JP3902875B2 - Puncture device - Google Patents

Puncture device Download PDF

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Publication number
JP3902875B2
JP3902875B2 JP29632598A JP29632598A JP3902875B2 JP 3902875 B2 JP3902875 B2 JP 3902875B2 JP 29632598 A JP29632598 A JP 29632598A JP 29632598 A JP29632598 A JP 29632598A JP 3902875 B2 JP3902875 B2 JP 3902875B2
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Japan
Prior art keywords
plunger
stopper
housing
puncture
lancet
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JP29632598A
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JP2000116768A (en
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耕一 園田
尚穂 西川
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TRUMO KABUSHIKI KAISHA
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TRUMO KABUSHIKI KAISHA
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Priority to JP10183794A priority Critical patent/JP2000014662A/en
Application filed by TRUMO KABUSHIKI KAISHA filed Critical TRUMO KABUSHIKI KAISHA
Priority to JP29632598A priority patent/JP3902875B2/en
Priority to TW088100639A priority patent/TW376309B/en
Priority to SG9900132A priority patent/SG89273A1/en
Priority to KR1019990001761A priority patent/KR100301308B1/en
Priority to US09/236,009 priority patent/US6261245B1/en
Priority to EP99400147A priority patent/EP0931507B1/en
Priority to EP05020687.9A priority patent/EP1609417B1/en
Priority to CNB991012674A priority patent/CN1167382C/en
Priority to DE69932191T priority patent/DE69932191T2/en
Priority to EP05020686.1A priority patent/EP1609416A3/en
Publication of JP2000116768A publication Critical patent/JP2000116768A/en
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Publication of JP3902875B2 publication Critical patent/JP3902875B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/150183—Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213—Venting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Description

【０００１】
【発明の属する技術分野】
本発明は、体液の臨床検査等をする場合の体液を採取方法として、指先等に穿刺針を刺し必要量の体液を採取するための穿刺器具に関する。
【０００２】
【従来の技術】
近年の糖尿病患者の増加に伴い日頃の血糖値の変動を患者自身モニターする自己血糖測定が推奨されてきている。血糖値測定をするための血液を採取する方法は針状や小刀状のランセットが装備された採血用穿刺器具が使用される。血液の採取は、採血用穿刺器具のランセットを穿刺される人に皮膚に刺して、切開し、切開後に切開部から流出する血液を例えば、試験紙あるいはピペット等に採血することにより行われる。糖尿病の患者は、乳幼児から、成人、老人、男性、女性、それに数多くの人種に分布しており個々により皮膚の厚みが違うのに対して、採血用穿刺器具は穿刺針の端面をキャップに突き当てることにより穿刺深さを調整していることから、例えば浅刺し用と深刺し用のキャップを交換することにより穿刺深さを調整している。上述の問題点を解決するためにＷＯ９７／０４７０７や米国特許第５６１３９７８では，穿刺具先端部のキャップ要素に任意にランセットの穿刺深さを調整することができる機能を提供している。
【０００３】
【発明が解決しようとする課題】
しかしながら、このような従来の穿刺器具においてはキャップ部に穿刺深さの調整を有することから、穿刺針の取り外しの際など使用中に誤って穿刺深さの設定を変更してしまう恐れがあるという問題があった。さらに、一旦キャップを取り外してから穿刺針をセットしなければならないという取り扱い時に、動作が増える問題があった。また、穿刺針の端面をキャップに突き当てることにより穿刺深さを調整していることから、穿刺針がキャップに突き当たった際に、その衝撃が穿刺時の穿刺針に直に伝わり、穿刺針のぶれによる痛みの増加の恐れがあった。
【０００４】
【発明が解決しようとする課題】
本発明は上記の課題を鑑み、多段階の穿刺の深さを調整する機構を備え、かつ誤って調整機能が回転し穿刺の深さの設定が変更するのを防止するための手段を有する穿刺器具を提供することにある。また、本発明は、穿刺時に穿刺針に伝わる衝撃を軽減できる穿刺器具を提供することにある。さらに、本発明はキャップ部ごと穿刺針の取り外しが行え、穿刺針の取り外しの際に一旦キャップを取り外すという操作の煩雑さを低減した穿刺器具を提供することを目的とする。
【０００５】
【課題を解決するための手段】
上記目的は以下の本発明によって解決される。
（１）本発明は、生体の表面を穿刺する器具において、
先端部が開口されているハウジングと、
先端方向に延びる穿刺針が設けられたランセットが取り付けられ、前記ハウジング内を摺動するプランジャーと、
前記プランジャーの後端方向に連結されるストッパーと、
前記ストッパーと当接する調整機構と、
前記プランジャーまたは前記ストッパーに接続し、前記ランセット、前記プランジャーおよび前記ストッパーを前記ハウジングの先端方向に移動させる穿刺用バネとからなり、
前記ハウジング内面には係合部が設けられ、
前記ランセット、前記プランジャーまたは前記ストッパーの少なくとも一つには、前記係合部と係合して、前記ランセット、前記プランジャーおよび前記ストッパーを第一の位置で係止する係止部が設けられており、
前記係合部と前記係止部との係合を解除することにより前記バネによって、前記ランセット、前記プランジャーおよび前記ストッパーが前記第一の位置より先端方向に移動した後に、前記ストッパーが前記調整機構と接触することにより、前記ランセット、前記プランジャーおよび前記ストッパーの移動を第二の位置で停止することを特徴とする穿刺器具である。
【０００６】
（２）本発明は、前記調整機構を前記ハウジング内で長手軸を中心とする軸回転させることにより、前記第二の位置を調整するものである上記（１）に記載の穿刺器具である。
