200803792 九、發明說明： 【發明所屬之技術領域】 本發明之優先權案為2005年2月25日申請之美國 暫時專利申請案，案號6〇/656,310。 本發明一般係關於_種方法及設備， 析脈博以镇测心房顔動，其使用一演算法錯 心房顫動之心律異常。 【先前技術】 封臟疋主要的彳’、^^官，其為供應血液流經全身的 2幫浦。心臟包含兩個上部腔室，即所謂的心房，以 戶=部腔室，稱為心室。右心房接收血，而左 心^接收從肺部來的飽氧血。當心房中充滿血液時， :臟：的出口閥門打開，心房將血液擠進心室中。接著 將乏氧血灌向肺部，且左心室將飽氧血灌向全身 。、、抵如此一來，心臟即主要如同一雙向幫浦運作。 跳門部的調節器’即所謂的竇房結，發出每次心 傳此信號由右心房中的竇房結發出，同時 ^二心房，且向下到房間隔再到房室結。這個常態 ί所刺激循環’即為正常竇性心律。心室的收縮則 句尸叮确的心跳。 種，I:異系可以有很多種。心房顫動是心律異常的- 變換模的方式收縮。心房的電激活持續 . W成抵達房室結的脈衝產生快速且高度不規 到達二二:ί室結進行過濾作用，只允許部份脈衝傳達 模式，1 至造成心跳的模式高度不規則。這個不規則的 等1·’Δ較早的研究中已顯示係為一雜亂模式（Bootsma nalyS1S of R'R Intervals in Patients with Atrial 5 200803792。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 The present invention generally relates to a method and a device, and analyzes the pulse of the heart to measure the atrial sensation, which uses an algorithm to correct the abnormal heart rhythm of the atrial fibrillation. [Prior Art] The main 彳', ^^ official of the viscera is the two pumps that supply blood through the body. The heart contains two upper chambers, the so-called atrium, which is called the ventricle. The right atrium receives blood, while the left heart receives oxygenated blood from the lungs. When the heart is full of blood, the dirty: outlet valve opens and the atrium squeezes blood into the ventricle. The hypoxic blood is then poured into the lungs, and the left ventricle is filled with oxygenated blood. In this way, the heart is mainly operated like the same two-way pump. The regulator of the jumping door, the so-called sinus node, sends out this heart signal every time it is emitted by the sinus node in the right atrium, and at the same time, the second atrium, and down to the interatrial septum to the atrioventricular node. This normal ί stimulates the cycle 'is the normal sinus rhythm. The contraction of the ventricle is a true heartbeat. Kind, I: There are many different types of different systems. Atrial fibrillation is abnormal in the heart rhythm - the mode of contraction. The electrical activation of the atria continues. The pulse of the arrival of the atrioventricular node is rapid and highly irregular. It reaches the 22nd: ί room knot filtering, only part of the pulse transmission mode is allowed, and the pattern causing the heartbeat is highly irregular. This irregular, etc., has been shown to be a messy pattern in earlier studies. (Bootsma nalyS1S of R'R Intervals in Patients with Atrial 5 200803792
Fibrillation at Rest and During Exercise· Circulation 41: 783, 1970)。本申請案中凡是提到「不規則」一詞，皆指 這一種幾乎僅發現存在於心房顫動中的雜亂心跳模式。 心房顫動是心律不整中最常見須要醫療照顧的一 種。心房顫動可由多種心臟狀況引起，例如心絞痛、心 肌梗塞及高血壓。這些狀況可能會使心房受拉扯或受 傷，並因此造成心臟系統中的不規則情形。心房顫動還 可能伴隨肺部問題或曱狀腺失調，並且具有嚴重的發/病 率和可能的致命性。任何人，不論年輕年老、女性男性， 包括視障/視盲人士，都可能會有心房顫動。 心房顫動的發生可能是斷續的或慣常性的。心房顏 動最嚴重的併發病，是在左心房形成血凝塊，可能導致 中風。然而，許多患有心房顫動的人，並不清楚自己有 異常心律。醫學界中有些人，因此倡導自行檢測脈博， 以偵測可能發生的心房顫動。然而，該文獻所揭露者， 大體上限於指示如何自行檢測個人之脈博，並額外配合 描述性資料做判斷。 ' α 用脈博偵測心房顫動的原因，是因為脈博通常和心 跳一致。左心室的收縮將血液射出至主動脈，造成的壓 力波即為在動脈系統中偵測得之脈博。然而當心房顫動 發生時，心跳之間的時間會有不規則的變化。 一、 當心跳之間的時間間隔較長時，血液有較長的時間 可注入心室，因些在這較長的時間間隔之後的該次心 跳，心室會喷射出較多的血液。大量的血液進入主動 脈，造成該次心跳收縮壓較高。 相反地，當心跳之間的時間間隔較短時，心室只有 較短的時間可注入血液，因些在這較短的時間間隔之後 6 200803792 的該次心跳，喷射出的血液較少，造成該次心跳收縮壓 較低。有些時候，心跳之間的時間間隔太短，造成後次 心跳的收縮壓過低，以致診脈無法診到該次脈博。這種 無法在動脈系統中診得脈博的心室收縮，所造成現象的 即為所謂的「脈搏短絀」。這在心房顫動中是相當常見 的。在脈搏短絀的狀況下，心室中心跳模式雖不規則， 但由於心跳之間最短的間隔，無法由脈博測得，故會造 成脈博模式中的不規則情況較少。因些，藉由分析心室 跳動的時間間隔判定是否存在心房顫動的方法，若應用 於脈博上時，未必會同樣有效。Fibrillation at Rest and During Exercise· Circulation 41: 783, 1970). The term "irregular" as used in this application refers to a disorderly heartbeat pattern that is found only in atrial fibrillation. Atrial fibrillation is one of the most common types of medical care required for arrhythmia. Atrial fibrillation can be caused by a variety of cardiac conditions, such as angina, myocardial infarction, and hypertension. These conditions can cause the atrium to be pulled or injured, and thus cause irregularities in the heart system. Atrial fibrillation may also be associated with lung problems or dysthymia, and has a severe onset/pathogenicity and possibly fatality. Anyone, young and old, male or female, including visually impaired/visual blind people, may have atrial fibrillation. The occurrence of atrial fibrillation may be intermittent or habitual. The most serious arrhythmia in the atrium is the formation of a blood clot in the left atrium that may cause a stroke. However, many people with atrial fibrillation are not aware of their abnormal heart rhythm. Some people in the medical profession advocate advocating self-testing to detect possible atrial fibrillation. However, the disclosure of this document is generally limited to indicating how to self-detect the pulse of the individual and to make additional judgments in conjunction with descriptive information. 