515703 8312twf.doc/009 A7 ____B7_ 五、發明説明（/ ) 本發明是有關於-種之感測器裝置，且特別是有關於 一種能同時測量心電、脈搏和聲波訊號之感測器裝置以及 其完整分析系統。 今曰之科學進步一日千里，幾乎每一個器官的功能都 有對應的方法可以測量和診斷。但以往的發展僅著眼於訊 號測量的精確，而往往運用許多侵體的工具與技術，譬如 心導管檢查之操作必須伸入一個管子經由動脈到達心臟， 不但相當危險也頗痛苦’但侵體技術往往無法顧及受試者 的感受。 相對於侵體技術之痛苦特性，非侵體技術只考慮非侵 體的方法，採取無痛無傷害的工具和技術，以測量和診斷 身體臟器的功能。但是由於無法進入人體，往往無法得到 最精確的生理訊號，在以前時常無法得到令人滿意的準確 性與實用性。 但近年來，訊號偵測與處理的技術已大幅進步，因此 已經可以藉由電腦強大運算力彌補非侵體技術的弱點，得 到有貫用價値的分析結果。其中心率變異性（Heart Rate Variability，HRV) (Anonymous 1996)分析即可作爲一個非 經濟部中央標隼局員工消費合作社印製 侵體診斷技術代表。 所謂心率變異性（HRV)分析，即是分析人體休止時心 率的微小變動，以偵測並定量心臟的自主神經功能。換言 之’我們已可在不干擾一個正常人作息之下，對其自主神 經功能進行分析或診斷。傳統上是利用標準胸腔心電圖作 偵測工具。 f 83. 3. 10,000 (請先閱讀背面之注意事項再填寫本頁) 4 本紙張尺度適用中國國家標準（CNS ) Μ規格（210Χ297公釐） 經濟部中央標隼局員工消費合作社印製 515703 8312twf.doc/009 A7 B7 五、發明説明（7/ ) 所謂自主神經系統包括交感神經和副交感神經，和人 體每日運作息息相關。如果自主神經失調，可能引起多種 急性或慢性疾病，譬如心臟病和高血壓等，嚴重者甚至引 發猝死等急症。即使是一般人，自主神經異常也常伴隨著 心悸、呼吸困難、腸胃道失常、和失眠等問題。所以自主 神經系統之分析或監測是有有其醫學的重要性。 HRV此由眾多自主神經診斷方法中脫穎而出，因爲它 至少包含下列幾項特質。1 :屬非侵體性之診斷技術，受 試者不須承受任何痛苦。2 :經過許多勸物和人體實驗， 已證實其反應自主神經功能的正確性。所以近年來這項技 術受到推肩，相關的硏究也不斷的進行(Anonymous 1996>。 心率除了靜飯恒疋、維持在每分鐘70次外，還隱藏 了一些規則或不規則的波動。這些波動或快或慢、或規則 或零亂’但由於這些波動的幅度不大，在過去的醫學硏究 中常將之忽略。有專家進一步發現有些波動和呼吸動作〜 致，有些則和呼吸無關。 藉由頻譜分析的協助下，硏究人員發現心率變異度中 微小的波動可明確的分爲兩群，一般稱爲高頻（High-frequency， HF) 和低頻 （Low-frequency component, LF) 成 份。高頻成份和動物的呼吸訊號同步，所以又稱爲呼吸成 份，於人體約3秒一次。低頻成份則來源不明，推測可能 和血管運動或感壓反射有關，於人體約10秒一次。部份 學者更進一步將低頻成份細分爲極低頻（Very-low frequency, VLF)和低頻成份。目前已有許多生理學家與心 4 (請先閲讀背面之注意事項再填寫本頁) -訂· 本紙張尺度適用中國國家標隼（CNS ) A4規格（210X297公釐） 83. 3. 1 〇,〇0() 經濟部中央標準局員工消費合作社印製 515703 8312twf .doc / 009 __ Β7 五、發明説明（3 ) 臟科醫師同思心率局頻變異性（HF)或總變異性（Total power, TP)能代表副交感神經功能，而低頻變異性和高頻變異性 之比値（LF/HF)能反應交感神經活性。 除了作爲自主神經指標外，亦有硏究發現心率變異性 能反應多樣身體資訊。譬如腦壓上升的病人其心率變異性 會下降。不久前於美國Framingham之調查發現，若老年 人之心率低頻成份降低達1個標準差，其面臨死亡的機會 是常人之1.7倍。 ： 此外’聲帶的聲波訊號，不但是人溝通的工具，也可 用以診斷包括感冒等呼吸系統疾病，因此聲波訊號也可以 成爲非侵體診斷技術所使用之指標之一。 而非侵體診斷技術發展中包含兩大部份，其一是感測 器，其二是數位訊號處理。而感測器之開發可謂此技術之 上游源頭，若無合適之感測器，再精良的數位訊號處理皆 無用武之地。即使有精準之感測器，如果使用方式不方便 也會使非侵體診斷技術讓受測者方便與舒適之目標大打折 扣。所以如何設計一個能同時倶備功能、舒適與方便特性 的感測器就成爲非侵體診斷技術發展的關鍵。 根據前述之目的，因此本發明發展一種感測器，能同 時測量心電、脈搏和聲波訊號，並兼倶方便與與舒適的特 性，以促進前述非侵體診斷技術之實用。本發明中利用心 電訊號以及心搏產生的聲音訊號，經過數位訊號處理之 後，轉換得到身體自主神經活性的定量値；並配合聲被訊 號之分析，以監測其他疾病。 〜 本纸張尺度適用中國國家標準（CNS ) Α4規格（210Χ29?公釐） 83. 3. 10,000 (請先閲讀背面之注意事項再填寫本頁) 訂- 4 ο 8312twf . doc/ 0 0 9 A7 __ B7 五、發明説明（今） ^ 依照本發明一較佳實施例，本發明設計發展一個三合 -一之感測器，能很方便的以非侵體之方式，由身體外= 頸部）測量到心電、脈搏與聲波訊號。並配合對應的分析 技術，將心電與脈搏訊號轉換成自主神經功能指標，將有 助於自主神經相關保健之推動。 < 本發明提供一種方便使用且使用者無痛苦之感測器以 及一個功能完整之分析系統，同時測量心電、脈搏和聲波 三種基本生理訊號，以進行電腦數位診斷，得到心臟功能、 自主神經功能、聲帶功能和呼吸道功能等生理指標。其所 測得之生理訊號，可以以線上（On七ne)分析或儲存後再離 線（Off-line)分析之方式進行，並可進而透過數位通訊，進 行離線或線上分析以達到通訊診治或保健之用途。 本發明並提供之功能完整之分析系統，利用從身體外 部（如頸部）所測得之心電與脈搏訊號分析自主神經功能。 並配合聲波訊號，如此一來可以利用使用攜帶方便之（頸 部）感測器，方便的進行各類原本需要標準心電圖才能達 成之硏究與應用。 經濟部中央標準局員工消費合作社印製 爲讓本發明之4述和其他目的、特徵、和優點能更明 顯易懂，下文特舉一較佳實施例，並配合所附圖式，作詳 細說明如下： 圖式之簡單說明： 第1A圖乃是依照本發明一較佳實施例的一種感測器 之結構示意圖。第1B圖是依照本發明一較佳實施例的該 感測器之使用示意圖。 83. 3. 10,000 (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 515703 經濟部中央榡準局員工消費合作社印製 8312twf.doc/009 A7 ___ ,_B7 ____ 五、發明説明（4 ) " " 第2圖是依照本發明一較佳實施例的該感測器之原理 示意圖。 第3圖是依照本發明一較佳實施例的該感測器對受測 者進行3秒鐘試驗之心電圖、脈搏圖與聲波圖。 第4圖是依照本發明一較佳實施例，該感測器及其分 析系統對心電、脈搏與聲波訊號收集、處理及分析之流程 示意圖。 第5圖是依照本發明一較佳實施例，以該感測器對受 測者頸部測量5秒鐘所獲得之心電與脈搏圖，以及對應之 心率週期圖，打點者爲電腦自動辨識之心跳代表尖峰。 第圖是依照本發明一較佳實施例，以該感測器對受 測者進行5分鐘試驗所獲得之心電圖以及心率週期圖，打 點者爲電腦自動辨識之心跳代表尖峰。 . 第7圖是依照本發明一較佳實施例，以該感測器對受 測者進行5分鐘試驗所獲得之脈搏圖以及心率週期圖，打 點者爲電腦自動辨識之心跳代表尖峰。 第8圖及第9圖分別是對第6圖與第7圖之資料進行 /頻譜分析，而得到各項定量資訊之圖示。 第1〇A圖是依照本發明一較佳實施例，以該感測器對 10位受測者收集之心電部分進行分析所得之定量資訊與以 傳統標準方法所得之資訊的比較。第10B圖是依照本發明 一較佳實施例，以該感測器對10位受測者收集之脈搏部 分進行分析所得之定量資訊與以傳統標準方法所得之資訊 的比較。 (請先閲讀背面之注意事項再填寫本頁) ,tr-- 線 紙張尺度適用中國國家標牟（) A側^ 2似297公釐） 83. 3. 10,000 5 v I 70 5 經濟部中央標準局員工消費合作社印製 8312twf. doc/ 009 A7 B7 五、發明説明（^ ) 圖式之標記說明： 1〇〇 :感應器= 101、102、103、104 ··電線 實施例 感測器 第1A圖乃是依照本發明一較佳實施例的一種感測器 100之結構示意圖，該感測器由一個麥克風和兩個電極構 成。而這些單獨的零件由一個具備彈性的主體支架整合在 一起，雖然電極需兩條電線10U02，而麥克風接兩條電 線103，104，共四條電線，但實際上也可將麥克風之外殼 與臨近的心電電極合倂爲一，共用一條電線，如此僅需三 條導線（如第1A圖之101與103合倂）。 如第1B圖所示，該感測器可以套在頸部，麥克風則 置於氣管旁，該處也是頸動脈經過之處。另一端則置於對 側頸部，兩端因彈性之主體支架產生輕微壓力夾住頸部， 不但能固定不致脫落，也提供電極、麥克風與頸部間良好 的接觸。 該感測器中並包含有放大器、多組高通及低通濾波器 及類比數位轉換器，其視不同使用情況，或配合後級分析 系統，而可以有不同之設計規劃。而該設計規劃，乃應用 目前已知之電機設計技術，並配合未來發展之電機設計及 無線通訊技術，在此不多贅述。 