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TW201321039A - 使用可植入式裝置之通訊系統 - Google Patents

使用可植入式裝置之通訊系統 Download PDF

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TW201321039A
TW201321039A TW101124932A TW101124932A TW201321039A TW 201321039 A TW201321039 A TW 201321039A TW 101124932 A TW101124932 A TW 101124932A TW 101124932 A TW101124932 A TW 101124932A TW 201321039 A TW201321039 A TW 201321039A
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implantable
frequency current
communication device
current characteristic
communication
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Todd Thompson
Mark Zdeblick
Yashar Behzadi
Benedict Costello
Timothy Robertson
Hooman Hafezi
George Savage
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Proteus Digital Health Inc
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • A61B5/0028—Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
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    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
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    • H01Q1/273—Adaptation for carrying or wearing by persons or animals
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37288—Communication to several implantable medical devices within one patient

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Abstract

本發明的系統包括可植入式裝置，其能偵測高及低頻率電流特徵。此可植入式裝置能與一通訊裝置通訊，該通訊裝置包括傳導元件、電子組件、以及以異質材料形式的部分電源。於與導電流體接觸時，此通訊裝置被啟動。

Description

使用可植入式裝置之通訊系統
本發明關於偵測一事件之通訊系統。更精確而言，本發明揭示包括可植入式引線與可攝取裝置間之通訊。
包括電子電路可攝取裝置已被提出用於種種不同的醫療應用，包括診斷及治療應用。此等裝置典型需要操作用的內部電源。此等可攝取裝置是可攝取電子囊劑，其於通過人體時收集資料，並傳送該資料到外部接收器系統。此類型電子囊劑的一個例子是在生物體內進行的攝影機。可吞嚥囊劑包括攝影機系統及用以將關注的區域成像於攝影機系統的光學系統。發射器傳送攝影機系統的視頻輸出而接收系統接收被傳送的視頻輸出。其他的例子包括可攝取成像裝置，其具有內部及機內的電源，其獲取來自身體內膣或體腔內部的影像。此裝置的電子電路組件被一在身體內部通過的不活潑的可攝取外殼(例如玻璃外殼)所包圍。其他的例子包括可攝取資料記錄器囊劑醫療裝置。所揭示之裝置(例如感測器、記錄器、電池等)的電子電路是包在不活潑材質組成的囊劑中。
在其他的例子中，易脆的射頻識別(RFID)標籤被用於藥品攝取監控應用方面。為使RFID標籤運作，每個應用/標籤要內部電源。RFID標籤是被配置來穿過身體傳送射頻信號的天線結構。
此等現存裝置呈現的問題在於電源在裝置內部且此種電源生產成本高且倘若電源洩露或受損則對周圍環境有潛在危害。此外，當裝置用在生物體內時，天線自裝置伸出對於天線受損或造成問題而言是需要擔心的事。
本發明揭露一種用以產生會指示事件發生的獨特特徵的系統。此系統包括能被置於含有導電流體之特定環境內的電路及組件。此一環境的例子是在容置導電流體的容器內部，諸如包括靜脈注射袋的具有溶液之密封袋。一例子是在諸如動物或人類的活機體的身體內部。此種系統是可攝取且/或可消化或部分可消化的。此種系統包括異質材料，產生電位差。此電位差因而電壓是用於電力開啟置於該架構內部之控制邏輯。離子或電流經由控制邏輯從第一異質材料流到第二異質材料且接著透過導電流體以完成一電路。控制邏輯控制二異質材料之間的傳導率且因而控制或調整傳導率。
因為該可攝取電路以可攝取且甚至可消化的組件所組成，即使在用於慢性情況時，該可攝取電路會導致不想要的負作用(若有的話)。可含有的組件的範圍的例子為：邏輯及/或記憶體元件；反器；信號傳輸元件；以及諸如電阻器或電感器的被動元件。在支架表面上之一或多個組件可以以任何方便的組態置放。在固態支架表面上有二或多個組件的地方可設有互連。可攝取電路之所有組件及支 架是可攝取的，且在某些例子中是可消化或部分可消化的。本發明另一態樣在於與可植入於病人之裝置通訊的可攝取電路。因此，於攝取之際，資訊能從該可植入式裝置接收或從該可攝取電路傳送至該可植入式裝置。
本揭露包括用以指示事件發生的多種態樣。如以下更詳細說明者，本發明的系統係與導電流體共用以藉由接觸導電流體與系統之間來指示被標記的事件。例如，本揭露的系統可以與醫藥製品共用且被指示出的事件是當該製品被服用或攝取時。名詞「被攝取」或「攝取或「攝取中」被瞭解係指任何身體內部的系統的引入。舉例來說，攝取中單純指將系統置入口中直到降結腸。因此，此攝取中一詞意指當系統被引入含有導電流體之環境時的時間上任何瞬間。另一例子是當非導電流體與導電流體混合時的情況。在此一情況中，系統會在非導電流體中且當兩液體混合時，系統與導電流體接觸且系統被啟動。又另一例子是當所需之特定液體的存在要被偵測時的情況。在此等例子中，在導電流體內之被啟動之系統的存在可被偵測到，且因而個別液體的存在會被偵測到。名詞「可植入式」包括任何完全可植入式或部分可植入式，以及以外科手術方式置於身體內部，諸如心臟內的引線，以及置於皮下或不需外科手術而被插入身體的裝置。
