CN114425125A

Movatterモバイル変換

Info

Publication number: CN114425125A
Application number: CN202011103447.3A
Authority: CN
Inventors: 宋雷
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2020-10-15
Filing date: 2020-10-15
Publication date: 2022-05-03

Abstract

The invention relates to a bubble detector for an interventional catheter and a vascular interventional therapy system. Specifically, the present invention provides a vascular interventional therapy system, comprising: monitoring a terminal; an interventional catheter; a syringe for delivering fluid through the interventional catheter; and the bubble detector, the bubble detector sets up intervene in the pipe and with monitor terminal connects, the bubble detector includes the body, the body includes input, output and communication end, and the bubble detector is right this is internal the input with fluid between the output carries out the bubble detection, the communication end with monitor terminal communicates.

Description

Translated fromChinese

用于介入导管的气泡探测器和血管介入治疗系统Air Bubble Detector and Vascular Interventional Therapy System for Interventional Catheters

技术领域technical field

本发明涉及血管介入治疗领域。更具体地，本发明涉及用于介入导管的气泡探测器和血管介入治疗系统。The present invention relates to the field of vascular interventional therapy. More particularly, the present invention relates to air bubble detectors and vascular interventional therapy systems for interventional catheters.

背景技术Background technique

本节中的内容仅提供涉及本发明的背景信息，其可能构成或可能不构成现有技术。The statements in this section merely provide background information related to the present disclosure, which may or may not constitute prior art.

血管介入治疗技术是相对于外科手术而言无需开刀也无需全身麻醉的一种导管技术。血管介入治疗技术利用介入导管经过血管的管腔到达体内远端的待治疗部位，并且通过给药或放置医疗器械的方式对体内远端的待治疗部位进行诊断和治疗。例如，操作者（又称为术者，如医生或医护人员）可以借助X光将不透光的医疗器械送达血管病变部位从而对病变进行治疗。很多疾病都可以通过血管介入治疗技术进行诊断和治疗，如冠心病、外周血管疾病、先天性心脏病、瓣膜疾病及心律失常疾病等。Vascular interventional therapy is a catheter technology that does not require surgery or general anesthesia compared to surgery. Vascular interventional therapy uses an interventional catheter through the lumen of the blood vessel to reach the site to be treated at the distal end of the body, and diagnoses and treats the site to be treated at the distal end of the body by means of drug administration or placement of medical devices. For example, an operator (also known as a surgeon, such as a doctor or medical staff) can use X-rays to deliver opaque medical devices to a vascular lesion to treat the lesion. Many diseases can be diagnosed and treated by vascular interventional technology, such as coronary heart disease, peripheral vascular disease, congenital heart disease, valve disease and arrhythmia disease.

血管介入治疗技术可以应用于血管成形术，血管造影术，血栓清除术等医疗领域。血管介入治疗技术的优点在于对患者的创伤低，减轻了患者的痛苦（例如心血管介入治疗无需对患者开胸），伤口容易愈合,治疗风险低，治疗费用低等优点。Vascular interventional therapy technology can be applied to medical fields such as angioplasty, angiography, and thrombectomy. The advantages of vascular interventional therapy are that the trauma to the patient is low, the pain of the patient is reduced (for example, there is no need to open the patient's chest for cardiovascular interventional therapy), the wound is easy to heal, the treatment risk is low, and the treatment cost is low.

血管介入治疗技术可以借助于医学成像技术，如使用末端连接有超声探针、光学探针的特殊导管进行的血管内成像技术。Vascular intervention techniques can be performed with the help of medical imaging techniques, such as intravascular imaging techniques using special catheters with ultrasound probes and optical probes attached to the ends.

举例而言，作为血管介入治疗技术的一个分支，心血管介入治疗用于诊断和治疗有关心血管的疾病。心血管介入治疗在医学成像技术以及其他医疗器械的辅助下，将介入导管刺穿体表的血管并送到需要进行治疗的位置以对有关心血管的疾病进行诊断和治疗。For example, as a branch of vascular interventional therapy technology, cardiovascular interventional therapy is used to diagnose and treat cardiovascular-related diseases. Cardiovascular interventional therapy, with the help of medical imaging technology and other medical devices, pierces the blood vessels on the body surface and sends the interventional catheter to the location where treatment is needed to diagnose and treat cardiovascular diseases.

血管介入治疗技术需要使用介入导管，如血管造影术介入导管、血管成形术介入导管、药物输送介入导管等。介入导管一般具有良好的血液相容性、良好的润滑性、良好的机械性能和抗扭结性、良好的可加工性、材料无毒无害性等特点。Vascular interventional therapy techniques require the use of interventional catheters, such as angiography interventional catheters, angioplasty interventional catheters, and drug delivery interventional catheters. Interventional catheters generally have the characteristics of good blood compatibility, good lubricity, good mechanical properties and kink resistance, good processability, and non-toxic and harmless materials.

在血管介入治疗技术中使用介入导管的目的是建立通道，从而把医疗器械（如导丝、支架、球囊等等）或药物通过该通道送到目标器官。举例而言，冠心病是由于动脉粥样硬化导致冠状动脉管腔狭窄使心肌供血不足而引发的一系列临床病症（常见症状有心绞痛、心肌梗死、心力衰竭、心律失常和猝死）。对于冠心病的治疗可以通过介入导管将医疗器械或药物送到冠状动脉。The purpose of using an interventional catheter in vascular interventional therapy is to establish a channel through which medical devices (such as guidewires, stents, balloons, etc.) or drugs are delivered to the target organ. For example, coronary heart disease is a series of clinical conditions (common symptoms are angina pectoris, myocardial infarction, heart failure, arrhythmia and sudden death) caused by atherosclerosis leading to stenosis of the coronary lumen and insufficient blood supply to the heart muscle. For the treatment of coronary heart disease, medical devices or drugs can be delivered to the coronary arteries through an interventional catheter.

在血管介入治疗过程中，必须排空介入导管内的气泡（空气或其他气体），因为进入人体内的空气会引起严重的栓塞并发症，严重时甚至会危及生命，因此排空介入导管内的气泡是血管介入治疗操作过程中必需的步骤。以冠心病的介入治疗为例，在通过介入导管将医疗器械或药物送到冠状动脉的过程中，为了让目标血管显影，操作者（如医生或医护人员）可以从导管末端推注造影剂。这个过程需要进行排气，因为如果把气泡推送进去就会造成空气栓塞，严重的情况下甚至会导致患者有生命危险。在治疗过程中，介入导管里充满血液，或者造影剂、生理盐水和血液的混合，但是不能存在气体。During vascular interventional therapy, air bubbles (air or other gases) in the interventional catheter must be evacuated, because the air entering the human body can cause serious embolic complications, even life-threatening in severe cases. Air bubbles are a necessary step during vascular interventional procedures. Taking the interventional treatment of coronary heart disease as an example, in the process of delivering medical devices or drugs to the coronary artery through an interventional catheter, in order to visualize the target blood vessel, the operator (such as a doctor or medical staff) can inject a contrast agent from the end of the catheter. This process requires venting, because if the air bubbles are pushed in, it will cause an air embolism, which can even lead to life-threatening patients in severe cases. During treatment, the interventional catheter is filled with blood, or a mixture of contrast, saline, and blood, but no gas can be present.

