TWI379662B - Diagnostic measuring device - Google Patents

Diagnostic measuring device Download PDF

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TWI379662B
TWI379662B TW98107378A TW98107378A TWI379662B TW I379662 B TWI379662 B TW I379662B TW 98107378 A TW98107378 A TW 98107378A TW 98107378 A TW98107378 A TW 98107378A TW I379662 B TWI379662 B TW I379662B
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Taiwan
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measuring instrument
radiation
diagnostic
electrode
body tissue
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TW98107378A
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Chinese (zh)
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TW201032777A (en
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Yoon Ok Kim
Ok Kyung Cho
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Flore Ingo
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Description

六、發明說明: 【發明所屬之技術領域】 本發明係關於一種醫學上測量儀器,尤指一種非侵入 性之診斷測量儀器。 【先前技術】 已知對身體組織供氧是屬於人類維持生命最重要的機 能,因此,目前血氧定量診斷方法在醫學上是非常重要的; 平常係利用所·脈搏血氧計;制而言,這類脈搏血氧 明感測||單元包含-具有兩個光源的光學測量單元,該 光源對身触織照料时㈣料和/或紅外光。此光線 在身體組_散射並且部分被錄。最储㈣當光電池 (光電二極體)形態的光感測器來偵測此散射光。光感測 3偵剩的散射光強度會_供應給受檢查身體組織的 ==亦/或缺氧的強度函數而改變。因此,可藉由脈 =氧^較。此外,習知的脈搏域計能產生容積脈波 Μ ’亦_反映在脈搏4 系統中血量變動的交藉产π, 由蓋之微血皆 里請I積域(所光電容積描記法 —近來已知不同診斷方法的综合應用,例如处 置舆生物邮測量的_血氧測量料 ^ 2測 =血管系_代謝疾病時,以便快迷;=!關 者健康狀態資訊的特殊優勢。 罪地獲得患 【發明内容】 1379662 本發明係有關一種非侵入性記錄身體組織的至少一種 生理參數的診斷測量儀器,該診斷測量儀器係由—具有至 少一用於照射待檢查身體組織之輻射源的光學測量單元及 至少一用於偵測由身體組織所散射亦/或傳送之輻射的轄 5射感測器所構成,其中該至少一輻射源與該至少一輻射咸 測器係設置於一般感測器外殼中。 本發明之目的係提供一種非侵入性測定生理參數的冷 斷測量儀器’該診斷測量儀器在技術上其功能性比先前技 術更為擴充。更具體而言’其目的在於創造一種一方面食b 10以低成本生產,而另一方面能讓使用者以舒服簡單的方式 來使用,例如也可經由自我診斷,持續監控現有疾病,以 早期識別疾病的感測器單元。 本發明係以最初提到的那種測量儀器為基礎來完成此 任務,該測量儀器用於記錄ECG信號的ECG單元包含兩個 15或兩個以上的ECG電極,其中ECG單元的至少一 ECG電 極係設置於感測器外殼之外殼表面上,該外殼内係設有一 生物電阻抗測量單元,該阻抗測量單元的至少一饋電電極 或量測電極係設置於感測器外殼之外殼表面上,使ECG電 極及饋電電極或量測電極與光學測量單元所擷取之身體組 20織部位的皮膚表面觸碰。 藉由本發明對於光學測量單元與ECG單元的整合,創 造出可提供複數個診斷測量值的小型裝置。可單獨或合併 求出這些測量值,以便快速可靠地獲得受檢查患者的健康VI. Description of the Invention: [Technical Field] The present invention relates to a medical measuring instrument, and more particularly to a non-invasive diagnostic measuring instrument. [Prior Art] It is known that oxygen supply to body tissues is the most important function of human life. Therefore, the current diagnostic method of oximetry is very important in medicine; the usual system uses the pulse oximeter; Such a pulse oximetry sensor||unit comprises - an optical measuring unit having two light sources, the light source being in contact with the woven material (four) and/or infrared light. This light is scattered in the body group and partially recorded. The most stored (four) photosensors in the form of photocells (photodiodes) to detect this scattered light. Light Sensing 3 The amount of scattered light that is detected will vary depending on the intensity function of the == and/or oxygen deficiency supplied to the examined body tissue. Therefore, it can be compared by pulse = oxygen. In addition, the conventional pulse domain meter can generate a volumetric pulse wave 亦 'also _ reflected in the pulse 4 system of blood volume changes in the production of π, the cover of the micro-blood in the I-domain (photoplethysmography - Recently, a comprehensive application of different diagnostic methods has been known, such as the treatment of 舆 邮 测量 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Obtaining the Invention [Abstract] 1379662 The present invention relates to a diagnostic measuring instrument for non-invasively recording at least one physiological parameter of body tissue, the diagnostic measuring instrument being an optical having at least one radiation source for illuminating body tissue to be examined The measuring unit and the at least one illuminating sensor for detecting radiation scattered and/or transmitted by the body tissue, wherein the at least one radiation source and the at least one radiation detector are disposed in a general sensing The object of the present invention is to provide a cold cut measuring instrument that non-invasively measures physiological parameters. The diagnostic measuring instrument is technically more functional than the prior art. Specifically, the purpose is to create a low-cost production of food b 10 on the one hand, and to allow users to use it in a comfortable and simple way on the other hand, for example, through self-diagnosis, to continuously monitor existing diseases for early identification. Sensor unit for disease. The present invention accomplishes this task on the basis of a measuring instrument of the kind originally mentioned, the measuring instrument for recording ECG signals comprising two or more ECG electrodes, wherein At least one ECG electrode of the ECG unit is disposed on a surface of the outer casing of the sensor housing, and the bioelectrical impedance measuring unit is disposed in the housing, and at least one feeding electrode or measuring electrode of the impedance measuring unit is disposed on the sensing unit. The surface of the outer casing of the casing is such that the ECG electrode and the feeding electrode or the measuring electrode are in contact with the skin surface of the body part 20 woven portion of the optical measuring unit. By the integration of the optical measuring unit and the ECG unit by the present invention, Create small devices that provide multiple diagnostic measurements. These measurements can be obtained individually or in combination for quick and reliable access to the inspection. Healthy persons

4 狀嘘資訊。此小型測量儀器可以低成本大量地預製成功能 π整的元件,然後組合成最多種不同類型的診斷設備。可 以一種非常簡單舒服的方式來進行實際測量。為了達到這 樣的效果,使感測器外殼表面與待檢查身體組織部位的皮 膚接觸,例如可藉由使患者手指放在感測器單元的外殼表 面來完成。接著藉由皮膚點觸碰該感測器單元同時進行光 學測量、ECG導出及阻抗測量。 15 本發明之感測器單元的ECG單元係藉由兩個或兩個以 上的。EC,電極來記錄ECG信號。藉此,有利於使本發明之 感測器單元的功能範圍比習知系統更為擴充。本發明之感 測器單元能一併記錄和估算脈搏血氧信號與腦信號的 較佳而。’ s又置用以估算光學測量的容積脈搏信號與 =信號在時序上的變化的估算單Μ達到此目的。此估 田單元可以是與④]里儀器形成—體的部分。也可設有與測 里,77開的估算單&,同時透過適當的數 測量信號傳送到估糞T 制,蚀笪^处&单凡。舉例而言’藉由適當的程式控 异早仏自動辨識出腳信號中的r波。然後自動 :二罝跳的時間點。此外’藉由適當的程式控制, r鮮:,辨識出容積脈搏信號中的最大值。根據容積 二二:的最大值,可以在感難單元所齡的周圍測 f占處制及得到心__觸發之脈波的時間點。最 L畏It此決疋出吻信號中的^皮與容積脈搏信號中後 、、'之間的時序間隔。此時序間隔為所謂的脈波速率 20 1379662 之度里。就某一方面而言,可根據脈波速率來描述血壓。 脈波速率減小會伴隨壓升高,㈣波料增加會引起 =降低。但是只有顯示出這樣傾向無法精確地由脈波速 決^血壓。再者’脈波料係取決於血液的密度,尤 其疋(例如主動脈)血管壁的彈性。接著,從血管的彈性 來看’可推測出可能存在有動脈硬化症。也可在此估算中 考^到心律絕對值、心律變化以及對應的心、律不整。舉例 而吕’可自動測定像竇性心律過快、竇性心律過緩、竇性 10 二跳停止及·職心鱗心律不整。也可減ECG信號 來描述-次心跳的心房收縮時間、心室收縮時間以及心室 舒張時間等。此外,還可初姆斷所取、臟電刺激信號通 道的阻斷(房室阻斷、分枝束阻斷等),甚至是血液循環障 礙或梗塞。其他在脈雜料的不規律可根據容積脈搏信 號加以偵測。 除此之外’本發_建立在發現結合不同診斷方法於 特定測量儀器中可開啟測定代謝參數之可能性的基礎上。 α根據本發明,習知的(光學)血氧測量單元不僅和ecg 單元結合,而且也和生物電阻抗測量單元結合在特定的測 量儀器中。由生物電阻抗測量單元所得到的測量信號可測 20定例如受檢查身體組織的組成。在此基礎上,較佳而言, 藉由連接至本發明之測量儀器之測量單元上適當的程式控 制估算單元就可以從血氧信號測定出組織中的微血管氧飽 和度。取決於受檢查身體組織類型而定的動脈血氧飽和度 1379662 jSa〇2)與靜脈血氧飽和度(Sv〇2)會決定出微血管(動 靜脈的)氧飽和度(St〇2)。 適用公式如下: κ * Sv〇2 + (1 _ K) * Sa〇2 = St〇2 5其中K為與組織有關的修正因子,該因子取決 織中動脈和靜脈之關容積比。此數值平均而言略低於 〇.5。根據本發明,藉由生物電阻抗測量可測定出相關组織 所決定的值,以便根據上述公式接著決定出靜脈血氧飽和 度。可使用本發明之感測器單元來測定血液循環ν,也就是 10取決於血液循環之受檢查身體組織的體積波動。根據關= 式 ’、 此量為在量測點處的代謝 V〇2 = V * (Sa〇2-Sv02) 最後可計算出局部耗氧量ν〇2 活性度量。 154 information. This small measuring instrument can be pre-fabricated in large quantities at low cost and then combined into the most diverse types of diagnostic equipment. The actual measurement can be made in a very simple and comfortable way. In order to achieve such an effect, contacting the surface of the sensor housing with the skin of the body tissue to be examined can be accomplished, for example, by placing the patient's finger on the outer surface of the sensor unit. The sensor unit is then touched by the skin point while performing optical measurements, ECG derivation, and impedance measurements. The ECG unit of the sensor unit of the present invention is composed of two or more. EC, the electrode to record the ECG signal. Thereby, it is advantageous to make the functional range of the sensor unit of the present invention more expandable than the conventional system. The sensor unit of the present invention can record and estimate the pulse oximetry signal and the brain signal together. The s s is used to estimate the optical pulse signal and the estimate of the change in the timing of the optical signal for this purpose. This estimation unit can be part of the body formed with the instrument in 4]. It can also be equipped with an estimate of 77 and an open estimate, and at the same time, through an appropriate number of measurement signals, it can be transmitted to the estimated manure T system, 笪 笪 ^ & For example, the r-wave in the foot signal is automatically recognized by the appropriate program control. Then automatically: the time point of the second jump. In addition, by appropriate program control, r fresh:, the maximum value in the volume pulse signal is identified. According to the maximum value of the volume 22:, it can be measured around the age of the difficulty unit and the time point at which the pulse of the heart __ is obtained. The most L is it, this is the timing interval between the skin and the pulse signal in the pulse signal. This timing interval is in the range of the so-called pulse rate 20 1379662. In one aspect, blood pressure can be described in terms of pulse rate. The decrease in pulse rate is accompanied by an increase in pressure, and (4) an increase in wave material causes a decrease in =. However, it has only been shown that such a tendency cannot accurately determine the blood pressure from the pulse rate. Furthermore, the pulse wave system depends on the density of the blood, especially the elasticity of the blood vessel wall (e.g., the aorta). Then, it can be inferred from the elasticity of blood vessels that arteriosclerosis may exist. It is also possible to estimate the absolute value of the heart rhythm, the heart rate change, and the corresponding heart and law irregularities. For example, Lu's can automatically measure sinus rhythm too fast, sinus rhythm is too slow, sinus 10 two-hop stop and volitional arrhythmia. The ECG signal can also be subtracted to describe the atrial contraction time, ventricular contraction time, and ventricular diastolic time. In addition, blockage of the irritated electrical stimulation signal channel (atrioventricular blockade, branching beam blockage, etc.), or even blood circulation disorders or infarction. Other irregularities in the pulse material can be detected based on the volume pulse signal. In addition, 'the present invention' is based on the discovery that the possibility of measuring metabolic parameters can be turned on in conjunction with different diagnostic methods in a particular measuring instrument. According to the invention, the conventional (optical) oximetry unit is integrated not only with the ecg unit but also with the bioelectrical impedance measuring unit in a particular measuring instrument. The measurement signal obtained by the bioelectrical impedance measuring unit can measure, for example, the composition of the examined body tissue. On the basis of this, preferably, the microvascular oxygen saturation in the tissue can be determined from the blood oxygen signal by an appropriate program control estimating unit connected to the measuring unit of the measuring instrument of the present invention. The arterial oxygen saturation (1379662 jSa〇2) and venous oxygen saturation (Sv〇2), depending on the type of body tissue being examined, determine the microvascular (arteriovenous) oxygen saturation (St〇2). The applicable formula is as follows: κ * Sv〇2 + (1 _ K) * Sa〇2 = St〇2 5 where K is the tissue-related correction factor, which depends on the volume ratio of the middle artery and vein. This value is on average slightly less than 〇.5. According to the present invention, the value determined by the relevant tissue can be determined by bioelectrical impedance measurement to determine the venous oxygen saturation according to the above formula. The sensor unit of the present invention can be used to determine blood circulation ν, i.e., 10 volume fluctuations of the examined body tissue depending on blood circulation. According to the off-form, the amount is the metabolism at the measurement point V〇2 = V * (Sa〇2-Sv02) Finally, the local oxygen consumption ν〇2 activity metric can be calculated. 15

