技术领域technical field
本发明属于医疗器械领域，尤其涉及一种血管内血栓抽吸系统。The invention belongs to the field of medical devices, in particular to an intravascular thrombus suction system.
背景技术Background technique
血栓形成(thrombosis)是指在一定条件下，血液有形成分在血管内形成栓子，造成血管部分或完全堵塞，相应部位血液供应障碍的病理过程。依血栓组成成分可分为血小板血栓、红细胞血栓、纤维蛋白血栓、混合血栓等。按血管种类可分为动脉性血栓、静脉性血栓及毛细血管性血栓。Thrombosis refers to the pathological process in which, under certain conditions, formed components of blood form emboli in blood vessels, resulting in partial or complete blockage of blood vessels and obstruction of blood supply to corresponding parts. According to the composition of thrombus, it can be divided into platelet thrombus, red blood cell thrombus, fibrin thrombus, mixed thrombus and so on. According to the type of blood vessel, it can be divided into arterial thrombosis, venous thrombosis and capillary thrombosis.
血栓栓塞(thromboembolism)是血栓由形成部位脱落，在随血流移动的过程中部分或全部堵塞某些血管，引起相应组织和(或)器官缺血、缺氧、坏死(动脉血栓)及淤血、水肿(静脉血栓)的病理过程。Thromboembolism (thromboembolism) is that the thrombus falls off from the site of formation and partially or completely blocks some blood vessels during the process of moving with the blood flow, causing ischemia, hypoxia, necrosis (arterial thrombosis) and congestion, Pathological process of edema (venous thrombosis).
由血栓形成和血栓栓塞两种病理过程所引起的血栓性疾病严重威胁人类的生命健康，其发病率高居各种疾病之首，且由于互联网带来的工作、生活中活动减少，血栓性疾病近年来还有渐增之势，是当代医学研究的重点和热点之一。The thrombotic disease caused by the two pathological processes of thrombosis and thromboembolism seriously threatens human life and health, and its incidence rate ranks first among various diseases. It is one of the key points and hot spots of contemporary medical research.
血栓性疾病的病因主要包括：年龄因素、活动减少、血管炎症等。肺栓塞(PE)亦称肺血栓栓塞，是由于内源性或外源性的栓子堵塞肺动脉主干或分支，引起肺循环障碍的临床表现和病理生理综合征。如在此基础上进一步发生肺出血或坏死者，即称为肺梗死。尸检资料表明，PE的发生年龄多在50～65岁,儿童患病率约为3％。而60岁以上可达20％。90％致死性PE发生在50岁以上。在女性20～39岁者其深静脉血栓的发生率较同龄男性高10倍，故PE之发生率相对增高。另外因下肢骨折、瘫痪、重症心肺疾病、手术等原因，致使长期不适当的卧床，或健康人平时肢体活动减少，降低了静脉血流的驱动力，也会导致血流淤滞，深静脉血栓形成。The etiology of thrombotic diseases mainly includes age factors, reduced activity, and vascular inflammation. Pulmonary embolism (PE), also known as pulmonary thromboembolism, is the clinical manifestation and pathophysiological syndrome of pulmonary circulation disturbance caused by endogenous or exogenous emboli blocking the main trunk or branches of the pulmonary artery. If further pulmonary hemorrhage or necrosis occurs on this basis, it is called pulmonary infarction. Autopsy data show that the age of occurrence of PE is mostly between 50 and 65 years old, and the prevalence rate of children is about 3%. And up to 20% over the age of 60. 90% of fatal PE occurs in people over the age of 50. In women aged 20 to 39, the incidence of deep vein thrombosis is 10 times higher than that of men of the same age, so the incidence of PE is relatively higher. In addition, due to lower extremity fractures, paralysis, severe cardiopulmonary disease, surgery, etc., long-term inappropriate bed rest, or reduced physical activity of healthy people, reduces the driving force of venous blood flow, which can also lead to blood stasis and deep vein thrombosis. .
