A performance test system for ultrasonic Doppler diagnostic instrument

Abstract

The present invention discloses a performance test system for an ultrasonic Doppler diagnostic instrument, and belongs to the technical field of medical devices. The test system comprises a simulated phantom, a simulated blood vessel, a circulation module and a detection module. The simulated phantom is made of a mixture of agar, silicon dioxide and water, and is used to simulate the acoustic and physical properties of human tissues, and provide test conditions for the target to be detected. The simulated blood vessel passes through the simulated phantom, and simulated blood is passed into the simulated blood vessel to simulate the human vascular environment. The circulation module provides the flow power of the simulated blood and controls the fluid dynamic parameters. The detection module obtains and analyzes the difference between the real-time detection data of the diagnostic instrument to be detected and the preset data, and outputs a performance evaluation. The material of the simulated phantom and the design of different detection sections enable the system to evaluate the performance of the ultrasonic Doppler diagnostic instrument under a variety of detection conditions.

Description

Technical Field

[0001] The invention belongs to the technical field of medical equipment, and in particular relates to a performance testing system for an ultrasonic Doppler diagnostic instrument. Background Art

[0002] With the advancement of medical diagnostic technology, ultrasonic Doppler diagnostic instruments play an increasingly important role in clinical applications. Ultrasonic Doppler diagnostic instruments can provide dynamic images of blood flow velocity and direction, which is particularly critical for the diagnosis of cardiovascular diseases. However, since the performance of the equipment is affected by many factors, its testing and calibration become necessary steps to ensure the accuracy of diagnosis. Currently, the performance testing of ultrasonic Doppler diagnostic instruments on the market mostly relies on standard phantoms, but these phantoms are often expensive and difficult to simulate various clinical situations.

[0003] According to the disclosed technical solutions, the announcement number CN106333707B discloses an ultrasonic Doppler spectrum correction method and device, which obtains Doppler frequency shift information detected according to ultrasonic echo signals in real time, detects changes in Doppler frequency shift information, and determines whether the changes in Doppler frequency shift information exceed a first set threshold. When the change in Doppler frequency shift information is greater than or equal to the first set threshold, Doppler scanning correction is started, and the Doppler scanning correction at least includes sampling line angle correction and blood flow direction correction, so that the ultrasonic diagnostic system transmits ultrasonic waves to the detected body tissue according to the corrected Doppler scanning parameters; the technical solution with the publication number CN110058055A proposes an ultrasonic transcranial Doppler blood flow analysis calibration system, which simulates human blood flow parameters to perform and realize TCD instrument blood flow parameter measurement detection; the technical solution with the publication number JP2009119299A proposes an ultrasonic adjustment circuit that can be used for different materials, so that the optimal ultrasonic working parameters can be automatically adjusted in the detection operation of different materials to ensure the detection quality.

[0004] The above technical solutions all propose a variety of technical solutions for optimizing or improving ultrasonic Doppler diagnostic instruments, but more solutions are needed for methods of evaluating the actual performance of diagnostic instruments by simulating real usage scenarios.

[0005] The foregoing discussion of the background art is intended only to facilitate an understanding of the present invention. This discussion does not acknowledge or admit that any of the material referred to is part of the common general knowledge. Summary of the invention

[0006] The purpose of the present invention is to provide a performance test system for an ultrasonic Doppler diagnostic instrument, which belongs to the technical field of medical devices. The test system includes a simulated phantom, a simulated blood vessel, a circulation module and a detection module. The simulated phantom is made of a mixture of agar, silica and water, and is used to simulate the acoustic and physical properties of human tissue and provide test conditions for the target to be detected. The simulated blood vessel passes through the simulated phantom, and simulated blood is passed into it to simulate the human vascular environment. The circulation module provides the flow power of the simulated blood and controls the fluid dynamic parameters. The detection module obtains and analyzes the difference between the real-time detection data of the diagnostic instrument to be detected and the preset data, thereby outputting a performance evaluation. The material of the simulated phantom and the design of different detection sections enable the system to evaluate the performance of the ultrasonic Doppler diagnostic instrument under a variety of detection conditions.

[0007] The present invention adopts the following technical solution: a performance test system of an ultrasonic Doppler diagnostic instrument, the test system is connected to a target to be detected, and comprises:

[0008] A simulation phantom, used to simulate the acoustic and physical properties of human tissue and provide test conditions for the target to be detected; the simulation phantom is a mixture of agar, silicon dioxide and water;

[0009] The simulated blood vessel is configured to be embedded in the simulated phantom, has a sufficient length to meet the detection of the target to be detected, and is provided with external input and output ends, and simulated blood is passed into the simulated blood vessel to simulate the vascular environment of the human body;

[0010] A circulation module, configured to connect the input end and the output end of the simulated blood vessel to provide the simulated blood with flow power and simultaneously control the fluid dynamic parameters of the simulated blood;

[0011] A detection module, configured to obtain a detection result of the target to be detected so as to evaluate the detection performance of the target to be detected;

[0012] The test system detects the simulated blood in the simulated blood vessel by using the target to be detected, collects and analyzes the real-time detection data of the target to be detected, and outputs the performance evaluation of the target to be detected after comparing the real-time detection data with the preset simulation detection data;

[0013] Wherein, the detection module comprises:

[0014] a target generation unit, communicatively coupled to the circulation module and configured to generate control instructions to the circulation module so that the circulation module generates a fluid state of simulated blood having specified fluid dynamic parameters;

[0015] A verification unit, comprising a plurality of sensors disposed inside the simulated blood vessel, configured to detect the physical parameters of the simulated blood in real time to determine whether the physical parameters of the simulated blood meet preset targets;