為了進行生物電阻抗測量,饋電電極或量測電極係設 置於感測器外殼之外殼表面上,使生物阻抗測量可以和血 氧測量與腳測制時進行。因此,身體_的相同部位, 亦即患者觸碰感測器外殼表面的位置係同時為 法所涵蓋。 $ 20 根據本發明,至少一ECG電極及阻抗測量單元的至少 -饋電電極或量測電極係設置於感測器外殼表面上。 - ECG電極及必要雜抗測量單元的另—饋電 電極係以方便使患者能觸碰到所有電極末端 1379662 手分別觸碰其中—個電極的方式設置。 根據一有利的配置,測量儀器包含一整合溫度與熱感 測器°此配置可用來測定局部熱產量。在最簡單的情況下, 溫度感測器(例如NTC元件)係適當地配置以測量在量測 5點處的皮膚表面溫度。較佳而言,可藉由熱感測器來進行 判定量測點處之位置、時間和深度的熱量測。根據熱交換 可推測出局部代謝活性。此外’熱慼測器適合用來測定局 部血液循環。關於熱量測更確切的背景資料,可參考Nitzan 等人所出版的刊物(Meir Nitzan, Boris Khanokh,,,Infrared 10 Radiometry of Thermally Insulated Skin for the Assessment ofFor bioelectrical impedance measurements, the feed or measurement electrodes are placed on the surface of the housing of the sensor housing to allow bioimpedance measurements to be made with blood oxygen measurement and foot measurement. Therefore, the same part of the body _, that is, the position of the patient touching the surface of the sensor housing, is also covered by the law. $20 According to the invention, at least one ECG electrode and at least a feed electrode or a measurement electrode of the impedance measuring unit are disposed on the surface of the sensor housing. - The ECG electrode and the additional feed electrode of the necessary hybrid anti-measurement unit are designed so that the patient can touch all the electrode ends. 1379662 The hands are respectively touched by one of the electrodes. According to an advantageous configuration, the measuring instrument comprises an integrated temperature and thermal sensor. This configuration can be used to determine local heat production. In the simplest case, a temperature sensor (e.g., an NTC element) is suitably configured to measure the skin surface temperature at 5 points of measurement. Preferably, the thermal sensor is used to determine the position, time and depth of the thermal measurement at the measurement point. Local metabolic activity can be inferred based on heat exchange. In addition, the 'thermal detector is suitable for measuring local blood circulation. For more accurate background information on heat measurements, refer to the publication published by Nitzan et al. (Meir Nitzan, Boris Khanokh,,, Infrared 10 Radiometry of Thermally Insulated Skin for the Assessment of

Skin Blood Flow”,Optical Engineering 33,1994, No. 9 p 2953 to 2956)。整體而言,熱感測器係提供能有利於用來測 定代謝參數的資料。 其中一項獨特的優勢是本發明結合了前面所述的測量 15方法,亦即血氧測量法、ECG測量、.溫度亦/或熱量測以及 生物電阻抗測量。所有測量信號可藉由適當的演算法估算 並且加以組合。藉由結合不同的測量方法可在病理變化的 辨識上達到高效率、重複性及可靠性。所有參數均有利於 彙總成使用者容易理解以及能提供使用者關於其一般健康 2〇狀態之直接而有根據之提示的整體指標。 由於藉由本發明之測量儀器可進行血糖濃度的非侵入 性間接測量,因此彙總於上文所概述之本發明之測量儀与 中不同測量方法的組合具有更大的優勢。以下陳述更詳細 966 966 說明及敘述藉由本發明裝置來測定血糖值; 在正常狀態下,也就是在休眠狀態和所謂的熱中性 區,人體的代謝主要是由血糖平衡所決定。因此,正常狀 量與 態下^體組織細胞中的血糖濃度可以描述為只是熱產 耗氧量的函數。適用的公式為: [Glu] = fj(AT, V02) » 10 [Glu]表示^糖濃度。熱產量ΔΤ可藉由本發明之感測器單元 的熱感測器,例如由祕溫度財膚表面制完全隔熱之 溫度的差來収UT = Ts。—T_y),fi(AT,ν祕產 罝與耗氧量對血糖濃度的函數相_。如上所述,耗氧量 係由靜脈與動脈血氧飽和度的差及錢循環而得。然而里 為了測定進食期間亦/歧食讀不久的血糖濃度,必須考 慮到在能量均衡巾能反㈣脂肪代謝部分的修正項。下列 為適用的公式: 15 [Glu] = fl(AT, V02) + X * f2(AT, V〇2) 〇 X為進食之後呈現負㈣@子。因此,χ係取決於所攝取食 物的組成。尤其是,X取決於參與代謝之脂肪與碳水化合物 的比例。如上所述,可根據脈波速率在時間軸上的變化來 測定因子X。如果只有攝取碳水化合物或直接攝取葡萄糖 20時,x為零。所攝取食物中脂肪的部分越多,X的量就會增 加。為了從脈波速率、血壓振幅亦/或脈搏在時間軸上的變 化來測定修正因子X,通常需要校正以適合該裝置相關的使 用者。對於脂肪代謝而言,f2 (ΔΤ,V〇2)表示熱產量與耗氧 量對血糖濃度的函數相關性。 因此可利用本發明之測量儀器,由局部耗 部熱產量來測定局部錢濃度。該測量儀器包含能達到此 效果的適當測量方法。如上所述,可結合血氧測量法與生 物電阻抗測里來進行耗氧量測定。另外還需要前述熱感測 f來測定熱產量。最後’為了能根據上述函數相關ϋ 算血糖濃度’修正因子χ應例如由脈波速率在時序上的變 化來決疋再者,如同上文所述,上述測定可藉由結合 k號與容積脈波信號的測量來完成。因此,為了測定血糖鲁 濃度,較佳為在本發明之診斷測量儀器中結合脈搏血氧 計、ECG單it、生物_抗測#以及熱感測器。 上述方法最初只提供細胞内血糖濃度的測定。在簡化 . 的態樣中,存在下列血糖濃度的相關式: [Glu]ce丨丨=a 十 b ”n (c * [Glu]b丨。。d) 15常數a、b和C係取決於受檢查患者的個人生理機能。可利 用適當的校正,例如與習知方法所進行之侵入性測定的血 糖值做比較來決定這些參數。 等 根據本發明’光學測量單元、ECG單元、阻抗測量單 兀以及如果溫度感測器或熱感測器存在時,係容置於一般 20感測器外殼内。於-較佳態樣中,該至少一 ECG電極及^ · 阻抗測罝單7G的至少-饋電電極或量測電極係配置成位於 感測器外殼上侧,由導電材料所製成的平面箱或金屬薄 。因此’該金㈣片亦/或金射g可至少包含—凹孔,使Skin Blood Flow", Optical Engineering 33, 1994, No. 9 p 2953 to 2956). Overall, thermal sensors provide information that can be used to determine metabolic parameters. One of the unique advantages is the present invention. Combined with the measurement 15 method described above, namely oximetry, ECG measurement, temperature and/or heat measurement, and bioelectrical impedance measurement. All measurement signals can be estimated and combined by appropriate algorithms. By combining different measurement methods, high efficiency, repeatability and reliability can be achieved in the identification of pathological changes. All parameters are conducive to the integration of the user's easy to understand and can provide users with a direct view of their general health status. Overall indicator according to the suggestion. Since the non-invasive indirect measurement of blood glucose concentration can be performed by the measuring instrument of the present invention, the combination of the measuring instrument of the present invention summarized above and the different measuring methods has a greater advantage. The following statement is more detailed 966 966 illustrating and describing the blood glucose level by the device of the present invention; under normal conditions, that is, in a dormant state The state and the so-called thermo-neutral region, the metabolism of the human body is mainly determined by the balance of blood sugar. Therefore, the normal amount and the blood glucose concentration in the tissue cells can be described as only a function of the oxygen consumption of heat production. It is: [Glu] = fj(AT, V02) » 10 [Glu] represents the concentration of sugar. The heat yield ΔΤ can be completely separated by the thermal sensor of the sensor unit of the present invention, for example, by the surface of the secret temperature surface. The difference in temperature of heat is UT = Ts. - T_y), fi (AT, ν secret 罝 and oxygen consumption as a function of blood glucose concentration _. As mentioned above, oxygen consumption is saturated by vein and arterial oxygen The difference between the degree and the money cycle. However, in order to determine the blood glucose concentration during the eating period or the eclipse reading, it is necessary to take into account the correction of the fat metabolism part of the energy balance towel. The following formula is applicable: 15 [ Glu] = fl(AT, V02) + X * f2(AT, V〇2) 〇X is negative (four)@子 after eating. Therefore, χ depends on the composition of the food ingested. In particular, X depends on participation. Metabolic fat to carbohydrate ratio, as described above, based on pulse rate at the time The change in the axis is used to determine the factor X. If only carbohydrates are ingested or glucose 20 is directly ingested, x is zero. The more fat in the food taken, the greater the amount of X. In order to get from pulse rate, blood pressure The amplitude and/or the change in pulse on the time axis to determine the correction factor X usually requires correction to suit the user associated with the device. For fat metabolism, f2 (ΔΤ, V〇2) represents heat production and oxygen consumption. A functional correlation to blood glucose concentration. Thus, the local money concentration can be determined from the localized heat production using the measuring instrument of the present invention. The measuring instrument includes an appropriate measuring method that can achieve this effect. As described above, oxygen consumption can be measured in combination with oximetry and bioelectrical impedance measurement. The aforementioned thermal sensing f is also required to determine the heat yield. Finally, in order to be able to calculate the blood glucose concentration according to the above function, the correction factor should be determined, for example, by the change of the pulse wave velocity in time series. As described above, the above measurement can be performed by combining the k number and the volume pulse. The measurement of the wave signal is done. Therefore, in order to measure the blood glucose concentration, it is preferred to incorporate a pulse oximeter, an ECG single it, a bio-anti-test #, and a thermal sensor in the diagnostic measuring instrument of the present invention. The above methods initially only provide for the determination of intracellular blood glucose concentrations. In the simplified version, there is a correlation of the following blood glucose concentrations: [Glu]ce丨丨=a ten b ”n (c * [Glu]b丨..d) 15 constants a, b, and C depend on The individual's physiology of the patient being examined. These parameters can be determined using appropriate corrections, such as blood glucose values for invasive measurements performed by conventional methods. etc. [Optical measurement unit, ECG unit, impedance measurement sheet in accordance with the present invention.兀 and if a temperature sensor or thermal sensor is present, the system is housed in a general 20 sensor housing. In a preferred embodiment, the at least one ECG electrode and the impedance meter 7G are at least The feed electrode or the measuring electrode is arranged on the upper side of the sensor housing, and the flat box or metal made of a conductive material is thin. Therefore, the gold (four) sheet and/or the gold shot g may include at least a recessed hole. ,Make

10 1379662 至少一輕射源所發出的輕射通過,進入待檢查的身體組織 内,或是使身體組織所散射亦/或傳送的輻射通過,傳送到 輻射感測器。可設置另一個用於溫度感測器或熱感測器的 凹孔。輻射源、輻射感測器及溫度感測器或熱感測器可設 5置在位於感測器外殼内的一般印刷電路板上。於是所需要 的測量方法係彙總在感測器外殼内,形成一個能毫無問題 地靈活整合成任何診斷儀器的單元。感測器外殼可具有小 於1 cmx 1 emx丨cm的尺寸,以便能在本發明的概念中毫 無問題地靈活運用。因此,其目的係利用至少一 ecg電極 10同時作,生物阻抗測量用饋電電極或量測電極。整體而 5,係:到一包含各種測量方法的超小型整合測量儀器。 所有測量方法可涵蓋受檢查身體組織的相同部位(例如患 者觸碰感測器外殼表面的指尖),以便如上所述地同時檢= 患者的代謝及心血管系統。因此進行測量變得非常地簡單 15 而有效。 根據本發明之一較佳具體例,生物電阻抗測量單元係 適,地配置β透過至少—對量測電極記錄皮膚表面的阻抗 测董U ° ϋ此’該對量測電極的紐距離小於—毫米至 數公分’ ^便在進行測量時,使用於局部記錄阻抗測量信 號之該對量㈣極的兩個·能同時與受檢查患者皮膚表 面的相同部㈣碰。藉由將電極距離縮短到小於—毫米至 幾公分無法像f知的生物阻抗測量法—樣地通過整 個身體進行積分’但是卻可以局部地記錄生物電阻抗。根 [S3 11 20 1379662 據本U所有電核與待檢查患者皮膚表面觸碰的某一相 同局。卩位’亦即所有電極係與身體的同—個部分(例如 手、手心、腳或腳趾)接觸。 為了測里局。Ρ電阻和電抗’本發明之 佳而言係包含-對•電極,以透過线表面對待檢= t的身體組織’亦即麵碰量測電極的皮膚表面部絲加 變頻交流電。 10 對應於量測電極的饋電電極距離較佳而言為幾毫米至 幾公分。將量測電極㈣電電極設計成互相平行延伸之接 觸條的配置結果證明是非常有利的。可容許在沒有任何扭 曲結果的影響下,例如因為電極與皮膚表面之間的轉移電 阻,來測定身體組織的局部阻抗。 15 /為了產生變頻父流電,本發明之診斷測量儀器較佳而 言,包含交流電產生器。阻抗測量信號係藉由類比/數位轉 換益數位化’然後進行離散傅立葉變換(DFT)。DFT、、寅算 法係提供阻抗的實料虛部,也就是電阻值和電抗值。、這 些數值可進—錢賴字處理朗於估算。 於一較佳態樣中,電極距離最大係達到⑺咖,於一特 20 佳態樣中,此距離為50微来至5 cm,於一更佳態樣中,此 距離為卿微米至! cm,而在—極佳態樣中,此距離為i麵 至 5 mm ° 本發明之測量_的配置可敎阻抗的局部時間變 化。為了達到這樣的效果,該測量儀器較佳而言係包含與 12 1379662 卩且㈣量單元連接的估算單元。麟算單元可以是受程式 ._的由㈣祕進雜抗測量 的估算。 牛例而CT由於-個脈搏期間内的血量變化 5部生物阻抗改變,藉此可!局 j猎由局部生物電阻抗來測定心 律。同時測定脈波振幅作為一個重要的生理參數。顯然脈 波振幅與體溫有關’這表示可藉由生物阻抗分析的辅助來 •㈣定受檢查者的體溫。再者,局部生物阻抗也取決於液體 體積’也就是取決於受檢查組織中的局部血量,藉此可測 10定受檢查組織中的局部血液循環(由血液循環所調節的局 部體積波動’例如以容積信號的形式呈現)。最後,身體的 Θ部生物電阻抗會隨著食物攝取量的函數而改變’所以如 眾所周知者’由血糖值所定義的代謝作用可藉由生物阻抗 來檢查。因此’本發明之測量儀器也藉由阻抗測量單元來 15提供非侵入性的血糖值監控,具有能檢查由葡萄糖所起始 Φ 的體内生理反應之葡萄糖亦/或能量需求的效果。藉由估算 單元中的軟體所執行的適當演算法,可由所記錄^阻抗測 量信號來描述血糖值及其在時序上的變化。 根據本發明之診斷測量儀器的另一較佳配置,係設置 2〇 —固疋裝置,用以固定待檢查患者的身體部位,例如手指。 在進行阻抗測量並且也進行脈搏血氡測量的情況下,身^體 組織(例如手指)作用在光學感測器亦/或作用在量測電極 與饋電電極上的接觸壓力會顯著影響測量信號。因此,藉 [S3 13 5 由固定裝置來提縣料接_ 固定裝置可包含-可充氣式氣塾㈣舉例而言, 部位壓在量測雷;地)將身體的相關 在里咐婦/或饋電電極上, 上,並且固定在該處。藉 在忐學感勒 部位的移動,也同時防止這樣的II固;^有_方止身體 在本發明之測量儀器的另一#==曲測量的結果。 式設置複數個饋電電極亦/或量 I’係以矩陣形 源與電_量巾赵不_=電此心在交流電 1他數齡t 崎。11財柄得到的 A他數據和資料可推測出關於PH值、pco2值 關於電解質平衡(Na+-、κ+ 2+ 2 八 La 、Mg2++濃度等)。 如上所述’本發明之測量儀器的光 15 射照射受檢查身體組織的咖及至少一用於 ==體_所散射亦/或傳送之姉的輻職測器。適 線源為能發出光輕射,亦即在對應光譜範圍内之光 僅光二極體甚或是雷射二極體。本發明之測量儀 證明特別有利於以至少兩種或甚至更好是三種不同 =波長來測量受檢查身體組織的輕射吸收,以據此測定組 織的灰氧濃度和血液循環。 20 據月b達到本發明之目的的配置,本發明之測量儀器 的光予測里單疋係由至少兩個用於偵測由身體組織所散射 或傳送之H射魏射感測器所構成,該等輻射感測器係 、輕射源不同的距離設置。這樣的配置可開啟能推測出 身體、、且織中輪射所涵蓋之距離的可能性。