目前血栓性疾病的主要治疗手段包括：抗凝、抗栓、溶栓等药物治疗，手术治疗以及介入治疗等。对陈旧性血栓经内科治疗效果不佳而侧支循环形成不良者，可考虑手术治疗，即手术取出血栓或切除栓塞血管段并重新吻合。介入治疗通过导管局部溶栓，通过导管负压抽吸血栓以及通过球囊、支架等器械机械式取栓。At present, the main treatment methods for thrombotic diseases include: anticoagulant, antithrombotic, thrombolytic and other drug therapy, surgical treatment and interventional therapy. Surgical treatment may be considered for old thrombus with poor medical treatment and poor collateral circulation, that is, surgical removal of thrombus or resection of embolized vessel segment and re-anastomosis. Interventional therapy uses catheters for local thrombolysis, catheter vacuum suction for thrombus, and mechanical thrombus removal by balloons, stents and other devices.
血栓形成后，容易脱落并随血液流动，移动的过程中部分或全部堵塞某些血管，引起相应组织和(或)器官缺血、缺氧、坏死等。血栓栓塞影响的严重程度与栓塞的位置及栓塞的时间有关。After the thrombus is formed, it is easy to fall off and flow with the blood, and partially or completely block some blood vessels during the movement, causing ischemia, hypoxia, necrosis, etc. of the corresponding tissues and (or) organs. The severity of thromboembolic effects is related to the location and timing of embolism.
抗凝、抗栓、溶栓等药物治疗，需要对整个血液循环系统用药，用药量大，见效慢，容易引起器官脏器出血等并发症。Anticoagulant, antithrombotic, thrombolytic and other drug treatments need to be administered to the entire blood circulation system. The dosage is large, the effect is slow, and it is easy to cause complications such as organ bleeding.
目前通过导管将溶栓药物注入局部的介入治疗，能降低药量，减少对整个血液循环系统的影响，但仍然存在见效慢的问题。At present, thrombolytic drugs are injected into local interventional therapy through catheters, which can reduce the dose of drugs and reduce the impact on the entire blood circulation system, but there is still the problem of slow effect.
血栓尤其是新鲜血栓在体内像果冻，没有机械强度，在体内容易破裂。通过球囊取栓，需要阻断远端血流，为了取栓尽量完全，取栓球囊需要贴壁，在移动时容易刮伤血管，通过支架取栓容易导致血栓破裂和取栓不完全。Thrombus, especially fresh thrombus, is like jelly in the body, has no mechanical strength, and is easy to rupture in the body. Through balloon thrombectomy, it is necessary to block the distal blood flow. In order to remove the thrombus as completely as possible, the thrombus removal balloon needs to stick to the wall, which is easy to scratch the blood vessel when moving, and thrombus removal through the stent is likely to cause thrombus rupture and incomplete thrombus removal.
导管负压抽吸血栓目前包括手动抽吸和伯努利效应将血栓抽吸至体外。手动抽吸不稳定且抽吸力小，几乎没有临床疗效。利用伯努利效应抽吸，其工作过程是驱动泵产生脉冲压力将生理盐水经导管注入并从导管头端侧孔反向喷射冲刷血栓，高速生理盐水同时产生局部低压区，使碎裂的血栓颗粒由导管排出孔吸出。该方法的不足之处在于将血栓抽吸至体外的同时，血液也一起抽吸至体外，导致患者血容量减少。Catheter negative pressure aspiration of thrombus currently includes manual aspiration and Bernoulli effect to aspirate the thrombus outside the body. Manual suction is unstable and the suction force is small, and there is almost no clinical effect. Using the Bernoulli effect for suction, the working process is to drive the pump to generate pulse pressure to inject normal saline through the catheter and spray it back from the side hole of the catheter head to wash away the thrombus. Particles are sucked out through the catheter discharge hole. The disadvantage of this method is that when the thrombus is sucked out of the body, the blood is also sucked out of the body together, resulting in decreased blood volume of the patient.
发明内容Contents of the invention
本发明所要解决的技术问题是提供一种血管内血栓抽吸系统，向血栓性疾病患者提供一种经皮使用的，快速、有效移除血栓的设备，系统在移除血栓的同时，不减少血容量，具有更高的有效性和安全性，并且无需外科手术。The technical problem to be solved by the present invention is to provide an intravascular thrombus suction system to provide patients with thrombotic diseases with a percutaneous, fast and effective device for removing thrombus. Blood volume, with higher efficacy and safety, and without surgery.
