JP3727554B2

JP3727554B2 - Infusion container plug

Info

Publication number: JP3727554B2
Application number: JP2001180483A
Authority: JP
Inventors: 信之田中; 俊雄則本; 勝士白川; 功大竹
Original assignee: Showa Denko KK
Current assignee: Resonac Holdings Corp
Priority date: 2001-06-14
Filing date: 2001-06-14
Publication date: 2005-12-14
Anticipated expiration: 2020-12-14
Also published as: JP2002028219A

Description

【０００１】
【産業上の利用分野】
本発明は、点滴輸液等に用いられる合成樹脂製の輸液容器の口栓体及びその製造方法に係り、特に輸液容器の口栓体のゴム栓部分に薬液注入又は排出用針の刺通時、引抜時又はこれらの繰り返し時にも液漏れのない口栓体及びその製造方法に関する。
【０００２】
【従来の技術】
近年、点滴注射等に使用する輸液容器としては、ガラス製の容器とか合成樹脂製のボトルやバッグ等が広く使用されているが、輸液容器には、その輸送、保管、使用時の耐破損性等の点で、後者の合成樹脂製のものが好適とされている。
一方、輸液容器用ゴム栓に関しては、点滴のための単なる針の刺通の他、他薬液を混合しながら点滴を行うための該薬液注入用針の刺通、点滴中止に伴う針の引抜き等ゴム栓固有の密封性を損なう損傷を受けやすい。即ち、輸液容器とゴム栓との間の密着面には、針刺通時及び引抜き時、特にその繰り返し時に大きい剪断応力を受けて密着状態が悪くなり、液漏れの原因になりやすい。又、針引抜き後のゴム栓の回復性も重要であり、針刺通孔が針引抜き後、瞬時に閉塞されなければ液漏れしてしまう。
上記のごとく、輸液容器はその開口部に薬液抽出入用針の刺通用ゴム栓を挿入施栓することが必要であるにもかかわらず、薬液抽出入用針の刺通、取外し時又はその繰り返し操作により液漏れ現象を呈しない程度に施栓するには、従来の技術では限界があった。
【０００３】
最近、上記ゴム栓に関する要望に答えるため、各種の提案がなされている。
例えば、合成樹脂製の輸液容器本体の開口部にゴム栓を融着一体化させる観点から、合成樹脂製フィルムをラミネートしたゴム栓を使用し、該ラミネート部分を合成樹脂製の支持体で把持させ、且つ該ラミネートフィルムと該支持体とを融着させてなる口栓体を、前記、輸液容器本体の開口部に融着させて液漏れを防ぐ技術が紹介されている（例えば、特開平２−１２７５号、特開平３−２０５１４１号、特開平５−８４２７５号の各公報）。
先ず、特開平２−１２７５号公報には、合成樹脂製フィルムをラミネートしたゴム栓の上下両面の各周縁部に凹部を周設し、これら凹部に嵌合する突起リブを持つ外郭支持体で挟持してなる口栓体が開示されえている。この場合、挟持方法としては、予め上下２部材に分割成形された外郭支持体でゴム栓を上下から挟持した後に該２部材を融着一体化させる場合と、ゴム栓を射出成形金型内に固定し、外郭支持体を一気に射出成形して、ゴム栓を外郭支持体により挟持させた状態を作り出す場合とが開示されている。
