JPH0246221B2 - - Google Patents

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Publication number
JPH0246221B2
JPH0246221B2 JP55043001A JP4300180A JPH0246221B2 JP H0246221 B2 JPH0246221 B2 JP H0246221B2 JP 55043001 A JP55043001 A JP 55043001A JP 4300180 A JP4300180 A JP 4300180A JP H0246221 B2 JPH0246221 B2 JP H0246221B2
Authority
JP
Japan
Prior art keywords
inner needle
tube
catheter
hub
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.)
Expired - Lifetime
Application number
JP55043001A
Other languages
Japanese (ja)
Other versions
JPS56139762A (en
Inventor
Hisata Sakae
Susumu Tanabe
Hiroshi Kamogawa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP4300180A priority Critical patent/JPS56139762A/en
Publication of JPS56139762A publication Critical patent/JPS56139762A/en
Publication of JPH0246221B2 publication Critical patent/JPH0246221B2/ja
Granted legal-status Critical Current

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Description

【発明の詳細な説明】[Detailed description of the invention]

この発明は血液を体外循環せしめ、血液の連続
モニタリングや連続血液分画、さらには人工腎臓
あるいは人工肺等の人工臓器によつて患者の血液
を浄化する際に、患者からの血液の吸引、返還等
をおこなうため血管内に穿刺固定される血管内留
置カテーテルに関する。 たとえば現在一般におこなわれている人工腎臓
による血液透析は、患者の動脈化静脈にそれぞれ
別個に2本の針を留置して吸引と返還をおこな
う。このように2個所に針を穿刺することは患者
への負担が大きく、またシヤント寿命の短縮を招
くなど必ずしも満足なものではない。そのため、
二重管構造のカテーテルを用いて血液の吸引と返
還を同時におこなう方法が開発され有望視されて
いる。この二重管構造のカテーテルは、一般にカ
テーテルチユーブを血管内に導くための内針を挿
通させる内側チユーブと、該内側チユーブの外側
に環状通路を形成する外側チユーブとからなる二
重管構造のカテーテルチユーブをハブに接続させ
たものであつて、上記環状通路の先端部分にて該
通路と連通する側孔を外側チユーブに設けてなる
ものである。 しかし、従来のこの種のカテーテルは内針の刃
面を上向きにしたとき外側チユーブの頂部および
底部、さらに左右側面にそれぞれ1個ないしそれ
以上設けたものが用いられていた。 このような側孔を有するカテーテルを用いて血
管を穿刺する場合、穿刺抵抗が増大し、穿刺痛を
増大させたり、しばしば穿刺を断念し、穿刺を繰
り返さざるを得ない場合があつたり、又、側孔の
破損や、血液循環したとき吸引側にあたる側孔部
が血管内壁と接近し、血管内壁面と側孔とが密着
し、側孔を閉塞させることがある等の問題があつ
た。 この発明は上記事情に鑑みてなされたものであ
つて、穿刺抵抗が比較的小さく、穿刺痛をやわら
げることができ側孔の破損、留置における血管内
壁との密着を防止し得る血管内留置カテーテルを
提供するものである。 上記目的を達成するものは、基端に内針ハブを
備えてなる内針と、少なくとも先端において、該
内針をその外周面と密接するようにして挿通させ
る内側通路を形成する内側チユーブと、該内側チ
ユーブの外側に環状通路を形成するとともに、先
端が前記内側チユーブに固着された外側チユーブ
と、該外側チユーブの先端部に設けられた前記環
状通路と外部とを連通する1以上の側孔とを有す
る可撓性カテーテルチユーブと、該カテーテルチ
ユーブの基端に取り付けられたカテーテルハブと
を備えた血管内留置カテーテルであつて、該血管
内留置カテーテルは、前記カテーテルハブと内針
ハブに、互いに係合する廻り止め機構を有し、該
廻り止め機構により内針が固定された状態で、挿
通された内針の軸を水平とし、内針刃面の先端を
真下に位置するようにし、内針刃面を上向きとな
るようにしたとき、前記カテーテルチユーブに
は、内針の軸と直交するカテーテル断面におけ
る、外側チユーブの円弧最頂部を基点として内針
の中心から左右30゜の範囲に入らない位置に前記
側孔のすべてが設けられている血管内留置カテー
テルである。さらに、前記側孔の中心の位置は、
前記円弧の最頂部を基点として内針の中心から左
右90゜以上の範囲内となる位置に設けられている
ことが好ましい。さらに、前記側孔は、前記内針
の刃面が上向きとなつている状態において、前記
環状通路の先端部に該当する位置であつて、前記
外側チユーブの左右側面に各1個、真下となる位
置に複数個設けられていることが好ましい。 以下、本発明の血管内留置カテーテルを図面に
示した実施例を用いて説明する。 本発明の血管内留置カテーテルは、基端に内針
ハブ20を備えてなる内針9と、この内針9をそ
の外周面と密接するようにして挿通させる内側通
路を形成した内側チユーブ11と、内側チユーブ
11の外側に環状通路を形成する外側チユーブ1
7とを有し、さらに外側チユーブ17の先端部に
環状通路15と外部とを連通する1以上の側孔3
1が穿設された可撓性カテーテルチユーブ7と、
カテーテルチユーブ7の基端に取り付けられたカ
テーテルハブを有している。そして、この血管内
留置カテーテルは、カテーテルハブ、と内針ハブ
20に互いに係合する廻り止め機構を有してお
り、この廻り止め機構により内針が固定された状
態となるように構成されている。具体的に説明す
ると、第1図は本発明に係わる血管内留置カテー
テルの一例を示すものであつて、分岐管1を有す
るポリカーボネート樹脂などからなり射出成形で
作られた外側ハブ3と、該ハブ3の先端部にロー
ト状に加工した基端が外側カシメハブ4とともに
取着され、他端がテーパ状尖端5を形成してなる
カテーテルチユーブ7とからなり、これら外側ハ
ブ3およびカテーテルチユーブ7の軸芯を通つて
ステンレススチール製の内針9が挿通されるよう
になつている。すなわち、カテーテルチユーブ7
は18G程度の内針9を挿通させる内側通路13
を形成する内側チユーブ11(たとえば外径1.53
mm、内径1.33mm)とその外側に同芯的に配設さ
れ、ふつそ樹脂もしくはX線不透過剤入りふつそ
樹脂等からなり押し出し成形でつくられた内側チ
ユーブ11との間に環状通路15を形成するふつ
そ樹脂もしくはX線不透過剤入りふつそ樹脂等か
らなり押し出し成形でつくられた例えば外径2.43
mm、内径2.03mmの外側チユーブ17とからなつて
いる。さらに該外側チユーブ17と該内側チユー
ブ11は熱型により先端部で溶融合体しテーパー
状尖端を持つ内側通路13、環状通路15を有す
るカテーテルチユーブ7を形成している。上記内
側通路13は分岐管1を越えた位置にまで延びて
いる内側チユーブがその端部をロート状に加工し
内側カシメハブ12とともに内側ハブ10の先端
部に固着されることにより内側ハブ10の軸芯通
路19と連通している。他方、環状通路15は分
岐管1の前方の外側ハブ3に取付部をロート状に
加工した外側チユーブ17の基端が外側カシメハ
ブ4とともに固着され分岐管1と連通している。
この環状通路15の先端はカテーテルチユーブ7
の先端を構成するテーパー状尖端5の開始部で前
述の如く該外側チユーブ17と該内側チユーブ1
1と溶融合体される事により止つている。 なお、内側チユーブ11および外側チユーブ1
7のそれぞれのハブ10,3への固着法は必ずし
もカシメによるものでなく、エポキシ樹脂等によ
る接着法もしくはインサート成形等によるもので
も良い。したがつてハブ10及び3は一体であつ
てもよい。ここで、内側ハブ10と外側ハブ3を
併せてカテーテルハブと呼ぶ。またカテーテル7
の先端部5においても全く別部材を溶融もしくは
接着等により外側チユーブ17、内側チユーブ1
1に固着するが、チユーブ17,11を最先端部
で溶融成形し、形成された先端部のポケツト部を
他もしくは同一の部材である程度充填固着してな
るものでもよい。 図中20は内針9の基端を固定する内針ハブで
あつて、ポリメチルペンテン、ポリプロピレンな
ど透明もしくは半透明の熱可塑性樹脂で射出成型
されたもので一端が内側ハブ10の基端と嵌合
し、他端がたとえばポリ塩化ビニルからなり2.5μ
の孔径の、またはポリエチレン等を焼結させた、
空気など気体を透過し血液を通さない撥水性フイ
ルター21を設けたキヤツプ23と嵌合し得るよ
うになつている。 尚、第10図に示す様に内側ハブ10にはスト
ツパ受37を一体的に設け内針ハブ20には杆状
体からなるストツパ39が内針9と平行にその内
針9の先端側に向けて突出する状態に取り付ける
ことは好ましい。つまり、内針9をカテーテルチ
ユーブに差し込んだ時、そのストツパ39の先端
がストツパ受37に当り、内針9の先端が刃面の
分だけカテーテルチユーブの先端から突出するよ
うに、内針9のカテーテルチユーブに対する挿入
深さを設定する様に形成する。 ストツパ受37の孔部41にストツパ39の先
端が嵌入する為、ストツパ39の位置が定まり、
従つて、内針ハブ20の回転が阻止される為、内
針9の刃面の向きと後述するカテーテルチユーブ
に設けられた側孔31の位置関係が定まる。スト
ツパー39は内針ハブ20と一体成形にてなるも
のでも良い。更には上記目的の為、ストツパ39
がある程度の長さ自由に移動可能でカテーテル先
端と内針先端との距離調整をした後それにあわせ
てストツパ39を内針ハブ20に固着できる様第
10図の如く接着部を内針ハブ20の後部に設け
エポキシ等で固着するのが望ましい。また内針9
の刃面の向きと、側孔31の位置関係を定める手
段としては、上述した手段の他に、内針ハブ20
を挿入するところの内側ハブ10の基端部内周面
に軸方向に沿う複数の廻り止めリブを等間隔に形
成し、内針ハブ20の先端外周面(ハブ3に挿入
される部分)にも、内側ハブ10の基端と嵌合し
た時内針刃面の向きと側孔31の位置関係がずれ
ない様に、複数個等間隔で形成するようにしても
よい。あるいは内側ハブ10の基端部内周面もし
くは外周面に軸方向に沿う凹部を1ケ所形成し、
これに嵌合するように内針ハブ20の先端外周面
に突出部を1ケ所形成してもよい。また、分岐管
1の先端は軟質塩化ビニールなどで押出成形され
た柔軟なチユーブ25を介してポリカーボネート
樹脂などで射出成形されたコネクター27が設け
られていて、このコネクター27の開口部にはポ
リプロピレンなどでつくられたキヤツプ29又は
血液循還回路の接続端子(図示しない)と適宜連
結し得るようになつている。 外側チユーブ17の先端のテーパー部5のテー
パー開始部には複数個の側孔31が設けられてい
て、環状通路15と連通している。 次に上記血管内留置カテーテルの使用方法を説
明する。フイルター21を設けたキヤツプ23を
内針ハブ20の後端に嵌合した後、内針9をカテ
ーテルチユーブに挿入・組込み一体とする。この
時内針ハブ20と内側ハブ10が密に嵌合するの
でカテーテルチユーブと内針の刃面の向きは所定
の位置関係を保つことができる。尚、内側ハブ1
0にストツパ受を一体的に設け内針ハブ20に
は、杆状体からなるストツパ39を内針9と平行
にその内針の先端側に突出する状態に取りつけた
場合には内針9の刃先が内側通路13を通じてカ
テーテルチユーブの先端から突出する状態になつ
たところでストツパ39の先端がストツパ受37
に当り、その位置に止まる。又、その時ストツパ
受37の孔部41にストツパ39の先端が嵌め込
まれる為、内針ハブ20の回転が阻止されると共
に内針9のの先端刃面の向きが所定の向きとな
る。従つて、内針9の刃面の向きが内側ハブ10
や、側孔31に対して所定の位置関係となる。
又、上述した他の廻り止め機構によつても同様に
刃面の向きを側孔31に対し所定の位置関係を保
つことができる。次に、血管内留置カテーテルを
血管に刺通する時は上記内針9の先端露出部分を
血管に突き刺す。この時内針9の刺通方向は液の
再循環の可能性を少なくする為、外側通路より内
側通路に流れる時は、血液の流れ方向に向け、逆
に内側通路より外側通路に流れるときは血液の流
れと逆方向に向ける。そして完全に突き刺さる
と、その内針9内に血液が流れ込み内針ハブ20
内に達する。ここで上記内針ハブ20は透明もし
くは半透明であるから外から血液を容易に観察す
ることができる。これによつて内針9の先端部が
確実に血管内に位置しているか否かが確認できる
のである。この確認後、その内針9を案内として
カテーテルチユーブを押し込み、そのカテーテル
チユーブの先端にある側孔31が完全に血管内に
入り込ませるようにする。この時、側孔31は第
2図又は第3図に示す様に挿通された内針9の軸
を水平にし、内針刃面33の最尖端32が真下に
位置するようにし、内針刃面33を上向きにした
時、内針9の軸と直交するカテーテル断面におい
て外側チユーブ17の円弧最頂部に位置する区域
であつて、その最頂点aを基点として内針9の中
心bから左右30゜の範囲に入らない位置に設けら
れている。より好ましくは第4図に示す如く側孔
31の位置が上記円弧の最頂点aを基点として内
針9の中心bから左右90゜以上の範囲に入る部位
に側孔31が設けられ、更により好ましくは側孔
31の位置が内針刃面を上向きにしたとき、環状
通路の先端に該当する部分であつて外側チユーブ
の左右側面に各1個、真下に複数個の側孔が設け
られると穿刺抵抗が小さく、穿刺痛をやわらげる
ことができるし、側孔31の破損や循環の際、吸
引側にあたる側孔部が血管壁と接近しているため
に生ずる血管内壁との密着を防止し得る。又、テ
ーパー状尖端5は同一物質からなり一体的に成形
されているため、カテーテルを血管内に刺通した
場合にもカテーテルが表皮及び組織により内側に
圧迫変形することなく、円滑に挿入できる。 又、側孔31を通じて血液が環状通路15に入
り込むため、透明あるいは透明に近いカテーテル
チユーブを通じて血液の流入を確認できる。つい
で、ハブ10および3を指で軽く保持し、内針先
端がカテーテル内にかくれるまで内針9をゆつく
りと抜く。そしてそのまま徐々にカテーテルチユ
ーブを血管内へ必要長さだけ押し進め、血管を外
部より圧迫することにより止血し、血液のカテー
テル内流入を1時停止させたのち、内針9を抜き
取る。この後、空気の混入のないように注意しな
がら体外循環回路等をハブ10の後端開孔部に接
続し、そこで血管への圧迫を開放する。又、分岐
管1側についてはチユーブ25をクランプしてキ
ヤツプ29をはずし、血液環循回路などの他端を
コネクター27と空気の混入ないように接続す
る。そして、ポンプを徐々に回転させながら、常
法に基づいた体外循環手段で体外循環を開始す
る。 なお、外側通路に関しては空気の混入を防ぎ、
循環開始までの間、できるだけカテーテル内の血
液凝固の可能性を無くするためのプライミング操
作、すなわち、あらかじめ、キヤツプ29をとり
はずし、コネクター27よりヘパリン化生理食塩
水入りの注射筒にて、コネクター27内、チユー
ブ25内、分岐部1内、内側ハブ10内及び環状
通路15の全てに液を満たし、再びキヤツプ29
をするか、嵌子等でチユーブをクランプしておく
こともできる。 さらに、内針抜去時のハブ10からの血液流出
を血管への圧迫なしに防ぐため、内側ハブ10後
方に外力より閉塞可能な弾性チユーブ(図示しな
い)を設け、その末端には他回路接続のためのハ
ブ10′(図示しない)を設け、該チユーブをク
ランプすることにより、それを可能にすることが
望ましい。 全ての側孔31の位置は第2図に示すように挿
通された内針9の軸を水平にし、内針刃面33を
上向きにしたとき(刃面33の最尖端32を真下
に位置させたとき)、内針9の軸と直交するカテ
ーテル断面において、外側チユーブ17の円弧最
頂部に位置する区域であつて、その最頂点aを基
点として内針9の中心bから左右30゜(θ=30゜)
の範囲に入らない位置に設けることが好ましい。
又、側孔は第1図に示される様に少くとも1つ環
状通路の最先端に設けることは好ましい。側孔を
環状通路の最先端に設けないと側孔とテーパー状
尖端5との間の環状通路に血液が滞留し、血液凝
固をひきおこすおそれがあるからである。 このようにして、全ての側孔31を配設し、外
側ハブ3と内針ハブ20の嵌合が密に行なわれる
ので、内針9とカテーテル側孔の位置がずれない
様になつており、カテーテル穿刺時の穿刺抵抗の