'α uses pulse to detect the cause of atrial fibrillation because the pulse is usually consistent with the heartbeat. The contraction of the left ventricle emits blood to the aorta, and the resulting pressure wave is the pulse detected in the arterial system. However, when atrial fibrillation occurs, there is an irregular change in the time between heartbeats. 1. When the time interval between heartbeats is long, the blood can be injected into the ventricle for a long time. Because of the heartbeat after this long interval, the ventricle will eject more blood. A large amount of blood enters the active vein, causing the heartbeat systolic pressure to be higher. Conversely, when the time interval between heartbeats is short, the ventricle has only a short time to inject blood, because after this short time interval, the heartbeat of 6 200803792, less blood is ejected, causing the The secondary heartbeat systolic pressure is lower. In some cases, the time interval between heartbeats is too short, causing the systolic pressure of the subsequent heartbeat to be too low, so that the diagnosis cannot be diagnosed. This phenomenon of ventricular contraction, which cannot be diagnosed in the arterial system, is caused by the so-called "pulse shortness". This is quite common in atrial fibrillation. In the case of short pulse, the ventricular center hopping mode is irregular, but because of the shortest interval between heartbeats, it cannot be measured by pulse, so there will be less irregularities in the pulse mode. Therefore, the method of determining whether there is atrial fibrillation by analyzing the time interval of ventricular beats may not be equally effective when applied to the pulse.
Bert K. Bootsma, Adriann J. Hoelen, Jan Strackee and Frits L.Meijler 等人所作，標題為 Analysis of R-R Intervals in Patients with Atrial Fibrillation at Rest and During Exercise，Circulation，Volume XLI，May 1970 的 文章，描述使用心電圖分析心室收縮間的時間間隔。該 篇文章中，對標準差除以心室跳動的時間間隔之平均 值，在正常狀態及心房顫動的情形下做評估。該篇文章 發現，使用該公式可精確無誤地分辨出心房顫動及正常 竇性心律。然而，此係根據心電圖判定心室收縮，無法 應用到脈博間隔上。 由於心房顫動的脈搏短础現象，由心電圖的心室收 縮所判定的結果，無法應用到藉由分析脈博判定的時間 間隔。尤有甚者，脈搏短絀的程度，是根據用以判定脈 搏的方法而定。若一方法僅偵測具有高收縮壓的脈博， 則其測得之脈博數將少於以另一靈敏度較高的方法所 測得者。越靈敏的技術，將偵測到越多的脈博數，但也 可能造成更多的誤判值。 200803792 舉例而g，使用具有手指探頭及光源和光電债測器 的光體積描記器時，若將儀器的靈敏度調高，則即便^ 最輕微的手指挪動，也會被偵測成脈博。儀器的靈敏度 設在最高時，正常竇性心律會因為手指挪動產生的雜 訊，而被偵測為不規則脈博。靈敏度設在最高時，^儀 器並不適合家用設定用於偵測心房顫動。但靈敏度^定 在最低，，又只有極少數脈博會被偵測到。因此了任何 儀器或是演算法，若想藉由脈博來偵測心房顫動，便必 須特別根據偵測心房顫動的目的做設計。 除此之外，尚有多種常見的心律異常，是不會增加 中風的風險的。舉例而言，早發性心房收縮或早^二心 至收縮，就可在許多人身上發現，即使沒有心臟狀況的 人也一樣。這些是間歇發生的，但卻比心房顫動更常 見，且一般不需要治療。因此，設計用以偵測心房顫動 的儀器，應戎包含一决异法，可將偵測到的早發性心博 剔除於不規則心律之外。若設計用以偵測心房顫動的儀 器’無法剔除早發性心博’决判的次數將會太高，儀器 的實用性將大大受限。時常使用該儀器偵測無徵兆的心 房顫動的人，會因為大部份的異常讀值是來自早發性心 博而非心房顫動，而很快捨棄該儀器不用。 美國專利第6,485,429號’描述使用振盪式血壓計偵 測心律不整之方法及設備。該專利揭露一種方法，用以 偵測多種心律異常，包括上心室早發性收縮、心室早發 性收縮、心房顫動、陣發性上心性頻脈、節律過速及心 室節律過缓。該專利之發明人使用該專利商品化的商 品，所做的一份研究中發現，該儀器僅偵測到有心房顫 動的病人之66.6%，但可偵測到85·7%有早發性心室收 8 200803792 縮 (Forstner K W, American Society of Hypertension 16th Annual Meeting 2003, page 25)。早發性心室收縮比 心房顫動還常見得多。因此，當意圖僅要偵測心房顫動 時，若一個儀器偵測到早發性心室收縮的比例非常高， 但偵測到心房顫動的比例卻相對低得多，該儀器的用處 顯然不大。 其他可偵測心律異常的專利，若拿來偵測心房顫 動’同樣會產生極高的誤判比例。美國專利第6,〇95,984 號描述一實施例（1-2-1部份），超過〇·5%的脈博變異都 被視為異常。最常見的心律異常，即竇性心律不整，若 依其疋義（Braunwald，E· Heart Disease A textbook of Cardiovascular Medicine 1992, P 674)，心跳變異率即超 過10%。美國專利第6,095,984號之演算法，會造成多 種來源錯誤讀值，且其並非特別設計以專門偵測心房顫 動的脈搏，因此該專利之方法及設備無法偵測心房顫 動’且不適於家用監測心房顫動。 藉由脈博間隔的不規則性偵測心房顫動的演算法， 應該要設計為可減少早發性心博的影響。 '減少^性心 博的影響的—個方法，係為限定用以判定脈博間隔的不 ，則性所使用的脈博數。舉例而言，若早發性心博平均 每二十次脈博發生-次，則限定僅分析十次脈博，便可 減少早發性心博在此分析期間發生的可能性。此方法已 被用於一訴訟案並發表於Wiesd等人所作之伙 =39-643 (2〇〇4)。本方法在此研究中用於分析名 人，其中54名發現有心房顫動。該研究使用一 ΪίΪ法，可計算—不規則指數，即為將脈博間的時間 間隔除以脈博_時間間隔之平均值所得之標準差，並 9 200803792 僅分析該自動振盪式血壓計所記錄的最後十筆脈博。所 有=錄之不規則指數若超過〇·〇6，卿定為不規則。本 研究發，有心房顫動的病人皆被測得，而16%沒 有心房顫動的病人亦測出不關顫動之靈敏 度為1〇〇/°且特異度為84%)。相較於Forstner所用的方 法，本方法在偵測心房顫動的比率上有大幅的進步。 雖然上述限定僅分析最後十次脈博的方法之靈敏度 表，絶佳，但在特異度方面還有進步的空間。早發性心 博是心律異常巾，—種常見的會降低不規職數之特異 度的症狀。例如，—個正常心博之前發生的心室早發性 心博，會在心博後產生一個停頓。早發性心博通常會產 正常心博低的脈壓。這個脈壓較低的早發性心博， 苇苇會被血壓計略過而不被記錄。因此早發性心博會造 ，一，停頓’其長度等同於兩次正常心跳間的時間^ 隔。若一名病人每分鐘心跳率是6〇下，正常心跳間停 頓^間隔即為-秒鐘。而血壓計臂帶量測早發性心室心 博日守，會出現兩秒鐘的間隔。九次一秒的脈博時間間隔 ^-次由早發性心室心博造成的兩秒的間隔，其不規則 ，數為0.29 ’遠超過驗〇 G6。若早發性心博在一次正 苇^博後0.5心發生，且被血壓計偵測得，會形成一個 長間隔接著-個短間隔。八個^少鐘的間隔、一個〇·5 秒的間隔及-個1·5秒的間隔，不規則指數會是〇 24, 仍然相當異常。 命頒與Josep^Wiesel之美國第6 519 49〇號專利，揭 路一種方法，藉由刪除比平均值短的脈博間隔，減少 f性心博的影響力。該方法某種程度上改進了由自動血 壓計偵測4軸㈣異度。“，若有演算法可辨視 200803792 出早奄性心博的I生’並删姊 較長間隔’可更-步減少誤判： 2幸乂紐及 繁，每間隔-次就會早發性心博發生頻 ^不是比平均時間間隔:樣=以 除，由於此模式非為典型的心房顫動，因此會】 則心律。心、房顫動的時間間隔會在平均值附近不斷Ϊ規 動，因此至少會有少數個接近平均值的時 = 此演算法剔除。 4不會破 偶爾早發性心博會頻繁發生且伴隨變動的間隔。兴 例來說，若正常心博的時間間隔是一秒鐘，一個病人1 血壓計記錄的一段時間内，可能會發生分別〇·5秒、〇 Μ 秒和0·85秒的早發性心博。若這些間隔因超過閾值而被 剔除，仍可能因其他間隔存在而造成很高的不規則指 數。降低頻繁早發性心博病人的誤判值，可使用另—演 算法。在心房顫動的情況下，不會存在正常心博，且^ 典型的一次血壓量測之10至40秒過程中，亦不可能备 有過半的時間間隔是幾乎一致的。另一方面，即使病人 有頻繁的早發性心博，通常仍有過半數的心博是正常心 博。