Arteriosclerosis detection method and device

Abstract

According to the arteriosclerosis detection method and device, the upper arm blood pressure is obtained based on the heart and ankle vascular index CAVI; systolic pressure Ps and diastolic pressure Pd are obtained; calculating to obtain a pulse pressure difference delta P, wherein the pulse pressure difference delta P = systolic pressure Ps-diastolic pressure Pd; measuring to obtain the distance Lca from the heart aortic valve to the ankle; measuring to obtain the time difference Tca of the pulse wave propagating from the heart to the ankle; a heart and ankle vascular index CAVI is obtained through calculation according to the following formula; # imgabs0 # is used for measuring and obtaining a pulse wave starting point time point TA1 of the ankle; measuring a pulse starting point TA2 of brachial artery pulse waves, and calculating TA1 to TA2 to obtain a time difference Tba; measuring to obtain a heart sound signal of cardiac pulsation, and obtaining a time difference T2 between a second heart sound and a first incision of the brachial artery; the time difference Tca is equal to the sum of the time difference Tba and the time difference T2. At least three blood pressure measuring devices and at least three electrocardio detection electrodes are arranged; the heart sound detection module is in electric signal connection with the heart sound detection sensor through a signal line; the heart sound detection sensor is used for being placed at the heart position of a detected person to obtain heart sound signals.

Description

Technical Field

[0001] The present invention relates to the technical field of arteriosclerosis measurement and evaluation devices and methods, and particularly relates to a method and device for detecting arteriosclerosis. Background Art

[0002] Cardiovascular diseases (CVDs) are the leading cause of death and disability globally. In China, cardiovascular disease deaths still rank first among the total causes of death for urban and rural residents, accounting for 48.98% and 47.35% of rural and urban death causes respectively in 2021, and 2 out of every 5 deaths are attributed to cardiovascular diseases.

[0003] As the most common pathogenic cause in cardiovascular diseases, the pathogenesis of arteriosclerosis is complex and diverse. Patients with arteriosclerosis face long-term blood circulation disorders and insufficient peripheral blood perfusion, which are extremely likely to induce a series of complications such as renal function decline, diabetes, stroke, and limb ischemic lesions. Arteriosclerosis may be asymptomatic in the early stage, and regular screening is the key to preventing serious complications. In view of this, incorporating arteriosclerosis detection into the routine health screening of the general population for regular, systematic evaluation and long-term follow-up observation is of great value for early disease detection, prevention strategy formulation, and treatment effect evaluation.

[0004] Common detection methods for arteriosclerosis include carotid ultrasound. Principle: Observe the thickness of the carotid artery intima and plaque formation through ultrasound to directly judge vascular lesions. Applicable situation: Early detection of atherosclerotic plaques. Blood test indicators: Blood lipids (such as LDL-C), C-reactive protein, homocysteine, etc., to assist in evaluating the risk of arteriosclerosis. CT angiography (CTA). Principle: Clearly show the vascular stenosis or calcified area through CT scanning and contrast agent imaging. Applicable situation: Used when suspected of severe arteriosclerosis or when surgical evaluation is required. The above methods usually rely on complex imaging equipment or invasive means such as blood drawing.

[0005] Non-invasive detection methods for arteriosclerosis can be based on pulse wave velocity (PWV). Principle: Measure the conduction velocity of the pulse wave in the artery when the heart beats. The faster the velocity, the worse the vascular elasticity. Applicable situation: Evaluate the degree of arteriosclerosis of the major arteries throughout the body (such as carotid artery, femoral artery). It can also be based on the ankle-brachial index (ABI). Principle: Compare the blood pressure ratio between the ankle and the upper arm. A value lower than 0.9 indicates possible stenosis or sclerosis of the lower limb artery. Applicable situation: Screen for lower limb artery diseases, especially suitable for diabetic patients.

[0006] In non-invasive measurements for detecting the degree of arteriosclerosis, parameters measured indirectly on the body surface, such as pulse wave velocity (PWV) and ankle brachial index (ABI), are usually used to evaluate the distensibility and stiffness of the arterial wall. Among them, PWV mainly assesses central arteriosclerosis, while ABI mainly reflects peripheral arteriosclerosis. This method has many advantages such as non-invasiveness, accurate measurement, and good repeatability, and is very suitable for popularization and application in family and community medical services.

[0007] However, many studies have found that PWV is easily affected by blood pressure changes. When measuring the same patient multiple times within half an hour, the maximum error can reach 15%. Since human blood pressure fluctuates under the influence of different time periods of the day and different internal and external factors, it is very important to exclude the influence of blood pressure fluctuations for accurately evaluating arteriosclerosis, and currently few household arteriosclerosis products can solve this problem.

[0008] Currently, the non-invasive arteriosclerosis detectors on the market for measuring ABI and PWV are bulky and usually used in combination with accessories such as trolleys, sensor boxes, and printers, and do not have portability. Their operation process is relatively complex and requires professional operators to complete the wearing of multiple sensors. For example, when wearing limb cuffs, the cuffs need to be adjusted to the appropriate tightness, and electrode clips for measuring electrocardiogram also need to be worn. Finally, a counterweight sandbag is used to fix the heart sound sensor at the measurement position, and this process needs to be completed by a professional doctor or nurse for the patient. Moreover, for the calculation of blood vessel length, height and gender or a manual tape measure are used for measurement, which has large errors and is cumbersome to operate. The measurement results of the above non-invasive arteriosclerosis detectors are relatively sensitive to the instantaneous fluctuations of blood pressure. To ensure the accuracy of the measurement results, it is required that the subject must be in a calm state before measurement and needs to be measured at a fixed time (such as fasting in the early morning), which greatly limits the application flexibility in the family scenario and cannot meet the needs of family users for detecting at any time. The household non-invasive arteriosclerosis detectors do not measure arteriosclerosis parameters comprehensively.

