CN110491231A - A kind of biomechanics experiment simulator of endovascular stent implantation - Google Patents
A kind of biomechanics experiment simulator of endovascular stent implantation Download PDFInfo
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Abstract
本发明公开了一种血管内支架植入的生物力学实验模拟装置，涉及医疗器械测试技术领域，其包括计算机、蠕动泵、连接管、储液箱、动脉血管模型、压力调节器和静脉血管模型：所述蠕动泵与连接管相连通，所述连接管的一端与储液箱相连通，所述连接管的另一端与动脉血管模型相连通。该血管内支架植入的生物力学实验模拟装置，通过设置两条病变血管模型，在其中一条病变血管模型内植入支架，另一条不植入血管支架，利用三个压力传感器检测两条病变血管模型数据，经过对比和分析，能够准确明了的得到植入支架后所受到生物压力变化的情况，这样能够精确、明显的反映出数据的变化，从而提高了本装置数据的准确性。
The invention discloses a biomechanical experimental simulation device for intravascular stent implantation, which relates to the technical field of medical device testing, and includes a computer, a peristaltic pump, a connecting pipe, a liquid storage tank, an arterial vessel model, a pressure regulator and a venous vessel model : the peristaltic pump communicates with the connecting tube, one end of the connecting tube communicates with the liquid storage tank, and the other end of the connecting tube communicates with the arterial vessel model. The biomechanical experimental simulation device for intravascular stent implantation sets up two diseased blood vessel models, implants a stent in one of the diseased blood vessel models, and does not implant a blood vessel stent in the other, and uses three pressure sensors to detect the two diseased blood vessels After comparison and analysis of the model data, it is possible to accurately and clearly obtain the change of biological pressure after the implantation of the stent, which can accurately and clearly reflect the change of the data, thereby improving the accuracy of the data of the device.
Description
技术领域technical field
本发明涉及医疗器械测试技术领域，具体为一种血管内支架植入的生物力学实验模拟装置。The invention relates to the technical field of medical device testing, in particular to a biomechanical experiment simulation device for intravascular stent implantation.
背景技术Background technique
血管内支架置入术可应用于动或者静脉系统的局限性狭窄或闭塞，重建血管通道并纠正血流动力学异常，利用穿刺、导管、球囊导管扩张形成和金属内支架置入等技术，使狭窄、闭塞的血管或腔道扩张、再通，解决传统手术盲区的一种技术。Intravascular stenting can be applied to the localized stenosis or occlusion of the arterial or venous system, reconstructing vascular channels and correcting hemodynamic abnormalities, using techniques such as puncture, catheter, balloon catheter expansion and metal stent placement, etc. It is a technique to dilate and recanalize narrowed or occluded blood vessels or lumens to solve the blind spots of traditional surgery.
在血管内支架进行动物实验、临床试验之前，血管内支架可以在体外进行近似真实状况地模拟植入实验测试其力学性能，这将为血管内支架的设计和研发提供尤为直观和客观的评价意见。现有的血管内支架植入实验模拟装置，在植入内支架时，通过采集支架进入血管内生物压力变化的数据，得出支架植入的各项数据，但是这样采集的数据，无法保证数据的准确性，造成实验模拟数据产生误差，从而降低了实验模拟装置的精确性，有可能带来严重的医疗事故。Before the endovascular stent is subjected to animal experiments and clinical trials, the endovascular stent can be simulated in vitro to simulate implantation experiments to test its mechanical properties, which will provide particularly intuitive and objective evaluation opinions for the design and development of the endovascular stent . The existing experimental simulation device for intravascular stent implantation obtains various data of stent implantation by collecting the data of biological pressure changes in the blood vessel when the stent is implanted, but the data collected in this way cannot guarantee the data The accuracy of the experimental simulation data will cause errors, thereby reducing the accuracy of the experimental simulation device, which may cause serious medical accidents.
发明内容Contents of the invention
(一)解决的技术问题(1) Solved technical problems
针对现有技术的不足，本发明提供了一种血管内支架植入的生物力学实验模拟装置，解决了现有的血管内支架植入实验模拟装置，在植入内支架时，通过采集支架进入血管内生物压力变化的数据，得出支架植入的各项数据，但是这样采集的数据，无法保证数据的准确性，造成实验模拟数据产生误差，从而降低了实验模拟装置的精确性，有可能带来严重医疗事故的问题。Aiming at the deficiencies of the prior art, the present invention provides a biomechanical experimental simulation device for intravascular stent implantation, which solves the problem of the existing experimental simulation device for intravascular stent implantation. The data of intravascular biological pressure changes can be used to obtain various data of stent implantation, but the data collected in this way cannot guarantee the accuracy of the data, resulting in errors in the experimental simulation data, thereby reducing the accuracy of the experimental simulation device, which may Bring about the problem of serious medical malpractice.
