JP5006317B2 - 静脈カテーテル挿入装置及びその利用方法 - Google Patents

静脈カテーテル挿入装置及びその利用方法 Download PDF

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JP5006317B2
JP5006317B2 JP2008520434A JP2008520434A JP5006317B2 JP 5006317 B2 JP5006317 B2 JP 5006317B2 JP 2008520434 A JP2008520434 A JP 2008520434A JP 2008520434 A JP2008520434 A JP 2008520434A JP 5006317 B2 JP5006317 B2 JP 5006317B2
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needle
insertion device
guide wire
catheter insertion
catheter
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アミール・ベルソン
グレゴリー・ダブリュー・ホール
スコット・エイ・ダニエル
ロバート・ブロマー
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Vascular Pathways Inc
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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
    • A61M25/09Guide wires
    • A61M25/09041Mechanisms for insertion of guide wires
    • 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
    • A61M25/09Guide wires
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • 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
    • 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
    • A61M25/065Guide needles
    • 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
    • A61M5/178Syringes
    • 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
    • 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
    • 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
    • A61M5/178Syringes
    • 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
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • 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
    • A61M5/178Syringes
    • 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
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • 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
    • A61M5/178Syringes
    • 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
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Description

本発明は、静脈カテーテルを患者の静脈又は動脈に挿入して配置するための装置及び方法に関する。本発明の装置及び方法によって、カテーテルを静脈又は動脈に安全に配置することが可能になり、そのことは、小さい、入り組んだ、弱っている、壊れやすい、且つ/又は、位置付け難い血管である場合に、特に重要である。装置及び方法によると、静脈カテーテルの配置後の針によって、偶発的に突き刺したり、雑菌が混入したりすることを予防できる。
以下の特許は、シリンジ及び針のための従来の静脈カテーテル挿入装置及び/又は安全装置について説明している。
EP00515710A1(静脈カテーテル及び挿入装置,Haining)
EP00515710B1(静脈カテーテル及び挿入装置,Haining)
US05019049(静脈カテーテル及び挿入装置,Haining)
US05176650(静脈カテーテル及び挿入装置,Haining)
EP00567321A2(針保護部を有する静脈カテーテル,Chang)
EP00652020B1(格納式の皮下注射針アセンブリ,Mahurkar)
EP00910988A1(血液サンプル収集アセンブリ,Mahurkar)
US05891105(皮下注射針アセンブリ,Mahurkar)
US03572334(静脈カテーテル配置ユニット,DeWitt)
EP00750916A2(保護用の針被覆容器,van Heugten)
EP00942761B1(格納式の針を備えた医療装置,Botich)
EP01075850B1(静脈カテーテルを挿入するための装置,Botich)
US05800395(格納式の針を備えた医療装置,Botich等)
US06436070(格納式の針を備えた医療装置,Botich等)
US23060760A1(格納式の針を備えたカテーテル挿入装置,Botich等)
WO00012160A1(格納式の針を備えた輸液装置,Botich等)
WO09632981A1(静脈カテーテルを挿入するための安全なスタイレット,Botich)
WO09824494A1(格納式の針を備えた医療装置,Botich)
EP01457229A1(静脈カテーテル挿入装置,Shue)
US24106903A1(静脈カテーテル挿入装置,Shue)
US03592192(カニューレの外部で嵌め込まれたカテーテルを備えた静脈カテーテル装置,Harautuneian)
US03610240(カニューレの内部で嵌め込まれたカテーテルを備えた静脈カテーテル装置,Harautuneian)
US04037600(カテーテル配置システム,Poncy等)
US04292970(静脈カテーテル始動装置,Hession)
US04834718(安全な注射針装置,McDonald)
US04944725(安全な注射針装置,McDonald)
US04909793(格納式のスタイレットを備えた静脈カテーテル装置,Vining等)
US04944728(静脈カテーテル配置装置,Carrell等)
US04966589(静脈カテーテル配置装置,Kaufman)
US05007901(静脈カテーテル挿入装置,Shields)
US05562629(ハンドルからカテーテルを解放する際、針の取り外しを可能にする、ハンドルと針と解放可能な保持機構とを利用するカテーテル配置システム,Haughton)
US05562634(自動的に引き込む針案内部を備えた静脈カテーテル,Flumene等)
US05573510(自動格納針を備えた安全な静脈カテーテル・アセンブリ,Isaacson)
US06056726(内臓式の安全な静脈カテーテル挿入装置,Isaacson)
WO09523003A1(内臓式の安全な静脈カテーテル挿入装置,Isaacson)
US05891098(安全な静脈カテーテル,Huang)
US05941854(静脈カテーテル,Bhitiyakul)
US05997507(付勢したバネで硬い針を格納可能な静脈カテーテル,Dysarz)
US06193690(傾斜面でラッチする静脈カテーテルのための装置,Dysarz)
US06221047(安全な静脈カテーテル・アセンブリ及び針を用いた利用方法,Greene)
US06689102(安全な静脈カテーテル・アセンブリ,Greene)
US06695814(安全な静脈カテーテル・アセンブリ及び針を用いた利用方法,Greene)
US21014786A1(安全な静脈カテーテル・アセンブリ及び針を用いた利用方法,Greene等)
US22165497A1(安全な静脈カテーテル・アセンブリ,Greene等)
WO00006226A1(安全な静脈カテーテル・アセンブリ及び針を用いた利用方法,Greene等)
US06322537(安全な静脈カテーテル,Chang)
US06620136(格納式の静脈カテーテル配置装置,Pressly,Sr等)
WO00047256A1(格納式の静脈カテーテル配置装置,Pressly,Sr等)
