JP2004358016A - Puncture needle for easy insertion along the puncture route - Google Patents
Puncture needle for easy insertion along the puncture route Download PDFInfo
- Publication number
- JP2004358016A JP2004358016A JP2003161594A JP2003161594A JP2004358016A JP 2004358016 A JP2004358016 A JP 2004358016A JP 2003161594 A JP2003161594 A JP 2003161594A JP 2003161594 A JP2003161594 A JP 2003161594A JP 2004358016 A JP2004358016 A JP 2004358016A
- Authority
- JP
- Japan
- Prior art keywords
- blade surface
- canula
- puncture
- tip
- puncture needle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Landscapes
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
【課題】固定された穿刺ルートを損傷せずに形成された穿刺ルートに沿って真っ直ぐに刺入できる穿刺針を提供することを目的とし、さらには、留置中にその刃先で血管内壁を損傷することのない穿刺針を提供することを目的とする。
【解決手段】筒状体の端部を斜めに横断するようにして刃面が形成された留置用穿刺針に於て、刃面１の先端１１からカヌラの中心軸までの最短距離がカヌラの針管の半径よりも小さくなるように、刃面の先端１１がカヌラの中心軸２側に偏心されたものとするとともに、カヌラの刃面と反対側のカヌラ側面が、刃面の先端に向けてカヌラの中心軸の側に屈曲が開始される屈曲点４と刃面の先端１１とを結ぶ延長線とカヌラの中心軸２とがなす角度が１５°以上、かつ３０°以内にあるものとする。
【選択図】 図１An object of the present invention is to provide a puncture needle that can be inserted straight along a puncture route formed without damaging a fixed puncture route, and furthermore, damages the inner wall of a blood vessel with its cutting edge during indwelling. It is an object of the present invention to provide a puncture needle that does not need to be used.
An indwelling puncture needle having a blade surface formed so as to obliquely cross an end portion of a cylindrical body, wherein the shortest distance from the distal end 11 of the blade surface 1 to the central axis of the canula is in the range of the canula. The tip 11 of the blade surface is eccentric to the central axis 2 of the cannula so as to be smaller than the radius of the needle tube, and the side surface of the canula opposite to the blade surface of the canula faces toward the tip of the blade surface. It is assumed that the angle formed by the extension line connecting the bending point 4 at which the bending is started toward the central axis of the canula and the tip 11 of the blade surface and the central axis 2 of the canula is 15 ° or more and within 30 °. .
[Selection diagram] Fig. 1
Description
【０００１】
【発明の属する技術分野】
本発明は血液透析や持続的・断続的な薬液投与、或いは断続的な血液サンプル採取等の用途に用いられる穿刺針について、固定された穿刺ルートを損傷せずに穿刺ルートに沿って真っ直ぐに刺入可能な穿刺針に関する。
【０００２】
【従来の技術】
例えば血液透析に際し、従来より金属性の針に人体固定用の翼が取り付けられた所謂翼付き留置針や、金属性の内針とプラスチック製の外針からなる留置針等が使用されており、患者にとってこの留置針を穿刺する際の苦痛は避けることの出来ない問題であった。
そこで、上記の問題を解決するために、本出願人はすでに留置針穿刺用ホール形成具を提案している（特許文献１参照）。この留置針穿刺用ホール形成具は、これを数日間程度人体に留置しておき、皮膚表面から血管に至る真っ直ぐな通路（穿刺ルートという）を形成するものであり、穿刺の際に先に使用した部位への針先端の挿入が容易であり、以後の穿刺の際には速やかに留置針を刺入できるという利点を有している。
【０００３】
【特許文献１】
特開２０００−１７６００９号公報（段落番号０００６−００１１、図１）
【０００４】
しかしながら、上記のような留置針穿刺用ホール形成具を用いて穿刺ルートを形成しても、通常の穿刺針を用いて穿刺ルートに沿った穿刺を行った場合には、（１）穿刺針の先端が鋭利であれば、穿刺ルートの近辺を損傷する危険がある。
（２）穿刺針の穿刺後に血管内壁の組織を針先端の刃面で損傷し、それが原因で血栓や血管瘤を生成するおそれがある。そこで、本出願人は、このような問題を解決するものとして、針先端の刃面形状を外周縁部のうちの少なくとも４０％の部分を研磨して丸く加工した透析用留置針、を提案した（特許文献２参照）。
【０００５】
【特許文献２】
特開２００１−２９３０８５号公報（段落番号０００９−００１４、００２２、図３、４、５、６）
【０００６】
上記特許文献２の留置針の採用によって、 （１）留置針の血管への刺入に際して痛みが少ないことから麻酔の必要が無い。 （２）血腫の生成が減少する。
（３）感染症が抑制される。 （４）あらかじめ穿刺ルートを確保しておくことで穿刺の際に失敗するのを防げる。 などの利点を得ることができた。
