Medicament connector and closed system drug-transfer device

Abstract

A medicament connector and a closed system drug-transfer device. The medicament connector (100) comprises: a first connector body (110), a needle body locking member (130), a first needle body (150), an air bladder (160), a first sealing member (120) and a gas-liquid separation membrane (140). The closed system drug-transfer device comprises the medicament connector (100) and a syringe connector (200), wherein the distal end of the medicament connector (100) is configured to connect to a medicament container (300), the proximal end of the medicament connector (100) is configured to connect to the distal end of the syringe connector (200), and the proximal end of the syringe connector (200) is configured to connect to a syringe (400). The medicament connector and the closed system drug-transfer device according to the present invention allow for operations such as liquid aspiration, drug compounding, transfer and injection as needed, and can be completely sealed against gas and liquid from the outside environment during the operations, so as to protect medical personnel and the environment.

Description

A pharmaceutical connector and a closed-loop drug preparation and transport system

[0001] This application claims priority to Chinese Patent Application No. 202411977660.5, filed on December 30, 2024, entitled "A Drug Connector and a Closed Drug Preparation and Transport System". Technical Field

[0002] This invention relates generally to the field of medical devices, and specifically to a drug connector and a closed drug preparation and transport system. Background Technology

[0003] When healthcare workers prepare, administer, and dispose of hazardous drugs, these drugs can enter their bodies through the skin, digestive tract, and respiratory tract, posing a threat to their health. Hazardous drugs include anti-tumor drugs, antiviral drugs, hormones, and some bioengineered drugs (such as targeted therapies). Healthcare workers who are exposed to hazardous drugs year-round are at risk of exposure at every stage of their work. Even with the use of biosafety cabinets, the risk of hazardous drug exposure cannot be completely eliminated.

[0004] The Closed System Drug-Transfer Device (CSTD) is an easy-to-use, needle-free system that provides healthcare professionals with a completely closed solution from drug preparation and transport to infusion. Especially in the preparation and transport of common anti-tumor drugs, it eliminates the risk of exposure due to leakage or needlestick injuries at the source, better protecting healthcare professionals from the harm caused by anti-tumor drug exposure.

[0005] When using a liquid transfer device to prepare or transfer liquids from a sealed container, a pressure difference arises inside and outside the container, hindering the delivery of the liquid. Typically, an additional gas chamber and gas passage are required to balance this pressure difference. Existing CSTD products (CN104800079A, US20140014210A) still pose a risk of liquid vapor evaporation into the environment because the gas chamber needs to be open to the outside atmosphere. While the CSTD products disclosed in CN114288181A and CN115607444A incorporate a sealed gas storage structure, this structure results in a large volume and requires a separate gas passage, making the structure complex and inconvenient to operate. Summary of the Invention

[0006] In order to overcome one or more of the problems existing in the prior art, the present invention provides a pharmaceutical connector and a closed pharmaceutical preparation and transport system using the same.

[0007] According to a first aspect of the present invention, a pharmaceutical connector is provided, wherein a distal end of the pharmaceutical connector is used for connection to a pharmaceutical container, and a proximal end of the pharmaceutical connector is used for connection to a pharmaceutical delivery device, the pharmaceutical connector comprising:

[0008] The first connector body has a first channel in the center of the body;

[0009] A needle body locking component is provided at the upper end of the first channel; a needle body mounting groove is provided in the center of the needle body locking component; a vertical guide groove is formed on the side wall of the needle body locking component or between the side wall and the wall of the first channel.

[0010] The first needle body has an axial channel, and its lower end is fixed in the needle body mounting groove of the needle body locking member. The lower end opening of the first needle body is connected to the guide groove. The axial channel of the first needle body and the guide groove constitute the first fluid passage.

[0011] The air bladder wraps around the first needle body and forms a sealed air chamber, with its lower end located outside the upper opening of the guide groove.

[0012] The first sealing element is disposed between the needle body locking element and the first channel wall, and its lower part seals the lower opening of the first fluid passage. The lower end face of the first sealing element forms a first annular surface. When the first annular surface is subjected to an upward external force, the first sealing element moves upward and can open the first fluid passage. When the external force is removed, the first sealing element returns to its original position due to its own elasticity and can close the first fluid passage.

[0013] The gas-liquid separation membrane is located at the bottom of the gas chamber and covers the upper opening of the guide channel. The gas-liquid separation membrane allows only gas to pass through, while liquid cannot pass through.

[0014] In a preferred embodiment of the present invention, the upper part of the first connector body is provided with a snap-fit ​​structure for connecting the mouth of the medicine container.

[0015] In a preferred embodiment, the snap-fit ​​structure includes an outer ring platform and an inner ring platform; both the outer ring platform and the inner ring platform are formed by multiple snap-fit ​​platforms surrounding each other, the outer ring platform is used to snap-fit ​​the mouth of the drug container, and the inner ring platform is used to support the airbag.

[0016] In a preferred embodiment, the air bladder has a head, a neck, and a body. The head is used to wrap the tip of the first needle body, and the neck is conical. A pressure platform extends outward from the connection between the head and the neck. The upper surface of the pressure platform is used to abut against the stopper of the drug container, and the lower surface is used to abut against the inner ring platform of the snap-fit ​​structure.

[0017] In a preferred embodiment of the present invention, a transverse guide hole is provided on the lower side wall of the needle mounting groove, and the lower end opening of the first needle body is connected to the guide groove through the guide hole.

[0018] In a preferred embodiment of the present invention, a concave guide groove is provided on the outer wall of the needle body lock; the first sealing member wraps around the outer wall of the needle body lock.

[0019] In a preferred embodiment of the present invention, the first sealing member is provided with an annular sealing platform that engages with the bottom surface of the needle body locking member, and the annular sealing platform seals the lower opening of the guide groove.