US06730062(取り外すことができない格納式の針を備えた安全なカテーテル,Hoffman等)
US23073956A1(取り外すことができない格納式の針を備えた安全なカテーテル,Hoffman等)
US24267204A1(静脈カテーテル・アセンブリを利用するために、必要に応じて針を保持及び固定する機構,Brustowicz)
WO03043686A1(流れ調整/自動バルブ静脈カテーテル,Garcia Andreo)
WO09222344A1(静脈カテーテル配置のための針保護部,Sircom)
WO09519193A1(格納式の静脈穿刺カテーテルの針及び容器,Ogle)
WO09705912A2(格納式の静脈穿刺カテーテルの針及び容器,Rohrbough等)
WO09721458A1(針先端に対する柔軟な延長部及び保護部を備えた静脈カテーテル,Hwang)
一形態において、本発明は、アクセス針、静脈カテーテル及び安全なガイドワイヤの調和のとれた移動を可能にする静脈カテーテル挿入装置として実現する。
装置は、静脈又は他の標的血管に穿刺するために、同軸に配列されたアクセス針及び静脈カテーテルを保持する。血液逆流チャンバによって、針の先端が静脈のルーメンにあることを視覚的に示唆することができる。アクセス針によって静脈を穿刺する際、柔軟で安全なガイドワイヤは、装置の外部に設けられた操作部を利用することで、アクセス針を通って静脈のルーメンに前進させられる。静脈のルーメンに配置された柔軟で安全なガイドワイヤを用いることによって、アクセス針及び静脈カテーテルは、静脈カテーテルの先端が静脈のルーメンの中に至るまで、安全に静脈の中に前進できる。代わりに、静脈カテーテルは、アクセス針が静止状態を保つ間、個別に前進してもよい。次に、操作部は、アクセス針及び安全なガイドワイヤを同時に抜き取るように、作動する。好ましくは、アクセス針及び安全なガイドワイヤは、バネ又は他の付勢部の作動によって、静脈カテーテルのみを静脈に残して、自動的に引き抜かれる。一旦、アクセス針及び安全なガイドワイヤが抜かれると、静脈カテーテルは、挿入装置から切断され、静脈内輸液、薬剤等の源泉に接続される。
他の形態において、本発明は、静脈カテーテルを挿入及び配置するための進歩した方法を提供する。その方法は、静脈カテーテルと同軸上に配置されたアクセス針を用いて静脈又は他の標的血管に穿刺し、静脈のルーメンでアクセス針の先端の場所を確認し、アクセス針を介して安全なガイドワイヤを静脈のルーメンの中に前進させ、静脈カテーテルの先端を静脈の中に前進させ、アクセス針及び安全なガイドワイヤを静脈カテーテル及び患者から、同時に引き抜くステップを含む。
本発明は静脈カテーテルの挿入に関して記載するが、本明細書に記載される装置及び方法は、静脈、動脈又は他の体内の構造に、種々のカテーテル又は同様の装置を挿入するために、容易に応用され得る。
図1は、本発明に係る静脈カテーテル挿入装置20の一実施の形態の分解図を示す。図2は、未配置状態、すなわち準備状態での静脈カテーテル挿入装置20の組立図を示す。図3は、前進した安全なガイドワイヤを備える静脈カテーテル挿入装置20の想定図である。
静脈カテーテル挿入装置20は、筐体1を含む。例示において、筐体1は、細長い中空のシリンダの形状を有する。人間工学に基づくハンドル形状を含むような、他の形状であってもよい。筐体1は、医療での利用に適した材料を用いて作られる。一実施の形態において、筐体1は、好ましくは、硬くて透明な医療グレードのプラスチックから射出成形される。代わりに、筐体1は、押し出しプラスチック管から機械加工されてもよい。
筐体1は、筐体1の軸とほぼ平行に、細長いスロット14を有する。スロット14は、筐体1の内部に沿ってスライダを移動させられるように、ドウェル・ピン(dowel pin)10に適合し、又は、スライダ4に接続箇所を提供する大きさである。スロット14の末端は、図2及び3に示されるように、三角の切り欠き部15に広がる。切り欠き部15は、他の形状であってもよい。
フロント・プラグ2は、筐体1の末端に収まる大きさである。フロント・プラグ2は、好ましくは、射出成形であり、又は代わりに、硬い透明な医療グレードプラスチックから機械加工されてもよい。フロント・プラグ2は、筐体1の末端に、接着、ピン止め、溶接又はしっかりと締結されている。フロント・プラグ2の末端は、ルアー・スリップ・フィッティング(luer slip fitting)16等を含む。ショルダ部又はフランジ17は、筐体1の末端に嵌合する。フロント・プラグ2の基端は、嵌合する連結部19と針保持部6で連結する連結部18を有する。図示する例では、連結部18は、針保持部6上で、対応する螺旋状のツメ又は4分の1回転分のネジの連結部19に連結するツメである。連結部18,19は他の形状であってもよい。
