TWI437976B - 可吞食的事件標示器及個人事件監視系統 - Google Patents
可吞食的事件標示器及個人事件監視系統 Download PDFInfo
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Description
本發明2009年4月28日提申之美國暫時申請案第61/173,511號及2009年4月28日提申之美國暫時申請案第61/173,564號有關,這些申請案的內容藉此參照而被倂於本文中。
本發明係關於高度可靠之可吞食的事件標示器及其使用方法。
在醫療及非醫療應用中有許多情形是吾人想要記錄一個人事件,即對於一既定的個人而言特定的事件。醫療應用的例子為,吾人會想要記錄下對於一既定的個人而言很特定的事件,其包括但不侷限於一或多個感興趣的生理變化的開始,這包括疾病症狀,藥物的服用等等。非醫療應用的例子為,吾人會想要記錄下對於一既定的個人而言很特定的事件,其包括但不侷限於某些特定種類食物的吞食,如對於在節食控制的個人而言,一運動食物療法的開始,等等。
因為有許多情況吾人想要記錄一個人事件,所以已有各種不同的方法及技術被開發出來讓此記錄成為可能。例如,日誌簿技術已被開發,其中個人,如病患及/或他們的健康照護,可例如藉由人工手寫或資料輸入事件的時間及日期來加以記錄。
然而,對於個人事件監視的改進持續地存在著需求。例如,當一事件發生時,手寫日誌會相當費時間且有可能發生錯誤。
一種具有高度可靠之事件標示器,如可吞食的事件標示器,被提供。事件標示器的態樣包括一支撐件,一與該支撐件實體地相結合的控制電路,用以控制該高度可靠之可吞食的事件標示器,一第一電化學物質其與該支撐件實體地相結合且電耦合至該控制電路,一第二電化學物質其電耦合至該控制電路且在一不同於該第一電化學物質的位置的位置處與該支撐件實體地相結合,使得該第一及第二電化學物質彼此被電隔離;及一薄膜其與該支撐件實體地相結合且相對於該第一電化學物質及第二電化學物質被放置,以產生一虛擬的雙極(dipole)長度,其比該第一及第二電化學物質所界定之實際的雙極長度還長。
一種具有高度可靠的事件標示器,例如可吞食的(ingestible)事件標示器(“IEM”,其在本文中有時被稱為“識別器”)被提供。該可吞食的事件標示器的態樣包括一支撐件,一與該支撐件實體地相結合的控制電路,用以控制該高度可靠之可吞食的事件標示器,一第一電化學物質其與該支撐件實體地相結合且電耦合至該控制電路,一第二電化學物質其電耦合至該控制電路且在一不同於該第一電化學物質的位置的位置處與該支撐件實體地相結合,使得該第一及第二電化學物質彼此被電隔離;及一薄膜其與該支撐件實體地相結合且相對於該第一電化學物質及第二電化學物質被放置,以產生一虛擬的雙極(dipole)長度,其比該第一及第二電化學物質所界定之實際的雙極長度還長。
如上文所述,本發明之可吞食的事件標示器(IEM)是高度可靠的。“高度可靠”係指本發明之可吞食的事件標示器在被使用於一應用中時正確地產生並發射一訊號的機率為80%或更高,譬如90%或更高,包括95%或更高。本發明之高度可靠的可吞食的事件標示器正地產生並發射一訊號的機率為99.5%或更高,譬如99.9%或更高,且在某些例子中,正確地產生並發射一訊號的機率為100%。如下文中進一步描述的,該等可吞食的事件標示器的高可靠度特徵係來自於該IEM的一或多個構成物(component)及/或結構特徵,這將於下文中詳下說明。如下文中更詳細的描述,該IEM的一或多個組成及/或結構特徵可給予IEM一或多個下列特徵:強化的訊號強度,延長的壽命,被胃液進一步濕潤,降低被腸胃道(GI)黏膜阻塞的可能性,降低被氣泡及/或抗發泡阻塞的可能性,降低漂浮的可能性。這些所想要的特徵可藉由一或多個結構特徵及/或化學成分(constituent)而被施加至一給定的IEM,這將於下文中詳細說明。
一可吞食的事件標示器是一種裝置,其被設計成可吞食的大小且包括一由IEM電路構件及一薄膜構成的IEM。該IEM亦可包括一賦形劑(vehicle)。一藥學的活性劑可存在於該薄膜及/或賦形劑中。因為IEM被作成可吞食的大小,所以在某些例子中,它們被作成可被放在人類的嘴中及被吞嚥的大小。在一些例子中,本發明的IEM最長的尺寸為30mm或更小,譬如20mm或更小,包括5mm或更小。
感興趣的事件標示器,如可吞食的事件標示器,的各種態樣被描述在PCT申請案第PCT/US2006/016370號其被公告為WO/2006/116718號;PCT申請案第PCT/US2007/082563號其被公告為WO/2008/052136號;PCT申請案第PCT/US2007/024225號其被公告為WO/2008/063626號;PCT申請案第PCT/US2007/022257號其被公告為WO/2008/066617號;PCT申請案第PCT/US2008/052845號其被公告為WO/2008/095183號;PCT申請案第PCT/US2008/053999號其被公告為WO/2008/101107號;PCT申請案第PCT/US2008/056296號其被公告為WO/2008/112577號;PCT申請案第PCT/US2008/056299號其被公告為WO/2008/112578號;及PCT申請案第PCT/US2008/077753號其被公告為WO/2009/042812號中;它們的揭示內容被倂於本文中以為參考。在某些態樣中,該等可吞食的事件標示器在研究個體服食後即瓦解。因此,在一些態樣中,在被送入人體中,如經由吞食,注射等,之後,構成物即被實體地分解,如溶解,剝蝕,腐蝕等等。這些態樣的構成物與被建構來被吞食且在通過腸胃道時實質地或完全地不受損傷地存活的裝置是區分開的。
在各種態樣中,該高度可靠的事件標示器包括一支撐件,一與該支撐件實體地相結合的控制電路,用以控制該高度可靠的事件標示器,一第一電化學物質其與該支撐件實體地相結合且電耦合至該控制電路,一第二電化學物質其電耦合至該控制電路且在一不同於該第一物質的位置的位置處與該支撐件實體地相結合,使得該第一及第二電化學物質彼此被電隔離;及一薄膜其與該支撐件實體地相結合且相對於該第一電化學物質及第二電化學物質被放置,以產生一虛擬的雙極長度,其比該第一及第二電化學物質所界定之實際的雙極長度還長。
該高度可靠的事件標示器可被建構來在目標部位與提供一電位差的流體,譬如導電流體,如胃液,接觸時被活化。在不同的態樣中,該控制電路控制經由改變該系統的整體阻抗的邏輯來控制傳導性。例如,該控制電路可被電耦接至一時鐘。該時鐘可提供一時鐘周期給該控制電路。根據該控制電路之被程式化的特徵,當該等時鐘循環的一被設定數字經過時,該控制電路改變介於該等電化學物質之間的傳導性。此循環可重復且該控制電可藉此產生一獨一無二的電流簽名特徵,其在本文中有時候被稱為“電流簽名(current signature)”。該控制電路亦可被電耦接至一記憶體。當與該導電流體接觸時,該時鐘及該記憶體兩者都是由產生於該等物質之間的電壓來提供電力。
關於該電流簽名,該電流簽名可將高度可靠的事件標示器類別與其它類別加以區別,或普遍性地獨一無二,譬如該電流簽名就像是人類的指紋一樣,其與其它任何人的任何其它指紋都不相同,因此可以在普遍性的層級上獨一無二地指認出一個人。在不同的態樣中,該控制電路可產生許多不同種類的通信,其包括但不侷限於:RF訊號,磁性訊號,導電性(近場)訊號,聲音訊號等等。
接收器,如到目前為止描述於本發明的不同態樣中者,並不需要任何額外的纜線或硬接線連接於該裝置與該通信的接收器之間,其在本文中有時候被稱為偵測器。
在一些例子中,該高度可靠的事件標示器包括兩個不一樣的電化學物質,其係分別作為陰極及陽極之用。當這兩個不同的電化學物質與體液,譬如胃液,接觸時,因為分別發生在這兩個不同的電化學物質處的氧化反應及還原反應的結果產生一電位差(電壓)於該陰極與該陽極之間。構成該等電化學物質之不同的電化學物質可用對於該IEM電路構件(circuitry component)將於其內操作的環境而言是適合的任兩種物質來製造。該等活性物質是任何具有不同的電化學電位的物質對。該等電化學物質可被選擇用以在與目標生理部位點接觸時提供一足以驅動該IEM電路構件的訊號產生元件的電壓。在有需要的時候,當電源的金屬與該目標生理部位點接觸時,該兩種不同的電化學物質所產生的電壓為0.001V或更高,包括0.01V或更高,譬如像是0.1V或更高,如0.3V或更高,包括0.5伏或更高,及包括1.0伏或更高,在某些態樣中,該電壓範圍從約0.001至約10伏,譬如從約0.01至約10V。
感興趣的陽極物質包括但不侷限於:鎂,鋅,鈉,鋰,鐵及它們的合金,如鎂的鋁及鋅合金,其可被插入或可不被插入許多物質,譬如具有Li,K,Ca,Na,Mg,及類此者。感興趣的陰極物質包括但不侷限於銅鹽,譬如像是碘化物,氯化物,溴化物的銅鹽,硫酸鹽,甲酸鹽,Fe3+
