TWI483706B - A quantification of cardiac status enabled device - Google Patents

A quantification of cardiac status enabled device Download PDF

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TWI483706B
TWI483706B TW101126548A TW101126548A TWI483706B TW I483706 B TWI483706 B TW I483706B TW 101126548 A TW101126548 A TW 101126548A TW 101126548 A TW101126548 A TW 101126548A TW I483706 B TWI483706 B TW I483706B
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time series
heartbeat
complexity
calculation module
heart
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TW201404358A (en
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Chien Sheng Liu
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Livestrong Biomedical Technology Co Ltd
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一種具有心臟狀態之量化功能的裝置 Device with quantitative function of heart state

本發明係指一種醫療輔助裝置,尤指一種具有心臟狀態之量化功能的裝置。 The invention relates to a medical auxiliary device, in particular to a device having a quantitative function of a heart state.

慢性非傳染性疾病(Chronic noncommuicable diseases,NCDs)為公共衛生及預防醫學的重要議題,隨著經濟化及全球化的步伐,NCDs已變成國家的健康負擔,而NCDs的防治,則可透過積極對生活型態的管理而的到效果,根據聯合國估計,目前全球8億6千萬人有慢性病,75-85%的醫療花費與慢性疾病相關,其中老年人口有40%患有慢性病,10年後將增加1倍,預估至2030年,臺灣65歲以上老人人口將佔總人口數之21%。大規模臨床試驗已證明心肌梗塞及死亡的預防可透過針對高危險族群評估予以早期發現及治療,但是這些治療多為提供一般性危險的平均評估,而沒有針對個別特定的治療。目前個人化醫療(personalized medicine)或是分層式醫療(stratified medicine)是針對個體特殊的處置使用有效且副作用較低在特定的族群,目前運用於心血管疾病作危險分層及預測的模型相當的眾多,包括如Framingham危險分數(FRS,Framingham risk score)或歐洲PROCAM模型等,可作為心血管疾病的定量預測參數指標。 Chronic noncommudable diseases (NCDs) are important issues in public health and preventive medicine. With the pace of economic globalization and globalization, NCDs have become a national health burden, and the prevention and control of NCDs can be positively According to the United Nations estimates, there are currently 860 million people worldwide with chronic diseases, and 75-85% of medical expenses are related to chronic diseases, of which 40% of the elderly have chronic diseases, 10 years later. It will be doubled. It is estimated that by 2030, Taiwan’s elderly population over 65 will account for 21% of the total population. Large-scale clinical trials have demonstrated that prevention of myocardial infarction and death can be detected and treated early for high-risk population assessments, but these treatments are mostly an average assessment of the general risk, but not for individual treatments. Currently, personalized medicine or stratified medicine is effective for specific treatments of individuals and has low side effects in specific ethnic groups. The current model for cardiovascular disease for risk stratification and prediction is quite comparable. Numerous factors, such as the Framingham risk score (FRS, Framingham risk score) or the European PROCAM model, can be used as quantitative predictors of cardiovascular disease.