図1−3の典型的な実施の形態では、スロット14及び三角形の切り欠き部15は、回転連結部18,19と協同的に作動するように、決定される。スロット14によって、アクチュエータ・ハンドル9が筐体1に関して長手方向の末端側に安全なガイドワイヤ11を前進させることが可能になる一方で、アクセス針8及び安全なガイドワイヤ11をあまりに早く抜いてしまうことを防ぐように、横移動が制限される。末端でスロット14を三角形の切り欠き部15に広げることによって、アクチュエータ・ハンドル9を横回転させることを選択でき、それによって、安全なガイドワイヤが完全に前進した後に、回転連結部18,19を切り離し、アクセス針8及び安全なガイドワイヤ11を引き抜くように付勢部12を解放することが可能になる。異なる形状又は異なる解放機構が回転連結部18,19に利用される場合、スロット14の形状及び三角形の切り欠き部15は、解放機構に適するように、変更されてよい。
針保持部6は、筐体1の中に収まる形状及び大きさである。図1−3に示す実施の形態において、針保持部6は、シリンダ状の筐体1の中にスライド可能に収まる大きさであるシリンダ形状を有する。他の形状であってもよく、概ね、針保持部6は、筐体1の内部形状に応じた形状である。針保持部6は、好ましくは射出成形され、代わりに、医療環境での利用に適した材料から機械加工されてもよい。一実施の形態において、針保持部6は、硬くて透明な医療グレードプラスチックを用いて形成される。鋭く傾斜した末端を有する管状アクセス針8は針保持突起部5に取り付けられ、針保持突起部5は次に、針保持部6に取り付けられる。アクセス針8は、好ましくは、ステンレス鋼製の皮下注射管を用いて作られる。アクセス針8のルーメンと連通する小さな空洞又は血液逆流チャンバが、針保持部6の中、すなわち針保持突起部5と針保持部6との間に位置付けられる。上述のように、針保持部6の末端は、フロント・プラグ2の基端の嵌合する連結部18と連結するように形成された連結部19を有する。一実施の形態において、連結部18,19は、針保持部6の回転によって、フロント・プラグ2に係止し、又解放するように備えられる。連結部18,19は、差し込み口金タイプの結合を利用して、係止及び解放してもよい。図示する例では、連結部は、フロント・プラグ2の対応するツメ状の連結部18と連結する螺旋状のツメの連結部19である。一実施の形態において、連結部は、針保持部6が1回転よりも少ない回転をすることによって、係止及び/又は解放する。他の実施の形態において、連結部は、針保持部6が半回転よりも少ない回転をすることによって、係止及び/又は解放する。さらに他の実施の形態において、連結部は、針保持部6が4分の1回転よりも少ない回転をすることによって、係止及び/又は解放する。連結部は他の形状であってもよい。
付勢部12は、針保持部6とフロント・プラグ2とを分離させるために、針保持部6とフロント・プラグ2との間に収まるように設けられる。針保持部6とフロント・プラグ2とが互いに係止されている場合、付勢部12の力は、連結部18,19によって抵抗される。一実施の形態において、付勢部12はバネである。図1は、未配置の状態の組み立てられた静脈カテーテル挿入装置20において、付勢部又は圧縮バネ12を圧縮状態で示す。
他の実施の形態において、連結部18,19は、互いに解放可能な接着剤で固着される2つの部材か、又は解放可能なリンクを有する一体の部材に置き換えられてもよい。アクセス針8及び安全なガイドワイヤ11が引き抜かれることが望まれ、その時に、アクチュエータが付勢部12を解放するように接着又はリンクを解くまで、部材(群)は、付勢部12を抑制するように形成される。このような構成によって、装置20は、再製造又は再利用され難くなる。
ANGIOCATHのような管状静脈カテーテル13は、アクセス針8と同軸上に設けられる。好ましくは、静脈カテーテル13は、静脈の壁を通って挿入される時のアクセス針8及び静脈カテーテル13の間の段差が最小になるように、アクセス針8及びテーパ状の末端に密着する。静脈カテーテル13を所定位置に保持するように、僅かな締まり嵌めによって、フロント・プラグ2の末端のルアー・スリップ・フィッティング16に取り付ける静脈カテーテル13は、基端に、ルアー・フィッティング27又は同様のものを有する。他の装置の形態では、静脈カテーテル13をフロント・プラグ2に取り付けるために、ルアー・ロック又は他の係止機構を利用してもよい。
