CN101217945B - 使用射频识别标签的口服用药依从性监视 - Google Patents

使用射频识别标签的口服用药依从性监视 Download PDF

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CN101217945B
CN101217945B CN2006800251198A CN200680025119A CN101217945B CN 101217945 B CN101217945 B CN 101217945B CN 2006800251198 A CN2006800251198 A CN 2006800251198A CN 200680025119 A CN200680025119 A CN 200680025119A CN 101217945 B CN101217945 B CN 101217945B
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capsule
rfid
tablet
rfid label
pill
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CN101217945A (zh
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彼得·K.·墨丘利
克里斯托佛·M.·琼斯
马尔科姆·W.·沃伦
苏姗·J.·巴比尼科
马克·T.·伯尼尤斯
弗洛·A.·卡斯蒂洛
保罗·E.·克兰雷
克里斯汀·L.·达诺斯基
马克·Sb·菲里克斯
罗伯特·B.·弗莱特谢尔
罗伯特·P.·哈莱
托马斯·H.·卡兰塔
克里斯·W.·麦克多加尔
米歇尔·A.·布莱斯勒
贝蒂娜·M.·罗斯纳
加伊米·西蒙
德伊德里·A.·斯特朗得
拉里·孙
道格拉斯·P.·怀特
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Priority to PCT/US2006/019079 priority patent/WO2006127355A2/en
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    • G06K7/10Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation
    • G06K7/10009Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
    • G06K7/10019Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers.
    • G06K7/10079Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers. the collision being resolved in the spatial domain, e.g. temporary shields for blindfolding the interrogator in specific directions
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    • H01Q1/22Supports; Mounting means by structural association with other equipment or articles
    • H01Q1/2208Supports; Mounting means by structural association with other equipment or articles associated with components used in interrogation type services, i.e. in systems for information exchange between an interrogator/reader and a tag/transponder, e.g. in Radio Frequency Identification [RFID] systems
    • HELECTRICITY
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    • H01Q1/00Details of, or arrangements associated with, antennas
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Abstract

本发明涉及使用射频识别标签的口服用药依从性监视。提供了一种用于口服药物提供的装置,包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于胶囊、片剂或丸剂中的RFID标签,该RFID标签包含天线;(c)选自包含磁体、铁磁物体、铁素体物体和电磁屏蔽物体的组的物体,该物体位于RFID标签的天线之内、之上或附近以改变RFID标签的天线特性,使得如果RFID标签在胶囊、片剂或丸剂分散到胃肠系统中之前被询问,那么RFID标签的响应被充分地改变或衰减,从而确定胶囊、片剂或丸剂尚未分散于胃肠系统中,并且使得如果RFID标签在胶囊、片剂或丸剂分散到胃肠系统中之后被询问,那么所述物体与RFID标签分开,使得RFID标签的响应被可充分检测,从而确定胶囊、片剂或丸剂已分散于胃肠系统中。另选地,开关可被用于通知装置的摄入并改变装置的响应。在另一实施例中,本发明是一种用于口服药物提供的装置,该装置包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于胶囊中的第一非反碰撞RFID标签;(c)位于胶囊中的第二非反碰撞RFID标签,使得如果这些RFID标签在胶囊、片剂或丸剂分散到胃肠系统中之前被RFID读取器询问,那么这些RFID标签的响应发生碰撞,并且使得在胶囊的可分散材料分散于胃肠系统中由此允许第一和第二非反碰撞标签彼此分开之后,这些RFID标签的响应彼此充分不同,从而确定胶囊已分散于胃肠系统中。