現再度參照系統與被攝取進活機體的製品共用的例子 ，當包括該系統的製品被服用或攝取時，裝置與身體的導電流體相接觸。當本發明的系統與體液相接觸時，產生電位且系統被啟動。一部分電源是由裝置提供，而另一部分的電位係由導電流體提供，此於下文詳述。
現參照圖1，包含本發明系統之可攝取囊劑14顯示於身體內部。囊劑14被配置為以口攝取的藥丸或囊劑形式的醫藥配方。於攝取之際，藥丸移至胃。到達胃之際，囊劑14與胃液18接觸並經歷與胃液18中諸如氫氯酸及其他消化器官的不同材料的化學反應。本發明系統係參照醫藥環境加以討論。然而，本發明的範圍不侷限於此。本發明能用於任何環境，例如，有導電流體或透過混合兩種或多種形成導電流體之成分而變成有導電流體處。此外，本發明系統可被攝取而不用經由載體囊劑的醫藥製品，其僅包括系統而沒有其他活性劑。例如，系統可用來編程一可植入式裝置15。
可植入式裝置15包括心律調整器15a(有時稱為容器)及引線15b至少其中之一者。引線的例子係揭示於美國專利第7,214,189號名為「Methods,and Apparatus for Tissue Activation and Monitoring」的專利，其整體揭露內容於此併入參考。當囊劑14的系統被啟動時，電流特徵17經使用的身體如以下至少參照圖5所述者。電流路徑可採任何路徑引線17。當電流到逹設置於使用者心臟13內之引線15b時，引線15b偵測並傳送資訊到心律調整器15a。心律調整器15a能解碼並判定編碼於該電流特 徵內的資訊。因此，在囊劑14中的系統能夠傳送資訊到心律調整器，且心律調整器儲存該資訊供後來傳輸之用或是立即傳送該資訊。根據本發明另一態樣，囊劑14中的系統包括心律調整器15的編程資訊。因此，一旦攝取囊劑14以及其內的系統啟動，該系統的電流特徵將會編碼資訊於該管所產生的該電流特徵內。該資訊接著被心律調整器15a透過引線15b接收，於是心律調整器15a被編程。引線及心律調整器15a能偵測及解碼與該系統相關聯的高頻資訊以及偵測與心臟相關聯的低頻資訊。
現參照圖2A，類似圖1之囊劑14的醫藥製品10係與諸如可攝取事件標記裝置或離子發射模組的系統12共同顯示。本發明範圍不侷限於製品10的形狀或種類。例如，熟於此技之人士會明白製品10可以是囊劑、限時釋放口服劑量、錠劑、膠囊、舌下錠、或任何可以與系統結合的口服劑量製品。在參照的態樣中，製品10使用將微裝置固定於醫藥製品外部的習知方法使系統固定在外部。將微裝置固定於醫藥製品外部的習知方法係揭示於2009年1月1日申請之第61/142,849之名為「HIGH-THROUGHPUT PRODUCTION OF INGESTIBLE EVENT MARKERS」的美國專利臨時申請案，以及2009年5月12日申請之第61/177,611號之名為「IGESTIBLE EVENT MARKERS COMPRISING AN IDENTIFIER AND AN INGESTIBLE COMPONENT」的美國專利臨時申請案，其各整體揭露內容於此併入參考。一旦被攝取，系統12便 與體液接觸而系統12被啟動。系統12利用電位差來電力開啟且之後調節傳導率以產生獨特且可識別的電流特徵。於啟動之際，系統12控制傳導率且因而電流以產生電流特徵。
有種種延遲系統12啟動的原因。為延遲系統12的啟動，系統12可塗覆以屏蔽材料或保護層。該層經過一段時間會溶解，從而允許系統12於製品10已到達目標位置時被啟動。
現參照圖2B，類似圖1之囊劑14的醫藥製品20係與諸如可攝取事件標記裝置或可識別發射模組的系統22共同顯示。本發明範圍不侷限於製品10的形狀或種類系統22被引入環境。例如，系統22可被包在醫藥製品以外服用的囊劑內。該囊劑可以僅是系統22的載具且不包含任何製品。再者，本發明範圍不侷限於製品20的形狀或種類。例如，熟於此技之人士會明白製品20可以是囊劑、限時釋放口服劑量、錠劑、膠囊、舌下錠、或任何可以與系統結合的口服劑量製品。在參照的態樣中，製品20使系統22放置在製品20的內部或固定在製品的內部。在一態樣中，系統22被固定製品20的內壁。當系統22設置於膠囊內部時，膠囊的內容物是非導電膠液。另一方面，倘若膠囊的內容物是非導電流體，則於另一態樣中，系統22被塗覆以護套以防止不想要之由膠囊內容物的啟動。倘若囊劑內容物是乾粉或微球粒，則系統22被設置或置於囊劑內部。倘若製品20是錠劑或硬藥丸，則系統22 被保持在錠劑內固設置。一旦被攝取，含有系統22的製品20被溶解。系統22與體液接觸且系統22被啟動。取決於製品20，系統22可以設置於接近中心或接近邊緣位置，端視初始攝取時間與系統22啟動之間所想要的啟動延遲而定。例如，系統22的中心位置表示系統22要較長的時間才會與導電流體接觸，且因而系統22要較長時間被啟動。因此，要花較長時間才會偵測到事件的發生。
現參照圖3，在一態樣中，圖2A及2B的系統11及系統22分別較詳細顯示為系統30。如上述，系統30與任何醫藥製品聯合使用，以決定病人何時服用醫藥製品。如上所指出者，本發明範圍不受限於環境及與系統30共用的製品。例如，系統30可置於囊劑內且囊劑置於導電流體中。囊劑接著經過一段時間溶解並系統30釋放進導電流體。因此，在一態樣中，囊劑會含有系統30而無製品。此種囊劑可接著用於任何有導電流體以及與任何製品共用。例如，囊劑可以滴進充填有航空燃油、鹽水、蕃茄醬、機油、或任何類似製品的容器。此外，含有系統30的囊劑可以在任何醫藥製品被攝取的相同時間被攝取，以便記錄諸如製品何時被服用的事件的發生。
在系統30與醫藥製品結合的特定例子中，當製品或藥丸被攝取時，系統30被啟動。系統30控制傳導率以產生要被偵測到的獨特電流特徵，從而表示該醫藥製品已被服用。系統30包括架構32。架構32係系統30的框架且多種組件附接到、沈積於或固定在架構32。在系統30的 此一態樣中，可消化的材料34與架構32實體結合。材料34可化學沈積於、蒸發到、固定在、或建構於架構32。材料34被沈積於架構32的一側。所關注之可用作為材料34的材料包括但不侷限於：Cu或CuI。材料34的沈積在協定之中可藉由物理氣相沈積、電沈積或電漿沈積。材料34可從0.05到約500μm厚，像是從約5到約100μm厚。形狀係由遮罩沈積、或光刻及蝕刻所控制。此外，即使只有顯示一用以沈積該材料的區域，但每一系統30可包含二或多個可以沈積材料34的電獨特區域，如所想要的。
在圖3所示之相反側的一不同側，沈積另一可消化材料36，使得材料34及36為異質。雖未顯示，但所之不同側可以是針對材料34所選之側的緊鄰側。本發明範圍不侷限於所選的側且「不同側」一詞可以指任何與首先選擇側相異的多個側。再者，即使系統的形狀顯示為正方形，但形狀可以是任何幾何上適合的形狀。材料34及36被選擇使得其當系統30與是體液的導電流體相接觸時產生電位差。所關注之材料36的材料可以包括但不侷限於Mg、Zn或其他負電性金屬。如上述關於材料34所指出者，材料36可化學沈積於、蒸發到、固定在、或建構於架構。而且，可要黏合層來幫助材料36(以及材料34，有需要時)黏到架構32。材料36的典型黏合層是Ti、TiW、Cr或類似材料。陽極材料及黏合層的沈積可以藉由物理氣相沈積、電沈積或電漿沈積。材料36可從0.05到約 500μm厚，像是從約5到約100μm厚。然而，本發明範圍不侷限於該厚度或任何材料或是任何用來沈積或固定材料到架構32的方法種類。
