Integrated fill and injection cap for a safety needle device

Abstract

A drug delivery safety device comprising: a safety needle device comprising a needle hub, a needle cannula, and a safety feature; and, a cap comprising a cap body, a proximal end of the cap body attached to the safety needle device, and a distal end having an access opening in fluid communication with the needle cannula. The safety needle device allows for an integrated device for both filling and injection that does not interfere with the passive safety feature. The cap can have a filling feature that engages with the safety feature of the safety needle device to keep it in a filling state.

Description

[0001] Case Analysis

[0002] This invention patent application is a divisional patent application. The original application of this divisional patent application is an invention patent application with an international filing date of December 13, 2017, international application number PCT / US2017 / 065956, Chinese national application number 201780076973.5, and an invention title of "Integrated Filling and Injection Cap for Safety Needle Device". Technical Field

[0003] In general, this disclosure relates to drug delivery safety devices. Specifically, this disclosure relates to a cap for a safety needle device that allows for integrated filling and injection. Background Technology

[0004] Accidental pricks from used needles can spread disease. Some needle components have been developed that include a needle shield, which is manually extended or rotated on the needle cannula after use. This procedure typically requires healthcare professionals to hold the syringe barrel in one hand and the shield in the other, assembling both before eliminating the risk of needlestick injury. Some safety needle devices offer passive safety features to provide post-injection needle shielding without additional user intervention. Passive safety features are activated in various ways, but generally involve a mechanical structure that locks the needle in place or covers it.

[0005] For drug delivery, a syringe is attached to a needle to fill it from a fluid supply or retention device (such as a vial), and then the drug is injected into the patient. The filled state of a safety needle device typically allows for multiple fills without activating the passive safety feature. For some safety needle devices, there is a risk of injection while the device is filled, which may prevent the passive safety feature from activating. After filling, the safety needle device is in the injection state, in which case the passive safety feature will activate upon completion of the injection.

[0006] There is a need to prevent the misuse of safety needle devices. There is also a need for a cap for safety needle devices that allows for both filling and injection in an integrated device without interfering with passive safety features. Summary of the Invention

[0007] This invention provides a cap for a safety needle device that allows for integrated filling and injection without interfering with passive safety features. The cap has an access opening in fluid communication with a needle cannula. The access opening may include an access protrusion extending from the distal end of the cap. Exemplary caps include, but are not limited to: a pin-needle cap comprising a pin, typically plastic, as an access protrusion for accessing a fluid supply; and a blunt-fill needle cap comprising a blunt-fill cannula, typically metal, secured in the access protrusion. The cap may have a filling feature that engages with a safety feature of the safety needle device to maintain it in a filled state.

[0008] Various embodiments are listed below. It should be understood that the embodiments listed below can be combined not only as listed below, but also in other suitable combinations according to the scope of this disclosure.

[0009] In one aspect, a drug delivery safety device includes: a safety needle device comprising a needle hub, a needle sheath, and a safety feature; and a cap comprising a cap body, the proximal end of the cap body being attached to the safety needle device, and the distal end of the cap body having an access opening in fluid communication with the needle sheath.

[0010] On the other hand, a safety needle device includes: a needle hub, a needle sleeve, and a safety feature; and a cap, the cap including a cap body having a proximal end attached to the safety needle device, an access opening in fluid communication with the needle sleeve, and a filling feature for holding the safety needle device in a filled state.

[0011] Other aspects include drug delivery methods, which include: obtaining any of the drug delivery safety devices disclosed herein; attaching a syringe to the drug delivery safety device; inserting the access protrusion of a cap into a fluid supply section; filling the syringe with fluid; removing the cap; and injecting the fluid into a patient. Attached Figure Description

[0012] Figure 1 This is a perspective view of a drug delivery safety device according to one embodiment.

[0013] Figure 2 It is based on Figure 1 A three-dimensional view of a drug delivery safety device, further including a pointed cap;

[0014] Figure 3 It is based on Figure 1 A perspective view of a drug delivery safety device used to fill syringes from vials;

[0015] Figure 4 It is based on the assembly of syringes. Figure 1 A cross-sectional view of a drug delivery safety device;

[0016] Figure 5 Provided including Figure 4 A close-up 3D view of the proximal end of the safety needle device;

[0017] Figure 6 From Figure 1 The internal view of the pin cap from the proximal end to the distal end of the cap included;

[0018] Figure 7 A schematic diagram of an exemplary filling feature that engages with an exemplary safety feature is shown;

[0019] Figure 8 A perspective view of a blunt filling needle cap according to one embodiment is provided;

[0020] Figure 9 Provided Figure 7 An exploded 3D view of a blunt filling needle cap;

[0021] Figure 10 Provided Figure 8 A cross-sectional view of a blunt-filled needle cap;

[0022] Figure 11 A perspective view of a drug delivery safety device according to one embodiment is provided;

[0023] Figure 12 Provided including Figure 11 A cross-sectional view of the safety needle device in the image;

[0024] Figure 13 From Figure 11 The internal view of the blunt filling needle cap from the proximal end to the distal end of the cap is included.