Description

使用射频识别标签的口服用药依从性监视
[0001](对相关申请的交叉引用)
[0002] 本申请要求在2005年5月20日提交的美国临时申请No. 60/683,141和在2006 年1月20日提交的No. 60/760, 903的优先权。
技术领域
[0003] 本发明涉及口服用药依从性监视,更具体地说,涉及与药物配方一起使用由患者摄入的射频识别标签。
背景技术
[0004] 患者对于他们的医生开处的用药方案(drug regimen)的非依从性导致医疗成本增加、并发症发生率增加以及药物浪费。非依从性是指不能在规定的时间服用规定的剂量, 这会导致治疗不足或治疗过度。在57份非依从性研究的调查中,不管药物治疗、患者人口特性、所提供的药物或研究方法如何,在所有的研究人群中,非依从性的范围为从15%到高 ii95% (Greenberg, Clinical Therapeutics, 6 (5) :592_599,1984)。
[0005] 在临床用药阶段,准确测量依从性可导致多种益处,诸如:提高临床研究的统计可靠性;使临床研究更快完成;以及按非依从程度的函数来确定非依从性的效果。在治疗阶段,准确测量依从性具有许多重要益处,诸如:关于出现与较差依从性有关的耐药感染的可能性,向患者进行警告;以及识别与服药过量有关的药物副作用。
[0006] 在使用产生条目以显示依从性的常规方法(例如,纸质日记)时,在任何临床试验期间对于给予患者的指令的依从性通常在相对较短的时期内小于50%并且在较长期的试验中小于 40% (Vrijens 和 Goetghebeur Jtatist,Med. 23,531-544,2004)。对于慢性疼痛患者的临床试验而言,当给予患者纸质日记(其被秘密装备成可跟踪日记的使用)时,仅报告了 11% 的依从性,而伪造条目高达 80% (Stone 等,Control Clin. Trials. 24,182-199, 2003),其中,在32%的研究天数中,纸质日记没有被打开,而这些天的依从性条目超过 90%。在临床研究中还高频率地出现如下情况:通过同时去除全部或大部分的药物,在去门诊之前故意倾倒药物(Coutts 等,Arch. Dis. Child. 67,332-333,1992 ;Rand 等,Am. Rev. Respir. Dis. 146,1559-1564,1992 ;Rudd 等,Clin. Pharmacol. Therap. 46,169-176,1989 ; Simmons等,Chest. 118,290-295,2000)。因此,非依从患者中的欺骗行为频繁出现在临床试验中,并且常常不被常规的监视方法所揭示。其结果是,产生难以解释、较差并且对于可靠预测临床试验的有效性无用的数据。更好地监视实际药物摄入时间将帮助缓解这些问题中的许多问题。例如,为了与依赖于指示患者服用药物的时间相比更好地解释药物代谢/药效,可针对实际药物摄入时间来校正药物的血液水平。但是,在临床试验中使用的大多数当前跟踪装置仅跟踪药物摄入过程的开始,即,跟踪药物容器被打开或激活的时间。为了更准确地监视临床试验的依从性,需要更完善的监视摄入药物的方法。
[0007] 通过受过训练的人员直接观察来确认用药依从性是有效的,但在大多数情况下是不实际的。通过血样或尿样分析确认用药依从性在大多数情况下也是不实际的。已开发了固定到患者皮肤上的透皮检测装置,该装置透过皮肤检测摄入的药物成分,并且这种装置可向位于诸如保健机构的外部地点处的远程接收器发射信号,参见USP 6,663,846和 USPAP 2005/0031536。已开发了在患者的呼吸中检测摄入的药物成分的电子传感器系统, 参见USPAP 2004/0081587。射频识别(RFID)标签已被加入药丸中,当被相应的射频“读取器”询问时,每个标签能够通过由标签发射的唯一代码来识别药物的类型、其剂量及其批号,参见USP 6,366,206。可将‘206专利的RFID加入例如检测pH值变化的生物传感器,以确定丸剂是否已溶解从而使RFID标签暴露于胃肠系统的环境。‘206专利的技术需要高度专门化的球形RFID半导体和生物传感器。如果可以以复杂性较低的方式使用RFID技术, 那将是本领域的进步。
发明内容
[0008] 本发明至少部分地是对于以上所述问题的解决方案。本发明提供了大量的新的和改进的通过使用RFID标签来确定用药依从性的可选方案。
[0009] 更具体地,本发明是一种用于口服药物提供的装置,该装置包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于所述胶囊、片剂或丸剂中的RFID标签,该 RFID标签包含天线;(c)选自包含磁体、铁磁物体、铁素体物体和电磁屏蔽物体的组的物体,该物体位于所述RFID标签的所述天线之内、之上或附近以改变所述RFID标签的天线特性,使得如果所述RFID标签在所述胶囊、片剂或丸剂分散到胃肠系统中之前被询问,那么所述RFID标签的响应被充分地改变或衰减,从而确定所述胶囊、片剂或丸剂尚未分散于胃肠系统中,并且使得如果所述RFID标签在所述胶囊、片剂或丸剂已经分散到胃肠系统中之后被询问,那么所述物体与所述RFID标签分开,使得所述RFID标签的响应可被充分检测, 从而确定所述胶囊、片剂或丸剂已分散于胃肠系统中。