心血管疾病位居國人十大死因第二位,由三段五級預防醫學角度出發,若能建立心血管風險評估與早期預警機制,及早提醒民眾未來心血管疾病可能發生的機率,可提高民眾對於心血管疾病的認知,對於相關疾病的預防必有其功效;國內外相關評估心血管風險之醫學 工具甚多,代謝症候群危險因子主要針對腹部肥胖、血壓、血糖、三酸甘油脂與高密度膽固醇進行評估;Framingham Risk Score變數包含性別、年齡、有無抽菸、有無糖尿病、收縮壓、總膽固醇、高密度膽固醇,利用這些變數預測未來十年死亡或心血管事件的風險;Expert system則以血壓高低和病人臨床上是否出現蛋白尿、心肌肥厚、腦血管惡化、腦中風與心衰竭等等來綜合評估心血管危險因子,故提早預警已成為當前減少心血管疾病風險之衛生政策努力推展的目標。唯目前的評估工具在使用上需要採集多種生理參數(例如需透過採血得到的膽固醇指數),於一般民眾所需之居家自主健康照護的應用上具有相當程度的不便性及困難度。 Cardiovascular disease ranks second among the top ten causes of death among Chinese people. From the perspective of three-stage and five-level preventive medicine, if a cardiovascular risk assessment and early warning mechanism can be established to remind people of the possibility of future cardiovascular disease, the public can be raised. Cognition of cardiovascular disease must have its effect on the prevention of related diseases; medicines for assessing cardiovascular risk at home and abroad There are many tools, metabolic syndrome risk factors are mainly for abdominal obesity, blood pressure, blood sugar, triglycerides and high-density cholesterol; Framingham Risk Score variables include gender, age, smoking, diabetes, systolic blood pressure, total cholesterol, High-density cholesterol, using these variables to predict the risk of death or cardiovascular events in the next decade; the Expert system is based on high blood pressure and clinical manifestations of proteinuria, cardiac hypertrophy, cerebral vascular deterioration, stroke and heart failure. Assessing cardiovascular risk factors, early warning has become the goal of current health policy efforts to reduce the risk of cardiovascular disease. Only the current assessment tools need to collect a variety of physiological parameters (such as the cholesterol index obtained through blood collection), which has a considerable degree of inconvenience and difficulty in the application of home-based independent health care required by the general public.

在生理機制上,心臟的活性可用來表示身體面對外在環境變化發生時能夠即時反應的程度,透過心臟活性的量化參數,將可應用於心臟狀態的長期評估、心血管疾病的早期預警以及居家自主性的健康照護;在心血管疾病的定量預測的相關研究中指出,可利用心率的變異程度來評估心臟的活性變化,其中,心率變異度(Heart Rate Variability,HRV)指透過心搏間隔時間序列的統計分析,或是經過傅立葉轉換後計算不同頻帶間能量的分布以及所占比例變化以了解交感及副交感神經對於心臟活性的影響;時間非可逆性(Time Irreversibility,TI)係指分析心搏間隔時間序列的離散程度,以量化心臟的活性參數。 In terms of physiological mechanisms, the activity of the heart can be used to indicate the extent to which the body can respond immediately to external environmental changes. Through quantitative parameters of cardiac activity, it can be applied to long-term assessment of cardiac status, early warning of cardiovascular disease, and Home-based health care; in the study of quantitative prediction of cardiovascular disease, it is pointed out that heart rate variability can be used to assess changes in heart activity, wherein Heart Rate Variability (HRV) refers to heart rate interval Statistical analysis of the sequence, or the Fourier transform to calculate the distribution of energy between different frequency bands and the proportion change to understand the effects of sympathetic and parasympathetic nerves on cardiac activity; Time Irreversibility (TI) refers to the analysis of heart beats The degree of dispersion of the time series is quantified to quantify the activity parameters of the heart.

在生理構造及生命機轉中,透過交感/副交感神經系統以及激素(腎上腺素)的調控,心臟可以在面對不同外界環境狀況時調整節律以應付生理的需要,其表現出來的特性即為心 臟的活性,在TI的研究理論中指出,正常的心臟具有較大的彈性,其心搏間隔時間序列的複雜度較高,且與其時間序列反轉後的時間序列相比可發現其兩者間的相似度較低,隨著慢性心血管疾病的出現與嚴重化,其複雜度會有降低的趨勢,相對的與反轉後的時間序列相似度較高,也就是心臟對於外界變化的反應能力下降,進而容易造成急性心臟疾病的發生,透過比較及量化兩時間序列的相似度,將可以了解心臟的特徵狀態。 In the physiological structure and life cycle, through the regulation of the sympathetic/parasympathetic nervous system and hormones (adrenalin), the heart can adjust the rhythm to meet the physiological needs in the face of different external environmental conditions, and its characteristics are the heart. Dirty activity, pointed out in TI's research theory, the normal heart has greater elasticity, the complexity of the heartbeat interval time series is higher, and the two can be found compared with the time series after the time series inversion. The similarity between the two is low. With the emergence and severity of chronic cardiovascular disease, the complexity will decrease. The relative degree of similarity with the reversed time series is higher, that is, the response of the heart to external changes. The ability to reduce the risk of acute heart disease, by comparing and quantifying the similarity of the two time series, will be able to understand the characteristic state of the heart.

