WO2023036338A1 - 一种高压造影注射器及附件 - Google Patents

一种高压造影注射器及附件 Download PDF

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Publication number
WO2023036338A1
WO2023036338A1 PCT/CN2022/118451 CN2022118451W WO2023036338A1 WO 2023036338 A1 WO2023036338 A1 WO 2023036338A1 CN 2022118451 W CN2022118451 W CN 2022118451W WO 2023036338 A1 WO2023036338 A1 WO 2023036338A1
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WIPO (PCT)
Prior art keywords
port
syringe
injector
pressure
accessories
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PCT/CN2022/118451
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English (en)
French (fr)
Inventor
堀信一
堀笃史
五十岚光夫
五十岚亮莱昂纳多
宫田智治
Original Assignee
临床支持有限公司
科斯米克M.E.公司
阿波罗Rt有限公司
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Publication of WO2023036338A1 publication Critical patent/WO2023036338A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body

Definitions

  • the utility model relates to the technical field of aseptic medical instruments, in particular to a high-pressure radiography syringe and accessories.
  • Contrast agent is one of the most commonly used drugs in interventional radiology operations. It is mainly injected into the human body through a high-pressure contrast injection syringe to display blood vessels and improve the accuracy of diagnosis.
  • the needle barrel of the injector When the traditional high-pressure radiography injector is in use, the needle barrel of the injector is directly connected with the connecting tube for use.
  • the extension tube When the contrast medium in the syringe is insufficient, the extension tube needs to be removed, and a special drug aspirator is used to suck the drug from the medicine bottle or bag into the syringe, then disconnect the drug aspirator and the syringe, and then reconnect the connecting tube. Attached to the syringe. Throughout the operation, the sequence of operations is cumbersome, and the drug is exposed to the air when the aspirator and syringe are disconnected, posing a risk of contamination.
  • the contrast agent when the contrast agent is injected into the human body through the connecting tube through the high-pressure contrast injection syringe, there may be air bubbles in the pipeline because the air is not exhausted when the medicine is sucked or the air enters when the components are connected. As the contrast agent enters the human body, it will cause unnecessary harm to the human body.
  • this utility model is to provide a high-pressure radiography injector and accessories that can perform continuous extraction and injection of contrast medium without repeated disassembly and assembly of the syringe, and can prevent air bubbles from being injected into the human body along with the contrast medium.
  • the utility model provides a high-pressure radiography syringe and accessories, including: a three-way pipeline with a first port, a second port and a third port; a bottle insertion needle inserted into a liquid medicine bottle; A first connecting tube between the bottle needle and the first port; one end is connected to the second port, and the other end is formed with a second connecting tube with an interface; and a syringe comprising a syringe and a rubber stopper, the syringe is connected to the first port Three ports are connected; the first port and the second port respectively have one-way valves arranged in the same direction; the first connecting pipe and the second connecting pipe are respectively provided with air bubble detection devices.
  • the one-way valve includes a valve body with openings on both sides, a top and a flexible valve piece; the top and the flexible valve piece are arranged inside the valve body; The tip is formed into a cone shape, and the middle part of the flexible valve plate abuts against the small-diameter end of the tip. Therefore, the one-way valve can realize conduction in one direction according to the magnitude of the liquid pressure on both sides.
  • the flexible valve plate is made of rubber material.
  • the second connecting pipe is connected to the microcatheter through the interface.
  • the third port and the interface are female Luer connectors; the output port of the syringe and the input port of the microcatheter are male Luer connectors.
  • the luer connector is easy to assemble and disassemble, with reliable performance and good sealing performance. Through the use of the male luer connector and the female luer connector, it helps to facilitate the assembly and disassembly of the entire pipeline of the high-pressure radiography syringe and accessories.
  • the bubble detection device is an ultrasonic bubble sensor. In this way, it is possible to detect the presence of air bubbles in the pipeline.
  • the syringe is connected to the injection head controlled by the control system through the rubber plug. In this way, it is possible to control the work of the injector through the control system.
  • the control system controls the injection head to stop the work of the syringe. This enables the syringe to stop functioning when air bubbles are detected, preventing air bubbles from entering blood vessels of the human body.
