CN106470607A - 用于导管的针捕获安全互锁设备 - Google Patents

用于导管的针捕获安全互锁设备 Download PDF

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CN106470607A
CN106470607A CN201580029194.0A CN201580029194A CN106470607A CN 106470607 A CN106470607 A CN 106470607A CN 201580029194 A CN201580029194 A CN 201580029194A CN 106470607 A CN106470607 A CN 106470607A
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pin
catheter block
conduit tube
clip
conduit
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CN106470607B (zh
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S·K·舍夫古尔
W·哈丁
J·斯托克斯
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Becton Dickinson and Co
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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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0097Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631Devices 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
    • 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
    • A61M39/22Valves or arrangement of valves
    • 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
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    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
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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
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    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
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    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3232Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
    • AHUMAN NECESSITIES
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    • 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
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    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • 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
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    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064Slit-valve
    • 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
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/066Septum-like element
    • 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
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0673Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
    • 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
    • A61M39/22Valves or arrangement of valves
    • A61M2039/226Spindles or actuating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
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    • A61M5/3273Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle

Abstract

导管组件(10)包括导管(22)、布置于导管(22)中的具有尖锐的远侧尖端的针(12)、容纳导管(22)和针(12)的导管座(14),导管座(14)具有包括凹口(36)的轴环(34)、当针(12)位于第一位置中时被连接至导管座(14)的针护罩(20)、以及布置于针护罩(20)中与针(12)配合的夹子(40),其中在针(12)的第一位置中夹子(40)接合导管座(14),并且当针(12)被抽出至第二位置时夹子(40)通过凹口(36)与导管座(14)脱离以包封针(12)的至少一部分。夹子(40)通过具有暴露于针护罩(20)的外侧的外壁(70)的铲状部(66)被安装于针护罩(20)的外壳体(38)中,以减小针护罩(20)的整体宽度。

Description

用于导管的针捕获安全互锁设备
相关申请
本申请根据35 U.S.C.§119(e)声明在2014年4月18日提交的美国临时专利申请序列号61/981,223、2014年4月18日提交的美国临时申请61/981,312、以及2014年11月10日提交的美国临时专利申请序列号62/077,760的优先权。以上申请中的均被整体地纳入本文加以参考。
技术领域
本发明的多种示范性实施例涉及导管。
背景技术
导管组件被用于将导管适当地放置于患者的脉管系统内。一旦放置到位,则诸如静脉导管的导管可以被用于将包括生理盐水、药用化合物、和/或营养成分的流体灌输至需要此类治疗的患者体内。导管额外还能够将流体从循环系统移除并且监测患者脉管系统内的状况。
发明内容
本发明的一个方面为提供导管组件,在所述导管组件中使用改进的夹子和针护罩以用于针保护。改进的布置更加紧凑,提供增进的针保护,并且降低导管组件的尺寸和复杂性。将释放凹口添加至导管座的轴环中以及通过凹口将夹子脱离使得针护罩比先前技术中的针护罩更加紧凑。在先前技术中,没有凹口,夹子不得不移动更长的距离以脱离导管座。额外地,通过改进的介于夹子和针护罩之间的附接界面减小针护罩的宽度。特别地,铲状部将夹子附接至针护罩,且铲状部的外表面暴露于针护罩的外侧。
能够通过提供导管组件实现本发明的前述以及/或者其他方面,所述导管组件包括导管、布置于导管中的具有尖锐的远侧尖端的针、容纳导管和针的导管座,导管座具有凹口、当针位于第一位置中时被连接至导管座的针护罩、以及布置于针护罩中的与针配合的夹子,其中在针的第一位置中,夹子接合轴环,当针被抽出至第二位置时夹子通过凹口与轴环脱离以包封针的至少一部分。
还能够通过提供导管组件实现本发明的前述以及/或者其他方面,所述导管组件包括导管、布置于导管中的具有尖锐的远侧尖端的针、容纳导管和针的导管座、被构造用于被连接至导管座的针护罩、以及布置于针护罩中的与针配合的夹子,夹子包括将夹子附接至针护罩的铲状部,其中铲状部的外表面暴露于导管组件的外侧。
还能够通过提供操作导管组件的方法实现本发明的前述以及/或者其他方面,所述方法包括将具有尖锐的远侧尖端的针布置于导管中,当针在其第一位置中使用时偏压夹子、将针从具有凹口的导管座移除、当针位于第二位置中时释放夹子以包封针的至少一部分、并且当针位于第二位置中时通过凹口将夹子与轴环脱离。