[0009] An ideal medical device needs to meet the functional requirements such as high-precision measurement, non-invasive technology, simple operation, and data sharing to adapt to family and clinical scenarios. However, the existing household arteriosclerosis assessment devices generally have problems such as large side effects, incomplete arteriosclerosis detection parameters, high costs, complex operation, and cumbersome wearing, and it is difficult to meet the actual needs of family health management.

[0010] How to design a non-invasive arteriosclerosis detection device with accurate measurement and simple use is a technical problem to be solved. Summary of the Invention

[0011] The technical solution of the present invention overcomes the shortcomings of the prior art, and proposes a non-invasive arteriosclerosis detection method, which can eliminate the influence of blood pressure fluctuations on arteriosclerosis detection, improve the accuracy of arteriosclerosis detection, and provides a non-invasive arteriosclerosis detection device, which is convenient to use and can be applied to the household scenario.

[0012] In this application, the technical solution to solve the above technical problems is an arteriosclerosis detection method. Based on the cardio-ankle vascular index CAVI, the upper arm blood pressure is obtained; the systolic blood pressure P s and the diastolic blood pressure P d are obtained; the pulse pressure difference ΔP is calculated, and the pulse pressure difference ΔP = systolic blood pressure P s - diastolic blood pressure P d ; the distance L from the aortic valve of the heart to the ankle is measured ca ; the time difference Tca of the pulse wave propagating from the heart to the ankle is measured; the cardio-ankle vascular index CAVI is calculated using the following formula; where ρ is the blood flow density; the starting time point TA1 of the pulse wave at the ankle is measured; the starting point TA2 of the pulse wave of the brachial artery is measured, and the time difference Tba is calculated by TA1 - TA2; the heart sound signal of the heart beat is measured, and the time difference T2 between the second heart sound and the first notch of the brachial artery is obtained; the time difference Tca = time difference Tba + time difference T2.

[0013] It can be that the distance L from the aortic valve of the heart to the ankle ca is obtained by the electronic flexible ruler module for the distance between the heart sound auscultation area and the ankle pulse wave measurement site.

[0014] It can be to measure the pulse wave velocity caPWV between the aorta and the ankle artery;

[0015] L ca is the distance from the aortic valve of the heart to the ankle, and Tca is the time difference of the pulse wave propagating from the heart to the ankle.

[0016] It can be to measure the brachial-ankle pulse wave velocity baPWV; L ba is the distance from the arm pulse wave measurement point measured by the electronic flexible ruler module to the ankle pulse wave measurement point; T ba represents the time difference of the pulse wave conduction from the arm to the ankle calculated based on the brachial artery and the ankle artery pulse waves.

[0017] It can be to measure the ankle-brachial index ABI, which refers to the ratio of the systolic blood pressure of the ankle artery to the systolic blood pressure of the upper arm artery, that is, the systolic blood pressure of the brachial artery; the calculation formula is: where aSBP represents the systolic blood pressure of the ankle artery, and bSBP hIt represents the value of the higher side in the systolic blood pressure of the upper arm artery. In actual measurement, the systolic blood pressures of the ankle and the upper arm are measured respectively by the limb cuff plethysmography method, and then the ABI value is calculated by substituting into the formula.

[0018] In this application, the technical solution for solving the above technical problem can also be an arteriosclerosis detection device for performing the above arteriosclerosis detection method; it includes a control module, a heart sound detection module, an electrocardiogram detection module, a pulse wave detection module, a blood pressure measurement device, and electrocardiogram detection electrodes; there are at least 3 blood pressure measurement devices, including blood pressure measurement device B1, blood pressure measurement device B2, and blood pressure measurement device B3; blood pressure measurement device B1 and blood pressure measurement device B2 are used to be placed at the two arms of the detector; blood pressure measurement device B3 is used to be placed at the ankle part; the pulse wave detection module is electrically connected to the blood pressure measurement device through a pulse wave signal line; the pulse wave detection module is used to obtain a pulse wave detection signal and blood pressure; there are at least 3 electrocardiogram detection electrodes, including electrocardiogram detection electrode A1, electrocardiogram detection electrode A2, and electrocardiogram detection electrode A3; electrocardiogram detection electrode A1 and electrocardiogram detection electrode A2 are used to be placed at the two arms of the detector; electrocardiogram detection electrode A3 is used to be placed at the ankle part; the control module is electrically connected to the electrocardiogram detection module, and the electrocardiogram detection module is electrically connected to the electrocardiogram detection electrodes through an electrocardiogram detection signal line; the electrocardiogram detection module is used to obtain an electrocardiogram detection signal; the pulse wave detection module is electrically connected to the blood pressure measurement device to obtain a pulse wave signal; the control module is electrically connected to the heart sound detection module, and the heart sound detection module is electrically connected to the heart sound detection sensor through a signal line; the heart sound detection sensor is used to be placed at the heart position of the detector to obtain a heart sound signal.

[0019] It can be that the electrocardiogram detection electrode A1 is arranged on the blood pressure measurement device B1; the electrocardiogram detection electrode A2 is arranged on the blood pressure measurement device B2.

[0020] It can be that the blood pressure measurement device includes a cuff main body, an airbag, an air duct, an electrocardiogram electrode, and an electrocardiogram detection signal line; one end of the electrocardiogram detection signal line is electrically connected to the electrocardiogram electrode; the other end of the electrocardiogram detection signal line is used to be connected to an electrocardiogram signal detection device; the airbag is arranged on the cuff main body, and the airbag is communicated with the air duct; the electrocardiogram electrode is arranged on the inner side of the cuff main body.

[0021] It can be that the blood pressure measurement device further includes a blood pressure detection control module; the blood pressure detection control module includes a control module A, an air pump, a pressure sensing module (i.e., a pulse wave detection module), and a power supply module; the air pump is communicated with one end of the air duct; the air pump is electrically connected to the control module; the pressure sensing module (i.e., a pulse wave detection module) is electrically connected to the control module; the power supply module is electrically connected to the control module.

