1289052 九、發明說明： 【發明所屬之技術領域】 本發明係有關一種生理訊號分析裝置，特別是有關一 種即時分析心率變異程度之裝置，利用内建有心率變異分 析模組之中央處理運算單元，提供使用者不僅可紀錄二^ 訊號，更進一步可獲得心率變異分析參數。 【先前技術】 按，自主神經系統分為交感神經與副交感神經，兩者 在體内分佈的位置不同，其作用也不一樣，大體上可以說 是交互與拮抗作用。交感神經的作用通常是在接受刺激時 顯現，例如瞳孔擴張、支氣管擴張、心跳加快，心收縮力 增強、血壓上昇、胃腸道的運動降低、體表及内臟器官的 血管收縮、血糖的濃度增加…·等，而副交感神經的作用則 與交感神經的作用相反。交感神經與副交感神經在體内保 持y種平衡的狀態，一有失調就會造成疾病，通常在白天 或警覺性高時交感神經的活性會較高；夜晚、飯後或睡覺 時，副交感神經系統的活性較高。一般正常健康的人，其 父感神經與副交感神經會互相協調，依照身體狀況不同而 =整，然而，當自主神經失調，無法依照身體狀況適時調 整’不僅可能造成呼吸困難、心悸、腸胃道失常和失眠···· 等問題，嚴重者更有可能引發心臟病、高血壓，甚至猝死。 在學術上與臨床醫學上研究自主神經機制已有多年， 目前最常使用的方式為從心率變異(Heart Rate Variability) 1289052 分析父感與副交感神經作用成份，心率變異主要是探討心 跳間期變化與生理機制反應相互間關聯所進行的分析，在 此指的心跳間期乃是心臟每一個規律跳動所間隔的時間。 依據1996年歐洲心臟學會與北美電生理學會所公開發表有 關心率變異訊號量測與分析標準，心率變異分析可分為時 域(Time domain)與頻域(Frequency domain)，時域分析是將 心跳間期做統計學上或幾何學上的計算，統計學計算例如 有：心跳間期的平均值（mean)、標準偏差（standard deviation ’ SD)、變異係數(coefficient 〇f variati〇n , cv)、相 鄰兩心跳間期差異的均方根(RMSSD)、相鄰兩心跳間期差 異的標準偏差(SDSD)…等；幾何學方法可求得例如有：心 率變異度二角指標(HRV triangular index)、所有心跳間期的 長方圖最小平方誤差的三角基準寬度(TINN)···等。 頻域分析是將心跳間期隨著時間而變動的訊號轉換成 心跳間期的頻譜，其強度為頻率正弦波振幅的平方，將相 對強度里化後’即為功率密度(p〇wer spectrai心批办， PSD) ’利用這樣的方法，可以將心率變異程度微小的波動 凸顯出來，心率變異度在頻域上進一步可以區分為高頻成 刀（High frequency ’ HF)與低頻成分(L〇w-freqUenCy，lf)， 在功率頻譜曲線下面積總和為總功率(T〇talp〇wer，τρ)，在 咼頻區域内面積為高頻功率（High- frequency p0wer， HFP)，在低頻率區域内面積即為低頻功率 power，LFP)。同樣在1996年歐洲心臟學會與北美電生理 學會所發衫，異城量職讀鮮巾，對於頻譜分 1289052 析後之高頻範圍定義為O.b-OjHz，其高頻功率與副交感神 經調節反應較為有關；而低頻範圍為0·04-0·15Ηζ，其低頻 功率可能與交感、副交感的調控以及腎素血管收縮有關。 由於自主神經的作用機制繁雜，調控因子多且驗證不易， 因此確切的生理機制仍有待許多更深入的研究。目前，除 高頻成分與低頻成分外，研究人員更進一步將低頻成分區 ' 分出極低頻(Very l〇w_frequency，VLF)成分，範圍約為$ 鲁 0·04Ηζ，且若為長時間(例如12小時或24小時)的心率變異 分析中’更有超低頻(Ultra low-frequency，ULF)成分，範圍 為$0·003Ηζ ’希望能以更細微的角度明確的驗證自律神經 調控機制。 心率變異程度除了代表人體心跳節律的週期變化，以 及反應自律神經調控機制外，更重要的，研究顯示，心率 變異程度的高低，與『猝死』的潛在風險有高度相關。近 年來，可能由於工作壓力或環境因素，造成猝死案例增多。 Φ 在醫學上所謂的『猝死』，是指患者在急性心臟徵狀發生後 一小時内死亡，而不論患者原本是否真的具有心臟方面的 疾病，這種死亡的發生時間，以及方式都是非預測性，毫 無預警的。一般發生猝死的原因與心臟血管方面的疾病有 關’諸如心臟病、冠狀動脈、心室纖維顫動··等，在西方 國豕，有百分之八十以上的猝死是由於冠狀動脈疾病所引 起，其它的原因，包括心室肥厚、心肌病變、心臟衰竭、 心肌炎，瓣膜性病變，或是先天性的心臟病等，而依照台 灣猝死的患者來看，大約有百分之七十五的人具有心肌梗 7 1289052 塞的病史。1289052 IX. Description of the Invention: [Technical Field] The present invention relates to a physiological signal analysis device, and more particularly to a device for instantly analyzing the degree of heart rate variability, using a central processing unit with a heart rate mutation analysis module built therein The user is provided not only to record the second signal, but also to obtain the heart rate variation analysis parameter. [Prior Art] According to the autonomic nervous system, the sympathetic nerve and the parasympathetic nerve are divided into two different locations in the body, and their roles are different. Generally speaking, they are interaction and antagonism. The role of sympathetic nerves is usually manifested when receiving stimulation, such as dilated pupils, bronchiectasis, rapid heartbeat, increased cardiac contractility, increased blood pressure, decreased gastrointestinal motility, vasoconstriction on the surface and internal organs, and increased blood glucose concentrations. ...·etc., and the role of the parasympathetic nerve is opposite to that of the sympathetic nerve. The sympathetic and parasympathetic nerves maintain a state of y balance in the body. When there is a disorder, it causes disease. Usually, the activity of the sympathetic nerve is high during the day or when the alertness is high. The parasympathetic nervous system is at night, after meals or when sleeping. The activity is higher. In normal normal health, the paternal and parasympathetic nerves will coordinate with each other, depending on the physical condition. However, when the autonomic disorder is not adjusted according to the physical condition, it may not only cause difficulty in breathing, palpitations, gastrointestinal disorders. And insomnia····, etc., severe cases are more likely to cause heart disease, high blood pressure, and even sudden death. The autonomic nervous mechanism has been studied in academic and clinical medicine for many years. The most commonly used method is to analyze the paternal and parasympathetic components from Heart Rate Variability 1289052. The heart rate variability is mainly to explore the changes in heartbeat interval. The analysis of physiological mechanisms is related to each other. The heartbeat interval referred to here is the time interval between each regular beat of the