TWI544917B - 醫藥劑量傳送系統 - Google Patents

醫藥劑量傳送系統 Download PDF

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TWI544917B
TWI544917B TW099100083A TW99100083A TWI544917B TW I544917 B TWI544917 B TW I544917B TW 099100083 A TW099100083 A TW 099100083A TW 99100083 A TW99100083 A TW 99100083A TW I544917 B TWI544917 B TW I544917B
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胡曼 哈佛茲
葛利葛瑞 慕
歐陽潔儀
羅伯特 達克
瑪利亞 胡藍
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波提亞斯數位康健公司
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    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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Description

醫藥劑量傳送系統
本發明大體上關於電子裝置，且更特定言之關於身為利用導電作用交流資訊之一通訊系統之一部分的電子裝置。
依據35 U.S.C. § 119(e)，本申請案主張2009年1月6日申請之臨時專利申請案序號第61/142,861號之申請日的優先權，該臨時專利申請案的內容以引用的方式併入本文中。
處方藥對於許多患者來說在正確使用時係有效的治療手段。但研究顯示平均有大約50%的患者並未遵循處方藥用藥規則。低比率嚴守用藥規則造成每年有大量的人住院及在家看護。僅只在美國，近來經評估由於患者不聽話而造成的花費每年超過千億美金。
患者聽話與否特別重要的一種情況為臨床研究方面。未能嚴格遵循臨床試驗設定條件的遠程後果遠遠超過可能被捲入試驗中的幾百個患者。在沒有修正係數的情況下發生脫軌的話，其結果可能從輕則無法獲得FDA核可到重則必須將建議劑量提高到超過完全遵守用藥規則之人所需的量。此種經加多的劑量可能導致副作用發生機率提高，從而可能因此使人更進一步不遵守用藥規則。
臨床研究通常登錄患者進行指定藥物治療手段，目標為測試與藥物治療在醫藥相關臨床終點時之作用有關的假設。此等研究舉例來說可能測量有著眾多不同臨床終點之任一者的交替藥物治療之間的關係，此等測量從生理、生化或心理方面的量測到疾病之表現、患者存活時間或生活品質。此外，藥物治療亦必須與任何觀察所得有害事件建立關聯以盡力辨識稀有有害反應或與其他醫藥之交互作用。
可靠地交互關聯極其特定藥物治療手段(包含劑量及投藥方法)與效力和安全性兩者的能力相當大程度取決於確實知道每位患者已依循處方治療手段。因此，患者聽命程度(包含精確投藥時間)的監控對於臨床試驗主持者以及整體上醫藥產業來說有相當高的價值。
因此，需要一種用於追蹤記錄已投送劑量及投藥時間的系統及方法。
本發明之裝置包含一載體組件及一經構形用以密封該載體組件之一內部容積的帽蓋，其中該帽蓋包含一用電流編碼資訊的通訊裝置。該裝置包含一可攝食的事件標記器或一離子發射模組識別器，其利用通過與該裝置接觸之導電流體的導電作用。本發明之裝置在製備一醫藥劑量方面有其用途。本發明之額外觀點包含依據本發明之方法製備的劑量。依據本發明之實施例製備的劑量在多樣不同應用中有其用途，此等應用包含臨床試驗。
本發明之裝置包含一載體組件及一經構形用以密封該載體組件之一內部容積的帽蓋，其中該帽蓋包含一可攝食的事件標記識別器。本發明之裝置在製備一醫藥劑量方面有其用途。本發明之額外觀點包含依據本發明之方法製備的劑量。依據本發明之各觀點製備的劑量在多樣不同應用中有其用途，此等應用包含臨床試驗。
在更詳細說明本發明時，首先探討本發明之裝置及其製備醫藥劑量之使用方法，然後說明此等方法之用途及其涉及之總成和系統。下文亦更詳細探討實行本發明之方法的套組。
如前所概述，提出用於製備醫藥劑量之裝置及其使用方法。“醫藥劑量”一辭係指含有活性劑之一已知量的實體離散結構，其中該活性劑已知量係在一活性劑投送事件已被選擇用於投送給一受者的活性劑已知量。因此，一醫藥劑量含有一醫藥活性劑(文中亦簡稱為“活性劑”)之一預定量。存在於醫藥劑量內之醫藥活性劑的量係經計算足以在一活性劑投送事件中投送給一受者時產生期望效果。藉由本發明之方法產生的醫藥劑量可具有多種不同組態之任一者。因此，醫藥劑量之形狀可為圓柱形、球形或橢圓形，或是任何其他適宜形狀。尤其是具有大致膠囊組態的醫藥劑量，如下文所將詳述。
本發明之裝置包含一載體組件及一經構形用以密封該載體組件之一內部容積的帽蓋，其中該帽蓋包含一可攝食事件標記識別器。該等裝置之組件可有變化，其中這些組件的不同觀點在下文詳述。
本發明之方法包含用一醫藥活性劑組合物裝填一載體組件然後用一帽蓋密封該載體組件以製成醫藥劑量。該載體組件係一盛裝醫藥活性劑組合物之一量的容器。視醫藥活性劑組合物之特定本質而定(詳見下文)，該載體組件可被構形為用以盛裝多種不同類型之組合物，包含液體及固體，譬如粉末、錠體、有塗層的顆粒組合物、丸體、珠粒及小球。雖說載體經構形用以盛裝的活性劑體積可有變化，在一些案例中，載體可經構形用以盛裝0至1克(譬如0至100毫克且包含0至5毫克)範圍的活性劑量。載體組件可有多種不同組態。載體組件之組態的實例包含但不限於部分盒狀、部分球狀、部分卵狀、部分圓錐狀等。