[0016] An evaluation unit, communicatively coupled to the target to be detected, configured to collect and analyze real-time detection data of the target to be detected, and output a performance evaluation of the target to be detected after comparing the real-time detection data with preset simulation detection data;

[0017] Preferably, the target to be detected is an ultrasonic Doppler diagnostic instrument;

[0018] Preferably, the fluid dynamic parameters include at least: flow velocity, flow direction, and fluid pressure;

[0019] Preferably, the simulated phantom has two or more materials with different component ratios on the radial side of the simulated blood vessel, so that at least two detection characteristics are generated on the radial side of the simulated blood vessel;

[0020] Preferably, the simulation phantom includes a plurality of detection segments; each of the detection segments has a detection thickness different from that of other detection segments; the detection thickness is the minimum distance between the surface of the detection segment and the simulated blood vessel inside;

[0021] Preferably, the detection module further comprises an interference signal generating unit; the interference signal generating unit is configured to generate a simulated interference signal controlled by the target generating unit;

[0022] Preferably, the detection characteristic refers to one or more of the following physical characteristics of the simulation phantom: density, attenuation rate of ultrasound waves, and hardness;

[0023] Furthermore, a method for testing the performance of an ultrasonic Doppler diagnostic instrument is proposed. The method is applied to the ultrasonic Doppler diagnostic instrument performance testing system. The method comprises the following steps:

[0024] S100: connecting the simulated blood vessel and the circulation module to form a closed fluid loop;

[0025] S200: setting a set of fluid dynamic parameters, starting the circulation module and waiting for the fluid dynamic parameters in the simulated blood vessel to stabilize;

[0026] S300: using the target to be detected to detect the simulated blood vessels in multiple detection segments of the simulated phantom, and collecting multiple detection results;

[0027] S400: After one of the detection conditions is met, the test of the fluid dynamic parameters of this group is completed;

[0028] Execute step S200 to step S400 in a loop until all the set multiple groups of fluid dynamic parameters are tested;

[0029] Preferably, the set of fluid dynamic parameters refers to a combination of multiple fluid dynamic parameters with different values ​​under the detection characteristics of the same simulated blood vessel;

[0030] Preferably, the detection conditions include at least the following conditions:

[0031] Complete the specified number of tests when the detection error in each test is less than the preset error threshold;

[0032] In tests greater than n times, the average detection error of the actual test value is greater than the preset error threshold;

[0033] In tests greater than n times, the variance of the actual test value is greater than a preset variance threshold.

[0034] The beneficial effects achieved by the present invention are:

[0035] The test system of the present invention uses a simulated phantom made of a mixture of agar, silicon dioxide and water, which can realistically simulate the acoustic and physical properties of human tissues; simulated blood is introduced into the simulated blood vessels to reproduce the human vascular environment; this precise simulation enables the test system to evaluate the performance of the ultrasonic Doppler diagnostic instrument under conditions close to the real human environment, thereby improving the accuracy and credibility of the test results;

[0036] The testing system of the present invention can evaluate the performance of the target to be tested under various testing conditions by setting different testing characteristics and testing thicknesses on the simulation phantom.

[0037] The test system of the present invention provides a variety of test conditions by controlling the fluid dynamic parameters of simulated blood, including flow rate, flow direction and fluid pressure; the detection module not only collects real-time detection data, but also performs precise control and monitoring through the target generation unit and the verification unit; the evaluation unit compares the real-time detection data with the preset simulation data and outputs a detailed performance evaluation report; this multi-dimensional evaluation method can comprehensively and meticulously reflect the various performances of the target to be detected, ensuring its reliability under various conditions;

[0038] The software and hardware parts of the test system of the present invention adopt a modular design, which is convenient for future upgrading or replacement of related software and hardware environments and reduces the cost of use. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The present invention can be further understood from the following description in conjunction with the accompanying drawings. The components in the figures are not necessarily drawn to scale, but the emphasis is placed on illustrating the principles of the embodiments. In different views, the same reference numerals designate corresponding parts.

[0040] Description of serial numbers: 1-test system; 2-simulation phantom; 3-simulation blood vessel; 4-circulation module; 5-detection module; 10-ultrasound Doppler diagnostic instrument; 11-probe; 12-beamformer; 13-image processing unit; 14-display unit; 15-control unit; 16-user input unit; 21-top surface; 22-bottom surface; 23-detection section; 24-detection plane; 31-sector-shaped part; 500-computer system; 502-bus; 504-processor; 506-main memory; 508-read-only memory; 510-storage device; 512-display; 514-input device; 516-cursor control device; 518-network device;

[0041] Figure 1 A schematic diagram of the framework of the test system of the present invention

[0042] Figure 2 is a schematic diagram of the ultrasonic Doppler diagnostic instrument described in an embodiment of the present invention;

[0043] Figure 3 is a schematic side view of a simulation phantom with a set flow direction x perpendicular to the simulated blood vessel in an embodiment of the present invention;

[0044] Figure 4 is a schematic diagram of the AA section of a simulation phantom with a set flow direction parallel to the simulated blood vessel in an embodiment of the present invention;

[0045] Figure 5 Schematic diagram of a computer system used by a detection module in an embodiment of the present invention. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical solutions and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with its embodiments; it should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention. For those skilled in the art, other systems, methods and / or features of this embodiment will become apparent after reviewing the following detailed description. It is intended that all such additional systems, methods, features and advantages are included in this specification. Included within the scope of the present invention and protected by the appended claims. Additional features of the disclosed embodiments are described in the following detailed description, and these features will be apparent from the following detailed description.