根據所述的揭露內容，材料34及36可以是任何具有不同電化電位的材料對。此外，在系統30係用於生物體內的態樣中，材料34及36能以任何兩種適合系統30將運作的環境之材料組成。例如，當與可攝取製品共用時，材料34及36係任何具有不同電化電位之可攝取的材料對。說明例包括當系統30與諸如胃液的離子溶液成接觸時的例子。適合的材料並不侷限於金屬，且在某些態樣中，該成對材料係選自金屬及非金屬，例如一對由金屬(諸如Mg)與鹽(諸如CuClor CuI)所組成。對於活性電極材料而言，任何成對的材料-金屬、鹽、或插層化合物-具有適當不同電化電位(電壓)及低界面阻力者係合適合的。
所關注之材質及配對包括但不侷限於以下表1所報告者。在一態樣中，該等金屬的一或二者可以被摻雜例如非金屬，以強化當其導電流體相接觸時產生於材質間的電位。在某些態樣中可用作為摻雜劑的非金屬包括但不侷限於：硫、碘及其類似物。在另一態樣中，材質為碘化銅(CuI)作為陽極而鎂(Mg)作為陰極。本發明的態樣所使用的電極材料對人體無害。
因此，當系統30與導電流體相接觸時，電流路徑，如圖5所示的例子者，係透過材料34與36間的導電流體形成。控制裝置38固定於架構32且電耦合到材料34與36。控制裝置38包括電子電路，例如能夠控制及改變材料34與36間之傳導率的控制邏輯。
產生於材料34與36間的電位提供用以操作系統的電力以及產生經過導電流體及系統的電流。在一態樣中，系統操作於直流模式。在一替代態樣中，系統控制電流的方向，使得電流方向以類似交流電的周期方式反向。當系統抵逹流體或電解液成分係由例如胃酸的生理流體所提供的導電流體或電解液處時，在材料34與36間的電流路徑便在系統30外部完成。經過系統30的電流路徑受控於控制裝置38。電流路徑的完成可讓電流流動，且接收器(未 顯示)能偵測電流的存在並辨識出系統30已被啟動且想要的事件正發生或已發生。此等接收器的說明例進一步參照圖7至12說明於下文。
在一態樣中，兩材料34與36在功能方面類似諸如電池之直流電源所需的兩電極。導電流體作用為完成電源所的電解液。所述之完成的電源可以被視為一種利用離子或諸如胃液、血、或其他體液及組織的導電溶液中的電化傳導率的電源。
此外，環境可以是有別於身體的環境，且液體可以是任何導電液體。例如，導電流體可以是鹽水或金屬為基礎的顏料。
在特定的態樣中，此兩種材料以附加的材質層屏蔽免於周圍環境傷害。當屏蔽溶解而該兩種異質材料曝露於目標位置時，電位於是產生。
在某些態樣中，完成的電源或電源供應係由活性電極材料、電解液、及非活性材料，諸如受電器、包裝等所組成。活性材料係任何具有不同電化電位的材料對。適合的材料不限於金屬，且在某些態樣中，成對的材料係選自金屬及非金屬，例如以金屬(諸如Mg)與鹽(諸如CuI)組成的一對。對於活性電極材料而言，任何成對的材料-金屬、鹽、或插層化合物-具有適當不同電化電位(電壓)及低界面阻力者係合適合的。
多種不同材料可被用作為形成電極的材料。在某些態樣中，電極材料被選擇於與例如胃的目標生理位置接觸之 際提供電壓，其足夠驅動識別器的系統。在某些態樣中，於電源之金屬與目標生理位置接觸之際由電極所提供的電壓係等於或高於0.001 V，包括等於或高於0.01 V，諸如等於或高於0.1 V，例如等於或高於0.3 V，包括等於或高於0.5 V，且含等於或高於1.0 V，其中在某些態樣中，電壓範圍從約0.001到約10伏特，諸如從約0.01到約10 V。
現參照圖3，材料34與36提供電位來啟動控制裝置38。一旦控制裝置38被啟動或被電力開啟，控制裝置38可以以獨特方式改變材料34與36間的傳導率。藉改變材料34與36間的傳導率，控制裝置38能夠控制經過圍繞系統30之導電流體的電流大小。此產生能被接收器(未顯示)所偵測及測量之獨特的電流特徵。接收器的說明例進一步參照圖7至12說明於下文。除了控制材料間電流路徑的大小以外，非導電材料、膜、或「裙部(skirt)」係用來增加電流路徑的「長度」，因此，作為增加傳導路徑之用，如揭露於2008年9月25日申請之序號第12/238,345且於2009年3月6日公開為第2009-0082645 A1號之名為「In-Body Device with Virtual Dipole Signal Amplification」的美國專利申請案，其整體內容於此併入參考。或者，此處通篇揭露內容中，名詞「非導電材料」、「膜」、及「裙部」可以與「電流路徑延伸器」互換而不影響此處本態樣及申請專利範圍的範疇。在35及37處所顯示之部位的裙部分別可以例如固定於架構32而與架 構32結合。裙部的種種形狀及配置係在本發明範圍內。例如，系統30可以整個或部分被裙部包圍，且裙部可以沿著系統30的中心軸線或對中心軸線偏心的方式設置。因此，此處本發明的範圍不侷限於裙部的形狀或尺寸。再者，在其他態樣中，材料34與36可被一裙部隔開設置於材料34與36間任何界定區域中的裙部所隔開。
現參照圖4，在另一態樣中，圖2A及2B的系統12及22分別更詳細顯示為系統40。系統40包括架構42。架構42類似圖3之架構32。在系統40的態樣中，可消化或可溶解材料44被沈積在架構42的一部位上。架構42的相同側的不同部位處沈積另一可消化材料46。更精確而言，材料44與46被選取使得當他們與諸如體液的導電液體接觸時形成一電位差。因此，當系統40與導電液體相接觸或部分接觸時，接著電流路徑，圖5所示的例子，透材料44與46間的導電液體形成。控制裝置48固定於架構42且電耦合到材料44與46。控制裝置48包括能夠控制材料44與46間的部分傳導路徑。材料44與46被非導電裙部49隔開。裙部49的種種例子揭露於2009年4月28日申請為美國專利臨時申請案第61/173,511號之名為「HIGHLY RELIABLE INGESTIBLE EVENT MAKERS AND METHODS OF USING SAME」的申請案，以及於2009年4月28日申請為美國專利臨時申請案第61/173,564號之名為「INGESTIBLE EVENT MARKERS HAVING SIGNAL AMPLIFIERS THAT COMPRISE AN ACTIVE AGENT」的申請案，以及於2008年9月25日申請為美國專利申請案第12/238,345號之名為「IN-BODY DEVICE WITH VIRTUAL DIPOLE AMPLIFICATION」的申請案；其等整體內容分別於此併入參考。
一旦控制裝置48被啟動或動力開啟，控制裝置48能改變材料44與46間的傳導率。因此，控制裝置48能夠控制經過圍繞系統40之導電液體的電流的大小。如上參照系統30所述，與系統40相關聯之獨特電流特徵能被接收器(未顯示)偵測到以標記系統40的啟動。說明例可見於下文描述的圖7至12的接收器的例子。為增加電流路徑的「長度」，裙部49的尺寸被改變。電流路徑愈長，則接收器愈容易偵測到電流。