虽然在介入导管的操作开始之前要进行排气，但是在后续程序中，如医疗器械进出或经介入导管给药的过程中，有时候由于负压的存在会把少量空气吸入介入导管，而即使是很小的气泡被推进血管（尤其是冠状动脉）也会造成危险。在现有技术中，只能依赖操作者自身格外小心地进行操作，并且要求操作者必须时刻仔细观察介入导管以判断介入导管内是否存在气泡。因此，现有技术的方法和设备对操作者（如医生或医护人员）要求极高，并且容易造成操作者视觉和精神上的疲劳，从而影响手术操作。另外，现有技术中存在以下缺点：人眼观察存在视觉盲区、检查精度低、对操作者的业务能力要求很高（例如缺乏经验的操作者有时难以发现气泡或者在操作过程中会无意中带入气泡）。Although venting is performed before the operation of the interventional catheter begins, during subsequent procedures, such as medical device entry and exit or drug delivery through the interventional catheter, sometimes a small amount of air is drawn into the interventional catheter due to the presence of negative pressure, even if It is the very small air bubbles that are pushed into the blood vessels (especially the coronary arteries) that can be dangerous. In the prior art, the operator can only rely on the operator to perform the operation with extreme care, and the operator must always carefully observe the interventional catheter to determine whether there is air bubbles in the interventional catheter. Therefore, the methods and devices of the prior art have extremely high requirements on operators (eg, doctors or medical staff), and are likely to cause visual and mental fatigue of the operators, thereby affecting the surgical operation. In addition, the prior art has the following shortcomings: human eye observation has blind spots, low inspection accuracy, and high requirements on the operator's business ability (for example, inexperienced operators sometimes find it difficult to find air bubbles or inadvertently carry air bubbles during operation. into air bubbles).

而且，即使在治疗过程中格外注意，仍然不可避免地出现一定比例的空气栓塞并发症，这会给患者带来不同程度上的不良后果。在现有技术中，没有用于血管介入治疗技术的气泡探测器和报警装置。Moreover, even with extra care during treatment, a certain percentage of air embolism complications are inevitable, which will bring different degrees of adverse outcomes to patients. In the prior art, there are no air bubble detectors and alarm devices used in vascular interventional therapy techniques.

因此，希望提出一种用于介入导管的气泡探测器和血管介入治疗系统，其能够自动地检测气泡并报警，这样即使是缺乏经验的操作者也能正常使用。Therefore, it is desirable to propose an air bubble detector for an interventional catheter and a vascular interventional therapy system, which can automatically detect air bubbles and give an alarm, so that even inexperienced operators can use them normally.

发明内容SUMMARY OF THE INVENTION

通过所提供的描述将更明显看到本发明更多的适用领域。应当理解，本部分的描述和特定例子仅用于说明，并不限制本发明的范围。Further areas of applicability of the present invention will become apparent from the description provided. It should be understood that the description and specific examples in this section are intended for illustration only and do not limit the scope of the invention.

根据本发明的用于介入导管的气泡探测器和血管介入治疗系统解决了现有技术中的缺陷。The bubble detector for an interventional catheter and a vascular interventional therapy system according to the present invention solves the deficiencies in the prior art.

根据本发明的优选实施例，提供了一种血管介入治疗系统，其包括：监测终端；介入导管；注射器，其用于通过所述介入导管输送流体；和气泡探测器，所述气泡探测器设置在所述介入导管中并且与所述监测终端连接，所述气泡探测器包括本体，所述本体包括输入端、输出端和通信端，气泡探测器对在所述本体内的所述输入端和所述输出端之间的流体进行气泡探测，所述通信端与所述监测终端连通。According to a preferred embodiment of the present invention, there is provided a vascular interventional therapy system comprising: a monitoring terminal; an interventional catheter; a syringe for delivering fluid through the interventional catheter; and a bubble detector provided with In the interventional catheter and connected with the monitoring terminal, the air bubble detector includes a body, the body includes an input end, an output end and a communication end, and the air bubble detector couples the input end and the communication end in the body. The fluid between the output ends is subjected to bubble detection, and the communication end is communicated with the monitoring terminal.

根据本发明的优选实施例，在所述气泡检测器和所述注射器之间设置连通板，所述连通器的头端连接到所述气泡探测器，所述连通器的尾端连接到所述注射器，所述连通板具有多个歧管，其中一个歧管与所述监测终端连通用于监测压力。According to a preferred embodiment of the present invention, a communication plate is provided between the air bubble detector and the syringe, the head end of the communication device is connected to the air bubble detector, and the tail end of the communication device is connected to the air bubble detector. In the syringe, the communication plate has a plurality of manifolds, wherein one of the manifolds communicates with the monitoring terminal for monitoring pressure.

根据本发明的优选实施例，所述连通板是四联四通，所述四连四通上分别设置有四个歧管，第一歧管连接压力监测器，第二歧管连接造影剂，第三歧管连接盐水，第四歧管用于排除废料。According to a preferred embodiment of the present invention, the communication plate is a quadruple spool, and the quadruple spools are respectively provided with four manifolds, the first manifold is connected to the pressure monitor, the second manifold is connected to the contrast agent, The third manifold is connected to brine and the fourth manifold is used to remove waste.

根据本发明的优选实施例，所述连通板是三联三通，所述三联三通上分别设置有三个歧管，第一歧管连接压力监测器，第二歧管连接盐水，第三歧管连接造影剂。According to a preferred embodiment of the present invention, the communication plate is a three-way three-way, three manifolds are respectively provided on the three-way three-way, the first manifold is connected to the pressure monitor, the second manifold is connected to the brine, and the third manifold is connected Connect the contrast agent.

根据本发明的优选实施例，在所述气泡探测器和所述连通板之间设置第一止血阀，所述第一止血阀具有三个端口，其中所述第一止血阀的第一端口与气泡探测器连接，所述第一止血阀的第二端口与所述连通板连接，所述第一止血阀的第三端口连接球囊导管用于进出医疗器械。According to a preferred embodiment of the present invention, a first hemostatic valve is provided between the air bubble detector and the communication plate, the first hemostatic valve has three ports, wherein the first port of the first hemostatic valve is connected to the The air bubble detector is connected, the second port of the first hemostatic valve is connected to the communication plate, and the third port of the first hemostatic valve is connected to a balloon catheter for entering and exiting medical instruments.

根据本发明的优选实施例，还包括第二止血阀，所述第二止血阀具有三个端口，其中所述第二止血阀的第一端口通过球囊导管与所述第一止血阀的第三端口连接，所述第二止血阀的第二端口与压力泵连接，医疗器械通过所述第二止血阀的第三端口送入。According to a preferred embodiment of the present invention, a second hemostatic valve is further included, the second hemostatic valve has three ports, wherein the first port of the second hemostatic valve passes through the balloon catheter and the third hemostatic valve of the first hemostatic valve. Three-port connection, the second port of the second hemostatic valve is connected to the pressure pump, and the medical device is fed through the third port of the second hemostatic valve.

根据本发明的优选实施例，所述气泡探测器中具有密闭的探测腔室，用于探测在所述探测腔室内的流体中是否存在气泡，所述探测腔室的一端与所述气泡探测器的输入端连通，用于从输入端的介入导管接收流体，所述探测腔室的另一端与所述气泡探测器的输出端连通，用于向输出端的介入导管输送流体。According to a preferred embodiment of the present invention, the air bubble detector has a closed detection chamber for detecting whether air bubbles exist in the fluid in the detection chamber, and one end of the detection chamber is connected to the air bubble detector. The input end of the detection chamber is communicated with the input end of the input end for receiving fluid from the interventional catheter at the input end, and the other end of the detection chamber is communicated with the output end of the bubble detector for delivering fluid to the interventional catheter at the output end.

根据本发明的优选实施例，所述介入导管从所述气泡探测器的输入端进入，贯穿所述气泡探测器延伸，并从所述气泡探测器的输出端伸出。According to a preferred embodiment of the present invention, the interventional conduit enters from the input end of the bubble detector, extends through the bubble detector, and protrudes from the output end of the bubble detector.