[0047] The same or similar reference numerals in the drawings of the embodiments of the present invention correspond to the same or similar components; in the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right" and the like indicating the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, it is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or component referred to must have a specific orientation. The invention is constructed and operated in a specific orientation, so the terms describing the positional relationship in the drawings are only used for exemplary description and cannot be understood as a limitation of this patent. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to the specific circumstances.

[0048] Embodiment 1: Exemplarily, a performance test system of an ultrasonic Doppler diagnostic instrument is proposed, wherein the test system is connected to a target to be detected and comprises:

[0049] A simulation phantom, used to simulate the acoustic and physical properties of human tissue and provide test conditions for the target to be detected; the simulation phantom is a mixture of agar, silicon dioxide and water;

[0050] The simulated blood vessel is configured to be embedded in the simulated phantom, has a sufficient length to meet the detection of the target to be detected, and is provided with external input and output ends, and simulated blood is passed into the simulated blood vessel to simulate the vascular environment of the human body;

[0051] A circulation module, configured to connect the input end and the output end of the simulated blood vessel to provide the simulated blood with flow power and simultaneously control the fluid dynamic parameters of the simulated blood;

[0052] A detection module, configured to obtain a detection result of the target to be detected so as to evaluate the detection performance of the target to be detected;

[0053] The test system detects the simulated blood in the simulated blood vessel by using the target to be detected, collects and analyzes the real-time detection data of the target to be detected, and outputs the performance evaluation of the target to be detected after comparing the real-time detection data with the preset simulation detection data;

[0054] Wherein, the detection module includes:

[0055] a target generation unit, communicatively coupled to the circulation module and configured to generate control instructions to the circulation module so that the circulation module generates a fluid state of simulated blood having specified fluid dynamic parameters;

[0056] A verification unit, comprising a plurality of sensors disposed inside the simulated blood vessel, configured to detect the physical parameters of the simulated blood in real time to determine whether the physical parameters of the simulated blood meet preset targets;

[0057] An evaluation unit, communicatively coupled to the target to be detected, configured to collect and analyze real-time detection data of the target to be detected, and output a performance evaluation of the target to be detected after comparing the real-time detection data with preset simulation detection data;

[0058] Preferably, the target to be detected is an ultrasonic Doppler diagnostic instrument;

[0059] Preferably, the fluid dynamic parameters include at least: flow velocity, flow direction, and fluid pressure;

[0060] Preferably, the simulated phantom has two or more materials with different component ratios on the radial side of the simulated blood vessel, so that at least two detection characteristics are generated on the radial side of the simulated blood vessel;

[0061] Preferably, the simulation phantom includes a plurality of detection segments; each of the detection segments has a detection thickness different from that of other detection segments; the detection thickness is the minimum distance between the surface of the detection segment and the simulated blood vessel inside;

[0062] Preferably, the detection module further comprises an interference signal generating unit; the interference signal generating unit is configured to generate a simulated interference signal controlled by the target generating unit;

[0063] Preferably, the detection characteristic refers to one or more of the following physical characteristics of the simulation phantom: density, attenuation rate of ultrasound waves, and hardness;

[0064] Furthermore, a method for testing the performance of an ultrasonic Doppler diagnostic instrument is proposed. The method is applied to the ultrasonic Doppler diagnostic instrument performance testing system. The method comprises the following steps:

[0065] S100: connecting the simulated blood vessel and the circulation module to form a closed fluid loop;

[0066] S200: setting a set of fluid dynamic parameters, starting the circulation module and waiting for the fluid dynamic parameters in the simulated blood vessel to stabilize;

[0067] S300: using the target to be detected to detect the simulated blood vessels in multiple detection segments of the simulated phantom, and collecting multiple detection results;

[0068] S400: After one of the detection conditions is met, the test of the fluid dynamic parameters of this group is completed;

[0069] Execute step S200 to step S400 in a loop until all the set multiple groups of fluid dynamic parameters are tested;

[0070] Preferably, the set of fluid dynamic parameters refers to a combination of multiple fluid dynamic parameters with different values ​​under the detection characteristics of the same simulated blood vessel;

[0071] Preferably, the detection conditions include at least the following conditions:

[0072] Complete the specified number of tests when the detection error in each test is less than the preset error threshold;

[0073] In tests greater than n times, the average detection error of the actual test value is greater than the preset error threshold;

[0074] In tests greater than n times, the variance of the actual test value is greater than the preset variance threshold;

[0075] As attached Figure 1 As shown, it is a schematic diagram of a framework of an exemplary embodiment of the test system; the target to be detected is an ultrasonic Doppler diagnostic instrument 10; the ultrasonic Doppler diagnostic instrument 10 is communicatively coupled to the detection module 5; preferably, the detection data and working parameters of the ultrasonic Doppler diagnostic instrument 10 can be collected by the detection module 5 through the communication line and stored in the memory inside the detection module 5 for subsequent use;

[0076] The test system further includes a simulation phantom 2; the simulation phantom 2 includes a simulation blood vessel 3 that runs through the simulation phantom 2; the number of the simulation blood vessels 3 may be 1 or 2; preferably, 2 simulation blood vessels 3 may be provided to simultaneously detect simulated blood having two flow directions; preferably, the simulation blood vessel may be a silicone rubber tube; the inner diameter of the simulation blood vessel 3 may be any size of 3 mm to 8 mm;

[0077] Further, each simulated blood vessel 3 is connected to a circulation module 4;

