TW201136568A - Apparatus for measuring opening and closing functions of a heart valve - Google Patents

Abstract

An apparatus for measuring opening and closing functions of a heart valve by using non-invasive radial artery blood pressure waveform and the method thereof, such an apparatus is convenient to operate, low cost, and can measure radial artery blood pressure waveform precisely, so as to detect the specific micro blood pressure waveform when the heart valve is opened or closed. To sum up, such an apparatus can not only facilitate the doctor to diagnose the opening and closing conditions of the heart valve, but also can help the patient to monitor the conditions of his/her heart valve.

Description

201136568 VI. Description of the Invention: [Technical Field] The present invention relates to measuring the opening and closing function of a heart valve, and more particularly to an apparatus for measuring the opening and closing function of a heart valve by a non-invasive radial blood pressure waveform and Measurement method. [Prior Art] In order to understand the blood flow of the heart, the conventional technique of inserting (or invading) the artery of the body (such as the aorta, the carotid, or the radial artery) with a liquid pressure gauge is obtained. Continuous arterial blood pressure waveform. The second diagram shows the relationship between the pressure waveform of the arteries obtained by the liquid pressure gauge breaking into the aorta (Aorta) and its time points of the heart cycle. It can be clearly seen from the blood pressure waveform of the aorta (A〇rta) in Fig. 1. When the aortic valve is opened, the blood pressure wave rises rapidly from the bottom line (the left ventricular ejection begins); ♦ the blood pressure wave reaches the highest point (ie, the main peak or the first wave front) when the flow rate of the liquid is highest; the left ventricular ejection ends, the aortic valve closes. At that time, the blood pressure waveform forms a valley bottom, after which the blood pressure wave rises slightly and then gradually drops to the bottom line (Baseline, the diastolic pressure).

Diastolic Pressure), formed a heavy beat wave (j) icrotic N〇tch; that is, the second wave front). The left ventricle (Left Ventricle) blood pressure waveform in Figure 1 is the liquid pressure gauge carbon into the left ventricle (Left ventricle). It is worth noting that the continuous blood pressure waveform does not have enough (four) to show the waveform at the time of the aortic closure. This is because the test force gauge is located in the left ventricle (10). In the left atrium of the third map (Left is the liquid pressure gauge charcoal into the left atrium (this Α Γ Γ 所 所 所 所 所 所 所 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压 血压

Left Atn〇Ventricuiar Valve ; control the left atrium to the left ventricle.) There are specific types of tests when opening or closing. However, this continuous blood pressure waveform is obtained via an invasive liquid pressure gauge. The focus of this issue is to use a non-intrusive instrument to obtain a specific waveform when the second reward is turned on or closed. The blood flow rate of the Aotic valve in the figure is the blood flow rate recorded by the liquid flow meter near the A tic valve. A detailed reading of the blood flow rate map reveals that when the aortic valve is opened, the blood stalk rises rapidly, _ the highest speed point, and when the large pulsation valve is closed, the blood money speed drops to zero. Another technical point of the present invention is to obtain a specific waveform of the aortic valve when it is opened and closed by a non-intelligence instrument. The ECG signal in Figure 1 is the ECG signal measured by the ECG ECG during the same period. Clinically, it has been found that the ECG signal cannot be used to discriminate the heart valve. The abnormality of the opening and closing functions. 0 In summary, the conventional liquid pressure gauge technique is often used by researchers to obtain the blood pressure waveform when the aortic valve is opened and closed, but because Invasive, clinically rarely used as a tool to break heart valve abnormalities. When it is suspected that the heart valve is abnormal, clinical clinics usually use blood analysis and electrocardiography (ECG 'Electrocardiography) to rule out the possibility of other similar symptoms (for example, too high or too low potassium (κ) concentration in the blood can cause arrhythmia It is suspected that the heart valve is abnormal; and the electrocardiogram can measure the ECG signal 'myocardial insufficiency' and arrhythmia in detail). Next, the clinician then uses Echocardiography to confirm the normal or abnormal sound waveform of any of the above-mentioned valves when they are turned on and off. In order to further analyze the insufficiency of the cardiac valve, [P (Prolapse) or jk fluid counterflow or Regurgitation, clinical cardiologist 201136568 often receives D-er Ultras〇und in the heart and surrounding blood. The image 'to confirm the details and extent of the heart valve disease (such as excessive palpitations, ignorance, discomfort, inability to lock, blood leakage ratio, etc.). Although both the heart sound machine and the Doppler ultrasound are the human type H, it is not easy to sneak into the blame, the operation and the training, and the doctors in the hospital can not be promoted to the general department (such as internal medicine, family medicine, medical department, Psychiatry, rehabilitation, etc.). Due to exposure reasons, heart sound machines and Doppler ultrasound are often not available to clinics, # or home use. Although the ECG can measure the detailed ECG signal, it can't be touched. Due to the simple operation and reasonable rationality of the wrist or arm type sphygmomanometer, 6 is one of the difficulties in the treatment of silk. The electronic sphygmomanometer usually contains a pumping pump, a gas valve, a gas meter, an air tube, a wristband with an air bag, a circuit module, and a casing for blood pressure measurement. The process towel and the air-sending valve cause the air bag to be pressurized and reduced. At the same time, the blood pressure pulse wave of the wrist and the radial artery is transmitted to the barometer through the air bag and the air pipe, and the soft and hard art on the circuit will be pure. The heart rate, the systolic blood pressure and the diastolic blood pressure are calculated by amplification, accounting and analysis. Although the above-mentioned existing blood pressure measurement technology can record the blood pressure waveform of the radial artery by a barometer, due to factors such as the material characteristics and geometry of the air bag, the original shape of the blood pressure wave cannot be completely transmitted to the air of the air bag, and The air bag is transmitted to the path of the barometer through the airway tube, and the blood pressure wave pattern is degraded (Dampening) and the intensity is weakened, resulting in the measured blood pressure waveform loss sensitivity (Acsiacy) and accuracy (Accuracy) Conventional wrist or arm electronic sphygmomanometers cannot be used to detect the specific fine blood 201136568 pressure wave pattern that occurs when the heart valve is opened and closed. In order to measure the more accurate brachial blood pressure waveform, the pulse instrument on the market adopts a round pressure sensor of about 5-mm diameter. When testing, the circular pressure sensor is fixed to the wrist with tape or rubber band. Above the artery, connect the signal wire to the circuit board or computer. Usually, the round pressure sensor is made of a resistive-type conductive material. Similar to the principle of the Strain Gauge, it contains an amplifier circuit. Temperature effect compensation, and linearization processing components. When the resistive material is stressed, the amount of change in resistance, current, or voltage is proportional to the pressure, so the pressure can be recorded by this relationship. The above technique can indeed measure the details and prototype of the brachial blood pressure waveform under ideal conditions', but its disadvantage is that it cannot accurately control the pressure of the circular pressure sensor fixed on the wrist surface. The present inventors have found that this pressure is very important for measuring blood pressure waveforms, and if the pressure is too light (for example, the above-mentioned conventional technique is only fixed with a tape or a rubber band), the wrist is hypertrophied, the radial artery is deep, or the pulse wave is encountered. In the case of weak conditions, the pressure sensor cannot obtain a clear blood pressure waveform signal. If the pressure is too heavy, the blood flow to the radial artery is severely obstructed, causing the measured blood pressure waveform to be distorted. Therefore, this conventional pulse diagnosis device cannot be used as an instrument for detecting the opening and closing of a heart valve. In addition, due to factors such as the size of the wrist and the deep position of the radial artery, the circular pressure device must be grasped by a trained physician or nursing staff to find the correct position of the artery and fixed. This kind of inconvenient operation is one of the factors that make the pulse diagnosis instrument or other similar equipment unable to become an electronic device. According to clinical statistics, patients with heart valve abnormalities are increasing, and mitral valve insufficiency accounts for 2-3% of the total population (see Hayek E, Gring CN, Grif f in BP (2005).