附图说明
通过参考附图的用于本发明的示范性实施例的描述,本发明的以上方面和特征将更加显而易见,其中:
图1说明根据本发明的实施例的导管组件的俯左视立体图;
图2说明导管组件的侧左视立体图;
图3说明导管组件的替代的侧左视立体图;
图4说明导管组件的俯视平面图;
图5说明导管组件的右侧视图;
图6说明导管组件的仰视平面图;
图7说明导管组件的已组装的导管座、针护罩、以及针的左方立体图;
图8说明导管组件的已组装的导管座、针护罩、以及针的右方立体图;
图9说明导管组件的已组装的导管座、针护罩、以及针的右侧视图;
图10说明导管组件的已组装的导管座、针护罩、以及针的仰视平面图;
图11说明导管组件的已组装的导管座、针护罩、以及针的仰视平面图;
图12说明导管组件的已组装的导管座、针护罩、以及针的俯视平面图;
图13说明导管组件的已组装的导管座、针护罩、以及针的右侧视图的剖视图;
图14说明导管组件的已分离的导管座、针护罩、以及针的左方立体图;
图15说明导管组件的已分离的导管座、针护罩、以及针的右方立体图;
图16说明导管组件的已分离的导管座、针护罩、以及针的右侧视图;
图17说明导管组件的已分离的导管座、针护罩、以及针的第二右侧视图;
图18说明导管组件的已分离的导管座、针护罩、以及针的仰视平面图;
图19说明导管组件的已分离的导管座、针护罩、以及针的俯视平面图;
图20说明导管组件的已分离的导管座、针护罩、以及针的右侧视图的剖视图;
图21为导管组件的导管座的右方立体图;
图22为导管组件的导管座的俯视平面图;
图23为导管组件的导管座的左方立体图;
图24为导管组件的导管座的前方侧视图;
图25为导管组件的导管座的右方侧视图;
图26为导管组件的导管座的后方侧视图;
图27为导管组件的导管座的左方立体图;
图28为导管组件的导管座的仰视平面图;
图29为导管组件的导管座的右方立体图;
图30说明导管组件的针护罩外壳体的右方立体图;
图31说明导管组件的针护罩外壳体的左方立体图;
图32说明导管组件的针护罩外壳体的第二左方立体图;
图33说明导管组件的针护罩外壳体的第二右方立体图;
图34说明导管组件的针护罩外壳体的前方侧视图;
图35说明导管组件的针护罩外壳体的后方侧视图;
图36说明导管组件的针护罩外壳体的右侧视图;
图37说明导管组件的针护罩外壳体的右侧视图;
图38说明导管组件的针护罩外壳体的俯视平面图;
图39说明导管组件的针护罩外壳体的仰视平面图;
图40说明导管组件的V形金属夹子的左方立体图;
图41说明导管组件的V形金属夹子的右方立体图;
图42说明导管组件的V形金属夹子的第二右方立体图;
图43说明导管组件的V形金属夹子的前方立视图;
图44说明导管组件的V形金属夹子的后方立视图;
图45说明导管组件的V形金属夹子的左方侧视图;
图46说明导管组件的V形金属夹子的右侧视图;
图47说明导管组件的V形金属夹子的俯视平面图;
图48说明导管组件的V形金属夹子的仰视平面图;
图49说明导管组件的垫圈的右方立体图;
图50说明导管组件的垫圈的左方立体图;
图51说明导管组件的垫圈的前方立视图;
图52说明导管组件的垫圈的仰视平面图;
图53说明导管组件的垫圈的左方侧视图的剖视图;
图54说明替代的带有翼部的导管座的右方立体图;
图55说明带有翼部的导管座的俯视平面图;
图56说明带有翼部的导管座的左方立体图;
图57说明带有翼部的导管座的前方视图;
图58说明带有翼部的导管座的左方侧视图;
图59说明带有翼部的导管座的后方立视图;
图60说明带有翼部的导管座的左方立体图;
图61说明带有翼部的导管座的仰视平面图;
图62说明带有翼部的导管座的第二右方立体图;
图63说明替代的侧端口导管座的右方立体图;
图64说明侧端口导管座的俯视平面图;
图65说明侧端口导管座的左方立体图;
图66说明侧端口导管座的前方立视图;
图67说明侧端口导管座的右侧视图;
图68说明侧端口导管座的后方立视图;
图69说明侧端口导管座的第二左方立体图;
图70说明侧端口导管座的仰视平面图;
图71说明侧端口导管座的第二右方立体图;
图72说明替代的带有针护罩和针座的侧端口导管座组件的左方立体图;
图73说明替代的带有针护罩和针座的侧端口导管座组件的右方立体图;
图74说明替代的带有针护罩和针座的侧端口导管座组件的俯视平面图;
图75说明替代的带有针护罩和针座的侧端口导管座组件的右方侧视图;
图76说明替代的带有针护罩和针座的侧端口导管座组件的仰视平面图;
图77说明当引导针被收回时图1-12的导管组件的剖视图;
图78说明当引导针被收回时图1-12的导管组件的第二剖视图;