[0025] Figure 14 A perspective view of a drug delivery safety device according to one embodiment is provided;

[0026] Figure 15 Is included Figure 14 A three-dimensional view of the blunt filling needle cap in the image;

[0027] Figure 16 From Figure 15 An internal view of the blunt-filled needle cap from the proximal end to the distal end of the cap;

[0028] Figure 17 A perspective view of a drug delivery safety device according to one embodiment is provided;

[0029] Figure 18 Is included Figure 17 A three-dimensional view of the pin cap;

[0030] Figure 19 From Figure 18 An internal view of the pin cap from the proximal end to the distal end of the cap;

[0031] Figure 20 A perspective view of a drug delivery safety device according to one embodiment is provided;

[0032] Figure 21 Is included Figure 20 A three-dimensional view of the pin cap;

[0033] Figure 22 From Figure 21 An internal view of the pin cap from the proximal end to the distal end of the cap;

[0034] Figure 23 It is a general flowchart depicting the functional architecture of the "3 options" passive safety device;

[0035] Figure 24 It is a flowchart depicting "3 options" in one embodiment;

[0036] Figure 25 It is a flowchart depicting "3 options" in one embodiment;

[0037] Figure 26 It is a flowchart depicting "3 options" in one embodiment;

[0038] Figure 27 This is a three-dimensional view of the drug delivery safety device before it is attached to the vial;

[0039] Figure 28 yes Figure 27 A 3D view of the drug delivery safety device after the vial has been filled;

[0040] Figure 29 yes Figure 27 A perspective view of the drug delivery safety device after the cap has been removed from the safety needle device;

[0041] Figure 30 This is a perspective view of a drug delivery safety device according to one embodiment;

[0042] Figure 31 It is in a filled state. Figure 30 A three-dimensional view of a drug delivery safety device;

[0043] Figure 32 yes Figure 30 A perspective view of the drug delivery safety device after the cap has been removed from the safety needle device;

[0044] Figure 33 This is a perspective view of a drug delivery safety device in a filled state according to one embodiment;

[0045] Figure 34This is a perspective view of a drug delivery safety device in a filled state according to one embodiment;

[0046] Figure 35 This is a perspective view of a hat according to one embodiment;

[0047] Figure 36 yes Figure 35 A cross-sectional view of the hat;

[0048] Figure 37 This is a perspective view of a drug delivery safety device according to one embodiment, in a filled state engaged with a vial; and

[0049] Figure 38 This is a cross-sectional view of an illustrative safety needle device. Detailed Implementation

[0050] Before describing several exemplary embodiments, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can have other embodiments and can be practiced or performed in various ways.

[0051] The cap of the safety needle device is configured to be removably attached to the safety needle device. The cap allows for an integrated drug delivery safety device for both filling and injection. The safety needle device has one or more safety features, which may be referred to as passive locking safety elements. The cap allows the safety needle device to remain in the filled state. With the cap removed, the safety needle device is in the injection state. The components herein facilitate a “3-option” passive safety device functional architecture that allows the user to use the same device for both filling and injection. Misuse of injection when the safety needle is in its filled state is also minimized and / or avoided. The device in the filled state is designed to prevent the user from administering injections to the patient, for example, using a blunt-filled plastic pin needle or vial access device, which would be very difficult, painful, and unconventional. The caps disclosed herein may limit passive locking safety elements, which is permissible because they would add these additional obstacles to injection when they do so. Regarding the specifics of pin needle caps and blunt-filled caps, user access to vials (including vials of varying depths) is unrestricted.

[0052] cap

[0053] The cap includes a cap body having a proximal end attached to a safety needle device and an access opening in fluid communication with the needle cannula of the safety needle device. The access opening may include an access protrusion extending from the distal end of the cap. Caps with access protrusions include pin-needle caps and blunt-filled needle caps. The access protrusion may have a vent lumen to allow pressure equalization within the vial (allowing for large-volume aspiration and / or aspiration without pre-air injection). The vent lumen may have a filter to prevent vial contamination.

[0054] A needle cap includes a needle, typically made of plastic. The needle may be designed to include internal features, a pipette, and / or facets to facilitate manufacturing and filling, minimize drug retention, and protect the needle sheath of the safety needle device. A blunt-fill needle cap includes a blunt-fill sheath, typically metallic, secured in the access protrusion. The blunt-fill sheath can be blunt and metallic, single-beveled, with a slit tip, fully sharp, or any desired tip geometry.

[0055] The cap can be made of suitable medical-grade materials, including polymers or metals. Preferably, the cap is injection molded using thermoplastic and / or thermoplastic elastomers (TPEs). The diaphragm inside the cap can be made of a suitable elastomer. The finger clips for the outer surface of the cap can be formed of the same elastomer as the diaphragm. The cap can be manufactured as a "two-injection" molded part.

[0056] The cap may have a filling feature to maintain it in a filled state. The filling feature is a characteristic of the cap, including its size or structure. The size of the cap, such as its length, may not restrict needle penetration, thereby keeping the needle assembly in a filled state. As a first, non-limiting example, the initial length of the needle sleeve of the lower safety needle assembly is sufficient to penetrate the diaphragm of the cap and allow fluid flow. A second, non-limiting example is that, when the cap is attached, the sleeve of the lower assembly is compressed to a length less than the actuation distance. The cap's structure may engage with the safety feature of the safety needle assembly. The cap's structure may be designed on its inner surface to contact the safety feature of the safety needle assembly. This structure may protrude from the inner surface, including, for example, ribs, protrusions, pillars, lugs, angled cams, etc.; and / or the structure may be below the inner surface, including, but not limited to, grooves, channels, tracks, etc.; and / or the structure may be an additional component, such as a tube, contained within the cap body. Pin-type caps and blunt-filled caps may optionally have a filling feature, depending on the lower safety needle assembly.

