CN103596616A - 减少血液喷溅的静脉内导管和插入装置 - Google Patents

减少血液喷溅的静脉内导管和插入装置 Download PDF

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CN103596616A
CN103596616A CN201280016223.6A CN201280016223A CN103596616A CN 103596616 A CN103596616 A CN 103596616A CN 201280016223 A CN201280016223 A CN 201280016223A CN 103596616 A CN103596616 A CN 103596616A
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insertion apparatus
guide wire
seal wire
safety guide
catheter insertion
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CN103596616B (zh
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A·贝尔森
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Vascular Pathways Inc
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    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
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    • A61M25/00—Catheters; Hollow probes
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A61M25/0905—Guide wires extendable, e.g. mechanisms for extension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1583—Needle extractors
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09066—Basic structures of guide wires having a coil without a core possibly combined with a sheath
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0637—Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin

Abstract

本发明公开一种静脉接入导管，其与针（7）、导丝（9）以及致动器（3）相结合，其中所述针同轴地装设在所述导丝之上，并且所述导管同轴地装设在所述针之上。位于所述接入导管的近端处的衬套包括擦拭元件和侧端口，所述擦拭元件用于在移除所述针和导丝时从它们清除血液，而所述侧端口用于在放置所述接入导管之后允许流体连接。

Description

减少血液喷溅的静脉内导管和插入装置
发明背景
本申请要求提交于2011年1月31日的临时申请第61/438,197号（代理人案号28175-707.101）的权益，其全部公开内容通过引用并入于此。
1.发明领域。本发明涉及用于通过导丝向患者的静脉或动脉中插入和放置接入导管的装置和方法。