現參照圖5，顯示圖3的系統30於啟動狀態且與導電流體相接觸。系統30透過接地點52接地。例如，當系統30與導電流體相接觸時，導電流體提供接地。系統30亦包括感測器模組74，其會參照圖6詳述。離子或電流路徑50形成於材料34與36間且透過導電流體與系統30相接觸。產生於材料34與36間的電位係透材料34/36與導電流體間的化學反應而產生。
系統30亦包括單元75。單元75包括致能通訊功能的態樣且依據本發明種種態樣能作用為以下任一者：接收器、發射器、或收發器。因此，在系統30外部的另一裝置，諸如行動電話、植入裝置、附接於使用者身體的裝置、或任何置於使用者皮膚下的裝置，透過單元75，例如 可與系統30通訊。單元75亦電連接到材料34與36。根據本發明一態樣，任何在系統30外部的裝置可使用流經圍繞系統30之環境與單元75或控制模組38通訊。例如，附接於使用者身體的補片或接收器、行動電話或由使用者手持的裝置、或植入裝置，其等任一者能透過使用者身體產生電流特徵。電流特徵能包括在其內編碼的資訊。使用單元75或控制模組38，電流特徵被系統30偵測，且被解碼以允許從系統30外部之裝置到系統30的通訊。於是，該外部裝置能以無線或透過傳導傳送一信號到單元75，其控制系統30的啟動。
倘若環境的條件改變以變成利於通訊，如環境之測量所決定者，則單元75傳送一信號到控制裝置38來改變材料34與36間的傳導率以允許使用系統30的電流特徵的通訊。因此，倘若系統30已被停用且倘若環境的阻抗適於通訊，則系統30能再度被啟動。
現參照圖5A，此顯示材料34的表面的分解圖。在一態樣中，材料34的表面並不平坦，但反而像是不規則表面。該不規則表面增加材料之表面區域，且因而，該區域與導電流體相接觸。在一態樣中，在材料34的表面處，在材料34與周圍導電流體之間有電化學反應，使得質量與導電流體互換。此處使用的名詞「質量」包括任何可以被加或移除自導電流體之作為發生於材料34之電化反應的一部分之離子或非離子物種。一例子包括材料是CuCl且當與導電流體相接觸時的例子，CuCl被轉換成Cu金屬 (固體)且Cl-被釋放進溶液。正離子的流進導電流體係電流路徑50來繪示。負離子以反方向流動。依類似方式，有涉及材料36的電化反應導致離子自導電流體釋放或移除。於此例子中，在材料34負離子的釋放及由材料36正離子的釋放透過控制裝置38控制之電流係彼此有關。反應速率及因此的離子發射速率或電流係受控於控制裝置38。控制裝置38能藉由改變其內部傳導率而增加或減少離子流的速率，其改變阻抗，且因此在材料34與36的電流及反應速率。透過控制反應速率，系統30能編碼在離子流中的資訊。因此，系統30使用子發射或流來編碼資訊。
控制裝置38可以改變離子流或電流的期間而同時保持電流或離子流大小接近常數，類似當頻率被調變且大小是常數時。而且，控制裝置38能改變離子流速率或電流的大小而同時保持期間接近常數。因此，使用種種在期間方面的變化的組合及改變速率或大小，控制裝置38編碼或離子流中資訊。例如，控制裝置38可使用但不侷限於以下技術的任一者，包括二元相位移鍵控(PSK)、調頻、調幅、開關按鍵、及利用開關按鍵的PSK。
如上所示，此處揭露的種種態樣，諸如圖3及48分別所示之系統30及40，包括作為控制裝置38或控制裝置48部分的電子組件。可存在的組組件包括但不侷限於：邏輯及/或記憶體元件、積體電路、電感器、電阻器、及用以測量種種參數的感測器。各個組值可以固定於架構 及/或另一組件。在支之表面上的組件可以以任何方便的組態配置。在固體支架的表面上有二或多個組件之處可提供互連。
如上所示，諸如控制裝置30及40的系統，控制異質材料間的傳導率且因而，離子流或電流的速率。透過依特定方式改變傳導率，系統能夠編碼離子流中的資訊及電流特徵。離子流或電流特徵係用來獨特地辨識特定系統。此外，系統30及40能夠產生種種不同的獨特模式或特徵，且因而提供額外資訊。例如，基於第二傳導率模式的第二電流特徵可用以提供額外資訊，該資訊可關於實體環境。為進一步說明，第一電流特徵可以是維持晶片上的振盪器的非常低的電流狀態，第二電流特徵可以是至少較與第一電流特徵相關聯之電流狀態高十的因數的電流狀態。
現參照圖6，顯示表示控制裝置38之方塊圖。裝置30包括控制模組62、計數器或時脈64、以及記憶體66。此外，控制裝置38顯示包括感測器模組72以及於圖5參照過的感測器模組74。控制模組62具有電耦合到材料34的輸入68以及電耦合到材料36的輸出70。控制模組62、時脈64、記憶體66以及感測器模組72/74亦具有電力輸入(有些未顯示)。每一個此等組件的電力係當系統30與導電流體相接觸時由材料34及36與導電流體間的化學反應所產生的電位所提供。控制模組62透過會改變系統30之全部阻抗的邏輯來控制傳導率。控制模組62電耦合到時脈64。時脈64供時脈週期給控制模組62。基於 控制模組62的經編程特性，當經設定之數目的時脈週期已經過時，控制模組62改變材料34與36的傳導率特性。此週期重覆且因此控制裝置38產生一獨特的電流特徵特性。控制模組62亦電耦合到記憶體66。時脈64及記憶體66係由材料34與36間所產生的電位來提供電力。
控制模組62亦電耦合到並與感測器模組72與74通訊。在所示的態樣中，感測器模組72是控制裝置38的一部分而感測器模組74是獨立的組件。於替代態樣中，可使用感測器模組72與74二者中的任一者而不用另一者，且本發明範圍並不侷限於感測器模組72或74的結構或功能位置。此外，系統30的任何組件可功能上或結構上移動、結合或復位而不會限制本發明所主張的範圍。因此，有可能具有一例如處理器的單一結構，其設計來執行以下有模組的功能：控制模組62、計數器或時脈64、記憶體66及感測器模組72或74。另一方面，亦可在本發明範圍內使此等功能組件的每一者位於電力鏈結且能構通訊的獨立結構中。
現再度參照圖6，感測器模組72或74能包括以下感測器的任一者：溫度、壓力、pH值水準及傳導率。在一態樣中，感測器模組72或74集結來自環境的資訊並將該類比資訊傳遞到控制模組62。控制模組接著將該類比資訊轉換成數位資訊，而該數位資訊以電流或產生離子流的質量傳送的速率編碼。在另一態樣中，感測器模組72或74集結來自環境的資訊並將該類比資訊轉換成數位資訊 且接著將該數位資訊傳遞到控制模組62。在圖5所示的態樣中，顯示感測器模組74電耦合到材料34與36以及控制模組38。在圖6所示的另一態樣中，感測器模組74在接點78電耦合到控制裝置38。接點78同時作為感測器模組74的電源以及感測器模組74與控制裝置38間的通訊通道二者。
