JP2004147750A

JP2004147750A - Blood sampling vessel holder

Info

Publication number: JP2004147750A
Application number: JP2002314087A
Authority: JP
Inventors: Yutaka Takashi; 豊高司; Norihiro Hiejima; 徳寛比恵島; Sakaki Hino; 賢樹日野
Original assignee: Nipro Corp
Current assignee: Nipro Corp
Priority date: 2002-10-29
Filing date: 2002-10-29
Publication date: 2004-05-27

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood sampling vessel holder which allows the blood sampling operators to be devoted to the putting of a blood sampling needle into or out of the blood vessels of a person desired to draw the blood while reducing the pain of the person desired to sample the blood caused by piercing with the blood sampling needle and enables the safe and accurate blood sampling operation by enabling the operation with a stable posture for the blood sampling operators and also enables the safe and accurate blood sampling operation which makes the blood sampling operators free from the risk of erroneous piercing by the accurate determination of the proceeding state of the blood sampling. <P>SOLUTION: A blood sampling vessel holder 1 is made as a cylindrical body 120 opened upward and a hollow needle 11 is built by protruding upward on the bottom part of the cylindrical body 120 and sealed up liquidtightly on the outer circumference thereof and wrapped with an elastic cap 2 with a rubber resilience. A hollow path 111 of the hollow needle 11 is bent at the bottom part of the cylindrical body 120 so as to communicate with a blood sampling means 4 from the side of the cylindrical body and a support part 13 is provided on the outer wall of the bottom part of the cylindrical body. <P>COPYRIGHT: (C)2004,JPO

Description

【０００１】
【発明の属する技術分野】
本発明は採血管ホルダーに関し、詳しくは筒状の採血管受部の底部から上向きの中空針を設けるとともに、中空路が採血管ホルダーの筒状体底部で屈曲され、筒状体側面から横方向の採血手段へと連通される採血管ホルダーに関する。
【０００２】
【従来の技術】
従来、採血のために減圧採血管に穿刺される採血セットは、例えば特公平３−３９６９５号の採血器具に示されるような一方に突出する採血針部および他方に突出する中空状の針管が弾性鞘体により被包された中空針部とからなる。中空針部は一般に金属製の針管の先端が先鋭角度に形成され、その先端部は採血管ホルダーの採血管の挿入方向に向けて挿入され、この中空針部が採血管の密封部材に刺通される際にその先端部はまず前記弾性鞘体を突き抜け、さらに採血管の密封部材に刺通されて弾性鞘体が密封部材によって軸方向に圧縮された状態となって中空針部先端の開放孔が採血管内に達したところで、中空針部の中空部が採血管内に連通されて採血管内の減圧によって血液が吸引され採血が開始される。
【０００３】
ところで、かかる従来の採血セットによれば採血操作者は、被採血者の血管に採血針を刺し入れて引き続いて採血管ホルダーを手に持ったまま採血管の挿入を行う操作まで一貫して行うため、不安定な姿勢での操作を次々と行わねばならず採血操作の熟練が求められ、また採血数が多いと労力も相当なものであった。
さらに、採血管への中空針着脱の際に採血操作者が誤って自分の指先に中空針を刺してしまうという、所謂誤穿刺の危険は常に存在している。さらに、かかる手に持っての採血は採血の進行状況確認という点からも、採血管を持つ角度などによっては採血終了のタイミングを的確にとらえ難いなどの問題点もあった。
【０００４】
一方、被採血者にとっても、この操作不安定に加え器具の外形寸法との関係で穿刺角度が大きくなってしまって、時として痛みを伴うものであった。そして、この穿刺角度の問題について、角度を血管の向きにできるだけ平行に近いものとする工夫が提案され、例えば特開平８−３０８８１８号公報において図４に表すように、採血管ホルダー２の下端と採血針１の穿刺部１４間の径方向に関する距離Ｌを小さくすることで血管への穿刺角θを小さく（浅く）しようとの提案が、また特開平１０−３３５０９号公報においては図５に表すように、血管刺通角度を小さくさせるために血管刺通側の針管４２を栓体刺通側針管４３に対して所定の角度をなすような折れ曲がり角をもたせた提案が行われている。
【０００５】
【特許文献１】
特公平０３−０３９６９５号公報（第２−４頁、第１図）
【特許文献２】
特開平０８−３０８８１８号公報（第４頁の右欄、第２図）
【特許文献３】
