CN101541359B - 药剂输送装置、胶囊和体内药物输送或诊断系统 - Google Patents
药剂输送装置、胶囊和体内药物输送或诊断系统 Download PDFInfo
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Abstract
一种药剂输送装置，其包括驱动机构和外壳(1)，该外壳(1)具有贮存器(2)，该贮存器(2)至少部分地填充有物质且至少一侧被柔性壁(21)密封。该驱动机构适于将活塞(23)压在柔性壁(21)上从而通过贮存器(2)中的开口(25)从贮存器(2)释放物质。这提供了一种安全且可靠的药剂输送装置。
Description
技术领域
本发明涉及一种药剂输送装置，其包括外壳，该外壳具有驱动机构和贮存器，该贮存器至少部分地填充有物质且至少一侧被柔性壁密封。本发明还涉及包括药剂输送装置的用于引入到体腔内的胶囊。本发明还涉及体内药物输送或诊断系统。
背景技术
用于引入到体腔内的胶囊或药丸是已知的且(例如)用于药剂释放和人或动物体内的胃肠(GI)道的诊断。用于药剂释放的电子药丸通常具有由生物相容性材料制成的外壳，该外壳容纳药剂贮存器和控制电子装置，该药剂储存器包含预定剂量的药剂，该电子装置用于精确地输送药剂到人或动物的GI道中预先选定的地点。该外壳还包含在受试者摄食药丸之后提供药丸与身体外部的无线通信链路的装置。该电子装置使得药丸能够使用传感器、定时或定位来在人或动物的GI道中的具体地点处输送附载药剂(on board medicament)。用于诊断GI道的胶囊或药丸通常包括传感器(且通常不是药物贮存器)，该传感器监控体温或pH值，和/或包括图像传感器，该图像传感器被布置成产生GI道的图像。
US 2004/0253304A1公开了一种带有药物输送装置的胶囊，该药剂输送装置包括由胶囊储存于贮存器中的如药物的物质和驱动机构，该驱动机构响应于环境敏感机构的状态变化适于驱动物质到GI道内。该驱动机构包括可移动的部件，诸如膜，其响应于发生器产生气体而在胶囊内移动。所产生或释放的气体在膜上产生增加的压力。压力加载的膜又将压力施加到物质上，从而将物质从药物贮存器中驱动出来到GI道内。在药剂输送装置的其它配置中，可移动的部件包括活塞。在药剂输送装置的又一配置中，未提供可移动的部件，但替代地，气体发生器直接作用于物质上。
已知的药剂输送装置的缺点在于在胶囊中的气体发生器产生相对高压的气体。在胶囊中暂时增加的压力导致有安全隐患和可靠性较差的药剂输送装置。
发明内容
本发明的目的在于提供一种药剂输送装置，这种药剂输送装置更可靠且更安全。本发明由独立权利要求限定。有利实施例由从属权利要求限定。
通过根据本发明的药剂输送装置来实现这个目的，该药剂输送装置的特征在于：驱动机构适于将活塞压在柔性壁上从而通过开口从贮存器释放物质。由于活塞压在柔性壁上，在胶囊内无需高压气体且因此提高了药剂输送装置的安全性和可靠性。另一优点在于活塞无需紧密地装配于外壳内，因为柔性壁而不是活塞密封药物贮存器。本发明的活塞并不是用于该物质的密封屏障，替代地，柔性壁起到这个功能，且活塞用作从贮存器释放物质的驱动元件。由于壁是柔性的，其遵循活塞的移动，活塞压在柔性壁上直到释放物质的至少一部分。
这个目的也通过包括根据本发明的药剂输送装置和用于控制活塞的电子电路的用于引入到体腔内的胶囊来实现。这个目的还通过包括具有根据本发明的药剂输送装置和布置成与电子电路通信的外部装置的胶囊的体内药物输送或诊断系统来实现。在根据本发明的胶囊的实施例中，外壳包括第一部件和第二部件，其中外壳的第一部件被固定到外壳的第二部件上从而将柔性壁夹持于外壳的第一部件与外壳的第二部件之间并且使驱动机构与贮存器隔开。以此方式，储存于贮存器中的物质被从驱动机构密封。
在根据本发明的胶囊的另一实施例中，外壳的第一部件包括突起且外壳的第二部件包括凹口，其中通过将突起插入于凹口内使得外壳的第一部件稳固到外壳的第二部件上而使柔性壁夹持于外壳的第一部件与外壳的第二部件之间。以此方式，扩大了柔性壁的密封长度，这增加了柔性壁的密封强度和因此增加了装置的可靠性。
