CN1738656A - 一种一次性使用的可佩戴的胰岛素分配装置,这种装置和程序控制器的组合,以及控制这种装置工作的方法 - Google Patents
一种一次性使用的可佩戴的胰岛素分配装置,这种装置和程序控制器的组合,以及控制这种装置工作的方法 Download PDFInfo
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Abstract
一种一次性使用的、可佩戴的、独立的胰岛素分配装置,它包括:壳体2;在所述壳体中的胰岛素源,其适于将胰岛素从所述胰岛素源泵送至一个导管8,以用于将所述胰岛素注射至该装置的使用者身上;所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;粘接层11,其设在所述平的表面上,以用于将所述表面粘接在所述皮肤表面上;和一个可取下的释放片12,其覆盖所述粘接层,以用于在使用所述装置之前保护所述的粘接层,所述释放片带有导管保护装置13,以便包围和保护所述导管的未端部分,使得为了露出所述粘接层而除去所述释放片可使所述未端部分露出;和包括致动器的泵装置,所述致动器包括形状记忆合金金属丝。
Description
本发明大体上涉及可佩戴的药物分配装置,尤其涉及胰岛素分配装置。
在注射胰岛素以治疗I型和II型糖尿病方面,极其重要的特点是操作的简单性、可靠性、成本和灵活性,所有这些都涉及依从问题,特别是在较轻微的II型糖尿病的情况下,该依从是一个涉及治疗病人成功率的重要结果的问题。
本发明的主要目的是要提供一种可佩戴的药物分配装置,尤其是胰岛素分配装置,该装置的特点和工作特性可支持和易于该装置的使用者依从。
本发明提供了一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;和
可取下的释放片,其覆盖所述粘接层,以用于在使用所述分配装置之前保护所述的粘接层,所述释放片带有导管保护装置,以便包围和保护所述导管的末端部分,使得为了露出所述粘接层而除去所述释放片可使所述末端部分露出。
这样,提供了一种容易使用的简单、可靠和成本低的装置,该装置还可以在开始使用它之前有效地保护导管不致损坏和被污染。
在另一个方面中,本发明提供了一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;和
记录和回放装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内,从而可以由所述分配装置记录和回放言语信息。
这样,提供了一种促进健康护理提供者和使用者之间简单通讯的装置,其操作很容易了解,并对坚持服药率具有良好效果。
在又一个方面中,本发明提供了一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;和
用于所述泵装置的致动器,所述致动器包括形状记忆合金金属丝,所述致动器优选地进一步包括棘轮齿轮或棘轮,适于与所述棘轮配合和与所述形状记忆合金金属丝的一端连接的棘爪,和与所述棘爪连接的弹簧装置,所述棘爪和所述金属丝,以及所述棘爪和所述弹簧装置之间的连接使得所述金属丝的收缩可克服所述弹簧装置的弹簧力,使所述棘轮转动。
这样,可以较低的成本提供所需能量非常低而可靠性程度高的泵装置。
在又一个方面中,本发明涉及一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;
用于所述泵装置的致动器,所述致动器优选地包括形状记忆合金金属丝,和
根据程序控制所述致动器工作的控制装置,所述程序由每24小时时间周期所述致动器的一定数量的致动序列组成,或者,与连接到所述控制装置的定时装置的提供相关,所述程序由按照一天的时间而变化的所述致动器的致动序列组成,或者,与连接到所述控制装置的定时装置和用于将数据输入到所述控制装置的输入装置的提供相关,使所述控制装置适于利用所述数据编程,或者使所述控制装置的程序适于包括如下算法,该算法用于根据有关该装置的使用者血液中的实际葡萄糖水平和/或所述使用者摄入的营养的数据的输入而自动改变所述致动器的致动序列。
这样,通过提供一种能够提供非常特殊的、调节得很好的、可以根据单个使用者的特殊进展改变的剂量的装置,可以提高依从性。
为了获得小型分配装置,所述泵装置可以包括用于在所述待分配的药物的圆柱形容器中移动活塞的活塞杆,和用于移动该活塞杆的致动器,其中所述活塞杆构造成使在所述致动器和所述活塞之间的所述活塞杆部分呈线形,而所述活塞杆的其余的部分呈弓形,该活塞杆可以包括布置成一排并且通过铰接元件互相连接的元件,其中每个元件带有一个与所述铰接元件隔开的表面,而且该表面构造成当所述活塞杆呈线形时其邻接相邻元件的相应表面,所述元件可以在其外表面上带有螺纹,以用于与所述致动器的相应螺纹相互配合。