ところが、上記のような透析用留置針を使用してもなお、針管の先端の形状が筒状体を斜めに横断する管周囲に均等でない形状ゆえに穿刺の際の針管に偏った力がかかってしまい、特に固定されて形成された穿刺ルートに挿入する場合にはルート周壁が皮膚組織のように必ずしも均質ではないことから真っ直ぐには刺入できずに斜めに刺入してしまい、したがって穿刺の際のコアリング防止のために形成させた刃面によって血管組織が損傷を受けたり、また、一般的な穿刺針では針先部分が細長くて鋭く、せっかく形成した穿刺ルートに沿わないで所望の穿刺部位からずれた部位へ穿刺することになり、穿刺針が穿刺ルートからずれて刺入された場合にはその穿刺ルートを損傷するのみならず患者の穿刺痛を増大させ、固定穿刺ルートを形成した意味が無くなってしまうという心配があった。
【０００７】
【発明が解決しようとする課題】
本発明は、このような事情に鑑みてなされたもので、固定された穿刺ルートを損傷せずに形成された穿刺ルートに沿って真っ直ぐ刺入できる穿刺針を提供することを目的とし、さらには、留置中にその刃先で血管内壁を損傷することのない穿刺針を提供することを目的とする。
【０００８】
【課題を解決するための手段】
本発明者等は上記の課題を解決するために、鋭意検討の結果、カヌラの刃面をカヌラの中心軸側に偏心させて先端部側面視（カヌラを側面から見た状態で）で刃面の先端がカヌラの外周壁よりも内側にあればよいこと、また固定された穿刺ルートに刺入する際にはカヌラの先端の針先角度は平ら過ぎずまたあまり鋭過ぎずに、カヌラの刃面の先端に向けて刃面の反対側の側壁から形成された屈曲線の概形線がカヌラの中心軸となす角度は適度な角度を有していなければならないことに想到し、本発明を完成した。
【０００９】
すなわち、本発明穿刺ルートに沿って刺入が容易な穿刺針は、筒状体の端部を斜めに横断するようにして刃面が形成された留置用穿刺針であって、カヌラの刃面先端からカヌラの中心軸までの最短距離がカヌラの半径よりも小さくなるように、刃面先端がカヌラの中心軸の側に偏心されてなるもので、これによって穿刺の際の針管の管周囲には比較的均等な力がかかることから、穿刺針が固定されたものとして形成された穿刺ルートに対して真っ直ぐに刺入できて好ましい。
【００１０】
そして本発明穿刺ルートに沿って刺入が容易な穿刺針において、その刃面先端の偏心の程度は、カヌラの刃面先端の位置がカヌラの刃面と反対側のカヌラ本体の外側面延長線（基準線）から１／８〜６／８偏心されているのが良く、より好ましくは、基準線から２／８〜４／８偏心されているのが良い。
なおここで、基準線とは、カヌラの刃面と反対側のカヌラ本体の外側面延長線を指しており、カヌラ中心線と平行な線を言う。本発明に関し以下の説明では、カヌラの刃面の先端の位置がこの基準線からカヌラの中心軸側に偏心されている距離を、カヌラの直径寸法を１とした距離の割合で表現している。
【００１１】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、カヌラの中心軸に対し前記基準線上にあるカヌラ側面の屈曲開始点と刃面先端とを結ぶ延長線がなす角度が１５°以上、かつ３０°内にあるのが好ましく、これによって固定されて形成された穿刺ルートに対してはある程度の刃先角度の確保によって穿刺の際のコアリング防止のために形成させた刃面による血管組織の損傷を招くことなく、かつ刃先角度が鋭過ぎてせっかく形成した穿刺ルートに沿わずに所望の穿刺部位からずれた部位へ向けて一気に穿刺してしまうのを避けることができる。
すなわち、上述の前記基準線上にあるカヌラ側面の屈曲（開始）点と刃面先端とを結ぶ延長線がなす角度が１５°以下ならば穿刺針に必要以上の鋭さを与えてしまって穿刺ルートに沿った刺入がコントロールし辛くなり、また３０°以上になると刃面が穿刺ルート側面をこするように進むこととなって刃面によるコアリングで血管壁組織が損傷を受け易くなってしまう。
なお上記の記述で、カヌラ側面の屈曲（開始）点とは、刃面と反対側のカヌラ側面から刃面の先端に向けて屈曲が開始される位置（屈曲点）を指している。
【００１２】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、刃面先端と反対側の刃面の端である刃面基端の位置が、前記屈曲点の位置よりもカヌラ本体側に位置しているものである。
これは、刃面は一般的に楕円形状に形成されており、もし刃面の基端の位置がカヌラの屈曲点よりカヌラのさらに先端側に位置していると、カヌラに流出入する血液の流量を確保するための開口面積が十分とれずに血流量が少なくなってしまうためである。
【００１３】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、刃面先端が鈍化されているものである。ここで、鈍化とは鋭利でない状態をいい、本発明の穿刺針においては先端が約２０μｍ〜１００μｍ（より好ましくは３０μｍ〜７０μｍ）の半径であるのが好適である。
これは、本発明穿刺針はすでに一度形成されたホールに対して刺入される用途ゆえ必要以上に先端が鋭い必要はなく、先端が２０μｍ未満では鋭利になり過ぎて不必要に形成されたホール壁面を傷つけるおそれがあり、また１００μｍを超えると血管への穿刺が容易でなくなる。
【００１４】
さらにまた、鈍化させておくのは刃面先端だけに限らず、刃面の外周縁部でも穿刺針の刺入時にコアリングを避けるためにも有効である。この刃面の外周縁部の鈍化は、前述した刃面がこのカヌラの中心軸に対して形成された角度によっても異なるが、概して約１μｍ〜１００μｍの半径であるのが好適である。
前述の刃面先端とともに刃面の外周縁部に適度な鈍化が要望されるのは、通常の皮膚組織を穿刺する注射針とは異なって、特にすでに形成された穿刺ルートの周壁が皮膚組織のように必ずしも均質でなく、固定ルートで刺入が簡単ながらも安易にルート周壁を削り取るような動きとなった場合に予期しない裂傷を招いてしまうおそれがあるゆえである。
そして、かかる微妙な要求性能に好適なのが合成樹脂製の穿刺ルート用穿刺針である。
【００１５】
すなわち、本発明穿刺ルートに沿って刺入が容易な穿刺針のもう一つの特長は、カヌラが合成樹脂材料によって成型されたものにおいて発揮される。
これは、合成樹脂材料であれば成型金型の設計や成型条件、樹脂材料の種類等の条件次第でカヌラの刃面先端や刃面の外周縁部に適度に鈍化させて成型でき、また合成樹脂材料製であることによって焼却処分が容易で廃棄物処理対策上取り扱いが簡単であるという特長もありきわめて有益である。
使用する合成樹脂材料の種類としては、ポリウレタン、ポリプロピレン、ポリカーボネート、ＡＢＳ樹脂、ポリエチレン、ポリテトラフルオロエチレン、ポリエーテルスルホン等が好適に使用される。なお、一般的な合成樹脂材料製の針径寸法としては、ステンレス鋼などの金属製の０．５〜１．８ｍｍφ（外径）程の針径寸法のものよりやや大きめの、０．８〜２．５ｍｍφ（外径）程度のものが好適に用いられる。
【００１６】
【発明の実施の形態】
次に、本発明の実施例について、図面を用いて説明する。
図１は、本発明の一実施例の要部を示す斜視図（先端側の斜め横方向から見た図）である。通常の穿刺針のカヌラは、図３に示すように、直線状のカヌラの先端に刃面を有しており、刃面の先端はカヌラの外周を通る長手軸（本発明以下の説明で偏心の程度を述べる‘基準軸’）と平行な線の上にある。
本発明の穿刺針は、従来の穿刺針とは異なり、図１に示すように、刃面先端が刃面１の先端１１とカヌラの中心軸２の最短距離がカヌラの半径より小さくなるように、カヌラの中心軸２の側に偏心されている。
【００１７】
