CN101472641A - 能够提供多种液体药剂的输液装置 - Google Patents
能够提供多种液体药剂的输液装置 Download PDFInfo
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Abstract
本发明涉及一种一次性输液装置,包括底座以及套管,所述底座布置为粘附到病人的皮肤上,所述套管布置为从所述底座延伸到病人的皮肤下,以便将液体药剂输送到病人体内。所述装置还包括第一源以及第二源,所述第一源布置为向所述套管提供第一液体药剂,而所述第二源布置为向所述套管提供第二液体药剂。
Description
技术领域
本申请要求于2006年3月16日提交的美国临时申请No.60/782,941的优先权,其通过引用结合于此。
背景技术
对于糖尿病1型(通常为幼发型)以及糖尿病2型(通常为成人晚发型)中胰岛素给药的严格控制提高了糖尿病病人的生活质量以及整体健康水平,胰岛素的给药是通过如下来实施的:通过长效胰岛素的皮下注射以满足病人的基本需求,以及通过短效胰岛素的皮下注射对饮食进行补偿。最近,电子外用胰岛素输液泵的发展已经允许快效胰岛素的持续输液,用来维持基本需求以及针对饮食的补偿剂量。这些输液系统改进了血糖水平的控制,然而,它们却有尺寸、成本以及复杂性方面的缺点,这阻挠了许多病人通过标准皮下注射来接受这一技术。这些泵被电子地控制,并且必须被编程以便提供要求量的基础胰岛素和大剂量(bolus)胰岛素。
发明内容
在本发明的一个实施例中,提供了一种一次性的输液装置,该装置包括底座、套管、第一源以及第二源,该底座布置为粘附到病人的皮肤上,该套管布置为从底座延伸到病人的皮肤下,以便将液体药剂输送到病人体内,该第一源布置为向套管提供第一液体药剂,该第二源布置为向套管提供第二液体药剂。
第一和第二源中的一个源可以布置为以固定体积增量提供其液体药剂。第一和第二源中的一个源可以包括贮液器和固定体积泵,该贮液器用于容纳液体药剂,该固定体积泵以固定体积增量将液体药剂输送到套管中,该固定体积泵可以包括活塞泵、圆顶泵(dome pump)或挤压管。
第一和第二源中的一个源可以包括贮液器。例如,第一源可以包括贮液器和泵,第二源可以包括端口。该端口可以布置为与套管连通和从装置外的器械中接收第二液体药剂。
第一和第二源中的一个源可以包括泵和机械电动机,该泵与贮液器连通,并布置为将液体药剂输送到套管中,该机械电动机驱动泵。该机械电动机可以包括卷簧(wind-up spring)。
第一和第二源中的一个源可以包括泵和填充端口,该填充端口与贮液器连通,以便能够利用装置外的器械来填充贮液器。该贮液器能够由柔性材料形成。
在另外一个实施例中,第一源可以包括第一贮液器,第二源可以包括第二贮液器,该装置可以还包括阀,该阀选择性地使第一贮液器与套管连通,或使第二贮液器与套管连通。
在另外一个实施例中,第一源可以包括第一贮液器和第一泵,该第一贮液器布置为容纳第一液体药剂,而该第一泵布置为将第一液体药剂输送到套管中;以及,第二源可以包括第二贮液器和第二泵,该第二贮液器布置为容纳第二液体药剂,而该第二泵布置为将第二液体药剂输送到套管中。第一和第二源中的一个源布置为以基本恒定的速度提供其有关液体药剂。该装置可以还包括速度调节器,该速度调节器使基本恒定的速度是可调节的。
第一源和第二源中的一个源可以是可更换贮液器。
在又一个实施例中,一次性输液装置包括底座、套管、第一源以及第二源,该底座布置为粘附到病人皮肤上,该套管布置为从底座延伸到病人皮肤下,以便将液体药剂输送到病人体内,该第一源布置为向套管提供第一液体药剂,而该第二源布置为向套管提供第二液体药剂。第一源包括贮液器以及泵,该泵将第一液体药剂从贮液器泵到套管中,以及,第二源包括端口,该端口从装置外的器械中接收第二液体药剂,并将第二液体药剂传送到套管中。
泵可以包括固定体积泵,该固定体积泵以固定体积增量将液体药剂输送到套管中。
固定体积泵可以包括活塞泵、圆顶泵或挤压管。
