JP4432734B2 - Medical device and manufacturing method thereof - Google Patents

Medical device and manufacturing method thereof Download PDF

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JP4432734B2
JP4432734B2 JP2004323960A JP2004323960A JP4432734B2 JP 4432734 B2 JP4432734 B2 JP 4432734B2 JP 2004323960 A JP2004323960 A JP 2004323960A JP 2004323960 A JP2004323960 A JP 2004323960A JP 4432734 B2 JP4432734 B2 JP 4432734B2
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tube
polybutadiene
tubular member
copolymer
polypropylene
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JP2006130144A (en
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秀樹 三谷
康博 西根
健 二塚
直樹 児玉
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Nipro Corp
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Description

本発明は、輸液、輸血、透析回路などに用いられる医療用具に関するものであり、より詳細には、異なる材料からなる管状部材、例えば軟質部材と硬質部材とを脱離し難いように接合された医療用具およびその製造方法に関する。   The present invention relates to a medical device used for infusion, blood transfusion, dialysis circuit, and the like, and more specifically, a tubular member made of different materials, for example, a medical device in which a soft member and a hard member are joined so as not to easily separate. The present invention relates to a tool and a method for manufacturing the same.

従来から、異なる材料製の部材が接合した医療用具として、ポリプロピレン製の点滴筒と軟質ポリ塩化ビニル製のチューブとが連結された点滴用具、ポリプロピレン製の輸液バックと軟質ポリ塩化ビニル製チューブとが連結された輸液用具等がある。テトラヒドロフラン、メチルエチルケトン、シクロヘキサノン、シクロヘキサンなどの溶剤型接着剤は、軟質ポリ塩化ビニル製チューブと軟質塩化ビニル製コネクター等の同種材料接着には効果があるが、軟質ポリ塩化ビニル製チューブと前記ポリプロピレン製の点滴筒などの接着には効果がなく、前記ポリプロピレン製材料に連結された軟質ポリ塩化ビニル製チューブは、長期保存においてクリープ、応力緩和が発生し、積極的に軟質ポリ塩化ビニル製チューブを引っ張った場合、前記チューブが連結部より脱落する危険があった。   Conventionally, as a medical device in which members made of different materials are joined, an infusion device in which a polypropylene drip tube and a soft polyvinyl chloride tube are connected, a polypropylene infusion bag and a soft polyvinyl chloride tube are provided. There are connected infusion devices and the like. Solvent adhesives such as tetrahydrofuran, methyl ethyl ketone, cyclohexanone, and cyclohexane are effective for bonding similar materials such as soft polyvinyl chloride tubes and soft polyvinyl chloride connectors, but soft polyvinyl chloride tubes and polypropylene There is no effect on the adhesion of the drip tube, etc., and the soft polyvinyl chloride tube connected to the polypropylene material is creeped and stress relaxed during long-term storage, and the soft polyvinyl chloride tube was actively pulled In such a case, there was a risk that the tube would fall off from the connecting portion.

このような問題を解決するためにUV硬化型接着剤または低融点材料部材を用いて接合することが行われている。さらには、軟質ポリ塩化ビニル製チューブと溶剤接着出来る材料を連結材料として使用することも行われてきた。前者の方法ではUV硬化型接着剤により接着可能な軟質材料製の管状部材と医療用具の管状部材を接合した第1管状部材に、UV硬化型接着剤では接着困難な材料製の管状第2部材を有する医療用具においては、リブ付きの接合空間にUV硬化型接着剤を充填して硬化し、脱離を阻止する方法が公知である(特許文献1)。しかし、UV硬化型接着剤を使用すると、滅菌による接続強度の低下や接着剤塗布の作業負担、あるいは被着物の材質が限定されるなどの問題があり、特に被接着体がポリブタジエンチューブなどの軟質材料の場合、UV硬化型接着剤との接着性がほとんどないという欠点がある。   In order to solve such problems, bonding is performed using a UV curable adhesive or a low-melting-point material member. Furthermore, a material that can be solvent-bonded to a soft polyvinyl chloride tube has been used as a connecting material. In the former method, the first tubular member made by joining the tubular member made of a soft material that can be bonded with the UV curable adhesive and the tubular member of the medical device, and the second tubular member made of a material difficult to bond with the UV curable adhesive. In a medical device having the above, there is a known method for preventing the detachment by filling a bonding space with ribs with a UV curable adhesive and curing it (Patent Document 1). However, when UV curable adhesives are used, there are problems such as a decrease in connection strength due to sterilization, the burden of applying adhesives, and the material of the adherend being limited. Especially, the adherend is a soft material such as a polybutadiene tube. In the case of the material, there is a drawback that there is almost no adhesion to the UV curable adhesive.

これらの方法に代わる後者の方法では、第1部材と第2部材との間に合成樹脂材料を含む第3部材を介挿し、第3部材のみを溶融した後、固化することによって第1部材と第2部材とを接合する(カシメる)ことも行われている(特許文献2)。この方法では、第3部材は第1および第2の部材の融点のうち、低い方よりさらに低い融点を有し、第3部材の融点を超えるが、第1および第2の部材の融点のうち低い方の温度より低い範囲の温度で加熱して接合する(カシメる)。したがって、第2管状部材が融点70〜80℃のポリブタジエンチューブである場合、ポリブタジエンチューブより融点が低く、かつ医療安全性に優れた第3部材の材料を選択することが難しく、かつ第3部材の形状、挿入位置決めなどが難しいという欠点がある。   In the latter method, which replaces these methods, a third member containing a synthetic resin material is inserted between the first member and the second member, and only the third member is melted and then solidified. Joining (caulking) the second member is also performed (Patent Document 2). In this method, the third member has a lower melting point than the lower one of the melting points of the first and second members, and exceeds the melting point of the third member, but of the melting points of the first and second members. Heat (join) by heating at a temperature lower than the lower temperature. Therefore, when the second tubular member is a polybutadiene tube having a melting point of 70 to 80 ° C., it is difficult to select a material for the third member having a lower melting point than that of the polybutadiene tube and excellent in medical safety, and There is a drawback that the shape and insertion positioning are difficult.