刃面１はその先端１１が中心軸２の位置を超え偏心されていてもよく、刃面１の先端１１の位置は、好ましくは、カヌラ外周の屈曲点４を通る長手軸２と平行な線（基準線）３から１／８〜６／８（但しカヌラの直径を１とする）偏心されているのが良く、より好ましくは基準線３から２／８〜４／８偏心されているのが良い。また、カヌラに流入する血液の流量を十分に確保する（血流量が少なくならない様にする）ためには、刃面１が楕円形状に形成されている場合、刃面１の基端１２がカヌラの屈曲点４より基端側に位置しているのがよい。
図２に示す穿刺針は、刃面１の基端１２がカヌラの屈曲点４より先端側に位置するというものであり、この場合にはカヌラ先端の開口面積が小さくなるので、十分な血液流量の確保ができない。
また、刃面１の先端１１や外周縁部は、丸くするなど鋭利ではない状態にする（鈍化する）のが好ましい。
【００１８】
本実施形態例のカヌラはステンレス鋼等の金属で形成され、以下の試験例でも金属製カヌラによる刺入試験を行ったが、前述したように合成樹脂製でもよく、またカヌラの表面には抗血栓性材料や抗菌性材料をコーティングしてもよい。
さらに、本発明の穿刺針は、これを内針として可塑性合成樹脂からなる外針と組合せて、二重針とした形態の穿刺針でも用いることができる。
【００１９】
〔試験例〕
ステンレス鋼（ＳＵＳ３０４）製のカヌラで、表１に示すような、刃面の先端位置を基準線〔カヌラの刃面と反対側のカヌラ本体の外側面延長線〕からカヌラの中心軸側に偏心されている距離を変化させた各穿刺針（外径１．２４０ｍｍ、肉厚０．１５ｍｍ、長さ７２ｍｍ、刃面長４．１ｍｍ）のサンプル各３本を用意し、各サンプルについて固定穿刺ルートの刺入試験評価としてカヌラの直進性の評価を行ったところ、表２に示すような結果が得られた。
但し、刺入試験は、刺入対象サンプルにカヌラを垂直に立てて、カヌラ基端側から１．９６Ｎ（２００ｇｆ）の力で押し込み、刺入点を起点として刺入角度を測定することによって行った。なお、刺入対象のサンプルとしては、生の牛肉を肉厚０．３５μｍのポリエチレンチューブに詰め込んだものを使用した。
表２から、刃面先端の位置の偏心程度の違いにより、刺入角度のずれに大きな差が生じることが確認された。〔ＳＤ＝標準偏差値〕
【００２０】
【表１】
【表２】
【発明の効果】
以上述べたことから、本発明穿刺ルートに沿って刺入が容易な穿刺針は、筒状体の端部を斜めに横断するようにして刃面が形成された留置用穿刺針において、カヌラの刃面先端からカヌラの中心軸までの最短距離がカヌラの半径よりも小さくなるように、刃面先端がカヌラの中心軸の側に偏心されており、これによって穿刺の際の針管の管周囲には比較的均等な力がかかることから、穿刺針が固定されて形成された穿刺ルートに対して真っ直ぐに刺入できて好ましい。
【００２３】
そして本発明穿刺ルートに沿って刺入が容易な穿刺針において、その刃面先端の偏心の程度は、カヌラの刃面先端の位置がカヌラの刃面と反対側のカヌラ本体の外側面延長線（基準線）から１／８〜６／８偏心されているのが良く、さらに基準線から２／８〜４／８偏心されていると穿刺針の穿刺が穿刺ルートに対してほとんどずれずにほぼ真っ直ぐに刺入できて好ましい。
【００２４】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、カヌラの中心軸に対し前記基準線上にあるカヌラ側面の屈曲点と刃面先端とを結ぶ延長線がなす角度が１５°以上でかつ３０°内にあるのが好ましく、これによって固定された穿刺ルートに対する穿刺針の穿刺には好適条件での刃先角度が確保され、刃先角度が鋭過ぎて形成した穿刺ルートに沿わないで所望の穿刺部位からずれた部位へ向けて一気に穿刺してしまうのを避けることができ、かつ刃先角度が緩過ぎることで発生する穿刺の際のコアリング防止のために形成させた刃面による血管組織の損傷を招くこともない。
【００２５】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、刃面先端と反対側の刃面の端である刃面基端の位置を、前記屈曲点の位置よりもカヌラ本体側に位置させるものであり、この場合一般的に楕円形状に形成されている刃面の開口面積が十分とれることとなり、したがってカヌラに流出入する血液の流量を十分確保することができて好ましい。
【００２６】
また、本発明穿刺ルートに沿って刺入が容易な穿刺針は、刃面先端が鈍化されておればよく、これは本発明穿刺針はすでに一度形成されたホールに対して刺入される用途上必要以上に先端が鋭い必要はなく、先端が２０μｍ〜１００μｍの範囲にあれば、先端が鋭利になり過ぎて形成されたホール壁面を傷つけることもなく、また１００μｍを超えて血管への穿刺が容易でなくなることもない。
さらにまた、鈍化させておくのは刃面先端だけに限らず、刃面の外周縁部でも刺入時にコアリングを避けるために有効であり、概して約１μｍ，〜１００μｍの半径とするのが好適である。
【００２７】
そして、本発明穿刺ルートに沿って刺入が容易な穿刺針のもう一つの特長は、カヌラが合成樹脂材料によって成型されたものにおいて発揮される。
これは、合成樹脂材料であれば成型金型の設計や成型条件、樹脂材料の種類等の条件次第でカヌラの刃面先端や刃面の外周縁部に適度に鈍化させて成型でき、また合成樹脂材料製であることによって焼却処分が容易で廃棄物処理対策上取り扱いが簡単で、汚染を発生させない確実な処分ができてきわめて有益である。
【００２８】
以上のように、本発明を採用することにより、固定された穿刺ルートの穿刺という特有な用途に用いる穿刺針として、先に形成された穿刺ルートを損傷せずに穿刺ルートに沿って真っ直ぐに穿刺針を刺入できる。また、穿刺針の留置中にはその刃先で血管内壁を損傷することがない。
【図面の簡単な説明】
【図１】本発明の一実施例の要部を示すカヌラの正面図、側面図である。
【図２】刃面が偏心しているが刃面の基端がカヌラの屈曲点より先端側に位置する例の要部を示すカヌラの側面図である。
【図３】刃面が偏心していない従来の穿刺針の要部を示すカヌラの側面図である。
【符号の説明】
１ 刃面
１１ 先端
１２ 基端
２ （カヌラの）中心軸
３ 基準線
４ 屈曲点
５ カヌラの中心軸に対し、基準線３上の屈曲点４と刃面先端１１とを結ぶ延長線がなす角度[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a puncture needle used for purposes such as hemodialysis, continuous / intermittent drug administration, or intermittent blood sample collection, which can be inserted straight along the puncture route without damaging the fixed puncture route. The present invention relates to an insertable puncture needle.
[0002]
[Prior art]
For example, in the case of hemodialysis, a so-called winged indwelling needle in which a wing for fixing the human body is attached to a metal needle or an indwelling needle composed of a metal inner needle and a plastic outer needle has been used. Pain when puncturing this indwelling needle was an inevitable problem for the patient.