一方、特開平３−２０５１４１号及び特開平５−８４２７５号の各公報には、フィルムをラミネートしたゴム栓の上下面外周縁部を、合成樹脂製外郭支持体で挟持一体化するにあたり、該合成樹脂製外郭支持体を内外２つの筒状体等に分割し、射出成形工程も利用して、上記ラミネートされたゴム栓を上記分割された外郭支持体により挟持し、熱融着により一体化する方法が提案されている。
【０００４】
上記従来法は、ゴム栓外周縁部を、２部分に分割した合成樹脂製外郭支持体により挟持した後、両者を熱融着して口栓体を造り、該口栓体を輸液容器本体の開口部に近い位置に液密に固定できるため、ゴム栓の強固な固定の点ではその目的を達成しているが、口栓体におけるゴム栓が受けている各種応力を考えると、先ず、ゴム栓の外周縁部が、２部分に分割された閉環状外郭支持体により上下から挟持される場合は、該挟持による圧縮応力を受け、しかもこの圧縮応力はゴム栓に対して、前記挟持部分に包囲された部分の中心から周縁部の挟持部分方向に向く引張応力を生み出すことになる。この引張応力は特にゴム栓の天面とか底面において大であり、輸液容器用針を刺通したときに該針を締めつける、ゴム栓の材質が本来有する収縮のための弾力性を低下させる方向に働いていることは明らかである。
また、ゴム栓を予め射出成形金型内にインサートとし、平滑な加圧面を有する加圧固定用の金型で固定し、金型キャビティ内に外郭支持体成形用合成樹脂を射出し、ゴム栓と一体化したゴム栓外郭支持体を成形する方法では、ゴム栓を挟持固定する圧縮応力を天面／底面方向に受けてゴム栓は多少偏平化した状態を保持しつつゴム栓外郭支持体が成形されており、ゴム栓には該圧縮応力により、その外周方向に向く引張応力が発生しており、刺通針締めつけ力等の低下等、前記２部分からなる外郭支持体により挟持した場合と同じことがいえる。
【０００５】
一方、ゴム栓の一端にリングを外嵌し、その圧縮応力によりゴム栓を圧縮縮径することにより、刺通された針の保持性を上げる等の試みも開示されている（実開平２−１０６２３６号公報）。しかし、この技術はゴム栓の天面側のみを圧縮縮径するための特殊なリングを強制的に嵌着させるものであり、実質的にはゴム栓の胴部側面のうち、天面側に切込みによる段差を設けて前記リングを嵌着する方法である。またリングの材質としては、かなり剛性の高いものが要求され、リングの厚肉化、外れ易い等の問題が発生する。いずれにしてもこの方法では、ゴム栓は側面の内、天面側の一部にのみかかる圧縮応力のため却って異常な変形、例えば、天面側以外の側面の膨出、増径等の変形を伴い、輸液容器への施栓自体が困難になるとか、針の刺通性の安定性が得られない他、リングの嵌着にかかわる繁雑性は避けられず、好ましい方法ではない。
【０００６】
【発明が解決しようとする課題】
これら従来の方法によれば、ゴム栓の本来有する締めつけ力の低下を伴い、具体的には輸液容器用針の刺通状態における針保持力とか、針の抜き後の孔の強力な閉塞力の低下を招いたり、針刺通性の安定性を欠く等の問題点は解決されていない。
従って本発明の課題は、ゴム栓を輸液容器本体開口部に強力に取り付け得ることは勿論、ゴム栓の本来有する弾力性を損なうことがないばかりか、刺通針に対する締めつけ力とか、針の刺通により生じた孔の閉塞力を更に増大させたゴム栓を提供することにある。加えるに、ゴム栓の側面からの圧縮応力にも関わらず、ゴム栓の異常な変形を伴わない方法を提供するものである。
【０００７】
【課題を解決するための手段】
上記の課題を解決するため、本発明者は鋭意研究をした結果、ゴム栓と合成樹脂製外郭支持体を一体化し、しかもその際、ゴム栓の胴部全側面から中心方向に圧縮応力を与えてゴム栓の径を減少（縮径）させることにより、針の刺通時の針締め付け力とか針抜き取り後の孔の強い閉鎖力が増大することを見い出し、本発明を完成するに至った。即ち、本発明の要旨は以下の通りである。