著るしい減少および穿刺痛の軽減を図ることがで
き、側孔の破損、穿刺のやり直しを防止し得るこ
とが見出された。 さらに、第3,4図に示す如く側孔31の中心
位置は上記円弧の最頂点aを基点として内針9の
中心bから左右90゜以上の範囲に入る部位とした
時は更にカテーテル穿刺時の穿刺抵抗の減少がよ
り顕著となる。又、側孔の位置が内針刃面を上向
きにしたとき環状通路の先端に該当する部分であ
つて外側チユーブの左右側面に各1個、真下に複
数個の側孔が設けられている場合には、前述の場
合と比較し複数個の側孔が底部側に過度に集中し
ていないため側孔地域のチユーブ強度が前述の場
合より強く側孔による外表面の凹凸も集中してい
ないためより側孔部の破損も少ないなどの効果が
ある。 以上のことを証明する実験例についてつぎに説
明する。 まず、従来例に従い、内針9の刃面33を上向
きにしたとき、外側チユーブ17の頂部および底
部に該当する個所に側孔31をそれぞれ1個所。
さらに両側面に各1個所の合計4個を設けたもの
Aを用いて鹿皮35に穿刺した場合(第6図参
照)と、第3〜5図に示すように内針9の刃面3
3を上向きにしたとき、外側チユーブ17の底部
に該当する部分に相互に1.1mm離間させて2個所、
さらに両側面に各1個所の合計4個設けたもの
B、さらにこのサンプルBにおいて両側面の側孔
の中心を外側チユーブの円弧最頂点から左右90゜
以上の範囲に設けたものB′、さらにこのサンプ
ルBにおいて両側面の側孔31を第2図に示すよ
うに角度θ=30゜からちようど、外ずれる位置に
設けた以外はサンプルBと全く同一のサンプルC
を用いて鹿皮35内に穿刺した場合(第8図参
照)とで穿刺時の最大刺通抵抗値を測定した。 なお、この実験においては全て、、外側チユー
ブ17として内径2.03mm、外径2.43mmの弗素樹脂
製チユーブに、内径1.1mmの円形側孔31を設け
たものを用い、鹿皮として、湿潤鹿皮(厚さ0.54
mm)を用い、穿刺角度30゜、穿刺速度30mm/分で
穿刺をおこなつたものである。その結果を下記表
に示す。この表中の測定値はサンプル20個の平均
値である。側孔破損率はその発生%である。
This invention allows blood to be circulated extracorporeally, and is used for continuous blood monitoring, continuous blood fractionation, and for purifying the patient's blood using an artificial organ such as an artificial kidney or an artificial lung. The present invention relates to an intravascular indwelling catheter that is punctured and fixed in a blood vessel for purposes such as the following. For example, in the currently commonly performed hemodialysis using an artificial kidney, two needles are placed separately in each of the patient's arterial veins for suction and return. Puncturing the needle in two locations in this manner is not necessarily satisfactory, as it places a heavy burden on the patient and shortens the life of the shunt. Therefore,
A method of simultaneously suctioning and returning blood using a double-tube catheter has been developed and is viewed as promising. This double-tube structure catheter generally consists of an inner tube through which an inner needle is inserted to guide the catheter tube into the blood vessel, and an outer tube that forms an annular passage outside the inner tube. A tube is connected to a hub, and a side hole communicating with the annular passage is provided in the outer tube at the tip of the annular passage. However, in conventional catheters of this type, one or more needles were provided at the top and bottom of the outer tube, as well as on the left and right sides, when the blade surface of the inner needle was oriented upward. When puncturing a blood vessel using a catheter with such a side hole, puncture resistance increases, leading to increased puncture pain, and the patient often has no choice but to abandon the puncture and repeat the puncture. There have been problems such as damage to the side hole, and when blood circulates, the side hole on the suction side comes close to the inner wall of the blood vessel, causing the inner wall surface of the blood vessel and the side hole to come into close contact, causing the side hole to be occluded. This invention has been made in view of the above circumstances, and is an intravascular indwelling catheter that has relatively low puncture resistance, can alleviate puncture pain, and can prevent damage to the side hole and close contact with the inner wall of the blood vessel during indwelling. It provides: The above object is achieved by: an inner needle having an inner needle hub at its proximal end; an inner tube forming an inner passage through which the inner needle is inserted in close contact with its outer peripheral surface at least at the distal end; an outer tube that forms an annular passage outside the inner tube and has a distal end fixed to the inner tube; and one or more side holes provided at the distal end of the outer tube that communicate the annular passage with the outside. an intravascular indwelling catheter comprising: a flexible catheter tube having a flexible catheter tube; and a catheter hub attached to a proximal end of the catheter tube; It has a rotation prevention mechanism that engages with each other, and with the inner needle fixed by the rotation prevention mechanism, the axis of the inserted inner needle is horizontal, and the tip of the inner needle blade surface is positioned directly below, When the inner needle blade surface is facing upward, the catheter tube has a cross section in the catheter tube perpendicular to the axis of the inner needle, in a range of 30 degrees left and right from the center of the inner needle, with the top of the arc of the outer tube as the base point. This is an intravascular indwelling catheter in which all of the side holes are provided in positions that cannot be entered. Furthermore, the position of the center of the side hole is
It is preferable that the needle be provided at a position within a range of 90° or more left and right from the center of the inner needle with the apex of the circular arc as the base point. Furthermore, when the blade surface of the inner needle faces upward, the side holes are located at positions corresponding to the distal end of the annular passage, and are located directly below the left and right sides of the outer tube. It is preferable that a plurality of them be provided at one position. DESCRIPTION OF THE PREFERRED EMBODIMENTS The intravascular indwelling catheter of the present invention will be described below using embodiments shown in the drawings. The intravascular indwelling catheter of the present invention includes an inner needle 9 having an inner needle hub 20 at its proximal end, and an inner tube 11 forming an inner passage through which the inner needle 9 is inserted in close contact with its outer peripheral surface. , an outer tube 1 forming an annular passage outside the inner tube 11
7, and one or more side holes 3 at the tip of the outer tube 17 that communicate the annular passage 15 with the outside.
1, a flexible catheter tube 7 having a hole drilled therein;
It has a catheter hub attached to the proximal end of the catheter tube 7. This intravascular indwelling catheter has a rotation prevention mechanism that engages the catheter hub and the inner needle hub 20 with each other, and is configured such that the inner needle is fixed by this rotation prevention mechanism. There is. Specifically, FIG. 1 shows an example of an intravascular indwelling catheter according to the present invention, which includes an outer hub 3 made of polycarbonate resin or the like and made by injection molding and having a branch pipe 1, and the hub. A funnel-shaped proximal end is attached to the distal end of the catheter tube 7 along with an outer caulking hub 4, and the other end has a tapered tip 5.The axes of the outer hub 3 and the catheter tube 7 An inner needle 9 made of stainless steel is inserted through the core. That is, catheter tube 7
is an inner passage 13 through which an inner needle 9 of approximately 18G is inserted.
The inner tube 11 (for example, outer diameter 1.53
mm, inner diameter 1.33 mm) and an inner tube 11 which is arranged concentrically on the outside and is made of Futsuso resin or Futsuso resin containing an X-ray opaque agent and made by extrusion molding, and an annular passage 15. For example, an outer diameter of 2.43 made by extrusion molding is made of a futsuso resin that forms or a futsuso resin containing an X-ray opaque agent.