Mitral valve prolapse". For example, 365 (9458): 507- 18), ^S1 201136568 Patients with incomplete aortic valve account for 2% of 65-year-olds, 3°/〇 for 75-year-olds, and 85 years of age or older 4% of the elderly (see Stewart BF, Siscovick D, Lind BK 'Gardin JM 'Gottdiener JS, Smith VE. Clinical factors associated with calcific aortic valve disease).

Cardiovascular Health Study. J Am Coll Cardiol. 1997; 29: 630-634). In summary, the clinicians in each department urgently need an easy-to-use, low-cost instrument for detecting abnormal heart valves, and the general patient or the public is in desperate need of a similar instrument (but the operation is simpler) and the price is lower. ) for home monitoring or self-examination. None of the foregoing prior art discloses or suggests that the non-invasive wrist and iliac artery blood pressure waveform instrument system of the present invention is useful for diagnosing heart valve opening and closing abnormalities. The inventor previously filed a patent application for the non-invasive brachial blood pressure waveform measurement system and its application (Application No. 093137742) to your Bureau (Intellectual Property Bureau of the Ministry of Economic Affairs of the Republic of China) and has been approved. This invention patent measures heart rate Variability and autonomic nerves in a hardware similar to the present application. However, in order to achieve the purpose of diagnosing a heart valve opening and closing abnormality, the analysis software and steps of the present application are quite different from the invention patent, and it is hereby indicated. SUMMARY OF THE INVENTION It is an object of the present invention to provide an apparatus and a measuring method for measuring the opening and closing function of a heart valve by using a non-invasive brachial blood pressure waveform, which mainly develops a non-invasive, easy-to-operate, low-cost, and An instrument that accurately measures the blood pressure pattern of the wrist and brachial artery to detect the special 201136568 micro-small ship type that occurs when the heart valve is opened and closed. This new type of canister valve is used by clinicians as a tool for diagnosing heart valve opening and closing abnormalities, as well as for home monitoring and general self-examination. In order to achieve the foregoing objectives, an apparatus for measuring the opening and closing function of a non-invasive radial blood pressure waveform according to the present invention includes a piezoelectric sensor, which is capable of continuous wrist wrist Recording and generating an electric wave representing a blood pressure pulse wave; a wristband containing a two-air bag, the wristband being attached to the wrist, and the airbag applying pressure to the piezoelectric sensor; Inflating and aligning the air bag; the circuit includes a central calculator, a dip, a city traversing device, a 峨 amplifying component, and a pneumatic gas connected to the X gas, operating the software, pure to the circuit Huan, the soft system controls the Wei bag, solves the maximum pressure of the m, and measures the blood pressure waveform of the brachial artery under the most test pressure, and the electric wave from the piezoelectric sensor is subjected to 遽, amplification and analysis. And the specific mode of the closing right; - the power supply, providing the inductor wire, the domain gas unit, the electric _ _ _ _ the required power supply body, for the charging domain unit, the circuit module, the operating body and the power supply set Features, she should have a money unit, a coffee set In the pump and the Wei Wei _ two air ducts, the air bag has two air nozzles, the Lizhong circuit module, and the other one is connected to Jingpu and the... When the pump accepts the operating software When the command begins to pump up, Cheng Jing, Wei Guan pressure, its value is controlled by _ 岐 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; The base of the piezoelectric inductor is a flexible printed circuit board, and the combining step is to arrange a plurality of piezoelectric elements in a row according to the width direction of the hand and to be fixed on the flexible circuit board. There is a gap of 1 to 2 mm; the circuit module 6 has a multi-Plexer and a related driving software, and the flexible circuit board transmits the electric wave signals from the piezoelectric elements. The cable is transmitted to the multi-signal scanner by a cable or a connector (c〇nnect〇r), which is connected to the signal filtering component and the signal amplifying component. When the blood pressure pulse wave measurement is performed, the multiple signal scanning is performed. The device sequentially captures each of the piezoelectric elements on the piezoelectric sensor The electric wave of the piece is compared with the piezoelectric element having the strongest electric wave as the measuring component; the piezoelectric sensor is disposed in the wristband, and one side of the piezoelectric sensor is in contact with the air bag in the wristband, and One side is in contact with the outer layer of the wristband; the piezoelectric sensor transmits the electric wave to the circuit module through the wire; the electric wave signal is transmitted to the circuit module through the two positive and negative wires. Secondly, in order to achieve the foregoing purpose, An apparatus for measuring a heart valve opening and closing function by using a non-invasive radial blood pressure waveform according to the present invention is different from the foregoing apparatus in that the operating software is carried on the circuit module, the operating software Controlling the air pressure of the airbag, finding the optimum test air pressure, measuring the brachial blood pressure waveform at the optimum test pressure, and transmitting the electric wave from the piezoelectric sensor to a computer carrying a computing software, by the calculation The soft body filters, amplifies, and analyzes the specific waveform of the heart valve opening and closing. In addition, in order to achieve the foregoing object, a method for measuring the opening and closing of a heart valve using the instrument for measuring the opening and closing function of a heart valve with a non-invasive radial blood pressure waveform according to the present invention is provided in accordance with the present invention, which includes: Taking the continuous blood pressure waveform of the subject (eg, 50 seconds to 5 minutes), calculating the / characteristic point of each cardiac cycle and two characteristic waves and their related twelve parameters (time parameter Ti To T6, the pressure parameter ^ to the support); (2) divide the time parameter of the above-mentioned subject (χ_axis, the unit is second) by the heartbeat cycle (that is, the per-wei required coffee, the unit is seconds), forming eight standardizations And the time parameter of no unit (Dimensi〇niess 〇r N〇rmaHzed) (NT1 to NT6); (3) the pressure parameter of the above-mentioned subject, the axis is in Volt) divided by the height of the main wave (Primary) For volts her), the pressure parameters of five fresh sputum units are formed (NT1 to (4); the ribs (ie, the main wave height) are not standardized); (4) as in steps (1) to (3), multiple normal people (such as ten people) Ten of the above) - a standardized parameter plus After averaging, define the specific blood type parameters of the normal human heart valve opening and closing, and store it in the electric reliance group database (CPU drama) as the wave number of the characteristic wave of any subject. And the heart valve opening and closing is the (4) benchmark; (5) the upper one of the higher than the financial pulse is greater than the New height (10) 5 (the recording of the new bed database and the normal person database of the step (4) is defined as The city wave with physiological significance, the other smaller pulse wave is regarded as the news; (6) If the blood of the physiologically significant blood of the subject is in the arbitrary-gamma__cut 3' Congling, Lin_step analysis (7) In accordance with step (6) 'If the subject's pulse wave is after the big move _ remuneration then at least two consecutive wavelets appear (according to the above ship point and coffee parameters, the _ small as the current ^ axis position should be between C and (between E), it is determined that the aortic ankle is insufficiency; s 3 201136568 Step (6), if the subject is in the last segment of the pulse wave (ie, the normal time unit before the next main wave is about 卜.b 0.3; or X - the axis position should be between the characteristic points of E and G). If at least two consecutive wavelets appear, then the decision is made. For mitral valve insufficiency; (9) If the aortic valve insufficiency of the subject occurs in most of the pulse waves (such as more than 50% of the continuous pulse measured; this value can be adjusted according to clinical experience), then Further, it is determined that the repetitive aortic valve is incompletely closed; conversely, if the aortic valve insufficiency of the subject only occurs in certain pulse waves (or less than 50% of the pulse waves), it is further determined that the sporadic aortic valve is insufficiency. 10) If the subject's mitral valve insufficiency occurs in most of the pulse waves (eg, more than 50% of the pulse wave; this value can be adjusted according to clinical experience), then further judged as a regular mitral valve Incomplete occlusion; conversely, if the subject's mitral valve insufficiency only occurs in certain pulse waves (or less than 5% of the pulse wave), it is further determined as sporadic mitral valve insufficiency. Finally, in order to achieve the foregoing object, a method for measuring the opening and closing of a heart valve using an apparatus for measuring a heart valve opening and closing function using a non-invasive brachial blood pressure waveform according to the present invention is different from the foregoing method. It is: (4) as in steps (1) to (3), after the eleven standardization parameters of a plurality of normal persons (such as more than ten persons) are purely averaged, the specific blood pressure waveform parameters of the mosquitoes can be defined and closed. 'And stored in the circuit module database (4), memory) or the computer, as a benchmark for the bullying-acceptance wave wave number and whether the heart valve opening and closing function is abnormal. In view of the above-mentioned objects, the present invention achieves the above-mentioned objects, the techniques, means and other functions of the present invention. 12 201136568 [Embodiment] Referring to Figures 2, 4, and 13 , an apparatus for measuring the opening and closing function of a heart valve by using a non-invasive radial blood pressure waveform is provided, which is easy to operate and can accurately measure the wrist. The device of the radial artery blood pressure wave type is mainly composed of a pressure sensor 10, a wristband 20, a charging and charging unit 30, a circuit module 40, an operating software 50, a power source 60, and a body 70. The composition, wherein: the piezoelectric sensor 10 is used to measure the wrist 90 iliac artery 91, which can continuously record and generate electric waves representing blood pressure pulses. The wristband 20 includes an air bag 21 which is attached to the wrist 9 , and which is pressed against the piezoelectric sensor 1 . The inflator unit 30 inflates and entrains the air bag 21. The circuit module 40 includes a central calculator 41, a memory 42, a signal filtering component 43, a signal amplifying component 44, and a gas pressure gauge 45 connected to the airbag 21. ® the operating software 50, which is carried in the circuit module 4〇, the operating software 4〇 controls the air pressure of the air bag 21 to find the optimum test pressure, and measures the radial artery 91 blood wave type at the optimum test pressure. The electric wave from the piezoelectric sensor 1 is subjected to furnace, amplification and analysis of a specific waveform when the heart valve is opened and closed. The power supply 60' provides the power source required for the operation of the ink-electric sensor 1, the filling unit 3, the circuit module 40, and the operating software 50. The body 70 is provided for the charging and charging unit 3, the circuit module 4, the operating software 50, and the power supply 6〇. (1) 201136568 is characterized in that the charging and deflating unit 3A includes a pump 31, a deflation valve 32, and two air guiding pipes connected to the pump 31 and the blast valve 32, and the air bag η has a messy mouth 21卜 212 'the one is connected to the barometer 45 of the circuit module 4, the other is connected to the air pipe through the pump 31 and the air valve 32, when the pump 31 accepts the operating software 5G command When the air pumping is started, the airing valve 32 is temporarily _, the air pressure of the air bag 21 is increased, and the value thereof is monitored by the air pressure meter 45; when the air venting valve receives the operating software 50 command to start deflation, the air venting valve 32 is opened, and the air bag is opened. 21, the air pressure is thus lowered; the piezoelectric sensor 10 is at least composed of a bimorph element u, the base of the piezoelectric inductor 10 is a flexible printed circuit board 121, and the combination step is to apply a plurality of piezoelectric electrodes. The components u are arranged in a row according to the width of the hand, and are fixed on the flexible circuit board 121. Each of the piezoelectric elements u has a gap of 2 mm therebetween. The circuit module 40 is provided with a multi-signal scanner. 46 (Multi_plexer) and a related driver software 47 'The flexible circuit board 121 will be The electric wave signals of the piezoelectric elements η are transmitted to the multi-signal scanner 46 by a cable or a connector, and are connected to the signal filtering component 43 and the signal amplifying component 44 for blood pressure pulse wave. During the measurement, the multi-signal scanner 46 sequentially captures the electric waves of the piezoelectric elements 11 on the piezoelectric sensor 10, and compares and selects the piezoelectric element 11 having the strongest electric wave as the measuring element; the piezoelectric sensing The device 1 is disposed in the wristband 2〇, and one surface of the piezoelectric sensor 10 is in contact with the air bag 21 in the wristband 2〇, and the other surface is in contact with the outer layer of the wristband 20; the piezoelectric sensor 1〇 transmits the electric wave 201136568 to the circuit module 40 through the wire. In addition, the circuit module of the above-described instrument system of the present invention and the operating software 5 of the circuit module 40 can also transmit the electric wave of the electric sensor to the computer 80 via a signal line. The specific waveform of the heart valve opening and closing is analyzed by the software contained in the computer 8; and the circuit module 40 in the instrument system of the present invention and the operating software 5 mounted on the circuit module 40 can also be used. The pressure sensor is transmitted to the computer via the wireless module, and the software loaded in the computer analyzes the specific waveform of the heart valve when it is opened and closed. According to the invention, the piezoelectric induction H 1G can be, but is not limited to, Tao Jing