在血管较小、迂曲、坍缩、脆弱和/或难以定位的情况下，接入导管向患者的静脉或动脉中的安全放置是特别困难的。在放置静脉内导管之后，由针造成意外穿刺和/或污染的风险尤其成为问题。因此，希望提供保护医务人员免于因缩回的导丝的移动而潜在地暴露于血液的装置和方法。
本发明特别关注的是，接入导管通常与针和导丝一起预先包装，其中针同轴地收纳在导丝上，并且导管同轴地收纳在针上。针稍稍延伸超出导管的远侧端头，以便可将针和导管的组装件引入静脉或其他血管之中。一旦检测到进入静脉（通常是通过观察回血），即可将导丝向静脉管腔中推进，在导丝上推进导管，并继而从导管移除针和导丝二者，留下导管可用于附接至流体、药物或其他静脉内材料的源。
针和导丝的移除可能成为问题，这是因为它们有携带患者血液的倾向并对治疗人员造成暴露风险。这在导丝具有诸如在至少一些下文所列的公开美国专利申请中那样的螺旋状或其他形状的端头的情况下尤其成为问题。
由于这些原因，期望提供与静脉内导管及其他血管接入导管一起使用的系统和方法，来降低在放置导管后从其撤回导丝和/或针时的失血和血液喷溅风险。尤其期望此类方法和装置可兼容于具有如下文所列专利公开中所述的自动针和导丝缩回机构的静脉导管。本文所描述的发明将会满足这些目标中的至少一些目标。
2.背景技术。本发明的主题涉及以下美国专利申请，它们的公开内容特此通过引用而全文并入于此。这些专利申请中所描述的静脉内导管插入装置的各个实施方式中的每一个均可与本发明的静脉内导管相组合以创造出静脉内导管系统。
US20100210934静脉内导管插入与血液取样装置及其使用方法
（Intravenous catheter insertion and blood sample devices and method ofuse）
US20100094310静脉内导管插入装置及其使用方法（Intravenouscatheter insertion device and method of use）
US20080300574静脉内导管插入装置及其使用方法（Intravenouscatheter insertion device and method of use）
还感兴趣的是描述了具有侧臂连接器的导管的以下美国专利：
5,704,914、5,154,703、5,084,023、4,585,440、4,509,534以及4,177,809。
发明内容
本发明提供静脉及其他血管接入导管，其适于在撤回用以引入导管的针和导丝后减少失血和血液喷溅。特别是，本发明提供一种导管插入装置，其包含接入导管、针、安全导丝以及致动器机构，该致动器机构用于在导管插入方案中选择性地推进安全导丝穿过针，以及选择性地在期望的点将针和安全导丝二者从导管撤回。本发明提供腔室以及隔膜或其他膜片，作为在近端衬套、外壳或该接入导管的其他组件上的“擦拭”元件。该腔室优选地装设在衬套的近端，该衬套具有与导管的近端间隔开的内部腔室。隔膜优选地装设在所述腔室的近侧，以便在导丝由致动器撤回时从导丝上擦除残留血液。针和/或导丝的插入工具可拆卸地接附至与隔膜相邻的衬套，以便可将针和导丝推进穿过隔膜并进入导管以进行选择性推进，以便允许以一般常规的方式将导管引入动脉或静脉中。致动器还适于撤回针和导丝，通常是在迅速使针和导管撤入和穿过衬套内部的弹簧或其他偏动元件的力量下撤回针和导丝。通常，导丝将会是“安全”导丝，在其远端具有当安全导丝从针的远侧端头撤离时所呈现的螺旋状或其他预成型防创伤形状，以便降低在推进导丝时损伤血管的风险。当撤回导丝时，安全端头在其穿过针腔时将被拉直，并且将会在衬套的内部中恢复螺旋状或其他配置，从而能够将其在处于动脉或静脉中时可能沾拾的血液排入衬套，而不是排入周围组织或外壳。该导丝继而可进一步撤回并穿过隔膜，以便在其被收回到致动器中以供安全处置之前清除任何残存血液。在衬套上提供侧端口，通常连同侧管，以便引入期望的流体，以便容纳存在于该衬套的近端上的隔膜或其他擦拭元件。