  • the utility model has a simple structure, can greatly save operation time and steps and reduce the labor intensity of the user, can effectively avoid the risk of misoperation and the risk of pollution caused by exposure of the contrast agent to the air, and can also prevent air bubbles from entering the human body with the contrast agent. cause unnecessary harm to patients.
  • Fig. 1 is a schematic structural view of a high-pressure radiography injector and accessories according to an embodiment of the present invention
  • Fig. 2 is a structural schematic diagram of the high-pressure radiography injector and the three-way pipeline in the accessories shown in Fig. 1;
  • Fig. 3 is the structural representation of the one-way valve in the three-way pipeline shown in Fig. 2;
  • a high-pressure radiography injector and accessories that can perform continuous contrast agent extraction and injection without repeated disassembly and assembly of the injector, and can prevent air bubbles from being injected into the human body along with the contrast agent.
  • Fig. 1 is a schematic structural view of a high-pressure radiography injector and accessories according to an embodiment of the present invention.
  • the high-pressure radiography injector and accessories include a three-way pipeline 1, first to third branches connected to the three-way pipeline 1, and various components arranged on these branches.
  • the first branch is composed of the first connecting pipe 21
  • the second branch is composed of the second connecting pipe 22
  • the third branch can be a third connecting pipe not shown, which is used to connect the three-way pipeline 1 with the later-described Syringe 5.
  • the high-pressure radiography injector and its accessories include a three-way pipeline 1, a first connecting pipe 21 as a first branch, a second connecting pipe 22 as a second branch, and a bottle insertion needle 3. , liquid medicine bottle 4 and syringe 5.
  • the three-way pipeline 1 is a flow joint in the high-pressure radiography syringe and its accessories.
  • FIG. 2 is a structural schematic diagram of the three-way pipeline 1 .
  • the three-way pipeline 1 includes a first port 11 , a second port 12 and a third port 13 .
  • the first port 11 is a port on the side of the liquid medicine bottle, and is connected to the liquid medicine bottle 4 through the first connecting tube 21 and the insertion needle 3 .
  • the second port 12 is a microcatheter side port, and is connected to the microcatheter 6 through a second connection tube 22 .
  • the third port 13 is a syringe-side port, which may be a female Luer connector with a locking mechanism.
  • the third connecting tube is omitted, and the syringe 5 is directly connected to the three-way pipeline 1 through the third port 13 .
  • the three-way pipeline 1 is formed into a substantially Y-shaped structure connecting various components of the high-pressure radiography injector and accessories through three ports.
  • FIG. 3 is a schematic structural view of the one-way valve 10 .
  • the one-way valve 10 includes a valve body 100 , a tip 110 and a flexible valve plate 120 .
  • the valve body 100 is the housing of a one-way valve, including a first valve cover 101 (ie, left side opening) with a first opening (ie, left side opening) and a second valve cover 101 with a second opening (ie, right side opening).
  • Cover 102 ie right side valve cover.
  • Inside the valve body 100 is formed a cavity formed by the abutment of the first valve cover and the second valve cover, and a top 110 and a flexible valve piece 120 are arranged in the cavity.
  • the apex 110 is formed in an umbrella shape, and is provided on the first valve cover 101 in a manner that its diameter gradually decreases from the first opening toward the second opening.
  • the apex 110 has a large-diameter end, a small-diameter end, and a slope connecting the two face, and is arranged on the first valve cover 101 so that the contrast medium can flow from the vicinity of the large-diameter end to the first opening, and the small-diameter end faces the second opening.
  • the flexible valve sheet 120 can be a soft rubber sheet that can be deformed under the action of liquid pressure.
  • the flexible valve sheet 120 is formed to have a larger diameter than the second opening, and is arranged such that one side surface abuts against the small diameter end of the tip 110, The other side surface covers the second opening.
  • the liquid pressure presses the flexible valve plate 120 against the second opening, so that the second opening blocked, preventing the flow of contrast medium.
  • the flexible valve plate 120 bends toward the tip 110 to form an umbrella under the action of the liquid pressure difference. Shape, so that the contrast agent can pass through the gap flowing out from the periphery of the flexible valve plate 120, so as to achieve the effect of conduction.
