JPS63270063A - Method for forming leading end pat of outer needle of indwelling needle - Google Patents

Method for forming leading end pat of outer needle of indwelling needle

Info

Publication number
JPS63270063A
JPS63270063A JP62105729A JP10572987A JPS63270063A JP S63270063 A JPS63270063 A JP S63270063A JP 62105729 A JP62105729 A JP 62105729A JP 10572987 A JP10572987 A JP 10572987A JP S63270063 A JPS63270063 A JP S63270063A
Authority
JP
Japan
Prior art keywords
tube
needle
core metal
mold
diameter
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.)
Granted
Application number
JP62105729A
Other languages
Japanese (ja)
Other versions
JP2520126B2 (en
Inventor
Eiji Shinozaki
篠崎 栄司
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.)
Nipro Corp
Nissho Corp
Original Assignee
Nipro Corp
Nissho 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 Nipro Corp, Nissho Corp filed Critical Nipro Corp
Priority to JP62105729A priority Critical patent/JP2520126B2/en
Publication of JPS63270063A publication Critical patent/JPS63270063A/en
Application granted granted Critical
Publication of JP2520126B2 publication Critical patent/JP2520126B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

PURPOSE:To prepare an indwelling needle having constant quality with good productivity, by a method wherein the outer needle of an indwelling needle, whose leading end part is not formed, constituted of a needle base and a tube made of a thermoplastic resin is inserted in a mold heated to predetermined temp. in such a state that a core metal is inserted in said outer needle to be fixed thereto and only the core metal is subsequently pushed in the mold up to a predetermined position. CONSTITUTION:A core metal 4 is inserted in the tube 3 of the outer needle 1 of an indwelling needle whose leading end part is not formed. Next, the tube 3 having the core metal 4 inserted therein is inserted in a mold 5, which has a hole diameter larger than the outer diameter of the core metal 4 and smaller than the outer diameter of the tube 3, preheated to predetermined temp. After the tube 3 is heated for a predetermined time and softened, the core metal 4 is further pushed in while the needle base 2 of the outer needle 1 is held and the leading end of the core metal is allowed to protrude by several mm from the cavity of the mold while the tube 3 is stretched. After the tube 3 is cooled, the core metal 4 is pulled off and, at last, the leading end part of the tube 3 is cut at a predetermined position.

Description

【発明の詳細な説明】 〈産業上の利用分野〉 本発明は留置針外針の先端部形成方法に関する。さらに
詳しくは、ステンレス製カニユーレとハブからなる内針
と熱可塑性樹脂製カニユーレとハブからなる外針とから
構成され、輸液治療や輸血治療などに際して、輸液注入
口を確保するために静脈内にその外針を留置して使用し
、またはこの留置された外針を介してカテーテルを挿入
するための留置針において、その静脈内に留置される留
置針外針の先端部形成方法に関する。
DETAILED DESCRIPTION OF THE INVENTION <Field of Industrial Application> The present invention relates to a method for forming the tip of an external indwelling needle. More specifically, it consists of an inner needle consisting of a stainless steel cannula and a hub, and an outer needle consisting of a thermoplastic resin cannula and hub. The present invention relates to a method for forming the tip of an indwelling outer needle that is indwelled in a vein in an indwelling needle for use with an indwelling outer needle or for inserting a catheter through the indwelling outer needle.

〈従来の技術〉 留置針は一般に熱可塑性樹脂製のカニユーレを有する外
針と、ステンレス製カニューレトハブとからなる内針と
から構成されており、外針にはハブを有するものとハブ
の無いものとがある。本発明はハブを有する留置針外針
について、その先端部の形成に好適な方法を提供するも
のであり、留置針外針の先端形成方法としては従来、全
体を射出成形する方法(特開昭53−1984号公報、
特開昭59−90564号公報、特開昭60−2200
70号公報、特開昭60−241451号公報)、先端
部を研削する方法(特公昭52−37310号公報、特
公昭53−43756号公報、特公昭54−30231
号公報)、チューブを加熱延伸した後先端を切断する方
法(特公昭49−5433号公報、特開昭53−153
062号公報、特開昭57−29365号公報、特公昭
61−24024号公報)などが知られている。以下従
来技術について簡単に説明する。
<Prior art> Indwelling needles generally consist of an outer needle with a cannula made of thermoplastic resin and an inner needle with a cannula hub made of stainless steel. There is something. The present invention provides a method suitable for forming the tip of an indwelling external needle having a hub. Conventionally, as a method for forming the tip of an indwelling external needle, a method of injection molding the entire body (Japanese Patent Application Laid-open No. Publication No. 53-1984,
JP-A-59-90564, JP-A-60-2200
70, Japanese Patent Application Laid-open No. 60-241451), method of grinding the tip (Japanese Patent Publication No. 52-37310, Japanese Patent Publication No. 53-43756, Japanese Patent Publication No. 54-30231)
(Japanese Patent Publication No. 49-5433, Japanese Patent Application Laid-Open No. 53-153)
062, Japanese Unexamined Patent Publication No. 57-29365, Japanese Patent Publication No. 61-24024), etc. are known. The prior art will be briefly explained below.