[0057] The cap engages with a portion of the safety pin device by methods including, but not limited to, snap-fit, rotatable engagement, and press-fit. The cap can be disengaged by pulling, quarter-turning, or squeezing. For squeeze-out embodiments, a latch on the cap may be present that requires only non-axial force.

[0058] In one or more embodiments, the safety feature is an actuation latch, such as in an energy storage latch safety pin device or a front-triggered safety pin device, and the filling feature is a rib that keeps the safety feature detached.

[0059] In one or more embodiments, the safety feature is a clamp, such as seen in a linear distance triggered safety pin device, and the filling feature is a tube, rib, or protrusion that keeps the clamp arm open.

[0060] In one or more embodiments, the safety feature is a guiding element of the housing, such as seen in a tube-in-tube safety needle device, while the filling feature is the size of the cap that allows for multiple fillings without activating the safety device.

[0061] Safety needle device

[0062] Any suitable needle device including a safety feature can be used with the cap disclosed herein. Exemplary safety needle devices include, but are not limited to, those described in commonly owned, jointly filed internal files P-15379@ (tube-in-tube), P-15380@ (energy storage latch), and P-15385@ (retractable case including rotational force trigger, linear distance trigger, and front-end trigger), the disclosures of which are incorporated herein by reference in their entirety. The types of safety features vary structurally and mechanically, but generally, safety needle devices have both a filled and an injected state.

[0063] 3. Choose the architecture

[0064] First, the product is packaged in a safe state, with the needle capped to prevent needlestick injury (NSI). This can be in the form of a rigid package or a blister pack with a separate cap. At this point, the user makes a first choice—fill (connecting the vial to fill the syringe or transfer fluid) or inject (inserting the needle into the patient to deliver the medication)—and they actively change the device to that state. Assuming the user chooses to fill, once they have finished filling, they now make a second choice: do I fill again (perform another vial connection), moving the product to the injection state, or move the product to the transport state? Note that each of these choices requires active user movement. Assuming the user chooses to move the product to the transport state, they now place the product in a safe state, thus preventing NSI. After transport, the user needs to make a third choice—actively changing the product to the injection state. Once in the injection state, the device automatically locks within 5 millimeters or less of the needle penetrating the patient's skin (or other medium), thus limiting passive safety.

[0065] When the device is in "filling mode," it is in a state that allows for potential needlestick injuries, and it does not lock when the needle enters the vial (or other medium) and then withdraws. This means that the user can insert the vial for an unlimited number of fills. Similarly, when the device is in "injection mode," it is also in a state that allows for potential needlestick injuries. However, once the needle enters the patient's body (or other medium) and then withdraws, it automatically locks after one use.

[0066] The user can move the injection state at any point in the process. This means the user can move from one state to injection, from filling to injection, or from transport to injection, as described above. To change the state in the 3-selection functional architecture, a combination of cap and safety needle devices can be used, including but not limited to the following embodiments.

[0067] Flip-cap—A flip-cap can be used to change state between initiation, filling, transport, and injection. The flip-cap is initially closed, can be flipped open for filling, can be flipped closed for transport, and can be removed before injection to achieve the injection state. However, unlike devices that limit the distance a needle can penetrate the vial to prevent passive safety device activation, the flip-cap here does not require limiting the distance of needle penetration. This solves the problems associated with devices that limit needle penetration distance, and the trade-offs regarding penetration depth in the filling and injection states. For example, in devices that limit needle penetration, the user can access the vial with only about 15 mm or less of needle length, and similarly, the device does not lock into the patient's skin until a depth of 15 mm or more is reached. Using the flip-cap disclosed herein, it can be used without locking when the cap is on the full length of the needle, and locks the needle almost immediately after penetration into the patient's skin (about 5 mm or less) when the cap is removed. Mechanisms that can use such a flip-cap include energy-storing latches, rotational force triggers, linear distance triggers, and tip triggers.

[0068] Double Caps – Double caps can be used to change states between initiation, filling, transport, and injection. Initially, the product has two caps. For filling, the first “microcap” is removed. For transport, the “microcap” is reattached. For injection, the “large cap” containing the “microcap” is removed (Note: If the user wants to go directly from filling to injection, the large cap can also be removed manually once filling is complete). Like the flip caps described above, double caps do not restrict distance. Therefore, a full needle can be used for filling if needed, and once both caps are removed, locking occurs almost immediately after the needle enters the patient's skin (approximately 5 mm or less). Mechanisms developed today that utilize this type of double cap include energy storage latches, rotational force triggers, linear distance triggers, and tip triggers.

[0069] Alternative Caps – Other alternative caps also apply to the three options. These include clothing pin caps, twist caps, basket caps with flexible arms, pin caps, clip-on caps, and caps with clip arms, as discussed below. Figure 27-37 As shown. The replacement cap can work with energy storage latches, rotational force triggers, linear distance triggers, and front-end triggers.