因此,如何提出一種具有心臟狀態之量化功能的裝置,用以即時了解心臟的特徵狀態,遂成為本領域技術人員之重要課題。 Therefore, how to propose a device having a quantitative function of the heart state for instantly understanding the characteristic state of the heart has become an important subject of those skilled in the art.

本發明提供一種心臟狀態之量化裝置,一濾波電路,係可將設置於生物之體表的電極所記錄之電位差訊號放大並濾波以產生心電訊號;一心搏間隔時間序列偵測演算模組,係依據該濾波電路產生之心電訊號計算每一個心搏之間隔時間並輸出對應之心搏時間序列;以及一複雜度計算模組,係將該心搏時間序列進行反轉計算以得到反轉時間序列,並比較該心搏時間序列與該反轉時間序列之複雜度的差異,以產生用以表示該生物之心臟之活性狀態的指標參數。 The present invention provides a cardiac state quantification device, a filter circuit for amplifying and filtering a potential difference signal recorded by an electrode disposed on a body surface of a living body to generate an electrocardiogram signal; a heart beat interval time series detection calculation module, Calculating an interval time of each heart beat according to the ECG signal generated by the filter circuit and outputting a corresponding heartbeat time sequence; and a complexity calculation module, performing the inversion calculation on the heartbeat time series to obtain a reverse A time series, and comparing the difference in complexity between the heartbeat time sequence and the inversion time series to generate an indicator parameter indicative of the activity state of the heart of the organism.

本發明所提供之心臟狀態之量化裝置,僅需量測人體之心電訊號即可得到量化的心臟狀態參數,相較於傳統使用的臨床評估工具,可降低多種生理參數收集的不便,提供使用者簡單、快速與方便使用之居家自主心臟狀態資訊健康管理的輔助裝置。 The apparatus for quantifying the state of the heart provided by the invention can obtain the quantified cardiac state parameters only by measuring the electrocardiogram signal of the human body, and can reduce the inconvenience of collecting various physiological parameters compared with the traditional clinical evaluation tools. An auxiliary device for information management of home autonomous heart state that is simple, fast and convenient to use.

請同時參閱第一圖及第二圖,第一圖係本發明之心臟狀態之量化裝置1的示意圖,第二圖係本發明之心臟狀態之量化裝置的功能方塊圖。第一圖之心臟狀態之量化裝置1包括訊號輸入單元11、類比放大/濾波電路單元12、中央處理單元13以及訊號輸出單元14。具體操作方式如第二圖所示,濾波(Amplifier/Filter)電路21可將設置於生物之體表的電極3所記錄之電位差訊號放大並濾波以產生心電訊號4。第一圖之中央處理單元可包括心搏間隔時間序列偵測演算模組(RR Interval Detection)22及複雜度計算模組(Complexity Calculation)23,其中,心搏間隔時間序列偵測演算模組22係依據該濾波電路21產生之心電訊號計算每一個心搏之間隔時間4並輸出對應之心搏時間序列,複雜度計算模組23係將該心搏時間序列進行反轉以得到反轉時間序列,並比較該心搏時間序列與該反轉時間序列之複雜度的差異,以產生用以表示該生物之心臟之活性狀態的指標參數。 Please refer to the first diagram and the second diagram at the same time. The first diagram is a schematic diagram of the apparatus 1 for quantifying the heart state of the present invention, and the second diagram is a functional block diagram of the apparatus for quantifying the heart state of the present invention. The cardiac state quantizing apparatus 1 of the first figure includes a signal input unit 11, an analog amplification/filtering circuit unit 12, a central processing unit 13, and a signal output unit 14. The specific operation mode is as shown in the second figure. The filter (Amplifier/Filter) circuit 21 can amplify and filter the potential difference signal recorded by the electrode 3 disposed on the body surface of the living body to generate the electrocardiogram signal 4. The central processing unit of the first figure may include a heart rate interval detection algorithm (RR Interval Detection) 22 and a complexity calculation module (Complexity Calculation) 23, wherein the heartbeat interval time series detection calculation module 22 Calculate the interval time 4 of each heart beat according to the ECG signal generated by the filter circuit 21 and output a corresponding heart beat time sequence, and the complexity calculation module 23 inverts the heart beat time series to obtain the inversion time. The sequence is compared and the difference in complexity of the heartbeat time sequence from the inversion time series is compared to generate an indicator parameter indicative of the activity state of the heart of the organism.