mm, and an outer tube 17 with an inner diameter of 2.03 mm. Furthermore, the outer tube 17 and the inner tube 11 are melted and fused at their distal ends by a heat mold to form a catheter tube 7 having an inner passage 13 having a tapered tip and an annular passage 15. The inner passage 13 is formed by forming an inner tube extending beyond the branch pipe 1 into a funnel shape at its end and fixing it to the tip of the inner hub 10 together with the inner caulking hub 12 so that the shaft of the inner hub 10 is formed. It communicates with the core passage 19. On the other hand, the annular passage 15 communicates with the branch pipe 1 by having the proximal end of an outer tube 17 having a funnel-shaped attachment portion fixed to the outer hub 3 in front of the branch pipe 1 together with the outer caulking hub 4 .
The tip of this annular passage 15 is the catheter tube 7.
At the beginning of the tapered point 5 constituting the tip of the outer tube 17 and the inner tube 1 as described above,
It is stopped by being fused with 1. In addition, the inner tube 11 and the outer tube 1
The method of fixing 7 to each hub 10, 3 is not necessarily by caulking, but may also be an adhesive method using epoxy resin or the like, insert molding, or the like. Therefore, the hubs 10 and 3 may be integral. Here, the inner hub 10 and the outer hub 3 are collectively referred to as a catheter hub. Also catheter 7
The outer tube 17 and the inner tube 1 are also formed by melting or gluing completely different materials at the tip 5 of
1, but the tubes 17 and 11 may be melt-molded at their distal ends, and the pockets of the formed distal ends may be filled and fixed to some extent with other or the same material. In the figure, reference numeral 20 denotes an inner needle hub for fixing the proximal end of the inner needle 9, which is injection molded from a transparent or translucent thermoplastic resin such as polymethylpentene or polypropylene. The other end is made of polyvinyl chloride and has a diameter of 2.5μ.
pore size, or sintered polyethylene, etc.
It can be fitted with a cap 23 provided with a water-repellent filter 21 that allows gases such as air to pass through but does not allow blood to pass through. As shown in FIG. 10, the inner hub 10 is integrally provided with a stopper receiver 37, and the inner needle hub 20 has a rod-like stopper 39 parallel to the inner needle 9 on the distal end side of the inner needle 9. It is preferable to attach it so that it protrudes toward the target. That is, when the inner needle 9 is inserted into the catheter tube, the tip of the stopper 39 hits the stopper receiver 37, and the inner needle 9 is inserted so that the tip of the inner needle 9 protrudes from the tip of the catheter tube by the blade surface. It is formed to set the insertion depth into the catheter tube. Since the tip of the stopper 39 fits into the hole 41 of the stopper receiver 37, the position of the stopper 39 is determined.
Therefore, since rotation of the inner needle hub 20 is prevented, the orientation of the blade surface of the inner needle 9 and the positional relationship between the side hole 31 provided in the catheter tube, which will be described later, are determined. The stopper 39 may be formed integrally with the inner needle hub 20. Furthermore, for the above purpose, stopper 39
After adjusting the distance between the catheter tip and the inner needle tip, the adhesive part is attached to the inner needle hub 20 as shown in FIG. 10 so that the stopper 39 can be fixed to the inner needle hub 20 accordingly. It is preferable to install it at the rear and fix it with epoxy or the like. Inner needle 9
In addition to the above-mentioned means, means for determining the direction of the blade surface and the positional relationship of the side hole 31 include the inner needle hub 20
A plurality of anti-rotation ribs are formed at equal intervals along the axial direction on the inner peripheral surface of the proximal end of the inner hub 10 where the needle is inserted, and also on the outer peripheral surface of the distal end of the inner needle hub 20 (the part inserted into the hub 3). A plurality of needles may be formed at equal intervals so that the orientation of the inner needle blade surface and the positional relationship of the side hole 31 do not deviate when the inner needle is fitted to the base end of the inner hub 10. Alternatively, one recess is formed along the axial direction on the inner circumferential surface or outer circumferential surface of the proximal end of the inner hub 10,
A protrusion may be formed at one location on the outer peripheral surface of the distal end of the inner needle hub 20 so as to fit therein. Further, the tip of the branch pipe 1 is provided with a connector 27 made of polycarbonate resin or the like by injection molding via a flexible tube 25 made of soft vinyl chloride or the like, and the opening of this connector 27 is made of polypropylene or the like. It can be appropriately connected to a cap 29 made of or a connection terminal (not shown) of a blood circulation circuit. A plurality of side holes 31 are provided at the taper start portion of the tapered portion 5 at the tip of the outer tube 17 and communicate with the annular passage 15 . Next, a method of using the above-mentioned intravascular indwelling catheter will be explained. After fitting the cap 23 provided with the filter 21 to the rear end of the inner needle hub 20, the inner needle 9 is inserted and assembled into the catheter tube. At this time, since the inner needle hub 20 and the inner hub 10 are tightly fitted, the orientations of the blade surfaces of the catheter tube and the inner needle can maintain a predetermined positional relationship. In addition, inner hub 1
If a stopper receiver is integrally provided on the inner needle hub 20 and a stopper 39 made of a rod-like body is attached to the inner needle hub 20 in parallel with the inner needle 9 so as to protrude toward the distal end of the inner needle, When the cutting edge protrudes from the distal end of the catheter tube through the inner passage 13, the distal end of the stopper 39 touches the stopper receiver 37.
It hits and stops in that position. Also, at this time, since the tip of the stopper 39 is fitted into the hole 41 of the stopper receiver 37, rotation of the inner needle hub 20 is prevented and the tip edge surface of the inner needle 9 is oriented in a predetermined direction. Therefore, the direction of the blade surface of the inner needle 9 is the inner hub 10.
, and has a predetermined positional relationship with respect to the side hole 31.
Further, the other rotation prevention mechanisms described above can similarly maintain the direction of the blade surface in a predetermined positional relationship with respect to the side hole 31. Next, when inserting the intravascular indwelling catheter into the blood vessel, the exposed tip portion of the inner needle 9 is inserted into the blood vessel. At this time, the insertion direction of the inner needle 9 is to reduce the possibility of recirculation of the fluid, so when the fluid flows from the outer passage to the inner passage, it is directed in the direction of blood flow, and when it flows from the inner passage to the outer passage, it is directed in the direction of blood flow. Aim in the opposite direction of blood flow. When it is completely penetrated, blood flows into the inner needle 9 and the inner needle hub 20