因此，若一次血壓量測中，發現大多數的時間間Ρ 都幾乎一致，則極有可能不是心房顫動。 目前需要的，是可家用的監測方法及設備，以侦測 可能存在的心房顫動，並向使用者溝通此情況，以馨生 提醒該使用者向專業醫師求教，以進一步進行檢測及二 療。 。 目前需要的，是一種方法，町分辨心房顫動及正常 11 200803792 的脈博模式和常/… 竇性心律不整，/Bert K. Bootsma, Adriann J. Hoelen, Jan Strackee and Frits L. Meijler et al., entitled Analysis of RR Intervals in Patients with Atrial Fibrillation at Rest and During Exercise, Circulation, Volume XLI, May 1970, describing the use The ECG analyzes the time interval between ventricular contractions. In this article, the mean value of the standard deviation divided by the interval of ventricular beats was evaluated in the normal state and atrial fibrillation. This article found that using this formula can accurately distinguish between atrial fibrillation and normal sinus rhythm. However, this is based on an electrocardiogram to determine ventricular contraction and cannot be applied to the pulse interval. Due to the short-term pulse phenomenon of atrial fibrillation, the results determined by the ventricular contraction of the electrocardiogram cannot be applied to the time interval determined by analyzing the pulse. In particular, the degree of shortness of the pulse is determined by the method used to determine the pulse. If a method only detects a pulse with a high systolic pressure, then the number of pulses measured will be less than that measured by another method with higher sensitivity. The more sensitive the technology, the more pulse counts will be detected, but it may also cause more false positives. 200803792 For example, when using a photoplethysmograph with a finger probe and a light source and a photoelectric detector, if the sensitivity of the instrument is raised, even the slightest finger movement will be detected as a pulse. When the sensitivity of the instrument is set to the highest, the normal sinus rhythm is detected as an irregular pulse due to the noise generated by the finger movement. When the sensitivity is set to the highest, the instrument is not suitable for home setting to detect atrial fibrillation. However, the sensitivity is fixed at the lowest level, and only a few pulse stations are detected. Therefore, any instrument or algorithm that wants to detect atrial fibrillation by pulse must be designed specifically for the purpose of detecting atrial fibrillation. In addition, there are many common heart rhythm abnormalities that do not increase the risk of stroke. For example, early-onset atrial contractions, early from the second heart to contraction, can be found in many people, even in people without heart conditions. These occur intermittently, but are more common than atrial fibrillation and generally do not require treatment. Therefore, instruments designed to detect atrial fibrillation should include a different method to exclude detected early onset heartbeats from irregular rhythms. If the instrument designed to detect atrial fibrillation is not able to eliminate the early onset of heartbeat, the number of judgments will be too high, and the practicality of the instrument will be greatly limited. People who often use the instrument to detect unexplained atrial fibrillation will quickly discard the instrument because most of the abnormal readings are from early onset heartbeat rather than atrial fibrillation. U.S. Patent No. 6,485,429 describes a method and apparatus for detecting arrhythmia using an oscillating sphygmomanometer. This patent discloses a method for detecting a variety of heart rhythm abnormalities, including early ventricular contractions, early ventricular contractions, atrial fibrillation, paroxysmal upper heart rate, hyperphagy, and ventricular arrhythmia. The inventor of the patent used the commercialized product of the patent, and found that the instrument only detected 66.6% of patients with atrial fibrillation, but detected 85.7% of early onset. The ventricle received 8 200803792 (Forstner KW, American Society of Hypertension 16th Annual Meeting 2003, page 25). Early onset ventricular contraction is much more common than atrial fibrillation. Therefore, when the intention is to detect only atrial fibrillation, if a device detects a very high proportion of early-onset ventricular contractions, but the proportion of atrial fibrillation detected is relatively low, the instrument is of little use. Other patents that detect abnormal heart rhythms, if used to detect atrial fibrillation, also produce a very high percentage of false positives. U.S. Patent No. 6, 〇95, 984 describes an embodiment (parts 1-2-1), and a pulse variation exceeding 〇·5% is regarded as an abnormality. The most common abnormal heart rhythm, sinus arrhythmia, is more than 10% in heart rate variability if it is based on Braunwald (E. Heart Disease A textbook