（３）本発明は、前記調整機構および前記ハウジングの一方に設けられた螺旋状の溝と他方に設けられた前記螺旋状の溝内に沿って移動する突起によって、前記調整機構を前記ハウジング内で長手軸を中心とする軸回転させることにより、前記第二の位置を調整するものである上記（１）乃至（２）に記載の穿刺器具である。
【０００７】
（４）本発明は、前記ハウジング内には前記ハウジングに固定され同軸方向に延びる接続部を有し、前記調整機構は前記接続部を覆うように嵌合するものであって、前記調整機構および前記接続部の一方に設けられた螺旋状の溝と他方に設けられた前記螺旋状の溝内に沿って移動する突起によって、前記調整機構を前記ハウジング内で長手軸を中心とする軸回転させることにより、前記第二の位置を調整するものである上記（１）乃至（３）に記載の穿刺器具である。
（５）本発明は、前記接続部が筒状体であり、その内部をストッパーが摺動するものである上記（１）乃至（４）に記載の穿刺器具である。
（６）本発明は、前記調整機構の筒状部分には長手軸方向に延びる一または二以上のスリットが設けられている上記（１）乃至（５）に記載の穿刺器具である。
【０００８】
（７）本発明は、前記調整機構が前記ハウジングの後端部より前記ハウジング内に未挿入部分を残して挿入され、前記未挿入部分を長手軸を中心とする軸回転させることにより、前記調整機構は前記ハウジング内で長手軸を中心とする軸回転をするものであり、さらに前記ハウジングの後端部には前記未挿入部分を保護するカバーが設けられている上記（１）乃至（６）に記載の穿刺器具である。
（８）本発明は、前記調整機構の少なくとも一部が筒状であり、前記ストッパーは前記調整機構の筒状内部を摺動するものであって、前記筒状内部および前記ストッパーの双方またはいずれか一方には前記ストッパーの移動抑制機構が設けられている上記（１）乃至（７）に記載の穿刺器具である。
【０００９】
（９）本発明は、前記移動抑制機構が前記筒状内部および前記ストッパーの双方に設けられ互い係止する突起である上記（１）乃至（８）に記載の穿刺器具である。
（１０）本発明は、前記調整機構および前記ハウジングには、前記調整機構を長手軸を中心とする軸回転させることにより、前記第二の位置を調整する際に、予め設定した前記第二の位置での前記調整機構の固定手段を有する上記（１）乃至（９）に記載の穿刺器具である。
【００１０】
（１１）本発明は、前記固定手段は、前記調整機構および前記ハウジングの一方に設けられた凸部、および他方の設けられた凹部による嵌合手段である上記（１）乃至（１０）に記載の穿刺器具である。
（１２）本発明は、前記ハウジング内には、前記ストッパーが前記調整機構と接触した際に前記調整機構が長手軸と垂直方向に撓みを生じた場合、前記撓みを許容できる空間を有する上記（１）乃至（１１）に記載の穿刺器具である。
【００１１】
（１３）本発明は、前記ハウジング内に長手軸方向に延びる軸方向溝を有し、前記プランジャーには前記軸方向溝内に沿って移動する突起が設けられている上記（１）乃至（１２）に記載の穿刺器具である。
（１４）本発明は、前記ランセットが、前記穿刺針を覆いかつ前記ハウジングの先端部に接続可能なキャップ内に長手軸方向に移動可能に収納されており、前記キャップを前記ハウジングの先端部に接続すると前記キャップ内に収納された状態で前記プランジャーに取り付けられる上記（１）乃至（１３）に記載の穿刺器具である。
【００１２】
【発明の実施の形態】
本発明の穿刺器具の実施の形態に一例を図面を参照して詳細に説明する。図１にその断面を示す穿刺器具１は主に生体の表面から血液等の体液を微量採取する際に用いるものである。穿刺器具１は、ハウジング２と、ハウジング２内部を摺動するプランジャー３と、プランジャー３の先端部に取り付けられかつ先端に延びる穿刺針４１を有するランセット４と、プランジャー３の後端方向に連結されるストッパー５と、ストッパー５と当接する調整機構１０と、プランジャー３、ランセット４およびストッパー５を先端方向に移動させるための穿刺用バネ６からなり、前記ハウジング２内面には係合部８が設けられ、プランジャー３には係合部８と係合してプランジャー３、ランセット４およびストッパー５を第一の位置で係止する係止部７が設けられている。
【００１３】
なお、第一の位置とは生体の表面を穿刺する前の状態をいい、具体的には図１に示す状態をいう。
【００１４】
ハウジング２は図１に示すような筒状のものであればその形状は特に限定しないが、握り易さを考慮すると円筒体が好ましく、さらには係合部８の周囲には平面を示す図４のようなに平面部２１を有すると後述する係止部７と係合部８との係合を解除を目視するこなく平面部２１に指を滑らせるだけで容易に行えるため望ましい。
【００１５】
穿刺用バネ６は一端をプランジャー３に他端をハウジング２内面に設けられた穿刺用バネ固定台９とに接続して圧縮されて挿入されているが、本発明においてはこの形態に限定する必要はなく、一端がランセット４またはストッパー５に接続し、他端が直接ハウジング２の内面に固定されるものであってもよい。また、穿刺用バネ６は、プランジャー３、ランセット４およびストッパー５を第一の位置から第二の位置まで移動させることができるものであればよく、形状は図に示すコイル状のもの他に板状などのものであってもよく、その材質も特に限定しない。なお、穿刺用バネ６は第一の位置では圧縮された状態にある。
【００１６】
なお、第二の位置とは穿刺針４１が生体の表面を穿刺する位置をいうが、穿刺器具１の先端部から穿刺針４１が突出した状態に限らず、例えば、穿刺器具１の先端部を生体の表面に押し当て先端部内に盛り上がった生体の表面を穿刺できる状態なども含まれる。
【００１７】
係止部７はプランジャー３に設けられているが、本発明においてはこの形態に限定する必要はなく、ランセット４またはストッパー５に設けてもよい。その形状も一端をプランジャー３等に固定するものではなく、両端をプランジャー３等に固定するＵ字状、Ｖ字状等の形状であってもよい。すなわち、係合部８との係合することでプランジャー３、ランセット４およびストッパー５を第一の位置で係止でき、可動して係合部８との係合を解除できるものであればよい。また、後述する係合部８がハウジング２の内面から外面へ貫通するものである場合には、係止部７はその一部が係合部８を介してハウジング２の外面へ突出しているものが、係合を解除する操作を考慮すると望ましい。
【００１８】
係合部８は、ハウジング２内面に設けられ係止部７と係合できるものであれば特に限定しないが、本実施形態に示すようなハウジング２の内面から外面へ貫通する孔であることが望ましい。これにより、確実に係止部７と係合で、かつ係止部７を押し込むことで容易に係合を解除することができる。
【００１９】
ストッパー５は、プランジャー３の後端方向に接続され、ストッパー側移動抑制機構５１が設けられている。ストッパー側移動抑制機構５１は、調整機構側移動抑制機構１０１と係合し、第一の位置から移動したプランジャー３、ランセット４およびストッパー５を第二の位置で停止させる。なお、本実施形態ではストッパー側移動抑制機構５１と調整機構側移動抑制機構１０１とは互いに凸状であるが、特に限定する必要はなく、一方が凸状、他方が凹状であるものや、互いに軸方向に内径もしくは外形が徐々に変化しテーパー状に噛み合うような構造のものであってもよい。また、ストッパー５は本実施形態に示すようにプランジャー３と別部材とする必要はなく、プランジャー３と一体化されたものであってもよい。
【００２０】
ストッパー５によって、ランセット４がストッパー５から離れているため、プランジャー３、ランセット４およびストッパー５が第一の位置から第二の位置で停止した時のランセットに伝わる衝撃を減衰することができる。すなわち、従来のようにランセットが直接動きを抑制されることにより直接ランセットに衝撃が加わることなく、衝撃により操作者の手から穿刺器具１が離れたり、穿刺動作が振れてしまったり、体液を採取される者に苦痛を与えることなどを防ぐことができる。
【００２１】
調整機構１０は、図１に示すようにハウジング２内を軸方向に移動可能であり、かつストッパー５がその内部を摺動できるものであればよく、具体的には筒状のものがあげられる。また、調整機構１０には上述した調整機構側移動抑制機構１０１が設けられている。さらに、調整機構１０はハウジング２に対する未挿入部分１０２を有することが望ましく、これによって調整機構１０を軸回転させる際の動力を伝達することができる。