スライダ4は、概ね、シリンダ形状であり、シリンダ状の筐体1の中にスライダ可能に収まる大きさである。スライダ4は、筐体1の内部形状によって、他の形状であってもよい。スライダ4は、好ましくは射出形成されたものであり、又は代わりに、適切な医療グレードの材料から機械加工されたものである。例えば、スライダは、硬い医療グレードプラスチックから形成されてもよい。ハンドル9又は作動部は、筐体1の中でスロット14を通じて伸びるスライダ4に、ドウェル・ピン10又は他の取付部材を用いて取り付けられる。スライダ4は、針保持部6の基端側の筐体1の中に収まる。ピン25は、スライダ4の末端表面から伸びて、針保持部6の基端の穴、ステップ、ボス又は同様の嵌合手段26と取り外し可能に結合するように形成される。静脈カテーテルを挿入及び配置する手技の適切な工程の間で、ピン25が嵌合手段26に連結すると、スライダ4の回転は、針保持部6に伝達され、それによって、連結部18,19の連結及び/又は解放が可能になる。ピン25及び手段26は例に過ぎない。ピン25が雌手段に置き換えられる一方で、嵌合する雄手段が針保持部6の基端面に設けられてもよい。更に、嵌合手段25,26は、細長いスロット及びスライダ4のスライド移動に対して、スライダ4が末端側に移動することにより嵌合手段25,26が結合するように、配列されてもよい。適宜、装置20は、装置20が作動した場合にスライダ4と針保持部6との間で取り外し不能に結合するように、形成されてもよい。
図3に示すように、安全なガイドワイヤ11は、スライダに取り付けられたハンドル9とともに前進し又後退するように、直接又は間接にスライダ4に取り付けられる。好ましい実施の形態において、安全なガイドワイヤ11は、超弾性のニッケル・チタニウム合金(ニチノール)のワイヤから形成される。この種のワイヤは極めて柔軟であるため、安全なガイドワイヤ11の前進中に曲がったり、又は屈曲することを防ぐように、その長さ方向に沿って概ね囲われた安全なガイドワイヤ11を備えることが好ましい。このため、図示する例は、針保持部6の基端に取り付けられる支持チューブ7を有する。安全なガイドワイヤ11は、シース・チューブ3の内部ルーメンを通って伸び、安全なガイドワイヤ11の基端はシース・チューブ3の基端に取り付けられる。シース・チューブ3の末端は次にスライダ4に取り付けられ、安全なガイドワイヤ11を間接的にスライダ4に取り付ける。支持チューブ7は、スライダ4が末端側に前進する時2つの部材が嵌り合うように、シース・チューブ3の中にスライド可能に収まる。支持チューブ7及びシース・チューブ3の嵌り合い動作によって、ガイドワイヤ11が前進するときに曲がったり、又は屈曲することを防ぐために、安全なガイドワイヤ11の基端部を種々の長さで支持する。支持チューブ7及びシース・チューブ3は、好ましくは、ステンレス鋼の皮下注射用の管を用いて作られるが、適切な医療グレードのプラスチック材料が用いられる。他の実施の形態において、大きい直径又は硬いガイドワイヤを用いた場合、嵌り込む支持チューブは必要ではなく、安全なガイドワイヤの基端は直接にスライダ4に取り付けられる。
図4A及び4Bは、静脈カテーテル挿入装置20とともに使用するための安全なガイドワイヤ11の詳細な図である。安全なガイドワイヤ11は、好ましくは、超弾性のニッケル・チタニウム合金のワイヤで直径約0.004−0.012インチであり、最も好ましくは、直径約0.008インチである。図4Bに示すように、安全なガイドワイヤ11の末端は、挿入される標的血管の内径よりも小さい外径を有する堅く巻かれた螺旋状に形成される。螺旋の先端は、標的血管の内部を突き刺し又は損傷することを防ぐために、ガイドワイヤの安全な緩衝器として機能する。コイル状のガイドワイヤの先端は、傷付き易く又は繊細な静脈を保護するために、特に有用である。ニッケル・チタニウム合金のワイヤが極めて柔軟であるために、螺旋状の末端湾曲部は、安全なガイドワイヤ11がアクセス針8の中に引き抜かれた場合に真っ直ぐになり、安全なガイドワイヤ11がアクセス針8から前進した場合に螺旋形状に完全に戻る。例示するように、安全なガイドワイヤ11の末端は、第1に、約0.167インチの直径で約0.75回転する小さい直径のコイルと、第2に、約0.175インチの直径で約1回転する大きい直径のコイルとを有する。第1及び第2のコイルは、好ましくは、互いに略同一平面上にあり、好ましくは、ガイドワイヤ11の直線基端部も略同一平面上にある。安全なガイドワイヤ11の他の形状は、末端の複数平面上のもの、末端の単一コイルのもの、末端の半径方向に詰まったもの、及び/又は、針の直径より小さい直径を有する球状端を含む。