Lead zirconate titanate (ΡΓΓ) piezoelectric sheet, or polymer polyvinylidene fiuoride (PVDF) piezoelectric sheet, or stress type (don't ^

Gauge) Piezoelectric element, or semiconductor type (Semiconductor), and piezoelectric sensor 1 according to the present invention, which is not built into the wristband 2〇, and one surface of the piezoelectric inductor 10 The airbag is in contact with the airbag in the wristband 2, and the other side is in contact with the outer fabric of the wristband 2, and the piezoelectric sensor 10 transmits the electric wave signal to the circuit module 40 through the wire. When testing, simply test the wrist strap 2〇 and its attached body 7〇 over the wrist 90. At the beginning of the test, the air bag 21 of the wristband 2 is pressurized and pressurized by the pump 31 of the charging and deflating unit 30, and at the same time, the air bag 21 also applies pressure to the piezoelectric sensor 10, the piezoelectric sensor 1〇 The pressure is applied to the radial artery 91 of the wrist 9 增强, which causes the pulse signal of the piezoelectric sensor 1 to be enhanced. [S 1 Referring to Figures 3a to 3c, one of the technical points of the present invention is to gradually increase the pressure of the air bag 21 from zero to a certain pressure by using the 15 201136568 Pu 31 (for example, taking 2 legs, as shown in the figure) 'This piezoelectric induction H is the blood pressure pulse of the 3b picture during this inflation period, and the primary peak height of each pulse wave (Fig. 3c). In general, &, the main wave is first changed from small to large, and then from large to small, when the main wave shows a maximum value (generally between 70-150 raraHg, Figure 3b), then The pressure of the air bag 21 is defined as the optimum test air pressure according to the present invention (〇ptimal “Pressure”). The inventors have found that the piezoelectric sensor 1 has the strongest blood pressure wave signal in this state, that is, the signal-noise. The ratio (Signal_t〇_N〇iseRati〇) is the highest. When the air pressure of the air bag 21 is lower than this value, the pressure signal is weak due to the poor pressure transmission between the piezoelectric sensor 1 and the radial artery; when the air bag 21 is weak; When the air pressure is higher than this value, the wristband 20, the squat bag 21, and the piezoelectric sensor 1 施 exert excessive pressure on the iliac artery 91, reducing the arterial flow rate, and also causing the pulse signal to be weakened and modified. The important steps of the present invention One is to measure the optimal test pressure at the beginning of the blood pressure waveform of the radial artery 91. Then, the air bag 21 is pressurized to or near the air pressure value, and then the blood pressure waveform monitoring is performed. The above aeration step is changed to quickly charge to a certain pressure value (for example, 20 0 mmHg), and then gradually reduce the pressure of the air bag 21. During this deflation period, according to the same principle and steps as above, the optimum test air pressure can be found. The shape and size of the piezoelectric sensor 10' described above does not hinder this. According to the invention, the sensing body member of the piezoelectric inductor 10 can be a circular shape, and the square shape is a sheet of other geometric shapes, and the thickness thereof can range from 0.1 leg to 5 mm, and the diameter or the length of the side can be From 1 to 100 mm, it is placed in the wristband 2〇 just above the wrist 90 iliac artery 91. The preferred state of the piezoelectric sensor 10 (No. 16 201136568 4) is a round foil 'The diameter is 2~5 coffee, the thickness is up to 3 legs, the electric wave signal is the lion's strip _ 做 _ 4 〇, its power supply stress-type Strain Gauge piezoelectric element or semiconductor type Semi_c〇nductQr Shi Xi piezoelectric The component requires an external power supply, but the PZT or p-win piezoelectric piece does not require a power supply. The battery or external power supply of the circuit module 40 is supplied through the wire, and is placed in the wristband 2〇 at a position just above the wrist 90 iliac artery 91. According to the fifth figure of the present invention, the pressure The other preferred state of the electric sensor 10 is a rectangular sheet whose length (along the direction of the hand) is 1 to 3 〇 coffee, and the width (between the width of the hand 熇 〜 ~ (10) 咖 'Other built in the wristband 20 or the power supply characteristics are the same as described above. When tested, since the piezoelectric sensor 1 〇 covers a large enough range, it is easier to position the radial artery 91. According to the sixth figure of the present invention, the piezoelectric sensor 10 A piezoelectric sensing module 12' may be composed of a plurality of (at least two) piezoelectric elements u and built in the wristband 20, wherein each piezoelectric element n is a square, rectangular, or circular piezoelectric sheet. And the side length (or diameter) is 3~5 legs' and the base of the sensing module 12 is a flexible circuit board 121 (fiexibie. In the step of combining, the plurality of piezoelectric elements u are arranged in a row in the width direction of the hand, and are fixed on the flexible circuit board 121, and a small gap is formed between the piezoelectric element n and the piezoelectric element u ( 〇·1~2mm) to avoid interference from adjacent waves. Further, a multi-plexer 46 and an associated driving software 47 are mounted on the piezoelectric sensing module 12 of the present invention. The flexible circuit board m transmits the electric wave signals from the sensing elements 11 to the multi-signal scanner 46 by a cable or cable connector, which is connected to the signal filtering component.