根据本发明的优选实施例，所述气泡探测器包括光源和光传感器，所述光源向所述光传感器发射光线，光路经过介入导管或探测腔室，当不存在气泡时，所述光传感器接收到的光强为阈值；当存在气泡时，所述光传感器接收到的光强大于阈值。According to a preferred embodiment of the present invention, the air bubble detector includes a light source and a light sensor, the light source emits light to the light sensor, and the light path passes through the interventional catheter or the detection chamber. When there is no air bubble, the light sensor receives the light. The light intensity of is the threshold value; when there are bubbles, the light intensity received by the light sensor is greater than the threshold value.

根据本发明的优选实施例，所述气泡探测器包括光源和光传感器，所述光源向所述光传感器发射光线，光路经过介入导管或探测腔室，当不存在气泡时，所述光传感器接收到的透光率为阈值；当存在气泡时，所述光传感器接收到的透光率大于阈值。According to a preferred embodiment of the present invention, the air bubble detector includes a light source and a light sensor, the light source emits light to the light sensor, and the light path passes through the interventional catheter or the detection chamber. When there is no air bubble, the light sensor receives the light. The light transmittance of the light sensor is a threshold value; when there are bubbles, the light transmittance received by the light sensor is greater than the threshold value.

根据本发明的优选实施例，所述气泡探测器包括光源和光传感器，其中来自所述光源的光以一定角度照射进入介入导管或探测腔室并发生折射，当不存在气泡时，经过折射后的光线沿第一方向射出；当存在气泡时，经过折射后的光线沿第二方向射出，第一方向不同于第二方向，其中在第二方向上设置有所述光传感器对光线进行接收。According to a preferred embodiment of the present invention, the bubble detector includes a light source and a light sensor, wherein the light from the light source is irradiated into the interventional catheter or the detection chamber at a certain angle and refracted, and when there is no bubble, the refracted light The light is emitted in a first direction; when there is a bubble, the refracted light is emitted in a second direction, the first direction is different from the second direction, wherein the light sensor is arranged in the second direction to receive the light.

根据本发明的优选实施例，所述气泡探测器具有超声波发射器和超声波接收器，其中所述超声波发射器向所述超声波接收器发射超声波信号，所述超声波信号经过介入导管或探测腔室，当不存在气泡时，所述超声波接收器接收到的超声波信号为阈值；当存在气泡时，所述超声波接收器接收到的超声波信号低于阈值。According to a preferred embodiment of the present invention, the bubble detector has an ultrasonic transmitter and an ultrasonic receiver, wherein the ultrasonic transmitter transmits an ultrasonic signal to the ultrasonic receiver, and the ultrasonic signal passes through an interventional catheter or a detection chamber, When there is no bubble, the ultrasonic signal received by the ultrasonic receiver is a threshold; when there is a bubble, the ultrasonic signal received by the ultrasonic receiver is lower than the threshold.

根据本发明的优选实施例，所述气泡探测器还可以包括截止阀，当探测到气泡存在时，所述监测终端报警并且通信所述气泡探测器以切断截止阀，从而将含有气泡的流体阻截。According to a preferred embodiment of the present invention, the air bubble detector may further include a shut-off valve, and when the existence of air bubbles is detected, the monitoring terminal alarms and communicates with the air bubble detector to cut off the shut-off valve, thereby blocking the fluid containing air bubbles .

根据本发明的优选实施例，提供了一种用于介入导管的气泡探测器，所述气泡探测器设置在所述介入导管中并且与监测终端连接，所述气泡探测器包括本体，所述本体包括输入端、输出端和通信端，气泡探测器对在所述本体内的所述输入端和所述输出端之间的流体进行气泡探测，所述通信端与所述监测终端连通。According to a preferred embodiment of the present invention, a bubble detector for an interventional catheter is provided, the bubble detector is arranged in the interventional catheter and is connected to a monitoring terminal, the bubble detector includes a body, and the body It includes an input end, an output end and a communication end, the air bubble detector detects the air bubbles in the fluid between the input end and the output end in the body, and the communication end is communicated with the monitoring terminal.

附图说明Description of drawings

在此描述的附图仅用于说明的目的，并不旨在以任何方式限制本发明的范围。The drawings described herein are for illustration purposes only and are not intended to limit the scope of the invention in any way.

图1是介入导管室的示意图Figure 1 is a schematic diagram of an interventional catheterization laboratory

图2示出了一种血管介入治疗系统。Figure 2 shows a vascular interventional therapy system.

图3示出了止血阀的透视图。Figure 3 shows a perspective view of the hemostatic valve.

图4示出了一种血管介入治疗系统。Figure 4 shows a vascular interventional therapy system.

图5示出了血管介入治疗系统。Figure 5 shows a vascular interventional therapy system.

图6是气泡探测器的示意图。Figure 6 is a schematic diagram of a bubble detector.

图7是气泡探测器的透视图。Figure 7 is a perspective view of a bubble detector.

图8示出了未组装状态的气泡探测器。Figure 8 shows the bubble detector in an unassembled state.

图9是气泡探测器的一个实施例的示意图。Figure 9 is a schematic diagram of one embodiment of a bubble detector.

图10是气泡探测器的一个实施例的示意图。Figure 10 is a schematic diagram of one embodiment of a bubble detector.

图11以示意图示出了气泡探测器与监测终端的连通。Figure 11 shows a schematic diagram of the communication of the bubble detector with the monitoring terminal.

图12是气泡探测器的一个实施例的示意图。Figure 12 is a schematic diagram of one embodiment of a bubble detector.

图13是气泡探测器的一个实施例的示意图，其中介入导管内没有气泡。Figure 13 is a schematic diagram of one embodiment of a bubble detector wherein no bubbles are present within the interventional catheter.

图14是气泡探测器的一个实施例的示意图，其中介入导管内存在气泡。Figure 14 is a schematic diagram of one embodiment of a bubble detector in which a bubble is present within an interventional catheter.

图15示出了探测腔室的各种截图形状。Figure 15 shows various screenshot shapes of the detection chamber.

图16是气泡探测器的一个实施例的示意图。Figure 16 is a schematic diagram of one embodiment of a bubble detector.

具体实施方式Detailed ways

各变型的下面描述在本质上仅仅是示例性的并且决不意于限制本发明的范围、其应用或用途。The following description of variations is merely exemplary in nature and is in no way intended to limit the scope of the invention, its application, or uses.

图1示意性地示出了介入导管室。如图所示，介入导管室中使用的系统可以分为流体填充部分和电子器件部分，它们由图中的虚线示意性地分开。系统的流体填充部分包括导管系统，其中导管系统可以包括导管（介入导管）和歧管，导管的至少一部分插入患者的体内，例如插入到患者的心脏部位，如图1所示。系统的电子器件部分包括传感器，其与导管相连，接收患者身体参数数据，并将参数数据以电信号的形式输送到带显示器的计算机，参数数据可以通过与计算机连接的打印机被打印输出。Figure 1 schematically shows an interventional catheter lab. As shown, the system used in the interventional catheter lab can be divided into a fluid-filled part and an electronics part, which are schematically separated by a dashed line in the figure. The fluid-filled portion of the system includes a catheter system, which may include a catheter (interventional catheter) and a manifold, at least a portion of which is inserted into the patient's body, eg, into the patient's heart, as shown in FIG. 1 . The electronic part of the system includes a sensor, which is connected to the catheter, receives the patient's body parameter data, and transmits the parameter data in the form of electrical signals to a computer with a display, and the parameter data can be printed out by a printer connected to the computer.

图2示出了一种血管介入治疗系统，其可用于血管介入治疗技术中的囊扩张术、支架置入术以及其他手术。Figure 2 illustrates a vascular interventional system that can be used for balloon dilation, stenting, and other procedures in vascular interventional techniques.