【００２２】
未挿入部分１０２は、誤操作により調整機構１０が設定した位置から移動するのを防ぐため、保護カバー１１によって覆われていることが望ましい。なお、保護カバー１１は、未挿入部分１０２の操作時に取り外し可能なもの、あるいは未挿入部分１０２を摘んで軸回転させることができる柔軟性を有するものなど、操作者が意図しない限り未挿入部分１０２を回転させることができない構造、材質からなるものが望ましい。
【００２３】
本実施形態において調整機構１０は、正面を図５およびその平面を図６に示すような構造となっている。すなわち、その外周に螺旋状の溝１０４が設けられている。この溝１０４は、後述する接続部１２に設けられた突起１２２が、その内部に沿って相対的に移動する。
【００２４】
また、本実施形態において調整機構１０は、ハウジング２を含む断面を示す図７、さらにその拡大された断面を図８に示すように、ハウジング２内面に設けられた穿刺用バネ固定台９から後端方向へ延び、その内部をストッパー５が摺動できる筒状である接続部１２に嵌合することによって設けられている。
【００２５】
接続部１２は、平面を示す図９および左側を示す図１１に示す突起１２２と、底面を示す図１０に示す固定用凸部１２３を有する。突起１２２は、調整機構１０を軸回転させると溝１０４内を相対的に移動し、調整機構１０を長手軸方向に移動させる。その結果、プランジャー３等の第二の位置を調整することができる。固定用凸部１２３は調整機構１０の内面に設けられた凹部１０５と係合ことにより、予め設定したプランジャー３等の第二の位置での調整機構１０の状態を固定することができる。なお、固定用凸部１２３は、突起１２２と必ずしも対角に位置しなくてもよく、また、一個所だけではなく複数個所に設けてもよい。
【００２６】
ここで、調整機構１０とストッパー５との関係について具体的に述べる。ストッパー３等の第一の位置から第二の位置への移動範囲は、調整機構１０の長手方向の位置と、ストッパー側移動抑制機構５１のＡ面（図１に示す）と調整機構側移動抑制機構１０１のＢ面（図１に示す）との距離Ｘ（図１に示す）により示される。図１２に第一の位置から第二の位置への移動範囲が小さい状態、図１３に第一の位置から第二の位置への移動範囲が大きい状態を示す。ここで、調整機構１０の長手方向の位置は、調整機構１０を軸回転させることにより、調整機構１０の螺旋状の溝１０４内の接続部１２の突起１２２の位置により決定される。すなわち、距離Ｘは調整機構１０を軸回転させることにより調整され、決定することができる。
【００２７】
さらに、調整機構１０の内面に設けられた凹部１０５と接続部１２に設けられた固定用凸部１２３との関係について具体的に述べる。例えば、調整機構１０の螺旋状の溝１０４の長手軸方向の位置の差（第一の位置から第二の位置への移動範囲が大きい状態と、第一の位置から第二の位置への移動範囲が小さい状態の差）を１ｍｍとし、凹部１０５を調整機構１０の内面に等間隔（穿刺器具１の長手方向中心軸を支点に角度４５度間隔）に５個設けると、１段階につき距離Ｘを０.２５ｍｍずつ調整することができる。また、調整機構１０の螺旋状の溝１０４の長手軸方向の位置の差（第一の位置から第二の位置への移動範囲が大きい状態と、第一の位置から第二の位置への移動範囲が小さい状態の差）を１ｍｍとし、凹部１０５を調整機構１０の内面に穿刺器具１の長手方向中心軸を支点に角度０度、１８度、５４度、１０８度、１８０度の位置に設定すると、距離Ｘを０.１ｍｍ、０.２ｍｍ、０.３ｍｍ、０.４ｍｍと、等間隔でなく任意の設定値に調整することもできる。
【００２８】
なお、未挿入部分１０２に目印１０６を設けておくと、調整機構１０が調整しようとしている設定値が目視できるため望ましい。
【００２９】
接続部１２は、長手軸方向に延びる一または二以上のスリット１２１を有することが望ましい。スリット１２１を設けることにより、ストッパー側移動抑制機構５１と調整機構側移動抑制機構１０１が接触した時に調整機構１０に生じる内側への撓みを許容することができる。これによりストッパー側移動抑制機構５１と調整機構側移動抑制機構１０１が接触した時の穿刺器具１の全体に生じる振動を軽減することが可能となり、振動により操作者の手から穿刺器具１が離れたり、穿刺動作が振れてしまったり、体液を採取される者に苦痛を与えることなどを防ぐことができる。
【００３０】
さらに、接続部１２を介して調整機構１０を接続することにより、図１に示すように調整機構１０の少なくとも調整機構側移動抑制機構１０１付近から先端方向への外面と、ハウジング内面との間に空間１３を設けながら調整機構１０を接続することができる。
【００３１】
空間１３は、ストッパー側移動抑制機構５１と調整機構側移動抑制機構１０１が接触した時に調整機構１０に生じる外側への撓みを許容することができる。これにより、上述した接続部１２にスリット１２１を設けた時と同様に、ストッパー側移動抑制機構５１と調整機構側移動抑制機構１０１が接触した時の穿刺器具１の全体に生じる振動を軽減することが可能となり、振動により操作者の手から穿刺器具１が離れてしまったり、体液を採取される者に与える苦痛を防ぐことができる。なお、調整機構１０にはハウジング２の内径とほぼ同一の外径部１０３を設けておくことによって、空間１３があっても調整機構１０を安定に軸回転させることができる。
【００３２】
なお本発明においては、接続部１２は必ずしも設ける必要はなく、ハウジング２の内面か調整機構１０の外面のいずれか一方に突起１２２に該当する突起、他方に螺旋状の溝１０４に該当する螺旋状の溝を設け、調整機構１０を軸回転させることにより、調整機構１０の位置を調整するものあってもよい。
【００３３】
ハウジング２の先端部には、キャップ１４を設けることが望ましい。これによって、プランジャー３等が第一の位置にあるときは、キャップの外に穿刺針１１が出ない構造となっており、誤って手や指をつけることの無いようにしている。キャップ１４とハウジング２の取り付け方法は、特に限定されず、簡単に取り外せるように嵌合ないしはネジ構造による螺着などがあげられる。なお、キャップ１４の生体の表面との接触面には開口部１４１が形成されており、その直径は穿刺部位を限定せずに穿刺が行えるように、１ｍｍ以上１０ｍｍ以下、好ましくは１ｍｍ以上６ｍｍ以下程度に設定すれば良い。
【００３４】
また、キャップは別の形態として、図１４にその先端部分の断面を示すキャップ１４ｂのような形態があげられる。すなわち、キャップ１４ｂは、その内部を摺動可能でかつ一端に穿刺針４１ｂを接続するランセット４ｂを収納するものである。このキャップ１４ｂによって、キャップ１４ｂをハウジング２ｂに接続することによって、ランセット４の他端をプランジャー３に接続することができ、後述する本実施形態の使用の説明と同様に使用をすることができる。
【００３５】
本実施形態においては、ハウジング２の内面に軸方向溝２２およびプランジャー３にぶれ防止突起３１を設けることが望ましい。ぶれ防止突起３１が軸方向溝２２内に沿って移動することによって、プランジャー３は軸回転方向にぶれることなく安定した状態で軸方向のみの移動が可能となり、その結果穿刺針４１を正確な位置に穿刺することができる。
【００３６】
上述した各構成部品の材質に関しては、特に限定されず、硬質プラスチック、金属等を適選使用できる。ただし、プランジャー３の少なくともハウジング２内面との摺動面、またはハウジング２の少なくともプランジャー３との摺動面は、摺動面の気密性を維持できる熱可塑性エラストマーやゴムなどの材質からなることが望ましい。気密性を維持することにより、ハウジング２の先端部を生体の表面に押し当て穿刺針４１で生体の表面を穿刺した後、プランジャー３が第二の位置から第一の位置方向へ戻る際に、ハウジング２内の生体の表面で封止された先端部とプランジャー３とが形成する空間が減圧状態となり、その結果生体の表面を吸引し、採取する体液を効果的に吸引することができる。また、予め吸引手段を設け、ハウジング２内の生体の表面で封止された先端部とプランジャー３とが形成する空間を減圧状態とし、その結果ハウジング２内方向に盛り上がった生体の表面を穿刺針４１で穿刺し、採取する体液を効果的に吸引することもできる。