  • two one-way valves 10 are arranged on the first port 11 and the second port 12 in the same direction.
  • the one-way valve 10 on the first port 11 is set in such a manner that the first opening faces the third port 13 of the three-way pipeline 1 , and the second opening faces the first connecting pipe 21 .
  • the one-way valve 10 on the second port 12 is set with a first opening facing the second connecting pipe 22 and a second opening facing the third port 13 of the three-way pipeline 1 .
  • the bottle insertion needle 3 is located at the tip end of the first connecting pipe 21 , that is, the end far away from the three-way pipeline 1 .
  • the bottle insertion needle 3 includes a puncture needle for piercing into the liquid medicine bottle 10 and a base located at the end of the puncture needle, and a flow channel for the contrast agent to flow is formed in the puncture needle.
  • an air vent is provided on the casing to prevent a vacuum state from being formed in the liquid medicine bottle 4 when the contrast agent is extracted.
  • the liquid medicine bottle 4 is a liquid medicine container, and a contrast medium is contained therein.
  • the bottle insertion needle 1 is inserted through the bottle cap of the liquid medicine bottle 4 through the puncture needle, and the contrast agent in the liquid medicine bottle 4 is introduced into the first connecting tube 21 .
  • an interface 221 is provided on the tip end of the second connecting pipe 22 , that is, on the end away from the tee line 1 .
  • the interface 221 adopts a female Luer connector, which is sealed by combining with the microcatheter 6 whose inlet port is formed as a male Luer connector.
  • the interface 221 is not limited thereto, and may also be formed into other structures capable of sealing connection with the microcatheter 6 .
  • the microcatheter 6 is connected to the patient, and is used for injecting the contrast medium flowing out from the second connecting tube 22 into the patient's body.
  • a syringe 5 is connected to the third port 13 of the three-way pipeline 1 .
  • the injector 5 is mainly used to extract the contrast agent from the liquid medicine bottle 4 through the first connecting tube 21 , and inject the contrast agent to the patient through the second connecting tube 22 and the microcatheter 6 .
  • the syringe 5 may include a syringe 51 and a rubber stopper 52 .
  • the tip of the syringe 51 is formed with a syringe interface (the output port of the injection) as a liquid output port.
  • the female Luer connector formed on the upper body is sealed and connected by a locking mechanism, but the structure of the syringe interface is not limited to this, and other types of connection mechanisms such as common connectors and quick-plug connectors can also be used.
  • the rubber stopper 52 can be connected with an injection head (not shown) controlled by a control system, and the piston moves in the syringe 51 under the drive of the injection head.
  • the injection head may include a servo motor and a screw rod, and the rotation of the servo motor is converted into linear motion under the drive of the control system.
  • the three-way pipeline 1 is provided with a one-way check valve 10 on the first port 11 and the second port 12 . Therefore, as shown in FIGS. 1 to 3 , when the contrast medium in the syringe 5 is exhausted and it is desired to draw the contrast medium into the syringe 51 , the rubber stopper 52 is operated to retreat, and the pressure in the syringe 51 decreases. At this time, in the one-way valve 10 on the first port 11, the liquid pressure at the first opening is lower than the liquid pressure at the second opening, so the flexible valve plate 120 moves toward the first opening under the action of the liquid pressure difference.
  • the side is bent into an umbrella shape, the second opening is connected, and the contrast medium is sucked into the syringe 5 from the liquid medicine bottle 4 through the first connecting tube 21 and the one-way valve 10 along the drug suction direction as shown by the arrow A in FIG. 1 .
  • the flexible valve plate 120 closes the second opening under the action of liquid pressure, and the contrast agent Cannot circulate here.
  • the rubber stopper 52 is operated to advance, and the pressure in the syringe 51 increases.
  • the liquid pressure at the first opening is higher than the liquid pressure at the second opening, so the flexible valve plate 120 closes the second opening under the action of the liquid pressure, and the contrast agent Cannot circulate here.
  • the one-way valve 10 on the second port 12 since the liquid pressure at the first opening is lower than the liquid pressure at the second opening, the flexible valve plate 120 moves toward the first opening side under the action of the liquid pressure difference.