[0070] Pin-type or blunt-filled needle caps—similar to double-caps, pin-type or blunt-filled needle caps may be packaged with or without a “microcap” (if the “microcap” is not present, the cap does not need to be removed and recapped). Pin-type or blunt-filled needle caps packaged with a microcap will involve removing the microcap for filling, replacing the microcap for transport, and removing the pin-type or blunt-filled needle cap for injection. However, unlike double-caps, pin-type and blunt-filled needle caps will have the additional advantages of (1) preventing the injection needle tip from becoming blunt, and (2) preventing the user from injecting with the device while it is in a filled state, as clinicians are unlikely to attempt to inject patients with a plastic-molded pin-type or blunt-filled needle. This also helps improve compliance with proper use of the device and makes learning more intuitive.

[0071] Please see the attached image. Figure 1-2 This is a perspective view according to an embodiment of a drug delivery safety device. The drug delivery device 100 includes a cap 102 and a safety needle device 120. The cap 102 is removably attached to a portion of the safety needle device 120 at its proximal end 104. The cap 102 engages with a portion of the safety needle device 120 by means including, but not limited to, snap-fit ​​engagement, rotatable engagement, and press-fit. The cap can be removed by pulling, quarter-turning, or squeezing.

[0072] At the distal end 106 of the cap 102, a finger handle 110 is provided, which also provides a gripping area. An access protrusion 112 extends from the shoulder 114 of the cap 102. The shoulder 114 serves as a pin stop for the vial. At the end of the access protrusion 112 is an angled tip 116 with an opening 118. The drug delivery safety device 100 may also include, for example... Figure 2 The pointed cap 124 is shown. The pointed cap 124 can be snap-fitted, rotatably fitted, or press-fitted to the distal end 106 of the cap 102. The cap 102 of this embodiment can be referred to as a pin cap.

[0073] Figure 3 The angled tip 116 of the pin cap 102 is shown when inserted into vial 126. A syringe 128 is attached to the hub of the safety needle assembly 120 and is filled with fluid from vial 126. A very small force (e.g., 0 lbs) is required to push the vial away from the pin cap.

[0074] An exemplary safety needle device is referred to herein as a "rotational force trigger," which combines Figure 4 The syringe and pin cap are shown in cross-section. Figure 5 A close-up perspective view of the proximal end of the "rotary force trigger" is shown. Embodiments of the "rotary force trigger" include one or more safety features in the form of a rotary cam, a locking clip, and / or a device cap. Figure 4-5In this embodiment, the rotational force-triggered drug delivery safety device 120 includes a needle hub 122 for attaching the drug delivery safety device 120 to a syringe 128; the needle hub 122 has an attached needle sheath 136. A device body 130 engaging the needle hub 122 closes a rotating cam 138. The rotating cam 138 engages the body 130 via a slot 140 in a sidewall 131 of the body 130. Figure 5 As shown in more detail, the slot 140 includes three sections: a proximal angled guide ramp 142, a ridge 144 located at the distal end of the angled guide ramp for accommodating a rotary cam, and an axial slot portion 146 distal to the ridge.

[0075] The needle cannula 136 is surrounded by a flexible shell 134, which connects a rotating cam 138 to a locking clip (not shown) near the distal end of the needle cannula 136, such that the needle cannula 136 is substantially covered by the flexible shell, but the distal tip 150 of the needle cannula 136 is exposed. The passive shielding system includes a triggering mechanism comprising a first spring 132 connecting the rotating cam 138 to the locking clip and a second spring (not shown) extending proximally from the rotating cam 138 toward the needle hub 122 in the body 130. The first spring 132 biases the locking clip distally, and the second spring biases the rotating cam 138 distally. The locking clip may be accommodated in a device cap 148 attached to the flexible shell 134.

[0076] The distal tip 150 of the needle cannula 136 passes through the diaphragm 152 as it enters the channel of the access protrusion 112. The diaphragm 152 is located at the distal end of the cap 102. Its proximity to the tip of the access protrusion 112 (e.g., a plastic pin) allows the diaphragm 152 to be penetrated only during use by pulling the cap 102 proximally toward the hub 122. This improves the diaphragm's seal and allows for the use of less elastomer. Furthermore, this position of the diaphragm reduces residual drug retention in the device.

[0077] Figure 6 This is an internal view from the proximal end to the distal end of the pin cap 102, showing the diaphragm 152 and the filling feature 154. The filling feature 154 is a rib on the inner surface of the cap 102. During assembly, the filling feature 154 interacts with the safety feature of the rotary cam 138 in the "rotational force trigger" embodiment via a slot 140 to maintain it in a filled state. An optional lumen vent 151 allows for pressure equalization within the vial (allowing for large-volume aspiration and / or aspiration without pre-injection of air). Figure 7 A syringe 128 with a slotted safety needle assembly is shown, wherein the filling feature 154 (e.g., rib) of the pin cap 102 is located in the slot 140 of the body 130.

[0078] Figure 8A perspective view of a blunt-filled needle cap 202 according to one embodiment is provided. At the proximal end 204, one or more clips 203 are provided for engagement with a portion of a needle safety device. The cap body 208 has a recess 205 for receiving a lower needle safety device with an actuation latch. At the distal end 206 of the cap 202, a finger handle 210 is provided. An access protrusion 212 extends from the shoulder 214 of the cap 202. A cap sleeve 213 extends from the distal end of the access protrusion 212. A miniature cap may be provided for the cap sleeve 213. The cap 202 of this embodiment may be referred to as a blunt-filled needle cap.

