TWI413770B - 無線生醫監測系統 - Google Patents
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Description
本發明係提供一種利用無線傳輸技術進行生理監測之無線生醫監測系統，特別是指一種利用植入式感測系統晶片配合無線傳輸技術進行監測之無線生醫監測系統。
在現今社會中，由於糖尿病及心血管疾病等慢性疾病的普及，因此在國人的十大死因中，糖尿病、腦血管疾病、心臟疾病以及高血壓疾病一直佔了很高的比例。由於這類型慢性疾病，必須針對血糖濃度、血壓、血脂及其他各種不同的生理訊號進行長期的控制與監測。例如對於糖尿病患者而言，監控每日的血糖濃度，將可有效地降低糖尿病患者併發心臟病、高血壓以及心肌梗塞等心臟疾病的風險。因此，如何能夠有效且便利地，使得病人體內的生理訊可以即時地傳輸至醫療單位，作為病人身體狀況判斷的依據，便成為開發這類生醫監測系統的一個重要研究方向。
在傳統的生醫監測系統中，主要是透過體外所連接的生理訊號監測裝置，定時擷取監測對象的生理訊號，並且透過外部儀器將所監控得到的病人生理訊號資料，傳送至醫療單位或是監測中心，以作為分析病人狀況的參考依據。然而，在習知技術中，以葡萄糖感測器為例，由於位於體外的非侵略性葡萄糖感測器，多半具有準確度以及可靠性欠佳的問題。因此，配合低侵入性程度的皮下植入式感測器之生醫監測系統，便成為另一個生醫監測系統上發展的方向。
在習知技術中生醫監測系統中所採用的皮下植入式感測器，由於設計上的限制，並無法提高該皮下植入式感測器在生物相容性、抗干擾能力、結構耐久性以及監測效果上的各種特性。再者，皮下植入式感測器必須透過各種不同的傳輸方式，來將監測到的生理訊號傳送至外部的表面傳輸器中。而習知技術中所使用的皮下植入式感測器，並無法達成即時且遠距地監控所需生理訊號的效果，故常使病患本身的病況診斷而受到延誤。
因此，本發明提出了一種新穎的無線生醫監測系統，來解決前述習知技術之生醫監測系統中所採用的感測器穩定性不佳，以及訊號傳輸不便的缺點。利用本發明所提出的無線生醫監測系統，可以有效地達成遠端醫療監控的目的，隨時監控病患的生理訊號。並且利用無線網路模組，將收集到的生理訊號資料傳送至外部監控中心以進行分析。藉由本發明的無線生醫監測系統，可以有效地避免習知技術中無線生醫監測系統的缺點，是一種有效且便利的新穎技術。
為達上述之目的，本發明的實施態樣中提供了一種無線生醫監測系統，其中包含：一個以上的植入式感測系統晶片；一表面傳輸器；以及一外部監控中心。其中該植入式感測系統晶片係透過無線網路與表面傳輸器連線，並透過外部網路再連接於外部監控中心。又，前述之植入式感測系統晶片包含：一生物相容性封裝部；一感測部；以及一無線傳輸部；其中感測部及無線傳輸部係被包覆於生物相容性封裝部內。該生物相容性封裝部可由聚氨酯(Polyurethane,PU)、聚乙烯(Polyethylene,PE)、聚甲基丙烯酸甲酯(Polymethylmethacrylate,PMMA)、聚酯類高分子(Polyester,PE)、氟化聚乙烯(Poly tetra fluoro ethylene,PTFE)、矽膠(Polydimethylsiloxane)、聚四甲叉丁二酸酯(Poly tetramethylene succinate,PTMS)或其他具有良好生物相容性之聚合物所構成。且感測部係包含了用以驅動流體及分離血液之介電電泳電極，以及電化學偵測電極。同時在感測部之兩端，係包含了使血液通過之流入口及流出口。前述之植入式感測系統晶片中，該無線傳輸部內包含了RF功率的裝置。在本發明之無線生醫監測系統所採用的植入式感測系統晶片上，該晶片係針對心跳、血糖、酵素濃度、蛋白質濃度或其他生理訊號進行監測。較佳的情況下則是對心血管疾病標記之乳酸脫氫酵素、葡萄糖氧化酵素或C反應蛋白、S-100蛋白進行監測。