まず全体を射出成形する方法についてであるが、特開昭
53−1984号公報の発明は、雌型に設けられたカテ
ーテル成形空隙部に金型雄部の心棒を挿通し、この心棒
の先端部を挾持体によって挾持固定して空隙部に樹脂を
圧入することを特徴とし、1産化を目的とするものであ
り、特開昭59−90564号公報の発明は、射出成形
用金型に、針基部に直結されたリングゲートを通して、
融点以上に加熱された溶融加工性含フツ素樹脂を射出し
、針基部、テーパ一部、筒針部の順に流動させたのち融
点以下に冷却固化することを特徴とし、工程の単純化を
目的とするものである。また特開昭60−22070号
公報の発明は、溶融状態で押出される合成樹脂内に留置
針の内型を同軸方向に挿入し、この内型によって前記樹
脂を成形した後、この成形樹脂を所定位置で切断するこ
とを特徴とし、連続的かつ効率的生産を可能とするもの
であり、特開昭60−241451号公報の発明は、留
置針先端部成型金型を加熱せしめて、溶融した合成樹脂
を射出成形した後、冷却固化することを特徴とし、肉厚
の極力薄肉化と生産能率の向上を目的とするものである
First, regarding the method of injection molding the entire body, the invention disclosed in Japanese Patent Application Laid-Open No. 1984-1984 involves inserting the mandrel of the male part of the mold into the catheter molding cavity provided in the female mold. The invention of JP-A No. 59-90564 is characterized by clamping and fixing the resin with a clamping body and press-fitting the resin into the cavity, and the invention of JP-A No. 59-90564 is an injection mold for injection molding. Through the ring gate directly connected to the needle base,
It is characterized by injecting a molten processable fluorine-containing resin heated above its melting point, causing it to flow in the order of the needle base, part of the taper, and the cylindrical needle, and then cooling and solidifying below the melting point. It is something to do. Furthermore, the invention disclosed in Japanese Patent Application Laid-open No. 60-22070 involves coaxially inserting an inner mold of an indwelling needle into a synthetic resin extruded in a molten state, molding the resin with the inner mold, and then molding the molded resin. It is characterized by cutting at a predetermined position and enables continuous and efficient production.The invention disclosed in Japanese Patent Application Laid-Open No. 60-241451 heats a mold for forming the tip of an indwelling needle to melt it. It is characterized by injection molding a synthetic resin and then cooling and solidifying it, with the aim of reducing the wall thickness as much as possible and improving production efficiency.

先端部を研削する方法については、特公昭52−373
10号公報の発明は、プラスチック管体をこの管体と同
質の素材で研磨することを特徴とし、暴立ちの防止を目
的とするものであり、特公昭53−43756号公報の
発明は、内針の外径より小さい内径の外針を加熱軟化せ
しめ、この加熱軟化中の外針内へ開き用治具を挿入せし
め、この開き用治具を外針内に挿入したまま外針を冷却
せしめ、冷却後開き用治具を抜き取り、抜き取り後外針
の先端部を研ぎ加工することを特徴とし、外針と内針と
の密着性を良くすることを目的としている。また特公昭
54−30231号公報の発明は、内針を外針に挿入し
た後外針の適宜部分を加熱軟化せしめ、外針内周が内針
外周に密着するまで外針を絞り加工し、その後内針を抜
かない状態のままで適宜位置にて外針を切断し、切断面
を研ぐことを特徴とし、外針のまくれおよび外針と内針
の密着不良防止を目的とし、製作時間の大幅な短縮を可
能とするものである。
Regarding the method of grinding the tip, see Japanese Patent Publication No. 52-373.
The invention disclosed in Japanese Patent Publication No. 10 is characterized by polishing a plastic tube with the same material as the tube, and is aimed at preventing unraveling. An outer needle having an inner diameter smaller than the outer diameter of the needle is heated and softened, an opening jig is inserted into the outer needle which is being softened by heating, and the outer needle is allowed to cool while the opening jig is inserted into the outer needle. , the opening jig is removed after cooling, and the tip of the outer needle is polished after removal, with the purpose of improving the adhesion between the outer needle and the inner needle. Further, the invention disclosed in Japanese Patent Publication No. 54-30231 involves inserting the inner needle into the outer needle, heating and softening appropriate parts of the outer needle, and drawing the outer needle until the inner periphery of the outer needle is brought into close contact with the outer periphery of the inner needle. After that, the outer needle is cut at an appropriate position without removing the inner needle, and the cut surface is sharpened.The purpose is to prevent curling of the outer needle and poor adhesion between the outer needle and the inner needle, and to save production time. This makes it possible to significantly shorten the time.

次にチューブを加熱延伸した後先端を切断する方法につ
いてであるが、特公昭49−5433号公報の発明は、
合成樹脂パイプを金属製カニユーレと同じ径の芯部材に
嵌装し、その状態において適宜回転させながら熱を与え
て合成樹脂パイプを適当に焼き切ることを特徴とし、金
属製カニユーレとの密着性を良くすることを目的とする
ものであり、特開昭53−153062号公報の発明は
、素材管を案内部材に嵌装し、該素材管の中央部を環状
に加熱軟化して延伸することを特徴とし、均一な肉厚に
延伸することを目的とするものである。
Next, regarding the method of heating and stretching the tube and then cutting the tip, the invention disclosed in Japanese Patent Publication No. 49-5433 is as follows.
It is characterized by fitting a synthetic resin pipe into a core member with the same diameter as the metal cannula, and applying heat while appropriately rotating the synthetic resin pipe in that state to appropriately burn out the synthetic resin pipe, thereby improving the adhesion with the metal cannula. The invention of JP-A-53-153062 is characterized in that a material tube is fitted into a guide member, and the center portion of the material tube is heated and softened in an annular shape to be stretched. The purpose is to stretch it to a uniform thickness.