在一个可选择的实施例中,该活塞杆可以包括条带,该条带在该条带的纵向方向的横向具有弓形横截面,其在所述致动器和所述活塞之间呈线形,而该条带的其余部分被绕成卷。该条带可以具有孔,优选地为横向延伸的缝隙,它们沿该条带的长度均匀地隔开,以接纳所述致动器的相应突出。
在再一个方面中,本发明涉及提供如上所述的分配装置和程序控制器的组合,所述分配装置和所述程序控制器包括用于相互数据通讯的配合的发送和/或接收装置,所述程序控制器优选为移动电话或个人计算机或膝上型计算机或手持计算机。
另外,本发明提供了一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;
用于所述泵装置的致动器,所述致动器优选地包括形状记忆合金金属丝,和
根据程序控制所述致动器工作的控制装置,
所述方法包括以下步骤:
为所述控制装置提供数据以用于在开始使用所述分配装置之前和/或之后,产生和/或修改所述程序。
而且,在又一方面,本发明也涉及一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;
记录和回放装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内,从而可以由所述分配装置记录和回放言语信息,和
手动控制所述分配装置的操作的手动操作装置;
所述方法包括下列步骤:
在所述记录装置中记录言语指令,以用于在所述分配装置的操作中给该装置的使用者发指令;和
回放所述言语指令。
最后,本发明涉及一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;和
与所述壳体关联的可编程计算装置,其优选地放置在所述壳体内部;和
信号转换装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内部,并适于将接收的音频信号转换为所述计算装置的输入信号,和将所述计算装置的输出信号转换为音频信号;
所述方法包括下列一个或多个步骤:
将音频信号传送至所述麦克风,以用于控制所述分配装置的工作;
接收从扬声器发出的音频信号,以用于评估所述分配装置的工作。
下面,将结合依照附图中所示的本发明(只是作为例子)的胰岛素分配装置的多种实施例,进一步详细地描述和说明本发明,其中:
图1为在该装置上安装用于将该装置粘接在使用者皮肤上的粘接垫之前,根据本发明的一种一次性使用的胰岛素分配装置的第一实施例的示意性立体图;
图2为从另一个角度看到的在其上已安装了该粘接垫的图1所示的装置的示意性立体图;
图3为图2所示装置的示意性的部分分解立体图;
图4为图2所示装置的完全分解示意图;
图5为连同根据本发明的编程装置的图2所示的装置的示意性立体图;
图6为图2所示装置的根据本发明的形状记忆合金致动器机构的示意性的比例放大的分解图;
图7为与图6相应的示意图,图中表示该形状记忆合金致动器的元件处在互相连接的工作相对位置;
图8为根据本发明的一次性胰岛素分配装置的更小型的第二实施例的示意性立体图;
图9为顶部去除以便显示该装置的配合元件的图8的装置的示意性立体图;
图10为从不同于图9的另一个角度看到的图8的装置的示意性立体图;
图11为图8-10的装置的示意性分解图;
图12a-12c为从卡普尔(carpule)的轴向看到的,图8-11的装置的致动机构的操作的示意性很强的视图,该图显示了棘爪齿轮或棘轮与弹簧元件和形状记忆合金金属丝的相互作用;
图13-15为致动器的第一实施例的示意图,该致动器带有用于本发明的小型分配装置的本发明的柔性活塞杆;
图16为致动器的第二实施例的示意性立体图,该致动器带有用于本发明的小型分配装置的本发明的柔性活塞杆;
图17-19为不同胰岛素分配程序的图表。
通常而言,尽管本发明的装置主要想用于分配胰岛素,但是它也可以用于分配其它药物,例如止痛药,抗生素等。因而每当此处使用术语胰岛素时,其它任何可分配的药物也意味着被术语胰岛素所覆盖,除非由使用术语胰岛素的上下文明确地指出或者暗示其不适用。而且,应当注意的是当使用术语卡普尔时,其绝非由WIPO解答或者商标解释所限定,而是用于表示适合储存和分配医药化合物的任何药筒,容器,安瓿等。
现参见图1,根据本发明的一次性使用的胰岛素分配装置,一般由数字1引用,包括一个不透水的基本上为圆柱形的壳体2。该壳体带有按钮3以用于致动和停止该装置,以及如下面所述,用于启动所谓的推注操作。
如下所述,该壳体还包括一个用于检查该装置工作的透明的窗口4和多个传送声波的孔5。
如下所述,在该壳体2的一个末端设置一个打眼锥6,该打眼锥具有一根尖的针7,该针贯穿与图中未示出的该壳体2内部的胰岛素容器或卡普耳连接的一根导管8。