[0078] Preferably, the circulation module 4 can be provided with fluid power required for simulating blood flow by a device such as a peristaltic pump, a plunger pump, a gear pump, or an electromagnetic pump; the circulation module 4 can have a flow control valve to control the on-off of the simulated blood in the simulated blood vessel, and further finely control fluid parameters such as the flow rate and pressure of the simulated blood;

[0079] Preferably, the detection module 5 may include a variety of sensors to directly monitor the real fluid parameters of the simulated blood in the simulated blood vessel to ensure the accuracy and reliability of the test; these sensors include flow sensors, pressure sensors, ultrasonic flow sensors and temperature sensors, etc.; the flow sensor can monitor the flow rate of the simulated blood in real time to ensure that it meets the preset fluid dynamic parameters; the pressure sensor is used to measure the fluid pressure in the blood vessel to ensure that the fluid remains stable under different test conditions; the ultrasonic flow sensor directly measures the speed and direction of the fluid through the ultrasonic Doppler effect to provide high-precision flow rate data; the temperature sensor is used to monitor the temperature of the fluid to ensure that the fluid dynamic parameters are not affected by temperature changes; these sensors work together to collect and analyze the fluid parameters of the simulated blood in real time to ensure the accuracy and reliability of the test results, thereby providing reliable data support for the performance evaluation of the ultrasonic Doppler diagnostic instrument;

[0080] Preferably, the detection module 5 is communicatively coupled to store the collected real-time data in an internal memory for comparison with the detection value of the ultrasonic Doppler diagnostic instrument 10;

[0081] like Figure 2 As shown, it is an exemplary structure of an ultrasonic Doppler diagnostic instrument; the ultrasonic Doppler diagnostic instrument 10 includes a probe 11, a beamformer 12, an image processing unit 13, a display unit 14 and a control unit 15; preferably, the ultrasonic Doppler diagnostic instrument 10 may also include a user input unit 16 for receiving user input information; wherein the input information may include setting the user's region of interest (ROI) and the operation mode setting required by the user; in addition, the user input unit 16 may include various input means, such as using a keyboard, a mouse, a touch screen, a trackball, a knob wheel, a knob switch, etc.; however, these components are not necessary components of the ultrasonic Doppler diagnostic instrument 10, and the ultrasonic Doppler diagnostic instrument 10 may be implemented by more or less components than the above components; each component will be described below;

[0082] Preferably, the probe 11 may include a plurality of 2D / 3D transducers (not shown in the figure); wherein the transducer may be a piezoelectric transducer that converts ultrasonic waves and electrical signals to each other through vibration and pressure changes; a capacitive transducer that converts ultrasonic waves and electrical signals to each other through capacitance changes; a magnetic transducer that converts ultrasonic waves and electrical signals to each other through magnetic field changes; and an optical ultrasonic detector that converts ultrasonic waves and electrical signals to each other through optical property changes, etc. In addition, the probe 11 may be a probe of any geometric structure as long as it can realize the high-speed beam interleaving function;

[0083] Preferably, the probe 11 includes a transmitter, which radiates an ultrasonic signal to a predetermined volume of the target object by driving a transducer or driving at least part of an element array (e.g., a piezoelectric crystal, etc.) inside the transducer; the transmitted ultrasonic signal is backscattered by a high-density interface and / or structure such as blood cells or muscle tissue in a human body to form a reflected wave signal that returns to a feedback element (e.g., a piezoelectric crystal); the reflected wave signal is received by a receiver and provided to a beam generator 12; that is, the probe 11 sends a focused ultrasonic beam to the target object along a transmission scan line by appropriately delaying the input time of a pulse input to each transducer; at the same time, the ultrasonic reflected wave signal reflected from the target object is input to each transducer at different receiving times, and each transducer amplifies the input ultrasonic reflected wave signal and outputs it to the beam generator 12;

[0084] Optionally, the probe 11 may be integrated with the ultrasonic Doppler diagnostic instrument 10, or coupled to the ultrasonic Doppler diagnostic instrument 10 by wired or wireless connection;

[0085] The beamformer 12 focuses the ultrasonic signal emitted by each transducer of the probe 11 on the target object, and applies a time delay to the ultrasonic reflection wave signal reflected from the target object back to each transducer to focus the ultrasonic reflection wave signal;

[0086] Preferably, the image processing unit 13 forms a plurality of two-dimensional image frames based on the ultrasonic echo signal output by the beamformer 12, and displays them on the display unit 14;

[0087] Preferably, the control unit 15 can be manually controlled by an operator, or automatically controlled by a program, to control specific working parameters of the probe 11, so that the probe 11 can send an ultrasonic beam with specified performance parameters such as frequency, power, and radiation angle;

[0088] Preferably, the image processing unit 13 and the control unit 15 each include at least one processor; the processor may be a central processing unit (CPU), a microprocessor, a digital signal processor (DSP), etc.;

[0089] In a preferred exemplary embodiment, when performing a detection operation on a human body, the imaging operation of the ultrasonic Doppler diagnostic instrument 10 can be performed in two stages; in the first stage, the ultrasonic Doppler diagnostic instrument 10 is used to search for multiple blood vessels located within the ROI; then in the second stage, the transmission parameters of the ultrasonic beam, such as frequency, power, etc., are adjusted and sent again to the position corresponding to the blood vessel (or blood flow) selected by the operator; the image processing unit 13 generates a spectral Doppler image based on the ultrasonic data obtained in the second stage, and displays it on the display unit 14; preferably, the control unit 15 can calculate the maximum velocity information with the maximum velocity value in the selected blood vessel (or blood flow) and the blood vessel angle of the selected blood vessel (or blood flow) according to the collected data through a preset algorithm program, and automatically adjust the sending position and sending angle of the ultrasonic beam in the second stage using the calculated maximum velocity information and blood vessel angle; in this way, the ultrasonic Doppler diagnostic instrument 10 can not only improve the time efficiency and the accuracy of the diagnosis position, but also prevent the image frame rate from decreasing;