【００３７】
なお、生体の表面を穿刺した後吸引するためには、プランジャー３が第二の位置に移動する際に、ハウジング２内の生体の表面で封止された先端部とプランジャー３とが形成する空間が陽圧となり、穿刺できなくなる可能性がある。そのため、陽圧となったハウジング２内の空気をハウジング２外へ逃すが、減圧となったハウジング２内に外気を流入させないため、ダックビル弁などの一方方向弁を、ハウジング２、プランジャー３およびキャップ１４のいずれか一つに設けておくことが望ましい。
【００３８】
次に本実施形態の使用の説明をする。まず、操作者はまず保護カバー１１を取り外し、調整機構１０を回転させ、測定に必要最低限の血液などの体液が採取できるプランジャー３、ランセット４およびストッパー５の第二の位置、すなわち穿刺針４１の移動距離を自ら設定をする。これにより、穿刺時に伴う痛みを必要最低限に押さえることが可能となる。調整機構１０は一度設定すれば頻繁に設定し直す必要がないため、保護カバー１１で覆うことにより誤操作によって穿刺深さが変更され必要以上に穿刺針が深く刺さることや採血ミス等をなくことができる。
【００３９】
次に、プランジャー３の先端部に穿刺針４１を有するランセット４を装着し、穿刺用バネ６の弾性力に抗してランセット４が装着されたプランジャー３を後端方向へ押し込み、係止部７を係合部８の縁部に係止させる。この時、穿刺用バネ６は圧縮状態で保持される。この状態で、生体の表面への穿刺の準備が完了する（図１参照）。
【００４０】
そして、キャップ１４の先端の開口部１４１を、例えば指先のような生体の表面に密着するように押しつけ、係合部８より突出した係止部７を押す。すると、係止部７と係合部８との係合が外され，収縮していた穿刺用バネ６がその弾性力により伸長し、プランジャー３が先端方向へ移動し、穿刺針４１がキャップ１４の開口部１４１より突出し、生体の表面１５を穿刺する（図２参照）。このとき、ストッパー５がプランジャー３と一緒にハウジング２内を摺動し、ストッパー５のストッパー側移動抑制機構５１が調整機構１０の調整機構側移動抑制機構１０１と接触することによりプランジャー３の先端方向への移動が規制され、同時にランセット４の穿刺針４１による生体の表面の穿刺の深さが、設定された深さに調整される。穿刺針４１が生体の表面を穿刺した後は、穿刺用バネ８は減衰運動を経て自然長に戻り、生体の表面から穿刺針が抜け、ハウジング２内に格納される（図３参照）。
【００４１】
このように、穿刺器具１は、ランセット４が穿刺以外はキャップ１４の先端部の開口部１４１から突出しないようになっており、誤って皮膚などを傷つけることが無く、感染なども防止することができ、安全性が高いものとなる。ストッパー５と調整機構１０によって、所定の穿刺位置への穿刺を再現性良く行うことができる。
【００４２】
【発明の効果】
本発明の穿刺器具は、ランセットの穿刺深さを調整する機構を備えているため、測定に必要最低限の血液量が取れる穿刺深さを操作者が自ら設定をすることができ、穿刺時に伴う痛みを必要最低限に押さえることが可能となる。
【図面の簡単な説明】
【図１】図１は、本発明の穿刺器具の一例の断面図である。
【図２】図２は、穿刺器具が生体の表面を穿刺した状態の断面図である。
【図３】図３は、穿刺器具が生体の表面を穿刺した後の断面図である。
【図４】図４は、穿刺器具のハウジングの平面図である。
【図５】図５は、穿刺器具の調整機構の正面図である。
【図６】図６は、穿刺器具の調整機構の平面図である。
【図７】図７は、穿刺器具のハウジングの断面図である。
【図８】図８は、穿刺器具のハウジングに設けられた接続部（図７の円内）の断面図である。
【図９】図９は、穿刺器具の接続部の平面図である。
【図１０】図１０は、穿刺器具の接続部の底面図である。
【図１１】図１１は、穿刺器具の接続部の左側面図である。
【図１２】図１２は、穿刺器具のプランジャーの第一の位置から第二の位置への移動範囲が小さい状態の断面図である。
【図１３】図１３は、穿刺器具のプランジャーの第一の位置から第二の位置への移動範囲が大きい状態の断面図である。
【図１４】図１４は、キャップを別の形態とした先端部分の断面図である。
【符号の説明】
１ 穿刺器具
２ ハウジング
２１ 平面部
２２ 軸方向溝
３ プランジャー
３１ ぶれ防止突起
４ ランセット
４１ 穿刺針
５ ストッパー
５１ ストッパー側移動抑制機構
６ 穿刺用バネ
７ 係止部
８ 係合部
９ 穿刺用バネ固定台
１０ 調整機構
１０１ 調整機構側移動抑制機構
１０２ 未挿入部分
１０３ ハウジング２の内径とほぼ同一の外径部
１０４ 溝
１０５ 凹部
１１ 保護カバー
１２ 接続部
１２１ スリット
１２２ 突起
１２３ 固定用凸部
１３ 撓みを許容する空間
１４ キャップ
１４１ 開口部
１５ 生体の表面[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a puncture device for collecting a necessary amount of bodily fluid by inserting a puncture needle into a fingertip or the like as a method of collecting bodily fluid when performing a clinical examination or the like of body fluid.
[0002]
[Prior art]
As the number of diabetic patients increases in recent years, self-blood glucose measurement for monitoring daily fluctuations in blood glucose level has been recommended. As a method for collecting blood for blood glucose level measurement, a blood collection puncture device equipped with a needle-like or knife-like lancet is used. The blood is collected by piercing the skin of a person to be punctured with a lancet of a blood collection puncture device, making an incision, and collecting the blood flowing out from the incision after the incision, for example, on a test paper or a pipette. Diabetic patients are distributed from infants to adults, elderly people, men, women, and many other races, and the thickness of the skin varies depending on the individual, while blood puncture devices use the end of the puncture needle as a cap. Since the puncture depth is adjusted by abutment, the puncture depth is adjusted by exchanging caps for shallow and deep punctures, for example. In order to solve the above-mentioned problems, WO97 / 04707 and US Pat. No. 5,613,978 provide a function that can arbitrarily adjust the puncture depth of the lancet on the cap element at the tip of the puncture tool.