[0022] It can be that the cuff main body is of a scroll clamp type.

[0023] It may be that the blood pressure detection and control module is provided on the cuff body.

[0024] It may be that the blood pressure detection and control module is connected to the blood pressure measurement cuff through an air duct.

[0025] It may be that the blood pressure detection and control module includes a pulse wave signal line, and the pulse wave signal line is electrically connected to the control module; the pulse wave signal line is used to output a pulse wave signal.

[0026] Compared with the prior art, one of the beneficial effects of the present invention is that the calculation of the cardio-ankle vascular index CAVI eliminates the influence of blood pressure fluctuations on the detection of arteriosclerosis, and the measurement accuracy is higher and more stable.

[0027] Compared with the prior art, one of the beneficial effects of the present invention is that the heart sound signal of the cardiac pulsation is measured, the time difference T2 between the second heart sound and the first notch of the brachial artery is obtained, which is used to calculate the time difference Tca. Calculating based on the second heart sound is more convenient and can improve the calculation accuracy.

[0028] Compared with the prior art, one of the beneficial effects of the present invention is the distance L from the aortic valve of the heart to the ankle ca , which is obtained by the electronic flexible ruler module for the distance between the heart sound auscultation area and the ankle pulse wave measurement site. The electronic flexible ruler module is an electronic flexible ruler sold on the market and can measure the distance by moving on the surface of the object to be measured.

[0029] Compared with the prior art, one of the beneficial effects of the present invention is that the pulse wave velocity caPWV between the aorta and the ankle artery is measured, and more multiple arteriosclerosis detection indexes can be obtained for mutual verification, improving the reliability of the measurement and providing comparative parameter data.

[0030] Compared with the prior art, one of the beneficial effects of the present invention is that the brachial-ankle pulse wave velocity baPWV is measured, and more multiple arteriosclerosis detection indexes can be obtained for mutual verification, improving the reliability of the measurement and providing comparative parameter data..

[0031] Compared with the prior art, one of the beneficial effects of the present invention is that the ankle-brachial index ABI is measured, and more multiple arteriosclerosis detection indexes can be obtained for mutual verification, improving the reliability of the measurement and providing comparative parameter data..

[0032] Compared with the prior art, one of the beneficial effects of the present invention is that a variety of physiological parameters, especially heart sound signals, are integrated in the arteriosclerosis detection device, which is convenient for measuring the cardio-ankle vascular index CAVI.

[0033] Compared with the prior art, one of the beneficial effects of the present invention is that the electrocardiogram detection electrode is provided on the blood pressure measuring device. The integrated sensor is convenient to use and reduces the complexity of different types of sensors.

[0034] Compared with the prior art, one of the beneficial effects of the present invention is that the electrocardiogram electrode is provided inside the cuff body, which is convenient for measuring the pulse wave and obtaining the electrocardiogram signal while measuring the blood pressure.

[0035] Compared with the prior art, one of the beneficial effects of the present invention is that the blood pressure measuring device integrates the cuff body, the airbag, the air duct, the electrocardiogram electrode, and the electrocardiogram detection signal line, enabling the blood pressure cuff to be used for measuring blood pressure and pulse wave, and also for electrocardiogram measurement, achieving multiple functions with one device.

[0036] Compared with the prior art, one of the beneficial effects of the present invention is that the electrocardiogram electrode is provided inside the cuff body. When the blood pressure cuff contacts the human arm, the electrocardiogram electrode fits closely naturally due to the fitting of the cuff. Moreover, when there is an alarm for the detachment of the electrocardiogram electrode, it is known that the placement of the cuff needs to be adjusted, and the positions can be adjusted and corrected mutually.

[0037] Compared with the prior art, one of the beneficial effects of the present invention is that the cuff body is of a scroll clip type, which is convenient for single-handed wearing and enhances the usability.

[0038] Compared with the prior art, one of the beneficial effects of the present invention is that the control module A, the air pump, and the pressure sensing module (i.e., the pulse wave detection module) are provided, enabling the cuff to be suitable for pulse wave detection and blood pressure detection based on the airbag, and capable of obtaining blood pressure data and pulse wave data simultaneously, achieving two functions with one action.

[0039] Compared with the prior art, one of the beneficial effects of the present invention is that the control module A is provided on the cuff body, making the measurement of blood pressure and pulse wave simpler. Further, the control module A can be provided with a wireless module to wirelessly transmit the measurement data of blood pressure and pulse wave to the arteriosclerosis detection device.

[0040] Compared with the prior art, one of the beneficial effects of the present invention is that the control module A is connected to the blood pressure measuring cuff through an air duct, and the pulse wave detection and blood pressure detection can be performed by the control module A. The control module A can provide more powerful computing power support and more accurate measurement.

[0041] Compared with the prior art, one of the beneficial effects of the present invention is that a separate pulse wave signal line is provided to output the pulse wave signal to other devices, facilitating further signal processing and analysis such as arteriosclerosis detection.

[0042] Compared with the prior art, one of the beneficial effects of the present invention is that the arteriosclerosis detection device integrates multiple physiological signals such as heart sound, electrocardiogram, blood pressure, and pulse wave, providing a hardware basis for more accurate arteriosclerosis detection.

[0043] Compared with the prior art, one of the beneficial effects of the present invention is that Interface A is used to send heart sound detection signals, electrocardiogram detection signals, and pulse wave detection signals to the arteriosclerosis detection data analysis module or device, and the interface provides multiple signal transmission paths.

[0044] Compared with the prior art, one of the beneficial effects of the present invention is that three blood pressure measurement devices are respectively arranged at two arm positions and one ankle position, facilitating the acquisition of multi-physiological signals at each position and providing a basis for multi-point detection signals for more accurate arteriosclerosis detection.