(二)技术方案(2) Technical solution
为达到以上目的，本发明采取的技术方案是：一种血管内支架植入的生物力学实验模拟装置，包括计算机、蠕动泵、连接管、储液箱、动脉血管模型、压力调节器和静脉血管模型：In order to achieve the above object, the technical solution adopted by the present invention is: a biomechanical experimental simulation device for intravascular stent implantation, including a computer, a peristaltic pump, a connecting tube, a liquid storage tank, an arterial vessel model, a pressure regulator and a venous vessel Model:
所述蠕动泵与连接管相连通，所述连接管的一端与储液箱相连通，所述连接管的另一端与动脉血管模型相连通，所述动脉血管模型的另一端通过压力调节器与静脉血管模型的一端相连通，所述静脉血管模型的另一端与储液箱的上表面相连通；The peristaltic pump communicates with the connecting tube, one end of the connecting tube communicates with the liquid storage tank, the other end of the connecting tube communicates with the arterial vessel model, and the other end of the arterial vessel model communicates with the One end of the venous blood vessel model is connected, and the other end of the venous blood vessel model is connected with the upper surface of the liquid storage tank;
所述动脉血管模型包括两条分支血管模型，且两条分支血管模型内均设置有病变血管模型，且其中一个病变血管模型上设置有高频摄像机，且设置有高频摄像机的病变血管模型左右两侧分别与两个压力传感器相连接，且另一个病变血管模型的右侧与压力传感器相连接，且压力传感器的数量为三个，且位于其中一个病变血管模型的右侧与建立通道管的一端相连通，所述建立通道管的另一端与穿刺接口相连通；The arterial blood vessel model includes two branch blood vessel models, and the two branch blood vessel models are equipped with diseased blood vessel models, and one of the diseased blood vessel models is provided with a high-frequency camera, and the left and right sides of the diseased blood vessel model with the high-frequency camera are set The two sides are respectively connected with two pressure sensors, and the right side of the other diseased blood vessel model is connected with the pressure sensor, and the number of pressure sensors is three, and they are located on the right side of one of the diseased blood vessel models and the side of the established channel tube. One end is connected, and the other end of the channel establishment tube is connected with the puncture interface;
所述动脉血管模型内设置有流量计，所述流量计位于分支血管模型的右侧，且流量计采动脉血管模型内血液流动的数据，经过信号模拟对比分析，显示出人工血液流量波形图；The arterial vessel model is provided with a flowmeter, the flowmeter is located on the right side of the branch vessel model, and the flowmeter collects blood flow data in the arterial vessel model, and after signal simulation and comparative analysis, an artificial blood flow waveform is displayed;
所述计算机通过采集血液流场数据，进行分析和整理，输出脉动频率、信号幅度的指令，经过DA数据模拟信号转换，把相关指令传递到蠕动泵内，控制血液流场，且三个压力传感器采集两条病变血管模型内压力变化的数据，经过相互之间对比和分析，显示出压力波形图；The computer collects the data of the blood flow field, analyzes and sorts it out, and outputs the instructions of the pulsation frequency and signal amplitude, and through the DA data analog signal conversion, transmits the relevant instructions to the peristaltic pump to control the blood flow field, and the three pressure sensors Collect the data of pressure changes in two diseased blood vessel models, and display the pressure waveform after comparing and analyzing each other;
所述高频摄像机实时拍摄病变血管内支架输运、植入、扩张、支撑过程，经过图像处理模块处理和解析，显示出支架运动的图像。The high-frequency camera shoots the process of stent transport, implantation, expansion and support in the diseased blood vessel in real time, and is processed and analyzed by the image processing module to display the moving image of the stent.
优选的，所述病变血管模型的材质为透明硅橡胶，血管长12-15cm、壁厚2.4-3.7mm、入口和出口截面内直径均为3-6cm。Preferably, the diseased blood vessel model is made of transparent silicone rubber, the length of the blood vessel is 12-15 cm, the wall thickness is 2.4-3.7 mm, and the internal diameters of the entrance and exit sections are both 3-6 cm.