of Cardiovascular Medicine 1992, P 674). The algorithm of U.S. Patent No. 6,095,984 causes multiple sources of erroneous readings, and is not specifically designed to specifically detect the pulse of atrial fibrillation, so the method and apparatus of the patent cannot detect atrial fibrillation' and is not suitable for home monitoring of the atrium. Trembling. The algorithm for detecting atrial fibrillation by irregularities in the pulse interval should be designed to reduce the effects of early onset heartbeat. The method of reducing the influence of the heartbeat is to limit the number of pulses used to determine the interval of the pulse. For example, if the onset of early onset of heartbeat occurs every 20 times, then limiting the analysis to only ten beats can reduce the likelihood that early onset heartbeat will occur during this analysis. This method has been used in a lawsuit and published in Wiesd et al. =39-643 (2〇〇4). This method was used to analyze celebrities in this study, of which 54 were found to have atrial fibrillation. The study uses a ΪίΪ method to calculate the irregularity index, which is the standard deviation obtained by dividing the time interval between pulse waves by the average of the pulse-time interval, and 9 200803792 analyzes only the automatic oscillating sphygmomanometer The last ten strokes recorded. If all the recorded irregularities exceed 〇·〇6, the clerk is irregular. In this study, patients with atrial fibrillation were measured, and 16% of patients without atrial fibrillation also measured a sensitivity of 1〇〇/° and a specificity of 84%. Compared to the method used by Forstner, this method has made significant progress in detecting the rate of atrial fibrillation. Although the above limitation only analyzes the sensitivity table of the last ten pulse methods, it is excellent, but there is room for improvement in terms of specificity. Early onset heart is an abnormal heart rhythm, a common symptom that reduces the specificity of irregularities. For example, a premature ventricular heartbeat that occurs before a normal heartbeat will cause a pause after the heartbeat. Early onset heartbeat usually produces a normal heartbeat low pulse pressure. This early-onset heartbeat with low pulse pressure will be skipped by the sphygmomanometer and not recorded. Therefore, the early onset of heartbeat will make one, pause, and its length is equal to the time between two normal heartbeats. If a patient's heart rate per minute is 6 ,, the interval between normal heartbeats is - seconds. The sphygmomanometer arm band measures the early onset ventricular heartbeat, and there will be a two-second interval. Nine times a second pulse interval ^- times two-second interval caused by early onset ventricular heartbeat, the irregularity, the number is 0.29 ' far more than the test G6. If the early onset heartbeat occurs at 0.5 heart after a sputum, and is detected by the sphygmomanometer, a long interval followed by a short interval will be formed. The interval of eight ^ few clocks, the interval of one 〇 · 5 seconds, and the interval of - 1.5 seconds, the irregular index will be 〇 24, still quite abnormal. The US patent No. 6 519 49 〇, issued by Josep^Wiesel, devised a method to reduce the influence of f-heartbeat by deleting the pulse interval shorter than the average. This method improves the 4-axis (four) dissimilarity detected by the automatic blood pressure meter to some extent. "If there is an algorithm that can discern 200803792 out of the early heart of the heart of the I' and delete the longer interval' can be more step-by-step reduction of misjudgment: 2 fortunately new and complicated, every interval - times will be early on The heartbeat frequency is not the average time interval: sample = to divide, because this mode is not typical atrial fibrillation, so it will be] heart rhythm. The time interval between heart and atrial fibrillation will continue to be circulated around the average, so At least a few will be close to the average = this algorithm is removed. 