图79说明当引导针被移动经过V形金属夹子并且针护罩被从导管座分离时图1-16的导管组件的剖视图;
图80说明当引导针被移动经过V形金属夹子并且针护罩被从导管座分离时图1-16的导管组件的第二剖视图;
图81说明与导管座接合的V形金属夹子的闩锁;
图82说明与导管座脱离的V形金属夹子的闩锁;
图83说明与导管座脱离并且分离的V形金属夹子的闩锁;
图84说明阻挡针的V形金属夹子的视图;
图85说明位于闭合位置中的V形金属夹子的视图;
图86说明V形金属夹子与不带有凹口的导管座轴环的有效包封的示意图;
图87说明V形金属夹子与不带有凹口的导管座轴环的有效包封的示意图;
图88说明V形金属夹子与带凹口的导管座轴环的有效包封的示意图;
图89说明V形金属夹子与带凹口的导管座轴环的有效包封的示意图;
图90说明处于自由状态中的导管座阀门致动器的操作;
图91说明处于已压缩状态中的导管座阀门致动器的操作;
图92说明处于自由状态中的导管座阀门致动器的第二实施例的操作;
图93说明处于已压缩状态中的导管座阀门致动器的第二实施例的操作;
图94说明导管座阀门致动器的另一个实施例;
图95说明示范性的导管组件的回血特征。
图96说明图95的导管组件的回血特征的针。
图97说明导管组件的第二示范性的回血特征。
图98说明在两个位置中存在回血的图97的导管组件的第二示范性的回血特征。
图99说明在三个位置中存在回血的导管组件的第三示范性的回血特征。
图100说明图94的致动器的示范性实施例的右方侧视图;
图101A说明在导管座组件中的图100的致动器的剖视图;
图101B说明当穿透隔膜时图101A的导管座组件的剖视图;
图101C说明当穿透隔膜时图101A的导管座组件的左方立体剖视图;
图102A说明导管座组件的另一个示范性实施例的剖视图;
图102B说明当穿透隔膜时图102A的导管座组件的剖视图;以及
图102C说明当穿透隔膜时图102A的导管座组件的左方立体剖视图。
具体实施方式
本文公开的导管组件为在共同拥有的美国专利申请公开号2014/0364809中公开的内容(其纳入本文加以参考)的改进。
图1-12说明导管组件10,所述导管组件10包括中空的金属引导针12、导管座14、针座16、以及针护罩20。针12具有磨尖的并且带斜面的远侧端部,并且最初延伸穿过针护罩20和导管座14。柔性导管管道22从导管座14的远侧端部延伸,且引导针12穿过导管管道22。最初,针12被插入至患者的静脉内。导管管道22通过针12被输送至静脉内。在导管管道22被插入之后,针12从患者的静脉和导管座14移除。针护罩20包封针12的尖端,并且在针从导管座14抽出过程中及之后保护免受针12扎伤。针护罩20能够与多种不同的导管一同使用。
如图12-20所说明的,导管组件包括导管座14以及从导管座14延伸的柔性导管管道22。金属楔子24被定位于导管座14中以保持导管管道22。弹性隔膜26被定位用于控制穿过导管座14的流体流动。致动器28被可移动地定位于导管座14中以接合隔膜26。偏压构件30接合致动器28以在近侧方向上偏压致动器28。
弹性隔膜26具有一个或多个预先形成的狭缝,所述预先形成的狭缝通常被闭合以有选择地防止不期望的流体流动穿过隔膜26。例如,隔膜26能够具有形成三个三角形挡板的三个狭缝,所述狭缝当被致动器28接合时打开。隔膜26由弹性材料制成,例如硅橡胶,所述弹性材料提供了用于狭缝的弹性闭合力。正如将被被领域的技术人员理解的,可以使用其他的隔膜26构造。
致动器28和偏压构件30(例如金属的或塑料的压缩弹簧)被定位于导管座14内。致动器28接合隔膜26,以打开狭缝并且允许流体流动穿过导管座14。偏压构件30能够使得致动器28返回至一个容许狭缝闭合的位置,从而防止流体流动穿过导管座14。
正如在图21-29的示范性实施例中最佳地示出的,导管座14包括具有外部鲁尔螺旋线32的近侧端部以及带凹口的轴环34。轴环34围绕导管座14的至少一部分延伸并且优选地被布置于导管座14的近侧端部处。轴环34具有将轴环34的第一端部和第二端部分开的缺口、开口或凹口36。
轴环34的一部分包括比导管座14的与轴环34相邻的一部分外直径更大的外直径。特别地,轴环34的一部分外直径相对于相邻的导管座14的外直径表面被提升。额外地,轴环34的开口36具有基本上等于或大于导管座14的与轴环34相邻的一部分外直径的外直径。
在示范性实施例中,针护罩20包括外壳体38、弹性夹子40、以及垫圈42。外壳体38包括孔眼,所述孔眼具有用于接收针12的远侧开口44和近侧开口46。外壳体38连接至导管座14并且包围夹子40和垫圈42。如图在30-39中最佳地示出的,外壳体38的远侧端部包括鼻部48、顶部凸缘50、以及基部52。当针护罩20被连接至导管座14时,鼻部48延伸至导管座14的内部内。