本发明为解决上述技术问题而采用的技术方案是提供一种血管内血栓抽吸系统，包括可经皮植入人体的抽吸导管和驱动模块，所述抽吸导管包括入血口、血流通道及出血口，所述抽吸导管的血流通道内设置有滤网，所述滤网和出血口之间或出血口处设置有叶轮；所述叶轮和所述驱动模块相连。The technical solution adopted by the present invention to solve the above technical problems is to provide an intravascular thrombus suction system, which includes a suction catheter and a driving module that can be implanted into the human body percutaneously. The suction catheter includes a blood inlet, a blood flow A channel and a bleeding port, a filter screen is arranged in the blood flow channel of the suction catheter, and an impeller is provided between the filter screen and the bleeding port or at the bleeding port; the impeller is connected to the driving module.
进一步地，所述驱动模块位于体外与所述抽吸导管分开设置，所述驱动模块的远端通过柔性传动结构与所述抽吸导管相连，所述驱动模块的近端通过信号线与控制模块相连。Further, the driving module is located outside the body and is set separately from the suction catheter, the distal end of the driving module is connected to the suction catheter through a flexible transmission structure, and the proximal end of the driving module is connected to the control module through a signal line connected.
进一步地，所述柔性传动结构包括驱动导丝以及为所述驱动导丝提供传动腔的传动导管，所述驱动导丝通过桥接结构与所述叶轮相连。Further, the flexible transmission structure includes a driving guide wire and a transmission catheter providing a transmission cavity for the driving guide wire, and the driving guide wire is connected to the impeller through a bridge structure.
进一步地，所述柔性传动结构的长度范围为80cm～200cm，所述驱动导丝为螺旋缠绕管或钢绞线。Further, the flexible transmission structure has a length ranging from 80 cm to 200 cm, and the driving guide wire is a helically wound tube or a steel strand.
进一步地，所述驱动模块包括支撑外壳、驱动马达及桥接结构，所述驱动模块桥接结构的远端连接所述柔性传动结构内的驱动导丝，所述驱动模块桥接结构的近端连接所述驱动马达的转轴。Further, the driving module includes a supporting shell, a driving motor and a bridge structure, the distal end of the bridge structure of the driving module is connected to the driving guide wire in the flexible transmission structure, and the proximal end of the bridge structure of the driving module is connected to the Drive the shaft of the motor.
进一步地，所述驱动马达为气动马达，所述支撑外壳内还设置有冷却结构、测速结构、排气结构及降噪结构，所述控制模块向所述驱动模块输出控制信号控制气源的输出气压对汽轮转速进行控制，同时所述测速结构反馈汽轮实际转速用于形成闭环控制。Further, the drive motor is an air motor, and a cooling structure, a speed measuring structure, an exhaust structure and a noise reduction structure are also arranged in the support shell, and the control module outputs a control signal to the drive module to control the output of the air source The air pressure controls the speed of the steam turbine, and at the same time, the speed measurement structure feeds back the actual speed of the steam turbine to form a closed-loop control.
进一步地，所述驱动马达为电动马达，所述支撑外壳内还设置有冷却结构，所述控制模块向所述驱动模块提供驱动信号机电源，所述驱动模块反馈电机的运行状态。Further, the driving motor is an electric motor, and a cooling structure is provided in the supporting shell, the control module provides driving signal power to the driving module, and the driving module feeds back the running state of the motor.
进一步地，所述驱动模块为位于体内的电机，与所述驱动模块相连的控制模块位于体外。Further, the driving module is a motor located inside the body, and the control module connected to the driving module is located outside the body.
进一步地，所述控制模块包括控制器主体、电气系统和控制器搭载的系统软件，并具有人机交互界面；所述控制器主体与所述驱动模块通过信号线相连，所述控制器主体传送并接收所述驱动模块内马达的运行参数；所述系统软件用于设置系统运行参数、控制系统运行、实时监控所述抽吸导管的运行状态。Further, the control module includes a controller body, an electrical system, and system software carried by the controller, and has a human-computer interaction interface; the controller body is connected to the drive module through a signal line, and the controller body transmits And receive the operating parameters of the motor in the drive module; the system software is used to set system operating parameters, control system operation, and monitor the operating status of the suction catheter in real time.