[0045] Compared with the prior art, one of the beneficial effects of the present invention is that the blood pressure measurement device is arranged at the other ankle position, facilitating the acquisition of multi-physiological signals at this position and providing a basis for multi-point detection signals for more accurate arteriosclerosis detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 is a connection schematic diagram of the arteriosclerosis detection device when used for arteriosclerosis detection;

[0047] Figure 2 is Figure 1 a schematic diagram of a part of

[0048] Figure 3 is Figure 1 a schematic diagram of a part of

[0049] Figure 4 is Figure 1 a schematic diagram of a part of

[0050] Figure 5 is a connection schematic of the arteriosclerosis detection device when used for arteriosclerosis detection Figure 1 ;

[0051] Figure 6 is a connection schematic of the arteriosclerosis detection device when used for arteriosclerosis detection Figure 2 ;

[0052] Figure 7 is a timing schematic diagram of each signal during arteriosclerosis detection;

[0053] Figure 8 is a schematic block diagram of the arteriosclerosis detection module;

[0054] Figure 9 is a schematic block diagram of the arteriosclerosis detection module;

[0055] Figure 10 It is a schematic diagram of a blood pressure measurement device;

[0056] Figure 11 It is a schematic diagram of a blood pressure measurement device;

[0057] Figure 12 It is a schematic diagram of a blood pressure detection and control module;

[0058] Figure 13 It is a schematic diagram of a blood pressure measurement device;

[0059] Figure 14 It is a flow schematic block diagram of arteriosclerosis detection;

[0060] Figure 15 It is a schematic diagram of a heart sound sensor and its fixing device. Detailed implementation manners

[0061] The following further details the content of the present invention in conjunction with each attached drawing.

[0062] As used herein, the term "prepared from" is synonymous with "comprising". The term "comprising" as used herein, "having", "containing" or any other variation thereof, is intended to cover non - exclusive inclusion. For example, a composition, step, method, article or device comprising the listed elements need not be limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article or device. The connecting phrase "consisting of" excludes any unstated element, step or component.

[0063] If used in a claim, this phrase will render the claim closed, excluding materials other than those described, except for conventional impurities associated therewith. When the phrase "consisting of" appears in a clause of the claim body rather than immediately following the subject, it only limits the elements described in that clause; other elements are not excluded from the claim as a whole. When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values and lower preferred values, this should be understood to specifically disclose all ranges formed by any pairing of any upper range limit or preferred value with any lower range limit or preferred value, regardless of whether the range is separately disclosed. For example, when the range "1 to 5" is disclosed, the described range should be interpreted to include the ranges "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its end values and all integers and fractions within the range. The singular form includes plural referents unless the context clearly indicates otherwise. "Optional" or "any one" means that the matter or event described thereafter may or may not occur, and the description includes both the case where the event occurs and the case where the event does not occur. Approximating language, as used in the specification and claims, is used to modify a quantity, indicating that the present invention is not limited to the specific quantity, but also includes modifications that are close to the quantity and acceptable without causing a change in the relevant basic functionality. Accordingly, modifying a numerical value with "about", "approximately", etc. means that the present invention is not limited to the exact numerical value. In some instances, the approximating language may correspond to the precision of the instrument for measuring the value. In the specification and claims of this application, range limitations may be combined and / or interchanged, and these ranges include all sub-ranges subsumed therein unless otherwise stated. In addition, the indefinite articles "a" and "an" before an element or component of the present invention do not limit the quantity requirement (i.e., the number of occurrences) of the element or component. Thus, "a" or "an" should be construed to include one or at least one, and the singular form of an element or component also includes the plural form unless the quantity is clearly meant to be singular above.

[0064] As Figure 1 and Figure 7 shown, in an embodiment of an arteriosclerosis detection method, based on the cardio-ankle vascular index CAVI, the upper arm blood pressure is obtained; the systolic blood pressure P s and the diastolic blood pressure P d are obtained; the pulse pressure difference ΔP is calculated, and the pulse pressure difference ΔP = systolic blood pressure P s - diastolic blood pressure P d ; the distance L from the aortic valve of the heart to the ankle is measured ca ; the time difference Tca for the pulse wave to propagate from the heart to the ankle is measured; the cardio-ankle vascular index CAVI is calculated using the following formula: Among them, ρ is the blood flow density; the starting point time TA1 of the pulse wave at the ankle is measured; the starting point TA2 of the pulse wave of the brachial artery is measured, and the time difference Tba is obtained by calculating TA1 - TA2; the heart sound signal of the heart beat is measured, and the time difference T2 between the second heart sound and the first notch of the brachial artery is obtained; the time difference Tca = the time difference Tba + the time difference T2. The distance L from the aortic valve of the heart to the ankle ca is obtained by the electronic flexible ruler module for the distance between the heart sound auscultation area and the ankle pulse wave measurement site.

[0065] Such as Figure 7 , in this application, it is necessary to first accurately detect the propagation time difference of the pulse wave through the heart sound signal and the ankle-brachial pulse wave signal, and then combine the measured blood pressure value and the heart-ankle distance, and substitute them into the formula to calculate the CAVI value.

[0066] In this application, after collecting synchronous electrocardiogram, heart sound and four-channel pulse data, first perform preprocessing such as noise removal on the heart sound and electrocardiogram signals, remove noises such as baseline drift and electromyogram interference, and retain the characteristics of the signals. Subsequently, electrocardiogram R peak recognition, heart sound S1 / S2 feature recognition, and pulse wave peak feature point c, aortic opening feature point b (wave trough), and dicrotic wave feature point recognition are performed.

[0067] Such as Figure 7 , the time difference Tba between the starting points of the ankle pulse wave and the brachial artery pulse wave, plus the time difference T2 between the second heart sound and the first notch of the brachial artery, gives Tca. Then caPWV and CAVI are calculated. Substitute the systolic and diastolic blood pressure values on the side with the higher systolic blood pressure of the upper arm, and calculate the final result through the CAVI calculation formula.

