CN1511048A - 流体泵的滴注装置 - Google Patents

流体泵的滴注装置 Download PDF

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CN1511048A
CN1511048A CNA028102037A CN02810203A CN1511048A CN 1511048 A CN1511048 A CN 1511048A CN A028102037 A CNA028102037 A CN A028102037A CN 02810203 A CN02810203 A CN 02810203A CN 1511048 A CN1511048 A CN 1511048A
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拉里·B·格雷
贾里德·哈米尔顿
理查德·拉尼根
布里安·特雷西
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Abstract

一种医疗设备,用于从终结于管针头的一条输运线向病人输送流体。医疗设备包括一个套管组件,用来将流体连接至插入病人身体的套管。套管组件具有相对于套管放置在固定位置的第一锁紧元件。滴注瓣将输运线连接到套管组件上。滴注瓣包括第二锁紧元件,用来与套管组件的第一锁紧元件接合;和提升片,用来将滴注瓣从套管组件上分开。第一和第二锁紧元件的接合需要滴注瓣相对于套管组件的最初配合。

Description

流体泵的滴注装置
技术领域和背景技术
本发明涉及将流体输送给病人的系统和方法,更具体地说,本发明涉及流体泵的滴注装置,它们可以用于把胰岛素等输送给病人。
目前,基本上有两种方法治疗糖尿病。一种方法是每天给病人多次注射长效胰岛素。第二种办法是为了更接近胰腺的功能给病人连续输送短效胰岛素。这可以通过使用注射器泵来实现。
注射器泵通常包括四个主要组件。这些组件是微处理器控制的注射器泵,充满了胰岛素的注射器,插座和管装置,以及套管。
注射器泵通过象传呼机那样佩带在病人皮带上的便携盒中,或者放置在口袋或乳罩中。注射器安装在注射器泵中并且成放足够三天使用的胰岛素。插座起到注射器和管装置之间对接的作用。在管装置的一端是通常由钢或特氟纶制造的套管。套管可以有利地放置在套管组件中。套管组件通常利用粘接剂连在病人身上,并且放置在腹部附近肚脐的一侧。将套管插入脂肪组织以在皮下注射胰岛素。
泵可能会妨碍或者使得病人不能进行一些活动,这种情况包括病人要洗澡或者进行体育运动。如果把包括套管在内的每个部件都移去,那么在将系统重新连接到病人身上时病人就会再挨一针。由于不想每次洗澡或运动后都挨一针,当前技术的管装置在套管组件处或靠近该处脱离开,同时遮盖住管以防止污染。有时候脱开和再连接管装置是困难的。
具有钢制皮下注射针头的套管已经和注射器泵一起使用很多年了。但是钢针会引起刺痛和不舒服的感觉。软的套管,如特氟纶制造的套管,可以帮助消除这种不舒服并且在本领域已经广为人知。软套管需要用钢制插入针头穿透皮肤和/或其它组织。在插入针头时,针头穿透套管外套中的第一个自密封隔膜。然后针头穿过软套管直到它伸出套管的外尖端。在将针头插入皮肤后,移去针头并且第一隔膜密封插入针头进入所引起的开口。然后通过在管装置的端部将管针头插入到套管外套中的第二个隔膜中使管装置与套管连接。
在移开插入针头后,第一个隔膜可能容易引起泄露的问题。在受压下这种泄露可能更普遍,例如当套管堵塞时。通常在发生堵塞时,压力达到一个阈值并且触发泵中的警报器。但是,如果第一个隔膜发生泄露,压力可能永远也达不到阈值,所以泵就一直输送胰岛素。这样,胰岛素就不停地从第一个隔膜泄露出去,永远也不会触发警报器,从而病人在一个不确定的时期内根本就不知道没有接收到药物。
发明内容
在本发明的第一个实施例中提供一种医疗设备,用于从终结于管针头的一条输运线向病人输送流体。医疗设备包括套管组件,用来将流体连接至插入病人身体的套管。套管组件具有相对于套管放置在固定位置的第一锁紧元件。滴注瓣将输运线连接到套管组件。滴注瓣包括第二锁紧元件和提升片,第二锁紧元件与套管组件的第一锁紧元件接合,而提升片用来将滴注瓣与套管组件分开。第一和第二锁紧元件的接合需要滴注瓣和套管组件的最初配合,随后将滴注瓣相对于套管组件转动以实现锁紧。
在相关的实施例中,套管组件可以包括隔膜外套,它限定了与套管接合的芯。隔膜外套包括位于芯内第一位置的第一隔膜,使得当滴注瓣和套管组件锁紧时,管针头穿透第一隔膜以允许输运线和套管之间的流体连通。隔膜外套还可以包括位于芯内第二位置的第二隔膜,使得可以通过第二隔膜将插入针头引入套管。
在另一个本发明相关的实施例中,套管组件进一步包括一个柔性管,它与套管和隔膜流体连通。当柔性管在第一位置时,可以通过隔膜将插入针头引入套管,当柔性管在第二位置时,通过隔膜引入的管针头允许输运线和套管之间的流体连通。
在本发明的另一个相关实施例中,设备进一步包括一个插入瓣。插入瓣包括穿透隔膜的插入针头,插入针头终结于一个尖锐末端,该末端略微越过套管的末端。插入瓣具有和自动插入装置接合的界面。