r 將依照本發明一較佳實施例的心電、脈搏和聲波三合 一感測器置於受試者頸部，以收集心電（Electrocardiogram， (請先閲讀背面之注意事項再填寫本頁) 、1T'515703 8312twf.doc / 009 A7 ____B7_ V. Description of the invention (/) The present invention relates to a kind of sensor device, and in particular to a sensor device capable of measuring ECG, pulse and sonic signals simultaneously, and Its complete analysis system. With the rapid progress of science today, almost every organ's function can be measured and diagnosed. However, previous developments only focused on the accuracy of signal measurement, and often used many invasive tools and techniques. For example, the operation of cardiac catheterization must extend into a tube through the artery to reach the heart. Not only is it dangerous and painful, but invasive technology Often the subject's feelings cannot be taken into account. Compared with the painful characteristics of invasive technology, non-invasive technology only considers non-invasive methods, and adopts painless and harmless tools and techniques to measure and diagnose the functions of body organs. However, because it is impossible to enter the human body, the most accurate physiological signals are often not obtained, and satisfactory accuracy and practicality have often not been obtained in the past. However, in recent years, the technology of signal detection and processing has greatly improved. Therefore, it is possible to make up for the weaknesses of non-invasive technology with the powerful computing power of computers, and to obtain consistent analysis results. The analysis of its Heart Rate Variability (HRV) (Anonymous 1996) can be used as a representative of invasion diagnostic technology printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs. The so-called heart rate variability (HRV) analysis is to analyze small changes in heart rate when the body is at rest to detect and quantify the heart's autonomic nerve function. In other words, ‘we can analyze or diagnose its autonomous nervous function without interfering with a normal person ’s work and rest. Traditionally, a standard chest electrocardiogram was used as the detection tool. f 83. 3. 10,000 (Please read the precautions on the back before filling out this page) 4 This paper size applies to Chinese National Standard (CNS) M specifications (210 × 297 mm) Printed by the Employees' Cooperative of the Central Bureau of Standards, Ministry of Economic Affairs 515703 8312twf .doc / 009 A7 B7 5. Description of the invention (7 /) The so-called autonomic nervous system includes sympathetic and parasympathetic nerves, which are closely related to the daily operation of the human body. If the autonomic nervous system is imbalanced, it may cause a variety of acute or chronic diseases, such as heart disease and hypertension, and even severe cases may cause sudden death and other emergencies. Even in normal people, abnormal autonomic nerves are often accompanied by palpitations, dyspnea, gastrointestinal disorders, and insomnia. Therefore, the analysis or monitoring of the autonomic nervous system has its medical importance. HRV stands out from many autonomic diagnostic methods because it includes at least the following characteristics. 1: Non-invasive diagnostic technology, subjects do not need to suffer any pain. 2: After many experiments and human experiments, the correctness of its response to autonomic nerve function has been confirmed. Therefore, in recent years, this technology has been pushed forward, and related research has been continuously carried out (Anonymous 1996 >. In addition to the constant meal, which is maintained at 70 times per minute, the heart rate also hides some regular or irregular fluctuations. These Fluctuations are fast or slow, or regular or random, but because the amplitude of these fluctuations is not large, they have often been ignored in past medical research. Some experts have further found that some fluctuations are related to breathing movements, and some are not related to breathing. With the help of spectrum analysis, researchers found that the small fluctuations in heart rate variability can be clearly divided into two groups, which are generally called high-frequency (HF) and low-frequency component (LF) components. The high-frequency component is synchronized with the animal's breathing signal, so it is also called the breathing component, which occurs about 3 seconds in the human body. The source of the low-frequency component is unknown, and it is speculated that it may be related to vascular movement or baroreflex, which is about 10 seconds in the human body. Part Scholars have further subdivided low-frequency components into very-low frequency (VLF) and low-frequency components. At present, many physiologists and minds 4 (please read first Please fill in this page again if you need to pay attention to the above)-Order · This paper size is applicable to China National Standard (CNS) A4 specification (210X297 mm) 83. 