[0079] Figure 9 Provided Figure 8 An exploded perspective view of a blunt filling needle cap 202, which includes a cap body 208, a diaphragm 252 and a cap sleeve 213, wherein the cap body 208 has a recess 205 and a clip 203. Figure 10 Provided assembled Figure 8 A cross-sectional view of the blunt filling needle cap 202 includes a cap body 208, a diaphragm 252 located at the distal end 206 of the cap 202, and a cap sleeve 213 located in the access protrusion 212, wherein the cap body 208 has a recess 205 and a clip 203. A seal can be provided between the cap sleeve 213 and the surface of the access protrusion 212.

[0080] The caps disclosed here are suitable for many different types of safety needle devices. Figure 38 A cross-sectional view of an exemplary tube-in-tube safety needle device 10 in a filled state is shown. The safety features are the guide elements (e.g., a first guide path, a second guide path, and a third guide path) of this exemplary safety needle device. The device has a housing 23 and an opening 24 at the distal end. A first guide path 30, a second guide path 32, and a third guide path 34 are disposed on the housing 23. The first guide path 30 and the third guide path 34 are generally parallel to a central axis extending along the housing 23. The second guide path 32 is positioned at an angle, curvature, or taper relative to the axis and intersects with the first guide path 30 and the third guide path 34, thereby separating the first guide path 30 from the third guide path 34. The second guide path 32 allows the guide element 52 to move between the first guide path 30 and the third guide path 34. In one or more embodiments, the first guide path 30, the second guide path 32, and the third guide path 34 are disposed on the inner diameter of the housing 23 to prevent tampering. In one or more embodiments, the first guide path 30, the second guide path 32, and the third guide path 34 are disposed on the inner diameter of the housing 23 so as not to obstruct the visibility of the needle sheath / needle tip. The cap size retention device disclosed herein is in a filled state.

[0081] Figure 11A perspective view of a drug delivery safety device according to one embodiment is provided. The drug delivery device 200 includes, according to... Figure 8-10 and Figure 13 The cap 202 and safety pin device 220 have an actuation latch (“energy-storing latch”) and are in an extended configuration. The cap 202 is removably attached to a portion of the safety pin device 220 at its proximal end 204. A cap sleeve 213 is located in an access protrusion 212 at the distal end 206 of the cap 202. The cap 202 can be snap-fitted, rotatably fitted, or press-fitted to a portion of the safety pin device 220.

[0082] Figure 12 Provided including Figure 11 A cross-sectional view of the safety needle device, including an actuation latch. The safety needle device 220 includes a housing 260 configured to be coupled to a syringe (not shown), the housing having a proximal end 261, a distal end 262, a casing 263, and an opening 264 located on the distal end 262. A tether 270 is disposed on the casing 263. The tether 270 is generally parallel to a central axis extending along the casing 263.

[0083] A needle hub 272 is disposed on the proximal end 261 of the housing 260. A needle sleeve 273 is attached to the needle hub 272. A needle support 271 extends from the needle hub 272 to support the needle sleeve 273. The distal end 262 of the housing 260 is coupled to a retractable sheath 275 such that the retractable sheath 275 is configured to move along a central axis in the housing 263. The retractable sheath 275 includes channels and holes to allow passage of the needle sleeve 273 and its distal tip 274.

[0084] The proximal end 276 of the retractable sheath 275 includes a retaining hook 277 extending radially outward from the proximal end 276 of the retractable sheath 275 and configured to engage an actuation latch 278 of the housing 263. The housing 260 has an opening for receiving the retractable sheath 275. The retractable sheath 275 is spring-loaded. The actuation latch 278 and the spring element 280 retain stored energy. At the start of injection, once the physician presses the actuation latch at a very short distance, the retaining hook 277 on the proximal end 276 of the retractable sheath 275 releases from engagement with the actuation latch 278, and the energy in the actuation latch 278 is released. A locking latch 282 is capable of clamping onto the distal tip 274 of the needle sheath 273 during injection, thereby passively locking the safety needle device and preventing needlestick injury to the physician. The safety features of the safety needle device include, but are not limited to, the actuation latch 278 and / or the locking latch 282.

[0085] Figure 13This is an internal view taken from the proximal end of the blunt filling needle cap 202, showing towards the distal end of the cap, revealing the septum 252 and the filling feature 254. The filling feature 254 is a rib on the inner surface of the recess 205 of the cap 202. The filling feature 254, during assembly, is... Figure 12 One or more activation latch safety features in an embodiment interact to keep it in a filled state.

[0086] Figure 14 A perspective view of a drug delivery safety device according to one embodiment is provided. Regarding the combination of a blunt filling needle cap and an energy-storing latching safety needle device, Figure 14 Similar to Figure 11 . Figure 14 The energy storage latch safety pin device is provided in a compression configuration. Therefore, Figure 14 and Figure 15 The blunt filling needle caps are respectively compared to Figure 11 and Figure 8 The blunt-filled needle cap is short, but similar in other respects. The drug delivery device 201 includes a cap 207 and a safety needle device 221, which has an actuation latch (“energy-storing latch”) and is in a compressed configuration. The cap 207 is removably attached to a portion of the safety needle device 221 at its proximal end 204. A cap sleeve 213 is located in an access protrusion 212 at the distal end 206 of the cap 202. The cap 207 can be snap-fitted, rotatably fitted, or press-fitted to a portion of the safety needle device 221.