  • the second opening is connected, and the contrast agent is injected into the patient's body from the syringe 5 through the second connecting tube 22 and the microcatheter 6 along the drug delivery direction as shown by the arrow B in FIG. 1 .
  • the first connecting pipe 21 and the second connecting pipe 22 are respectively provided with air bubble detection devices 210 and 220 for detecting whether there are air bubbles in the flow path.
  • Ultrasonic waves receive feedback echoes. Since the echoes reflected in different media (especially liquid and air) are different, it is determined that there are air bubbles flowing in the pipeline when changes in the echo signal are detected.
  • the air bubble detection device 210 is disposed between the first port 11 and the insertion needle 3 , and is used to detect whether the contrast medium circulating through the first connecting tube 21 contains air bubbles.
  • the air bubble detection device 220 is disposed between the second port 12 and the interface 221 , and is used to detect whether the contrast medium flowing through the second connecting tube 22 contains air bubbles.
  • the air bubble detection device 210 and/or the air bubble detection device 220 When the air bubble detection device 210 and/or the air bubble detection device 220 detects air bubbles, it will send a signal to the control system, and the control system will stop the injection head after receiving the signal and give an alarm. Therefore, when air bubbles are detected, the function of the syringe 5 can be stopped, preventing the air bubbles from entering the blood vessels of the human body.
  • the syringe 5 When the utility model is in use, firstly, the syringe 5 is installed on the injection head, and the injection head is operated to draw contrast agent to the syringe 5 and remove air. Then as shown in Figure 1, the liquid medicine bottle 4 is connected to the first port 11 of the three-way pipeline 1 through the first connecting tube 21, the second connecting tube 22 is connected to the second port 12, and the syringe 5 is directly