特別引人注意的一種載體組件組態為部分膠囊組態。部分膠囊組態係具有一第一開放端及一第二封閉端的組態，其中該開放端與封閉端以一足以向該載體組件提供一期望內部容積的距離分隔。適用的部分膠囊組態可有多種不同斷面組態，其中斷面組態係在該開放端由該載體組件之壁界定的形狀。特別引人注意的斷面組態包含但不限於圓形、矩形、三角形、方形及卵形，以及不規則的斷面組態。
本發明之部分膠囊組態載體組件可依期望具有不同尺寸。在一些案例中，載體組件之長度在1公釐至50公釐的範圍內，譬如5公釐至30公釐且包含10公釐至20公釐。載體組件之外徑可有變化，在一些案例中為1公釐至30公釐，譬如5公釐至20公釐且包含5公釐至10公釐。載體組件之內徑亦可有變化，從0.5公釐至29.99公釐，譬如3.0公釐至19.99公釐且包含3.0公釐至9.99公釐。載體組件之壁可有變化，前提是其厚度足以承受醫藥活性劑組合物，在一些案例中壁厚範圍為0.01公釐至2公釐，譬如0.01公釐至0.2公釐且包含0.01公釐至0.1公釐。依期望，此等尺寸在載體組件中可為恆定或可變。舉例來說，內徑可為沿著膠囊長度為恆定或者可有變化。
本發明之載體組件譬如部分膠囊組態的載體組件可為利用任何適宜手段由任何適宜材料製成。可用來製造載體組件的材料包含用於習知醫藥膠囊劑量的生理可接受聚合材料。此等材料可為透明或不透明的，且依期望可為有色的。當中尤其令人注意的是剛性材料及彈性材料二者。
適於製造本發明載體組件的合適聚合物包含但不限於：明膠類，聚乙烯醇(PVA)；天然及合成多醣類，包含支鏈澱粉、紅藻膠、三仙膠、聚葡萄胺糖洋菜膠類，及纖維素材料類，譬如羧甲基纖維素、羥丙基甲基纖維素(HPMC)、甲基纖維素、羥乙基纖維素、羥乙基甲基纖維素、羥丙基纖維素；聚乙二醇類(PEGs)，聚乙烯氧化物類(PEOs)、PEG與PEO之聚合物；丙烯酸及甲基丙烯酸基聚合物類，譬如EUDRAGIT ETM、EUDRAGIT LTM及/或EUDRAGIT STM甲基丙烯酸聚合物類、EUDRAGIT RLTM及/或EUDRAGIT RSTM甲基丙烯酸銨共聚物類；普維酮(聚乙烯氫吡咯酮)、聚乙二醇化甘油酯類(譬如GELUCIRE 44/14TM、GELUCIRE 50/02TM、GELUCIRE 50/13TM及GELUCIRE 53/10TM聚合物類)；羧乙基聚合物類(譬如CARBOPOLTM聚合物類)；聚氧乙烯-聚氧丙烯共聚物類(譬如POLOXAMER188TM聚合物)；及類似物。
載體組件的表面可為平滑的或係由設置成任何圖案的崎嶇及/或溝槽組成。在期望情況，載體組件具有隔間或隔板。載體組件可有多個隔間，致使每一隔間具有不同的活性劑釋放特性，或是含有不同的醫藥活性劑組合物，例如像美國專利第4,738,724號、5,672,359號及5,443,461號所述，該等專利之內容以引用的方式併入本文中。
載體組件可為利用任何適宜手段製造，包含模塑等。製造手段包含但不限於美國專利第5,705,189號、4,576,284號、4,591,475號、4,655,840號、4,738,724號、4,738,817號及4,790,881號所揭示者，該等專利之內容以引用的方式併入本文中。另一選擇，載體組件可為取自販售商譬如Qualicaps Inc.,Whitsett NC。
在本發明的方法中，該載體組件可裝有多種不同類型的醫藥活性劑組合物。用以裝填該載體組件的協定可因醫藥活性劑組合物的本質而異。舉例來說，可流動的組合物譬如液體及固體(微粒及小球組合物為可流動固體之實例)可被傾注到該載體組件之內部空間內，不管是手動進行、使用一自動化裝置或是二者之組合，以便用該醫藥活性劑組合物裝填該載體組件。不可流動的固體譬如錠體或膠囊可被定位在載體組件之內部容積以內，同樣不管是手動進行、使用一自動化裝置或是二者之組合，以便裝填該載體組件。
如前所述，該醫藥活性劑組合物可為固體或液體組合物。所述固體組合物包含但不限於：粉末、丸體(例如呈小珠或小球之形式)、有塗層的顆粒及錠體。所述液體組合物可為多樣，例如在黏度、顏色等方面有所變化。本發明之醫藥活性劑組合物包含一醫藥活性劑，其係單獨存在或係與一賦形劑組合，其中該賦形劑可包含一或多種不同組份，譬如填充物、黏合劑、著色劑等。
在本文中，“活性劑”一辭包含會在與一活體譬如人類接觸後產生一生理效果例如一有利或有用效果的任何化合物。活性劑可有別於此等賦形劑組份譬如填充物、黏合劑、著色劑等。活性劑可為能夠調整一活受體內之一生物程序的任何分子。在一些案例中，活性劑可為一用於診斷、治療或疾病防制或是當作一藥物之一組份的物質。所述活性劑之廣泛類型包含但不限於：心血管用劑類；痛覺舒緩劑類例如止痛藥類、麻醉藥類、抗炎劑類等；作用於神經的劑類；化療(例如抗腫瘤)劑類等。所述活性劑類進一步揭示於經公開為WO 2006/116718號之PCT專利申請案第US2006/016370號，其完整內容以引用的方式併入本文中。
醫藥活性劑組合物可如前所述進一步包含一賦形劑組份，賦形劑組份可包含一或多種成分，包含但不限於填充物、黏合劑、崩解劑、著色劑等。所述賦形劑組份進一步見於經公開為WO 2006/116718號之PCT專利申請案第US2006/016370號，其完整內容以引用的方式併入本文中。可存在於本發明之組合物中的組份的額外說明可見Remington’s Pharmaceutical Sciences,Mace Publishing Company,Philadelphia,Pa.,17th ed.(1985)。
在一些案例中，該等方法可包含在該載體組件中提供一獨立於該活性劑組合物之填充組合物。舉例來說，在一些案例中，該載體組件被裝填有一醫藥活性劑組合物及一不同填充組合物，其中該填充組合物可因多種不同目的而被包含。一種所述填充組合物係向醫藥劑量組合物賦予一大於胃液之密度的填充物。據此，所述填充組合物係向醫藥劑量組合物賦予一大於0.8或更高、譬如1.0或更高且包含1.2或更高之密度的填充物。任何適宜材料可用作填充組合物，包含以上所述用作賦形劑組份的材料。