[0020] In a preferred embodiment, multiple reinforcing ribs are provided on the inner wall of the first sealing element below the annular sealing platform. The multiple reinforcing ribs are spaced apart along the inner wall of the first sealing element, and the gaps between adjacent reinforcing ribs form a drainage groove, which corresponds to the flow guide groove.

[0021] In a preferred embodiment, the lower part of the first connector body is configured as a Luer connector structure.

[0022] According to a second aspect of the present invention, a closed drug preparation and delivery system is provided, comprising a drug connector and a syringe connector, wherein the distal end of the drug connector is used to connect to a drug container, the proximal end of the drug connector is used to connect to the distal end of the syringe connector, and the proximal end of the syringe connector is used to connect to a syringe.

[0023] The pharmaceutical connector adopts the pharmaceutical connector described in the first aspect of the present invention.

[0024] Syringe connectors include:

[0025] The second connector body has a second channel in the center of the body;

[0026] A sealing assembly is disposed at the distal end of the second channel. A second fluid passage is formed in the sealing assembly. The sealing assembly contains a second seal, which controls the opening and closing of the second fluid passage.

[0027] When the syringe connector is connected to the drug connector, the first seal and the second seal squeeze each other, thereby opening the first fluid passage and the second fluid passage; when the first seal and the second seal are released from the squeeze, the first seal and the second seal return to their original positions based on their own elasticity, thereby closing the first fluid passage and the second fluid passage.

[0028] In a preferred embodiment of the invention, the proximal end of the drug connector and the distal end of the syringe connector are connected by a locking Luer connector structure, wherein the proximal end of the syringe connector has a locking Luer connector structure for locking connection with the syringe.

[0029] In a preferred embodiment of the present invention, the upper section of the second connector body extends outward with a connecting groove, and the inner wall of the connecting groove is provided with an internal thread.

[0030] In a preferred embodiment, a gripping part is provided on the outer wall of the connecting groove.

[0031] In a preferred embodiment, a syringe seat is provided at the proximal end of the second connector body. The syringe seat is sleeved on the lower outer periphery of the second connector body, and an external thread is provided on the outer wall of the syringe seat for connecting with a syringe. The syringe seat can rotate independently around the second connector body.

[0032] In a preferred embodiment, a slot is provided on the lower end of the outer wall of the connecting groove, and a latch is provided in the slot. The latch is elastic. Multiple ears are provided on the upper end of the syringe seat, which are used to engage with the slot. After engagement, the syringe seat and the second connector body are fixed together and rotate.

[0033] In a preferred embodiment of the present invention, the sealing assembly includes:

[0034] A sealing rod is fixedly installed in the second channel of the second connector body, and the upper end of the sealing rod has an enlarged portion;

[0035] The second sealing element is disposed on the outer periphery of the sealing rod, with its upper end abutting against the enlarged portion of the sealing rod and extending outward to form a second annular surface; a second fluid passage is formed in the second sealing element, the upper end of the second fluid passage is closed by the enlarged portion of the sealing rod; the lower end of the second fluid passage is connected to the second channel.

[0036] When the proximal end of the drug connector and the distal end of the syringe connector are aligned, the first annular surface of the first seal and the second annular surface of the second seal press against each other, causing the first seal to deform upward and open the first fluid passage; at the same time, the second seal deforms downward and opens the second fluid passage.

[0037] In another preferred embodiment of the invention, the sealing assembly includes:

[0038] The second needle body is fixedly disposed at the upper end of the second channel of the second connector body; the second needle body has an axial channel, which forms a second fluid passage.

[0039] The second sealing element is wrapped around the outer periphery of the second needle body, and its upper end extends outward to form a second annular surface;

[0040] When the proximal end of the drug connector and the distal end of the syringe connector are aligned, the first annular surface of the first seal and the second annular surface of the second seal press against each other, causing the first seal to deform upward and open the first fluid passage; at the same time, the tip of the second needle pierces the second seal and opens the second fluid passage.

[0041] In yet another preferred embodiment of the invention, the sealing assembly includes:

[0042] The second seal has a second fluid passage; the upper part of the second seal has a second annular surface.

[0043] The third seal is disposed below the second seal and seals with the second channel;

[0044] When the proximal end of the drug connector and the distal end of the syringe connector are aligned, the first annular surface of the first seal and the second annular surface of the second seal press against each other, causing the first seal to deform upward and open the first fluid passage; at the same time, the second seal presses downward against the third seal and opens the second fluid passage.

[0045] In a preferred embodiment of the present invention, the closed drug preparation and delivery system of the present invention may further include a syringe, the syringe including a barrel and a piston assembly disposed in the barrel.

[0046] The pharmaceutical connector of the present invention and the closed-loop drug preparation and transport system using the same can perform liquid extraction, drug mixing, transfer, injection, etc. as needed. During the entire operation, it can be completely sealed from the outside gas and liquid to protect medical personnel and the environment. It also has the advantages of small and compact structure and convenient operation. Attached Figure Description

[0047] Figure 1 is a three-dimensional structural diagram of the drug connector in this invention.

[0048] Figure 2 is a schematic diagram of the split structure of the drug connector in this invention.

[0049] Figure 3 is a cross-sectional view of the pharmaceutical connector in this invention.

[0050] Figure 4 is a three-dimensional structural diagram (upright) of the first connector body in this invention.

[0051] Figure 5 is another three-dimensional structural schematic diagram (inverted) of the first connector body in this invention.

[0052] Figure 6 is a cross-sectional view of the first connector body in this invention.

[0053] Figure 7 is a three-dimensional structural diagram of the pin body lock in this invention.