據此可檢查血液10 1379662 At least one light source emits a light shot through the body tissue to be examined, or the body tissue is scattered and/or transmitted through the radiation sensor and transmitted to the radiation sensor. Another recess for the temperature sensor or thermal sensor can be set. The radiation source, radiation sensor, and temperature sensor or thermal sensor can be placed on a general printed circuit board located within the sensor housing. The required measurement methods are then integrated into the sensor housing to form a unit that can be flexibly integrated into any diagnostic instrument without problems. The sensor housing can have a size of less than 1 cm x 1 emx 丨 cm so that it can be used without problems in the concept of the present invention. Therefore, the object is to simultaneously use at least one ecg electrode 10 for a feed electrode or a measuring electrode for bioimpedance measurement. Overall, 5, is: to an ultra-small integrated measuring instrument that contains various measurement methods. All measurement methods may cover the same part of the body tissue being examined (e.g., the fingertip of the patient touching the surface of the sensor housing) to simultaneously detect the patient's metabolism and cardiovascular system as described above. Therefore, the measurement becomes very simple and effective. According to a preferred embodiment of the present invention, the bioelectrical impedance measuring unit is adapted to be configured to transmit at least β-the impedance of the surface of the skin to be measured by the measuring electrode, and the distance of the pair of measuring electrodes is less than - From millimeters to several centimeters' ^, when the measurement is performed, the two (four) poles used for locally recording the impedance measurement signal can simultaneously collide with the same portion (four) of the skin surface of the examined patient. By shortening the electrode distance to less than - mm to a few centimeters, it is impossible to integrate the whole body by bioelectrical impedance measurement, but the bioelectrical impedance can be recorded locally. Root [S3 11 20 1379662 According to this U, all the electric cores are in the same state as the surface touch of the patient's skin to be examined. The 卩 position, that is, all electrode systems are in contact with the same part of the body (such as the hand, palm, foot or toe). In order to measure the game. ΡResistance and Reactance ′ In the present invention, it is preferred to include a pair of electrodes for transducing alternating current through the surface of the surface of the surface of the measuring electrode. The feed electrode distance corresponding to the measuring electrode is preferably from several millimeters to several centimeters. It is proved to be very advantageous to design the measuring electrodes (four) to form the contact electrodes extending parallel to each other. The local impedance of the body tissue can be tolerated without any distortion results, for example due to transfer resistance between the electrode and the skin surface. 15 / In order to generate a frequency conversion parent current, the diagnostic measuring instrument of the present invention preferably comprises an alternating current generator. The impedance measurement signal is converted by the analog/digital conversion and then subjected to Discrete Fourier Transform (DFT). The DFT and 寅 algorithm provide the imaginary part of the impedance, that is, the resistance value and the reactance value. These values can be entered. In a preferred embodiment, the maximum distance between the electrodes is (7) coffee, and in a special aspect of 20, the distance is 50 micrometers to 5 cm. In a better aspect, the distance is from the micron to the micro! Cm, and in a very good aspect, this distance is from i-face to 5 mm. The configuration of the invention can vary the local time of the impedance. In order to achieve such an effect, the measuring instrument preferably comprises an estimating unit connected to the 12 1379662 ( and (4) measuring unit. The lining unit can be estimated by the program (4). Cattle and CT due to changes in blood volume during a pulse period 5 bio-impedance changes, this can be! The local hunter measures the heart rhythm by local bioelectrical impedance. At the same time, the pulse amplitude is measured as an important physiological parameter. Obviously, the pulse amplitude is related to body temperature', which means that it can be assisted by bioimpedance analysis. (4) Determine the body temperature of the examinee. Furthermore, the local bioimpedance also depends on the volume of the liquid 'that is, depending on the amount of local blood in the tissue being examined, thereby measuring the local blood circulation (local volume fluctuations regulated by blood circulation) in the examined tissue. For example, in the form of a volume signal). Finally, the body's crotch bioelectrical impedance changes as a function of food intake' so as is well known, the metabolism defined by blood glucose values can be examined by bioimpedance. Thus, the measuring instrument of the present invention also provides non-invasive blood glucose monitoring by means of an impedance measuring unit, having the effect of being able to check the glucose and/or energy requirements of the in vivo physiological response of Φ initiated by glucose. The blood glucose value and its variation in timing can be described by the recorded impedance measurement signal by estimating the appropriate algorithm performed by the software in the unit. According to another preferred configuration of the diagnostic measuring instrument of the present invention, a sputum-fixing device is provided for fixing a body part of a patient to be examined, such as a finger. In the case of performing impedance measurement and also performing pulse blood sputum measurement, the contact pressure of the body tissue (e.g., a finger) acting on the optical sensor and/or on the measuring electrode and the feeding electrode can significantly affect the measurement signal. Therefore, by [S3 13 5 by the fixed device to mention the material connection _ the fixture can contain - inflatable gas (4), for example, the part pressure in the measurement of mine; ground) will be related to the body in the wife / or feed The electric electrode is on, above, and fixed there. By the movement of the part of the drop-out feeling, it is also prevented from being such a solid; the body has another #== the result of the measurement of the measuring instrument in the present invention. A plurality of feed electrodes are also set and/or the amount I' is in a matrix form. The source and the electricity are _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ The data and data obtained from the 11th fiscal rule can be inferred about the pH value, pco2 value, and electrolyte balance (Na+-, κ+ 2+ 2 八 La, Mg2++ concentration, etc.). As described above, the light of the measuring instrument of the present invention illuminates the coffee body of the examined body tissue and at least one of the radiation sensors for the scatter and/or transmission of the == body. The appropriate source is light that emits light, that is, light in the corresponding spectral range, only the light diode or even the laser diode. The meter of the present invention proves to be particularly advantageous for measuring the light absorption of the examined body tissue in at least two or even more preferably three different wavelengths to determine the gray oxygen concentration and blood circulation of the tissue. 20 According to the configuration of the present invention for the purpose of the present invention, the optical pre-measurement unit of the measuring instrument of the present invention is composed of at least two H-radiation sensors for detecting scattering or transmission by body tissues. The radiation sensors are arranged at different distances from the light source. Such a configuration opens the possibility of inferring the distance covered by the body and the ray in the weave. According to this, blood can be checked

14 i3?9662 5 ::、不同深度組織層中的氧濃度。可利用較 :信號受雜血㈣響吨大,而纽㈣近表面^^ 中的轄射吸故受微也管系統中的血液影響比較大 再者,使用-個用於侧所傳送輕射的輕射感測器 =制身體組織所散射(折回)之輪射_射感㈣ ^^的二傳送過程中所細到的測量信號受動脈血吸 的^比较大,而散射輻射主要是來自於接近表面_ ^因此可推測出吸收,並藉此推測出微血管系統中的氧 3里0 10 其中-項優勢是在本發明之測量儀器的配置中,至卜 二==π能選擇性照射不同體積範圍之受: —身體、、且織的效果。舉例而言,為了達到這樣的效果,可 „能照射不同體積範圍之受檢查身體組織的輕射 15 f。藉此可早地進行光吸收的不同測量。可利用血 富含氧亦/餘氧來檢查受檢查身體組織之血液循環中由代 =引:的變化。這裡所利用的因子是以局部耗氧量變化 作為、、且織代謝活性的函數。可變耗氧量 出與耗氧量直接相關的局部能量消耗量。其中特= 20 到關注較這樣的配置可進而推測出血糖值。因此,本發 明之射勤转觀血糖值的非侵人性败。富氧或缺 =血的血液循環對於選擇性照射的體積影 =如兩個具有不同空間轎射特性的輻二 來達成。舉例而吕’可使用具有相似波長(例如630譲和 15 IS] 1379662 650 nm)的一發光二極體及一雷射作為輻射源。但是這兩 個輻射源的輻射孔徑角不同。舉例而言,雖然發光二極體 以大孔徑角來照射身體組織,但雷射二極體卻是以極小的 孔徑角進入身體組織。結果兩個輻射源擷取到不同體積範 5圍的身體組織。因為在大孔徑角的情況下,發光二極體會 比雷射擷取到更大體積範圍之未供應血液的表皮層。未供 應血液的表皮層事實上不會受到血紅素濃度變化的影響。 因此,由身體組織所散射亦/或傳送的發光二極體輻射強度 與血紅素濃度變化的相關性低於雷射輻射的強度。先決條 10件是選擇兩個輻射源所分別發出的輻射波長,使氧合血紅 素亦/或非氧合血紅素所吸收的輻射強度不同。因此,波長 應在600與700 nm之間,較佳為在630與650 nm之間。 根據能達到本發明之目的之診斷測量儀器的配置,該 至少一輻射源係連接至一光導元件,例如一光纖。藉由該 光導元件將该輻射源亦/或該等輻射源所發出的輻射傳導至 感測器外殼表面。如此可有利於使數個輕射源,例如數個 黏合在一般基板上的LED晶片的輻射耦合到特定的光導元 件中。不同輕射源可用不同的方法輕合至光導元件。以這 樣的方式’可達到使不同來源具有不同輕射特性 20入待檢查的身體組_。或者可將光導元件連接至能產生 進入身體組織内的定向輻射亦/或漫輻射的光學系統。以這 樣的方式,可選擇性地檢查不同深度的組織層。舉例而古, 光導元件可以是在出口形成像Y字形分叉的光纖。連接至 16 1379662 :分ΤΓ出口端的是聚光透鏡,該聚光透鏡能產生 進入深層組織内的定向(大致平 生 6, ^ „ ν , 丁的)輕射。而輻射則以 讀方式Μ-Μ末端引出,料在靠近表_ 位。 在本發明之測量儀器可提供極為小型且堅固之 較佳配置中’可設想將至少-細源設置於-擴散騎的 15 20 :空廳中。舉例而言’該中空反射器可由一種所謂的 烏布里希球(Ulbnehtsph⑽)所構成,在本發·概念中, 中空反射㈣幾何·並不限於球形。烏布里希球係表示 其内部具有-擴散反射塗層的—中空體。細源於内部所 反射及散㈣輻射接近理想的漫射,也狀說,輕射源, 例如發光二極體的方向特性被破壞殆盡。可將能產生進入 身體組織内之定向ϋ射的絲系統連接至中空反射器。此 .外,該中空反射器可包含使漫輕射通過而進入身體組織内 的-出口孔。以這樣的方式’可對不同體積範_身體組 織進行上述的光學測量。中空反射器不一定要中空,也可 以由外部、㈣塗布的翻_所製成。實際喊射源(例 如LED晶片)可埋置在中空反射器的材料中,並且可透過 由中空反射器導出的接線供應電流。以這樣的方式可以使 光學測量單元小型化。中空反射器可以低成本大量地預製 成極為小型的元件。 本發明之測量儀H可有利於藉由身體域所散射亦/或 傳送之至少一輻射源的輻射來測定代謝參數。如果受檢查14 i3?9662 5 ::, Oxygen concentration in different depth tissue layers. Can be used more: the signal is affected by the mixed blood (four) louder than the ton, and the New (four) near surface ^ ^ in the ejaculation of the suction is affected by the micro-tube system, the blood is relatively large, use - for the side to transmit light Light-emitting sensor = the scattering of the body tissue (return) _ Sense of radiation (4) ^ ^ The measurement signal that is fined during the second transmission process is relatively large by the arterial blood suction, and the scattered radiation mainly comes from Close to the surface _ ^ Therefore, the absorption can be inferred, and thereby the oxygen in the microvasculature is estimated to be 0 0. The advantage of the item is that in the configuration of the measuring instrument of the present invention, the selective irradiation of the second to the π can be different. The range of volume is: - the effect of the body, and the weave. For example, in order to achieve such an effect, it is possible to illuminate a light shot 15 f of the examined body tissue of different volume ranges, whereby different measurements of light absorption can be performed early. Blood can be used to enrich oxygen/excess oxygen. To check the change in the blood circulation of the examined body tissue by the generation = reference: The factor used here is a function of the local oxygen consumption as a function of the metabolic activity. The variable oxygen consumption and oxygen consumption Directly related local energy consumption, in which special = 20 to focus on such a configuration can further infer the blood sugar level. Therefore, the invention of the present invention changes the blood sugar level of non-invasiveness. Oxygen-rich or lack of blood The volumetric shadow of the selective illumination is achieved as two radians with different spatial