填充物亦可為被包含用以在一裝置或識別器譬如一可攝食事件標記(IEM，其亦被稱為離子發射模組)識別器被放在載體組件內時填滿所出現的任何閒置空間。劑量之識別器組件提供許多好處。識別器的存在允許吾人監測投藥之精確時間及頻率還有患者反應。這些可藉由本發明之方法及劑量之使用而獲得的資訊可被用在許多背景中，例如用來提升臨床研究之整體品質和精度。利用此資訊，吾人可輕易地認出遵守治療規則的臨床試驗對象並排除不守規則的人以便獲得關於一已知活性劑之功效的更精準資料。此資訊亦可與各種生理資料組合以便獲得關於一已知活性劑之效果的更詳盡資料。
本發明之方法亦尋得與藥劑師之用途，藥劑師可製備包含一IEM的患者客製劑量，即便所述活性劑之原始生產者不提供包含一IEM之劑量。IEM係一種經訂定尺寸為可攝食的裝置，且包含一導電率控制模組及一在與導電流體接觸之後變完整的部分電源。由於IEM被訂定尺寸為可攝食的，其大小係被訂為可放入人嘴中被吞嚥。在一些案例中，本發明之IEM的最大尺寸為30公釐或更小，例如20公釐或更小，包含5公釐或更小。因此，當今可取得的任何醫藥組合物可利用本發明之方法及組件與一IEM建立關聯。
在將醫藥活性劑組合物(及依期望之任何任選填充組合物)放入載體組件之內部容積內後，隨後用一帽蓋密封所得已裝填載體組件。帽蓋係一經構形以與一載體組件之開放端匹配成一密封關係的結構物，致使當帽蓋與載體組件之開放端建立關聯時，該載體組件之一內部容積及其內容物(醫藥活性劑組合物)被密封阻絕於由該載體與帽蓋界定之劑量結構之外界環境，致使氣體和液體無法輕易地在該劑量結構的內外環境之間通過。帽蓋可由任何適當材料製成，包含以上關於載體組件所述之材料。在一些案例中，帽蓋係由微晶體纖維素、交聯羧甲基纖維素鈉及硬脂酸鎂。
本發明之帽蓋包含一或多個IEM識別器。該一或多個IEM識別器可存在於帽蓋之多種不同位置，包含內部位置及外部位置。內部位置包含界定於帽蓋內側且經構形用以收納IEM的區域。外部位置包含外表面及內表面。帽蓋之外表面為當帽蓋與載體組件處於一密封關係時面向帽蓋之外界環境的表面。外表面依期望可為帽蓋之一側表面或是帽蓋之一頂表面。帽蓋之內表面為當帽蓋與載體組件處於一密封關係時面向由載體組件及帽蓋界定之內部容積的表面。一給定帽蓋可包含單一個IEM或是二或更多個IEM，譬如三個或更多個可攝食事件標記器。
該一或多個IEM與帽蓋穩定地相關。因此，該等識別器例如藉由使用一黏著劑而被固定在帽蓋之一位置，譬如帽蓋之一外表面。所述黏著劑包含但不限於：糖及纖維素黏著劑，蛋白質黏著劑譬如玉米蛋白或酪蛋白，聚矽氧黏著劑，聚合物黏著劑、包含丙烯酸及甲基丙烯酸黏著劑，蟲膠，及類似物。
所述IEM為在IEM與一(或多個)目標生理位置接觸後經由一獨特電流特徵之生成來聯絡資訊的識別器，該獨特電流特徵流過一導電環境，譬如一導電流體。IEM可因特定實施例及組合物之預期應用而異，前提是其在與一目標生理位置譬如胃液或腸液接觸後會被激活(起動)。因此，IEM可為一當在一目標部位被激活、例如當IEM接觸一目標身體部位時會產生一經編碼有資訊之獨特電流特徵的識別器。IEM可為能夠在激活後提供一可偵測信號的任何組件或裝置。依據本發明之各觀點的IEM包括一用於產生一獨特電流特徵的控制單元。IEM可經構形為一旦組合物與一生理目標部位發生接觸時產生獨特電流特徵。視實施例而定，目標生理部位或位置可有變化，其中代表性目標生理部位包含但不限於胃腸道中之一位置，譬如嘴、食道、胃、小腸、大腸等。IEM可被構形為在與目標部位之流體譬如胃液接觸後即被激活，與目標部位之特定組合物無關。必要時，識別器可經構形為在組合物與一目標生理部位接觸後被詢問激活。IEM可經構形為在一段指定時間長度之後被激活，其中目標部位係在一段指定時間長度之後抵達。
視一特定應用之需求而定，從IEM取得的資訊可為一般的，致使該資訊僅確認組合物已接觸目標部位。另一選擇，該資訊可為獨特的，其以某些方式獨特地從一批劑量中之一群或複數個不同標記器當中確認一特定IEM已接觸一目標生理部位。因此，IEM可為當與一批劑量搭配使用時會發出一電流特徵的IEM，其電流特徵係無法與該批之任一其他劑量構件之IEM所發出的電流特徵區別。另一選擇，該批之每一IEM可發出一獨特信號，至少係相對於該批之所有其他IEM。在此等案例中，該批之每一IEM產生一電流特徵，其相對於該批中所有其他IEM獨特地表明該特定IEM。IEM可發出一係一普及獨特電流特徵的獨特電流特徵(其中此一電流特徵可能類似於人的指紋，其與任一其他個體之任一其他指紋不同且因此在一普及水準上認出一個體)。電流特徵可為直接輸送關於一給定事件的資訊或是提供一識別碼，此識別碼可用於從一資料庫(亦即一鏈結識別碼與組合物)擷取關於事件之資訊。
IEM之電流產生期的持續時間可有變化，依據本發明之教示，從0.1微秒至48小時或更久，譬如從0.1微秒至24小時或更久，譬如0.1微秒至4小時或更久，譬如1秒至4小時，包含1分鐘至10分鐘。視給定實施例而定，IEM可產生編碼於該電流特徵中的相同資訊一次；另一選擇，IEM可經構形以產生具有相同資訊之電流特徵二或更多次，其中離散相同電流特徵之集合可被統稱為冗餘信號。
除了產生一獨特電流特徵，依據本發明之其他觀點，IEM可經構形以產生多種不同類型之信號，其包含但不限於：RF信號，磁信號，音波信號等。