在另一个相关实施例中,第一锁紧元件是锁紧凸耳,第二锁紧元件是凸耳容纳器,反之亦可。套管组件可以包括柔软的过成型(overmold)体。
根据本发明的一个实施例,提供一种医疗设备,用于从终结于管针头的一条输运线向病人输送流体,该设备包括用来插入病人身体的套管。一根柔性管与套管和隔膜流体连通。当柔性管在第一位置时,可以通过隔膜将插入针头引入套管,当柔性管在第二位置时,通过隔膜插入的管针头允许输运线和套管之间的流体连通。
根据本发明相关的实施例,设备进一步包括滴注瓣和套管组件,其中滴注瓣包括管针头,套管组件包括套管。当滴注瓣和套管组件接合时,管针头穿过隔膜以允许输运线和套管之间的流体连通。该设备进一步包括将滴注瓣固定到套管组件上的锁紧机构。锁紧机构可以包括滴注瓣上的锁舌,锁舌插入套管组件上的锁舌容纳器。作为另一个例子,锁紧机构可以包括位于包含隔膜的隔膜外套上的第一锁紧元件,和位于滴注瓣上的第二锁紧元件。将第一和第二锁紧元件连接在一起可能需要滴注瓣和套管组件的最初配合,以及随后的相对于套管组件转动滴注瓣的锁紧。在各个实施例中,第一锁紧元件是锁紧凸耳,第二锁紧元件是锁紧凸耳容纳器,反之亦可。在各个实施例中,隔膜外套可以旋转到一个允许滴注瓣和隔膜外套接合在一起的接合位置并且相对于套管组件转动滴注瓣以将滴注瓣锁紧到隔膜外套上。然后可以将隔膜外套旋转到稳定的位置,这个位置防止滴注瓣的转动。
根据本发明的另一个实施例,提供一种方法,用于从终结于管针头的一条输运线向病人输送流体。该方法包括穿过隔膜和套管插入插入针头,隔膜和套管具有相对的定向。套管插入病人的组织。在从套管和隔膜中拔出插入针头后,管针头穿过隔膜插入。隔膜和套管的相对定向改变并且流体通过输运线和套管输送。
根据本发明的另一个实施例,提供一个与流体输送装置连接的管装置,流体输送装置包含与套管组件流体连通的流体源。管装置包括一定长度的管,管具有第一端和第二端。与第一端连接的插座用来连接流体输送装置。插座包括控制器,控制器允许流体输送装置从第一种结构转换到第二种结构。滴注瓣与第二端连接以连接套管组件。
在本发明的另一个相关实施例中,流体输送装置的第一种结构是蓄液装载位置,第二种结构是操作位置。控制器能够允许流体输送装置从第二种结构转换到第一种结构。控制器可以包括与流体输送装置对接的凸缘。在另外的实施例中,控制器可以包括连接流体输送装置的电路,或者产生光信号和磁信号中的一种。插座可以包括卢尔(luer)连接器用来和流体输送装置接合。
在本发明另一个相关的实施例中,流体输送装置可以是一个滴注泵,泵具有容积可变的蓄液器和驱动组件。驱动组件包括一个筒,在筒端有一个间隙孔,筒的特征在于一条纵向的筒旋转轴线。驱动组件进一步包括插入间隙孔的活塞杆,和具有外螺纹的转动驱动螺杆。通过相对筒轴线转动筒,外螺纹可移动地与活塞杆上的螺纹啮合。在第一种结构时,外螺纹和活塞杆上的螺纹啮合,在第二种结构时,外螺纹和活塞杆上的螺纹分离。控制器能够允许筒转动以使杆螺纹与驱动螺杆螺纹机械啮合或分离。控制器可以包括凸缘,用来移走筒上的锁片,允许筒转动。
根据本发明的另一个实施例,提供一个用来和流体输送装置连接的管道。管道包括一定长度的管,管具有第一端。与第一端连接的插座用来连接流体输送装置。插座包括控制器,控制器允许流体输送装置从第一种结构转换到第二种结构。
在本发明的一个相关实施例中,第一种结构可以是蓄液装载位置,第二种结构是操作位置。插座可以包括卢尔(luer)连接器用来和流体输送装置接合。控制器可以包括与流体输送装置对接的凸缘。控制器可以包括到流体输送装置的电子电路,或者产生光信号和磁场中的一种。
在本发明的另一个实施例中,提供一种方法用来从流体输送装置向多孔介质提供流体。该方法包括将永久性固定在管装置上的插座与流体输送装置连接。通过插座控制流体输送装置的结构。管装置与多孔介质连接以允许流体从流体输送装置流动到多孔介质。
在本发明相关的实施例中,控制流体输送装置的结构可以包括允许泵从第一结构移动到第二结构。流体输送装置的第一种结构可以是装载位置,第二种结构可以是操作位置。控制流体输送装置的结构可以包括在插座上移动凸缘或产生磁场或光信号中的一种。流体输送装置可以是滴注泵。
附图的简要说明
通过下面的详细描述并参考附图可以更容易理解本发明前面的特征,其中附图包括:
图1是根据本发明一个实施例的向病人输送流体的滴注装置10的透视图;
图2是根据本发明一个实施例的示于图1中的滴注装置的进一步分解图;
图3是根据本发明一个实施例的套管组件的横截面视图,其中套管组件上连接(和锁紧)着滴注瓣;
图4是根据本发明一个实施例的滴注瓣连接(和锁紧)到套管组件上的横截面视图;
图5是图4的实施例的侧视图,其中滴注瓣位于与套管组件接合的位置;
图6是图4的实施例的透视图,其中滴注瓣与套管组件接合;
图7是图4实施例的顶视图,其中管装置锁紧到套管组件上;
图8是图4实施例的侧视图,其中管装置锁紧到套管组件上;
图9是根据本发明一个实施例的滴注瓣接合(和锁紧)到套管组件上的横截面视图,其中套管组件包括包含在隔膜外套中的第一隔膜和第二隔膜;
图10是图9实施例的顶视图,其中滴注瓣位于与套管组件接合的位置;
图11是图9实施例的侧视图,其中滴注瓣位于与套管组件接合的位置;