[0010] 在另一实施例中,本发明是一种用于口服药物提供的装置,该装置包括:(a)被设计为分散于胃肠系统中的片剂、丸剂或胶囊;(b)位于片剂、丸剂或胶囊中的RFID标签,该 RFID标签包含开关,该开关响应于胃肠系统中的状况而接通或关断,使得如果所述RFID标签在所述片剂、丸剂或胶囊分散到胃肠系统中之前被询问,那么所述RFID标签的响应表示所述胶囊尚未分散于胃肠系统中,并且使得如果所述RFID标签在所述片剂、丸剂或胶囊分散到胃肠系统中之后被询问,那么所述RFID标签的响应表示所述片剂、丸剂或胶囊已分散于胃肠系统中。
[0011] 在另一实施例中,本发明是一种用于口服药物传送的装置,该装置包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于所述胶囊中的第一非反碰撞RFID标签;(c)位于所述胶囊中的第二非反碰撞RFID标签,使得如果这些RFID标签在所述胶囊、 片剂或丸剂分散到胃肠系统中之前被RFID读取器询问,那么这些RFID标签的响应发生碰撞,并且使得在所述胶囊的可分散材料已经分散于胃肠系统中由此允许第一非反碰撞标签和第二非反碰撞标签彼此分开之后,这些RFID标签的响应彼此充分不同,从而确定所述胶囊已分散于胃肠系统中。
附图说明
[0012] 图1是口服药物提供系统的部分为截面、部分完整的放大图,该口服药物提供系统包含在RFID标签之上含有一对铁素体环的凝胶胶囊;
[0013] 图2是图1的口服药物提供系统在胶囊已分散到胃肠系统中之后的放大图;
[0014] 图3是口服药物提供系统的部分为截面、部分完整的放大图,该口服药物提供系统包含在RFID标签之上含有圆筒形磁体的片剂或丸剂;
[0015] 图4是口服药物提供系统的部分为截面、部分完整的放大图,该口服药物提供系统包含含有分别位于RFID标签的两端的一对铁素体盘的药物片剂;
[0016] 图5是口服药物提供系统的部分为截面、部分脱离、部分完整的放大图,该口服药物提供系统包含含有位于RFID标签的邻近其天线线圈的空腔中的磁体的胶囊;
[0017] 图6是口服药物提供系统的部分为截面、部分完整的放大图,该口服药物提供系统包含含有位于RFID标签附近的铁棒的药物片剂;
[0018] 图7是凝胶胶囊的部分为截面、部分完整的放大图,该凝胶胶囊包含具有被金箔杯屏蔽的天线的RFID标签;
[0019] 图8是凝胶胶囊的部分为截面、部分完整的放大图,该凝胶胶囊包含具有被嵌入凝胶胶囊中的金粒子屏蔽的天线的RFID标签;
[0020] 图9是凝胶胶囊的部分为截面、部分完整的放大图,该凝胶胶囊包含具有被嵌入涂敷在RFID标签上的阿拉伯树胶中的金粒子屏蔽的天线的RFID标签;
[0021] 图10是药物片剂的部分为截面、部分完整的放大图,该药物片剂包含具有被嵌入涂敷在RFID标签上的阿拉伯树胶中的金粒子屏蔽的天线的RFID标签;
[0022] 图11是具有使RFID标签的天线短路的外部细铁丝的RFID标签的放大图;
[0023] 图12是图11的RFID标签在其被暴露于胃液十分钟被腐蚀并切断了细铁丝之后的放大图;
[0024] 图13是在暴露于胃液的情况下接通的开关的部分为截面、部分完整的放大侧视图;
[0025] 图14是图13的开关在暴露于胃液之后的部分为截面、部分完整的放大侧视图;
[0026] 图15是凝胶胶囊的部分为截面、部分完整的放大图,该凝胶胶囊包含由动力发电机供电的有源RFID标签并加入了传导性开关;
[0027] 图16是更详细地示出了图15的传导性开关的示意图;
[0028] 图17是药物片剂的部分为截面、部分完整的放大图,该药物片剂包含由通过与电池的阳极和阴极接触的胃肠系统的电解质的作用而激活的电池供电的有源RFID标签;
[0029] 图18是药物片剂的部分为截面、部分完整的放大图,该药物片剂包含有源RFID标签和溶解性链接开关;
[0030] 图19是药物胶囊的部分为截面、部分完整的放大图,该药物胶囊包含有源RFID标签和基于开关的传感器;
[0031] 图20是药物片剂的部分为截面、部分完整的放大图,该药物片剂包含有源RFID标签和基于电容器的开关;
[0032] 图21是药物胶囊的部分为截面、部分完整的放大图,该药物胶囊包含有源RFID标签和基于温度的开关;
[0033] 图22是典型的现有技术RFID系统的示意图,该RFID系统包含无源RFID标签和 RFID读取器或询问器;[0034] 图23示出了包含被RFID读取器询问的一对无源非反碰撞RFID标签的凝胶胶囊的截面图;
[0035] 图M示出了包含被RFID读取器询问的一对无源非反碰撞RFID标签的片剂的截面图;以及
[0036] 图25示出了被RFID读取器询问的一对分开的无源非反碰撞RFID标签。 具体实施方式
[0037] 现在参照图1,该图示出了本发明的口服药物提供系统10,该系统包含上凝胶胶囊部分11和下凝胶胶囊部分12。Texas Instruments公司的低频RFID标签14位于系统10 的胶囊内。标签14被封装在玻璃内并包含被编码用以识别药物类型、剂量、批号等的RFID 芯片。标签14包含天线。系统10的胶囊内的剩余体积当然可用于容纳药物配方13。一对铁素体环15和16位于RFID标签14周围以改变RFID标签的天线特性,从而如果RFID 标签14在胶囊11/12分散到胃肠系统中之前被询问,那么RFID标签的响应通过铁素体环 15/16被充分地改变或衰减,以确定胶囊、片剂或丸剂没有分散于胃肠系统中。
[0038] 术语“改变RFID标签的天线特性”指的是改变天线的谐振频率和/或降低来自天线的有效信号强度。在本发明中使用的具体RFID标签并不是关键的。例如,该RFID标签不必为低频RFID标签。当然,RFID标签应被充分封装或以另外的方式进行保护,从而使它在胃肠系统的环境中工作足够长的时间以实现其目的。如本领域公知的那样,RFID标签可被预先编程或者是可编程的。在本发明中可使用任何类型的RFID标签。RFID标签优选是由来自RFID读取器的信号供电的无源RFID标签。但是,如下面更详细地说明的那样,在本发明中也可以使用有源RFID标签(例如,通过与RFID标签相关联的电池供电的有源RFID 标签)以及有电池辅助的无源RFID标签。