鹽,譬如正磷酸鹽,焦磷酸鹽等等。該等金屬的一或者或兩者可被摻雜一非金屬,用以強化部分電源或一電池的電壓輸出。在某些態樣中可被用作為摻雜劑的非金屬包括但不侷限於:硫酸,碘化物及類此者。在某些態樣中,該等電化學物質為作為陽極的碘化亞銅(CuI)或氯化亞銅(CuCl)及作為陰極的鎂(Mg)金屬或鎂合金。本發明的態樣使用不會對人體造成傷害的電化學物質。當該等物質被外露且與體液,譬如胃酸或其它種類的流體(單獨地或與一所想要的導電媒介先驅物結合),接觸時一電位差,亦即電壓,會因為分別發生在兩個電化學物質處的氧化反應及還原反應而被產生在這兩個電化學物質之間。一電壓電池或蓄電池可因而被產生。因此,在本發明的實施例中,這些電力供應可被建構成當這兩個不同的物質在目標位置點,如胃,消化道等等,被外露時,一電壓即被產生。
感興趣的電化學物質包括在接觸到液態的生理流體,譬如像是胃酸,時若會產生氣泡的話也只會產生少量氣泡的電化學物質。感興趣的電化學物質包括金屬合金,感興趣的金屬合金包括但不侷限於Mg,Zn,Al及Li的合金。當有金屬合金時,金屬合金的量的範圍是在0.01至15重量百分比,譬如0.1至15重量百分比,包括1至15重量百分比之間。一或多種不同的合金元件可存在該合金中。在一些態樣中,感興趣的合金為“無氣泡”鎂合金,其為MgAl或MgZn合金,譬如但不侷限於:AZ31鎂合金,AZ61鎂合金,及類此者。
高度可靠的事件標示器,如IEM,可包括一固體支撐件。在某些態樣中,該固體支撐件是很小的,如它被作成寬度的範圍在約0.01mm至約20mm之間,如在約0.1mm至約10mm之間,包括在約0.5mm至約2mm之間;長度的範圍在約0.01mm至約20mm之間,如在約0.1mm至約20mm之間,包括在約0.5mm至約2mm之間;及高度的範圍在約0.01mm至約10mm之間,如在約0.05mm至約2mm之間,包括在約0.1mm至約0.5mm之間。該固體支撐件可以有各種不同的構型,譬如但不侷限於:晶片構型,圓柱形構型,球形構型,盤狀構型等等,一特定的構型可根據打算中的應用,製造方法等等來加以選擇。雖然用來製造該固體支撐件的材料可以有很多變化,但在某些態樣中,該固體支撐件是用半導體材料,如矽,製造。
“單一積體電路”一詞係指一包括用於該裝置之所有想要的不同功能方塊之單一電路結構。在這些態樣中,該積體電路是一單整塊的積體電路(亦被稱為IC微電路,微晶片,矽晶片,電腦晶片或晶片)其為微型化的電子電路(其可包括半導體裝置,以及被動元件)其被製造在一薄的半導體材料基材的表面上。本發明的某些態樣的積體電路可以是複合式積體電路,其為由結合於一基材或電路板上之個別的半導體裝置以及被動元件所建構之被微型化的電子電路。
IEM可使用任何方便的準則(protocol)來製造。感興趣的IEM製造準則包括但不侷限於PCT申請案第PCT/US2006/016370號其被公告為WO/2006/116718號;PCT申請案第PCT/US2007/082563號其被公告為WO/2008/052136號;PCT申請案第PCT/US2007/024225號其被公告為WO/2008/063626號;PCT申請案第PCT/US2007/022257號其被公告為WO/2008/066617號;PCT申請案第PCT/US2008/052845號其被公告為WO/2008/095183號;PCT申請案第PCT/US2008/053999號其被公告為WO/2008/101107號;PCT申請案第PCT/US2008/056296號其被公告為WO/2008/112577號;PCT申請案第PCT/US2008/056299號其被公告為WO/2008/112578號;及PCT申請案第PCT/US2008/077753號,它們的揭示內容被倂於本文中以為參考。
一既定的IEM可包括一單一的IEM,或兩個或更多個IEM,譬如三個或更多個,四個或更多個,五個或更多個,六個或更多個,七個或更多個,八個或更多個,九個或更多個,或十個或更多個IEM。
在一些例子中,一IEM可包括一可腫脹的(swellable)或吸水性塗層,其用來以所想要的方式控制IEM的微環境。在某些例子中,感興趣的可腫脹的塗層為水凝膠(hydrogel)塗層。水凝膠塗層是由一或多種不同的不溶於水的聚合物所構成的聚合物塗層,該塗層在接觸一水性媒介物時會吸收水,以產生一具有很高的水含量,譬如90%或更高的w/w,包括95%或更高的w/w如99%或更高的w/w,之水合物凝膠結構。任何生理可接受的水凝膠構成物可被用作為塗層,感興趣的水凝膠構成物可包括下列聚合物中的一或多種:聚乙烯氧化物,醋酸鹽等等。在一些例子中,該水凝膠塗層可包括一或多種可在該可吞食的事件標示器到達目標生理部位時提供一受控制的環境(例如在傳導性或pH方面)的化學劑。感興趣的化學劑包括但不侷限於:生理可接受的電解質的鹽類,譬如但不侷限於:鈉離子,氯離子,鉀離子及鈣離子,鎂離子等等。感興趣的生理上特別相容的的鹽類包括但不侷限於:KCl,NaCl,MgCl2
及類此者。所想要的pH的範圍在1至8之間,譬如2至7之間,且可藉由任何適當的緩衝劑的存在來施加。
塗層可以有各種不同的構型,譬如像是層狀,卡勾配合預製膠囊構件等等。當塗層存在時,塗層可以只覆蓋該可吞食的事件標示器的一部分覆蓋整個裝置。該塗層的厚度可以是均一的。
IEM可包括至少一對訊號發射元件,如以第一及第二電化學物質的形式,其具有一實際的雙極長度。同樣存在的是一薄膜,其例如可產生一虛擬的雙極長度於該對發射元件之間,該虛擬的雙極長度大於該實際的說極長度。除了控制介於該等物質之間的電流路徑的大小之外,一薄膜(其在本文中有時候被稱為“放大器”)被用來增加該電流路徑的“長度”,因此是用來增大該傳導路徑,就如同描述於2008年9月25日提申,名稱為“In-Body Device with Virtual Dipole Signal Amplification”的美國專利申請案第12/238,345號,及2009年9月21日提申,名稱為“Communication System with Partial Power Source”的美國專利申請案第12/564,017號中者,這些申請案的全部內容被倂於本文中以為參考。或者,在整個揭示內容中,“薄膜”及“放大器”等詞與“電流路徑擴大器”在不影響本發明的態樣及申請專利範圍的範圍下被互換地使用。雖然該薄膜所提供的虛擬的雙極的長度可改變,但在某些例子中,該虛擬的雙極的長度比存在於該對發射元件之間的實際的雙極的長度大了兩倍或更多倍,譬如三倍或更多倍,如五倍或更多倍,二十倍或更多倍,等等。由於在一既定的IEM中的實際的雙極的長度可以改變,在某些例子中其範圍在100微米至2公分之間,譬如在300微米至1公釐之間,所以在一些例子中,虛擬雙極的長度的範圍在約200微米至20公分之間,譬如在600微米至20公釐之間。除了本發明的IEM更包括一薄膜之外,該薄膜更包括一生理的活性劑。
該薄膜可具有許多不同的構型,只要該構型能夠提供一虛擬的雙極,其長度大於兩個或更多個,譬如一對,訊號發射元件之間的實際雙極的長度即可。在某些態樣中,該薄膜是一個被設置在該對訊號發射元件之間的結構。該薄膜可具有二維度或三維度的構型,且可具有任何形狀,譬如像是方形,圓盤形,三角形,卵形,不規則形等等,這將於下文中進一步說明。在某些例子中,由該訊號放大元件所提供的該虛擬的雙極的長度係與該訊號放大元件的特定形狀有關。例如,當該訊號發射元件具有一圓盤構型時,該虛擬的雙極的長度與該圓盤的半徑係實質相同,或完全相同。
在某些例子中,該對發射元件是一對設置在一固體支撐件的相反側上的電化學物質,如該固體支撐件包含一積體電路的例子。例如,當該積體電路具有一上電化學物質及一下電化學物質於積體電路的相反側或表面上時,該薄膜可以是一被設置在該上及下電化學物質之間的緣物質(或複合物質)。該薄膜的外緣可延伸超出也可不延伸超出該等電化學物質的邊緣,這些不同的態樣將於下文中更詳細地說明。
圖1A提供依據本發明的一IEM的態樣的圖式,其具有一延伸超出該等薄膜的外緣的薄膜,以提供一虛擬的雙極其長度大於該等薄膜之間的實際雙極的長度。如圖1A所示,IEM 10包括積體電路2其具有一上電化學物質4(其可包含兩種不同的物質層)及一下電化學物質6。圖中亦顯示一盤狀的薄膜8。圖1B提供圖1A中所示之IEM的上視圖,其顯示上電化學物質4的盤狀及該上電化學物質在該圓盤形的薄膜8的中心的定位。該薄膜的邊緣延伸超出該等電化學物質的邊緣的距離可改變,且在某些態樣中為0.05mm或更多,如0.1mm或更多,包括1.0mm或更多,譬如5.0mm或更多且包括10mm或更多,在某些態樣中該距離不超過100mm。