附图说明
图1示出了根据本发明的静脉内导管和插入装置的分解图。
图2示出了处于备用的未展开状态下的所述静脉内导管和插入装置的装配图。
图3示出了处于备用的未展开状态下的静脉内导管和插入装置。
图4示出了在已推进导丝的情况下的图3的静脉内导管和插入装置。
图5示出了在已缩回导丝和针的的情况下的图3的静脉内导管和插入装置。
图6为图3的静脉内导管的放大图。
图7示出了具有单独的侧臂接合器的静脉内导管和插入装置的实施方式。
图8为图7的侧臂接合器的放大图。
图9为根据本发明的静脉内导管的另一实施方式的放大图。
图10和图11图示了用于与所述静脉内导管和插入装置一起使用的导丝的另一实施方式。图10为该导丝的近端视图，而图11为该导丝的侧视图。
图12图示了用于与所述静脉内导管和插入装置一起使用的可转向导丝的实施方式。
具体实施方式
图1示出了根据本发明的静脉内导管100和插入装置20的一个实施方式的分解图。图2示出了处于备用的未展开状态下的静脉内导管100和插入装置20的装配图。在以下通过引用并入于此的专利申请中详细描述了可在本发明中使用的附加静脉内导管插入装置，这些专利申请包括：US20100210934、US20100094310和US20080300574。
静脉内导管插入装置20具有外壳21，该外壳21包括近端外壳1，该近端外壳1粘接或以其他方式连接至远端外壳11。在所示的示例中，近端外壳1的形式为细长空心圆筒。远端外壳11可选地形成为人体工学手柄形状，该形状设计成让使用者的拇指和食指来握持。其他形状亦有可能。外壳21具有细长槽22，该细长槽22与外壳21的纵轴大致平行地从近端外壳1延伸至远端外壳11。导丝推进滑块3沿着近端外壳1和远端外壳11的外部纵向滑动，并且具有经槽22伸入到外壳21内部的舌片23。持针器6可在外壳21的内部中滑动，并且位于导丝推进滑块3的舌片23的远端。持针器6的远端包括鲁尔滑动配件（luer slip fitting）16或类似物。在持针器6中紧邻鲁尔滑动配件16近端之处存在缺口24。按钮25位于远端外壳11的一侧上，该按钮25具有突片26，该突片26配置用于在持针器6处于其最远端位置时啮合持针器6中的缺口24。圆柱形导丝挡块2胶接至近端外壳1的近端中。
具有尖锐且成斜面的远端29的管状不锈钢皮下注射针7用粘合剂13粘合或者以其他方式附接至持针器6的远端。优选地，针7具有一个或多个切入其各侧面的槽27，该槽27连接至针腔以供血液通过。导丝9用粘合剂14粘合或以其他方式附接至导丝推进滑块3的舌片23。导丝9优选地由诸如超弹性镍钛合金丝等高弹性材料制成，其直径大约为0.003-0.012英寸并且最为优选地直径大约为0.004英寸。导丝9的直径可以是均匀的，或者可例如通过磨削而将其直径制成阶梯形或逐渐变细。例如，可对0.008英寸直径的丝进行无心磨削，以创造出具有短锥形过渡的0.004英寸直径的远端部分。可选地，导丝9的近端部分可由支撑管8来支撑，该支撑管8由不锈钢或镍钛合金皮下注射管材制成或者由模塑成型或挤塑成型的聚合物管制成。构建导丝9的另一选择是例如通过焊接、模锻、压接和/或胶接，将高弹性材料（诸如超弹性镍钛合金丝）的较短远端部分联结至较大直径的实心或管状近端部分。如图9中最佳地示出，导丝9的远端预成型为紧卷螺旋28，其外径小于其将要插入到的目标血管的内直径。该螺旋端头28充当导丝9上的安全缓冲器，以避免刺穿或损伤目标血管的内部。盘绕的导丝端头28在保护脆弱的或纤细的静脉方面特别有用。由于镍钛合金丝的极大柔韧性，螺旋远端弯曲线28在导丝9撤回至针7中时可拉直，并且在导丝9被推出针7时完全恢复成螺旋配置而无塑性变形。在所示的该示例中，导丝9的远端具有大约0.75圈的直径为大约0.167英寸的第一小直径线圈，以及大约1圈的直径为大约0.175英寸的第二较大直径线圈。该第一线圈和第二线圈优选地彼此大致共面，并且优选地还与导丝9的笔直近端部分12大致共面。导丝9的其他配置可包括：多平面、单线圈、在末端为整圆弧以及/或者直径小于针的直径的球状末端。
