阅读说明：本技术 一种超声经颅多普勒血流分析仪检测系统及检测方法 (Detection system and detection method of ultrasonic transcranial Doppler blood flow analyzer ) 是由 姚绍卫 刘茹 王丽明 张崴 严甜 苏根发 颜廷善 于 2021-09-30 设计创作，主要内容包括：本发明公开了一种超声经颅多普勒血流分析仪检测系统及检测方法,系统包括：弦线式测试件、超声功率计和被测TCD仪；方法包括如下步骤：(1)设置计量检测的环境条件；(2)设置弦线式测试件的技术条件；(3)测量流速、工作距离、距离选通误差和超声输出功率这4个检测指标。本发明能够给出超声经颅多普勒血流分析仪的计量特性以及对应的计量检测系统及方法,提出计量特性的计量指标。(The invention discloses a detection system and a detection method of an ultrasonic transcranial Doppler blood flow analyzer, wherein the system comprises: the device comprises a string type test piece, an ultrasonic power meter and a tested TCD instrument; the method comprises the following steps: (1) setting environmental conditions for metering detection; (2) setting technical conditions of a chord line type test piece; (3) measuring 4 detection indexes of flow speed, working distance, range gating error and ultrasonic output power. The invention can provide the metering characteristics of the ultrasonic transcranial Doppler blood flow analyzer and a corresponding metering detection system and method, and provides the metering indexes of the metering characteristics.)

1. An ultrasonic transcranial Doppler blood flow analyzer detection system, comprising: the device comprises a string type test piece, an ultrasonic power meter and a tested TCD instrument; the string type test piece is used as a test phantom, and the ultrasonic power meter is used for measuring the maximum output sound power value of the tested TCD instrument.

2. The ultrasonic transcranial doppler flow analyzer detection system according to claim 1, wherein the ultrasonic power meter is selected to be (0-500) mW.

3. The ultrasonic transcranial doppler blood flow analyzer detection system according to claim 1, wherein the string-type test piece is provided with a rectangular groove for containing a liquid medium serving as a human body medium; a handle clamping frame is fixed above the rectangular groove and used for clamping a probe of the TCD instrument to be tested, and the probe monitors the movement of a chord line driven under a liquid medium to simulate blood flow movement; a pulley block is arranged in the rectangular groove, so that the strings are wound on the pulley at a fixed angle, and included angles of the TCD ultrasonic probe and the strings are 30 degrees, 45 degrees and 60 degrees; the string type test piece is provided with a control host machine which controls the string to be driven on the pulley at a certain speed.

4. A method of testing the ultrasonic transcranial doppler blood flow analyzer test system of claim 1, comprising the steps of:

(1) setting environmental conditions for metering detection;

(2) setting technical conditions of a chord line type test piece;

(3) measuring 4 detection indexes of flow speed, working distance, range gating error and ultrasonic output power.

5. The detection method of the ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (1), the environmental conditions of the metering detection are specifically as follows: air temperature: 15-35 ℃; relative humidity: relative humidity is not more than 85%; power supply voltage and frequency: (220 +/-11) V, (50 +/-1) Hz; and others: the surrounding of the equipment has no strong vibration, electromagnetic interference and corrosive gas, and the influence of other cold and heat sources and strong light irradiation is avoided.

6. The method for detecting an ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (2), the technical conditions of the string type test piece are as follows: the measurement range of the string transmission speed is (10-200) cm/s, and the maximum allowable error is +/-3.0%; TCD probe to chord angle: continuously adjustable, at least comprising 30 °, 45 ° and 60 °; the depth of the water tank is more than 160mm, and the maximum allowable error of the scribed line is 0.5 mm; wire diameter: selected from 0.2mm, 0.3mm, 0.4mm and 0.5mm, and the maximum allowable error of the wire diameter is 0.01 mm.

7. The method for detecting an ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (3), the step of measuring the flow rate specifically comprises the following steps:

(a) selecting blood vessels, filtering, sampling areas, adjusting sound power and receiving gain at the optimal position;

(b) the working distance and the sampling volume conform to maximum and minimum working distances at specified sampling volumes as published by the manufacturer in product standards;

(c) the included angle between the Doppler sound beam axis and the target motion direction is selected to be 30 degrees, 45 degrees or 60 degrees, and the Doppler angle of the TCD instrument is considered to be set to be 0 degree when the displayed flow speed error is calculated;

(d) when the flow rate measuring range is tested, the flow rate of the string type testing piece is respectively arranged at the maximum value and the minimum value of the flow rate range of the tested TCD instrument;

(e) during the measurement of the flow velocity measurement error, the flow velocity of the string type test piece is respectively set at 1/3 and 2/3 of the flow velocity measurement range of the tested TCD instrument;

(f) measuring the flow rate corresponding to the frequency spectrum, and calculating the reading error of the blood flow rate according to the formula (1):

in the formula: delta v is the blood flow velocity measurement error of the TCD instrument, cm/s; v. of₁Reading the blood flow speed of the TCD instrument in cm/s; v. of₀The string transmission speed, cm/s, set for the string test piece.