3. 1 〇 ， 〇0 () Printed by the Staff Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 515703 8312twf .doc / 009 __ Β7 V. Description of the invention (3) The visceral physician thinks that the local frequency variability (HF) or total power (TP) of the heart rate can represent parasympathetic nerve function, while the low frequency variability and The ratio of high frequency variability (LF / HF) can reflect sympathetic nerve activity. In addition to being used as an autonomic nerve indicator, it has also been found that the performance of heart rate variability responds to a variety of physical information. For example, patients with increased brain pressure have reduced heart rate variability. A recent survey in Framingham, United States found that if the elderly's heart rate and low frequency components are reduced by 1 standard deviation, their chance of facing death is 1.7 times that of ordinary people. In addition, the vocal vocal signal is not only a tool for human communication, It can be used to diagnose respiratory diseases including colds, so the sonic signal can also be one of the indicators used in non-invasive diagnostic technology. There are two parts, one is the sensor, and the other is the digital signal processing. The development of the sensor can be described as the upstream source of this technology. If there is no suitable sensor, then the sophisticated digital signal processing is useless. .Even if there is an accurate sensor, if it is inconvenient to use, non-invasive diagnostic technology will greatly reduce the goal of convenience and comfort for the test subject. So how to design a sense that can simultaneously provide function, comfort and convenience. The detector has become the key to the development of non-invasive diagnostic technology. According to the foregoing purpose, the present invention develops a sensor that can measure ECG, pulse and sonic signals simultaneously, and combines convenience and comfort characteristics to promote the aforementioned Practicality of non-invasive diagnostic techniques. In the present invention, a cardiac signal and a sound signal generated by a heartbeat are processed by a digital signal, and then converted into a quantitative measurement of the body's autonomic nerve activity; and the analysis of the acoustic signal is used to monitor other diseases. ~ This paper size applies the Chinese National Standard (CNS) Α4 specification (210 × 29? Mm) 83. 3. 10,000 (Please read the notes on the back before filling this page) Order-4 ο 8312twf. Doc / 0 0 9 A7 __ B7 V. Description of the invention (today) ^ According to a preferred embodiment of the present invention, a three-in-one sensor is designed and developed in the present invention, which can be conveniently used in a non-invasive manner from the outside of the body to the neck ) ECG, pulse and sonic signals are measured. In conjunction with the corresponding analysis technology, the conversion of ECG and pulse signals into indicators of autonomic nerve function will help promote the promotion of autonomic-related health care. < The present invention provides a sensor that is easy to use and painless for the user, and a fully functional analysis system that simultaneously measures three basic physiological signals of electrocardiogram, pulse and sound waves for computer digital diagnosis to obtain heart function and autonomic nerves. Physiological indicators such as function, vocal cord function and respiratory function. The measured physiological signals can be analyzed online or on-line after being stored, and can be analyzed offline or online through digital communication to achieve communication diagnosis or health care. Of its purpose. The present invention also provides a fully functional analysis system that analyzes autonomic nerve functions using ECG and pulse signals measured from outside the body (such as the neck). And in conjunction with the sonic signal, this makes it easy to use and carry the (neck) sensor, which is convenient for all kinds of research and applications that originally required standard ECG to achieve. Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs in order to make the description and other purposes, features, and advantages of the present invention more comprehensible, a preferred embodiment will be given below in conjunction with the accompanying drawings for detailed description. As follows: Brief description of the drawings: FIG. 1A is a schematic structural diagram of a sensor according to a preferred embodiment of the present invention. FIG. 1B is a schematic diagram of using the sensor according to a preferred embodiment of the present invention. 83. 3. 10,000 (Please read the notes on the back before filling out this page) This paper size is applicable to China National Standard (CNS) A4 (210X297 mm) 515703 Printed by the Consumers' Cooperative of the Central Procurement Bureau of the Ministry of Economic Affairs 8312twf.doc / 009 A7 ___, _B7 ____ 5. Explanation of the Invention (4) " " Figure 2 is a schematic diagram of the principle of the sensor according to a preferred embodiment of the present invention. Fig. 3 is an electrocardiogram, a pulse graph, and a sound wave pattern of the sensor for a 3-second test on the subject according to a preferred embodiment of the present invention. Fig. 4 is a schematic diagram of the process of collecting, processing and analyzing the ECG, pulse and sonic signals by the sensor and its analysis system according to a preferred embodiment of the present invention. FIG. 5 is an electrocardiogram and pulse chart obtained by measuring the neck of the subject for 5 seconds with the sensor according to a preferred embodiment of the present invention, and a corresponding heart rate cycle chart. Heartbeat represents a spike. The figure is an electrocardiogram and a heart rate cycle graph obtained by performing a 5-minute test on the subject with the sensor according to a preferred embodiment of the present invention. The ticker represents the spikes that are automatically recognized by the computer. Fig. 7 is a pulse chart and a heart rate cycle chart obtained by performing a 5-minute test on the subject with the sensor according to a preferred embodiment of the present invention. The ticker represents the spike of the heartbeat automatically recognized by the computer. Figures 8 and 9 are graphs of the quantitative information obtained by performing / spectrum analysis on the data in Figures 6 and 7. Fig. 10A is a comparison between quantitative information obtained by analyzing the electrocardiogram collected by 10 subjects with the sensor according to a preferred embodiment of the present invention and information obtained by a conventional standard method. Fig. 10B is a comparison of quantitative information obtained by analyzing the pulse portion collected by 10 subjects with the sensor according to a preferred embodiment of the present invention and information obtained by a conventional standard method. (Please read the precautions on the back before filling this page), tr-- The paper size of the paper is applicable to the Chinese national standard (A side ^ 2 like 297 mm) 83. 3. 10,000 5 v I 70 5 Central standard of the Ministry of Economic Affairs Printed by the Consumer Cooperatives of the Bureau 8312twf. Doc / 009 A7 B7 V. Description of the Invention (^) Symbols of the drawings: 100: Sensor = 101, 102, 103, 104 ·· Example of wire sensor 1A FIG. Is a schematic structural diagram of a sensor 100 according to a preferred embodiment of the present invention. The sensor is composed of a microphone and two electrodes. These separate parts are integrated by a flexible main body bracket. Although the electrode requires two wires 10U02 and the microphone is connected to two wires 103 and 104, a total of four wires, it is actually possible to connect the microphone housing to the adjacent one. The ECG electrodes are combined into one and share one wire, so only three wires are needed (such as 101 and 103 in Figure 1A). As shown in Figure 1B, the sensor can be placed around the neck, and the microphone is placed next to the trachea, where the carotid artery passes. The other end is placed on the opposite side of the neck, and the neck is clamped by the slight pressure generated by the elastic main body at both ends. Not only can it be fixed and not fall off, it also provides good contact between the electrode, microphone and neck. The sensor also includes amplifiers, multiple sets of high-pass and low-pass filters, and analog-to-digital converters, which can have different design plans depending on different use cases or with a post-analysis system. The design plan is based on the current known motor design technology, and is compatible with the future development of motor design and wireless communication technology, so I won't go into details here. r Place the ECG, pulse and sonic three-in-one sensor according to a preferred embodiment of the present invention on the subject's neck to collect ECG (Electrocardiogram, (Please read the precautions on the back before filling this page) ), 1T '