图2的左侧（两个虚线框以外的区域）示出了导丝、球囊、介入导管和动脉鞘。在使用中，动脉鞘置入动脉中，为其他血管介入治疗器械提供通路。动脉鞘可具有自封闭的特点以防止动脉血反流出体外。介入导管通过动脉鞘被送入要治疗的部位处。导丝沿介入导管送入，然后可沿导丝送入球囊。The left side of Figure 2 (the area outside the two dashed boxes) shows the guidewire, balloon, interventional catheter, and arterial sheath. In use, the arterial sheath is placed in the artery to provide access to other vascular interventional devices. The arterial sheath can be self-sealing to prevent arterial blood from flowing back out of the body. The interventional catheter is delivered through the arterial sheath at the site to be treated. The guide wire is advanced along the interventional catheter, and then the balloon can be advanced along the guide wire.

图2的右侧上方虚线框内的区域示出了止血阀、延长管、连通板和注射器。图2中示出的止血阀是呈Y形的止血阀，其又称为Y阀，当然也可以使用其他形式的止血阀。在介入手术治疗中，需要将导丝、介入导管、介入装置等放置在血管中。由于存在血压，血管内的血液可能沿着介入导管行进，并从患者身上流出。设置止血阀可以限制血液流出，并且在发现气泡的情况下可以用于排出气泡。The area within the dashed box on the upper right side of Figure 2 shows the hemostatic valve, extension tube, communication plate and syringe. The hemostatic valve shown in FIG. 2 is a Y-shaped hemostatic valve, which is also called a Y valve. Of course, other forms of hemostatic valves can also be used. In interventional surgery, a guide wire, an interventional catheter, an interventional device, etc. need to be placed in the blood vessel. Due to the presence of blood pressure, blood within the vessel may travel along the interventional catheter and out of the patient. A hemostatic valve is provided to restrict blood outflow and can be used to expel air bubbles if they are found.

参照图3并继续参照图2，图3示出了止血阀的透视图，止血阀100具有三个端口，其中第一端口110与动脉鞘连接，另外在第一端口110与动脉鞘之间也可以设置气泡探测器（图2和3中未示出），这时第一端口连接气泡探测器的输入端，气泡探测器如下详细描述；第二端口120通过延长管与连通板的头端200连接；第三端口130可以连接球囊导管用于进出导丝、球囊、支架等医疗器械。连通板是一种歧管装置，其用作血管介入手术的非侵入性的辅助工具。Referring to Figure 3 and with continued reference to Figure 2, Figure 3 shows a perspective view of a hemostatic valve, thehemostatic valve 100 has three ports, wherein thefirst port 110 is connected to the arterial sheath, and also between thefirst port 110 and the arterial sheath A bubble detector (not shown in Figures 2 and 3) can be provided, at this time the first port is connected to the input end of the bubble detector, which is described in detail below; thesecond port 120 communicates with thehead end 200 of the plate through an extension tube Connection; thethird port 130 can be connected to a balloon catheter for entering and exiting medical devices such as guide wires, balloons, and stents. A communication plate is a manifold device used as a non-invasive aid in vascular interventional procedures.

在图2所示的实施例中，连通板为四联四通，四联四通的头端连接延长管的一端，延长管的另一端连接止血阀的第二端口120。连通板的头端200与止血阀相连，连通板的尾端250与注射器相连。注射器可以是三环注射器，其可用于推注盐水或造影剂等流体。图2所示的四联四通上分别设置有四个歧管，第一歧管210连接动脉压力监测器，第二歧管220连接造影剂，第三歧管230连接盐水，第四歧管240用于排出废料。In the embodiment shown in FIG. 2 , the communication plate is a four-way four-way, the head end of the four-way four-way is connected to one end of the extension tube, and the other end of the extension tube is connected to thesecond port 120 of the hemostatic valve. Thehead end 200 of the communication plate is connected to the hemostatic valve, and thetail end 250 of the communication plate is connected to the syringe. The syringe can be a three-ring syringe, which can be used to bolus fluids such as saline or contrast media. The four-way four-way shown in FIG. 2 is respectively provided with four manifolds, the first manifold 210 is connected to the arterial pressure monitor, thesecond manifold 220 is connected to the contrast agent, the third manifold 230 is connected to the saline, and the fourth manifold 240 is used to discharge waste.

也可以使用其他形式的连通板，如三联三通等。例如，图4示出了用于血管介入治疗系统的三联三通和注射器。三联三通上分别设置有三个歧管，第一歧管410连接压力监测器，第二歧管420连接盐水，第三歧管430连接造影剂。三联三通的头端400连接延长管的一端，延长管的另一端连接止血阀（未示出）的第二端口。注射器可用于推注盐水、造影剂或其他流体，注射器与三联三通的尾端440连接。Other forms of connecting plates, such as triple tee, etc., can also be used. For example, Figure 4 shows a triple tee and injector for a vascular interventional system. Three manifolds are respectively provided on the triple tee, thefirst manifold 410 is connected to the pressure monitor, thesecond manifold 420 is connected to the saline, and thethird manifold 430 is connected to the contrast agent. Thehead end 400 of the three-way three-way is connected to one end of the extension tube, and the other end of the extension tube is connected to the second port of the hemostatic valve (not shown). The syringe can be used for bolus injection of saline, contrast medium or other fluids, and the syringe is connected to thetail end 440 of the triple tee.

返回参照图2，止血阀的第三端口130可以通过球囊导管与另一止血阀300相连。所述另一止血阀300也是Y形止血阀，其具有三个端口，其中另一止血阀300的第一端口310通过球囊导管与止血阀100的第三端口130连接，另一止血阀300的第二端口320通过另一延长管与压力泵连接，导丝等医疗器械可以通过另一止血阀300的第三端口330送入。Referring back to FIG. 2 , thethird port 130 of the hemostatic valve may be connected to anotherhemostatic valve 300 via a balloon catheter. The otherhemostatic valve 300 is also a Y-shaped hemostatic valve, which has three ports, wherein thefirst port 310 of the otherhemostatic valve 300 is connected with thethird port 130 of thehemostatic valve 100 through a balloon catheter, and the otherhemostatic valve 300 Thesecond port 320 of thesecond port 320 is connected to the pressure pump through another extension tube, and medical instruments such as guide wires can be fed through thethird port 330 of anotherhemostatic valve 300 .

在介入治疗手术期间，动脉鞘用于穿刺动脉，如桡动脉或股动脉，介入导管经由动脉鞘被送入患者体内。例如，在利用血管介入治疗技术治疗冠心病的过程中，造影术介入导管进入左或右冠状动脉,推注造影剂进行冠脉造影。操控工具用于导丝的推入，例如图2所示，操控工具将导丝从另一止血阀300的第三端口330推入，经过球囊导管进入止血阀100的第三端口，然后将导丝通过介入导管送至待治疗的部位（如冠脉狭窄部位）,顺着导丝将球囊送到冠脉狭窄病变处，在该冠脉狭窄病变处，血管由于斑块而变硬变窄，有可能造成动脉的完全堵塞。用压力泵加压使球囊膨胀，挤压狭窄的斑块，使管腔扩大并使血流通畅。另外，还可以植入支架，即，将支架送至血管病变处，使已经预先装好的球囊膨胀从而撑开动脉血管，将医疗器械撤回，而将支架永久留在病变血管内，以保持管腔通畅，改善心肌血流，减轻胸痛等症状。During interventional procedures, an arterial sheath is used to puncture an artery, such as the radial or femoral artery, through which an interventional catheter is introduced into the patient. For example, in the process of using vascular interventional therapy technology to treat coronary heart disease, angiography interventional catheter is inserted into the left or right coronary artery, and a contrast agent is injected to perform coronary angiography. The manipulation tool is used to push the guide wire. For example, as shown in FIG. 2 , the manipulation tool pushes the guide wire from thethird port 330 of the otherhemostatic valve 300 into the third port of thehemostatic valve 100 through the balloon catheter, and then pushes the guide wire into the third port of thehemostatic valve 100 through the balloon catheter. The guide wire is sent through the interventional catheter to the site to be treated (such as coronary stenosis), and the balloon is sent along the guide wire to the coronary stenosis lesion, where the blood vessel is hardened due to plaque Narrow, potentially causing complete blockage of the artery. Pressurized with a pressure pump to inflate the balloon, squeezing the narrowed plaque, widening the lumen and allowing blood to flow freely. Alternatively, stents can be implanted, i.e., the stent is delivered to the vascular lesion, a pre-installed balloon is inflated to open the artery, the medical device is withdrawn, and the stent is permanently left in the diseased vessel to maintain The lumen is unobstructed, the myocardial blood flow is improved, and symptoms such as chest pain are relieved.