さらには、軟質ポリ塩化ビニル製チューブと溶剤で接着出来る材料を連結材料として使用する方法として、ポリプロピレン製点滴筒の下部に軟質ポリ塩化ビニル製チューブと溶剤接着性に優れるポリ塩化ビニル(PVC)あるいはアクリルニトリル−ブタジエン−スチレン共重合体(ABS樹脂)で作製された接続具を前記点滴筒下部に超音波溶着し、該接続具に軟質ポリ塩化ビニル製チューブを内挿入し、溶剤接着する方法が公知である(特許文献3)。しかし、この接続具材料は、軟質ポリ塩化ビニル製チューブとの接着性がよいが、後述するポリブタジエンチューブと溶剤接着性に劣る欠点がある。   Furthermore, as a method of using a material that can be bonded to a soft polyvinyl chloride tube and a solvent as a connecting material, a soft polyvinyl chloride tube and a polyvinyl chloride (PVC) excellent in solvent adhesive property are installed under the polypropylene drip tube. There is a method in which a connector made of an acrylonitrile-butadiene-styrene copolymer (ABS resin) is ultrasonically welded to the lower part of the drip tube, a soft polyvinyl chloride tube is inserted into the connector, and a solvent is bonded. Known (Patent Document 3). However, this connector material has good adhesiveness to a soft polyvinyl chloride tube, but has a disadvantage that it is inferior to the later-described polybutadiene tube and solvent adhesiveness.

特公平2−18103号公報Japanese Patent Publication No.2-18103 特開平2−80059号公報Japanese Patent Laid-Open No. 2-80059 特開昭63−283651号公報JP-A 63-283651

近年、ポリ塩化ビニル成形品を使用した後に廃棄するに当たり、焼却を行うとダイオキシンなどの有害ガスを発生することが問題となり、ポリ塩化ビニルに代わるプラスチック成形品が多種使用されている。これらのプラスチックの中でもポリブタジエンまたはスチレン系エラストマーは軟質材料として柔軟性、透明性に優れ、かつ、グリセリン、インシュリン等の薬剤を吸着しないことから非吸着軟質材料として注目されている。その中でも特にポリブタジエンが価格、医療安全性、機能性等の面から非ポリ塩化ビニル管状部材の医療用具として多種使用されている。その代表例として、第1部材の硬質管状部材であるポリプロピレン系点滴筒(点滴筒)と該点滴筒に嵌合(接合)した第2部材の軟質ポリブタジエン管状部材(ポリブタジエンチューブ)がある。   In recent years, when a polyvinyl chloride molded product is used and then discarded, incineration causes a problem of generating harmful gases such as dioxins, and various plastic molded products are used instead of polyvinyl chloride. Among these plastics, polybutadiene or styrene-based elastomers are attracting attention as non-adsorbing soft materials because they are excellent in flexibility and transparency as soft materials and do not adsorb drugs such as glycerin and insulin. Among them, polybutadiene is particularly used as a medical device for non-polyvinyl chloride tubular members from the viewpoint of price, medical safety, functionality and the like. A typical example is a polypropylene drip tube (drip tube) which is a rigid tubular member of a first member and a soft polybutadiene tubular member (polybutadiene tube) which is a second member fitted (joined) to the drip tube.

このような点滴筒とポリブタジエンチューブの接合は、例えば、ポリブタジエンチューブを点滴筒の下部に設けられた大径管状突出部(突出部内面に高さ0.3mm以下のリブ付き)とテーパー状の小径管状突出部との間に環状隙間を形成し、その隙間末端までポリブタジエンチューブを外バメ挿入し、大径管状突出部内面のリブはポリブタジエンチューブ挿入先端部の外表面に接触するように設計工夫されている。小径管状突出部先端直径はポリブタジエンチューブ内径より小であり、小径管状末端部直径はポリブタジエンチューブ内径直径より大きい。しかし、エチレンオキサイドガス滅菌処理、エチレンオキサイドガス脱気処理等を含めた60℃×24時間以上の熱処理により、ポリブタジエンチューブの残留応力緩和による緩みや、長期保存による反発弾性の低下(クリープ)によりポリブタジエンチューブのゆるみが生じる。   Such a drip tube and a polybutadiene tube can be joined by, for example, a large-diameter tubular projecting portion (with a rib having a height of 0.3 mm or less on the inner surface of the projecting portion) provided on the bottom of the drip tube and a tapered small diameter. An annular gap is formed between the tubular projection and the polybutadiene tube is inserted into the outer end of the gap, and the rib on the inner surface of the large-diameter tubular projection is designed to contact the outer surface of the polybutadiene tube insertion tip. ing. The small diameter tubular protrusion tip diameter is smaller than the polybutadiene tube inner diameter, and the small diameter tubular end diameter is larger than the polybutadiene tube inner diameter. However, due to heat treatment at 60 ° C for 24 hours or longer including ethylene oxide gas sterilization treatment, ethylene oxide gas degassing treatment, etc., the polybutadiene tube loosens due to relaxation of residual stress, and the rebound resilience (creep) decreases due to long-term storage. Tube loosening occurs.

従って、前記大径管状突出部とポリブタジエンチューブとの間の環状隙間に、UV硬化型接着剤を流し込み(塗布)、環状隙間をふさぐ方法が一般的に行われている。しかし、市販UV硬化型接着剤は点滴筒の材料であるポリプロピレンとポリブタジエンチューブの両者材料との接着力が弱く、接着剤の塗布が不十分であるとポリブタジエンチューブの閉塞等の異常現象で点滴筒内に圧力がかかった場合、点滴筒内部の輸液が漏れる危険がある。またUV硬化型接着剤を管理する事は難しく、さらにUV照射という手段を必要とする欠点を有する。   Therefore, a method is generally used in which a UV curable adhesive is poured (applied) into the annular gap between the large-diameter tubular protrusion and the polybutadiene tube to close the annular gap. However, commercially available UV curable adhesives have weak adhesive strength between both the polypropylene and polybutadiene tubes, which are the materials of the drip tube, and if the adhesive is insufficiently applied, the drip tube may become abnormal due to an abnormal phenomenon such as clogging of the polybutadiene tube. If pressure is applied inside, there is a risk of infusion in the drip tube leaking. Moreover, it is difficult to manage the UV curable adhesive, and further, there is a drawback that means of UV irradiation is required.

また、ポリブタジエンチューブを接続するためのコネクター、ポート等の硬質環状部材等の医療用具材料はポリブタジエンチューブより硬度の大きいポリプロピレン、ポリカーボネート、ポリエチレン、アクリルニトリル−ブタジエン−スチレン共重合体等が多く用いられているが、難接着材料であるポリブタジエンチューブを完全に接合するための方策が現時点では見出されていない。   In addition, polypropylene, polycarbonate, polyethylene, acrylonitrile-butadiene-styrene copolymer, etc., which are harder than polybutadiene tubes, are often used as medical device materials such as connectors for connecting polybutadiene tubes and rigid annular members such as ports. However, no measures have been found at present for completely joining the polybutadiene tube, which is a difficult-to-adhere material.

本発明の目的は、ポリプロピレンなどの硬質管状部材と軟質材料であるポリブタジエンチューブを強固に接合した医療用器具および該硬質管状部材にポリブタジエンチューブを強固に接合する方法、ならびにそのための接続具を提供することにある。   An object of the present invention is to provide a medical device in which a rigid tubular member such as polypropylene and a polybutadiene tube, which is a soft material, are firmly bonded, a method for firmly bonding a polybutadiene tube to the rigid tubular member, and a connection tool therefor. There is.