[0003]
[Problems to be solved by the invention]
However, in such a conventional puncture device, since the puncture depth is adjusted in the cap portion, there is a risk that the puncture depth setting may be changed accidentally during use, such as when removing the puncture needle. There was a problem. Furthermore, there has been a problem that the operation is increased during handling in which it is necessary to set the puncture needle after removing the cap once. Since the puncture depth is adjusted by abutting the end face of the puncture needle against the cap, when the puncture needle hits the cap, the impact is directly transmitted to the puncture needle at the time of puncture, and the puncture needle There was a risk of increased pain due to shaking.
[0004]
[Problems to be solved by the invention]
In view of the above problems, the present invention includes a mechanism for adjusting the depth of multi-stage puncture and having means for preventing the adjustment function from rotating accidentally and changing the puncture depth setting. To provide an instrument. Moreover, this invention is providing the puncture device which can reduce the impact transmitted to a puncture needle at the time of puncture. Furthermore, an object of the present invention is to provide a puncture device in which the puncture needle can be removed together with the cap portion, and the complexity of the operation of once removing the cap when the puncture needle is removed is reduced.
[0005]
[Means for Solving the Problems]
The above object is solved by the present invention described below.
(1) The present invention relates to an instrument for puncturing the surface of a living body,
A housing with an open end;
A lancet provided with a puncture needle extending in the distal direction is attached, and a plunger that slides in the housing;
A stopper connected in the rear end direction of the plunger;
An adjustment mechanism in contact with the stopper;
A puncture spring that is connected to the plunger or the stopper and moves the lancet, the plunger, and the stopper toward the distal end of the housing;
An engagement portion is provided on the inner surface of the housing,
At least one of the lancet, the plunger, or the stopper is provided with a locking portion that engages with the engaging portion and locks the lancet, the plunger, and the stopper at a first position. And
After the engagement between the engagement portion and the locking portion is released, the spring moves the lancet, the plunger, and the stopper in the distal direction from the first position, and then the stopper is adjusted. The puncture device is characterized in that the movement of the lancet, the plunger and the stopper is stopped at a second position by contact with a mechanism.
[0006]
(2) The puncture device according to (1), wherein the adjustment mechanism is configured to adjust the second position by rotating the adjustment mechanism around the longitudinal axis in the housing.
(3) In the present invention, the adjustment mechanism is disposed in the housing by a spiral groove provided in one of the adjustment mechanism and the housing, and a protrusion that moves along the spiral groove provided in the other. The puncture device according to (1) or (2) above, wherein the second position is adjusted by rotating the shaft around the longitudinal axis.
[0007]
(4) In the present invention, the housing includes a connection portion that is fixed to the housing and extends in the coaxial direction, and the adjustment mechanism is fitted so as to cover the connection portion. The adjustment mechanism is rotated about the longitudinal axis in the housing by a spiral groove provided on one side of the connecting portion and a protrusion that moves along the spiral groove provided on the other side. By this, it is a puncture device as described in said (1) thru | or (3) which adjusts said 2nd position.
(5) The present invention is the puncture device according to the above (1) to (4), wherein the connection portion is a cylindrical body, and a stopper slides inside the connection portion.
(6) The puncture device according to (1) to (5), wherein the cylindrical portion of the adjustment mechanism is provided with one or more slits extending in a longitudinal axis direction.
[0008]
(7) In the present invention, the adjustment mechanism is inserted from the rear end portion of the housing leaving an uninserted portion in the housing, and the uninserted portion is rotated about a longitudinal axis to adjust the adjustment. The mechanism rotates around the longitudinal axis in the housing, and a cover for protecting the non-inserted portion is provided at the rear end of the housing. It is a puncture device as described in above.
(8) In the present invention, at least a part of the adjustment mechanism is cylindrical, and the stopper slides inside the cylindrical interior of the adjustment mechanism, and both or either of the cylindrical interior and the stopper The puncture device according to any one of the above (1) to (7), wherein the stopper is provided with a movement restraining mechanism for the stopper.
[0009]
(9) The present invention is the puncture device according to any one of (1) to (8), wherein the movement suppressing mechanism is a protrusion that is provided in both the cylindrical interior and the stopper and is locked to each other.
(10) In the adjustment mechanism and the housing, when the second position is adjusted by rotating the adjustment mechanism about the longitudinal axis, the second position set in advance is set in the adjustment mechanism and the housing. The puncture device according to any one of (1) to (9), wherein the puncture device has fixing means for the adjusting mechanism at a position.
[0010]
(11) In the present invention described in (1) to (10), the fixing means is a fitting means including a convex portion provided on one of the adjusting mechanism and the housing and a concave portion provided on the other. This is a puncture device.
(12) In the housing, the housing has a space that allows the bending when the adjusting mechanism bends in a direction perpendicular to the longitudinal axis when the stopper contacts the adjusting mechanism. A puncture device according to any one of 1) to (11).
[0011]
(13) In the present invention, the housing has an axial groove extending in the longitudinal axis direction, and the plunger is provided with a protrusion that moves along the axial groove. The puncture device according to 12).
(14) In the present invention, the lancet is housed in a cap that covers the puncture needle and is connectable to the distal end portion of the housing so as to be movable in the longitudinal axis direction, and the cap is attached to the distal end portion of the housing. The puncture device according to any one of (1) to (13), wherein the puncture device is attached to the plunger in a state of being accommodated in the cap when connected.
[0012]
DETAILED DESCRIPTION OF THE INVENTION
An example of the embodiment of the puncture device of the present invention will be described in detail with reference to the drawings. The puncture device 1 whose cross section is shown in FIG. 1 is mainly used when collecting a small amount of body fluid such as blood from the surface of a living body. The puncture device 1 includes a housing 2, a plunger 3 sliding inside the housing 2, a lancet 4 having a puncture needle 41 attached to the distal end portion of the plunger 3 and extending to the distal end, and a rear end direction of the plunger 3 A stopper 5, which is connected to the stopper 5, an adjustment mechanism 10 which contacts the stopper 5, a plunger 3, a lancet 4 and a puncture spring 6 for moving the stopper 5 in the distal direction. A portion 8 is provided, and the plunger 3 is provided with a locking portion 7 that engages with the engaging portion 8 to lock the plunger 3, the lancet 4, and the stopper 5 at the first position.
[0013]
The first position refers to a state before puncturing the surface of the living body, and specifically refers to the state shown in FIG.
[0014]
The shape of the housing 2 is not particularly limited as long as the housing 2 has a cylindrical shape as shown in FIG. 1, but a cylindrical body is preferable in consideration of ease of gripping. Further, a plane around the engaging portion 8 is shown in FIG. It is desirable to have the flat surface portion 21 as described above because the engagement between the locking portion 7 and the engagement portion 8 described later can be easily performed by simply sliding the finger on the flat surface portion 21 without visually observing the release.
[0015]
The puncture spring 6 is compressed and inserted with one end connected to the plunger 3 and the other end connected to a puncture spring fixing base 9 provided on the inner surface of the housing 2, but the present invention is limited to this form. There is no need, and one end may be connected to the lancet 4 or the stopper 5 and the other end may be directly fixed to the inner surface of the housing 2. Further, the puncture spring 6 may be any one that can move the plunger 3, the lancet 4 and the stopper 5 from the first position to the second position. A plate-like thing may be sufficient and the material is not specifically limited. The puncture spring 6 is in a compressed state at the first position.