図5A、5B及び5Cは、静脈カテーテル挿入装置20とともに利用するための他の安全なガイドワイヤ11の詳細な図である。この実施の形態において、約0.008インチの直径のニッケル・チタニウム合金のワイヤの末端部分は、研削、引き伸ばし等によって、約0.004インチの直径にまで先細りにされ、その結果、より柔軟になり、かつ、より小さい直径の静脈に使用するためのより小さい直径の螺旋に形成することが可能になる。ガイドワイヤの先端の螺旋状の湾曲部は、標的血管の内径より小さい外径を有する。例図では、螺旋状の湾曲部は、第1に、約0.034インチの直径で約0.75回転する小さい直径のコイルと、第2に、約0.059インチの直径で約1回転する大きい直径のコイルとを有する。第1及び第2のコイルは、好ましくは、好ましくは、互いに略同一平面上にあり、好ましくは、ガイドワイヤ11の直線基端部も略同一平面上にある。
安全なガイドワイヤ11は他の大きさ及び形状であってもよい。
図1−3に示す静脈カテーテル挿入装置20を組み立てるために、アクセス針8は、針保持突起部5の基端面に直接に固着され、針保持突起部5は、次に針保持部6の中に固着される。支持チューブ3は、針保持部6の末端穴に配置され、血液逆流チャンバの基端面に直接に固着される。形成された安全なガイドワイヤ11は、アクセス針8及び支持チューブ7のルーメンを通って、安全なガイドワイヤ11のコイル部分がアクセス針8の傾斜に接触するまで、前進する。シース・チューブ3は、スライダ4を通ってスライド移動し、その末端面と同一面に重なる時に直接に固着される。シース・チューブ3及びスライダ4のアセンブリは、安全なガイドワイヤ11の上を前進する。安全なガイドワイヤ11がシース・チューブ3の基端と同一面に重なる時に、その2つは固着される。バネ12は針保持突起部5の上で圧縮し、フロント・プラグ2の中に前進し、そして、フロント・プラグ2及び針保持部6の連結部18,19が結合する。このコンポーネントのアセンブリは、筐体1の中に配置され、フロント・プラグ2が筐体1と同一面に重なるまで前進し、そして、フロント・プラグ2は適切な位置合わせのために回転する。フロント・プラグ2が筐体1に固着される。ドウェル・ピン10及びハンドル9は、互いにスライダ4にとともに圧縮される。ハンドル9は、安全なガイドワイヤ11をアクセス針8の中に引き抜くように基端側にスライド移動し、それによって、螺旋状の末端湾曲部を直線状にする。次に、静脈カテーテル13はアクセス針8と同軸上に装着される。適宜、静脈カテーテル13を挿入する装置は、針カバー又は他の保護パッケージとともに備えられる。静脈カテーテル13を含む組み立てられた静脈カテーテル挿入装置20は、次に、梱包され、ラベルが貼られ、滅菌される。
上述の組み立てに関する説明は、静脈カテーテル挿入装置20の実施の形態を製造する工程の例を示すものであり、それによって、種々のコンポーネントの相互関係が理解されるであろう。本明細書に記載した内容の改良及び変形は、特に選ばれたアセンブリ又は製造技術に基づくことが予期される。例えば、固着されるコンポーネントが、単一の統合的な部材から形成されること等である。製造工程は、静脈カテーテル挿入装置20の他の実施の形態を組み立てるために、改良され又適応され得る。
図6は、本発明に係る静脈カテーテル挿入装置20の他の実施の形態の内部を示す図である。本実施の形態は、図1−3の静脈カテーテル挿入装置20に多くで類似する。静脈カテーテル挿入装置20は、筐体1、筐体1とともに一体的に適宜成形されるフロント・プラグ2、針保持部6に取り付けられる針8、安全なガイドワイヤ11、スプリング12及び静脈カテーテル13を含む。しかし、ハンドル9及びスライダ4の機能は、安全なガイドワイヤ11に接触しているフリクション・ホイール(friction wheels)22,23の組に係合するサムホイール21によって代替される。同様に、シース・チューブ3及び支持チューブ7の機能は、ガイドワイヤ・スプール24によって代替される。これらの手段によって、静脈カテーテル挿入装置20をよりコンパクトな形態で構成することが可能になる。使用時に、安全なガイドワイヤ11は、サムホイール21を回転させることによって、前進する。サムホイール21の横移動によって、針保持部6をフロント・プラグ2から解放し、付勢部12膨脹することを可能にして、その結果、針8及び安全なガイドワイヤ11を筐体1に後退させる。代わりに、分離ボタン、レバー、又は他の作動部によって、針8及び安全なガイドワイヤ11を引き抜いてもよい。ガイドワイヤ・スプール24は適宜、安全なガイドワイヤ11の筐体1への後退を補助するために、旋回バネ又は同様の機構(図示せず)を含む。