4 will not break the interval of occasional early onset of frequent heartbeats and accompanying changes. For example, if the normal heartbeat interval is one second Clock, a period of time recorded by a patient 1 sphygmomanometer may occur in early onset heartbeats of 〇·5 seconds, 〇Μ seconds, and 0·85 seconds. If these intervals are removed due to exceeding the threshold, it may still be due to Other intervals exist to cause a high irregular index. To reduce the false positive value of frequent early onset heartbeat patients, another algorithm can be used. In the case of atrial fibrillation, there is no normal heartbeat, and ^ typical once Blood pressure measurement during 10 to 40 seconds It is also impossible to have more than half of the time interval is almost the same. On the other hand, even if the patient has frequent early onset heartbeat, usually more than half of the heartbeats are normal heartbeats. Therefore, if a blood pressure measurement is used It is found that most of the time is almost the same, it is very likely that it is not atrial fibrillation. What is needed is a home monitoring method and equipment to detect possible atrial fibrillation and communicate this to the user. Xinsheng reminded the user to ask a professional doctor for further testing and second treatment. What is needed now is a method to distinguish atrial fibrillation and normal 11 200803792 pulse mode and often /... sinus arrhythmia, /
目萷另需要的，疋一種方法及設備，用 間内偵測不規則的脈博節律並儲存該資訊， 的脈博節律做比較。 Λα 韦’例如 心博。 用以於一段時 ，以供和日後 目前另需要的，S-種非侵入性的、相對上較 的方法及設備，其可偵測不規則的脈博節律以#測= 頭動’且適用於所有年齡、並可供聽礙/視礙人士使用， 且使用上相對簡便易用。 目前另需要的，是一種監測方法及設備，其可偵測 不規則脈搏的存在，且可顯示並儲#:0一預定時間間 隔内不規則脈搏的數目；及ii}選定的間隔内，脈博間的 持續期間。 另有一需要，係為一種監測方法及設備，其可根據 針對選定的脈博資料進行演算或啟發操作，以判定一脈 博模式是否為不規則。 目前需要的，是一種方法及設備，其使用一血壓計 偵測不規則之脈博模式，並藉此偵測心房顫動的存在。 目剷需要的，是一種方法及設備，用以偵測心房顫 ，的存在，其係使用體積描記器如具有光源及光電探測 器之手指探頭，以偵測不規則之脈博模式。 【發明内容】 本發明提供一種方法及設備，其可藉由以下幾點， 判定心房顫動之存在··⑴於一段短時間内偵測脈博間 隔’以判定該間隔是否形成一雜亂、不規則的模式；（ii) 判疋遠脈博間隔是否顯示可能的心房顫動，及接著,·（出） 與使用者溝通該資訊，使其可向專業醫師求教，以進一 12 200803792 =二檢測及治療。本發明亦提供—種方法及設備，其 、了段時間内偵測不規則的脈博節律並儲存該資 多個Z與日後的脈博節律進行轉。本發明亦可偵測 夕们^之模式’並將不同時段之模式進行比較。 由心目,丨1H步提供—種非侵人性之方法及設備，藉 儲：並：規ϋ，脈博模式，以偵測心房顫動。本發明可 之數曰、不貝汛，例如一段預定時間間隔内不規則脈博 亦可㈣i選定的間隔内，脈博間的持續顧。本發明 關資料進行演算或啟發操作，以判定不 規則脈博模式是否存在。 使用：手2用:可充氣式臂帶，將其纏繞於 ’可於臂帶進㈣氣或穩定充壓 帶洩氣時偵測得脈博間隔，少於最低 七=閣值’本發明允許剔除該至少-或多個脈博 比臨ΐ:段脈博間隔之百分比，超過-百分 異常脈博間tiC複數個脈博間隔變動之 邮I 買性心律，偵測正常心律。 得。;式肢體間透光之變動測 诱#之2: 會變穿過肢體-部位之光線。該 定。又σ脈博—致’故脈博間的時間間隔可依此判 之』^巾吏用其他體積描記儀器、量測每次脈博 、之超音波儀器、偵測動脈内血流之超音波都 200803792 卜勒儀器、或對動脈局部加壓之 、 在。使用上述任—技術，皆可判宏=捕1偵蜊脈博的存 本發明之監测方法，包括偵專間的時間間隔。 個或多個預定因素分析該不規則：：規，，搏、根據一 通比資訊，透過例如螢幕顯示、蚩，、及舁謗使用者溝 覺、振動或其他可感知之方式面列印、響音、或聽 本發明運用演算或啟發科技，以 否為可能的心房顫動存在的徵兆。 不規則脈搏是 本發明之其他特徵及優點， 奶 下列之詳細說明。 、> 心相關圖式詳述於 【實施方式】 本發明之一實施例中，使用以_ 、 偵測得之脈博。該可充氣式臂帶;=式臂帶儀器 備，其以振盪或聽診裝置量測血壓了w為―已知的設 將該可充氣式臂帶儀器繞詈_ 臂，並充氣至高於收縮壓。於臂帶护，佔例如手 停止臂帶的錢使臂帶處於_固定氣。如此=脈， 5力穩定時監測脈博。傳送每次脈博的時間至二：：帶 裔。該處理器中含有指令，可執行如上所述之方ς ，外，該處理器儲存每次脈博的時間、脈博間的 1其他，至記憶财。該記憶體可包含ram ^ 他裝置^憶體，或包含硬碟、軟碟或其他裝置記憶體二 該處理态包含一微處理器及—專用積體電路 ~ (applications specific integrated drcu化 asic)，一可程 化，輯陣列(pr〇grammable l〇gic array; pLA)或精簡指令 本日日片(reduced instruction set chip; RISC) 〇 該處理器根據脈博間隔判定脈博的模式是否指向 14 200803792 心房顫動。處理器接著傳送較結果至—印表機 振器及/或-聽覺產生，。這些儀器可顯示該脈 博杈式係為規則、不規則、為可能的心 絡醫師，亦可顯示其他資訊，例如脈博數Y $應連 ”>本實施例中使用振盪法偵測脈博及血壓的自動血 壓计，已發展70成。為考量在較高臂帶壓力時之脈博短 絀、及正常心跳時收縮壓可能受呼吸變異的影響，並 少早發性心博的影響，發展出—套演算法，僅分析臂帶 沒壓時測狀最後十纽博。計算後十:欠脈博的平 均和標準差，並判定標準差除以平均所得之商數。 將所得之商數與閾值0·06相較。若該商數大於該閾 值、，則判定該脈博的模式為不規則。如前所述，此方法 已被用於一訴訟案並發表於Wiesel等人所作之pace， 27:639-643 (2004)，用於450名門診病人，其中54名發 現有心房顫動。以本方法之壓讀值彳貞測心房顏動， 靈敏度達100%且特異度達84〇/〇。 該儀器記錄的所有脈博時間間隔，皆用以判定一平 均日守間間隔。若有發現不規則的讀值，可用兩方法中之 一者以增進心房顫動之特異度（見第3圖及第4圖）。 於本發明（第1圖）之第一較佳方法中，使用所有該 自動血壓計記錄之時間間隔，用以判定一平均時間間隔 (見第5圖）。凡是超過平均值25%的所有間隔、或低於 ^均值25%的’ 一率予以剔除（見第6圖）。計算剩餘的 日守間間隔’取得新的平均值和標準差。計算新標準差和 新平均值的比例，算得一新的不規則指數。若此不規則 指少於0.066，則推定心律規則。若不規則指數等於或 大於0.066，則推定心律不規則且可能係為心房顫動。 15 200803792 若剔除高或低於臨界值之時間間隔後，已無剩餘的時間 間隔，此模式與心房顫動不一致，而是典型的每兩次發 生一次的早發性心博，則此心律為規則。第丨圖為本處 所述方法之流程示意圖。將此演算法運用在之前所述研 究(Wiesel et al，PACE，27:639-643 (2004))中 247 筆不規 則的讀值上，所有有心房顫動的病人仍偵測為不規則心 律，但之前測得係不規則心律但非為心房顫動之病人， 有大約一半被重新歸類為規則心律。此方法增進特異度 到達92%，同時靈敏度仍維持在100%。 於本發明之第二較佳方法中（第2圖），儀器中記錄 的所有脈博時間間隔，係由最短間隔排列至最長間隔。 明確地說，該血壓計中記錄的所有時間間隔，係由最短 間隔排列至最長間隔（見第7圖及第8圖）。計算由最短 的間隔開始的頭三個時間間隔之標準差（見第6圖）。標 準差對平均數之比率，即為該三筆間隔的不規則指數。 若不規則指數少於大約〇·〇1，表示這三筆間隔幾乎相 同。接著以最短間隔之後的三筆脈博計算其不規則指 數。以此類推，直到計算出最長三筆時間間隔之不規則 指數。若有50%或超過50%的不規則指數少於大約 0.01 ’則該心律為規則心律（見第9圖之不規則心律）。 將此演算法運用在之前所述研究中247筆不規則的讀值 上，所有有心房顫動的病人仍偵測為不規則心律，但之 前測得係不規則之讀值，有大約三分之二被重新歸類為 規則心律。此方法之特異度為94%而靈敏度仍維持在 100%。第2圖為本處所述方法之流程示意圖。 本發明另有一實施例，其中脈博係藉由光線透過身 體之肢體如手指之變化而監測。光線由一光源射出，透 16 200803792 過受測者的手指或其他肢體，並由一偵測器接收。該偵 測器藉由透過肢體的光線變化，偵測脈博。此偵測器可 包含習知的脈博量測儀器。偵測器將每次量得之脈博時 間，傳送至一處理器。該處理器執行上述操作程序。可 使用光源偵測器之靈敏度調節器，以習知方法調節偵測 器之靈敏度，以偵測來自光源之光線。偵測脈博時，將 手指或其他肢體置於光源及偵測器之間，啟動電源發射 光線，以透過手指到達偵測器。 本發明之優點為提供一種方法及設備，可藉由複數 個心跳、脈博或其他量測，簡易地偵測不規則心跳之存 在。 進一步的優點為，本發明可區分出心房顫動心律、 及含有正常及異常心律的非心房顫動心律。 再進一步的優點，為本發明提供相對上簡單且非侵 入式之家用監測。 本發明包含一種設備及方法，其中包括用以將脈博 間隔依最長至最短或最短至長之順序儲存之裝置；計算 前η個時間間隔之不規則指數I.sub.l之裝置，其中該不 規則指數I · sub · 1係為該前η個時間間隔之平均值及標準 差之商數；計算由第二個時間間隔起算之η次時間間隔 的不規則指數I.sub.2之裝置，其中該不規則指數I.sub.2 係為由第二個時間間隔起算之η次時間間隔之平均值及 標準差之商數；續繼計算不規則指數I.sub.m之裝置， 其中m之範圍係從1到N-(n-l)，且η為脈博間隔的總 數；根據該不規則指數 I.sub.l，I.sub.2, ··· I.sub.N-(n-l) 中有多少百分比，即P，少於一閾值T，判定可能的心 房顫動，若Ρ超過一臨界值P.sub.cutoff，則該心律顯示 17 200803792 沒有心房顫動，且若少於或等於一臨界值P.sub.cutoff， 則該心律係為心房顫動。 本發明雖已以上述之特定實施例敘明，但熟習該技 藝者應可據此輕易作出改變、調整、及其他使用。本發 明較佳係以如下所附之申請專利範圍為範圍，而非以本 說明書所揭露之部份為限。 18 200803792 【圖式簡單說明】 第1圖為本發明第一個方法中，用以判定可能的心 房顫動的演算法（演算法I)之流程圖。 