[0039] 现在参照图2,当图1的口服药物提供系统被咽下时,胶囊部分分散在胃或肠道中,由此允许RFID标签14与铁素体环15/16分开,使得RFID标签14的响应可被充分检测, 从而确定胶囊已分散于胃肠系统中。应当理解,在本发明中有用的胶囊可由凝胶以外的诸如羟丙基甲基纤维素的材料制成。本发明的胶囊也可由分散于酸环境中但不分散于水中的诸如聚(N,N-9-二乙氨乙基甲基丙烯酸酯(diethylaminoethyl methacrylate))的材料制成。
[0040] 使用的具体RFID读取器在本发明中并不是关键的。优选地,RFID读取器系统由电池供电并被包含在通过带子配戴在腕部的袋子中。RFID读取器可被编程为感测和记录药物的类型及其给药时间,以供以后下载或优选用于无线下载至例如保健专家,该保健专家甚至可向系统发送提醒信号以向患者提醒他/她的不依从行为。另选地,RFID读取器系统可被加入配戴在腕部的表状器具中。或者,RFID读取器系统可类似夹在腰带上的手机那样被夹在腰带上。
[0041] 现在参照图3,该图示出了口服药物提供系统20的部分为截面、部分完整的放大图,该口服药物提供系统20包括在RFID23标签之上包含圆筒形磁体22的片剂或丸剂21。 磁体22改变RFID标签的天线特性,使得如果RFID标签在片剂或丸剂21分散到胃肠系统中之前被询问,那么RFID标签23的响应被充分地改变或衰减,从而确定片剂或丸剂21尚未分散于胃肠系统中,并且使得如果RFID标签23在片剂或丸剂21分散到胃肠系统中之后被询问,那么圆筒形磁体22与RFID标签23分开,使得RFID标签23的响应可充分检测,从而确定片剂或丸剂21已分散于胃肠系统中。
[0042] 现在参照图4,该图示出了口服药物提供系统30的部分为截面、部分完整的放大图,该口服药物提供系统30包括包含分别位于RFID标签34的两端的一对铁素体盘32/33的药片31。铁素体盘32/33改变RFID标签34的天线特性,使得如果RFID标签34在片剂31分散到胃肠系统中之前被询问,那么RFID标签34的响应被充分地改变或衰减,从而确定片剂31尚未分散于胃肠系统中,并且使得如果RFID标签34在片剂31分散到胃肠系统中之后被询问,那么铁素体盘32/33与RFID标签34分开,使得RFID标签34的响应可充分被检测,从而确定片剂31已分散于胃肠系统中。
[0043] 现在参照图5,该图示出了口服药物提供系统40的部分为截面、部分脱离、部分完整的放大图,该口服药物提供系统40包括胶囊41/42,该胶囊41/42含有位于RFID标签44的邻近其天线线圈45的空腔中的磁体43。磁体43改变RFID标签44的天线特性,使得如果RFID标签44在系统40分散到胃肠系统中之前被询问,那么RFID标签44的响应被充分地改变或衰减,从而确定系统40尚未分散于胃肠系统中,并且使得如果RFID标签44在系统40分散到胃肠系统中之后被询问,那么磁体43与RFID标签44分开,使得RFID标签44的响应可被充分检测,从而确定系统40已分散于胃肠系统中。另选地,RFID标签的空腔例如(不是对其进行限制)可填充有可在系统40被摄入时会分散到胃肠系统中的可分散铁素体成分。
[0044] 现在参照图6,该图示出了口服药物提供系统50的部分为截面、部分完整的放大图,该口服药物提供系统50包括含有位于RFID标签53附近的铁棒52的药片51。铁棒52改变RFID标签53的天线特性,使得如果RFID标签53在系统50分散到胃肠系统中之前被询问,那么RFID标签53的响应被充分地改变或衰减,从而确定系统50尚未分散到胃肠系统中,并且使得如果RFID标签53在系统50分散到胃肠系统中之后被询问,那么铁棒52与RFID标签53分开,使得RFID标签53的响应可被充分检测,从而确定系统50已分散于胃肠系统中。
[0045] 现在参照图7,该图示出了本发明的口服药物提供系统10a,该口服药物提供系统IOa包括上凝胶胶囊部分Ila和下凝胶胶囊部分13a的。Texas Instruments公司的低频RFID标签1½位于系统IOa的胶囊内。标签1½被封装在玻璃15a内并包含被编码用以识别药物类型、剂量、批号等的RFID芯片16a。标签1½包含具有与芯片16a连通的铁素体芯19a的铜线圈天线18a和电容器17a。系统IOa的胶囊内的剩余体积20a当然可用于容纳药物配方。
[0046] 如本领域公知的那样,RFID标签可被预先编程或者是可编程的。铜线圈天线18a和铁素体芯19a是优选的用于本发明的RFID标签1½的天线系统,这是因为即使工作波长相对较长,该天线系统也是紧凑的。与铜线圈天线18a尺寸相同的常规偶极天线需要相对较短的工作波长,由于这种短波长辐射容易被水吸收或衰减,因此,所述短的波工作波长可使通过人体组织的电磁波通信变复杂或者甚至受到阻碍。
[0047] 金箔杯1¾位于上凝胶胶囊部分Ila内。当用RFID读取器(诸如例如可从Texashstruments公司或UMoelting公司(Wood Dale, IL)得到的RFID读取器)询问系统IOa时,由于金箔12a屏蔽了天线18a,因此系统IOa不能响应。但是,当系统IOa被咽下时,胶
9囊部分Ila和13a分散于胃或肠道内,由此使RFID标签1½脱离金箔杯12a的屏蔽作用,从而RFID标签Ha现在将响应RFID读取器。
[0048] 上凝胶胶囊部分Ila可分散于胃或肠道内。但是,在图7所示的实施例中,由于只要下胶囊部分13a分散于胃或肠道内,RFID标签就会与金箔1¾分开,因此上胶囊部分是否这样可分散并不是关键的。虽然优选如图1所示将金箔1¾放在上胶囊部分Ila内,但金箔1¾可被放在上胶囊部分Ila的外面。虽然金是屏蔽RFID标签14a的天线18a的优选材料,但也可以使用可有效屏蔽电磁波并被准许摄入的任何金属或其它材料(例如,铁和镍被FDA列为:一般视为可安全摄入)。
[0049] 应当理解,在本发明中有用的胶囊可由凝胶以外的诸如羟丙基甲基纤维素的材料制成。本发明的胶囊也可由分散于酸环境中但不分散于水中的诸如包含N,N-9-二乙氨乙基甲基丙烯酸酯的聚合物的材料制成。类似地,代替作为用于包含电磁屏蔽材料的涂敷材料的阿拉伯树胶,可以使用诸如包含N,N-9-二乙氨乙基甲基丙烯酸酯的聚合物、羟丙基甲基纤维素或凝胶的材料。