図7−9は、図1−3又は図6を参照して説明したような静脈カテーテル挿入装置20を用いた静脈カテーテル挿入方法を示す。静脈カテーテル挿入装置20は、使い捨てで再利用しない装置であり、図2に示すような準備状態すなわち未配置状態で滅菌して、医師又は医療従事者に供給される。使用時に、医師は、静脈カテーテル挿入装置20を操作するハンドルとして筐体1を使用する。未配置状態の装置を用いて、アクセス針8が図7に示すように静脈に突き刺すために使用される。静脈血が血液逆流チャンバに観察される場合、アクセス針8の末端は静脈のルーメンにある。医師は、次に、アクセス針8から静脈のルーメンに安全なガイドワイヤ11を伸ばすために、ハンドル9を末端側に前進させることができる。安全なガイドワイヤ11の末端部は、偶発的に静脈の遠方の壁に突き刺したり、又は、他の静脈の損傷を防ぐように、その螺旋形状が安全な緩衝器として作動すると想定される。このように配置された安全なガイドワイヤ11を用いて、医師は、静脈カテーテル13の末端が静脈のルーメンに位置するまで、静脈カテーテル挿入装置20を安全に継続して前進させることが可能になる。一旦、静脈カテーテル13が静脈の中の柔軟な遠方に挿入されると、医師がスライダ4を回転させるハンドル9を回転させ、次にスライダ4が針保持部6を回転させて、フロント・プラグ2の嵌合する連結部19から針保持部6の連結部18を解放する(上で例示した実施の形態において、ハンドルは、筐体1にあるスロット14の末端の三角形の切り欠き部15によって可能になる反時計回りの方向に移動する。更に作動機構が備える手段は図1−3により詳細に示す。)。ハンドル9が解放されると、付勢要素(ここでは、圧縮バネ12)が針保持部6及びスライダ4を基端側に押し、これによって同時にアクセス針8及び安全がガイドワイヤ11を筐体1の中に引き抜き、静脈カテーテル13だけを静脈のルーメンに留置する。図8は、筐体1の中に引き抜かれているアクセス針8及び安全なガイドワイヤ11を示す。三角形の切り欠き部15の形状によると、ハンドル9は、付勢要素12の影響により基端側に移動する場合、細長いスロット14の中に滑らかに移動できる。最後に、静脈カテーテル13は、図9に示すようにフロント・プラグ2の末端に収まるルアー・スリップ16から解放され、静脈内輸液の源泉、シリンジ、又は他の装置が静脈カテーテル13のルアー・フィッティング27に取り付けられる。
静脈カテーテル挿入装置20はアクセス針8及び安全なガイドワイヤ11を同時に引き抜くことが望ましいが、作動機構はアクセス針8及び安全なガイドワイヤ11を順に引き抜くように変形されてもよい。例えば、作動機構はアクセス針8を最初に引き抜き、次に、少し遅れて、安全なガイドワイヤ11を引き抜いてもよい。
代わりに、作動機構は、アクセス針8及び安全なガイドワイヤ11を選択的に引き抜くために、1つの作動部の2つの別個の動作、又は、2つの別個の作動部の選択的な動作が必要となるように変形されてもよい。
静脈カテーテル挿入装置20の他の実施の形態において、圧縮バネ12が作動機構から除かれてもよく、その場合、アクセス針8及び安全なガイドワイヤ11がハンドル9を用いて手動で引き抜くことができる。一旦、静脈カテーテル13が患者の静脈に挿入されると、針保持部6をフロント・プラグ2から解放するために、ハンドル9が横に回転し、次に、ハンドル9は、アクセス針8及び安全なガイドワイヤ11を筐体1の中に引く抜くために、スロット14に沿って基端側に移動する。
本発明は、例示的な実施の形態及び本発明を実施するための最良の実施の形態に関して本明細書で説明したが、多くの改善、改良、種々の実施の形態の組み合わせ、適応及び変形が、本発明の精神と射程から逸脱しない限り、本発明になされることは明らかであろう。例えば、例示した実施の形態には全ての寸法及び材料が含まれ、又、図は、本発明の好ましい実施の形態の例として意図するにすぎず、本発明の射程を限定することを意図するものではない。
本発明に係る静脈カテーテル挿入装置の分解図。 未配置状態、すなわち準備状態での静脈カテーテル挿入装置の組立図。 前進した安全なガイドワイヤを備えた静脈カテーテル挿入装置の想定図。 静脈カテーテル挿入装置とともに使用するための安全なガイドワイヤの詳細な図。 静脈カテーテル挿入装置とともに使用するための他の安全なガイドワイヤの詳細な図。 本発明に係る静脈カテーテル挿入装置の他の実施の形態を示す図。 本発明に係る静脈カテーテル挿入方法を示す図。

Claims (13)

  1. 筐体と、
    上記筐体に対してスライド移動可能な針保持部に取り付けられた管状アクセス針と、
    上記筐体の末端に取り外し可能に取り付けられ、上記管状アクセス針と同軸に配置される管状カテーテルと、