第2圖為本發明第二個方法中，用以判定可能的心 房顫動的演算法（演算法II)之流程圖。 第3圖為顯示規則的竇性心律之脈博時間間隔之圖 表。 第4圖為顯示心房顫動之脈博時間間隔之圖表。 第5圖為顯示具有早發性心博的竇性心律之脈博時 間間隔之圖表，其係於應用方法I之前，該心律記錄為 較長的時間間隔。 第6圖為顯示圖表5應用方法I之後，所得之脈博 時間間隔之圖表。 第7圖為顯示具有頻發及變化的早發性心博的竇性 心律之脈博時間間隔之圖表，該心律記錄為較長及較短 的時間間隔。 第8圖為顯示第7圖之心律依方法II儲存後，所得 之時間間隔之圖表。 第9圖顯示依方法II儲存後之心房顫動的脈博時間 間隔之圖表。 【主要元件符號說明】 19For other purposes, a method and device are used to compare the pulse rhythm of the irregular pulse cadence and store the information. Λα 韦', for example, Xinbo. For a period of time, for the current and future needs, S-type non-invasive, relatively high-level methods and equipment, which can detect irregular pulse rhythm with #测=头动' and apply It is available to all ages and is accessible to people with impaired/disordered access and is relatively easy to use. What is needed at present is a monitoring method and device that can detect the presence of an irregular pulse and can display and store the number of irregular pulses within a predetermined time interval of "0"; and ii) within the selected interval, the pulse The duration of the blog. Another need is a monitoring method and apparatus that can perform a calculation or heuristic based on selected pulse data to determine whether a pulse mode is irregular. What is needed is a method and apparatus that uses a sphygmomanometer to detect irregular pulse patterns and thereby detect the presence of atrial fibrillation. What is needed for the eye shovel is a method and apparatus for detecting the presence of atrial fibrillation using a plethysmograph such as a finger probe with a light source and a photodetector to detect an irregular pulse pattern. SUMMARY OF THE INVENTION The present invention provides a method and apparatus for determining the presence of atrial fibrillation by the following points: (1) detecting a pulse interval in a short period of time to determine whether the interval forms a disorder or irregularity. (ii) determine whether the far-end pulse interval shows possible atrial fibrillation, and then, (out) communicate the information to the user so that they can consult a professional physician to enter a 12 200803792 = two detection and treatment . The present invention also provides a method and apparatus for detecting irregular pulse rhythms over a period of time and storing the plurality of Zs and future pulse rhythms for rotation. The present invention can also detect the mode of the ’ ^ ^ and compare the patterns of different time periods. From the mind, 丨1H step provides a non-invasive method and equipment, borrowing: and: regulation, pulse mode, to detect atrial fibrillation. The present invention can be used for a number of 曰, 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 汛 不 不 不 不 不 不 不 不 不 不 不 不 不The data of the present invention is subjected to calculation or heuristic operation to determine whether or not the irregular pulse mode exists. Use: Hand 2: Inflatable arm band, which is wrapped around 'can detect the pulse interval when the arm is brought into the (4) gas or the stable charging belt is deflated, less than the lowest seven = the value of the 'the invention allows to eliminate The at least one or more pulse-comparisons: the percentage of the interval of the pulse-pulse interval, the excess-percent abnormality, the tiC, the number of pulse intervals, the change of the postal I buy rhythm, detecting the normal heart rhythm. Got it. Change of light transmission between limbs #2: It will change the light through the limb-part. The decision. σ脉博—the time interval between the sigmoids can be judged according to this. ^When using other plethysmographs, measuring each pulse, the ultrasonic instrument, and detecting the ultrasound flow in the arteries. Both 200803792 Buhler instruments, or local compression of the arteries. Using any of the above-mentioned techniques, it is possible to judge the monitoring method of the present invention, including the time interval between the investigations. One or more predetermined factors analyze the irregularity::,, according to the information, through the screen display, 蚩, and 舁谤 user's gully, vibration or other perceptible way to print, ring Tone, or to listen to the invention using calculus or inspirational technology, to see if there is a sign of possible atrial fibrillation. Irregular pulse is another feature and advantage of the present invention, the following detailed description of the milk. <Heart-related diagrams are described in detail. [Embodiment] In one embodiment of the present invention, a pulse detected by _ is used. The inflatable armband; = armband instrument, which measures blood pressure by shaking or auscultation device w is "known to set the inflatable armband instrument around the arm" and inflated to