[0090] In order for an ultrasound Doppler diagnostic instrument to obtain imaging display, five basic conditions must be met: (1) ultrasound is used as the detection information carrier or energy source; (2) there is a propagation medium for ultrasound; (3) there is safe ultrasound energy that produces reflection and scattering; (4) there is a medical ultrasound Doppler diagnostic transducer; (5) there is a closed-loop system for transmitting beam forming and receiving echo image formation. From the perspective of engineering technology, ultrasound Doppler diagnostic imaging deeply involves multiple technical aspects such as transducer technology, computer platform technology, full-digital ultrasound diagnostic technology, three-dimensional imaging technology, and color blood flow imaging technology (Doppler technology);

[0091] In a preferred exemplary embodiment, the simulation phantom is prepared by mixing agar, silicon dioxide powder, evaporated milk and a large amount of pure water in different proportions; and optionally, the simulation phantom may also contain glycerin, wood powder, pigment or other additives; by changing the proportions of the above various raw material formulas, it is possible to change various physical properties of the simulation phantom, such as density, elastic modulus, attenuation rate of ultrasound, etc.;

[0092] Exemplarily, the weight volume ratio w / v of the agar is 2% to 6%;

[0093] Exemplarily, the weight-to-volume ratio w / v of the silicon dioxide is 0% to 4%;

[0094] Exemplarily, the weight-to-volume ratio (w / v) of the evaporated milk is 0-30%;

[0095] Exemplarily, the simulation phantom may further include a preservative;

[0096] Preferably, the simulation phantom can be made by the following steps:

[0097] (1) Prepare the materials used in the simulation phantom according to the formula ratio, and put the formula materials except agar powder into a container, heat the container, and stir it evenly with a glass rod, boil the solution, and keep it above 90 degrees;

[0098] (2) Gradually dissolve agar powder into the solution, filter out the scum during the dissolution process, and continue to stir the solution until no bubbles are visible in the solution;

[0099] (3) The solution obtained in step (2) is sucked into a molding mold, and after a negative pressure is formed inside the molding mold, the molding mold is gradually cooled and shaped to obtain a simulation phantom;

[0100] In a preferred embodiment, the simulation phantom is as shown in the attached Figure 3 and attached Figure 4 As shown; among them, Figure 3 is a side view of the simulated phantom with a set flow direction x perpendicular to the simulated blood vessel; Figure 4 An AA cross-sectional view of the simulated phantom with a set flow direction parallel to the simulated blood vessel;

[0101] Preferably, the simulation phantom is a truncated cone-shaped phantom with a smaller diameter on the top surface 21 and a larger diameter on the bottom surface 22;

[0102] Preferably, the simulation phantom can be divided into four detection segments 23, such as a, b, c, and d indicated in the figure; and in more embodiments, the number of the detection segments 23 can be less or more, for example, there can be 3, 5, or 6 detection segments;

[0103] Preferably, the cross-sectional length of each detection segment in the direction x may be 15 cm or 20 cm, or a shorter or longer length;

[0104] Further, as attached Figure 4 As shown, preferably, the simulation phantom can be divided into a sector-shaped part every 90 degrees, such as the sector-shaped part 31 shown in the figure; wherein each sector-shaped part 31 has different detection characteristics, such as density, attenuation rate of ultrasound, hardness, or one or more property differences, so as to generate different feedbacks to the ultrasound detection signal;

[0105] Combined with Figure 3 and attached Figure 4, on each detection segment 23, a detection plane 24 for placing the probe to be detected is intercepted; the width of the detection plane 24 can at least accommodate the stable placement of the probe to be detected; the distance from the detection plane 24 to the simulated blood vessel is the detection thickness; preferably, the difference in the detection thickness of each detection segment 23 can be 1 mm, 2 mm, 3 mm, 4 mm, or individually set according to the detection characteristics required by the simulation phantom;

[0106] During the operation, the probe 11 can be controlled by an operator or by an automated device such as a robotic arm or a moving slide rail, so that the probe 11 moves on multiple detection segments 23 to obtain ultrasonic Doppler images at different detection distances; after completing the test of one or more detection segments of a fan-shaped part 31; the simulation phantom is rotated around an axis parallel to the direction x to continue the detection of the next fan-shaped part 31.

[0107] Embodiment 2: This embodiment should be understood as including at least all the features of any one of the foregoing embodiments and further improved on this basis:

[0108] In an exemplary embodiment, the following three detection conditions can be used to test a set of hydrodynamic parameters of the ultrasonic Doppler diagnostic instrument 10;

[0109] Detection condition 1: In each test, the detection error E should be less than a preset error threshold ; if N tests are performed and the actual value of each test is M i , the preset simulated value is S i , where the detection error E i can be expressed as:

[0110] E i =|M i -S i |,

[0111] Then the detection condition 1 is:

[0112] ;

[0113] Detection condition 2: In more than K tests (K < N), the average detection error E of the actual test values avg is greater than the preset error threshold ; that is:

[0114] ;

[0115] Detection condition 3: In more than K tests (K < N), the variance σ of the actual test values 2 is greater than the preset variance threshold σ max ; that is:

[0116] ;

[0117] Under the above-mentioned detection condition 1, the ultrasonic Doppler diagnostic instrument of the target to be detected can be considered to have passed the performance test; when the detection conditions 2 and 3 are met, it is determined that the performance of the ultrasonic Doppler diagnostic instrument of the target to be detected has a large error during the test, and the test is terminated when the predetermined number of tests N is not met, and relevant technical personnel detect the factors affecting the performance in the target to be detected and / or the test system 1.