[S 43 and signal amplifying element 44. When the blood pressure pulse wave measurement is performed, the multi-signal scanner 17 201136568 46 sequentially captures the electric wave signals of the piezoelectric elements u on the piezoelectric sensor module 12, and compares and selects the piezoelectric elements with the strongest electric wave signals. Compared with other piezoelectric elements 1 , the position of the training element 11 must be exactly above or near the secret 91, so the shout obtained is the strongest. According to this (4), the piezoelectric element U with the strongest signal is selected as the measuring element' while the signal of the other piezoelectric element U is no longer used, as for other measuring steps (such as the most appropriate amount of pressure, etc.) The same as the rest state. The number of the above-mentioned multiple components is at least two, and preferably three to five, with a target range of 10 to 25 coffee. Compared with the other preferred state examples described above, the piezoelectric sensor module 12 uses the soft t-board 121 as a base to test the pressure on the surface of the wrist 90, and has a large sensing range, which is suitable for various hand sizes. The piezoelectric inductors 1 of the two preferred states shown in the above fifth and sixth figures have the advantage that the pulse wave side range is enlarged and can be adapted to different hand sizes. In addition, the general public can measure it themselves without having to be operated by a trained physician or caregiver. According to the invention, the 'Kin 2G can be the cloth wristband 20 of the stomach area in the electronic ▲ pressure gauge, and the air bag 2 is contained therein. The size of the air bag 21 is determined according to the standard wrist pressure measurement. (The width along the direction of the hand is between 6〇~9〇, and the circumference along the width of the hand is between 8〇15〇mm). In order to facilitate the strap, the wrist strap is usually equipped with a U-shaped or a U-shaped piece. The opening size of the plastic sheet is equivalent to the thickness and width of the wrist. It is convenient for the wrist strap 9Q and its upper body 7 () Attached to the wrist 9 ' 'This plastic piece also contains a protruding clasp, exposed to the wristband 90 fabric, its role is to combine the body of the body (4) body 7G, above the county 跋 wristband 20. According to the fifth and sixth embodiments of the present invention, a pocket can be added to the airbag 21 of the wristband 201136568 20, and the piezoelectric sensing component is mounted therein, when the airbag 21 is inflated. At the same time, the piezoelectric sensor 1 can be accurately pressed; likewise, the pocket of the piezoelectric sensor 10 can be fixed at other positions within the wristband 20, for example, between the wristband 20 fabric and the airbag. In the meantime, Eli pressure. According to the present invention, the pump 31 is similar to the air pump used in a general electronic sphygmomanometer. It receives a DC power source to push the blade and rotates to inflate. According to the present invention, the deflation valve 32 can be an On-Off solenoid valve switch similar to that used in general electronic sphygmomanometers, which accepts a programmed command to open or close the air valve; and the deflation valve 32 can be analogous (Anai 〇g) electromagnetic The valve switch, the size of the valve opening is determined by the voltage or current value. 'This type is more than the valve 〇11_0忖 switch (only fully open or fully closed), more able to regulate the deflation speed. According to the invention, the substrate of the circuit module 4 can be a printed circuit board, which is embedded with a central calculator (cpu) 41, a memory 42 (such as Flash or RAM, etc.), a barometer. 45. Signal filtering component 43, signal amplifying component 44, buzzer, real clock ({^1_1[-(;:1〇(±), and other electronic components, etc.) for facilitating display of the test process and results, the circuit The module 4 can include a liquid bb (LCD) or a light-emitting diode (led) display. In addition, the circuit module can also be equipped with a multi-signal scanner (Multi_piexer) 46 to comply with the foregoing Figure 6 According to the present invention, the circuit module 4〇 carries an operating software 5〇, and the software program can be operated by the flow chart shown in the wire 7® (such as a pump, a gas valve, Central calculator, barometer, liquid crystal display, piezoelectric sensor, etc.) to achieve the following goals: (1) control the air pressure of the air bag; (2) find the optimum test pressure according to the steps of the present invention; (3) according to the steps of the present invention Measuring the brachial artery waveform at the optimal test pressure; (4) Filtering and amplifying the measured wave signal; (5) analyzing and calculating the measured wave signal, and judging whether the function of opening and closing the heart valve is abnormal, and (6) analyzing the original data and analyzing The result is stored in the memory and the test result is displayed on the liquid crystal display (see description below). According to the present invention, the power source 70 can be a general dry battery (disposable), a lithium battery (rechargeable), a nickel-hydrogen battery (repeatable) Provided by charging or other types of batteries. The power supply 70 required by the present invention can be provided by a general AC power source (such as 11 〇V or 220 V, etc.) If an AC power source is used, the circuit module 4 of the present invention can be retrofitted. An AC-to-DC transformer (Transf0rmer or Adapt〇r) to provide the power required to accept the circuit components of the direct-voltage IL. According to the present invention, the signal line is a signal conductor conforming to RS232 or USB (including both ends of the connectors) Preferably, the signal wire is a low noise wire having a protective outer layer. According to the present invention, the computer 80 can be a desktop computer, a notebook computer, or a small computer. Electric Netbook Computer, or Smartphones (such as the iPhone of American Apple Company or Hero of Taiwan HTC Company). According to the present invention, the desktop or portable computer 8 can have an operation, storage, display, and transmission function The system, and the main unit 7〇 and the computer 8〇 can be connected to the standard interface (such as RS-232 (COM Port), USB, IEEE 1394, etc.) through the 201136568. This connection can also be wireless (Wireless). According to the present invention, among the wireless transmission technologies, a commercially available RF (Radio Frequency) wireless module can be used, and the frequency range can be in the commonly used iSMBand (ie [industry, science, medical] shared frequency band), among which the most commonly used communication protocol Bluetooth (Blue Tooth, 2. 4 GHz) Wi-Fi or WiMax (including IEEE 802. lib, 802.1 la, and 802·1 lg, 450 MHz to 2. 7 GHz), and low frequency ISM (433 to 915) • MHz) ° In addition, the US Food and Drug Administration (FDA) has also established a WMTS channel (608~1429 MHz) for medical devices. Generally, the RF wireless module operates in a pair of two-way mutual transmission mode. Taking the application of the present invention as an example, one of the wireless transceiver module devices is disposed in the body 70 of the present invention, and the other is disposed in the computer or the Smartph〇ne. . According to the inventors' experiments, it has been found in human body that the normal human hand brachial artery blood pressure waveform has six characteristic points (A, B, C, D, E, F) and three characteristic waves (main wave, second wave or ® tremor) Wave, third wave) as shown in Figure 8. The ratio of the characteristic point to the blood flow rate map has been confirmed by the Doppler ultrasound blood flow meter in Example 6 of the present application. The inventors have also found that 'Aortic Incomplete Closing and Regurgitation' 'the original blood that has been injected will flow from the aorta into the left ventricle', so in the Dicrotic Notch (the second wave) A continuous wavelet will appear immediately (as shown in Figures 9a and 9b). The inventors have further discovered that if the patient has a mitral valve insufficiency (Mitral vaive prolapse an (} regurgitation), when the left ventricle collapses, blood will flow from the left ventricle into the left heart 21 201136568 room, so in the heavy beat wave After that, there will be continuous wavelets before the next main wave (as shown in Fig. 10b). According to these clinical findings, the aforementioned non-invasive blood pressure pulse measurement technique is reused. The present invention (4) non-invasive secrets The method for measuring the opening and closing of a heart valve by the instrument for measuring the opening and closing function of the blood pressure waveform includes the following steps of measuring the function of opening and closing the heart valve and determining whether it is abnormal: (1) taking the subject Regular (such as 50 seconds to 5 minutes) continuous blood pressure waveform, calculate the six characteristic points of each heart and three characteristic waves and their related ten Lu parameters (time parameters T1 to T6, pressure parameters P1 to P6; see Figure 8 and Table 1). (2) Divide the time parameter of the above-mentioned subject, in seconds, by the heartbeat period (ie, the time required for each heartbeat, in seconds) to form six Standardized and no single (Dimensionless or Normalized) of the time parameter (NT1 to the NT6); this step to eliminate the influence of the speed of the heartbeat time parameters. (3) Divide the pressure parameter (^ axis, in volts “Η) of the above test subject by the primary peak height (in volts Volt) to form five standardized and unitless pressure parameters (NT1). To NT5; the towel Bb (ie the main wave height) is not standardized; see Figure 8 and Table 1). (4) If steps (1) to (3), multiple normal people (such as more than ten) After averaging eleven standardized parameters, the "specific blood pressure waveform parameters when the normal heart valve is opened and closed" are defined and stored in the circuit module or computer database (CPU, memory, etc.) of the present invention. As a criterion for determining the wave number of the characteristic wave of any subject and whether the heart valve opening and closing function is abnormal. (5) The pulse wave of the above-mentioned subject is the highest wave height A at the main wave height (four) (This value can be augmented and the normal person database in step (4) is defined as "the blood vessel with physiological meaning" "The pulse of the small pulse is regarded as noise. (6) If the subject has physiological The wave number of the blood pressure wave of significance is greater than 3 in any cardiac cycle. (7) Cheng (6), if the subject's pulse wave appears at least two consecutive peaches after the aortic valve is closed (according to the lining point and time parameter silk standard, Lai Xiaobo appears X - The position of the shaft should be between C and E, see Figure 8, _ is defined as aortic valve insufficiency. (8) Bearing (6), if the subject is in the last segment of the pulse (ie before the next main wave) The normalized time unit of about .1-0·3; or the χ_axis position should be between the characteristic points of E and G (see Figure 8). If at least two consecutive wavelets appear, the mitral valve insufficiency is determined. (9) If the subject's aortic valve insufficiency occurs in most of the pulse waves (eg, more than 50% of the continuous pulse measured; this value can be adjusted according to clinical experience), it is further determined as "regular aorta The valve is incompletely closed (as shown in Figure 9b); otherwise, if the subject's aortic valve insufficiency only occurs in certain pulse waves (or less than 5% of the pulse), then further judged, Incidental aortic valve insufficiency, (as shown in Figure 9a) (10) If the subject's mitral valve Incomplete occlusion occurs in most of the pulse waves (eg [more than 50% of the pulse; this value can be adjusted according to clinical experience), then further judgment 23 201136568 is defined as recurrent - valvular insufficiency" (such as the persuasion) As shown in the figure); conversely, if the subject's second _ lock incomplete only occurs in certain pulse waves (or less than 5G% of the pulse wave), then it is further determined as "occasion mitral valve insufficiency, (11) (11) The analysis of each step (6) to (9) above can be interpreted by the naked eye in addition to the available software program to confirm the judgment is correct. Table 1. Definition of blood pressure waveform characteristic parameter values (see section 8) Fig.) Parameter/parameter definition 3-wave type ''' Number of peaks 3 ^^ Main peak point Β ^ ^ Main trough point A, G ~- Sub-peak point DF ^~ Sub-valley point C, E ~~~ Time parameter Tl =ab T2=bc T3=cd T4=de T5=ef T6=fg Normalized time parameter NTl=ab/ag~NT2=bc/ag NT3=cd/ag NT4=de/ag NT5=ef/ag ---- ----

24 201136568 NT6-fg/ag . Pressure parameter Pl=Aa P2=Bb P3=Cc P4=Dd P5=Ee ----- P6=Ff Normalized force parameter NPl=Aa/Bb NP2=Cc/Bb NP3=Dd /Bb NP4=Ee/Bb NP5=Ff/Bb § Master: (1) Lowercase £1,]3. , (1, 6, f, g, etc. are time points, the unit is seconds