於一較佳態樣中,心搏間隔時間序列偵測演算模組及複雜度計算模組之功能可透過軟體或軔體以演算法方式實現之。例如,可利用軟體完成心搏間隔時間序列偵測(RR Interval Detection)演算法及複雜度計算(Complexity Calculation)演算法,再由該中央處理單元執行該些演算法。 In a preferred aspect, the functions of the heartbeat interval time series detection calculation module and the complexity calculation module can be implemented algorithmically by software or carcass. For example, the software can perform a RR Interval Detection algorithm and a Complexity Calculation algorithm, and the central processing unit executes the algorithms.

第三圖係本發明之複雜度計算演算法之功能方塊圖,首先,將偵測/輸入之一固定資料長度的心搏間隔時間序列反轉,再將此二時間序列利用相位空間重建(Phase Space Reconstruction,PSR)方式分別建立相對應的相位空間矩陣(PSR Matrix #1, PSR Matrix #2),以用來表示該時間序列的複雜度,最後,透過矩陣的互斥或(XOR)運算,將兩矩陣重複區域去除後,所剩下非重複區域可用於比較及量化兩時間序列的相似度。 The third figure is a functional block diagram of the complexity calculation algorithm of the present invention. First, the heartbeat interval time sequence of one of the fixed data lengths is detected/inverted, and the two time series are reconstructed by phase space (Phase). The Space Reconstruction (PSR) method establishes the corresponding phase space matrix (PSR Matrix #1, respectively). PSR Matrix #2) is used to indicate the complexity of the time series. Finally, after the matrix repeating region is removed by the mutual exclusion or (XOR) operation of the matrix, the remaining non-repetitive regions can be used to compare and quantize the two. The similarity of time series.

第四圖係本發明之正常心搏間隔時間序列及其複雜度相位矩陣,第五圖顯示其反轉序列及其複雜度相位矩陣,可以發現在正常個案中,其心搏間隔時間序列的複雜度較高且兩時間序列間的相似度較低。 The fourth figure is the normal heartbeat interval time series of the present invention and its complexity phase matrix, and the fifth figure shows the reverse sequence and its complexity phase matrix, which can be found to be complicated in the heartbeat interval time series in normal cases. The degree is higher and the similarity between the two time series is lower.

第六圖係本發明之具有慢性心血管疾病患者所紀錄之心搏間隔時間序列及其複雜度相位矩陣,第七圖顯示其反轉序列及其複雜度相位矩陣,可以發現在異常個案中,其心搏間隔時間序列的複雜度較低且兩時間序列間的相似度較高。 The sixth figure is the heartbeat interval time series and its complexity phase matrix recorded by the patient with chronic cardiovascular disease of the present invention, and the seventh figure shows the reverse sequence and its complexity phase matrix, which can be found in the abnormal case, The complexity of the heartbeat interval time series is low and the similarity between the two time series is high.

第八圖係利用本發明所收集之正常與異常訊號其個別量化指標參數統計結果,橫坐標為收案編號,縱坐標為量化指標參數,可以發現正常個案的量化指標參數值較高(表示相似度較低,皆在數值60之上),而異常個案的量化指標參數值較低(表示相似度較高,皆在數值60之下)。 The eighth figure is the statistical result of the individual quantitative index parameters of the normal and abnormal signals collected by the present invention, the abscissa is the receipt number, and the ordinate is the quantitative index parameter, and the quantitative parameter value of the normal case can be found to be high (representing similarity) The degree is lower, both above the value of 60), while the value of the quantitative indicator parameter of the abnormal case is lower (indicating that the similarity is higher, all below the value 60).