maneuver characteristics. For example, Lu can use a light-emitting diode with similar wavelengths (eg 630 譲 and 15 IS) 1379662 650 nm) The body and a laser act as a radiation source. However, the radiation sources have different radiation aperture angles. For example, although the light-emitting diode illuminates the body tissue with a large aperture angle, the laser diode is extremely small.The aperture angle enters the body tissue. As a result, the two radiation sources draw body tissues of different volume ranges, because in the case of large aperture angles, the light-emitting diodes extract a larger volume of un-supplied blood than the laser. The epidermal layer. The epidermal layer that is not supplied with blood is not actually affected by the change in hemoglobin concentration. Therefore, the correlation between the radiation intensity of the light-emitting diode scattered and/or transmitted by the body tissue and the change in hemoglobin concentration is lower than that. The intensity of the laser radiation. The first 10 items are the wavelengths of the radiation emitted by the two sources, so that the oxyhemoglobin and/or non-oxyhemoglobin absorb different radiation intensities. Therefore, the wavelength should be 600. Between 700 nm, preferably between 630 and 650 nm. According to the configuration of the diagnostic measuring instrument capable of achieving the object of the present invention, the at least one radiation source is connected to a light guiding element, such as an optical fiber. The element conducts the radiation source and/or the radiation emitted by the radiation sources to the surface of the sensor housing. This may facilitate the bonding of several light source sources, for example, a plurality of light sources on a general substrate. The radiation of the LED wafer is coupled into a particular light guiding element. Different light source sources can be lightly coupled to the light guiding element in different ways. In this way, it is possible to achieve a body group with different light-light characteristics from different sources. Alternatively, the light guiding element can be attached to an optical system that produces directional radiation and/or diffuse radiation into the body tissue. In this manner, tissue layers of different depths can be selectively examined. For example, the light guiding element can be The exit forms an optical fiber like a Y-shaped bifurcation. Connected to 16 1379662: the exit end of the splitter is a concentrating lens that produces an orientation (substantially flat 6, ^ „ ν, D) light into the deep tissue. . The radiation is extracted in the end of the Μ-Μ, and is close to the table _ bit. In a preferred configuration in which the measuring instrument of the present invention can be provided in an extremely small and sturdy manner, it is conceivable to arrange at least a fine source in the 15 20: empty chamber of the diffusion ride. For example, the hollow reflector can be constructed of a so-called Ubnehtsph (10). In the present concept, the hollow reflection (four) geometry is not limited to a sphere. The Ubri ball system represents a hollow body with a diffuse reflective coating inside. The source is reflected from the inside and the (4) radiation is close to the ideal diffusion. It is also said that the directional characteristics of the light source, such as the light-emitting diode, are destroyed. A wire system capable of producing directional jets into the body tissue can be attached to the hollow reflector. Additionally, the hollow reflector can include an exit orifice that allows a diffuse light to pass into the body tissue. The optical measurements described above can be performed on different volume models in such a manner. The hollow reflector does not have to be hollow, but can also be made of an outer, (four) coated turn. The actual source of the shunt (e.g., an LED chip) can be embedded in the material of the hollow reflector and can be supplied with current through the wiring derived from the hollow reflector. In this way, the optical measuring unit can be miniaturized. Hollow reflectors can be prefabricated in large quantities at very low cost into extremely small components. The meter H of the present invention can facilitate the determination of metabolic parameters by radiation of at least one source of radiation that is scattered and/or transmitted by the body domain. If checked

LSI 17 身體,織〉肖耗了氧’則氧合血紅素會轉變成非氧合血紅 素三藉由比較來自選擇性照射之不同體積範圍的輻射,可 測定出氧合血紅素與非氧合血紅素濃度比的變化。進而導 出局部耗氧量,最後可(間接)導出血糖值。 5 就實際應用而言’本發明之測量儀器可連接至任何程 f控制裝置’例如電腦、行動電話、手持裝置等具有可在 /私式控制裝置上執打軟體以進行所記錄之測量信號估算 2功能者。由於感測H外殼的尺寸很小,因此也可以整合 例如眼鏡、手錶或首料任何配件巾,或是整合在衣服 (戶=的智慧型服幻卜在這樣的配置中,以任何方式 控制錢並存的數據處理電路係用來處理所得到的 =1宮號°這樣的處理很料藉由配置適當的軟體來完 5時也可記憶和儲存由軟體所測定的診斷數據。可追 15 =3::歷程及對應療法的功效。遠程數據傳輸 :里勤所_和估算的料數據是合理而以可行的。 可Γ數據網路(例如網際網路)來進行數據 者’舉例而言’如果本發明之測量儀器整合在行 20 =:二=數據可藉由行動無線網路來傳送。原始 =里w或估料轉輯例如可傳送至中樞站(健診 著時,展⑪心—u文件t作並且監控個別值隨 ^門發展的私。纽,例續 :慮已歸檔的患者資料(包括慢性病或過去 來估异數據。接著可藉由資料網或通訊網將結果送回例如 18 5 =本=知裳f使用者關於該使用者的健康狀態。 選擇性、>丨旦^之心儀器可以從中樞站啟動更進一步的 的,了此外’為了達到由估算結果來增加病史的目 10 路將回覆的查詢回傳給患者。資料 結果可自動傳送給執行檢查的醫師。如果測量及估 >月白顯示出緊急的醫療情形時,則可立刻啟動必要 的措知(例如自動發出求救警報)。遠錄據傳輸的另一項 優點在於裳置本身不需要執行估算測量信號所需要的軟 體,只要在接收資料的中心位置處執行即可,該軟體必須 保持可用並轉持在良好的狀態下。 15 對於脈搏血氧測量而言’身體組織(例如手指)作用 在光學感測器上的接觸壓力會顯著影響測量信號。因此, 可合理地使本發明之測量儀器備有用以測定身體組織.之接 觸壓力的裝置。此裝置可以是習知的壓力感測器,例如為 壓電電阻元件形式者。也可以光學方法來測定接觸壓力。 因為接觸壓力對於測量信號有特殊的影響,所以也可以由 (脈搏血氧)信號本身來測定接觸壓力。所測定的接觸壓 力接著可考慮用來進一步估算測量信號,以補償接觸壓力 對於例如血液循環的影響。 20 【實施方式】 請參閱第一圖,本發明之測量儀器1,該測量儀器1係 整合於由電腦2與鍵盤3所構成的電腦系統,測量儀器1 包含在鍵盤3的使用者介面處存取的不同測量方法’電腦 19 系j用者利用指尖與此鍵盤3觸碰來進行測量,整合在 :里议器1的是光源4、4’ ’例如為能發出各種不同波長光 二的X光―杨體形式者,為了達成此目的,各種不同的發 光半導體70件係、容置於一般感測器外殼(鍵盤3外殼)内。 也可=用光波導管將光線由不同的光源導引至鍵盤 3的使 用者"面’再者’測量儀器1包含-或數個光感測器5,這 一光感測器5分別緊鄰著光源4和4’設置,光感測器5接 收來自光源4亦/或4’ ’於使用者指尖處的組織内所散射的 光線,此外,熱感測器6亦緊鄰著光源4亦/或4,設置, ,此以確保在與光學測量相同_量位置處可完成根據熱 里測的血液供應測定;此外,四個電極7亦/或7,全部都設 置於感測n外殼表面上,以測量生物電阻抗。I置使用者 用一隻手同時觸碰兩個電極7亦/或7,,兩個接觸面之中的 了個接觸面係用以施加電流於測量位置,而另-個接觸面 係用來進行電㈣量,以這制方式可確侧量結果不會 受到量測電極的接觸電阻影響,兩個電極7也用來作為ECG 單兀的ECG電極7,該ECG單元亦整合在測量儀器1之中, 刀別用丸尖觸碰兩個電極7以產生兩點導數(臂對臂測 量)’利用電腦2處理由整合於鍵盤3的測量儀器丨所得到 的測®信號,將藉此方式所得到的生理參數顯示在連接至 電腦2之顯示器9的顯示螢幕上,舉例而言,顯示内容顯 不出動脈氧飽和度(Sa〇2)、微血管氧飽和度(St〇2)與靜 脈氧飽和度(Sv〇2)’進一步顯示的是所測定的心律 1379662 和組織脂肪含量⑽,最後亦顯示血糖值⑽使 可以在任何時候測定其所關注的這些生理參數,使 =細電極Η上,__㈣的按_ 5 15 f成此目的電腦2處理測量信號之後,接著立刻藉 =顯不斋9顯示這些參數,測量儀ϋ 1的使用者實際上^ 需要為了測定生理參數而中斷在電腦2上的工作。 月> 閱第目測里儀II !設置兩種照射不同體積範 圍之受檢查身體組織_射源4和4,,為了達到這樣的效 果’此兩_射源4和4,具有不同的空間輻射特性,也就 是不同的輻射角’輕射源4是發光二極體,而輕射源4,是 雷射,例如所謂的VCSEL-雷射(垂直共振腔面射型雷射) ’發光二極體4和雷射4,兩者發出具有極相似波長(例如 咖⑽和咖nm),但是具有不同孔徑角(例如25。和55。) 的光,可對金液中由代謝所引起的氧含量變化進行不同的 測量,為了達到這樣的效果’兩種輻射源4和4,所分別發 出的輕射波長必須在能狗使氧合錄素與非氧合企紅素吸 收不同光強度的範圍内’為了能對血液中的氧含量(氧飽 和度)進行絕對量測’必須有其他的輕射源(第i圖未圖 示),其光波長位於氧合缝素與非氧合錄素的光吸收大 致相等(所明的等吸收點)的光譜範圍内,所發出的光可 藉由適當的光纖導引至鍵盤3使用者介面的相應位置,在 此情況下’發光二極體4亦/或雷射4減光_末端,可 將發光二極體4和雷射4’連接至適當的光纖,使它們以所 21 I S3 20 1379662 期望的不同孔徑角來照射待檢查的身體組織,因此,可利 用兩種輕射源來檢查不同體積的身體組織,因為在 =角的情況下’發光二極體4所檢查到未供應血液的表皮 ^ =比用雷射4,所檢查的更大,利用細感測器Μ 射源4、4’,在身體組織内散射與部分吸收的光, 輻射感測斋5不需要直接設置在測量儀器 ^的是藉由設置在_顧1内敎_料光導= 來提供光線’為了使輕射源4的光與輻射源4,的光具有差 異,可利用不同的時間模組並且藉由該時間模組 器5所偵測的信號解調來操作光源4和4,。或者, 15 20 同的波長為基礎,使輕射源4和4,的轄射具有差異。輕射 源4和4’所發出輻射的輕射強度會隨著通過身體組織的路 徑長度而減弱,而且強度衰減也和熟悉的朗伯-比爾定律 aambert Beer law)中已知的吸收物質(氧合血紅素) 有關’藉由輕射感測器5,可測定所關注參數的強度衰減, 該強度衰減分別由輻射源4和4,各自擷取之受檢查身體組 織的體積範圍所表示’可藉由適當程式控制的估算單元使 欲分,至不同輻射源4和4,的參數強度衰減彼此相關,以 便用這樣的方式來進行微差測量,在最簡單的情況下,由 輻射源4和4’的輻射參數強度衰減來計算商,由這些商的 變化可推測出代謝作用的改變,舉例而言,假如血糖值在 進食之後上升’於是(在一定時間的延遲之後)會有更多 的葡萄糖進入身體組織的細胞内並且在該處轉換,在這樣 22 1379662 的過程中會消耗更多的氡,這些氧會經由血液而被細胞吸 收,於是由於血液的消耗,氧合血紅素會變成非氧合血紅 素,因此非氡合血紅素對氧合i紅素的比例會增加,由於 來自輻射源4和4’之輻射的孔徑角不同,所以血紅素濃度 5的改變對於相關的強度衰減會有不同的影響,因此可由參 數強度衰減的商來偵測血紅素濃度的改變,而可間接推測 出耗氧量,因為耗氧量係取決於血糖值,所以也可藉由如 • 上所述之輻射吸收的微差測量來測定血糖值,為了補足此 方法’係利用設置的電極7和7’進行光學測量的生物阻抗 1〇分析,以達到這樣的效果,尤其生物阻抗測量的目的是測 $局部的血液供應,該測量也可以作為浙耗氧量应血糖 值,另-個參數,也可以只利用適當的光學元件(例如分 束器、透鏡等)而以-個輕射源4來產生不同孔徑角的輕 ”本發明之診斷測量儀器1還有利於以脈搏同步 的方式來進行測量值的估算,因為本發明之测量儀器i包 含脈搏1 己錄用的適當感测器(例如ECG),所以是可㈣, 20 ί::;旦:rf脈波最大值亦/或最小值時,選擇性地估 = 里核抗測量所得_測量值,以編肖取決於脈 =檢可利用本發明之診斷測量儀器1、分別 的比例=及脈据/組織中的脈搏相關血量對脈搏無關血量 可獲得有用的診斷二據與脈搏無關的代謝數據, 23 ί S3 1379662 10 15LSI 17 body, woven > Xiao Oxygen', then oxygenated hemoglobin will be converted into non-oxyhemoglobin three by comparing the different volume range of radiation from selective irradiation, can be measured oxyhemoglobin and non-oxygenation The change in hemoglobin concentration ratio. In turn, the local oxygen consumption is derived, and finally the blood glucose value can be derived (indirectly). 5 For practical applications, the measuring instrument of the present invention can be connected to any control device such as a computer, a mobile phone, a handheld device, etc., having a software that can be executed on a private control device for the measurement of the recorded measurement signal. 2 function. Since the size of the sensing H casing is small, it is also possible to integrate any accessory towel such as glasses, a watch or a first material, or integrate it into a clothing (a smart type of clothing) in such a configuration to control the money in any way. The coexisting data processing circuit is used to process the obtained =1 号 ° °. Such processing is expected to be able to memorize and store the diagnostic data determined by the software by configuring the appropriate software. 5 = 3 :: The efficacy of the course and the corresponding therapy. Remote data transmission: The data of the logistics and estimated data is reasonable and feasible. The data network (such as the Internet) can be used to perform data 'for example' if The measuring instrument of the present invention is integrated in line 20 =: two = data can be transmitted by the mobile wireless network. The original = inner w or estimated material transfer can be transmitted to the central station, for example, when the medical examination is held, the exhibition 11 heart-u The document t and monitors the individual value of the private development of the door. Example: Continue to consider the archived patient data (including chronic disease or past estimates). The results can then be sent back via the data network or communication network, for example, 18 5 =本=知裳f user about The user's health status. Selective, > 丨 ^ 之 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器 仪器The results of the data can be automatically transmitted to the physician performing the examination. If the measurement and estimation > month indicates an urgent medical situation, the necessary measures can be activated immediately (for example, a distress alert is automatically issued). One advantage is that the skirt itself does not need to perform the software required to estimate the measurement signal, as long as it is performed at the center of the received data, the software must remain available and be held in good condition. 