本発明者らは上記課題を解決するために種々、鋭意検討したところ、ブタジエン単位含有量が5〜45重量%、好ましくは、10〜40重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物が成形性、硬度、およびポリブタジエンチューブとの溶剤接着性に優れることを見出し、本発明に到達した。   The inventors of the present invention have made various studies in order to solve the above problems. As a result, the styrene-butadiene copolymer having a butadiene unit content of 5 to 45% by weight, preferably 10 to 40% by weight, or the copolymer The inventors have found that the composition of the coalescence and polystyrene is excellent in moldability, hardness, and solvent adhesiveness with the polybutadiene tube, and have reached the present invention.

すなわち、本発明は融点90℃以上の熱可塑性プラスチックの硬質材料からなる第1管状部材の端部に設けられた接続具に、ポリブタジエンの軟質材料からなる第2管状部材を接合した医療用具において、接続具はブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含むことを特徴とする医療用具である。
また、本発明は融点90℃以上の熱可塑性プラスチックの硬質材料からなる第1管状部材の端部に、ブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含む接続具を嵌合し、そして該接続具にポリブタジエンの軟質材料からなる第2管状部材を溶剤により接合することを特徴とする医療用具の製造方法である。
That is, the present invention provides a medical device in which a second tubular member made of a polybutadiene soft material is joined to a connection tool provided at an end of a first tubular member made of a thermoplastic hard material having a melting point of 90 ° C. or higher. The connecting device is a medical device comprising a styrene-butadiene copolymer having a butadiene content of 5 to 45% by weight or a composition of the copolymer and polystyrene.
The present invention also provides a styrene-butadiene copolymer having a butadiene content of 5 to 45% by weight or the copolymer at the end of the first tubular member made of a thermoplastic hard material having a melting point of 90 ° C. or higher. A medical device manufacturing method comprising: fitting a connector including a composition with polystyrene; and joining a second tubular member made of a soft material of polybutadiene to the connector using a solvent.

さらに、本発明は融点90℃以上の熱可塑性プラスチックの硬質材料からなる第1管状部材とポリブタジエンの軟質材料からなる第2管状部材を接合する接続具であって、ブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含むことを特徴とする接続具である。   Furthermore, the present invention is a connection tool for joining a first tubular member made of a thermoplastic hard material having a melting point of 90 ° C. or more and a second tubular member made of a soft material of polybutadiene, and having a butadiene content of 5 to 45 weight. % Styrene-butadiene copolymer or a composition of the copolymer and polystyrene.

本発明では、スチレン−ブタジエン共重合体を接続具として使用するため、硬質材料である第1管状部材(融点90℃以上の熱可塑性プラスチック)と軟質材料である第2管状部材(ポリブタジエンチューブ)を強固に接合できる。   In the present invention, since a styrene-butadiene copolymer is used as a connector, a first tubular member (a thermoplastic having a melting point of 90 ° C. or higher) that is a hard material and a second tubular member (polybutadiene tube) that is a soft material are used. Can be joined firmly.

本発明において、硬質材料からなる第1管状部材としては管状部材であるとともに、端部に接続具を嵌合できる端部(例えば、小径管状突出部)を有することが必要である。このような管状部材としては、輸液回路、輸液バッグまたは点滴筒などが含まれる。このような部材の材料としては、融点90℃以上の熱可塑性プラスチック、例えばポリプロピレン、エチレン−プロピレンコポリマー、ポリプロピレンとポリプロピレンエラストマーなどから成形された管状部材がある。特に、硬質材料として汎用されるポリプロピレンが好ましい。   In the present invention, the first tubular member made of a hard material is a tubular member, and it is necessary to have an end portion (for example, a small-diameter tubular projecting portion) capable of fitting a connection tool at the end portion. Such tubular members include infusion circuits, infusion bags or infusion tubes. As a material of such a member, there is a tubular member formed from a thermoplastic having a melting point of 90 ° C. or higher, for example, polypropylene, ethylene-propylene copolymer, polypropylene and polypropylene elastomer and the like. In particular, polypropylene which is widely used as a hard material is preferable.

第1管状部材の具体例として、図2で示す点滴筒でもって説明する。図2に点滴筒1の概略図を示し、図3に点滴筒下部(脚部)拡大断面図を示し、図4に点滴筒下部底面図を示す。点滴筒本体1には底部中央に薬液流出口と、薬液流出口の一部を構成する小径管状突出部4と、この外方に位置し、これと同心円状の大径環状突出部6を有し、さらに小径管状突出部4と大径管状突出部6との間に凹部5を形成する(図3)。小径管状突出部4は接続具固定内壁となり、大径管状突出部6は接続具固定外壁となり、前記凹部5は接続具を嵌合する箇所である。
脚部はテーパー状の小径管状突出部、スチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物で作製された円筒中空管状の接続具3を固定保持するための接続具固定内壁4および接続具固定外壁6を備える。接続具固定内壁4と接続具固定外壁6の環状隙間凹部5に、スチレン−ブタジエン共重合体で作られた接続具3の凸部先端部7を挿入する(図5)。接続具固定外壁6の先端部を超音波溶着機、熱板プレス機等で折り曲げ、接続具3を装着してもよい(図6)。この場合、接続具3には、折り曲げ部に嵌合する凹部を設けていることが好ましい。
A specific example of the first tubular member will be described using an infusion tube shown in FIG. FIG. 2 is a schematic view of the drip tube 1, FIG. 3 is an enlarged cross-sectional view of the lower portion (leg part) of the drip tube, and FIG. 4 is a bottom view of the drip tube. The drip tube main body 1 has a chemical solution outlet, a small-diameter tubular protrusion 4 constituting a part of the chemical outlet, and a large-diameter annular protrusion 6 concentrically arranged on the outer side. Further, a recess 5 is formed between the small-diameter tubular protrusion 4 and the large-diameter tubular protrusion 6 (FIG. 3). The small-diameter tubular projecting portion 4 becomes a connecting fixture fixing inner wall, the large-diameter tubular projecting portion 6 becomes a connecting fixture fixing outer wall, and the concave portion 5 is a place where the connecting fixture is fitted.
The leg is a tapered small-diameter tubular protrusion, a cylindrical hollow tubular connector 3 made of a styrene-butadiene copolymer or a composition of the copolymer and polystyrene, and a connector fixing inner wall 4 for fixing and holding the connector. And a connector fixing outer wall 6. The convex part front-end | tip part 7 of the connection tool 3 made from the styrene-butadiene copolymer is inserted in the annular clearance concave part 5 of the connection tool fixing inner wall 4 and the connection tool fixing outer wall 6 (FIG. 5). The distal end portion of the connecting fixture fixing outer wall 6 may be bent by an ultrasonic welding machine, a hot plate press or the like, and the connecting fixture 3 may be attached (FIG. 6). In this case, it is preferable that the connector 3 is provided with a recess that fits into the bent portion.