Then, in order to solve the above problem, the present applicant has already proposed an indwelling needle puncturing hole forming tool (see Patent Document 1). This indwelling needle puncture hole forming tool is to be left in the human body for several days to form a straight path from the skin surface to the blood vessel (referred to as a puncturing route). This has the advantage that the needle tip can be easily inserted into the punctured site, and the indwelling needle can be quickly inserted in the subsequent puncture.
[0003]
[Patent Document 1]
JP 2000-17609 A (paragraph number 0006-0011, FIG. 1)
[0004]
However, even if the puncture route is formed using the indwelling needle puncture hole forming tool as described above, if puncture is performed along the puncture route using a normal puncture needle, (1) the puncture needle If the tip is sharp, there is a risk of damaging the vicinity of the puncture route.
(2) The tissue on the inner wall of the blood vessel is damaged by the blade surface at the tip of the needle after the puncture of the puncture needle, which may cause a thrombus or an aneurysm to be generated. In order to solve such a problem, the present applicant has proposed an indwelling needle for dialysis in which at least 40% of the outer peripheral edge portion of the needle tip is polished and processed into a round shape. (See Patent Document 2).
[0005]
[Patent Document 2]
JP 2001-293085 A (paragraphs 0009-0014, 0022, FIGS. 3, 4, 5, 6)
[0006]
The use of the indwelling needle described in Patent Document 2 (1) does not require anesthesia since the indwelling needle has less pain when inserted into a blood vessel. (2) Hematoma generation is reduced.
(3) Infectious diseases are suppressed. (4) By securing a puncture route in advance, failure at the time of puncture can be prevented. And so on.
However, even when using the indwelling needle for dialysis as described above, a biased force is applied to the needle tube at the time of puncturing because the shape of the tip of the needle tube is not uniform around the tube obliquely crossing the cylindrical body. In particular, when inserting into a puncture route that is fixed and formed, since the peripheral wall of the route is not necessarily homogeneous like skin tissue, it cannot be pierced straight, but pierces diagonally, and therefore punctures. The vascular tissue may be damaged by the blade surface formed in order to prevent coring at the time, and the tip of a general puncture needle is elongated and sharp, and the desired puncture does not follow the puncture route formed preciously When a puncture needle is inserted out of the puncture route, it will not only damage the puncture route but also increase the puncture pain of the patient and form a fixed puncture route. Meaning there was a concern that disappears.
[0007]
[Problems to be solved by the invention]
The present invention has been made in view of such circumstances, and has as its object to provide a puncture needle that can be inserted straight along a puncture route formed without damaging a fixed puncture route. It is another object of the present invention to provide a puncture needle that does not damage the inner wall of a blood vessel with its cutting edge during placement.