Reach within. Here, since the inner needle hub 20 is transparent or semi-transparent, blood can be easily observed from the outside. This makes it possible to confirm whether the tip of the inner needle 9 is reliably located within the blood vessel. After this confirmation, the catheter tube is pushed in using the inner needle 9 as a guide so that the side hole 31 at the tip of the catheter tube is completely inserted into the blood vessel. At this time, as shown in FIG. 2 or 3, the side hole 31 is such that the axis of the inserted inner needle 9 is horizontal, and the most pointed end 32 of the inner needle blade surface 33 is located directly below. When the surface 33 faces upward, it is the area located at the top of the arc of the outer tube 17 in the catheter cross section perpendicular to the axis of the inner needle 9, and extends 30 left and right from the center b of the inner needle 9 with the top a as the base point. It is located at a position that does not fall within the range of °. More preferably, as shown in FIG. 4, the side hole 31 is provided in a region where the position of the side hole 31 is within a range of 90 degrees or more from the left and right from the center b of the inner needle 9 with the apex a of the arc as the base point, and even more preferably. Preferably, the position of the side hole 31 is a portion corresponding to the tip of the annular passage when the inner needle blade surface faces upward, and one side hole each is provided on the left and right sides of the outer tube, and a plurality of side holes are provided directly below. The puncture resistance is small, which reduces puncture pain, and prevents close contact with the inner wall of the blood vessel, which occurs when the side hole 31 is damaged or during circulation because the side hole on the suction side is close to the blood vessel wall. obtain. Further, since the tapered tip 5 is made of the same material and integrally molded, even when the catheter is inserted into a blood vessel, the catheter can be inserted smoothly without being compressed and deformed inward by the epidermis and tissue. Furthermore, since blood enters the annular passage 15 through the side hole 31, the inflow of blood can be confirmed through the transparent or nearly transparent catheter tube. Next, hold the hubs 10 and 3 lightly with your fingers, and slowly pull out the inner needle 9 until the tip of the inner needle is hidden inside the catheter. Then, the catheter tube is gradually pushed into the blood vessel by the necessary length, and the blood vessel is compressed from the outside to stop the bleeding.After temporarily stopping the flow of blood into the catheter, the inner needle 9 is removed. Thereafter, an extracorporeal circulation circuit or the like is connected to the rear end opening of the hub 10, taking care not to introduce air, and the pressure on the blood vessel is released there. On the branch pipe 1 side, the tube 25 is clamped, the cap 29 is removed, and the other end of the blood circulation circuit is connected to the connector 27 in a manner that prevents air from entering. Then, while gradually rotating the pump, extracorporeal circulation is started using a conventional extracorporeal circulation means. In addition, regarding the outside passage, prevent air from entering.
Until the start of circulation, a priming operation is performed to eliminate the possibility of blood coagulation inside the catheter as much as possible. In other words, the cap 29 is removed in advance, and a syringe containing heparinized saline is inserted into the connector 27 from the connector 27. , the inside of the tube 25, the inside of the branch part 1, the inside of the inner hub 10, and the annular passage 15 are all filled with liquid, and the cap 29 is filled again.
Alternatively, you can clamp the tube with a forceps or the like. Furthermore, in order to prevent blood outflow from the hub 10 when the inner needle is removed without putting pressure on blood vessels, an elastic tube (not shown) that can be closed by external force is provided at the rear of the inner hub 10, and the end thereof is connected to other circuits. It is desirable to make this possible by providing a hub 10' (not shown) for clamping the tube. The positions of all the side holes 31 are as shown in FIG. In the cross section of the catheter perpendicular to the axis of the inner needle 9, this is the area located at the top of the arc of the outer tube 17, and is 30° left and right (θ =30°)
It is preferable to provide it at a position that does not fall within the range of .
Further, it is preferable that at least one side hole is provided at the leading end of the annular passage as shown in FIG. This is because if the side hole is not provided at the leading end of the annular passage, blood may accumulate in the annular passage between the side hole and the tapered tip 5, causing blood coagulation. In this way, all the side holes 31 are arranged and the outer hub 3 and the inner needle hub 20 are tightly fitted, so that the positions of the inner needle 9 and the catheter side hole do not shift. It has been found that puncture resistance and puncture pain during catheter puncture can be significantly reduced, and damage to the side hole and re-puncture can be prevented. Furthermore, as shown in FIGS. 3 and 4, when the center position of the side hole 31 is within a range of 90 degrees or more from the left and right from the center b of the inner needle 9 with the apex a of the circular arc as the base point, furthermore, when the catheter is punctured, The decrease in puncture resistance becomes more pronounced. In addition, when the position of the side hole corresponds to the tip of the annular passage when the inner needle blade surface is facing upward, and there is one side hole each on the left and right sides of the outer tube and multiple side holes directly below. Compared to the case described above, the tube strength in the side hole area is stronger than in the case described above because the multiple side holes are not concentrated excessively on the bottom side, and the irregularities on the outer surface due to the side holes are not concentrated. This has effects such as less damage to the side holes. Next, an experimental example to prove the above will be explained. First, according to the conventional example, when the blade surface 33 of the inner needle 9 is facing upward, one side hole 31 is formed at a location corresponding to the top and bottom of the outer tube 17.
Furthermore, when the deerskin 35 is punctured using the needle A, which has four punctures, one on each side (see Figure 6), and the blade surface 3 of the inner needle 9 as shown in Figures 3 to 5.
When 3 is facing upward, there are two places at a distance of 1.1 mm from each other at the bottom of the outer tube 17.
Furthermore, Sample B has four holes in total, one on each side, and Sample B has the center of the side holes on both sides within a range of 90 degrees or more from the top of the arc of the outer tube to the left and right, and Sample C is exactly the same as Sample B, except that the side holes 31 on both sides of Sample B were provided at positions just off the angle θ = 30° as shown in Figure 2.
The maximum puncture resistance value at the time of puncturing was measured when puncturing the inside of the deerskin 35 (see FIG. 8) using the following. In all experiments, a fluororesin tube with an inner diameter of 2.03 mm and an outer diameter of 2.43 mm was used as the outer tube 17, and a circular side hole 31 with an inner diameter of 1.1 mm was used. (thickness 0.54
The puncture was performed using a needle (mm) at a puncture angle of 30° and a puncture speed of 30 mm/min. The results are shown in the table below. The measured values in this table are the average values of 20 samples. The side hole failure rate is the percentage of occurrence.