导丝9放置成同轴地穿过针7的内腔移动。可选地，柔性系链4从导丝推进滑块3的舌片23连接至持针器6的近端。可选地，可提供持针器盖5以帮助将该系链4粘附至持针器6的近端。系链4的长度防止导丝9相对于针7向近端撤回得过远，这是因为如果小直径远端线圈28被完全从针腔中撤回，则其将难以重新插入针7的近端之中。在另一选择中，塑料凸件或诸如闸门等另一物理结构可代替使用系链来充当用以阻止导丝9撤出至超过期望点的止动器。可选地，可将该止动器配置成使得其能够在发生强力缩回（诸如由弹簧10所引发的缩回）时被超越，从而允许导丝9的完全缩回。在另一选择中，可将外壳21配置成使得导丝9或连接至导丝9的结构在导丝9到达相对于针6过近的位置之前将会碰到前挡块，诸如导丝挡块2或外壳21的近端。
近端外壳1、远端外壳11、导丝推进滑块3、按钮25、持针器6、导丝挡块2以及持针器盖5可由适于在医疗应用中使用的任何材料来形成。例如，这些部件中的一些或所有部件可由诸如丙烯酸或聚碳酸酯等刚性、透明的医用级塑料模塑成型和/或机械加工而成。
压缩弹簧10或类似的偏动构件放置在持针器6与外壳21的远端之间，以在近端方向上推动持针器6。弹簧10的力受到按钮25的突片26的抵抗，该突片26在持针器6处于其最远端位置时啮合持针器6中的缺口24。应当注意的是，在图1中，将弹簧10示出为如其在未展开状态下的组装好的静脉内导管插入装置20中那样处于压缩状态。
在图6中以放大图示出的静脉内导管100具有导管管道102，该导管管道102具有同轴地安装在插入装置20的针7周围的内腔。导管管道102优选地由例如PTFE、聚丙烯或聚乙烯等具有低摩擦系数的柔性医用级聚合物压制而成。优选地，静脉内导管管道102具有与针7及锥形远端的紧配合，以便在针7和导管管道102被插入穿过静脉壁时最小化它们之间的任何梯级。
导管管道102的近端连接至近端配件104，该近端配件104连接至柔性侧臂管106的远端，该柔性侧壁管106从近端配件104的侧面横向延伸。优选地，近端配件104由透明聚合物模塑而成，以便能够在该近端配件104中观察到来自针7的回血。鲁尔配件108或类似的配件附接至侧臂管106的近端。形成从该鲁尔配件108经过侧臂管106抵达近端配件104和导管管道102的流体流通路径。优选地，该流体流通路径不受可干扰流体流通或可成为血栓形成病灶的障碍物、直径突变或死腔的影响。可选地，静脉内导管100可包括翼片105，该翼片105在插入静脉内导管100之后帮助将其敲入患者的皮肤。翼片105可以是刚性的或柔性的，并且可选地可以与近端配件104一体模塑成型。
止血阀110位于近端配件104的近端侧。止血阀110优选地配置成弹性膜片112，且在弹性膜片112的中心具有小孔114。该孔114在插入装置20的针7周围形成滑动密封。备选地，弹性膜片112可以是完整的，而针7在其插入穿过膜片112时将形成孔114。弹性膜片112可由乳胶、硅胶、聚氨酯或另一医用级弹性体制成。可选地，可使用少量诸如硅油等医用级润滑剂来减少穿过止血阀110的针7的摩擦力。还可使用业界已知的其他配置的止血阀，诸如那些具有膜片、孔、狭缝或鸭嘴阀等不同配置的止血阀。可选地，可以使用不止一个止血阀110或不同止血阀110的组合。
可选地，擦拭元件120位于止血阀110的近端处。该擦拭元件120适于在导丝9和针7从静脉内导管100撤回时，从它们的表面清除血液。擦拭元件120可由吸收材料或超强吸收材料制成，以从针7和导丝9的表面吸收血液。合适的材料的示例包括但不限于药棉、纱布、毛毡、天然或人造海绵、开孔泡沫塑料等。备选地，可将擦拭元件120配置成弹性膜片，其像刮板那样发挥作用来从导丝9的表面清除血液。弹性膜片优选地将足够有弹性，以适应针7的较大直径，并且继而当针6已撤回时适应导丝9的较小直径。优选地，将擦拭元件120制成为在中心具有孔或狭缝122，该孔或狭缝122与止血阀110中的孔114对准。备选地，擦拭元件120可以是完整的，而针7在其被插入穿过擦拭元件120时将形成孔122。