点滴筒の材料としては、一般的にはポリプロピレン、エトレン−プロピレンコポリマー、ポリプロピレンとポリプロピレンエラストマーのブレンドなどがある。点滴筒は、外径が約14〜17mmであり、内径が約13〜16mm、長さが約50〜70mmである。脚部を構成する小径管状突出部4は、外径が約2〜4mmであり、内径が約1〜3mmであり、長さが約5mm〜20mmである。接続具3を保持するための脚部を構成する接続具固定内壁4の厚みは約1〜2mmであり、長さは約1〜3mm、接続具固定外壁6の厚みは約1〜2mmであり、長さは約2〜5mmである。凹部を構成する接続具固定内壁4と接続具固定外壁6の環状隙間凹部5は、隙間幅約0.5〜2mmである。これらの寸法は一例であって、本発明を制限するものではない。   Examples of drip tube materials generally include polypropylene, ethrene-propylene copolymer, and a blend of polypropylene and polypropylene elastomer. The drip tube has an outer diameter of about 14-17 mm, an inner diameter of about 13-16 mm, and a length of about 50-70 mm. The small-diameter tubular protrusion 4 constituting the leg has an outer diameter of about 2 to 4 mm, an inner diameter of about 1 to 3 mm, and a length of about 5 to 20 mm. The thickness of the connecting fixture fixing inner wall 4 constituting the legs for holding the connecting fixture 3 is about 1 to 2 mm, the length is about 1 to 3 mm, and the thickness of the connecting fixture fixing outer wall 6 is about 1 to 2 mm. The length is about 2-5 mm. The annular clearance recess 5 between the connecting fixture fixing inner wall 4 and the connecting fixture fixing outer wall 6 constituting the recess has a clearance width of about 0.5 to 2 mm. These dimensions are examples and do not limit the present invention.

本発明において軟質材料からなる第2管状部材としては、ポリブタジエンが含まれる。ポリブタジエンとしては、シンジオタクチック1,2−ポリブタジエンを単独で重合した重合体、これを共重合した共重合体、または、これらの重合体または共重合体を主成分とする組成物であり、シンジオタクチック1,2−ポリブタジエンにスチレンを共重合した共重合体、または、例えばスチレン−イソプレン−スチレンのスチレン系エラストマーをブレンドしたものも含まれる。1、2−ポリブタジエンは共重合体中、50〜100モル%を占めることが望ましく、また、重合体または共重合体は組成物中に、50〜100重量%含まれることが望ましい。該チューブは、外径が2〜5mmであり、内径が約1〜4mmであり、長さが約100cm〜200cmを有する。本発明ではJISK6301による硬度80〜90Aの軟質ポリブタジエンチューブが好ましい。JISK6301による硬度95A以上のポリブタジエンチューブは、硬く容易に折れ曲がりやすい欠点がある。チューブの内径、外径および長さは、使用目的に応じて任意に選択できる。
チューブの内径、外径および長さは、使用目的に応じて任意に選択できる。
In the present invention, the second tubular member made of a soft material includes polybutadiene. The polybutadiene is a polymer obtained by polymerizing syndiotactic 1,2-polybutadiene alone, a copolymer obtained by copolymerizing the polymer, or a composition containing these polymers or copolymers as a main component. A copolymer obtained by copolymerizing styrene with tactic 1,2-polybutadiene, or a blend of a styrene elastomer such as styrene-isoprene-styrene is also included. It is desirable that 1,2-polybutadiene accounts for 50 to 100 mol% in the copolymer, and the polymer or copolymer is desirably contained in the composition in an amount of 50 to 100% by weight. The tube has an outer diameter of 2-5 mm, an inner diameter of about 1-4 mm, and a length of about 100 cm to 200 cm. In the present invention, a soft polybutadiene tube having a hardness of 80 to 90 A according to JISK6301 is preferred. A polybutadiene tube having a hardness of 95A or more according to JISK6301 has a drawback that it is hard and easily bends. The inner diameter, outer diameter, and length of the tube can be arbitrarily selected according to the purpose of use.
The inner diameter, outer diameter, and length of the tube can be arbitrarily selected according to the purpose of use.

本発明において第1管状部材の端部に設けられる接続具とは、薬液流出口とともに、第1管状部材に接合できる部分と第2軟質管状部材を接合できる部分を有する管状中空管である。該接続部材の形状、サイズなどは、特に制限されない。
その形状の一例を図5および図6に示す。このような接続具3は中央に第1管状部材1の薬液流出口と連通する薬液流路、および該薬液流路の上端に第1管状部材1の接続具固定内壁4および接続具固定外壁6と接して同心円状であって、かつ、先端部が外方に突出した肉厚凸部7が形成されている。第1管状部材の環状隙間凹部5にこの凸部7が嵌着される。嵌着された後、必要により接続具固定外壁6の一部を溶融して、溶融部分によって凸部7がかしめられていてもよい。接続具3の薬液流路の中間部には第2管状部材9を係止できる環状リブ8が形成されていてもよい。接続具3は、外径約4〜8mm、内径で約2〜5mmであり、全長は約8〜12mmである硬質円筒中空管である。接続具3の内径上部の凸部7は、厚み約0.5〜2mm、幅1〜2mmであり、接続具の環状リブ8は厚み約0.5〜2mmである。なお、接続具3はテーパー状であってもかまわない。これらの寸法は、一例であって、本発明を制限するものではない。
接続具の材料は、ブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含む。
In the present invention, the connector provided at the end of the first tubular member is a tubular hollow tube having a portion that can be joined to the first tubular member and a portion that can join the second flexible tubular member together with the chemical solution outlet. The shape and size of the connecting member are not particularly limited.
An example of the shape is shown in FIGS. Such a connecting tool 3 has a chemical liquid channel communicating with the chemical liquid outlet of the first tubular member 1 at the center, and a connector fixing inner wall 4 and a connector fixing outer wall 6 of the first tubular member 1 at the upper end of the chemical liquid channel. A thick convex portion 7 is formed which is concentric with and in contact with the tip, and whose tip portion protrudes outward. The convex portion 7 is fitted into the annular gap concave portion 5 of the first tubular member. After the fitting, if necessary, a part of the connector fixing outer wall 6 may be melted, and the convex portion 7 may be caulked by the melted portion. An annular rib 8 that can lock the second tubular member 9 may be formed in the middle portion of the chemical liquid flow path of the connector 3. The connector 3 is a rigid cylindrical hollow tube having an outer diameter of about 4 to 8 mm, an inner diameter of about 2 to 5 mm, and an overall length of about 8 to 12 mm. The convex portion 7 at the upper part of the inner diameter of the connector 3 has a thickness of about 0.5 to 2 mm and a width of 1 to 2 mm, and the annular rib 8 of the connector has a thickness of about 0.5 to 2 mm. The connection tool 3 may be tapered. These dimensions are examples and do not limit the present invention.
The material of the connector includes a styrene-butadiene copolymer having a butadiene content of 5 to 45% by weight or a composition of the copolymer and polystyrene.