[0008]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the present inventors have made intensive studies and found that the blade surface of the canula was eccentric to the central axis side of the canula, and the blade surface was viewed from the side of the tip (in a state where the canula was viewed from the side). The tip of the cannula should not be too flat or too sharp when penetrating the fixed puncture route, as long as the tip of the cannula is inside the outer peripheral wall of the cannula. It has been conceived that the angle formed by the outline of the bending line formed from the side wall opposite to the blade surface toward the tip of the surface with the central axis of the canula must have an appropriate angle, and the present invention completed.
[0009]
In other words, the puncture needle that can be easily inserted along the puncture route of the present invention is an indwelling puncture needle having a blade surface formed so as to obliquely cross the end of the cylindrical body, and has a cannula blade surface. The tip of the blade surface is eccentric to the central axis of the cannula so that the shortest distance from the distal end to the central axis of the cannula is smaller than the radius of the cannula. Since a relatively uniform force is applied to the puncture needle, it is preferable that the puncture needle can be inserted straight into a puncture route formed as a fixed one.
[0010]
In the puncture needle that can be easily inserted along the puncture route of the present invention, the degree of eccentricity of the tip of the blade surface is determined by the extension of the outer surface of the cannula main body at the position of the tip of the canula blade surface opposite to the canula blade surface. The eccentricity is preferably 1/8 to 6/8 eccentric from the (reference line), and more preferably 2/8 to 4/8 eccentric from the reference line.
Here, the reference line refers to an extension of the outer surface of the canula main body on the opposite side to the blade surface of the canula, and refers to a line parallel to the center line of the canula. In the following description of the present invention, the distance at which the position of the tip of the blade surface of the canula is eccentric from this reference line toward the central axis side of the canula is expressed as a ratio of the distance with the diameter of the canula being set to 1. .
[0011]
In addition, the puncture needle that can be easily inserted along the puncture route of the present invention has an angle of 15 ° with respect to the central axis of the canula, which is an extension line connecting the bending start point of the canula side surface on the reference line and the tip of the blade surface. As described above, it is preferable that the angle is within 30 °, and a blood vessel is formed by a blade surface formed to prevent coring at the time of puncturing by securing a certain angle of the blade edge with respect to the puncturing route fixed and formed. It is possible to prevent the puncture from being performed at a stretch toward a site deviated from a desired puncture site without causing damage to the tissue and without following the puncture route formed with a sharp edge angle.
That is, if the angle formed by the extension line connecting the bend (start) point of the cannula side surface on the above-mentioned reference line and the tip of the blade surface is 15 ° or less, sharpness is given to the puncture needle more than necessary, and the puncture route is changed. It is difficult to control the puncture along the puncture, and when the angle is 30 ° or more, the blade surface advances so as to rub the side surface of the puncture route, and the vascular wall tissue is easily damaged by coring by the blade surface.
In the above description, the bending (starting) point of the canula side surface refers to a position (bending point) where bending starts from the canula side surface opposite to the blade surface toward the tip of the blade surface.
[0012]
In addition, in the puncture needle that can be easily inserted along the puncture route of the present invention, the position of the blade surface base end, which is the end of the blade surface opposite to the blade surface tip, is closer to the cannula main body than the position of the bending point. What is located.
This is because the blade surface is generally formed in an elliptical shape, and if the position of the base end of the blade surface is located further to the distal end side of the canula than the bending point of the canula, blood flowing into and out of the canula can be reduced. This is because the opening area for securing the flow rate is not sufficient and the blood flow rate is reduced.
[0013]
In addition, the puncture needle that can be easily inserted along the puncture route of the present invention has a blunted tip of the blade surface. Here, the term “dull” refers to a non-sharp state, and in the puncture needle of the present invention, the tip preferably has a radius of about 20 μm to 100 μm (more preferably 30 μm to 70 μm).
This is because the puncture needle of the present invention does not need to be sharpened unnecessarily because the puncture needle is used to pierce the hole that has already been formed. If the tip is less than 20 μm, the hole becomes too sharp and is formed unnecessarily. The wall surface may be damaged, and if it exceeds 100 μm, it becomes difficult to puncture the blood vessel.
[0014]
Further, the blunting is effective not only at the tip of the blade surface but also at the outer peripheral edge of the blade surface to avoid coring when the puncture needle is inserted. The dulling of the outer peripheral edge of the blade surface depends on the angle formed by the above-mentioned blade surface with respect to the central axis of the cannula, but it is generally preferable that the radius be about 1 μm to 100 μm.
The reason that moderate blunting is required at the outer peripheral edge of the blade surface together with the above-mentioned blade surface tip is different from a normal injection needle that punctures skin tissue, and in particular, the peripheral wall of the already formed puncture route has a peripheral wall of skin tissue. This is because, when the movement is not always homogeneous and the piercing is easily performed on the fixed route, but the root peripheral wall is easily scraped, an unexpected tear may be caused.
A puncture needle for a puncture route made of synthetic resin is suitable for such delicate performance requirements.
[0015]
That is, another feature of the puncture needle that can be easily inserted along the puncture route of the present invention is exhibited in a case where the cannula is molded from a synthetic resin material.
This means that if it is a synthetic resin material, it can be molded by appropriately dulling the tip of the blade surface of the cannula or the outer peripheral edge of the blade surface depending on the design of the mold, the molding conditions, the type of resin material, etc. Since it is made of a resin material, it can be incinerated easily and is easy to handle in terms of waste treatment measures, which is extremely useful.