(2) Uppercase A, b, c, D, E, F, G, etc. are points on the blood pressure waveform, and the coordinate unit is (pressure 'sec) or (voltage, second). The present invention further provides a hospital for hospital use. The novel heart valve physiological signal monitoring instrument system (shown in FIG. 11) monitored by the patient includes (a) the non-invasive precise blood pressure wave type measuring technology and the instrument system thereof according to the present invention, and is coupled to the patient Wrist (b) conventional wireless signal transmission technology, and a set of wireless transmission transceiver modules are placed in the host of (a) 'the other group is placed in the bedside analyzer in the ward to receive the patient's physiological signals' (C) Measure the blood pressure waveform of the heart disease with the instrument system of (a) above, and determine whether the patient has a cardiac valve insufficiency, (d) the physiological signal of (c) with the wireless transmission module of (b) From the host of (a) to the bedside analyzer of (b), and the bedside analyzer will further illuminate the patient's physiology and its sub-reductions from Network, LAN) or the Internet (Internet) ) Out of the ward. The present invention further provides a novel heart valve physiological signal monitoring instrument system for monitoring a home patient (as shown in FIG. 12), which comprises (4) the non-invasive precise blood pressure wave type measuring technology of the present invention and Its instrument system, equipped with the wrist of the patient (6) conventional wireless transmission technology, · __ group wireless transmission (four) module placed in the host of (4), the other group placed in the home patient responsible for receiving (four) physiological signals In the bedside analyzer, (6) measure the blood pressure waveform of heart disease with the instrument system of (a) above, and determine whether the patient has rotten lock; ^All, (4) wireless transmission of (5) physiological signal to (6) Module 纟 (4) domain Wei Zhi (6) bedside points (four), secret edge analyzer and then the patient's physiological position and its analysis results regularly paste off (such as (10) (4) transmission or telephone modem (Modem) to the health authorities (such as Health Bureau, Department of Health, Hospital, Clinic, Medical Website, etc.) According to the present invention, the health authority can also transmit instructions of medical experts to the bedside analyzer of the home patient through the Internet (ie, two-way communication). The above analysis steps and clinical applications will The following actual clinical cases are described in detail. The embodiments are merely illustrative of the invention, and are not intended to limit the invention, and are specifically illustrated. Example 1: Non-invasive hand-cranial arterial blood pressure wave type instrument for heart-to-heart unlocking The subject of the instrument system consists of the following components (see Figures 2, 4 and 13): (a) A piezoelectric sensor consisting of a strainer (StrainGauge), its body 15 26 201136568 The size of the 5-leg round sheet (3mm thick) 'includes signal filtering, amplification, correction, temperature compensation and other circuits. In addition to the circular sensor body 15, there is another wire π connected to the body 70 (wrist physiological monitoring The circuit module 4 〇. The wire 16 functions to provide the piezoelectric sensor 10 power and transmit the piezoelectric signal to the circuit module 4 (b) the body 70 (wrist physiological monitor host), It contains a pumping pump, a venting valve, a standard 2A dry battery (two), an RS232 port, a barometer, and a circuit module with a central processing unit, s memory, and signal processing (filtering, amplification, calibration). This version of the body 70 also has a cover And a cover of the lower cover, the cover comprises a buckle and a small opening, and the cover can be fixed on the wrist wristband 20, and the upper cover has a button for operating the body 7 (c) the wristband 20, which contains a gas. The bag and a u-shaped plastic sheet, the plastic sheet has a buckle piece and a small hole 'can be combined with the lower cover of the body 70. The length of the wrist band 2 is longer than the length of the wrist of the general wrist, so it is around the wrist 9〇— After the week, the remaining length can be reversed and fixed with the devil. The operation steps of the instrument system are described as follows: (d) The finger is placed on the wrist of a subject 9 〇 (both left and right hands), and the radial artery 91 is measured. The exact position (e) The body 15 of the circular piezoelectric sensor 1 of (a) is fixed with a tape over the radial artery 91. (0) The body 70 of (b) is attached to the wrist of the subject by the wristband 20 of (c). (g) According to the "starting of the body 70 of (b), the 'key, start the test, this hiring Control the software to give instructions to the pumping pump, start pumping (at this time the vent valve is closed), when the air bag is pressurized

When L S to 200 mmHg (barometer value), the control software 5 〇 gives the command to release the bleed valve. 27 201136568 Slow deflation. At the same time, the control software 50 and the circuit module 40 read and store the pressure value of the barometer and the pulse signal of the piezoelectric sensor 10 at a speed of 500 data points per second, manipulate the software 50 and calculate the deflation period (200 drops) Up to 30 mmHg, about 20 seconds) The wave height of each pulse (ie, the peak-valley), and the pressure value at which the maximum wave height occurs is determined. This pressure value (93 mmHg) is the optimum test pressure. (h) The control software 50 then issues an instruction to the air pump of the charging and deflating unit 30 to raise the air pressure of the air bag from 30 mmHg to the optimum test air pressure (93 mmHg), and then the control software 5 and the circuit module 40 are also The 5 〇〇 data point rate reads the pulse sensor of the piezoelectric sensor 1 ,, and samples for 5 seconds, and stores the data and the corresponding time value (taken from the Real-Time Clock) in the circuit module 4 The memory of 〇. (i) Open a personal computer 8 〇 and connect it to the RS-232 port of the unit 70 with its RS_232 (c〇Mp〇rt) cable. The personal computer 8〇 operation software gives instructions to the main circuit 7〇 circuit module 40 and its operating software 5〇, and starts data download (such as pseudo-Download) ° (j) PC 80 control program will download the data in χ_γ mode Fig., in which the axis of the axis tree is 10 (in seconds), the γ axis is the digitized side of the piezoelectric sensor 1〇6; (2) the dynasty). In this example, the continuous pulse wave result of the tester is as shown in the first marriage. Since the measured continuous pulse wave shows three waves in each touch, the heart of the subject is unlocked and sounded. In this example, the eleven standardized parameters of ten healthy subjects (5 males and 5 females) are averaged (as shown in Fig. 8), and then defined as, when the normal human heart valve is opened, "Special mad pressure wave parameters", see Table 2. The data is stored in the instrument system database (4), memory, computer, etc. of the present invention, as a computer software-like Wei and his. The benchmark for whether the bribe film opening and closing function is abnormal.