IEM可因特定實施例及組合物之預期應用而異，前提是其會在與一目標生理位置譬如胃接觸後被激活(亦即起動)。IEM包含一由一導電流體譬如胃酸變完整的部分電源，及一導電率控制單元。不同類型之IEM的實例包含但不限於揭示於下列文獻者：PCT申請案第PCT/US2006/016370號，其被公開為WO/2006/116718號；PCT申請案第PCT/US2007/082563號，其被公開為WO/2008/052136號；PCT申請案第PCT/US2007/024225號，其被公開為WO/2008/063626號；PCT申請案第PCT/US2007/022257號，其被公開為WO/2008/066617號；PCT申請案第PCT/US2008/052845號，其被公開為WO/2008/095183號；PCT申請案第PCT/US2008/053999號，其被公開為WO/2008/101107號；PCT申請案第PCT/US2008/056296號，其被公開為WO/2008/112577號；PCT申請案第PCT/US2008/056299號，其被公開為WO/2008/112578號；PCT申請案第PCT/US2008/077753號；及2009年9月21日申請之美國專利申請案第12/564,017號，該等專利申請案之內容以引用的方式併入本文中。
該帽蓋可有多種不同組態，前提是其經構形為當其與載體組件之開放端建立關聯時密封該載體組件之開放端。帽蓋可有多種不同組態，允許其當其與載體組件之開放端建立關聯時密封該載體組件之開放端。在一些案例中，帽蓋具有聯鎖元件，此等聯鎖元件搭配或體組件之開放端之匹配元件操作以密封載體組件之開放端。聯鎖元件的實例為螺桿螺紋及扣接配合元件。另一選擇，帽蓋可有一區或端經構形以壓入配合載體組件之內側且密封載體組件之內容物。此種組態之一實例為其中帽蓋具有一由剛性材料建構的末端，其中該端之組態略大於載體組件之開放端。在載體組件之開放端係由一彈性體材料製成的情況，帽蓋之剛性端可藉由拉伸載體之開放端而被壓入配合至載體之開放端內。當任何拉伸力自載體之開放端移除時，載體之開放端隨後會順應帽蓋之剛性端成密封關係。另一選擇，帽蓋可包含一具有某種程度之柔性的可壓縮端。此柔性足以向帽蓋賦予藉由壓縮該可壓縮端產生一壓縮端、將該帽蓋壓縮端放入載體組件開放端內然後移除壓縮力而使帽蓋之柔軟端壓入配合至載體組件之開放端內的能力。當該壓縮端因壓縮力之移除而膨脹時，該壓縮端成一密封關係順應載體組件開放端之組態以將載體組件之內容物密封在載體組件內。
一具有可壓縮端的帽蓋可以多種不同方式提供。一種可壓縮端係一由可壓縮材料製成的末端。所述可壓縮材料為柔性的。另一選擇，該可壓縮端可包含向該可壓縮端提供可壓縮能力的一或多個缺口。
需要時，帽蓋可用一黏著劑固定於載體組件之開放端，合適黏著劑的實例如前所述。因此，帽蓋可被膠黏至載體組件之開放端上以便密封載體組件開放端。
在一些實例中，於載體及/或帽蓋中提供通道或類似結構，此等通過促進劑量形式之液體穿透、載體組件之溶解且/或減低劑量形式之浮力。此等孔若存在則其直徑可為10-3公釐至5公釐，譬如0.1公釐至2公釐。
今參照圖1A和2A，一醫藥劑量載體系統10包含一帽蓋20及殼體或殼體50。系統10之殼體50界定一腔穴且包含一開放端60及一封閉端70。封閉端70有一部分平坦的底座，有側壁從該底座以一向上方向延伸，在開放端60以一開口終結以於其內界定該腔穴。封閉端70亦可為一圓邊結構，譬如一半球形端壁，還有其他組態，且有一圓錐形組態等。
系統10在殼體50之內壁上包含一接合區65。當帽蓋20以一足以在殼體50與帽蓋20之間產生一密封的方式插入殼體50之開放端60內時，接合區65可與帽蓋20接合。帽蓋20及殼體50的尺寸經選擇致使帽蓋20之外壁與殼體50之接合區65之內壁之間發生接觸。
如前所述，系統10可被裝填一醫藥活性劑組合物及或一填充組合物。依據本發明之一觀點，系統10被裝填呈錠體之形式的一種醫藥活性劑組合物及兩種填充組合物。因此，殼體50被裝填一種醫藥活性劑錠30及兩種填充組合物35和37。儘管在殼體50所界定的腔穴內以一特定順序顯示，本發明之範圍不受錠體30及填充組合物35和37之相對位置或順序限制。舉例來說，錠體30可如圖1A所示被定位在填充組合物37的位置。此外，錠體30及填充組合物35和37的方位可被翻轉以更好地配合系統10之組裝，如圖1B和2B所示，且本發明之範圍不限於此。填充組合物35和37之至少一者係由一會對整個系統10賦予一密度的材料製成。依據本發明之一觀點，該密度可為大於系統10所進入或被導入之環境譬如胃液之密度。因此，填充組合物35和37之任一者可被用來改變系統10之浮力，另一個填充組合物可被用來阻止錠體30及另一填充組合物在殼體50所界定之腔穴內發生移動。依據本發明之另一觀點，填充組合物二者皆可被用於改變系統10之浮力。依據本發明之教示，填充組合物之任一者可被換成一醫藥製劑，致使系統10包含兩種(或更多種)不同醫藥活性劑，其在不同時間或相同時間釋入周遭環境內。
今參照圖1A和1B，在組裝系統10時，醫藥活性劑譬如錠體30及兩種填充組合物35和37如圖所示被定位在殼體50內。此定位步驟可為手動完成或藉由自動化方法完成，譬如經由一組裝機、遠端機器人、或其他自動化裝置的使用完成。在將錠體30及填充組合物35和37放入殼體50內後，用帽蓋20密封殼體50之開放端60以密封系統10。利用帽蓋20密封殼體50之開放端60可為手動完成或藉由自動化方法完成，譬如經由一組裝機、遠端機器人、或其他自動化裝置的使用完成。
如圖1A和2A所示，由殼體50界定且容納錠體30及填充組合物35和37的腔穴由帽蓋20密封。帽蓋20可被壓入配合至殼體50之開放端60之內側。依據本發明之另一觀點，帽蓋20可被膠黏至接合區65。
今參照圖1A和2A，帽蓋20在其一頂部外表面上包含一裝置40譬如IEM。裝置40經由一適當固定方法的使用而被固定在帽蓋20之上表面。舉例來說，依據本發明之一觀點，裝置40利用一適當黏著劑膠黏至帽蓋20。另一選擇，如圖1B和2B所示，裝置40可係固定於帽蓋20之一底部內表面，致使當帽蓋20被定位在殼體50之腔穴內時，裝置40被密封於其內且受保護不與系統10所進入之周遭環境接觸，直到帽蓋20脫離殼體50。