如可從圖1A及1B所示的態樣中可看出的,該上及下電化學物質是平面的電化學物質,這些電化學物質可具有任何適合的形狀,如方形,圓盤形等等。該圓盤形的薄膜或放大器18為一平面的圓盤結構,該薄膜的邊緣延伸超出該平面的上及下電化學物質的邊緣。在所示的態樣中,該薄膜的半徑比該上及下電化學物質的半徑大了1mm或更多,譬如大了10mm或更多。
該薄膜可具有“二維度”或“三維度”構型。感興趣的薄膜構型被描述在PCT申請案第US2008/077753號其被公開為WO2009/042812號以及美國專利暫時申請案第61/142,849及61/173,511號中,這些申請案的揭示內容被倂於本文中以為參考。在一些例子中,本發明的IEM包括一薄膜其具有一經過選擇的構型用以降低與目標生理部位接觸之後訊號被破壞的可能性。一種會發爭的訊號遭破壞的事件為,該IEM黏附到胃-腸(GI)道的壁上,譬如胃壁上,因而讓該IEM無法與目標生理部位的流體自由地相互作用。該薄膜可被建構成不會黏附於GI道壁上之三維度的形狀。此種構型的一個例子被示於圖1C及1D中。圖1C提供一IEM 10的剖面圖,其包括一IEM電路構件12及一薄膜14其具有反向的(opposing)彎曲緣16及18。圖1E及1F提供其它種類的薄膜的圖式,其具有不會黏附於GI道壁上的三維度形狀。在圖1E中,IEM 10包括IEM電路構件12其被設置在該薄膜14的中央。該薄膜14包括突出部15其可防止IEM電路構件12的底側平躺在一GI道壁上。在圖1F中,該IEM 10包括被設置在該薄膜14的中央之IEM電路構件12,該薄膜14具有一內凹的構型,其可防止該IEM電路構件的底側平躺在一GI道壁上。
或者,該薄膜可包括一或多個可展開的(deployable)元件,用來防止IEM黏附到腸胃道壁上。此一IEM的一個例子被示於圖2A中,其顯示一具有IEM電路構件22及薄膜24的IEM 20。圖2A亦顯示出具有相反構型之可展開的元件26及28。因為這些元件是可展開的,所以在該IEM被吞食之前它們是以第一構型呈現,在吞食之後即展開至一第二位置。一可展開的構型被顯示在圖2B中,其中圖2A的IEM 20的臂26的端部27係以一在接觸水性流體後即溶化之生理可接受的膠水25來與該薄膜24相結合。關於圖2B所示的IEM,當其與目標生理流體(譬如胃液)接觸時,該膠水即溶解而將該臂釋開,使得該IEM具有圖2A所示的構型。
在另一感興趣的構型中,該IEM電子構件未被設置在該薄膜的中央。此一IEM的一個例子被示於圖3中,其中該IEM 30包括未被設置在該薄膜34的中央之IEM電路構件32。
當有需要時,一或多個可促進該IEM在液體環境中(譬如,在胃液中)運動的構件可具有一薄膜。例如一IEM可具有一不是在薄膜的中央的重量。此一構型的一個例子被示於圖4中。在圖4中,IEM 40包括IEM電路構件42及薄膜44。重量46亦被示於圖4中,其沒有位在該薄膜44的中央。在與流體接觸時,該重量係用來將該IEM移動於箭頭所示的方向上,使得該IEM沉入並浸沒到該流體中。在圖4所示的態樣中,該重量的密度大於胃液的密度且將該重量所在之該IEM的一側相對於該IEM之相反側向下拉。該IEM可具有一不是設置在該薄膜的中央的可腫脹的構件,而不是一重量,該可腫脹的構件在接觸到水性流體時會腫脹使得它的密度相對於胃液降低且將該IEM的一側相對於相反側提舉起來。此一IEM的一個例子被示於圖5中,其中IEM 50包括IEM電路構件52及薄膜54,以及可用水腫脹的(water-swellable)構件56。該可用水腫脹的構件56在有水的環境中會腫脹用以將該IEM的一側相對於相反側提舉起來,如圖中箭頭所示。
為了要在存在於一液體環境中(譬如一目標生理流體中)時強化該IEM的運動,可在接觸到該目標生理流體時產生氣泡之冒泡的結構可與該薄膜的一或多個位置相結合。一或多個冒泡結構可與該薄膜相結合。感興趣的薄膜是包括與該薄膜的相反側相結合之兩個不同的冒泡結構的薄膜,使得一第一冒泡結構位在該薄膜的一第一側上及一第二冒泡結構位在該薄膜的一第二側上。在此配位中,該等冒泡結構在產生氣泡時會迫使該IEM因為施加在該薄膜的邊緣上的力量而在一液體環境中轉動。包括冒泡結構的IEM的例子被示於圖6A及6B中。圖6A顯示一種IEM 60其具有一被設置在該薄膜64的中央的IEM電路構件62。冒泡結構66及68亦被示於圖6A中,它們在接觸到一生理流體時會產生氣泡。氣泡施加相反力量於該薄膜的邊緣上,造成IEM如箭頭所示地轉動。在圖6B中,IEM 63與圖6A的IEM 60類似,但不同處在於該薄膜具有彎曲的邊緣65及67。該冒泡結構可包括任何適合的冒泡物質,其是生理可接受的且在接觸一水性流體(如胃液)時會產生氣泡。該冒泡物質可產生各式氣體,譬如像是二氧化碳,氫氣,氧氣,及類此者。在一些例子中,感興趣的冒泡物質為包括鎂的冒泡物質,其在與一水性生理流體接觸時會產生氫氣。其它感興趣的冒泡物質包括酸來源,譬如但不侷限於食物酸,酸與水合解酸劑,譬如檸檬酸,酒食酸,蘋果酸,反丁烯二酸,己二酸及琥珀酸。感興趣的碳酸鹽來源包括但不侷限於乾燥的固體碳酸鹽及重碳酸鹽,譬如重碳酸鈉,碳酸鈉,重碳酸鉀及碳酸鉀,碳酸鎂及類此者。
該薄膜可用數種不同的物質來製造,該薄膜可用一單一物質製成或可以是兩種或更多種不同種類的物質的一合成物(composite)。在選擇適合的物質時,感興趣的一項特性為機械強度。如上文中提到的,該薄膜物質可以是兩種或更多種物質的一複合結構,如一絕緣物質被沉積在一金屬層上。
在某些例子中,該薄膜將具有一機械強度,其足以承受胃腸(GI)道的機械力而不會自我折疊並喪失其形狀。此所想要的機械強度可被加以選擇以至少持續該通信的期間,其可以是1秒鐘或更長,譬如至少1分鐘或更長,長達6小時或更長。在某些態樣中,該所想要的機械強度被加以選擇用以維持1分鐘至30鐘的期間。所想要的機械強度可藉由適當地選擇聚合物或填料,或機械設計(如,如多層式的壓層,或放大器表面的曲率)來達成,用以提高最終結構的機械強度。
本發明的薄膜是被電絕緣的薄膜。因此,製造該薄膜的物質為電絕緣物質。一既定的物質是電絕緣的,如果它的電阻率(resistivity)比該裝置於其中操作的媒介(如,胃液)的電組率高2倍或更高,譬如高10倍或更高,包括比該裝置於其中操作的媒介的電阻率高100倍或更高。
該薄膜感興趣的其它特性包括可吞食性及低的阻塞風險。該薄膜用安全且可吞食的物質來製造是較佳的,譬如像是食品添加物或藥品賦形劑。用一種可以確保胃腸(GI)道被一或多個裝置阻塞的風險很低的方式來製造該薄膜亦是所想要的。這可藉由該放大器物質的化學或物理溶解或消化,或該薄膜的機械性分解,或上述的組合來達成。例如,該薄膜可包含一或多種物質,其在一段時間之後化學地或物理地溶解於該GI流體中。該物質亦可被選擇,用以在到達該GI道之化學環境不同(例如,pH的改變,如從胃中的pH 1-2改變為腸內的pH>5)或脢的組成物的改變(如,存在結腸內的脢)的某些部分時變成可溶解。該薄膜亦可被機械地設計成具有一脆弱點,它是可溶解的且可讓整個結構分解掉。該薄膜可由數個層構成,例如一可溶解的或腫脹的內層及一可控制該內部層的溶解率的外層;在一段時間之後,該內層溶解或腫脹,將整個結構炸裂開。該薄膜並不需要完全是可溶解的或可消化的來消除阻塞的風險;該薄膜在該胃腸道內受到中度的機械應變時會皺摺或斷裂而變成機械地易曲折或易脆的就已足夠。
在某些態樣中,該薄膜亦可作為活性的藥學劑(active pharmaceutical agent)的容器。該薄膜將具有提高雙極及作為藥物儲藏處的雙重作用。如上文所述,感興趣的薄膜包括一數量的藥學活性劑。“藥學活性劑”(其在本文中亦被稱為藥物(drug)一詞係指當與一活的生物(如,哺乳動物,譬如人類)接觸時可以產生藥學上的結果,例如有利的或有用的結果,的化合物或化合物的混合物。藥學活性劑與賦形劑,賦形物,稀釋劑,潤滑劑,結合劑及其它配製輔助劑等構成物,及包覆或其它保護構成物是可區別的。該藥學活性劑可以是能夠在一活的生物體中調整生物處理(biological process)之任何分子,以及其結合部分或片段。在某些態樣中,該藥學活性劑可以是一使用在診斷,治療,或疾病防治上的物質,或作為一藥物的構成物。在某些態樣中,該藥學活性劑可以是一化學物質,譬如像是麻醉毒品或迷幻藥,其可影響中央神精系統及造成行為的改變。
存在於該薄膜中之該藥學活性劑的數量是可以改變的。在一些例子中,存在於該薄膜中之該藥學活性劑的量是在0.01重量%至100重量%之間。特別感興趣的藥學活性劑包括但不侷限於下文中所描述及所列出者。