また特開昭57−29365号公報の発明は、予備成形
チューブを、注射用カニユーレの外径と同一な外径を有
する成形芯棒に嵌装し、かつ両者を同軸回転させながら
前記予備成形チューブの両切断端部相当位置を局部的に
加熱するとともに、この予備成形チューブの他端部側を
軸方向に引き延ばした後、その引き延ばし加熱部を冷却
して所定長さに切断することを特徴とし、段部のない滑
らかなかつ注射用カニユーレとの密着性の良い留置針の
提供を目的としており、特公昭61−24024号公報
の発明は、プラスチック製チューブに芯金を挿入し、こ
のチューブを回転させながらその中央部を加熱延伸して
その加熱部にチューブの軸線に対して比較的小さい角度
を有する第2テーパ部を形成させ、この第2テーパ部の
最小直径部の周囲に加熱された丸棒を押圧して湾曲凹溝
をチューブの周囲に形成させ、ついでその湾曲凹溝にお
いてチューブを切断して第1テーパ部を形成することを
特徴とし、先端形状が鋭利で品質の一定した留置針を提
供することを目的とするものである。
Further, the invention of JP-A-57-29365 discloses that a preformed tube is fitted into a formed core rod having the same outer diameter as the outer diameter of an injection cannula, and while both are coaxially rotated, the preformed tube is The preformed tube is heated locally at positions corresponding to both cut ends of the preformed tube, and the other end of the preformed tube is stretched in the axial direction, and then the stretched and heated portions are cooled and cut into a predetermined length. The purpose of the invention is to provide an indwelling needle that is smooth without a stepped part and has good adhesion to an injection cannula. A second tapered part having a relatively small angle with respect to the axis of the tube is formed in the heated part by heating and stretching the central part while stretching, and a heated circle is formed around the smallest diameter part of this second tapered part. An indwelling needle with a sharp tip shape and uniform quality, characterized by pressing a rod to form a curved groove around the tube, and then cutting the tube at the curved groove to form a first tapered part. The purpose is to provide the following.

〈発明が解決しようとする問題点〉 しかしながら前記全体を射出成形する方法は、成形時間
が長い、細い留置針外針の製作が難かしい、先端が傷付
きやすく、また整列を自動化しにくいため成形後の処理
に手間がかかる、金型が高価である、内針の太さにバラ
ツキがある場合には内針と外針の嵌合強度にバラツキが
生じる、ホットランナ金型を用いる場合を除き材料ロス
が生じ不経済であるなどの欠点がある。
<Problems to be Solved by the Invention> However, the method of injection molding the entire body requires a long molding time, is difficult to manufacture a thin outer indwelling needle, the tip is easily damaged, and alignment is difficult to automate. Post-processing is time-consuming, the mold is expensive, and if the thickness of the inner needle varies, the strength of the fit between the inner and outer needles will vary, unless a hot runner mold is used. It has disadvantages such as material loss and being uneconomical.

また先端部を研削する方法は、研削により静電気が生じ
粉塵がカニユーレ先端に付着するという欠点があり、チ
ューブを加熱延伸した後先端を切断する方法は、カニユ
ーレ先端寸法のバラツキが大きく、また加工時間が長い
という欠点がある。
In addition, the method of grinding the tip has the disadvantage that static electricity is generated by grinding and dust adheres to the tip of the cannula, while the method of cutting the tip after heating and stretching the tube results in large variations in the dimensions of the tip of the cannula, and also takes longer processing time. It has the disadvantage of being long.

本発明は上記の問題点に鑑みて鋭意検討の結果完成され
たもので、カニユーレ先端形状のバラツキが少なく、加
工時間が大幅に短縮された留置針外針の製造方法を提供
することを目的とする。
The present invention was completed as a result of intensive studies in view of the above-mentioned problems, and an object of the present invention is to provide a method for manufacturing an external indwelling needle that has less variation in the shape of the cannula tip and significantly shortens the processing time. do.

く問題点を解決するための手段〉 すなわち本発明は、(至)針基と熱可塑性樹脂製のチュ
ーブとから構成される先端部未形成の留置針外針を用意
し、該外針のチューブに、該チューブの内径より小さな
外径を有する芯金を、該チューブの先端から所定長引っ
込んだ位置まで挿入する。(イ)芯金がチューブ内を移
動しないように保持しながら、前記芯金の挿入されたチ
ューブを、芯金の外径より大きくかつチューブの外径よ
り小さな穴径を有するあらかじめ所定温度に加熱された
金型に該チューブが支える状態になるまで挿入し、次い
で前記芯金を金型の所定の位置まで押し込む。 (つ)
チューブを所定時間加熱して軟化させた後、前記外針の
針基を保持しながら前記芯金をさらに押し込み、芯金の
先端を金型のキャビティから数組突出させる。
Means for Solving the Problems> That is, the present invention provides an indwelling outer needle with an unformed tip consisting of a needle base and a tube made of thermoplastic resin, and a tube of the outer needle. Then, a core metal having an outer diameter smaller than the inner diameter of the tube is inserted from the tip of the tube to a position where it is retracted by a predetermined length. (b) While holding the core metal so that it does not move inside the tube, heat the tube into which the core metal has been inserted to a predetermined temperature in advance with a hole diameter larger than the outer diameter of the core metal and smaller than the outer diameter of the tube. The tube is inserted into the mold that has been prepared until it is supported, and then the core metal is pushed into the mold to a predetermined position. (tsu)
After the tube is heated for a predetermined period of time to soften it, the core metal is further pushed in while holding the needle base of the outer needle, so that several pairs of tips of the core metal protrude from the cavity of the mold.

国前記金型から前記芯金の挿入されたチュ、−ブを引き
出す。 オ)冷却後チューブから芯金を引き抜く。 (
力)チューブの先端部を所定の位置で切断する。 の各
工程からなることを特徴とする留置針外針の先端部形成
方法に関する。
Then, pull out the tube into which the core metal is inserted from the mold. e) After cooling, pull out the core metal from the tube. (
(Force) Cut the tip of the tube in place. The present invention relates to a method for forming a distal end portion of an external indwelling needle, characterized by comprising the following steps.

〈実施例〉 次に図面を参考に本発明の実施例について説明する。<Example> Next, embodiments of the present invention will be described with reference to the drawings.

第1図は本発明に係る留置針外針と芯金および金型の関
係を示す図、第2図および第3図はそれぞれ本発明に係
る留置針外針の先端形成方法の工程(イ)および工程(
つ)を説明するための図である。
FIG. 1 is a diagram showing the relationship between the outer indwelling needle, the core bar, and the mold according to the present invention, and FIGS. 2 and 3 are the steps (a) of the method for forming the tip of the outer indwelling needle according to the present invention, respectively. and process (
FIG.