依據本發明之另一觀點，裝置40包含一如PCT申請案第PCT/US2008/077753號中揭示之虛擬偶極元件，該申請案之內容以引用的方式併入本文中。依據本發明之另一觀點，裝置40為肉眼不可見。
今參照圖1A及2A，如前所述，帽蓋20包含一塞入殼體50之開放端60內的插入部分80。插入部分80係與裝置40所在表面相對。如圖所示，插入部分80界定至少一切除部分90，該切除部分允許插入部分80被塞入開放端60內。開放端60可為可展延的以張開並壓力配合至插入部分80上並提供一牢固配合。因此，帽蓋20可經捏夾以在用於將插入部分80密封於開放端60內時塞入殼體50之開放端60內。
今參照圖1B和2B，如前所述，帽蓋20包含一塞入殼體50之開放端60內的插入部分80。插入部分80被定位在帽蓋20之底部表面附近。帽蓋20之底部表面經塑形以接納被定位並固定在該底部表面上的裝置40。如圖所示，插入部分80界定複數個切除部分90，該等切除部分允許插入部分80塞入開放端60內。但本發明之範圍不受帽蓋20底部表面之形狀或其上之切除部分數量限制。開放端60可為可展延的以張開並壓入配合至插入部分80上並提供一牢固配合。另一選擇且依據本發明之另一觀點，開放端60可為剛性且為錐形(圖中未示)以匹配地接納帽蓋20之一錐形插入部分(圖中未示)，其中該錐形部分或開放端60與帽蓋20之錐形插入部分被膠黏在一起。因此，帽蓋20可被壓入並膠黏至殼體50之開放端60內以使帽蓋20固定於殼體50。
今參照圖3A、3B及3C，帽蓋20包含插入部分80。依據本發明之一觀點，插入部分80界定四個通道或缺口92、94、96及98。每一缺口具有一近似弦月之形狀，如圖所示。然缺口92、94、96及98可具有促進帽蓋20塞入開放端60內之任何合適形狀，例如多邊形形狀。如圖所示，帽蓋20之插入部分80包含一周向環狀斜邊脊部。
在一些案例中，固定於殼體50之末端的帽蓋20可被一包覆式帽蓋組件覆蓋。該包覆式帽蓋組件可由多樣材料製造，譬如用於載體組件的任一材料。該包覆式帽蓋可由一不透明材料製造以便隱藏裝置40之存在並且避免在打包及處理期間與周遭環境接觸。該包覆式帽蓋組件可為彈性體的，例如藉此在與載體組件處於密封關係的帽蓋上方提供一牢固配合。
今參照圖4，依據本發明之另一觀點，一醫藥劑量系統130包含一包覆式帽蓋132。醫藥劑量系統130包含一利用一帽蓋134密封的載體組件140。帽蓋134在其一外表面上包含一裝置136譬如一電流特徵產生裝置或IEM。包覆式帽蓋132被定位在帽蓋134上方。包覆式帽蓋132如圖所示固定於載體組件140，這在醫藥劑量系統130被攝食時防止裝置136與導電流體之間發生接觸。一旦包覆式帽蓋132脫離載體組件140，裝置136即與周遭環境發生接觸，且若該環境包含一導電流體譬如胃液，則裝置136被激活並產生一可被偵測及解碼以擷取資訊的電流特徵。
若需要，製備劑量傳送系統的方法可進一步包含製備安慰劑醫藥劑量。安慰劑醫藥劑量可依一類似於包含一醫藥活性劑之劑量之製備的方式製備，差別在於不將醫藥活性劑放入載體組件內。取而代之係將一沒有活性劑(例如如前所述)的賦形劑組合物放入載體組件內然後用帽蓋密封。製備安慰劑劑量的方法包含欲將醫藥劑量用於臨床試驗的方法。
依據本發明之更另一觀點，製備一劑量傳送系統的方法可進一步包含製備在載體內有一裝置的劑量，舉例來說其係單獨使用或搭配一填充物使用。此等觀點除了其他應用更可經由一獨特電流特徵之產生促進劑量傳送系統之一攝食事件之標記。
依據本發明之另一觀點，可將兩種不同的藥劑放入殼體50內並用一填充組合物分隔。此種實體分隔在不同藥劑必須在溶液中混合才會起作用的案例中為有利。因此，當殼體50被溶解時，兩種獨立藥劑被釋入周遭流體譬如胃液內。這導致兩種原本分開的藥劑發生接觸並結合，藉此允許兩種不同藥劑精準傳送至一目標部位並組合。
本發明之觀點進一步包含使用依據前述方法製造之醫藥劑量的方法。整體而言，本發明之方法會包含將一或多個醫藥劑量投送給一受者，例如使一受者攝食本發明之醫藥劑量。該等劑量可被投送給許多不同類型的受者。一般而言這些受者是“哺乳類動物”，此辭係用來廣泛地描述在哺乳類動物範圍內的生物，包含食肉動物(例如狗和貓)、齧齒動物(例如小鼠、天竺鼠及大鼠)、以及靈長動物(例如人類、猩猩及猴子)。在攝食後，一獨特電流特徵由IEM產生且例如被一接收器偵測，例如見下列文獻：PCT申請案第PCT/US2006/016370號，其被公開為WO/2006/116718號；PCT申請案第PCT/US2007/082563號，其被公開為WO/2008/052136號；PCT申請案第PCT/US2007/024225號，其被公開為WO/2008/063626號；PCT申請案第PCT/US2007/022257號，其被公開為WO/2008/066617號；PCT申請案第PCT/US2008/052845號，其被公開為WO/2008/095183號；PCT申請案第PCT/US2008/053999號，其被公開為WO/2008/101107號；PCT申請案第PCT/US2008/056296號，其被公開為WO/2008/112577號；PCT申請案第PCT/US2008/056299號，其被公開為WO/2008/112578號；PCT申請案第PCT/US2008/077753號；2009年10月13日申請之美國專利申請案第61/251,088號；及及2009年12月15日申請之PCT專利申請案第PCT/US2009/068128號，該等專利申請案之內容以引用的方式併入本文中。