现参见图2-3,该壳体2固定地容纳在粘接垫10的凹槽9中,所述凹槽9由对皮肤友好的粘接材料的板11(例如在造口袋(ostomy pouch)领域中所熟知的,可参见欧洲专利申请0413250号和欧洲专利申请0092999号)和由附着在该板11上的泡沫材料制成的一个相对可压缩的部分10a的组合形成。导管8穿过该垫10的平面部分11。按钮3由泡沫材料10a保护,从而避免例如当使用者睡着时无意中操作该按钮。
为了保护该板11的粘接表面,将一个滑动释放薄膜12粘在该粘接板11的底面上,使得当将该垫粘接在该分配装置的使用者的皮肤上时,粘接性保持完整。该释放薄膜12带有容纳该导管8和该打眼锥6的针7的一个中空的保护突出部分13,使得在使用该分配装置1之前,该突出部分13可保护该针7和该导管8。如下面结合图4所述,该壳体2带有一个端盖14,通过带有图中没有示出的一个内部弹性体块的一个连通套管15和使该导管8与该壳体2的内部连通的一个连通通道,将该导管8安装在该端盖14上。
在使用中,使用者取下该保护的释放片12,将该针7的尖端露出,使得在将粘接垫10a,11粘附在使用者腹部皮肤上的同时,可以将该针插入皮下。当将该针7和导管8插入皮下且该装置粘接在使用者皮肤上时,除去该打眼锥6,从而使该导管8和该壳体2的内部连通,以便将胰岛素送至该装置使用者的皮下。
当除去它时,该套管15中的弹性体块密封该针7的出口孔,使得胰岛素不能通过所述出口孔泄漏,而只能被迫从卡普耳流至导管8中。
图4表示根据本发明的胰岛素分配装置的元件的分解图。现参见该图,壳体2包含一个存贮和分配胰岛素的容器或卡普耳16。如上所述,该容器或卡普耳16为众所周知的类型,它具有一个容纳导管18的可穿孔的分配突出部分17,用于当该针7从该套管15的内部的所述弹性块缩回时,通过该连通套管15使该容器16的内部与该导管8连通。
一个带有活塞20的轴19容纳于该容器16中,使得该轴向着该分配突出部分17的轴向移动可将胰岛素通过该导管18压至导管8。该轴19由一个形状记忆合金致动器驱动转动和移动。该形状记忆合金致动器将在下面结合图6进行更详细的说明。
用于将动力供给该形状记忆合金致动器的电池21安装在靠近该壳体2的端盖22处。
该形状记忆合金致动器包括一个棘爪齿轮或棘轮23,一个导向套管24,一个弹簧轮25和一条形状记忆金属丝26。下面,将参照图6和7更详细地说明该形状记忆合金致动器的工作。
如下所述,印刷电路板27用于控制该分配装置的功能和其各个工作步骤。
最后,为了下述的目的,在该壳体2内部,靠近该接收和发射声波的孔5的地方,设置一个组合式麦克风/扬声器28。
现参见图5,靠近该分配装置示出一个具有编程键30和显示器31的编程装置或控制器29,用于与图中没有示出的设置在该壳体2内部的接收机/发送机进行通讯。该通讯可利用红外信号或其他适当的信号发生。这些信号从通向该控制器29的内部的发送器/接收器的开口32传至该壳体2的端盖22上的通至在该壳体2内的所述没有示出的发送器/接收器的开口33(见图2);和从该开口33传至该开口32。
现参见图6和图7,通过棘轮23在R2方向的逆时针旋转,使轴19在箭头R1方向轴向移动,从而导致与内螺纹37啮合的螺纹36作所述的轴向移动,从而使活塞20进一步移动进入卡普耳16中,通过导管18,将胰岛素分配至导管8(图4)。
棘轮23的旋转是利用附着在导电杆38和39上的形状记忆合金(例如,镍钛诺)金属丝26进行的,所述导电杆分别固定在位于不导电的导向套管24的凹部40和位于导电的弹簧轮25的凹部41中。
该凹部40上设置图中没有示出的电触点,用于使该杆39与电池21电连接,以将电流按照印刷电路板27中的程序元件所控制的方式和顺序,供给SMA金属丝26,以加热该金属丝。
该弹簧轮25具有U形的弹簧臂44和45,用于分别在向着该棘轮23的中心的方向上将弹簧力加在其末端46和47上,从而使该末端46和47恒定地受到偏压,以与该棘轮23的齿啮合。
止动销42和43与印刷电路板27电连接,用于当该弹簧轮臂48与所述止动销接触时,向其发出电信号。
如上所述,该杆38与电源电连接,使电流可以流过该杆38,金属丝26,杆39,环形凹部41和弹簧轮25,以加热该金属丝26,从而使该金属丝收缩,并利用与该弹簧轮的一个齿啮合的臂末端46,使该棘轮在箭头R2方向转动一个齿的距离,直至该臂48与该止动销42接触,将信号发射至控制印刷电路板27为止。这样,通过该金属丝26的电流中断,该SMA金属丝26冷却和膨胀。
另一个臂末端47,如同一个棘爪一样,与该棘轮23的一个齿啮合,并防止该棘轮23沿顺时针方向转动。弹簧轮25在切线方向的弹簧作用使臂42向后运动,与该止动销43接触,从而拉紧该膨胀的SMA金属丝26。