【表】 上記表から実際よりやや過酷な条件で完全に破
損を生じないグループは無かつたが本試験結果よ
り側孔の位置によつてカテーテルの穿刺操作に大
きく影響を与えることが理解できよう。なお、サ
ンプルAの場合、第6図の如く穿刺時に頂部の側
孔31が被穿刺層にひつかかり穿刺を断念せざる
を得ない場合もあつた。 これらの実験等から、上述の如く側孔の位置を
適切に設けることによつて穿刺抵抗および穿刺痛
の低下、さらに側孔の破損防止等の効果を得るこ
とができるとともに血管内にカテーテルを留置し
た場合も側孔が真横から下部側にあれば第7図に
示すごとく側孔と血管壁が接近しすぎて血管壁が
吸引されて側孔が閉塞される可能性もほとんどな
いことが確認された。
[Table] From the table above, there was no group that did not completely break under conditions that were slightly harsher than the actual conditions, but from this test result it can be understood that the position of the side hole has a large effect on the catheter puncture operation. . In the case of sample A, as shown in FIG. 6, there were cases in which the side hole 31 at the top got caught in the layer to be punctured during puncturing, forcing the puncturing to be abandoned. These experiments have shown that by appropriately locating the side hole as described above, it is possible to reduce puncture resistance and puncture pain, and to prevent damage to the side hole. Even when indwelling, if the side hole is from the side to the bottom side, as shown in Figure 7, it is confirmed that there is almost no possibility that the side hole and the blood vessel wall will be too close and the blood vessel wall will be sucked and the side hole will be occluded. It was done.