製備醫藥劑量並將其投送給例如如前所述之受者的方法在許多不同應用有其用途。一種應用為利用該等劑量之識別器當作IEM。本發明之醫藥劑量可用於治療及非治療應用，例如見於下列文獻：PCT申請案第PCT/US2006/016370號，其被公開為WO/2006/116718號；PCT申請案第PCT/US2007/082563號，其被公開為WO/2008/052136號；PCT申請案第PCT/US2007/024225號，其被公開為WO/2008/063626號；PCT申請案第PCT/US2007/022257號，其被公開為WO/2008/066617號；PCT申請案第PCT/US2008/052845號，其被公開為WO/2008/095183號；PCT申請案第PCT/US2008/053999號，其被公開為WO/2008/101107號；PCT申請案第PCT/US2008/056296號，其被公開為WO/2008/112577號；PCT申請案第PCT/US2008/056299號，其被公開為WO/2008/112578號；及PCT申請案第PCT/US2008/077753號，該等專利申請案之內容以引用的方式併入本文中。
所述應用包含實際傳送到體內之藥劑的自動偵測及辨識，其可為依下述方式完成：(1)監控患者對於處方治療規則之遵守程度；(2)基於患者守規矩的程度修改治療規則；(3)監控患者在臨床試驗中的遵守程度；(4)監控受控物質之使用；及類似方式。這些不同例示應用的每一者在下列文獻中有更詳細敘述：PCT申請案第PCT/US2006/016370號，其被公開為WO/2006/116718號；PCT申請案第PCT/US2007/082563號，其被公開為WO/2008/052136號；PCT申請案第PCT/US2007/024225號，其被公開為WO/2008/063626號；PCT申請案第PCT/US2007/022257號，其被公開為WO/2008/066617號；PCT申請案第PCT/US2008/052845號，其被公開為WO/2008/095183號；PCT申請案第PCT/US2008/053999號，其被公開為WO/2008/101107號；PCT申請案第PCT/US2008/056296號，其被公開為WO/2008/112577號；PCT申請案第PCT/US2008/056299號，其被公開為WO/2008/112578號；及PCT申請案第PCT/US2008/077753號，該等專利申請案之內容以引用的方式併入本文中。
在某些實施例中，本發明之製造醫藥劑量的方法被用在臨床試驗中。採用本發明之方法及組合物的臨床試驗包含多患者研究，此等研究係為了收集一新醫藥活性劑之安全性及效力資料而進行。臨床試驗的實例包含研究者在初期召集健康的志願者及/或患者進行小規模前導研究然後在患者中進行較大規模研究的研究，其通常比較新產品與一當前指定的治療方案。此外，臨床試驗亦可比較所述活性劑與一安慰劑組合物。在這些案例中，安慰劑可依一類似於本發明製造醫藥劑量之方法的方式製備，差別在於不將醫藥活性劑組合物密封於載體組件內。當在一給定臨床試驗中收集到正面的安全性及效力資料，可增加患者之數量。臨床試驗的規模可從一個國家中的單一中心試驗至多個國家中的多中心試驗。
使用依據本發明製備之醫藥劑量進行臨床試驗提供許多好處。其一為臨床試驗管理者(運作此臨床試驗的人)可使用標準載體組件及帽蓋且依一給定醫藥活性劑組合物之需求訂製這些東西。
本發明亦提出包含一或多個如前所述之本發明醫藥劑量的系統。除了本發明的醫藥劑量，該系統可包含與身體有關聯的信號接收器以偵測代表從依據本發明之教示之醫藥劑量載體收到的編碼資訊之電壓電位的變化。所述與身體有關聯的接收器包含見於下列文獻者：PCT申請案第PCT/US2008/052845號，其被公開為WO/2008/095183號；及PCT申請案第PCT/US2006/016370號，其被公開為WO/2006/116718號，該等申請案的內容以引用的方式併入本文中。如此等相關申請案所述，接收器可被植入患者之體表上。該等系統可進一步包含額外的資料中繼及/或處理組件，譬如無線通信裝置(譬如行動電話)；如可在電腦及資訊系統中找到的資料處理器等。
本發明亦提出用於實行所述方法的套組。套組可包含一或多個如前所述之本發明載體組件及相關帽蓋。套組之載體組件及相關帽蓋會經配備以接收內有密封的一或多種醫藥活性劑組合物之劑量；譬如醫藥活性劑組合物係獨立於所述套組提供。必要時，套組亦可包含一或多個填充組合物。一給定套組可包含足夠的載體組件及帽蓋以製作1或更多、包含5或更多、譬如50或更多、100或更多、1000或更多、5000或更多、或10000或更多的醫藥劑量。
所述套組亦可包含如何利用套組之組件實行本發明之方法的使用指南。使用指南可被記錄在一適當記錄媒體或基體上。舉例來說，使用指南可為印在一基體譬如紙或塑膠等上。因此，使用指南可作為一包裝插入物、套組或其組件之容器之標籤(亦即伴隨著包裝或次包裝)出現在套組中。在其他實施例中，使用指南係以存在於一適當電腦可讀儲存媒體譬如CD-ROM、磁碟上的電子儲存資料檔案存在。在更其他實施例中，實際的使用指南不存在於套組內，但提供從一遠端源例如經由網際網路獲取使用指南的手段。此實施例之一實例為一包含一網址的套組，吾人可自該網址瀏覽及/或下載使用指南。關於使用指南，此種獲取使用指南的手段係記錄在一適當基體上。
所述套組之一些或所有組件可被打包於適當包裝內以維持無菌。必要時套組之組件係被打包在一套組容納元件內以造出單一易取單元，其中該套組容納元件可為一箱子或類似結構且可以是或不是氣密容器。
應理解到本發明不侷限於所述特定實施例，因為其可有變化。亦應理解到文中所述用語僅係為了描述特地特定實施例，且非意欲設限，因為本發明之範圍將由隨附申請專利範圍限制。
在提出數值範圍時，應理解到除非文中另有明確說明，否則所述範圍上限與下限之間的任何居間數值(至下限之單位的十分之一)及所述範圍中之任何其他明述或居間數值皆涵蓋於本發明內。這些較小範圍的上限及下限可被獨立地包含在此等較小範圍中且同樣在本發明之內，依循所述範圍中之任何指定排他限制值。在所述範圍包含這些極限值之一或二者時，除此等內含極限值之任一者或二者的範圍亦被包含在本發明之內。