参照图5，其示出了根据本发明的一个实施例的血管介入治疗系统1。血管介入治疗系统1包括监测终端20、介入导管21、气泡探测器22和注射器23。监测终端20可以是导管室心电血压监测终端，其可用于监测和显示患者的心电图和血压，和/或其他人体参数。监测终端还可以监测导管室内的各个装置，例如监测终端可以监测气泡探测器和连通板。监测终端还可以用作导管室内各个装置的控制器，例如监测终端可以用于控制气泡探测器。监测终端还可以用作报警器以在探测到气泡时报警。优选地，监测终端可以是显示器的形式。另外，监测终端还可以连接到打印机或其他设备。总之，监测终端可以用于监测患者身体参数、监测血管介入治疗系统的操作状态、控制血管介入治疗系统的操作、在探测到气泡时报警等。注射器23优选是可控注射器，其可以用于通过介入导管向患者体内输送药剂等。Referring to Fig. 5, there is shown a vascular interventional therapy system 1 according to an embodiment of the present invention. The vascular interventional therapy system 1 includes a monitoring terminal 20 , an interventional catheter 21 , abubble detector 22 and a syringe 23 . The monitoring terminal 20 can be a catheter room ECG blood pressure monitoring terminal, which can be used to monitor and display the patient's electrocardiogram and blood pressure, and/or other human parameters. The monitoring terminal can also monitor various devices in the catheter chamber, for example, the monitoring terminal can monitor the air bubble detector and the communication plate. The monitoring terminal can also be used as a controller for various devices in the catheter chamber, for example, the monitoring terminal can be used to control the air bubble detector. The monitoring terminal can also be used as an alarm to alert when air bubbles are detected. Preferably, the monitoring terminal may be in the form of a display. In addition, the monitoring terminal can also be connected to a printer or other device. In a word, the monitoring terminal can be used to monitor the patient's body parameters, monitor the operation state of the vascular interventional therapy system, control the operation of the vascular interventional therapy system, and give an alarm when air bubbles are detected. Syringe 23 is preferably a controllable syringe that can be used to deliver medicaments or the like into a patient through an interventional catheter.

介入导管21用于在治疗（手术）过程中为其他医疗器械提供稳定的操作平台，起到引导的作用，并且可以用于造影和测量血压等人体参数。The interventional catheter 21 is used to provide a stable operating platform for other medical instruments in the course of treatment (surgery), play a guiding role, and can be used for angiography and measurement of human parameters such as blood pressure.

在介入导管操作开始时候的排气过程要求：（1）导管在进入体内前先用含有肝素的生理盐水冲管，尽量排空管内的空气；（2）导管送入体内后，打开止血阀（止血阀连接在介入导管的末端），利用血液的自然压力回流把导管里残留的微少气泡排出去。The venting process at the beginning of the interventional catheter operation requires: (1) flush the catheter with normal saline containing heparin before entering the body, and try to evacuate the air in the tube; (2) after the catheter is sent into the body, open the hemostatic valve ( The hemostatic valve is connected to the end of the interventional catheter), which uses the natural pressure backflow of the blood to discharge the tiny air bubbles remaining in the catheter.

气泡探测器22可以设置在介入导管21中并且和监测终端20连接。具体地，气泡探测器22可以具有多个输入\输出端，其中气泡探测器22的一个输入端可与注射器23（如可控注射器）相连，注射器23可由监测终端20控制经过气泡探测器22向介入导管21输送药剂或其他物质，最终将药剂或其他物质输送到患者体内。优选地，可以在气泡检测器和注射器之间设置连通板，该连通板可以是四联四通或三联三通。连通板可以具有多个歧管，连通板中的一个歧管可以与监测终端连通用于监测压力，连通器的头端可以连接到气泡探测器，连通器的尾端可以连接到注射器。优选地，可以在气泡探测器和连通板之间设置止血阀（图5中未示出）。优选地，气泡探测器可以设置在动脉鞘和止血阀之间，即气泡探测器设置在动脉鞘和止血阀之间的一段介入导管中，止血阀的第一端口与气泡探测器的输入端连接。或者，气泡探测器可以设置在动脉鞘和连通板之间（图5中未示出）。优选地，可以在多个适合位置设置多于一个气泡探测器。Abubble detector 22 may be provided in the interventional catheter 21 and connected to the monitoring terminal 20 . Specifically, thebubble detector 22 can have multiple input/output terminals, wherein one input terminal of thebubble detector 22 can be connected to a syringe 23 (eg, a controllable syringe), and the syringe 23 can be controlled by the monitoring terminal 20 to pass through thebubble detector 22 to the injector 23. The interventional catheter 21 delivers a drug or other substance, ultimately delivering the drug or other substance into a patient. Preferably, a communication plate may be provided between the bubble detector and the syringe, and the communication plate may be a quadruple-four-way or triple-three-way. The communication plate may have a plurality of manifolds, one of the manifolds of the communication plate may be communicated with the monitoring terminal for monitoring the pressure, the head end of the communication connector may be connected to the air bubble detector, and the tail end of the communication connector may be connected to the syringe. Preferably, a hemostatic valve (not shown in FIG. 5 ) may be provided between the bubble detector and the communication plate. Preferably, the air bubble detector can be arranged between the arterial sheath and the hemostatic valve, that is, the air bubble detector is arranged in a section of interventional catheter between the arterial sheath and the hemostatic valve, and the first port of the hemostatic valve is connected to the input end of the air bubble detector . Alternatively, a bubble detector can be placed between the arterial sheath and the communication plate (not shown in Figure 5). Preferably, more than one bubble detector may be provided in a plurality of suitable locations.

气泡探测器22也可以与其他输入源相连，或者气泡探测器22可以具有另外的输入端，以向介入导管进行输入，具体的输入源取决于不同的手术类型，如造影术、扩张术、植入术、切除术等。Theair bubble detector 22 may also be connected to other input sources, or theair bubble detector 22 may have additional inputs for input to the interventional catheter, depending on the type of procedure, such as angiography, dilation, implantation Surgery, resection, etc.

图6是气泡探测器的示意图，其具有流体入口和流体出口，流体（如血液）从入口流入并从出口流出，在气泡探测器中进行检测。气泡探测器通过线缆与监测终端连通，在探测到气泡的时候通过监测终端报警。6 is a schematic diagram of a bubble detector having a fluid inlet and a fluid outlet, from which a fluid (eg, blood) flows in and out of which is detected in the bubble detector. The air bubble detector is connected to the monitoring terminal through a cable, and alarms through the monitoring terminal when air bubbles are detected.