【図面の簡単な説明】[Brief explanation of drawings]

第1図は本発説に係わる血管内留置カテーテル
の一例を示す断面図、第2図は第1図―線に
沿う断面図、第3図は本発明に係わる血管内留置
カテーテルのカテーテルチユーブ部の先端部を一
部切欠して示す側面図、第4図は第3図の―
線に沿う断面図、第5図は第3図の―線に沿
う断面図、第6図は従来の血管内留置カテーテル
の穿刺状態を示す側面図、第7図は従来の血管内
留置カテーテルの血管内留置状態を示す側面図、
第8図は本発明の血管内留置カテーテルの穿刺状
態を示す側面図、第9図は本発明の他の実施例の
要部の側断面図、第10図は本発明のさらに他の
実施例の要部の側面図である。 1……分岐管、3……外側ハブ、4……外側カ
シメハブ、5……テーパー状尖端、、7……カテ
ーテルチユーブ、9……内針、10……内側ハ
ブ、11……内側チユーブ、12……内側カシメ
ハブ、13……内側通路、15……環状通路、1
7……外側チユーブ、19……軸芯通路、20…
…内針ハブ、21……フイルター、23……キヤ
ツプ、25……チユーブ、27……コネクター、
29……キヤツプ、31……側孔、33……刃
面、35……鹿皮、37……ストツパ受、39…
…ストツパ、40……ストツパーカシメ部、4
0′……ストツパーカシメ部(接着剤)、41……
孔部。
FIG. 1 is a sectional view showing an example of an intravascular indwelling catheter according to the present invention, FIG. 2 is a sectional view taken along the line shown in FIG. 1, and FIG. 3 is a catheter tube portion of the intravascular indwelling catheter according to the present invention. Fig. 4 is a side view showing a partially cutaway tip of the
5 is a sectional view taken along line - in FIG. 3, FIG. 6 is a side view showing the puncture state of a conventional intravascular indwelling catheter, and FIG. 7 is a sectional view of a conventional intravascular indwelling catheter. A side view showing the intravascular indwelling state,
FIG. 8 is a side view showing the puncturing state of the intravascular indwelling catheter of the present invention, FIG. 9 is a side cross-sectional view of the main part of another embodiment of the present invention, and FIG. 10 is still another embodiment of the present invention. FIG. DESCRIPTION OF SYMBOLS 1... Branch tube, 3... Outer hub, 4... Outer caulking hub, 5... Tapered tip, 7... Catheter tube, 9... Inner needle, 10... Inner hub, 11... Inner tube, 12...Inner caulking hub, 13...Inner passage, 15...Annular passage, 1
7... Outer tube, 19... Shaft core passage, 20...
...Inner needle hub, 21...Filter, 23...Cap, 25...Tube, 27...Connector,
29...Cap, 31...Side hole, 33...Blade surface, 35...Deerskin, 37...Stopper holder, 39...
...Stopper, 40...Stopper caulking part, 4
0'... Stopper caulking part (adhesive), 41...
Hole.