8. The detection method of the ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (3), the measuring working distance is specifically as follows: detecting a string by using the TCD at the nominal maximum working distance and the nominal minimum working distance of the TCD, setting the string speed at the middle value of the flow speed measuring range of the TCD, increasing and decreasing the working distance until the optimal frequency spectrum is obtained, and respectively measuring for 3 times and taking an average value; the maximum working distance of the calibrated ultrasonic transcranial Doppler blood flow analyzer is given by formula (2):

in the formula: l is_maxIs the average maximum working distance, mm; l is_iIs (i ═ 1,2,3), maximum working distance in a single measurement, mm; the minimum working distance of the tested TCD instrument can be given by equation (3):

in the formula: l is_minIs the average minimum working distance, mm; l is_iIs (i ═ 1,2,3), minimum working distance in a single measurement, mm.

9. The detection method of the ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (3), the measurement range gating error is specifically: the sampling volume of the TCD instrument is set to be 4mm and 20mm, other states are set to be optimal, an ultrasonic Doppler string type testing piece is adopted, a handle clamping frame is adjusted, the distance between a tested point of the string type testing piece and a probe is 50mm, the distance gating of the TCD instrument is also set to be 50mm, the tested point of the string type testing piece is detected by the TCD instrument, the TCD instrument has an obvious Doppler frequency spectrum signal, the setting value of the distance gating is increased and decreased until the Doppler frequency spectrum signal disappears or the upper and lower intensities are the same, the setting values of the distance gating in two directions are recorded, the average value of the setting values is taken, and the absolute value of the difference between the setting values and the actual value (50mm) is used as the distance gating errors of the two sampling volumes of 4mm and 20 mm.

10. The method for detecting an ultrasonic transcranial Doppler blood flow analyzer according to claim 4, wherein in the step (3), the step of measuring the ultrasonic output power specifically comprises the following steps:

(a) the ultrasonic power meter is placed on a stable workbench, and the base is adjusted to enable the instrument to be in a horizontal state. Debugging the instrument according to the operation instructions of different types of ultrasonic power meters;

(b) vertically coupling a probe of the TCD instrument to an input window of an ultrasonic power meter, and removing bubbles on the surface of an ultrasonic transducer in the coupling process;

(c) performing zero adjustment on the ultrasonic power meter;

(d) opening a switch of the tested TCD instrument to enable the switch to be in a strong transmitting state, and reading the maximum output sound power value of the tested TCD instrument according to the verification method of the used ultrasonic power meter;

(e) and (3) measuring the maximum output sound power of the tested TCD for n times (n is more than or equal to 3) according to the steps, and taking the arithmetic average value of the n times of measurement as the measured value of the output sound power of the tested TCD.

Technical Field

The invention relates to the technical field of metering monitoring, in particular to a detection system and a detection method of an ultrasonic transcranial Doppler blood flow analyzer.

Background

An ultrasonic transcranial Doppler blood flow analyzer (hereinafter referred to as 'TCD' apparatus) can be used for non-invasively detecting cerebral fundus and cervical artery blood flow parameters under physiological and pathological conditions by acquiring ultrasonic Doppler echo signals of the cranium and provides important information for diagnosis and treatment of related diseases.

The TCD instrument generally comprises a host, a probe, a display, an audio monitoring and recording part, a printing part and the like, and is conventionally configured to be a 2MHz pulse wave probe and a 4MHz continuous wave probe respectively. Clinically, the TCD instrument measures the blood flow velocity of intracranial blood vessels (such as willis ring) and common carotid artery via weak parts of skull (such as temporal bone and occipital bone) and neck soft tissue, and then calculates a series of hemodynamic parameters.