heart. According to the 1996 European Heart Association and the North American Electrophysiology Society, the heart rate variability analysis can be divided into time domain and frequency domain. Time domain analysis is the heartbeat. Intervals are statistically or geometrically calculated. Statistical calculations include, for example, the mean (mean), standard deviation ' SD, and coefficient of variation (coefficient 〇f variati〇n , cv) of the heartbeat interval. The root mean square (RMSSD) of the difference between adjacent two heartbeat periods, the standard deviation of the difference between adjacent two heartbeat periods (SDSD), etc.; geometric methods can be found, for example,: heart rate variability two-angle index (HRV triangular Index), the triangular reference width (TINN) of the least square error of the histogram of all heartbeat intervals. The frequency domain analysis is to convert the signal of the heartbeat interval with time to the spectrum of the heartbeat interval, and its intensity is the square of the amplitude of the frequency sine wave. After the relative intensity is neutralized, it is the power density (p〇wer spectrai heart). Batch, PSD) 'With this method, small fluctuations in heart rate variability can be highlighted. Heart rate variability can be further divided into high frequency HF and low frequency components in the frequency domain (L〇w-freqUenCy , lf), the sum of the areas under the power spectrum curve is the total power (T〇talp〇wer, τρ), and the area in the 咼 frequency region is high-frequency p0wer (HFP), and the area in the low-frequency region is For low frequency power, LFP). Also in 1996, the European Society of Cardiology and the North American Electrophysiology Society issued a shirt, the city to read fresh towels, for the spectrum of 1289052 after the analysis of the high frequency range defined as Ob-OjHz, its high frequency power and parasympathetic regulation Related; while the low frequency range is 0·04-0·15Ηζ, its low frequency power may be related to the regulation of sympathetic, parasympathetic and renin vasoconstriction. Because the mechanism of action of autonomic nerves is complicated, the regulatory factors are many and the verification is not easy, the exact physiological mechanism still needs to be studied in more depth. At present, in addition to high-frequency components and low-frequency components, the researchers further divide the low-frequency component region into very low-frequency (Very l〇w_frequency, VLF) components, the range is about $ 0 04, and if it is long (for example In the heart rate variability analysis of 12 hours or 24 hours, there is a more ultra low-frequency (ULF) component with a range of $0·003Ηζ. It is hoped that the autonomic nervous regulation mechanism can be clearly verified at a more subtle angle. In addition to the cyclical changes in heart rate rhythm and the mechanism of autonomic regulation of the heart, more importantly, studies have shown that the degree of heart rate variability is highly correlated with the potential risk of sudden death. In recent years, there have been cases of sudden deaths due to work stress or environmental factors. Φ In medicine, the so-called “death” refers to the death of a patient within one hour after the onset of acute cardiac symptoms, regardless of whether the patient originally had a heart disease, the time and manner of such death are non-predictive. Sex, no warning. The cause of sudden death is generally related to cardiovascular diseases such as heart disease, coronary artery, ventricular fibrillation, etc. In Western countries, more than 80% of sudden deaths are caused by coronary artery disease, others Causes include ventricular hypertrophy, myocardial disease, heart failure, myocarditis, valvular disease, or congenital heart disease. According to Taiwan's sudden death, about 75% of people have myocardial infarction. 7 1289052 The history of the plug.
