CN103124581A - 肠内给养组件 - Google Patents

肠内给养组件 Download PDF

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CN103124581A
CN103124581A CN2011800360919A CN201180036091A CN103124581A CN 103124581 A CN103124581 A CN 103124581A CN 2011800360919 A CN2011800360919 A CN 2011800360919A CN 201180036091 A CN201180036091 A CN 201180036091A CN 103124581 A CN103124581 A CN 103124581A
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pipeline
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B.H.西尔弗
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Medela Holding AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/1011Locking means for securing connection; Additional tamper safeties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2072Venting means for internal venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1027Quick-acting type connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1033Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1094Tube connectors; Tube couplings at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection

Abstract

提供了一种用于与诸如肠内给养注射器或管路的注射器或延长管路一起使用的肠内给养系统。该系统具有用于平衡管路内的压力的特征。该系统包括管,该管具有第一端部、第二端部、外侧壁、在所述第一端部和靠近所述第二端部的位置之间在所述管内的导管、第一孔口和第二孔口。第二孔口位于第一孔口的下游,其从导管的端部以下的一点延伸至沿导管的长度的一点。这有助于缓解某些不期望的抽吸问题,并且抑制细菌聚集和生长。为了防止在管路内(如在孔口处)的过度负压,管路可包括形成于其中的可伸缩特征。