【０００８】
（第１）合成樹脂製輸液容器の本体開口部に取り付けられる、円柱状のゴム栓とゴム栓外郭支持体を有する、ゴム栓をインサートしたインサート射出成形により製造された口栓体において、該ゴム栓の天面及び底面の外周縁部及び胴部全側面のうち少なくとも胴部全側面は、合成樹脂製のゴム栓外郭支持体から圧縮応力を受けて該ゴム栓外郭支持体と密着状態にあり、ゴム栓の天面及び底面の径のうち少なくとも一方が成形時に射出された樹脂及び射出の結果成形されたゴム栓外郭支持体からゴム栓の胴部側面に与えられた圧縮応力により１〜１０％縮径し、天面の空気接触部及び／又は底面の液体接触部は膨出変形している輸液容器用口栓体。
（第２）樹脂の射出が、インサートされたゴム栓の胴部外方に設けられた射出ゲートより行われたものである上記第１記載の輸液容器用口栓体。
（第３）樹脂の射出が、インサートされたゴム栓の胴部外方に同一間隔に設けられた射出ゲートより行われたものである上記第２記載の輸液容器用口栓体。
（第４）圧縮応力が、ゴム栓の胴部側面から中心方向への圧縮応力である上記第１ないし３のいずれかに記載の輸液容器用口栓体。
（第５）天面から底面に針を突き刺通して液漏れが生じず、かつ針を抜いてもその孔を直ちに封止しうるものである上記第１ないし４のいずれかに記載の輸液容器用口栓体。
（第６）ゴム栓の天面及び底面の径のうち少なくとも一方が２〜８％縮径している上記第１ないし５のいずれかに記載の輸液容器用口栓体。
（第７）ゴム栓の天面及び底面の径のうち少なくとも一方が３〜６％縮径している上記第１ないし６のいずれかに記載の輸液容器用口栓体。
（第８）ゴム栓の胴部側面中央には、天面及び底面の径よりも大である突出部が周設されている上記第１ないし７のいずれかに記載の輸液容器用口栓体。
（第９）突出部が断面台形状である上記第８記載の輸液容器用口栓体。
（第１０）ゴム栓の底面の液体接触部外周縁又は天面の空気接触部外周縁には環状リブを有する上記第１ないし９のいずれかに記載の輸液容器用口栓体。
（第１１）ゴム栓の天面又は底面の少なくとも一面の外周縁部には環状凹溝が形成されてなり、該ゴム栓の天面及び底面の外周縁部、及び胴部全側面がゴム栓外郭支持体から圧縮応力を受けている上記第１ないし１０のいずれかに記載の輸液容器用口栓体。
（第１２）ゴム栓とゴム栓外郭支持体との密着が融着である上記第１ないし１１のいずれかに記載の輸液容器用口栓体。
（第１３）ゴム栓の底面及び胴部側面のうち少なくとも底面には、合成樹脂製フィルムがラミネートされてなり、ゴム栓とゴム栓外郭支持体との密着のうち少なくとも一部が該フィルムとゴム栓外郭支持体との融着である上記第１ないし１２のいずれかに記載の輸液容器用口栓体。
（第１４）ゴム栓の底部及び胴部側面に合成樹脂フィルムがラミネートされてなる上記第１３記載の輸液容器用口栓体。
（第１５）ゴム栓外郭支持体が、ゴム栓の胴部側面に沿った底面からの伸長部を有さず、かつゴム栓の胴部側面にのみ形成された上記第１ないし１４のいずれかに記載の輸液容器用口栓体。
（第１６）ゴム栓外郭支持体が、ゴム栓の胴部側面に沿った底面からの伸長部を有さず、かつゴム栓の胴部側面と該胴部側面から更にゴム栓の天面、底面に沿ってその外周縁部にまでリブ状に延存した補強枠を有する上記第１ないし１５のいずれかに記載の輸液容器用口栓体。
【０００９】
以下、本発明の内容について詳説する。
本発明において使用されるゴム栓は、従来輸液容器の口栓に使用されてきたものを含め、使用される薬液に対する耐性があれば充分であるが、日本薬局方に係る輸液用プラスチック容器試験法及び輸液用ゴム栓試験法の規格に適合したものが実用上使用される。