近來研究顯示’心率變異的程度可以做為評估摔死發 風險的一個指標，依據I"2年Huikuri HV等人、溯 =Sasaki T.等人所發表之研究顯示，心率變異度的降低與 A死的發生機率升高具有相當程度的_。由於心率變異 可X反應u臟的•動狀態與人體自律神經調控機制，當 心臟活動或自律神經調控正常時，表示人體的心跳節律; =依照身體狀況適時調整，因此心率變異度較高；而當心 里、動，、系或自律神經無法即時反應身體狀況，則心率變 2對的會降低。因此，雖然目前尚無法確認猝死真正的 七原因，但除了心臟病、冠狀動脈疾病、心律不整、心 肌纖維顫動...等高危_子外變異亦可以做為評估摔 機率的4要參考指狀—。這#的參考指標對於現 h過勞死案舰年增加情訂更顯重要，過勞死屬摔 ，-種’主要為長域於因功、環境所帶來極度心理及 ^里的壓力負荷下引發猝關—種情況，研究指出，在職 =上長時.作者的心、率變異度f遍低於正常時間工作 者，且相對的發生猝死案例較高。 雖然，自1996年歐洲心臟學會與北美電生理學會已公 開發表有關心率變異訊號量測與分析標準，已奠定^續二 關心率變異的分析研究鮮，但在實際應訂，、目前:電 讯垅的擷取與心率變異的分析仍為獨立進行事件，市面上 ，關心率變異分析的產品，多以分析套裝軟體為主，例如 Z_HRV。因此知率變異分析上，料作法乃絲得受測 1289052 者心電訊號後，再傳送至電腦進行心率變異分析演算，進 =知到結果。雖然以今日的技術發展，訊號的傳輸已經相 二陕逮且方便，且訊號自動傳輪亦非難事，但考慮心電訊 號的1測必須使用電極貼片，傳輸到電腦後，又必須操作 2變異分析介面，且心率變異對於—般人而言並葬相當 。因此，直至目前為止，即使研究上已顯示心率變異 做為評估人體狀況，包含自律神經、摔死風險··等 在 的參考指標，但對於—般大μ謂是相當陌 領域7率變異分析仍然主要使用於研究、臨床於醫院...等 發展有前Γ率變異分析’仍以套裝分析軟體為主要 民眾，侧取為獨立進行，無法普及使麟一般 Λ 疋以’本發明提出一心率蠻昱八把壯人 本:上的感測電極或外接式感測電極:直斤^ 的心率變n t之中央處理單元進行時域及頻域 羊爻異分析，並將結果顯示於顯示介 變析從一開始的訊號擷取；;:單 而言，藉由心率變異參數的變化二對於使用者 訊息，適時調整作息，對 又仵自身身體的預警 、自我健康照護有相當大的應用。 【發明内容】 本發明之主要目的係在提供 裡+鏈異即時分析裝 1289052 置二藉由本體上感測電極的設計與包含心 莫组 的中央處理運算單元，仫7文^刀析择 變異分析。 ’、11在擷取訊賴’㈣進行心率 供《明^另—目的係在提供—種具有心率變里參數分 析功此之心電訊號量測裝置’該裝 · 理，提供_變異分析參數了直接進心率變異分析處 本卷月之再目的係在提供一種生 =身率體變::， 瞭解自身身體狀況，適時調整作息，達到預警作用。 為達上述之目的’本發明係結合微小電訊號感測技 術與訊號處理’ _二感測電極進行訊號量測，並配合一 中央運算處理單元進行心率變異的演算與分析，除記錄心 電訊，外’更提供心率變異分析參數’不僅操作簡便，且 可以單-細制訊賴取與，辞變異分析之目的，提供 使用者隨，瞭解自身身體狀況，進行自我健康照護。 底下藉由具體實施例配合所附的圖式詳加說明，當更 容易瞭解本發明之目的、技術内容、特點及其所達成之功 效 【實施方式】 本發明係提出-種心率變異即時分析裝置，結合微小 電訊5虎感測原理與訊5虎分析處理，達到以單一裝置掘取並 分析心率變異功能，提供生理預警訊息之應用。 首先，就心率變異分析的原理而言，雖然心率變異所 1289052 能反應的生理機制研究，至今尚未完全確定，但 法與流私，部已在1996年，歐洲心臟 - 卞 门研九軚的，咼、低頻選用範 ^:明二：〜異为析標準”乂下係藉由第⑺與第2 t明歐如臟學會與北錢生理學會所發表之心率變異 = 第1圖所不，係為一筆心電訊號示意圖；第2 ❿ ^示係、為〜率變異分析流程示意圖。在心率變異分析 ’百先如步驟S1G所示，#|取或輸人—段心電訊號，心 ，訊號的時間長短可為5分鐘、12小時或24小時···等，依 j用者需求而決定。目前在臨床上係通常以5分鐘為基 、刀析區攸，且一般認為5分鐘以上的心電訊號所分析的 心率變異結果較具生理上意義;接下來係如步驟S2〇，將心 電成遽轉換為數位格式；以利如步驟S3Q，進行R波識別 偵測在般正常的心電訊號中，R波係為心電訊號中最 大波峰處，如第丨圖標示#處，在心電訊號處理上，由於r 、較為月"、、頁，因此不管在心跳計算、心率分析，係通常以尺 :皮為债測標的；將每一個R波識別出後，如步驟S4〇，進 仃RR間期的計算，RR間期為心臟每一次跳動所間隔的時 間，在將每一個R波標示出後，即可求得每一個RR間期， ，形成一連串RR間期序列；然後，如步驟S50，剔除掉不 符s的RR間期序列，在此，由於心率變異主要計算心跳間 1289052 期的變化程度，因此，對於 跳 者而言’例如第3圖所示的轉不整，其二==測 變動較大，因此，所計算得 1本就 正顯示出受測者的生理狀況，是以，需將 ，:而挑選變異因子的方法係有相當多種，例= 差方式，將超出狀間期平均1個或3個以上禪準 j 間期剔除，或以利用平均方式’將發生心律不忒f = 間期^上/下—個的RR間期平均…等，將刀 心跳的剔除後，即完成㈣㈣選處理律 係可得到如步驟_所示的正常狀況下規律的心跳門^ ’ 稱為N_N間期序列；此時，即可將:跳間期， 域上的統計分析，如步驟S7〇所示如^序列進行時 平均值、標準偏差、變異係數==如#心跳間期的 析，係需如步= ===錢行頻域分 計算並重新等距轉，由於内差保值 樣頻率並不完全相同，是以，必須將n_n= = 保值方式轉換成一連續訊號，再重新樣序= :驟，頻域的心率變異分析，利用如傅立葉轉換= 功率、低頻功率與總功率，即可頻域後，計鼻其高頻 LF/TP...等心率變異相議域分析參數。、LF、LF/HF、 以上係為心率變異相關原理 率變異分析對於評估人體自律神經:=有= 12 1289052 應用，但受限於心率變異分析仍以電腦介面操作為主，且 心電訊號的擷取較為繁複，因此，心率變異參數仍未被廣 泛應用。然，為使心率變異分析可更方便、快速，且做為 生理狀況預警的參考，本發明係提出一心率變異即時分析 裝置，不僅具有心電訊號量測與心率變異分析功能，且操 作簡便，其具體之裝置設計說明如后。Recent studies have shown that the degree of heart rate variability can be used as an indicator to assess the risk of death. According to I"2 years of research by Huikuri HV et al., Tradition=Sasaki T. et al., the reduction of heart rate variability and A The probability of death is increased to a considerable extent. Because the heart rate variability can react with the X-organic state and the autonomic nervous system of the human body, when the heart activity or autonomic regulation is normal, it indicates the heartbeat rhythm of the human body; = timely adjustment according to the physical condition, so the heart rate variability is higher; When the heart, the movement, the system, or the self-regulatory nerve cannot respond to the physical condition immediately, the heart rate becomes 2 pairs. Therefore, although it is still impossible to confirm the seven reasons for sudden death, in addition to heart disease, coronary artery disease, arrhythmia, myocardial fibrillation, etc., high-risk _ extra-external variation can also be used as a reference for assessing the rate of fall. —. The reference index of this # is more important for the current increase in the number of cases of the dead ship. The overworked death is a fall, and the kind of 'mainly for the long-term stress and the extreme stress caused by the environment and the environment. Under the circumstances of the situation, the study pointed out that the incumbent = long time. The author's heart and rate variability f is lower than the normal time workers, and the relative sudden death cases are higher. Although, since 1996, the European Society of Cardiology and the North American Electrophysiology Society have publicly published standards for the measurement and analysis of heart rate variability signals, and have established the analysis of the second interest rate variation, but in practice, the current: Telecommunications The analysis of sputum extraction and heart rate variability is still an independent event. On the market, the product of interest