在示范性实施例中,鼻部48的尺寸被设计为稍小于导管座14的内部,以便于以宽松的公差进行装配。顶部凸缘50通过侧面凹陷对和基部52间隔开,所述侧面凹陷对接收鲁尔螺旋线32并且防止当被组装时导管座14相对于针护罩20旋转。基部52包括突出部54,并且所述突出部54具有弯曲的顶部表面和弯曲的切除部分56。突出部54的尺寸被设计为装配至轴环34的开口36中,并且切除部分56的尺寸被设计为容许轴环34穿过其中。
根据在图40-48中说明的示范性实施例,夹子40为基本上V形的弹性夹子40,所述V形的弹性夹子40具有通过倾斜的或弯曲的V段64连接的第一腿部60和第二腿部62。第一腿部60包括具有倾斜的导入部分68的基本上U形的铲状部66。铲状部66包括通过底部74连接的外壁70和内部72。倒钩对76从铲状部66的内壁72向外延伸。第一旗状部78从第二腿部62朝向第一腿部60延伸,并且第二旗状部80从第一腿部60朝向第二腿部62延伸。足部82从第一旗状部78向外延伸远离第一腿部60和第二腿部62,并且闩锁84从足部82向上延伸并且被定位于第一腿部60和第二腿部62之间。特别地,闩锁84被布置于代表第一腿部60的平面和代表第二腿部62的平面之间。这样的构造期望用于创造更加紧凑的夹子40。可选的加强部86能够从足部82向下延伸。
夹子40被连接至外壳体38,且铲状部66被定位于外壳体38的外壁周围。铲状部66被附接至外壳体38的外壁以使得铲状部66的外壁70暴露于针护罩20的外侧。与铲状部66被接收于外壳体38的内部腔内以使得外壁70不暴露于外壳体38外侧的布置相比,这个构造有利地减小针护罩20的宽度。如在图79-85中最佳地示出的,铲状部66的内壁72被定位于凹陷中,并且两个倒钩76延伸远离内壁72以接合在针护罩20中的突出部对89。两个倒钩76帮助将夹子40牢固地紧固至针护罩20的内表面。夹子40可以由金属、高弹体、聚合物、或复合材料形成。在多种示范性实施例中,夹子40由弹性金属薄片形成,诸如不锈钢。
根据在图49-53中说明的示范性实施例,垫圈42包括以基本上L形被连接在一起的基部88和侧壁90。侧壁90包括漏斗92和开口94。针12包括变形部96,例如形成于针12的远侧端部附近的卷曲部或伸出部。在垫圈42中的开口94的尺寸被设计为容许针轴穿过,而不容许变形部96穿过。漏斗92使得在组装过程中针12的近侧端部最初被插入穿过垫圈42更加容易。
图54-62描绘替代的示范性的具有稳定翼对216的导管座214。图63-76描绘另一个替代的示范性的具有稳定翼对316和侧端口318的侧端口导管座314。侧端口与内部管道阀门(未示出)相连通,如在美国专利No.4,231,367中描述的,所述美国专利No.4,231,367的内容纳入本文加以参考。替代的导管座214、314均具有带有开口236、336的轴环234、334以接收针护罩20的闩锁84。
导管组件能够包括最初被附接至针座16的塞子320。在针座16和针护罩20已经被从导管座移除之后,塞子320能够被从针座16移除并且附接至导管座的打开的近侧端部。虽然仅通过侧端口导管314进行描述,但是塞子320能够与导管座14、214、314中的任一一同使用。
图77-85描绘在操作过程中的图1-12的导管组件。最初,针护罩20被连接至导管座14,并且引导针12穿过导管座14和针护罩20。当针12在使用中(第一位置)时,针护罩20的鼻部48(在图30中标出的)可以或可以不延伸至导管座14内。通过将第一臂部60和第二臂部62朝向彼此按压而将夹子40偏压至已锁定位置内,针12与夹子40相互配合。在已锁定位置中,闩锁84接合轴环34,从而防止针护罩20从导管座14移除,正如在图81中最佳地示出的。与此同时,在已锁定位置中,闩锁84从轴环开口36偏移。闩锁84的位置相对于针12从中心偏移。夹子40也位于打开位置中,从而容许针12移动穿过夹子40。
当针12被从导管座14收回并且进入针护罩20内时,针12的尖端通过夹子40,并且夹子40被容许弹性地扩张,从而导致第二臂部62移动远离第一臂部60。当夹子40侧向地扩张时,第一旗状部78和第二旗状部80阻挡外壳体38孔眼的远侧开口44,从而防止针12的尖端离开外壳体38的远侧端部。
第二腿部62的移动将闩锁84从与轴环34的接合侧向地移动至与轴环开口36对准的位置,从而容许针护罩20与导管座14脱离或解锁。闩锁84移动的方向为相对于针12的中心线垂直。闩锁84移动并非径向地朝向或者远离针12。此外,当闩锁84被调整时,闩锁84移动至居中的位置,并且随后相对于针12完全地移动偏移中心。位于针12的第一位置和第二位置中的闩锁84的偏移中心位置为彼此对称地相对的。