    上記管状アクセス針を通って前進できるような大きさ及び形状をした安全なガイドワイヤと、
    上記管状アクセス針を通って上記管状カテーテルに対して末端側に上記安全なガイドワイヤを適宜、前進させ、続けて上記安全なガイドワイヤ及び上記管状アクセス針を上記管状カテーテルに対して基端側に引き抜くように構成された作動機構とを備えるカテーテル挿入装置において、
    上記作動機構の作動に基づいて、上記管状カテーテルに対して基端側に、上記安全なガイドワイヤ及び上記管状アクセス針を自動的に引き抜くように構成された付勢部と、
    上記管状アクセス針を通って末端側に上記安全なガイドワイヤを適宜、前進させるために、上記筐体に対して末端側に移動するように構成された作動ハンドルとをさらに備え、
    上記作動ハンドルは、上記管状カテーテルに対して基端側に上記安全なガイドワイヤ及び上記管状アクセス針を引き抜くために、横に回転するように設けられることを特徴とするカテーテル挿入装置。
  2. さらに、上記筐体に細長いスロットを備え、
    上記細長いスロットは、狭い基端部及び広い末端部を有し、
    上記作動ハンドルは、上記細長いスロットに関して移動可能であり、その結果、上記管状アクセス針を通って末端側に上記安全なガイドワイヤを適宜、前進させるために、上記細長いスロットの上記狭い基端部によって、上記作動ハンドルが長手方向に移動することが制限され、又、上記安全なガイドワイヤ及び上記管状アクセス針を上記管状カテーテルに関して基端側に引き抜くように作動させるために、上記広い末端部によって、作動ハンドルが横に回転することが可能になることを特徴とする請求項1に記載のカテーテル挿入装置。
  3. さらに、上記筐体の末端に取り付けられるフロント・プラグを備え、
    上記フロント・プラグは、上記針保持部の末端の螺旋状のツメと回転可能に連結するツメを有する基端を有し、
    上記付勢部は、上記付勢部がフロント・プラグと上記針保持部との間で圧縮される圧縮状態を有し、
    上記作動ハンドルの横移動によって上記針保持部が回転し、その結果、上記針保持部を上記フロント・プラグから解放し、上記付勢部が上記針保持部を筐体に関して基端側に押すことを可能にすることを特徴とする請求項2に記載のカテーテル挿入装置。
  4. 上記フロント・プラグが、さらに、末端を有し、上記末端が上記管状カテーテルを上記フロント・プラグに解放可能に取り付けるルアー・スリップ・フィッティングを有することを特徴とする請求項3に記載のカテーテル挿入装置。
  5. さらに、上記筐体の中に位置付けられるスライダを備え、
    上記スライダは、上記作動ハンドルに接続され、
    上記スライダは、上記針保持部と結合し、上記針保持部を上記フロント・プラグから解放するために上記スライダの回転を上記針保持部に伝達する突起を末端に有することを特徴とする請求項3に記載のカテーテル挿入装置。
  6. 上記安全なガイドワイヤが上記スライダに接続されていることを特徴とする請求項5に記載のカテーテル挿入装置。
  7. さらに、上記管状アクセス針を通って基端側に上記安全なガイドワイヤを適宜、前進させるために、筐体に関して回転するように設けられたサムホイールを備えることを特徴とする請求項1に記載のカテーテル挿入装置。
  8. 上記安全なガイドワイヤは、螺旋状の湾曲部が形成された末端部を有することを特徴とする請求項1から7のいずれか1項に記載のカテーテル挿入装置。
  9. 上記安全なガイドワイヤの螺旋状の湾曲部が、第1螺旋旋回部及び第2螺旋旋回部を有し、上記第1螺旋旋回部が上記第2螺旋旋回部より小さい直径を有することを特徴とする請求項8に記載のカテーテル挿入装置。
  10. 上記安全なガイドワイヤの上記螺旋状の湾曲部の上記第1螺旋旋回部が、上記第2螺旋旋回部と略同一面上にあることを特徴とする請求項9に記載のカテーテル挿入装置
  11. 上記安全なガイドワイヤは、基端部及び末端部を有し、
    上記基端部は、上記末端部の直径より大きい直径を有することを特徴とする請求項1から10のいずれか1項に記載のカテーテル挿入装置。
  12. 上記安全なガイドワイヤの上記末端部は、螺旋状の湾曲部に形成されていることを特徴とする請求項11に記載のカテーテル挿入装置。
  13. 上記安全なガイドワイヤは、超弾性のニッケル・チタニウム合金を用いて形成されることを特徴とする請求項1から12のいずれか1項に記載のカテーテル挿入装置。
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