15 For pulse oximetry In contrast, the contact pressure of the body tissue (such as a finger) acting on the optical sensor can significantly affect the measurement signal. Therefore, it is reasonable to make the measuring instrument of the present invention useful for measuring the contact pressure of body tissue. The device may be a conventional pressure sensor, such as in the form of a piezoresistive element. Optical methods may also be used to determine contact. Since the contact pressure has a special influence on the measurement signal, the contact pressure can also be determined from the (pulse oximetry) signal itself. The measured contact pressure can then be considered for further estimation of the measurement signal to compensate for the contact pressure for example [Embodiment] Referring to the first figure, the measuring instrument 1 of the present invention is integrated into a computer system composed of a computer 2 and a keyboard 3, and the measuring instrument 1 is included in the keyboard 3. Different measurement methods for accessing the user interface 'The computer 19 system j uses the fingertip to touch the keyboard 3 to perform measurement, and is integrated in: the light source 4, 4'', for example, can emit various kinds of In order to achieve this goal, a variety of different light-emitting semiconductors 70 pieces are housed in a general sensor housing (keyboard 3 housing). It is also possible to use a light waveguide to guide the light from different light sources to the user of the keyboard 3, and the measuring instrument 1 includes - or a plurality of light sensors 5, which are respectively in close proximity The light sources 4 and 4' are disposed, and the light sensor 5 receives light scattered from the light source 4 and/or 4'' in the tissue at the fingertip of the user. In addition, the thermal sensor 6 is also adjacent to the light source 4. / or 4, set, , to ensure that the blood supply measurement according to the heat measurement can be completed at the same position as the optical measurement; in addition, four electrodes 7 and/or 7, all of which are disposed on the surface of the sensing n On, to measure bioelectrical impedance. I put the user to touch the two electrodes 7 and/or 7 simultaneously with one hand, and one of the two contact faces is used to apply current to the measurement position, and the other contact surface is used. The amount of electricity (four) is measured. In this way, the result of the side measurement is not affected by the contact resistance of the measuring electrode. The two electrodes 7 are also used as the ECG electrode 7 of the ECG unit, and the ECG unit is also integrated in the measuring instrument 1 Among them, the knife touches the two electrodes 7 with the tip of the pellet to generate a two-point derivative (arm-to-arm measurement). The computer 2 is used to process the measurement signal obtained by the measuring instrument integrated in the keyboard 3, and this way The resulting physiological parameters are displayed on the display screen of the display 9 connected to the computer 2, for example, the display shows no arterial oxygen saturation (Sa〇2), microvascular oxygen saturation (St〇2) and venous oxygen. Saturation (Sv〇2)' further shows the measured heart rhythm 1371662 and tissue fat content (10), and finally shows the blood glucose level (10) so that the physiological parameters of interest can be determined at any time, so that = fine electrode __(4) Press _ 5 15 f to make 2 computers for this purpose After the measurement signal, immediately followed by fast 9 = not show significant parameters, measuring instrument ^ ϋ user 1 actually requires for the measurement of physiological parameters interrupted working on the computer 2. Month> Read the visual inspection instrument II! Set two kinds of examined body tissues _radiation sources 4 and 4 that illuminate different volume ranges, in order to achieve such an effect 'the two _ sources 4 and 4 have different spatial radiation Characteristics, that is, different radiation angles, 'light source 4 is a light-emitting diode, and light source 4 is a laser, such as a so-called VCSEL-laser (vertical cavity surface-emitting laser) 'lighting diode Body 4 and Laser 4, both emit light with very similar wavelengths (eg, coffee (10) and coffee nm), but with different aperture angles (eg, 25 and 55.), which can cause oxygen in the gold liquid caused by metabolism. The content changes are measured differently. In order to achieve such an effect, the two kinds of radiation sources 4 and 4, respectively, must emit light at a wavelength that can absorb different light intensities in the dog's oxygenated and non-oxygenated erythropoietin. In order to be able to measure the oxygen content (oxygen saturation) in the blood, there must be other light source (not shown in Fig. i) whose wavelength is at the oxygen interstitial and non-oxygenated The light absorption is approximately equal (the apparent absorption point) within the spectral range The light can be guided to the corresponding position of the user interface of the keyboard 3 by a suitable optical fiber, in which case the 'light emitting diode 4' or the laser 4 dimming _ end can be used to illuminate the diode 4 and The laser 4' is connected to the appropriate fiber so that they illuminate the body tissue to be examined at different aperture angles desired by 21 I S3 20 1379662, so two light sources can be used to examine different volumes of body tissue because In the case of = angle, the epidermis of the uncharged blood detected by the light-emitting diode 4 is larger than that of the laser 4, and the fine sensor is used to detect the source 4, 4' in the body tissue. Internal scattering and partially absorbed light, radiation sensing fast 5 does not need to be directly set in the measuring instrument ^ is provided by _ _ 1 1 敎 料 light guide = to provide light 'in order to make light source 4 light and radiation The light of source 4 has a difference, and the light sources 4 and 4 can be operated by using different time modules and demodulating the signals detected by the time module 5. Or, 15 20 is based on the same wavelength, so that the light source 4 and 4 have different apjections. The light-intensity of the radiation emitted by the light source 4 and 4' is attenuated with the length of the path through the body tissue, and the intensity decay is also known as the absorption material (oxygen) in the familiar amberbert Beer law. Hemoglobin) [With the light sensor 5, the intensity attenuation of the parameter of interest can be determined, which is represented by the volume ranges of the irradiated sources 4 and 4, respectively, of the body tissue being examined. The parameter intensity attenuation to the different radiation sources 4 and 4 is correlated with each other by an appropriate program-controlled estimating unit to perform the differential measurement in such a manner that, in the simplest case, by the radiation source 4 and 4's radiation parameter intensity decay is used to calculate the quotient, and changes in these quotients can be inferred to change the metabolism. For example, if the blood glucose level rises after eating' then (after a certain time delay) there will be more Glucose enters the cells of the body tissue and switches there, in the process of 22 1379662 will consume more sputum, which will be absorbed by the cells through the blood, so by Blood consumption, oxyhemoglobin will become non-oxyhemoglobin, so the proportion of non-conjugated heme to oxygenated erythropoietin will increase, because the angle of the radiation from the radiation source 4 and 4' is different, so the blood red The change of the concentration of 5 has different effects on the related intensity decay. Therefore, the change of hemoglobin concentration can be detected by the quotient of the parameter intensity attenuation, and the oxygen consumption can be indirectly estimated because the oxygen consumption depends on the blood glucose level. Therefore, the blood glucose level can also be measured by the differential measurement of the radiation absorption as described above, in order to complement this method, the bioimpedance analysis of the optical measurement using the set electrodes 7 and 7' is performed to achieve this. The effect, especially the purpose of bioimpedance measurement, is to measure the local blood supply. This measurement can also be used as a blood glucose value for the blood consumption of Zhejiang, another parameter, or just use appropriate optical components (such as beam splitters, lenses). And the light measuring source 4 is used to generate light of different aperture angles. The diagnostic measuring instrument 1 of the present invention is also advantageous for estimating the measured values in a pulse synchronous manner, because The measuring instrument i of the invention includes a suitable sensor (such as an ECG) that has been pulsed, so it is possible to (4), 20 ί::; dan: when the maximum value of the rf pulse wave is also/minimum, the selectivity is estimated to be Nuclear resistance measurement _ measured value, according to the pulse = detection can be used with the diagnostic measuring instrument of the present invention 1, the respective ratio = and the pulse-related blood volume in the tissue can be useful for pulse-related blood volume Diagnostic data and pulse-independent metabolic data, 23 ί S3 1379662 10 15

請參閱第二圖,本發明之測量儀器!包含光學測量單 元100’該光學測量單元10(H系用於光學測量已知測量點處 之身體組織血衫制氧濃度,光學難單元100所記錄 的血氧信號餘積脈波信號係傳送至分析單元110,測量儀 器1的另-個必要元件是用來測定局部熱產量的熱量測單 元120’熱量測單元120是可隔離受檢查身體部位的—特殊 熱慼測器。於是此部位只能透私流吸誠放熱,因此可 藉由溫度的時間分_量來測定供血量,在壯量大的情 况下’叉檢查身體雜能在很_時間内達到最高溫度, 在供血量小的情況下,要花較長的時間,此外,由於只利 用動脈溫度和局賴產絲測定測量位置處的溫度,所以 藉由測量溫度的外推,可推測出動脈溫度。甚至可將熱量 測單元120所記錄的測量信號傳送至分析單元ιι〇,以進行 進步的處理,此外,該測量儀器1包含阻抗測量單元 i30 ’該阻抗測量單元i3G係用來記錄生物電阻抗測量的局 =織參數,阻抗測量單元⑽的測量信號也同樣利用分 抑早疋110進行處理,最後’設有用以記錄ECG錢的ECG 早7" 132 ’ECG單元132也連接至分析單元110,以處理ECG 參閱第-圖,配置到光學測量單元则的測 :儀益1的柄4及光感測器5,熱量測單元12G係連接至 ^慼測II 6,阻抗測量單元⑽储由診_量儀器i的電 ^ 7亦/或7來記錄測量信號’分析單元1HH系進行所有測 篁信號的預處理,為了達到這樣的效果,信號係通過帶通 20 1379662 滤波器,以過遽在淨頻率分別為5〇和6〇 Hz之區域内的干 擾,此外,使信號經過雜訊抑制,來自光學測量單元1〇〇、 熱量測單元120、阻抗測量單元130及ECG單元132之通過 刀析單元110之處理過的信號係進入估算單元14〇,估算單 5 7G 140負責由測量信號計算出必要的診斷參數首先由阻 ^"、、i里單元130依照時間所記錄的測量信號來計算受檢杳 身體組織的組成(含水量、脂肪含量等),由光學測量單元 1〇〇的扣唬-以阻抗測量所測定的組織參數為基礎-計 算動脈血氧飽和度及微血管氧飽和度,由熱量測單元120 1〇的測量信號以及可由時間相關阻抗測量所導出的容積脈波 ,據進一步決定的是供血量與動脈溫度’脈波速率是由ecg 單元=的信號及光學測量單元1〇〇的信號所決定,最後, 利用估算單it 14〇㈣之前所有的計算結果料算在測量 點^靜脈如氧飽和度和其他的代謝參數,特別是局部耗 15氧量及血糖激度,藉由診斷單元150來判讀計算結果,在 電腦2上也作為軟體的診斷單元15()可用來估算由估算單 元140所計算的局部代謝參數,估算單元14〇及診斷單元 :士5〇係連接至能啟動顯示器9的圖形單元16〇,以顯示測量 、、口果’所得到的數據可記憶在記憶料1?〇巾,亦即同時 加=憶相關測量的日期和時間,此外,設置可將電腦2盘數 連接⑽輸所計算之生理參數的介面單元⑽,藉由 :=18〇可將所有數據和參數,特別是記憶在記_ 疋中據和參數傳送至未確切圖示的pc以供醫師進 25 tSl =儀,在該處進行更詳細的分析,尤其是可以核 ==所長期記錄的數據和參數的改變,以推測現 亦即請本發明之测量儀器1的第二實施例, αί話1G ’可了解習知操作鍵11係位於設備10的 旦儀51 i I平配置整合於行動電話10外殼側面區域的是測 :儀=的診療測量感測器,行動電話㈣使用者用手指 觸碰來進行測量’四個電極”,或 ;又置=電話1〇的侧面外殼表面上,以測量生物電阻 15 動_1G的使隻手同時與兩個電極7亦/ ^觸,,分_指额兩個電極觸碰以得到兩點導數(臂 = ::),利用行動電話1〇的微處理器(圖未示)來處 動電話10之測量儀器1的不同感測器所記錄 =夏域,將藉此方式所得到的生理參數顯示在行動電 ==幕12上,^柯叫任何如_其所關注 、- 使用者只要將手指放到電極7、7,上,另外用 手指驅動操作鍵U就能達到這樣的效果, ;,制措施會自動辨識觸碰並且開始测量,利用行動二 話10的微處理器處理測量信號之後,接著立刻藉由營幕12 參,,了細的功能可用來作為醫學測量儀 間接法的其疋成 所述之用於非侵入性测定城值之 的基礎上,該方法係檢查由體内葡萄播所起始的生 理反應之葡萄糖亦/或能量轉換的效應,請參考第一圖所 20 1379662 示’實例說明的相關敘述,與鍵盤3相似,光源4、4,及光 感測器5也不需要直接設置在行動電話10的外殼表面上, 取而代之的是可藉由光導纖維將光線由外殼表面導出亦/ 或導引至外殼表面’而實際光源亦/或感測器係設置在外殼 5内部’可將數個光源亦/或感測器耦合到特定的光導纖維。 請參閱第四圖,本發明之測量儀器1另—實施例,測 里儀益1的各種不同測量單元係整合在外形尺寸非常小的 感測器外殼400内’設置在感測器外殼400上側的是平面 型ECG電極7 ’其係由薄導電箔所構成,將測量儀器1安裝 10到電腦鍵盤3或行動設備時,係以使用者能觸碰到ecg電 極7及另一個具有各種不同ECG導出末端的電極(圖未示) 的方式來設置感測器外殼4〇〇,ECG電極7適合為薄的不銹 鋼箱’實例所示其尺寸為5 mm (w) X 8 mm (L) X 1.8 mm⑻ 之微型外殼的小型結構模組可以靈活而且低成本地將測量 15儀器安裝到市售各種設備的不同外殼中,為了能同時測定 動脈血氧飽和度,係將光學測量單元100,亦即脈搏血氧計 整合在感測器外殼4〇〇内,該脈搏血氧計包含一或數個光 輻射感測器’其輕射可通過Ecg電極7的凹孔410,此外, 该脈搏血氧計還包含兩個光輻射感測器,例如為光電二極 20體形式者,身體組織(例如按壓在電極7的手指)内所散 射的光會下降通過電極7的兩個凹孔42〇和430而到達輻 射感測器’凹孔420和430係以距凹孔410不同的距離設 置’在此測量儀器1中,來自外殼棚内部的兩個或數個 27 IS3 1379662 光輕射源(例如發光二極辦、 適當的導紐巾,nubP、有—係連制光導纖維中或 :’並且將測量儀器1所有心::在有相== 到待檢查的身體組織内n f” 5導纖維或適當成形的導光體,該 自刀__合至一光 r檢查身體_内循環之血液的; 僅發光二極體適用而且其他輕射源,;如= 振腔面射型雷射(vc:SEL)也適合 /、 感測器,亦即熱阻器整合在感測器外殼400内= 1〇定讀^组織的熱性質,在咖電極?中設置另一個凹孔 ’在感測H外殼軸設置熱阻器,使軸 ==好的熱接觸,熱阻器係設置在光輕射源之 ==孔與第-光電二極體之光導纖維的凹孔 Z之間,測讀器!可再增設阻抗測量單元⑽而不會有 上^= I為了 樣的效果’必須在感測器外殼400 :置至卜附加平面電極(圖未示)作為阻抗测量單 70 ㈣電_或量測電極,可以適當地使用相同的量 測電極來記錄生物阻抗信號和ECG信號,為了使測量儀器】 (=如與行動電話1〇的電子線路)電性接觸利用適當的 )導線佈線將感測器外殼棚與所有整合的測量單元直 裝在帶狀電纜450上,因此可利用帶狀電纜45〇進行 的,氣安裝,帶狀電鏡45G在適當位置處可具有加強件糊 以提升其穩定性。 清參閱第五圖’與第四圖有關的光導元件500以及全 部輕合在光導元件500底面的四個LED晶片501、502、503、 504 ’該LED晶片501、502、503、504構成測量儀器1之 光學測量單元100的光源,藉由此一特定光導元件5〇〇將 5所有LED晶片501、502、503、504所發出的輻射導引至感 測器外殼400的表面,這四個LED晶片501、502、503、504 一起黏合在例如PCB的一基板(未圖示)上。 