本発明に用いるブタジエン−スチレン共重合体としては、スチレン−ブタジエン−スチレン共重合体(SBS)またはスチレン−ブタジエン共重合体(SBまたはSBC)が挙げられ、ブロックまたはランダム共重合体を含む。またはこれらの共重合体とポリスチレンとの組成物であってもよい。ポリスチレンの割合は、前記共重合体中のスチレン単位含有量に応じて変化する。
本発明では、ブタジエン含有量とは、上記共重合体または該共重合体とポリスチレンの全重量に対するブタジエン含有量をいう。すなわち、本発明ではスチレン単位含有量95〜55重量%およびブタジエン単位含有量5〜45重量%の共重合体または該共重合体とポリスチレンとの組成物、好ましくは、スチレン単位含有量90〜60重量%、ブタジエン単位含有量10〜40重量%の共重合体または該共重合体とポリスチレンとの組成物を使用する。このようなスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物は、成形性、硬度およびポリブタジエンチューブとの溶剤接着性に優れる。ブタジエン単位含有量が45重量%を超えると、粘着性、柔軟性が生じ、成形時の離型性に劣る。また、ブタジエン単位含有量が5重量%未満であると、ポリブタジエンチューブとの溶剤接着性(引張り接着強度で評価)は実用に耐えない強度以下になる。
Examples of the butadiene-styrene copolymer used in the present invention include styrene-butadiene-styrene copolymer (SBS) and styrene-butadiene copolymer (SB or SBC), and include block or random copolymers. Or the composition of these copolymers and polystyrene may be sufficient. The proportion of polystyrene varies depending on the styrene unit content in the copolymer.
In the present invention, the butadiene content refers to the butadiene content relative to the total weight of the copolymer or the copolymer and polystyrene. That is, in the present invention, a copolymer having a styrene unit content of 95 to 55% by weight and a butadiene unit content of 5 to 45% by weight or a composition of the copolymer and polystyrene, preferably a styrene unit content of 90 to 60 A copolymer having a content of 10% by weight and a butadiene unit content of 10 to 40% by weight or a composition of the copolymer and polystyrene is used. Such a styrene-butadiene copolymer or a composition of the copolymer and polystyrene is excellent in moldability, hardness, and solvent adhesion to a polybutadiene tube. When the butadiene unit content exceeds 45% by weight, adhesiveness and flexibility are generated, and the mold release property during molding is poor. Further, when the butadiene unit content is less than 5% by weight, the solvent adhesion to the polybutadiene tube (evaluated by the tensile adhesive strength) is less than the strength that cannot be practically used.

スチレン−ブタジエン−スチレン共重合体または該共重合体とポリスチレンとの組成物に代えて、アクリルニトリル−ブタジエン−スチレン−メチルメタアクリレート共重合体の透明ABS、メチルメタアクリレート(MMA)、メチルメタアクリレート−ブタジエン−スチレン(MBS)、スチレン、スチレン−エチレン−プロピレン−スチレン(SEPS)、ポリカーボネートを使用して、硬質管状第1部材とポリブタジエンチューブを溶剤接着し、引っ張り接着強度で測定したところ、溶剤接合部分のポリブタジエンチューブが破断せずに容易に抜け実用に耐えない欠点があった。   Instead of the styrene-butadiene-styrene copolymer or the composition of the copolymer and polystyrene, transparent ABS, methyl methacrylate (MMA), methyl methacrylate of acrylonitrile-butadiene-styrene-methyl methacrylate copolymer -Butadiene-Styrene (MBS), Styrene, Styrene-Ethylene-Propylene-Styrene (SEPS), Polycarbonate, Solvent Bonding of Hard Tubular First Member and Polybutadiene Tube, and Measurement by Tensile Bond Strength There was a drawback that the polybutadiene tube of the part was not easily broken without breaking and could not be put to practical use.

本発明の医療用具の一実施態様として、図1に示される硬質第1管状部材が点滴筒1であり、軟質第2管状部材がポリブタジエンチューブ9である点滴注射などに使用される医療用具がある。基本的には、点滴筒1の上部に輸液容器に刺通する導入針2を有し、点滴筒1下部にポリブタジエンチューブ9を接合し、このポリブタジエンチューブ9の他端は静脈針13を装着するフリーロックコネクター12を接合する。さらに、前記点滴筒1の下流側のチューブ9に取り付けられ、該チューブ内部を流れる輸液の流量を調整するクランプ11とからなる。一般に、精密に輸液の点滴を行うには、点滴速度、輸液量を管理調整できる輸液ポンプ10が点滴筒1とフリーロックコネクター12の間のポリブタジエンチューブ9に設けられる。
第1管状部材である点滴筒1は、融点90℃以上の熱可塑性プラスチックからなる成形品からなり、側壁は柔軟性および透明性を有している。従って、透明な点滴筒1により、点滴中に流出口からの点滴液の落下が確可能となっている。具体的には、点滴筒1本体と、該本体の上端部に輸液容器の密栓に刺通する導入針2を接続し、かつ下部はテーパー状筒体とそれに続く脚部を有する。本発明では、点滴筒1とポリブタジエンチューブ9がスチレン−ブタジエン共重合体で作られた接続具によって接合されている。
As an embodiment of the medical device of the present invention, there is a medical device used for instillation injection or the like in which the hard first tubular member shown in FIG. 1 is an infusion tube 1 and the soft second tubular member is a polybutadiene tube 9. . Basically, it has an introduction needle 2 that pierces the infusion container at the top of the infusion tube 1, a polybutadiene tube 9 is joined to the bottom of the infusion tube 1, and a venous needle 13 is attached to the other end of the polybutadiene tube 9. Join the freelock connector 12. Furthermore, it comprises a clamp 11 which is attached to the tube 9 on the downstream side of the infusion tube 1 and adjusts the flow rate of the infusion flowing through the tube. In general, in order to accurately infuse an infusion, an infusion pump 10 capable of managing and adjusting the infusion rate and the amount of infusion is provided in the polybutadiene tube 9 between the infusion tube 1 and the freelock connector 12.
The drip tube 1 as the first tubular member is a molded product made of a thermoplastic having a melting point of 90 ° C. or higher, and the side wall has flexibility and transparency. Therefore, the transparent drip tube 1 can reliably drop the drip liquid from the outlet during the drip. Specifically, the drip tube 1 is connected to the main body, and the upper end of the main body is connected to the introduction needle 2 that is pierced through the hermetic stopper of the infusion container, and the lower portion has a tapered tube and a leg portion that follows it. In the present invention, the drip tube 1 and the polybutadiene tube 9 are joined by a connector made of a styrene-butadiene copolymer.