图12是图9实施例的透视图,其中滴注瓣与套管组件接合;
图13是根据本发明一个实施例的滴注瓣接合(和锁紧)到套管组件上的横截面视图,其中套管组件包括位于可转动隔膜外套中的单一隔膜;
图14是图13实施例的透视图,其中滴注瓣位于与套管组件接合的位置;
图15是图13实施例的侧视图,其中滴注瓣位于与套管组件接合的位置;
图16是图13实施例的透视图,其中滴注瓣接合并锁紧到套管组件上;
图17是图13实施例的侧视图,其中滴注瓣接合并锁紧到套管组件上;
图18是图13实施例的透视图,其中滴注瓣锁紧在隔膜外套上并且隔膜外套旋转90度;
图19是根据本发明一个实施例的滴注瓣的横截面视图,其中滴注瓣包括单独一个位于可旋转隔膜外套中的隔膜;
图20是图19实施例的透视图,其中滴注瓣位于与套管组件接合的位置;
图21是图19实施例的顶视图,其中滴注瓣位于与套管组件接合的位置;
图22是图19实施例的侧视图,其中滴注瓣位于与套管组件接合的位置;
图23是图19实施例的透视图,其中滴注瓣接合到套管组件1902上;
图24是图19实施例的侧视图,其中滴注瓣接合到套管组件1902上;
图25是图19实施例的透视图,其中通过转动滴注瓣25使锁紧凸耳与凸耳容纳器配合;
图26是图19实施例的透视图,其中锁紧凸耳已经与凸耳容纳器配合并且旋转了隔膜外套1904;
图27是根据本发明一个实施例的插座和滴注泵的最高层视图;
图28是图27的滴注泵驱动机构的分解视图;
图29示出了图27的泵筒锁紧机构的一个实施例;
图30是图27的泵筒锁紧机构的分解视图;
图31示出了当图27的滴注泵处于装载位置时驱动螺杆与活塞杆之间的关系;
图32示出了当图27的滴注泵处于已配合位置时驱动螺杆与活塞杆之间的关系;
图33示出了根据本发明一个实施例的锁紧插座与蓄液器之间的连接;
图34示出了根据本发明一个实施例的锁紧插座与蓄液器之间的另一种连接;
图35示出了根据本发明一个实施例的将小直径蓄液器与泵组件一起使用的适配器;
图36是当泵处于装载位置时图35的适配器的轴向视图;和
图37是当泵处于已配合位置后图35的适配器的轴向视图。
具体实施例的详细描述
图1是根据本发明一个实施例的滴注装置10的整体视图,它用来将流体输送给病人。它也可以用来将流体输送装置中的流体输送到多孔介质中。在描述中,滴注泵是流体输送装置的一个例子,而人体组织则是多孔介质的一个例子。流体可以是药物,如胰岛素等。在连续的附图中类似的标号将赋给相同或类似的部件。
滴注装置10包括管装置11。管装置11包括管13。管13的一端连接插座12,在管装置11的另一端连接着滴注瓣14,其中管13和泵组件(未示出)在插座14处接合,而滴注瓣14则与套管组件15对接。
套管组件15包括套管体17。套管16接在套管体17上以对病人进行皮下注射。套管16可以用钢制造,或者为了使病人舒服一些可以采用软的和/或柔软的材料如特氟纶或其它塑料制成。套管16可以以多种角度从套管体17的底部或侧部伸出。例如,套管16可以以15-30度这样较浅的角度从套管体17的前边伸出。当然可以使用的例子不限于此,另一个例子是套管16可以与套管体17的底部呈90度角。在下面包括图2在内的附图中将更详细地描述套管组件15。
在套管体17内有适于接收套管16近端或上游端的通道。该通道至少包括一个可以被滴注针头或注射针头穿透的自密封隔膜。
图2是示于图1的滴注组件各个部件的进一步分解图。根据本发明的一个实施例,可以通过将套管16穿过套管锁紧环21中的孔来装配套管组件。然后利用夹卡固定机构、超声焊接或其它的已知方法将套管锁紧环21连接在芯插入物22上。套管16的近端张开,使得它可以被捕获并且固定在芯插入物22和锁紧环21之间。套管锁紧环21和芯插入物22都可以用塑料或其它合适的材料制造。
芯插入物22限定了具有第一端和第二端的通道。如上所述第一端16接收套管的近端。芯插入物22的第二端起到隔膜外套23的作用。自密封隔膜24插入到隔膜外套23的开口端,然后外套利用超声工艺张开以捕获芯插入物22内的隔膜24。为了用户的舒适性,对芯插入物22和锁紧环21进行过成型以形成柔软的体17。
套管组件的体17通常是紧凑、较小的部件。当从上面观察时,套管体17可以是圆形、椭圆形或三角形,和/或将其延长以易于病人佩带的形状。体17的全部或者部分201可以制成透明的以便于对芯插入物22和/或滴注位置的观察。
可以利用插入瓣25帮助将套管16插入皮下。插入瓣25包括通常用钢制造的插入针头26,它用来帮助套管16插入皮肤。在插入套管16后,移开插入瓣25,并且将滴注瓣14可拆卸地连到套管组件15上以将流体输送给病人。
根据本发明的一个实施例,图3示出了其上连有插入瓣25的套管组件15的横截面视图。插入瓣25支撑插入针头26的近端,插入针头26从插入瓣25伸出并且具有尖锐的远端。当没有使用插入瓣25并且将其从套管组件15中移开后,针头防护装置202(示于图2)盖住插入针头26的尖端,防护装置26防止与针头26的意外接触。