[0050] 现在参照图8,该图示出了本发明的另一口服药物提供系统21a,该口服药物提供系统21a包括上凝胶胶囊部分23a和下凝胶胶囊部分22a。Texas Instruments公司的低频RFID标签2¾位于系统21a的胶囊内。标签2¾被封装在玻璃^a内并包含被编码用以识别药物类型、剂量、批号等的RFID芯片27a。标签2¾包含具有与芯片27a连通的铁素体芯30a的铜线圈天线29a和电容器^a。系统21a的胶囊内的剩余体积31a当然可用于容纳药物配方。上胶囊23a包含金粒子Ma。当用RFID读取器询问系统21a时,由于金粒子2½屏蔽了天线^a,因此系统21a不能响应。但是,当系统21a被咽下时,胶囊部分23a和2¾分散于胃或肠道内,由此使RFID标签2¾脱离金粒子Ma的屏蔽作用,从而RFID标签2¾现在将响应RFID读取器。下凝胶胶囊部分2¾可分散于胃或肠道内。但是,在图8所示的实施例中,由于只要上胶囊部分23a分散于胃或肠道内,RFID标签就会与下胶囊部分2¾分开,因此下胶囊部分是否这样可分散并不是关键的。
[0051] 现在参照图9,该图示出了本发明的另一口服药物提供系统32a,该口服药物提供系统3¾包括上凝胶胶囊部分3½和下凝胶胶囊部分33a。Texas Instruments公司的低频RFID标签3¾位于系统32a的胶囊内。标签3¾被封装在玻璃36a内并包括被编码用以识别药物类型、剂量、批号等的RFID芯片37a。标签3¾包含具有与芯片37a连通的铁素体芯40a的铜线圈天线39a和电容器38a。系统32a的胶囊内的剩余体积43a当然可用于容纳药物配方。RFID标签35a的上端涂敷有包含金粒子42a的阿拉伯树胶层41a。当用RFID读取器询问系统3¾时,由于金粒子4¾屏蔽了天线39a,因此系统3¾不能响应。但是,当系统3¾被咽下时,阿拉伯树胶41a分散于胃或肠道内,由此使RFID标签3¾脱离金粒子42a的屏蔽作用,从而RFID标签3¾现在将响应RFID读取器。
[0052] 现在参照图10,该图示出了本发明的另一口服药物提供系统44a,该口服药物提供系统4½包括含有药物配方的片剂或丸剂45a。TexasInstruments公司的低频RFID标签46a位于片剂或丸剂45a内。标签46a被封装在玻璃47a内并包括被编码用以识别药物类型、剂量、批号等的RFID芯片48a。标签46a包含具有与芯片48a连通的铁素体芯51a的铜线圈天线50a和电容器49a。RFID标签46a涂敷有包含金粒子53a的阿拉伯树胶层52a。当用RFID读取器询问系统44a时,由于金粒子53a屏蔽了天线50a,因此系统4½不能响应。但是,当系统4½被咽下时,片剂或丸剂45a以及阿拉伯树胶5¾分散于胃或肠道内,由此使RFID标签46a脱离金粒子53a的屏蔽作用,从而RFID标签46a现在将响应RFID读取器。应当理解,包含金粒子53a的阿拉伯树胶层5¾也可位于片剂或丸剂4¾的表面上。
[0053] 在另一实施例中,本发明是一种口服药物提供装置,该口服药物提供装置包括:(a)被设计为分散于胃肠系统中的药物片剂、丸剂或胶囊;(b)位于所述片剂、丸剂或胶囊中的RFID标签,该RFID标签包含开关,该开关响应于胃肠系统中的状况而接通或关断,使得如果RFID标签在所述片剂、丸剂或胶囊分散到胃肠系统中之前被询问,那么RFID标签的响应表示胶囊尚未分散于胃肠系统中,并且使得如果RFID标签在所述片剂、丸剂或胶囊已经分散到胃肠系统中之后被询问,那么RFID标签的响应表示该片剂、丸剂或胶囊已分散于胃肠系统中。如果RFID标签是有源RFID标签,那么所述开关优选在片剂、丸剂或胶囊已分散于胃肠系统中之后打开RFID标签(因此,术语“询问”在本发明中始终包含从这种有源RFID标签读取信号)。另选地,所述开关可被用于改变RFID标签的逻辑功能,这不是限制性的。
[0054] 现在参照图11,该图示出了具有从中突出的细铁丝5¾的RFID标签Ma。铁丝5¾用作RFID标签的“开关”,当铁丝5¾被切断时关闭RFID标签或优选地打开RFID标签。例如,铁丝5¾可被定位为使RFID标签5½的天线短路,从而当铁丝5¾被切断时,RFID标签5½将响应RFID读取器。现在参照图12,该图示出了在RFID标签Ma已暴露于胃的酸性环境之后的图11的RFID标签Ma。细铁丝55a已因腐蚀被切断。图11的RFID标签可由此被放置在药物胶囊内或者加工在药物片剂或丸剂中,从而当胶囊、片剂或丸剂被摄入时,RFID标签将响应RFID读取器。应当理解,可以使用其它材料来代替铁丝55a,诸如在暴露于胃肠系统中时会分散的导电材料,如包含N,N-9-二乙氨乙基甲基丙烯酸酯的聚合物的层,该层包含相对较高浓度的印刷于胶囊或片剂上的金粒子,使得在其分散于胃肠系统中之前该层是导电的。
[0055] 现在参照图13,该图示出了 RFID标签(未示出)的开关系统,该开关系统用于在开关的触点闭合时将RFID标签打开。图13的开关系统包含具有渗水盘57a的小壳体56a和水膨胀凝胶62a。上触点59a与从壳体56a延伸出的第一电引线58a连接。下触点60a与从壳体56a的底部延伸出的第二电引线61a连接。现在参照图14,当该开关系统暴露于水中时(例如,在摄入到胃中之后),水膨胀凝胶6¾膨胀并将上触点59a推至与下触点60a电接触,由此关闭开关,以关断或优选打开(或关闭)RFID标签。这种RFID标签可被置于药物胶囊中或加工在药物片剂或丸剂中,从而当胶囊、片剂或丸剂被摄入时,RFID标签将响应(或停止响应)RFID读取器。