[0118] Embodiment 3: This embodiment should be understood to include at least all the features of any of the above embodiments, and further improve on the basis thereof:

[0119] For example, Figure 5 A schematic diagram depicting a computer system 500 in which the detection module described herein in the test system described herein may be implemented;

[0120] The computer system 500 includes a bus 502 or other communication mechanism for transmitting information, and one or more processors 504 coupled to the bus 502 for processing information; the processor 504 may be, for example, one or more general-purpose microprocessors;

[0121] The computer system 500 also includes a main memory 506, such as a random access memory (RAM), a cache, and / or other dynamic storage device, coupled to the bus 502 for storing information and instructions to be executed by the processor 504; the main memory 506 may also be used to store temporary variables or other intermediate information during the execution of instructions to be executed by the processor 504; these instructions, when stored in a storage medium accessible to the processor 504, present the computer system 500 as a special-purpose machine customized to perform the operations specified in the instructions;

[0122] The computer system 500 may also include a read-only memory (ROM) 508 or other static storage device coupled to the bus 502 for storing static information and instructions for the processor 504; a storage device 510 such as a disk, an optical disk, or a USB drive (flash drive) will be coupled to the bus 502 for storing information and instructions;

[0123] And further, coupled to the bus 502 may also include a display 512 for displaying various information, data, media, etc., an input device 514 for allowing a user of the computer system 500 to control, manipulate, and / or interact with the computer system 500;

[0124] A preferred way to interact with the management system may be through a cursor control device 516, such as a computer mouse or similar control / navigation mechanism;

[0125] Furthermore, the computer system 500 may also include a network device 518 coupled to the bus 502; wherein the network device 518 may include, for example, a wired network card, a wireless network card, a switching chip, a router, a switch, and other components;

[0126] In general, the terms "engine", "component", "system", "database", etc., as used herein, may refer to logic embodied in hardware or firmware, or to a collection of software instructions, possibly with entry and exit points, written in a programming language such as Java, C, or C++; software components may be compiled and linked into executable programs, installed in a dynamic link library, or may be written in an interpreted programming language (e.g., BASIC, Perl, or Python); it should be understood that software components may be called from other components or from themselves, and / or may be called in response to detected events or interrupts;

[0127] Software components configured to execute on a computing device may be provided on a computer-readable medium, such as a compact disc, digital video disc, flash drive, diskette, or any other tangible medium, or as a digital download (and may be initially stored) in a compressed or installable format that requires installation, decompression, or decryption prior to execution); such software code may be stored in part or in whole on a memory device of the executing computing device for execution by the computing device; software instructions may be embedded in firmware, such as an EPROM. It should also be understood that hardware components may consist of connected logic units (such as gates and flip-flops), and / or may consist of programmable units (such as programmable gate arrays or processors);

[0128] Computer system 500 includes the techniques described herein that may be implemented using custom hardwired logic, one or more ASICs or FPGAs, firmware, and / or program logic that, in combination with the computer system, renders computer system 500 a special-purpose computing device;

[0129] According to one or more embodiments, the techniques herein may be performed by computer system 500 in response to processor 504 executing one or more sequences of one or more instructions contained in main memory 506; such instructions may be read into main memory 506 from another storage medium, such as storage device 510; execution of the sequences of instructions contained in main memory 506 causes processor 504 to perform the process steps described herein; in alternative embodiments, hard-wired circuitry may be used in place of or in combination with software instructions;

[0130] As used herein, the term "non-transitory media" and similar terms refer to any media that store data and / or instructions that cause a machine to operate in a specific manner; such non-transitory media may include non-volatile media and / or volatile media; non-volatile media include, for example, optical or magnetic disks, such as storage device 510; volatile media include dynamic memory, such as main memory 506;

[0131] Among them, common forms of non-transitory media include, for example, floppy disks, diskettes, hard disks, solid-state drives, magnetic tapes or any other magnetic data storage medium, CD-ROMs, any other optical data storage medium, any physical medium having a pattern of holes, RAM, PROM and EPROM, FLASH-EPROM, NVRAM, any other memory chip or cartridge, and network versions thereof;

[0132] Non-transient media are distinct from transmission media but may be used in conjunction with transmission media; transmission media participate in the transmission of information between non-transient media; for example, transmission media include coaxial cables, copper wires, and optical fibers, including the wires that make up bus 502; transmission media may also take the form of sound waves or light waves, such as radio waves and infrared data communications.

[0133] Although the present invention has been described above with reference to various embodiments, it should be understood that many changes and modifications may be made without departing from the scope of the present invention. That is, the methods, systems and devices discussed above are examples. Various configurations may appropriately omit, replace or add various processes or components. For example, in alternative configurations, the method may be performed in an order different from the order described, and / or various components may be added, omitted and / or combined. Moreover, the features described with respect to certain configurations may be combined in various other configurations, such as different aspects and elements of the configurations may be combined in a similar manner. In addition, the elements therein may be updated as the technology develops, i.e., many elements are examples and do not limit the scope of the present disclosure or claims.