本発明の医療用具を用いて点滴を行うには、まず、輸液ポンプ10のドアを開け、ポリブタジエンメインチューブ9を装着しない状態で輸液ポンプ10の電源スイッチを入れた後、クランプ11で、ポリブタジエンメインチューブ9を閉じた状態で点滴筒1に備えられた導入針2を輸液容器のゴム栓に刺通すると共に、点滴筒1を手で前後に押しながらプライミングし、点滴筒1に輸液を1/3溜め込む。次に、クランプ11を開いて静脈針13の先端迄輸液を充填しクランプ11を閉じる。次に、輸液ポンプ10内に設置されているチューブクランプ11を解除し、点滴筒1とクランプ11の間のポリブタジエンメインチューブ9を輸液ポンプ10に装着し、輸液ポンプ10のドアを閉じ、輸液流量、点滴する輸液総量(予定量)を設定した後、クランプ11を開き、点滴筒1内、および静脈針13の先端に輸液の滴下が無いことを確認後、静脈針13を穿刺し、輸液ポンプ10の開始スイッチを押し、輸液供給を開始する。輸液供給中にポリブタジエンメインチューブ9が不慮の事故で折れたりするとポリブタジエンメインチューブが閉塞し、チューブ内に急激な圧力がかかり、点滴筒1とポリブタジエンメインチューブ9の接続部がポリブタジエンチューブ9の内圧負荷(上昇)による膨張で容易に抜ける危険があるが、本発明ではポリブタジエンメインチューブと接合(接着)が強固にできるスチレン−ブタジエン−スチレン共重合体を接続部品として使用するため、これらの危険を回避できる。 In order to perform infusion using the medical device of the present invention, first, the door of the infusion pump 10 is opened, the power switch of the infusion pump 10 is turned on without the polybutadiene main tube 9 being attached, While the tube 9 is closed, the introduction needle 2 provided in the infusion tube 1 is pierced through the rubber stopper of the infusion container, and priming is performed while pushing the infusion tube 1 back and forth by hand. 3 accumulate. Next, the clamp 11 is opened, the infusion solution is filled up to the tip of the venous needle 13, and the clamp 11 is closed. Next, the tube clamp 11 installed in the infusion pump 10 is released, the polybutadiene main tube 9 between the infusion tube 1 and the clamp 11 is attached to the infusion pump 10, the door of the infusion pump 10 is closed, and the infusion flow rate is set. After setting the total amount (planned amount) of the infusion to be instilled, the clamp 11 is opened, and after confirming that there is no infusion of the infusion in the infusion tube 1 and at the tip of the vein needle 13, the vein needle 13 is punctured and the infusion pump Press the 10 start switch to start the infusion supply. Polybutadiene main tube 9 during the infusion supply is occluded polybutadiene main tube when broken or in accidents, takes a sudden pressure in the tube, the connection portion of the drip chamber 1 and the polybutadiene main tube 9 is pressure load of polybutadiene tubing 9 Although there is a risk of easily coming off due to expansion due to (rising), in the present invention, a styrene-butadiene-styrene copolymer that can be firmly joined (adhered) to the polybutadiene main tube is used as a connecting part, so these risks are avoided. it can.

本発明の医療用具の製造方法は、硬質材料からなる第1管状部材の端部に設けられた管状突出部に、接続具を嵌合し、そして該接続具に軟質材料からなる第2管状部材を溶剤により接合することを特徴とする。
本発明で使用する溶剤としては、溶剤型接着剤、例えば、シクロヘキサン、シクロヘキサノン、酢酸エチル、メチルエチルケトンまたはテトラヒドロフランがある。
In the method for producing a medical device of the present invention, a connecting tool is fitted to a tubular projecting portion provided at an end of a first tubular member made of a hard material, and the second tubular member made of a soft material is connected to the connecting tool. Are bonded with a solvent.
Examples of the solvent used in the present invention include solvent-type adhesives such as cyclohexane, cyclohexanone, ethyl acetate, methyl ethyl ketone, and tetrahydrofuran.

本発明方法の一実施態様としては、ポリプロピレン製硬質管状部材(点滴筒)下部の小径管状突出部4と大径管状突出部6の間に位置する環状隙間凹部5に、スチレン−ブタジエン共重合体で成形した接続具3の凸部7を挿入し、熱プレスで強固に接合する。その接合方法は、特開昭63−283651号公報の方法に記載される超音波でも良い。
次いで、外表面をスチレン−ブタジエンと溶剤接着できる溶剤(シクロヘキサン、シクロヘキサノン、酢酸エチル等)で濡らしたポリブタジエンチューブ9を接続具3内面に接触させながら、環状リブ8まで内挿入し、接続具3と溶剤で接着する。環状リブ8を設ける理由は、ポリブタジエンチューブ9に故意に引っ張り力がかかった場合、溶剤接合部のポリブタジエンチューブ径が小さくなり、輸液量が変化するのを防止すると共に、超音波接着が不充分でも点滴筒からの輸液が漏れにくい長所がある。
As an embodiment of the method of the present invention, a styrene-butadiene copolymer is formed in an annular gap recess 5 located between a small-diameter tubular protrusion 4 and a large-diameter tubular protrusion 6 below a polypropylene rigid tubular member (drip tube). The convex portion 7 of the connector 3 molded in step 1 is inserted and firmly joined by hot pressing. The joining method may be an ultrasonic wave described in the method of JP-A-63-283651.
Next, the polybutadiene tube 9 wetted with a solvent (cyclohexane, cyclohexanone, ethyl acetate, etc.) whose outer surface is solvent-bonded to styrene-butadiene is inserted into the annular rib 8 while contacting the inner surface of the connector 3, and the connector 3 Adhere with solvent. The reason for providing the annular rib 8 is that when a tensile force is intentionally applied to the polybutadiene tube 9, the diameter of the polybutadiene tube at the solvent joint portion is reduced to prevent the infusion volume from changing, and even if the ultrasonic bonding is insufficient. There is an advantage that the infusion from the drip tube is difficult to leak.