現參照圖5B，系統30包括連接到根據要執行之感測功能的特定型態所選擇的材料39的pH值感測器模組76。pH值感測器模組76亦連接到控制裝置38。材料39以非導電阻隔件55而與材料34電隔離。在一態樣中，材料39是鉑。在操作方面，pH值感測器模組76使用材料34與36間的電位差。pH值感測器模組76測量材料34與材料39間的電位差並將該直記錄供以後比較之用。pH值感測器模組76亦測量材料39與材料36間的電位差並將該直記錄供以後比較之用。pH值感測器模組76使用該等電位值記算周圍環境之pH水準。pH值感測器模組76提供該資訊給控制裝置38。控制裝置38改變產生離子傳送的質量傳送的速率及電流以將與離子傳送中之pH水準有關的資訊編碼，其可被接收器(未顯示)所偵測。接收器的說明例進一步參照圖7至12說明於下文。因此，系統30可以決定並提供有關pH水準的資訊給環境的外源。
如上所示，控制裝置38能事先被編程以輸出一預先界定之電流特徵。在另一態樣中，系統能包括接收器系統，其能當系統被啟動時接收編程資訊。在未顯示的另一態 樣中，開關64及記憶體66能結合成一個裝置。
除上述組件以外，系統30亦可包括一或其他電子組件。所注之電子組件包括但不侷限於：例如以積體電路形式的附加邏輯及/或記憶體元件；電力調節裝置，例如電池、燃料電池或電容器；感測器、刺激器等；被動元件，例如電感器、電阻器等。
在某些態樣中，可攝取電路包括塗層。此塗層的目的能改變，例如，於處理期間、於儲存期間或甚至於攝取期間保護電路、晶片及/或電池或任何組件。在此等例子中，可包括在該電路頂面上的塗層。同樣關注的塗層是設計來於儲存期間保護該可攝取電路，但於使用期間馬上溶解。例如，塗層於與諸如胃液的水性流體或如上述的導電流體相接觸之際溶解。同樣關注的是保護處理塗層，其被用來允許使用在其他方面損害裝置的特定組值的處理步驟。例如，在產生具異質材料沈積在頂面及底面的晶片的態樣中，製品需要被切丁。然而，切丁程序會刮掉異質材料，而且還可能有關液體會致異質材料排出或溶解。在此等例子中，亦可利用在材料上的保護塗層防止與組件於處理期間的機械或液體接觸。可溶解塗層的另一目的可用以延遲裝置的啟動。例如，可利用置放在異質材料上且花一段例如五分鐘與接觸胃液時溶解的塗層。該塗層亦能是對環境敏感的塗層，例如，溫度或pH敏感塗層，或是其他化學敏感塗層，以一受控的方式溶解且允許吾人於想要時啟動該裝置。可在胃部存活但在小腸溶解的塗層亦是受到關注 的，例如，吾人想要延遲啟動直到該裝置離開胃部為止時。此種塗層的一個例子是聚合物，其在低pH值不溶，但在較高pH值時變成可溶。此外所關注的是醫藥配方保護塗層，例如膠囊液體保護塗層，其防止電路被膠囊的液體啟動。
受關注的識別器包括二異質材料，其作用類似電源的電極(例如陽極及陰極)。此處提到電極或陽極或陰極僅是為了作為說明例。本發明範圍並不侷限於所使用的標籤且包括於二異質材料間產生電位的態樣。因此，當提及電極、陽極、或陰極時，其係為了二異質材料間產生電位的參照。
當材料曝露且與諸如胃液或其他種類的流體(獨自或與乾燥傳導介質先質結合)的體液相接觸時，電位差，亦即電壓，產生於電極間作為發生在該二電極材料之個別氧化及還原反應的結果。於是，在本發明態樣中，配置此種電源使得當二異質材料曝露到例如胃、消化道等目標位置時，產生電壓。
在某些態樣中，一或二金屬可被摻雜非金屬，例如，以強化電池的電壓輸出。在某些態樣中可用作為摻雜劑的非金屬包括但不侷限於：硫、碘及其類似者。
為說明之目的，種種接收器可與本發明的種種態樣共用。在有時於本文稱為「信號接收器」的接收器的一個例子中，可使用二或多個不同解調協定來解碼一給定的接收信號。在某些例子中，可使用同調解調協定及差分同調解 調協定。圖7提供根據本發明一態樣接收器如何可實施一同調解調協定的功能方塊圖。應注意圖7只顯示一部分的接收器。圖7顯示一旦決定載波頻率(以及載波信號向下混合成載波偏移)，將信號向下混合成基頻的程序。載波信號2221與第二載波信號2222在混合器2223混合。窄低通濾波器2220被施以適合的頻寬以減少界外雜訊的影響。根據本發明的同調解調方案解調在方塊2225發生。複合信號的展開相位2230被決定。可施加任選的第三混合器階級，其中使用相位展開來估計計算出與實際載波頻率間的頻率差動。接著在方塊2240利用封包的結構來決BPSK信號之FM編碼區域的開始。主要地，作為該複合解調信號之中的FM沿的同步標頭的存在係用以決定封包的起始界。一旦決定了封包的起始點，信號便在IQ平面上的方塊2250旋轉而在方塊2260標準位元識別且最後被解碼。
除了解調以外，穿體通訊模組可包括前向偵錯模組，該模組可提供額外增益來對抗來自不需要之信號及雜訊的干擾。所關注之前向偵錯模組包括描述於序號PCT/US2007/024225且公開為WO 2008/063626的PCT申請案中，其內容於此併入參考。在某些例子中，前向偵錯模組可利用任何方便的協定，諸如里憄索羅門校正碼(Reed-Solomon)、高利(Golay)、漢明(Hamming)、BCH以及渦輪(Turbo)協定，來識別並校正(界內)解碼錯誤。
在另一例子中，接收器包括如圖8所示之功能方塊圖口中的信標。圖8簡圖中的方案概括一種用以識別有效信標的技術。進入信號2360代表被電極接收、經一高頻信號鏈(包括該載波頻率)帶通濾波(諸如從10 KHz至34KHz)、以及從類比轉換成數位的信號。信號2360接著在方塊2361被抽取並在混合器2362以正常驅動頻率(諸如12.5 KHz、20 HHz等)被混合。結果信號在方塊2364被抽取並在方塊2365被低通濾波(諸如5 KHz BW)以產生被向下混合成載波偏移的載波信號2369。信號2369進一步被方塊2367處理(快速傅立葉轉換且接著二最強峰值偵測)以提供正真實的載波頻率信號2368。此一協定準確決定被傳送信標之載波頻率。
圖9提供根據本發明一態樣之信號接收器的積體電路組件的方塊功能圖。在圖9中，接收器2700包括電極輸入2710。電耦合到電極輸入2710的是2720及2730。在一態樣中，穿體傳導通訊模組2720係實施為低頻(LF)信號鏈。同樣所顯示的是CMOS溫度感測模組2740(用以偵測周圍溫度)及三軸加速計2750。接收器2700亦包括處理引擎2760(例如微處理器及數位信號處理器)、非揮發性記憶體2770(用於資料儲存)及無線通訊模組2780(用於資料傳輸到另一裝置，例如於資料上傳的動作中)。
圖10提供根據本發明一態樣配置以實施圖9描述之接收器的功能方塊圖之電路的更詳細的方塊圖。在圖10 中，接收器2800包括電極e1、e2及e3(2811、2812及2813)，其等例如接收由所關注之整合環境模型(IEM)及/或感測生理參數或生物指標傳導傳送的信號。被電極2811、2812及2813接收的該等信號被電耦合到該等電極的多工器2820多工處理。
多工器2820電耦合到高帶通濾波器2830及低帶通濾波器2840二者。高及低頻信號鏈提供可編程增益以涵蓋想要的位準或範圍。在此特定態樣中，高帶通濾波器2830通過在10 KHz到34 KHz頻帶中的頻率而過濾除來自帶外頻率的雜訊。此高頻帶可改變且可包括，例如，3 KHz到300 KHz的範圍。通過的頻率接著在被轉換器2834轉換成數位信號之前被放大器2832放大，用以輸入進高功率處理器2880(顯示為DSP)，其電耦合到高頻信號鏈。