a higher than systolic pressure . In the arm guard, for example, the hand stops the arm belt and the arm belt is in the _ fixed gas. So = pulse, 5 pulse monitoring when monitoring the pulse. Send the time of each pulse to two:: bring people. The processor contains instructions that can execute the above-mentioned method. In addition, the processor stores the time of each pulse, and the other between the pulse and the memory. The memory may include a ram ^ device, or a hard disk, a floppy disk or other device memory. The processing state includes a microprocessor and a dedicated integrated circuit (applications specific integrated drcu asic). A pr〇grammable l〇gic array (pLA) or a reduced instruction set chip (RISC), the processor determines whether the mode of the pulse is directed to 14 200803792 atrium according to the pulse interval Trembling. The processor then transmits the resulting result to the printer vibrator and/or - audible generation. These instruments can display the pulse-type system as a regular, irregular, possible cardiologist, and can display other information, such as the pulse number Y $ should be connected.> In this embodiment, the oscillation method is used to detect the pulse. The automatic blood pressure monitor with blood pressure has been developed by 70%. In order to consider the short pulse of the high arm band pressure and the normal heartbeat, the systolic blood pressure may be affected by the respiratory variability, and the effect of less early onset heartbeat Developed a set-up algorithm that only analyzes the last ten Newborns when the armband is not pressed. After calculating the tenth: the average and standard deviation of the pulse, and the standard deviation divided by the average quotient. The quotient is compared with a threshold of 0·06. If the quotient is greater than the threshold, then the mode of the pulse is determined to be irregular. As described above, this method has been used in a lawsuit and published in Wiesel et al. Pace, 27:639-643 (2004), for 450 outpatients, 54 of whom were found to have atrial fibrillation. The atrial pressure was measured by the pressure reading of this method with a sensitivity of 100% and specificity. 84〇/〇. All pulse time intervals recorded by the instrument are used to judge An average daily guard interval. If an irregular reading is found, one of the two methods can be used to increase the specificity of atrial fibrillation (see Figures 3 and 4). In the present invention (Fig. 1) In a first preferred method, all of the intervals recorded by the automatic sphygmomanometer are used to determine an average time interval (see Figure 5). All intervals above 25% of the average, or 25% below the mean 'The rate is eliminated (see Figure 6). Calculate the remaining daily inter-spacing interval' to obtain a new average and standard deviation. Calculate the ratio of the new standard deviation to the new average, and calculate a new irregular index. If the irregularity is less than 0.066, the rhythm rule is presumed. If the irregularity index is equal to or greater than 0.066, the heart rhythm is estimated to be irregular and may be atrial fibrillation. 15 200803792 If the time interval between high or lower than the critical value is removed, there is no The remaining time interval, which is inconsistent with atrial fibrillation, is a typical early-onset heartbeat that occurs twice every two times. This heart rhythm is a rule. The figure is a schematic flow chart of the method described in this section. Using 247 irregular readings in the previously described study (Wiesel et al, PACE, 27:639-643 (2004)), all patients with atrial fibrillation were still detected as irregular rhythms, but previously measured About half of patients with irregular heart rhythm but not atrial fibrillation are reclassified as regular rhythm. This method increases the specificity to 92% while maintaining sensitivity at 100%. In the second preferred method of the present invention (Fig. 2), all pulse time intervals recorded in the instrument are arranged from the shortest interval to the longest interval. Specifically, all time intervals recorded in the sphygmomanometer are arranged from the shortest interval to the longest interval (see section Figure 7 and Figure 8. Calculate the standard deviation of the first three time intervals starting from the shortest interval (see Figure 6). The ratio of the standard deviation to the mean is the irregular index of the three intervals. If the irregularity index is less than approximately 〇·〇1, it means that the three intervals are almost the same. The irregular index is then calculated with the three strokes after the shortest interval. And so on, until the