[0068] Such as Figure 7 , the electrocardiogram signal is at the top, followed by the heart sound signal, the brachial artery pulse wave signal, and the ankle pulse wave signal; each heart beat corresponds to a complete electrocardiogram signal, and the position of the R wave of the electrocardiogram signal corresponds to the first heart sound; that is, the peak value of the first heart sound signal corresponds to the position of the R wave of the electrocardiogram signal.

[0069] Aortic valve opening occurs at the initial stage of ventricular systole (the beginning of the ejection phase), when blood is rapidly pumped into the aorta, generating a pressure wave that propagates along the arterial system. The rise time (T1) of the brachial artery pulse wave reflects the time required for the pressure wave to travel from the aortic root to the brachial artery. Aortic valve closure occurs at the end of ventricular systole (the end of the ejection phase), when the aortic pressure briefly drops to form a notch. The corresponding reverse pressure wave also takes time to travel to the brachial artery, forming T2. Although aortic valve opening and closure correspond to different cardiac cycle phases, the propagation speed of the pressure wave in the arterial system is the same. Therefore, the propagation time from the aortic root to the brachial artery remains consistent in both cases (T1 and T2).

[0070] Aortic valve opening occurs at the initial stage of ventricular ejection, when blood flow impact may trigger complex physiological noises (such as blood flow turbulence and muscle activity interference), making it difficult to detect the opening sound and obtain T1. The closing sound (corresponding to the second heart sound) is clearer and easier to identify, and the notch is a distinct feature point of the brachial artery pulse wave. The time difference T2 between the two is easier to accurately measure.

[0071] From the technical solution of this application, the measurement results of CAVI show that when using T2 in combination with other parameters, the reproducibility is good, and it can effectively distinguish patients with different degrees of arteriosclerosis (such as patients with diabetes and coronary heart disease have significantly elevated CAVI). This verifies the practicality of the measurement method based on T2 in clinical practice.

[0072] At the same time, it is also more accurate to calculate Tba by subtracting the time T1 from the electrocardiogram R wave to the starting point of the brachial artery wave from the time Tca from the electrocardiogram R wave to the starting point of the ankle artery wave, and it can also verify whether the time difference Tba between the starting points of the ankle pulse wave and the brachial artery pulse wave is correct. The time difference T1 from the electrocardiogram R wave to the starting point of the brachial artery is used to verify whether the rise time T1 of the brachial artery pulse wave is correct.

[0073] In this application, based on the reasoning of physical principles, it is considered that T1 and T2 are consistent and can be substituted for each other. The acquisition of T1 requires the accurate detection of the peak point of the first heart sound signal. However, the peak point of the first heart sound signal is not easy to detect, so the error in obtaining T1 will be relatively large. If T2 is used to replace T1, the starting point of T2 corresponds to the peak point of the second heart sound signal, which is easier to obtain than the starting point of T1.

[0074] In some embodiments, the above calculation process can be completed based on the heart sound signal, the brachial artery pulse wave signal, and the ankle pulse wave signal.

[0075] In other embodiments, the above calculation process can be completed based on the electrocardiogram signal, the heart sound signal, the brachial artery pulse wave signal, and the ankle pulse wave signal. When the electrocardiogram signal is added, the R wave position can be used to replace the first heart sound signal.

[0076] As Figure 1 and Figure 2 shown, an embodiment of an arteriosclerosis detection method measures the pulse wave velocity caPWV between the aorta and the ankle artery; L ca is the distance L from the aortic valve of the heart to the ankle ca , and Tca is the time difference for the pulse wave to propagate from the heart to the ankle.

[0077] As Figure 1 and Figure 2 shown, an embodiment of an arteriosclerosis detection method measures the brachial-ankle pulse wave velocity baPWV; L ba is the distance measured by the electronic flexible ruler module from the pulse wave measurement point of the arm to the pulse wave measurement point of the ankle; T ba represents the time difference of the pulse wave conduction from the arm to the ankle calculated based on the pulse waves of the brachial artery and the ankle artery.

[0078] As Figure 2 and Figure 5 shown, blood pressure measuring devices are arranged at the positions of labels B1, B2, B3, B4. In an embodiment of an arteriosclerosis detection method based on this device, the ankle-brachial index ABI is measured, which refers to the ratio of the systolic blood pressure of the ankle artery to the systolic blood pressure of the upper arm artery, that is, the systolic blood pressure of the brachial artery; the calculation formula is: wherein, aSBP represents the systolic blood pressure of the ankle artery, and bSBP h represents the higher value of the systolic blood pressure of the upper arm artery. In actual measurement, the systolic blood pressures of the ankle and the upper arm are measured respectively by the limb cuff vibration method, and then the ABI value is calculated by substituting into the formula.

[0079] As Figure 1 , an arteriosclerosis detection device is used to execute the above arteriosclerosis detection method; it includes a control module, a heart sound detection module, an electrocardiogram detection module, a pulse wave detection module, a blood pressure measuring device, and electrocardiogram detection electrodes.

[0080] As Figure 1 , blood pressure measuring devices are arranged at the positions of labels B1, B2, B3. In an arteriosclerosis detection device, there are at least 3 blood pressure measuring devices, including blood pressure measuring device B1, blood pressure measuring device B2, and blood pressure measuring device B3; blood pressure measuring device B1 and blood pressure measuring device B2 are used to be placed at the two arms of the detector; blood pressure measuring device B3 is used to be placed at the ankle part. The pulse wave detection module is electrically connected to the blood pressure measuring device through a pulse wave signal line; the pulse wave detection module is used to obtain a pulse wave detection signal and blood pressure. As Figure 1 shown, there may also be blood pressure measuring device B3 or blood pressure measuring device A3 used to be placed at the same ankle part.

[0081] As Figure 2 , there may also be a blood pressure measurement device B4 for placement on the other ankle.