Description

肠内给养组件
相关申请的交叉引用
本申请是提交于2010年7月23日的、名称为“Enteral Feeding Connector and Assembly”(肠内给养连接器和组件)的美国临时专利申请序列号61/367,228的非临时性申请,该申请的内容以引用方式全文并入本文中。
技术领域
本发明大体上涉及管路连接器和管路,并且更特别地在一个方面涉及包括改进的管路的肠内给养组件,该管路设计成解决不期望的真空以及过压问题。
背景技术
诸如给养管的流体输送系统用来将营养物质和药物输送给患者。由给养管给养的状态在本领域中被称为肠内给养或管给养。
例如,在新生儿病房中,婴儿常常被肠内给养。管被插入婴儿的口腔或鼻腔开口中并向下穿过食道以将流体输送到身体的胃或肠道区域。在该示例中,母乳或代乳品通过注射器输送到诸如肠内管的肠内输送系统中,以便输送到婴儿的胃内。然而,肠内给养系统也可供儿童或成人使用。有时候,使用蠕动泵来输送来自给养袋的流体。
在使用给养管的过程中,在管和/或婴儿的胃部中可能逐步形成过压。备选地,在吸气期间可能存在过度真空状态,其中管路在其远端末端中的开口处产生不期望的抽吸力。
发明内容
提供了一种改进的肠内给养系统。该系统包括管,该管具有第一端部、第二端部、外侧壁、在所述第一端部和靠近所述第二端部的位置之间在所述管内的导管、第一孔口和第二孔口。第二孔口位于第一孔口的下游,其从导管的端部以下的点延伸至沿导管的长度的点。这有助于缓解某些不期望的抽吸问题,并且抑制细菌聚集和生长。为了防止在管路内的过度负压,如在孔口处,管路可包括形成于其中的可伸缩特征。可伸缩特征可包括变薄区,该变薄区在施加过度负压时收缩,从而有效地切断正施加的进一步的负压,并且向临床医生提供过度真空正被施加的指示。
支撑结构可以笼式结构形式附加地存在于管路上。管路可包括在被笼式结构包围的区域中的变薄区,在过度的压力施加到管路内时,变薄区鼓起。
单向阀可以在管段的端部处或沿管段的长度可拆卸地附接到管段。当单向阀附接到管段的端部时,可以将顶盖或注射器推入阀门内,以将空气输送到阀门内的通道,空气接着流过管路。在一些实施例中,单向阀可沿管段的长度放置以从管路中的导管内释放压力。
在另一个实施例中,提供了一种肠内给养系统,其包括第一管段,第一管段包括第一端部、第二端部、外侧壁和在第一管段内的导管,该导管从第一端部延伸至第二端部。第一管段可以可拆卸地附接到管路。
在结合描绘各种实施例的以下附图考虑某些实施例的下面的详细描述之后,本发明的这些和其它方面、目的和成就将被进一步理解,其中。
附图说明
本文参照附图描述了各种示例性实施例,其中相同的标记表示相同的部件。
图1是肠内给养系统的透视图;
图2是具有用于解决远端末端处的抽吸问题的新型修改的肠内给养管;
图3示出对图2的管路的修改的近端结构;
图4是类似图2的肠内给养管段,其被修改以改型到标准管路上;
图5是带有压力释放阀的肠内给养管的放大的局部视图;
图6是带有压力释放阀的肠内给养管的放大的局部视图;
图7A是带有单向阀的肠内给养管段的局部视图;
图7B是图7A的单向阀的俯视图;以及
图8是具有用于解决管内的过度压力问题的新型修改的肠内给养管。
具体实施方式
本文将描述用于与肠内给养管一起使用的本发明的连接器和组件,但可以设想,本发明的连接器组件可以在可能受益于这类组件的任何装置中使用。
图1是根据示例性实施例的典型肠内给养系统100的透视图。肠内给养系统100具有注射器110和管120。注射器110具有远端112、近端114和柱塞118。在近端114处为注射器顶端116。管路120具有第一端部122和第二端部124。在该系统100中,管120的第一端部122和注射器顶端116可以可拆卸地固定到一起。为了将注射器顶端116固定到管120的第一端部122,注射器顶端116被手动插入管120的第一端部122中。
图2示出具有新型修改的肠内给养管。管800形式上类似于标准肠内给养管,但具有若干新特征。一个特征是在管端部802中,其被插入患者体内。在标准肠内管路中一直存在孔口804(有时称为排放眼)位于实心管端部802上游的情况。这在管端部中的眼下方留下能在其中保留流体的空间。为了消除管端部中的这种不期望的流体旋涡(其中例如可能发生细菌生长),在管端部802中形成另一个孔口806。在该实施例中,该孔口从管端部的内部通道808的位置下方的点(示出在808'处)延伸至其上方的点。因此,在管端部内部最顶端中的任何流体将具有排放的出口,以便消除上述流体旋涡或圈闭。
在某些情况下,可能希望施加抽吸力到管800。为了降低软组织可能被例如在孔口804处的过度的负压无意地拉起并因此受创伤的可能性,管800具有在812处形成于其中的可伸缩特征。在该实施例中,可伸缩特征812具有形成于管路侧壁中的变薄区814。变薄区814设计成在该区域中收缩管路的内部,使得变薄侧壁814'将基本上沿管路的轴线会合到一起,用来进一步切断在管端部802处的真空(负压)的施加。
围绕变薄区814设置支撑结构以在正常使用中相反地保持管路打开,除了在产生不期望的真空的情况之外。这里,该支撑结构采取围绕管路侧壁形成的周围泡罩的形式。当然,支撑结构可以是撑条、腹板等,其用来使变薄区814上游和下游的管路的部分保持分开,并且使管路通道808在正常使用中保持打开。例如,图3示出已添加到管路(如通过压力配合、熔合、胶粘、超声焊接等)的柔性笼式结构820。笼式结构820具有上环821和下环822和在两者间延伸的肋824。笼式结构820保持管路的完整性并使通道808打开,除了在存在施加的不期望真空的情况之外。
返回图2,顶盖825设置成封闭管路800的上游端801。上游端801在这里示出为适于接纳例如给养注射器的顶端或者来自将连接到管路的装置的某些其它顶端或端部执行器。顶盖825经由栓系件826栓系到管800。顶盖825不但在连接之前使管保持封闭中有用,而且也在使用中有用,如在更换连接到管路的物件时。
就这一点而言,图3的实施例也具有栓系的顶盖,但略微被修改。尤其应注意的是,在该实施例中,肠内给养管路的上游端已适于具有与其一体形成的连接器结构,至少对于注射器/容器连接部分来说。如因此将看到的,外表面210在该区域中具有形成于其上的一个或多个凸缘/隆起220。
该顶盖828具有呈形成于其上的塞829形式的“不接触”特征,塞829通过顶盖封闭小孔215装配进内部导管216并封闭内部导管216。因此,抓握顶盖828的用户不需要接触塞829,从而降低污染导管216的风险。其它不接触特征可能存在于可与给养系统一起使用的各种连接器上,例如,在美国临时专利申请序列号61/367,228中描述的那些,该申请以引用方式并入本文中。
图4示出诸如图2的肠内给养管的肠内给养管的备选实施例。如图4所示,给养管800与图2所示给养管相同,但设计成被插入或改型到标准管路,例如,图1所示的管路第一端部122。图4的实施例因此具有短管部分803,其终止于具有开口805的顶端807。顶端807尺寸设计成以过盈配合、鲁尔锁、螺纹配合等装配到标准管路近端中。
图5是带有真空释放阀830的肠内给养管的放大的局部视图。图5所示真空释放阀830为弹簧加载阀,并且可以存在于第一管段803上以除了或代替笼式结构820或可伸缩特征812来提供真空释放。真空释放阀830包括从管路800延伸的外壳832。在外壳832的一端处为开口834。弹簧836驻留在外壳832内,并且用来将闭合件按压在开口834上且在管路800内的真空足够高时打开。真空释放阀830可以是单向阀,允许空气流过管路800并经由开口834进入外壳832。
图6是带有压力释放阀840的肠内给养管的放大的局部视图。图6所示压力释放阀840为伞阀,并且可以存在于第一管段803上以除了或代替柔性笼式结构820或可伸缩特征812来提供压力释放。压力释放阀840包括杆842和头部844。杆842被放置成通过管路800中的孔。压力释放阀840可以是单向阀,允许流体流过管路800并经由开口834离开外壳832。
图7A是带有单向阀910和栓系的顶盖925的肠内给养管段的局部视图。单向阀910可以可拆卸地附接到管段122,如图7A所示。因此,当顶盖925或注射器被推入阀门910时,柔性元件914自身伸缩,从而打开进入阀门910的顶部的通道。顶盖925可包括孔口或其它装置以允许空气进入阀门。诸如肠内给养的流体可然后流入阀门910并流入管路122,或者可以允许空气离开以便排气。阀门910具有在室916中的柔性细长构件914。柔性构件914具有扇形区域917,并且在远端918处固定,但在近端919处纵向自由移动。近端919位于阀门结构的顶部盘921内(图7B中示出),并且封闭在其中的孔口。当被例如注射器顶端按压时,近端向远端移动,从而打开孔口。当注射器被移除时,柔性构件914返回至其静止位置,从而封闭孔口。阀门910可以是注射阀,例如由Halkey Roberts制造的注射阀,例如245 SERIES Swabable Valve。
图8是具有用于解决如在远端末端处的其它问题的新型修改的肠内给养管。图8中的肠内给养管类似于图3中的肠内给养管,并且具有变薄区814的附加特征,但这里设计成在过度的压力施加到管路800中时伸展或“鼓起”。因此,用户可通过观察变薄区814而简单地判断管路800内或婴儿的胃内是否存在过大的压力。当在扩展位置时,变薄区814可接触笼824。变薄区814也可设计成在过度的真空压力被施加时在该区域中收缩管路的内部,如参照图3所描述的。
以上已经描述了各种示例性实施例和方法。然而,本领域的技术人员将理解,在不脱离本发明的范围和精神的情况下可以做出改变和修改。在本发明的一些实施例中可存在附加的和/或不同的特征。