请參閱苐六圖,本發明之測量儀器1的替代實施例, 該測量儀器1包含兩個手指夾板601和602,透過該手指爽 10板601、602可將左右手的一根手指分別固定在測量儀器1 的輪射感測器5上,ECG測量與阻抗測量用的輕射源4、轄 射感測器5、電極7、7’,還有熱感測器6均整合在手指炎 板601内,請參閱第八圖所示,實例的特點是輻射源4所 產生的光係由輻射感測器5以雙重的方式,也就是在藉由 15輻射感測器5(該等輻射感測器5設置在輻射源4對面的手 指夾板601上半部)傳送的方向上以及另外在藉由整合於 手指夾板601下半部之輻射感測器5(該等輻射感測器偵測 手指組織内散射回來的光線)傳送的方向上進行測量,設 置用於透射測定法的是分別位於輻射源4與對面輻射减測 20器5的透鏡6〇3、604,設置透鏡603使光的定向輻射照射 到組織内,透鏡604將透射光集中並聚焦在輻射感測器' 5 上,設置在手指夾板602中的只有兩個電極7、7,,這兩 個電極7、7’制乍為整合於手指夾板刪之電極的相對電 1379662 極’這些配置係用來進行ECG測量(兩點導數)以及(總 體)生物阻抗測量,手指夾板601和602係藉由電繞605、 咖連接至中央單元撕,中央單元_包含測量儀器i的 分析早το 11〇、估算單元14〇和診斷單元15〇。藉由營幕_ 5來顯=所得到的測量值,如第六圖所示,可供量測由娜 感測器5所記錄的各種光學測量值,例如為光強度形式者, 其中透射強度為而由不同組織部位所散射回來的強度 為/脱和“。可在(人造)標準物質上進行測量以作為校 正之用。然後可得到/re/值。這四個測量值係構成進一步估 10 鼻的基礎。 請參閱第七圖,其中設有一(或數個)LEDS 702的中 空反射器701,該LED702是能在所有空間方向上發光的 SMD-LED,LED 702的光在中空反射器701的内部表面進行 漫反射,中空反射器701係以一種烏布里希球所構成。連 I5接至中空反射器701的是聚光透鏡形式的光學系統7〇3,如 第七圖所示,該聚光透鏡會由LED 702所發出的光產生定 向輻射,此外,中空反射器701還包含出口孔7〇4,漫輕射 係通過該出口孔704進入身體組織,在出口孔704的範固 内亦可設置適當的光學系統,以得到期望的輻射角,利用 2〇具有不同焦距範圍的透鏡可以產生不同的輻射角,第七圖 所示的結構可有利於以低成本大量地製造成小型的預製單 元。將LED702的電性連接導出中空反射器701,該中 空反射器701例如可形成為由透明塑膠材料所製成的實心 1379662 體’而將LED 702埋置在裡面’然後在外部用擴散反射材 料(例如氧化鋁或硫酸鋇)加以塗布。 請參閱第八圖,表示一替代結構,其中,發光二極體 8〇1係耦合至Y字形分叉的光導纖維802,聚光透鏡803係 5連接在左邊分支的末端,進而可得到由輻射源801所發出 之輻射的定向輻射,從出口孔804發射一光錐,其孔徑角 係對應於光導纖維802内部的最大全反射角,以這樣的方 式’可以檢查不同體積範圍的身體組織。 請參閱第九圖’本發明之測量儀器1之感測器外殼 表面上的光學測量單元100之感測器,該測量儀器丨係靠 在待檢查的身體組織上,光學系統7〇3和出口孔7〇4位於 測定面平面上的,光學系統703和出口孔7〇4係分別設置 在轴線901的左邊和右邊,此外,將轄射感測器5設置在 轴線901上’每個輪射感測器5都具有距光學系統7〇3和 15 出口孔704相同的距離,這兩個輻射感測器5具有距輕射 源不同的雜’此配置可以考慮到由身體組織内的已侦測 輻射所涵韻距離’因此可以在不同深度組織層中檢查血 液中和組織t的氧濃度。 至十二圖’本發明之診斷測量儀器1之感 十一圖所示,感測器外殼400 置’電極7和7,係配置到ecg單元ΐ32 單元130,如第十二圖所示,爲用 ' 臂騎難_對電極配置,第十 31 [S1 ==二單:包含_交_ (請參閱第六圖)進行受檢查患者的手指部位 點測量的情況下,電7’ ’ _四 不會扭曲制量,餘7 2 之間的過渡電阻 至幾公分,如第十、〗的距離可以只有幾亳米 7, 圖所示,在測量過程中四個電極7、 15 全部同時與皮膚表面的相同部位,例如患者的手指觸 ’可錯由供應變頻交流電來測量複阻抗,(未圖示 _電£权由電極7來記制量錢,測量信號係藉由 =數位轉換器(同樣未圖示)數位化,然後進行離散傅 >、變換’於是結果係提供阻抗的實部和虛部’也就是電 阻值和電抗值,這魏值可進—步進行數字處理以用於估 异’如第十、十—_示’電極7、7’係形成為互相平行間 隔,列且彼此藉由中間間隔絕緣的條帶。設置在中間間隔 的疋光源4、輻射感測器5以及熱感測_ 6,所有感測器係 與待檢查的身體組織接觸。 請參閱第十三圖,本發明之測量儀器丨的另一實例, 襄設在感測器外殼400外部的是ECG電極7,用一隻手的手 指頭與此ECG電極7觸碰,將另一隻手的手指頭插入管狀 孔13内,設置在管狀扎13内部的是電極7、7’ 、輻射源 4、輻射感測器5以及熱感測器6 ’另外設置在管狀孔η内 部的是能將手指固定並且以限定壓力將手指輕輕壓在感測 器上的可充氣式氣墊14,為了清楚起見,圖中係省略測量 20 儀操作鍵u及用以讀出測量 睛參閱第十四圖,本發明之,顯不螢幕. 元130的轉換技術配置,該 儀器1之阻抗測量單 外部週期信號61的數位信號發二:元:包含-饋入 換器62將數位信號轉換成類號60,错由數位/類比轉 行放大,以這樣的方式產生變頻5二’=,^ 極7供應至身體_,連 ^彳5號’、#由饋電電 器66和_料器R7 大益65下游的是可變· .大和魏後峨比信賴換成 二?:由數位傅立葉變換單元69進行變換,將傅4: =純絲實部和虛部分職存在 71,= 存❹、71可_介面72進行⑽。 此暫 【圖式簡單說明】 筮一圖本發明者斷測量儀器整合於電腦鍵盤示意圖。 =圖本發明診_量儀H的功能方塊圖。 圖本發明珍斷測量儀器整合於行動電話示意圖。 四圖本發明診斷測量儀器的感測器外殼示意圖。 五圖本發明診斷测量儀器的光導元件示意圖。 第"、圖本發明診斷測量儀器的另-實施例。 第七圖本發明具有輻射源的中空反射器示意圖。 第八圖本發明γ_字形分叉的光導元件示意圖。 第九圖本發明診斷測量儀器之光學測量單元配置的〜貧 1379662 施例。 第十圖本發明具有電極、輻射源、輻射感測器及熱感測器 之感測器外殼的外殼表面之一配置實施例。 第十二圖本發明感測器外殼的外殼表面之另一配置實施 5 例。 第十二圖本發明用於ECG測量與生物阻抗測量的相對電 極配置實施例。 第十三圖本發明診斷測量儀器的另一實施例。 第十四圖本發明診斷測量儀器之阻抗測量單元的方塊電 10 路圖。 【主要元件符號說明】 1 測量儀器 10 行動電話 100 光學測量單元 110 分析單元 15 120 熱測量單元 130 阻抗測量單元 132 ECG單元 140 估算單元 150 診斷單元 160 圖形單元 170 記憶單元 180 介面單元 11 操作鍵 12 螢幕 20 13 管狀孔 14 充氣式氣塾 2 電腦 3 鍵盤 4 光源(輻射源、 發光二極體) 4, 光源(輻射源、 雷射) 400 感測器外殼 410 凹孔 1379662 (S3 420 凹扎 430 凹孔 - 440 凹扎 450 帶狀電纜 460 加強件 5 光感測器(輻射感測器) 5 500 光導元件 501 LED晶片 502 LED晶片 503 LED晶片 504 LED晶片 6 熱感測器 • 60 數位信號發生器 61 饋入外部週期信號 10 62 數位/類比轉換器 63 放大器 65 放大器 66 可變衰減器 67 深通濾、波器 68 類比/數位雛器 * 69 數位傅立葉變換單元 601 手指夾板 602 手指夾板 15 603 透鏡 604 透鏡 • 605 電纜 606 電纜 607 中央單元 608 螢幕 7 電極(ECG電極、 饋電電極) 7, 電極 70 暫存器. 20 71 暫存器 72 介面 701 中空反射器 702 LEDs 703 光學系統 704 出口孔 705 電性連接 801 發光二極體 35 1379662 802 光導纖維 803 聚光透鏡 804 出口孔 9 顯示器 901 軸線Please refer to the second figure, the measuring instrument of the invention! The optical measuring unit 100 is included (the H system is used for optically measuring the oxygen concentration of the body tissue at a known measuring point, and the blood oxygen signal residual pulse signal recorded by the optical hard unit 100 is transmitted to The analysis unit 110, another necessary component of the measuring instrument 1 is a heat measuring unit 120 for determining the local heat yield. The heat measuring unit 120 is a special thermal detector that can isolate the body part to be inspected. It can only be used to absorb heat from the private stream. Therefore, the amount of blood can be measured by the time-quantity of the temperature. In the case of a large amount of growth, the fork can check the body's energy to reach the highest temperature in a very short period of time. In the case of a small amount, it takes a long time. In addition, since the temperature at the measurement position is measured only by the arterial temperature and the hairline, the temperature of the artery can be estimated by extrapolation of the measured temperature. The measurement signal recorded by the heat measuring unit 120 is transmitted to the analysis unit ιι to perform advanced processing. In addition, the measuring instrument 1 includes an impedance measuring unit i30. The impedance measuring unit i3G is used to record the raw The measurement signal of the impedance measurement of the object is also processed by the impedance measurement unit (10). Finally, the ECG unit 132 with the ECG for recording ECG money is also connected to the analysis. Unit 110, for processing the ECG, refer to the first figure, the measurement to the optical measuring unit: the handle 4 of the Yiyi 1 and the photo sensor 5, and the heat measuring unit 12G is connected to the measuring unit II 6, the impedance measuring unit (10) Storage diagnosis _ quantity instrument i electric ^ 7 also / or 7 to record the measurement signal 'analysis unit 1HH system for all the pre-processing of the measurement signal, in order to achieve this effect, the signal is passed through the bandpass 20 1379662 filter, Interference in the region where the net frequencies are 5〇 and 6〇Hz, respectively, and the signal is subjected to noise suppression from the optical measuring unit 1〇〇, the heat measuring unit 120, the impedance measuring unit 130, and the ECG unit. The signal processed by the knife analyzing unit 110 enters the estimating unit 14A, and the estimating unit 5 7G 140 is responsible for calculating the necessary diagnostic parameters from the measurement signal, which is first recorded by the unit 130 in accordance with the time. Measurement signal comes Calculate the composition of the body tissue (water content, fat content, etc.), and calculate the arterial oxygen saturation and microvascular oxygen saturation based on the optical measurement unit 1〇〇-based on the tissue parameters measured by impedance measurement. The measurement signal from the heat measurement unit 120 1 以及 and the volume pulse wave derived from the time-dependent impedance measurement, according to further determination is the blood supply volume and the arterial temperature 'pulse wave rate is the signal and optical measurement by the ecg unit= The signal of unit 1〇〇 is determined. Finally, all the calculation results before the estimation of it 14 〇 (4) are calculated at the measurement point ^ vein such as oxygen saturation and other metabolic parameters, especially local consumption of 15 oxygen and blood sugar The diagnosis unit 150 is used to interpret the calculation result, and the diagnostic unit 15 (also as a software on the computer 2) can be used to estimate the local metabolic parameters calculated by the estimation unit 140, the estimation unit 14 and the diagnosis unit: It is connected to the graphic unit 16A capable of starting the display 9, so as to display the measurement, and the data obtained by the word "can be memorized in the memory material 1? wipes, that is, simultaneously add = recall related test Date and time, in addition, set the interface unit (10) that can connect the computer's 2 disk number to the physiological parameter calculated by (10), and: = 18〇 can put all the data and parameters, especially the memory in the record The parameters are transmitted to the pc that is not exactly shown for the doctor to enter the 25 tSl = instrument, where a more detailed analysis is performed, in particular, the data of the long-term record and the change of parameters can be verified by the kernel == In the second embodiment of the measuring instrument 1 of the invention, it can be understood that the conventional operating key 11 is located in the device 10 and the flat configuration is integrated in the side area of the outer casing of the mobile phone 10. Measuring sensor, mobile phone (4) user touches with a finger to measure 'four electrodes', or; set = phone 1 〇 on the side of the outer casing surface to measure the bio-resistance 15 With the two electrodes 7 also / ^ touch, the two electrodes touched to get the two-point derivative (arm = ::), using the mobile phone 1 〇 microprocessor (not shown) to call 10 different measuring instruments of the measuring instrument 1 recorded = Xia domain, will be used this way The physiological parameters that are displayed are displayed on the mobile power == screen 12, ^ 柯 is called _ its concern, - the user simply puts the finger on the electrodes 7, 7, and drives the operation key U with the finger to achieve this The effect of the system will automatically identify the touch and start the measurement. After processing the measurement signal with the microprocessor of the action 2, then immediately by the camp 12, the fine function can be used as a medical measuring instrument. The method is based on the non-invasive measurement of the city value, the method is to check the effect of glucose and/or energy conversion of the physiological reaction initiated by the grape in vivo, please refer to the first Figure 20 1379662 shows a related description of the example, similar to the keyboard 3, the light sources 4, 4, and the light sensor 5 need not be directly disposed on the outer surface of the mobile phone 10, but instead can be optical fiber Light is also directed from the surface of the outer casing and/or directed to the surface of the outer casing 'and the actual light source and/or the sensor is disposed inside the outer casing 5' can couple several light sources and/or sensors to a particular optical fiber. Referring to the fourth figure, in addition to the embodiment of the measuring instrument of the present invention, various measuring units of the measuring instrument 1 are integrated in the sensor housing 400 having a very small outer shape and disposed on the upper side of the sensor housing 400. The planar ECG electrode 7' is composed of a thin conductive foil. When the measuring instrument 1 is mounted 10 to the computer keyboard 3 or the mobile device, the user can touch the ecg electrode 7 and the other has various ECGs. The end of the electrode (not shown) is used to set the sensor housing 4〇〇, and the ECG electrode 7 is suitable for a thin stainless steel box. The example shows a size of 5 mm (w) X 8 mm (L) X 1.8 The small-sized module of the micro-shell of mm(8) can be used to install the measuring instrument 15 in different housings of various commercially available devices flexibly and at low cost. In order to simultaneously measure arterial oxygen saturation, the optical measuring unit 100, that is, the pulse is used. The oximeter is integrated in a sensor housing 4〇〇, the pulse oximeter comprising one or several optical radiation sensors 'light-lighting through a recess 410 of the Ecg electrode 7, in addition, the pulse oximeter Also includes two optical radiation sensing For example, in the form of a photodiode 20 body, light scattered in body tissue (eg, a finger pressed against the electrode 7) will descend through the two recessed holes 42 and 430 of the electrode 7 to reach the radiation sensor's recessed hole. 420 and 430 are set at different distances from the recess 410. In this measuring instrument 1, two or more 27 IS3 1379662 light source sources from the inside of the housing shed (for example, a light-emitting diode, a suitable guide towel) , nubP, has - tied optical fiber in or: 'and will measure the whole heart of the instrument 1:: in the phase == to the body tissue to be inspected nf" 5 fiber or appropriately