connected to the third port. Port 13, and air bubble monitoring devices are provided on the first connecting pipe 21 and the second connecting pipe 22 respectively. After removing the air in the pipeline, connect the microcatheter 6 to the interface 221 of the second connecting pipe 22 and also remove the air in the pipeline.
  • the injection head operates to control the injector 5 to inject the contrast agent into the patient, and control the injector 5 to extract the contrast agent from the liquid medicine bottle 4 when the contrast agent is exhausted, and repeat until the operation is completed.
  • the microcatheter 6 , the second connecting tube 22 , the syringe 5 , the liquid medicine bottle 4 , the first connecting tube 21 and the three-way pipeline 1 are sequentially removed.
  • contrast agent is taken as an example above for description, but the present invention is not limited to injection of contrast agent, and can also be used for injection of various other medicinal liquids.
  • the contrast agent is always delivered in a closed pipeline, which can effectively avoid the risk of contamination caused by exposure of the contrast agent to the air;
  • the syringe By installing the air bubble monitoring device, the syringe can be stopped immediately when air bubbles are detected in the pipeline, thereby preventing the air bubbles from entering the human body with the contrast agent and causing unnecessary damage to the human body.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

一种高压造影注射器及附件，包括：具有第一端口（11）、第二端口（12）和第三端口（13）的三通管路（1）；插入药液瓶（4）的插瓶针（3）；连接插瓶针（3）与第一端口（11）的第一连接管（21）；一端连接第二端口（12），另一端形成有接口（221）的第二连接管（22）；以及包括针筒（51）和胶塞（52）的注射器（5），注射器（5）与第三端口（13）连接；第一端口（11）与第二端口（12）分别具有同向设置的单向阀（10）；第一连接管（21）和第二连接管（22）上分别设置有气泡检测装置（210，220）。该高压造影注射器及附件结构简单，能大大节省操作时间和步骤且减轻用户的劳动强度，能有效避免发生误操作的风险和造影剂暴露在空气中造成污染的风险，还能防止气泡随造影剂进入人体而对患者造成不必要的伤害。

Description

一种高压造影注射器及附件 技术领域
本实用新型涉及无菌医疗器械技术领域，尤其涉及一种高压造影注射器及附件。
背景技术
造影剂是介入放射学操作中最常使用的药物之一，主要通过高压造影注射器注入人体，用于血管的显示，提高诊断的准确性。
传统的高压造影注射器在使用时，注射器的针筒直接与连接管连接使用。当针筒内造影剂不足时，需要去除延长管路，使用专用的吸药器从药瓶或袋式包装中将药剂吸入注射器，然后断开吸药器和注射器的连接，再重新将连接管接到注射器上。在整个操作过程中，操作顺序麻烦，且在断开吸药器和注射器连接时药剂会暴露于空气中从而带来污染的风险。