在根据本发明的胶囊的实施例中，活塞具备螺纹孔并由驱动机构的螺纹构件驱动，该螺纹构件安装于电动机上。在活塞中的螺纹孔与安装到电动机上的螺纹构件的组合有利地提供简单的且熟知的驱动机构。
在根据本发明的胶囊的实施例中，在从贮存器释放物质期间与柔性壁接触的活塞的表面的一部分包括低摩擦材料。这有利地减小了活塞与柔性壁之间的摩擦，造成柔性壁对活塞表面改进的适应性。
附图说明
将参看附图来进一步阐明和描述本发明的这些和其它方面。
图1是具有根据本发明的药剂输送装置的胶囊的实施例的示意截面图；
图2是具有根据本发明的药剂输送装置的胶囊的实施例的透视截面图；以及
图3是具有根据本发明的药剂输送装置的胶囊的实施例的截面图。
附图未按照比例绘制。总体而言，在附图中，相同的构件用相同的附图标记来表示。
具体实施方式
将作为实例在下文中解释在胶囊中提供的根据本发明的药剂输送装置的实施例。但本发明并不限于这些实例且也可应用于其它药剂输送装置。
图1是胶囊100的示意截面图，胶囊100是通过例如摄食用于受试者(人或动物)的自含式电子受控药剂输送系统。胶囊100包括圆柱形外壳1，在该圆柱形外壳1中安装了电子控制电路40、用于诊断目的的传感器和药剂输送装置等。外壳1优选地由生物相容性(bio-compatible)材料制成使得胶囊100对于至少其经过人或动物的GI道所需要的时间量而言是生物相容的。生物相容性材料优选地在室温和低于室温下是稳定的使得胶囊100具有长的保存限期。外壳1可由生物安全的聚合材料制成，诸如，聚四氟乙烯、聚丙烯、聚乙烯、丙烯酸树脂等。外壳1更优选地由用于制作可植入装置的材料制成，可植入装置包括起搏器导线和心脏假体装置(cardiac prosthesis device)，诸如人工心脏、心脏瓣膜、主动脉内气囊和心室辅助装置。组装的胶囊100的大小优选地适于由人或动物吞咽。优选地，组装的胶囊100的直径大约为1cm且长度为2至3cm。
电源6向电子控制电路40加电以使用于诊断目的的传感器和药剂输送装置操作。电源6额外地向胶囊100所容纳的任何其它电动器件加电。电源6可为电池、电容器或用于提供电力供应的任何其它已知装置。
电子控制电路40例如用于通信和用于控制储存于贮存器2中的物质的释放并可包括但不限于用于电动机的驱动单元、微处理器、用于在不进行物理接触的情况下确定胶囊100位置的传感器、温度传感器、图像传感器，诸如RF收发器和天线的通信装置。RF收发器提供RF链路且用于发射信号到胶囊100外部和从胶囊100外部接收信号。举例而言，收发器与便携式装置(未图示)通信，便携式装置能够通过发射随后由收发器接收的信号来编程药剂释放分布图(profile)。便携式装置也可通过例如红外链路与基站(未图示)通信，该基站用于与例如医学专家通信。对于长的保存限期，必需的是电子控制电路40完全与电源6去耦合，否则小的泄露电流最终将会放空电源6。为启动电子电路，其必须被唤醒，且为了该目的，可设计唤醒电路(未图示)，唤醒电路通过集成到胶囊100内的天线所接收到的感应辐射从外部加电。
电子控制电路40包括很多需要相互电连接的电子构件。对于这个目的，采用一个连续柔性箔来提供印刷电路板，在该印刷电路板上附连各种电子构件。各种电子构件在柔性箔上的附连和在柔性箔1上电子构件之间的电连接的集成减少了构件数目且因此增加了胶囊100的可靠性。
贮存器2用于储存可经由例如外壳1中的分配孔25输送到人体内GI道中的物质。该物质可指药物、非药用物质、造影剂、放射剂(radiological agent)和成像标记。在此实施例中，该物质优选地为用于治疗GI道疾病的药剂。分配孔25可包括可移除的密封或插塞，密封或插塞例如包括溶解于人或动物体中GI道中的材料，从而打开分配孔25。药剂输送装置还包括可移动的活塞23，该可移动的活塞23由受电子控制电路40控制的例如(步进)电动机22驱动。电机22例如经由螺杆机构24朝向分配孔25平移活塞23。在另一实施例中，电机22是直接朝向分配孔25驱动活塞23的线性电机。
贮存器2的一侧被柔性壁21密封，柔性壁21附连到外壳1上。活塞23的表面26的一部分压在柔性壁21上，且柔性壁21的一部分接触活塞23的表面26的一部分且调整成活塞23表面26的接触表面的形状。为了防止活塞23旋转，活塞23例如具备槽口，该槽口运行于在外壳1中提供的轨道内(未图示)。活塞23经由电机22朝向分配孔25移动。当活塞23接触柔性壁21并压在柔性壁21上时，柔性壁21压在贮存器2中的物质上，且结果，使物质通过分配孔25从贮存器2中释放。