[0054] Figure 8 is a cross-sectional view of the pin body lock component in this invention.

[0055] Figure 9 is a three-dimensional structural diagram of the airbag in this invention.

[0056] Figure 10 is a cross-sectional view of the airbag in this invention.

[0057] Figure 11 is a three-dimensional structural schematic diagram (upright) of the first sealing element in this invention.

[0058] Figure 12 is another three-dimensional structural schematic diagram (inverted) of the first sealing element in this invention.

[0059] Figure 13 is a cross-sectional view of the first sealing element in this invention.

[0060] Figure 14 is a cross-sectional view of the three states of the drug connector in this invention, wherein (a) is a state in which neither the distal nor proximal end is conductive; (b) is a state in which the distal end is conductive but the proximal end is not conductive; and (c) is a state in which both the distal and proximal ends are conductive.

[0061] Figure 15 is a schematic diagram of the connection state between the medicine connector and the syringe in this invention.

[0062] Figure 16 is a schematic diagram of the separate states of the closed drug preparation and transport system according to the present invention.

[0063] Figure 17 is a three-dimensional structural diagram of the syringe connector in this invention.

[0064] Figure 18 is a schematic diagram of the split structure of the syringe connector in this invention.

[0065] Figure 19 is a cross-sectional view of the syringe connector in this invention.

[0066] Figure 20 is a three-dimensional structural diagram of the second connector body in this invention.

[0067] Figure 21 is a cross-sectional view of the second connector body in this invention.

[0068] Figure 22 is a three-dimensional structural diagram (upright) of the second sealing element in this invention.

[0069] Figure 23 is another three-dimensional structural schematic diagram (inverted) of the second sealing element in this invention.

[0070] Figure 24 is a cross-sectional view of the second sealing element in this invention.

[0071] Figure 25 is a three-dimensional structural diagram of the sealing rod in this invention.

[0072] Figure 26 is a cross-sectional view of the sealing rod in this invention.

[0073] Figure 27 is a three-dimensional structural diagram of the syringe holder in this invention.

[0074] Figure 28 is a cross-sectional view of the syringe holder in this invention.

[0075] Figure 29 is a schematic diagram of the closed-loop drug preparation and transport system of the present invention in the non-conductive working state.

[0076] Figure 30 is a magnified view of part A in Figure 29.

[0077] Figure 31 is a schematic diagram of the working state of the closed drug preparation and transport system of the present invention.

[0078] Figure 32 is a magnified view of part B in Figure 31.

[0079] Figure 33 is a cross-sectional view of a syringe connector according to another embodiment of the present invention.

[0080] Figure 34 is a cross-sectional view of a syringe connector according to another embodiment of the present invention.

[0081] Figure 35 is a cross-sectional view of a syringe connector according to another embodiment of the present invention. Detailed Implementation

[0082] To make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0083] In this article, "distal" or "upper" refers to the end furthest from the operator's hand or the end closest to the medicine container, while "proximal" or "lower" refers to the end closest to the operator's hand or the end furthest from the medicine container. The ordinal numbers "first," "second," "third," etc., preceding the part names below are for distinction only and do not represent importance or other meanings.

[0084] Referring to Figures 1-3 and 29-32, in one specific embodiment of the present invention, the drug connector 100 includes a first connector body 110, a first sealing element 120, a needle locking element 130, a gas-liquid separation membrane 140, a first needle body 150, and an air bladder 160. The drug connector 100 serves as an intermediate connector for drug preparation and transfer. The distal end of the drug connector 100 is used to connect to the drug container 300, and the proximal end of the drug connector 100 is used to connect to a drug transport device. The drug container 300 can be either a drug bottle (e.g., a vial) or a drug bag (e.g., an infusion bag), and can contain either liquid or powdered drugs. The drug transport device includes, but is not limited to, syringes, drug delivery connectors, and tubing.

[0085] Referring specifically to Figures 4-6, the first connector body 110 has a first channel 111 in its center. A locking Luer connector structure is provided at the lower part 113 of the first connector body, with a tapered internal channel and external threads on the outer wall. A snap-fit ​​structure 112 for connecting the mouth of the medicine container is provided at the upper part of the first connector body 110. In the embodiment shown in Figures 4-6, the snap-fit ​​structure 112 includes an outer ring platform 1121 and an inner ring platform 1122. Both the outer ring platform 1121 and the inner ring platform 1122 are formed by multiple ring platforms surrounding each other, thus possessing a certain degree of elasticity. The outer ring platform 1121 is used to snap-fit ​​the mouth of the medicine container 300, and the inner ring platform 1122 is used to support the airbag 160 and limit the position of the medicine container 300. In other embodiments, the inner ring platform 1122 may be omitted. The snap-fit ​​structure 112 can be integrally formed with the first connector body 110 or can be a detachable and replaceable independent component; a suitable snap-fit ​​structure can be selected according to the type of medicine container.

[0086] Referring specifically to Figures 7-8, the needle locking member 130 is located at the upper end of the first channel 111. A needle mounting groove 1301 is provided in the center of the needle locking member 130, and a transverse guide hole 1303 is formed on the lower side wall of the needle mounting groove 1301. A vertically recessed guide groove 1304 is formed on the outer side wall of the needle locking member 130, and an enlarged hole 1305 is provided at the upper end of the guide groove 1304. There are multiple guide holes 1303 and guide grooves 1304, and each guide hole 1303 communicates with a corresponding guide groove 1304. A membrane mounting groove 1306 and an airbag mounting groove 1307 are also formed on the upper part of the needle locking member 130. The membrane mounting groove 1306 is used to fix the gas-liquid separation membrane 140, and the airbag mounting groove 1307 is used to fix the airbag 160. The outer periphery of the needle locking member 130 is also provided with a buckle 1308 for engaging with the first connector body 110 and a sealing member mounting groove 1309 for fixing the upper end of the first sealing member 120.