[0087] Figure 15 A perspective view of a blunt-filled needle cap 207 according to one embodiment is provided. At the proximal end 204, one or more clips 203 are provided for engagement with a portion of a needle safety device. The cap body 208 has a recess 209 for receiving the needle safety device in a compressed state, the needle safety device having an actuation latch. At the distal end 206 of the cap 207, a finger handle 210 is provided. An access protrusion 212 extends from the shoulder of the cap 207. A cap sleeve 213 extends from the distal end of the access protrusion 212. A miniature cap may be provided for the cap sleeve 213. The cap 207 of this embodiment may be referred to as a blunt-filled needle cap.

[0088] Figure 16 From Figure 15 An internal view of the blunt-filled needle cap from the proximal end to the distal end of the cap. Figure 16 The septum is not depicted, but it is otherwise similar. Figure 13 And in fact, a diaphragm is usually present. The rib-shaped filling feature 254, during assembly, is... Figure 14 One or more actuation latch safety features of the safety pin device 221 interact to keep it in a filled state.

[0089] Figure 17 A perspective view of a drug delivery safety device according to one embodiment is provided. Regarding the use of an energy-storing latch safety needle device in an extended configuration, Figure 17 Similar to Figure 11 .exist Figure 17 In the middle, the cap is a pin cap, similar to... Figure 1 The pin cap is used in various safety pin devices. Therefore, Figure 17 and 18 The pin cap has a recess to accommodate the actuation latch. Figure 17 The drug delivery device 300 includes a cap 302 and a safety needle device 320, the safety needle device 320 having an actuation latch (“energy-storing latch”) and being in an extended configuration. The cap 302 is removably attached to a portion of the safety needle device 320 at its proximal end 304. A shoulder 314 acts as a pin stop for the vial. An angled tip 316 with an opening 318 is provided at the end of an access protrusion 312 located at the distal end 306 of the cap 302. The cap 302 can be snap-fitted, rotatably fitted, or press-fitted to a portion of the safety needle device 320.

[0090] Figure 18 A perspective view of a pin cap 302 according to one embodiment is provided. At the proximal end 304, one or more clips 303 are provided for engagement with a portion of a pin safety device. The cap body 308 has a recess 305 for receiving a lower pin safety device with an actuation latch. At the distal end 306 of the cap 302, a finger handle 310 is provided. A shoulder 314 serves as a pin stop for a vial. A beveled tip 316 with an opening 318 is provided at the end of an access protrusion 312 located at the distal end 306 of the cap 302. A miniature cap may be provided for the beveled tip 316. The cap 302 of this embodiment may be referred to as a pin cap.

[0091] Figure 19 From Figure 18 An internal view of the pin cap from the proximal end to the distal end of the cap. Figure 19 The diaphragm is not shown, but it is otherwise similar. Figure 13 And in fact, a diaphragm is usually present. The rib-shaped filling feature 354, during assembly, is... Figure 17 One or more actuating latch safety features of the safety pin device 320 interact to keep it in a filled state.

[0092] Figure 20 A perspective view of a drug delivery safety device according to one embodiment is provided. Figure 20 Similar to the use of the energy storage latch safety needle device under compressed conditions. Figure 14 . Figure 20-21 Including similar Figure 18 It has a pin cap, but it is shorter in length. Figure 20 The drug delivery device 301 includes a cap 307 and a safety needle device 321, the safety needle device 321 having an actuation latch (“energy-storing latch”) and being in a compressed configuration. The cap 307 is removably attached to a portion of the safety needle device 321 at its proximal end 304. A shoulder 314 acts as a needle stop for the vial. A beveled tip 316 with an opening 318 is provided at the end of an access protrusion 312 located at the distal end 306 of the cap 307. The cap 307 can be snap-fitted, rotatably fitted, or press-fitted to a portion of the safety needle device 321.

[0093] Figure 21 A perspective view of a pin cap 307 according to one embodiment is provided. At the proximal end 304, one or more clips 303 are provided for engagement with a portion of a pin safety device. The cap body 308 has a recess 309 for receiving a lower pin safety device with an actuation latch. At the distal end 306 of the cap 307, a finger handle 310 is provided. An inclined tip 316 with an opening 318 is provided at the end of an access protrusion 312 located at the distal end 306 of the cap 307. A miniature cap may be provided for the inclined tip 316. The cap 307 of this embodiment may be referred to as a pin cap.

[0094] Figure 22 From Figure 21 An internal view of the pin cap from the proximal end to the distal end of the cap. Figure 22 The diaphragm is not shown, but it is otherwise similar. Figure 13 And in fact, a diaphragm is usually present. The rib-shaped filling feature 354, during assembly, is... Figure 20 One or more actuating latch safety features of the safety pin device 321 interact to keep it in a filled state.