图7示出了气泡探测器的透视图，其可以具有盒状的本体，该本体具有输入端、输出端和通信端。输入端用于使流体流入，流经气泡探测器的本体，并从输出端流出。通信端用于与监测终端通信，用于向监测终端传送信号以报告气泡监测的情况，并用于从监测终端接收信号以采取动作。图8示出了未组装状态的气泡探测器，其示出了气泡探测器本体、导线、紧固件等。Figure 7 shows a perspective view of a bubble detector, which may have a box-like body with an input, an output, and a communication terminal. The input is used to allow fluid to flow in, through the body of the bubble detector, and out of the output. The communication terminal is used for communicating with the monitoring terminal, for transmitting a signal to the monitoring terminal to report the situation of bubble monitoring, and for receiving a signal from the monitoring terminal to take an action. Figure 8 shows the bubble detector in an unassembled state, showing the bubble detector body, wires, fasteners, etc. FIG.

图9以示意图示出了气泡探测器的一个实施例，其中气泡探测器的输入端与一段介入导管连接，该段介入导管向气泡探测器输入流体（如血液），气泡探测器中具有密闭的探测腔室，用于探测在探测腔室内的流体中是否存在气泡，探测腔室的一端与气泡探测器的输入端连通，用于从输入端的介入导管接收流体，探测腔室的另一端与气泡探测器的输出端连通，用于向输出端的介入导管输送流体。换言之，介入导管被分为两截，气泡探测器插入两截介入导管中，气泡探测器的探测腔室分别于两段介入导管相连，形成密封的且内部连通的流体通道，气泡探测器对探测腔室内的流体进行探测以确定是否存在气泡。FIG. 9 shows an embodiment of a bubble detector in a schematic diagram, wherein the input end of the bubble detector is connected to a section of an interventional catheter, and the section of the interventional catheter supplies fluid (such as blood) to the bubble detector, and the bubble detector has a closed The detection chamber is used to detect whether there are air bubbles in the fluid in the detection chamber, one end of the detection chamber is communicated with the input end of the air bubble detector, and is used to receive the fluid from the intervention catheter at the input end, and the other end of the detection chamber is connected to the air bubble. The output end of the probe is in communication for delivering fluid to the interventional catheter at the output end. In other words, the interventional catheter is divided into two sections, the bubble detector is inserted into the two sections of the interventional catheter, and the detection chambers of the bubble detector are respectively connected with the two sections of the interventional catheter to form a sealed and internally connected fluid channel. The fluid in the chamber is probed to determine the presence of air bubbles.

图10以示意图示出了气泡探测器的另一个实施例，其中介入导管从气泡探测器中穿过，即，介入导管从气泡探测器的一端（输入端）进入，贯穿气泡探测器延伸，并从气泡探测器的另一端（输出端）伸出。换言之，介入导管保持成完整的一段（没有被气泡探测器断开），介入导管从气泡探测器中通过，气泡探测器对从其内穿过的这一段介入导管进行探测以确定是否存在气泡。Figure 10 shows, in schematic view, another embodiment of a bubble detector in which an interventional conduit passes through the bubble detector, ie, the interventional conduit enters from one end (input end) of the bubble detector, extends through the bubble detector, and Protrudes from the other end (output end) of the bubble detector. In other words, the interventional catheter remains as a complete segment (not disconnected by the bubble detector), the interventional catheter is passed through the bubble detector, and the bubble detector detects the segment of the interventional catheter through which it passes to determine the presence of air bubbles.

图11以示意图示出了气泡探测器与监测终端的连通。在血管介入治疗过程中，气泡探测器的通信端与监测终端（如导管室心电血压监测终端）连通并通信，以在手术过程中实时探测气泡并在探测到气泡的情况下实现自动报警的功能。同时，监测终端还可以对气泡探测器进行控制。Figure 11 shows a schematic diagram of the communication of the bubble detector with the monitoring terminal. In the process of vascular interventional therapy, the communication terminal of the bubble detector is connected and communicated with the monitoring terminal (such as the ECG blood pressure monitoring terminal of the catheter room), so as to detect the bubble in real time during the operation and realize the automatic alarm when the bubble is detected. Function. At the same time, the monitoring terminal can also control the bubble detector.

返回参照图5，如上所述，在血管介入治疗过程中必须及时有效地探测出介入导管中的气泡，以保证患者的健康和生命安全。因此，本发明在介入导管21中设置了气泡探测器22，以用于实时探测气泡的存在。气泡探测器22的通信端可与监测终端20通信，用于在探测到气泡存在时通过监测终端20报警，报警装置可以是单独的声音报警装置或光学报警装置，或者二者的结合。例如，报警的方式可以是蜂鸣或者闪灯。Referring back to FIG. 5 , as described above, air bubbles in the interventional catheter must be detected in a timely and effective manner during the vascular interventional treatment, so as to ensure the health and life safety of the patient. Therefore, in the present invention, anair bubble detector 22 is provided in the interventional catheter 21 for detecting the existence of air bubbles in real time. The communication end of theair bubble detector 22 can communicate with the monitoring terminal 20 for alarming through the monitoring terminal 20 when the presence of air bubbles is detected. For example, the way of alarm can be buzzer or flashing light.

参照图12，其示出了根据本发明的一个实施例的气泡探测器。气泡探测器可以是基于光强的气泡探测器。该气泡探测器可以包括上下两个外壳，两个外壳装配后形成气泡探测器的本体，在本体中可以包括光源和光传感器，气泡探测器还可以包括电池以为其内的部件供电，或者气泡探测器可以使用交流电供电。光源向光传感器发射光线，光路经过介入导管（或探测腔室）。光可以为可见光或不可见光，如紫外线、红外线、远红外线等。光传感器可以用于探测光强，当介入导管中的流体发生变化时光强就会发生变化。例如，当不存在气泡时，光传感器接收到的光强为阈值，即正常值。当有气泡经过时，光源发出的光线透过气泡被光传感器接收，由于透过流体和透过气体后的光强是不一样的，因此存在气泡时得到的光强与阈值不同，例如存在气泡时得到的光强大于阈值的光强。可以使用单片机实时捕获光传感器的数值，并通过预设算法进行判断，以确定是否有气泡存在。气泡探测器还可以包括电子处理单元，以用于对光传感器的数据进行处理和分析，从而判断是否存在气泡。或者，气泡探测器可以仅将数据传输至监测终端，由监测终端的处理器来对数据进行存储、处理和判断。Referring to Figure 12, a bubble detector according to one embodiment of the present invention is shown. The bubble detector may be a light intensity based bubble detector. The bubble detector can include two upper and lower shells, and the two shells can be assembled to form the body of the bubble detector, which can include a light source and a light sensor, and the bubble detector can also include a battery to supply power to the components in it, or the bubble detector AC power can be used. The light source emits light to the light sensor, and the light path passes through the interventional catheter (or detection chamber). The light can be visible light or invisible light, such as ultraviolet, infrared, far infrared, and the like. Light sensors can be used to detect the light intensity, which changes when the fluid in the interventional catheter changes. For example, when there is no air bubble, the light intensity received by the light sensor is a threshold value, that is, a normal value. When a bubble passes through, the light emitted by the light source passes through the bubble and is received by the light sensor. Since the light intensity after passing through the fluid and passing through the gas is different, the light intensity obtained when there is a bubble is different from the threshold. For example, there is a bubble. The resulting light intensity is greater than the threshold light intensity. The value of the light sensor can be captured in real time by a single chip microcomputer, and judged by a preset algorithm to determine whether there is a bubble. The air bubble detector may further include an electronic processing unit for processing and analyzing the data of the light sensor, so as to determine whether air bubbles exist. Alternatively, the bubble detector can only transmit data to the monitoring terminal, and the processor of the monitoring terminal can store, process and judge the data.