第1図〜第3図に示されるように、本発明による留置針
外針の先端部形成は、針基(2)と熱可塑性樹脂製のチ
ューブ(3)とから構成される先端部未形成の留置針外
針(1)に、この外針(11のチューブ(3)に挿入さ
れる芯金(4)および、ヒータブロック(6)を備えた
留置針外針の先端部形成用金型(5)を用いることによ
って行われる。
As shown in FIGS. 1 to 3, the tip of the indwelling outer needle according to the present invention is formed by forming a needle base (2) and a thermoplastic resin tube (3). A mold for forming the tip of the outer indwelling needle (1), which is equipped with a core bar (4) to be inserted into the tube (3) of the outer needle (11) and a heater block (6). This is done by using (5).

すなわち、まず(3)第1図に示されるような先端部未
形成の留置針外針(1)を用意し、そのチューブ(3)
に、チューブ(3)の内径より小さな外径を有する芯金
(4)を、チューブ(3)の先端から所定長引っ込んだ
位置まで挿入する。次に(イ)芯金(4)が・チューブ
(3)内を移動しないようにたとえば針基(2)と芯金
(4)とを同軸上に固定した状態で、前記芯金(4)の
挿入されたチューブ(3)を、芯金(4)の外径より大
きくかつチューブ(3)の外径より小さな穴径を有する
あらかじめ所定温度に加熱された金型(5)に該チュー
ブ(3)が支える状態になるまで挿入し、次いで第2図
に示すように前記芯金(4)を金型(5)の所定の位置
まで押し込む。そして(つ)チューブ(3)を所定時間
加熱して軟化させた後、第3図に示すように、前記外針
(1)の針基(2)を保持しながら、前記芯金(4)を
さらに押し込み、芯金(4)の先端を金型のキャビティ
から数組突出させる。それから(即金型(5)から芯金
(4)の挿入されたチューブ(3)を引き出し、オ)チ
ューブ(3)を冷却後このチューブ(3)から挿入され
ていた芯金(4)を引き抜き、最後に(力)チューブ(
3)の先端部を所定の位置で切断すればよい。
That is, first (3) prepare an external indwelling needle (1) with an unformed tip as shown in FIG.
Then, a core metal (4) having an outer diameter smaller than the inner diameter of the tube (3) is inserted from the tip of the tube (3) to a position where it is retracted by a predetermined length. Next, (a) With the needle base (2) and the core metal (4) fixed coaxially so that the core metal (4) does not move inside the tube (3), The inserted tube (3) is placed in a mold (5) that has been heated to a predetermined temperature and has a hole diameter larger than the outer diameter of the core metal (4) and smaller than the outer diameter of the tube (3). 3) until it is supported, and then push the core metal (4) into the mold (5) to a predetermined position as shown in FIG. After (1) heating the tube (3) for a predetermined time to soften it, as shown in FIG. 3, while holding the needle base (2) of the outer needle (1), Push in further to make several sets of tips of the core metal (4) protrude from the cavity of the mold. Then (pull out the tube (3) with the core metal (4) inserted from the ready-to-mold mold (5), and e) after cooling the tube (3), pull out the core metal (4) that was inserted from this tube (3). , and finally the (force) tube (
The tip of 3) may be cut at a predetermined position.

ここで留置針外針(1)の先端形成に用いられる金型(
5)は、好ましくは、金型(5)のキャビティが第1図
に示されるように、チ□−ブ(3)の外径より十分に大
きな口径のチューブ挿入口(7)に続き比較的大きなテ
ーパをもって縮径するチューブ(3)の外径より大きな
穴径の第1テーパ部(8)と、第1テーパ部(8)に続
き緩やかなテーパをもって縮径する第2テーパ部(9)
、および第2テーパ部(9)に続く同径筒状に形成され
た、チューブ(3)の外径より小さくかつ芯金(4)の
外径より大きな穴径のストレート部(10)を含むもの
であり、前記チューブ(3)の外径(Dt)と肉厚(t
)、芯金(4)の外径(Dm)、ストレート部(lO)
の穴径(Dc)とは、好ましくは下記(I+ないし匝式
を満足するものである。
Here, the mold (
5) is preferably such that the cavity of the mold (5) is relatively connected to the tube insertion port (7) having a diameter sufficiently larger than the outer diameter of the tube (3), as shown in FIG. A first taper part (8) having a hole diameter larger than the outer diameter of the tube (3) that reduces in diameter with a large taper, and a second taper part (9) that reduces in diameter with a gentle taper following the first taper part (8).
, and a straight part (10) which is formed into a cylindrical shape with the same diameter and has a hole diameter smaller than the outer diameter of the tube (3) and larger than the outer diameter of the core metal (4) following the second tapered part (9). The outer diameter (Dt) and wall thickness (t
), outer diameter of core metal (4) (Dm), straight part (lO)
Preferably, the hole diameter (Dc) satisfies the following (I+ or box type).

0.06≦Dc −Dm≦0.2曲曲・・・・(■)t
(Dt−Dm≦1,5t ・・・・・・・・・・・・・
・・・・・(n)0.5t≦Dt−Dc≦t ・・・・
・・・・・・・・・・・・・・(I′ll1(但し、D
t%Dm、 Dcおよびtの単位は絹である。) 次に本発明に係る留置針外針の先端部形成方法について
さらに詳しく説明する。
0.06≦Dc -Dm≦0.2 songs...(■)t
(Dt-Dm≦1,5t ・・・・・・・・・・・・・
...(n) 0.5t≦Dt-Dc≦t ...
・・・・・・・・・・・・・・・(I'll1(However, D
t%Dm, Dc and t are in silk. ) Next, the method for forming the distal end portion of an external indwelling needle according to the present invention will be described in more detail.