irregular index of the longest three time intervals is calculated. If 50% or more than 50% of the irregularity index is less than about 0.01', the heart rhythm is a regular heart rhythm (see irregular heart rhythm of Fig. 9). Applying this algorithm to the 247 irregular readings in the previous study, all patients with atrial fibrillation still detected irregular heart rhythm, but the previously measured irregular readings were about three-thirds. The second was reclassified as a regular heart rhythm. The specificity of this method is 94% and the sensitivity is still maintained at 100%. Figure 2 is a schematic flow diagram of the method described herein. In another embodiment of the invention, the pulse is monitored by light changes through the limbs of the body, such as fingers. The light is emitted by a light source and passes through the finger or other limb of the subject and is received by a detector. The detector detects the pulse by changing the light transmitted through the limb. The detector can include a conventional pulse measuring instrument. The detector transmits the pulse time of each measurement to a processor. The processor executes the above operational procedures. The sensitivity of the detector can be adjusted in a conventional manner using a sensitivity detector of the light source detector to detect light from the source. When detecting a pulse, place your finger or other limb between the light source and the detector to activate the power source to emit light to reach the detector through your finger. It is an advantage of the present invention to provide a method and apparatus for easily detecting the presence of irregular heartbeats by a plurality of heartbeats, pulse trains, or other measurements. A further advantage is that the present invention distinguishes between atrial fibrillation rhythm and non-atrial fibrillation rhythm containing normal and abnormal heart rhythms. Yet a further advantage provides the invention with relatively simple and non-invasive home monitoring. The present invention comprises an apparatus and method comprising means for storing pulse intervals in a sequence from longest to shortest or shortest to long; means for calculating an irregular index I.sub.l of the first n time intervals, wherein Irregular index I · sub · 1 is the quotient of the mean and standard deviation of the first n time intervals; the device for calculating the irregular index I.sub.2 of the n time interval from the second time interval Wherein the irregularity index I.sub.2 is the quotient of the average value and the standard deviation of the η time intervals from the second time interval; and the device for calculating the irregularity index I.sub.m, wherein The range of m is from 1 to N-(nl), and η is the total number of pulse intervals; according to the irregular index I.sub.l, I.sub.2, ··· I.sub.N-(nl How many percentages, ie, P, less than a threshold T, to determine possible atrial fibrillation, if Ρ exceeds a critical value of P.sub.cutoff, then the rhythm shows 17 200803792 no atrial fibrillation, and if less than or equal to one The threshold value P.sub.cutoff, then the heart rhythm is atrial fibrillation. The present invention has been described in terms of the specific embodiments described above, but those skilled in the art should be able to make changes, modifications, and other uses. The invention is preferably limited to the scope of the following appended claims, and not to the extent of the disclosure. 18 200803792 [Simple description of the diagram] Figure 1 is a flow chart of the algorithm (algorithm I) used to determine possible atrial fibrillation in the first method of the present invention. Figure 2 is a flow chart of the algorithm (algorithm II) used to determine possible atrial fibrillation in the second method of the present invention. Figure 3 is a graph showing the time interval of the sinus rhythm of the rule. Figure 4 is a graph showing the time interval of atrial fibrillation. Figure 5 is a graph showing the pulse time interval of sinus rhythm with early onset heartbeat, which is recorded before the application method I, which is recorded as a longer time interval. Figure 6 is a graph showing the resulting pulse time interval after the application of Method I in Figure 5. Figure 7 is a graph showing the time interval of pulsatile rhythm with frequent and varied early heartbeats recorded as longer and shorter intervals. Figure 8 is a graph showing the time interval obtained after the heart rhythm of Figure 7 is stored according to Method II. Figure 9 is a graph showing the pulse time interval of atrial fibrillation after storage according to Method II. [Main component symbol description] 19