由于柔性壁21密封贮存器2中的物质，活塞23仅用于从贮存器2按压物质穿过分配孔25。该活塞23不具有密封功能，正常情况下总体上把该密封功能归因于各个活塞。由于活塞23并不形成用于贮存器2中的物质的密封，对于活塞23到外壳1内的装配并无严格的公差要求。实际上，活塞23甚至并不需要接触外壳1的内表面以提供物质从贮存器2的适当释放。活塞23的表面26可具备具有低摩擦性的材料，诸如TeflonTM。以此方式，接触该接触表面26的柔性壁21能够以相对较小的摩擦在活塞23的表面26上滑移且柔性壁21将在活塞23与外壳1之间的空间中以最佳方式折叠。
柔性壁21由提供贮存器2密封的材料制成并具有柔性，该柔性允许调整成活塞23表面26的形状而不撕裂或损坏柔性壁。这种材料可为例如基于聚合物的层压件，诸如医药级聚乙烯/聚三氟氯乙烯(PE/PCTFE)柔性薄膜。
图2示出具有根据本发明的药剂输送装置的胶囊100的透视截面图且图3是具有根据本发明的药剂输送装置、电子控制电路40和电机22的胶囊100的的截面图，该电子控制电路40具有若干不同构件，电机22经由螺杆机构24朝向分配孔25驱动活塞23使得活塞23的表面26压在柔性壁21上。通过将外壳的第一部件11的突起31插入到外壳的第二部件12的凹口32内，外壳1的第一部件11被固定到外壳1的第二部件12上。在突起31与凹口32之间夹持柔性壁21的一部分以提供柔性壁21的固定。以此方式，柔性壁21密封贮存器2中的物质并因此形成物质与药剂输送装置和胶囊100的其余构件之间的屏障。为了增强柔性壁21的密封性质，可使用生物相容性粘合剂用于柔性壁21在突起31与凹口32之间的粘附，或替代地，可采用超声摩擦加热。应当指出的是外壳1的第一部件11包括贮存器2且包括药剂输送装置和胶囊100的其余构件的外壳2的第二部件通过柔性壁21与贮存器2隔开。突起31和凹口32提供柔性壁21夹持于外壳1的第一部件11和第二部件12之间的增加的长度，从而增加了柔性壁21的密封强度并最小化物质到贮存器2外部的泄露。
柔性箔上附连各种电子构件，该柔性箔电附连且机械附连到电机22上。
总之，本发明提供了一种药剂输送装置，该药剂输送装置包括驱动机构和具有贮存器的外壳，该外壳至少部分地填充有物质且至少在一侧上被柔性壁密封。该驱动机构适于将活塞压在柔性壁上从而通过贮存器中的开口从贮存器释放物质。这提供一种安全且可靠的药剂输送装置。
应当指出的是，上述实施例说明了本发明而非限制本发明，且在不偏离所附权利要求书的范畴的情况下，本领域技术人员应能设计出许多替代的实施例。在权利要求书中，置于括号中的任何附图标记不应被认为限制权利要求书。词语“包括(包含)”并不排除在权利要求中所列出的元件或步骤之外的其它元件或步骤的存在。在元件之前的词语“一(一个)”并不排除多个这样的元件的存在。
Claims (6)
1.一种用于引入到体腔内的可摄食的胶囊(100)，所述胶囊(100)为药剂输送装置并包括：
具有开口(25)的外壳(1)；
柔性壁(21)，其固定到外壳(1)的内侧壁以限定胶囊的第一部分和第二部分，其中胶囊的第一部分流体地连接到开口(25)，该柔性壁相对于该第二部分将该第一部分密封，且该胶囊的第一部分限定了贮存器(2)，所述贮存器(2)至少部分地填充有物质；
设置在该胶囊的第二部分内的驱动机构，适于将活塞(23)压在所述柔性壁(21)上以减小该第一部分的体积，从而通过位于该胶囊的第一部分内的开口(25)从所述贮存器(2)释放所述物质；以及
设置在该第二部分内用以控制所述驱动机构的电子电路(40)。
2.根据权利要求1所述的可摄食的胶囊(100)，其特征在于，所述外壳(1)包括第一部件(11)和第二部件(12)，其中所述外壳(1)的所述第一部件(11)固定到所述外壳(1)的所述第二部件(12)上，从而将所述柔性壁(21)夹持于所述外壳(1)的所述第一部件(11)与所述外壳(1)的所述第二部件(12)之间并使所述驱动机构与所述贮存器(2)隔开。