留置針外針(11を構成するチューブ(3)は熱可塑性
樹脂のたとえばポリエチレンやポリプロピレン、テトラ
フルオロエチレン、フッ化エチレンーフロヒレン共重合
体、エチレン−テトラフルオロエチレン共重合体などを
用いて押出成形されており、留置針のサイズおよびチュ
ーブ(3)の形成材料によってその外径詔よび肉厚が決
められている。そしてこのチューブ(3)に挿入される
芯金(4)のサイズも留置針のサイズによって決められ
ており、芯金(4)の外径は留置針内針を構成するステ
ンレス製カニユーレの外径より僅かに小さい。芯金(4
)のチューブ(3)への挿入は図示されていない専用の
機械を用いて自動的に行われるが、特殊な場合を除いて
一般に芯金(4)は、その先端がチューブ(3)の先端
から4〜6門、好ましくは約5N引っ込んだ位置まで挿
入される。
The tube (3) constituting the indwelling needle outer needle (11) is extruded using a thermoplastic resin such as polyethylene, polypropylene, tetrafluoroethylene, fluorinated ethylene-fluoroethylene copolymer, ethylene-tetrafluoroethylene copolymer, etc. The outer diameter and wall thickness of the indwelling needle are determined by the size of the indwelling needle and the material from which the tube (3) is made.The size of the core bar (4) inserted into this tube (3) is also determined by the size of the indwelling needle and the material from which the tube (3) is made. The outer diameter of the core bar (4) is determined by the size of the needle, and the outer diameter of the core bar (4) is slightly smaller than the outer diameter of the stainless steel cannula that constitutes the inner needle of the indwelling needle.
) is automatically inserted into the tube (3) using a special machine (not shown), but except in special cases, the tip of the core bar (4) is generally inserted into the tube (3). from 4 to 6 points, preferably to a retracted position of about 5N.

金型(5)は第1図に示されるように第1テーバ部(8
)と第2テーパ部(9)およびストレート部(1o)と
からなるキャビティを有しており、第1テーパ部(8)
は穴径がチューブ(3)の外径より大きく形成されてお
り、特にそのチューブ挿入口(7)はチューブ(3)を
挿入し易いようにチューブ(3)より十分に大きな口径
に形成されている。そして第1テーパ部(8)のテーパ
は特に限定されるものではないが一般に約300〜60
°に形成される。
The mold (5) has a first tapered portion (8) as shown in FIG.
), a second tapered part (9) and a straight part (1o), and a first tapered part (8).
The hole diameter is larger than the outer diameter of the tube (3), and in particular, the tube insertion port (7) is formed to have a sufficiently larger diameter than the tube (3) so that the tube (3) can be easily inserted. There is. The taper of the first tapered part (8) is not particularly limited, but is generally about 300 to 60.
Formed at °.

第2テーパ部(9)は留置針外針(11の先端形状を決
定する部分であり、第1テーパ部(8)と連続して小さ
なテーパをもって縮径し、ストレート部(10)に連続
する。そして第2テーパ部(9)の穴径は第1テーパ部
(8)との接点ではチューブ(3)の外径より大径で、
かつストレート部(lO)との接点ではチューブ(3)
の外径より小径になっており、そのテーパは好ましくは
4°〜15°に形成されている。テーパが15°以上の
場合には、形成された留置針外針の刺通抵抗が大きくな
るため、これを患者の静脈などに刺通した場合患者に苦
痛を与えることになり、またテーパが4°より小さい場
合には、テーパが長すぎ従って留置針の内針と外針の密
着部が長くなりすぎ、内針と外針の嵌合が強すぎて操作
しにくくなり、また密着部すなわち薄肉部を長くすると
当然に肉厚が小さくなり、肉厚が小さくなりすぎたため
に刺通時に留置針外針が捲れてしまうことがあるので好
ましくない。
The second tapered part (9) is a part that determines the tip shape of the indwelling needle outer needle (11), and is continuous with the first tapered part (8), reduces in diameter with a small taper, and continues to the straight part (10). The hole diameter of the second tapered part (9) is larger than the outer diameter of the tube (3) at the point of contact with the first tapered part (8),
and the tube (3) at the point of contact with the straight part (lO)
The taper is preferably formed at 4° to 15°. If the taper is 15 degrees or more, the penetration resistance of the formed indwelling external needle will be large, and if it is inserted into a patient's vein, it will cause pain to the patient. If the taper is smaller than °, the taper is too long, and therefore the contact part between the inner and outer needles of the indwelling needle becomes too long, the fit between the inner needle and the outer needle is too strong, making it difficult to operate, and the contact part, i.e., the wall is thin. If the length is made longer, the wall thickness will naturally become smaller, and if the wall thickness becomes too small, the outer indwelling needle may be turned over during piercing, which is not preferable.

ストレート部(1o)の穴径はチューブ(3)の外径よ
り小さく芯金(4)の外径より大きく形成されており、
ストレート部(10)の長さは、留置針のサイズによっ
て決まっている。
The hole diameter of the straight part (1o) is smaller than the outer diameter of the tube (3) and larger than the outer diameter of the core bar (4).
The length of the straight portion (10) is determined by the size of the indwelling needle.

次に工程(3)において芯金(4)の挿入されたチュー
ブ(3)を工程(イ)において、あらかじめ所定温度に
加熱された金型(5)にチューブ(3)がつがえる状態
になるまで挿入し、次いで芯金(4)を金型(5)の所
定の位置まで押し込むという点についてであるが、ここ
でチューブ(3)が金型に支える状態になるまで挿入し
た後、さらにチューブ(3)と芯金(4)とを同時に押
し進めるよろにしないのは、芯金(4)がさらに金型(
5)内に進入するのに対し、チューブ(3)の金型(5
)内への進入が十分でなく、従ってチューブ(3)に折
曲部分が生じ成形不良の原因になるからである。また芯
金(4)の金型(5)内への押し込みは、芯金(4)の
先端がストレート部(1(1)内にO〜2朋進入するま
で行うのが好ましい。
Next, in step (3), the tube (3) into which the core metal (4) has been inserted is inserted into the mold (5), which has been heated to a predetermined temperature, in step (a). Regarding the point of inserting the core bar (4) until it reaches a predetermined position in the mold (5), insert it until the tube (3) is supported by the mold, and then push the core bar (4) further into the mold (5). (3) and the core metal (4) are not pushed together at the same time because the core metal (4) is pushed further into the mold (
5), whereas the mold (5) of the tube (3)
) is not sufficiently penetrated into the tube (3), resulting in a bent portion in the tube (3), which may cause molding defects. Further, it is preferable to push the core metal (4) into the mold (5) until the tip of the core metal (4) enters the straight part (1 (1) by 0 to 2 degrees.