29 201136568 P3=28.4 P4=28.5 P5=27. 3 P6=27.8 Normalized pressure parameter NP1=0.869 NP2=〇.959 NP3=〇. 963 NP4=〇. 938 NP5=〇. 940 Note: (1) Lowercase a, b, c, d, e, f, g, etc. are time points, the unit is seconds (2) uppercase A, B, C, D, E, F, G, etc. are the points on the blood pressure waveform curve, and the coordinate unit is ( mV, sec) Example 2: Non-invasive wrist radial artery blood pressure waveform measuring instrument system for subjects with sporadic aortic valve insufficiency. The soft and hard parts of the instrument and the operation part of this example are similar to the example 1, but the measured results are as shown in Fig. 9a. Since two of the five cycles of the measured continuous pulse show a continuous nucleus after the tremor wave (depending on; the ship is greater than 3), the #three-sided period has no such continuous wavelet (the total wave number of the cycle is equal to 3) ). Therefore, it was determined that the subject was inadvertent aortic valve insufficiency. Example 3: Non-invasive wrist radial artery blood pressure waveform measuring instrument is used in subjects with frequent aortic valve insufficiency. This example is similar to the soft and hard county operation department purchase _ instance 丨, but the measured surname is as shown in Figure 9b. Because of the secret wave seven of _ _ shot a post after the heavy beat wave 30 201136568 = display even private waves (recording head fine; the total wave number of the axis is greater than 3), so it is determined that the test is a regular aortic valve insufficiency . An example 4. A non-invasive wrist radial artery blood pressure waveform measuring instrument system is used for subjects with sporadic mitral valve insufficiency. The soft and hard parts of the instrument and the operation part of this example are similar to the example i, but the measured results are as shown in the figure. Since one of the five cycles of the measured continuous pulse wave is at the end (the display of the lower wire is continuous Yao (the number of touches is greater than 3), the other four cycles do not have this continuous wavelet (the total wave of the cycle) The number is equal to 3). Therefore, the subject was determined to be sporadic mitral valve insufficiency. Example 5: Non-invasive hand-cranked blood pressure wave type aging is used for subjects with frequent mitral valve insufficiency. The soft and hard parts of the instrument and the operation part of this example are similar to the example 丨, but the measured result is shown in Figure l〇b. Since the measured continuous pulse wave is in the last stage of each of the five cycles (the next wave is not started) Previously) shows a continuous wavelet (indicated by the arrow; the total wave number of the week is greater than 3), so the subject is determined to be a frequent mitral valve insufficiency. Example 6: Non-invasive wrist radial artery blood pressure waveform measuring instrument The system is measured and compared with Doppler Ultrasound. The soft and hard parts of the instrument and the operation part of this example are similar to the example 丨, but the DW-A ultrasound A is measured while measuring the blood pressure waveform of the wrist and brachial artery. Doppler mtrasciund; USCOM Pty Ltd, Sydney NSW 2000, Austra Lia; http://www. uscom. com, au/contact/index, html) in the heart of the heart [s] output (Ultrasonic Cardiac Output Monitor; see Figure 15) and the big move 31 201136568 pulse blood flow, the 16th _ shows the results of the comparison between the blood and the blood flow of the Doppler ultrasound. The image of the aortic valve is increased from zero when the aortic valve is opened. The pressure of the Qi Libo type is also increased by the bottom of the valley (ie, diastolic blood pressure); when the blood flow of the aorta reaches the highest value ^, the pressure of the blood pressure waveform also reaches its apex; when the aorta is closed, the blood flow drops to zero. The Qianbo type is just in the valley of the domain and the heavy ship. The above experimental results confirm that the non-invasive wrist and blood pressure measuring instrument system of the present invention is used for the sensitivity of the opening and closing of the heart valve (this example is an aortic valve). And the above-mentioned embodiments and illustrations are only the preferred embodiments of the present invention, and the scope of the present invention cannot be limited thereto, that is, the scope of patent application according to the present invention. Made by The changes and modifications should be within the scope of the patent of the present invention. [Simplified illustration] Figure 1 is the arterial blood pressure waveform obtained by the liquid pressure gauge breaking into the aorta (A〇rta) and its circulation with the heart. Correlation diagram of each time point. Lu Di 2 is a block diagram of the present invention. Fig. 3a is a diagram showing the relationship between air pressure and time of the airbag used in the present invention. Fig. 3b is a blood pressure wave type signal used in the present invention. Diagram of relationship with barometric pressure Fig. 3c is a peak diagram of the blood pressure waveform of the wrist radial artery when used in the present invention. Fig. 4 is a schematic view showing the use of a piezoelectric inductor in the present invention. Fig. 5 is a schematic view showing another embodiment of the present invention using a piezoelectric inductor. Fig. 6 is a schematic view showing still another embodiment of the piezoelectric sensor used in the present invention. 32 201136568 Figure 7 is a flow chart of the control software of the present invention. Figure 8 is a blood pressure waveform diagram of a wrist flexing artery showing the state of blood pressure waveform in the wrist of a normal person. Fig. 9a is a blood pressure waveform diagram of a wrist flexor artery, showing the state of the blood pressure waveform of the wrist flexing artery of the patient with occasional large dynamic occlusion. The first figure is a blood pressure waveform diagram of a wrist flexing artery, showing the state of the blood pressure waveform of the wrist flexing artery of the patient with frequent and large pulsation. Fig. 10a is a state diagram of a blood pressure waveform of a wrist and a wrist artery showing the state of blood pressure waveform of the wrist of the patient with occasional mitral valve insufficiency. Figure 10b is a blood pressure waveform diagram of a wrist flexor artery showing the state of blood pressure waveform of the wrist flexing artery of the patient with frequent mitral valve insufficiency. Figure 11 is a system diagram of the physiological signal monitoring instrument used in the hospital ward of the present invention. Figure 12 is a system diagram of the physiological signal monitoring instrument used in the home patient of the present invention. Figure 13 is a schematic illustration of a non-invasive radial artery blood pressure waveform measuring device of the present invention. Fig. 14 is a blood pressure waveform diagram of the wrist flexor artery measured by the present invention, showing the blood vessel wave state of the subject with a sound heart valve. Fig. 15 is a view showing the measurement of the wrist blood pressure waveform of the wrist and the use of the Doppler ultrasound in the heart socket, the reading and the field pulse flow. Figure 16 is a graph of the blood pressure test of the wrist. ... [Main component symbol description] 33 201136568 Piezoelectric sensor 10 Piezoelectric element 11 Piezoelectric sensor module 12 Flexible circuit board 121 Main body 15 Conductor 16 Wrist strap 20 Air bag 21 Air nozzle 211 Air nozzle 212 Filling and deflating unit 30 Deflating Valve 32 Pump 31 Circuit Module 40 Central Calculator 41 Memory 42 Signal Filtering Element 43 • Signal Amplifying Element 44 Barometer 45 Multiple Signal Scanner 46 Operating Software 50 Power 60 Body 70 Computer 80 Wrist 90 Driving Software 47 Radial Artery 91 Doppler Ultrasonic A • 34

Claims (1)