第九圖係利用本發明所收集之正常與異常訊號其量化指標參數的統計分析結果,可以發現正常個案之量化指標參數的均值為66.8,標準差為5.67,而異常個案之量化指標參數的均值為46.5,標準差為9.8,兩者間具有明顯的統計差異,因此透過本發明所量化之指標可應用於心臟狀態的輔助參考依據。 The ninth figure is the statistical analysis result of the quantitative index parameters of the normal and abnormal signals collected by the present invention, and the average value of the quantitative index parameters of the normal case is 66.8, the standard deviation is 5.67, and the mean value of the quantitative index parameter of the abnormal case is obtained. At 46.5, the standard deviation is 9.8, and there is a significant statistical difference between the two, so the index quantified by the present invention can be applied to the auxiliary reference of the heart state.

綜上所述,本發明之心臟狀態之量化裝置先找出人體心臟之心搏時間序列,再對該心搏時間序列進行反轉以得到反轉時間序列,並比較該心搏時間序列與該反轉時間序列之複雜度的 差異,以產生用以表示該生物之心臟之活性狀態的指標參數。如此,該指標參數可提供一般使用者及醫護人員作為心血管相關疾病之早期預警的輔助參考依據 In summary, the heart state quantification device of the present invention first finds the heartbeat time sequence of the human heart, and then inverts the heartbeat time sequence to obtain a reverse time series, and compares the heartbeat time sequence with the Reverse the complexity of the time series The difference is to generate an indicator parameter indicative of the active state of the heart of the organism. In this way, the indicator parameters can provide general users and medical staff as an auxiliary reference for early warning of cardiovascular related diseases.

上述實施形態僅例示性說明本發明之原理、特點及其功效,並非用以限制本發明之可實施範疇,任何熟習此項技藝之人士均可在不違背本發明之精神及範疇下,對上述實施形態進行修飾與改變。任何運用本發明所揭示內容而完成之等效改變及修飾,均仍應為下述之申請專利範圍所涵蓋。因此,本發明之權利保護範圍,應如後述之申請專利範圍所列。 The above-described embodiments are merely illustrative of the principles, features, and effects of the present invention, and are not intended to limit the scope of the present invention. Any person skilled in the art can recite the above without departing from the spirit and scope of the present invention. The embodiment is modified and changed. Any equivalent changes and modifications made by the disclosure of the present invention should still be covered by the following claims. Therefore, the scope of protection of the present invention should be as set forth in the scope of the claims described below.

1、2‧‧‧心臟狀態之量化裝置 1, 2‧‧‧ Quantitative device for cardiac status

11‧‧‧輸入單元 11‧‧‧ Input unit

12‧‧‧類比放大/濾波電路單元 12‧‧‧ analog amplification/filtering circuit unit

13‧‧‧中央處理單元 13‧‧‧Central Processing Unit

14‧‧‧訊號輸出單元 14‧‧‧Signal output unit

21‧‧‧濾波電路 21‧‧‧Filter circuit

22‧‧‧心搏間隔時間序列偵測演算模組 22‧‧‧ Heartbeat Interval Time Series Detection and Calculation Module

23‧‧‧複雜度計算模組 23‧‧‧Complexity Calculation Module

3‧‧‧電極 3‧‧‧Electrode

4‧‧‧心電訊號 4‧‧‧ ECG signal

5‧‧‧心搏間隔時間序列 5‧‧‧ Heartbeat interval time series

第一圖係本發明之心臟狀態之量化裝置的示意圖。 The first figure is a schematic illustration of a quantification device for the heart state of the present invention.

第二圖係本發明之心臟狀態之量化裝置的功能方塊圖。 The second figure is a functional block diagram of the quantification device of the heart state of the present invention.

第三圖係本發明之複雜度計算演算法之功能方塊圖。 The third figure is a functional block diagram of the complexity calculation algorithm of the present invention.

第四圖係本發明之正常心搏間隔時間序列及其複雜度相位矩陣。 The fourth figure is the normal heartbeat interval time series of the present invention and its complexity phase matrix.

第五圖係本發明所述之正常心搏間隔時間序列之反轉時間序列及其複雜度相位矩陣。 The fifth figure is the inverse time series of the normal heartbeat interval time series and its complexity phase matrix according to the present invention.

第六圖係本發明所述之異常心搏間隔時間序列及其複雜度相位矩陣。 The sixth figure is the abnormal heartbeat interval time series and its complexity phase matrix according to the present invention.