Claims (20)

1.一种肠内给养系统,包括:
管,其具有第一端部、第二端部、外侧壁、在所述第一端部和所述第二端部附近的位置之间在所述管内的导管;
第一孔口;以及
第二孔口,其位于所述第一孔口的下游,其中所述第二孔口从所述导管的端部下方的一点延伸至沿所述导管的长度的一点。
2.根据权利要求1所述的肠内给养系统,所述管还包括形成于所述管上的可伸缩特征,当施加真空时,所述可伸缩特征将所述导管的至少一部分在所述管内收缩。
3.根据权利要求2所述的肠内给养系统,所述可伸缩特征包括形成于所述管外侧壁中的变薄区。
4.根据权利要求3所述的肠内给养系统,所述可伸缩特征还包括围绕所述变薄区延伸的支撑结构。
5.根据权利要求4所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的多个臂,其中所述臂至少跨越所述变薄区的长度。
6.根据权利要求4所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的多个腹板,其中所述腹板至少跨越所述变薄区的长度。
7.根据权利要求4所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的笼式结构,其中所述笼至少跨越所述变薄区的长度。
8.根据权利要求5所述的肠内给养系统,其中当施加在所述导管内的真空压力大于预定的真空压力时,所述变薄区朝所述多个臂向外扩展。
9.根据权利要求1所述的肠内给养系统,所述管还包括在所述第一端部处用栓系件附接到所述管的顶盖。
10.根据权利要求9所述的肠内给养系统,其中所述顶盖包括在所述顶盖的所述内表面内的塞,所述塞的尺寸设计成和成形为配合在所述导管内且封闭所述导管。
11.一种肠内给养系统,包括:
第一管段,其包括第一端部、第二端部、外侧壁和在所述第一管段内且从所述第一端部延伸至所述第二端部的导管,所述导管设计成在所述管内超出设定阈值的真空下自身收缩并封闭所述导管;
其中所述第一管段可以可拆卸地附接到管路。
12.根据权利要求11所述的肠内给养系统,其中当所述第一管段附接到所述管路时,所述第一管段导管与所述管路内的导管流体连通。
13.根据权利要求11所述的肠内给养系统,所述管还包括形成于所述管上的可伸缩特征,当施加真空时,所述可伸缩特征使所述导管的至少一部分在所述管内收缩。
14.根据权利要求13所述的肠内给养系统,所述可伸缩特征还包括形成于所述管的外侧壁中的变薄区。
15.根据权利要求14所述的肠内给养系统,所述可伸缩特征还包括围绕所述变薄区延伸的支撑结构。
16.根据权利要求15所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的多个臂,其中所述多个臂至少跨越所述变薄区的长度。
17.根据权利要求15所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的多个腹板,其中所述腹板至少跨越所述变薄区的长度。
18.根据权利要求15所述的肠内给养系统,其中所述支撑结构还包括从所述管路的所述外侧壁延伸的笼式结构,其中所述笼至少跨越所述变薄区的长度。
19.根据权利要求11所述的肠内给养系统,所述管路还包括单向阀。
20.根据权利要求19所述的肠内给养系统,所述管还包括在所述第一端部处用栓系件附接到所述管的顶盖。
CN2011800360919A 2010-07-23 2011-07-22 肠内给养组件 Pending CN103124581A (zh)

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