特開平１０−０３３５０９号公報（第５頁の右欄、第１９図）
【０００６】
しかしながら特開平８−３０８８１８号公報や特開平１０−３３５０９号公報に提案されたいずれの採血セットにおいても、前者における採血針ホルダー２や後者におけるホルダー本体１を操作者が手に持って行うものであって、不安定な操作性という点からは従来の問題を根本的に解決するものではなかった。特に、特開平１０−３３５０９号公報の提案では、ホルダー本体１の先端からガイド枠２０が突出したさらにその先端付近から採血針４の血管刺通側の針管４２が突き出た構造であり、操作者は血管６の表面からガイド枠２０の突出した距離を考慮に入れてホルダー本体１を浮かした状態に保って操作しなければならず、正確な操作性という点からは満足できるものではなかった。
【０００７】
【発明が解決しようとする課題】
本発明は上記問題点を解決するもので、採血操作者が安定した姿勢で操作できて操作者が被採血者の血管への採血針の刺し入れに専念できて被採血者にとっても採血針の穿刺による痛みを軽減でき、採血操作者自身の誤穿刺の危険もなく、かつ採血操作が採血採取の進行状況を眼で見て正確に把握できるような、安全で確実な採血操作を可能とする採血管ホルダーを提供するものである。
【０００８】
【課題を解決するための手段】
すなわち、本発明採血管ホルダーは、上方に開口した筒状体の内側に採血管受部が採血管を所定の深さまで嵌入可能に設けられ、その筒状体の底部から上方に向け採血管の栓体に刺通されて連結される中空針が設けられるとともに、この中空針の中空路は筒状体の底部で屈曲して採血管ホルダーの筒状体側面から横方向に被採血者側の採血手段へと連通され、筒状体の底部外壁に支持部が設けられたものである。
【０００９】
この発明によって、採血管ホルダー内に突設された中空針の中空路が筒状体の底部近傍で屈曲して筒状体側面から横方向に被採血者側の採血手段へと連通されていることにより筒状体の底部外壁に支持部を設けることができ、その支持部が自立可能な形状となされている場合にはこの採血管ホルダーを被採血者の採血部位の近くのテーブルの上に置いた状態に自立させて用いることができ、採血操作者が採血管ホルダーを持ったまま操作をしなくてよくて安定した姿勢で採血操作できる。したがって、採血操作者は採血管ホルダーの外形の如何にかかわらず、被採血者の血管への採血針の刺し入れ角度を無理のない操作で理想的なものにすることができるため、被採血者にとっても採血針の穿刺による痛みを軽減できて好ましい。また、中空針は採血管ホルダーの筒状体の内側に設けられていて外部には直接露出せず、採血操作者自身の誤穿刺の危険がない。
【００１０】
なお本発明採血管ホルダーによれば、採血管は採血の間もほぼ直立状態が維持されていることから、採血操作者にとって採血状況を眼でより正確に把握でき、さらに採血終了後採血管を採血管ホルダーから抜き去り専用サンプル台に立てる時に採血管の栓体密封側を上に向けることになるので、採血管の上下が転倒されて採取した血液が最低一度は混和されて均一なサンプルが得られて好ましい。
【００１１】
そしてまた、本発明採血管ホルダーにおいて、採血手段に対する連結方法が筒状体の底部近傍に取付けられたチューブを介してなされた場合には、チューブの長さは被採血者の採血部位のすぐ近くにこの採血管ホルダーを置いて採血操作がなされたり、あるいは透析や栄養注入のための回路からバイパスで取り出される採取ジョイントにすぐに連結できる程度の長さのものであり、被採血者の姿勢やバイパス回路の位置関係に関係なくチューブの可撓性を生かせて自在に接続がなされるので操作性に優れている。
【００１２】
さらにまた、本発明採血管ホルダーにおいて、採血手段に対する連結方法が筒状体の底部近傍に形成されたルアー結合部を介してなされた場合には、ルアー結合部を介することによって、被採血者の血管に直接差し入れられる採血針、翼付採血針器具、あるいは透析や栄養注入のための回路からバイパスを経て血液採取される輸液チューブ類の管径寸法や方法について等、多様な採血手段に対応して採血可能となされて有用である。
【００１３】
【発明の実施の形態】
以下、図面を参照しつつ、本発明採血管ホルダーについて詳述する。
図１は、本発明の実施形態の一例で、採血手段４に連結された筒状体からなる採血管ホルダー１の上部から採血管３が栓体封止部３４側から嵌入される形態の採血セットを表す。図２は、本発明の実施形態の他の一例で、採血管ホルダー１底部で屈曲した中空針１１の中空路１１１が筒状体側面からルアー結合部１０を介して採血手段へと連結される形態の採血セットを表す。図３は、本発明採血管ホルダー１を用いた、中空針１１の穿刺・抜去過程を示す要部の説明図である。
【００１４】
図１中、３は採血管、１は採血管ホルダー、４はその採血管ホルダー１に接続される採血手段であり、採血管ホルダー１は上方に開口した概形筒状体をなしてその内側の採血管受部１２に採血管３を所定深さの位置で固定できるような構造（ここでは詳細は省略するが、例えば採血管３上部の栓体封止部３４と係止可能な可撓性の係止アダプターが筒状体１２０内側に内嵌されるなど）を構成する。また、筒状体１２０内側の底部からは上方に向けて中空針１１が突設され、この中空針１１は採血管受部１２に採血管３が挿入される際に採血管３の栓体３２の中央穿刺部３３から刺通し、中空針１１の中空路１１１が採血管３の内部（減圧されている）に連通されその減圧側に吸引されるようにして採血が行われる。
ここで、中空針１１（一般に内径寸法が１．０〜０．２５ｍｍ程の針管であり、金属製の中空針管の先端が鋭角に切断された形状）は、外周をゴム弾性を有する弾性キャップ２で液密に封鎖状態に被包されており、図３の説明で後述するが、この弾性キャップ２は中空針１１の採血管３への刺し込みにより栓体３２に押し当てられて長さ方向に折り重ねられ、採血終了の後には中空針１１が採血管３の栓体３２から引き抜かれるにしたがって、弾性キャップ２はそのゴム弾性により復元されて再び中空針１１を液密に封鎖して被包させるようになっている。
【００１５】
そして、中空針１１の中空路１１１は前記採血管ホルダー１の筒状体１２０の底部で屈曲して、筒状体側面から横方向に被採血者側の採血手段へと連通されている。したがって、筒状体の底部外壁には突出するものがなく支持部１３を形成させることができてこの採血管ホルダー１は支持部１３を底面として自立可能となされ、採血操作者が採血管ホルダー１を被採血者の採血部位近くのテーブル上に置いたまま採血操作可能となって採血操作者は安定した姿勢で操作できるので被採血者の血管への採血針の刺し入れに専念できて操作の安全が図られ、また被採血者にとっても採血針の穿刺時の痛みが軽減される。さらには、中空針１１は筒状体１２０の内側にあって採血操作者自身の誤穿刺の危険がない。