第七圖係本發明所述之異常心搏間隔時間序列之反轉時間序列及其複雜度相位矩陣。 The seventh figure is the inverse time series of the abnormal heartbeat interval time series and the complexity phase matrix thereof according to the present invention.

第八圖係利用本發明之心臟狀態之量化裝置所收集之正常與異常訊號其個別量化指標參數統計結果。 The eighth graph is a statistical result of the individual quantitative index parameters of the normal and abnormal signals collected by the quantification device of the cardiac state of the present invention.

第九圖係利用本發明之心臟狀態之量化裝置所收集之正常與異常訊號其量化指標參數的統計分析結果。 The ninth graph is a statistical analysis result of the quantified index parameters of the normal and abnormal signals collected by the quantification device of the cardiac state of the present invention.

2‧‧‧心臟狀態之量化裝置 2‧‧‧Quantity device for cardiac status

21‧‧‧濾波電路 21‧‧‧Filter circuit

22‧‧‧心搏間隔時間序列偵測演算模組 22‧‧‧ Heartbeat Interval Time Series Detection and Calculation Module

23‧‧‧複雜度計算模組 23‧‧‧Complexity Calculation Module

3‧‧‧電極 3‧‧‧Electrode

4‧‧‧心電訊號 4‧‧‧ ECG signal

5‧‧‧心搏間隔時間序列 5‧‧‧ Heartbeat interval time series

Claims (4)

一種心臟狀態之量化裝置,包括:一濾波電路,係可將設置於生物之體表的電極所記錄之電位差訊號放大並濾波以產生心電訊號;一心搏間隔時間序列偵測演算模組,係依據該濾波電路產生之心電訊號計算每一個心搏之間隔時間並輸出對應之心搏時間序列;以及一複雜度計算模組,係將該心搏時間序列進行反轉以得到反轉時間序列,並比較該心搏時間序列與該反轉時間序列之複雜度的差異,以產生用以表示該生物之心臟之活性狀態的指標參數。 A device for quantifying a cardiac state, comprising: a filter circuit for amplifying and filtering a potential difference signal recorded by an electrode disposed on a body surface of a living body to generate an electrocardiogram signal; and a heartbeat interval time series detection calculation module Calculating an interval time of each heartbeat according to the ECG signal generated by the filter circuit and outputting a corresponding heartbeat time sequence; and a complexity calculation module, inverting the heartbeat time sequence to obtain a reverse time series And comparing the difference between the heartbeat time sequence and the complexity of the inversion time series to generate an indicator parameter indicative of the activity state of the heart of the organism. 如申請專利範圍第1項所述之心臟狀態之量化裝置,其中,該複雜度計算模組係將一固定資料長度的心搏間隔時間序列進行反轉以得到該反轉時間序列,再將該心搏間隔時間序列及該反轉時間序列利用相位空間重建方式分別建立相對應的相位空間矩陣,以用來表示該該心搏間隔時間序列及該反轉時間序列的複雜度。 The apparatus for quantifying cardiac status according to claim 1, wherein the complexity calculation module inverts a time interval interval of a fixed data length to obtain the reverse time sequence, and then The heartbeat interval time series and the inversion time series respectively establish a corresponding phase space matrix by phase space reconstruction to indicate the complexity of the heartbeat interval time series and the inversion time series. 如申請專利範圍第2項所述之心臟狀態之量化裝置,其中,該複雜度計算模組係透過矩陣的互斥或運算,以將該心搏間隔時間序列及該反轉時間序列之相位空間矩陣之重複區域去除後,將所剩下之非重複區域進行比較及量化。 The apparatus for quantizing a cardiac state according to claim 2, wherein the complexity calculation module transmits the heartbeat interval time series and the phase space of the inversion time series through mutual exclusion or operation of the matrix. After the repeated regions of the matrix are removed, the remaining non-repetitive regions are compared and quantified. 如申請專利範圍第1項所述之心臟狀態之量化裝置,其中,該心搏間隔時間序列偵測演算模組及該複雜度計算模組係利用軟體或韌體予以實現。 The apparatus for quantifying a heart state according to claim 1, wherein the heartbeat interval time series detection calculation module and the complexity calculation module are implemented by using a software or a firmware.
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