As the type of synthetic resin material to be used, polyurethane, polypropylene, polycarbonate, ABS resin, polyethylene, polytetrafluoroethylene, polyether sulfone, and the like are suitably used. The needle diameter of a general synthetic resin material is 0.8 to 0.8 mm, which is slightly larger than that of a metal such as stainless steel having a needle diameter of about 0.5 to 1.8 mmφ (outer diameter). Those having a diameter of about 2.5 mm (outer diameter) are preferably used.
[0016]
BEST MODE FOR CARRYING OUT THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a perspective view showing a main part of one embodiment of the present invention (a view as viewed from an oblique lateral direction on the tip side). As shown in FIG. 3, the cannula of a normal puncture needle has a blade surface at the tip of a straight cannula, and the tip of the blade surface is a longitudinal axis passing through the outer periphery of the canula (eccentric in the following description of the present invention). Is on a line parallel to the 'reference axis').
The puncture needle of the present invention is different from the conventional puncture needle in that the shortest distance between the
[0017]
The blade surface 1 may have its
The puncture needle shown in FIG. 2 is such that the
Further, it is preferable that the
[0018]
The cannula of the present embodiment is formed of a metal such as stainless steel. In the following test examples, a penetration test was performed using a metal cannula. However, as described above, the cannula may be made of a synthetic resin. A thrombotic or antimicrobial material may be coated.
Further, the puncture needle of the present invention can be used as a puncture needle in the form of a double needle by combining this as an inner needle with an outer needle made of a plastic synthetic resin.
[0019]
(Test example)
A stainless steel (SUS304) cannula, as shown in Table 1, the tip position of the blade surface is eccentric from the reference line (extended line of the outer surface of the cannula body opposite to the cannula blade surface) to the central axis side of the cannula. Three samples of different puncture needles (outer diameter 1.240 mm, wall thickness 0.15 mm, length 72 mm, blade surface length 4.1 mm) with different distances are prepared, and a fixed puncture route is set for each sample. When the straightness of the canula was evaluated as an evaluation of the penetration test, the results shown in Table 2 were obtained.
However, the insertion test is performed by setting the cannula vertically on the sample to be inserted, pushing the cannula from the base end of the cannula with a force of 1.96 N (200 gf), and measuring the insertion angle with the insertion point as a starting point. Was. As a sample to be inserted, a raw beef packed in a 0.35 μm-thick polyethylene tube was used.
From Table 2, it was confirmed that the difference in the eccentricity of the position of the tip of the blade surface caused a large difference in the deviation of the insertion angle. [SD = standard deviation]
[0020]
[Table 1]
[Table 2]
【The invention's effect】
From the above description, the puncture needle that can be easily inserted along the puncture route of the present invention is an indwelling puncture needle in which the blade surface is formed so as to obliquely cross the end of the cylindrical body. The tip of the blade face is eccentric to the central axis of the canula so that the shortest distance from the tip of the blade face to the central axis of the cannula is smaller than the radius of the cannula, so that the tip end of the needle tube at the time of puncturing is eccentric. Since a relatively uniform force is applied to the puncture needle, it is preferable that the puncture needle can be inserted straight into a puncture route formed by fixing the puncture needle.
[0023]
In the puncture needle that can be easily inserted along the puncture route of the present invention, the degree of eccentricity of the tip of the blade surface is determined by the extension of the outer surface of the cannula main body at the position of the tip of the canula blade surface opposite to the canula blade surface. It is good to be eccentric from 1/8 to 6/8 from the (reference line), and if it is eccentric from 2/8 to 4/8 from the reference line, the puncture of the puncture needle hardly shifts with respect to the puncture route. It is preferable because it can be inserted almost straight.
[0024]
In addition, the puncture needle that can be easily inserted along the puncture route of the present invention has an angle formed by an extension line connecting the bending point of the cannula side surface on the reference line and the tip of the blade surface with respect to the central axis of the cannula is 15 ° or more. It is preferable that the angle is within 30 °, so that the puncture needle can puncture the fixed puncture route with a suitable cutting edge angle under suitable conditions, and the cutting edge angle is too sharp to follow the puncturing route formed. Vessel tissue formed by a blade surface formed to prevent puncturing at a stretch from the puncture site of the puncture site, and to prevent coring at the time of puncture caused by too small a blade edge angle It does not cause any damage.
[0025]
In addition, the puncture needle that can be easily inserted along the puncture route of the present invention moves the position of the blade surface base end, which is the end of the blade surface opposite to the blade surface tip, to the cannula main body side from the position of the bending point. In this case, the opening area of the blade surface generally formed in an elliptical shape is sufficient, and therefore, it is preferable because a sufficient flow rate of blood flowing into and out of the cannula can be secured.
[0026]
In addition, a puncture needle that can be easily inserted along the puncture route of the present invention may have a blunt tip of the blade surface. This is because the puncture needle of the present invention can be inserted into a hole that has already been formed once. It is not necessary that the tip is sharper than necessary, and if the tip is in the range of 20 μm to 100 μm, the tip will not be too sharp and will not damage the formed hole wall surface. It is not easy.
Further, the dulling is not limited to the tip of the blade surface, but is effective for avoiding coring at the time of insertion even at the outer peripheral edge of the blade surface. Generally, the radius is preferably about 1 μm and about 100 μm. It is.
[0027]
Another feature of the puncture needle that can be easily inserted along the puncture route of the present invention is exhibited in the case where the cannula is molded from a synthetic resin material.
This means that if it is a synthetic resin material, it can be molded by appropriately dulling the tip of the blade surface of the cannula or the outer peripheral edge of the blade surface depending on the design of the mold, the molding conditions, the type of resin material, etc. Since it is made of a resin material, incineration is easy, handling is easy in terms of waste disposal measures, and it is extremely useful because it can be securely disposed without causing contamination.