继续参照图12，在本发明的另一实施例中，气泡探测器可以是基于透光率的气泡探测器。该气泡探测器可以包括上下两个外壳，两个外壳装配后形成气泡探测器的本体，在本体中可以包括光源和光传感器，气泡探测器还可以包括电池以为其内的部件供电，或者气泡探测器可以使用交流电供电。该气泡探测器可以利用透光率来探测介入导管（或探测腔室）内是否有气泡。例如，当介入导管（或探测腔室）内没有气泡时，其透光率为正常值（阈值）,当介入导管（或探测腔室）内存在气泡时，其透光率超出正常值（阈值）,则可以确定存在导致透光率超出阈值的气泡。与监测终端通信的气泡探测器则通过监测终端报警。Continuing to refer to FIG. 12 , in another embodiment of the present invention, the bubble detector may be a light transmittance-based bubble detector. The bubble detector can include two upper and lower shells, and the two shells can be assembled to form the body of the bubble detector, which can include a light source and a light sensor, and the bubble detector can also include a battery to supply power to the components in it, or the bubble detector AC power can be used. The air bubble detector can use light transmittance to detect the presence of air bubbles in the interventional catheter (or detection chamber). For example, when there are no air bubbles in the interventional catheter (or detection chamber), its transmittance is normal (threshold), and when there are air bubbles in the interventional catheter (or detection chamber), its transmittance exceeds the normal value (threshold). ), it can be determined that there are bubbles that cause the transmittance to exceed the threshold. The bubble detector communicating with the monitoring terminal will give an alarm through the monitoring terminal.

图12示出了介入导管贯穿气泡探测器延伸的实施例，该气泡探测器也可以适用包括探测腔室的实施例。在优选实施例中，可以在气泡探测器内设置多个光源和多个光传感器以提高检测精度。Figure 12 shows an embodiment in which an interventional catheter extends through a bubble detector, which may also be adapted to an embodiment including a detection chamber. In a preferred embodiment, multiple light sources and multiple light sensors can be arranged in the bubble detector to improve detection accuracy.

参照图13，其示出了根据本发明的一个实施例的基于光折射的气泡探测器。注意图13仅为表示光线折射的示意图，不代表其等同于实际光路。气泡探测器可以包括上下两个外壳，两个外壳装配后形成气泡探测器的本体，在本体中可以包括光源和光传感器，气泡探测器还可以包括电池以为其内的部件供电，或者气泡探测器可以使用交流电供电。Referring to Figure 13, a light refraction based bubble detector is shown according to one embodiment of the present invention. Note that Fig. 13 is only a schematic diagram showing the refraction of light, and does not mean that it is equivalent to the actual light path. The air bubble detector can include upper and lower casings, and the two casings are assembled to form the body of the air bubble detector. The body can include a light source and a light sensor. The air bubble detector can also include a battery to supply power to the components inside, or the air bubble detector can Use AC power.

该气泡探测器可以利用光的折射来判断介入导管内是否有气泡。具体地，气泡探测器包括光源和光传感器。光源发出的光可以为可见光或不可见光，如紫外线、红外线、远红外线等。来自光源的光以一定角度照射进入介入导管，例如图13所示，在垂直于介入导管延伸方向（即垂直于介入导管纵向轴线）的截面中，光线与垂直轴线成15至75度角度、优选成30至60度角、最优选成45度角。在另一实施例中，光线可以与介入导管延伸方向成15至75度角度、优选成30至60度角、最优选成45度角（未示出），即，光源和光线与介入导管在同一水平面上。光线照射到介入导管后发生折射。当介入导管内没有气泡时，经过折射后的光会沿第一方向从介入导管射出，在第一方向上没有光传感器对光线进行接收，如图13所示，其中圆圈内的阴影线表示介入导管内充满流体而没有气泡。The bubble detector can use the refraction of light to determine whether there is a bubble in the interventional catheter. Specifically, the bubble detector includes a light source and a light sensor. The light emitted by the light source can be visible light or invisible light, such as ultraviolet, infrared, far infrared, and the like. The light from the light source is irradiated into the interventional catheter at an angle, such as shown in Figure 13, in a cross-section perpendicular to the direction in which the interventional catheter extends (ie, perpendicular to the longitudinal axis of the interventional catheter), the light is at an angle of 15 to 75 degrees to the vertical axis, preferably At an angle of 30 to 60 degrees, most preferably at an angle of 45 degrees. In another embodiment, the light may be at an angle of 15 to 75 degrees, preferably 30 to 60 degrees, and most preferably 45 degrees (not shown) to the direction in which the interventional catheter extends, ie, the light source and the light are at an angle of 15 to 75 degrees to the direction in which the interventional catheter extends. on the same level. Refraction occurs when light hits the interventional catheter. When there is no air bubble in the interventional catheter, the refracted light will be emitted from the interventional catheter in the first direction, and no light sensor will receive the light in the first direction, as shown in Figure 13, where the hatched line in the circle indicates the interventional catheter. The catheter is filled with fluid without air bubbles.

图14示出了介入导管内存在气泡的情况，在这种情况下，经过折射后的光会沿第二方向从介入导管射出，第一方向和第二方向是不同的。在第二方向上设置有光传感器对光线进行接收。当光传感器在第二方向上接收到光信号时，则可以确定存在导致光线在第二方向上折射的气泡。与监测终端通信的气泡探测器则通过监测终端报警。FIG. 14 shows a situation in which air bubbles exist in the interventional catheter. In this case, the refracted light is emitted from the interventional catheter in a second direction, and the first direction and the second direction are different. A light sensor is arranged in the second direction to receive light. When the light sensor receives the light signal in the second direction, it can be determined that there is a bubble that causes the light to be refracted in the second direction. The bubble detector communicating with the monitoring terminal will give an alarm through the monitoring terminal.

图13和14所示的气泡探测器可以适用介入导管贯穿气泡探测器延伸的实施例，也可以适用包括探测腔室的实施例。在优选实施例中，可以在气泡探测器内设置多个光源和多个光传感器以提高检测精度。The bubble detectors shown in Figures 13 and 14 are applicable to embodiments in which an interventional catheter extends through the bubble detector, as well as embodiments that include a detection chamber. In a preferred embodiment, multiple light sources and multiple light sensors can be arranged in the bubble detector to improve detection accuracy.

在包括探测腔室的实施例中，优选的是，在垂直于探测腔室纵向轴线（即垂直于探测腔室延伸方向）的截面中，可以使探测腔室具有各种适合于光线折射的截面形状，例如三角形、梯形、菱形、矩形等等。这些截面形状使得光线照射到其上时能够形成更清晰且更容易区分的光路，以提高检测精度。图15示出了探测腔室的各种截图形状。In the embodiment including the detection chamber, preferably, in the section perpendicular to the longitudinal axis of the detection chamber (ie perpendicular to the extension direction of the detection chamber), the detection chamber can have various sections suitable for light refraction Shapes such as triangles, trapezoids, diamonds, rectangles, etc. These cross-sectional shapes enable a clearer and easier-to-distinguish optical path when light hits it, improving detection accuracy. Figure 15 shows various screenshot shapes of the detection chamber.