[0056] 现在参照图15,该图示出了本发明的一个口服药物提供系统实施例IOb的部分为截面、部分完整的放大图,该口服药物提供系统实施例IOb包含上凝胶胶囊部分lib和下凝胶胶囊部分12b。凝胶胶囊llb/12b包含药物配方1¾和由动力发电机供电并加入了传导性检测器的有源封装RFID标签14b。动力发电机由悬挂在线圈17b中的磁体18b构成。电容器19b向RFID电路16b提供电力。当口服药物提供系统IOb进入胃肠系统中时,凝胶胶囊llb/12b、药物配方1¾和有源RFID标签14b被分散于胃肠系统的电解质溶液中,并且磁体18b在线圈17b中的移动使电容器19b充电以向RFID电路16b供电。当传导性检测器系统感测胃肠系统的电解质溶液的导电性时,传导性检测器系统的电极20ab和20bc激活RFID电路16b。RFID电路16b与天线15b (示为缠绕在铁素体芯上的铜线圈)连接,该天线发射优选被编码用以识别药物配方、剂量和批号的信号。另选地(并且优选地),动力发电机由电池代替。
[0057] 现在参照图16,该图更详细地示出了图15的传导性检测器的示意图。加入P-FET晶体管22b和偏压电阻器21b,以在通过电极20ab和20bg检测胃肠系统的电解质溶液的导电性时从电容器19b激活RFID电路16b。另外,可以使用本领域公知的电子设计方法用n-FET、CM0S门或其它电子电路来代替p_FET电路。
[0058] 现在参照图17,该图示出了药物片剂30b的部分为截面、部分完整的放大图,该药物片剂30b包含药物配方31b和由通过与电池的铜阳极3¾和锌阴极34b接触的胃肠系统电解质溶液的作用而激活的电池供电的有源RFID标签32b。在本实施例中,开关和RFID电源是统一的,即,当片剂30b的RFID标签被分散于胃肠系统中时,其电解质溶液通过铜阳极33b和锌阴极34b产生用于RFID标签32b的电力。本实施例的在阳极中使用铜并在阴极中使用锌在本发明中并不重要,即,可以使用诸如碳和锌或者银和锌的任何适当的材料对。
[0059] 现在参照图18,该图示出了药物片剂40b的部分为截面、部分完整的放大图,该药物片剂40b包含药物配方41b和包含与天线系统4¾连接的RFID电路4¾的有源RFID标签42b。RFID电路43b由电池44b供电。凝胶48b中由粉末状银、碳或其它导电材料形成的导电层在电极46b和47b之间提供导电,使得当片剂40b分散于胃肠道中时,其电解质溶液溶解凝胶48b并改变电极46b和47b之间的传导性,由此激活RFID电路43b。
[0060] 现在参照图19,该图示出了本发明的一个口服药物提供系统实施例50b的部分为截面、部分完整的放大图,该口服药物提供系统实施例50b包含上凝胶胶囊部分51b和下凝胶胶囊部分52b。凝胶胶囊51b/52b包含药物配方5¾和包含与天线系统57b连接的RFID电路^b的有源封装RFID标签Mb。RFID电路55b由电池56b供电。水膨胀聚合物60b的垫盘被定位为,当口服药物提供系统50b分散于胃肠系统中时,其电解质溶液使水膨胀聚合物60b膨胀,从而导致电导体58b接触电导体59b,改变了导体58b和59b之间的导电性,由此激活RFID电路55b。应当理解,水膨胀聚合物60b的膨胀可容易地被布置为打开开关而不是关闭开关。例如,水膨胀聚合物的膨胀可容易地被布置为打开图19所示类型的开关或断开细丝。另选地,导体58b和59b之间的空间可填充有会溶解于胃肠系统中的可溶性材料,从而允许导体接触和关闭开关。另选地,可以使用压力开关以在本发明的有源RFID标签分散于胃肠道中时感测增加的压力。
[0061] 现在参照图20,该图示出了本发明的一种口服药物提供片剂61b的部分为截面、部分完整的放大图。片剂61b包含药物配方62b和包含与天线系统66b连接的RFID电路64b的有源封装RFID标签63b。RFID电路64b由电池6¾供电。水膨胀聚合物68的膜位于第一电容板69b和第二电容板70b之间,从而当口服药物提供系统61b分散于胃肠道中时,其电解质溶液使水膨胀聚合物70b膨胀,从而改变板69b和70b之间的电容,由此通过电导体67b和68b激活RFID电路55b。另选地,电容板69b和70b可包含置于63b的表面附近的导电丝或垫盘,使得周围的介电常数随着(从空气到胃肠电解质的)摄入而变化,从而改变电容,由此激活RFID电路。
[0062] 现在参照图21,该图示出了本发明的一个口服药物提供系统实施例70b的部分为截面、部分完整的放大图,该口服药物提供系统实施例70b包含上凝胶胶囊部分71b和下凝胶胶囊部分72b。凝胶胶囊71b/72b包含药物配方7¾和包含与天线系统77b连接的RFID电路75b的有源封装RFID标签74b。RFID电路75b由电池7¾供电。热敏电阻7¾与RFID电路7¾电连通,从而当口服药物提供系统70b分散于胃肠道中时,RFID电路7¾可感测由此带来的温度变化,并开始通过天线系统77b发送(或改变)其信号。RFID电路7¾优选被编程为区分在患者咽下口服药物提供系统70b时和在将口服药物提供系统70b例如放入一杯热水中时出现的温度随时间分布图。另选地,可以使用感温开关来代替热敏电阻78b。
[0063] 在另一实施例中,本发明是一种口服药物提供装置,该口服药物提供装置包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于所述胶囊中的第一非反碰撞RFID标签;(c)位于所述胶囊中的第二非反碰撞RFID标签,使得如果RFID标签在所述胶囊、片剂或丸剂分散到胃肠系统中之前被RFID读取器询问,那么RFID标签的响应碰撞,并且在所述胶囊的可分散材料分散于胃肠系统中由此允许第一和第二非反碰撞标签相互分开之后,RFID标签的响应充分相互不同,从而确定胶囊已分散于胃肠系统中。
[0064] 现在参照图22,该图示出了典型的RFID系统IOc的示意图,该RFID系统IOc包含无源RFID标签Ilc和通常与用于数据存储和操纵的主机计算机或微处理器系统13c相关联的RFID读取器或询问器12c。RFID读取器或询问器12c发射射频供能/命令信号14c,该射频供能/命令信号14c被RFID标签Ilc接收以产生要由读取器12c接收的返回数据信号15c。