Claims (1)

【特許請求の範囲】 1 基端に内針ハブを備えてなる内針と、少なく
とも先端において、該内針をその外周面と密接す
るようにして挿通させる内側通路を形成する内側
チユーブと、該内側チユーブの外側に環状通路を
形成するとともに、先端が前記内側チユーブに固
着された外側チユーブと、該外側チユーブの先端
部に設けられた前記環状通路と外部とを連通する
1以上の側孔とを有する可撓性カテーテルチユー
ブと、該カテーテルチユーブの基端に取り付けら
れたカテーテルハブとを備えた血管内留置カテー
テルであつて、該血管内留置カテーテルは、前記
カテーテルハブと内針ハブに、互いに係合する廻
り止め機構を有し、該廻り止め機構により内針が
固定された状態で、挿通された内針の軸を水平と
し、内針刃面の先端を真下に位置するようにし、
内針刃面を上向きとなるようにしたとき、前記カ
テーテルチユーブには、内針の軸と直交するカテ
ーテル断面における外側チユーブの円弧最頂部を
基点として、内針の中心から左右30゜の範囲に入
らない位置に前記側孔のすべてが設けられている
血管内留置カテーテル。 2 前記側孔の中心の位置は、前記円弧の最頂部
を基点として内針の中心から左右90゜以上の範囲
内となる位置に設けられている特許請求の範囲第
1項に記載の血管内留置カテーテル。 3 前記側孔は、前記内針の刃面が上向きとなつ
ている状態において、前記環状通路の先端部に該
当する位置であつて、前記外側チユーブの左右側
面に各1個、真下となる位置に複数個設けられて
いる特許請求の範囲第1項または第2項に記載の
血管内留置カテーテル。
[Scope of Claims] 1. An inner needle having an inner needle hub at its proximal end, an inner tube forming an inner passage through which the inner needle is inserted in close contact with its outer peripheral surface at least at its distal end; an outer tube that forms an annular passage outside the inner tube and has a distal end fixed to the inner tube; and one or more side holes provided at the distal end of the outer tube that communicate the annular passage with the outside. an intravascular indwelling catheter comprising: a flexible catheter tube having a flexible catheter tube; and a catheter hub attached to a proximal end of the catheter tube, the intravascular indwelling catheter having a It has an engaging detent mechanism, and with the inner needle fixed by the detent mechanism, the axis of the inserted inner needle is horizontal and the tip of the blade surface of the inner needle is positioned directly below,
When the inner needle blade surface is facing upward, the catheter tube has a needle in the range of 30 degrees left and right from the center of the inner needle, with the top of the arc of the outer tube in the catheter cross section perpendicular to the axis of the inner needle as the base point. An intravascular indwelling catheter in which all of the side holes are provided in positions that cannot be entered. 2. The intravascular device according to claim 1, wherein the center of the side hole is located within a range of 90° or more left and right from the center of the inner needle with the top of the circular arc as a base point. Indwelling catheter. 3. When the blade surface of the inner needle faces upward, the side holes are located at positions corresponding to the distal end of the annular passage, and one each on the left and right side surfaces of the outer tube, and directly below the outer tube. The intravascular indwelling catheter according to claim 1 or 2, wherein a plurality of intravascular indwelling catheters are provided.
JP4300180A 1980-04-02 1980-04-02 Catheter detained in blood vessel Granted JPS56139762A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP4300180A JPS56139762A (en) 1980-04-02 1980-04-02 Catheter detained in blood vessel