[0028]
As described above, by adopting the present invention, a puncture needle used for a specific application of puncturing a fixed puncture route can be punctured straight along the puncture route without damaging the previously formed puncture route. A needle can be inserted. Also, during placement of the puncture needle, the inner edge of the blood vessel is not damaged by the cutting edge.
[Brief description of the drawings]
FIG. 1 is a front view and a side view of a cannula showing a main part of an embodiment of the present invention.
FIG. 2 is a side view of a canula showing an essential part of an example in which the blade face is eccentric but the base end of the blade face is located on the distal side from the bending point of the canula.
FIG. 3 is a side view of a cannula showing a main part of a conventional puncture needle whose blade surface is not eccentric.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1
Claims (7)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2003161594A JP2004358016A (en) | 2003-06-06 | 2003-06-06 | Puncture needle for easy insertion along the puncture route |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2003161594A JP2004358016A (en) | 2003-06-06 | 2003-06-06 | Puncture needle for easy insertion along the puncture route |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2004358016A true JP2004358016A (en) | 2004-12-24 |
Family
ID=34053966
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2003161594A Pending JP2004358016A (en) | 2003-06-06 | 2003-06-06 | Puncture needle for easy insertion along the puncture route |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2004358016A (en) |
Cited By (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007296280A (en) * | 2006-04-27 | 2007-11-15 | River Seiko:Kk | Endoscopic syringe |
| JP2011250999A (en) * | 2010-06-02 | 2011-12-15 | Asahi Kasei Kuraray Medical Co Ltd | Puncture needle and blood vessel surface incisura formation instrument |
| JP2014200551A (en) * | 2013-04-08 | 2014-10-27 | オリンパス株式会社 | Puncture needle |
| JP2015009104A (en) * | 2013-07-02 | 2015-01-19 | 旭化成メディカル株式会社 | Needle |
| JP5656846B2 (en) * | 2009-09-08 | 2015-01-21 | テルモ株式会社 | Mixing device and double needle insertion method |
| KR101537185B1 (en) * | 2014-02-17 | 2015-07-15 | 김경균 | Medicial injection syringe and |
| JP2016187395A (en) * | 2015-03-30 | 2016-11-04 | 大日本印刷株式会社 | Needle-like member and puncture instrument |
| CN109674497A (en) * | 2018-11-22 | 2019-04-26 | 贝普医疗科技有限公司 | A kind of needle tubing for sunkening cord |
| CN110354334A (en) * | 2019-07-24 | 2019-10-22 | 河南曙光汇知康生物科技股份有限公司 | Transfusion port puncture needle head and its manufactured transfusion port puncture needle |
| JP2022514818A (en) * | 2018-12-21 | 2022-02-16 | アボット ダイアベティス ケア インコーポレイテッド | Systems, devices, and methods for insertion of analyte sensors |
| US12239463B2 (en) | 2020-08-31 | 2025-03-04 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte sensor insertion |
| US12268496B2 (en) | 2017-01-23 | 2025-04-08 | Abbott Diabetes Care Inc. | Systems, devices and methods for analyte sensor insertion |
| US12274548B2 (en) | 2006-10-23 | 2025-04-15 | Abbott Diabetes Care Inc. | Sensor insertion devices and methods of use |
| US12408847B2 (en) | 2018-06-07 | 2025-09-09 | Abbott Diabetes Care Inc. | Focused sterilization and sterilized sub-assemblies for analyte monitoring systems |
| US12558122B2 (en) | 2010-03-24 | 2026-02-24 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| US12569173B2 (en) | 2009-02-03 | 2026-03-10 | Abbott Diabetes Care Inc. | Analyte sensor and apparatus for insertion of the sensor |
| US12569168B2 (en) | 2020-09-15 | 2026-03-10 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
| US12576599B2 (en) | 2020-09-15 | 2026-03-17 | Abbott Diabetes Care Inc. | Systems, devices, and methods for an analyte sensor |
| US12582334B2 (en) | 2011-12-11 | 2026-03-24 | Abbott Diabetes Care Inc. | Analyte sensor devices, connections, and methods |
| US12599317B2 (en) | 2015-05-14 | 2026-04-14 | Abbott Diabetes Care Inc. | Compact medical device inserters and related systems and methods |
| US12611121B2 (en) | 2021-07-16 | 2026-04-28 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
| US12616396B2 (en) | 2021-11-19 | 2026-05-05 | Abbott Diabetes Care Inc. | Analyte sensor devices, connections, and methods |
-
2003
- 2003-06-06 JP JP2003161594A patent/JP2004358016A/en active Pending
Cited By (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007296280A (en) * | 2006-04-27 | 2007-11-15 | River Seiko:Kk | Endoscopic syringe |
| US12274548B2 (en) | 2006-10-23 | 2025-04-15 | Abbott Diabetes Care Inc. | Sensor insertion devices and methods of use |
| US12611125B2 (en) | 2006-10-23 | 2026-04-28 | Abbott Diabetes Care Inc. | Sensor insertion devices and methods of use |
| US12569173B2 (en) | 2009-02-03 | 2026-03-10 | Abbott Diabetes Care Inc. | Analyte sensor and apparatus for insertion of the sensor |
| JP5656846B2 (en) * | 2009-09-08 | 2015-01-21 | テルモ株式会社 | Mixing device and double needle insertion method |