芯金(4)の進入が不足し、その先端が第2テーパ部に
あるような場合には、チューブ(3)の加熱部分が不足
し成形不良を生ずることがあるからであり、また芯金(
4)が進入しすぎてストレート部(10)に2朋以上進
入した場合には、芯金(4)の先端がチューブ(3)の
外に出てしまうことがあり、その結果次の工程(つ)を
行うことができず成形不良を生ずることがあるからであ
る。
This is because if the core metal (4) does not enter enough and its tip is at the second tapered part, the heated part of the tube (3) may be insufficient and defective molding may occur. (
4) enters the straight part (10) more than two times, the tip of the core bar (4) may come out of the tube (3), and as a result, the next step ( This is because it may not be possible to carry out the following steps, resulting in molding defects.

金型(5)の温度はチューブ(3)の形成材料によって
異なるが、樹脂の軟化温度よりは若干高い温度に設定さ
れており、たとえば材料がポリエチレンの場合には95
〜105°c1好ましくは100±1℃であり、ポリプ
ロピレンの場合には105〜115°C1好ましくは1
10f:1’C1エチレン−テトラフルオロエチレン共
重合体の場合には200〜220°C1好ましくは21
0−!:2°Cである。
The temperature of the mold (5) varies depending on the material forming the tube (3), but it is set at a temperature slightly higher than the softening temperature of the resin. For example, when the material is polyethylene,
~105°C1 preferably 100±1°C, and in the case of polypropylene 105-115°C1 preferably 1
10f: 1'C1 200 to 220°C1 preferably 21 in the case of ethylene-tetrafluoroethylene copolymer
0-! :2°C.

次に工程(つ)の金型(5)内に挿入されたチューブ(
3)を所定時間加熱し軟化させた後、芯金(4)をさら
に押し込み、芯金(4)の先端を金型(5)のキャビテ
ィから数趨突出させるという点についてであるが、チュ
ーブ(3)の加熱時間はチューブの形成材料によって異
なり、金型(5)の温度を所定の温度に設定して、たと
えばチューブ(3)の形成材料をポリエチレンにした場
合には約0.5秒であり、ポリプロピレンにした場合に
は約0.5秒、エチレン−テトラフルオロエチレンにし
た場合には約0,7秒である。また芯金(4)のキャビ
ティからの突出長(第1図で言えばストレート部(1o
)からの突出長)は2〜4朋が好ましい。突出長が2朋
以下の場合には先端部の成形不良が生じることがあり、
突出長が4朋を超える場合にはチューブ(3)がちぎれ
てしまうことがあるからである。
Next, the tube (
3) is heated for a predetermined period of time to soften it, and then the core bar (4) is further pushed in, causing the tip of the core bar (4) to protrude in several directions from the cavity of the mold (5). The heating time in step 3) varies depending on the tube forming material; for example, if the temperature of the mold (5) is set to a predetermined temperature and the tube (3) is formed from polyethylene, the heating time will be approximately 0.5 seconds. When using polypropylene, it takes about 0.5 seconds, and when using ethylene-tetrafluoroethylene, it takes about 0.7 seconds. Also, the protrusion length of the core metal (4) from the cavity (in Fig. 1, the straight part (1 o
) is preferably 2 to 4 mm. If the protrusion length is less than 2 mm, molding defects at the tip may occur.
This is because if the protrusion length exceeds 4 mm, the tube (3) may break.

次にチューブ(3)の外径(Dt)と肉厚(【)、芯金
(4)の外径(Dm)、ストレート部(10)の穴径(
Dc)の関係についてであるが、Dt、Dm%Dc、1
の単位をミリメートルとした場合、Dt、 Dm、 D
c、  tは0.06≦Dc −Dm≦0.2・曲間・
・・・・・(■)t  <  Dt  −Dm  ≦ 
1.5t      ・・・・・・・・・・・・・  
(ロ)0.5 t≦Dt −Dc ≦t  ・・・・・
・・・・・・・ (III)の関係を満足するのが好ま
しい。
Next, the outer diameter (Dt) and wall thickness ([) of the tube (3), the outer diameter (Dm) of the core metal (4), and the hole diameter (
Regarding the relationship Dc), Dt, Dm%Dc, 1
When the unit of is millimeter, Dt, Dm, D
c, t are 0.06≦Dc −Dm≦0.2・between songs・
...(■)t<Dt-Dm≦
1.5t ・・・・・・・・・・・・・・・
(b) 0.5 t≦Dt −Dc≦t・・・・・・
It is preferable that the relationship (III) is satisfied.

III式においてDc −Dmが0.2より大きい場合
には留置針外針の刺通抵抗が大きくなり、0.06より
小さい場合にはチューブ(3)が切れたり、またたとえ
成形できたとしても刺通時に外針が捲くれることかあり
問題である。
In formula III, if Dc - Dm is larger than 0.2, the penetration resistance of the external indwelling needle becomes large, and if it is smaller than 0.06, the tube (3) may break or even if it can be formed. The problem is that the outer needle may curl during piercing.

(IIJ式においてDt −Dmが1.5tより大きい
場合にはチューブ(3)の外径を絞りすぎることになり
成形不良になり易い。またこの成形不良を回避するため
には加熱時間を長くすれば良いが、不経済である。Dt
−Dmがt以下の場合には芯金(4)がチューブ(3)
内をスムーズに摺動せず、従う、 てチューブ(3)の
非成形部分が伸びて金型(5)内のチューブ(3)の長
さが狂う。
(In the IIJ type, if Dt - Dm is larger than 1.5t, the outer diameter of the tube (3) is too narrowed, which tends to result in molding defects. Also, in order to avoid this molding defect, it is necessary to increase the heating time. It's good, but it's uneconomical.Dt
- If Dm is less than t, the core metal (4) is the tube (3)
If the tube (3) does not slide smoothly inside the mold (5), the unformed part of the tube (3) will stretch and the length of the tube (3) in the mold (5) will be incorrect.