还可利用从该止动销42和43发出的信号指示泵的正确工作和作为通过该导管8施加的剂量数目的指示。
现在参考图8-12,根据本发明的医疗泵51的更小型的第二实施例包括壳体上部52和壳体下部53,上部52具有:声孔54,其允许音频信号相对不受阻碍地通过上部52的壁进出音频元件54a,推注按钮孔55,其允许推注按钮56的下压,和检查孔57,其由透明元件57a覆盖,以允许监视设在壳体中的胰岛素卡普尔58的内含物。
下部53附着到由释放片覆盖的粘接垫59,并带有与图1-4的实施例的相应元件非常类似的针保护突出或缺口61。卡普尔58以与图1-4的实施例所述的同样方式配合导管/打眼锥组件62。
图8-12的实施例在结构和操作上非常类似于图1-4的实施例,不同之处在于刚性线形轴或活塞杆19由本发明的柔性活塞杆63和形状记忆合金金属丝致动器的设计所代替,这将在下面进行描述。
对应于图4的活塞20的活塞64连接到柔性活塞杆63的一端,该柔性活塞杆63由一系列元件65组成,这些元件65通过铰接机构66(见图13-15)互相连接并且布置成在两个引导壁63a和63b之间移动。活塞64邻接卡普尔58的可移动壁或活塞66,从而活塞64的移动将胰岛素从卡普尔58挤出而进入导管组件62。
元件65通过铰链66互相形成一体,该铰链66允许相邻的元件相对于彼此从图14a所示的互相邻接的位置枢转到图14b所示的位置,其中在图14a所示的位置,元件65一起形成线形活塞杆,邻接表面65a和铰链66提供刚性,从而使得活塞杆63能够对卡普尔的活塞66施加压力而不会侧向偏转,在图14b所示的位置,所述元件彼此离开地枢转,从而允许活塞杆63的弯曲,这允许该装置具有小型的结构,并且活塞杆的初始主要部分沿着卡普尔68的长度延伸。
柔性活塞杆63的材料可以是任何合适的可模塑材料,但是由于费用和重复利用问题,它优选地为诸如Nylon和POM这样的塑料材料。
每个元件65在具有圆柱形构造的元件的两个相对部分69和70上带有外螺纹67,以允许棘爪齿轮或棘轮72(图12)的内螺纹71与之啮合,从而棘轮72的旋转将活塞杆63移动到卡普尔58中。至少与铰链66一致的元件65的侧面是平面,以允许铰链的实际模制。当由棘轮72的内螺纹71轴向移动时,该平的侧面或平的相对侧面也允许阻止活塞杆63绕其轴旋转。
棘轮72由形状记忆合金致动器旋转,该致动器包括诸如镍钛诺(Nitinol)的形状记忆合金的金属丝73,该金属丝的一端连接铆钉74,另一端通过卷曲部76连接致动器弹簧杆75的自由端。金属丝73围绕销73a延伸以改变方向。致动器弹簧杆75的自由端定位成使得它啮合棘轮72的齿并且被所述杆的弹簧力偏压以在切向(箭头R1)和径向(箭头R2)施加弹簧力。两个端止动销77和78限制了致动器弹簧杆端部75的切向运动。
爪簧杆79定位成使得其端部啮合棘轮72的齿并且被偏压以在径向(箭头R3)施加弹簧力。爪簧杆79的该端部被两个止动销80大幅限制,从而只能基本上在径向移动。
电池81将能量供应给镍钛诺金属丝73的端部以加热它而导致它收缩。电池81通过柔性印刷电路薄膜连接到铆钉74和卷曲部76,在该印刷电路薄膜上包含了加热和冷却金属丝73的任何程序化顺序以及该装置的任何其它电控制功能所必需的控制电路。
棘轮72沿箭头R4的逆时针方向的旋转如图12a-12c所示地发生。在图12a中,金属丝73冷却并膨胀,从而致动器弹簧杆端部75处于邻接端止动销78的最右边位置。爪簧末端79锁定棘轮72以阻止顺时针旋转。
在图12b中,镍钛诺金属丝73被加热并且收缩,由此克服弹簧力R1和R2而向左边牵引致动器杆末端75直到它邻接端止动销77。
在图12c中,镍钛诺金属丝73被冷却并且致动器弹簧杆末端75逆时针转动棘轮72直到再次邻接端止动销78,同时爪杆端部克服弹簧力R3而齿合。由此,棘轮被旋转了其一个齿的圆周距离。
当棘轮旋转时,与柔性活塞杆元件65的螺纹67啮合的该轮的内螺纹71将活塞杆63移动到卡普尔58中以用于通过导管62分配胰岛素。
端止动销77和78电连接到柔性印刷电路板薄膜82,从而可以通过记录表示致动器正确运行的、端止动销77和78与弹簧杆端部75之间的电接触来监视致动器的正确运行。
柔性活塞杆63也可以通过其它致动器被移动,例如在图1-4的实施例中所描述的。
现在参考图16,与图8-11中所述的相同的卡普耳58位于通常由数字90表示的致动器附近,并且该致动器的活塞91邻接卡普耳的不可见活塞66。
活塞91连接到钢带92的一端,该端在与沿该带的纵向垂直方向具有弓形横截面。该弓形形状导致了抵抗侧向偏转的带92的刚性,从而该带可以将压力传送到活塞91而不会由于侧向偏转而塌缩。
一排等间距的延伸孔93设在该带92中以用于接纳辊95的肋94,该辊95具有啮合涡轮97的齿轮96。可以类似于图6-7或8-12的形状记忆合金致动器的致动器致动该涡轮。