実施例1
(a)評価用サンプルの作製
表1および表3に示すスチレン−ブタジエン共重合体または各種配合割合の該共重合体とポリスチレンとの組成物(試料A〜F)から、内径約3.6mm、外径約6.6mm、肉厚約1.5mm、長さ約8mmの円筒中空管をシリンダー温度170〜200℃、金型温度20〜25℃の条件下で射出成形し、ポリブタジエン溶剤接着強度評価用サンプルを作製した。
単軸押出機を使用して、シリンダー温度130〜150℃で、外径約3.6mm、内径約2.3mmのポリブタジエンチューブを押し出し、長さ約10cmにカットしたチューブを作製した。
(b)ポリブタジエンチューブ溶剤接着方法
約23℃の室温でシクロヘキサノンを上記チューブ先端部より約8mm表面塗布したポリブタジエンチューブを、上記円筒中空管の末端迄、即ち、約8mm内挿入(内バメ)し、約23℃の室温で1〜2日放置後、約60℃の乾熱乾燥機で約24時間熱処理し、約23℃の室温で1日以上放置した。
(c)チューブ接着性評価方法
上記で作製した円筒中空管とポリブタジエンチューブを使用して、円筒中空管の内径部と溶剤接着したポリブタジエンチューブの引張り最大強度を約23℃にて島津製作所製万有試験機(型式:AG−500D)で測定した。その結果を表2および表4に示す。
(c)−1 引張り最大強度測定条件
測定条件:中央にφ3.8mmの円孔がある厚さ約4mmのステンレス製試験保持具を引張り試験機の上部チャックに取り付け、その孔に円筒中空管に内挿入し接着したポリブタジエンチューブを通し、引張り速度500mm/分、チューブ試験長40mmで引張り最大強度を測定した。
(c)−2 引張り接着最大強度の評価
下記(1)および(2)の基準を両方満足するもの:○(合格)
下記(1)または(2)の基準の両方共満足しないもの:×(不合格)
(1)チューブ引張り平均最大強度 4Kg以上
(2)チューブ引張り最大強度試験後のチューブ破断状態でチューブが円筒中空内で破断している。
(d)円筒中空管の射出成形性評価
各種樹脂の射出成形に於いて、一般に使用される射出成形樹脂と相対評価した。
金型離型時間、円筒中空管の外観等に関して問題なし:○
粘着性あり、金型離型時間長く、円筒中空管外観斑有り:×
Example 1
(A) Preparation of sample for evaluation From the composition (samples A to F) of the styrene-butadiene copolymer shown in Table 1 and Table 3 or the copolymer and polystyrene in various blending ratios, an inner diameter of about 3.6 mm, A cylindrical hollow tube with an outer diameter of about 6.6 mm, a wall thickness of about 1.5 mm, and a length of about 8 mm is injection-molded under conditions of a cylinder temperature of 170 to 200 ° C. and a mold temperature of 20 to 25 ° C. An evaluation sample was produced.
Using a single screw extruder, a polybutadiene tube having an outer diameter of about 3.6 mm and an inner diameter of about 2.3 mm was extruded at a cylinder temperature of 130 to 150 ° C. to produce a tube cut to a length of about 10 cm.
(B) Polybutadiene tube solvent adhering method At about 23 ° C., a polybutadiene tube having a surface coated with cyclohexanone of about 8 mm from the tip of the tube is inserted into the end of the cylindrical hollow tube, ie, about 8 mm. After standing at a room temperature of about 23 ° C. for 1 to 2 days, it was heat-treated in a dry heat dryer at about 60 ° C. for about 24 hours and left at a room temperature of about 23 ° C. for over 1 day.
(C) Tube Adhesive Evaluation Method Using the cylindrical hollow tube and polybutadiene tube prepared above, the maximum tensile strength of the inner diameter portion of the cylindrical hollow tube and the solvent-bonded polybutadiene tube is about 23 ° C., manufactured by Shimadzu Corporation. Measured with a universal testing machine (model: AG-500D). The results are shown in Tables 2 and 4.
(C) -1 Maximum tensile strength measurement conditions Measurement conditions: A stainless steel test holder having a thickness of about 4 mm with a circular hole of φ3.8 mm in the center is attached to the upper chuck of the tensile tester, and a cylindrical hollow tube is inserted into the hole. Through a polybutadiene tube inserted and bonded into the tube, the maximum tensile strength was measured at a pulling speed of 500 mm / min and a tube test length of 40 mm.
(C) -2 Evaluation of Maximum Tensile Bond Strength Satisfying both the following criteria (1) and (2): ○ (pass)
What does not satisfy both of the following criteria (1) or (2): x (failed)
(1) Tube tensile average maximum strength 4 Kg or more (2) The tube is broken in the hollow cylindrical shape in the tube rupture state after the tube tensile maximum strength test.
(D) Evaluation of injection moldability of cylindrical hollow tube In the injection molding of various resins, relative evaluation was made with an injection molding resin generally used.
No problem with mold release time, appearance of cylindrical hollow tube, etc.
Adhesive, long mold release time, cylindrical hollow tube appearance spots: ×

比較例1
表5に示される透明性成形材料(試料)で、内径約3.6mm、外径約6.6mm、肉厚約1.5mm、長さ約8mmの円筒中空管を成形し、その円筒中空管に室温(23℃)でシクロヘキサノンをチューブ先端部より約8mm表面塗布したポリブタジエンチューブ(外径約3.6mm、内径約2.3mm、長さ約10cm)先端部を円筒中空管の末端部まで、約8mm内挿入(内バメ)し、約23℃の室温で1〜2日放置後、約60℃の乾熱乾燥機で約24時間熱処理し、約23℃の室温で1日以上放置した。中空円筒管とポリブタジエンチューブの引張り接着強度を島津製作所製万能試験機(型式:AG−500D)で測定した。ポリブタジエンチューブの溶剤接着方法および測定条件は実施例のチューブ接着性評価方法と同一である。
これらの結果を表1〜表4(本発明)および表5、6(比較例)に示す。
Comparative Example 1
Using the transparent molding material (sample) shown in Table 5, a cylindrical hollow tube having an inner diameter of about 3.6 mm, an outer diameter of about 6.6 mm, a wall thickness of about 1.5 mm, and a length of about 8 mm is molded. Polybutadiene tube (outside diameter: about 3.6 mm, inside diameter: about 2.3 mm, length: about 10 cm) with cyclohexanone applied to the empty tube at room temperature (23 ° C.) about 8 mm from the tip of the tube. Inserted into part 8 mm (inside swallow), left at room temperature of about 23 ° C. for 1-2 days, heat-treated in a dry heat dryer at about 60 ° C. for about 24 hours, and at room temperature of about 23 ° C. for over 1 day I left it alone. The tensile bond strength between the hollow cylindrical tube and the polybutadiene tube was measured with a universal testing machine (model: AG-500D) manufactured by Shimadzu Corporation. The solvent adhesion method and measurement conditions of the polybutadiene tube are the same as the tube adhesion evaluation method of the example.
These results are shown in Tables 1 to 4 (present invention) and Tables 5 and 6 (Comparative Examples).

Figure 0004432734
Figure 0004432734

スチレン−ブタジエン共重合体:KK38はスチレン/ブタジエン=70/30(重量比)、KR05はスチレン/ブタジエン=75/25(重量比)である。   Styrene-butadiene copolymer: KK38 is styrene / butadiene = 70/30 (weight ratio), and KR05 is styrene / butadiene = 75/25 (weight ratio).