shaped light guide, the Knife __ combined with a light r to check the blood of the body _ inner circulation; only the illuminating diode is applicable and other light source, such as = cavity surface type laser (vc: SEL) is also suitable /, sensing , that is, the thermal resistor is integrated in the sensor housing 400 = 1 〇 读 ^ ^ 组织 组织 组织 组织 ^ ^ ^ 咖 咖 咖 咖 咖 咖 咖 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感 感Axis == good thermal contact, the thermal resistor is set in the light source of the light source == hole and the photodiode of the photodiode Between the holes Z, the reader! The impedance measuring unit (10) can be added without the effect of ^=I for the sample 'must be in the sensor housing 400: set to the additional plane electrode (not shown) as the impedance Measuring unit 70 (four) electric _ or measuring electrode, the same measuring electrode can be used to record the bio-impedance signal and the ECG signal, in order to make the measuring instrument (== such as the electronic circuit of the mobile phone) electrically contact Appropriate) wire routing allows the sensor housing shed and all integrated measuring units to be mounted directly on the ribbon cable 450, so that the ribbon cable 45 can be used for gas installation, and the strip electron microscope 45G can have a suitable position. Strengthen the paste to improve its stability. Referring to the fifth figure 'the light guiding element 500 related to the fourth figure and the four LED chips 501, 502, 503, 504 which are all lightly coupled to the bottom surface of the light guiding element 500, the LED chips 501, 502, 503, 504 constitute a measuring instrument. The light source of the optical measuring unit 100, by which the radiation emitted by all the LED chips 501, 502, 503, 504 is guided to the surface of the sensor housing 400 by the specific light guiding element 5? The wafers 501, 502, 503, 504 are bonded together on a substrate (not shown) such as a PCB. Referring to FIG. 6 , an alternative embodiment of the measuring instrument 1 of the present invention, the measuring instrument 1 includes two finger splints 601 and 602 through which a finger of the right and left hands can be respectively fixed in the measurement. On the wheel sensor 5 of the instrument 1, the light source 4 for the ECG measurement and impedance measurement, the ray detector 5, the electrodes 7, 7', and the thermal sensor 6 are integrated in the finger plate 601. In the eighth embodiment, the example is characterized in that the light source generated by the radiation source 4 is in a dual manner by the radiation sensor 5, that is, by the 15 radiation sensor 5 (the radiation sensing The device 5 is disposed in the direction in which the upper half of the finger splint 601 opposite the radiation source 4 is transmitted and additionally by the radiation sensor 5 integrated in the lower half of the finger splint 601 (the radiation sensors detect finger tissue) The internally scattered light is measured in the direction of transmission, and the lenses 6 〇 3, 604 respectively disposed on the radiation source 4 and the opposite radiation minus 20 are provided for the transmission measurement, and the lens 603 is provided to directional radiation of the light. Illuminating into the tissue, lens 604 concentrates the transmitted light and focuses it on the spoke On the sensor '5, there are only two electrodes 7, 7 disposed in the finger splint 602, and the two electrodes 7, 7' are made up of the opposite electro-electrodes 1371662 poles integrated in the electrode of the finger splint. Used for ECG measurement (two-point derivative) and (overall) bioimpedance measurement, finger splints 601 and 602 are connected to the central unit by electric winding 605, coffee, and the central unit _ contains the analysis of measuring instrument i το 11〇 The estimating unit 14A and the diagnostic unit 15A. The measured value obtained by the camp _ 5, as shown in the sixth figure, can be used to measure various optical measurements recorded by the sensor 5, for example, in the form of light intensity, wherein the transmission intensity The intensity that is scattered back by different tissue parts is /. and can be measured on the (artificial) reference material for correction. Then the /re/ value can be obtained. These four measurements constitute a further estimate. 10 The basis of the nose. Please refer to the seventh figure, which is provided with a hollow reflector 701 of one (or several) LEDS 702, which is an SMD-LED capable of emitting light in all spatial directions, and the light of the LED 702 is in the hollow reflector The inner surface of the 701 is diffusely reflected, and the hollow reflector 701 is composed of a Ubrich ball. The connection of the I5 to the hollow reflector 701 is an optical system 7〇3 in the form of a collecting lens, as shown in the seventh figure. The concentrating lens generates directional radiation by the light emitted by the LED 702. In addition, the hollow reflector 701 further includes an exit hole 7〇4 through which the diffuse light ray enters the body tissue, and the vent of the exit hole 704 Appropriate optical system can also be set in the solid In order to obtain the desired radiation angle, different radiation angles can be generated by using 2 lenses with different focal length ranges, and the structure shown in the seventh figure can be advantageously manufactured into a small prefabricated unit at a low cost. The flexible connection leads to a hollow reflector 701, which may be formed, for example, as a solid 1379662 body made of a transparent plastic material and embedding the LED 702 therein' and then externally diffusing a reflective material (such as alumina or The barium sulfate is coated. Referring to the eighth figure, an alternative structure is shown in which the light-emitting diodes 8〇1 are coupled to the Y-shaped bifurcated optical fibers 802, and the collecting lens 803 is connected at the end of the left branch. The directional radiation of the radiation emitted by the radiation source 801 can be obtained, and a light cone is emitted from the exit aperture 804, the aperture angle of which corresponds to the maximum total reflection angle inside the optical fiber 802, in such a manner that different volumes can be inspected. Scope of body tissue. Please refer to the ninth figure, the sensor of the optical measuring unit 100 on the surface of the sensor housing of the measuring instrument 1 of the present invention. The measuring device is placed on the body tissue to be inspected, the optical system 7〇3 and the outlet opening 7〇4 are located on the plane of the measuring surface, and the optical system 703 and the outlet opening 7〇4 are respectively disposed on the left side of the axis 901 and On the right, in addition, the illuminating sensor 5 is placed on the axis 901. Each of the strobe sensors 5 has the same distance from the exit holes 704 of the optical systems 7〇3 and 15, which are two radiation sensors. 5 has a different kind of light source than the light source. This configuration can take into account the distance from the detected radiation in the body tissue. Therefore, the oxygen concentration in the blood and tissue t can be checked in different depth tissue layers. Figure 2 is a perspective view of the diagnostic measuring instrument 1 of the present invention, the sensor housing 400 is provided with 'electrodes 7 and 7, which are arranged to the ecg unit ΐ 32 unit 130, as shown in the twelfth figure, for the 'arm Riding difficulty _ counter electrode configuration, the tenth 31 [S1 == two single: including _ cross _ (see the sixth figure) in the case of the finger position measurement of the patient being examined, the electricity 7' ' _ four will not be distorted Production, the transition resistance between the remaining 7 2 to a few centimeters, such as the tenth, the distance can only There are a few metres of rice 7, as shown in the figure, during the measurement process, all the four electrodes 7, 15 are simultaneously at the same part of the skin surface, for example, the patient's finger touches. It is wrong to supply the variable frequency alternating current to measure the complex impedance (not shown). The electric weight is recorded by the electrode 7, and the measurement signal is digitized by a = digital converter (also not shown), and then the discrete Fu > transform is performed. Then the result is the real part and the virtual of the impedance. '' is the resistance value and the reactance value, which can be digitally processed for estimation'. For example, the tenth, tenth, and the 'electrodes 7, 7' are formed in parallel with each other, column and each other. Strips insulated by intermediate spaces. The xenon light source 4, the radiation sensor 5, and the thermal sensing _6 disposed at the intermediate interval are in contact with the body tissue to be inspected. Referring to FIG. 13, another example of the measuring instrument of the present invention is disposed outside the sensor housing 400 as an ECG electrode 7, which is touched by the finger of one hand with the ECG electrode 7. The finger of one hand is inserted into the tubular hole 13, and the inside of the tubular tie 13 is the electrode 7, 7', the radiation source 4, the radiation sensor 5, and the thermal sensor 6' are additionally disposed inside the tubular hole η It is an inflatable air cushion 14 capable of fixing a finger and gently pressing a finger on the sensor with a limited pressure. For the sake of clarity, the measurement unit 20 is omitted and the measuring eye is read. The fourteenth figure, the present invention, shows the screen. The conversion technique of the element 130, the impedance measurement of the instrument 1 is performed by the digital signal of the single external periodic signal 61. The binary: inclusion-infeed converter 62 converts the digital signal into Class number 60, the error is amplified by digital/analog conversion, in such a way that the frequency conversion 5 2 '=, ^ pole 7 is supplied to the body _, and the connection number 5 ', # is fed by the electric appliance 66 and the _ hopper R7 The downstream of the 65 is variable. · Dahe Wei Houwei is more than two trustworthy?: by the number of Fourier Conversion unit 69 converts the 4 Fu: pure silk = real and imaginary part of the post 71 is present, = ❹ The memory, interface 71 can be _ 72 ⑽. This brief [simplified description of the diagram] 筮一图 The inventor of the inventor disconnected the measuring instrument integrated into the computer keyboard schematic. = Functional block diagram of the diagnostic instrument _ meter H of the present invention. The invention is integrated with a mobile phone schematic diagram. Figure 4 is a schematic view of the sensor housing of the diagnostic measuring instrument of the present invention. Figure 5 is a schematic view of a light guiding element of the diagnostic measuring instrument of the present invention. A further embodiment of the diagnostic measuring instrument of the present invention. Figure 7 is a schematic view of a hollow reflector of the invention having a radiation source. Figure 8 is a schematic view of a γ-shaped bifurcated light guiding member of the present invention. The ninth figure is an example of the configuration of the optical measuring unit of the diagnostic measuring instrument of the present invention. Figure 11 shows an embodiment of a configuration of an outer surface of a sensor housing having electrodes, radiation sources, radiation sensors and thermal sensors. Fig. 12 shows another example of the configuration of the outer surface of the outer casing of the sensor housing of the present invention. Twelfth Figure The present invention is a relative electrode configuration embodiment for ECG measurement and bioimpedance measurement. Thirteenth embodiment Another embodiment of the diagnostic measuring instrument of the present invention. Figure 14 is a block diagram of the impedance measuring unit of the diagnostic measuring instrument of the present invention. [Main component symbol description] 1 Measuring instrument 10 Mobile phone 100 Optical measuring unit 110 Analysis unit 15 120 Thermal measuring unit 130 Impedance measuring unit 132 ECG unit 140 Estimating unit 150 Diagnostic unit 160 Graphic unit 170 Memory unit 180 Interface unit 11 Operation key 12 Screen 20 13 Tubular hole 14 Inflatable gas cylinder 2 Computer 3 Keyboard 4 Light source (radiation source, LED) 4, Light source (radiation source, laser) 400 Sensor housing 410 Recessed hole 1379662 (S3 420 concave 430 concave Hole - 440 Draw 450 Ribbon Cable 460 Reinforcement 5 Light Sensor (radiation sensor) 5 500 Light Guide Element 501 LED Chip 502 LED Chip 503 LED Chip 504 LED Chip 6 Thermal Sensor • 60 Digital Signal Generator 61 Feeding external periodic signal 10 62 Digital/analog converter 63 Amplifier 65 Amplifier 66 Variable attenuator 67 Deep-pass filter, waver 68 Analog/digital device* 69 Digital Fourier transform unit 601 Finger splint 602 Finger splint 15 603 Lens 604 lens • 605 cable 606 cable 607 central unit 60 8 Screen 7 electrode (ECG electrode, feed electrode) 7, electrode 70 register. 20 71 register 72 interface 701 hollow reflector 702 LEDs 703 optical system 704 outlet hole 705 electrical connection 801 LED 35 1379662 802 optical fiber 803 condenser lens 804 exit hole 9 display 901 axis