[0095] Figure 23 It is a flowchart depicting the overall functional architecture of the "3 options" passive safety device. Figure 24 This is a flowchart depicting "3 options" of an embodiment using a flip cap without distance limitations. Figure 25 This is a flowchart depicting "3 options" for an embodiment using a double cap. Figure 26 This is a flowchart depicting "3 options" of embodiments using pin caps or blunt filler caps.

[0096] Figure 27-29 An embodiment referred to as a "clothing pin cap" is provided. This embodiment includes internal ribs to prevent security locking during filling. Option 3 eliminates the need for a second cap. Figure 27This is a perspective view of the drug delivery safety device 400 prior to engagement with the vial 426 of fluid 425. Figure 27 In the middle, cap 402 and safety pin device 420 are locked in the starting position. Figure 27 In this design, the cannula of the safety needle device 420 is recessed into the cap 402. A syringe 428 is attached to the needle hub of the safety needle device 420, which is filled with fluid 425 from a vial 426. A small force (e.g., 0 lbs) is required to push the vial away from the cap 402, which lacks the access protrusion of a pin-needle cap and a beveled tip; it also lacks the access protrusion of a blunt needle filling cap and a cap cannula. Figure 28 yes Figure 27 A perspective view of the drug delivery safety device 400 after vial filling. To begin filling, the cap 402 is squeezed to pull it back, exposing the cannula 436 through an access opening (not shown) in the cap 402. The cap 402 can be locked back or spring back. The distal tip 450 of the cannula 436 is inserted into the vial 426. The cap 402 can be squeezed to pull it off for injection, or reset back to begin delivery, or it can be injected directly. It may have two discrete locking points to initiate safety, retract injection, or act as a ratchet, allowing the cap 402 to move axially on squeeze but locking on release. Figure 29 After removing cap 402 from safety needle device 420 Figure 27 A three-dimensional view of the drug delivery safety device 400.

[0097] Figure 30-32 An embodiment known as a "twist cap" is provided. Internal spiral ribs prevent safety locking during filling. Option 3 eliminates the need for a second cap. Figure 30 This is a perspective view of the drug delivery safety device 500 before engagement with the vial, wherein the cap 502 and safety needle device 520 are locked in the initial position. Figure 30 In this design, the cannula of the safety needle device 520 is recessed into the cap 502. The syringe 528 is attached to the needle hub 422 of the safety needle device 520. A small force (e.g., 0 psi) is required to push the vial away from the cap 502, which has no pin-needle cap access protrusion and angled tip; it also has no blunt needle filling cap access protrusion and cap cannula. Figure 31 It is in a filled state. Figure 30A perspective view of the drug delivery safety device 500. To begin filling, the cap 502 is twisted to pull back and expose the cannula 536 through the access opening 549 of the cap 502, and the cap 502 locks back (the screw cannot be reversed). The distal tip 550 of the needle cannula 536 is inserted into the vial. The cap 502 can be unscrewed for injection, or reset to the starting position (braking) for transport, or injected directly. No complex movement is required like the clothing pin cap described above. A simple twist changes the cap's position. The cap screw can have sufficient pitch to prevent axial reverse drive, which prevents the cap from being exposed to sharp objects. Figure 32 yes Figure 30 A perspective view of a drug delivery safety device 500 after removing the cap 502 from a safety needle device 420 including a cannula 536 and a distal top 550. The drug delivery safety device 500 includes an access opening 549.

[0098] Figure 33 A drug delivery safety device 560 is provided, comprising a cap 562, referred to as a "basket cap with a flexible arm," attached to a safety needle device 564, which is attached to a syringe 568. This embodiment includes internal ribs to prevent safety locking during filling. A second cap is required. The cannula 567 of the safety needle device 564 is exposed for insertion into a vial 569. The cannula 567 of the safety needle device 564 passes through an access opening (not shown) in the cap 562. The arm 566 reduces the chance of injection during filling because the arm 566 will come into contact with the patient's skin. However, the arm 566 flexes open for use with the vial 569.

[0099] Figure 34 A drug delivery safety device 570 is provided, comprising a cap 572, referred to as a "pin cap," attached to a safety needle device 574, which is attached to a syringe 578. This embodiment includes internal ribs to prevent safety locking during filling. A second cap is required. A cannula 577 of the safety needle device 574 passes through an access opening 575 of the cap 572 for insertion into a vial 579. Multiple pins 576 reduce the chance of injection during filling. The pins 577 will contact the patient's skin and cause negative feedback, but act as stabilizers for the rubber stopper. The visual appearance of the pins prevents the user from contacting the patient's skin.

[0100] Figures 35-36 An example of what is referred to as a "flip-top cap" is provided. Figure 35 This is a perspective view of a drug delivery safety device 600 including a cap 602 and a safety needle device 620. The protective surface 605 of the cap 602 covers the cannula of the safety needle device 620. The safety needle device 620 is attached to a syringe 628. A second cap is required. Figure 36 yes Figure 35A cross-sectional view of cap 602. Cap 602 includes a protective surface 605, which includes an access opening 607. By pulling back the collet 609, the sleeve is exposed and moves freely through the access opening 607. Collet 609 is actually the outer diameter (OD) of cap 602. Collet 609 abuts against ( Figure 34 The movement of the main body 630 of the safety needle device 620 causes the locking arm 611 to flex and open. The distal end of the impact cap 602 will not retract; the cap 602 will only retract when the clamp 609 is pulled, which prevents accidental needle exposure.