rate variation analysis is mostly based on analysis software, such as Z_HRV. Therefore, in the analysis of the rate of variation, the material processing method is measured by the 1289052 ECG signal, and then transmitted to the computer for heart rate variability analysis and calculation. Although with the development of today's technology, the transmission of the signal has been caught and convenient, and the automatic transmission of the signal is not difficult, but considering the measurement of the ECG signal must use the electrode patch, after transmission to the computer, must operate 2 The variation analysis interface, and the heart rate variability is quite common for ordinary people. Therefore, until now, even if the heart rate variability has been shown in the study as a reference index for assessing the human body's condition, including autonomic nerves, risk of falling, etc., it is still quite a strange field. Mainly used in research, clinical in hospitals, etc., there are developments of pre-experimental rate variability. 'There is still a package analysis software for the main people, and the side is taken independently, and it is impossible to popularize the general Λ 疋 '昱 把 把 壮 : 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上 上From the beginning of the signal capture;;: In terms of the change of heart rate variability parameters, the user's message, timely adjustment of work and rest, has a considerable application to the body's early warning, self-health care. SUMMARY OF THE INVENTION The main object of the present invention is to provide a +in-chain instant analysis device 1289052. The design of the sensing electrode on the body and the central processing unit including the heart group are performed. analysis. ', 11 in the 讯 讯 赖 ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心 心The direct purpose of the heart rate variability analysis department is to provide a kind of life = body rate change::, to understand their own physical condition, adjust the work schedule in time, to achieve early warning. In order to achieve the above purpose, the present invention combines the micro-signal sensing technology and the signal processing ' _ two sensing electrodes for signal measurement, and cooperates with a central processing unit to perform calculation and analysis of heart rate variability, except for recording cardiac telemetry. The external 'more heart rate variability analysis parameter' is not only easy to operate, but also can be used for the purpose of single-and-fine communication and rhythm analysis, providing users with their own physical condition and self-health care. The purpose of the present invention, the technical contents, the features, and the effects achieved by the present invention will be more readily understood by the following detailed description of the embodiments. The present invention is directed to a heart rate variability analysis device. In combination with the micro-telephone 5 tiger sensing principle and the 5 tiger analysis processing, it can achieve the application of physiological warning information by sourcing and analyzing heart rate variability in a single device. First of all, in terms of the principle of heart rate variability analysis, although the physiological mechanism of heart rate variability 1288952 can not be completely determined, but the law and smuggling, the Ministry has been in 1996, the heart of Europe - 卞门研九軚,咼, low frequency selection Fan ^: Ming 2: ~ different as the standard of analysis" under the (7) and 2 t Mingou ivory society and the North Money Physiology Society published heart rate variability = Figure 1, no For a schematic diagram of the ECG signal; the second ❿ ^ shows the schematic diagram of the analysis of the rate variation analysis. In the heart rate variability analysis, the first step is shown in step S1G, #| take or lose the human heart signal, heart, signal The length of time can be 5 minutes, 12 hours or 24 hours, etc., depending on the needs of users. Currently, in clinical practice, it is usually based on 5 minutes, and it is generally considered to be more than 5 minutes. The heart rate variability analysis analyzed by the electrocardiogram signal is more physiologically significant; the next step is to convert the electrocardiogram into a digital format as in step