【００１０】
ゴム栓とゴム栓外郭支持体との間の密着は、ゴム栓外郭支持体の有する圧縮応力を該ゴム栓がその胴部全側面から受けることによっても達成されるが、合成樹脂製フィルムでラミネートされたゴム栓を使用し、該フィルムとゴム栓外郭支持体との間の熱融着を図れば上記密着は一層効果的である。
この合成樹脂製フィルムは、上記のごとくゴム栓とゴム栓外郭支持体との融着による液密シールの点で効果的であるが、さらに底面、即ち薬液に接する面に存在すれば、薬液によるゴム栓成分の浸出が抑えられるため、この点でも有用な手段である。
【００１１】
上記合成樹脂製フィルムでラミネートされたゴム栓を製造する方法は特に限定されるものではないが、未架橋ゴム材料を合成樹脂製フィルムの間に挟んで（例えば特開平２−１２７５号公報記載の方法）、又は該フィルム上に流し、架橋と同時にゴム栓を成形する方法が簡単で好ましい。しかし、ゴム栓とゴム栓外郭支持体との接触関係、ゴム栓と薬液との接液関係を考慮すれば、少なくとも底面にはラミネートされていることが好ましい。さらにはゴム栓の胴部側面にラミネートされていることが液密シール性の点で一層好ましい。
なお、ここに使用される合成樹脂製フィルムは、ゴム栓外郭支持体と融着性を有する材質のもの、又は薬液に対して耐性を有することが求められるが、前者の融着性が特に求められる場合はポリエチレン、ポリプロピレン、エチレン／酢酸ビニール共重合体等が例示できるが、後者の耐薬液性が特に求められる場合は、ポリエステル、ポリテトラフルオルエチレン等が好適に使用される。両者が求められる場合はポリエチレン、ポリプロピレン等が特に好適である。
また、上記ラミネート用フィルムの厚みは特に限定されるものではないが、ラミネートの容易性、融着力を考慮すれば１０〜１００μｍ程度が好適である。
【００１２】
ゴム栓とゴム栓外郭支持体との密着面は、針の刺通時又は引き抜き時に絶えず剪断剥離応力を受けるため、ゴム栓及びゴム栓外郭支持体の機械的一体化を図る方法も好ましく採用される。
ゴム栓については、その胴部側面中央に天面及び底面の径よりも大である、所望巾の突出部を周設することにより、前記剪断剥離応力にはかなり対抗できる、機械的的一体化が得られる。なお、ここにいう胴部側面中央とは、該突出部の中央がほぼ胴部側面の中央近辺にあることを意味し、正確な中心位置である必要はない。また、突出部の巾、高さは特に限定されるものではないが、断面台形状の突出部であることが耐剪断剥離応力の点で特に好ましい。
ゴム栓外郭支持体については、ゴム栓の胴部側面のみに形成されたものでもよいが、胴部側面からさらにゴム栓の天面及び又は底面外周縁部に延在し、該外周縁部に周設された環状凹溝にまで達する補強枠を形成することにより、両者の一体化は一層向上する。
ゴム栓の底面の液体接触部外周縁又は天面の空気接触部外周縁に沿って環状リブを設ければ、該環状リブは後述のインサート射出成形時に金型面におけるゴム栓位置決めに有用であるが、環状リブの形成自体、ゴム栓体の変形を防止するリブの働きをし、好ましい態様である。
【００１３】
ゴム栓がその胴部全側面においてゴム栓外郭支持体から圧縮応力を受け、ゴム栓の天面又は底面が縮径した状態にする方法は特に限定されるものではないが、ゴム栓の外径よりも小の内径を有するゴム栓外郭支持体に該ゴム栓を強制的に挿入させる方法は、両径の差が大きいほど、その挿入作業が困難になる。しかし、ゴム栓を割金型内に予めインサートして置き、その胴部全側面又は該胴部全側面と天面、底面の外周縁部にゴム栓外郭支持体を射出成形する、いわゆるインサート成形の方法によればこの目的は簡単に達成でき、好適である。
