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CN101065161A - 电子可控药丸 - Google Patents

电子可控药丸 Download PDF

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CN101065161A
CN101065161A CNA2005800406743A CN200580040674A CN101065161A CN 101065161 A CN101065161 A CN 101065161A CN A2005800406743 A CNA2005800406743 A CN A2005800406743A CN 200580040674 A CN200580040674 A CN 200580040674A CN 101065161 A CN101065161 A CN 101065161A
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G·R·朗戈埃斯
G·利科莱泽斯
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Abstract

本发明提供了一种电子可控药丸(100)或药物输送系统。药丸(100)包括外罩(102)；药物存储器(104)，用于存储所述药物；电子可控释放阀、泵或舱(106)，用于在通过胃肠道时分配存储在药物存储器(104)中存储的一种或多种药物；决策和控制逻辑电路(108)，用于打开和闭合阀(106)；电池(109)；以及至少一个传感器(110)。该决策和控制逻辑电路(108)根据由该至少一个传感器(110)感测的条件打开和闭合阀(106)。

Description

电子可控药丸
技术领域
本公开内容通常涉及药物输送系统。本公开内容尤其涉及具有至少一个用于输送至少一种药物的传感器的电子可控药丸和系统。
背景技术
人们摄取的诸如阿司匹林的药物，通常穿过胃肠(GI)道，其中它们被吸收用于治疗疾病或病症。物体通常在20-40小时内通过GI道。可获得几种药物作为时间释放胶囊(time release capsule)，用于在不同的时间将药物的部分释放到人体中。时间释放胶囊利用胃肠道中的化学物质和胶囊包覆之间的化学反应，溶解和释放药物。食品，尤其是蛋白质和脂肪，以及GI化学性质影响了药物通过胃的行进速度。同样地，包括可获得作为时间释放胶囊的药物在内的药物，在通过GI道时不遵循精确的分配和溶解模式。
例如，一个人可能在胃肠道中具有多于“标准”量的化学物质，这是由于病症、早些时候服用的药物等，并且因此导致时间释放胶囊的包覆比标准反应得更快。因此，由时间释放胶囊释放药物的速率比预期速率更快。然而，另一个人可能在胃肠道中具有少于“标准”量的化学物质，并且导致时间释放胶囊的包覆比标准反应得更慢，由此释放药物的速率比预期速率更慢。
发明内容
本公开内容提供了一种具有至少一个用于输送或分配药物的传感器的电子可控药丸或药物输送系统。药物的分配基于位置探测，使用至少一个传感器读数，即至少一个感测的条件或参数，诸如pH、传导率(含水量)水平等，该读数由沿着胃肠道的至少一个传感器获取。例如，对于正常患者，如果该至少一个传感器感测了低pH水平，该电子可控药丸可以确定其位于胃中。如果pH水平开始升高，电子可控药丸可以确定其正离开胃并进入小肠。
该电子可控药丸包括决策和控制逻辑电路，用于根据感测到的条件控制阀、泵或舱的打开和闭合，从而分配存储在药丸的药物存储器中的药物。优选地，在吞咽了电子可控药丸之后，连续地读出该一个或多个传感器，并且将该数据提供给决策和控制逻辑电路。逻辑电路的至少一个处理器分析该数据并且确定药丸沿着胃肠道的相对位置。可以通过访问在处理器中存储的一个或多个查找表来确定药丸的位置。该查找表优选地使该一个或多个感测的条件与沿胃肠道的相对位置相关。
一旦确定了该相对位置，决策和控制逻辑电路确定是否控制阀的打开或闭合从而分配药物存储器中的药物。用将分配药物的定位或位置编程药丸。因此，如果已确定的相对位置基本上符合至少一个预编程位置，该逻辑电路向阀发射信号，用于打开阀。该信号的电压水平确定了阀的打开量。
预想的是，根据患者医学轮廓或者可以改变沿着胃肠道的已感测的条件、诸如pH、传导率(含水量)水平等的预先存在的疾病，而定制地编程或设计该药丸。
附图说明
下面将参考附图描述本公开内容的各种实施例，其中：
图1是根据本发明具有至少一个传感器的电子可控药丸的示意图；以及
