CN116773664A - Blood simulation phantom performance detection method and device - Google Patents
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Abstract
Description
技术领域Technical field
本发明涉及医疗器械质量检测领域，尤其是涉及仿血体模性能检测方法以及装置。The present invention relates to the field of medical device quality testing, and in particular to a blood-imitation phantom performance testing method and device.
背景技术Background technique
多普勒原理在超声诊断技术中的成功应用，是20世纪人类在医学和仪器工程领域取得的重大进步之一。超声多普勒频移现象是由于声源与接收器或回波目标(反射体、散射体)相对运动而产生的物理效应。目前临床所用设备的工作模式分为连续波多普勒(CWD)、脉冲波多普勒(PWD)和彩色多普勒血流成像(CFM)三种，涉及的回波目标包括血液中的红血球、心肌、血管壁以及与运动器官紧临的组织，而信息展现和提供方式则包括了多普勒频谱、彩色血流图和可听声信号三种。在具体产品中，国内通称的“彩超”，即国外所称的“三功式(triplex)”仪器，集二维(2D)灰阶成像、多普勒彩色血流图、多普勒能量图、连续和脉冲波多普勒频谱、多普勒声音信号等多种信息形式；国外所称的“双功(duplex)”仪器，即国内所指带有脉冲多普勒频谱和可听声信号输出的高档黑白超；经颅多普勒血流仪、多普勒胎儿脐血流仪只提供与血液流速对应的频谱和声音；胎儿心率(音)仪以声音监测胎儿心率；而近年上市的胎儿监护仪则集脐血流和心率检测于一身。The successful application of the Doppler principle in ultrasonic diagnostic technology is one of the major advances made by mankind in the fields of medicine and instrument engineering in the 20th century. The phenomenon of ultrasonic Doppler frequency shift is a physical effect caused by the relative motion between the sound source and the receiver or echo target (reflector, scatterer). Currently, the working modes of clinical equipment are divided into three types: continuous wave Doppler (CWD), pulsed wave Doppler (PWD) and color Doppler flow imaging (CFM). The echo targets involved include red blood cells and myocardium in the blood. , blood vessel walls, and tissues close to moving organs, and the information display and provision methods include Doppler spectrum, color blood flow map, and audible sound signals. Among the specific products, what is commonly known as "color ultrasound" in China is what is known abroad as "triplex" instrument, which integrates two-dimensional (2D) grayscale imaging, Doppler color blood flow map, and Doppler energy map. , continuous and pulse wave Doppler spectrum, Doppler sound signal and other information forms; the so-called "duplex" instrument abroad is what is referred to domestically as having pulse Doppler spectrum and audible sound signal output High-end black and white ultrasound; transcranial Doppler blood flow meter and Doppler fetal umbilical blood flow meter only provide spectrum and sound corresponding to blood flow rate; fetal heart rate (sound) meter monitors fetal heart rate with sound; and fetal heart rate (sound) meter that has been launched in recent years The monitor integrates umbilical blood flow and heart rate detection.
与其它医用超声仪器一样，为确保其在临床应用中的安全有效，在产品研制、生产、上市批准、购买验收、定期校验以及同类产品的对比等环节上，均须对多普勒系统的性能进行科学检测和客观评价。Like other medical ultrasound instruments, in order to ensure its safety and effectiveness in clinical applications, the Doppler system must be inspected during product development, production, marketing approval, purchase acceptance, regular calibration, and comparison of similar products. Performance is scientifically tested and objectively evaluated.
目前常用仿血体模对多普勒设备的性能进行检测，但仿血体模本身的性能没有一种具体的检测方法和设备，当用性能不合格的仿血体模来检测多普勒设备时，检测的结果准确性低。Currently, blood-imitation phantoms are commonly used to test the performance of Doppler equipment. However, there is no specific testing method or equipment for the performance of the blood-imitation phantom itself. When using unqualified blood-imitation phantoms to test Doppler equipment, When, the accuracy of the detection results is low.
发明内容Contents of the invention
为了克服现有技术的不足，本发明的目的之一在于提供一种仿血体模性能检测方法，能够检测仿血体模的性能，提高多普勒设备检测准确率。In order to overcome the shortcomings of the existing technology, one of the purposes of the present invention is to provide a method for detecting the performance of a simulated blood phantom, which can detect the performance of the simulated blood phantom and improve the detection accuracy of Doppler equipment.