この場合、ゴム栓はその胴部全側面等において圧縮応力を受けたとしても、ゴム栓自体の体積は不変であるから、本発明にいう天面又は底面の少なくとも一方の縮径のみを伴う、体積減少によるゴム栓の変形を図ることは不可能であり、縮径により天面又は底面部分の体積減少をさせるためには、ゴム栓の他の部分における体積増大、即ち体積変位を伴わなければならない。
【００１４】
本発明においては、ゴム栓はその胴部全側面等からの圧縮応力に基づく体積減少分を、天面又は底面におけるその垂直方向への体積増大、即ち、膨出変形という現象を発生させることにより解決しようとするものである。
しかし、本発明においてはその本来の目的である、輸液容器のゴム栓への針の刺通、引抜き又はこれらの繰り返し時に液漏れ防止の観点のみからみれば、この圧縮応力は高いほど好ましいが、ゴム栓の縮径が大となり、その締めつけ力が過大になると針の刺通及び引抜き作業自体が困難になり、輸液作業に支障をきたす恐れがある。
これらの点を考慮し、本発明においてはゴム栓の天面又は底面の縮径の範囲が１〜１０％である必要があり、好ましくは２〜８％であり、更に好ましくは３〜６％であることを見出したが、この場合、１％未満では所期の効果は得られず、従来と同様に液漏れ現象が見られる。逆に１０％を超えると、ゴム栓への針の刺通とか、針の引抜きに相当の大きい力を要するに至り、上記のごとく輸液作業に支障を来し、いずれも好ましくない。上記耐液漏れ及び作業性の点では２〜８％の場合がより効果的である。縮径が３〜６％の場合は総合的にみて最も好ましい範囲である。
【００１５】
本発明に係る輸液容器用口栓体は、ゴム栓又は合成樹脂製フィルムでラミネートされたゴム栓とゴム栓外郭支持体を構成要素とするが、ゴム栓外郭支持体はゴム栓の胴部側面に沿って底面からさらに伸長させ、その先端には外方に突出する環状リブをフランジとして形成した構造にしておけば、合成樹脂製輸液本体開口部にもフランジを設けることにより、両者の結合は容易になる。両者の結合には超音波接着その他、合成樹脂成形体において通常行われる融着方法が適用できる。更に、上記のようにゴム栓外郭支持体を伸長させることなく、ゴム栓の胴部側面にのみ形成した口栓体、又は胴部側面と該胴部側面から更にゴム栓の天面、底面に沿ってその外周縁部にまでリブ状に延在させて補強枠を形成した口栓体を形成しておくこともでき、この場合は該口栓体を合成樹脂製輸液本体開口部に予め形成された口栓体受け部に嵌挿し、両者間を公知の各種熱融着手段により液密に融着する方法が効果的な方法として採用することができる。
【００１６】
本発明は又、ゴム栓とゴム栓外郭支持体を有する口栓体の製造方法をも提供するものであり、特にゴム栓を割金型内に予めインサートしておき、ゴム栓外郭支持体を射出成形する方法を開示するものである。
本発明に係る口栓体の製造方法によれば、ゴム栓を金型内に予めインサートし、ゴム栓の位置決めをするためにその天面又は底面を金型表面に仮固定をする。この位置決めのための仮固定の方法としては、ゴム栓の天面又は底面の相対する金型表面にゴム栓固定用吸引孔を開口させ、ゴム栓を該金型表面の所定位置において吸引固定する方法があるが、金型の所定位置に環状溝を設け、ゴム栓の天面又は底面の外周縁に沿って設けた環状リブを嵌挿する方法が、位置決めがより簡単であり、好ましい。なお、本発明においては、ゴム栓をその胴部全面から圧縮し、縮径する方法をとるため、上記環状リブの嵌挿方法をとる場合は環状リブも縮径できるように上記環状溝は該環状の中心方向にやや拡幅せしめておく必要がある。