插入针头26的近端位于圆柱形(阴)连接器31内,连接器具有敞开的端部,它滑到并且与套管组件15的阳隔膜外套23配合。插入针头26的远端穿过自密封隔膜24和芯插入物22并且插入套管16。在插入瓣25和隔膜外套23完全配合后,插入针头26的尖端可以稍微越过套管16的远端。插入瓣可以与自动插入装置(未示出)对接,当病人缺乏技巧或力量使得他或她自己不能将套管16插入皮下时,就可以使用自动插入装置。为了和自动插入装置对接,插入瓣25可以包括具有一对翼205、206和安装孔203、204的平顶,以用来连接自动插入装置(见图2)。当手动插入套管16时,病人抓紧所附的插入瓣25和/或套管体17并且推动套管16,随着插入针头26的插入,套管也进入滴注位置。在插入套管16之前可以对滴注位置用消毒液进行预处理,或在病人皮肤上放置安装胶布,当然也可以使用其它的已知处理方法。在将套管16插入病人皮肤后,插入瓣25和针头26从套管组件15中拔出。通过将与套管体17底部连接在一起的胶条的覆盖物撕去,并且将粘接剂281按紧到病人的皮肤或安装胶布上,就可以将套管组件15固定到病人身上。
再回来参考图1和图2,在把套管组件15固定到病人身上后,滴注瓣14连接到允许管装置11和套管16实现流体连通的套管组件15上。滴注瓣14可以连接到套管组件15的顶部或者其一侧。根据本发明的一个实施例,图4是滴注瓣14与套管组件15配合(或锁紧)在一起的横截面视图。滴注瓣14包括用适当的粘接剂连接在管13内部的滴注针头42。在各种不同的实施例中,管可以是微孔管。滴注针头42的近端位于滴注瓣14上的阴连接器45中,连接器45大致为圆柱形,端部敞开,它滑到套管组件15的阳隔膜外套23上并且与之配合。滴注针头42的尖锐远端一般不超出阴连接器45的开口端,以避免不小心被针刺到和/或避免损坏针头。当滴注瓣14与套管组件15配合在一起后,滴注针头穿透隔膜24,允许管13中的流体流经套管16。滴注针头42的长度使得它不能伸入到套管16中和损坏套管16。
为了避免不小心使滴注瓣14和套管组件15分离,可以提供一种锁紧机构。锁紧机构可以包括滴注瓣14的阴连接器45上的锁紧容纳器43和套管组件的芯插入物22上的锁紧凸耳44,锁紧容纳器43和锁紧凸耳44配合在一起,当然还可以有别的形式的锁紧机构。例如锁紧凸耳44可以设置在隔膜外套23上。图5是侧视图,示出了滴注瓣14在适当的位置与套管组件15配合在一起。为了将阳隔膜外套23滑进阴连接器45中,容纳器43的开口槽51与锁紧凸耳44对齐。在完全插入后,阴连接器45的基底壁可以抵接着阳隔膜外套23的远端,和/或滴注瓣14的远端可以与套管组件15的主体接触,从而滴注针头穿透隔膜外套内的隔膜。
图6是一个详细的透视图,它示出了已经与套管组件15配合在一起的滴注瓣14。为了将滴注瓣14锁紧在套管组件15上,通过顺时针转动滴注瓣14使得锁紧凸耳44(示于图4)与凸耳容纳器43配合在一起。锁紧凸耳44(示于图4)防止当施加纵向力时、如在拉动管13时,滴注瓣14与套管组件15分开。在各个实施例中,滴注瓣14还可以包括夹卡固定机构以防止滴注瓣14被不小心旋转打开。夹卡固定机构可以包括棘爪62和套管体17上的槽63,当顺时针转动滴注瓣14时,棘爪62与槽63配合在一起。当然夹卡固定机构不限于此。
图7和图8示出了锁紧在套管组件中的管装置11的顶视图和侧视图。通过把滴注瓣14上的提升片71提起并且逆时针旋转滴注瓣14以将槽51(示于图4)与锁紧凸耳44(示于图4)对齐,可以很容易地将滴注瓣14从套管组件15上移去。然后将滴注瓣14从套管组件15上拉开,而隔膜24(示于图4)可以自密封。
根据本发明的另一个实施例,图9示出了连在套管组件91上的滴注瓣97的横截面视图,套管组件91包括位于隔膜外套94内的第一隔膜92和第二隔膜93。隔膜外套94限定了与套管95耦合在一起的通道。第一隔膜92所处的位置利于插入针头96的穿透,而第二隔膜位于可以让滴注针头99穿透的位置。为了在皮下插入套管95,插入针头96插入第一隔膜92和套管95。在将套管95插入后,移去插入针头96并且第一隔膜92自密封以防止流体泄露。套管组件91利用粘接剂连在用户的身体上或者安装胶布上。
与前面的实施例类似,管98在其第一端与滴注瓣97连接,在第二端与插座(未示出)连接,而插座与泵对接。滴注针头99在第一端连接到管98的内部并且位于滴注瓣97上的阴连接器901中,该连接器大致为圆柱形,具有敞开的端部。当滴注瓣97与套管组件91配合时,连接器901滑到阳隔膜外套94上并且与之配合,从而滴注针头99穿透第二隔膜93,允许管98中的流体流进套管95。
图10和11是滴注瓣97位于与套管组件91相配合的位置时的顶视图和侧视图。插入针头96已经被移开,为了防止由于在不小心的情况下滴注瓣97与套管组件91分离开,可以提供锁紧机构以将滴注瓣97固定到套管组件91上。例如,套管组件91可以包括与滴注瓣97上的锁紧凸耳1101(见图11)配合的凸耳容纳器1001(见图10)。为了将滴注瓣97锁紧在套管组件91上,通过顺时针转动滴注瓣可以将锁紧凸耳与凸耳容纳器1001配合在一起。这种形式的配合可以防止在拉动管时管的脱离。图12示出了滴注瓣97与套管组件91配合在一起并锁住的状态。
为了将滴注瓣97从套管组件91上移开,只需要提起提升片1201并且逆时针转动滴注瓣97。然后可以将滴注瓣97与套管组件91拉开,并且第二隔膜93(示于图9)自密封。