[0016]
The second position refers to a position where the puncture needle 41 punctures the surface of the living body. However, the second position is not limited to the state in which the puncture needle 41 protrudes from the distal end portion of the puncture device 1. This includes a state in which the surface of the living body pressed against the surface of the living body and swelled in the tip can be punctured.
[0017]
The locking portion 7 is provided on the plunger 3, but in the present invention, it is not necessary to be limited to this form, and may be provided on the lancet 4 or the stopper 5. The shape is not fixed to the plunger 3 or the like at one end, but may be U-shaped or V-shaped such that both ends are fixed to the plunger 3 or the like. That is, as long as the plunger 3, the lancet 4 and the stopper 5 can be locked at the first position by engaging with the engaging portion 8 and can move and release the engagement with the engaging portion 8. Good. Further, when the engaging portion 8 described later penetrates from the inner surface to the outer surface of the housing 2, a part of the locking portion 7 protrudes to the outer surface of the housing 2 through the engaging portion 8. However, it is desirable to consider the operation of releasing the engagement.
[0018]
The engaging portion 8 is not particularly limited as long as it is provided on the inner surface of the housing 2 and can be engaged with the locking portion 7. However, the engaging portion 8 may be a hole penetrating from the inner surface of the housing 2 to the outer surface as shown in the present embodiment. desirable. Thus, the engagement with the locking portion 7 can be surely engaged, and the engagement can be easily released by pushing in the locking portion 7.
[0019]
The stopper 5 is connected in the rear end direction of the plunger 3, and a stopper side movement suppression mechanism 51 is provided. The stopper side movement suppression mechanism 51 engages with the adjustment mechanism side movement suppression mechanism 101, and stops the plunger 3, the lancet 4 and the stopper 5 moved from the first position at the second position. In the present embodiment, the stopper side movement suppression mechanism 51 and the adjustment mechanism side movement suppression mechanism 101 are convex with respect to each other. However, there is no particular limitation, and one of them is convex, the other is concave, It may have a structure in which the inner diameter or the outer shape gradually changes in the axial direction and meshes in a tapered shape. Moreover, the stopper 5 does not need to be a separate member from the plunger 3 as shown in this embodiment, and may be integrated with the plunger 3.
[0020]
Since the lancet 4 is separated from the stopper 5 by the stopper 5, the impact transmitted to the lancet when the plunger 3, the lancet 4 and the stopper 5 are stopped at the second position from the first position can be attenuated. That is, the lancet is restrained from moving directly as in the conventional case, so that the lancet is not directly impacted, the puncture device 1 is separated from the operator's hand, the puncture operation is shaken, or body fluid is collected. It can prevent suffering from suffering.
[0021]
As shown in FIG. 1, the adjusting mechanism 10 may be any one that can move in the axial direction in the housing 2 and that the stopper 5 can slide in the inside. Specifically, the adjusting mechanism 10 may be a cylindrical one. . The adjustment mechanism 10 is provided with the adjustment mechanism side movement suppression mechanism 101 described above. Furthermore, it is desirable that the adjusting mechanism 10 has a non-inserted portion 102 with respect to the housing 2, so that the power for rotating the adjusting mechanism 10 can be transmitted.
[0022]
The non-inserted portion 102 is preferably covered with the protective cover 11 in order to prevent the adjustment mechanism 10 from moving from the set position due to an erroneous operation. It should be noted that the protective cover 11 can be removed when the non-inserted portion 102 is operated, or has a flexibility such that the non-inserted portion 102 can be picked and rotated so that the non-inserted portion 102 is provided unless the operator intends to do so. It is desirable to use a structure and material that cannot be rotated.
[0023]
In this embodiment, the adjustment mechanism 10 has a structure as shown in FIG. That is, a spiral groove 104 is provided on the outer periphery thereof. In the groove 104, a projection 122 provided on the connecting portion 12 described later relatively moves along the inside thereof.
[0024]
Further, in this embodiment, the adjusting mechanism 10 is rearward from the puncture spring fixing base 9 provided on the inner surface of the housing 2 as shown in FIG. It extends in the end direction, and is provided by fitting the inside thereof into a connecting portion 12 having a cylindrical shape in which the stopper 5 can slide.
[0025]
The connection part 12 has the protrusion 122 shown in FIG. 9 which shows the plane and FIG. 11 which shows a left side, and the convex part 123 for fixation shown in FIG. 10 which shows a bottom face. The protrusion 122 relatively moves in the groove 104 when the adjusting mechanism 10 is rotated, and moves the adjusting mechanism 10 in the longitudinal axis direction. As a result, the second position of the plunger 3 or the like can be adjusted. The fixing convex portion 123 can be engaged with the concave portion 105 provided on the inner surface of the adjusting mechanism 10 to fix the state of the adjusting mechanism 10 at the second position such as the plunger 3 set in advance. Note that the fixing protrusions 123 do not necessarily have to be diagonally positioned with respect to the protrusions 122, and may be provided not only at one place but at a plurality of places.
[0026]
Here, the relationship between the adjusting mechanism 10 and the stopper 5 will be specifically described. The movement range from the first position to the second position of the stopper 3 or the like includes the position in the longitudinal direction of the adjustment mechanism 10, the A surface (shown in FIG. 1) of the stopper side movement suppression mechanism 51, and the adjustment mechanism side movement suppression. This is indicated by a distance X (shown in FIG. 1) to the B surface (shown in FIG. 1) of the mechanism 101. FIG. 12 shows a state where the movement range from the first position to the second position is small, and FIG. 13 shows a state where the movement range from the first position to the second position is large. Here, the position in the longitudinal direction of the adjustment mechanism 10 is determined by the position of the protrusion 122 of the connection portion 12 in the spiral groove 104 of the adjustment mechanism 10 by rotating the adjustment mechanism 10 in the axial direction. That is, the distance X can be adjusted and determined by rotating the adjusting mechanism 10 about the axis.
[0027]
Further, the relationship between the concave portion 105 provided on the inner surface of the adjusting mechanism 10 and the fixing convex portion 123 provided on the connection portion 12 will be specifically described. For example, the difference in the position in the longitudinal axis direction of the spiral groove 104 of the adjustment mechanism 10 (the state in which the movement range from the first position to the second position is large and the movement from the first position to the second position) If the five recesses 105 are provided on the inner surface of the adjustment mechanism 10 at equal intervals (at an angle of 45 degrees with the longitudinal central axis of the puncture device 1 as a fulcrum) on the inner surface of the adjustment mechanism 10, the distance X is 1 step. Can be adjusted in increments of 0.25 mm. Further, the difference in the position in the longitudinal axis direction of the spiral groove 104 of the adjusting mechanism 10 (the state in which the movement range from the first position to the second position is large and the movement from the first position to the second position) The difference in the state where the range is small) is 1 mm, and the recess 105 is set on the inner surface of the adjustment mechanism 10 at positions of 0 degrees, 18 degrees, 54 degrees, 108 degrees, and 180 degrees with the longitudinal center axis of the puncture device 1 as a fulcrum. Then, the distance X can be adjusted to 0.1 mm, 0.2 mm, 0.3 mm, and 0.4 mm, not an equal interval, but an arbitrary set value.