[0101] Figure 37 A drug delivery safety device 580 is provided, comprising a cap 582, referred to as a "cap with a gripping arm," attached to a safety needle device 584, which is attached to a syringe 588. A second cap is required. The cannula of the safety needle device 584 passes through an access opening (not shown) in the cap 582. The gripping arm 586 reduces the chance of injection in a filled state because the arm 586 will come into contact with the patient's skin. However, the gripping arm 586 flexes open for use with a vial 589 and grips the neck of the vial 589 for stability.

[0102] Throughout this specification, references to "one embodiment," "some 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 appearing in various places in this specification, such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in one embodiment," do not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, a particular feature, structure, material, or characteristic may be combined in any suitable manner.

[0103] Although this disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative 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 the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, this disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A drug delivery safety device, the drug delivery safety device comprising: As a safety pin device for a rotational force trigger, the safety pin device includes: The safety needle device body (130) is used to engage a needle hub, the needle hub being configured to attach the safety needle device to a syringe; A slot (140) is provided on the side wall of the safety needle device body (130), the slot (140) comprising: an angled guide ramp (142) on the proximal side; a ridge (144) at the distal end of the angled guide ramp for accommodating a rotary cam (138); and an axial slot portion (146) on the distal side of the ridge. A safety feature, comprising a rotating cam (138) enclosed within the safety pin device body (130), the rotating cam engaging the safety pin device body (130) via the slot (140); and A needle cannula, wherein the needle cannula is surrounded by a flexible shell (134), the flexible shell (134) connecting the rotary cam (138) to a locking clip disposed near the distal end of the needle cannula as a component of a safety needle device serving as a rotational force trigger, such that the needle cannula is substantially covered by the flexible shell (134); and The hat, which has a hat body, The proximal end of the cap is attached to the safety needle device, and the distal end of the cap has an access opening that is in fluid communication with the needle cannula. The access opening has an access protrusion that extends from the distal end of the cap, and the proximal end of the cap is removably attached to the safety needle device. The inner surface of the cap has a filling feature (154) that can engage with the safety needle device to maintain the safety needle device in a filled state. During assembly, the filling feature (154) interacts with the rotating cam (138), which is a component of the safety needle device that serves as a rotational force trigger, by being located in the slot (140) to hold the rotating cam (138) in a filled state for filling fluid into the safety needle device.

2. The drug delivery safety device of claim 1, wherein, The distal tip of the needle cannula is exposed through the flexible shell.

3. The drug delivery safety device according to claim 1, wherein the safety feature further includes a triggering mechanism, the triggering mechanism comprising a first spring connecting the rotating cam to the locking clip and a second spring extending proximally toward the needle hub in the safety needle device body.

4. The drug delivery safety device according to claim 3, wherein, The first spring biases the locking clamp to the distal side, and the second spring biases the rotating cam to the distal side.

5. The drug delivery safety device of claim 3, wherein, The locking clip is housed in the device cap.

6. The drug delivery safety device of claim 5, wherein, The device cap is attached to the flexible shell.

7. The drug delivery safety device according to claim 1, wherein, The filling feature includes a rib located on the inner surface of the cap body, the rib contacting the safety feature of the safety pin device.

8. The drug delivery safety device of claim 7, wherein, The safety feature of the safety needle device includes an activation latch, and the rib holds the activation latch in a filled state for filling fluid into the safety needle device.

9. The drug delivery safety device of any one of claims 1 to 8, wherein, The safety feature of the safety needle device includes a clamp, and the filling feature keeps the clamp open in a filled state for filling fluid into the safety needle device.

10. The drug delivery safety device according to any one of claims 1 to 8, wherein, The safety feature includes a guide element for the housing of the safety needle device.

11. The drug delivery safety device according to any one of claims 1 to 8, wherein, During assembly, the filling feature interacts with the rotating cam by being located in the slot to keep the filling feature in a filled state for filling fluid into the safety needle device.

12. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap buckle engages with the safety pin device.

13. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap is rotatably fitted to the safety pin device.

14. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap is press-fitted to the safety needle device.

15. The drug delivery safety device of any one of claims 1 to 8, wherein, The proximal end of the cap is removably attached to a portion of the safety pin device.

16. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap also includes a diaphragm located at the distal end of the cap body near the access opening and a venting lumen, which allows for pressure equalization within the vial when the needle cannula is inserted into the vial.

17. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap also includes a finger handle.

18. The medication delivery safety device of claim 1, wherein, The cap also includes a shoulder located at the distal end of the cap body, and the access protrusion extends from the shoulder.

19. The drug delivery safety device of any one of claims 1 to 8, wherein, The access protrusion includes a slanted tip and a tip cap, the tip cap covering the slanted tip.

20. The drug delivery safety device of any one of claims 1 to 8, wherein, The cap also includes a blunt filler sleeve extending from the distal end of the access protrusion and in fluid communication with the needle cannula, and a seal between the blunt filler sleeve and the inner surface of the access protrusion.

21. The drug delivery safety device of claim 20, further comprising a tip cap covering the tip of the blunt filler sleeve.

Images