根据本发明的另一个实施例,图13示出了连接到套管组件1302上的滴注瓣1301的横截面视图,其中套管组件1302包括位于可旋转隔膜外套1304中的单一隔膜1303。单一隔膜1303和可旋转隔膜外套1304可以防止在双隔膜设计中所固有的泄露问题,同时仍然允许例如隔膜外套1304在插入针头插入时的垂直放置,或者在与滴注瓣1301配合后的水平放置。
隔膜外套1304利用例如枢轴或铰链机构等可旋转地连接到套管组件上。柔性管1306的第一端连接到隔膜外套1304和/或隔膜1303上,在它的第二端连接着安装在套管组件1302内的套管1307的近端。柔性管1306可以利用适当的粘接剂连接隔膜外套1304和/或套管组件1302,当然连接方法不限于此。
管1308在其第一端与滴注瓣1301连接,在第二端与插座(未示出)连接,插座与泵组件对接。滴注针头1309连接到管1308第一端的内部并且位于滴注瓣1301上的具有开口端的阴连接器1310内。连接器1310和阳隔膜外套1304可以是多种形状,例如圆柱形、长方形或正方形。在滴注瓣1301与套管组件1302配合后,将连接器1310滑到阳隔膜外套1304上并且与之配合,使得滴注针头1309穿透隔膜1303以允许管1308内的流体流进套管1307中。在各个实施例中,滴注针头1305比插入针头1305略大,从而密封先前由插入针头1305所产生的孔。
滴注瓣1301很容易与套管组件1302连接和脱离。图14和图15分别是示出滴注瓣1301位于与套管组件1302配合在一起的透视图和侧视图。已经旋转了隔膜外套1304使之与套管组件1302的纵轴垂直,从而允许插入滴注瓣1301。插入针头1305已经移走。为了防止滴注瓣1301与套管组件1302由于不小心而分离,可以提供锁紧机构。锁紧机构可以包括位于滴注瓣1301上的锁舌1401和1402,当把滴注瓣1301推到套管组件1302上时,锁舌与套管组件1302上的锁舌容纳器1403和1404接合。图16和17分别示出了滴注瓣1301与套管组件1302配合并且闭锁在一起的透视图和侧视图。这时滴注针头1309穿透隔膜外套1304中的隔膜1303(见图13)。在滴注瓣1301和隔膜外套1304与套管组件1302配合在一起并且锁住后,可以把滴注瓣1301和隔膜外套1304旋转90度,这样如图18所示滴注瓣与套管组件1302平齐。利用夹卡动作可以用爪(未示出)把滴注瓣1301锁在套管组件1302上。在旋转隔膜外套1304时,柔性管1306弯曲,在管1308和套管1307之间提供防泄漏的流体通道。
为了把滴注瓣1301从套管组件1302上移去,需要把滴注瓣1301提起,然后旋转90度,使得隔膜外套1304再次与套管组件1302的纵轴垂直。捏住锁舌1401和1402使它们相向靠近,从套管组件1302上把滴注瓣1301拉开,就把滴注瓣1301拆下了。
根据本发明的另一个实施例,图19是连接到套管组件1902上的滴注瓣1901的横截面视图,与前面的实施例相似,套管组件包括位于可旋转的隔膜外套1904内的单一隔膜1903,但是本实施例采用了不同的锁紧机构。图19示出了处于配合位置但还没有锁住的滴注瓣1901和套管组件1902。插入针头1905已经移走了。
容纳滴注针头1909的阴连接器1910(见图20)位于滴注瓣1901上,其端部是敞开的,大致为圆柱形,所以它可以滑到阳隔膜外套1904上并且与之配合。图20、21和22分别是透视图、顶视图和侧视图,它们示出了滴注瓣1901与套管组件1902接合在一起的位置。阳隔膜外套1904包括锁紧凸耳2001,它与连接器1910上的凸耳容纳器2002配合。用户把阴连接器1910上的容纳器槽2003与锁紧凸耳2001对齐,使得阴连接器1910可以滑到阳隔膜外套1904上并且与之配合。图23和24分别示出了与套管组件1902配合的滴注瓣1901的透视图和侧视图。这时滴注针头1909穿透了隔膜1903(见图19)。
如图25所示,然后逆时针旋转滴注瓣25(根据凸耳容纳器的位置也有可能是顺时针),锁紧凸耳2001就与凸耳容纳器2002接合在一起。接合后,滴注瓣1901和隔膜外套1904可以旋转90度,如图26所示,这时滴注瓣1901就与套管组件1902相平齐。利用夹卡动作可以用爪(未示出)把滴注瓣1901锁在套管组件1902上。在隔膜外套1904旋转时,柔性管1906弯曲,在管1908和套管1907之间提供防泄漏的流体通道。
为了把滴注瓣1901从套管组件1902上移去,需要把滴注瓣1901上的提升片2601提起,然后把滴注瓣1901旋转90度,使得隔膜外套1904与套管组件1902的纵轴垂直。顺时针转动滴注瓣90度,从套管组件1902上把滴注瓣1901拉开,就把滴注瓣1901拆下了。
参考图1,管13的一端与插座12连接,插座与流体输送装置(未示出)对接并且接收来自流体输送装置送来的流体。流体可以是药物,如胰岛素。流体输送装置可能是滴注泵组件,当然不限于此。
插座12可以具有多种形状。例如,插座12的形状可以是不对称的,或者为圆形、椭圆形。插座12可以用塑料、金属或其它合适的材料制成。插座12可以包括承接管13的容纳器。管13可以用合适的粘接剂永久地连接在插座12上。在其它的实施例中,可以用卢尔(luer)连接把管13可拆卸地连接到插座12上。