【００１６】
ところで、図１の実施形態例では、翼付採血器具の形態の採血針４２の針管が採血路４１１に連通されたチューブ４１を経て採血管ホルダー１の中空針１１の中空路１１１に連通され、このチューブ４１は採血管ホルダー１に一体的に連結されたものであるが、採血手段４との連結の形態としてはこれに限定することなく他の連結手段が用いられてもよく圧入、接着、融着、溶着による接合や螺合、嵌合、テーパ嵌合等により着脱自在となされていてもよい。また、被採血者側の採血手段も実施形態の一例に限ることなく翼状部を伴わない形態の採血針類や、透析や栄養注入のための回路中の採取ジョイントに螺合、嵌合、一体的接続など、他の連結手段による接続がなされる場合であっても本発明は適用される。
【００１７】
なお、採血管ホルダー１はポリオレフィン系の樹脂やポリカーボネート樹脂、ポリ塩化ビニル樹脂、ポリアセタール樹脂等によって成型され、係止アダプター（前述、図示せず）も同様に可撓性を有する熱可塑性樹脂により成型される。
また、チューブ４１としてはポリオレフィン系の樹脂やエチレン・酢酸ビニル共重合体樹脂や軟質塩化ビニル樹脂などが好適に用いられて、柔軟性、耐熱性、対衝撃性、廃棄性など医療用の材料として必要な、一般には透明あるいは半透明で可撓性を有する管状体が好適に用いられる。
【００１８】
採血管３は、有底管３１の開口部が管内部を減圧状態にとして栓体３２で封止されたもので、有底管３１はガラス材のほかにポリオレフィン系樹脂やポリカーボネート樹脂などが好適に用いられ、栓体３２は中空針１１を穿刺し易いように薄肉厚になされた中央穿刺部３３から穿刺された中空針が抜去された後においても即針孔を閉塞して液密状態を維持させる必要から、ゴム材料が用いられる。
【００１９】
次に図２は、本発明の実施形態の他の一例で、筒状体１２０の底部で屈曲した中空針１１の中空路１１１が、図１のチューブ４１の連結に代えてルアー結合部１０を介して筒状体の側面から横方向に被採血者側の採血手段４へと連通されて連結される形態の採血セットであって、さらには図１の金属製の中空針に代えて合成樹脂製の中空針１１が適用されたものである。すなわち、採血手段との連結をルアー結合部１０を介して被採血者の血管に直接差し入れられる採血針、翼付採血針器具、あるいは透析や栄養注入用回路からバイパスを経て血液採取される等多様な採血手段と自在にワンタッチ連結可能とし、中空針の合成樹脂化によりルアー結合部を備えた採血管ホルダーのセット全体をオールプラスチック化して焼却処分可能とし、廃棄処理合理化と廃棄物汚染防止が図られたものである。
【００２０】
図２において、中空針１１は弾性キャップ２の先端部と採血管３の栓体３２を刺通し易いようにその先端が尖った針先端部１４に形成され、針中空部１１１は筒状体１２０内側の底部で屈曲されて注射針のハブや輸液チューブ等採血手段に連結させるためのルアーテーパ部１０へと連通されている。また、中空針１１は弾性キャップ２によって被包されるとともに、その側壁には針中空部１１１に連通して小孔１５が設けられている。
ここで弾性キャップ２は、中空針１１管外壁に密着されて前記小孔１５を液密に封鎖させており、その先端部分には中空針１１への刺通抵抗が大きくならないように孔部２１が開けられている。ここで、この先端部分は孔部２１の代わりに中空針１１が挿入される際だけ押し拡げられる切れ目が形成されていたり、あるいは弾性キャップ２の先端部分の厚さが肉薄の極薄膜に成形されていてもよく、中空針１１の刺通抵抗を少なくするような加工がなされておればよい。
そして、中空針１１を合成樹脂製とする場合に用いられる合成樹脂の種類は、ポリオレフィン系樹脂、ポリアセタール樹脂、ポリエチレンテレフタレート樹脂等のほか、それらの樹脂にガラス繊維やグラファイト、無機フィラー、カーボンナノチューブ等が配合されて強度強化されたものなど、特に穿刺抵抗に耐えるという性能上剛性を有するものが好適に用いられる。
【００２１】
また、弾性キャップ２の材質としては、天然ゴム、合成ポリイソプレンゴム、ブチルゴム、クロロプレンゴム、シリコンゴム、ウレタンゴム、スチレンブタジエンゴム、エチレンプロピレンゴム、アクリルゴム、フッ素ゴム、熱可塑性エラストマー等が挙げられ、チューブ状弾性体で中空針１１管外壁を被包させ十分な密着力が得られる内径寸法であるとともに、後述する中空針１１の採血管３への刺し込みによって一度その長さ方向に折り重ねられたものが抜き去られる際にもスムーズに復元できるだけの弾性をもたせて設計されなければならない。
【００２２】
さらに図２の中空針１１に設けられた小孔１５は、針中空部１１１に連通して中空形状の針管の軸方向に対して交差する方向に向けて開穿され、中空針に被包される弾性キャップ２が中空針の管外壁に密着されて小孔１５が液密に封鎖させ得る状態であれば必ずしも管壁に対し９０度でなくてもよく、むしろ本実施形態においては血液がスムーズに流れるように若干の傾斜角度を持たせ計２〜４ヵ所が設けられている。
【００２３】
なお、ルアー結合部１０を介して連結される採血手段が図２の実施形態の例のような被採血者の血管に直接差し入れられる形態の採血針４２である場合には、この採血針を伴った採血管ホルダー１を被採血者の腕（採血部位）に対し概直交方向に軽く押し当てて採血針の刺し入れのために被採血者の血管の向きに針先を若干動かして後、その採血管ホルダー１の採血管受部１２内に採血管３を所定の深さまで嵌入させる際採血操作者は採血管ホルダー１の筒状体底部外壁の支持部１３を被採血者の腕上にそっと当てたまま操作すればよく、したがってその採血管ホルダー１の支持部１３が被採血者の腕の曲面にほぼ沿った平滑面となされていることで、採血操作者は採血管ホルダー１を持った手をフラつかせることなく安定した姿勢で採血操作できて好ましい。
【００２４】
続いて、図３を参照しながら、本発明採血具の要部における採血管３に対する中空針１１の穿刺・抜去の過程について、図２の実施形態例の場合を例にあげて説明する。なお詳細は省略するが、採血管ホルダー１の採血管受部１２に挿入された採血管３の停止深さは、係止アダプター（前述、図示せず）との係止位置が調節され、中空針１１が採血管の密封部材に刺通される際に針中空部１１１に連通された小孔１５がタイミングよく採血管内に連通され、採血管内の減圧により血液が吸引されて採血が開始されるような寸法関係に設計されたものとする。
【００２５】
図３は、（ａ）：中空針１１が採血管３の栓体３２に刺通される前の状態
（ｂ）：針中空部１１１が小孔１５を経て採血管３内部と連通された状態
（ｃ）：ふたたび中空針１１が栓体３２から抜去された状態