在再一个实施例中,一次性输液装置包括底座、套管、第一源以及第二源,该底座布置为粘附到病人皮肤上,该套管布置为从底座延伸到病人皮肤下,以便将液体药剂输送到病人体内,该第一源布置为向套管提供第一液体药剂,而该第二源布置为向套管提供第二液体药剂。该第一源是容纳第一液体药剂的第一贮液器,而该第二源是容纳第二液体药剂的第二贮液器。该装置还包括将第一和/或第二液体泵送到套管中的泵。该泵可以是与套管连通的单泵,以及该装置可以还包括选择性地将第一贮液器和第二贮液器连接到泵上的阀。该泵可以包括第一泵以及第二泵,该第一泵将第一液体药剂从第一贮液器中泵送到套管中,而该第二泵将第二液体药剂从第二贮液器中泵送到套管中,以及该装置可以还包括选择性地将第一泵以及第二泵连接到套管上的阀。
附图说明
在所附权利要求书中具体说明了本发明认为新颖的特征。本发明连同其他特点以及优点通过参考以下说明连同附图可以非常好地理解,在这几个附图中,相同的附图标记指的是相同的构件,其中:
图1是输液端口的侧视图,该输液端口可以用于实践本发明;
图2是根据本发明的一个实施例的输液端口、加载薄膜以及胰岛素贮液器的侧视图;
图2A是示例了图2中的系统的操作的一个潜在方式的示意图;
图2B是示例了图2中的系统的操作的另外一个潜在方式的示意图;
图3是根据本发明的另外一个实施例的包括机械计时器的一次性胰岛素输液系统的部分剖掉的侧视图;
图4是根据本发明的一个实施例的一次性胰岛素输液系统的透视图,该一次性胰岛素输液系统提供胰岛素的基础给药及大剂量给药;
图4A示出了图4中的系统的操作的更多细节的部分剖掉的侧视图;
图5是一次性胰岛素输液系统的透视图,该一次性胰岛素输液系统向使用者提供胰岛素的基础给药速度调节以及大剂量给药;
图6是根据本发明的一个实施例的一次性胰岛素输液系统的侧视图,该一次性胰岛素输液系统包括恒定胰岛素给药装置以及独立配置(separate mating)大剂量给药装置;
图7是根据本发明的另外一个实施例的胰岛素输液系统的部分剖掉的俯视图,该胰岛素输液系统的胰岛素输送速度由室压决定;
图7A是一个示意图,其示例了图7的系统的操作的一个潜在的方式;
图8是根据本发明的一个实施例的胰岛素输液系统的侧视图,该胰岛素输液系统的胰岛素大剂量输送体积通过蠕动动作控制;
图9是图8的系统的端视图;
图10是实施本发明的另一个系统的示意图;
图11是实施在胰岛素输送之前的本发明的大剂量泵的剖掉部分的侧视图;以及
图12是实施在胰岛素输送之后的本发明的图11的大剂量泵的剖掉部分的侧视图。
具体实施方式
图1示出了输液端口10,诸如胰岛素或肠促胰岛素的液体药剂可以使用标准注射器用手注射进端口10中。端口10包括漏斗端口12、插入针14以及注射薄膜16。端口10通过胶带20可以粘附到皮肤18上。该系统避免了需要多个每日经皮的针棍以完成胰岛素剂量的供应。
端口10还包括套管15。套管15由漏斗端口12支撑。由本领域技术可知,一旦针14以及套管15布置于所示出的皮肤18下方,针14就被移除,把套管15留在部署位置,并准备好将胰岛素输送到病人体中。
图2示出根据本发明的一个实施例的系统30。系统30包括类似于端口10的输液端口32,用于长效胰岛素或短效胰岛素的输送。在从套管41抽回针39之前示出端口32。系统30包括第一源31以及泵38,第一源31包括贮液器34,贮液器34可以通过端口36以及泵38被快效胰岛素填充。能够提供另外一个贮液器,如随后将看到的。端口允许贮液器34在内部容纳诸如快效胰岛素的第一液体药剂,例如用于用餐时的输送,而端口32的漏斗端口33形成第二源43,并允许例如在早上醒来后输送诸如缓效(slow acting)胰岛素的第二液体药剂。通过泵38可以输送快效胰岛素,泵38可以用手指挤压。
当系统30包括多个贮液器时,系统30可以具有用于在任何给定时间选择哪种胰岛素输液的机构。系统30还通过让病人将致动器按压期望次数,来提供控制每种特定胰岛素决定要输送多少。例如,每次致动可以输送0.5单位的胰岛素,因此,如果需要3单位的胰岛素,那么压下6次将输送所要求的量。
图2A示出了系统30的操作的一个方式。快效胰岛素通过加载端口36可以被装进贮液器34中。泵38可以是活塞泵,特别是固定行程活塞泵,该固定行程活塞泵每次致动时提供预定体积的胰岛素。因此泵38的按压次数决定从贮液器34输送到端口32和套管41的快效胰岛素的量。当要输送缓效胰岛素时,诸如在早上醒来时,可以通过漏斗端口33输送缓效胰岛素。关于这一点,将注意到泵33允许从诸如注射器39的系统30外的器械接收缓效胰岛素。还将注意到,输液系统30还包括单向阀45和47。阀45在泵38和贮液器34之间,而阀47在端口32和泵38之间。