[0082] As Figure 1 , an arteriosclerosis detection device, the electrocardiogram detection electrodes have at least 3, including electrocardiogram detection electrode A1, electrocardiogram detection electrode A2, electrocardiogram detection electrode A3; electrocardiogram detection electrode A1 and electrocardiogram detection electrode A2 are used for placement on the two arms of the detector; electrocardiogram detection electrode A3 is used for placement on the ankle; the control module is electrically connected to the electrocardiogram detection module, and the electrocardiogram detection module is electrically connected to the electrocardiogram detection electrodes through electrocardiogram detection signal lines; the electrocardiogram detection module is used to obtain electrocardiogram detection signals; the pulse wave detection module is electrically connected to the blood pressure measurement device to obtain pulse wave signals; the control module is electrically connected to the heart sound detection module, and the heart sound detection module is electrically connected to the heart sound detection sensor through a signal line; the heart sound detection sensor is used to be placed at the heart position of the detector to obtain heart sound signals.

[0083] As Figure 3 , the heart sound detection module is electrically connected to the heart sound detection sensor through a signal line.

[0084] As Figure 4 , electrocardiogram detection electrode A1 and electrocardiogram detection electrode A2 are used for placement on the two arms of the detector; electrocardiogram detection electrode A3 is used for placement on the ankle; the electrocardiogram detection module is electrically connected to the electrocardiogram detection electrodes through electrocardiogram detection signal lines.

[0085] As Figure 5 , blood pressure measurement devices B1, B2, B3, B4; blood pressure measurement devices B1 and B2 are placed on the two arms of the detector; blood pressure measurement devices B3 and B4 are placed on the ankles. The pulse wave detection module is electrically connected to the blood pressure measurement device through a pulse wave signal line; the pulse wave detection module is used to obtain pulse wave detection signals and blood pressure.

[0086] As Figure 6 , and Figure 10 and Figure 11 as shown, an arteriosclerosis detection device, the electrocardiogram detection electrode A1 is provided on the blood pressure measurement device B1; the electrocardiogram detection electrode A2 is provided on the blood pressure measurement device B2; the electrocardiogram detection electrode A3 is provided on the blood pressure measurement device B3.

[0087] As Figure 8 and Figure 9As shown in the figure, an arteriosclerosis detection device, the arteriosclerosis detection module includes a control module, a heart sound detection module, an electrocardiogram detection module, and a pulse wave detection module; the control module is connected to an external computer through interface A. The external computer or remote server can obtain various detection parameters. The detection parameters include the cardio-ankle vascular index CAVI, the pulse wave velocity caPWV between the aorta and the ankle artery, the brachial-ankle pulse wave velocity baPWV, the measured ankle-brachial index ABI, which refers to the ratio of the systolic blood pressure of the ankle artery to the systolic blood pressure of the upper arm artery, i.e., the systolic blood pressure of the brachial artery, electrocardiogram signals, heart sound signals, pulse wave signals, and blood pressure values.

[0088] As Figure 10 , Figure 11 and Figure 13 shown in the figure, the blood pressure measurement device and the electrocardiogram detection electrode are integrally arranged. The electrocardiogram detection electrode is arranged on the blood pressure measurement device; the electrocardiogram detection module is electrically connected to the electrocardiogram detection electrode through an electrocardiogram detection signal line.

[0089] As Figure 13 shown in the figure, an electrocardiogram detection electrode is arranged on the blood pressure measurement device.

[0090] As Figure 10 and Figure 11 shown in the figure, the blood pressure measurement device includes a cuff body, an airbag, an air duct, an electrocardiogram electrode, and an electrocardiogram detection signal line; one end of the electrocardiogram detection signal line is electrically connected to the electrocardiogram electrode; the other end of the electrocardiogram detection signal line is used to connect to an electrocardiogram signal detection device; the airbag is arranged on the cuff body, and the airbag is communicated with the air duct; the electrocardiogram electrode is arranged on the inner side of the cuff body.

[0091] As Figures 10 to 12 shown in the figure, the blood pressure measurement device further includes a blood pressure detection control module; the blood pressure detection control module includes a control module A, an air pump, a pressure sensing module, i.e., a pulse wave detection module, and a power supply module; the air pump is communicated with one end of the air duct; the air pump is electrically connected to the control module; the pressure sensing module, i.e., the pulse wave detection module, is electrically connected to the control module; the power supply module is electrically connected to the control module.

[0092] As Figure 13 shown in the figure, in the blood pressure measurement device, the cuff body is of a scroll clip type.

[0093] As Figure 10 shown in the figure, in the blood pressure measurement device, the blood pressure detection control module is arranged on the cuff body.

[0094] As Figure 10 and Figure 11 shown in the figure, in the blood pressure measurement device, the blood pressure detection control module is connected to the blood pressure measurement cuff through an air duct;

[0095] As Figure 10 andFigure 11 As shown, in the blood pressure measurement device, the blood pressure detection and control module includes a pulse wave signal line, and the pulse wave signal line is electrically connected to the control module; the pulse wave signal line is used to output a pulse wave signal.

[0096] As Figure 13 , the electrocardiogram electrode is made of silver ion polyamide fabric and directly adheres to the skin to conduct electricity. As Figure 14 , after wearing the integrated new clip-type sensor of three-way silver ion polyamide fabric electrocardiogram electrodes combined with a blood pressure cuff, a new clip-type cuff without electrocardiogram electrodes, and a heart sound sensor, turn on the machine for hardware self-check and parameter calibration, and judge whether the heart sound sensor, electrocardiogram electrode, and pulse wave sensor are worn properly according to the conditions set by the system.

[0097] For the heart sound sensor, it can be judged whether the heart sound sensor is worn correctly by whether the amplitude of the collected heart sound signal is greater than the pre-set heart sound signal amplitude. If it is less than the set threshold, the operator is prompted by the speaker of the system to re-wear the heart sound sensor until the sensor is worn correctly.