3636

Claims (1)

1379662 - 101年5月|〇日修正替換頁 七、申請專利範圍: 1、 一種非侵入性記錄身體組織的至少一種生理參數的 診斷測量儀器,該診斷測量儀器係由具有至少一用於照射 待檢查身體組織之輻射源的一光學測量單元及至少一用於 偵測由身體組織所散射亦/或傳送之輻射的輻射感測器所 構成,其中該至少一輻射源與該至少一輻射感測器係設置 於一般感測器外殼内,其特徵為藉由兩個或兩個以上的ECG 電極來記錄ECG信號的一 ECG單元,其中該ECG單元的至 φ 少一 ECG電極係設置於感測器外殼之外殼表面上,以及一 生物電阻抗測量單元,其中該阻抗測量單元的至少一饋電 電極或量測電極係設置於感測器外殼之外殼表面上,使ECG 電極及饋電電極或量測電極與光學測量單元所擷取之身體 組織部位的皮膚表面觸碰,該至少一個輻射源係設置於一 擴散反射的中空反射器中。 2、 如申請專利範圍第1項之診斷測量儀器,其特徵為 一溫度感測器或熱感測器係設置於該感測器外殼内或該感 ®測11外殼上。 3、 如申請專利範圍第1項之診斷測量儀器,其特徵為 該至少一 ECG電極及該至少一饋電電極或量測電極係設計 成由導電材料所製成的平面箔或金屬薄片。 4、 如申請專利範圍第3項之診斷測量儀器,其特徵為 該ECG電極或該饋電電極或量測電極具有至少一凹孔,使 至少一輻射源所發出的輻射通過,進入待檢查的身體組織 37 1379662 101年5月p日修正替換頁* 内,或是使身體組織所散射亦/或傳送的輻射通過,傳送 · 輻射感測器。 '1 5、 如申請專利範圍第4項之診斷測量儀器,其特徵為 至少有另一個用於溫度感測器或熱感測器的凹孔。 · 6、 如申請專利範圍第1項之診斷測量儀器,其特徵為 該ECG電極的其中至少一個同時為該生物電阻抗測量單^ 的一饋電電極或量測電極。 =7、如申請專利範圍第1項之診斷測量儀器,其特徵為 該生物電阻抗測量單元係配備用以藉由至少一對量測電極 來記錄皮膚表面的阻抗測量信號,該對量測電極的電極距 離小於-亳米至數公分’以便在測量過程中,使該對量測 電極的兩個電極能同時與該皮膚表面的相同部位觸碰,以 局部記_阻抗測量信號。 M 8、如申請專利範圍第7項之診斷測量儀器,其特徵為 :對,電電極,以透過皮膚表面對該身體組織,亦即在觸 碰該畺測電極的皮膚表面部位施加變頻交流電。 ^旦9、如申請專利範圍第7項之診斷測量儀器,其特徵為 φ ^里測電極和饋電電極係設計成互相平行延伸的接觸條。 10二如申請專利範圍第1項之診斷測量儀器,其特徵 ,估算單元,係連接至該生物電阻抗測量單元,用以測 疋局部阻抗測量信號的時間變化。 如申請專利範圍第1項之診斷測量儀器,其特徵 、、、口疋裝置,用以將待檢查患者的身體部位固定至該减 38 1379662 101年5月^日修正替換頁 4 測器外殼上。 12、 如申請專利範圍第11項之診斷測量儀器,其特徵 _ 為該固定裝置係設計成一手指夾板。 13、 如申請專利範圍第11項之診斷測量儀器,其特徵 為該固定裝置包含能將身體部位壓在該量測電極亦/或饋 電電極上的一可充氣式氣墊。 14、 如申請專利範圍第1項之診斷測量儀器,其特徵 為連接至一娛樂設備或通訊技術設備或連線至另一可攜式 φ設備或配件。 15、 如申請專利範圍第14項之診斷測量儀器,其特徵 為該設備為一行動裝置,尤其是筆記型電腦、膝上型電腦 、行動電話、掌上型電腦或手持裝置。 16、 如申請專利範圍第1項之診斷測量儀器,其特徵 為該光學測量單元包含至少兩個用於偵測由身體組織所散 射亦/或傳送之賴射的轄射感測器,該等賴射感測器係以距 輻射源不同的距離設置。 17、 如申請專利範圍第1項之診斷測量儀器,其特徵 為至少一輻射源的光輻射具有能照射受檢查身體組織之不 同體積部位的效果。 18、 如申請專利範圍第17項之診斷測量儀器,其特徵 為設置具有不同空間輻射特性的兩個輻射源。 19、 如申請專利範圍第1項之診斷測量儀器,其特徵 為該至少一輻射源係連接至一光導元件,該光導元件係將 39 1379662 101年5月曰修正替換頁 該輻射源所發出的輻射傳導至感測器外殼表面。 20、如申請專利範圍第19項之珍斷測量儀器,其特徵 為能產生進入身體組織内的定向輻射亦/或漫輻射的一光 學系統係連接至該光導元件。 2卜如申請專利範圍第!項之診斷測量儀器,其特徵為該 中空反射器係由一種烏布里希球所構成。 22、如中請專利範§|第丨項之診_量儀器,其特徵為 能產生進入身體組織内之定向輻射的—光學系統係連接至該 中空反射器。 23、 如申請專利範圍第丨項之診斷測量儀器,其特徵 為該中空反射器包含使漫輻射通過而進入身體組織内的至 少一出口孔。 24、 如申睛專利範圍第i項之診斷測量儀器,其特徵 為該至少一種生理參數是為血糖值。 25、 一種非侵入性記錄身體組織的至少一種生理參數 的診斷測量儀器,該診斷蜊量儀器係由具有至少一用於照 射待檢查身體組織之輻射裉的一光學測量單元及至少一用 於偵測由身體組織所散射亦/或傳送之輻射的輻射感測器 所構成,其特徵為該至少〜輻射源係設置於一擴散反射的 中空.反射器中。 26、 如申請專利範圍第25項之診斷測量儀器,其特徵 為該中空反射器係由一種烏布里希球所構成。 27、 如申請專利範圍第25項之診斷測量儀器,其特徵 40 1379662 • 101年5月日修正替換頁 f _ 為能產生進入身體組織内之定向輻射的一光學系統係連接 至該中空反射器。 28、如申清專利範圍第25項之診斷測量儀器,其特徵 V 為該中空反射器包含使漫輻射通過而進入身體組織内的至 0 t 少一出口孔。 411379662 - May 101 | Next day revised replacement page VII. Patent application scope: 1. A non-invasive diagnostic measuring instrument for recording at least one physiological parameter of body tissue, the diagnostic measuring instrument having at least one for irradiation An optical measurement unit for examining a radiation source of body tissue and at least one radiation sensor for detecting radiation scattered and/or transmitted by body tissue, wherein the at least one radiation source and the at least one radiation sensor The device is disposed in a general sensor housing and is characterized by an ECG unit for recording ECG signals by two or more ECG electrodes, wherein the ECG unit is set to the sensing of less than one ECG electrode system a surface of the outer casing of the casing, and a bioelectrical impedance measuring unit, wherein at least one feeding electrode or measuring electrode of the impedance measuring unit is disposed on a surface of the outer casing of the sensor housing, so that the ECG electrode and the feeding electrode or The measuring electrode is in contact with the skin surface of the body tissue portion taken by the optical measuring unit, and the at least one radiation source is disposed in a diffuse reflection hollow inverse Vessel. 2. The diagnostic measuring instrument of claim 1, wherein a temperature sensor or a thermal sensor is disposed in the sensor housing or on the sensing 11 housing. 3. The diagnostic measuring instrument of claim 1, wherein the at least one ECG electrode and the at least one feeding electrode or measuring electrode are designed as planar foils or foils made of a conductive material. 4. The diagnostic measuring instrument of claim 3, wherein the ECG electrode or the feeding electrode or the measuring electrode has at least one recessed hole, so that at least one radiation source emits radiation and enters the to be inspected. Body tissue 37 1379662 May 2011 p modified within the replacement page *, or the body tissue scattered and / or transmitted radiation through, transmission / radiation sensor. A diagnostic measuring instrument according to claim 4, characterized in that it has at least one other recess for a temperature sensor or a thermal sensor. 6. The diagnostic measuring instrument according to claim 1, wherein at least one of the ECG electrodes is simultaneously a feeding electrode or a measuring electrode of the bioelectrical impedance measuring unit. The diagnostic measuring instrument of claim 1, wherein the bioelectrical impedance measuring unit is provided with an impedance measuring signal for recording a skin surface by at least one pair of measuring electrodes, the pair of measuring electrodes The electrode distance is less than - 亳 to a few centimeters' so that during the measurement, the two electrodes of the pair of measuring electrodes can simultaneously touch the same portion of the skin surface to locally measure the impedance measurement signal. M8. The diagnostic measuring instrument according to claim 7, characterized in that: the electric electrode is applied to the body tissue through the skin surface, that is, a variable frequency alternating current is applied to the skin surface portion of the electrode to be touched. A diagnostic measuring instrument according to claim 7 of the patent application, characterized in that the measuring electrode and the feeding electrode are designed as contact strips extending parallel to each other. 10 II. For the diagnostic measuring instrument of claim 1 of the patent scope, the characteristic and estimating unit is connected to the bioelectrical impedance measuring unit for measuring the time variation of the local impedance measuring signal. For example, the diagnostic measuring instrument of claim 1 has the features, and the mouth and mouth device for fixing the body part of the patient to be inspected to the minus 38 1379662. . 12. A diagnostic measuring instrument according to claim 11 of the patent scope, characterized in that the fixing device is designed as a finger splint. 13. The diagnostic measuring instrument of claim 11, wherein the fixing device comprises an inflatable air cushion capable of pressing a body part against the measuring electrode and/or the feeding electrode. 14. A diagnostic measuring instrument as claimed in claim 1 which is characterized in that it is connected to an entertainment device or communication technology device or to another portable device or accessory. 15. A diagnostic measuring instrument according to claim 14 which is characterized in that the device is a mobile device, in particular a notebook computer, a laptop computer, a mobile phone, a palmtop computer or a handheld device. 16. The diagnostic measuring instrument of claim 1, wherein the optical measuring unit comprises at least two conditioned sensors for detecting scatter and/or transmission by body tissue, such The radiation sensor is arranged at a different distance from the radiation source. 17. A diagnostic measuring instrument according to claim 1 wherein the optical radiation of at least one of the radiation sources has the effect of illuminating different volumetric locations of the body tissue being examined. 18. A diagnostic measuring instrument according to clause 17 of the patent application, characterized in that two radiation sources having different spatial radiation characteristics are provided. 19. The diagnostic measuring instrument according to claim 1, wherein the at least one radiation source is connected to a light guiding element, and the light guiding element is modified by a replacement page of the source of the light. Radiation is conducted to the surface of the sensor housing. 20. A decimating measuring instrument according to claim 19, characterized in that an optical system capable of producing directional radiation and/or diffuse radiation into the body tissue is connected to the optical guiding element. 2 Bu as the scope of patent application! The diagnostic measuring instrument of the present invention is characterized in that the hollow reflector is composed of a Ubrich ball. 22. A diagnostic apparatus according to the present invention, characterized in that an optical system capable of generating directional radiation entering the body tissue is coupled to the hollow reflector. 23. The diagnostic measuring instrument of claim 3, wherein the hollow reflector comprises at least one exit aperture for passage of diffuse radiation into the body tissue. 24. The diagnostic measuring instrument of claim i, wherein the at least one physiological parameter is a blood glucose level. 25. A diagnostic measuring instrument for non-invasively recording at least one physiological parameter of body tissue, the diagnostic measuring instrument comprising an optical measuring unit having at least one radiation enthalpy for illuminating body tissue to be examined and at least one for detecting A radiation sensor that measures radiation scattered and/or transmitted by body tissue is characterized in that the at least radiation source is disposed in a diffusely reflecting hollow reflector. 26. The diagnostic measuring instrument of claim 25, wherein the hollow reflector is comprised of a Ubrich ball. 27. A diagnostic measuring instrument as claimed in claim 25, characterized in that it is attached to the hollow reflector in an optical system capable of generating directional radiation entering the body tissue. . 28. The diagnostic measuring instrument of claim 25, wherein the hollow reflector comprises an exit orifice that passes through the diffused radiation into the body tissue to less than 0 t. 41
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