除非另有定義，文中所述所有技術性及科學性術語均具有如熟習本發明所屬技藝之人熟知的相同意思。儘管任何類似或等效於文中所述的方法及材料亦可用於本發明之實行或測試，代表性範例方法及材料如本文所述。
本說明書引用之所有公開案及專利均視同每一個別公開案或專利經明確且個別地表示以引用的方式併入本文中以揭示及明述與所引用公開案有關之方法及/或材料。任何公開案的引用係針對其等在申請日之前的內容且不應解釋為認可本發明未經標明先於此等本質為習知發明的此等公開案。再者，文中提供之公開日期可能異於實際公開日期這可能需要單獨確認。
應理解到在本說明書及申請專利範圍項中，除非文中另有明確敘述，否則單數形“一”及“該”包含複數個指述對象。更應理解到申請專利範圍項可能經起草以排除任何選用元素。因此，此聲明係欲當作諸如“僅只”、“僅有”及類似排他性用語在與申請專利範圍元素之列舉有關時的使用或“負面”限制的使用之先述基礎。
文中某些範圍已用在數值之前加上“約”字的方式呈現。“約”字係用來為其後精確數字以及靠近或近似所述數字的數字提供字義支援。在判定一數字是否靠近或近似一明確敘述數字時，靠近或近似的未明述數字可為在其出現的內容當中會提供該明確敘述數字之實質等效的數字。
熟習此技藝者在閱讀本說明書之後會理解到，文中所提每一個別實施例具有離散組件和特徵，這些組件和特徵可輕易地從其他幾個實施例之任一者的特徵分開或與其他幾個實施例之任一者的特徵結合而未脫離本發明之範圍或精神。任何明述方法可依文中所述事件順序或是依邏輯上可行之任何其他順序執行。
儘管以上為方便理解已藉由範例和實例詳細說明本發明，熟習此技藝者從本發明之教示可輕易理解到可對本發明進行某些變化和修改而未脫離隨附申請專利範圍項之精神或範圍。
10．．．醫藥劑量載體系統
20．．．帽蓋
30．．．醫藥活性劑錠
35．．．填充組合物
37．．．填充組合物
40．．．裝置
50．．．殼體
60．．．開放端
65．．．接合區
70．．．封閉端
80．．．插入部分
90．．．切除部分
92．．．缺口
94．．．缺口
96．．．缺口
98．．．缺口
130．．．醫藥劑量系統
132．．．包覆式帽蓋
134．．．帽蓋
136．．．裝置
140．．．載體組件
圖1A係一依據本發明之醫藥劑量傳送系統的局部切除正面透視圖，在該傳送系統之外部定位有一電流特徵產生裝置。
圖1B係一依據本發明之醫藥劑量傳送系統的局部切除正面透視圖，在該傳送系統之內部定位有一電流特徵產生裝置。
圖2A係一圖1A醫藥劑量傳送系統的分解透視圖。
圖2B係一圖1B醫藥劑量傳送系統的分解透視圖。
圖3A係一用於依據本發明之圖1醫藥劑量的帽蓋的仰視圖。
圖3B係一圖3A帽蓋的側視圖。
圖3C係一圖3A帽蓋的透視圖。
圖4係一依據本發明具備一包覆式帽蓋之醫藥劑量的剖面圖。
10．．．醫藥劑量載體系統
20．．．帽蓋
30．．．醫藥活性劑錠
35．．．填充組合物
37．．．填充組合物
40．．．裝置
50．．．殼體
60．．．開放端
65．．．接合區
70．．．封閉端
80．．．插入部分
90．．．切除部分

Claims (24)

  1. 一種用於追蹤傳送參數的醫藥傳送系統，該系統包括：一具有一封閉端及一開放端的載體殼體，其中該載體殼體界定一腔穴；一定位於該載體殼體之腔穴內的藥劑；及一包括一頂端及一底端的帽蓋，其中該底端包含一密封部分，該密封部分與該載體殼體之開放端處於實體聯繫關係以密封容納該藥劑之該腔穴，其中該密封部分界定至少一通道以讓該帽蓋塞入該載體殼體之開放端內；及一與該系統相關的裝置，其中該裝置產生一可辨識電流特徵以聯絡資訊，其中該裝置被固定於該帽蓋之該頂端致使該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸。
  2. 如申請專利範圍第1項之系統，其中該至少一通道允許該帽蓋被壓入配合至該載體殼體之開放端內。
  3. 如申請專利範圍第1項之系統，其中該密封部分利用一黏著劑固定於該載體殼體之開放端。
  4. 如申請專利範圍第1項之系統，其中該裝置包括：一框架；一被固定在該框架內的導電率控制模組，用於產生代表該資訊之可辨識電流特徵； 一被固定於該框架且電耦接至該導電率控制模組的第一材料；及一被固定於該框架且電耦接至該導電率控制模組的第二材料，其中該第一材料及該第二材料藉由一不導電材料分隔且經選擇以在與一導電流體發生接觸時產生一電壓電位。
  5. 一種醫藥載體，其包括：一界定一腔穴的殼體，其中該殼體包含一開放端及一封閉端；一定位於該殼體之腔穴內用於改變該載體之浮力的設備；一包括一頂端及一底端的帽蓋，其中該底端界定至少一通道，該通道用於讓該帽蓋塞入該殼體之開放端內以密封該腔穴之內容物；及一電流控制裝置，其被固定於該帽蓋用於產生一獨特電流特徵，其中該電流控制裝置被固定於帽蓋的頂端致使該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸，其中該電流控制裝置包括：一導電率控制模組，其被固定於一框架內用於產生一可辨識電流特徵；及一部分電源，其包括彼此隔絕之一第一材料及一第二材料，且該第一材料及該第二材料皆電耦接至該導電率控制模組，其中該第一材料及該第二材料被固定於該框 架。
  6. 如申請專利範圍第5項之載體，其中該電流控制裝置之部分電源在該第一材料及該第二材料透過一與之接觸的導電流體電耦接時產生一電壓電位，且該電壓電位被用於激活該導電率控制模組以產生該可辨識電流特徵。
  7. 如申請專利範圍第6項之載體，其中該電流控制裝置被固定於該帽蓋之頂端致使該電流控制裝置在該殼體與該導電流體發生接觸之大約同時與該導電流體發生接觸，且因此該電流控制裝置在與該導電流體接觸後被激活。