图2B示出了系统30可以操作的另一个方式。这里,除了用于快效胰岛素的贮液器34之外,系统包括另一个贮液器35以容纳缓效胰岛素。通过端口36将快效胰岛素加载到贮液器34中。可以通过端口37将缓效胰岛素加载到贮液器35中。阀40控制选择哪个贮液器以及所选择胰岛素的输送速度。泵38,可以是固定行程活塞泵,被用于通过端口32将所选择胰岛素泵出到患者体内。阀45和47保持在泵38的相对侧上。
图3示出了系统50,系统50用于每单位时间恒定输送固定量的胰岛素。随着时间输送的胰岛素是快效胰岛素,以便满足基础需求。该胰岛素容纳在贮液器52中。还提供附加端口54,用于针对饮食的快效胰岛素的注射。
在机械计时器泵56的控制下恒定地输送在贮液器52中的胰岛素。计时器泵在本技术领域中是已知类型,其包括卷绕机(winder)58、卷簧60和齿轮62。齿轮62驱动蜗轮63并引导螺杆65驱动活塞67。活塞67因此对贮液器52增压,以提供恒定流量的胰岛素到套管66,当诸如在用餐中需要大剂量快效胰岛素时,端口54被用来将快效胰岛素注射进入到贮液器52中。当贮液器满时,更多已经注射的胰岛素将代替来自贮液器52的同样量的胰岛素,以便将该同样量的胰岛素注射入和注射出套管66。
图4示出了具有输液端口加上用于针对饮食的大剂量给药机构的装置实施例70,输液端口用于每单位时间输送固定量的快效胰岛素。提供滑块72,以便增压胰岛素室(未示出)。填充薄膜74允许室被填充。触发器76可以被压下,用于输送每个测量剂量的胰岛素。
现在参看图4A,在这里可以看到在病人部署套管73之后滑块72实行了附加的功能。更具体来说,针71可以从套管73收回,以便让套管73留在完全部署位置,用于将胰岛素输送到病人体中。为此目的,滑块72连接到容纳在输液管73中的装置针71上。当滑块在箭头75的方向上向后滑时,针71收回。最后,针被针抓取室77抓取。滑块72更向后的移动最终使针头71a被针排出器79获取。当滑块72更向后移动时,针排出器79受到斜坡81的作用而使针头在箭头79a的方向上被移除。这样的针头移除迫使针退出滑块72。在这一点上,针在装置70内落下,且不能再使用。现在装置就安全了,并在其被使用完毕后准备好被抛弃。
图5示出了具有转盘的类似装置80,该转盘用于每单位时间输送由使用者调节的可变量的快效胰岛素。这一实施例对于在一天中不同时间可能需要不同量的基础胰岛素支持的病人特别有帮助。装置80还包括机构,该机构包括卷绕件84和用于针对饮食进行大剂量输送胰岛素的触发器86。提供填充薄膜88,以便利用快效胰岛素来填充胰岛素贮液器(未示出)。
图6示出了具有内部贮液器92和附加大剂量模块94的输液端口90的一个实施例,内部贮液器92容纳快效胰岛素,用于单位时间恒定输送固定量的快效胰岛素来满足病人的基础需求,而附加大剂量模块94提供独立大剂量输送。模块94配合到内部贮液器上,用于饮食的需要。模块94可以容纳足够的胰岛素,以便比容纳在贮液器92内的胰岛素维持得久很多。当贮液器92被排空时,模块94可以简单地像与贮液器92配合那样与另外一个贮液器配合。通过输液管96可以输送恒定馈给的胰岛素和大剂量胰岛素。装置可以用胶带98粘附到皮肤上。
图7示出了用于输送恒定流量的胰岛素的一次性胰岛素输液装置100,该装置100利用基本恒定的压力源以及小流量控制孔。更具体地说,装置100包括贮液器101,贮液器101包括用于容纳快效胰岛素的室102。室102的壁104包括小孔106。室102的另外一个壁109可以在弹簧110的作用下移动,弹簧110位于膨胀室112内。这使贮液器102增压,以便通过孔106控制胰岛素的流量,并使其进入到输液管或套管108中。因此,图7中的装置100类似于图3中的装置,类似之处为胰岛素的贮液器被增压以便将恒定流量的胰岛素输送到套管中。
图7A是类似于图7中的装置100的另外一个装置115的操作的示意图。在这里,可以看到利用在增压贮液器102内的气体来增压胰岛素。孔106通过受控制的量来限制胰岛素流到输液管106或套管108的流量。另外,装置115包括大剂量泵114,以便从另外一个贮液器(或相同的贮液器)中将大剂量的快效胰岛素泵送到输液管或套管108中。泵114可以是固定行程活塞泵。还有,象前一个实施例一样,单向阀45和47布置在泵114的相对侧。