[0134] Specific details are given in the specification to provide a thorough understanding of the exemplary configurations including implementations. However, the configurations may be practiced without these specific details. For example, well-known circuits, processes, algorithms, structures, and techniques have been shown without unnecessary details to avoid obscuring the configurations. This description provides only example configurations and does not limit the scope, applicability, or configurations of the claims. On the contrary, the foregoing description of the configurations will provide those skilled in the art with an enabling description for implementing the described techniques. Various changes may be made to the functions and arrangements of the elements without departing from the spirit or scope of the present disclosure.

[0135] In summary, it is intended that the above detailed description is considered to be illustrative rather than restrictive, and it should be understood that the above embodiments should be understood to be only used to illustrate the present invention and not to limit the scope of protection of the present invention. After reading the contents of the present invention, the technician can make various changes or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

Claims

1. An ultrasonic Doppler diagnostic instrument performance test system, It is characterized in that The test system is connected to a target to be detected and comprises: A simulation phantom, used to simulate the acoustic and physical properties of human tissue and provide test conditions for the target to be detected; the simulation phantom is a mixture of agar, silicon dioxide and water; The simulated blood vessel is configured to be embedded in the simulated phantom, has a sufficient length to meet the detection of the target to be detected, and is provided with external input and output ends, and simulated blood is passed into the simulated blood vessel to simulate the vascular environment of the human body; two simulated blood vessels are provided to simultaneously detect simulated blood with two flow directions; the inner diameter of the simulated blood vessel is 3 mm to 8 mm; A circulation module, configured to connect the input end and the output end of the simulated blood vessel to provide the simulated blood with flow power and simultaneously control the fluid dynamic parameters of the simulated blood; The circulation module is provided with fluid power required for simulating blood flow by a peristaltic pump, a plunger pump, a gear pump or an electromagnetic pump; the circulation module is provided with a flow control valve to control the on-off of the simulated blood in the simulated blood vessel; A detection module, configured to obtain a detection result of the target to be detected so as to evaluate the detection performance of the target to be detected; The test system detects the simulated blood in the simulated blood vessel by using the target to be detected, collects and analyzes the real-time detection data of the target to be detected, and outputs the performance evaluation of the target to be detected after comparing the real-time detection data with the preset simulation detection data; Wherein, the detection module comprises: a target generation unit, communicatively coupled to the circulation module and configured to generate control instructions to the circulation module so that the circulation module generates a fluid state of simulated blood having specified fluid dynamic parameters; A verification unit, comprising a plurality of sensors disposed inside the simulated blood vessel, configured to detect the physical parameters of the simulated blood in real time to determine whether the physical parameters of the simulated blood meet preset targets; An evaluation unit, communicatively coupled to the target to be detected, configured to collect and analyze real-time detection data of the target to be detected, and output a performance evaluation of the target to be detected after comparing the real-time detection data with preset simulation detection data; The ultrasonic Doppler diagnostic instrument was tested for a set of fluid dynamic parameters using the following three testing conditions; Detection conditions: In each test, the detection error E should be less than the preset error threshold ϵ; if N tests are performed, the actual value of each test is M i , the preset analog value is S i , where the detection error E i It is expressed as: E i =|M i -S i |, Then the test condition 1 is: ∀E i ∈{1,2,……,N},E i <ϵ; Detection condition 2: In tests more than K times (K < N), the average detection error E of the actual test values avg is greater than the preset error threshold ϵ; that is: ； Test condition 3: In tests more than K times (K < N), the variance σ of the actual test values 2 is greater than the preset variance threshold σ max ; that is: ； Under the above-mentioned test condition 1, the ultrasonic Doppler diagnostic instrument of the target to be detected is deemed to have passed the performance test; and when the test conditions 2 and 3 are met, it is determined that the performance of the ultrasonic Doppler diagnostic instrument of the target to be detected has a large error during the test, so that the test is terminated when the predetermined number of tests N is not met, and the relevant technical personnel detect the factors affecting the performance in the target to be detected and / or the test system; The target to be detected is an ultrasonic Doppler diagnostic instrument; The ultrasonic Doppler diagnostic instrument comprises a probe, a beam generator, an image processing unit, a display unit and a control unit; the ultrasonic Doppler diagnostic instrument comprises a user input unit for receiving user input information; wherein the input information comprises setting the user's region of interest and the operation mode setting required by the user; in addition, the user input unit comprises a keyboard, a mouse, a touch screen, a trackball, a knob wheel and / or a knob switch; The probe includes a plurality of 2D / 3D transducers; wherein the transducers are piezoelectric transducers that mutually convert ultrasonic waves and electrical signals through vibration and pressure changes; capacitive transducers that mutually convert ultrasonic waves and electrical signals through capacitance changes; magnetic transducers that mutually convert ultrasonic waves and electrical signals through magnetic field changes; and optical ultrasonic detectors that mutually convert ultrasonic waves and electrical signals through optical property changes; and the probe is any probe of a geometric structure capable of realizing a high-speed beam interleaving function; The probe includes a transmitter, which radiates an ultrasonic signal to a predetermined volume of a target object by driving a transducer or at least a part of an element array inside the transducer; the transmitted ultrasonic signal is backscattered by the target object to form a reflected wave signal that returns to the feedback element; the reflected wave signal is received by a receiver and provided to a beam generator; the probe sends a focused ultrasonic beam to the target object along a transmission scan line by appropriately delaying the input time of a pulse input to each transducer; at the same time, the ultrasonic reflected wave signal reflected from the target object is input to each transducer at different receiving times, and each transducer amplifies the input ultrasonic reflected wave signal and outputs it to the beam generator; The probe is integrated with