[0087] The first needle body 150 has an axial channel, a pointed upper end, and a lower end fixed in the needle mounting groove 1301 of the needle body locking member 130. A chamber 1302 is formed between the lower end of the first needle body 150 and the needle mounting groove 1301. The lower opening of the first needle body 150 communicates with the chamber 1302, and a guide hole 1303 is provided on the side wall of the chamber 1302. Thus, the axial channel of the first needle body 150, the chamber 1302, the guide hole 1303, and the guide groove 1304 constitute the first fluid passage 170. The gas-liquid separation membrane 140 is fixedly disposed in the membrane mounting groove 1306 and covers all the magnification holes 1305. The function of the gas-liquid separation membrane 140 is to allow only gas to pass through and not liquid to pass through.

[0088] Referring specifically to Figures 9-10, the airbag 160 surrounds the first needle body 150, forming a sealed air chamber 180. Its lower part is positioned outside the gas-liquid separation membrane 140 and fixed in the airbag mounting groove 1307. The airbag 160 is made of flexible material. The airbag 160 in this invention has a dual function: firstly, to seal the first needle body 150, preventing the risk of drug leakage due to the exposed first needle body 150; secondly, to store a certain volume of air to balance the internal and external pressure difference during the input or output of drug into the drug container. The shape and volume of the airbag 160 are not strictly limited and can be appropriately set according to the specifications of the drug container. In one embodiment shown in Figures 9-10, the airbag 160 has a head 161, a neck 162, and a body 163. The head 161 is used to wrap the tip of the first needle body 150, and the neck 162 is conical. A pressure platform 164 extends outward from the connection between the head 161 and the neck 162. The upper surface of the pressure platform 164 abuts against the stopper of the medicine container 300, and the lower surface abuts against the upper end face of the inner ring platform 1122 of the snap-fit ​​structure 112. A connecting rib 165 may also be provided on the peripheral wall of the neck 162. In other embodiments, the airbag 160 may also be spherical, cylindrical, conical, or other irregular shapes.

[0089] Referring specifically to Figures 11-13, the first sealing element 120 has a first shaft hole 121 in the center, specifically including an upper end 122, a waist 123, and a lower end 124. The first shaft hole 121 is used to wrap the outer periphery of the needle body locking element 130. The upper end 122 is fixed in the sealing element mounting groove 1309. An annular sealing platform 128 is provided on the inner wall of the lower end 124, which engages with the bottom surface of the needle body locking element 130, and the annular sealing platform 128 seals the lower opening of the guide groove 1304. The lower surface 129 of the annular sealing platform 128 is preferably a slope. The bottom surface of the lower end 124 forms a first annular surface 126. Multiple reinforcing ribs 125 are provided on the inner wall of the first sealing element 120 below the annular sealing platform 128. The multiple reinforcing ribs 125 are spaced apart along the inner wall of the first sealing element 120, and the gaps between adjacent reinforcing ribs 125 form a guide groove 127, which corresponds to the guide groove 1304. The first sealing element 120 acts as a switch for the first fluid passage 170. When the first annular surface 126 is subjected to an upward force, the annular sealing platform 128 disengages from the bottom surface of the needle lock 130, opening the lower end opening of the guide groove 1304, thereby opening the first fluid passage 170. When the upward force is eliminated, the annular sealing platform 128 automatically resets using elastic force, closing the lower end opening of the guide groove 1304, thereby closing the first fluid passage 170.

[0090] The guide groove in this invention can be formed in a variety of ways, including in the side wall of the needle lock or in the gap between the outer wall of the needle lock and the first channel wall.

[0091] Referring specifically to Figure 14 (the first connector body 110 is not shown), the drug connector 100 of the present invention has three states. Figure 14(a) shows the state where neither the distal nor proximal end is conductive, i.e., the non-working state. Figure 14(b) shows the state where the distal end is conductive but the proximal end is not conductive. In actual operation, after the distal end of the drug connector 100 is connected to the drug container 300, under the action of external force, the air bladder 160 is compressed and deformed downwards, and the tip of the first needle 150 pierces the top of the air bladder 160 and enters the drug container 300; at the same time, some of the air in the air bladder 160 enters the interior of the drug container 300 through the gas-liquid separation membrane 140 and the first fluid passage 170. Figure 14(c) shows the state where both the distal and proximal ends are conductive. Based on Figure 14(b), the first annular surface 126 of the first seal 120 at the proximal end of the drug connector 100 is deformed upward under force, and the annular sealing platform 128 moves upward to disengage from the bottom surface of the needle body lock 130. The guide groove 1304 is opened, so that the liquid medicine in the drug container 300 can flow downward through the first fluid passage 170 and enter the liquid medicine transfer device.

[0092] As can be seen, the first fluid passage 170 in this invention serves as both a gas passage and a liquid passage, greatly simplifying the structure. Furthermore, because a gas-liquid separation membrane 140 is provided between the gas chamber 180 and the first fluid passage 170, the liquid medication in the medication container 100 can only flow downwards and will not enter the gas chamber 180. When the distal end of the medication connector 100 is disconnected from the outside, the air bladder 160 returns to its original shape while simultaneously drawing in residual liquid from the tip of the first needle body 150 back into the first needle body 150 and encasing it in the air bladder 160, achieving a complete seal of the medication.