在当旗状部78、80阻挡针12时的位置中,夹子40移动至闭合位置。与此同时,针12进入从第一针位置抽出的第二位置,这进一步防止针12的使用。如上所述,第一位置被理解为例如针12在进入第二位置之前的所有的位置。
当针12在近侧方向上被进一步牵拉时,针12的轴滑动穿过针护罩20,直至形成于针12的远侧端部附近的变形部96与垫圈42配合并且接合为止,如图80中所示。在垫圈42中的开口的尺寸被设计为容许针轴穿过,而不容许变形部96穿过。因此,垫圈42防止当针12位于第二位置中时针12的远侧尖端和变形部96离开针护罩20。垫圈42和针护罩20的组合包封位于这个第二位置中的针12的远侧尖端。针12的进一步向近侧移动引起针护罩20被牵拉远离导管座14。
夹子40和垫圈42的组合作为示范性的针尖端保护机构。这个针尖端保护机构包封远侧的针尖端和变形部96,并且防止针12的这些部分离开针护罩20。
能够在美国专利Nos.6,749,588和7,604,616、以及美国专利申请公开No.2014/0364809中找到更多关于在这个实施例中使用的针尖端保护机构类型的信息,所述美国专利Nos.6,749,588和7,604,616、以及美国专利申请出版物No.2014/0364809的内容被纳入本文加以参考。在这个实施例中描述的特征(包括针保护特征)能够与本申请通篇描述的特征组合使用。
正如在图86-89中所描绘的,夹子40和带凹口的轴环34的使用容许更小更紧凑的设计。如果没有轴环开口36,那么闩锁84将不得不移动距离B1以通过轴环并且容许针护罩20的脱离。如果有轴环开口36,那么闩锁84无需通过整个导管座14并且仅需移动小于B1的距离B2
图90和91描绘导管阀门致动器28的使用。引导针12最初延伸穿过致动器28、隔膜26、楔子24、以及导管管道22。在引导针12和导管管道22被插入至患者体内之后,针12被收回,从而闭合隔膜26。当阳型鲁尔连接器98被插入至导管座14内时,鲁尔连接器98抵靠致动器28并且在远侧方向上移动致动器28,从而压缩偏压构件30。鲁尔连接器38的进一步插入将致动器28移动穿过隔膜26,从而打开狭缝并且容许流体流动穿过导管座14。
当鲁尔连接器98被移除时,偏压构件30在相反的方向上移动致动器28,从而将其从隔膜26移除,闭合狭缝,并且防止流体流动穿过其中。与鲁尔连接器98被移除之后致动器将保留在隔膜中的一次性使用导管不同的是,这容许导管当处于患者的静脉中时被重复使用。然而,一次性使用导管也能够与本文描述的针护罩20一同使用。
致动器28具有包围内部通道的致动器筒100。致动器筒100为基本上管状的构件并且内部通道为基本上圆筒形的。致动器筒100的第一端部具有带有倒角外表面的鼻部以接合隔膜26。管状构件具有一个或多个开口102以允许流体环绕致动器筒100流动穿过致动器筒100。致动器28包括用于接合阳型鲁尔连接器的后部分。
在图90中示出的第一示范性实施例中,致动器28包括在筒中的第一组和第二组开口102,且第一组开口在鼻部附近。在图79-80的致动器28中也示出开口。图90的致动器28的后部分还包括从筒延伸并且连接至环106的腿部组104。在这个实施例中描述的特征能够与本申请通篇描述的特征组合使用。
在图92-94中示出的第二示范性实施例中,致动器28A包括沟槽组101A和开口组102A。沟槽101A从鼻部朝向致动器筒100A的背部延伸。开口102A被定位为朝向筒100A的后方。当致动器28A延伸穿过隔膜26时,沟槽101A将流体引流至保留在隔膜26的近侧部上的开口102A。沟槽101A可以被定位于开口102A的侧部上或者直接地与开口102A对齐。致动器的后部分包括从筒延伸的腿部组104A。正如图94中所说明的,环106A可以被连接至腿部104A以接合鲁尔连接器98,或者鲁尔连接器98可以直接地接合腿部104A,如图92和93中所说明的。在这个实施例中描述的特征能够与本申请通篇描述的特征组合使用。
在示范性实施例中,偏压构件30为弹簧,例如带有远侧端部和近侧端部的螺旋压缩弹簧。弹簧可以由金属、塑料、高弹体、或者另一种适合的弹性材料制成。弹簧的远侧端部与导管座14的内表面形成过盈配合。过盈配合可能足以保持弹簧,即使在负载过程中。弹簧的近侧端部连接至致动器28。在这个实施例中描述的特征能够与本申请通篇描述的特征组合使用。