进一步地，所述滤网的网孔面积范围为0.1mm2-16mm2。Further, the mesh area of the filter screen is in the range of 0.1mm2 -16mm2 .
本发明对比现有技术有如下的有益效果：本发明提供的血管内血栓抽吸系统，驱动叶轮旋转的驱动装置可位于体内或体外。驱动装置高速旋转时带动叶轮高速旋转，在入血口形成负压区，将含有血栓的血液吸入抽吸导管，经过滤网时，血液可以通过，但大于滤网网孔的血栓则无法通过，从而可将血栓和血液进行分离，血液通过出血口回到血管。相对于球囊支架等取栓方式，本发明提供的血管内血栓抽吸系统无需阻断血流，采用负压的抽吸方式，取栓更安全，不担心血栓破裂和脱落。相对于现有的抽吸导管技术，采用本发明提供的血管内血栓抽吸系统时，病人血液经过滤网后又回到血液循环而无失血，导管撤出体外时血栓也一并移出。Compared with the prior art, the present invention has the following beneficial effects: In the intravascular thrombus suction system provided by the present invention, the driving device for driving the rotation of the impeller can be located inside or outside the body. When the driving device rotates at high speed, it drives the impeller to rotate at high speed, forming a negative pressure area at the blood inlet, sucking the blood containing thrombus into the suction catheter, and passing through the filter, the blood can pass through, but the thrombus larger than the mesh of the filter cannot pass through. Thus, the thrombus and blood can be separated, and the blood returns to the blood vessel through the bleeding port. Compared with the thrombus removal methods such as balloon stent, the intravascular thrombus aspiration system provided by the present invention does not need to block the blood flow, and adopts the negative pressure suction method, which is safer for thrombus removal without worrying about thrombus rupture and shedding. Compared with the existing suction catheter technology, when the intravascular thrombus suction system provided by the present invention is used, the patient's blood returns to the blood circulation after passing through the filter screen without blood loss, and the thrombus is also removed when the catheter is withdrawn from the body.
附图说明Description of drawings
图1为本发明血管内血栓抽吸系统的结构示意图；Fig. 1 is a schematic structural view of the intravascular thrombus suction system of the present invention;
图2为本发明血管内血栓抽吸系统的工作示意图。Fig. 2 is a working schematic diagram of the intravascular thrombus suction system of the present invention.
图中：In the picture:
1 抽吸导管 2 滤网 3 叶轮1 Suction duct 2 Strainer 3 Impeller
11 入血口 12 出血口 13 血流通道11 Blood inlet 12 Blood outlet 13 Blood flow channel
4 传动导管 5 血管 6 血栓4 Drive catheter 5 Blood vessel 6 Thrombus
7 血液7 blood
具体实施方式Detailed ways
下面结合附图和实施例对本发明作进一步的描述。The present invention will be further described below in conjunction with the accompanying drawings and embodiments.
图1为本发明血管内血栓抽吸系统的结构示意图。Fig. 1 is a schematic structural view of the intravascular thrombus suction system of the present invention.
请参见图1，本发明提供的血管内血栓抽吸系统，包括可经皮植入人体的抽吸导管1和驱动模块(图未示)，抽吸导管1包括入血口11、血流通道13及出血口12，抽吸导管1的血流通道13内设置有滤网2，滤网2和出血口12之间或出血口12处设置有可旋转的叶轮3；叶轮3和所述驱动模块相连。较佳地，滤网2的网孔面积范围为0.1mm2-16mm2。Please refer to Fig. 1, the intravascular thrombus suction system provided by the present invention includes a suction catheter 1 and a driving module (not shown) that can be implanted percutaneously in the human body, and the suction catheter 1 includes a blood inlet 11, a blood flow channel 13 and the bleeding port 12, a filter screen 2 is arranged in the blood flow channel 13 of the suction catheter 1, and a rotatable impeller 3 is arranged between the filter screen 2 and the bleeding port 12 or at the bleeding port 12; the impeller 3 and the driving module connected. Preferably, the mesh area of the filter screen 2 is in the range of 0.1mm2 -16mm2 .