At present, the related standards belong to the standards of the pharmaceutical industry, are suitable for factory inspection of transcranial Doppler blood flow analyzers, and have not been provided in national calibration standards for metering detection of transcranial Doppler blood flow analyzers. Therefore, it is necessary to accurately define the measurement characteristics of the transcranial doppler blood flow analyzer, and a measurement characteristic detection system and a measurement characteristic detection method for the measurement characteristics are proposed to provide measurement characteristic indexes.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a detection system and a detection method for an ultrasonic transcranial Doppler blood flow analyzer, which can provide the metering characteristics of the ultrasonic transcranial Doppler blood flow analyzer and a corresponding metering detection system and method, and provide the metering indexes of the metering characteristics.

In order to solve the above technical problem, the present invention provides a detection system of an ultrasonic transcranial doppler blood flow analyzer, comprising: the device comprises a string type test piece, an ultrasonic power meter and a tested TCD instrument; the string type test piece is used as a test phantom, and the ultrasonic power meter is used for measuring the maximum output sound power value of the tested TCD instrument.

Preferably, the range of the ultrasonic power meter is (0-500) mW.

Preferably, the string type test piece is provided with a rectangular groove for containing liquid media serving as human body media; a handle clamping frame is fixed above the rectangular groove and used for clamping a probe of the TCD instrument to be tested, and the probe monitors the movement of a chord line driven under a liquid medium to simulate blood flow movement; a pulley block is arranged in the rectangular groove, so that the strings are wound on the pulley at a fixed angle, and included angles of the TCD ultrasonic probe and the strings are 30 degrees, 45 degrees and 60 degrees; the string type test piece is provided with a control host machine which controls the string to be driven on the pulley at a certain speed.

Correspondingly, the detection method of the ultrasonic transcranial Doppler blood flow analyzer comprises the following steps:

(1) setting environmental conditions for metering detection;

(2) setting technical conditions of a chord line type test piece;

(3) measuring 4 detection indexes of flow speed, working distance, range gating error and ultrasonic output power.

Preferably, in the step (1), the environmental conditions for metering detection are specifically: air temperature: 15-35 ℃; relative humidity: relative humidity is not more than 85%; power supply voltage and frequency: (220 +/-11) V, (50 +/-1) Hz; and others: the surrounding of the equipment has no strong vibration, electromagnetic interference and corrosive gas, and the influence of other cold and heat sources and strong light irradiation is avoided.

Preferably, in the step (2), the technical conditions of the string type test piece are as follows: the measurement range of the string transmission speed is (10-200) cm/s, and the maximum allowable error is +/-3.0%; TCD probe to chord angle: continuously adjustable, at least comprising 30 °, 45 ° and 60 °; the depth of the water tank is more than 160mm, and the maximum allowable error of the scribed line is 0.5 mm; wire diameter: selected from 0.2mm, 0.3mm, 0.4mm and 0.5 mm; the maximum allowable error of the wire diameter is 0.01 mm.

Preferably, in the step (3), the measuring of the flow rate specifically includes the following steps:

(a) selecting blood vessels, filtering, sampling areas, adjusting sound power and receiving gain at the optimal position;

(b) the working distance and the sampling volume conform to maximum and minimum working distances at specified sampling volumes as published by the manufacturer in product standards;

(c) the included angle between the Doppler sound beam axis and the target motion direction is selected to be 30 degrees, 45 degrees or 60 degrees, and when the displayed flow velocity error is calculated, the Doppler angle of the TCD instrument is set to be 0 degree in consideration of the actual included angle;

(d) when the flow rate measuring range is tested, the flow rate of the string type testing piece is respectively arranged at the maximum value and the minimum value of the flow rate range of the tested TCD instrument;

(e) during the measurement of the flow velocity measurement error, the flow velocity of the string type test piece is respectively set at 1/3 and 2/3 of the flow velocity measurement range of the tested TCD instrument;

(f) measuring the flow rate corresponding to the frequency spectrum, and calculating the reading error of the blood flow rate according to the formula (1):

in the formula: delta v is the blood flow velocity measurement error of the TCD instrument, cm/s; v. of₁Reading the blood flow speed of the TCD instrument in cm/s; v. of₀The string transmission speed, cm/s, set for the string test piece.

Preferably, in the step (3), the measuring the working distance specifically includes: detecting a string by using the TCD at the nominal maximum working distance and the nominal minimum working distance of the TCD, setting the string speed at the middle value of the flow speed measuring range of the TCD, increasing and decreasing the working distance until the optimal frequency spectrum is obtained, and respectively measuring for 3 times and taking an average value; the maximum working distance of the calibrated ultrasonic transcranial Doppler blood flow analyzer is given by formula (2):

in the formula: l is_maxIs the average maximum working distance, mm; l is_iIs (i ═ 1,2,3), maximum working distance in a single measurement, mm; the minimum working distance of the tested TCD instrument can be given by equation (3):

in the formula: l is_minIs the average minimum working distance, mm; l is_iIs (i ═ 1,2,3), minimum working distance in a single measurement, mm.