通过旋转涡轮97,齿轮96和辊95被旋转,由此容纳在狭缝93中的肋94从辊解开带92并且将它移动到卡普耳中,由此活塞91移动卡普耳活塞并从卡普耳58分配胰岛素,该卡普耳以与图8-12的卡普耳58相同的方式位于分配装置中。
依靠电路板27的各种控制元件的设计和编程,根据本发明的医药分配装置或胰岛素泵可以有几种不同的工作方式。
1、流量恒定的独立泵
该泵起到恒流泵的作用,并且可以设计成不同流速,例如20单位/24小时,30单位/24小时等。通过压下该推注按钮3并按下去,泵送程序开始;再向下压该按扭3并按住它,泵送程序结束,而在该推注按钮3上的短时间的按压启动一定量的胰岛素的推注附加剂量。
图17示出了该类型的一个可能设计,其中线100表示对应于50单位/24小时的恒定流速,在开始之后的20和21小时之间停止流动,其由101表示。推注额外的剂量由102和103表示。其它的流速用虚线表示。
2、流量变化的独立泵
将一个定时装置加在印刷电路板27上,从而使一个标准程序控制该泵在重复的24小时周期所分配的流量。预先编程的操作指令可例如使晚上的剂量比白天的剂量小,和在进餐时间给于额外的剂量。
图18示出了该类型的一个可能设计,其中线104表示夜晚剂量105,白天剂量106,进餐时间剂量107,剂量暂停108和推注109。其它的剂量程序由虚线表示。
3、1型可编程泵:
该泵不带有预先确定的程序,但在印刷电路板27中带有一个可编程部件,可以由使用者或医生利用控制器29编程。编程必须能通过有该分配装置提供于其中的包装材料进行,使得使用者可在假期中或类似时,不必携带控制器,即可用消毒包装运输该装置。该控制器为专用部件,例如可以通过USB插头与PC连接,或者可以带有移动电话传输数据的能力。这样,该控制器可由医生或使用者编程,并用于所有随后使用的一次性分配装置的工作编程。
4、2型可编程泵:
这个泵以与1型可编程泵同样的方式工作,但控制器为掌上型控制器或膝上型PC。这样有一个附加的优点是,使用者可将健康信息和葡萄糖水平测量结果直接输入该控制器或编程部件中,从而将这种信息通知医生。当医生决定是否要为随后使用的一次性分配装置改变该控制器或编程部件的编程功能时,可利用这个信息。
5、带有音频输入和输出的可编程泵
通过使该分配装置配备麦克风/扬声器28和在该印刷电路板27上设置适当的记录/回放芯片,可以由该分配装置记录短信息,并且当适当地操纵该推注按钮3或安装在该壳体2上的单独的记录按钮(没有示出)时,由该装置发射该短信息。
利用这种音频能力,使用者可以记录用言语表达的关于葡萄糖水平,膳食组成,锻炼等的信息。定时器可以记录每一个记录信息的时间。然后,医生可以使用这些记录的信息以及关于推注剂量的数目和时间、泵送停止和分配胰岛素用的程序的信息,以评估治疗和决定改变编程和给病人的指令。这些指令由医生通过移动电话等记录下来,使得可在预先确定的时间,将信息自动地传达给使用者。例如,这种信息可以为“记得测量您的葡萄糖水平”(每天早晨8点钟,由该分配装置传达给使用者的信息程序)等。
另外,在编程线路中可以包括标准的指令,使该泵可以将言语信息,而不是音频信号(例如嘟嘟声)传达给使用者。例如,该信息可以为:“泵停止了”或“这是您连续第三个推注,并且您今天总共使用了八个推注剂量”或“该泵将在二小时内排空”等。一般来说,在依从性方面,上述的音频能力使该带有这种能力的分配装置对使用者更友好,特别是对开始治疗或不是十分熟悉的使用者更友好。
6、闭环可重新编程的泵:
该控制器或安装在印刷电路板27上的计算部件可以编程,以对关于关于使用者输入的血液中实际的葡萄糖水平的信息以及其它信息(例如有关最后一餐的时间和构成的数据)做出反应,从而考虑这个信息而改变分配流量或剂量的程序,使得该分配装置在一定程度上可构成一个闭环、模糊逻辑、半自动自行重新编程的胰岛素分配装置。
现在参考图19,该图表示一种分配程序,其可以用于泵类型3-6,其中流速根据时间和/或输入数据而变化。
该可编程控制器29可以为一个无绳的移动通讯装置,例如,通过发送至发送器/接收器28和由发送器/接收器28接收的音频信号,与分配装置进行通讯的移动电话。为了避免外部的音频信号干扰使该装置的程序,该传输应由识别码开始和结束。可以利用其他信号辨识或保护程序(例如加密)。为了改变安装在印刷电路板27上的该可重新编程的计算部件的程序,可将音频信号转换为控制信号。
信号转换装置可将由接收器接收的音频信号转换为该计算装置的输入信号;和将该计算装置的输出信号转换为由扬声器传送的音频信号。
还可利用无线的所谓的SMS信号,例如通过IR信号或所谓的蓝牙通讯技术,在无绳移动通讯部件和该分配装置之间传送信息。