插座12可以包括控制器,它允许流体输送装置从第一种结构转换到第二种结构。第一和第二种结构可以分别是泵积蓄负载位置和泵操作位置。尽管在图27-37中以凸缘的形式实现控制器,应该理解可以以很多种形式实现控制器,其中包括但不限于:机械的、电的、磁的、或光的形式。例如,插座12可以包括一个凸缘或其它的机械突起以与泵组件对接,或者插座12可以产生磁场或光信号,这些磁场和光信号分别由泵组件上的霍尔效应传感器或光传感器所探测。当然,还可以有其它的形式。在另一个实施例中,插座12中的一根电线可以完成泵组件中的一个电路。
图27是根据本发明一个实施例的插座和滴注泵的整体视图。泵组件2710包括使蓄液组件2715向用户输送药物的部件。蓄液组件2715可以包括足够让一个典型用户使用几天的药物,如胰岛素等。插座2725和蓄液组件接合,插座2725可以永久地连在管装置2720上以向病人输送流体。
图28示出了滴注泵驱动机构的分解视图。蓄液组件2715包括蓄液器2830,活塞2835,活塞杆2840。蓄液器2830含有输送给用户的药物并且具有可变的内部容积。内部容积是蓄液器的液体容量。插入蓄液器底部的活塞2835使得当活塞沿着蓄液器的纵轴移动时蓄液器的容积随之变化。活塞杆2840利用杆的纵轴与活塞连接,杆的纵轴与蓄液器的纵轴分开并且平行。活塞杆2840至少在其杆长的一部分上具有螺纹。圆柱形泵筒2845承接蓄液组件2715。泵筒限制活塞杆,使得杆沿着泵筒的纵轴定向。泵筒2845含在泵组件中,并且可以包括一个锁紧机构,如锁片,以防止泵筒相对于组件转动。泵组件2715中的齿轮箱2855包括驱动螺杆以及转动驱动螺杆的马达和齿轮。驱动螺杆2850上有螺纹,它的纵轴与泵筒的纵轴平行但彼此分开。插座2725与蓄液器顶部连接。
图29示出了本发明一个实施例的泵筒锁紧机构。泵筒2845在它的一端(示于图31)具有间隙孔3072,在将蓄液组件2715插入泵筒2845的过程中间隙孔用来引导活塞杆2840。为了保证在插入蓄液组件的过程中驱动螺杆2850不与活塞杆2840相干涉,泵筒2845相对于泵组件2710保持固定的位置,例如可以通过让泵筒中的锁片3060与泵组件10中的泵筒止动片3065相接合以保持泵筒相对于泵组件的位置。图30是泵筒的详细视图,示出了锁片3060和泵筒止动片3066。再参考图29,插座2725包括凸缘2970,当插座2725转动时,它使得锁片3060从泵筒止动片3066中移出,从而允许插座2725转动泵筒2845。
图31和32是沿着泵筒2845纵轴的视图,分别示出了在装载位置和配合位置时驱动螺杆2850和活塞杆2840的关系。如图31所示,在装载时定位蓄液组件2715使得活塞杆2840不与驱动螺杆2850接触。通过正确定位泵筒2845相对于泵组件2710的位置,活塞杆2840与驱动螺杆2850之间的间隙由泵筒2845基底上的间隙孔3072的布置所确定,间隙孔3072承接并且引导活塞杆2840。可以锥化间隙孔3072以便于杆2840的插入。驱动螺杆2850装配到泵筒2845中的间隙孔3072中。一旦蓄液组件2715插入泵组件2710中,如图32所示,通过锁紧插座2725转动泵筒2845,使得活塞杆2840转动并且与驱动螺杆2850配合。这个实施例便于简化蓄液组件的装载。
在本发明特定的实施例中,活塞杆的螺纹和驱动螺杆的螺纹是偏梯形螺纹。这个实施例的好处在于可以消除活塞杆上与杆纵轴方向垂直的作用力。这种作用力可能导致杆的偏移和略过驱动螺杆上的一个螺纹,导致输送给用户的药物不足。偏梯形螺纹消除了作用力的正交分量。
在本发明的一个实施例中,如图33所示,锁住的插座2725可以利用锥化的卢尔(luer)连接连接到蓄液器2830上。蓄液器具有整体模铸在蓄液器顶部的阳卢尔(luer)楔销。具有内阴螺纹的环面3378环绕阳卢尔(luer)。与之类似,插座2725包括配合的阴卢尔(luer)和具有螺纹的阳连接。
在本发明的另一个实施例中,在蓄液器2830和插座2725之间提供针连接。如图34所示,蓄液器包括橡胶隔膜3480,隔膜利用弯曲金属环连在蓄液器上。与插座整体形成的针3485穿透隔膜并且流体可以从蓄液器流进管装置。
在本发明的另一个实施例中,如图35所示,提供一个适配器3595,从而允许直径0比泵筒2845的直径小得多的蓄液器3590与泵组件2710一起使用。适配器3595可以是单独一个部件或者可以与锁紧插座2725是一个整体。适配器3595与蓄液器3590的轴线对齐并且偏离,而蓄液器3590的轴与泵筒的纵轴平行,所以在转动时活塞杆2840与驱动螺杆配合。图36和37示出了小直径蓄液器3590的轴向视图,分别给出了蓄液器在适配器3595的装载位置和配合位置。很明显,当与活塞3835和蓄液器3590配合时,适配器所提供的偏移允许活塞杆3840以与图31和32的实施例同样的方式和驱动螺杆3850接合。
已经描述了本发明的多个实施例以及它们的优点和可选择特征,很明显这些实施例通过示例来说明而不是局限于此。对于本领域专业人员来讲,无须偏离本发明的精神和范围就可以很容易针对这些实施例设计出改变和改进,或者设计出其它的实施例。所有的这些改进都在本发明的权利要求范围内。