图8和图9示出了实施本发明的另一个一次性胰岛素输液装置120。这里,提供体积调节机构,以便控制利用每次致动所输送的胰岛素体积。这种致动可以是手动来调节针对饮食的大剂量,或是以可调有效基础速度每隔特定时间间隔进行输送。
更具体来说,装置120包括用于容纳快效胰岛素的贮液器122。装置还包括具有凹槽126的盘124,凹槽126的深度沿着盘124的圆周增加。柔性管130从贮液器122绕着盘124并在凹槽126内延伸。皮带132从固定结点134沿着管130延伸到致动器136。随着盘在顺时针方向上旋转,管130的增加长度将保留在凹槽126中。相反地,盘124在逆时针方向上的旋转将使管130的减少长度保留在凹槽126中。当致动器136在箭头138方向上移动时,皮带132对不在凹槽126内的管130的部分进行作用(压缩),以便使测量的大剂量胰岛素被输送到输液管140中。因此,随着更多的导管受到皮带的作用,更大体积的大剂量通过蠕动动作来输送。盘124可以利用拨盘来旋转,例如图5的装置86的拨盘82。
图10用示意图示例了实施本发明的另一个一次性胰岛素输液装置150的操作。在这里,有分别用于快效胰岛素和缓效胰岛素的独立贮液器152和154。每个贮液器与其各自的泵相关联。贮液器152与泵156相关联,而贮液器154与泵158相关联。泵156和158可以是所示的固定行程活塞泵。贮液器152和154在泵156和158的泵送动作下将其各自的胰岛素输送到共用端口160,该共用端口160连接到套管162上。单向阀145和147位于泵156的相对侧上,而单向阀141和143位于泵158的相对侧上。
图11和图12示出了实施本发明的大剂量泵170。如所示例的,泵170采用的是圆顶泵的形式。图11示出了被病人的手指172压下之前的泵170,而图12示出了在压下以及胰岛素输送之后的泵。泵170可以布置为在每次致动下输送0.5单位的胰岛素,并利用泵的每次致动提供触觉反馈。
可以注意到,泵包括弹性薄膜174,薄膜174通过密封环178密封到底座176上。底座可以通过胶带(未示出)粘附到病人皮肤上。泵170还包括进给阀180,当薄膜返回到图11所示出的构造时,进给阀180允许胰岛素进入到由薄膜174以及底座176形成的内腔184中。如图12所示,当薄膜被压下时,输出阀182允许胰岛素从腔184中流出。内腔可以布置为针对泵170的每次按压而排出0.5单位体积的胰岛素。因此,例如,如果一顿饭需要3单位的胰岛素,那么泵170可以下压6次,以便将要求量的胰岛素输送到病人体中。
虽然示出并说明了本发明的具体实施例,但是可以有修改,因此所附权利要求意在涵盖本发明的权利要求所限定的本发明的真正精神以及范围之内的所有变化以及修改。
Claims (26)
1.一种一次性输液装置,包括:
底座,其布置为粘附到病人皮肤上;
套管,其布置为从所述底座延伸到病人皮肤下,以便将液体药剂输送到病人体内;
第一源,其布置为向所述套管提供第一液体药剂;以及
第二源,其布置为向所述套管提供第二液体药剂。
2.根据权利要求1所述的装置,其中,所述第一以及第二源中的一个源布置为以固定体积增量提供液体药剂。
3.根据权利要求2所述的装置,其中,所述第一以及第二源中的一个源包括贮液器以及固定体积泵,所述贮液器用于容纳所述液体药剂,所述固定体积泵以固定体积增量将所述液体药剂输送到所述套管中。
4.根据权利要求3所述的装置,其中,所述固定体积泵包括活塞泵。
5.根据权利要求3所述的装置,其中,所述固定体积泵包括圆顶泵。
6.根据权利要求3所述的装置,其中,所述固定体积泵包括挤压管。
7.根据权利要求1所述的装置,其中,所述第一以及第二源中的一个源包括贮液器。
8.根据权利要求7所述的装置,其中,所述第一源包括贮液器和泵,所述第二源包括端口。
9.根据权利要求8所述的装置,其中,所述端口布置为与所述套管连通,并从所述装置外的器械中接收所述第二液体药剂。
10.根据权利要求7所述的装置,其中,所述第一和第二源中的一个源包括泵以及机械电动机,所述泵与所述贮液器连通并布置为将所述液体药剂输送到所述套管中,所述机械电动机驱动所述泵。
11.根据权利要求10所述的装置,其中,所述电动机包括卷簧。