另一方面，通过高压造影注射器通过连接管向人体注入造影剂时，管路中可能会因为在吸药时未排尽空气或是各构件连接时跑入空气等原因而存在气泡，这些气泡如果随着造影剂进入人体，会对人体造成不必要的伤害。
实用新型内容
实用新型要解决的问题：
针对上述问题，本实用新型的目的在于提供一种无需反复拆装注射器就能进行连续的造影剂抽取和注射，且能防止气泡随造影剂注入人体的高压造影注射器及附件。
解决问题的技术手段：
为解决上述问题，本实用新型提供一种高压造影注射器及附件，包括：具有第一端口、第二端口和第三端口的三通管路；插入药液瓶的插瓶针；连接所述插瓶针与所述第一端口的第一连接管；一端连接所述第二端口，另一端形成有接口的第二连接管；以及包括针筒和胶塞的注射器，所述注射器与所述第三端口连接；所述第一端口与所述第二端口分别具有同向设置的单向阀；所述第一连接管和所述第二连接管上分别设置有气泡检测装置。
根据本实用新型，在同向设置的两个单向阀的共同作用下，在注射器的任何一个动作中，能始终确保两个单向阀中仅有一个导通，能实现药液在抽吸和注射不同阶段的自动控制。因此，无需反复从管路上拆装注射器就能在一次手术中进行连续的造影剂抽取和注射，能避免发生误操作的风险和造影剂暴露在空气中造成污染的风险。同时，还能通过气泡检测装置实时检测管路中是否存在气泡。
也可以是，本实用新型中，所述单向阀包括两侧开口的阀体、顶尖和挠性阀片；所 述顶尖和所述挠性阀片设置于所述阀体的内部；所述顶尖形成为锥状，所述挠性阀片的中部抵接于所述顶尖的小径端。由此单向阀能根据两侧液体压力的大小实现单一方向的导通。
也可以是，本实用新型中，所述挠性阀片由橡胶材料构成。
也可以是，本实用新型中，所述第二连接管通过所述接口连接微导管。
也可以是，本实用新型中，所述第三端口及所述接口为母鲁尔接头；所述注射器的输出口及所述微导管的输入口为公鲁尔接头。鲁尔接头装卸方便、性能可靠且密封性良好，通过公鲁尔接头与母鲁尔接头的配合使用，有助于方便组装和拆卸高压造影注射器及附件的整个管路。
也可以是，本实用新型中，所述气泡检测装置是超声波气泡传感器。由此能检测管路中是否存在气泡。
也可以是，本实用新型中，所述注射器通过所述胶塞连接由控制系统控制的注射头。由此能通过控制系统实现控制注射器的工作。
也可以是，本实用新型中，所述气泡检测装置在检测到气泡时，所述控制系统控制所述注射头停止所述注射器的工作。由此能在检测到气泡时使注射器停止功能，防止气泡进入人体血管。
实用新型效果：
本实用新型结构简单，能大大节省操作时间和步骤且减轻用户的劳动强度，能有效避免发生误操作的风险和造影剂暴露在空气中造成污染的风险，还能防止气泡随造影剂进入人体而对患者造成不必要的伤害。
附图说明
图1是根据本实用新型一实施形态的高压造影注射器及附件的结构示意图；
图2是图1所示高压造影注射器及附件中的三通管路的结构示意图；
图3是图2所示三通管路中的单向阀的结构示意图；
符号说明：
1、三通管路；10、单向阀；100、阀体；101、第一阀盖；102、第二阀盖；110、顶尖；120、挠性阀片；11、第一端口；12、第二端口；13、第三端口；21、第一连接管(第一支路)；22、第二连接管(第二支路)；210、220、气泡检测装置；221、接口(微导管接口)；3、插瓶针；4、药液瓶；5、注射器；51、针筒；52、胶塞；6、微导管；A、吸药方向；B、出药方向。
具体实施方式
以下结合附图和下述实施方式进一步说明本实用新型，应理解，附图和下述实施方式仅用于说明本实用新型，而非限制本实用新型。
在此公开一种无需反复拆装注射器就能进行连续的造影剂抽取和注射，且能防止气泡随造影剂注入人体的高压造影注射器及附件。
图1是根据本实用新型一实施形态的高压造影注射器及附件的结构示意图。高压造影注射器及附件包括三通管路1、与该三通管路1连接的第一至第三支路、以及设置在这些支路上的各组件。其中第一支路由第一连接管21构成，第二支路由第二连接管22构成，第三支路可以是未图示的第三连接管，用于衔接三通管路1与后述的注射器5。
具体而言，如图1所示，高压造影注射器及附件包括三通管路1、作为第一支路的第一连接管21、作为第二支路的第二连接管22、插瓶针3、药液瓶4以及注射器5。
三通管路1是高压造影注射器及附件中的流路接头。图2是三通管路1的结构示意图。如图2所示，三通管路1包括第一端口11、第二端口12和第三端口13。其中第一端口11为药液瓶侧端口，通过第一连接管21和插瓶针3连接药液瓶4。第二端口12为微导管侧端口，通过第二连接管22连接微导管6。第三端口13为注射器侧端口，其可以是具有锁定机构的母鲁尔接头，本实施形态中省略了第三连接管，注射器5直接通过第三端口13连接三通管路1。由此，三通管路1形成为通过三个端口衔接高压造影注射器及附件中的各个组件的大致Y字状的结构。