該藥學活性劑在該薄膜中的配置可根據一薄膜的特定構型而改變。例如,該活性劑可被均質地散布在該薄膜中。或者,該活性劑被侷限在該薄膜中的特定的位置,使得該薄膜包括具有該藥學活性劑的區域及不具有該藥學活性劑的區域。此種薄膜的一個例子為一多孔性薄膜,其中該薄膜上的孔都被填入一藥學活性劑。在這些態樣中,該多孔性的百分比在腫脹之後是在5%至75%之間。
在一些例子中,該薄膜被建構來提供存在於該薄膜內的該藥學活性劑之受控制的釋出。“受控制的釋出”一詞係指該薄膜被建構成讓該藥學活性劑在與目標生理部位接觸時以一預定的方式從該薄膜被釋出。換言之,該藥學活性劑在與目標生理部位接觸時以一種已經預定的方式,(譬如,以在一段延長的時間內等方式)從該薄膜被釋出。因此,該藥學活性劑係在一段時間內以預定的時間間隔或逐漸地從該薄膜釋出。
該薄膜可被建構來提供該藥學活性劑用各種不同的方法受控制地釋出。例如,當該薄膜是一均質的結構時,該薄膜之訊號構成物或成分(ingredient)可被加以選擇用以提供該藥學活性劑從該薄膜受控制地釋出。或者,當該薄膜是多孔式結構時,該多孔性可被加以選擇,用以施加所想要的受控制釋出特徵至該薄膜。
在其它的例子中,一或多種塗層可被用來施加受控制的釋出特徵至該薄膜。在一些例子中,該活性劑從該薄膜釋出的輪廓(profile)受由一施用至該薄膜上的單一塗層來加以控制。在其它態樣中,一薄膜可包括兩層或更多層不同的塗層。在其它的例子中,該等塗層可用能夠提供所想要之可控制的釋出輪廓之可部分地或完全地溶解的聚合物基質材料來製造。感興趣的塗層包括下文中所詳細描述者。
在某些例子中,該薄膜具有多層構型。多層式薄膜構型可用數種不同方式來建構。在一些態樣中,兩層或更多層不同的層的該多層式薄膜可包括相同的活性劑,該多層式構型(例如,兩層不同的層具有不同的成分)提供該活性劑一所想要之受控制的釋出輪廓。在這些態樣中,在每一包含該活性劑的層中之活性劑的量可以是相同的,也可以是不同的。在其它的態樣中,一多層式膜的兩層或更多層可包括不同的活性劑。
當有需要的時,該多層式薄膜的每一層可包括一IEM。在這些例子中,一既定的IEM將具有一多層式薄膜,而一不同的IEM出現在該多層式薄膜的兩層或多層中。
在有需要時,該薄膜可被建構成該活性劑從該薄膜的釋出與該事件標示器的啟動相結合,使得該IEM的啟動及通信與活性劑的釋出,即該活性劑從該薄膜釋出的開始,同時發生。
如將於下文中進一步說明的,該IEM的其它構成物可被建構來施加一受控制的釋出輪廓至與該薄膜相結合的活性劑,而這些其它的構成物可以額外地或與上文中所描述之薄膜受控制的釋出構成物相結合地存在。例如,當該IEM包括一賦形劑,如藥丸或膠囊,時該賦形劑可被建構來控制該活性劑從該薄膜的釋出。
該薄膜可用數種物質,物質種類,及/或物質的組合來製造。感興趣的物質種類包括但不侷限於:基質物質;填料物質;可溶性崩散劑物質;增塑劑;塗層;及濕潤劑。
該薄膜的表面亦包含一抗黏著層,其可防止發射器黏附於胃黏膜上或被胃腸道內的東西,譬如食物殘渣,阻擋到。一抗黏著層亦可被用來防止兩個或更多個裝置彼此黏在一起或阻擋了彼此的通信。
在不同的態樣中,該薄膜可用不同的物質,物質種類,及/或物質的組合來製造。該等物質種類包括但不侷限於:薄膜形成或結合/黏合劑;填料;可溶性物質或崩散劑;增塑劑;塗層;及濕潤劑。
該膜形成劑或結合/黏合劑包括但不侷限於例如:洋菜、鹿角菜膠、醋酸纖維素、幾丁聚糖、共聚維酮、乙基纖維素、明膠、樹膠類(像是阿拉伯膠、三仙膠、關華豆膠等)、糖類(像是乳糖、甘露糖醇、木糖醇等)、水凝膠類(如羥乙基纖維素、藻酸鈉、烏拉坦等)、丙烯酸聚合物、醋酸纖維素、羥丙基纖維素、羥丙基甲基纖維素、羥乙基纖維素、羧甲基纖維素、乙基纖維素、甲基丙烯酸共聚物、羥乙基纖維素甲酯、聚乙二醇、聚醋酸乙烯酞酸酯、聚乙烯醇、聚維酮、澱粉、卡波姆、糊精、羥丙基甲基纖維素、聚(甲基乙烯基醚/馬來酸酐)、聚葡萄胺糖、單油酸甘油酯、聚環氧乙烷、聚卡波菲、阿拉伯膠、長角豆膠、糖粉、棉籽油、葡萄糖結合劑(dextrates)、葡萄糖、扁油酸甘油酯、氫化植物油、羥丙基澱粉、菊糖、乳糖、葡萄糖、矽酸鋁鎂、麥芽糊精、麥芽糖、甲基纖維素、泊洛沙姆、聚卡波菲、聚葡萄糖、聚甲基丙烯酸酯類、硬脂酸、蔗糖、葵花油、玉米醇溶蛋白、硬脂酸鋁、矽酸鈣、膠體二氧化矽、硬脂酸棕櫚酸甘油酯、果膠、聚乙烯烷基醚類、丙烯碳酸酯、抗壞血酸鈉、醋酸鋅、烏拉坦、藻酸銨、縮水蘋果酸氯非尼拉明、酞酸二丁酯、癸二酸丁二酯、酞酸二乙酯、酞酸二甲酯、乳酸乙酯、香草醛、蟲膠等等。
該填料包括但不限於例如氧化物類,像是二氧化鈦、氧化鎂等;矽酸鹽類,像是矽酸鎂;磷酸類,像是磷酸氫二鈣;碳酸鹽類及碳酸氫鹽類;澱粉類;纖維素系物質,像是微晶纖維素;阿拉伯膠、洋菜、藻酸、卡波姆、羧甲基纖維素、鹿角菜膠、酞酸醋酸纖維素、長角豆膠、幾丁聚糖、糖粉、共聚維酮、棉籽油、葡萄糖結合劑、糊精、葡萄糖、乙基纖維素、明膠、扁油酸甘油酯、關華豆膠、氫化植物油、羥乙基纖維素、羥乙基甲基纖維素、羥丙基纖維素、羥丙基澱粉、羥丙基甲基纖維素、菊糖、乳糖、葡萄糖、矽酸鋁鎂、麥芽糊精、麥芽糖、甲基纖維素、微晶纖維素、泊洛沙姆、聚卡波菲、聚葡萄糖、聚環氧乙烷、聚甲基丙烯酸酯、聚維酮、藻酸鈉、澱粉、硬脂酸、蔗糖、葵花油、玉米醇溶蛋白、膨潤土、硬脂酸鈣、卡波姆、纖維素、膠體二氧化矽、高嶺土、麥芽糖醇、芝麻油、乙醇酸澱粉鈉、山梨糖醇酯類、黃蓍樹膠、三仙膠、甘露糖醇、藻酸銨、碳酸鈣、磷酸鈣、硫酸鈣、纖維素、醋酸纖維素、赤藻糖醇、果糖、富馬酸、硬脂酸棕櫚酸甘油酯、異麥芽酮糖醇、高嶺土、乳糖醇、碳酸鎂、氧化鎂、甘露糖醇、二甲矽油(simethicone)、海藻糖、木糖醇等等。
可溶性物質或崩散劑包括但不限於例如藻酸鹽類(鈉鹽或鈣鹽);交聯羧甲基纖維素鈉、羧甲基纖維素鈉、交聯聚維酮、羥丙基、纖維素、羥丙基甲基纖維素、羥甲基纖維素、乳糖甘露糖醇、聚乙烯醇,以及鹽類像是氯化鈉或氯化鉀、藻酸、藻酸鈣、羧甲基纖維素、纖維素、幾丁聚糖、膠體二氧化矽、交聯羧甲基纖維素鈉、交聯聚維酮、琥珀辛酯鈉、關華豆膠、羥丙基纖維素、矽酸鋁鎂、甲基纖維素、微晶纖維素、波拉克林鉀、聚維酮、藻酸鈉、乙醇酸澱粉鈉、澱粉等等。
該增塑劑包括但不限於例如癸二酸二丁酯、檸檬酸三乙酯、安卓汀(andtriacetin)、檸檬酸乙醯三丁酯、檸檬酸乙醯三乙酯、苯甲酸苯甲酯、酞酸醋酸纖維素、氯丁醇、糊精、酞酸二丁酯、癸二酸二丁酯、酞酸二乙酯、酞酸二甲酯、甘油、單硬脂酸甘油酯、酞酸羥甲基纖維素、甘露醇、礦物油、羊毛脂醇類、棕櫚酸、聚乙二醇、聚甲基丙烯酸酯、聚酞酸醋酸乙烯酯、丙二醇、2-吡咯啶酮、山黎糖醇、硬脂酸、三醋精、檸檬酸三丁酯、三乙醇胺、檸檬酸三乙酯等等。
塗層包括但不限於例如聚甲基丙烯酸酯類(pH敏感型)及聚酞酸醋酸乙烯酯(pH敏感型)及羥丙基甲基纖維素(濕氣屏障)、檸檬酸乙醯基三丁酯、檸檬酸乙醯基三乙酯、碳酸鈣、羧甲基纖維素鈉、棕櫚蠟、醋酸纖維素、酞酸醋酸纖維素、鯨蠟醇、幾丁聚糖、乙基纖維素、果糖、明膠、甘油、扁油酸甘油酯、硬脂酸棕櫚酸甘油酯、羥乙基纖維素、羥乙基甲基纖維素、羥丙基纖維素、羥甲基纖維素、酞酸羥甲基纖維素、異麥芽酮糖醇、葡萄糖、麥芽糖醇、麥芽糊精、甲基纖維素、微晶蠟、石蠟、泊洛沙姆、聚葡萄糖、聚乙二醇、聚酞酸醋酸乙烯酯、聚乙烯醇、聚維酮、蟲膠、蔗糖、氧化鈦、檸檬酸三丁酯、檸檬酸三乙酯、香草醛、木糖醇、玉米醇溶蛋白、滑石、三乙醇胺、藻酸銨、縮水蘋果酸氯非尼拉明、共聚維酮、醋酸乙酯等等。在使用塗層時,該塗層厚度範圍可為0.1到200μm厚,像是1到100或1到100μm。受到關注的是在接觸到目標生理部位時能調控藥學活性劑從膜層釋出之塗層。
濕潤劑包括例如聚乙二醇、琥珀辛酯鈉、硫酸月桂酯鈉、聚環氧乙烷、卵磷脂、泊洛沙姆及聚維酮,氯化苯二甲烴銨(benzalkonium chloride)、苄索氯銨、西吡氯銨、琥珀辛酯鈉、羥甲基纖維素、泊洛沙姆、聚乙烯烷基醚、聚氧乙烯烷基醚、聚氧乙烯蓖麻油衍生物、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯硬脂酸酯、硫酸月桂酯鈉、山梨糖醇酯類、苯甲醇、苯甲酸苯甲酯、西吡氯銨、環糊精、單硬脂酸甘油酯、卵磷脂、葡甲胺、泊洛沙姆、聚維酮、碳酸氫鈉、硬脂酸、磺丁基-β-環糊精等等。
該薄膜的表面亦可含有抗黏著層,其可防止IEM黏附到胃壁上或者或被胃腸道內的東西,譬如食物殘渣,阻擋到。一抗黏著層亦可被用來防止兩個或更多個裝置彼此黏在一起或阻擋了彼此的通信。在這些態樣中,可用來作抗黏著層之材料包括但不限於例如乙基纖維素、微晶纖維素、纖維素衍生物、矽酸鹽類像是矽酸鎂或矽酸鋁、氧化物類像是氧化鈦等。如上所述地,亦可採用以上材料或其類似物質之混合物。
在特定態樣中,抗黏著層很重要。在這些態樣中,可用來作抗黏著層之材料包括但不限於例如乙基纖維素、微晶纖維素、纖維素衍生物、矽酸鹽類像是矽酸鎂或矽酸鋁、氧化物類像是氧化鈦等。如上所述地,亦可採用以上材料或其類似物質之混合物。