のそれぞれのステップにおける、中空針１１周辺の状態を表している。
【００２６】
図３（ａ）において、採血管ホルダー１の筒状体１２０内側に突設された中空針１１には弾性キャップ２が管外壁に密着して被包されており、中空針１１の針中空部１１１に連通した小孔１５を液密に封鎖させており、また弾性キャップ２の先端部分には孔部２１が開けられ、本実施形態の例においては中空針１１の先端部１４の一部が僅かにその孔部２１から突出された状態となされている。なお弾性キャップ２は、その嵌合部２２が中空針１１の根元付近に形成された段差部１６と係合されて固定されている。
【００２７】
つづく同図（ｂ）においては、中空針１１が採血管３の栓体３２に形成された中央穿刺部３３から刺通され、さらに採血管３の内側に押し進められるに従って弾性キャップ２が蛇腹状に折りたたまれて圧縮されてゆく。そして、所定の位置まで押し進められたところで弾性キャップ２の軸方向に圧縮された反発力以上の係止力で採血管３が前出採血管ホルダー１の内部に係止されるとともに、中空針１１の小孔１５を経て針中空部１１１が採血管３内に連通されて採血管内の減圧により血液が吸引されて採血が開始される。
【００２８】
やがて血液の採取が済むと、同図（ｃ）に示すように中空針１１が採血管３の栓体３２から抜去されて栓体３２はそのゴム弾性によって封止されるとともに、一度蛇腹状に折りたたまれた弾性キャップ２は復元力により元どおり中空針１１の管外壁に密着して被包され再び小孔１５が液密に封鎖されて血液漏出が阻止される。なお、この中空針１１の管外壁に密着された弾性キャップ２がスムーズに（ａ）→（ｂ）→（ｃ）と蛇腹状に折りたたまれかつ復元できるように、中空針１１の管外壁にはシリコン系やパラフィン系の適度な粘度の潤滑性物質が塗布されていても動作上効果的である。
【００２９】
【発明の効果】
以上詳述した如く、本発明採血管ホルダーは、上方に開口した筒状体の内側に採血管受部が採血管を所定の深さまで嵌入可能に設けられ、その筒状体の底部から上方に向け採血管の栓体に刺通されて連結される中空針が設けられるとともに、この中空針の中空路は筒状体の底部で屈曲して採血管ホルダーの筒状体側面から横方向に被採血者側の採血手段へと連通され、筒状体の底部外壁に支持部が設けられたものであり、採血管ホルダー内に突設された中空針の中空路が筒状体の底部近傍で屈曲して筒状体側面から横方向に被採血者側の採血手段へと連通されていることにより筒状体の底部外壁に支持部を設けることができ、その支持部に支えられてこの採血管ホルダーが自立可能となされ被採血者の採血部位の近くのテーブル上に置いて自立させ用いることができ、採血操作者が採血管ホルダーを持ったままで操作をしなくてよく安定した姿勢で採血操作できる。したがって、採血操作者は採血管ホルダーの外形の如何にかかわらず、被採血者の血管への採血針の刺し入れに専念できて安定した姿勢で採血操作でき、被採血者に対しても採血針の穿刺による痛みを軽減できて好ましい。また、中空針は採血管ホルダーの筒状体の内側に設けられていて外部には直接露出せず、採血操作者自身の誤穿刺の危険がない。
あるいはまた、採血管は採血の間もほぼ直立状態が維持されていることから、採血操作者にとって採血状況を眼でより正確に把握でき、さらに採血終了後には採血管を採血管ホルダーから抜き去り専用サンプル台に立てる際に採血管の栓体密封側を上に向けることになるので、採血管の上下が転倒されて採取した血液が最低一度は混和されるので均一なサンプルが得られて好ましい。
【００３０】
そしてまた、本発明採血管ホルダーにおいて、採血手段に対する連結方法が、筒状体の底部近傍に取付けられたチューブを介してなされた場合に、チューブの長さは被採血者の採血部位のすぐ近くにこの採血管ホルダーを置いて採血操作がなされたり、あるいは透析や栄養注入のための回路からバイパスで取り出される採取ジョイントにすぐに連結できる程度の長さのものであり、被採血者の姿勢やバイパス回路の位置関係に関係なくチューブの可撓性を生かせて自在に接続がなされて操作性に優れている。
【００３１】
さらにまた、本発明採血管ホルダーにおいて、採血具との連結が被採血者側の採血手段に対して筒状体の底部から横方向に向けて形成されたルアー結合部を介して連結された場合には、ルアー結合部を介することによって被採血者の血管に直接差し入れられる採血針、翼付採血針器具、あるいは透析や栄養注入のための回路からバイパスを経て血液採取される輸液チューブなど多様な採血手段に対応して採血可能で使い勝手がよい。また、被採血者の血管に直接差し入れられる採血針が取付けられている形態の場合、採血管ホルダーの筒状体底部外壁が被採血者の腕の曲面にほぼ沿った平滑面となされれば、採血操作者は採血管ホルダーを持った手をフラつかせることなく安定した姿勢で採血操作できて好ましい。
【図面の簡単な説明】
【図１】本発明採血管ホルダーを適用した実施形態の一例の採血セットの構成を表す。
【図２】本発明採血管ホルダーを適用した実施形態の他の一例の採血セットの構成を表す。
【図３】本発明実施形態の一例の要部を表す採血セットの動作を説明する図面である。
【図４】代表的な採血セットの改良提案の従来例の一つを表す説明図である。
【図５】代表的な採血セットの改良提案の従来例他の一つを表す説明図である。
【符号の説明】
１採血管ホルダー
１０ルアー連結部
１１中空針
１１１中空路
１２採血管受部
１２０筒状体
１３支持部
１４針先端部
１５小孔
１６段差部
２弾性キャップ
２１孔部
２２嵌合部
３採血管
３１有底管
３２栓体
３３中央穿刺部
３４栓体封止部
４採血手段
４１チューブ
４１１採血路
４２採血針[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a blood collection tube holder, and more particularly, to provide an upward hollow needle from the bottom of a cylindrical blood collection tube receiving section, and a hollow path is bent at the bottom of the cylindrical body of the blood collection tube holder, and a lateral direction is formed from the side of the cylindrical body. And a blood collection tube holder communicated with the blood collection means.