Claims (43)

1.一种医疗设备,用于从终结于管针头的一条输运线向病人输送流体,该医疗设备包括:
一个套管组件,用来将流体连接至插入病人身体的套管,套管组件具有相对于套管放置在固定位置的第一锁紧元件;和
一个滴注瓣,用来将输运线连接到套管组件,该滴注瓣包括:
第二锁紧元件,用来与套管组件的第一锁紧元件接合;和
提升片,用来将滴注瓣从套管组件上分开,其中第一和第二锁紧元件的接合需要滴注瓣和套管组件的最初配合,随后是相对于套管组件转动滴注瓣而锁紧。
2.如权利要求1所述的医疗设备,其中第一锁紧元件是锁紧凸耳,第二锁紧元件是凸耳容纳器。
3.如权利要求1所述的医疗设备,其中第一锁紧元件是凸耳容纳器,第二锁紧元件是锁紧凸耳。
4.如权利要求1所述的医疗设备,其中套管组件包括隔膜外套,它限定了与套管接合的芯,隔膜外套包括位于芯内第一位置的第一隔膜,使得当滴注瓣和套管组件锁紧时,管针头穿透第一隔膜以允许输运线和套管之间的流体连通。
5.如权利要求4所述的医疗设备,其中隔膜外套包括位于芯内第二位置的第二隔膜,使得可以通过第二隔膜将插入针头引入套管。
6.如权利要求1所述的医疗设备,其中套管组件包括柔软的过成型体。
7.如权利要求1所述的医疗设备,套管组件进一步包括:
一个柔性管,它与套管流体连通;和
一个隔膜,它与柔性管流体连通,其中当柔性管在第一位置时,可以通过隔膜将插入针头引入套管,当柔性管在第二位置时,通过隔膜插入的管针头允许输运线和套管之间的流体连通。
8.如权利要求1所述的设备,进一步包括一个插入瓣。插入瓣包括插入到通过隔膜的通道中的插入针头,在插入后,插入瓣进一步穿过套管延伸,终结于一个尖锐末端,该末端略微越过套管的末端。
9.如权利要求1所述的设备,其中插入瓣具有和自动插入装置接合的界面。
10.一种医疗设备,用于从终结于管针头的一条输运线向病人输送流体,该医疗设备包括:
一个套管,用来插入病人身体;
一根柔性管,与套管流体连通;和
一个隔膜,与柔性管流体连通,其中当柔性管在第一位置时,可以通过隔膜将插入针头引入套管,当柔性管在第二位置时,通过隔膜插入的管针头允许输运线和套管之间的流体连通。
11.如权利要求10所述的设备,进一步包括:
一个滴注瓣,它包括管针头;和
一个套管组件,它包括套管;
其中当滴注瓣和套管组件接合时,管针头穿过隔膜以允许输运线和套管之间的流体连通。
12.如权利要求11所述的设备,进一步包括将滴注瓣固定到套管组件上的锁紧机构。
13.如权利要求12所述的设备,其中锁紧机构包括滴注瓣上的锁舌,锁舌插入套管组件上的锁舌容纳器。
14.如权利要求12所述的医疗设备,其中隔膜位于隔膜外套中,锁紧机构包括位于隔膜外套上的第一锁紧元件和位于滴注瓣上的第二锁紧元件,其中将第一和第二锁紧元件连接在一起需要滴注瓣和套管组件的最初配合,以及随后的相对于套管组件转动滴注瓣而锁紧。
15.如权利要求14所述的医疗设备,其中第一锁紧元件是锁紧凸耳,第二锁紧元件是锁紧凸耳容纳器。
16.如权利要求14所述的医疗设备,其中第一锁紧元件是锁紧凸耳容纳器,第二锁紧元件是锁紧凸耳。
17.如权利要求14所述的设备,其中隔膜外套可以旋转到一个接合位置,在该位置允许滴注瓣和隔膜外套接合在一起并且相对于套管组件转动滴注瓣以将滴注瓣锁紧到隔膜外套上,和
其中可以将隔膜外套旋转到一个稳定的位置,这个位置防止滴注瓣的转动。
18.如权利要求10所述的设备,进一步包括一个插入瓣,插入瓣包括插入针头,用来通过隔膜插入到通道中,在插入后,插入瓣进一步穿过套管延伸,终结于一个尖锐末端,该末端略微越过套管的末端。
19.如权利要求18所述的设备,其中插入瓣具有和自动插入装置接合的界面。
20.一种方法,用于从终结于管针头的一条输运线向病人输送流体,该方法包括:
穿过隔膜和套管插入插入针头,隔膜和套管具有相对的定向;
将套管插入病人的组织;
从套管和隔膜中拔出插入针头;
穿过隔膜插入管针头;
改变隔膜和套管的相对定向;和
通过输运线和套管输送流体。
21.一种将流体输送装置与套管组件流体连通的管装置,流体输送装置具有第一种结构和第二种结构,该管装置包括:
一定长度的管,管具有第一端和第二端;
与第一端连接的插座,用来连接流体输送装置,插座包括控制器,控制器允许流体输送装置从第一种结构转换到第二种结构;和
滴注瓣,与第二端连接以连接套管组件。
22.如权利要求21所述的管装置,其中源的第一种结构是蓄液装载位置,第二种结构是操作位置。
23.如权利要求21所述的管装置,其中控制器能够允许流体输送装置从第二种结构转换到第一种结构。
24.如权利要求21所述的管装置,其中控制器包括与流体输送装置对接的凸缘。
25.如权利要求21所述的管装置,其中控制器包括产生光信号和磁场中的一种。
26.如权利要求21所述的管装置,其中控制器包括到流体输送装置的电子电路。
27.如权利要求21所述的管装置,其中插座包括LUER连接器用来和流体输送装置接合。