為使本發明之目的、特徵及功效，茲藉由下述具體之實施例，並配合所附之圖式，對本發明做一詳細說明，說明如後：
如同第一圖所示，本發明之無線生醫監測系統10包含了一個以上的植入式感測系統晶片12；一表面傳輸器14；以及一外部監控中心16。其中該植入式感測系統晶片12係透過無線網路與表面傳輸器14連線，並透過網際網路連接於外部監控中心。其中該表面傳輸器14可固定地穿戴於受測者體外之表面，亦可以為僅在需要生理訊號之資料時進行靠近植入式感測系統晶片12之手持式表面傳輸器14。在第一圖中可以看到受測者的體內可以具有複數個植入式感測系統晶片12，該複數個植入式感測系統晶片12係包含了用來量測如心跳、血糖指數、酵素濃度、蛋白質濃度等各種生理訊號之感測部，以及將所取得的單一或複數之生理訊號透過無線傳輸方式傳送至表面傳輸器14的無線傳輸部。當表面傳輸器14接收到來自複數個植入式感測系統晶片12的生理訊號後，如同第一圖所示，表面傳輸器14會將其資料暫時儲存於記憶部18中，並經由排序部20之處理後，於適當之順序下，經由無線傳輸部22將生理訊號的資料傳送至外部監控中心16。外部監控中心16可為一外部之伺服器、工作站或其他類似之裝置，其目的主要在於透過網際網路以有線或無線之方式連接於表面傳輸器14以獲取資料或給予命令。當外部監控中心16自表面傳輸器14獲取生理訊號的資料後，便利用其內部的資料庫比對分析所獲取的生理訊號是否異常，同時將該獲取之生理訊號儲存於外部監控中心16之中以形成一生理訊號的資料庫。當獲取之生理訊號經比對判斷為產生異常時，外部監控中心便發出命令給予表面傳輸器14，要求重新測量生理訊號或是針對其他必要的生理訊號進行額外的監控。同時，由於外部監控中心16係由專業醫療人員所管理，可同時將該異常之生理訊號加以輸出與分析，並交由專業醫療人員進行解讀以及後續必要之處置。同時，醫療人員亦可透過外部監控中心16來控制表面傳輸器14命令複數個植入式感測系統晶片12進行不同生理訊號的擷取。
第二圖為如本發明之無線生醫監測系統之整合系統架構圖。本發明之無線生醫監測系統之整合系統架構包含了表面傳輸器26以及植入體內的植入感測系統晶片28。在表面傳輸器26的部份包含了用來控制與暫存資料及命令的控制部42與用來感應植入感測系統晶片28的天線40，而在植入感測系統晶片28則包含了用來獲取生理訊號之感測部32、用來處理所收集的生理訊號資料並傳輸至表面傳輸器26之無線傳輸部36、用來傳遞資料至表面傳輸器26之天線34以及提供前述感測部32、無線傳輸部36、天線34等電力之電池30。其中表面傳輸器26的控制部42如同前述第一圖之內容，係將其資料暫時儲存於控制部的記憶部中，並經由排序部之處理後，於適當之順序下，經由無線傳輸部將生理訊號的資料傳送至外部監控中心，或是將外部監控中心的命令透過天線40傳送至各個植入感測系統晶片28。另外在植入感測系統晶片28中，具有如同第二圖所示之架構，其中關於感測部32之詳細構造及作用原理將再後續詳述。在植入感測系統晶片28的感測過程中，首先係由感測部32將所獲得的生理訊號之資料傳送至無線傳輸部36的多工器，並經由內部之資料轉換、暫存之程序後，傳輸至連接於天線34之傳輸器後，將資料傳輸至表面傳輸器26以進行後續傳輸。在接收由外部監控中心傳遞的命令時，該命令係由表面傳輸器26透過天線34傳輸至內部的時脈恢復器及調解讀取器，再透過微控制器之處理，將接收到的命令傳送至感測部32中以執行命令。植入感測系統晶片28中的電池30則為可無線充電式電池，係透過整流器將電流傳送至感測部32、無線傳輸部36以及天線34。植入感測系統晶片28中包含了軟體部分以及硬體部分，軟體部分包含植入式感測系統晶片網路之頻道分配、輸出功率協定、適用於進身網路之路徑協定、網路拓璞決策系統以及建立身體狀態資料庫，以供監測生理資訊及醫療參考之用。硬體部份則是如同前述之監測多種生理參數的感測部32，以及作為微型無線網路收發之用的無線傳輸部36與天線34。