[0002]
[Prior art]
2. Description of the Related Art Conventionally, a blood collection set that punctures a reduced-pressure blood collection tube for blood collection includes a blood collection needle portion protruding to one side and a hollow needle tube protruding to the other side as shown in a blood collection device of Japanese Patent Publication No. 3-39695. A hollow needle encapsulated by a sheath. In general, the tip of a metal needle tube is formed at an acute angle in the hollow needle portion, and the tip portion is inserted in the direction of insertion of the blood collection tube of the blood collection tube holder, and this hollow needle portion penetrates the sealing member of the blood collection tube. When the distal end of the hollow needle portion is opened, the distal end portion first penetrates through the elastic sheath body, and is further pierced by the sealing member of the blood collection tube so that the elastic sheath body is compressed in the axial direction by the sealing member. When the hole reaches the inside of the blood collection tube, the hollow portion of the hollow needle portion is communicated with the blood collection tube, blood is sucked by the reduced pressure in the blood collection tube, and blood collection is started.
[0003]
By the way, according to such a conventional blood collection set, the blood collection operator consistently performs operations up to inserting a blood collection needle into a blood vessel of the blood collection target and subsequently inserting a blood collection tube while holding the blood collection tube holder in his hand. Therefore, operations in an unstable posture must be performed one after another, and skill in blood collection operation is required. In addition, when the number of blood collections is large, labor is considerable.
Furthermore, there is always a danger of so-called puncture in which the blood sampling operator accidentally stabs his or her finger when inserting or removing the hollow needle from the blood collection tube. In addition, there is a problem in that the blood collection held in such a hand is difficult to accurately determine the end timing of the blood collection depending on the angle at which the blood collection tube is held and the like, from the viewpoint of confirming the progress of blood collection.
[0004]
On the other hand, for the blood sampling person, the puncture angle becomes large due to the external dimensions of the device in addition to the unstable operation, which is sometimes painful. With respect to the problem of the puncture angle, a device has been proposed to make the angle as close as possible parallel to the direction of the blood vessel. For example, as shown in FIG. 4 in JP-A-8-308818, as shown in FIG. A proposal to reduce (shallow) the puncture angle θ to the blood vessel by reducing the radial distance L between the puncture portions 14 of the blood collection needle 1 is shown in FIG. 5 in Japanese Patent Application Laid-Open No. 10-33509. As described above, a proposal has been made in which the needle tube 42 on the blood vessel piercing side is bent at a predetermined angle with respect to the needle tube 43 on the plug piercing side in order to reduce the blood vessel piercing angle.
[0005]
[Patent Document 1]
Japanese Patent Publication No. 03-039695 (pages 2-4, Fig. 1)
[Patent Document 2]
JP-A-08-308818 (right column on page 4, FIG. 2)
[Patent Document 3]
JP-A-10-033509 (right column of page 5, FIG. 19)
[0006]
However, in any of the blood collection sets proposed in JP-A-8-308818 and JP-A-10-33509, the operator holds the blood sampling needle holder 2 in the former and the holder main body 1 in the latter by hand. Therefore, the conventional problem was not fundamentally solved in terms of unstable operability. Particularly, in the proposal of Japanese Patent Application Laid-Open No. 10-33509, the guide frame 20 protrudes from the tip of the holder main body 1 and the needle tube 42 on the blood vessel piercing side of the blood collection needle 4 projects from near the tip. Must be operated while keeping the holder body 1 floating in consideration of the distance of the guide frame 20 protruding from the surface of the blood vessel 6, which is not satisfactory in terms of accurate operability.
[0007]
[Problems to be solved by the invention]
The present invention solves the above-described problems, and enables a blood collection operator to operate in a stable posture, concentrate on inserting a blood collection needle into a blood vessel of a blood collection target, and provide a blood collection needle for a blood collection target. Pain due to puncture can be reduced, and there is no danger of accidental puncture by the blood collection operator, and a safe and reliable blood collection operation that enables the blood collection operation to accurately grasp the progress of blood collection by eye A blood collection tube holder is provided.
[0008]
[Means for Solving the Problems]
That is, in the blood collection tube holder of the present invention, the blood collection tube receiving portion is provided so as to be able to fit the blood collection tube to a predetermined depth inside the cylindrical body opened upward, and the blood collection tube is directed upward from the bottom of the cylindrical body. A hollow needle which is pierced and connected to the stopper is provided, and the hollow passage of the hollow needle is bent at the bottom of the cylindrical body and laterally from the side of the cylindrical body of the blood collection tube holder on the side of the blood collection subject. The support is provided on the bottom outer wall of the cylindrical body, communicating with the blood collecting means.
[0009]
According to the present invention, the hollow path of the hollow needle protruding into the blood collection tube holder is bent near the bottom of the cylindrical body and communicates laterally from the side surface of the cylindrical body to the blood collection means on the blood collection subject side. In this way, a supporting portion can be provided on the bottom outer wall of the cylindrical body, and when the supporting portion has a self-supporting shape, the blood collection tube holder is placed on a table near a blood collection site of a blood collection subject. The blood collection operator can use the blood collection operator in a stable posture without using the blood collection tube holder while holding the blood collection tube holder. Therefore, regardless of the outer shape of the blood collection tube holder, the blood collection operator can make the angle at which the blood collection needle is inserted into the blood vessel of the blood collection target an ideal one by a reasonable operation. This is preferable because pain caused by puncturing of the blood collection needle can be reduced. Further, the hollow needle is provided inside the tubular body of the blood collection tube holder and is not directly exposed to the outside, so that there is no danger of erroneous puncture by the blood collection operator himself.
[0010]
According to the blood collection tube holder of the present invention, since the blood collection tube is maintained almost upright during the blood collection, the blood collection operator can more accurately grasp the blood collection status with the eyes, and furthermore, the blood collection tube after the blood collection is completed. When pulling out from the blood collection tube holder and setting it on the special sample stand, the stopper side of the blood collection tube is turned up, so the blood collection tube is turned upside down and the collected blood is mixed at least once to obtain a uniform sample. Obtained and preferred.
[0011]
Further, in the blood collection tube holder of the present invention, when the connection method to the blood collection means is performed via a tube attached near the bottom of the cylindrical body, the length of the tube is very close to the blood collection site of the blood collection subject. Blood collection operation is performed by placing this blood collection tube holder on the blood collection tube, or it is of a length that can be immediately connected to the collection joint extracted by bypass from the circuit for dialysis and nutrient infusion, and Regardless of the positional relationship of the bypass circuit, the tube can be freely connected by utilizing the flexibility of the tube, so that the operability is excellent.