图2是根据本发明具有至少一个传感器的电子可控药丸的结构图。
具体实施方式
根据本发明的电子可控药丸或药物输送系统由图1和2示出，并且下文中将用特征进一步描述。电子可控药丸100是自包含(self-contained)的电子可控药物输送系统。正如下面详细所述的，该电子可控药丸100包括已编程的电子器件，其根据诸如pH、传导率水平(含水量)等沿着胃肠道的至少一个已感测的条件或参数，来控制释放机构，用于分配药物。药丸100由生物相容的材料制成，从而药丸100至少对于其穿过胃肠道所需的时间量是生物相容的。该生物相容材料优选在室温下是稳定的，从而药丸具有长保存期限。
正如在此和在权利要求中使用的，词语“药物”指的是药、非药物质、造影剂、气体、流体、液体、化学药品、放射性制剂、成像标记物、监视人生命的传感器，以及适于由药丸100分配的其它物质。
该电子可控药丸100包括外壳或外罩102，其定义了开口103；药物存储器104，用于存储药物；电子可控释放阀、泵或舱106，用于经由开口103分配存储在药物存储器104中的药物；决策和控制逻辑电路108，用于打开和闭合该阀106；以及至少一个传感器110(传感器110A和110B示出在图1和2中)。药丸100还包括电池112，用于对药丸100的各个部件供电。决策和控制逻辑电路108根据由如下面进一步描述的该至少一个传感器110感测的条件来打开和闭合该阀106。
优选地，壳102能抵抗诸如胃酸和来自胆囊的胆汁的体液。壳102优选由用于制造可植入设备的材料制造，所述可植入设备包括起搏导线和心脏假体设备，诸如人工心脏、心脏瓣膜、主动脉内球囊和心室辅助设备。这些材料包括钛、从Dow Chemical Company可获得的Pellethane2363聚醚氨酯系列材料和从Polymer Technology Group有限公司可获得的Elasthane聚醚氨酯。其他材料包括也可从Polymer Technology Group有限公司获得的PurSil和CarboSil。
壳102的至少一部分优选包括如图1所示的金属衬垫111，用于通过在患者身上放置磁探测器而探测药丸100沿着胃肠道的位置。当磁探测器感测到金属衬垫111时，可以容易地核实药丸100沿着胃肠道的位置。除金属衬垫111之外，壳102可以包括一个或多个其它设备或物质，诸如RF设备、天线、射线透射物质、成像标记物、红外探测器等，其允许从患者外部探测药丸(100)。
优选地，在吞咽了电子可控药丸100之后，从传感器110A、110B中之一或两者中连续读出一个或多个传感器读数，并且将该数据提供给包括至少一个处理器200的决策和控制逻辑电路108。该至少一个处理器200分析该数据并且确定药丸100沿着胃肠道的相对位置。药丸100的位置可以通过访问一个或多个查找表或者存储在处理器200中的其它数据结构来确定。该查找表使该一个或多个传感器读数或感测的条件与沿着胃肠道的相对位置相关。由下列表格示出了典型的查找表，其将感测的pH水平与沿着胃肠道的各个相对位置相关。
  pH水平   胃肠道中位置
  7.4-7.7   口
  6.3-6.9   食道
  4.0-4.8   胃
  7.0-9.0   小肠
  4.0-6.5   结肠
优选地，该至少一个处理器200包括定时电路，用于定时药丸100通过胃肠道的时间。根据任意给定时刻的特定时间，该至少一个处理器200被编程，以确定分析哪个数据，即，由传感器110A提供的数据或由传感器110B提供的数据或两者。例如，从服用了药丸100之后的两分钟到三分钟，该至少一个处理器200被编程，以分析来自传感器110A的数据。从服用了药丸100之后的三分钟到五分钟，该至少一个处理器200被编程，以分析来自传感器110B的数据。从服用了药丸100之后的五分钟到十分钟，该至少一个处理器200被编程以分析来自传感器110A和110B两者的数据。由该定时电路提供的时间也可以与存储在该至少一个处理器200中的查找表相关，以确定在服用之后的任意给定时间，药丸100位于沿着胃肠道的何处。
一旦确定了相对位置，决策和控制逻辑电路108确定是否控制阀106的打开和闭合，以分配存储在药物存储器104中的药物。用将分配药物的定位和位置编程药丸100。因此，如果已确定的相对位置基本上符合如由逻辑电路108例如使用比较器而确定的至少一个预编程位置，逻辑电路108就向释放控制器120发射信号用于控制阀106。释放控制器120可操作地与阀106关联或者可操作地与阀106通信，用于打开阀106。该释放控制器120包括用于译码由逻辑电路108发射的信号并控制阀打开量的电路。