为了克服现有技术的不足，本发明的目的之二在于提供一种仿血体模性能检测装置，能够检测仿血体模的性能，提高多普勒设备检测准确率。In order to overcome the shortcomings of the existing technology, the second object of the present invention is to provide a performance detection device of a simulated blood phantom, which can detect the performance of the simulated blood phantom and improve the detection accuracy of Doppler equipment.
本发明的目的之一采用如下技术方案实现：One of the purposes of the present invention is achieved by adopting the following technical solutions:
一种仿血体模性能检测方法，包括以下步骤：A method for testing the performance of a simulated blood phantom, including the following steps:
S1:仿血液以速度v进入仿血体模的仿血管；S1: Simulated blood enters the simulated blood vessel of the simulated blood body model at speed v;
S2:激光换能器发出频率为f的激光照射到仿血管中的仿血液，激光在仿血液中的速度为c，仿血液接收到的激光频率为β为移动后的仿血液与激光换能器的连线与速度方向的夹角；S2: The laser transducer emits a laser with frequency f and irradiates the imitation blood in the imitation blood vessel. The speed of the laser in the imitation blood is c. The frequency of the laser received by the imitation blood is β is the angle between the line connecting the moved imitation blood and the laser transducer and the speed direction;
S3:仿血液将激光反射给激光换能器，激光换能器接收到的反射激光频率为 S3: The imitation blood reflects the laser to the laser transducer. The frequency of the reflected laser received by the laser transducer is
S4:计算仿血体模的多普勒频移fd＝f″-f；S4: Calculate the Doppler frequency shift f d = f″-f of the blood-imitation phantom;
S5:将计算出的多普勒频移量fd与仿血体模多普勒频移量的理论值进行比较，判断仿血体模性能。S5: Compare the calculated Doppler frequency shift f d with the theoretical value of the Doppler frequency shift of the blood-imitation phantom to determine the performance of the blood-imitation phantom.
进一步的，在步骤S1中，通过泵驱动所述仿血液以速度v进入仿血体模的仿血管，通过流量计监测所述仿血液的速度。Further, in step S1, the simulated blood is driven by a pump to enter the simulated blood vessel of the simulated blood phantom at a speed v, and the speed of the simulated blood is monitored by a flow meter.
进一步的，所述仿血管与水平面成45度角，β为45度， Further, the artificial blood vessel forms an angle of 45 degrees with the horizontal plane, and β is 45 degrees.
进一步的，在步骤S5中，当计算出的多普勒频移量fd与仿血体模多普勒频移量的理论值的差值在小于等于5％，判断仿血体模性能合格；当多普勒频移量fd与仿血体模多普勒频移量的理论值的差值大于5％，判断仿血体模性能不合格。Further, in step S5, when the difference between the calculated Doppler frequency shift amount f d and the theoretical value of the Doppler frequency shift amount of the artificial blood phantom is less than or equal to 5%, the performance of the artificial blood phantom is judged to be qualified. ; When the difference between the Doppler frequency shift amount f d and the theoretical value of the Doppler frequency shift amount of the artificial blood phantom is greater than 5%, the performance of the artificial blood phantom is judged to be unqualified.
进一步的，所述仿血体模中填充仿血组织。Further, the imitated blood phantom is filled with imitated blood tissue.
本发明的目的之二采用如下技术方案实现：The second object of the present invention is achieved by adopting the following technical solutions:
一种仿血体模性能检测装置，用于实施上述仿血体模性能检测方法，包括储存罐、驱动泵、激光换能器以及仿血管，所述储存罐、所述驱动泵以及仿血体模通过所述仿血管连通，所述仿血管部分位于所述仿血体模中并与水平面形成夹角，所述驱动泵驱动所述储存罐内的仿血液以预设速度沿仿血管进入仿血体模，所述激光换能器向仿血体模中的仿血管发射激光，并接收仿血液反射的激光。An imitation blood phantom performance testing device used to implement the above-mentioned imitation blood phantom performance detection method, including a storage tank, a driving pump, a laser transducer and an imitation blood vessel, the storage tank, the driving pump and the imitation blood phantom The model is connected through the simulated blood vessel. The simulated blood vessel part is located in the simulated blood phantom and forms an angle with the horizontal plane. The driving pump drives the simulated blood in the storage tank to enter the simulated blood vessel along the simulated blood vessel at a preset speed. Blood phantom, the laser transducer emits laser to the imitated blood vessels in the imitated blood phantom, and receives the laser reflected by the imitated blood.