虽然,本发明的基本概念为整个装置是一次性使用的,但可以有一种变型,即具有记录和回放元件和相应的电池,并且可能具有带有计算部件的电路板的接收器/发送器部件28是可重复使用的,并可易松开地容纳于该装置的一次性使用部分上提供的一个座中。
Claims (31)
1.一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;和
可取下的释放片,其覆盖所述粘接层,以用于在使用所述分配装置之前保护所述的粘接层,所述释放片带有导管保护装置,以便包围和保护所述导管的末端部分,使得为了露出所述粘接层而除去所述释放片可使所述末端部分露出。
2.如权利要求1所述的分配装置,其中所述导管保护装置包括在所述释放片中的缺口。
3.一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;
记录和回放装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内,从而可以由所述分配装置记录和回放言语信息。
4.一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;和
用于所述泵装置的致动器,所述致动器包括形状记忆合金金属丝。
5.如权利要求4所述的分配装置,其中所述致动器还包括棘轮齿轮或棘轮,适于与所述棘轮配合和与所述形状记忆合金金属丝的一端连接的棘爪,和与所述棘爪连接的弹簧装置,所述棘爪和所述金属丝,以及所述棘爪和所述弹簧装置之间的连接使得所述金属丝的收缩可克服所述弹簧装置的弹簧力,使所述棘轮转动。
6.一种一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置,它包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;
用于所述泵装置的致动器,优选为包括形状记忆合金金属丝的致动器;和
根据程序控制所述致动器工作的控制装置。
7.如权利要求6所述的分配装置,其中所述程序由每24小时时间周期所述致动器的一定数量的致动序列组成。
8.如权利要求6所述的分配装置,它还包括与所述控制装置连接的定时装置,其中所述程序由按照一天的时间变化的所述致动器的致动序列组成。
9.如权利要求6所述的分配装置,它还包括:
与所述控制装置连接的定时装置;
将数据输入所述控制装置的输入装置,所述控制装置可利用所述数据编程。
10.如权利要求9所述的分配装置,其中所述控制装置的程序包括根据关于装置的使用者血液中的实际葡萄糖水平和/或所述使用者摄入的营养的数据的输入而自动改变所述致动器的致动序列的算法。
11.如权利要求3-10中任一所述的分配装置,它还包括:
导管,其用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;和
可取下的释放片,其覆盖所述粘接层,以用于在使用所述分配装置之前保护所述的粘接层,所述释放片带有导管保护装置,以便包围和保护所述导管的未端部分,使得为了露出所述粘接层而除去所述释放片可使所述未端部分露出。
12.如权利要求11所述的分配装置,其中所述导管保护装置包括在所述释放片中的缺口。
13.如权利要求1-2和4-10中任一所述的分配装置,它还包括:
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;和
记录和回放装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内,从而可以由所述分配装置记录和回放言语信息。
14.如权利要求4-5中任一所述的分配装置,它还包括根据程序控制所述致动器工作的控制装置。
15.如权利要求14所述的分配装置,其中所述程序由每24小时时间周期所述致动器的一定数量的致动序列组成。
16.如权利要求14所述的分配装置,它还包括与所述控制装置连接的定时装置,其中所述程序由按照一天的时间变化的所述致动器的致动序列组成。
17.如权利要求14所述的分配装置,它还包括:
与所述控制装置连接的定时装置;
将数据输入所述控制装置的输入装置,所述控制装置可利用所述数据编程。
18.如权利要求17所述的分配装置,其中所述控制装置的程序包括根据关于装置的使用者血液中的实际葡萄糖水平和/或所述使用者摄入的营养的数据的输入而自动改变所述致动器的致动序列的算法。
19.如上述任一权利要求所述的分配装置,其中所述泵装置包括用于在所述待分配的药物的圆柱形容器中移动活塞的活塞杆,和用于移动所述活塞杆的致动器,其中所述活塞杆构造成使在所述致动器和所述活塞之间的所述活塞杆部分呈线形,而活塞杆其余的部分呈弓形。
20.如权利要求19所述的分配装置,其中所述活塞杆包括布置成一排并且由铰接元件互相连接的元件。