图16示出了根据本发明的一个实施例的气泡探测器。气泡探测器可以是基于超声波的气泡探测器。该气泡探测器可以包括上下两个外壳，两个外壳装配后形成气泡探测器的本体，在本体中可以包括超声波发射器和超声波接收器，气泡探测器还可以包括电池以为其内的部件供电，或者气泡探测器可以使用交流电供电。该气泡探测器可以利用超声波在不同介质中的传输效率的不同来判断介入导管内是否存在气泡。气泡探测器可以具有超声波发射器和超声波接收器。超声波发射器向超声波接收器发射超声波信号，该超声波信号经过介入导管（或探测腔室）。例如，当介入导管（或探测腔室）内没有气泡时，其传输信号几乎没有衰减，即为正常值（阈值）,当介入导管（或探测腔室）内存在气泡时，其传输信号有衰减，低于正常值（阈值）,则可以确定存在导致传输信号衰减的气泡。与监测终端通信的气泡探测器则通过监测终端报警。Figure 16 shows a bubble detector according to one embodiment of the present invention. The bubble detector may be an ultrasonic based bubble detector. The bubble detector can include two upper and lower shells, and the two shells can be assembled to form a body of the bubble detector. The body can include an ultrasonic transmitter and an ultrasonic receiver. The bubble detector can also include a battery to supply power to the components in it. Alternatively the bubble detector can be powered using alternating current. The bubble detector can use the difference in transmission efficiency of ultrasonic waves in different media to determine whether there are bubbles in the interventional catheter. The bubble detector may have an ultrasonic transmitter and an ultrasonic receiver. The ultrasound transmitter transmits an ultrasound signal to the ultrasound receiver, which passes through the interventional catheter (or detection chamber). For example, when there is no air bubble in the interventional catheter (or detection chamber), its transmission signal has almost no attenuation, which is a normal value (threshold value). When there is air bubble in the interventional catheter (or detection chamber), its transmission signal is attenuated. , below the normal value (threshold), it can be determined that there are air bubbles that cause attenuation of the transmission signal. The bubble detector communicating with the monitoring terminal will give an alarm through the monitoring terminal.

在另一个实施例中，气泡探测器还可以包括内置的印刷电路板，印刷电路板上集成布置有微控制器。工作中，超声波发射器发出超声波信号，该超声波信号传输经过介入导管（或探测腔室），超声波接收器接收超声波信号，从而形成回路。当介入导管（或探测腔室）内没有气泡时，超声波接收器接收正常超声波信号；当介入导管（或探测腔室）内存在气泡时，超声波接收器接收异常超声波信号。超声波回路检测到异常，并发信号给微控制器，微控制器可以向监测终端报警，微控制器也可以停止介入导管内的流体输送。In another embodiment, the bubble detector may further include a built-in printed circuit board with a microcontroller integrated therein. In operation, the ultrasonic transmitter sends out ultrasonic signals, which are transmitted through the interventional catheter (or detection chamber), and the ultrasonic receiver receives the ultrasonic signals to form a loop. When there are no air bubbles in the interventional catheter (or detection chamber), the ultrasonic receiver receives normal ultrasonic signals; when there are air bubbles in the interventional catheter (or detection chamber), the ultrasonic receiver receives abnormal ultrasonic signals. The ultrasonic circuit detects an abnormality and sends a signal to the microcontroller. The microcontroller can alarm the monitoring terminal, and the microcontroller can also stop the fluid delivery in the interventional catheter.

图16示出了介入导管贯穿气泡探测器延伸的实施例，该气泡探测器也可以适用包括探测腔室的实施例。在优选实施例中，可以在气泡探测器内设置多个超声波发射器和多个超声波接收器以提高检测精度。Figure 16 shows an embodiment in which an interventional catheter extends through a bubble detector, which may also be adapted to an embodiment including a detection chamber. In a preferred embodiment, a plurality of ultrasonic transmitters and a plurality of ultrasonic receivers can be arranged in the bubble detector to improve detection accuracy.

在优选实施例中，气泡探测器还可以包括电源开关和电源指示灯以指示电源的接通和切断。气泡探测器还可以包括电源线和电源插头。气泡探测器还可以包括观察窗，该观察窗优先由透明材料制成以观察气泡探测器内部的情况。气泡探测器还可以包括用于容纳螺钉和螺母的槽口，螺钉和螺母用于将气泡探测器的不同部分（如上下壳体）紧固在一起。In a preferred embodiment, the bubble detector may also include a power switch and a power indicator to indicate power on and off. The bubble detector may also include a power cord and power plug. The bubble detector may also include a viewing window, preferably made of a transparent material, for viewing the interior of the bubble detector. The bubble detector may also include notches for receiving screws and nuts for securing together different parts of the bubble detector, such as the upper and lower housings.

当然，也可以使用其他探测气泡的装置与方法。Of course, other devices and methods for detecting air bubbles may also be used.

当气泡探测器探测到气泡时，监测终端自动报警。也可以设置额外的报警装置与气泡探测器通信以在探测到气泡时自动报警。报警可以使得操作者得知介入导管中存在气泡。这时操作者可以暂停手术，打开止血阀，血液会由于压力的原因自动从导管流出，从而将气泡带出来。When the bubble detector detects bubbles, the monitoring terminal will automatically alarm. Additional alarm devices can also be set up to communicate with the bubble detector to automatically alarm when a bubble is detected. An alarm can make the operator aware of the presence of air bubbles in the interventional catheter. At this time, the operator can suspend the operation, open the hemostatic valve, and the blood will automatically flow out of the catheter due to the pressure, thereby bringing out the air bubbles.

优选地，气泡探测器还可以包括截止阀，当探测到介入导管内存在气泡时，监测终端（或报警装置）报警并且通信气泡探测器以切断截止阀，从而将含有气泡的流体阻截。也就是说，截止阀在探测到气泡时自动切断，不能再向血管内推注流体。截止阀可设置有开关，根据需要控制截止阀的启动。在介入导管进入患者体内之前存在排除气泡的排气过程，在这个过程中，操作者主动地将导管内的残留气体全部排出。在其此间，可以将截止阀和监测终端（或报警装置）关闭。在将导管内的气体完全排出之后，可以开启截止阀和监测终端（或报警装置）。Preferably, the air bubble detector may further include a shut-off valve, when the presence of air bubbles in the interventional catheter is detected, the monitoring terminal (or alarm device) alarms and communicates with the air bubble detector to cut off the shut-off valve, thereby blocking the fluid containing air bubbles. That is, the shut-off valve automatically shuts off when air bubbles are detected, and no more fluid can be injected into the blood vessel. The shut-off valve can be provided with a switch to control the start-up of the shut-off valve as required. Before the interventional catheter enters the patient's body, there is an exhaust process of removing air bubbles. During this process, the operator actively exhausts all the residual gas in the catheter. During this time, the shut-off valve and monitoring terminal (or alarm device) can be closed. After the gas in the conduit is completely exhausted, the shut-off valve and monitoring terminal (or alarm device) can be opened.

在一个优选实施例中，可以在气泡探测装置的通路上开一个侧孔，需要排气时开放，使得气泡可以从该侧孔排出去。In a preferred embodiment, a side hole can be opened on the passage of the air bubble detection device, which is opened when air needs to be exhausted, so that air bubbles can be discharged from the side hole.

本发明的气泡探测器可以在所有的介入导管操作时使用，包括血管介入，外周动脉如颈动脉，肾动脉，下肢动脉介入治疗，肿瘤的介入栓塞等等。也就是说，在需要使用导管的介入治疗场合，本发明的气泡探测装置都可以使用。The air bubble detector of the present invention can be used in all interventional catheter operations, including vascular intervention, peripheral arteries such as carotid artery, renal artery, lower extremity artery interventional therapy, tumor interventional embolization and the like. That is to say, the air bubble detection device of the present invention can be used in any interventional treatment occasion requiring the use of a catheter.

本发明的描述在本质上仅仅是示例性的，并且不脱离本发明精神的变型都应包含在本发明的范围内。这些变化不能视为脱离本发明的精神和范围。The description of the invention is merely exemplary in nature, and modifications that do not depart from the spirit of the invention are intended to be included within the scope of the invention. These changes should not be considered as a departure from the spirit and scope of the present invention.