201136568 VII. Scope of application: 1. An instrument for measuring the opening and closing function of a heart valve with a non-invasive radial blood pressure waveform, comprising: - a piezoelectric sensor for measuring the wrist and iliac artery, It can continuously record and generate electric waves representing the blood pressure pulse wave; - the wristband 'ribs contain - recorded, the wristband is carried on the wrist, and the air bag applies pressure to the piezoelectric sensor; '-the air-filling unit Touching the wire and the domain; - a circuit module comprising - a central calculator, a memory, a signal filtering component, a signal amplifying component, and a barometer connected to the air bag; - operating software 'Wei Circuit module, the soft system of operation (4) The air pressure of the airbag is 'search for the most suitable position, and the blood pressure waveform is slid under the optimum clock, and the electric wave from the piezoelectric sensor is filtered, amplified and analyzed for the opening of the heart valve and a specific wave type when closed; a power supply, providing a power supply for the Wei Wei H, the domain transfer element, the electric power group, and the operation software operation; a body for the gas unit, the circuit module, the operation software, and Power setting The sign is that the heart-filled early Yuan contains #—助浦,——麟阀 and other only the pump and __two air pipe, the air bag has two air nozzles, one of which is the module's chaotic juice' The other one is connected to the squad and the sputum sputum, and when the pump accepts the operation software command to start pumping, the bubble valve is closed [s] 35 201136568, and the air pressure of the air bag is raised. The value is monitored by a barometer; when the vent valve accepts the operation software command to start deflation, the vent valve is opened, and the air bag pressure is lowered; the piezoelectric sensor is at least composed of two piezoelectric elements, the piezoelectric sensor The base of the device is a flexible printed circuit board. The combination step is to arrange a plurality of piezoelectric elements in a row according to the width direction of the hand, and is fixed on the flexible circuit board. 1~2 mm gap; the circuit module is provided with a multi-signal scanner (Mul ti-Plexer) and an associated driving software, the flexible circuit board uses the electric wave signals from the piezoelectric elements as wires (Cable Or wire) or connector The multi-signal scanner is further connected to the signal filtering component and the signal amplifying component. When the blood pressure pulse wave is measured, the multi-channel scanner sequentially captures the electric wave of each piezoelectric component on the piezoelectric sensor. And comparing and selecting the piezoelectric component with the strongest electric wave as the measuring component; the piezoelectric sensor is disposed in the wristband' and one side of the piezoelectric sensor is in contact with the airbag in the wristband, and the other side is connected with the wrist The outer layer of the fabric is in contact with the outer layer; the piezoelectric sensor transmits the electric wave to the circuit module through the wire; the electric wave signal is transmitted to the circuit module through the two positive and negative wires. 2. The apparatus for measuring the opening and closing function of a heart valve by a non-invasive radial blood pressure waveform as described in claim 1 of the patent application, wherein the piezoelectric inductor is a ceramic zirconate titanate (PZT) piezoelectric sheet, A polymer (P〇lyvinylidenefluoride; PVDF) piezoelectric sheet, a strain type (Strain Gauge) piezoelectric element or a semiconductor type (Semi-Conductor). 3. The instrument for measuring the opening and closing function of the heart valve according to the non-invasive radial blood pressure waveform 36 201136568 as described in claim 1 of the patent scope, wherein the piezoelectric sensor is a round shape and the square shape is other geometric figures. The sheet may have a thickness ranging from 〇1 coffee to 5 coffee, and the diameter or side length may be from 1 mm to 100. 4. Apparatus for measuring the opening and closing of a heart valve by a non-invasive radial blood pressure waveform as described in the scope of the patent application, wherein the air bag has a pocket thereon for the piezoelectric sensor to be placed. 5. If you apply for the ninth item, you can use the non-invasive secret blood pressure waveform to measure the opening and closing function of the heart valve. The pump is an air pump. The helium valve is a solenoid valve switch or analogy. (Anal〇g) Solenoid valve switch. 6. If the application for the lion's sacral blood pressure waveform is measured, the heart valve is opened and closed, and the circuit module further includes a liquid crystal (LCD) or a light-emitting diode (LED). monitor. 7. The instrument for measuring the opening and closing function of the heart valve by translating the human brachial blood pressure waveform as described in the general _ , item, wherein the operating soft system transmits the electric wave from the piezoelectric sensor via a signal line To the computer. 8. The apparatus for measuring the opening and closing function of a heart valve by a non-invasive radial artery blood pressure waveform as described in the patent application specification, wherein the operating soft system transmits the electric wave from the piezoelectric sensor via a wireless module. Pass to the computer. 9. A method for measuring the opening and closing of a heart valve using the item i of the scope of the patent application, which comprises the following steps: G) taking a continuous blood pressure waveform of the tree of the subject, such as 5G seconds to 5 minutes, Calculate six characteristic points per heart cycle and three characteristic waves and their fine 12_37 201136568 parameters (time parameters T1 to T6, pressure parameters P1 to P6); (2) Time parameters of the above subjects ( The X-axis 'in seconds' divided by the heartbeat period (ie, the time required for each heartbeat, in seconds) 'forms six time-division (Dimensionless or Normalized) time parameters (NT1 to NT6); (3) The pressure parameters (y-axis, in volts v〇it) of the above test subjects are divided by the main wave saliency (Primary Peak Height 'in volts Volt) to form five standardized and unitless pressure parameters (NT1 to NT5; where Bb (ie, the main wave height) is not standardized); &quot; (4) If steps (1) to (3) 'equalize eleven standardized parameters of multiple normal people (such as more than ten) , defining a specific blood pressure waveform parameter when a normal human heart valve is opened and closed, and Stored in the circuit module database (cpu, memory) as a reference for determining the wave number of the characteristic wave of any subject and whether the heart valve opening and closing function is abnormal; (5) the above test Any wave height of the pulse wave is greater than 5% of the main wave height (Bb) (this value can be adjusted according to the clinical experience and the normal person database of step (4)) is defined as a blood pressure wave with physiological significance, and the rest is smaller. The pulse wave is regarded as noise; (6) If the wave number of the physiological blood pressure wave of the double tester is greater than 3 in any cardiac cycle, a warning is issued and further analysis is performed; (7) Step (6), If the subject's pulse wave appears at least two consecutive wavelets after the aortic valve is closed (according to the above characteristic point and time parameters, the X-segment of continuous wavelet should be between), and the aorta is a large artery _ (8) In accordance with step (6), if the subject is in the last segment of the pulse (ie, the next main wave before 38 201136568 is about 0.1-0.3 of the standardized time unit; or the χ-axis position should be between E and At least two consecutive wavelets appear between the characteristic points of G, It is determined that the mitral valve is insufficiency; (9) If the subject's aortic valve insufficiency occurs in most of the pulse waves (for example, more than 50% of the continuous pulse waves measured; this value can be adjusted according to clinical experience), Further, it is determined that the repetitive aortic valve is incompletely closed; conversely, if the aortic valve insufficiency of the subject only occurs in certain pulse waves (or less than 50% of the pulse waves), it is further determined that the sporadic aortic valve is locked. Incomplete; ® (10) If the subject's mitral valve insufficiency occurs in most of the pulse waves (eg, more than 50% of the pulse; this value can be adjusted according to clinical experience), then further determined to be regular The valvular atresia is incomplete; on the other hand, if the mitral valve insufficiency of the subject only occurs in certain pulse waves (or less than 5% of the pulse wave), it is further determined that the mitral valvular insufficiency . 10. The method for measuring the opening and closing of a heart valve according to the application of the scope of the patent application mentioned in claim 9 wherein the steps of step (6) to step (9) are interpreted by the naked eye, Confirm that the judgment is correct. 11. A method for measuring the opening and closing of a heart valve using the scope of the patent application </ RTI> comprising the following steps: (1) taking a continuous blood pressure pattern of the subject (eg, 50 seconds to 5 minutes). Calculate the six characteristic points of each _^ dirty period and the three parameters related to the three characteristics (time parameters T1 to T6, pressure parameters P1 to P6); (2) The time parameters of the above-mentioned subjects (χ— The axis, in seconds, divided by the heartbeat cycle (ie, the time required for each heartbeat, in seconds), forming six standardized and no units 39 201136568 (Dimensionless or Normalized) time parameters (NT1 to Machi 6); (3 The pressure parameter (y-axis, in volts v〇lt) of the above test subject is divided by the primary peak height (in volts v〇lt) to form five standardized and unitless pressure parameters (10) SNT5 ; + Bb (ie, the main wave height) is not standardized); (4) If steps (1) to (3) are used to average the eleven normalized parameters of multiple normal persons (eg, more than ten), define a specific blood pressure waveform parameter when a normal person's dirty thief opens and closes, and Stored in the electronic library data library, memory, or the computer as a benchmark for bullying-receiving characteristic wave readings and abnormal function of opening and closing of the valve; (5) Any wave height of the pulse wave is greater than the main wave height (rib) jumper (this value can be a thief bed and the normal person in step (4) #料库关关整) is defined as a physiologically significant blood pressure wave The wave is regarded as noise; (6) The wave number of the physiological blood pressure wave of the right sputum is greater than 3 in any cardiac cycle, and a warning is issued and further analyzed; (7) Step (6), if subject At least two consecutive wavelets appear after the aortic valve is closed (according to the characteristic point and time parameter of ±, the X-axis of continuous wavelet appears between C and E), Huding (8) In accordance with step (6), if the subject is in the last segment of the pulse wave (ie, the normal time unit before the next main wave is about 1. 1-0. 3; or the position of the χ axis should be between E and Between the characteristic points of G), if at least two consecutive wavelets appear, the mitral valve is determined to be closed. Incomplete; (9) If the aortic valve insufficiency of the subject occurs in most of the pulse waves (for example, 5 (10) or more of the continuous pulse wave measured by 201136568; this value can be adjusted according to clinical experience), it is further determined to be recurrent. The aortic valve is incompletely closed; conversely, if the subject's aortic wide-locking insufficiency only occurs in certain pulse waves (or less than 50% of the pulse waves), it is further determined that the incident aortic valve is incompletely closed; (10) The mitral valve insufficiency of the subject occurs in most of the pulse waves (for example, more than 50% of the pulse wave; this value can be adjusted according to clinical experience), and further determined as frequent mitral valve insufficiency; If the subject's mitral valve atresia only occurs in certain pulse waves (or less than 50% of the pulse wave), it is further determined as sporadic mitral valve insufficiency.