[0012]
Furthermore, in the blood collection tube holder of the present invention, when the connection method to the blood collection means is performed via a luer connection portion formed near the bottom of the cylindrical body, the blood collection device is connected to the blood collection device through the luer connection portion. It supports a variety of blood collection methods, such as blood sampling needles that can be inserted directly into blood vessels, winged blood sampling needle devices, or the diameter and method of infusion tubes that are drawn from the dialysis or nutrient infusion circuit via a bypass. It is useful because blood can be collected.
[0013]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, the blood collection tube holder of the present invention will be described in detail with reference to the drawings.
FIG. 1 shows an example of an embodiment of the present invention, in which a blood collection tube 3 is fitted from the upper side of a plug sealing portion 34 from above a blood collection tube holder 1 formed of a cylindrical body connected to a blood collection unit 4. Represents a set. FIG. 2 shows another example of the embodiment of the present invention, in which the hollow path 111 of the hollow needle 11 bent at the bottom of the blood collection tube holder 1 is connected to the blood collection means from the side surface of the cylindrical body via the luer connection portion 10. 1 represents a morphological blood collection set. FIG. 3 is an explanatory view of a main part showing a process of puncturing and removing the hollow needle 11 using the blood collection tube holder 1 of the present invention.
[0014]
In FIG. 1, reference numeral 3 denotes a blood collection tube, 1 denotes a blood collection tube holder, and 4 denotes a blood collection means connected to the blood collection tube holder 1. The blood collection tube holder 1 forms a generally cylindrical body that is opened upward and has an inner side. A structure that allows the blood collection tube 3 to be fixed at a position of a predetermined depth to the blood collection tube receiving portion 12 (a detailed description is omitted here; (For example, an internal locking adapter is fitted inside the cylindrical body 120). A hollow needle 11 protrudes upward from the bottom inside the cylindrical body 120. The hollow needle 11 is inserted into the plug 32 of the blood collection tube 3 when the blood collection tube 3 is inserted into the blood collection tube receiving portion 12. The blood is collected by piercing through the central puncture portion 33 of the hollow needle 11 so that the hollow path 111 of the hollow needle 11 communicates with the inside of the blood collection tube 3 (decompressed) and is sucked toward the reduced pressure side.
Here, the hollow needle 11 (generally a needle tube having an inner diameter of about 1.0 to 0.25 mm, in which the tip of a metal hollow needle tube is cut at an acute angle) has an elastic cap 2 having rubber elasticity on the outer periphery. The elastic cap 2 is pressed against the plug 32 by the insertion of the hollow needle 11 into the blood collection tube 3 to be described later with reference to FIG. After the end of blood collection, as the hollow needle 11 is pulled out from the plug 32 of the blood collection tube 3, the elastic cap 2 is restored by its rubber elasticity, and the hollow needle 11 is closed again in a liquid-tight manner and covered. It is designed to be wrapped.
[0015]
The hollow path 111 of the hollow needle 11 is bent at the bottom of the cylindrical body 120 of the blood collection tube holder 1 and communicates laterally from the side surface of the cylindrical body to the blood collection means on the blood collection subject side. Therefore, there is no protrusion on the bottom outer wall of the cylindrical body, and the support portion 13 can be formed. The blood collection tube holder 1 can be self-standing with the support portion 13 as the bottom surface. The blood collection operation can be performed while the blood collection operator is placed on a table near the blood collection site of the blood collection recipient, and the blood collection operator can operate in a stable posture. Safety is achieved, and the pain at the time of puncturing the blood collection needle is also reduced for the blood collection subject. Furthermore, since the hollow needle 11 is inside the cylindrical body 120, there is no danger of erroneous puncture by the blood sampling operator himself.
[0016]
In the embodiment of FIG. 1, the needle tube of the blood collection needle 42 in the form of a winged blood collection device is connected to the hollow channel 111 of the hollow needle 11 of the blood collection tube holder 1 via the tube 41 connected to the blood collection channel 411. Although this tube 41 is integrally connected to the blood collection tube holder 1, the connection form with the blood collection means 4 is not limited to this, and other connection means may be used. It may be detachable by joining, screwing, fitting, taper fitting, or the like by fusion or welding. Further, the blood collection means on the side of the blood collection subject is not limited to the example of the embodiment, and is screwed, fitted, and integrated with a blood collection needle having no wings or a blood collection joint in a circuit for dialysis or nutrient injection. The present invention is applied to a case where a connection is made by another connecting means such as a dynamic connection.
[0017]
The blood collection tube holder 1 is molded from a polyolefin-based resin, a polycarbonate resin, a polyvinyl chloride resin, a polyacetal resin, or the like, and the locking adapter (not shown) is also molded from a thermoplastic resin having flexibility. Is done.
As the tube 41, a polyolefin-based resin, an ethylene / vinyl acetate copolymer resin, a soft vinyl chloride resin, or the like is suitably used, and is used as a medical material such as flexibility, heat resistance, impact resistance, and disposability. A necessary, generally transparent or translucent, flexible tubular body is preferably used.
[0018]
The blood collection tube 3 is one in which the opening of the bottomed tube 31 is sealed with a plug 32 while keeping the inside of the tube under reduced pressure. The bottomed tube 31 is preferably made of a polyolefin resin or a polycarbonate resin in addition to a glass material. The plug 32 immediately closes the needle hole even after the punctured hollow needle is withdrawn from the central puncture part 33 which is made thin so as to easily puncture the hollow needle 11 to maintain a liquid-tight state. A rubber material is used because it needs to be maintained.
[0019]
Next, FIG. 2 shows another example of the embodiment of the present invention, in which the hollow path 111 of the hollow needle 11 bent at the bottom of the tubular body 120 is connected to the luer connecting portion 10 instead of the connection of the tube 41 of FIG. 1. A blood collection set in a form of being connected to and connected to blood collection means 4 on the side of a blood collection subject laterally from the side surface of a cylindrical body via a cylindrical body, further comprising a synthetic resin instead of the metal hollow needle of FIG. The hollow needle 11 made of the product is applied. That is, the blood sampling means can be directly connected to the blood vessel of the blood-collecting subject via the luer connection part 10 through a blood sampling needle, a winged blood sampling needle instrument, or blood can be collected from a dialysis or nutrient infusion circuit via a bypass. With a flexible one-touch connection to various blood collection means, making the entire set of blood collection tube holders with a luer connection part made of synthetic resin with a hollow needle possible to be incinerated by disposal, streamlining waste treatment and preventing waste contamination. It was done.