本发明提供的血管内血栓抽吸系统中，所述驱动模块可以为位于体内的电机，叶轮3由体内电机驱动，控制模块可以位于体外。在本实施例中，较佳地，所述驱动模块位于体外与抽吸导管1分开设置，下面以驱动模块设置在体外的结构作为具体实施例进行详细说明。In the intravascular thrombus suction system provided by the present invention, the driving module may be a motor located inside the body, the impeller 3 is driven by the motor inside the body, and the control module may be located outside the body. In this embodiment, preferably, the driving module is located outside the body and arranged separately from the suction catheter 1 , and the structure in which the driving module is arranged outside the body will be described in detail below as a specific example.
本实施例提供的血管内血栓抽吸系统，所述驱动模块的远端通过柔性传动结构与抽吸导管1相连，所述驱动模块的近端通过信号线与控制模块相连。所述柔性传动结构包括驱动导丝以及为所述驱动导丝提供传动腔的传动导管4，所述驱动导丝通过桥接结构与叶轮3相连。优选地，所述柔性传动结构的长度范围为80cm～200cm，所述驱动导丝为螺旋缠绕管或钢绞线。所述驱动模块包括支撑外壳、驱动马达及桥接结构，所述驱动模块桥接结构的远端连接所述柔性传动结构内的驱动导丝，所述驱动模块桥接结构的近端连接所述驱动马达的转轴。In the intravascular thrombus suction system provided in this embodiment, the distal end of the driving module is connected to the suction catheter 1 through a flexible transmission structure, and the proximal end of the driving module is connected to the control module through a signal line. The flexible transmission structure includes a driving guide wire and a transmission catheter 4 providing a transmission cavity for the driving guide wire, and the driving guide wire is connected to the impeller 3 through a bridge structure. Preferably, the flexible transmission structure has a length ranging from 80 cm to 200 cm, and the driving guide wire is a helically wound tube or a steel strand. The drive module includes a supporting shell, a drive motor and a bridge structure, the far end of the bridge structure of the drive module is connected to the driving guide wire in the flexible transmission structure, and the proximal end of the bridge structure of the drive module is connected to the drive motor. shaft.
本实施例中，所述驱动马达可以为气动马达或电动马达，所述驱动马达为气动马达时，所述支撑外壳内还设置有冷却结构、测速结构、排气结构及降噪结构，所述控制模块向所述驱动模块输出控制信号控制气源的输出气压对汽轮转速进行控制，同时所述测速结构反馈汽轮实际转速用于形成闭环控制。所述驱动马达为电动马达时，所述支撑外壳内还设置有冷却结构，所述控制模块向所述驱动模块提供驱动信号机电源，所述驱动模块反馈电机的运行状态。In this embodiment, the driving motor may be an air motor or an electric motor. When the driving motor is an air motor, a cooling structure, a speed measuring structure, an exhaust structure and a noise reduction structure are also arranged in the supporting shell. The control module outputs a control signal to the drive module to control the output air pressure of the air source to control the speed of the steam turbine, and at the same time, the speed measurement structure feeds back the actual speed of the steam turbine to form a closed-loop control. When the driving motor is an electric motor, a cooling structure is also provided in the supporting shell, the control module provides driving signal power to the driving module, and the driving module feeds back the running state of the motor.
所述控制模块包括控制器主体、电气系统和控制器搭载的系统软件，并具有人机交互界面；所述控制器主体与所述驱动模块通过信号线相连，所述控制器主体传送并接收所述驱动模块内马达的运行参数；所述系统软件用于设置系统运行参数、控制系统运行、实时监控所述抽吸导管的运行状态。The control module includes a controller body, an electrical system, and system software carried by the controller, and has a human-computer interaction interface; the controller body is connected to the drive module through a signal line, and the controller body transmits and receives the The operating parameters of the motor in the drive module; the system software is used to set system operating parameters, control system operation, and monitor the operating status of the suction catheter in real time.