測成においてD【−Dcがtよりも大きい場合にはチュ
ーブ(3)の外径および肉厚を絞りすぎることになり成
形不良になり易い。またこの成形不良を回避するために
は加熱時間を長くすれば良いが不経済である。
If D[-Dc is larger than t during measurement, the outer diameter and wall thickness of the tube (3) will be reduced too much, which tends to result in poor molding. Further, in order to avoid this defective molding, it is possible to lengthen the heating time, but this is uneconomical.

Dt −Dcが0.5tよりも小さい場合にはチューブ
(3)の肉厚の絞りが足りず、先端の薄肉化ができない
When Dt - Dc is smaller than 0.5t, the wall thickness of the tube (3) is not sufficiently reduced, and the tip cannot be thinned.

〈実施例1〉 ポリプロピレン(チッソ石油化学■製、K −1011
)製のチューブを用いて本発明に係る方法および従来の
加熱延伸法により留置針外針を製造し、そのサイズ別の
不良率および製造の1サイクルに要する時間を比較した
ところ、それぞれ第1表および第2表のような結果が得
られた。
<Example 1> Polypropylene (manufactured by Chisso Petrochemical Co., Ltd., K-1011
) was used to manufacture indwelling external needles by the method according to the present invention and the conventional heating stretching method, and the defective rate by size and the time required for one manufacturing cycle were compared, and the results are shown in Table 1. The results shown in Table 2 were obtained.

但し、加熱延伸法としては、テーパ治具の挿入されたカ
ニユーレ形成用チューブを、ヒータブロックの空間(穴
径3〜4朋)に挿入して加熱軟化させた後、当該チュー
ブの上部を固定具で支持固定した状態でチューブとテー
パ治具とを同時に下降させて延伸する(下降圧、!l1
00〜2001!M、下降速度20〜30朋/秒)方法
を採用し、不良率は外観および外針と内針の密着部の長
さで判定した。密着部の規格は、サイズが12G〜20
Gの場合には7−1−Q、50゜22Gの場合には4±
0.5 txtsとした。
However, in the heating stretching method, a cannula forming tube into which a taper jig has been inserted is inserted into the space of the heater block (hole diameter 3 to 4 mm), heated and softened, and then the upper part of the tube is inserted into the fixing tool. While supporting and fixing the tube and the taper jig, simultaneously lower it and stretch it (descending pressure, !l1
00~2001! M, descending speed 20 to 30 h/sec) method was adopted, and the defective rate was determined based on the appearance and the length of the contact portion between the outer needle and the inner needle. The size of the contact part is 12G to 20
7-1-Q for G, 4± for 50°22G
0.5 txts.

従来の加熱延伸法に比べて不良率が大幅に減少し、また
製造サイクルが大幅に短縮されているのがわかる。
It can be seen that the defective rate is significantly reduced and the manufacturing cycle is significantly shortened compared to the conventional hot stretching method.

第  1  表 以  下  余  白 第  2  表 〈発明の効果〉 以上説明してきたことから明らかなように、本発明に係
る留置針外針の先端部形成方法を用いれば、カニユーレ
先端形状のバラツキが少なく、また加工時間を大幅に短
縮できるので、先端形状が鋭利で内針との密着性の良い
、品質の安定した留置針外針を低コストで製造すること
ができる。
Table 1 below Margin Table 2 <Effects of the invention> As is clear from the above explanation, if the method for forming the tip of an external indwelling needle according to the present invention is used, variations in the shape of the cannula tip can be reduced. In addition, since the processing time can be significantly shortened, it is possible to manufacture an external indwelling needle with a sharp tip shape, good adhesion to the inner needle, and stable quality at a low cost.

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

第1図は本発明に係る留置針外針と芯金および金型の関
係を示す図、第2図および第3図はそれぞれ本発明の留
置針外針の先端部形成方法の工程(イ)および工程(つ
)の説明図である。 〈主な符号の説明〉 l:留置針外針   2:針基 3:チューブ    4:芯金 5:金型      6:ヒータブロツク8:第1テー
パ部  9:第2テーパ部lOニストレード部
FIG. 1 is a diagram showing the relationship between the outer indwelling needle, the core bar, and the mold according to the present invention, and FIGS. 2 and 3 are the steps (a) of the method for forming the tip of the outer indwelling needle of the present invention, respectively. and is an explanatory diagram of the process (one). <Explanation of main symbols> 1: Outer needle of indwelling needle 2: Needle base 3: Tube 4: Core metal 5: Mold 6: Heater block 8: First taper part 9: Second taper part lO Nistrade part

Claims (1)