薄膜亦可使用傳統步驟來製作。感興趣的薄膜製造方法包括但不限於PCT/US08/77753所述,其揭示倂此以為參考。
可吞食的事件標示器可進一步地含有賦形劑構成物,該IEM及該薄膜與該賦形劑穩固地結合。該賦形劑構成物可為任何習知的生理可接受之載體組成物(composition)。‘‘生理可接受之載體組成物”係意指可吞食之組成物,其中該組成物可為固體或流體。感興趣的固體賦形劑構型包括錠劑及膠囊形態。該賦形劑構成物,若有,可由多種不同的材料製成。感興趣的材料可見於Remington's Pharmaceutical Sciences,Mace Publishing Company,費城,賓州,17th
版(1985)。
綜上所述,本發明之可吞食的事件標示器可把一或多種IEM/薄膜構成物與賦形劑組合,其中該賦形劑可為任何習知的藥學可接受之載體構成物。於某些例子中,該賦形劑構成物可被建構成能賦予結合在薄膜上之藥學活性劑具有受控制的釋放特性。舉例來說,該IEM/薄膜構成物可存於固態之錠賦形劑中,其中該固態錠劑在IEM與目標生理部位接觸一段特定時間後會分解掉,而讓含於IEM內之任何活性劑釋放出來。
即使在未投予活性劑的情況下亦可使用賦形劑。在某些態樣中,使用賦形劑可提高IEM之可吞食性。讓IEM與例如錠劑或膠囊(其可被作傳統上的大小或更小)之賦形劑穩固地結合在一起,可避免IEM黏著到嘴巴內。於某些例子中,該賦形劑可為小型錠劑(例如迷你錠),其可用例如生理可接受之黏著劑來黏附到該可吞食的事件標示器上。
於某些例子中,IEMs係由與錠劑形態之固態賦形劑構成物穩固結合之IEM所構成。於此等例子中,受到關注的是錠賦形劑元件,其被建構成在該IEM與目標生理部位接觸時能促進該電化學物質或IEM電化學物質與流體的接觸。於此等錠劑構型中,該錠劑可含有一或多種流體通道,像是溝槽、渠道、管或類似結構,其可用來把流體從該IEM環境輸送到與錠賦形劑結合之電化學物質處。感興趣的通道構型可為能把該電化學物質構成物產生之任何氣泡送離該電化學物質構成物及/或者使得該電化學物質構成物不易形成氣泡。於此等例子中,該IEM被建構成讓該電化學物質相對於該通道被設置成使得在該通道內的流體接觸該電化學物質。此一IEM的一個例子被示於圖7中。在圖7中,IEM 70包括IEM 71(其由IEM電路構件72及薄膜73所構成)其與該錠賦形劑構成物74的上表面穩固定結合。圖7亦顯示出渠道75及76,其被建構成可提供一流體通道給該IEM電路構件72的底側電化學物質構成物。圖7B提供IEM 70的一剖面圖。在一既定的錠劑構型中,該錠劑可包括一或多個流體通道,多條流體通道可如所需地相交會,以提供所想要的氣泡運動。圖8提供另一種IEM 80的頂視圖,該錠賦形劑構成物81包括流體通道85,86,87及88,它們相交會於該IEM 83底下,該IEM 83是由IEM電路構件84及薄膜82所構成。
在這些包括一或多條流體通道的IEM構型中,一定的流體通道可以是空的,用以在該IEM與流體接觸時提供流體對於該電化學物質構成物之未受禁止的接近。或者,該流體通道可被填入一物質,其可將該流體從該環境輸送至該電化學物質構成物,譬如像是將流體從一個地點吸引至另一地點的物質,一吸水的水凝膠物質,及類此者。當有需要時,鹽類或其它控制傳導率的藥劑亦可被使用。
當有需要時,該IEM可含有藥學活性劑。如上所述地,該藥學活性劑(若存在的話)可存於賦形劑及/或薄膜中。綜上所述,本發明之薄膜可含有一份量之活性劑,像是藥學活性劑或診斷劑。
“藥學活性劑”包括任何化合物或多種化合物之混合物,其可於接觸活生物體例如人類時產生有利或有用之生理效果。藥學活性劑(在此亦可稱為“藥物”)係與像是輔劑、載劑、稀釋劑、潤滑劑、黏合劑及其他配方助劑,以及包膠劑或其他保護性構成物不同的。該等藥學活性劑可為任何可調節活的主體之生理過程的分子及其結合部份或片段。在特定的樣例中,該藥學活性劑可為能用於診斷、治療或預防疾病或者作為醫藥成份之物質。在特定樣例中,該藥學活性劑可為化學物質,像是麻醉劑或是迷幻藥,其可影響中樞神經系統及導致行為改變。
該藥學活性劑可與活的主體體內目標產生交互作用。該目標可為多種不同類型之天然結構,其中感興趣的目標包含細胞內及細胞外目標。此等目標可為蛋白質、磷脂質、核酸等等,其中以蛋白質特別受關注。特殊且感興趣的蛋白質類目標包括但不限於酶類例如激酶、磷酸酶、還原酶、環氧化酶、蛋白酶等等,涉及蛋白質-蛋白質交互作用之結構域之目標像是SH2、SH3、PTB及PDZ域,結構蛋白質像是肌動蛋白、微管蛋白等,薄膜受器,免疫球蛋白等像是IgE,細胞黏著受器像是整合素(integrins)等,離子通道、跨薄膜運輸泵、轉錄因子、訊號蛋白等等。
該藥學活性劑可含有與該等目標產生結構性交互作用所需之一或多種官能基,視特定藥物及鎖定之目標而定,該等官能基可為例如產生厭水、親水、靜電或甚至於共價交互作用所需之基團。當目標為蛋白質時,該藥學活性劑可包括與該蛋白質產生結構性交互作用(像是氫鍵、厭水性-厭水性交互作用、靜電交互作用等等)所需之官能基且可含有至少一種胺基、醯胺基、硫氫基、羰基、羥基或羧基,例如至少兩種此等化學官能基團。
感興趣的藥學活性劑可包括環狀碳結構或雜環結構及/或芳香族或多芳香族結構,其可用一或多種以上官能基來取代。同樣受到關注之藥學活性劑還有雙分子之結構,包括肽類、醣類、脂肪酸類、類固醇類、嘌呤類、嘧啶類,及其衍生物、結構類似物或組合。此等化合物可藉由選汰來確認有用物質,多種不同的篩選方法乃為此技術所習知。
藥學活性劑可衍生自天然或合成之化合物,其可有多種來源,包括天然或合成之化合物集庫(library)。舉例來說,有多種裝置可用來隨機或指定的合成多種有機化合物及雙分子,包括隨機排列之寡核苷酸及寡肽。或者,亦可直接得自或輕易製得細菌、真菌、植物及動物萃取物形式之天然化合物集庫。此外,天然或合成之化合物及集庫亦可透過習知的化學性、物理性或生化性方法來輕易地修改,且可用來製造組合性集庫。習知的藥物亦可接受直接或隨機的化學性修改處理,像是醯化、烷化、酯化、醯胺化等以製得結構類似物。
因此,該藥學活性劑可來自天然或合成之分子集庫,包括透過組合方法製得之化合物集庫,例如化合物多樣性組合式集庫。當取自此等集庫時,採用藥物之基團可於該活性之適當選汰(screening)檢定中展現出某種程度之所需活性。組合式集庫及製造及篩選此等集庫之方法乃為此技術所習知且述於美國專利第5,741,713號;第5,734,018號;第5,731,423號;第5,721,099號;第5,708,153號;第5,698,673號;第5,688,997號;第5,688,696號;第5,684,711號;第5,641,862號;第5,639,603號;第5,593,853號;第5,574,656號;第5,571,698號;第5,565,324號;第5,549,974號;第5,545,568號;第5,541,061號;第5,525,735號;第5,463,564號;第5,440,016號;第5,438,119號;第5,223,409號;其揭示倂此以為參考。
關注的活性劑的廣泛種類包括但不限於心血管劑;疼痛-緩解劑,如止痛藥、麻醉劑、消炎藥等;神經-作用劑;化學治療劑(如抗腫瘤藥);神經治療劑,如抗-痙攣劑等。
感興趣的藥學活性劑包括但不限於示於PCT申請案第PCT/US2006/016370號者,其列示之藥學活性劑的揭露倂此以為參考。
有需要時,既定之IEM可含有非活性劑之鹽類構成物,該構成物係由一或多種非活性劑鹽類所組成。於某些例子中,所選擇之IEM中此鹽構成物之份量係得以在IEM接觸到目標生理部位例如胃時增強該IEM產生之通信強度。通信強度強化之幅度會有所不同,於某些例子中,相較於適當的對照組(例如由類似IEM-其與研究之受測IEM唯一的不同僅在於缺乏該鹽類構成物-產生之通信強度)該通信強度強化之幅度可達10倍或以上,像是20倍或以上,包括50倍或以上。該非活性劑鹽構成物之份量足以提供所需之溝通強度強化作用。非活性劑鹽類可有所不同,感興趣的非活性劑鹽類包括但不限於:藥學可接受之電解質,像是但不限於鈉離子、氯離子、鉀離子及鈣離子、鎂離子等。受關注且具體的生理可相容之鹽類包括但不限於KCl、NaCl、MgCl2
等等。當存在時,此非活性劑鹽類可為薄膜、IEM及賦形劑之一或多者的一部份。
同樣感興趣的是消泡劑,該等化學劑可減少氣泡的表面張力。感興趣的消泡劑包括但不限於:矽酮油-基之化學劑,像是西甲矽油(simethicone)、倍半油酸三梨糖醇酯等等。當存在時,該消泡劑於IEM內之份量可有所不同,範圍在0.01到10 mg之間,像是0.1到100μg,且包含0.1到10μg。當存在時,此消泡劑可為薄膜、IEM及賦形劑之一或多者的一部份。