[0020]
In FIG. 2, the hollow needle 11 is formed at a needle tip 14 having a sharpened tip so that the distal end of the elastic cap 2 and the plug 32 of the blood collection tube 3 can be easily pierced. And is connected to a luer taper portion 10 for connection to a blood sampling means such as a hub of an injection needle or an infusion tube. The hollow needle 11 is covered by the elastic cap 2, and a small hole 15 is provided on the side wall thereof so as to communicate with the needle hollow portion 111.
Here, the elastic cap 2 is in close contact with the outer wall of the hollow needle 11 to seal off the small hole 15 in a liquid-tight manner, and the distal end thereof has a hole 21 so as not to increase the penetration resistance to the hollow needle 11. Is open. Here, the end portion has a cut formed to be pushed and expanded only when the hollow needle 11 is inserted instead of the hole portion 21, or the end portion of the elastic cap 2 is formed into a very thin film having a small thickness. The processing may be performed so as to reduce the penetration resistance of the hollow needle 11.
The type of synthetic resin used when the hollow needle 11 is made of synthetic resin includes polyolefin-based resin, polyacetal resin, polyethylene terephthalate resin, and the like, as well as glass fibers, graphite, inorganic filler, carbon nanotube, and the like. In particular, those having a rigidity in terms of performance that can withstand puncture resistance, such as those in which the strength has been enhanced by blending with, are preferably used.
[0021]
Examples of the material of the elastic cap 2 include natural rubber, synthetic polyisoprene rubber, butyl rubber, chloroprene rubber, silicon rubber, urethane rubber, styrene butadiene rubber, ethylene propylene rubber, acrylic rubber, fluorine rubber, and thermoplastic elastomer. The inner diameter of the hollow needle 11 tube is covered with a tubular elastic body so that a sufficient adhesion force can be obtained, and the tube is once folded in the length direction by inserting the hollow needle 11 into the blood collection tube 3 described later. It must be designed with enough elasticity to allow it to be restored smoothly even if it is pulled out.
[0022]
Further, the small hole 15 provided in the hollow needle 11 of FIG. 2 is opened in a direction intersecting with the axial direction of the hollow needle tube in communication with the needle hollow portion 111, and is covered by the hollow needle. If the elastic cap 2 is in close contact with the outer wall of the tube of the hollow needle so that the small hole 15 can be closed in a liquid-tight manner, the angle may not necessarily be 90 degrees with respect to the tube wall. There are a total of 2 to 4 places with a slight angle of inclination so that they can flow.
[0023]
In addition, when the blood collection means connected via the luer connection part 10 is the blood collection needle 42 in a form directly inserted into the blood vessel of the blood collection subject as in the example of the embodiment of FIG. The blood collection tube holder 1 is gently pressed in a direction substantially perpendicular to the arm (blood collection site) of the blood collection target to slightly move the needle tip in the direction of the blood collection tube for inserting the blood collection needle. When fitting the blood collection tube 3 to a predetermined depth in the blood collection tube receiving portion 12 of the blood collection tube holder 1, the blood collection operator gently places the support portion 13 of the outer bottom wall of the cylindrical body of the blood collection tube holder 1 on the arm of the blood collection subject. The blood collection operator holds the blood collection tube holder 1 because the support portion 13 of the blood collection tube holder 1 has a smooth surface substantially along the curved surface of the arm of the blood collection subject. Blood sampling in a stable posture without flapping hands Preferably made.
[0024]
Next, the process of puncturing and removing the hollow needle 11 from the blood collection tube 3 in the main part of the blood collection device of the present invention will be described with reference to FIG. 3 by taking the case of the embodiment of FIG. 2 as an example. Although not described in detail, the stop depth of the blood collection tube 3 inserted into the blood collection tube receiving portion 12 of the blood collection tube holder 1 is adjusted by adjusting the locking position with a locking adapter (not shown). When the needle 11 is pierced through the sealing member of the blood collection tube, the small hole 15 communicated with the needle hollow portion 111 is communicated with the blood collection tube at a good timing, and blood is sucked by the reduced pressure in the blood collection tube to start blood collection. It is assumed that they are designed in such a dimensional relationship.
[0025]
3A shows a state before the hollow needle 11 is pierced through the plug 32 of the blood collection tube 3, and FIG. 3B shows a state in which the needle hollow part 111 is communicated with the inside of the blood collection tube 3 through the small hole 15. (C): A state around the hollow needle 11 in each step in a state where the hollow needle 11 is removed from the plug 32 again.
[0026]
In FIG. 3A, an elastic cap 2 is tightly wrapped around the outer wall of the hollow needle 11 protruding from the inside of the tubular body 120 of the blood collection tube holder 1. The small hole 15 communicating with 111 is closed in a liquid-tight manner, and a hole 21 is formed in the distal end of the elastic cap 2. In the embodiment of the present embodiment, a part of the distal end 14 of the hollow needle 11 is partially closed. It is slightly projected from the hole 21. The elastic cap 2 has its fitting part 22 engaged and fixed to the step part 16 formed near the root of the hollow needle 11.
[0027]
In FIG. 2B, the hollow needle 11 is pierced from the central puncture portion 33 formed in the plug 32 of the blood collection tube 3, and the elastic cap 2 is bellowed as the hollow needle 11 is further pushed into the blood collection tube 3. It is folded and compressed. When the blood collection tube is pushed to a predetermined position, the blood collection tube 3 is locked inside the preceding blood collection tube holder 1 by a locking force greater than the repulsion force compressed in the axial direction of the elastic cap 2, and the hollow needle 11. The hollow portion 111 of the needle is communicated with the blood collection tube 3 through the small hole 15, blood is sucked by the reduced pressure in the blood collection tube, and blood collection is started.