【特許請求の範囲】 1)(ア)針基と熱可塑性樹脂製のチューブとから構成
される先端部未形成の留置針外針を用意し、該外針のチ
ューブに、該チューブの内径より小さな外径を有する芯
金を、該チューブの先端から所定長引っ込んだ位置まで
挿入する。 (イ)芯金がチューブ内を移動しないように保持しなが
ら、前記芯金の挿入されたチューブを、芯金の外径より
大きくかつチューブの外径より小さな穴径を有するあら
かじめ所定温度に加熱された金型に該チューブが支える
状態になるまで挿入し、次いで前記芯金を金型の所定の
位置まで押し込む。 (ウ)チューブを所定時間加熱して軟化させた後、前記
外針の針基を保持しながら、前記芯金をさらに押し込み
、芯金の先端を金型のキャビティから数mm突出させる
。 (エ)前記金型から前記芯金の挿入されたチューブを引
き出す。 (オ)冷却後チューブから芯金を引き抜く。 (カ)チューブの先端部を所定の位置で切断する。 の各工程からなることを特徴とする留置針外針の先端部
形成方法。 2)前記金型のキャビティが、、チューブの外径より十
分に大きな口径のチューブ挿入口に続き比較的大きなテ
ーパをもって縮径するチューブの外径より大きな穴径の
第1テーパ部と、該第1テーパ部に続き緩やかなテーパ
をもって縮径する第2テーパ部、および該第2テーパ部
に続く同径筒状に形成された、チューブの外径より小さ
くかつ芯金の外径より大きな穴径のストレート部を含む
ものであることを特徴とする特許請求の範囲第1項記載
の留置針外針の先端部形成方法。 3)前記チューブの外径(Dt)と肉厚(t)、芯金の
外径(Dm)、金型のストレート部の穴径(Dc)とが
下記( I )ないし(III)式: 0.06≦Dc−Dm≦0.2・・・( I ) t<Dt−Dm≦1.5t・・・(II) 0.5t≦Dt−Dc≦t・・・(III) (但し、Dt、Dm、Dcおよびtの単位はmmである
。) を満足する特許請求の範囲第2項記載の留置針外針の先
端部形成方法。
[Scope of Claims] 1) (A) An indwelling outer needle with an unformed tip consisting of a needle base and a tube made of thermoplastic resin is prepared, and a needle is inserted into the outer needle tube from the inner diameter of the tube. A core metal having a small outer diameter is inserted from the tip of the tube to a position where it is retracted a predetermined length. (b) While holding the core metal so that it does not move inside the tube, heat the tube into which the core metal has been inserted to a predetermined temperature in advance with a hole diameter larger than the outer diameter of the core metal and smaller than the outer diameter of the tube. The tube is inserted into the mold that has been prepared until it is supported, and then the core metal is pushed into the mold to a predetermined position. (c) After the tube is heated for a predetermined period of time to soften it, the core metal is further pushed in while holding the needle base of the outer needle, so that the tip of the core metal protrudes several mm from the cavity of the mold. (d) Pulling out the tube into which the core metal has been inserted from the mold. (e) After cooling, pull out the core metal from the tube. (F) Cut the tip of the tube at a predetermined position. A method for forming the tip of an external indwelling needle, comprising the steps of: 2) The cavity of the mold includes a first tapered portion having a hole diameter larger than the outer diameter of the tube, the diameter of which decreases with a relatively large taper following a tube insertion port having a diameter sufficiently larger than the outer diameter of the tube; A second taper part whose diameter decreases with a gentle taper following the first taper part, and a hole diameter smaller than the outer diameter of the tube and larger than the outer diameter of the core bar, which is formed into a cylindrical shape with the same diameter and continues from the second taper part. 2. A method for forming a distal end portion of an external indwelling needle according to claim 1, characterized in that the distal end portion of an external indwelling needle includes a straight portion. 3) The outer diameter (Dt) and wall thickness (t) of the tube, the outer diameter (Dm) of the core metal, and the hole diameter (Dc) of the straight part of the mold are expressed by the following formulas (I) to (III): 0 .06≦Dc-Dm≦0.2...(I) t<Dt-Dm≦1.5t...(II) 0.5t≦Dt-Dc≦t...(III) (However, Dt , Dm, Dc, and t are in mm.) The method for forming the distal end of an external indwelling needle according to claim 2, which satisfies the following.
JP62105729A 1987-04-28 1987-04-28 Method for forming the tip of the indwelling needle Expired - Lifetime JP2520126B2 (en)

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JP62105729A JP2520126B2 (en) 1987-04-28 1987-04-28 Method for forming the tip of the indwelling needle

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Application Number Priority Date Filing Date Title
JP62105729A JP2520126B2 (en) 1987-04-28 1987-04-28 Method for forming the tip of the indwelling needle

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JPS63270063A true JPS63270063A (en) 1988-11-08
JP2520126B2 JP2520126B2 (en) 1996-07-31

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0778045A2 (en) 1995-12-04 1997-06-11 Nissho Corporation Method of making an intravenous catheter and the cannula made by the method
EP0850655A3 (en) * 1996-12-30 1998-11-18 JOHNSON &amp; JOHNSON MEDICAL, INC. Catheter tip mold and cut process
EP0856329A3 (en) * 1996-12-30 1999-09-08 JOHNSON &amp; JOHNSON MEDICAL, INC. Catheter beveling and die cut process
JP2017023358A (en) * 2015-07-21 2017-02-02 日本ゼオン株式会社 Method and apparatus for manufacturing medical tapered member
CN109808189A (en) * 2017-12-04 2019-05-28 迈得医疗工业设备股份有限公司 A molding plug insertion apparatus is melted for remaining needle

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0778045A2 (en) 1995-12-04 1997-06-11 Nissho Corporation Method of making an intravenous catheter and the cannula made by the method
EP0778045A3 (en) * 1995-12-04 1998-01-14 Nissho Corporation Method of making an intravenous catheter and the cannula made by the method
US6083440A (en) * 1995-12-04 2000-07-04 Nissho Corporation Method of making an outer cannula for an intravenous cannula and a cannula made by the method
EP0850655A3 (en) * 1996-12-30 1998-11-18 JOHNSON &amp; JOHNSON MEDICAL, INC. Catheter tip mold and cut process
EP0856329A3 (en) * 1996-12-30 1999-09-08 JOHNSON &amp; JOHNSON MEDICAL, INC. Catheter beveling and die cut process
JP2017023358A (en) * 2015-07-21 2017-02-02 日本ゼオン株式会社 Method and apparatus for manufacturing medical tapered member
CN109808189A (en) * 2017-12-04 2019-05-28 迈得医疗工业设备股份有限公司 A molding plug insertion apparatus is melted for remaining needle
CN109808189B (en) * 2017-12-04 2024-01-26 迈得医疗工业设备股份有限公司 Core rod insertion device for molding indwelling needle melting head

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