进一步的，还包括流量计，所述流量计安装于所述仿血管，监测所述仿血液的速度。Furthermore, it also includes a flow meter, which is installed on the simulated blood vessel and monitors the speed of the simulated blood.
进一步的，所述仿血管由聚四氟乙烯或聚乙烯制成。Further, the artificial blood vessel is made of polytetrafluoroethylene or polyethylene.
进一步的，位于所述仿血体模中的所述仿血管与水平面呈45°夹角。Further, the artificial blood vessel located in the artificial blood phantom forms an included angle of 45° with the horizontal plane.
进一步的，所述激光换能器位于所述仿血体模上方。Further, the laser transducer is located above the imitation blood phantom.
相比现有技术，本发明仿血体模性能检测方法通过采用激光换能器发出频率为f的激光照射到仿血管中的速度为c仿血液上，仿血液将激光反射至激光换能器，通过计算仿血液接收到的激光频率f'来计算激光换能器接收到的反射激光频率f”，从而计算出仿血体模的多普勒频移量，并将计算出的多普勒频移量fd与仿血体模多普勒频移量的理论值进行比较，从而评价仿血体模的性能。Compared with the existing technology, the performance detection method of the imitation blood phantom of the present invention uses a laser transducer to emit a laser with a frequency of f and irradiate it onto the imitation blood at a speed of c, and the imitation blood reflects the laser to the laser transducer. , by calculating the laser frequency f' received by the simulated blood, the reflected laser frequency f" received by the laser transducer is calculated, thereby calculating the Doppler frequency shift of the simulated blood phantom, and the calculated Doppler The frequency shift amount f d is compared with the theoretical value of the Doppler frequency shift amount of the artificial blood phantom to evaluate the performance of the artificial blood phantom.
附图说明Description of drawings
图1为本发明仿血体模性能检测方法的流程图；Figure 1 is a flow chart of the blood-imitation phantom performance testing method of the present invention;
图2为本发明仿血体模性能检测装置的结构示意图。Figure 2 is a schematic structural diagram of the blood-imitation phantom performance testing device of the present invention.
图中：10、储存罐；20、驱动泵；30、流量计；40、仿血管；50、激光换能器；201、仿血体模；200、仿血组织。In the picture: 10. Storage tank; 20. Drive pump; 30. Flow meter; 40. Imitation blood vessel; 50. Laser transducer; 201. Imitation blood phantom; 200. Imitation blood tissue.
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 technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.
需要说明的是，当组件被称为“固定于”另一个组件，它可以直接在另一个组件上或者也可以存在另一中间组件，通过中间组件固定。当一个组件被认为是“连接”另一个组件，它可以是直接连接到另一个组件或者可能同时存在另一中间组件。当一个组件被认为是“设置于”另一个组件，它可以是直接设置在另一个组件上或者可能同时存在另一中间组件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的。It should be noted that when a component is referred to as being "fixed to" another component, it can be directly on the other component or another intermediate component may be present through which it is fixed. When a component is said to be "connected" to another component, it can be directly connected to the other component or there may be another intermediate component present at the same time. When a component is said to be "disposed on" another component, it can be directly located on the other component or another intervening component may be present. The terms "vertical," "horizontal," "left," "right" and similar expressions are used herein for illustrative purposes only.
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which the invention belongs. The terminology used herein in the description of the invention is for the purpose of describing specific embodiments only and is not intended to limit the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
图1为本发明仿血体模性能检测方法的流程图，本发明仿血体模性能检测方法包括以下步骤：Figure 1 is a flow chart of the blood imitation phantom performance detection method of the present invention. The blood imitation phantom performance detection method of the present invention includes the following steps:
S1:仿血液以速度v进入仿血体模的仿血管；S1: Simulated blood enters the simulated blood vessel of the simulated blood body model at speed v;
S2:激光换能器发出频率为f的激光照射到仿血管中的仿血液，激光在仿血液中的速度为c，仿血液接收到的激光频率为 S2: The laser transducer emits a laser with frequency f and irradiates the imitation blood in the imitation blood vessel. The speed of the laser in the imitation blood is c. The frequency of the laser received by the imitation blood is
S3:仿血液将激光反射给激光换能器，激光换能器接收到的反射激光频率为β为移动后的仿血液与激光换能器的连线与速度方向的夹角，β为移动后的仿血液与激光换能器的连线与速度方向的夹角；S3: The imitation blood reflects the laser to the laser transducer. The frequency of the reflected laser received by the laser transducer is β is the angle between the line connecting the moved imitation blood and the laser transducer and the velocity direction; β is the angle between the line connecting the moved imitation blood and the laser transducer and the velocity direction;
S4:计算仿血体模的多普勒频移量fd＝f″-f；S4: Calculate the Doppler frequency shift f d = f″-f of the blood-imitation phantom;
S5:将计算出的多普勒频移量fd与仿血体模多普勒频移量的理论值进行比较，判断仿血体模性能。S5: Compare the calculated Doppler frequency shift f d with the theoretical value of the Doppler frequency shift of the blood-imitation phantom to determine the performance of the blood-imitation phantom.