  8. 如申請專利範圍第6項之載體，其中該電流控制裝置被固定於該帽蓋之頂端，且其中該載體進一步包括一被定位在該帽蓋之頂端上方的包覆式帽蓋，致使該包覆式帽蓋在其溶解之前阻止該導電流體與該電流控制裝置接觸，這導致該載體之導入環境之時間與該導電率控制模組之激活之間的一延遲，且藉此延遲該可辨識電流特徵之產生。
  9. 如申請專利範圍第6項之載體，其中該電流控制裝置被固定於該帽蓋之底端致使該電流控制裝置在該帽蓋脫離該殼體之後與周遭環境發生接觸，且藉此延遲該電流控制裝置產生該可辨識電流特徵。
  10. 如申請專利範圍第5項之載體，其中該帽蓋在該底端包含一錐形部分且該殼體在該開放端包含一錐形部分，致使該等錐形部分公母匹配且膠黏在一起，藉此導致該帽蓋被固定於該殼體之開放端以密封該腔穴。
  11. 如申請專利範圍第5項之載體，其中該帽蓋被機械地塞入該殼體之開放端以密封該殼體之腔穴。
  12. 如申請專利範圍第5項之載體，其進一步包括一定位於該殼體之腔穴內的藥劑。
  13. 如申請專利範圍第5項之載體，其中該設備具有一向該裝置賦予一大於胃液之密度的組合物。
  14. 一種用於提供與一醫藥產品之攝食有關之資訊的可攝食載體，該載體包括：一界定一腔穴的可溶解外殼，其中該外殼包含一開放端及一封閉端，且該醫藥產品可定位在由該外殼界定之該腔穴內；一帽蓋，其包括一頂端及一包含一固定部分的底端，其中該固定部分界定複數個通道，該等通道允許該帽蓋插入至該外殼之開放端內；及一被固定於該帽蓋的電流特徵產生裝置，其用於產生一代表與該醫藥產品之攝食有關之資訊的電流特徵，其中該 電流特徵產生裝置被固定於帽蓋的頂端致使該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸，其中該電流特徵產生裝置包括：一框架；一被固定於該框架用於產生代表該資訊之該電流特徵的導電率控制模組；及一部分電源，其包括皆電耦接至該導電率控制模組之一第一材料及一第二材料，其中該第一材料及該第二材料被固定於該框架且藉由一不導電材料分隔，且其中該部分電源在該第一材料及該第二材料透過一與之接觸的導電流體電耦接時產生一電壓電位，且該電壓電位激活該導電率控制模組且因此激活該裝置。
  15. 如申請專利範圍第14項之載體，其中該載體進一步包括一定位於該帽蓋周圍且固定於該帽蓋的包覆式帽蓋，致使該包覆式帽蓋藉由延遲該裝置與該導電流體間之接觸而造成該裝置之激活之一延遲，且因此造成該電流特徵之產生之一延遲。
  16. 如申請專利範圍第14項之載體，其中該裝置被放在由該外殼界定之腔穴內。
  17. 如申請專利範圍第14項之載體，其中該載體進一步包括一定位於由該外殼界定之腔穴內的填充組合物以阻止該醫藥 產品及該裝置在由該外殼界定之腔穴內發生移動。
  18. 如申請專利範圍第14項之載體，其進一步包括一定位於由該外殼界定之腔穴內的浮力改變設備。
  19. 如申請專利範圍第14項之載體，其中該固定部分被膠黏至該外殼之開放端內。
  20. 如申請專利範圍第14項之載體，其中該固定部分被機械地固定於該外殼之開放端。
  21. 如申請專利範圍第14項之載體，其中該固定部分被壓入配合至該外殼之開放端。
  22. 一種用於追蹤傳送參數的醫藥傳送系統，該系統包括：一具有一封閉端及一開放端的載體殼體，其中該載體殼體界定一腔穴；一定位於該載體殼體之腔穴內的藥劑；一包括一頂端及一底端的帽蓋，其中該底端包含一密封部分，該密封部分與該載體殼體之開放端處於實體聯繫關係以密封容納該藥劑之該腔穴，其中該密封部分界定至少一通道以讓該帽蓋塞入該載體殼體之開放端內；及一與該系統相關的裝置，其中該裝置產生一可辨識電流特徵以聯絡資訊，其中該裝置被固定於該帽蓋之該頂端致使 該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸，其中該密封部分界定至少一通道，該通道允許該帽蓋被壓入配合至該載體殼體之開放端內。
  23. 一種用於追蹤傳送參數的醫藥傳送系統，該系統包括：一具有一封閉端及一開放端的載體殼體，其中該載體殼體界定一腔穴；一定位於該載體殼體之腔穴內的藥劑；一包括一頂端及一底端的帽蓋，其中該底端包含一密封部分，該密封部分與該載體殼體之開放端處於實體聯繫關係以密封容納該藥劑之該腔穴，其中該密封部分界定至少一通道以讓該帽蓋塞入該載體殼體之開放端內；及一與該系統相關的裝置，其中該裝置產生一可辨識電流特徵以聯絡資訊，其中該裝置被固定於該帽蓋之該頂端致使該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸，其中該密封部分利用一黏著劑固定於該載體殼體之開放端。
  24. 一種用於追蹤傳送參數的醫藥傳送系統，該系統包括：一具有一封閉端及一開放端的載體殼體，其中該載體殼體界定一腔穴；一定位於該載體殼體之腔穴內的藥劑；一包括一頂端及一底端的帽蓋，其中該底端包含一密封部分，該密封部分與該載體殼體之開放端處於實體聯繫關係 以密封容納該藥劑之該腔穴，其中該密封部分界定至少一通道以讓該帽蓋塞入該載體殼體之開放端內；及一與該系統相關的裝置，其中該裝置產生一可辨識電流特徵以聯絡資訊，其中該裝置被固定於該帽蓋之該頂端致使該裝置能夠在該載體殼體與周遭環境發生接觸時與周遭環境發生接觸，其中該裝置包含：一框架；一被固定在該框架內的導電率控制模組，用於產生代表該資訊之可辨識電流特徵；一被固定於該框架且電耦接至該導電率控制模組的第一材料；及一被固定於該框架且電耦接至該導電率控制模組的第二材料，其中該第一材料及該第二材料藉由一不導電材料分隔且經選擇以在與一導電流體發生接觸時產生一電壓電位。
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