[0098] For the electrocardiogram sensor, it can be judged whether the heart sound sensor is worn correctly by whether the amplitude of the collected electrocardiogram signal is greater than the pre-set electrocardiogram signal amplitude. If it is less than the set threshold, the operator is prompted by the speaker of the system to re-wear the integrated new clip-type sensor of electrocardiogram electrodes combined with a blood pressure cuff until the sensor is worn correctly.

[0099] As Figure 15 , a heart sound sensor and its fixing device are shown. The fixing device is a rectangular counterweight. Using this device, the heart sound sensor can be stably fixed and adhered to the target position to ensure the accuracy of heart sound signal detection.

[0100] The pulse wave sensor is a pressure sensor; for the pulse wave sensor, it can be judged whether the pulse wave sensor is worn correctly by whether the amplitude of the collected pulse wave signal is greater than the pre-set pulse wave signal amplitude. If it is less than the set threshold, the operator is prompted by the speaker of the system to re-wear the integrated new clip-type sensor of electrocardiogram electrodes combined with a blood pressure cuff until the sensor is worn correctly. The vibration measurement method blood pressure measurement module can be a separate module or a sub-module in the pulse wave detection module, and is used for blood pressure measurement based on the pulse wave, that is, obtaining the blood pressure value based on the pulse wave.

[0101] After each sensor is correctly worn, the collected heart sound signals, electrocardiogram signals, and four-channel pulse wave signals are amplified and filtered through a signal conditioning circuit, sent to the controller MCU after analog-to-digital conversion, and after computer processing, the obtained arteriosclerosis parameter signals are sent to display terminals such as a computer display screen and a mobile app.

[0102] A method for detecting arteriosclerosis in this application is a new evaluation method that is almost unaffected by blood pressure changes: the Cardio-Ankle Vascular index (CAVI) is proposed. Through research and analysis, it is highly correlated with PWV and can be used as an independent predictor of arteriosclerosis.

[0103] A method for detecting arteriosclerosis in this application integrates the measurement of CAVI and ABI and can be used for home arteriosclerosis assessment, providing an effective solution for the early detection of arteriosclerosis and home health management. By introducing the CAVI parameter, a CAVI calculation model based on the measurement data of this device is established. Compared with the traditional PWV parameter, CAVI is not affected by blood pressure fluctuations and can more accurately reflect the degree of vascular wall sclerosis, providing a more reliable indicator for the assessment of arteriosclerosis.

[0104] When wearing the heart sound sensor, a certain pressure needs to be applied. Due to the different shapes of the chest wall auscultation areas of subjects of different genders, such as Figure 15 , this application designs the use of a "day-shaped" counterweight block (a figure can be added) as a counterweight structure. The sensor can move on its crossbar to change the overall structure and center of gravity to adapt to the shapes of the chest wall auscultation areas of different users. The fixing method of the heart sound sensor is changed from a weighted sandbag to a "day-shaped" counterweight lead, which can quickly provide stable pressure when the chest auscultation area is uneven, without repeatedly adjusting the shape of the sandbag.

[0105] In this application, for the acquisition of electrocardiogram signals, the clip electrodes or suction cup electrodes commonly used in traditional medical monitoring devices are abandoned. Instead, silver ion polyamide fabric that can directly contact the skin is innovatively used as the lead electrode material, and it is attached to the inner side of the blood pressure cuff as the lead electrode. A flexible electronic soft ruler module is used to calculate the blood vessel length, which is simple and convenient to operate, and does not require the user to manually input information. The electrocardiogram electrode is made of silver ion polyamide fabric and conducts electricity by directly contacting the skin.

[0106] In this application, the blood pressure measurement device not only simplifies the wearing process but also improves the wearing comfort, which highly fits the usage scenario of home arteriosclerosis monitoring. At the same time, the blood pressure cuff is replaced from the traditional strap type to a clip-type cuff, and the user can quickly complete the wearing of the cuff on the other hand with one hand;

[0107] This application is dedicated to the development of a home-use arteriosclerosis monitor that integrates CAVI and ABI measurements, with the following innovations. Introduction of the CAVI parameter: In this study, the CAVI is introduced into the home-use arteriosclerosis assessment instrument. By synchronously analyzing the cardio-ankle pulse wave and heart sound signals, the CAVI index can effectively eliminate the interference of blood pressure fluctuations on arteriosclerosis assessment. This feature makes the device very suitable for dynamically monitoring vascular health status and has significant advantages in the early screening of diseases, which can help users detect potential vascular problems in a timely manner.

[0108] Design optimization of the blood pressure measurement device, i.e., the sensor: The number of sensors in this design has not increased compared with existing advanced devices, but key optimizations have been made in the sensor structure and wearing method: Secondly, the integrated design of the flexible electrode and the cuff completes the wearing of the heart electrode while the cuff is worn; at the same time, the blood pressure cuff has been replaced from the traditional strap type to a clip-type cuff, allowing users to quickly wear the cuff on the other hand with one hand; in addition, since the heart electrode is attached to the inner side of the cuff, the lead-off detection circuit inside the board can be used to detect whether the cuff and the electrode are worn, so that the program can control the automatic start of measurement without manual initiation. These optimizations simplify the wearing process, improve the convenience of user operation, and contribute to the promotion of the home use of arteriosclerosis detectors.

[0109] Use a flexible electronic soft ruler module to calculate the blood vessel length, which is simple and convenient to operate and does not require the user to manually input information. This application designs a complete home monitoring solution. The overall design of the device is compact, portable, easy to operate and understand, and suitable for home users. Users can transmit the measurement data to the PC or the app mobile terminal in real time for convenient data management and analysis. At the same time, the system also has the function of automatically generating diagnostic reports, providing professional health advice for users and helping users better understand their own vascular health status.

[0110] The above are only the embodiments of this application, and do not limit the scope of this application. Any equivalent structural or equivalent process transformations made by using the content of the application specification and the drawings, or directly or indirectly applied in other related technical fields, are similarly included in the scope of protection of this application.