本發明所採用之植入式感測系統晶片28為一整合之生醫無線近身網路系統單晶片(Bio Medical Wireless-SoC,BMW-SoC)，其詳細之架構如同第三圖所示。在本發明所提出的系統單晶片架構中，將積體電路化之電壓及電流放大電路(IA/TIA)整合入系統晶片(包括MCU/ADC/RF)中，以放大電化學偵測電極所感測到的各式電壓或電流型態的感測訊號。同時，考量到植入式感測系統晶片可能發生電源不足的問題，亦於系統晶片上整合入電源管理的電路，以減低晶片的消耗功率。經由上述的整合，即可得到如同本發明之生醫無線監測系統所採用的生醫無線近身網路系統單晶片(Bio Medical Wireless-SoC,BMW-SoC)。利用該系統單晶片，可以使本發明之無線生醫監測系統如同第一圖所示，將植入感測系統晶片可作為與表面傳輸器及外部監控中心監測受測者身體狀況之平台。
第四圖則為本發明之無線生醫監測系統所使用的植入式感測系統晶片之整體示意圖。其中包含了生物相容性封裝部44、感測部46、無線傳輸部48、電池50、天線(圖未示)以及流入口52與流出口54。植入式感測系統晶片整體係採用皮下植入的方式植入於受測對象體內，並將體內反應所偵測到的生理訊號經由各種無線傳輸訊號讀取各種生理訊號數據以及植入者身份訊息。如同第四圖所示，血液係經由流入口52通過感測部46之後自流出口54流出，並且在感測部46中藉由電極的感測得到各種所欲收集的生理訊號數據。之後該收集到的生理訊號數據會被傳送到無線傳輸部48中，其詳細結構如同第二圖及第三圖之前述內容，可進行內部生理訊號數據的向外傳遞以及外部命令的回傳，同時在必要的情況下亦可在無線傳輸部48存入不同受測者的身份確認資料，以藉此在以透過無線網路與外部監控中心連線時，直接與植入者之醫療記錄資料庫相連結。同時在底部的電池50可以提供感測部46、無線傳輸部48與天線(圖未示)的運作所需電力。該天線可為電池底部的一線圈或其他適合之型態之天線，透過無線傳輸系統，能夠將電能傳輸進入植入式感測系統晶片上的線圈，並且獲得電能存於電池50中。利用本發明無線生醫監測系統中所採用的植入式感測系統晶片，亦可以提供作為身份確認之用，以有效地簡化醫療診斷的流程。在晶片植入的程序上，生物相容性封裝部44可以避免植入人體時所造成的傷害，該生物相容性封裝部44的材質可為聚氨酯(Polyurethane,PU)、聚乙烯(Polyethylene,PE)、聚甲基丙烯酸甲酯(Polymethylmethacrylate,PMMA)、聚酯類高分子(Polyester,PE)、氟化聚乙烯(Poly tetra fluoro ethylene,PTFE)、矽膠(Polydimethylsiloxane)、聚四甲叉丁二酸酯(Poly tetramethylene succinate,PTMS)或聚甲基丙烯酸甲酯(Poly methyl methacrylate,PMMA)。又，所植入之植入式感測系統晶片，必須採用低電流電壓的驅動系統，同時需具有省電或是低耗能技術的特點。因此，本發明之無線生醫監測系統，可以有效地供給植入式感測系統晶片足夠的電量，透過無線傳輸系統，能夠傳輸電能進入體內的晶片上的線圈或天線，並獲得電能。
第五A圖則說明了本發明之無線生醫監測系統中植入式感測系統晶片感測部的構造，其中包含了微幫浦部58、電化學偵測電極60、流入口56、流出口62以及流道64。感測部本身係在流道64中利用電化學的方法，針對如葡萄糖、膽固醇酵素、乳酸脫氫酵素、葡萄糖氧化酵素C反應蛋白或S-100蛋白等醣類、酵素或蛋白質之濃度變化進行檢測。流道64前後端分別包含有血液之流入口56及流出口64，流道64後端則製作有一白金或其他金屬所製成之電化學偵測電極60，其係用於量測呼吸、心跳、醣類濃度、酵素濃度或蛋白質濃度等各類生理訊號。流道64前端則是製作有用以驅動流體及分離血液之微幫浦部58，該微幫浦部58係為一介電電泳電極66，如同第五B圖所示之流道電極示意圖，流道中包含了三種電極。