[单向阀的结构]
在第一端口11和第二端口12上还分别设置有单向阀10。图3是单向阀10的结构示意图。如图3所示，单向阀10包括阀体100、顶尖110和挠性阀片120。阀体100是单向阀的壳体，包括具有第一开口(即左侧开口)的第一阀盖101(即左侧阀盖)和具有第二开口(即右侧开口)的第二阀盖102(即右侧阀盖)。在阀体100的内部形成有由第一阀盖与第二阀盖彼此对接而成的空腔，在空腔中设置有顶尖110和挠性阀片120。
顶尖110形成为伞状，以随着从第一开口向着第二开口而直径逐渐减小的形式设置于第一阀盖101，换言之，顶尖110具有大径端、小径端以及连接两者的倾斜面，且以可从大径端附近向第一开口流通造影剂的形式设置于第一阀盖101，小径端则朝向第二开口。
挠性阀片120可以是能在液体压力的作用下发生变形的软橡胶片，挠性阀片120形成为比第二开口大径，且设置为一侧表面与顶尖110的小径端抵接、另一侧表面覆盖第二开口。
由此，当第一开口侧的压力大于第二开口侧时，即造影剂要从第一开口流向第二开 口时，液体压力将挠性阀片120压在第二开口处，使得第二开口被堵住，从而无法流通造影剂。反之，当第二开口侧的压力大于第一开口侧时，即造影剂要从第二开口流向第一开口时，挠性阀片120在液体压差的作用下向顶尖110一侧弯曲成伞状，由此造影剂可以从挠性阀片120周边流出的空隙通过，从而达到导通的效果。
本实施形态中，两个单向阀10在第一端口11和第二端口12上同向设置。具体而言，第一端口11上的单向阀10以第一开口朝向三通管路1的第三端口13，第二开口朝向第一连接管21的形式进行设置。第二端口12上的单向阀10以第一开口朝向第二连接管22、第二开口朝向三通管路1的第三端口13的形式进行设置。
又如图1所示，在第一支路上，插瓶针3位于第一连接管21的梢端、即远离三通管路1的一端。插瓶针3包括用于刺入药液瓶10的穿刺针和位于穿刺针的末端的基座，穿刺针内形成有供造影剂流通的流道。此外，在壳体上设有透气口，能防止抽取造影剂时在药液瓶4中形成真空状态。药液瓶4是药液的容器，内部容纳有造影剂。插瓶针1通过穿刺针插通药液瓶4的瓶盖，将药液瓶4中的造影剂引入第一连接管21。
在第二支路上，在第二连接管22的梢端、即远离三通管路1的一端上设有接口221。接口221采用母鲁尔接头，通过与输入口形成为公鲁尔接头的微导管6结合从而密封连接。但接口221不限于此，也可以形成为其他能与微导管6密封连接的结构。微导管6与患者连接，用于将从第二连接管22流出的造影剂输入患者体内。
在三通管路1的第三端口13上连接有注射器5。注射器5主要用于通过第一连接管21从药液瓶4抽取造影剂，通过第二连接管22和微导管6向患者注射造影剂。本实施形态中，注射器5可以包括针筒51和胶塞52。在针筒51的梢端形成有作为液体输出端的注射器接口(注射剂的输出口)，本实施形态中，该注射器接口可以形成为公鲁尔接头，与在三通管路1的第三端口13上形成的母鲁尔接头通过锁定机构密封连接，但注射器接口的结构不限于此，也可以是普通接头、快速插拔接头等其他类型的连接机构。胶塞52可以与由控制系统控制的注射头(未图示)连接，在注射头的带动下在针筒51中进行活塞运动。注射头可以包括伺服马达和丝杆，并在控制系统的驱动下将伺服马达的转动转化为直线运动。
如上所述，三通管路1在第一端口11和第二端口12上设置有同向的单向阀10。因此，如图1至图3所示，在例如注射器5中的造影剂用尽而希望向针筒51内抽入造影剂时，操作胶塞52后退，针筒51内的压强降低。此时，在第一端口11上的单向阀10中，第一开口处的液体压强小于第二开口处的液体压强，因此挠性阀片120在液体压差的作用下向第一开口一侧弯曲成伞状，第二开口导通，造影剂如图1中的箭头A所示沿着吸药方向从 药液瓶4经第一连接管21和单向阀10而吸入注射器5。而在第二端口12上的单向阀10中，由于第一开口处的液体压强大于第二开口处的液体压强，因此挠性阀片120在液体压力的作用下封闭第二开口，造影剂在此无法流通。
另一方面，在例如注射器5中容纳有造影剂且需要向患者进行注射时，操作胶塞52前进，针筒51内的压强增大。此时，在第一端口11上的单向阀中，第一开口处的液体压强大于第二开口处的液体压强，因此挠性阀片120在液体压力的作用下封闭第二开口，造影剂在此无法流通。而在第二端口12上的单向阀10中，由于第一开口处的液体压强小于第二开口处的液体压强，因此挠性阀片120在液体压差的作用下向第一开口一侧弯曲成伞状，第二开口导通，造影剂如图1中的箭头B所示沿着出药方向从注射器5经第二连接管22和微导管6而注入患者体内。
像这样，在本实用新型中，在注射器5的胶塞52后退时，第一端口11上的单向阀10导通而第二端口12上的单向阀10关闭，造影剂被吸入注射器5且患者血液不会被吸入针筒。而在注射器5的胶塞52前进时，第一端口11上的单向阀10关闭而第二端口12上的单向阀10导通，注射器5向患者注射造影剂且无法从药液瓶吸入造影剂。换言之，在同向设置于第一端口11和第二端口12上的两个单向阀10的共同作用下，在注射器5的任何一个动作中，能始终确保两个单向阀10中仅有一个导通，因此可实现药液在抽吸和注射不同阶段的自动控制。