[0065] 现在参照图23,该图示出了凝胶胶囊21c/22c的截面图,该凝胶胶囊21c/22c包含药物配方25c、第一非反碰撞无源RFID标签23c、第二非反碰撞无源RFID标签Mc,使得如果RFID标签23c和2½在胶囊21c/22c分散到胃肠系统中之前被来自RFID读取器26c的供能/命令信号28c询问,那么RFID标签23c/Mc的响应数据信号29c发生“碰撞”。有源RFID标签是具有其自身电源(通常为电池)的RFID标签。无源RFID标签是由进入的射频信号供电的RFID标签。术语“碰撞”在本领域中被公知为同时来自两个或更多个有源或无源RFID标签的数据信号在RFID读取器处相互干扰(“碰撞”)(例如,参见MicrochipTechnology Inc. , microID 13.56 MHz RFID SystemDesign Guide (2004)的第 7 页)。因此,术语“非反碰撞RFID标签”指的是这样的RFID标签,该RFID标签的数据信号将在RFID读取器处与来自另一非反碰撞RFID标签的数据信号碰撞和干扰。由于RFID标签23c和24c是非反碰撞标签并且由于RFID标签23c和2½ —起处于胶囊系统21c/22c中,因此,来自RFID标签23c和Mc的数据信号29c在读取器26c处碰撞。提供计算机或微处理器系统27c用于数据存储和操纵。
[0066] 现在参照图24,该图示出了片剂30c的截面图,该片剂30c包含药物配方31c、第一非反碰撞有源RFID标签32c、第二非反碰撞有源RFID标签33c,使得如果RFID标签32c和33c在片剂30c分散到胃肠系统中之前被RFID读取器3½询问,那么RFID标签32c/33c的数据信号37c在读取器3½处发生“碰撞”。提供计算机或微处理器系统35c用于数据存储和操纵。
[0067] 现在参照图25,该图示出了被来自RFID读取器43c的供能/命令信号45c/47c询问的一对分开的无源非反碰撞RFID标签41c和42c (例如,它们在胃肠系统中分开的情况)。RFID标签41c和42c产生要由读取器43c接收的数据信号46c和48c。RFID标签41c相比于RFID标签42c足够接近读取器43c,使得数据信号46c和48c可被读取器43c
13区分。提供计算机或微处理器系统Mc用于数据存储和操纵。
[0068] 优选地,在本发明中使用一对有源或无源的非反碰撞RFID标签。但应当理解,可以使用多于两个的这种RFID标签。各个非反碰撞RFID标签优选被编码用以(通过其数据信号)识别药物类型、剂量和批号。在本发明中使用的具体非反碰撞RFID标签并不是关键的。但是,优选用诸如玻璃的惰性材料来封装RFID标签。
[0069] 例子 1
[0070] 用铁素体环(National Magnetics Group,Bethlehem PA)覆盖一系列六个唯一编码的玻璃封装的动物永久识别RFID标签(StoeltingCompany,Wooddale IL)并将其放在具有由食品级乳糖构成的模拟药物配方的凝胶胶囊中(大致如图1所示)。用便携式RFID读取器(兼容Allflex ISO的RF/ID便携式读取器,型号:930002-001)分别询问各胶囊,但读取器指示“没有发现标签”。在搅拌的情况下,将胶囊放入一系列包含900mL的37°C的USP模拟胃液的一升烧杯中。胶囊分散,并且与各RFID标签保持约10厘米的距离的读取器在以下的时间作出“发现标签”的响应:1. 50、1. 80、1. 85、1. 87、1. 88和1. 95分钟。
[0071]例子 2
[0072] 用铁素体环(National Magnetics Group, Bethlehem PA)覆盖一系列六个唯一编码的玻璃封装的动物永久识别RFID标签(StoeltingCompany,Wooddale IL)并将其放在具有由食品级乳糖构成的模拟药物配方的凝胶胶囊中(大致如图1所示,只是使用了三个铁素体环)。用便携式RFID读取器(兼容Allflex ISO的RF/ID便携式读取器,型号:930002-001)分别询问各胶囊,但读取器指示“没有发现标签”。在搅拌的情况下,将胶囊放入一系列包含900mL的37°C的USP模拟胃液的一升烧杯中。胶囊分散,并且与各RFID标签保持约10厘米的距离的读取器在以下的时间作出“发现标签”的响应:1. 58,2. 22,2. 33、3. 25、3. 50 和 7. 92 分钟。
[0073]例子 3
[0074] 用一对铁素体环(National Magnetics Group,Bethlehem PA)覆盖一系列唯一编码的玻璃封装的动物永久识别RFID标签(StoeltingCompany,Wooddale IL)并将其放在具有由食品级乳糖构成的模拟药物配方的凝胶胶囊中(大致如图1所示)。令四只健康的成年比格犬口服包含所述RFID标签和铁素体环的单个胶囊。为了从RFID标签读取无线电信号,将接收器(Stoelting Company, Wooddale IL)手动保持在距离犬的腹部区域的皮肤约2cm以内。以1分钟的间隔确定在胶囊溶解并且铁素体套筒提供之后的RFID标签的第一次读取的时间,直到成功实现第一次读取。然后,随时间(1、2、4、8和24小时)读取随后的信号,直到RFID标签和铁素体环穿过胃肠(GI)道从而被从收集的粪便中重新获得为止。RFID标签和铁素体环穿过GI道的时间及其在粪便中出现的时间也在各个收集间隔(例如,0-24和对-48小时)被监视。犬在最初的实验中在给药前后均可自由进食。犬在随后的实验中在头天晚上(-16小时)禁食,然后在给药之后4小时可自由进食。
[0075] 在未禁食的犬中,在给药之后10. 3士5. 1分钟内读取到无线电信号,个体差异为4〜16分钟。在给药头天晚上禁食,将至检测到第一信号的时间缩短到给药之后6士 1分钟,个体差异更低,在5至7分钟之间。很容易在随后的时间点(给药之后的1、2、4、8和对小时)通过RFID读取器读取到由RFID标签发射的无线电信号,从而指示所述装置在GI道的不同区域内的位置。对于未禁食的犬,在M-30小时内,而对于禁食的犬,在M-48小时之间,从粪便中重新获得了所有装置。除了其信号强至足以从身体以外10-12cm读取到的一个标签以外,从RFID标签发射的无线电信号的可读性在距离动物体2-3cm内。