3.根据权利要求2所述的可摄食的胶囊(100)，其特征在于，所述外壳(1)的所述第一部件(11)包括突起(31)且所述外壳的所述第二部件(12)包括凹口(32)，其中通过将所述突起(31)插入到所述凹口(32)内使得所述外壳(1)的所述第一部件(11)固定到所述外壳(1)的所述第二部件(12)上，从而将所述柔性壁(21)夹持于所述外壳(1)的所述第一部件(11)与所述外壳(1)的所述第二部件(12)之间。
4.根据权利要求1所述的可摄食的胶囊(100)，其特征在于，所述活塞(23)具备螺纹孔并由所述驱动机构的螺纹构件(24)驱动，所述螺纹构件(24)安装到电动机(22)上。
5.根据权利要求1所述的可摄食的胶囊(100)，其特征在于，在从所述贮存器(2)释放所述物质期间接触所述柔性壁(21)的所述活塞(23)的表面(26)的一部分包括低摩擦材料。
6.一种体内药剂输送或诊断系统，其包括根据权利要求1所述的胶囊和布置成与所述电子电路(40)通信的外部装置。
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| PCT/IB2007/054491 WO2008062335A1 (en) | 2006-11-21 | 2007-11-06 | Medicament delivery device, capsule and in vivo medicine delivery or diagnostic system |
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| US (2) | US9878094B2 (zh) |
| EP (1) | EP2086611B1 (zh) |
| JP (1) | JP5697871B2 (zh) |
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| US9833562B2 (en) | 2009-12-16 | 2017-12-05 | Becton, Dickinson And Company | Self-injection device |
| US10195340B2 (en) | 2009-12-16 | 2019-02-05 | Becton, Dickinson And Company | Self-injection device |
| CN103418075A (zh) * | 2012-05-21 | 2013-12-04 | 国际商业机器公司 | 用于从伴随诊断链接的智能药丸分发药物的方法和系统 |
Also Published As
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| US9878094B2 (en) | 2018-01-30 |
| CN101541359A (zh) | 2009-09-23 |
| WO2008062335A1 (en) | 2008-05-29 |
| US20100056874A1 (en) | 2010-03-04 |
| EP2086611B1 (en) | 2016-08-03 |
| US20180200426A1 (en) | 2018-07-19 |
| JP5697871B2 (ja) | 2015-04-08 |
| JP2010509969A (ja) | 2010-04-02 |
| EP2086611A1 (en) | 2009-08-12 |
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Address after: California, USA Patentee after: Biola Therapeutics Inc. Address before: California, USA Patentee before: Baozhenati |
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| CP01 | Change in the name or title of a patent holder |