[0028]
Note that it is desirable to provide the mark 106 in the non-inserted portion 102 because the set value that the adjustment mechanism 10 is to adjust can be visually confirmed.
[0029]
The connecting part 12 preferably has one or more slits 121 extending in the longitudinal axis direction. By providing the slit 121, it is possible to allow inward bending that occurs in the adjustment mechanism 10 when the stopper side movement suppression mechanism 51 and the adjustment mechanism side movement suppression mechanism 101 come into contact with each other. As a result, it is possible to reduce the vibration generated in the entire puncture device 1 when the stopper-side movement suppression mechanism 51 and the adjustment mechanism-side movement suppression mechanism 101 are in contact with each other. Further, it is possible to prevent the puncturing operation from being shaken or causing pain to a person who collects body fluid.
[0030]
Further, by connecting the adjusting mechanism 10 via the connecting portion 12, as shown in FIG. 1, between the outer surface of at least the adjusting mechanism side movement suppressing mechanism 101 from the vicinity of the adjusting mechanism side toward the distal end and the inner surface of the housing as shown in FIG. The adjusting mechanism 10 can be connected while providing the space 13.
[0031]
The space 13 can allow outward deflection of the adjustment mechanism 10 when the stopper side movement suppression mechanism 51 and the adjustment mechanism side movement suppression mechanism 101 come into contact with each other. As a result, the vibration generated in the entire puncture device 1 when the stopper-side movement suppression mechanism 51 and the adjustment mechanism-side movement suppression mechanism 101 are in contact with each other is reduced in the same manner as when the slit 121 is provided in the connection portion 12 described above. Thus, the puncture device 1 is separated from the operator's hand due to vibration, and the pain given to a person who collects body fluid can be prevented. In addition, by providing the adjustment mechanism 10 with an outer diameter portion 103 that is substantially the same as the inner diameter of the housing 2, the adjustment mechanism 10 can be stably rotated even if there is a space 13.
[0032]
In the present invention, the connecting portion 12 is not necessarily provided, and either the inner surface of the housing 2 or the outer surface of the adjusting mechanism 10 has a spiral shape corresponding to the protrusion corresponding to the protrusion 122 and the other corresponding to the spiral groove 104. There may be a case in which the position of the adjustment mechanism 10 is adjusted by providing a groove and rotating the adjustment mechanism 10 about its axis.
[0033]
It is desirable to provide a cap 14 at the tip of the housing 2. Thus, when the plunger 3 or the like is in the first position, the puncture needle 11 does not come out of the cap, so that a hand or a finger is not accidentally applied. A method of attaching the cap 14 and the housing 2 is not particularly limited, and examples thereof include fitting or screwing with a screw structure so that the cap 14 and the housing 2 can be easily removed. An opening 141 is formed on the contact surface of the cap 14 with the surface of the living body, and the diameter thereof is 1 mm or more and 10 mm or less, preferably 1 mm or more and 6 mm or less so that puncture can be performed without limiting the puncture site. What is necessary is just to set to a grade.
[0034]
Further, as another form of the cap, there is a form like a cap 14b whose cross section is shown in FIG. That is, the cap 14b accommodates the lancet 4b that can slide inside and connects the puncture needle 41b to one end. By connecting the cap 14b to the housing 2b with the cap 14b, the other end of the lancet 4 can be connected to the plunger 3, and can be used in the same manner as described in the use of this embodiment described later. .
[0035]
In the present embodiment, it is desirable to provide the anti-shake projection 31 on the axial groove 22 and the plunger 3 on the inner surface of the housing 2. As the anti-shake protrusion 31 moves along the axial groove 22, the plunger 3 can move in the axial direction in a stable state without being shaken in the axial rotation direction. As a result, the puncture needle 41 can be moved accurately. Can be punctured into position.
[0036]
The material of each component described above is not particularly limited, and hard plastic, metal, and the like can be appropriately used. However, the sliding surface of the plunger 3 with at least the inner surface of the housing 2 or the sliding surface of the housing 2 with at least the plunger 3 is made of a material such as a thermoplastic elastomer or rubber capable of maintaining the airtightness of the sliding surface. It is desirable. By maintaining the airtightness, when the distal end of the housing 2 is pressed against the surface of the living body and the surface of the living body is punctured with the puncture needle 41, the plunger 3 returns from the second position toward the first position. The space formed by the distal end portion sealed by the surface of the living body in the housing 2 and the plunger 3 is in a decompressed state, and as a result, the surface of the living body can be sucked and the collected body fluid can be sucked effectively. . In addition, suction means is provided in advance, and the space formed by the tip 3 and the plunger 3 sealed with the surface of the living body in the housing 2 is brought into a decompressed state, and as a result, the surface of the living body that swells in the housing 2 is punctured. It is also possible to effectively aspirate the body fluid that is punctured with the needle 41 and collected.
[0037]
In order to suck after puncturing the surface of the living body, when the plunger 3 moves to the second position, the distal end portion sealed with the surface of the living body in the housing 2 and the plunger 3 are formed. There is a possibility that the space to perform becomes positive pressure and puncture is impossible. Therefore, air in the housing 2 that has become positive pressure is released to the outside of the housing 2, but in order not to allow outside air to flow into the housing 2 that has been reduced in pressure, a one-way valve such as a duckbill valve is connected to the housing 2, the plunger 3, and It is desirable to provide one of the caps 14.
[0038]
Next, the use of this embodiment will be described. First, the operator first removes the protective cover 11 and rotates the adjustment mechanism 10 so that the second position of the plunger 3, the lancet 4 and the stopper 5 from which body fluid such as blood necessary for measurement can be collected, that is, the puncture needle. 41 is set by itself. This makes it possible to suppress the pain associated with puncturing to the minimum necessary. Since the adjustment mechanism 10 does not need to be reset frequently once set, the puncture depth is changed by an erroneous operation by covering with the protective cover 11, and the puncture needle is stuck deeper than necessary and blood collection mistakes are eliminated. it can.
[0039]
Next, the lancet 4 having the puncture needle 41 is attached to the distal end portion of the plunger 3, and the plunger 3 to which the lancet 4 is attached is pushed toward the rear end against the elastic force of the puncture spring 6, and locked. The part 7 is locked to the edge of the engaging part 8. At this time, the puncture spring 6 is held in a compressed state. In this state, preparation for puncturing the surface of the living body is completed (see FIG. 1).
[0040]
And the opening part 141 of the front-end | tip of the cap 14 is pressed so that it may contact | adhere to the surface of a biological body like a fingertip, for example, and the latching | locking part 7 which protruded from the engaging part 8 is pushed. Then, the engagement between the locking portion 7 and the engaging portion 8 is released, the contracted puncture spring 6 is extended by its elastic force, the plunger 3 is moved in the distal direction, and the puncture needle 41 is capped. 14 protrudes from the opening 141 and punctures the surface 15 of the living body (see FIG. 2). At this time, the stopper 5 slides in the housing 2 together with the plunger 3, and the stopper side movement suppression mechanism 51 of the stopper 5 comes into contact with the adjustment mechanism side movement suppression mechanism 101 of the adjustment mechanism 10, whereby the plunger 3 Movement in the distal direction is restricted, and at the same time, the puncture depth of the surface of the living body by the puncture needle 41 of the lancet 4 is adjusted to the set depth. After the puncture needle 41 punctures the surface of the living body, the puncture spring 8 returns to its natural length through a damping motion, and the puncture needle comes out of the surface of the living body and is stored in the housing 2 (see FIG. 3).