优选的，所述储液箱内储存有人工血液，人工血液是人工合成具有携氧功能的氟碳化合物，氟碳代血液是由全氟化合物组成的胶体超微乳剂，具有良好的携氧能力，在一定浓度和氧分压条件下，其氧溶解度为水的20倍，比血液高2倍。Preferably, artificial blood is stored in the liquid storage tank, the artificial blood is artificially synthesized fluorocarbon compound with oxygen-carrying function, and the fluorocarbon blood is a colloidal ultramicroemulsion composed of perfluorinated compounds, which has good oxygen-carrying capacity , under certain concentration and oxygen partial pressure conditions, its oxygen solubility is 20 times that of water and 2 times higher than that of blood.
优选的，所述支架在压力气囊充气加压时产生塑性变形，压力气囊放气后,支架仍保持扩张状态，且支架的材质应该有低屈服应力和高弹性模量，以便在压力气囊充气后，支架弹性回缩小。Preferably, the stent is plastically deformed when the pressure balloon is inflated and pressurized. After the pressure balloon is deflated, the stent remains in an expanded state, and the material of the stent should have low yield stress and high elastic modulus, so that after the pressure balloon is inflated , the bracket elastic back shrinks.
优选的，所述压力调节器调节动脉血管模型和静脉血管模型之间血液的压力。Preferably, the pressure regulator regulates the pressure of blood between the arterial vessel model and the venous vessel model.
(三)有益效果(3) Beneficial effects
本发明的有益效果在于：The beneficial effects of the present invention are:
1、该血管内支架植入的生物力学实验模拟装置，通过设置两条病变血管模型，在其中一条病变血管模型内植入支架，另一条不植入血管支架，利用三个压力传感器检测两条病变血管模型数据，经过对比和分析，能够准确明了的得到植入支架后所受到生物压力变化的情况，这样能够精确、明显的反映出数据的变化，从而提高了本装置数据的准确性。1. The biomechanical experimental simulation device for intravascular stent implantation, by setting up two diseased blood vessel models, a stent is implanted in one of the diseased blood vessel models, and the other is not implanted with a vascular stent, and three pressure sensors are used to detect the After comparison and analysis of the diseased blood vessel model data, the change of biological pressure after implanting the stent can be accurately and clearly obtained, which can accurately and clearly reflect the change of the data, thereby improving the accuracy of the data of the device.
2、该血管内支架植入的生物力学实验模拟装置，通过设置计算机和蠕动泵，使用采集的血液流场具体的数据，计算并分析出脉动频率和信号幅度，经过DA数据模拟信号转换，传递到蠕动泵内，蠕动泵工作，使得动脉血管模型和静脉血管模型内血液循环流动，相似的模拟仿真了人体血流循环系统，同时采用流量计监控血液流场。2. The biomechanical experimental simulation device for intravascular stent implantation uses the specific data of the collected blood flow field to calculate and analyze the pulsation frequency and signal amplitude by setting a computer and a peristaltic pump. After DA data analog signal conversion, transmission Into the peristaltic pump, the peristaltic pump works to make the blood circulation flow in the arterial blood vessel model and the venous blood vessel model. The similar simulation simulates the human blood circulation system, and at the same time, the flow meter is used to monitor the blood flow field.
3、该血管内支架植入的生物力学实验模拟装置，通过设置高频摄像机，在植入支架的过程中，能够观察到支架在血管内运输、植入、扩张和支撑的全过程，方便人们及时调节支架，给人们操作带来了便捷。3. The biomechanical experimental simulation device for intravascular stent implantation can observe the whole process of stent transportation, implantation, expansion and support in the blood vessel during the process of implanting the stent by setting a high-frequency camera, which is convenient for people The timely adjustment of the bracket brings convenience to people's operation.
附图说明Description of drawings
图1为本发明装置整体结构示意图；Fig. 1 is a schematic diagram of the overall structure of the device of the present invention;
图2为计算机控制程序流程框图。Figure 2 is a flow chart of the computer control program.