12.根据权利要求7所述的装置,其中,所述第一以及第二源中的一个源包括泵以及填充端口,所述填充端口与所述贮液器连通,以便能够利用所述装置外的器械来填充所述贮液器。
13.根据权利要求7所述的装置,其中,所述贮液器由柔性材料形成。
14.根据权利要求1所述的装置,其中,所述第一源包括第一贮液器,所述第二源包括第二贮液器,且所述装置还包括阀,所述阀选择性地将所述第一贮液器与所述套管连通或将所述第二贮液器与所述套管连通。
15.根据权利要求1所述的装置,其中,所述第一源包括第一贮液器以及第一泵,所述第一贮液器布置为容纳所述第一液体药剂,所述第一泵布置为将所述第一液体药剂输送到所述套管中,以及所述第二源包括第二贮液器以及第二泵,所述第二贮液器布置为容纳所述第二液体药剂,所述第二泵布置为将所述第二液体药剂输送到所述套管中。
16.根据权利要求1所述的装置,其中,所述第一以及第二源中的一个源布置为以基本恒定的速度提供与其有关的液体药剂。
17.根据权利要求16所述的装置,还包括速度调节器,所述速度调节器使所述基本恒定的速度能够被调节。
18.根据权利要求1所述的装置,其中,所述第一以及第二源中的一个源包括可更换贮液器。
19.一种一次性输液装置,包括:
底座,其布置为粘附到病人皮肤上;
套管,其布置为从所述底座延伸到病人皮肤下,以便将液体药剂输送到病人体内;
第一源,其布置为向所述套管提供第一液体药剂;以及
第二源,其布置为向所述套管提供第二液体药剂;
其中,所述第一源是贮液器以及泵,所述泵将所述第一液体药剂从所述贮液器泵送到所述套管中,以及
其中,所述第二源是端口,其从所述装置外的器械中接收所述第二液体药剂,并将所述第二液体药剂传输到所述套管中。
20.根据权利要求19所述的装置,其中,所述泵是固定体积泵,其以固定体积增量将所述液体药剂输送到所述套管中。
21.根据权利要求20所述的装置,其中,所述固定体积泵包括活塞泵。
22.根据权利要求20所述的装置,其中,所述固定体积泵包括圆顶泵。
23.根据权利要求20所述的装置,其中,所述固定体积泵包括挤压管。
24.一种一次性输液装置,包括:
底座,其布置为粘附到病人皮肤上;
套管,其布置为从所述底座延伸到病人皮肤下,以便将液体药剂输送到病人体内;
第一源,其布置为向所述套管提供第一液体药剂;
第二源,其布置为向所述套管提供第二液体药剂,
其中,所述第一源是容纳所述第一液体药剂的第一贮液器,
其中,所述第二源是容纳所述第二液体药剂的第二贮液器;以及
泵,其将所述第一和/或第二液体药剂泵送到所述套管中。
25.根据权利要求24所述的装置,其中,所述泵是单泵,其与所述套管连通,所述装置还包括阀,所述阀选择性地将所述第一以及第二贮液器连接到所述泵上。
26.根据权利要求24所述的装置,其中,所述泵包括第一泵以及第二泵,所述第一泵将所述第一液体药剂从所述第一贮液器泵送到所述套管中,所述第二泵将所述第二液体药剂从所述第二贮液器泵送到所述套管中,所述装置还包括阀,所述阀选择性地将所述第一泵以及所述第二泵连接到所述套管上。
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- 2007-02-12 US US11/705,812 patent/US8114064B2/en active Active
- 2007-02-12 US US11/705,814 patent/US20070299399A1/en not_active Abandoned
- 2007-02-12 US US11/705,816 patent/US20070299400A1/en not_active Abandoned
- 2007-02-12 US US11/705,813 patent/US20070299398A1/en not_active Abandoned
- 2007-02-12 US US11/705,811 patent/US8758308B2/en active Active
- 2007-02-12 US US11/705,815 patent/US20070299397A1/en not_active Abandoned
- 2007-03-09 CA CA002681456A patent/CA2681456A1/en not_active Abandoned