在某些例子中,該IEM含有一或多種界面活性劑。感興趣的界面或性劑包括但不限於:離子性界面活性劑,例如陰離子界面活性劑、陽離子界面活性劑及兩性離子界面活性劑,以及非離子界面活性劑及表面活性生物性調節劑。感興趣的界面活性劑包括但不限於:蓖麻油衍生物、膽固醇、聚醇溶甘油酯類、乙醯單甘油酯類、山梨糖醇脂肪酸酯類、泊洛沙姆類、聚山梨酸酯類、聚氧乙烯山梨糖醇脂肪酸酯類、聚氧乙烯化合物類、單甘油酯類或其乙氧化衍生物、二甘油酯或其聚氧乙烯衍生物、琥珀辛酯鈉、硫酸月桂酯鈉、膽酸或其衍生物,乙氧基化醇類、乙氧化酯類、乙氧化醯胺類、聚氧丙烯化合物類、丙氧基化醇類、乙氧基/丙氧基嵌段聚合物、丙氧基化酯類、烷醇醯胺類、胺氧化物類、多元醇之脂肪酸酯類、乙二醇酯類、二甘醇酯類、丙二醇酯類、甘油酯類、聚甘油脂肪酸酯類、SPANTM
界面活性劑類像是山梨糖醇酯類)、TWEENTM
界面活性劑像是蔗糖酯類、葡萄糖(右旋糖)酯類;鹼金屬界面活性劑、四級銨化合物類、醯胺-胺類、胺-醯亞胺類、西甲矽油、卵磷脂類、醇類、磷脂質類,及其混合物。當存在時,該界面活性劑可佔該IEM組成物(composition)的0.01到10%,例如可為0.01到100 ppm,包括0.1到100 ppm。當存在時,界面活性劑可為薄膜、IEM及賦形劑中的一或多者的一部份。
於某些例子中,該IEM組成物可含有一或多種崩散劑。藉著崩散劑一詞意指一種能促使至少部份的IEM(像是賦形劑或薄膜)在接觸到目標生理部位時破碎分解之化學劑。因此,崩散劑可於IEM接觸到液體像是胃液時促進該IEM賦形劑構成物例如錠劑的機械性瓦解。感興趣的崩散劑包括但不限於以上列示之崩散劑,例如微晶纖維素、澱粉、乙醇酸澱粉鈉、交聯之聚乙烯吡咯啶酮、交聯之羧甲基纖維素、藻酸等。當存在時,該崩散劑可佔該IEM組成物之0.01到15%,例如可為0.01到100 ppm,包括0.1到10 ppm。當存在時,崩散劑可為薄膜、IEM及賦形劑中的一或多者的一部份。
該IEM組成物亦可含有一或多種抗氧化劑,其可用來增進該IEM之上架壽命安定性。感興趣的抗氧化劑包括但不限於:生育酚及其衍生物、抗壞血酸及其衍生物、丁基羥基甲氧苯、丁基羥基甲苯、富馬酸、蘋果酸、沒食子酸丙酯、焦亞硫酸鹽及其衍生物。當存在時,該抗氧化劑之量可為0.01到10%,例如可為0.01到100 ppm且包括0.1到1 ppm。當存在時,抗氧化劑可為薄膜、IEM及賦形劑中的一或多者的一部份。
本發明之IEM可進一步地含有防腐劑,舉例來說該防腐劑包括但不限於氯化苯二甲烴銨及其衍生物、苯甲酸、苯甲醇及其衍生物、溴硝醇、對羥基苯甲酸酯、西曲溴銨、氯已定、甲酚及其衍生物、咪唑啉基脲、苯酚、苯氧乙醇、苯乙基醇、苯汞鹽類、硫柳汞、抗壞血酸及其衍生物。該防腐劑之份量可為0.01到10mg,例如可為0.1到100μg且包括0.1到1μg。當存在時,防腐劑可為薄膜、IEM及賦形劑中的一或多者的一部份。
本發明之IEMs可包含一或多種微-環境調整劑,其可於IEM接觸到目標生理部位時改變或調控該IEM之微環境。感興趣的微環境調整劑包括但不限於界面活性劑、崩散劑、抗-氧化劑及防腐劑。一既定的IEM可含有一或多種此等構成物當作微-環境調整劑。此等類型化學劑之實例及份量可依前文所述。當存在時,微-環境調整劑可為薄膜、IEM及賦形劑中的一或多者的一部份。
於某些情況下,本發明之IEM組成物中該賦形劑之水不可溶構成物及水可溶構成物間的比例係經過選擇以提供所需特性(例如賦形劑之溶解性、IEM之操作等)。於某些例子中,賦形劑之水不可溶構成物之分率(fraction)可為0.01到1,例如可為0.1到0.9且包括0.5到0.8。於某些例子中,該可吞食的事件標示器中可溶性構成物的分率可高達90重量%。
一可吞食的事件標示器可包括一吸收流體,如水,的構成物,用以增加該IEM的重量(例如,用以在該IEM於一生理部位接觸流體時確保它會下沉)。此吸收構成物可以是該薄膜,該賦形劑,或該IEM的一些其它的構成物,譬如一覆蓋層或塗層。當該吸收構成物存在時,它可用各種適合的材料來製造,譬如像是上文所列出的水凝膠物質。
本發明的IEM可包括一受控制的啟動元件。該IEM中提供受控制的啟動之受控制的啟動元件對各式不同種類的刺激物是敏感的。該受控制的啟動元件可以對其敏感之感興趣的刺激物包括但不侷限於:液體(濕潤),時間,pH,離子強度,傳導性,生物分子(如,存在於胃,小腸,結腸中之特定的蛋白質或脢),血液,溫度,特定的輔劑(食物成分,譬如像是脂肪,鹽,糖,或藥物(其共存在臨床上是相關的),在胃中的細菌,壓力及光線。
該受控制的啟動元件是由一或多種可提供所想要之受控制的啟動功能的構成物所構成,使得該受控制的啟動元件對於感興趣的刺激物是敏感的。構成該受控制的啟動元件的構成物的本質是可能改變的。例如,當感興趣的刺激物是溫度時,該受控制的啟動元件可以是一物質的障礙物,譬如一薄膜(如,一聚合膜)其溶解性是溫度的函數,特別是在接近人體的溫度時變成可溶解的薄膜。此一薄膜在室溫時可以是不可溶解的/不透水的,但在37℃時則是可溶解的/可透水的。可被用作為此薄膜之感興趣的物質包括但不侷限於列在下文中的聚合物。在壓力是感興趣的刺激物的例子中,該受控制的啟動元件可以是一具有特定的機械強度之壓敏物質,如,一膠囊或外殼(例如,纖維素製成的外殼),使得在一高於壓力門檻值的壓力下,該元件會崩壞並讓該高度可靠的事件標示器被啟動並通信。在其它感興趣的態樣中,該等刺激物可以是光線。例如,該刺激物可以是一已被附著在一腫瘤上的螢光標籤。當該IEM通過該腫瘤時,該受控制的啟動元件可包括一可提供一用於該標籤之刺激波長的光線的構成物以及一可偵測從該標籤被發出的光線的構成物。任何傳統的光源及偵測器都可被使用。當該偵測器構成物偵測到該被發出的光現時,它將以一種受控制的方式啟動該IEM。
在某些態樣中,本發明之該一或多個受控制的啟動元件提供受控制的啟動,即一種與目標部位環境實質無關或完全無關的啟動方式,如同上文所述者。在一感興趣的態樣中,該受控制的啟動元件包括一乾燥的導電媒介,其在與該目標部位流體結合時會在由第一及第二不同物質的存在下產生一離子媒介以啟動該電池,如同上文所述者。當存在時,該乾燥的導電媒介先驅物可以是各種不同種類的組成物中的任何一種。感興趣的組成物包括但不侷限於:生理上可接受的電解質的鹽類,譬如像是但不侷限於:鈉離子,氯離子,鉀離子及鈣離子,鎂離子等等。感興趣的特定的生理上相容的鹽類包括但不侷限於:KCl,NaCl,MgCl2
,及類此者。本發明的態樣包括一乾燥的導電媒介先驅物。當該先驅物是鹽類時,如上文所述者,該乾燥的鹽類可用任何方便的形式來提供,譬如像是乾凍化的鹽類成分。
感興趣的受控制的啟動元件被進一步描述於PCT申請案第PCT/US2007/082563號中,其被公告為WO 2008/052136號;該申請案的內容被倂於本文中以為參考。
各種製造方法可被用來製造本發明的IEM。當該IEM不包含賦形劑時,該IEM及薄膜構成物可如上文所述地加以製造。當該IEM包括一賦形劑時,該IEM可用一些方式與該賦形劑牢牢地結合。牢牢地相結合係指該IEM與該賦形劑不會彼此分離,至少在被有需要的患者服用,如吞食,之前是不會彼此分離。該IEM與該賦形劑可用數種不同的方式比此牢牢地結合。
感興趣的IEM的製造方法包括但不侷限於PCT申請案第PCT/US2006/016370號及PCT/US08/77753號;以及美國專利暫時申請案第61/142,849號中者,這些申請案的內容被包括於本文中以為參考。
包括一IEM及一通信偵測構件,如接收器形式,其在本文中有時亦被稱為“偵測器”,的系統亦被提供。感興趣的接收器是那些被建構來收來自一IEM的訊號的接收器。該偵測構件根據該IEM所產生之通信的本質而有顯著的不同。因此,該接收器可被建構來接收多種不同的通信,其包括但不侷限於:RF訊號,磁性訊號,導電性(近場)訊號,聲音訊號等等。在某些態樣中,該接收器被建構來接收來自一IEM之導電性訊號,使得兩個構件使用該病患的身體作為通信媒介。因此,被傳送於該IEM與該接收器之間的訊號經過該身體,且需要該身體作為傳導媒介。該IEM發出的訊號可以一種被傳導通過身體組織之交流電(A.C.)電壓訊號形式被發射穿過皮膚或該病患身體的其它身體組織且從皮膚或其它身體組織被接收。因此,這些態樣不需要任何額外的纜線或硬接線,或甚至是無線電鏈連接來將感測器資料從自律感測器單元傳送至中央發射及接收單元,因為該感測器資料經由病患的皮膚及其它身體組織被直接交換。此通信方式的優點在於,接收器可被安排在病患的身體的任何所想要的位置,接收器因而被自動地連接至被需要的電導體,以達成通信,即該通信係經由病患的皮膚及其它身體組織所提供之電導體來實施。