[0076] 例子 4
[0077] 在凝胶胶囊中放置如图23所示并在一起的两个Moelting公司的动物永久识别无源RFID标签(符合Allflex ISO的FDX-B发射应答器;可植入12mm)。胶囊的剩余部分填充有药物成分。用便携式RFID读取器(兼容Allflex ISO的RF/ID便携式读取器,型号:930002-001)来询问胶囊,但是即使在Ocm读取距离的情况下,读取器也指示“没有发现标签”。在搅拌的情况下,将该胶囊放在一升烧杯中的37°C下的900mL的USP模拟胃液中。 胶囊在约两分钟之后分散,并且与该一升烧杯保持约10厘米的距离的读取器作出“发现标签”的响应。以IOcm的读取距离执行了六次相同的实验,以下是其至成功读出的时间(分: 秒的形式):1:45、2:02、1:45、2:10、1:45 和 1:49。
[0078] 例子 5
[0079] 大致如图7所示在包含药物配方的加有金箔的凝胶胶囊中放置433MHz无源RFID 标签。用便携式RFID读取器antermec IPShtellitag便携式读取器)来询问胶囊,但是读取器指示“没有发现标签”。在搅拌的情况下,将该胶囊放入一升烧杯中的37°C下的900mL 的USP模拟胃液中。胶囊在约两分钟之后分散,并且与该一升烧杯保持约10厘米的距离的读取器作出“发现标签”的响应。
[0080] 例子 6
[0081] 大致如图15所示在包含药物配方的大凝胶胶囊中放置具有传导性开关的433MHz 有源RFID标签(只是该RFID标签由电池供电并且天线螺旋盘绕在电介质中)。在搅拌的情况下,将该胶囊放在置于包含40升37°C的USP模拟胃液的50升聚乙烯槽的中心的塑料丝网篮中。一接收偶极天线位于槽的底部。另一接收偶极天线位于槽外。凝胶胶囊在模拟胃液内分散,并且传导性开关打开RFID标签,该RFID标签然后发射其433MHz信号。槽中天线接收到的信号强度为约5纳瓦。靠着槽保持在槽外的天线接收到的信号强度为约0. 1 纳瓦。距离槽70厘米的保持在槽外的天线接收到的信号强度为约0.01纳瓦。保持在槽和天线之间的臂轻微地0_3dB)降低了天线接收到的信号强度。
[0082] 距离槽甚至更远的保持在槽外的天线接收到的可检测到的最小信号强度被估计为约0. 0001纳瓦。槽外天线接收到的信号强度仅轻微地依赖于RFID标签的天线的位置 (约l-5dB的差异)。
[0083] 结论
[0084] 虽然以上根据本发明的优选实施例说明了本发明,但可以在本公开的精神和范围内对其进行修改。本申请因此旨在覆盖使用本文公开的一般原理的本发明的任何变化、用途或适应。此外,本申请旨在覆盖在与本发明所属领域的公知或习惯实践的范围内并落入以下权利要求的限制内的这些对于本公开的背离。

Claims (11)

1. 一种用于确定用药依从性的装置,包括:(a)会分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于所述胶囊、片剂或丸剂中的射频识别(RFID)标签,该RFID标签包含天线;(c) 选自包含磁体、铁素体物体和电磁屏蔽物体的组的物体,该物体位于所述RFID标签的所述天线之内、之上或附近以改变所述RFID标签的天线特性,使得如果所述RFID标签在所述胶囊、片剂或丸剂分散到胃肠系统中之前被询问,那么所述RFID标签的响应被充分地改变或衰减,从而确定所述胶囊、片剂或丸剂尚未分散于胃肠系统中,以及使得如果所述RFID标签在所述胶囊、片剂或丸剂已经分散到胃肠系统中之后被询问,那么所述物体与所述RFID 标签分开,使得所述RFID标签的响应被充分检测,从而确定所述胶囊、片剂或丸剂已分散于胃肠系统中。
2.根据权利要求1所述的装置,其中,所述磁体包括铁磁物体。
3.根据权利要求1或2所述的装置,其中,部件(c)的所述物体在胃肠系统中分解。
4.根据权利要求1或2所述的装置,其中,所述RFID标签选自包含有源RFID标签和无源RFID标签的组。
5.根据权利要求4所述的装置,还包括位于所述片剂、丸剂或胶囊中的药物制剂。
6. 一种用于确定用药依从性的装置,包括:(a)被设计为分散于胃肠系统中的片剂、丸剂或胶囊;(b)位于片剂、丸剂或胶囊中的RFID标签,该RFID标签包含开关,该开关响应于胃肠系统中的状况而接通或关断,使得如果所述RFID标签在所述片剂、丸剂或胶囊分散到胃肠系统中之前被询问,那么所述RFID标签的响应表示所述片剂、丸剂或胶囊尚未分散于胃肠系统中,以及如果所述RFID标签在所述片剂、丸剂或胶囊分散到胃肠系统中之后被询问,那么所述RFID标签的响应表示所述片剂、丸剂或胶囊已分散于胃肠系统中。
7.根据权利要求6所述的装置,其中,所述RFID标签选自包含有源RFID标签和无源 RFID标签的组。
8.根据权利要求7所述的装置,还包括位于所述片剂、丸剂或胶囊中的药物制剂。
9. 一种用于确定用药依从性的装置,包括:(a)被设计为分散于胃肠系统中的胶囊、片剂或丸剂;(b)位于所述胶囊、片剂或丸剂中的第一非反碰撞RFID标签;(c)位于所述胶囊、片剂或丸剂中的第二非反碰撞RFID标签,使得如果这些RFID标签在所述胶囊、片剂或丸剂分散到胃肠系统中之前被RFID读取器询问,那么这些RFID标签的响应发生碰撞,并且使得在所述胶囊、片剂或丸剂的可分散材料已经分散于胃肠系统中由此允许第一非反碰撞标签和第二非反碰撞标签彼此分开之后,这些RFID标签的响应彼此充分不同,从而确定所述胶囊、片剂或丸剂已分散于胃肠系统中。
10.根据权利要求9所述的装置,其中,所述RFID标签选自包含有源RFID标签和无源 RFID标签的组。
11.根据权利要求10所述的装置,还包括位于所述片剂、丸剂或胶囊中的药物制剂。
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