因此，当药丸100到达目标位置，阀106在逻辑电路108和释放控制器120的控制下打开，并且药品从药物存储器104中分配出。通过部分地打开阀106，或者通过使用泵阀缓慢地抽吸，药物以受控方式分配。由于逻辑电路108控制药物分配，药物大体上根据释放轮廓分配。当药丸100穿过小肠时，典型释放轮廓使必须释放药物。
根据本发明，在药丸行进通过胃肠道期间，依附于优选的释放轮廓，这是由于决策和控制逻辑电路108被编程用于闭合阀106和控制阀106打开的量，用于控制阀打开的大小。通过控制阀打开的大小或阀打开的频率，正如由喷墨打印机等的微流体(microfluidic)系统所允许的，电子可控药丸100可以精确地控制遵循由传感器110A、110B感测的一个或多个条件释放的药物的量。
由该至少一个处理器200传递到阀106的释放控制器120的信号的电压水平，确定了阀打开的大小，用于控制在沿着胃肠道的特定位置分配的药物量。当药物分配将要终止时，由该至少一个处理器200将另一信号发射到阀106的释放控制器120，用于闭合阀106。
逻辑电路108通过使用查找表连续地将至少一个感测的条件与药丸100沿着胃肠道的相对位置相关，来确定终止分配药物。如上所述，用将分配药物的定位或位置编程药丸100。因此，如果确定的相对位置不基本上符合如由逻辑电路108例如使用比较器而确定的至少一个预编程位置，逻辑电路108就向释放控制器120发射信号用于闭合阀106。
释放控制器120优选是微机电机构，其能够接收来自该至少一个处理器200的信号并且产生具有可变电压水平的信号到电子可控阀106，用于闭合阀106和控制阀打开的大小或阀106打开的程度(根据接收到的信号的电压水平)。在最简单的情况下，释放控制器120是晶体管或D/A电路，其提供电压给阀106，致使其打开或闭合。
电子可控阀106优选是微机电机构，诸如，MEMS-阀，其可以受到能够具有可变电压水平的信号的电子控制。每个电压水平相应于阀打开的不同大小的开口，并且一个电压水平(或者所有电压水平都不，即，无信号)相应于正被闭合的阀106。阀106在操作上类似于在喷墨打印机中用于根据阀打开量而分配墨水的阀。该阀106具有用于在小型化系统中控制液体或气体的微小量移动的微流体阀的特征。
预想的是，根据患者医学轮廓或者可以改变沿着胃肠道感测的条件、诸如pH、传导率(含水量)水平等的预先存在的疾病，而定制地编程该药丸100。参考图2，决策和控制逻辑电路108包括开始定时器机构114，用于使逻辑电路108和传感器110A、110B激活，以连续地读出数据。在优选实施例中，开始定时器机构114是具有用于感测诸如水、唾液等液体存在的传感器116的微机电(MEM)机构。当摄取或服用了药丸100时，传感器116感测存在液体，并且向逻辑电路108发射电信号用于激活逻辑电路108。依次地，逻辑电路108向传感器110A、110B发射信号，用于激活它们，并且连续地读出数据。
在备选实施例中，开始定时器机构114是按钮，按下其而向逻辑电路108发射电信号。在人或动物服用药丸100之前按下按钮。
在另一实施例中，对逻辑电路108和传感器110A、110B的激活，通过溶解薄的水溶性包覆而实现，所述薄的水溶性包覆分离开关的两个电触点，由此允许开关闭合电路。在又一实施例中，由患者或护理者手动触发开关。
本领域技术人员可以意识到，根据本公开内容的电子可控药丸100适用于对药用成分定量给药，所述药用成分难以使用可溶性胶囊或压制药丸而定量给药，其可能伤害口或胃，或者其可能在口或胃中自身受损。与使用常规药丸相比，使用本公开内容的药丸100也更易于实现对液相药品的定量给药。
优选地，该至少一个处理器200存储接收自传感器110A、110B的数据，从而一旦药丸100通过胃肠道可以取回数据。通过用具有至少一个天线的通信电路装配药丸100，可以从患者体内将数据传送到安装在患者外部的数据记录器。该数据可以用于确定是否已感测的条件或参数是正常的。例如，可以确定是否在胃肠道的各个部分的pH水平在认为是正常的范围内。如果不是，可以如本领域中已知地，执行用于校正胃肠道的一个或多个部分的pH水平的治疗，或者通过服用一个或多个药丸100，该药丸用于分配至少一种药物，以便增加或减少胃肠道的一个或多个部分的pH水平。
本公开内容的所述实施例是说明性的，而非限制性的，并且并不意图表示本公开内容的全部实施例。可以进行各种修改和变化，而不脱离如在下面的权利要求中文字地和法律上承认的等效方案中所陈述的公开内容的精神和范围。