| US12558122B2 (en) | 2010-03-24 | 2026-02-24 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| US12575856B2 (en) | 2010-03-24 | 2026-03-17 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| US12588928B2 (en) | 2010-03-24 | 2026-03-31 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| US12605186B2 (en) | 2010-03-24 | 2026-04-21 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| US12605185B2 (en) | 2010-03-24 | 2026-04-21 | Abbott Diabetes Care Inc. | Medical device inserters and processes of inserting and using medical devices |
| JP2011250999A (en) * | 2010-06-02 | 2011-12-15 | Asahi Kasei Kuraray Medical Co Ltd | Puncture needle and blood vessel surface incisura formation instrument |
| US12582334B2 (en) | 2011-12-11 | 2026-03-24 | Abbott Diabetes Care Inc. | Analyte sensor devices, connections, and methods |
| JP2014200551A (en) * | 2013-04-08 | 2014-10-27 | オリンパス株式会社 | Puncture needle |
| JP2015009104A (en) * | 2013-07-02 | 2015-01-19 | 旭化成メディカル株式会社 | Needle |
| KR101537185B1 (en) * | 2014-02-17 | 2015-07-15 | 김경균 | Medicial injection syringe and |
| JP2016187395A (en) * | 2015-03-30 | 2016-11-04 | 大日本印刷株式会社 | Needle-like member and puncture instrument |
| US12599317B2 (en) | 2015-05-14 | 2026-04-14 | Abbott Diabetes Care Inc. | Compact medical device inserters and related systems and methods |
| US12495993B2 (en) | 2017-01-23 | 2025-12-16 | Abbott Diabetes Care Inc. | Systems, devices and methods for analyte sensor insertion |
| US12268496B2 (en) | 2017-01-23 | 2025-04-08 | Abbott Diabetes Care Inc. | Systems, devices and methods for analyte sensor insertion |
| US12569166B2 (en) | 2017-01-23 | 2026-03-10 | Abbott Diabetes Care Inc. | Systems, devices and methods for analyte sensor insertion |
| US12408847B2 (en) | 2018-06-07 | 2025-09-09 | Abbott Diabetes Care Inc. | Focused sterilization and sterilized sub-assemblies for analyte monitoring systems |
| CN109674497A (en) * | 2018-11-22 | 2019-04-26 | 贝普医疗科技有限公司 | A kind of needle tubing for sunkening cord |
| US12521041B2 (en) | 2018-12-21 | 2026-01-13 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte sensor insertion |
| JP7449289B2 (en) | 2018-12-21 | 2024-03-13 | アボット ダイアベティス ケア インコーポレイテッド | Systems, devices, and methods for insertion of analyte sensors |
| JP2022514818A (en) * | 2018-12-21 | 2022-02-16 | アボット ダイアベティス ケア インコーポレイテッド | Systems, devices, and methods for insertion of analyte sensors |
| US12616395B2 (en) | 2019-01-03 | 2026-05-05 | Abbott Diabetes Care Inc. | Systems, devices, and methods for assembling an applicator and sensor control device |
| CN110354334A (en) * | 2019-07-24 | 2019-10-22 | 河南曙光汇知康生物科技股份有限公司 | Transfusion port puncture needle head and its manufactured transfusion port puncture needle |
| US12239463B2 (en) | 2020-08-31 | 2025-03-04 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte sensor insertion |
| US12576599B2 (en) | 2020-09-15 | 2026-03-17 | Abbott Diabetes Care Inc. | Systems, devices, and methods for an analyte sensor |
| US12569168B2 (en) | 2020-09-15 | 2026-03-10 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
| US12611121B2 (en) | 2021-07-16 | 2026-04-28 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
| US12616396B2 (en) | 2021-11-19 | 2026-05-05 | Abbott Diabetes Care Inc. | Analyte sensor devices, connections, and methods |
| US12616397B2 (en) | 2022-03-16 | 2026-05-05 | Abbott Diabetes Care Inc. | Analyte sensor devices, connections, and methods |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2004358016A (en) | Puncture needle for easy insertion along the puncture route | |
| JP7337046B2 (en) | needle and catheterization devices | |
| US20020177864A1 (en) | Vascular needle | |
| US4889529A (en) | Needle | |
| US4826492A (en) | Medical probe | |
| US20200008838A1 (en) | An implant needle | |
| WO2002078772A1 (en) | Medical syringe, and method of producing the same | |
| JPS60194961A (en) | Diagnostic syringe needle | |
| JPS5875541A (en) | Trocar needle | |
| JPS633625B2 (en) | ||
| JP2001293085A (en) | Indwelling needle for dialysis | |
| CN114504700A (en) | Puncture needle and catheter assembly | |
| JP2011250999A (en) | Puncture needle and blood vessel surface incisura formation instrument | |
| US20050010178A1 (en) | Expandable penetrating needle and method of use | |
| JP2004057516A (en) | Double needle assembly | |
| US20160361086A1 (en) | Medical Instrument for Insertion into a Body Region of a Subject | |
| JP2008229371A (en) | Indwelling needle for dialysis | |
| JP5687439B2 (en) | needle | |
| JP3030963U (en) | Needle without free piece formation at puncture site | |
| JP4997456B2 (en) | Endoscopic syringe | |
| JP2004248694A (en) | Medical needle | |
| JP2022006616A (en) | Puncture needle | |
| CN222968631U (en) | Puncture needles and interventional devices | |
| JP6332786B2 (en) | Medical needle and puncture device | |
| CN219147792U (en) | Tenosynovitis minimally invasive surgical knife |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20060127 |
|
| A977 | Report on retrieval |
Free format text: JAPANESE INTERMEDIATE CODE: A971007 Effective date: 20080521 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20080526 |
|
| RD02 | Notification of acceptance of power of attorney |
Free format text: JAPANESE INTERMEDIATE CODE: A7422 Effective date: 20080630 |
|
| A521 | Written amendment |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20080722 |
|
| A521 | Written amendment |
Free format text: JAPANESE INTERMEDIATE CODE: A821 Effective date: 20080630 |
|
| A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20090203 |