[0093] Figure 15 shows the connection state of the proximal end of the drug connector 100 directly with the syringe 400 in this invention. The syringe 400 includes a barrel 401 and a piston assembly 402 located in the barrel 401. The front end of the barrel 401 has a standard Luer connector structure for locking and sealing with the first connector body 110. The front end 403 of the syringe 400 acts as a trigger for the first seal 120 of the drug connector 100. When the syringe 400 is tightened, the front end 403 presses against the first annular surface 126 of the first seal 120, opening the first fluid passage 170. The syringe 400 draws or injects the drug liquid through the up-and-down movement of the piston assembly 402. When the syringe 400 is loosened, the front end 403 disengages from the first annular surface 126, the first seal 120 resets, and the first fluid passage 170 closes. The syringe 400 can adopt an existing standard syringe structure or other non-standard structures, as long as it can achieve a sealed connection with the drug connector 100 and has aspiration and injection functions.

[0094] Referring to Figures 16 and 29-32, the closed-loop drug preparation and transport system according to the present invention includes a drug connector 100 and a syringe connector 200. The distal end of the drug connector 100 is used to connect to a drug container 300, the proximal end of the drug connector 100 is used to connect to the distal end of the syringe connector 200, and the proximal end of the syringe connector 200 is used to connect to a syringe 400.

[0095] Figures 17-19 illustrate a first embodiment of the syringe connector 200 of the present invention. The syringe connector 200 mainly includes a second connector body 210 and a sealing assembly. The sealing assembly includes a second seal 220 and a sealing rod 230. In some cases, the syringe connector may also include a syringe seat 240.

[0096] Referring specifically to Figures 20-21, the second connector body 210 has a second channel 211 in its center. A sealing rod fixing member 215 for securing the lower end of the sealing rod 230 is provided in the upper section of the second channel 211. The upper end of the second connector body 210 has a sealing member snap-fit ​​part 216. A connecting groove 213 extends outward from the upper section of the second connector body 210, and an internal thread 214 is provided on the inner wall of the connecting groove 213. The connecting groove 213 is threadedly connected to the lower part of the first connector body 110. A gripping part 217 is provided on the outer wall of the connecting groove 213; the gripping part 217 can be a raised strip or other rough surface. The operator rotates the second connector body 210 using the gripping part 217 to tighten or loosen it from the first connector body 110. A retaining groove 218 is also provided on the outer wall of the connecting groove 213, and a retaining tongue 219 is provided in the retaining groove 218; the retaining tongue 219 is elastic. The lower part 212 of the second connector body is set as a standard Luer connector structure, that is, the lower section of the second channel 211 is tapered.

[0097] Referring specifically to Figures 22-26, the sealing rod 230 includes an umbrella-shaped rod head, a rod body 232, and a rod foot 234. The umbrella-shaped rod head has an enlarged portion 231. The rod foot 234 is fixed to the sealing rod fixing member 215 in the second channel 211 by a snap-fit ​​component. The rod body 232 is provided with a groove 233 for engaging with the second sealing member 220.

[0098] The second seal 220 has a second shaft hole 227 in the center for fitting the rod body 232 of the sealing rod 230. The second seal 220 includes an inner ring 221, a middle ring 222, and an outer ring 223, which are interconnected. A second fluid passage 226 is formed between the inner ring 221 and the middle ring 222. The outer ring 223 is used to connect with the sealing snap-fit ​​portion 216 of the second connector body 210. The enlarged portion 231 of the sealing rod 230 is used to cover the upper opening 225 of the second fluid passage 226. A second annular surface 224 is formed on the upper edge of the second seal 220.

[0099] When the proximal end of the drug connector 100 and the distal end of the syringe connector 200 are aligned, they are tightened by the grip 217. This causes the first annular surface 126 of the first seal 120 and the second annular surface 224 of the second seal 220 to press against each other, deforming the first seal 120 and the second seal 220 upwards and downwards respectively, thereby opening the first fluid passage 170 and the second fluid passage 226. Loosening the grip 217 causes the first annular surface 126 of the first seal 120 and the second annular surface 224 of the second seal 220 to disengage. The first seal 120 and the second seal 220 then return to their original positions downwards and upwards respectively due to their elasticity, thereby closing the first fluid passage 170 and the second fluid passage 226 respectively.

[0100] Both the distal end of syringe connector 200 and the proximal end of drug connector 100 are standard Luer connectors. Whether connected to each other or to other standard Luer connectors, their sealing structure can be opened to control the flow of fluid. When the connector is tightened under external force, the internal seal is displaced due to axial compression, thus opening the flow path. When the connector is loosened under external force, the axial compression force disappears, the internal seal returns to its original state, and the flow path is closed. The flow of fluid is controlled by adjusting the tightness of the Luer connector; the tighter it is tightened, the greater the axial compression force and the larger the opening of the flow path.

[0101] Referring specifically to Figures 27-28, the syringe holder 240 is used to connect the syringe 400. The syringe holder 240 is fitted around the outer periphery of the lower part 212 of the second connector body. The upper end of the syringe holder 240 extends inwardly and is provided with a locking head 244 for engaging with the lower part 212 of the second connector body. The locking head 244 has spaced-apart separation grooves 245 around its circumference, which provide a certain degree of elasticity, facilitating engagement between the syringe holder 240 and the corresponding grooves on the second connector body 210. The upper end of the syringe holder 240 extends outwardly and is provided with multiple ears 243, which engage with the slots 218 on the second connector body 210. The lower outer wall of the syringe holder 240 is provided with external threads 242 for connecting to the syringe. Normally, after the syringe holder 240 is fitted onto the second connector body 210, the ear 243, blocked by the latch 219, allows the syringe holder 240 to rotate independently around the second connector body 210. This allows the lower part of the syringe holder 240 to be screwed tightly connected to other Luer connectors, preventing the rotation of the syringe holder 240 from affecting the movement of the second connector body 210. In some cases, the syringe holder 240 can also be axially pushed, causing the ear 243 to engage with the slot 218, thereby allowing the syringe holder 240 and the second connector body 210 to rotate together.