开始使用时，通过人机界面向控制器输入控制参数并由控制器转换为运行参数；运行时控制器通过信号线向驱动模块发送驱动信号，控制驱动模块内马达依据所设运行参数运行；驱动模块通过柔性传动结构将转动扭矩传递至抽吸导管1内的叶轮3，叶轮3转动，血液和血栓6一同从入血口11吸入，经过滤网2时，血液正常能通过从出血口12流出并进入血液循环系统，血栓6留在滤网2上。抽吸导管1移出体外时，血栓6跟随抽吸导管1一起移出体外。When starting to use, control parameters are input to the controller through the man-machine interface and converted into operating parameters by the controller; during operation, the controller sends a driving signal to the drive module through the signal line, and controls the motor in the drive module to run according to the set operating parameters; the drive The module transmits the rotational torque to the impeller 3 in the suction catheter 1 through the flexible transmission structure. The impeller 3 rotates, and the blood and thrombus 6 are sucked together from the blood inlet 11. When passing through the filter 2, the blood can normally flow out from the outlet 12. And enter the blood circulation system, the thrombus 6 stays on the filter screen 2. When the suction catheter 1 is moved out of the body, the thrombus 6 is moved out of the body together with the suction catheter 1 .
综上，驱动叶轮旋转的驱动装置可位于体内或体外。抽吸导管1经皮进入有血栓的动脉或静脉。驱动装置高速旋转时带动叶轮3高速旋转，在入血口11形成负压区，将含有血栓6的血液吸入抽吸导管1，经过滤网2时，血液7可以通过，但大于滤网2网孔的血栓6则无法通过，从而可将血栓6和血液7进行分离，血液7通过出血口12回到血管5。相对于球囊支架等取栓方式，本发明提供的血管内血栓抽吸系统无需阻断血流，采用负压的抽吸方式，取栓更安全，不担心破裂和脱落。相对于现有的抽吸导管技术，采用本发明提供的血管内血栓抽吸系统时，病人血液经过滤网2后又回到血液循环而无失血，抽吸导管1撤出体外时血栓也一并移出。In summary, the driving means for driving the rotation of the impeller can be located inside or outside the body. Suction catheter 1 is inserted percutaneously into the thrombused artery or vein. When the driving device rotates at a high speed, it drives the impeller 3 to rotate at a high speed, forming a negative pressure zone at the blood inlet 11, sucking the blood containing thrombus 6 into the suction catheter 1, and passing through the filter 2, the blood 7 can pass through, but it is larger than the filter 2 The thrombus 6 in the hole cannot pass through, so that the thrombus 6 and the blood 7 can be separated, and the blood 7 returns to the blood vessel 5 through the bleeding port 12 . Compared with the thrombus removal methods such as balloon stent, the intravascular thrombus aspiration system provided by the present invention does not need to block the blood flow, and adopts the negative pressure suction method, which is safer for thrombus removal without worrying about rupture and falling off. Compared with the existing suction catheter technology, when the intravascular thrombus suction system provided by the present invention is used, the patient's blood returns to the blood circulation after passing through the filter screen 2 without blood loss, and the thrombus also remains intact when the suction catheter 1 is withdrawn from the body. and move out.
虽然本发明已以较佳实施例揭示如上，然其并非用以限定本发明，任何本领域技术人员，在不脱离本发明的精神和范围内，当可作些许的修改和完善，因此本发明的保护范围当以权利要求书所界定的为准。Although the present invention has been disclosed above with preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art may make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the present invention The scope of protection should be defined by the claims.
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| CN201610230786.5ACN107252339B (en) | 2016-04-14 | 2016-04-14 | Endovascular thrombus aspiration system |
| Application Number | Priority Date | Filing Date | Title |
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| CN201610230786.5ACN107252339B (en) | 2016-04-14 | 2016-04-14 | Endovascular thrombus aspiration system |
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| CN107252339A CN107252339A (en) | 2017-10-17 |
| CN107252339Btrue CN107252339B (en) | 2019-11-08 |
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| CN201610230786.5AActiveCN107252339B (en) | 2016-04-14 | 2016-04-14 | Endovascular thrombus aspiration system |
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