Hilt、. 本紙張尺度適用中國國家標準（CNS ) A4規格（210 X 297公釐） 83. 3. 10,000 515703 8312twf.doc/009 A7 B7 · 五、發明説明（、） ECG)、脈搏（Pulse)及聲波（Voice Sound)訊號。一般收集時 間爲五分鐘，期間心電、脈搏及聲波訊號經放大器放大、 帶通濾波器濾波之後，傳入類比數位轉換器進行例如：每 秒256至44000次之資料取樣。並可合倂使用一數位電腦 進行取樣及後續分析工作，該電腦含有微處器及適量的 記憶體。數位化之訊號同時存錄於固態記憶體或磁碟中， 可於測試中直接進行線上（on-line)分析，亦可先儲存於該 電腦中，甚或是傳至如個人電腦或掌上型電腦（Personal digital assistant，PDA)中，待測試結束後或一定時間之後 再進行離線（off-line)分析。 第4'圖中繪示依照本發明一較佳實施例，該感測器及· 其分析系統對於訊號收集、處理及分析之流程示意圖，並 將於下面詳述之。 脈搏收集 經濟部中央標準局員工消費合作社印製 (請先閲讀背面之注意事項再填寫本頁) 第3圖是依照本發明一較佳實施例的該感測器對受測 者進行3秒鐘試驗之心電圖、脈搏圖與聲波圖。心電圖由 電極（Electrode)測得。脈搏圖與聲.波圖由麥克風 (Microphone)測得，第0至2秒爲脈搏訊號，第2至3秒 時受試者說話，得到高頻率之聲波訊號。 麥克風置於頸動脈上，可以收集頸動脈發出之脈搏聲 響與震動，經由一般之麥克風放大器即可得到實用之訊號 /'雜訊比例（signal/noise ratio)，如第3圖下端之左側波型。 可以進一步在麥克風之後端處理添加一低通濾波器（如第2 圖），則可以濾除高頻千擾。 9 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 83. 3. 10,000Hilt .. This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) 83. 3. 10,000 515703 8312twf.doc / 009 A7 B7 · V. Description of Invention (, ECG), Pulse (Pulse) And Voice Sound signals. The general collection time is five minutes. During the ECG, pulse and sonic signals are amplified by the amplifier, filtered by the band-pass filter, and then passed to the analog digital converter for example: 256 to 44,000 data samples per second. It can also be combined with a digital computer for sampling and subsequent analysis. The computer contains a microprocessor and an appropriate amount of memory. Digital signals are simultaneously stored in solid-state memory or magnetic disks, which can be directly analyzed on-line during the test, can also be stored in the computer first, or even transmitted to a personal computer or palmtop computer (Personal digital assistant (PDA)), perform off-line analysis after the test is completed or after a certain period of time. Figure 4 'shows a schematic diagram of the sensor and its analysis system for signal collection, processing and analysis according to a preferred embodiment of the present invention, which will be described in detail below. Pulse Collection Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back before filling this page) Figure 3 shows the sensor for 3 seconds on the subject according to a preferred embodiment of the present invention Test electrocardiogram, pulse graph and sonic graph. The electrocardiogram was measured by an electrode. The pulse and sound waves are measured by a microphone. The pulse signal is from 0 to 2 seconds, and the subject speaks at 2 to 3 seconds to obtain a high-frequency sound wave signal. The microphone is placed on the carotid artery, and the pulse sound and vibration from the carotid artery can be collected, and the practical signal / noise ratio can be obtained through a general microphone amplifier, as shown in the left side of Figure 3 . You can further add a low-pass filter (as shown in Figure 2) to the rear end of the microphone to filter out high-frequency interference. 9 This paper size applies to China National Standard (CNS) A4 (210X297 mm) 83. 3. 10,000
I 經濟部中央標準局員工消費合作社印製 515703 8312twf.doc/009 A7 B7 五、發明説明（2 ) 聲波收集 麥克風置於氣管附近，可以收集發聲時氣管內聲帶之 聲響與震動，經由一般之麥克風放大器即可得到實用之訊 號/雜訊比例，如第3圖下端之右側波型。可以進一步在 麥克風之後端處理添加一高通濾波器（如第2圖），則可以 濾除低頻干擾。 心電收集 該感測器中兩端之電極構成電位訊號收集的基本迴 路。而爲了簡化使用方法並增加可靠度，心電收集乃採用 二電極輸入法，但二電極輸入與三電極差分輸入比較起 來，有較'嚴重之雜訊干擾問題；不過這個雜訊干擾問題可 以運用適度之濾波線路與光隔離線路予以克服。譬如本發 明之一較佳實施例中.，即採用放大器線路（參見Kuo 1999) 放大二電極之心電輸入，並得到實用訊號/雜訊比例之波 型（如第3圖上端）。 心跳辨識 數位化之心電與脈搏訊號需先進行處理，標定心電與 脈搏訊號中的心跳訊號，估算每一心跳之週期，進行心跳 週期數列之數位訊號處理（Digital Signal Processing, DSP)，產生具備生理或臨床意義之資訊（Kuo et al. 1999;I Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 515703 8312twf.doc / 009 A7 B7 V. Description of the invention (2) The sound wave collection microphone is placed near the trachea, and the sound and vibration of the vocal cords in the trachea can be collected during vocalization. The amplifier can get a practical signal / noise ratio, such as the right waveform at the bottom of Figure 3. You can further add a high-pass filter (as shown in Figure 2) to the rear end of the microphone to filter out low-frequency interference. ECG collection The electrodes at both