[0102] In other embodiments, the syringe seat 240 may be omitted, and the external thread connecting the syringe 400 may be directly formed on the lower outer wall of the second connector body 210.

[0103] Referring to Figure 15, the closed-loop drug preparation and delivery system of the present invention may further include a syringe 400. The syringe 400 includes a barrel 401 and a piston assembly 402 located within the barrel 401. The front end of the barrel 401 has a standard Luer connector structure for locking and sealing with the second connector body 210 and the syringe seat 240. The syringe 400 draws or injects the drug solution by the up-and-down movement of the piston assembly 402. The syringe 400 can adopt an existing standard syringe structure or other non-standard structures, as long as it can achieve a sealed connection with the syringe connector 200 and have both drawing and injection functions.

[0104] The working process of the closed-loop drug preparation and transport system of the present invention is described in detail below.

[0105] Referring to Figures 29-32, in use, first connect the proximal end of syringe connector 200 to syringe 400, and the distal end of drug connector 100 to drug container 300. At this time, with the distal end of drug connector 100 connected to drug container 300, the first needle body 150 punctures the tip of balloon 160 and the rubber stopper at the opening of drug container 300, establishing communication with drug container 300. During this communication process, because balloon 160 is compressed, some of the air inside can enter drug container 300 through the first fluid passage 170, achieving pressure balance. Since the sealing elastic element at the proximal end of drug connector 100 is not under stress and remains sealed, there will be no leakage or contamination (see Figures 29-30).

[0106] Next, connect and tighten the syringe connector 200 and the drug connector 100 together, and then tighten the syringe 400 to the syringe connector 200. Subsequently, by tightening the syringe connector 200 and the drug connector 100, the first annular surface 126 of the first seal 120 and the second annular surface 224 of the second seal 220 are pressed against each other, causing the first seal 120 and the second seal 220 to deform upwards and downwards respectively, thereby opening the first fluid passage 170 and the second fluid passage 226 respectively (see Figures 31-32). Perform operations such as liquid dispensing, drug mixing, quantitative drug dispensing, and injection using the syringe 400 as needed. After the operation is completed, loosen the syringe connector 200 and the drug connector 100. The first annular surface 126 of the first seal 120 and the second annular surface 224 of the second seal 220 disengage, and the first seal 120 and the second seal 220 return to their original positions downwards and upwards respectively due to their own elasticity, thereby closing the first fluid passage 170 and the second fluid passage 226 respectively. During the drug transfer process, the syringe 400 and syringe connector 200 can be detached together and then connected to another drug container 300 (or other drug transfer device) equipped with a drug connector 100. Throughout this process, the drug solution remains completely sealed to protect medical personnel and the environment.

[0107] Figure 33 illustrates a second embodiment of the syringe connector 200 of the present invention. The syringe connector 200 includes a second connector body 210 and a sealing assembly. The sealing assembly includes a sealing rod 230, a second sealing element 220, and a limiting element 260. The structures of the second connector body 210 and the sealing rod 230 are basically the same as those in the first embodiment. The sealing rod 230 is fixed to the upper end of the second channel 211. A second fluid passage 226 is formed in the second sealing element 220. The upper opening of the second fluid passage 226 is closed by the top of the sealing rod 230. The upper end of the second sealing element 220 extends outward to form a second annular surface 224. The limiting element 260 is fixedly disposed in the middle of the second sealing element 220. A groove 250 is formed in the second channel 211. When the second annular surface 224 is subjected to downward pressure, the second sealing element 220 can slide downward along the groove 250, thereby opening the second fluid passage 226. When the pressure disappears, the second sealing element 220 slides upward along the groove 250 by elastic force, thereby closing the second fluid passage 226.

[0108] Figure 34 illustrates a third embodiment of the syringe connector 200 of the present invention. The syringe connector 200 includes a second connector body 210 and a sealing assembly. The second connector body 210 has a second channel 211 at its center. The sealing assembly includes a second seal 220, a second needle body 270, and a limiting member 260. The second needle body 270 is fixedly disposed at the upper end of the second channel 211. The second needle body 270 has an axial channel that forms a second fluid passage 226. The second seal 220 wraps around the outer periphery of the second needle body 270, and its upper end extends outward to form a second annular surface 224. The limiting member 260 is fixedly disposed in the middle of the second seal 220. When the second annular surface 224 is subjected to downward pressure, the tip of the second needle body 270 pierces the second seal 220, opening the second fluid passage 226. When the pressure disappears, the second seal 220 returns to its original position by elasticity and wraps around the second needle body 270, thereby closing the second fluid passage 226.

[0109] Figure 35 illustrates a fourth embodiment of the syringe connector 200 of the present invention. The syringe connector 200 includes a second connector body 210 and a sealing assembly. The second connector body 210 has a second channel 211 in its center. The sealing assembly includes a second seal 220 and a third seal 280. The second seal 220 forms a second fluid passage 226. The upper part of the second seal 220 has a second annular surface 224. The middle part of the second seal 220 has a limiting member 260, which abuts against the upper end face of the second channel 211. The third seal 280 is disposed at the lower part of the second seal 220, and the upper end face of the third seal 280 forms a snap-fit ​​seal with the inner wall of the second channel 211. When the second annular surface 224 is subjected to downward pressure, the second seal 220 presses down on the third seal 280, opening the second fluid passage 226. When the pressure disappears, the second seal 220 and the third seal 280 return to their original positions by elastic force, thereby closing the second fluid passage 226. In this embodiment, the second seal 220 and the third seal 280 can also be integrally formed. The middle part of the second fluid passage 226 can also be an open structure, which can be sealed when connected to the inner wall of other Luer connectors.