the ultrasonic Doppler diagnostic instrument, or is coupled to the ultrasonic Doppler diagnostic instrument by wired or wireless connection; The beamformer focuses the ultrasonic signal emitted by each transducer of the probe on the target object, and applies a time delay to the ultrasonic reflected wave signal reflected from the target object back to each transducer to focus the ultrasonic reflected wave signal; The image processing unit forms a plurality of two-dimensional image frames based on the ultrasonic echo signal output by the beamformer, and displays the two-dimensional image frames on the display unit; The control unit is manually controlled by an operator or automatically controlled by a program to control specific working parameters of the probe so that the probe sends an ultrasonic beam with specified performance parameters; The image processing unit and the control unit both include at least one processor; when performing detection operations on a human body, the imaging operation of the ultrasonic Doppler diagnostic instrument is performed in two stages; in the first stage, the ultrasonic Doppler diagnostic instrument is used to search for multiple blood vessels located in the region of interest; then in the second stage, the emission parameters of the ultrasonic beam are adjusted and the ultrasonic beam is sent again to the position corresponding to the blood vessel or blood flow selected by the operator; the image processing unit generates a spectral Doppler image based on the ultrasonic data obtained in the second stage and displays it on the display unit; the control unit calculates the maximum velocity information with the maximum velocity value in the selected blood vessel or blood flow and the blood vessel angle of the selected blood vessel or blood flow according to the collected data through a preset algorithm program, and automatically adjusts the sending position and sending angle of the ultrasonic beam in the second stage using the calculated maximum velocity information and blood vessel angle; The basic conditions that must be met for ultrasound Doppler diagnostics to obtain imaging display are: (1) ultrasound is used as the detection information carrier or energy source; (2) there is a propagation medium for ultrasound; (3) there is safe ultrasound energy that produces reflection and scattering; (4) there is a medical ultrasound Doppler diagnostic transducer; (5) there is a closed-loop system for transmitting beam forming and receiving echo image forming; The simulation phantom is prepared by mixing agar, silicon dioxide powder, evaporated milk and a large amount of pure water in different proportions; the simulation phantom also contains glycerin, wood powder, pigment or other additives; The weight volume ratio w / v of the agar is 2% to 6%; The weight volume ratio w / v of the silicon dioxide is 0% to 4%; The weight-to-volume ratio (w / v) of the evaporated milk is 0-30%; The simulation phantom also includes a preservative; The simulation phantom is prepared by the following steps: (1) Prepare the materials used in the simulation phantom according to the formula ratio, and put the formula materials except agar powder into a container, heat the container, and stir it evenly with a glass rod, boil the solution, and keep it above 90 degrees; (2) Gradually dissolve agar powder into the solution, filter out the scum during the dissolution process, and continue to stir the solution until no bubbles are visible in the solution; (3) The solution obtained in step (2) is sucked into a molding mold, and after a negative pressure is formed inside the molding mold, the molding mold is gradually cooled and shaped to obtain a simulation phantom; The simulation phantom is a truncated cone-shaped phantom with a smaller top diameter and a larger bottom diameter; The simulation phantom is divided into 4 detection sections; The cross-sectional length of each detection segment in the direction x is 15 cm or 20 cm; The simulation phantom is divided into a sector-shaped part every 90 degrees, and each sector-shaped part has different detection characteristics; On each detection segment, a detection plane for placing the probe of the target to be detected is intercepted; the width of the detection plane is at least enough to accommodate the stable placement of the probe of the target to be detected; the distance from the detection plane to the simulated blood vessel is the detection thickness; the difference in the detection thickness of each detection segment is individually set according to the detection characteristics required by the simulated phantom; During the operation, the probe is controlled by an operator, or by a robot arm or a mobile slide rail automation device, so that the probe moves on multiple detection sections to obtain ultrasonic Doppler images at different detection distances; after completing the test of one or more detection sections of a sector-shaped part; the simulation phantom is rotated around an axis parallel to the direction x to continue to test the next sector-shaped part; The fluid dynamic parameters include at least: flow velocity, flow direction, and fluid pressure; The simulated phantom has two or more materials with different component ratios on the radial side of the simulated blood vessel, so that at least two detection characteristics are generated on the radial side of the simulated blood vessel; The simulation phantom includes a plurality of detection segments; each of the detection segments has a detection thickness different from that of other detection segments; the detection thickness is the minimum distance between the surface of the detection segment and the simulated blood vessel inside; The detection module further comprises an interference signal generating unit; the interference signal generating unit is configured to generate a simulated interference signal controlled by the target generating unit; The detection characteristics refer to one or more of the following physical characteristics of the simulation phantom: density, attenuation rate of ultrasound, and hardness; An ultrasonic Doppler diagnostic instrument performance testing method applied to the ultrasonic Doppler diagnostic instrument performance testing system; the testing method comprises the following steps: S100: connecting the simulated blood vessel and the circulation module to form a closed fluid loop; S200: setting a set of fluid dynamic parameters, starting the circulation module and waiting for the fluid dynamic parameters in the simulated blood vessel to stabilize; S300: using the target to be detected to detect the simulated blood vessels in multiple detection segments of the simulated phantom, and collecting multiple detection results; S400: After one of the detection conditions is met, the test of the fluid dynamic parameters of this group is completed; Execute step S200 to step S400 in a loop until all the set multiple groups of fluid dynamic parameters are tested; The set of fluid dynamic parameters refers to a combination of multiple fluid dynamic parameters with different values ​​under the detection characteristics of the same simulated blood vessel; The detection conditions include at least the following conditions: Complete the specified number of tests when the detection error in each test is less than the preset error threshold; In tests greater than n times, the average detection error of the actual test value is greater than the preset error threshold; In tests greater than n times, the variance of the actual test value is greater than a preset variance threshold.

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