S2〇; in order to perform the R wave recognition detection in the normal heart as in step S3Q In the electrical signal, the R wave is the largest in the ECG signal. At the peak, such as the 丨 icon shows #, in the ECG signal processing, because r, more months ",, page, so in the heartbeat calculation, heart rate analysis, usually the ruler: skin for the debt measurement; will each After an R wave is recognized, as in step S4〇, the RR interval is calculated, and the RR interval is the time interval between each beat of the heart. After each R wave is marked, each RR can be obtained. Interval, , form a series of RR interval sequence; then, as in step S50, the RR interval sequence that does not conform to s is eliminated, and since the heart rate variation mainly calculates the degree of change of the heartbeat interval 1289052, therefore, for the hopper 'For example, the change shown in Figure 3 is different, and the second == measurement changes are large. Therefore, the calculated one is showing the physiological condition of the subject, so that the variation factor is selected. There are quite a number of methods, for example, the difference mode, which will remove the average interval of 1 or more than the zen period j, or use the average method to 'generate arrhythmia f = interval ^ up / down - Average RR interval, etc., after the knife heartbeat is removed, The (4) (4) selection processing law system can obtain the regular heartbeat gate under normal conditions as shown in step _ ^ is called the N_N interval sequence; at this time, it can be: hop period, statistical analysis on the domain, such as step S7 〇 If the sequence is performed, the mean value, standard deviation, and coefficient of variation == such as the analysis of the #heartbeat interval, the system needs to be calculated as step = === money line frequency domain and re-equal turn, due to the internal difference value The sample frequencies are not exactly the same, so the n_n== preserved mode must be converted into a continuous signal, and then the sample sequence = :, frequency domain heart rate variability analysis, using, for example, Fourier transform = power, low frequency power and total power, After the frequency domain, the high-frequency LF/TP... and other heart rate variability parameters can be analyzed. , LF, LF/HF, the above is the heart rate variability related principle rate variation analysis for the evaluation of human autonomic nerves: = have = 12 1289052 applications, but limited by heart rate variability analysis is still based on computer interface operations, and ECG signals The retrieval is more complicated, so the heart rate variability parameters are still not widely used. However, in order to make the heart rate variability analysis more convenient and rapid, and as a reference for the physiological condition early warning, the present invention proposes a heart rate variability real-time analysis device, which not only has the functions of ECG measurement and heart rate variability analysis, but also has simple operation. The specific device design description is as follows.
/·，—為本發明之一較佳實施例的結構方塊示意圖 如圖所示，本發明係包括二感測電極1〇、1〇,，用以與受$ 者體表接觸，擷取受測者之心電訊號；一類比訊號處理才 組20係與感測電極10、10，電性連接，用以將所擷取到言 受測者之心電訊號進行訊號放大、訊號濾波··等處理；_ 類比/數位轉換單元30，係將經類比訊號處理模組2〇所^ 理完成的心電訊號轉換成一數位格式的心電訊號，以傳^ 至數位訊號處理模組40進行一心率變異分析處理，在數j 訊號處理模組40中係設有一中央處理運算單元42,用以逢 轉換成數位袼式的心電訊舰行如前述步驟伽 - S9G的心率變異分析處理，以得到至3 ㈣電顯示單元5G ’係與該數倾號處理老 單元50 ^當心率變異參數計算完成，係傳輸至顯六 50 P 々顯示所計算得到的心率變異參數，顯示輩-、=式’例如為液晶顯示面版、LED顯示、二 及一電源模組6〇，係與上 版...4，^ 應整體震置的冑力、、肖魏I、=疋電性連接，用以你 式，或A象广力她’在此，電源模組可為-電池开 $為豕庭肖電力料部騎 4开 13 1289052 其中，上述之心率變異參數係可為時 域分析結果，時域分析結果包括有心跳間期、、、°、、或頻 期的平均值、標準包括偏差、變 ^、跳間 inr...等參數，㈣域分析結果係包括有®、 U7、UVHF、lf/TP···等參數。 運4 本發明的數位訊號處理模組4〇中，該中央處理 模=0^1係更可連接設有—儲存單元44與-資料傳輸 藉由儲存單元44係可儲存轉換為數位格式之數位 二、電《以及運算完畢的該等心率變異參數；而藉由與資 料傳輸模組70的連接，更可將儲存於儲存單元44内的資 2，包含數位心電訊號與參數等，傳送至―外部數位資訊 裝置72，其中，該資料傳輸模組7〇係可採usb傳輸介面、 藍=專輸介面、紅外線傳輸介面、數據機…等，而外部數 位貝，裝置72，係可例如為個人電腦、pDA、手機、資料 庫…等。而更進-步，本發明之心率變異即時分析裝置更 可一操控單元8〇,該操控單元80係同樣與該中央處理 運异單兀42連接，受測者藉由設定該操控單元8〇係可進 而控制整個數位訊號處理模組4〇的作動，用以進行如量測 功旎的選擇、儲存單元44内資料的增刪、傳輸，受測者個 人貧料的輸入以及日期設定· ·等功能，在此，操控單元8〇 係可採按鍵、旋鈕、觸碰式面版…等形式。 利用上述之設計，使用者不僅可方便的操控整個裝 置’且貧料可以無線或有線方式傳輸至電腦、手機、PDA 或資料庫，不僅可備份個人的心電訊號相關資料，且可進 1289052 灯自我健康管理對於遠距醫療及居家照護領域，亦具有相 當大之應用潛能。 