ends of the sensor constitute the basic circuit for potential signal collection. In order to simplify the use and increase the reliability, ECG collection uses the two-electrode input method. However, compared with the three-electrode differential input, the two-electrode input has a more serious noise interference problem; however, this noise interference problem can be applied. Moderate filtering lines and optical isolation lines are overcome. For example, in a preferred embodiment of the present invention, an amplifier circuit (see Kuo 1999) is used to amplify the ECG input of the two electrodes and obtain a waveform of a practical signal / noise ratio (such as the upper end of FIG. 3). Heartbeat identification digital ECG and pulse signals need to be processed first. The heartbeat signals in the ECG and pulse signals are calibrated, the period of each heartbeat is estimated, and the digital signal processing (DSP) of the heartbeat cycle sequence is generated. Information of physiological or clinical significance (Kuo et al. 1999;
Yang et al. 2000)。而數位訊號處理更包括頻域分析、時域 分析及非線性分析等。 首先以尖峰撿測程序，將每次心跳波動之最高點找 出，作爲每次心跳之代表，見第5圖，其是依照本發明一 10 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 83. 3. 10,000 (請先閲讀背面之注意事項再填寫本頁)Yang et al. 2000). Digital signal processing includes frequency domain analysis, time domain analysis, and nonlinear analysis. First, the peak picking procedure is used to find the highest point of each heartbeat fluctuation. As a representative of each heartbeat, see Figure 5, which is based on the paper size of the present invention according to the Chinese National Standard (CNS) A4 specification (10 210X297 mm) 83. 3. 10,000 (Please read the notes on the back before filling this page)
-、1T 515703 3312twf.doc/009 A7 B7 五 經濟部中央標準局員工消費合作社印製 發明説明（〇[) 較佳實施例，以該感測器置於受測者頸部測量5秒鐘所_ 得之心電與脈搏圖，以及對應之心率週期圖，打點者爲電 腦自動辨識之心跳代表尖峰。而第6圖則是對受測者進行 5分鐘試驗所獲得之心電圖以及心率週期圖，打點者爲電 腦自動辨識之心跳代表尖峰；同樣地’第7圖則是對受測 者進行5分鐘試驗所獲得之脈搏圖以及心率週期圖，打點 者爲電腦自動辨識之心跳代表尖峰。 從每個心跳代表尖峰中，電腦程式測量其高度和持續 時間等參數，並將各參數之平均値和標準差算出作爲標準 模版。接下來每個心跳都以此模版進行比對，如果某一心 跳之比對結果落在標準模版三個標準差之外，將被認爲是 雜訊而刪除。接下來將鄰近兩個心跳尖峰之相隔時間測出 作爲該次之:心跳之週期。將所有心跳週期之平均値和標準 差算出，再進行所有心跳週期之確認，如果某一心跳週期 落在三個標準差之外，它也會被認爲是雜訊或不穩定訊號 而濾掉。通過此辨識程序的心跳週期序列將進行後續分 析。 頻域分析 將所有合格之心跳週期序列以7.11 Hz之頻率進行取 樣與保値程序以維持其時間連貫性，頻譜分析採用傅立葉 轉換方法。首先消除訊號的直線飄移以防止低頻帶的干 擾，亦採用Hamming運算以避免頻譜中個別頻率成份之 互相滲漏（leakage)(Kuo 1999; Kuo 與 Chan 1993)。接下來 取288秒之資料（共2048點）施行快速傅立葉轉換（Fast 11 (請先閲讀背面之注意事項再填寫本頁) 訂' 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 83. 3. 10,000 515703 8312twf.doc/009 A7 B7 五、發明説明（v。） '-、 1T 515703 3312twf.doc / 009 A7 B7 The invention description (0 [) printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs is a preferred embodiment. The sensor is placed on the subject's neck and measured for 5 seconds. _ The graph of ECG and pulse, and the corresponding heart rate cycle graph. The ticker represents the spike of the heartbeat automatically recognized by the computer. Figure 6 is an electrocardiogram and heart rate cycle graph obtained from a 5-minute test on the subject. The ticker represents the spike of the heartbeat automatically recognized by the computer. Similarly, Figure 7 is a 5-minute test on the subject. The obtained pulse chart and heart rate cycle chart represent the spike of the heartbeat automatically recognized by the computer. From each spike represented by the heartbeat, a computer program measures parameters such as its height and duration, and calculates the mean and standard deviation of each parameter as a standard template. Next, each heartbeat is compared with this template. If the comparison result of a heartbeat falls outside the three standard deviations of the standard template, it will be considered as noise and deleted. Next, the interval between two adjacent heartbeat spikes is measured as the second time: the heartbeat cycle. Calculate the average 値 and standard deviation of all heartbeat cycles, and then confirm all heartbeat cycles. If a heartbeat cycle falls outside the three standard deviations, it will also be considered as noise or unstable signals and filtered out. . The sequence of heartbeat cycles through this identification procedure will be analyzed later. Frequency domain analysis All qualified heartbeat cycle sequences are sampled and maintained at a frequency of 7.11 Hz to maintain their time continuity. Fourier transform method is used for spectrum analysis. First, the signal's linear drift is eliminated to prevent interference in the low frequency band. Hamming operation is also used to avoid mutual leakage of individual frequency components in the frequency spectrum (Kuo 1999; Kuo and Chan 1993). Next take 288 seconds of data (a total of 2048 points) and perform a fast Fourier transform (Fast 11 (please read the precautions on the back before filling this page). Order 'This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) 83. 3. 10,000 515703 8312twf.doc / 009 A7 B7 V. Description of the invention (v.) ''