該接收器可包括多種不同種類的接收器元件,其中該接收器元件的本質會隨著訊號產生元件所產生的訊號的本質而改變。在某些態樣中,該接收器可包括一或多種電化學物質(譬如,2種或更多的電化學物質,3種或更多的電化學物),及/或包括多對電化學物質,譬如2對或更多對,3對或更多對,4對或更多對電化學物質等等,用來偵測一IEM發出的訊號。在某些態樣中,該接收器包括兩種或三種電化學物質,它們以彼此相隔一距離的方式被設置,以容許該等電化學物質能夠偵測一電壓差。介於任兩個電化學物質之間的該距離可改變,且在某些態樣中,其範圍在約0.1公分至約5公分之間,譬如在0.5公分至約2.5公分之間,如約1公分。
除了接收元件,譬如電極電化學物質,之外,本發明的接收器可包括一或多個積體電路構件,一或多個電力構件(譬如電力接收器或電池),訊號傳送構件,外殼構件等等。
感興趣的接收器包括外部接收器及植入式接收器兩者。在外部接收器的例子中,該接收器是在生物體外的(ex vivo),意謂著在使用時該接收器是出現在身體的外面。在該接收器是植入式接收器的例子中,該接收器是在生物體內的(in vivo)。不論是在生物體內或是在生物體外,該接收器至少在它接收發射自該IEM的訊號期間都牢牢地與身體結合。
在某些態樣中,該接收器被建構來提供被接收到的訊號的資料至該病患外的一個地點。例如,該接收器可被建構來提供資料至一外部的資料收器,如該外部資料接收器可以是一監視器的形式(譬如,一床邊監視器),一電腦,一個人數位助理(PDA),電話,簡訊裝置,智慧型手機,等等。該接收器可被建構來將被接收到的訊號的資料轉傳至該病患的外面的地點。或者,該接收器可被建構成能夠被一外部的審問裝置審問,用以將一被接收到的訊號的資料提供至一外面的地點。
感興趣的接收器包括但不侷限於描述在:PCT申請案第PCT/US2006/016370號其被公告為WO/2006/116718號;PCT申請案第PCT/US2008/052845號其被公告為WO/2008/095183號;PCT申請案第PCT/US2007/024225號其被公告為WO/2008/063626號及PCT/US2008/085048號;以及美國專利暫時申請案第61/160,289號中的接收器;這些申請案的內容被倂於本文中以為參考。
本發明的系統可包括一外部裝置其不同於該接收器(其在某些態樣中可以被植入或被局部地施用),此外部裝置提供數項功能。此設備可包括能夠提供病患回饋及適當的臨床調整的能力。例如,該裝置可被建構來被設置在床上與病患相鄰,如一床邊的監視器。其它的形式包括但不侷限於PDA,電話(譬如智慧型手機),電腦等等。在一些例子中,該外部裝置被建構來提供提供藥學的及生理的資訊,該資訊的形式可經由一傳送媒介,如電話線,被傳送至一遠端地點,譬如一診所,或傳送至一中央監視代理機構。該外部裝置可從藥物吞食報告及從生理偵測裝置中(譬如像是一心律調節器裝置所產生的報告或一用來偵測藥丸之專屬的植入物)讀出該將於本說明書的下面段落中詳細說明的資訊。該外部設備的目的是要從病患中取得資料並放入該外部裝置中。該外部設備的一項特徵為它能夠以一種可經由一傳送媒介,譬如電話線,被傳送至一遠端地點,譬如診所,或傳送至一中央監視代理機構的形式之藥學的及生理的資訊。
本發明的態樣更包括使用IEM,譬如上文中所描述者,的方法。本發明的方法大體上包括將一IEM提供給一個體(subject),例如藉由自行服用或透過他人的輔助,譬如健康照護人員的幫助。大體上,本發明的方法將包括把EM放入到一個體的嘴巴內使得該個體將該IEM吞下。在此方式中,該個體吞食該IEM。IEM可被使用在各式個體上。通常,這些個體是“哺乳動物”或“哺乳類”,這些詞被廣意地使用來描述在哺乳動物綱內的生物,其包括肉食動物目(如,狗及貓),囓齒目(如,小鼠,天竺鼠,大鼠),及靈長目(如,人類,黑猩猩,猴子)。在某些態樣中,該等個體可以是人類。
在吞食之後,該等方法包括從該被吞食的IEM發射一或多種訊號,例如,當該IEM與該目標生理部位時發射訊號。如上文中所描述的,被發射的訊號的本質會大幅地改變。在某些例子中,該被發射的訊號是一被傳導性地傳輸(conductively transmitted)的訊號。本發明的方法亦可包括接收一從IEM發出的訊號,如在一接收器處接收,就如上文中所述者。在某些例子中,該被接受到的訊號是一被傳導性地傳輸的訊號。
該IEM可被運用在各式的應用中,這些應用可以是醫學的本質亦可以是非醫學的本質的應用。感興趣的應用包括但不侷限於:監視病患與醫囑治療計畫的相容性;根據病患相容性來制定專屬的治療計畫;監視病患在臨床試驗的相容性;監視受控制的物質的使用;監視一感興趣的個人事件的發生,譬如像是症狀的發生等等,及類此者。感興趣的應用被進一步描述在PCT申請案第PCT/US2006/016370號其被公告為WO/2006/116718號;PCT申請案第PCT/US2007/082563號其被公告為WO/2008/052136號;PCT申請案第PCT/US2007/024225號其被公告為WO/2008/063626號;PCT申請案第PCT/US2007/022257號其被公告為WO/2008/066617號;PCT申請案第PCT/US2008/052845號其被公告為WO/2008/095183號;PCT申請案第PCT/US2008/053999號其被公告為WO/2008/101107號;PCT申請案第PCT/US2008/056296號其被公告為WO/2008/112577號;PCT申請案第PCT/US2008/056299號其被公告為WO/2008/112578號;及PCT申請案第PCT/US2008/077753號;它們的揭示內容被倂於本文中以為參考。
包含一或多個上文所述的IEM之套件亦被提供。在具有多個IEM的態樣中,IEM可被被覆在一單一的容器內,如單一的管子,瓶子,小藥瓶,及類此者中,或一或多個劑量可被單獨地封包使得某些套件可具有多於一個的IEM容器。在某些態樣中,該等套件亦可包括一接收器,如上文中所描述者。在某些態樣中,該等套件亦可包括一外部的監視裝置,如上文中所描述者,其可提供與一遠端地點,如醫生的辦公室,一中央設施等等,的通信,該遠端地點獲得並處理這些被得到之有關於該組成物的使用的資料。
該等套件亦可包括如何使用套件的構成物來實施本發明的方法的指示。該等指示可被記錄在一適當的記錄媒體或基材上。例如,該等指示可被印在一基材上,譬如紙或塑膠等等。因此,該等指示可如一包裝插入物般地存在該套件中,存在於該套件或其構成物(即,與該包裝或子包裝相關的構成物)的容器的標籤上。在其它態樣中,該等指示係以一在適當的電腦可讀取的儲存媒介,如CD-ROM,光碟片等,上的電子儲存資料檔的形式被呈現。在另外其它的態樣中,實際的指示並不在該套件中,而是提供可從遠端來源,如透過網際網路,取得指示的機構。此態樣的一個例子是一種包括了網址的套件,指示可在該網址所在網頁上查看及/或可從該處下載。就如同該等指示一樣,用來獲得該等指示的手段被記錄在一適當的基材上。
該套件的一些或所有構件都被包在一適當的包裝內以保持無菌性(sterility)。在該套件的許多態樣中,該套件的構件被包裝在一套件容納元件內,以形成一單一且易於操控的單元該套件容納元件,如盒子或類似的結構,可以是一氣密的容器或不是一氣密的容器,用以進一步保持該套件的一些或所有構件的無菌性。
應被瞭解的是,本發明並不侷限於本文所描述的特定態樣,而是可以改變的。同樣應被瞭解的是,本文中所使用的術語只是為了描述特定的態樣,而不是要用來限制,因為本發明的範圍將只由下面的申請專利範圍來界定。
當一數值範圍被提供時,應被瞭解的是,達到下限值的單位的十分之一(除非本文中有明確之其它意思的表達)之每一介於該範圍的上及下限之間之介於中間的數值及在該被敘明的(stated)範圍內之任何其它被敘明的或介於中間的數值都被包含在本發明中。這些較小範圍的上及下限可被獨立地包括在這些較小的範圍內且亦被包含在本發明中,在該被敘明的範圍內可以有任何特定之被排除在外的極限值。當該被敘明的範圍包括一或兩個極限值時,排除此被包括在內的極限值的一者或兩者的範圍亦被包括在本發明內。
除非被不同地界定,否則所有使用於本文中之技術及科學術語具有與本發明所屬技術領域中具有一般知識者所共同瞭解的意義相同的意義。與本文中所描述之方法及物質類似或等效的任何方法及物質亦可在實施或測試本發明時被使用,本文中所描述的代表性的示範性方法及物質。
此說明書中所援引的出版物及專利都被倂於本文中以為參考,就像是每一個別的出版物或專利都藉由參考而被明確地及個別地指出將被包含於本文中且藉由參考被結合於本文中,用以配合被援引的這些出版物來揭露及描述該等方法及/或物質。任何出版物的援引是因為它的揭示內容在本案申請日之前且不應被解讀為放棄以先發明的本質主張本發明發生在該出版物之前的權利。