接下來’為能更清楚闡明本發明之技術内容與特徵， 係以第4圖為主，同時配合本發明之一較佳裝置實施例示 意圖進行說明，如第5圖所示，本發明裝置在實施設計上 係可包含一本體100，其内部具有一容置空間（圖未示），外 4係具有至少一操作面102、102,；二感測電極10、10,係 喪设於操作面102上左、右兩側；而類比訊號處理模組20、 類比/數位轉換單元30與數位訊號處理模組40，包含中央 處理運异單元42與儲存單元44，係設於容置空間中（圖未 不），而用以顯示心率變異參數結果的顯示單元5〇與進行功 能控制的操控單元80亦設於操作面1〇2上，另資料傳輸模 組70係設於另一操作面102,上。 當裝置運作時，首先，就心電訊號的擷取，本發明係 藉由二感測電極1〇、10,接觸體表方式記錄心電訊號 〇從心 電圖訊號量測原理來看，由於心臟收縮_舒張活動時，心肌 的電流活動會傳導至體表，因此，藉由接觸於體表的電極， 係可記錄心臟活動的電位變化。目前在臨床上，最普遍使 用的乃為12導程心電圖，其中包括3個標準導程(standard Lads)1、11、111 ;三個加壓導程(Augmented Leads) aVR、 aVL、aVF 以及六個胸導程(Chest Leads)V卜 V2、V3、V4、 V5、V6。在此，本發明之感測電極1〇、1〇，採以左、右方 式設於操作面102上之用意，係主要希望記錄第I導程的心 電訊號’受測者僅需將左、右手手指分別觸碰兩侧之感測 15 1289052 活動時的電位變化， 電極10、10,，即可透過手指獲得心臟 進而測得第I導程的心電訊號。The present invention includes two sensing electrodes 1〇, 1〇 for contacting the body surface of the user, and receiving The heart of the tester's heart signal; a type of analog signal processing group 20 series and the sensing electrodes 10, 10, electrically connected, used to extract the signal from the subject's ECG signal amplification, signal filtering · The analog/digital conversion unit 30 converts the ECG signal processed by the analog signal processing module 2 into an ECG signal in a digital format for transmission to the digital signal processing module 40. The heart rate variability analysis process is provided with a central processing unit 42 in the number j signal processing module 40 for converting the heart rate variability analysis processing into a digital 心 type of gamma-type ship, such as the aforementioned step gamma-S9G, to obtain To 3 (4) electric display unit 5G 'system and the number of the old number of the old unit 50 ^ When the heart rate variability parameter is calculated, the system transmits to the display of the heart rate variability parameter, showing the generation -, = = For example, a liquid crystal display panel, an LED display, And a power module 6 〇, the system and the upper version ... 4, ^ should be the overall shock of the force, Xiao Wei I, = 疋 electrical connection, for your style, or A like Guangli she 'in Therefore, the power module can be - the battery is opened for the power of the 肖庭肖, and the motor is riding 4, 13 1289052, wherein the heart rate variability parameter can be a time domain analysis result, and the time domain analysis result includes a heartbeat interval, The average value of °, or the frequency period, the standard includes parameters such as deviation, change ^, jump inr..., and (4) the results of the domain analysis include parameters such as ®, U7, UVHF, lf/TP···. In the digital signal processing module 4 of the present invention, the central processing module is further connected to the storage unit 44 and the data transmission can be stored and converted into a digital format by the storage unit 44. 2. The "the heart rate variability parameter of the calculation" is completed, and the resource 2 stored in the storage unit 44, including the digital ECG signal and parameters, can be transmitted to the data transmission module 70. The external digital information device 72, wherein the data transmission module 7 can adopt a usb transmission interface, a blue=special interface, an infrared transmission interface, a data machine, etc., and an external digital device, the device 72 can be, for example, Personal computer, pDA, mobile phone, database...etc. Further, the heart rate variability analysis device of the present invention can further be a control unit 8 〇, and the control unit 80 is also connected to the central processing unit 兀 42, and the subject is set by the control unit 8〇 The system can further control the operation of the entire digital signal processing module 4 to perform selection of the power measurement, addition, deletion, transmission of the data in the storage unit 44, input of the personal poor material of the testee, and date setting. Function, here, the manipulation unit 8 can adopt a form such as a button, a knob, a touch panel, and the like. With the above design, the user can not only conveniently control the entire device' and the poor material can be wirelessly or wiredly transmitted to a computer, mobile phone, PDA or database, not only can back up personal ECG related data, but also can enter 1289052 lights. Self-health management also has considerable application potential for telemedicine and home care. In the following, in order to clarify the technical content and features of the present invention, FIG. 