可选地，在静脉内导管100的近端配件104上可存在鲁尔配件27或类似的配件，该鲁尔配件27以稍微过盈的配合安装至持针器6的远端上的鲁尔滑动配件16，以便如图1和图2中所示那样将静脉内导管100固定就位。该装置的备选配置可使用鲁尔锁或其他锁定机构来暂时将静脉内导管100附接至插入装置20。备选地，针7穿过止血阀110和擦拭元件120的摩擦力可足以将静脉内导管100保持在插入装置20上。
本文所述的任何实施方式中的静脉内导管100的一个可选特征为装置142，该装置142用于选择性地堵塞或封堵经过柔性侧臂管106的流体流通。该装置142的形式可以是如图1和图2中所示的，位于柔性侧臂管106上或位于鲁尔配件108上的管夹或旋塞阀。备选地，可将单独的旋塞阀连接至鲁尔配件108，用以选择性地堵塞流体流通。
图3至图5图示了使用静脉内导管插入装置20（诸如以上结合图1、图2和图6所描述的插入装置）来插入静脉内导管100的方法中的步骤。如图3中所示，提供静脉内导管100和插入装置20作为以备用的未展开状态供给医生或其他医疗从业人员的一次性、不可重复使用的无菌装置。在另一选择中，可将该装置储存成让导丝9的远端螺旋部分28从针7的端头推进至远端处从而使其在储存期间不拉直。在这种情况下，操作者将在使用之前将导丝9完全缩回至针7中。在使用中，操作者使用外壳21作为手柄来操纵静脉内导管100和插入装置20。在装置处于未展开状态的情况下，使用针7来刺穿静脉。当在近端配件104中观察到静脉血时，操作者知道针7的远侧端头连同导管管道102的远端部分处在静脉腔中。如图4中所示，操作者可继而在远端方向上推进滑块3，以使导丝9伸出针7并伸入静脉腔中。导丝9的远端部分呈现其螺旋配置28来充当安全缓冲器，以防止对静脉远壁的意外刺穿或对静脉的其他损伤，并且还实现沿着诸如阀或弯曲等障碍的通路。通过如此展开导丝9，操作者可安全地继续推进静脉内导管100直至将其足够远地插入到静脉中，操作者继而按下按钮25以使突片26从持针器6中的缺口24脱离。弹簧10在近端方向上推动持针器6和滑块3，从而同时将针7和导丝9撤回至外壳21中，而仅将静脉内导管100留在静脉腔中。图5示出了在针7和导丝9撤回至外壳21中的情况下的插入装置20。优选地，如图5中所示，当插入装置20处于展开位置时，导丝9的远侧端头上的线圈28是可见的。这允许操作者验证导丝9为完整的，并且只有静脉内导管100被留在了患者的静脉中。
虽然期望插入装置20同时撤回针7和导丝9，但还可修改致动器机构以便依次撤回针7和导丝9。例如，致动器机构可首先撤回针7，并继而在少许延迟之后撤回导丝9。备选地，可修改致动器机构，以要求一个致动器构件的两个单独运动，或者要求两个单独的致动器构件的选择性移动，来选择性地撤回针7和导丝9。作为另一备选方案，可从致动器机构中省略弹簧10，从而允许使用滑块3来手动地撤回针7和导丝9。一旦已将静脉内导丝100插入到患者的静脉中，则沿着槽22向近端移动滑块3以将针7和导丝9撤回至外壳21中。
图7示出了具有单独的侧臂接合器130的静脉内导管100和插入装置20的实施方式。图8为图7的侧壁接合器130的放大图。静脉内导管100的结构与以上结合图6描述的静脉内导管类似，区别在于近端配件104在其远端上具有凸形鲁尔连接器132，该凸形鲁尔连接器132与导管管道102的近端上的凹形鲁尔连接器134联锁。