低功率處理器2840顯示通過在0.5 Hz到150 Hz範圍的低頻，而濾除界外頻率。頻帶可改變且可包括例如，小於300 Hz的頻率，諸如小於200 Hz，包括小於150 Hz。通過頻率信號被放大器2842放大。同樣顯示的是電耦合到第二多工器2860的加速計2850。多工器2860將來自加速計的信號與來自放大器2842的放大信號多工處理。經多工處理的信號接著被亦電耦合到低功率處理器2870的轉換器2864轉換成數位信號。
在一態樣中，數位加速計(諸如由Analog Devices製造者)，可以取代加速計2850來實施。藉使用數位加速 計可得到種種優點。例如，因為數位加速計會產生的信號已經是數位格式，數位加速計會旁通轉換器2864且電耦合到低功率微控制器2870，於該情形中不再需要多工器2860。而且，該數位信號可被組態而當偵測到動作時將自己開啟，進一步保存電力。此外，可實施連續步級計數。數位加速計可包括FIFO緩衝器以幫助控制被傳送到低功率處理器2870之資料流。例如，資料可在FIFO內緩衝直到滿為止，在該時處理器可被觸發而從閒置狀態被喚醒且接收該資料。
低功率處理器2870可以例如是德州儀器(Texas Instruments)的MSP430微控制器。接收器2800的低功率處理器2870保持閒置狀態，其如前述，需要最小電流引出，例如等於或小於10 .mu.A，或等於或小於1 .mu.A。
高功率處理器2880可以例如是德州儀器(Texas Instruments)的VC5509數位信號處理器。高功率處理器2880於現用狀態期間執行信號處理動作。此等動作，如前述，比閒置狀態需要更大量電流，例如，等於或大於30 .mu.A，諸如等於或大於50 .mu.A的電流，且可包括，例如，諸如掃瞄傳導傳送的信號、接收時傳導處理傳送的信號、獲得及/或處理生理資料等。
亦顯示於圖10的是電耦合到高功率處理器2880的快閃記憶體2890。在一態樣中，快閃記憶體2890可電耦合到低功率處理器2870，其提供較佳的功率效率。
無線通訊元件2895係顯示電耦合到高功率處理器2880且可包括例如藍牙無線通訊收發器。在一態樣中，無線通訊元件2895係電耦合到高功率處理器2880。在另一態樣中，無線通訊元件2895係電耦合到高功率處理器2880及低功率處理器2870。再者，可實施無線通訊元件2895具有其自己的電源使得其可獨立於接收器的其他組件被例如微處理器開啟及關閉。
考慮到例如閒置狀態，以下段落提供根據本發明一態樣顯示於圖10之接收器組件於種種拉收器狀態的範例配置。應了解到替代組態可依據想要的應用加以實施。
例如，在一閒置狀態中，接收器引出最小電流。接收器2880被配置使得低功率處理器2870係處於不活動狀態(諸如閒置狀態)而高功率處理器2880係處於不活動狀態(諸如閒置狀態)，且有關周邊電路的電路方塊及其所需電源於種種現用狀態期間保持關閉(例如，無線通訊模組2895及類比前端)。例如，低功率處理器可具有32 KHz的振盪器活動的且可消耗一些等於或小於.mu.A電流。在閒置狀態中，低功率處理器2870可例如，等待一信號以便轉移到現用狀態。該信號可以是外部的，諸如一個中斷或由諸如計時器的周邊裝置其中之一者由內部產生。於高功率處理器的閒置狀態期間，高功率處理器可例如運作32 KHz的鐘錶石英。高功率處理器可例如，等待一信號以便轉移到現用狀態。
當接收器處於側錄(sniff)狀態時，低功率處理器 2870係處於閒置狀態且該側錄功能所需之包括A/C轉換器的類比前端是開啟的(換言之，高頻信號鏈)。如前述，信標信號模組可實施種種類型的側錄信號以達到低功率效率。
於偵測一被傳送信號之際，可進入到高功率解調及解碼狀態。當接收器係處於解調及解碼狀態時，低功率處理器2870係處於活動狀態且高功率處理器2880係處於活動狀態。高功率處理器2880可以例如從12 MHz或接近具可給予裝置108 MHz時脈速度之PLL為基礎的時脈倍頻器(clock multiplier)的鐘錶石英振盪器運行。低功率處理器2870可例如於活動狀態期間以1 MHz到20 MHz的範圍運作內部R-C振盪器以及以每MHz 250至300 uA範圍的時脤速度消耗功率。活動狀態允許接下來的任何傳輸。所需的傳輸可觸發無線通訊模組關閉循環到開啟。
當接收器於收集心電圖(ECG)及加速計狀態時，有關加速計及/或ECG信號調節鏈的電路方塊開啟。高功率處理器2880於收集期間係處於閒置狀態，而於理及傳輸期間係處於活動狀態(例如，從12 MHz或接近具可給予裝置108 MHz時脈速度之PLL為基礎的時脈倍頻器的鐘錶石英振盪器運行)。低功率處理器2870於此狀態期間係處於活動狀態且可以1 MHz到20 MHz的範圍運作內部R-C振盪器以及以每MHz 250至300 uA範圍的時脤速度消耗功率。
低功率處理器(例如圖10所示之MSP)及高功率處 理器(例如圖10所示之DSP)可使用任何方便的通訊協定彼此通訊。在某些例子中，當有此二元件時，彼此透過一系列周邊介面匯流排(下文稱「SPI匯流排」)。以下說明描述實施發信號及發訊息方案以允許高功率處理器及低功率處理器沿著SPI匯流排來回通訊及傳送訊息。就以下處理器間通訊的說明而言，「LPP」及「HPP」用來分別代替「低功率處理器」及「高功率處理器」，以與圖10保持一致。然而，此討論可應用於圖10所示之處理器以外的處理器。
圖11提供根據本發明一態樣之接收器有關高頻信號鏈的接收器中硬體的方塊圖。於圖11中，接收器2900包括電耦合到多工器2920的接收器探針(例如以電極2911、2912及2913的形式)。同樣顯示的高通濾波器2930及低通濾波器2940，提供帶通濾波器用來消除任何界外頻率。在所示的態樣中，提供10 KHz到34 KHz的帶通來通過落在該頻帶以內的載波信號。載波頻率的例子可包括但不侷限於12.5 KHz及20 KHz。可以有一或多個載波存在。此外，接收器2900包括類比數位轉換器2950，例如，在500 KHz取樣。該數位信號之後被DSP處理。顯示於此態樣中的是DMA到DSP單元2960，其傳送該數位信號到DSP的專用記憶體。直接記憶體存取提供允許DSP的其餘部分保持在低功率模式的好處。
包括一接收器之系統的一個例子係顯示於圖12。在圖12中，系統3500包括醫藥組成物3510，其包含諸如 可攝取事件指示器的可攝取裝置「IEM」。同樣存在於系統3500中是信號接收器3520。信號接收器3520被配置以偵測從IEM 3510發射的信號。信號接收器3520亦包括生理感測能力，諸如ECG及運動感測能力。信號接收器3520被配置以傳送資料到一外部裝置或個人數位助理(PDA)3530(諸如智慧型電話或其他無線通訊致能裝置)，其接著將該資料傳送到伺服器3540。伺服器3540可依所需配置，例如，用以提供病人導向的許可。例如，伺服器3540可配置來例如，經由介面(諸如網路界面)允許家屬看護3550參與病人的治療方案，該介面允許家屬看護3550監控由伺服器3540所產生之警示及趨勢，並提供支援回到病人，如箭號3560所示者。伺服器3540亦可配置來直接提供回應給病人，例如，以病人警示、病人誘因等形式，如箭號3565所示者，其經由PDA 3530中繼到病人。伺服器亦可與健康中心專業人員(例如註冊護士、醫師)3555互動，其能使用資料處理演繹法來得到病人健康、用藥意願的測量，例如健全指示摘要、警示、跨病人基準等，並提供通知的臨床通訊及支援回到病人，如箭號3580所示者。