Claims

1. An arteriosclerosis detection method, based on the cardio-ankle vascular index (CAVI), characterized in that Get upper arm blood pressure; get systolic blood pressure P s and diastolic blood pressure P d ; Calculate to obtain the pulse pressure difference ΔP, where the pulse pressure difference ΔP = systolic blood pressure P s - diastolic blood pressure P d ; Measure the distance L from the aortic valve of the heart to the ankle ca ; Measure the time difference T for the pulse wave to propagate from the heart to the ankle ca ; the cardio-ankle vascular index (CAVI) is calculated using the following formula; where ρ is the blood flow density; the starting time point TA1 of the pulse wave at the ankle is measured; the starting point TA2 of the pulse wave of the brachial artery is measured, and the time difference Tba is obtained by calculating TA1 - TA2; the heart sound signal of the heart beat is measured, and the time difference T2 between the second heart sound and the first notch of the brachial artery is obtained; the time difference Tca = the time difference Tba + the time difference T2.

2. The arteriosclerosis detection method according to claim 1, characterized in that The distance L from the heart's aortic valve to the ankle ca , obtained by measuring the distance between the heart sound auscultation area and the ankle pulse wave measurement site using an electronic flexible ruler module.

3. The arteriosclerosis detection method according to claim 2, characterized in that Measure the pulse wave velocity caPWV between the aorta and the ankle artery; L ca is the distance from the aortic valve of the heart to the ankle, and Tca is the time difference for the pulse wave to travel from the heart to the ankle.

4. The arteriosclerosis detection method according to claim 1, characterized in that Measure the brachial-ankle pulse wave velocity baPWV; L ba is the distance from the arm pulse wave measurement point to the ankle pulse wave measurement point measured by the electronic flexible ruler module; T ba represents the pulse wave conduction time difference from the arm to the ankle calculated based on the brachial artery and ankle artery pulse waves.

5. The arteriosclerosis detection method according to claim 1, characterized in that the ankle-brachial index (ABI) is measured, which is the ratio of the systolic blood pressure of the ankle artery to the systolic blood pressure of the upper arm artery, i.e., the systolic blood pressure of the brachial artery; The calculation formula is as follows: where aSBP represents the ankle arterial systolic blood pressure, and bSBP h represents the higher value of the systolic blood pressure of the brachial artery. In actual measurement, the systolic blood pressures of the ankle and the upper arm are measured respectively by the four-limb cuff plethysmography method, and then the ABI value is calculated by substituting into the formula.

6. An arteriosclerosis detection device, characterized in that it is used to execute the arteriosclerosis detection method according to any one of claims 1 to 5; it includes a control module, a heart sound detection module, an electrocardiogram detection module, a pulse wave detection module, a blood pressure measurement device, and electrocardiogram detection electrodes; there are at least 3 blood pressure measurement devices, including blood pressure measurement device B1, blood pressure measurement device B2, and blood pressure measurement device B3; Blood pressure measurement device B1 and blood pressure measurement device B2 are used to be placed at the two arms of the detector; blood pressure measurement device B3 is used to be placed at the ankle; The pulse wave detection module is electrically connected to the blood pressure measurement device through a pulse wave signal line; the pulse wave detection module is used to obtain a pulse wave detection signal and blood pressure; There are at least 3 electrocardiogram detection electrodes, including electrocardiogram detection electrode A1, electrocardiogram detection electrode A2, and electrocardiogram detection electrode A3; Electrocardiogram detection electrode A1 and electrocardiogram detection electrode A2 are used to be placed at the two arms of the detector; electrocardiogram detection electrode A3 is used to be placed at the ankle; the control module is electrically connected to the electrocardiogram detection module, and the electrocardiogram detection module is electrically connected to the electrocardiogram detection electrodes through an electrocardiogram detection signal line; the electrocardiogram detection module is used to obtain an electrocardiogram detection signal; The pulse wave detection module is electrically connected to the blood pressure measurement device to obtain a pulse wave signal; The control module is electrically connected to the heart sound detection module, and the heart sound detection module is electrically connected to the heart sound detection sensor through a signal line; the heart sound detection sensor is used to be placed at the heart position of the detector to obtain a heart sound signal.

7. The arteriosclerosis detection device according to claim 6, characterized in that the electrocardiogram detection electrode A1 is arranged on the blood pressure measurement device B1; the electrocardiogram detection electrode A2 is arranged on the blood pressure measurement device B2; the electrocardiogram detection electrode A3 is arranged on the blood pressure measurement device B3.

8. The arteriosclerosis detection device according to claim 6, characterized in that the blood pressure measurement device includes a cuff main body, an airbag, an air duct, an electrocardiogram electrode, and an electrocardiogram detection signal line; one end of the electrocardiogram detection signal line is electrically connected to the electrocardiogram electrode; The other end of the electrocardiogram detection signal line is used to connect with an electrocardiogram signal detection device; The airbag is arranged on the cuff body, and the airbag is communicated with the air duct; The electrocardiogram electrode is arranged on the inner side of the cuff body.

9. The arteriosclerosis detection device according to claim 7, characterized in that The blood pressure measurement device further includes a blood pressure detection control module; The blood pressure detection control module includes a control module A, an air pump, a pressure sensing module and a pulse wave detection module, and a power supply module; The air pump is communicated with one end of the air duct; The air pump is electrically connected with the control module; The pressure sensing module and the pulse wave detection module are electrically connected with the control module; The power supply module is electrically connected with the control module.

10. The arteriosclerosis detection device according to claim 8, characterized in that It further includes any one or more of the following technical features: TA10: The cuff body is of a scroll clip type; TA20: The blood pressure detection control module is arranged on the cuff body; TA30: The blood pressure detection control module is connected with the blood pressure measurement cuff through an air duct; TA40: The blood pressure detection control module includes a pulse wave signal line, and the pulse wave signal line is in electrical signal communication with the control module; the pulse wave signal line is used for outputting a pulse wave signal.

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