图95-99描绘多种示范性的导管组件的回血特征。回血为证实针尖端进入静脉内的可见血液现象。当血液移动至中空针12的敞开远侧端部内、从针尖端附近的针12中的凹口或开口402(在图13中也可见)出去、并且向上穿过介于针12和导管管道22的内侧之间的内部环形空间时,看到穿过导管管道的一级回血400。当血液从针12的背部出来并且进入针座/柄中的回血室时,看到在针座/柄16中的二级回血404。空气通过针座/柄16的背部中的塞子由多孔的薄膜或微型沟槽排出。当来自一级回血400的血液流动至导管座14内并且停止于血液控制隔膜26处时在导管座14中存在三级回血406。空气通过在血液控制隔膜26外周中的微型沟槽排出。在这个实施例中描述的特征能够与本申请通篇描述的特征组合使用。
图100更详细地说明图94的致动器。致动器554能够被用于在图90-93中说明的导管组件中。致动器554包括鼻部558,所述鼻部558当致动器554穿透至导管座组件的隔膜538内时减小摩擦。致动器554还包括开口555,所述开口555在垂直于致动器554的中心线的方向上延伸穿过致动器554。例如,致动器554能够包括两个矩形的开口555,然而可以构思更多的或更少的开口。
致动器554还包括多个沟槽557,所述多个沟槽557在平行于致动器554的中心线的平面上沿致动器554的外表面的远侧部分轴向地延伸。例如,基本上彼此径向等距的四个沟槽557能够沿致动器554的远侧部分的外表面,然而可以构思更多的或更少的沟槽557。沟槽557能够为进入致动器554内多种深度的。由于沟槽557不延伸穿过致动器554,因此沟槽557与开口555不同。
开口555和沟槽557有利地提供用于流体在导管座组件内侧移动的增加的区域。增加的区域有利地容许流体冲刷,并且防止在隔膜的近侧端部和远侧端部中的流体凝结。额外地,开口555和多个沟槽557有利地最小化流体的淤塞并且容许更多的混合。沟槽57进一步防止在操作过程中隔膜密封于致动器的外侧表面上。通过不形成密封界面,允许流体通过沟槽57泄露穿过隔膜并且提供额外的冲刷。
图101A说明在导管座组件中的图100的致动器554。类似于上述实施例的,导管座组件还包括导管座514、隔膜538以及偏压构件556。如所说明的,致动器554的开口555和沟槽557提供用于在导管座514内侧的流体流动的更多的区域,因此实现上述优势。
图101B和101C说明当偏压构件556被压缩并且致动器554穿透隔膜538时的导管座组件。导管座组件可以被构造为使得致动器554的开口555和/或沟槽557可选地穿透隔膜538。在这个实施例中,致动器554中的开口555不穿透隔膜538。然而,在致动器554中的沟槽557穿透隔膜538。除了上述优势之外,这个构造还容许增进的流体流动穿过沟槽557从隔膜538的近侧端部到达远侧端部。在完成导管组件的操作之后,通过由偏压构件556施加的力,致动器554被从隔膜538抽出。导管组件被构造用于在按压致动器554基础上的多种用途。在这个实施例中描述的特征(包括致动器)能够与本申请通篇描述的特征组合使用。
图102A说明在导管座组件中的致动器664的另一个实施例。导管座组件包括具有侧端口668的导管座662。侧端口668提供通往在导管座662中的流体流动的第二通路。导管座662的主要孔与侧端口668的交叉处包括套筒672。套筒672提供介于侧端口668和导管座662之间的有选择的流体连通。特别地,当通过侧端口668施加足够的流体压力时,套筒672压缩。套筒672的压缩容许流体进入导管座662。导管座组件还包括隔膜670以及向致动器664提供张力的偏压构件666。
致动器664包括以类似于上述的方式延伸穿过致动器664的多个开口665。致动器664包括具有不同尺寸和类似间隔的两个四开口行665,然而可以构思开口665的多种数量、尺寸和间隔。如所说明的,开口665提供用于在导管座662内的流体流动的更多区域,因此实现以上结合图100-101C描述的类似的优势。
图102B和102C说明当致动器664穿透隔膜670并且压缩偏压构件666时的导管座组件。导管座组件被构造为使得致动器664的开口665可选地穿透隔膜670。在这个实施例中,在致动器664中的开口665不穿透隔膜670。除了上述优势之外,这个构造还容许介于侧端口668和导管座662之间的在隔膜670的近侧端部处的增大的流体流动。如果在致动器664中的开口665穿透隔膜670,那么将在隔膜670的远侧端部处也将产生增进的流体混合。
当完成导管组件的操作时,通过由偏压构件666施加的力,致动器664被从隔膜670抽出。导管组件被构造用于在按压致动器664基础上的多种用途。在这个实施例中描述的特征(诸如致动器)能够与本申请通篇描述的特征组合使用。