图中：1计算机、2蠕动泵、3连接管、4储液箱、5动脉血管模型、6压力调节器、7静脉血管模型、8分支血管模型、9病变血管模型、10高频摄像机、11压力传感器、12建立通道管、13压力球囊、14流量计。In the figure: 1 computer, 2 peristaltic pump, 3 connecting pipe, 4 liquid storage tank, 5 arterial vessel model, 6 pressure regulator, 7 venous vessel model, 8 branch vessel model, 9 lesion vessel model, 10 high-frequency camera, 11 Pressure sensor, 12 establish channel tube, 13 pressure balloon, 14 flow meter.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
如图1-2所示，本发明提供一种技术方案：一种血管内支架植入的生物力学实验模拟装置，包括计算机1、蠕动泵2、连接管3、储液箱4、动脉血管模型5、压力调节器6和静脉血管模型7：As shown in Figure 1-2, the present invention provides a technical solution: a biomechanical experimental simulation device for intravascular stent implantation, including a computer 1, a peristaltic pump 2, a connecting tube 3, a liquid storage tank 4, and an arterial vessel model 5. Pressure regulator 6 and venous vessel model 7:
蠕动泵2与连接管3相连通，连接管3的一端与储液箱4相连通，连接管3的另一端与动脉血管模型5相连通，动脉血管模型5的另一端通过压力调节器6与静脉血管模型7的一端相连通，静脉血管模型7的另一端与储液箱4的上表面相连通；The peristaltic pump 2 is connected with the connecting pipe 3, one end of the connecting pipe 3 is connected with the liquid storage tank 4, the other end of the connecting pipe 3 is connected with the arterial vessel model 5, and the other end of the arterial vessel model 5 is connected with the pressure regulator 6 and One end of the venous blood vessel model 7 is connected, and the other end of the venous blood vessel model 7 is connected to the upper surface of the liquid storage tank 4;
动脉血管模型5包括两条分支血管模型8，且两条分支血管模型8内均设置有病变血管模型9，且其中一个病变血管模型9上设置有高频摄像机10，且设置有高频摄像机10的病变血管模型9左右两侧分别与两个压力传感器11相连接，且另一个病变血管模型9的右侧与压力传感器11相连接，且压力传感器11的数量为三个，且位于其中一个病变血管模型9的右侧与建立通道管12的一端相连通，建立通道管12的另一端与穿刺接口13相连通；The arterial blood vessel model 5 includes two branch blood vessel models 8, and the two branch blood vessel models 8 are provided with diseased blood vessel models 9, and one of the diseased blood vessel models 9 is provided with a high-frequency camera 10, and is provided with a high-frequency camera 10 The left and right sides of the diseased blood vessel model 9 are respectively connected to two pressure sensors 11, and the right side of the other diseased blood vessel model 9 is connected to the pressure sensor 11, and the number of pressure sensors 11 is three, and they are located in one of the lesion The right side of the blood vessel model 9 communicates with one end of the channel tube 12, and the other end of the channel tube 12 communicates with the puncture interface 13;
动脉血管模型5内设置有流量计14，流量计14位于分支血管模型8的右侧，且流量计14采动脉血管模型5内血液流动的数据，经过信号模拟对比分析，显示出人工血液流量波形图；The arterial vessel model 5 is provided with a flowmeter 14, the flowmeter 14 is located on the right side of the branch vessel model 8, and the flowmeter 14 collects the data of the blood flow in the arterial vessel model 5, and after signal simulation and comparative analysis, it shows the artificial blood flow waveform picture;
计算机1通过采集血液流场数据，进行分析和整理，输出脉动频率、信号幅度的指令，经过DA数据模拟信号转换，把相关指令传递到蠕动泵2内，控制血液流场，且三个压力传感器11采集两条病变血管模型9内压力变化的数据，经过相互之间对比和分析，显示出压力波形图；Computer 1 collects blood flow field data, analyzes and sorts them out, and outputs pulsation frequency and signal amplitude instructions. After DA data analog signal conversion, the relevant instructions are transmitted to the peristaltic pump 2 to control the blood flow field, and the three pressure sensors 11 Collect the data of the pressure change in the two diseased blood vessel models 9, and display the pressure waveform after comparing and analyzing each other;
高频摄像机10实时拍摄病变血管内支架输运、植入、扩张、支撑过程，经过图像处理模块处理和解析，显示出支架运动的图像。The high-frequency camera 10 shoots the process of stent transport, implantation, expansion, and support in the diseased blood vessel in real time, and is processed and analyzed by the image processing module to display images of the stent movement.
病变血管模型9的材质为透明硅橡胶，血管长12-15cm、壁厚2.4-3.7mm、入口和出口截面内直径均为3-6cm。The diseased blood vessel model 9 is made of transparent silicone rubber. The length of the blood vessel is 12-15 cm, the wall thickness is 2.4-3.7 mm, and the internal diameter of the entrance and exit sections are both 3-6 cm.
储液箱4内储存有人工血液，人工血液是人工合成具有携氧功能的氟碳化合物，氟碳代血液是由全氟化合物组成的胶体超微乳剂，具有良好的携氧能力，在一定浓度和氧分压条件下，其氧溶解度为水的20倍，比血液高2倍。Artificial blood is stored in the liquid storage tank 4. The artificial blood is artificially synthesized fluorocarbon compound with oxygen-carrying function. Fluorocarbon blood is a colloidal ultramicroemulsion composed of perfluorinated compounds, which has good oxygen-carrying capacity. Under the condition of oxygen partial pressure and oxygen partial pressure, its oxygen solubility is 20 times that of water and 2 times higher than that of blood.