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP4300180A JPS56139762A (en) 1980-04-02 1980-04-02 Catheter detained in blood vessel

Publications (2)

Publication Number Publication Date
JPS56139762A JPS56139762A (en) 1981-10-31
JPH0246221B2 true JPH0246221B2 (en) 1990-10-15

Family

ID=12651761

Family Applications (1)

Application Number Title Priority Date Filing Date
JP4300180A Granted JPS56139762A (en) 1980-04-02 1980-04-02 Catheter detained in blood vessel

Country Status (1)

Country Link
JP (1) JPS56139762A (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60212170A (en) * 1984-04-05 1985-10-24 バス・カス・オブ・カナダ・リミテツド Improved cannula
US5108366A (en) * 1990-09-28 1992-04-28 Ovamed Corporation Delivery catheter
JPH04219239A (en) * 1990-12-19 1992-08-10 Sumitomo Bakelite Co Ltd Laminated high-design sheet
JP5528519B2 (en) * 2012-09-28 2014-06-25 日機装株式会社 Indwelling needle for extracorporeal circulation
JP6344944B2 (en) * 2014-03-28 2018-06-20 日機装株式会社 Indwelling needle for extracorporeal circulation

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS52101897A (en) * 1976-01-26 1977-08-26 Raulerson James D Catheter device
JPS5321494B2 (en) * 1974-03-08 1978-07-03

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5321494U (en) * 1976-08-03 1978-02-23

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5321494B2 (en) * 1974-03-08 1978-07-03
JPS52101897A (en) * 1976-01-26 1977-08-26 Raulerson James D Catheter device

Also Published As

Publication number Publication date
JPS56139762A (en) 1981-10-31

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