21.如权利要求19所述的分配装置,其中每个元件带有一个表面,该表面与所述铰接元件隔开并且构造成当所述活塞杆呈线形时邻接相邻元件的相应表面。
22.如权利要求20或21所述的分配装置,其中所述元件可以在其外表面上带有螺纹,以用于与所述致动器的相应螺纹相互配合。
23.如权利要求19所述的分配装置,其中所述活塞杆包括条带,该条带在该条带的纵向方向的横向具有弓形横截面。
24.如权利要求23所述的分配装置,其中所述条带在所述致动器和所述活塞之间呈线形,而该条带的其余部分被绕成卷。
25.如权利要求23或24所述的分配装置,其中所述条带具有孔,优选地为横向延伸的缝隙,它们沿该条带的长度均匀地隔开,以用于接纳所述致动器的相应突出。
26.如权利要求6-25任一所述的分配装置和程序控制器的组合,所述分配装置和所述程序控制器包括用于相互数据相互通讯的协同的发送和/或接收装置。
27.根据权利要求26所述的组合,其中所述程序控制器为移动电话或个人计算机或膝上型计算机或手持计算机。
28.一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上;
用于所述泵装置的致动器,优选为包括形状记忆合金金属丝的致动器,和
根据程序控制所述致动器工作的控制装置,
所述方法包括以下步骤:
为所述控制装置提供数据,以用于在开始使用所述分配装置之前和/或之后,产生和/或修改所述程序。
29.一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;
记录和回放装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内,从而可以由所述分配装置记录和回放言语信息,和
手动控制所述分配装置的操作的手动操作装置;
所述方法包括下列步骤:
在所述记录装置中记录言语指令,以用于在所述分配装置的操作中给该装置的使用者发指令;和
回放所述言语指令。
30.一种控制一次性使用的、可佩戴的、独立的药物分配装置,尤其是胰岛素分配装置的工作的方法,该装置包括:
壳体;
在所述壳体中的胰岛素源;
在所述壳体中的泵装置,其适于将胰岛素从所述胰岛素源泵送至导管,以用于将所述胰岛素注射至该装置的使用者身上,所述导管与所述壳体关联,并与所述壳体的基本上平的表面基本垂直地突出,所述平的表面用于紧靠该装置的使用者的皮肤表面;
粘接层,其设在所述平的表面上,以用于将所述平的表面粘接在所述皮肤表面上;
与所述壳体关联的组合式麦克风和扬声器,其优选地放置在所述壳体内;和
与所述壳体关联的可编程计算装置,其优选地放置在所述壳体内部;和
信号转换装置,其与所述组合式麦克风和扬声器连接,并与所述壳体关联,其优选地放置在所述壳体内部,并适于将接收的音频信号转换为所述计算装置的输入信号,和将所述计算装置的输出信号转换为音频信号;
所述方法包括下列一个或者多个步骤:
将音频信号传送至所述麦克风,以用于控制所述分配装置的工作;
接收从扬声器发出的音频信号,以用于评估所述分配装置的工作。
31.控制根据权利要求6-25任一所述的分配装置的操作的方法,所述方法包括以下步骤:为所述控制装置提供数据以用于在开始使用所述分配装置之前和/或之后,产生和/或修改所述程序。
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2003
- 2003-12-19 AT AT03779766T patent/ATE385814T1/de not_active IP Right Cessation
- 2003-12-19 AU AU2003287926A patent/AU2003287926A1/en not_active Abandoned
- 2003-12-19 DE DE60319142T patent/DE60319142T2/de not_active Expired - Lifetime
- 2003-12-19 WO PCT/DK2003/000916 patent/WO2004056412A2/en active IP Right Grant
- 2003-12-19 DK DK03779766T patent/DK1583571T3/da active
- 2003-12-19 EP EP03779766A patent/EP1583571B1/en not_active Expired - Lifetime
- 2003-12-19 JP JP2004561091A patent/JP2006511263A/ja active Pending
- 2003-12-19 CN CNA2003801087835A patent/CN1738656A/zh active Pending