Preferably, in the step (3), the measuring the range gating error specifically includes: the sampling volume of the TCD instrument is recommended to be set to be 4mm and 20mm, other states are set to be optimal, an ultrasonic Doppler string type testing piece is adopted, a handle clamping frame is adjusted, the distance between a tested point of the string type testing piece and a probe is 50mm, the distance gating of the TCD instrument is also set to be 50mm, the tested point of the string type testing piece is detected by the TCD instrument, the TCD instrument has an obvious Doppler frequency spectrum signal, the setting value of the distance gating is increased and decreased until the Doppler frequency spectrum signal disappears or the upper and lower intensities are the same, the distance gating setting values in two directions are recorded, the average value of the distance gating setting values is taken, and the absolute value of the difference between the distance gating setting values and the actual value (50mm) is used as the distance gating errors of the two sampling volumes of 4mm and 20 mm.

Preferably, in the step (3), the measuring of the ultrasonic output power specifically includes the following steps:

(a) the ultrasonic power meter is placed on a stable workbench, and the base is adjusted to enable the instrument to be in a horizontal state. Debugging the instrument according to the operation instructions of different types of ultrasonic power meters;

(b) vertically coupling a probe of the TCD instrument to an input window of an ultrasonic power meter, and removing bubbles on the surface of an ultrasonic transducer in the coupling process;

(c) performing zero adjustment on the ultrasonic power meter;

(d) opening a switch of the tested TCD instrument to enable the switch to be in a strong transmitting state, and reading the maximum output sound power value of the tested TCD instrument according to the verification method of the used ultrasonic power meter;

(e) and (3) measuring the maximum output sound power of the tested TCD for n times (n is more than or equal to 3) according to the steps, and taking the arithmetic average value of the n times of measurement as the measured value of the output sound power of the tested TCD.

The invention has the beneficial effects that: the invention provides corresponding standard equipment and a corresponding method, which help a metering department to carry out metering calibration of an ultrasonic transcranial Doppler blood flow analyzer, help a hospital clinical engineer to carry out quality control work of the ultrasonic transcranial Doppler blood flow analyzer, ensure the accuracy and safety and effectiveness of the clinical application of the ultrasonic transcranial Doppler blood flow analyzer and improve the diagnosis and treatment quality.

Drawings

FIG. 1 is a schematic structural diagram of a detection system according to the present invention.

FIG. 2 is a schematic view of the testing structure of the string type testing device of the present invention.

FIG. 3 is a schematic view of the flow rate measurement range and error measurement process according to the present invention.

Fig. 4 is a schematic diagram of a working distance measuring process according to the present invention.

FIG. 5 is a schematic diagram of a range gate error detection process according to the present invention.

Fig. 6 is a schematic view of the ultrasonic output function detection process of the present invention.

Detailed Description

As shown in fig. 1 and 2, an ultrasonic transcranial doppler blood flow analyzer detection system includes: the device comprises a string type test piece, an ultrasonic power meter and a tested TCD instrument; the string type test piece is used as a test phantom, and the ultrasonic power meter is used for measuring the maximum output sound power value of the tested TCD instrument.

The measuring range of the ultrasonic power meter is (0-500) mW.

The string type test piece is provided with a rectangular groove for containing liquid media serving as human body media; a handle clamping frame is fixed above the rectangular groove and used for clamping a probe of the TCD instrument to be tested, and the probe monitors the movement of a chord line driven under a liquid medium to simulate blood flow movement; the pulley block is arranged in the rectangular groove, so that the strings are wound on the pulley at a fixed angle, and included angles of the TCD ultrasonic probe and the strings are 30 degrees, 45 degrees and 60 degrees. The string type test piece is provided with a control host machine which controls the string to be driven on the pulley at a certain speed.

Correspondingly, the detection method of the ultrasonic transcranial Doppler blood flow analyzer comprises the following steps:

(1) setting environmental conditions for metering detection;

(2) setting technical conditions of a chord line type test piece;

(3) measuring 4 detection indexes of flow speed, working distance, range gating error and ultrasonic output power.

