clamp 72 prevents movement of the first and second arms 74, 76 during filling. When the syringe 94 has been filled and injection is to be administered, the anti-trigger cap 86 is removed from the drug delivery safety device 60.

[0065] Front-end trigger

[0066] exist Figure 9One embodiment shown in the diagram is referred to as a "front-end trigger." The drug delivery safety device 100 includes a needle hub 12 having a needle cannula 14 for connection to a syringe 94, and at least two flexible arms 102 axially adjacent to the needle cannula 14 to connect a trigger housing 104 to the needle hub 12. Figure 10 As shown in Figure 11, the trigger housing 104 includes a hole 106 in its distal wall 108 through which the distal tip 32 of the cannula 14 protrudes. The trigger mechanism inside the trigger housing 104 is constituted by a spring 110 (shown in Figure 11) connecting the trigger housing 104 to the flexible arm 102. The trigger mechanism also includes... Figure 12 The double-leaf spring locking clip 112, shown in more detail, has a first spring 114 that removably engages a flexible arm 102 and a second spring 116 that engages a trigger housing 104 to retain the locking clip 112 within the trigger housing 104. The second spring 116 includes a distal tip cap 118, which, before triggering (… Figure 11A It contacts the needle insertion tube to keep the needle tip cap 118 from aligning with the hole 106 of the trigger housing 104 and the hole 120 of the locking clip 112.

[0067] End cap 122 connects the distal ends of the two flexible arms. Trigger housing 104 is mounted on end cap 122. (As shown) Figure 11A As shown in -C, the spring 110 indirectly connects the locking clip 112 to the flexible arm 102 via engagement with the end cap 122. The end cap includes a hole 124 that aligns with the hole 106 in the trigger housing 104 and the hole 120 in the locking clip 112.

[0068] Figure 9 Also shown is an anti-trigger element for use with the drug delivery safety device 100. A removable anti-trigger sleeve 126 is hollow and configured to mount on the drug delivery safety device 100 to engage the needle hub 12. The anti-trigger sleeve 126 includes ribs configured to press against a first spring 114 of a locking clip 112. When in place, the removable anti-trigger sleeve 126 restrains movement of the trigger housing 104. A removable filler cap 128 covers the distal opening of the anti-trigger sleeve 126 to prevent access to the needle cannula 14 until the syringe is to be filled, at which point the removable filler cap is removed and the ribs of the anti-trigger sleeve 126 prevent the first spring 114 from disengaging from the flexible arm 102. When the syringe 94 is filled and injection is to be administered, the removable sleeve 126 is removed from the drug delivery safety device 100.

[0069] Throughout this specification, the terms "one embodiment," "some embodiments," "various embodiments," "one or more embodiments," or simply "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, phrases such as "in one or more embodiments," "in some embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" appearing in various places throughout the specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, the specific feature, structure, material, or characteristic may be combined in one or more embodiments in any suitable manner.

[0070] While this disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative examples of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from its spirit and scope. Therefore, this disclosure is intended to include modifications and variations falling within the scope of the appended claims, as well as their equivalents.

Claims

1. A drug delivery safety device, comprising: Needle hub, the needle hub including a needle cannula having a distal tip; At least two flexible arms near the needle cannula, the flexible arms connecting a trigger housing at the distal end of the needle cannula to the needle hub, wherein the trigger housing has an aperture exposing the distal tip of the needle cannula; The trigger mechanism within the trigger housing includes a spring connecting the trigger housing to the flexible arm, and a double-leaf spring locking clip. The double-leaf spring locking clip includes an opening aligned with a distal opening of the trigger housing, a first spring removably engaging the flexible arm, and a second spring engaging the trigger housing. The second spring includes a distal needle tip cap that contacts a needle insertion tube inside the trigger housing and is not aligned with a hole in the trigger housing or a hole in the double-leaf spring locking clip. The force applied to the proximal end of the trigger housing compresses the spring, causing the trigger housing to move proximally and disconnecting the first leaf spring of the double-leaf spring locking clamp from the flexible arm; and The subsequent reduction of the force applied to the trigger housing towards the proximal end causes the spring to be decompressed and the double-leaf spring locking clip to move towards the distal end, such that the distal tip cap of the second leaf of the double-leaf spring locking clip is disconnected from the needle tube and covers the distal tip of the needle tube.

2. The drug delivery safety device according to claim 1, wherein, The drug delivery safety device is connected to the syringe via the needle hub.

3. The drug delivery safety device according to claim 1 or 2, wherein, The at least two flexible arms are two flexible arms.

4. The drug delivery safety device according to claim 1 or 2, wherein, The spring is a coil spring or a leaf spring.

5. The drug delivery safety device according to claim 1 or 2, further comprising an end cap connecting the at least two flexible arms, wherein, The trigger housing is mounted on the end cap.

6. The drug delivery safety device according to claim 5, wherein, The first leaf of the double-leaf spring locking clip is removably engaged with the end cap.

7. The drug delivery safety device according to claim 1 or 2 further includes a removable anti-trigger cap, the removable anti-trigger cap being mounted on the trigger housing and preventing triggering of the trigger mechanism, the removable anti-trigger cap including an internal rib that engages the double-leaf spring locking clip and prevents a first portion of the double-leaf spring locking clip from disconnecting when a proximal force is applied.

8. The drug delivery safety device according to claim 1 or 2, further comprising a bracket and a pull pin, the bracket engaging the drug delivery safety device on either side of the trigger housing to restrain movement of the trigger housing, wherein, The pull pin facilitates the removal of the bracket to allow the trigger housing to move.

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