4 is mainly used, and at the same time, a schematic diagram of a preferred device embodiment of the present invention is described. As shown in FIG. 5, the device of the present invention is The implementation design may include a body 100 having an accommodating space (not shown) therein, the outer 4 series having at least one operation surface 102, 102, and the second sensing electrodes 10 and 10 being disposed on the operation surface. The upper left and right sides of the 102; and the analog signal processing module 20, the analog/digital conversion unit 30 and the digital signal processing module 40, including the central processing and translating unit 42 and the storage unit 44, are disposed in the accommodating space ( The display unit 5 and the control unit 80 for performing the function control are also disposed on the operation surface 1〇2, and the data transmission module 70 is disposed on the other operation surface 102. ,on. When the device is operated, firstly, in view of the extraction of the electrocardiogram signal, the present invention records the electrocardiogram signal by means of the second sensing electrodes 1〇, 10, and contacts the body surface 〇 from the principle of measuring the electrocardiogram signal, due to the contraction of the heart When _ diastolic activity, the current activity of the myocardium is transmitted to the body surface, so the potential change of cardiac activity can be recorded by contacting the electrodes on the body surface. Currently in clinical practice, the most commonly used is a 12-lead ECG, including three standard lead (standard Lads) 1, 11, 111; three Augmented Leads aVR, aVL, aVF and six Chest Leads V Bu V2, V3, V4, V5, V6. Herein, the sensing electrodes 1〇, 1〇 of the present invention are disposed on the operation surface 102 in a left-right manner, and it is mainly intended to record the first-lead ECG signal. The subject only needs to be left. The right hand finger touches the two sides to sense the potential change of the 12 1289052 activity, and the electrodes 10, 10 can obtain the first lead ECG signal through the finger to obtain the heart.
接續，在訊號的處理上，雖就第5圖而言，容置空間 二於谷置空間内之元件未有㈣，但其詳細運作係如以 理^明耳先’與感測電極1〇、1〇,電性連接之類比訊號處 、:且2G係會將所測得第〗導程的心電訊號進行訊號放 ^戒號濾波處理；然後’傳送至類比/數位轉換單元30， 、成數位心電訊號；以供設於數位訊號處理模組4〇内 It央處輯算單元42進行心率類分析，在巾央處理運 异早70 42㈣建有轉變異分析雜式漁，可對該數位 心電訊號進行如前述倾抓步驟S7G或辣s3〇•步驟 S90的心率變異分析處理，得到時域及頻域的心率變異參 數’然後’將料參數以及触心電訊_存於儲存單元 44内’同時，將獲得的心率變異參數結果傳送至設於操作 面1〇2上的顯示單元5〇，俾供受測者可得知己身的心 異結果，達到生理預警之作用。 70_② 於操作面膨㈣料傳輸模組 7〇(圖中係以聰傳輸埠⑽為例），可將裝置與一 訊裝置72連接，進而將存放於儲存單元44内的資料傳送 至外部f，置72内，在此資料傳輸模組70係不限於卿 介面’藍芽介面、紅外線介面、數據機等形式均可 本發明裝置_資料相树及錄方式傳輸資料。而另 -方面’上叙所有功_進行，受财係可 作面⑽上的驗單元8G方便賴作，使得麻裝置3 16 1289052 機、關機、時間設定、受測者資料輸入、資料讀取、資 刪除、資料傳輸···等功能均能簡便的運作。 本發明之設計，除上述内容外，在感測電極10、1〇, 上，係更可以一外部訊號感測電極120替代，同樣來進行 〜電Λ號塁測’如第5圖所示。利用設於本體刚上之一 - 冑極轉接埠130，係可與-外部訊號感測電極12〇連接，讓 受測者在不方便穩定手持本發明裝置時，可以外部訊號感 ㈨電極精量測；在娜喊後，囉將訊號傳送至 類比/數位轉換單元3〇進行與前述一樣的處理。外部訊號感 測電極120乃[§]樣為二電極設計，主要可黏貼於受測者體 表除了方便無法穩定手持本發明裝置之受測者進行量測 外，且依照黏貼位置向量不同，係可進行第j導程、第Η 導程或第III導程的心電訊號，提供使用者可視需求紀錄不 同導程的心電訊號。 、综上所述，本發明結合微小生理訊號感測技巧與時/頻 φ 域祗號處理决异技術，設計一有別以往之心率變異即時分 析裝置，將原本分開進行的心電量測與心率變異分析，進 f的可以單一裝置一次完成，其裝置設計不僅提供使用 者可即時即地的記錄心電訊號，且所獲得的心率變異分析 〜果更可做為自主神經調控機制以及猝死風險的評估參 考，舞於自我保健、自我預警有相當良好之應用。 以上所述之實施例僅係為說明本發明之技術思想及特 點，其目的在使熟習此項技藝之人士能夠瞭解本發明之内 奋並據以實施，當不能以之限定本發明之專利範圍，即大 17 1289052 凡依本發明所揭示之糈神所作之均等變化或修飾，仍應涵 蓋在本發明之專利範圍内。 【圖式簡單說明】 第1圖為正常節律之心電訊號波形示意圖。 第2圖為心率變異分析處理流程示意圖。 第3圖為心律不整之心電訊號波形示意圖。 | 第4圖為本發明裝置之方塊示意圖。 第5圖為本發明裝置之一較佳實施例結構示意圖。 【主要元件符號說明】 10、10’感測電極 20 類比訊號處理模組 30 類比/數位轉換單元 40 數位訊號處理模組 • 42中央處理運算單元 44儲存單元 50 顯示單元 60 電源模組 70 資料傳輸模組 72 外部數位資訊裝置 80 操控單元 100本體 18 1289052In the continuation, in the processing of the signal, although in Figure 5, the components in the accommodating space 2 in the valley space are not (4), but the detailed operation is as follows: , 1〇, the electrical connection analog signal, and the 2G system will measure the measured ECG signal by the signal filtering; then 'transfer to the analog/digital conversion unit 30, The digital ECG signal is used for heart rate analysis in the IT signal processing module 4 in the digital signal processing module 4, and the change processing heterogeneous fish is built in the towel processing. The digital electrocardiographic signal performs a heart rate variability analysis process such as the aforementioned tilting step S7G or the hot s3 〇 step S90, and obtains the heart rate variability parameter 'and then the material parameter and the touch center telecommunications_ in the time domain and the frequency domain _ stored in the storage unit At the same time, the result of the heart rate variability parameter obtained is transmitted to the display unit 5〇 provided on the operation surface 1〇2, so that the subject can know the different results of the body and achieve the physiological warning function. 