Founer Transform) ’得到功率密度頻譜，並對取樣與 Hamming運算造成之影響進行補償（Ku〇 1999; KuQ et al 1999) 〇 、 心率變異之功率密度頻譜（PSD)藉由積分的方式定量 其中2個頻帶之功率，包括低頻（LF，大約0.04-0.15 Hz)功 率和高頻（HF，大約0.15-0.4 Hz)功率。同時求出總功率（T〇tal power，TP)與低頻/高頻功率比値（LF/HF)等量化參數 (Anonymous 1996; Kuo et al. 1999; Yang et al. 2000)。這些 參數並經由對數轉換以達到常態分佈(Kuo et al.. 1999)。 第8圖及第9圖即分別是對第6圖與第7圖之資料進 行頻譜分析，而得到各項定量資訊之圖示。 頻域分析之判請 、 實驗結果以HF和TP爲心臟副交感神經活性之指標， 並以LF/HF爲心臟交感神經活性之指標，而LF則視爲交 感和副交感神經功能之統合指標。 經濟部中央樣準局員工消費合作社印製 第10A圖是以本發明感測器對10位受測者收集之心 電部分進行分析所得之定量資訊(以E表之）與以傳統彳寧準 方法(Anonymous 1996)所得之資訊(以T表之）的比較。而 第10B圖是以本發明感測器對10位受測者收集之脈搏部 分進行分析所得之定量資訊（以Μ表之）與以傳統標準方法 (Anonymous 1996)所得之資訊（以Τ表之）的比較。 因此本發明之感測器可成功地由頸部之心電與脈搏# 析得到自主神經指標。而該自主神經指標與由傳統標準法 分析得到的自主神經指標有良好的線性相關，相關系@(r) 83. 3. !0,〇〇〇 (請先閲讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準（CNS ) A4規格（210X29*7公釐） 經濟部中夬標準局員工消費合作社印製 )15703 五、發明説明（v\ ) 大於0.95。所以證明頸部所獲得之心電與脈搏訊號同樣也 能正確地反應自主神經功能’並且本發明的分析系統確實 有能力偵測得到的自主神經指標並分析反應出自主神經功 肯b 。 本發明中所提供之技術已成功診斷麻醉深度（Yang et al. 1996)、腦死（Kuo et al. 1997)、重症預後（Yien et al· 1997)、老化（Kuo et al. 1999)、性別差異（Kuo et al· 1999) 等功能或疾病。 本發明採用之心電、脈搏、聲波三合一感測器’可從 身體外部（較佳爲頸部）獲得心電與脈搏訊號，以分析評量 自主神經功能，實爲一個使用簡便而功能完整之自主神經 分析系統。並從聲波訊號而分析診斷其他疾病。 也可配合傳統之生理監視系統，於醫院、安養院或家 庭中測量一個人之自主神經功能或其他生理狀況，達到養 生保健的目的。 本發明之感測器可以作爲現在標準生理監測儀之輸入 裝置，只要套在頸部，即可測量心電、脈搏和聲波等生理 訊號’應用於醫院病人和加護病房病人皆相當方便，病人 不需承受痛苦就可以得知部分身體狀態。 本發明之感測器及分析系統可i一步推廣至一般個 人，配合個人化之家用電jf或掌上型電腦，在家中自行使 用’而成爲個人化之生理監測儀。更可配合無線傳輸系統 或行動通訊技術，則形成遠距心電、脈波和聲波監測系統， 達到通訊保健之用途。更進一步，該三合一感測器更可配 本紙張尺度適财關家轉（CNS)八4祕（2lQx297公董） 83. 3. 10,000 (請先閱讀背面之注意事項再填寫本貫) 訂 -後_· 515703 A7 B7 3l2twf.doc/009 五、發明説明（〇/ ) „——1---5——j——^— (請先閲讀背面之注意事項再填寫本頁) 合包括於行動電話之中之微電腦，而使生理監測成爲行動 電話之括充功能，則行動電話即升級爲自主神經功能分析 儀。甚或配合手錶內之微電腦，而成爲全天候之個人監測 儀。 由上述本發明較佳實施例可知，本發明之感測器及其 分析系統具有下列優點： 1·結構輕巧不複雜，方便使用者配帶使用，且成本低 廉。 2·使用介面與許多現有技術相容，可以輕易擴充，或 依使用者之需求而個人化，易於拽廣至家庭或個人。 3·針對個人化需求，量身訂作，並可以分析之結果配 合其他醫療諮詢軟體，而達到家庭保健之結果。 4·更可配合未來無線通訊技術或無線傳輸技術而使 用，進而應用於遠距診斷或醫療。 雖然本發明已以一較佳實施例揭露如上，然其並非用 以限定本發明，任何熟習此技藝者，在不脫離本發明之精 神和範圍內，當可作各種之更動與潤飾，因此本發明之保 護範圍當視後附之申請專利範圍所界定者爲準。 經濟部中央標準局員工消費合作社印褽 14 83.3. !〇,〇〇〇 本紙張尺度適用中國國家榡準（CNS ) A4規格（210X297公釐）Founer Transform) 'Get the power density spectrum and compensate for the effects of sampling and Hamming operations (Ku 1999; KuQ et al 1999) 〇 The power density spectrum (PSD) of the heart rate variability is quantified by integration The power of the frequency band includes low frequency (LF, about 0.04-0.15 Hz) power and high frequency (HF, about 0.15-0.4 Hz) power. At the same time, quantitative parameters such as total power (TP) and low-frequency / high-frequency power ratio (LF / HF) were obtained (Anonymous 1996; Kuo et al. 1999; Yang et al. 2000). These parameters are log transformed to achieve a normal distribution (Kuo et al .. 1999). Figures 8 and 9 are the graphs of the quantitative information obtained by performing spectrum analysis on the data in Figures 6 and 7, respectively. In the frequency domain analysis, the experimental results used HF and TP as indicators of cardiac parasympathetic nerve activity, and LF / HF as indicators of cardiac sympathetic nerve activity, and LF as a unified indicator of sympathetic and parasympathetic nerve function. Printed in Figure 10A by the Consumer Cooperatives of the Central Sample Bureau of the Ministry of Economic Affairs, the quantitative information (shown in Table E) obtained by analyzing the ECG portion collected by 10 subjects with the sensor of the present invention and the traditional Suining standard Comparison of information obtained by methods (Anonymous 1996) (shown as T). Figure 10B is the quantitative information (as shown in Table M) obtained by analyzing the pulse portion collected by 10 subjects with the sensor of the present invention and the information (as shown in Table T) obtained by the traditional standard method (Anonymous 1996). )Comparison. Therefore, the sensor of the present invention can successfully obtain the autonomic nerve index from the ECG and pulse # analysis of the neck. The autonomic nerve index has a good linear correlation with the autonomic nerve index obtained by the analysis of the traditional standard method. The relationship is @ (r) 83. 