其分別是化學電極68與介電電泳(Dielectrophoreis,DEP)電極66及物理電極70。其中化學電極有兩組電極，並共用銀電極、白金電極或其他金屬電極測量葡萄糖或乳酸的部分，再由另一組電極進行電化學測量電流值，以獲得如蛋白質及酵素等其他待測生理訊號之濃度變化值。微幫浦部58中的介電電泳電極66整合了旅波技術的使用，將微幫浦部58同時作為流體驅動以及分離血液之用，在微幫浦部58中，可以將血液中的血漿及其他待測物質利用旅波技術及電化學作用加以分離，使得後端的電化學偵測電極60能夠得到更為精確的偵測結果。當血液流過電化學偵測電極60並取得所需的生理訊號數據之後，便經由流出口62回到受測者的體內。感測部的參數量測方式則可使用致電氧化酵素催化反應或親合力交互作用兩大反應機制，但整個感測部中的各項量測參數則整合於單一系統中。於每次量測之後，在不需將系統重新取出的情況下，可自我重新設定到可再次進行量測之狀態。
第六A、六B、六C圖則說明了顯示了本發明之無線生醫監測系統中植入式感測系統晶片感測部的感測機制。如同第六A、六B、六C圖所示，本發明之植入式感測系統晶片中感測部的電化學偵測電極突破先前技術中電化學偵測只能以酵素氧化還原反應進行檢測的方式，而是使用致電氧化酵素催化反應(charge producing oxidase catalytic reaction,CPOCR)將如葡萄糖氧化酵素之類的受測成分與生物分子相結合，並固定於薄膜和基材之上。同時施予極化電位，藉由葡萄糖氧化酵素催化葡萄糖氧化反應後所產生的過氧化氫氧化分解所釋出的電子，依其電子釋出量推算出受測成分中的蛋白質濃度。亦或是可以採用結構應力與親合力交互作用(substrate stress inducing affinity interaction,SSIAS)，藉由抗體、抗原之間的親合性鍵結，利用其在懸臂樑系統上會產生結構應力的差異，根據其位移量推算出受測成分中的蛋白質濃度。在第六A圖中，利用金、白金、銀或其他金屬所製成之感應電極之表面先形成末端為胺基之含硫長鏈，並且在該末端為胺基之含硫長鏈上連接具有導電性之有機連結分子72，在表面形成末端為羧基之結構後，在待測之血液通過的情況下，可以吸附如C反應蛋白、S-100蛋白之末端具有胺基之抗體於感應電極之表面形成吸附層，接著可再吸付如C反應蛋白、S-100蛋白之各種抗體相對應之抗原於前述之吸附層表面。藉由吸附不同濃度所造成電極上電化學性質的變化，可以有效地監測出不同種類生理參數的變化。在醣類濃度及酵素濃度的變化偵測上，則如同第六B、六C圖所示，葡萄糖與乳酸鹽感測器的感測原理是利用葡萄糖氧化酵素及乳酸脫氫酶(LDH)感測，其機制如同第六B、六C圖反應式所示，當電位太高且反應的速度太慢時，可藉由加入催化劑或中介物降低偵測電位，如反應式中的亞鐵氰化鉀(Potassium Ferrocyanide,K3
Fe(CN)6
)。藉由加入中介物達到降低偵測電位的目的，主要是利用改變酵素反應式的生成物，並利用電化學法偵測其氧化及還原電流的大小變化，即可間接偵測葡萄糖與乳酸的濃度。同時之後再利用電化學儀器，以循環伏安法(CV Method)將葡萄糖氧化酵素(Glucose Oxidase,GOD)及乳酸脫氫酶(Lactate dehydrogenase,LDH)吸附至工作電極上。
第七圖則說明了顯示了本發明之無線生醫監測系統中植入式感測系統晶片感之製造方法，以偵測血液中葡萄糖的植入式感測系統晶片為例，其材料主要是利用葡萄糖氧化酵素來偵測葡萄糖在電極上所偵測的電極電壓，其中電極係由鉻(Cr)、金(Au)、銀(Ag)、白金(Pt)等材質或其合金所製成，並以鉻薄膜協助金(Au)或銀(Ag)等薄膜材料之附著，再依第七圖之電極製程製作出電化學感測電極。其中該電極之製程流程係先將基材之玻璃清洗乾淨，再利用光微影技術以光罩製作出所需圖樣。之後，藉由物理薄膜沉積之方式鍍上薄膜，最後再以光阻剝離法顯影，即可完成所需電化學感測電極中之工作電極與輔助電極；另外，藉由重複以上步驟，同樣使用光微影技術以光罩製作出另一幾何圖樣，並用物理薄膜沉積法與光阻剝離法完成參考電極。其他不同種類之酵素或蛋白質的植入式感測系統晶片亦可利用相同的程序加以製造，只要將葡萄糖氧化酵素替換為受測物相對應之酵素即可。