28.如权利要求21所述的管装置,其中流体输送装置是一个滴注泵,该泵具有容积可变的蓄液器和驱动组件,驱动组件包括一个筒,在筒端有一个间隙孔,筒的特征在于一条纵向的筒旋转轴线,驱动组件进一步包括插入间隙孔的活塞杆,和具有外螺纹的转动驱动螺杆,通过相对筒轴线转动筒,外螺纹可移动地与活塞杆上的螺纹啮合,在第一种结构时,外螺纹和活塞杆上的螺纹啮合,在第二中结构时,外螺纹和活塞杆上的螺纹分离,和
其中控制器能够允许筒转动以使杆螺纹与驱动螺杆螺纹机械啮合或分离。
29.如权利要求28所述的管装置,其中控制器包括凸缘,用来移走筒上的锁片,允许筒转动。
30.如权利要求20所述的管装置,其中套管组件具有相对于套管放置在固定位置的第一锁紧元件;和
滴注瓣包括:
管针头;
第二锁紧元件,用来与套管组件的第一锁紧元件接合;和
提升片,用来将滴注瓣从套管组件上分开,其中第一和第二锁紧元件的接合需要滴注瓣和套管组件的最初配合,随后是相对于套管组件转动滴注瓣而锁紧。
31.如权利要求30所述的管装置,其中当滴注瓣锁紧到套管组件上时管针头穿透套管组件中的隔膜,允许管装置和从套管组件中伸出的套管之间的流体连通。
32.一个用来和流体输送装置连接的管道,该流体输送装置具有第一种结构和第二种结构,该管道包括:
一定长度的管,管具有第一端;和
与第一端连接的插座,用来连接流体输送装置,插座包括控制器,控制器允许流体输送装置从第一种结构转换到第二种结构。
33.如权利要求32所述的管道,其中第一种结构是蓄液装载位置,第二种结构是操作位置。
34.如权利要求32所述的管道,其中插座包括卢尔连接器,用来和流体输送装置接合。
35.如权利要求32所述的管道,其中控制器包括与流体输送装置对接的凸缘。
36.如权利要求32所述的管道,其中控制器包括产生光信号和磁场中的一种。
37.如权利要求32所述的管道,其中控制器包括完成流体输送装置中的电子电路。
38.一种方法,用来从流体输送装置向多孔介质提供流体流动,该方法包括:
将插座与流体输送装置连接,插座永久性固定在管装置上;
通过插座控制流体输送装置的结构;和
将管装置与多孔介质连接以允许流体从流体输送装置流动到多孔介质。
39.如权利要求38所述的方法,其中控制流体输送装置的结构包括允许泵从第一结构移动到第二结构。
40.如权利要求39所述的方法,其中流体输送装置的第一种结构是装载位置,第二种结构是操作位置。
41.如权利要求38所述的方法,其中控制流体输送装置的结构包括在插座上移动凸缘。
42.如权利要求38所述的方法,其中控制流体输送装置的结构包括产生磁场或光信号中的一种。
43.如权利要求38所述的方法,其中流体输送装置是滴注泵。
CNB028102037A 2001-05-18 2002-05-20 流体泵的滴注装置 Expired - Fee Related CN1306969C (zh)

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CN107440681A (zh) * 2006-02-09 2017-12-08 德卡产品有限公司 用于分配流体的器件
CN101066480B (zh) * 2006-02-16 2011-11-16 安尼马斯公司 直插式安全输液装置
CN114712615A (zh) * 2006-12-22 2022-07-08 F·霍夫曼-拉罗氏股份公司 用于维持输送治疗流体的系统和装置
CN104302350A (zh) * 2012-03-07 2015-01-21 德卡产品有限公司 输液泵组件
CN105327428A (zh) * 2015-11-20 2016-02-17 无锡顶点医疗器械有限公司 一种用于胰岛素泵的分体式一次性输注管路
CN105327428B (zh) * 2015-11-20 2018-12-14 无锡顶点医疗器械有限公司 一种用于胰岛素泵的分体式一次性输注管路

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US20160051757A1 (en) 2016-02-25
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US20200360602A1 (en) 2020-11-19
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US9173996B2 (en) 2015-11-03
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EP1815879A3 (en) 2007-11-14
DE60217853D1 (de) 2007-03-15
US20020173769A1 (en) 2002-11-21
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US20190175827A1 (en) 2019-06-13
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US10207048B2 (en) 2019-02-19

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