僅管有申請專利範圍，本發明亦指以下條款：
1.一種用於通訊之可植入式裝置，其具有使用電流特徵傳遞資訊的通訊裝置，該通訊裝置包含：支撐結構；第一材料，與該支撐結構實體結合；以及 第二材料，在一有別於該第一材料之位置處與該支撐結構實體結合，使得該第一材料與該第二材料彼此電隔離，其中，該支撐結構包括一控制模組，用以控制該第一材料與該第二材料間之傳導率以產生具資訊的高頻電流特徵，且其中該可植入式裝置能偵測及解碼該高頻電流特徵以及低頻電流特徵。
2.如條款1之裝置，其中，該低頻電流特徵係由使用者身體所產生。
3.如條款1或2之裝置，進一步包含一衛星單元，其包括一處理器及多數個電極，其中至少一電極接收該高頻電流特徵。
4.一種系統，包含如前述條款中任一條款之裝置，以及一與該通訊裝置通訊之可植入式裝置，該可植入式裝置包括心律調整器及引線的至少其中之一者。
5.一種通訊系統，該系統包含：通訊裝置，用以使用電流特徵傳遞資訊，其中該裝置包含：支撐結構；第一材料，與該支撐結構實體結合；以及第二材料，在一有別於該第一材料之位置處與該支撐結構實體結合，使得該第一材料與該第二材料彼此電隔離，其中，該支撐結構包括一控制模組，用以控制該第一 材料與該第二材料間之傳導率以產生具資訊的高頻電流特徵；以及可植入式裝置，與使用者身體結合，其中該可植入式裝置偵測及解碼由該通訊裝置所產生之資訊，其中，當該鏖通訊裝置係與導電流體相接觸時，該通訊裝置產生該電流特徵。
6.如條款5之系統，進一步包含非導電膜，其固定於該支撐結構且相對該第一材料與該第二材料設置，以有助於該第一材料與該第二材料間之電流路徑的延伸。
7.如條款5或6之系統，其中，該可植入式裝置係設置於心臟以提供定步脈衝到心臟之可植入式刺激裝置與可植入式感測裝置之至少其中之一者。
8.如條款5至7中的任一條款之系統，其中，該可植入式裝置係選自於實質上由可植入式神經裝置及可植入式心臟裝置所組成之群組。
9.如條款5至8中的任一條款之系統，進一步包含以結合之可攝取形式的醫藥製品，該醫藥製品與該通訊裝置結合。
10.如條款5至9中的任一條款之系統，其中，該通訊裝置係容裝於一囊劑內，該囊劑於與該導電流體接觸之際崩解，且其中該通訊裝置遞送該可植入式裝置之編程資訊及指令的至少其中之一者。
11.如條款5至10中的任一條款之系統，其中，該資訊包括該通訊裝置的識別，且/或其中該資訊包括該通訊 裝置的啟動時間。
12.如條款5至11中的任一條款之系統，其中，該可植入式裝置係一偵測器，其設置於皮膚下用以記錄與該裝置相關聯之資訊。
13.一種可植入式單元，用以遞送定步脈衝且用以通訊裝置通訊，該可植入式引線包含：至少一導線；耦合到該導線的處理器，該處理器包含：匯流排；高頻偵測模組，耦合到該匯流排，用以接收及解碼一高頻電流特徵；低頻偵測模組，耦合到該匯流排，用以接收及解碼一低頻電流特徵；多數個耦合到該處理器之分別定址的電極，各電極能夠接收該高頻電流特徵與低頻電流特徵的至少其中之一者，其中該高頻電流特徵包括用於通訊之在其內編碼的資訊，且該低頻電流特徵係與生理參數有關。
14.如前述任一條款之裝置及/或系統，進一步包含一醫藥製品。
15.可產生於如條款14之裝置或系統之攝取時的電位差之用途，用以電力開啟在該裝置內部之控制邏輯，該控制邏輯透過該第一材料與該第二材料間之導電流體來控制傳導率。
16.一種系統，包含如條款1至3中的任一條款之裝 置及如條款13之單元。
應了解到本發明不侷限於此處描述的特定實施例或態樣，且因此可以改變。亦應了解到此處使用的專有名詞僅是為了說明特定態樣之目的，且不是為了限制，因為本發明範圍僅受到附加之申請專利範圍的限制。
應了解到有提供值的範圍處，除非上下文清楚指示，否則每一中介值到下限的單位的十分位，在該範圍上限與下限之間，且任何其他敘述或在該敘述範圍中的中介值，係包含在本發明以內。此等小範圍之上及下限可獨立包括於小範圍且亦包含在本發明以內，受到該敘述範圍中任何特別排除的限制。所敘述的範圍該等限制的一或二者，排除所包括之限制的任一或二者的範圍亦包含在本發明內。
除非特別界定，否則此處使用的所有技術及科學名詞與熟於本發明所屬之此技術之人士一般所了解者相同。雖然類似或等同此處所描述之任何方法及材料亦能用於本發明的實施及測試，但現將描述代表性的說明方法及材料。
於本說明書引用的所用公開案及專利於此併入參考如同每一個別公開案或專利被特別及個別指出要被併入參考，且於此併入參考以揭示及說明與所引用之該等公開案有關的方法及/或材料。任何公開案的引用係針對在申請日前的其揭示且不應解釋為許可本發明係無權由於習知發明而早於此公開案。再者，所提供之公開案的日期可能與實際公開日不同，可能需要個別確認。
應注意，當使用於本文中及所附之申請專利範圍時， 單數形式「一」、「一個」及「該」包括複數的意涵，除非內文中有清楚地作出相反的表示。應進一步指出的是，申請專利範圍可被撰寫成排除任何非必要的元件。因此，此陳述是要為使用像是「唯一」、「僅」及其它類似排除性術語來作為請求元件的限制或「負面」限制提供先行詞基礎。
在閱讀此揭露內容時將會變得很清楚的是，描述及例示於本文中的各實施例具有分離的構件及特徵，它們可以很輕易地與其它數個實施例中的任何一者的特徵分開或結合而不偏離本發明的範圍或精神。任何被描述的方法可依照所描述的事件順序或依照邏輯上可能的任何其它順序來實施。
雖然上述的發明已藉由為了清楚瞭解的目的以例示的方式予以詳細地描述，在發明的教導下對於在此技藝中具有一般技術者而言很明顯的是，一些改變及修改可在不偏離本案申請專利範圍的精神與範圍為被達成。
因此，上文只是例示本發明的原理。將可被瞭解的是，熟習此技藝者將能夠達成各種配置，它們雖然沒有被明確地描述或顯示於本文中，但仍體現發明的原理且亦被包括在本發明的精神與範圍內。再者，描述於本文中的所有例子及條件式語言原則上都是要用來幫助讀者瞭解本發明的原理及本案發明人對於推進此技藝所貢獻的概念，且應被解讀為不受限於被特定地描述的例子及條件。再者，本文中描述本發明的原理、態樣及實施例的所有陳述以及其 特定的例子都是要用來涵蓋本發明在結構及功能上的等效物。此外，這些等效物包括目前已知的等效物及在未來發展出來的等效物，即實施相同的功能而不論其結構之開發出來的任何元件。因此，本發明的範圍並不侷限於本文中所示及描述的示範性實施例。相反地，本發明的範圍及精神是由所附的申請專利範圍來體現。
10‧‧‧醫藥製品
11‧‧‧囊劑
11a‧‧‧凹穴
12‧‧‧系統
12a‧‧‧系統
12b‧‧‧單元
12c‧‧‧凹穴
13‧‧‧心臟
14‧‧‧囊劑
15‧‧‧可植入式裝置
15a‧‧‧心律調整器
15b‧‧‧引線
17‧‧‧路徑
20‧‧‧醫藥製品
22‧‧‧系統
30‧‧‧系統
32‧‧‧架構
34‧‧‧材料
35‧‧‧裙部
36‧‧‧材料
37‧‧‧裙部
38‧‧‧控制裝置材料
39‧‧‧材料