[气泡检测]
本实施形态中，在第一连接管21和第二连接管22上还分别设置有用于检测流路中是否存在气泡的气泡检测装置210和220，它们可以是超声波气泡传感器，向管路中发射超声波并接受反馈的回声，由于在不同的介质(特别是液体和空气)中反射的回声不同，因此当检测到回声信号出现变化时判定管路中有气泡流过。具体而言，气泡检测装置210设置于第一端口11与插瓶针3之间，用于检测流通于第一连接管21的造影剂中是否含有气泡。气泡检测装置220设置于第二端口12与接口221之间，用于检测流通于第二连接管22的造影剂中是否含有气泡。当气泡检测装置210和/或气泡检测装置220发现气泡时，会向控制系统发送信号，控制系统在接到信号后会停止注射头的工作，并且予以警报。由此能在检测到气泡时使注射器5停止功能，防止气泡进入人体血管。
本实用新型在使用时，首先将注射器5安装在注射头上，通过操作注射头来向注射器5吸取造影剂并排除空气。接着如图1所示将药液瓶4通过第一连接管21连接三通管路1的第一端口11，将第二连接管22连接至第二端口12，将注射器5直接连接至第三端口 13，并分别在第一连接管21和第二连接管22上设置气泡监测装置。在将管路中的空气排除后，将微导管6连接至第二连接管22的接口221并同样排除管路中的空气。之后操作注射头控制注射器5向患者注射造影剂，并在造影剂用尽时控制注射器5从药液瓶4抽取造影剂，如此重复直至手术完成。在手术完成后，依次移除微导管6、第二连接管22、注射器5、药液瓶4、第一连接管21以及三通管路1。
以上以造影剂为例进行了说明，但本实用新型不限于注射造影剂，也可以用于注射其他各种药液。
本实用新型具有以下优点：
1)无需反复从管路上拆装注射器就能在一次手术中进行连续的造影剂抽取和注射，能大大节省操作时间和步骤，减轻了用户的劳动强度，能有效避免发生误操作的风险；
2)造影剂始终在密闭管路中传递，能有效避免造影剂暴露在空气中造成污染的风险；
3)通过安装气泡监测装置，能在检测到管路中存在气泡时立刻使注射器停止工作，从而能防止气泡随造影剂进入人体，对人体造成不必要的伤害。
以上的具体实施方式对本实用新型的目的、技术方案和有益效果进行了进一步详细说明，应当理解的是，以上仅为本实用新型的一种具体实施方式而已，并不限于本实用新型的保护范围，在不脱离本实用新型的基本特征的宗旨下，本实用新型可体现为多种形式，因此本实用新型中的实施形态是用于说明而非限制，由于本实用新型的范围由权利要求限定而非由说明书限定，而且落在权利要求界定的范围，或其界定的范围的等价范围内的所有变化都应理解为包括在权利要求书中。凡在本实用新型的精神和原则之内的，所做出的任何修改、等同替换、改进等，均应包含在本实用新型的保护范围之内。

Claims (8)

  1. 一种高压造影注射器及附件，其特征在于，
    包括：
    具有第一端口、第二端口和第三端口的三通管路；
    插入药液瓶的插瓶针；
    连接所述插瓶针与所述第一端口的第一连接管；
    一端连接所述第二端口，另一端形成有接口的第二连接管；以及
    包括针筒和胶塞的注射器，所述注射器与所述第三端口连接；
    所述第一端口与所述第二端口分别具有同向设置的单向阀；
    所述第一连接管和所述第二连接管上分别设置有气泡检测装置。
  2. 根据权利要求1所述的高压造影注射器及附件，其特征在于，
    所述单向阀包括两侧开口的阀体、顶尖和挠性阀片；
    所述顶尖和所述挠性阀片设置于所述阀体的内部；
    所述顶尖形成为锥状，所述挠性阀片的中部抵接于所述顶尖的小径端。
  3. 根据权利要求2所述的高压造影注射器及附件，其特征在于，
    所述挠性阀片由橡胶材料构成。
  4. 根据权利要求1所述的高压造影注射器及附件，其特征在于，
    所述第二连接管通过所述接口连接微导管。
  5. 根据权利要求4所述的高压造影注射器及附件，其特征在于，
    所述第三端口及所述接口为母鲁尔接头；
    所述注射器的输出口及所述微导管的输入口为公鲁尔接头。
  6. 根据权利要求1所述的高压造影注射器及附件，其特征在于，
    所述气泡检测装置是超声波气泡传感器。
  7. 根据权利要求1所述的高压造影注射器及附件，其特征在于，
    所述注射器通过所述胶塞连接由控制系统控制的注射头。
  8. 根据权利要求1至7中任一项所述的高压造影注射器及附件，其特征在于，
    所述气泡检测装置在检测到气泡时，所述控制系统控制所述注射头停止所述注射器的工作。
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