[0028]
When the collection of blood is completed, the hollow needle 11 is pulled out of the plug 32 of the blood collection tube 3 as shown in FIG. The folded elastic cap 2 is tightly covered with the outer wall of the hollow needle 11 by the restoring force, and the small hole 15 is closed again in a liquid-tight manner to prevent blood leakage. In addition, the outer wall of the hollow needle 11 is formed so that the elastic cap 2 adhered to the outer wall of the hollow needle 11 can be smoothly folded and restored in a bellows shape in the order of (a) → (b) → (c). Even if a lubricating substance having a suitable viscosity such as a silicon-based or paraffin-based substance is applied, it is effective in operation.
[0029]
【The invention's effect】
As described in detail above, in the blood collection tube holder of the present invention, a blood collection tube receiving portion is provided inside a cylindrical body that is open upward so as to be able to fit a blood collection tube to a predetermined depth, and is upward from the bottom of the cylindrical body. A hollow needle is provided which is pierced and connected to the plug of the blood collection tube, and the hollow passage of the hollow needle is bent at the bottom of the cylindrical body and is laterally covered from the side of the cylindrical body of the blood collection tube holder. The support is provided on the bottom outer wall of the cylindrical body, which is communicated with the blood collecting means on the blood collector side, and the hollow path of the hollow needle protruding into the blood collection tube holder is near the bottom of the cylindrical body. The supporting part can be provided on the bottom outer wall of the cylindrical body by bending and communicating laterally from the side surface of the cylindrical body to the blood collection means on the side of the blood collection subject. The vessel holder is made self-supporting and placed on a table near the blood collection site of the Is not be used, it can be bled operated by blood sampling operator is stabilized well without an operation while having a blood collection tube holder position. Therefore, regardless of the outer shape of the blood collection tube holder, the blood collection operator can concentrate on inserting the blood collection needle into the blood vessel of the blood collection target, perform the blood collection operation in a stable posture, and perform the blood collection needle for the blood collection target. This is preferable because pain caused by puncturing can be reduced. Further, the hollow needle is provided inside the tubular body of the blood collection tube holder and is not directly exposed to the outside, so that there is no danger of erroneous puncture by the blood collection operator himself.
Alternatively, since the blood collection tube is maintained almost upright during the blood collection, the blood collection operator can more accurately grasp the blood collection status with eyes, and after the blood collection is completed, pull out the blood collection tube from the blood collection tube holder. When standing on a dedicated sample stand, the stopper side of the blood collection tube is turned up, so the blood collection tube is turned over and the collected blood is mixed at least once, so that a uniform sample is obtained, which is preferable. .
[0030]
Further, in the blood collection tube holder of the present invention, when the connection method to the blood collection means is performed through a tube attached near the bottom of the cylindrical body, the length of the tube is very close to the blood collection site of the blood collection subject. The blood collection holder is placed on the blood collection tube, and the blood collection operation can be performed. Regardless of the positional relationship of the bypass circuit, the tube can be freely connected by utilizing the flexibility of the tube, and the operability is excellent.
[0031]
Furthermore, in the blood collection tube holder of the present invention, when the connection with the blood collection tool is connected to the blood collection means on the blood collection subject side via a luer coupling portion formed from the bottom of the cylindrical body toward the lateral direction. Blood sampling needles that can be inserted directly into the blood vessel of the recipient via a luer connection, winged blood sampling needle devices, or infusion tubes that collect blood via a bypass from a circuit for dialysis or nutrient infusion. Blood can be collected according to the blood collection means and is easy to use. In addition, in the case of a form in which a blood collection needle that is directly inserted into a blood vessel of a blood collection subject is attached, if the cylindrical body bottom outer wall of the blood collection tube holder is formed as a smooth surface substantially along the curved surface of the blood collection subject's arm, It is preferable that the blood collection operator can perform the blood collection operation in a stable posture without fluttering the hand holding the blood collection tube holder.
[Brief description of the drawings]
FIG. 1 shows a configuration of a blood collection set according to an embodiment to which the blood collection tube holder of the present invention is applied.
FIG. 2 shows a configuration of a blood collection set according to another embodiment of the present invention to which the blood collection tube holder is applied.
FIG. 3 is a view for explaining the operation of a blood collection set representing a main part of an example of the embodiment of the present invention.
FIG. 4 is an explanatory diagram showing one conventional example of a proposal for improving a typical blood collection set.
FIG. 5 is an explanatory view showing another example of a conventional example of a typical blood collection set improvement proposal.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Blood collection tube holder 10 Luer connection part 11 Hollow needle 111 Hollow path 12 Blood collection tube receiving part 120 Cylindrical body 13 Supporting part 14 Needle tip part 15 Small hole 16 Stepped part 2 Elastic cap 21 Hole part 22 Fitting part 3 Blood collection tube 31 Bottomed tube 32 Plug 33 Central puncture part 34 Plug sealing part 4 Blood collection means 41 Tube 411 Blood collection path 42 Blood collection needle

Claims

上方に開口した筒状体の内側に採血管受部が採血管を所定の深さまで嵌入可能に設けられ、その筒状体の底部から上方に向け採血管の栓体に刺通されて連結される中空針が設けられるとともに、この中空針の中空路は筒状体の底部で屈曲して採血管ホルダーの筒状体側面から横方向に被採血者側の採血手段へと連通され、筒状体の底部外壁に支持部が設けられた採血管ホルダー。A blood collection tube receiving portion is provided inside the cylindrical body opened upward so as to be able to fit the blood collection tube to a predetermined depth, and is pierced upward from the bottom of the cylindrical body and connected to the plug of the blood collection tube. A hollow needle is provided, and the hollow passage of the hollow needle is bent at the bottom of the cylindrical body and communicates laterally from the side of the cylindrical body of the blood collection tube holder to the blood collection means on the blood collection subject side, and the cylindrical shape is formed. Blood collection tube holder with support on the bottom outer wall of the body.

採血手段に対する連結は、筒状体の底部近傍に取付けられたチューブを介してなされるものである請求項１記載の採血管ホルダー。2. The blood collection tube holder according to claim 1, wherein the connection to the blood collection means is made via a tube attached near the bottom of the cylindrical body.

採血手段に対する連結は、筒状体の底部近傍に形成されたルアー結合部を介してなされるものである請求項１記載の採血管ホルダー。2. The blood collection tube holder according to claim 1, wherein the connection to the blood collection means is made via a luer connection formed near the bottom of the cylindrical body.