图9为根据本发明的静脉内导管100的另一实施方式的放大图。近端配件104和侧臂106可如图9中所示与静脉内导管100成为一体，或者它们可以类似于图7和图8中所示那样是单独的侧壁接合器的一部分。在该实施方式中，近端配件104具有第一腔室136和第二腔室138，其中第一腔室136与导管管道102流体连接，而第二腔室138通过止血阀110而与第一腔室136分隔开。可选地，用于从导丝9清除血液的擦拭元件120位于第二腔室138的近侧。优选地，将第二腔室138的尺寸设为允许导丝9的盘绕端头128在其经止血阀110撤回之后恢复其盘绕的配置。任何来自导丝9的血液滴落或喷溅都将发生在第二腔室138中。可选的擦拭元件120将会在从第二腔室138撤回导丝9时帮助从其清除任何残存血液。
图10和图11图示了用于与本发明的静脉内导管100和插入装置20一起使用的导丝9的另一优选实施方式。图10为导丝9的近端视图，而图11为导丝9的侧视图。导丝9优选地由诸如超弹性镍钛合金丝等高弹性材料制成，其具有大约为0.003-0.012英寸并且最为优选地大约为0.004英寸的均匀直径。导丝9的远端预成型为紧卷螺旋28，其外径小于其将要插入到的目标血管的内直径。由于镍钛合金丝的极大柔韧性，螺旋远端弯曲线28在导丝9撤回至针7中时可拉直，并且在导丝9被推出针7时完全恢复成螺旋配置而无塑性变形。在所示的示例中，导丝9的螺旋远端弯曲线28的形式为具有大约三个直径基本均匀的线圈或线卷的螺旋线。在特别优选的实施方式中，螺旋远端弯曲线28的螺旋线圈具有大约为0.052英寸（约为1.3mm）的外径。备选地，螺旋远端弯曲线28的形式可以是具有直径渐缩或渐增的线圈的锥形螺旋线。在所示的示例中，螺旋远端弯曲线28的螺旋线圈具有垂直于由导丝9的近端部分12所限定的轴并与之偏离的中心轴。在其他实施方式中，螺旋远端弯曲线28的中心轴可从导丝9的近端部分12的轴偏斜。在通过引用而并入于此的专利申请US20100210934、US20100094310以及US20080300574中描述了导丝9的螺旋远端弯曲线28的其他可能的配置。
导丝9的近端部分12优选地由支撑管8来支撑，该支撑管8由不锈钢或镍钛合金皮下注射管材制成，或者备选地，是由诸如但不限于FEP、PEEK或HDPE等聚合物制成的模塑成型或挤压成型管。支撑管8将优选地具有足以让导丝9的近端部分12插入并从中通过的内径，例如0.006英寸的内径来容纳0.004英寸直径的导丝9。支撑管8将优选地具有大约为0.012-0.016英寸并且最优选地大约为0.014英寸的外径。可选地，支撑管8可胶接或以其他方式附接至导丝9的近端部分12，其中支撑管8的远端位于离螺旋远端弯曲线28近侧的短距离处。支撑管8可具有锥形远端144，该锥形远端可通过模塑工艺或通过在装配期间应用粘合剂片或其他材料片来形成。
图12图示了用于与本发明的静脉内导管100和插入装置20一起使用的导丝9的另一实施方式。导丝9可由均匀直径丝或锥形丝制成，并且可选地可以由上述支撑管8来支撑。导丝9的螺旋远端弯曲线28可为本文中所述或并入本文的任何配置。在导丝9中离螺旋远端弯曲线28近侧的短距离（例如，1至5mm）处存在大约30至60度的弯折140。该弯折140可正好位于支撑管8的远端144，或者可选地，该弯折140可位于离支撑管8的远端144的远侧的短距离（例如，1至5mm）处。弯折140允许以可转向的方式使用导丝9，从而有助于越过迂曲和/或分支的血管。
虽然在此已关于示例性实施方式和本发明最优实践模式而描述了本发明，但对于本领域一般技术人员显而易见的是，可在不偏离本发明精神和范围的情况下，对本发明做出许多修改、改变和变更，以及各个特征和实施方式的改进和子组合。

Claims (14)

1.一种导管插入装置，包括：
外壳；
附接至持针器的管状接入针，其中所述持针器可相对于所述外壳滑动；
管状导管，其具有近端衬套，该近端衬套可释放地附接在所述外壳的远端，并且同轴地位于所述管状接入针的周围，所述衬套具有内部和隔膜，其中所述管状接入针穿过所述隔膜；