雖然本發明已以較佳實施例揭露如上，然其並非用以限定本發明，任何熟習此技藝者，在不脫離本發明之精神和範圍內，當可作些許之更動與潤飾，舉凡一切針對本發明技術手段之替代、修飾或是變更，當不脫離本發明之發明精神及範疇。
10．．．無線生醫監測系統
12．．．植入式感測系統晶片
14．．．表面傳輸器
16．．．外部監控中心
18．．．記憶部
20．．．排序部
22．．．無線傳輸部(輸出)
24．．．無線傳輸部(輸入)
26．．．表面傳輸器
28．．．植入感測系統晶片
30．．．電池
32．．．感測部
34．．．天線
36．．．無線傳輸部
40．．．天線
42．．．控制部
44．．．生物相容性封裝部
46．．．感測部
48．．．無線傳輸部
50．．．電池
52．．．流入口
54．．．流出口
56．．．流入口
58．．．微幫浦部
60．．．電化學偵測電極
62．．．流出口
64．．．流道
66．．．介電電泳電極
68．．．化學電極
70．．．物理電極
72．．．導電性之有機連結分子
第一圖為本發明之無線生醫監測系統圖。
第二圖為如本發明之無線生醫監測系統之整合系統架構圖。
第三圖為生醫無線近身網路系統單晶片的架構圖。
第四圖為本發明之無線生醫監測系統所使用的植入式感測系統晶片之整體示意圖。
第五A圖為本發明之無線生醫監測系統中植入式感測系統晶片感測部的構造。
第五B圖為本發明之無線生醫監測系統中植入式感測系統晶片感測部之流道電極示意圖。
第六A圖為本發明之無線生醫監測系統中植入式感測系統晶片感測部的蛋白質抗體抗原感測機制。
第六B圖為為本發明之無線生醫監測系統中植入式感測系統晶片感測部的葡萄糖感測機制。
第六C圖為為本發明之無線生醫監測系統中植入式感測系統晶片感測部的乳酸鹽感測機制。
第七圖為本發明之無線生醫監測系統中植入式感測系統晶片之製造方法。
10．．．無線生醫監測系統
12．．．植入式感測系統晶片
14．．．表面傳輸器
16．．．外部監控中心
18．．．記憶部
20．．．排序部
22．．．無線傳輸部(輸出)
24．．．無線傳輸部(輸入)
Claims (9)
- 一種無線生醫監測系統，其中該無線生醫監測系統包含：複數個植入式感測系統晶片，每一植入式感測系統晶片包含一生物相容性封裝部、一感測部及一無線傳輸部，該感測部及該無線傳輸部係被包覆於該生物相容性封裝部內；一表面傳輸器，係用於供設置於被植入該等植入式感測系統晶片之被植入者的身體外部；以及一外部監控中心；其中該等植入式感測系統晶片係透過各自的無線傳輸部與該表面傳輸器連線，並透過外部網路連接於該外部監控中心，每一植入式感測系統晶片的該感測部包含：一流入口，以引入一待測流體；一流道，係連接該流入口；一流出口，係連接該流道，以引出該待測流體；一微幫浦部，係配置於靠近該流入口且位於該流道的前段，該微幫浦部係為一介電電泳電極；及一電化學偵測電極，係配置於靠近該流出口且位於該流道的後段。
- 如申請專利範圍第1項所述之無線生醫監測系統，其中該生物相容性封裝部係為聚氨酯、聚乙烯、聚甲基丙烯酸甲酯、聚酯類高分子、氟化聚乙烯、矽膠、聚四甲叉丁二酸酯或其他具有良好生物相容性之聚合物所構成。
- 如申請專利範圍第1項所述之無線生醫監測系統，其中該感測部係包含用以驅動流體及分離血液之介電電泳電極及電 化學偵測電極。
- 如申請專利範圍第1項所述之無線生醫監測系統，其中該感測部係包含使血液通過之流入口及流出口。
- 如申請專利範圍第1項所述之無線生醫監測系統，其中該無線傳輸部係包含RF功率裝置。