具体的，在步骤S1中，通过泵驱动仿血液以速度v进入仿血体模的仿血管，通过流量计监测仿血液的速度，流量计检测的流速范围为1.6ml/s～16ml/s。检测温度为25℃。仿血液颗粒浓度范围达到正常人的血细胞比容水平(40％左右)。仿血管采用聚四氟乙烯或者聚乙烯材质，贴合人体血管材质。仿血管与水平面成45度角，β为45度，在步骤S5中，当计算出的多普勒频移量fd与仿血体模多普勒频移量的理论值的差值在小于等于5％，判断仿血体模性能合格；当多普勒频移量fd与仿血体模多普勒频移量的理论值的差值大于5％，判断仿血体模性能不合格。Specifically, in step S1, the simulated blood is driven by a pump to enter the simulated blood vessel of the simulated blood phantom at a speed v, and the speed of the simulated blood is monitored by a flow meter. The flow rate detected by the flow meter ranges from 1.6ml/s to 16ml/s. The detection temperature is 25℃. The concentration range of imitation blood particles reaches the hematocrit level of normal people (about 40%). The imitation blood vessels are made of polytetrafluoroethylene or polyethylene and fit the material of human blood vessels. The angle between the artificial blood vessel and the horizontal plane is 45 degrees, and β is 45 degrees. In step S5, when the difference between the calculated Doppler frequency shift amount f d and the theoretical value of the Doppler frequency shift amount of the artificial blood phantom is less than or equal to 5%, the performance of the artificial blood phantom is judged to be qualified; when more than If the difference between the Puler frequency shift amount f d and the theoretical value of the Doppler frequency shift amount of the artificial blood phantom is greater than 5%, the performance of the artificial blood phantom is judged to be unqualified.
请继续参阅图2，本发明还涉及仿血体模性能检测装置，用于实施上述仿血体模性能检测方法，仿血体模性能检测装置用于检测仿血体模201。Please continue to refer to Figure 2. The present invention also relates to a blood-imitation phantom performance detection device, which is used to implement the above blood-imitation phantom performance detection method. The blood-imitation phantom performance detection device is used to detect the blood-imitation phantom 201.
仿血体模201内部填充仿血组织200，具体的，仿血体模201的结构如公开号CN109431541A，名称为一种超声多普勒仿血流体模的专利所示，仿血体模201外壳采用亚克力板，长底面板有两个孔，通过真空封闭橡皮封堵，用来填充仿组织材料。仿血组织200材料选用水性凝胶基高分子复合材料。上面板有一个孔，用来安装激光换能器。激光换能器的作用是发射激光和接收散射回来的激光。两个仿血管互相平行并于地面成45度角。两个仿血管内径分别为8mm、壁厚1.65mm，4mm、壁厚0.8mm。两个管子之间有渐变通道，用宝塔螺纹接头。The interior of the imitated blood phantom 201 is filled with imitated blood tissue 200. Specifically, the structure of the imitated blood phantom 201 is shown in a patent titled an ultrasonic Doppler imitated blood fluid phantom with publication number CN109431541A. The imitated blood phantom 201 The outer shell is made of acrylic panels, and the long bottom panel has two holes, which are sealed by vacuum sealing rubber and used to fill the tissue-like material. The material of imitation blood tissue 200 is a water-based gel-based polymer composite. The upper panel has a hole for mounting the laser transducer. The function of the laser transducer is to emit laser light and receive the scattered laser light. The two artificial blood vessels are parallel to each other and at an angle of 45 degrees to the ground. The inner diameters of the two simulated blood vessels are 8mm, wall thickness 1.65mm, and 4mm, wall thickness 0.8mm. There is a gradual channel between the two pipes, using a pagoda threaded joint.