在另一个示范性实施例中,如上所述的导管座的轴环能够被限定凹口的任何其他结构替代。例如,轴环可以为在导管座中的沟槽或凹陷。因此,在导管座中的沟槽能够以类似于上述的方式被用于与夹子接合和脱离。在这个实施例中描述的特征能够与本申请通篇描述的特征组合使用。
前述的某些示范性实施例的详细的描述已经被提供用于解释本发明的原理及其实际应用,因此使得本领域的技术人员理解用于多种实施例并且带有适于构思的实际用途的多种修改的发明。本说明并非意在穷尽性的或者限制将本发明限制于公开的示范性实施例。本文公开的实施例和/或元件中的任一可以与彼此组合以形成未特别地公开的实施例的多种额外的实施例。因此,额外的实施例是可能的并且意在被包含在本说明及其附属权利要求范围内。本说明描述具体的示例以实现可以以另一种方式实现的更加具体的目标。
正如在本申请中使用的,术语“前方”、“后方”、“上”、“下”、“向上”、“向下”以及其他方向性描绘词意在便于描述本发明的示范性实施例,并非意在将本发明的示范性实施例的结构限制于任何具体的位置或方位。程度术语,诸如“基本上”或“近似地”被本领域的技术人员理解为指的是在给定的值之外的合理的范围,例如与已描述的实施例的制造、组装、和使用相关的通常的公差。

Claims (23)

1.一种导管组件,包括:
导管;
布置于导管中的具有尖锐的远侧尖端的针;
容纳导管和针的导管座,导管座具有凹口;
当针位于第一位置中时被连接至导管座的针护罩;以及
布置于针护罩中的与针配合的夹子,其中
在针的第一位置,夹子接合导管座,和
当针被抽出至第二位置时夹子通过凹口与导管座脱离以包封针的至少一部分。
2.根据权利要求1所述的导管组件,其中:
导管座包括轴环,并且
凹口被布置于轴环上。
3.根据权利要求2所述的导管组件,其中轴环的一部分具有比导管座的与轴环相邻的一部分外直径更大的外直径。
4.根据权利要求2所述的导管组件,其中轴环的凹口具有基本上等于或大于导管座的与轴环相邻的一部分外直径的外直径。
5.根据权利要求2所述的导管组件,其中轴环包括外部鲁尔螺旋线。
6.根据权利要求1所述的导管组件,其中在针使用过程中针的第一位置将夹子偏压至打开位置。
7.根据权利要求1所述的导管组件,其中针的第二位置容许当针使用之后被抽出时夹子移动至闭合位置以阻挡针的远侧尖端。
8.根据权利要求7所述的导管组件,其中夹子包括阻挡位于第二位置中的针的远侧尖端的一个或多个旗状部。
9.根据权利要求1所述的导管组件,还包括
被布置于针护罩中与针配合的垫圈,其中
针还包括变形部;以及
当针位于第二位置中时,垫圈防止针的远侧尖端和变形部离开针护罩。
10.根据权利要求9所述的导管组件,其中
当针位于第二位置中时夹子和垫圈包封针的远侧尖端。
11.根据权利要求1所述的导管组件,其中
夹子包括将夹子附接至针护罩的铲状部,并且铲状部的外表面暴露于导管组件的外侧。
12.根据权利要求11所述的导管组件,其中
铲状部包括一个或多个倒钩,并且
所述一个或多个倒钩接合针护罩的内表面。
13.根据权利要求2所述的导管组件,其中
轴环被布置于导管座的近侧端部上,并且
夹子包括被构造用于与轴环和针护罩接合和脱离的闩锁。
14.根据权利要求13所述的导管组件,其中
夹子包括两个腿部,并且
闩锁被布置于两个腿部之间。
15.根据权利要求13所述的导管组件,其中当针位于第一位置中时闩锁从凹口偏移以接合轴环。
16.根据权利要求13所述的导管组件,其中当针位于第二位置中时闩锁与凹口对准以脱离轴环。
17.根据权利要求13所述的导管组件,其中闩锁侧向地移动以脱离轴环。
18.根据权利要求13所述的导管组件,其中闩锁在已接合位置和已脱离位置中的每一个处相对于针从中心偏移。
19.一种导管组件,包括:
导管;
布置于导管中的具有尖锐的远侧尖端的针;
容纳导管和针的导管座;
被构造用于连接至导管座的针护罩;以及
布置于针护罩中的与针配合的夹子,夹子包括将夹子附接至针护罩的铲状部,其中
铲状部的外表面暴露于导管组件的外侧。
20.根据权利要求19所述的导管组件,其中
铲状部包括一个或多个倒钩,并且
所述一个或多个倒钩接合针护罩的内表面。
21.一种操作导管组件的方法,包括:
将具有尖锐的远侧尖端的针布置于导管中;
当针在其第一位置中使用时偏压夹子;
将针从具有凹口的导管座移除;
当针位于第二位置中时释放夹子以包封针的至少一部分;和
当针位于第二位置中时通过凹口将夹子从导管座脱离。
22.根据权利要求21所述的方法,还包括当针位于第一位置中时接合夹子和导管座。
23.根据权利要求21所述的方法,还包括
当夹子接合导管座时连接导管座和针护罩;和
当夹子与导管座脱离时断开导管座和针护罩的连接,
其中夹子被布置于针护罩中。
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