- 如申請專利範圍第1項所述之無線生醫監測系統，其中該植入式感測系統晶片係針對心跳、血糖、酵素濃度、蛋白質濃度或其他生理訊號進行監測。
- 如申請專利範圍第6項所述之無線生醫監測系統，其中該植入式感測系統晶片係針對心血管疾病標記之酵素或蛋白質進行監測。
- 如申請專利範圍第7項所述之無線生醫監測系統，其中該酵素係為乳酸脫氫酵素或葡萄糖氧化酵素。
- 如申請專利範圍第7項所述之無線生醫監測系統，其中該蛋白質係為C反應蛋白或S-100蛋白。
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| TW098113628A TWI413770B (zh) | 2009-04-24 | 2009-04-24 | 無線生醫監測系統 |
| US12/556,675 US20100274101A1 (en) | 2009-04-24 | 2009-09-10 | Wireless monitoring bio-diagnosis system |
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| TWI413770B true TWI413770B (zh) | 2013-11-01 |
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| US20180235470A1 (en) * | 2014-08-28 | 2018-08-23 | Aum Cardiovascular, Inc. | Devices, systems and methods for the detection of anatomical or physiological characteristics |
| TWI572328B (zh) * | 2015-03-24 | 2017-03-01 | Wearable Compound Vessel Flow Detector | |
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| US10750981B2 (en) | 2015-09-25 | 2020-08-25 | Sanmina Corporation | System and method for health monitoring including a remote device |
| US10194871B2 (en) | 2015-09-25 | 2019-02-05 | Sanmina Corporation | Vehicular health monitoring system and method |
| US9788767B1 (en) | 2015-09-25 | 2017-10-17 | Sanmina Corporation | System and method for monitoring nitric oxide levels using a non-invasive, multi-band biosensor |
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| TWI644800B (zh) * | 2018-01-15 | 2018-12-21 | 國立臺灣師範大學 | 含有二硫化鉬之生物感測晶片以及應用該生物感測晶片之檢測裝置 |
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| TW201038942A (en) | 2010-11-01 |
| US20100274101A1 (en) | 2010-10-28 |
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