應被指出的是,當使用於本文中及申請專利範圍中時,單數形式用詞“一”,“一個”及“該”包括了複數對象,除非上下文清楚地有不同的指示。應進一步被指出的是,申請專利範圍可被撰寫成排出任何非必要的元件。因此,此陳述是要來作為與申請專利範圍中排除性用語,如“唯一”,“只有”及類此者,的使用或“負面”限制的使用的先行基礎(antecedent base)。
熟習此技藝者在閱讀此揭示內容時將可瞭解的是,本文中所描述及例舉的各個態樣的每一者都具有不同的構件及特徵,它們可以很容易地與其它數個態樣的任何一者的特徵分開或相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被描述的事件的順序來實施或以任何邏輯上可能之任何其它順序來實施。
雖然本發明為了應楚瞭解的目的已經以圖式及舉例的方式詳細加以描述,但對於熟習此技藝者而言,在本發明的教示下可以完成某些改變及修改而不偏離申請專利範圍所界定的精神與範圍。
因此,以上只是闡述本發明的原理。將被瞭解的是,熟習此技藝者將能夠作出各式的構造,它雖然沒有被明確地描述或顯示於本文中,但能夠體現本發明的原理且被包括在本發明的經神與範圍內。又,所有被描述於本文中之例子及條件式語句原則上都是要幫助讀者瞭解本發明的原理及發明者對於未來技術所貢獻的概念,且不應被解讀為限制在該等被明確地描述的例子及條件。再者,本文中描述原理,態樣及本發明的態樣以及其特定的例子的所有陳述都包含結構上及功能上的等效物。此外,這些等效物包括目前知道的等效物及未來發展的等效物,即實施相同的功能之任何被開發的元件,不論其結構為何。因此,本發明的範圍並不侷限於本文中所示及所描述的示範性態樣。本發明的範圍及精神是由下面的申請專利範圍來體現。
2...積體電路
10...IEM
4...上電化學物質
6...下電化學物質
8...薄膜
12...IEM電路構件
14...薄膜
16...彎曲的邊緣
18...彎曲的邊緣
20...IEM
22...IEM電路構件
24...薄膜
26...反向的邊緣
28...反向的邊緣
27...端部
25...膠水
30...IEM
32...IEM電路構件
34...薄膜
40...IEM
42...IEM電路構件
44...薄膜
46...重量
50...IEM
52...IEM電路構件
54...薄膜
60...IEM
62...IEM電路構件
64...薄膜
66...冒泡結構
68...冒泡結構
65...彎曲的邊緣
67...彎曲的邊緣
71...IEM
72...IEM電路構件
73...薄膜
74...錠賦形劑構成物
75...渠道
76...渠道
80...IEM
81...錠賦形劑構成物
84...IEM電路構件
82...薄膜
85...通道
86...通道
87...通道
圖1A至1F提供依據本發明的不同態樣的IEM構型的圖式。
圖2A及2B提供一IEM的圖例,其包括一具有展開臂之薄膜。
圖3提供一IEM的圖式,其中該IEM組成相對於該薄膜被偏心地設置。
圖4提供一IEM的圖式,其具有一被設置在該薄膜的一側上的重量。
圖5提供一IEM的圖式,其具有一被設置在該薄膜的側面上可用水膨脹的組成。
圖6A及6B提供不同的IEM構型的圖式,其結合冒泡的(effervescent)結構。
圖7A,7B及8提供具有藥片構型的IEM的不同圖式。
71...IEM
72...IEM電路構件
73...薄膜
74...錠賦形劑構成物
75...渠道
76...渠道
Claims (20)
- 一種可吞食的事件標示器,其包含:一電路元件,其包含:一控制電路,其包含一上表面面及一下表面;一第一電化學材料,其界定一第一外周邊邊緣,該第一電化學材料電耦合至該控制電路的該上表面;一第二電化學材料,其界定一第一外周邊邊緣,該第二電化學材料電耦合至該控制電路的該下表面,其中該第一及第二電化學材料彼此被電隔離;及一設置在該第一及第二電化學材料之間的薄膜,其包含一訊號放大元件,該訊號放大元件包含一設置在該第一及第二電化學材料之間的絕緣材料,該絕緣材料被作成可增加一通過身體內的導電液體之介於該第一及第二電化學材料之間的電流路徑的長度的大小以形成用於該導電液的通道並藉以提高介於其間的路徑的傳導性,其中該絕緣材料包含第三外周邊邊緣,其延伸超出該第一及第二電化學材料各自的第一及第二外周邊邊緣;其中該第一及第二電化學材料被建構來提供一電壓電位差至該控制電路,其為該第一及第二電化學材料接觸身體內的該導電液體的結果;其中當施加該電壓電位置該控制電路時,該電路元件產生一被傳導性地傳送的訊號,其包含使用身體作為導電媒介的電流路徑,使得該訊號經由身體組織被傳導於該電路元件和一接收器之間。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該控制電路被電耦合至該第一及第二電化學材料,其中該控制電路被建構來控制介於該第一及第二電化學材料之間的電壓電位差。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該第一及第二電化學材料被被建構來在一目標生理部位與一導電液體接觸時提供一電壓電位差,其中該電位差提供用於通信的能量。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該薄膜是一平面結構。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該薄膜包含多個塗層及多個層的至少一者。
- 如申請專利範圍第1項之可吞食的事件標示器,其更包含至少一受控制的啟動元件。
- 如申請專利範圍第1項之可吞食的事件標示器,其更包含一非活性劑鹽類,一消泡劑,一微環境調整劑及一可溶解的構成物的至少一者,該可溶解的構成物包含一重量其等於或大於該事件標示器的總重量的90%。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該薄膜包含反向的(opposing)彎曲邊緣,一或多個突出物,或一或多個可展開的元件,的至少一者。
- 如申請專利範圍第1項之可吞食的事件標示器,其更包含一重量其被偏心地(non-centrically)設置在該薄膜上。
- 如申請專利範圍第1項之可吞食的事件標示器,其更包含一可用水腫脹的(water-swellable)構件,其被偏心地設置在該薄膜上。
- 如申請專利範圍第1項之可吞食的事件標示器,其中該事件標示器包含一活性劑。
- 如申請專利範圍第11項之可吞食的事件標示器,其中該薄膜包含該活性劑。
- 如申請專利範圍第11項之可吞食的事件標示器,其中該薄膜備建構來可控制地釋出該活性劑。
- 如申請專利範圍第1項之可吞食的事件標示器,其更包含一具有錠劑形態的固體構件,其中該錠劑包含至少一流體通道(passageway)。
- 一種個人事件監視系統,其包含:一可吞食的事件標示器,其包含:一電路元件,其包含:一控制電路,其包含一上表面面及一下表面;一第一電化學材料,其界定一第一外周邊邊緣,該第一電化學材料電耦合至該控制電路的該上表面;一第二電化學材料,其界定一第一外周邊邊緣,該第二電化學材料電耦合至該控制電路的該下表面,其中該第一及第二電化學材料彼此被電隔離;及一設置在該第一及第二電化學材料之間的薄膜,其包含一訊號放大元件,該訊號放大元件包含一設置在該第一及第二電化學材料之間的絕緣材料,該絕緣材料被作成可 增加一通過身體內的導電液體之介於該第一及第二電化學材料之間的電流路徑的長度的大小以形成用於該導電液的通道並藉以提高介於其間的路徑的傳導性,其中該絕緣材料包含第三外周邊邊緣,其延伸超出該第一及第二電化學材料各自的第一及第二外周邊邊緣;其中該第一及第二電化學材料被建構來提供一電壓電位差至該控制電路,其為該第一及第二電化學材料接觸身體內的該導電液體的結果;其中當施加該電壓電位置該控制電路時,該電路元件產生一被傳導性地傳送的訊號,其包含使用身體作為導電媒介的電流路徑,使得該訊號經由身體組織被傳導於該電路元件和一接收器之間。
- 如申請專利範圍第15項之個人事件監視系統,其中該可吞食的事件標示器包含一活性劑。
- 如申請專利範圍第15項之個人事件監視系統,其中該活性劑係位在該薄膜上。
- 如申請專利範圍第15項之個人事件監視系統,其中該事件標示器更包含一非活性劑鹽類,一消泡劑,一微環境調整劑及一可溶解的構成物的至少一者,該可溶解的構成物具有一重量其等於或大於該事件標示器的總重量的90%。
- 如申請專利範圍第15項之個人事件監視系統,其中該薄膜是一平面結構。
- 如申請專利範圍第15項之個人事件監視系統,其 中該薄膜包含反向的(opposing)彎曲邊緣,一或多個突出物,或一或多個可展開的元件,的至少一者。
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