40‧‧‧系統
42‧‧‧架構
44‧‧‧材料
46‧‧‧材料
48‧‧‧控制裝置
49‧‧‧裙部
50‧‧‧電流路徑
52‧‧‧接地點
55‧‧‧控制模組
62‧‧‧控制模組
64‧‧‧時脈
66‧‧‧記憶體
68‧‧‧輸入
70‧‧‧輸出
72‧‧‧感測器模組
74‧‧‧感測器模組
75‧‧‧單元
75a‧‧‧單元
76‧‧‧pH值感測器模組
78‧‧‧接點
2220‧‧‧窄低通濾波器
2221‧‧‧載波信號
2222‧‧‧載波信號
2223‧‧‧複合混合器
2225‧‧‧方塊
2230‧‧‧展開相位
2240‧‧‧封包尋檢器
2250‧‧‧相位旋轉器
2260‧‧‧資料解碼器
2360‧‧‧信號
2361‧‧‧抽取
2262‧‧‧複合混合器
2364‧‧‧CIC抽取
2365‧‧‧寬有限脈衝響應濾波器(FIR LPF)
2367‧‧‧方塊
2368‧‧‧載波頻率信號
2369‧‧‧信號
2700‧‧‧接收器
2710‧‧‧電極輸入
2720‧‧‧穿體傳導通訊模組
2730‧‧‧生理感測模組
2740‧‧‧溫度感測模組
2750‧‧‧加速計
2760‧‧‧處理引擎
2770‧‧‧記憶體
2780‧‧‧無線通訊模組
2800‧‧‧接收器
2811‧‧‧電極
2812‧‧‧電極
2813‧‧‧電極
2820‧‧‧多工器
2830‧‧‧高帶通濾波器
2840‧‧‧低帶通濾波器
2842‧‧‧放大器
2850‧‧‧加速計
2860‧‧‧多工器
2864‧‧‧轉換器
2870‧‧‧低功率處理器
2880‧‧‧高功率處理器(DSP)
2890‧‧‧快閃記憶體
2895‧‧‧無線通訊元件
2900‧‧‧接收器
2911‧‧‧電極(探針)
2912‧‧‧電極
2913‧‧‧電極
2920‧‧‧多工器
2930‧‧‧高通濾波器
2940‧‧‧低通濾波器
2950‧‧‧類比數位轉換器
2960‧‧‧DMA到DSP單元
3500‧‧‧系統
3510‧‧‧醫藥組成物
3520‧‧‧信號接收器
3530‧‧‧個人數位助理(PDA)
3540‧‧‧伺服器
3550‧‧‧家屬看護
3555‧‧‧健康中心專業人員
3560‧‧‧箭號
3565‧‧‧箭號
3580‧‧‧箭號
圖1顯示根據本發明教示之事件指示器系統與可植入式裝置通訊。
圖2 A顯示圖1之醫藥製品，該事件指示器系統在該醫藥製品的外部。
圖2B顯示圖圖1之醫藥製品，該事件指示器系統位在該醫藥製品的內部。
圖3是方塊圖，表示具有置於相反端之異質材料的事件指示器系統的一態樣。
圖4是方塊圖，表示具有置於相同端且被非導電材料隔開之異質材料的事件指示器系統的另一態樣。
圖5顯示當圖3之事件指示器系統與導電流體接觸而成活性狀態時透過導電流體的離子轉移或電流路徑。
圖5A顯示圖5之異質材料之表面的分解圖。
圖5B顯示具有pH值感測器單元之圖5之事件指示器系統之異質材料。
圖6是一用於圖3及圖4之系統中之控制裝置之一態 樣的方塊圖。
圖7是一解調電路的功能方塊圖，其根據本發明一態樣實施可在接收器中的同調解調。
圖8繪示根據本發明一態樣之用於接收器內部之信標模組的功能方塊圖。
圖9是根據本發明之可在接收器中之不同功能樣組的方塊圖。
圖10是一根據本發明一態樣之接收器的方塊圖。
圖11提供一根據本發明一態樣之接收器中高頻信號鏈的方塊圖。
圖12提供一如何使用根據本發明一態樣之包括信號接收器及可攝取事件製造器之系統的圖。
3500‧‧‧系統
3510‧‧‧醫藥組成物
3520‧‧‧信號接收器
3530‧‧‧個人數位助理(PDA)
3540‧‧‧伺服器
3550‧‧‧家屬看護
3555‧‧‧健康中心專業人員
3560‧‧‧箭號
3565‧‧‧箭號
3580‧‧‧箭號

Claims (13)

  1. 一種用於通訊之可植入式裝置，其具有使用電流特徵傳遞資訊的通訊裝置，該通訊裝置包含：支撐結構；第一材料，係與該支撐結構實體結合；以及第二材料，係在一有別於該第一材料之位置處與該支撐結構實體結合，使得該第一材料與該第二材料彼此電隔離，其中，該支撐結構包括一控制模組，用以控制該第一材料與該第二材料間之傳導率以產生具資訊的高頻電流特徵，且其中該可植入式裝置能偵測及解碼該高頻電流特徵以及低頻電流特徵。
  2. 如申請專利範圍第1項之裝置，其中，該低頻電流特徵係由使用者身體所產生。
  3. 如申請專利範圍第1項之裝置，進一步包含一衛星單元，其包括一處理器及多數個電極，其中至少一電極接收該高頻電流特徵。
  4. 一種通訊系統，該系統包含：通訊裝置，用以使用電流特徵傳遞資訊，其中該裝置包含：支撐結構；第一材料，係與該支撐結構實體結合；以及第二材料，係與該第一材料絕緣，且在一有別於該第一材料之位置處與該支撐結構實體結合，使得該第一 材料與該第二材料彼此電隔離，其中，該支撐結構包括一控制模組，用以控制該第一材料與該第二材料間之傳導率以產生具資訊的高頻電流特徵；以及可植入式裝置，與使用者身體結合，其中該可植入式裝置偵測及解碼由該通訊裝置所產生之資訊，其中，當該通訊裝置係與導電流體相接觸時，該通訊裝置產生該電流特徵。
  5. 如申請專利範圍第4項之系統，進一步包含非導電膜，其係固定於該支撐結構且相對該第一材料與該第二材料設置，以有助於該第一材料與該第二材料間之電流路徑的延伸。
  6. 如申請專利範圍第5項之系統，其中，該可植入式裝置係設置於心臟以提供定步脈衝到心臟之可植入式刺激裝置與可植入式感測裝置之至少其中之一者。
  7. 如申請專利範圍第5項之系統，其中，該可植入式裝置係選自於實質上由可植入式神經裝置及可植入式心臟裝置所組成之群組。
  8. 如申請專利範圍第6項之系統，進一步包含以結合之可攝取形式的醫藥製品，該醫藥製品係與該通訊裝置結合。
  9. 如申請專利範圍第6項之系統，其中，該通訊裝置係容裝於一囊劑內，該囊劑於與該導電流體接觸之際崩解，且其中該通訊裝置遞送該可植入式裝置之編程資訊及指 令的至少其中之一者。
  10. 如申請專利範圍第6項之系統，其中，該資訊包括該通訊裝置的識別。
  11. 如申請專利範圍第6項之系統，其中，該資訊包括包括該通訊裝置的啟動時間。
  12. 如申請專利範圍第5項之系統，其中，該可植入式裝置為一偵測器，其係設置於皮膚下用以記錄與該裝置相關聯之資訊。
  13. 一種可植入式單元，用以遞送定步脈衝且用以通訊裝置通訊，該可植入式引線包含：至少一導線；耦合到該導線的處理器，該處理器包含：匯流排；高頻偵測模組，係耦合到該匯流排，用以接收及解碼一高頻電流特徵；低頻偵測模組，係耦合到該匯流排，用以接收及解碼一低頻電流特徵；多數個耦合到該處理器之分別定址的電極，各電極能夠接收該高頻電流特徵與低頻電流特徵的至少其中之一者，其中該高頻電流特徵包括用於通訊之在其內編碼的資訊，且該低頻電流特徵係與生理參數有關。
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US8730031B2 (en) 2014-05-20
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