-
2005
- 2005-06-21 US US11/157,479 patent/US7785288B2/en active Active
-
2010
- 2010-06-18 US US12/818,830 patent/US8469920B2/en active Active
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2012
- 2012-12-05 US US13/705,638 patent/US8801655B2/en not_active Expired - Lifetime
-
2014
- 2014-08-01 US US14/449,439 patent/US9308319B2/en not_active Expired - Lifetime
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Cited By (9)
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CN101808681B (zh) * | 2007-09-28 | 2012-10-10 | 凯利宝医疗公司 | 具有双阀系统的一次性输注装置 |
CN104906656A (zh) * | 2010-04-21 | 2015-09-16 | 艾伯维生物技术有限公司 | 用于治疗药剂的受控输送的可佩戴自动注射装置 |
CN104906656B (zh) * | 2010-04-21 | 2020-01-10 | 艾伯维生物技术有限公司 | 用于治疗药剂的受控输送的可佩戴自动注射装置 |
CN104043159A (zh) * | 2013-03-14 | 2014-09-17 | 精工爱普生株式会社 | 液体输送装置以及液体输送方法 |
CN107847665A (zh) * | 2015-09-25 | 2018-03-27 | 泰尔茂株式会社 | 给药液装置 |
CN107847665B (zh) * | 2015-09-25 | 2020-06-30 | 泰尔茂株式会社 | 给药液装置 |
CN109414546A (zh) * | 2016-06-23 | 2019-03-01 | 特克法马许可公司 | 用于药物输送装置的分段式活塞杆 |
CN106362248A (zh) * | 2016-08-25 | 2017-02-01 | 吴建耀 | 用于智能药物输注系统的贴附板及智能药物输注系统 |
CN111032119A (zh) * | 2017-06-20 | 2020-04-17 | 瓦莱里塔斯有限公司 | 液压药剂输送装置的延时机构 |
Also Published As
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US8469920B2 (en) | 2013-06-25 |
US7785288B2 (en) | 2010-08-31 |
WO2004056412A3 (en) | 2004-09-30 |
EP1583571B1 (en) | 2008-02-13 |
US8801655B2 (en) | 2014-08-12 |
US9308319B2 (en) | 2016-04-12 |
DK1583571T3 (da) | 2008-06-16 |
US20130102964A1 (en) | 2013-04-25 |
AU2003287926A8 (en) | 2004-07-14 |
ATE385814T1 (de) | 2008-03-15 |
JP2006511263A (ja) | 2006-04-06 |
US20160184513A1 (en) | 2016-06-30 |
US20050273059A1 (en) | 2005-12-08 |
EP1583571A2 (en) | 2005-10-12 |
AU2003287926A1 (en) | 2004-07-14 |
DE60319142T2 (de) | 2009-02-05 |
US20100256565A1 (en) | 2010-10-07 |
WO2004056412A2 (en) | 2004-07-08 |
US20140343496A1 (en) | 2014-11-20 |
DE60319142D1 (de) | 2008-03-27 |
US9757512B2 (en) | 2017-09-12 |
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