Claims (20)

1、一种药物输送系统(100)，用于在通过胃肠道时分配药物，所述系统(100)包括：
外罩(102)；
存储器(104)，用于在所述外罩(102)中存储所述药物；
阀(106)，与所述存储器(104)流体相通；
至少一个传感器(110)，用于感测至少一个参数；以及
电路(108)，用于根据所述至少一个感测的参数控制所述阀(106)以打开和闭合所述阀(106)，从而从所述存储器(104)中分配所述药物。
2、根据权利要求1所述的系统(100)，其中，所述外罩(102)由选自下列组中的至少一种材料制成，所述组包括钛、Pellethane2363聚醚氨酯系列材料、Elasthane聚醚氨酯、PurSil和CarboSil。
3、根据权利要求1所述的系统(100)，其中，所述电路包括至少一个处理器(200)，其存储至少一个数据结构，所述数据结构使所述至少一个感测的参数与沿着胃肠道的位置相关。
4、根据权利要求3所述的系统(100)，其中，所述至少一个数据结构是查找表。
5、根据权利要求1所述的系统(100)，还包括电池(112)，用于为所述电路(108)和所述至少一个传感器(110)供电。
6、根据权利要求1所述的系统(100)，其中，所述电路(108)包括开始定时器机构(114)，用于使所述逻辑电路(108)和所述至少一个传感器(110)激活。
7、根据权利要求6所述的系统(100)，其中，所述开始定时器机构(114)是微机电(MEM)机构，其具有用于感测液体的存在的传感器(116)。
8、根据权利要求1所述的系统(100)，还包括释放控制器(120)，其与所述阀(106)可操作地通信，用于在接收到来自所述电路(108)的至少一个信号时控制打开和闭合所述阀(106)。
9、根据权利要求8所述的系统(100)，其中，所述释放控制器(120)根据所述至少一个信号的电压水平控制所述阀(106)打开的程度。
10、根据权利要求1所述的系统(100)，其中，所述系统(100)包括允许从胃肠道外部探测到所述系统(100)的至少一种物质或设备。
11、根据权利要求1所述的系统(100)，其中，所述电路(108)包括至少一个处理器(200)，对所述处理器进行编程，使得在沿着胃肠道的至少一个位置分配所述药物。
12、一种用于在胃肠道中分配药物的方法，所述方法包括如下步骤：
在具有开口(103)的外罩(102)中提供药物；
使用位于胃肠道中的至少一个传感器获得至少一个读数；以及
通过分析所述至少一个读数确定是否经由所述开口(103)来分配所述药物。
13、根据权利要求12所述的方法，其中，所述外罩(102)由选自下列组中的至少一种材料制成，所述组包括钛、Pellethane2363聚醚氨酯系列材料、Elasthane聚醚氨酯、PurSil和CarboSil。
14、根据权利要求12所述的方法，其中，确定步骤包括使用数据结构使得所述至少一个读数与沿着胃肠道的位置相关的步骤。
15、根据权利要求12所述的方法，还包括提供电源以对用于获得所述至少一个传感器读数的至少一个传感器(110)供电的步骤。
16、根据权利要求15所述的方法，还包括提供开始定时器机构(114)以使所述至少一个传感器(110)激活的步骤。
17、根据权利要求16所述的方法，其中，所述开始定时器机构(114)是微机电(MEM)机构，其具有用于感测液体的存在的传感器(116)。
18、根据权利要求12所述的方法，还包括如下步骤：
提供控制经由所述开口(103)分配所述药物的阀(106)；以及
提供释放控制器(120)，其与所述阀(106)可操作地通信，用于控制打开和闭合所述阀(106)。
19、根据权利要求17所述的方法，还包括控制所述阀(106)的打开程度的步骤。
20、根据权利要求12所述的方法，还包括为所述外罩(102)提供允许从胃肠道外部探测到所述外罩(102)的至少一种物质或设备的步骤。
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