Figure 0004432734
Figure 0004432734

Figure 0004432734
Figure 0004432734

スチレン/ブタジエン重量比;D−KX405=24/76、 D−KX408=43/57   Styrene / butadiene weight ratio; D-KX405 = 24/76, D-KX408 = 43/57

Figure 0004432734
Figure 0004432734

Figure 0004432734
Figure 0004432734

Figure 0004432734
Figure 0004432734

表1〜6から明らかなように、本発明の円筒中空管(接続具)は、ポリブタジエンチューブとの引張り接着最大強度(Kg)が大きく、チューブ引張り試験後のチューブ接着部の破断状態は少なく、かつ、チューブ接着性に優れるとともに、成形性にも優れる。   As is apparent from Tables 1 to 6, the cylindrical hollow tube (connector) of the present invention has a high maximum tensile bond strength (Kg) with the polybutadiene tube, and the tube bonded portion after the tube tensile test is less broken. And it is excellent in tube adhesiveness and moldability.

本発明の医療用具を示す概略図である。It is the schematic which shows the medical device of this invention. 図1に示す医療用具の点滴筒およびそれに接合された導入針を示す外観図である。It is an external view which shows the infusion tube of the medical device shown in FIG. 1, and the introduction needle joined to it. 図1に示す点滴筒下部断面図である。It is a drip pipe lower part sectional view shown in FIG. 図1に示す点滴筒下部底面図である。FIG. 2 is a bottom view of the drip tube shown in FIG. 1. 点滴筒下部とそれに接合した接続具を示す断面図である。It is sectional drawing which shows a drip pipe lower part and the connector joined to it. 点滴筒下部とそれに接合した接続具を示す断面図である。It is sectional drawing which shows a drip pipe lower part and the connector joined to it.

符号の説明Explanation of symbols

1 点滴筒
2 導入針
3 接続具
4 小径管状突出部(接続具固定内壁)
5 環状隙間(凹部)
6 大径管状突出部(接続具固定外壁)
7 接続具の凸部7
8 接続具の環状リブ
9 ポリブタジエンチューブ
10 輸液ポンプ
11 クランプ
12 フリーロックコネクター
13 静脈針
1 Infusion tube 2 Introducing needle 3 Connection tool 4 Small-diameter tubular protrusion (connector fixing inner wall)
5 annular gap (concave)
6 Large-diameter tubular projection (outer wall for fixing fixture)
7 Convex part 7 of connector
8 Annular rib of connector 9 Polybutadiene tube 10 Infusion pump 11 Clamp 12 Free lock connector 13 Intravenous needle

Claims (8)

融点90℃以上の熱可塑性プラスチックの硬質材料であるポリプロピレン、エチレン−プロピレンコポリマーまたはポリプロピレンとポリプロピレンエラストマーのブレンドからなる第1管状部材の端部に設けられた接続具に、ポリブタジエンの軟質材料からなる第2管状部材を接合した医療用具において、接続具はブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含むことを特徴とする医療用具。 A connector provided at the end of the first tubular member made of polypropylene, an ethylene-propylene copolymer, or a blend of polypropylene and polypropylene elastomer, which is a thermoplastic hard material having a melting point of 90 ° C. or higher, is made of a soft material of polybutadiene. 2. A medical device in which two tubular members are joined, wherein the connector includes a styrene-butadiene copolymer having a butadiene content of 5 to 45% by weight or a composition of the copolymer and polystyrene. . 前記第1管状部材が、輸液回路、輸液バッグ、または点滴筒である、請求項1記載の医療用具。   The medical device according to claim 1, wherein the first tubular member is an infusion circuit, an infusion bag, or an infusion tube. 前記第2管状部材がJISK6301による硬度80〜90Aのポリブタジエンチューブである、請求項1記載の医療用具。   The medical device according to claim 1, wherein the second tubular member is a polybutadiene tube having a hardness of 80 to 90A according to JISK6301. 融点90℃以上の熱可塑性プラスチックの硬質材料であるポリプロピレン、エチレン−プロピレンコポリマーまたはポリプロピレンとポリプロピレンエラストマーのブレンドからなる第1管状部材の端部に、ブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含む接続具を嵌合し、そして該接続具にポリブタジエンの軟質材料からなる第2管状部材を溶剤により接合することを特徴とする医療用具の製造方法。 Styrene having a butadiene content of 5 to 45% by weight at the end of the first tubular member made of polypropylene, an ethylene-propylene copolymer or a blend of polypropylene and polypropylene elastomer, which is a hard material of a thermoplastic having a melting point of 90 ° C. or higher A medical device characterized by fitting a connector containing a butadiene copolymer or a composition of the copolymer and polystyrene, and joining a second tubular member made of a soft polybutadiene material to the connector with a solvent. Tool manufacturing method. 前記第1管状部材が、輸液回路、輸液バッグまたは点滴筒である、請求項記載の医療用具の製造方法。 The method for manufacturing a medical device according to claim 4 , wherein the first tubular member is an infusion circuit, an infusion bag, or an infusion tube. 溶剤が溶剤型接着剤である、請求項記載の医療用具の製造方法。 The method for producing a medical device according to claim 4 , wherein the solvent is a solvent-type adhesive. 溶剤が、シクロヘキサン、シクロヘキサノン、酢酸エチル、メチルエチルケトンまたはテトラヒドロフランある、請求項記載の医療用具の製造方法。 The method for producing a medical device according to claim 4 , wherein the solvent is cyclohexane, cyclohexanone, ethyl acetate, methyl ethyl ketone, or tetrahydrofuran. 融点90℃以上の熱可塑性プラスチックの硬質材料であるポリプロピレン、エチレン−プロピレンコポリマーまたはポリプロピレンとポリプロピレンエラストマーのブレンドからなる第1管状部材とポリブタジエンの軟質材料からなる第2管状部材を接合する接続具であって、ブタジエン含有量が5〜45重量%であるスチレン−ブタジエン共重合体または該共重合体とポリスチレンとの組成物を含むことを特徴とする接続具。 A connector for joining a first tubular member made of polypropylene, an ethylene-propylene copolymer or a blend of polypropylene and polypropylene elastomer, and a second tubular member made of a soft material of polybutadiene, which are hard materials of thermoplastics having a melting point of 90 ° C. or higher. And a styrene-butadiene copolymer having a butadiene content of 5 to 45% by weight or a composition of the copolymer and polystyrene.
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JP5446458B2 (en) * 2009-05-22 2014-03-19 ニプロ株式会社 Drip tube
CN105106015B (en) * 2015-10-10 2018-10-02 青岛华仁堂健康科技有限公司 Novel infusion is managed with mouth
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