[0041]
As described above, the puncture device 1 is configured such that the lancet 4 does not protrude from the opening 141 at the tip of the cap 14 except for puncture, so that the skin or the like is not accidentally damaged and infection can be prevented. Can be made safe. The stopper 5 and the adjusting mechanism 10 can puncture a predetermined puncturing position with good reproducibility.
[0042]
【The invention's effect】
Since the puncture device of the present invention is provided with a mechanism for adjusting the puncture depth of the lancet, the operator can set the puncture depth at which the minimum blood volume necessary for measurement can be obtained, and is accompanied at the time of puncture. It is possible to minimize pain.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view of an example of a puncture device of the present invention.
FIG. 2 is a cross-sectional view of a state where a puncture device has punctured the surface of a living body.
FIG. 3 is a cross-sectional view after the puncture device has punctured the surface of a living body.
FIG. 4 is a plan view of the housing of the puncture device.
FIG. 5 is a front view of the adjustment mechanism of the puncture device.
FIG. 6 is a plan view of the adjustment mechanism of the puncture device.
FIG. 7 is a cross-sectional view of the housing of the puncture device.
FIG. 8 is a cross-sectional view of a connecting portion (inside the circle in FIG. 7) provided in the housing of the puncture device.
FIG. 9 is a plan view of a connection portion of the puncture device.
FIG. 10 is a bottom view of the connecting portion of the puncture device.
FIG. 11 is a left side view of the connection portion of the puncture device.
FIG. 12 is a cross-sectional view of a state where the movement range from the first position to the second position of the plunger of the puncture device is small.
FIG. 13 is a cross-sectional view of the puncture device with a large range of movement of the plunger from the first position to the second position.
FIG. 14 is a cross-sectional view of a tip portion having a different cap shape.
[Explanation of symbols]
1 Puncture device
2 Housing
21 Plane section
22 Axial groove
3 Plunger
31 Shake prevention protrusion
4 Lancet
41 Puncture needle
5 Stopper
51 Stopper side movement restraint mechanism
6 Puncture spring
7 Locking part
8 engaging part
9 Puncture spring fixing base
10 Adjustment mechanism
101 Adjustment mechanism side movement suppression mechanism
102 Not inserted part
103 Outer diameter portion substantially the same as the inner diameter of the housing 2
104 groove
105 recess
11 Protective cover
12 connections
121 slit
122 protrusion
123 convex part for fixing
13 Space allowing bending
14 cap
141 opening
15 Surface of living body

Claims (1)

生体の表面を穿刺する器具において、
先端部が開口されているハウジングと、
先端方向に延びる穿刺針が設けられたランセットを、その内部に長手軸方向に摺動可能に収納し、前記ハウジングの先端部に接続可能なキャップと、
前記ランセットが取り付けられ、前記ハウジング内を摺動するプランジャーと、
前記プランジャーの後端方向に連結されるストッパーと、前記ストッパーと当接する調整機構と、
前記プランジャーまたは前記ストッパーに接続し、前記ランセット、前記プランジャーおよび前記ストッパーを前記ハウジングの先端方向に移動させる穿刺用バネとからなり、
前記ランセットは、前記キャップを前記ハウジングの先端部に接続すると前記キャップ内に収納された状態で前記プランジャーに取り付けられるように構成され、
前記ハウジング内面には係合部が設けられ、
前記ランセット、前記プランジャーまたは前記ストッパーの少なくとも一つには、前記係合部と係合して、前記ランセット、前記プランジャーおよび前記ストッパーを第一の位置で係止する係止部が設けられており、
前記係合部と前記係止部との係合を解除することにより前記バネによって、前記ランセット、前記プランジャーおよび前記ストッパーが前記第一の位置より先端方向に移動し、前記穿刺針が前記キャップの開口部より突出した後に、前記ストッパーが前記調整機構と接触することにより、前記ランセット、前記プランジャーおよび前記ストッパーの移動を第二の位置で停止することを特徴とする穿刺器具。In an instrument that punctures the surface of a living body,
A housing with an open end;
A lancet provided with a puncture needle extending in the distal direction is accommodated therein so as to be slidable in the longitudinal axis direction, and a cap connectable to the distal end of the housing;
A plunger to which the lancet is attached and slides in the housing;
A stopper connected in the rear end direction of the plunger, an adjustment mechanism that comes into contact with the stopper,
A puncture spring that is connected to the plunger or the stopper and moves the lancet, the plunger, and the stopper toward the distal end of the housing;
The lancet is configured to be attached to the plunger in a state of being accommodated in the cap when the cap is connected to a distal end portion of the housing.
An engagement portion is provided on the inner surface of the housing,
At least one of the lancet, the plunger, or the stopper is provided with a locking portion that engages with the engaging portion and locks the lancet, the plunger, and the stopper at a first position. And
By releasing the engagement between the engagement portion and the locking portion, the lancet, the plunger, and the stopper are moved in the distal direction from the first position by the spring, and the puncture needle is moved to the cap. After protruding from the opening , the puncture device stops the movement of the lancet, the plunger and the stopper at the second position by the stopper coming into contact with the adjusting mechanism.
JP29632598A 1998-01-22 1998-10-19 Puncture device Expired - Lifetime JP3902875B2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
JP10183794A JP2000014662A (en) 1998-01-22 1998-06-30 Humor examination device
JP29632598A JP3902875B2 (en) 1998-10-19 1998-10-19 Puncture device
TW088100639A TW376309B (en) 1998-01-22 1999-01-16 Body-fluid inspection device
KR1019990001761A KR100301308B1 (en) 1998-01-22 1999-01-21 Body-fluid inspection device
SG9900132A SG89273A1 (en) 1998-01-22 1999-01-21 Body-fluid inspection device
EP99400147A EP0931507B1 (en) 1998-01-22 1999-01-22 Body-fluid inspection device
US09/236,009 US6261245B1 (en) 1998-01-22 1999-01-22 Body-fluid inspection device
EP05020687.9A EP1609417B1 (en) 1998-01-22 1999-01-22 Lancing device with depth adjustment
CNB991012674A CN1167382C (en) 1998-01-22 1999-01-22 Body-fluid inspection device
DE69932191T DE69932191T2 (en) 1998-01-22 1999-01-22 Device for the examination of body fluid
EP05020686.1A EP1609416A3 (en) 1998-01-22 1999-01-22 Body-fluid inspection device

Applications Claiming Priority (1)

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JP29632598A JP3902875B2 (en) 1998-10-19 1998-10-19 Puncture device

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JP2005224790A Division JP4145313B2 (en) 2005-08-03 2005-08-03 Puncture device
JP2006127950A Division JP2006255432A (en) 2006-05-01 2006-05-01 Puncture device

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