支架在压力气囊充气加压时产生塑性变形，压力气囊放气后,支架仍保持扩张状态，且支架的材质应该有低屈服应力和高弹性模量，以便在压力气囊充气后，支架弹性回缩小。The stent undergoes plastic deformation when the pressure balloon is inflated and pressurized. After the pressure balloon is deflated, the stent remains expanded, and the material of the stent should have low yield stress and high elastic modulus, so that the elastic rebound of the stent shrinks after the pressure balloon is inflated. .
压力调节器6调节动脉血管模型5和静脉血管模型7之间血液的压力。The pressure regulator 6 regulates the pressure of blood between the arterial blood vessel model 5 and the venous blood vessel model 7 .
通过设置两条病变血管模型9，在其中一条病变血管模型9内植入支架，另一条不植入血管支架，利用三个压力传感器11检测两条病变血管模型9数据，经过对比和分析，能够准确明了的得到植入支架后所受到生物压力变化的情况，这样能够精确、明显的反映出数据的变化，从而提高了本装置数据的准确性。By setting two diseased blood vessel models 9, a stent is implanted in one of the diseased blood vessel models 9, and the other is not implanted with a blood vessel stent, and three pressure sensors 11 are used to detect the data of the two diseased blood vessel models 9. After comparison and analysis, it is possible to Accurately and clearly obtain the change of the biological pressure received after the stent is implanted, so that the change of the data can be accurately and obviously reflected, thereby improving the accuracy of the data of the device.
通过设置计算机1和蠕动泵2，使用采集的血液流场具体的数据，计算并分析出脉动频率和信号幅度，经过DA数据模拟信号转换，传递到蠕动泵2内，蠕动泵2工作，使得动脉血管模型5和静脉血管模型7内血液循环流动，相似的模拟仿真了人体血流循环系统，同时采用流量计14监控血液流场。By setting the computer 1 and the peristaltic pump 2, using the collected blood flow field specific data, calculate and analyze the pulsation frequency and signal amplitude, after DA data analog signal conversion, transfer to the peristaltic pump 2, the peristaltic pump 2 works, making the arteries The blood circulation in the blood vessel model 5 and the venous blood vessel model 7 is similar to the simulation of the blood circulation system of the human body, and the flow meter 14 is used to monitor the blood flow field.
通过设置高频摄像机10，在植入支架的过程中，能够观察到支架在血管内运输、植入、扩张和支撑的全过程，方便人们及时调节支架，给人们操作带来了便捷。By setting the high-frequency camera 10, during the process of implanting the stent, the whole process of the stent being transported, implanted, expanded and supported in the blood vessel can be observed, which is convenient for people to adjust the stent in time, and brings convenience to people's operation.
本发明的操作步骤为：The operating steps of the present invention are:
S1、使用时，人们首先采集血液流场数据，进行分析和整理，输出脉动频率和信号幅度指令，经过DA数据模拟信号转换，把相关指令传递到蠕动泵2内，控制储液箱4内的人工血液通过连接管3输送到动脉血管模型5内，在压力调节器6的作用下，人工血液通过静脉血管模型7流回储液箱4；S1. When in use, people first collect blood flow field data, analyze and sort them out, output pulsation frequency and signal amplitude commands, and pass the relevant commands to the peristaltic pump 2 after DA data analog signal conversion to control the liquid in the liquid storage tank 4 The artificial blood is transported into the arterial vessel model 5 through the connecting tube 3, and under the action of the pressure regulator 6, the artificial blood flows back to the liquid storage tank 4 through the venous vessel model 7;
S2、在人工血液流通的过程中，人们通过压力球囊13导入支架，在压力传感器11和高频摄像机10的作用下，实现检测病变血管模型9内压力值的变化和支架输运、植入、扩张、支撑过程，在计算机1上显示压力波形图像和支架运动图像。S2. In the process of artificial blood circulation, people introduce the stent through the pressure balloon 13, and under the action of the pressure sensor 11 and the high-frequency camera 10, realize the detection of the change of the pressure value in the diseased blood vessel model 9 and the transportation and implantation of the stent , expansion, and support processes, the pressure waveform image and the stent motion image are displayed on the computer 1 .
以上所述的具体实施方式，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应理解的是，以上所述仅为本发明的具体实施方式而已，并不用于限制本发明，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The specific embodiments described above have further described the purpose, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above descriptions are only specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.
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