[0110] The features in the above embodiments can be used interchangeably without conflict. For example, the sealing snap-fit ​​portion 216 in the first embodiment can replace the limiting member 260 in other embodiments; that is, the limiting member 260 can be omitted and directly formed from the upper end of the second connector body 210. Furthermore, the connecting groove 213 and syringe seat 240 in the first embodiment are also applicable to other embodiments.

[0111] The above embodiments are only used to illustrate and not limit the technical solutions of the present invention. Although the above embodiments have described the present invention in detail, those skilled in the art should understand that modifications or equivalent substitutions can be made to the present invention, but any modifications and partial substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of the claims of the present invention.

Claims

A pharmaceutical connector (100) has a distal end for connection to a pharmaceutical container (300) and a proximal end for connection to a pharmaceutical delivery device, characterized in that... The pharmaceutical connector (100) includes: The first connector body (110) has a first channel (111) in the center; A needle lock (130) is provided at the upper end of the first channel (111); a needle mounting groove (1301) is provided in the center of the needle lock (130); a vertical guide groove (1304) is formed on the side wall of the needle lock (130) or between the side wall and the wall of the first channel. The first needle body (150) has an axial channel and its lower end is fixed in the needle mounting groove (1301) of the needle body locking member (130). The lower end opening of the first needle body (150) is connected to the guide groove (1304). The axial channel of the first needle body (150) and the guide groove (1304) constitute the first fluid passage (170). An air bladder (160) surrounds the first needle body (150) and forms a sealed air chamber (180), with its lower end located outside the upper opening of the guide groove (1304); A first sealing element (120) is disposed between the needle body locking element (130) and the first channel wall, and its lower part seals the lower opening of the first fluid passage (170); the lower end face of the first sealing element (120) forms a first annular surface (126). When the first annular surface (126) is subjected to an upward external force, the first sealing element (120) moves upward and can open the first fluid passage (170); when the external force is removed, the first sealing element (120) returns to its original position by its own elasticity and can close the first fluid passage (170); A gas-liquid separation membrane (140) is located at the bottom of the gas chamber (180) and covers the upper opening of the guide groove (1304). The gas-liquid separation membrane (140) allows only gas to pass through while liquid cannot. The pharmaceutical connector according to claim 1 is characterized in that, The upper part of the first connector body (110) is provided with a snap-fit ​​structure (112) for connecting the mouth of the medicine container (300). The pharmaceutical connector according to claim 2 is characterized in that, The snap-fit ​​structure (112) includes an outer ring platform (1121) and an inner ring platform (1122); both the outer ring platform (1121) and the inner ring platform (1122) are surrounded by multi-lobed snap-fit ​​platforms. The outer ring platform (1121) is used to snap-fit ​​the mouth of the medicine container (300), and the inner ring platform (1122) is used to support the airbag (160). The pharmaceutical connector according to claim 3 is characterized in that, The airbag (160) has a head (161), a neck (162) and a body (163). The head (161) is used to wrap the tip of the first needle body (150), and the neck (162) is conical. A pressure platform (164) extends outward from the connection between the head (161) and the neck (162). The upper surface of the pressure platform (164) is used to abut against the stopper of the medicine container (300), and the lower surface is used to abut against the inner ring platform (1122) of the snap-fit ​​structure (112). The pharmaceutical connector according to claim 1 is characterized in that, A transverse guide hole (1303) is provided on the lower side wall of the needle mounting groove (1301), and the lower end opening of the first needle body (150) is connected to the guide groove (1304) through the guide hole (1303). The pharmaceutical connector according to claim 1 is characterized in that, A concave guide groove (1304) is provided on the outer wall of the needle body lock (130); the first seal (120) covers the outer wall of the needle body lock (130). The pharmaceutical connector according to claim 1 is characterized in that, The first sealing element (120) is provided with an annular sealing platform (128) that engages with the bottom surface of the needle body locking element (130), and the annular sealing platform (128) seals the lower opening of the guide groove (1304). The pharmaceutical connector according to claim 7 is characterized in that, Multiple reinforcing ribs (125) are provided on the inner wall of the first sealing member (120) below the annular sealing platform (128). The multiple reinforcing ribs (125) are spaced apart along the inner wall of the first sealing member (120). The gap between adjacent reinforcing ribs (125) forms a drainage groove (127), which corresponds to the guide groove (1304). The pharmaceutical connector according to any one of claims 1-8 is characterized in that, The lower part of the first connector body (110) is configured as a Luer connector structure. A closed-loop drug preparation and delivery system includes a drug connector (100) and a syringe connector (200), wherein the distal end of the drug connector (100) is used to connect to a drug container (300), the proximal end of the drug connector (100) is used to connect to the distal end of the syringe connector (200), and the proximal end of the syringe connector (200) is used to connect to a syringe (400), characterized in that... The pharmaceutical connector (100) includes: The first connector body (110) has a first channel (111) in the center; A needle lock (130) is provided at the upper end of the first channel (111); a needle mounting groove (1301) is provided in the center of the needle lock (130); a vertical guide groove (1304) is formed on the side wall of the needle lock (130) or between the side wall and the wall of the first channel. The first needle body (150) has an axial channel and its lower end is fixed in the needle mounting groove (1301) of the needle body locking member (130). The lower end opening of the first needle body (150) is connected to the guide groove (1304). The axial channel of the first needle body (150) and the guide groove (1304) constitute the first fluid passage (170). An air bladder (160) surrounds the first needle body (150) and forms a sealed air chamber (180), with its lower end located outside the upper opening of the guide groove (1304); The first sealing element (120) is disposed between the needle body locking element (130) and the first channel wall, and its lower part seals the lower opening of the first fluid passage (170); the lower end surface of the first sealing element (120) forms a first annular surface (126); A gas-liquid separation membrane (140) is located at the bottom of the gas chamber (180) and covers the upper opening of the guide groove (1304). The gas-liquid separation membrane (140) allows only gas to pass through while liquid cannot. The syringe connector (200) includes: The second connector body (210) has a second channel (211) in the center of the body; A sealing assembly is disposed at the distal end of the second channel (211), a second fluid passage (226) is formed in the sealing assembly, and a second seal (220) is contained in the sealing assembly, the second seal (220) controlling the opening and closing of the second fluid passage (226); When the syringe connector (200) is connected to the drug connector (100), the first seal (120) and the second seal (220) squeeze each other, thereby opening the first fluid passage (170) and the second fluid passage (226); when the first seal (120) and the second seal (220) are released from the squeeze, the first seal (120) and the second seal (220) return to their original positions by their own elasticity, thereby closing the first fluid passage (170) and the second fluid passage (226). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The upper part of the first connector body (110) is provided with a snap-fit ​​structure (112) for connecting the mouth of the medicine container (300). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, A transverse guide hole (1303) is provided on the lower side wall of the needle mounting groove (1301), and the lower end opening of the first needle body (150) is connected to the guide groove (1304) through the guide hole (1303). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, A concave guide groove (1304) is provided on the outer wall of the needle body lock (130); the first seal (120) covers the outer wall of the needle body lock (130). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The first sealing element (120) is provided with an annular sealing platform (128) that engages with the bottom surface of the needle body locking element (130), and the annular sealing platform (128) seals the lower opening of the guide groove (1304). The closed-loop drug preparation and transport system according to claim 14 is characterized in that, Multiple reinforcing ribs (125) are provided on the inner wall of the first sealing member (120) below the annular sealing platform (128). The multiple reinforcing ribs (125) are spaced apart along the inner wall of the first sealing member (120). The gap between adjacent reinforcing ribs (125) forms a drainage groove (127), which corresponds to the guide groove (1304). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The proximal end of the drug connector (100) is connected to the distal end of the syringe connector (200) via a locking Luer connector structure, the proximal end of the syringe connector (200) having a locking Luer connector structure for locking connection with the syringe (400). The closed-loop drug preparation and transport system according to claim 16 is characterized in that, The upper section of the second connector body (210) extends outward with a connecting groove (213), and the inner wall of the connecting groove (213) is provided with an internal thread (214). The closed-loop drug preparation and transport system according to claim 17 is characterized in that, A gripping part (217) is provided on the outer wall of the connecting groove (213). The closed-loop drug preparation and transport system according to claim 18 is characterized in that, The proximal end of the second connector body (210) is provided with a syringe seat (240), which is sleeved on the lower outer periphery of the second connector body (210). The outer wall of the syringe seat (240) is provided with an external thread (242) for connecting with the syringe (400). The syringe seat (240) can rotate independently around the second connector body (210). The closed-loop drug preparation and transport system according to claim 19 is characterized in that, A slot (218) is provided on the lower end of the outer wall of the connecting groove (213), and a latch (219) is provided in the slot (218). The latch (219) is elastic. Multiple ears (243) are provided on the upper end of the syringe seat (240). The ears (243) are used to engage with the slot (218). After engagement, the syringe seat (240) and the second connector body (210) are fixed together and rotate. The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The sealing assembly includes: A sealing rod (230) is fixedly disposed in the second channel (211) of the second connector body (210), and the upper end of the sealing rod (210) has an enlarged portion (231); A second sealing element (220) is disposed on the outer periphery of the sealing rod (230), with its upper end abutting against the enlarged portion (231) of the sealing rod and extending outward to form a second annular surface (224); a second fluid passage (226) is formed in the second sealing element (220), the upper end of the second fluid passage (226) being closed by the enlarged portion (231) of the sealing rod (230); the lower end of the second fluid passage (226) is connected to the second channel (211); When the proximal end of the drug connector (100) and the distal end of the syringe connector (200) are aligned, the first annular surface (126) of the first seal (120) and the second annular surface (224) of the second seal (220) press against each other, causing the first seal (120) to deform upward and open the first fluid passage (170); at the same time, the second seal (220) deforms downward and opens the second fluid passage (226). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The sealing assembly includes: The second needle body (270) is fixedly disposed at the upper end of the second channel (211) of the second connector body (210); the second needle body (270) has an axial channel, which forms a second fluid passage (226); The second sealing element (220) is wrapped around the outer periphery of the second needle body (270), and its upper end extends outward to form a second annular surface (224); When the proximal end of the drug connector (100) and the distal end of the syringe connector (200) are aligned, the first annular surface (126) of the first seal (120) and the second annular surface (224) of the second seal (220) press against each other, causing the first seal (120) to deform upward and open the first fluid passage (170); at the same time, the tip of the second needle body (270) pierces the second seal (220) and opens the second fluid passage (226). The closed-loop drug preparation and transport system according to claim 10 is characterized in that, The sealing assembly includes: The second seal (220) has a second fluid passage (226); the upper part of the second seal (220) has a second annular surface (224); The third seal (280) is disposed below the second seal (220) and seals the second channel (211); When the proximal end of the drug connector (100) and the distal end of the syringe connector (200) are aligned, the first annular surface (126) of the first seal (120) and the second annular surface (224) of the second seal (220) press against each other, causing the first seal (120) to deform upward and open the first fluid passage (170); at the same time, the second seal (220) presses the third seal (280) downward and opens the second fluid passage (226). The closed-loop drug preparation and transport system according to any one of claims 10-23 is characterized in that, It also includes a syringe (400), which includes a barrel (401) and a piston assembly (402) disposed in the barrel (400).

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