70_2 in the operation surface expansion (four) material transfer module 7〇 (in the figure, the Cong transmission device (10) is taken as an example), the device can be connected to the information device 72, and the data stored in the storage unit 44 can be transmitted to the external f. In the case of 72, the data transmission module 70 is not limited to the interface of the blue interface, the infrared interface, the data machine, etc., and the device of the present invention can be transmitted by the data phase tree and the recording mode. On the other hand, the above-mentioned all the work is carried out, and it is convenient for the inspection unit 8G on the financial department (10) to make the machine, shutdown, time setting, subject data input, data reading. Functions such as deletion, data transfer, etc. can be easily operated. In the design of the present invention, in addition to the above, on the sensing electrodes 10, 1 , , an external signal sensing electrode 120 can be replaced, and the same is performed as shown in FIG. 5 . It can be connected to the external signal sensing electrode 12〇 by using one of the first-bend transfer 埠130, so that the subject can feel the external signal when it is inconvenient and stable to hold the device of the present invention. After the screaming, the signal is transmitted to the analog/digital conversion unit 3, and the same processing as described above is performed. The external signal sensing electrode 120 is [§]-like as a two-electrode design, and can be mainly adhered to the body surface of the subject, except for the measurement of the subject who cannot stably hold the device of the present invention, and according to the vector of the adhesive position, The ECG signal of the jth lead, the third lead or the lead III can be provided to provide an ECG signal that the user can record different lead according to the needs. In summary, the present invention combines the micro-physiological signal sensing technique with the time/frequency φ domain nickname processing singularity technique to design a heart rate variability instant analysis device that is different from the previous one. Heart rate variability analysis, the f can be completed in a single device, the device design not only provides the user to record the ECG signal in real time, and the heart rate variability analysis obtained can be used as the autonomic nervous mechanism and the risk of sudden death. The evaluation reference, dance to self-health, self-warning has a fairly good application. The embodiments described above are merely illustrative of the technical spirit and characteristics of the present invention, and the purpose of the present invention is to enable those skilled in the art to understand the scope of the present invention and to limit the scope of the invention. , </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; [Simple description of the diagram] Figure 1 is a schematic diagram of the waveform of the ECG signal of the normal rhythm. Figure 2 is a schematic diagram of the heart rate variability analysis process. Figure 3 is a schematic diagram of the waveform of the ECG signal with arrhythmia. Figure 4 is a block diagram of the apparatus of the present invention. Figure 5 is a schematic view showing the structure of a preferred embodiment of the apparatus of the present invention. [Main component symbol description] 10, 10' sensing electrode 20 analog signal processing module 30 analog/digital conversion unit 40 digital signal processing module • 42 central processing arithmetic unit 44 storage unit 50 display unit 60 power module 70 data transmission Module 72 external digital information device 80 control unit 100 body 18 1289052
102、102’操作面 110 USB傳輸埠 120外部訊號感測電極 130電極轉接埠 19102, 102' operation surface 110 USB transmission 埠 120 external signal sensing electrode 130 electrode transfer 埠 19