3.! 0, 〇〇〇 (Please read the precautions on the back before filling this page ) This paper size is in accordance with Chinese National Standard (CNS) A4 (210X29 * 7mm). Printed by the Consumers' Cooperative of the China Standards Bureau of the Ministry of Economic Affairs. 15703 5. The invention description (v \) is greater than 0.95. Therefore, it is proved that the ECG and pulse signals obtained from the neck can also correctly reflect the autonomic nerve function 'and that the analysis system of the present invention is indeed capable of detecting the autonomic nerve index obtained and analyzing and reflecting the autonomic nerve function b. The technology provided in the present invention has successfully diagnosed the depth of anesthesia (Yang et al. 1996), cerebral death (Kuo et al. 1997), severe prognosis (Yien et al. 1997), aging (Kuo et al. 1999), gender Differences (Kuo et al. 1999) and other functions or diseases. The three-in-one ECG, pulse, and acoustic wave sensor used in the present invention can obtain ECG and pulse signals from the outside of the body (preferably the neck) to analyze and evaluate autonomic nerve function, which is a simple and convenient function. Complete Autonomic Neural Analysis System. And analyze other diseases from sonic signals. It can also cooperate with the traditional physiological monitoring system to measure a person's autonomic nervous function or other physiological conditions in a hospital, nursing home or family, to achieve the purpose of health care. The sensor of the present invention can be used as an input device of a current standard physiological monitor. As long as it is placed on the neck, it can measure the physiological signals such as ECG, pulse and sound waves. It is quite convenient for patients in hospitals and intensive care units. You need to endure the pain to know some body conditions. The sensor and analysis system of the present invention can be extended to ordinary individuals in one step, and can be used at home to personalize a physiological monitor with a personalized home electronic jf or a palm computer. It can also cooperate with wireless transmission system or mobile communication technology to form a long-distance ECG, pulse wave and sound wave monitoring system, which can achieve the purpose of communication and health care. Furthermore, the three-in-one sensor can be equipped with the paper size of the CNS, 8 secrets (2lQx297 public director) 83. 3. 10,000 (please read the precautions on the back before filling in this document) Order -After_ · 515703 A7 B7 3l2twf.doc / 009 V. Description of the invention (〇 /) ———— 1 --- 5——j —— ^ — (Please read the notes on the back before filling this page) Included If the microcomputer in the mobile phone makes physiological monitoring become the function of the mobile phone, the mobile phone will be upgraded to an autonomic nerve function analyzer. Or even with the microcomputer in the watch, it will become an all-weather personal monitor. It can be known from the preferred embodiments of the invention that the sensor and the analysis system of the present invention have the following advantages: 1. The structure is light and uncomplicated, which is convenient for users to carry and use, and the cost is low. 2. The use interface is compatible with many existing technologies, It can be easily expanded, or personalized according to the needs of users, and is easily extended to families or individuals. 3. According to personal needs, tailor-made, and the results of analysis can be combined with other medical consulting software to achieve family insurance. The result can be used. 4. It can be used in conjunction with future wireless communication technology or wireless transmission technology, and then applied to remote diagnosis or medical treatment. Although the present invention has been disclosed as above with a preferred embodiment, it is not intended to limit the present invention. Anyone who is familiar with this skill can make various modifications and retouching without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the scope of the attached patent application. Standard Bureau employee consumer cooperative seal 14 83.3.! 00,00 This paper size is applicable to China National Standard (CNS) A4 (210X297 mm)