安全导丝，其经尺寸设定并配置成经过所述管状接入针推进；
致动器机构，其配置用于选择性地在远端方向上经过所述管状接入针推出所述安全导丝，以及继而相对于所述管状导管在近端方向上同时撤回所述安全导丝和所述管状接入针；以及
血液喷溅腔室，其装设在所述管状导管的所述近端衬套与所述致动器之间。
2.如权利要求1所述的导管插入装置，还包括侧壁连接器，该侧壁连接器连接至所述衬套，以便在已将所述针撤回穿过所述隔膜时从所述内部接收血液。
3.如权利要求1所述的导管插入装置，还包括擦拭元件，该擦拭元件位于所述血液喷溅腔室的近端侧，以便在所述导丝由所述致动器撤回时从所述导丝擦除残留血液。
4.如权利要求1所述的导管插入装置，其中所述致动器机构同轴地在所述管状接入针和所述安全导丝以及联锁之上压缩位于所述外壳的远端处的压缩弹簧，所述联锁可选择性地释放以允许所述压缩弹簧伸长从而同时地撤回所述安全导丝和所述管状接入针。
5.如权利要求1所述的导管插入装置，还包括：致动器手柄，其配置用于相对于所述外壳远端地移动，以便选择性地在远端方向上经过所述管状接入针推出所述安全导丝，其中所述致动器手柄配置用于横向旋转以促动所述联锁，从而允许所述安全导丝和所述管状接入针相对于所述管状导管在近端方向上的撤回。
6.如权利要求5所述的导管插入装置，还包括：
位于所述外壳中的细长槽，所述细长槽具有狭窄的近端部分和扩宽的远端部分；
其中所述致动器手柄可相对于所述细长槽移动，使得所述细长槽的所述狭窄的近端部分约束所述致动器手柄纵向移动，以便选择性地在远端方向上经过所述管状接入针推出所述安全导丝，并且所述扩宽的远端部分允许所述致动器手柄横向移动，以便促动所述安全导丝和所述管状接入针相对于所述管状导管在近端方向上的撤回。
7.如权利要求6所述的导管插入装置，其中所述联锁包括贴附至所述外壳的所述远端的前插头，所述前插头具有近端，该近端具有可旋转地与所述持针器的远端上的螺旋棘爪相联锁的突片，并且所述偏动构件具有压缩状态，其中所述弹簧偏动构件被压缩在所述前插头与所述持针器之间，并且其中所述致动器手柄的横向移动使所述持针器旋转，从而将所述持针器从所述前插头释放出来，并允许所述偏动构件相对于所述外壳在近端方向上推动所述持针器。
8.如权利要求7所述的导管插入装置，其中所述前插头还包括远端，该远端具有鲁尔滑动配件，用于可释放地将所述管状导管附接至所述前插头。
9.如权利要求7所述的导管插入装置，其中所述致动器机构还包括位于所述外壳内的滑块，所述滑块连接至所述致动器手柄，所述滑块具有远端，该远端具有凸出物，该凸出物配置用于啮合所述持针器以及将所述滑块的旋转传递至所述持针器以便从所述前插头释放所述持针器。
10.如权利要求1所述的导管插入装置，其中所述安全导丝具有形成为螺旋弯曲线的远端部分，其中所述安全导丝的所述螺旋弯曲线包括第一螺旋线卷和第二螺旋线卷，所述第一螺旋线卷具有比所述第二螺旋线卷更小的直径。
11.如权利要求7所述的导管插入装置，其中所述安全导丝的所述螺旋弯曲线的所述第一螺旋线卷大致与所述第二螺旋线卷共面。
12.如权利要求1所述的导管插入装置，其中所述安全导丝包括近端部分和远端部分，所述近端部分具有比所述远端部分的直径更大的直径。
13.如权利要求12所述的导管插入装置，其中所述安全导丝的所述远端部分形成为螺旋弯曲线。
14.如权利要求1所述的导管插入装置，其中所述安全导丝由超弹性镍钛合金所形成。
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US8690833B2 (en) 2014-04-08
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US20120197200A1 (en) 2012-08-02

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