仿血体模性能检测装置包括储存罐10、驱动泵20、流量计30、仿血管40以及激光换能器50。The simulated blood phantom performance testing device includes a storage tank 10 , a driving pump 20 , a flow meter 30 , a simulated blood vessel 40 and a laser transducer 50 .
储存罐10用于存储仿血液，仿血液颗粒浓度范围达到正常人的血细胞比容水平(40％左右)。The storage tank 10 is used to store imitation blood, and the imitation blood particle concentration range reaches the hematocrit level of normal people (about 40%).
驱动泵20用于驱动储存罐10内的仿血液以速度v沿仿血管40流动。驱动泵20通过仿血管40与储存罐10连通。The driving pump 20 is used to drive the simulated blood in the storage tank 10 to flow along the simulated blood vessel 40 at a speed v. The driving pump 20 communicates with the storage tank 10 through the artificial blood vessel 40 .
流量计30安装于仿血管40上，用于监测仿血液的速度，流量计检测的流速范围为1.6ml/s～16ml/s。The flow meter 30 is installed on the imitation blood vessel 40 and is used to monitor the speed of the imitation blood. The flow rate range detected by the flow meter is 1.6ml/s～16ml/s.
仿血管40用于连接储存罐10以及驱动泵20，并且仿血管40贯穿仿血体模201。位于仿血体模201中的仿血管40与水平面形成夹角。在本实施例中，位于仿血体模201中的仿血管40与水平面的夹角为45度。仿血管40采用聚四氟乙烯或者聚乙烯材质，贴合人体血管材质。The artificial blood vessel 40 is used to connect the storage tank 10 and the driving pump 20 , and the artificial blood vessel 40 penetrates the artificial blood phantom 201 . The artificial blood vessel 40 located in the artificial blood phantom 201 forms an angle with the horizontal plane. In this embodiment, the angle between the artificial blood vessel 40 located in the artificial blood phantom 201 and the horizontal plane is 45 degrees. The imitation blood vessel 40 is made of polytetrafluoroethylene or polyethylene and fits the material of human blood vessels.
激光换能器50能够发出波长为λ，频率为f的激光。激光换能器50位于仿血体模201上部，激光换能器50发出的激光照射至仿血体模201内部的仿血管40中移动的仿血液上，仿血液将激光反射至激光换能器50。The laser transducer 50 can emit laser light with a wavelength λ and a frequency f. The laser transducer 50 is located on the upper part of the imitation blood phantom 201. The laser emitted by the laser transducer 50 is irradiated onto the imitation blood moving in the imitation blood vessels 40 inside the imitation blood phantom 201. The imitation blood reflects the laser to the laser transducer 50. .
使用仿血体模性能检测装置时，驱动泵20驱动储存罐10内的仿血液以速度v沿仿血管40流动，进入仿血体模201内的仿血管40中。流量计30监测仿血液的速度。激光换能器50发出频率为f的激光，激光在仿血液中的速度为c，仿血液接收到的激光频率为仿血液将激光反射给激光换能器50，激光换能器50接收到的反射激光频率为/>β为移动后的仿血液与激光换能器50的连线与速度v方向的夹角。计算仿血体模201的多普勒频移量fd＝f″-f，将计算出的多普勒频移量fd与仿血体模201多普勒频移量的理论值进行比较，判断仿血体模201性能。When using the artificial blood phantom performance testing device, the driving pump 20 drives the artificial blood in the storage tank 10 to flow along the artificial blood vessel 40 at a speed v and enter the artificial blood vessel 40 in the artificial blood phantom 201 . Flow meter 30 monitors the speed of the simulated blood. The laser transducer 50 emits a laser with a frequency f, the speed of the laser in the imitation blood is c, and the frequency of the laser received by the imitation blood is The imitation blood reflects the laser to the laser transducer 50, and the frequency of the reflected laser received by the laser transducer 50 is/> β is the angle between the line connecting the moved imitation blood and the laser transducer 50 and the speed v direction. Calculate the Doppler frequency shift amount f d of the artificial blood phantom 201 = f″-f, and compare the calculated Doppler frequency shift amount f d with the theoretical value of the Doppler frequency shift amount of the artificial blood phantom 201 , to judge the performance of imitation blood phantom 201.
以上实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进演变，都是依据本发明实质技术对以上实施例做的等同修饰与演变，这些都属于本发明的保护范围。The above embodiments only express several embodiments of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present invention, which are equivalent modifications to the above embodiments based on the essential technology of the present invention. and evolution, these all belong to the protection scope of the present invention.
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