- 2007-03-09 WO PCT/US2007/006190 patent/WO2007108991A2/en active Application Filing
- 2007-03-09 WO PCT/US2007/006182 patent/WO2007108988A2/en active Application Filing
- 2007-03-09 CN CNA2007800173600A patent/CN101472641A/zh active Pending
- 2007-03-09 WO PCT/US2007/006243 patent/WO2007109006A2/en active Application Filing
- 2007-03-09 EP EP07752851A patent/EP1998839A2/en not_active Withdrawn
- 2007-03-09 EP EP07752909A patent/EP1998841A2/en not_active Withdrawn
- 2007-03-09 EP EP07752791A patent/EP1998827A2/en not_active Withdrawn
- 2007-03-09 CA CA002681789A patent/CA2681789A1/en not_active Abandoned
- 2007-03-09 WO PCT/US2007/006181 patent/WO2007108987A2/en active Application Filing
- 2007-03-09 CA CA002681805A patent/CA2681805A1/en not_active Abandoned
- 2007-03-09 WO PCT/US2007/006115 patent/WO2007108969A2/en active Application Filing
- 2007-03-09 AU AU2007227657A patent/AU2007227657A1/en not_active Abandoned
- 2007-03-09 CN CNA2007800173634A patent/CN101489620A/zh active Pending
- 2007-03-09 JP JP2009500409A patent/JP2009529961A/ja active Pending
- 2007-03-09 JP JP2009500410A patent/JP2009529962A/ja active Pending
- 2007-03-09 AU AU2007227638A patent/AU2007227638A1/en not_active Abandoned
- 2007-03-09 CA CA002681457A patent/CA2681457A1/en not_active Abandoned
- 2007-03-09 JP JP2009500417A patent/JP2009529964A/ja active Pending
- 2007-03-09 JP JP2009500403A patent/JP2009529960A/ja not_active Abandoned
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110141719A (zh) * | 2013-12-19 | 2019-08-20 | 美敦力迷你迈德公司 | 贴身注射器及其使用方法 |
CN112105329A (zh) * | 2018-05-11 | 2020-12-18 | 百时美施贵宝公司 | 用于递送组合疗法的装置和系统 |
US11944588B2 (en) | 2018-05-11 | 2024-04-02 | Bristol-Myers Squibb Company | Devices and systems for delivery of combination therapies |
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