In the step (1), the environmental conditions of the metering detection are specifically as follows: air temperature: 15-35 ℃; relative humidity: relative humidity is not more than 85%; power supply voltage and frequency: (220 +/-11) V, (50 +/-1) Hz; and others: the periphery of the equipment has no strong vibration, electromagnetic interference and corrosive gas, so that the influence of other cold and heat sources and strong light irradiation is avoided;

in the step (2), the technical conditions of the string type test piece are as follows: the measurement range of the string transmission speed is (10-200) cm/s, and the maximum allowable error is +/-3.0%; TCD probe to chord angle: continuously adjustable, at least comprising 30 °, 45 ° and 60 °; the depth of the water tank is more than 160mm, and the maximum allowable error of the scribed line is 0.5 mm; wire diameter: selected from 0.2mm, 0.3mm, 0.4mm and 0.5 mm; the maximum allowable error of the wire diameter is 0.01 mm.

As shown in fig. 3, in step (3), the flow rate measurement specifically includes the following steps:

(a) selecting blood vessels, filtering, sampling areas, adjusting sound power and receiving gain at the optimal position;

(b) the working distance and the sampling volume conform to maximum and minimum working distances at specified sampling volumes as published by the manufacturer in product standards;

(c) the included angle between the Doppler sound beam axis and the target motion direction is selected to be 30 degrees, 45 degrees or 60 degrees, and when the displayed flow velocity error is calculated, the Doppler angle of the TCD instrument is set to be 0 degree in consideration of the actual included angle;

(d) when the flow rate measuring range is tested, the flow rate of the string type testing piece is respectively arranged at the maximum value and the minimum value of the flow rate range of the tested TCD instrument;

(e) during the measurement of the flow velocity measurement error, the flow velocity of the string type test piece is respectively set at 1/3 and 2/3 of the flow velocity measurement range of the tested TCD instrument;

(f) measuring the flow rate corresponding to the frequency spectrum, and calculating the reading error of the blood flow rate according to the formula (1):

in the formula: delta v is the blood flow velocity measurement error of the TCD instrument, cm/s; v. of₁Reading the blood flow speed of the TCD instrument in cm/s; v. of₀The string transmission speed, cm/s, set for the string test piece.

As shown in fig. 4, in step (3), the measuring of the working distance specifically includes: detecting a string by using the TCD at the nominal maximum working distance and the nominal minimum working distance of the TCD, setting the string speed at the middle value of the flow speed measuring range of the TCD, increasing and decreasing the working distance until the optimal frequency spectrum is obtained, and respectively measuring for 3 times and taking an average value; the maximum working distance of the calibrated ultrasonic transcranial Doppler blood flow analyzer is given by formula (2):

in the formula: l is_max-average maximum working distance, mm; l is_i- (i ═ 1,2,3), maximum working distance for a single measurement, mm; the minimum working distance of the tested TCD instrument can be given by equation (3):

in the formula: l is_min-average minimum working distance, mm; l is_i- (i ═ 1,2,3), minimum working distance of a single measurement, mm.

As shown in fig. 5, in step (3), the step of measuring the range gating error specifically includes: the sampling volume of the TCD instrument is recommended to be set to be 4mm and 20mm, other states are set to be optimal, an ultrasonic Doppler string type testing piece is adopted, a handle clamping frame is adjusted, the distance between a tested point of the string type testing piece and a probe is 50mm, the distance gating of the TCD instrument is also set to be 50mm, the tested point of the string type testing piece is detected by the TCD instrument, the TCD instrument has an obvious Doppler frequency spectrum signal, the setting value of the distance gating is increased and decreased until the Doppler frequency spectrum signal disappears or the upper and lower intensities are the same, the distance gating setting values in two directions are recorded, the average value of the distance gating setting values is taken, and the absolute value of the difference between the distance gating setting values and the actual value (50mm) is used as the distance gating errors of the two sampling volumes of 4mm and 20 mm.

As shown in fig. 6, in step (3), the step of measuring the ultrasonic output power specifically includes the following steps:

(a) the ultrasonic power meter is placed on a stable workbench, and the base is adjusted to enable the instrument to be in a horizontal state. Debugging the instrument according to the operation instructions of different types of ultrasonic power meters;

(b) vertically coupling a probe of the TCD instrument to an input window of an ultrasonic power meter, and removing bubbles on the surface of an ultrasonic transducer in the coupling process;

(c) performing zero adjustment on the ultrasonic power meter;

(d) opening a switch of the tested TCD instrument to enable the switch to be in a strong transmitting state, and reading the maximum output sound power value of the tested TCD instrument according to the verification method of the used ultrasonic power meter;

(e) and (3) measuring the maximum output sound power of the tested TCD for n times (n is more than or equal to 3) according to the steps, and taking the arithmetic average value of the n times of measurement as the measured value of the output sound power of the tested TCD.