【００１７】
ゴム栓が位置決めされた金型面とその相対する金型面との位置関係は、後述の偏平凹部がない場合は、0.２〜0.４ｍｍ程度の間隙を残す程度の位置にあることが好ましい。この理由はゴム栓をその胴部側面から圧縮した場合のゴム栓の変形空間を残しておくことが好ましいからであり、また上記間隙程度であれば、ゴム栓外郭支持体の射出成形時に樹脂が侵入するおそれはないからである。
該偏平凹部がある場合は、該相対する金型面と接触していてもよい。
【００１８】
ゴム栓が仮固定された金型面又はその相対する金型面には、縮径したゴム栓の底面又は天面で覆うことのできる程度の大きさの偏平凹部が形成されており、射出成形時におけるゴム栓胴部側面からの圧縮によるゴム栓の膨出変形場所を構成している。
上記偏平凹部は、上下金型の少なくとも一方にあれば一応その目的を達成するが、天面又は底面の縮径の度合いを大きくしたい場合は、一凹部の容積を大きくするよりも、両面の金型に偏平凹部を形成した方がゴム栓の縮径、膨出という変形を無理なく起こし得る。
上記ゴム栓固定用吸引孔はこの偏平凹部内面に開口していてもよい。また、ゴム栓が仮固定された金型面と相対する金型面に偏平凹部を形成する場合は、ゴム栓の膨出変形に伴う空気を排出するためのベント孔を設けることが望ましい。
【００１９】
上述の偏平凹部の容積は、ゴム栓の底面又は天面の縮径に基づくゴム栓厚さ増加分（天面又は底面側膨出変形分）を吸収できるに十分なものである必要がある。又上記射出圧力によりゴム栓の厚さの増加（膨出変形）は、天面又は底面の可及的広い面積にわたり起こさせる方が容易であり、従って偏平凹部の内径は大であるほどその深さは小で十分となる。
従って凹部の深さは縮径の所望程度により決められるものであり、一概には規定できないが、ゴム栓の天面又は底面の径を１〜１０％縮径させるためには、ゴム栓の材質に基づく変形性を考慮すると0.２〜５ｍｍ程度が好適である。0.２ｍｍ未満ではゴム栓の十分な膨出が困難となり、ひいては縮径の程度も不十分になり所期の目的を達成し難くなる。逆に５ｍｍを超える程の膨出変形は通常起こり難いものであるから、５ｍｍを超える深さは余り意味がない。
【００２０】
ゴム栓の胴部側面に圧縮応力を与えて天面又は底面の縮径を生じさせる方法としては、ゴム栓外郭支持体の射出成形圧を上げる方法が最も簡単であるが、ゴム栓外郭支持体のゴム栓天面側又は底面側を厚肉に構成することにより、合成樹脂の成形収縮特性を利用する方法もあり、好ましく利用できる。
【００２１】
ゴム栓の天面又は底面の径を１〜１０％縮径の範囲で所望の値をとるように制御するためには、射出樹脂圧の制御による方法の他、天面又は底面の変形度合いをストレインゲージで検出する方法が最も便利である。金型内の樹脂圧と縮径の関係とか、金型の凹部に膨出するゴム栓により凹部内のゲージ端子の受けるストレインを予め求め、射出成形時における所定の樹脂圧とかストレイン値の設定維持、保圧の維持及び冷却の工程を経ることにより所望の縮径度が容易に得られる。
【００２２】
ゴム栓の天面又は底面と接触又は相対する金型面は、入子金型にすることにより、前記ゴム栓の固定吸引孔又はベント孔の設置が容易になる。また、この入子金型に通気性の金属粉体の焼結成形体を使用すると、上記、固定吸引孔又はベント孔の設置が簡単になり、好ましく採用される態様である。
【００２３】
射出成形金型のキャビティは、ゴム栓の天面及び底面側金型及び胴部を囲む金型で構成されるが、射出用ゲートはゴム栓の胴部外方であって天面及び底面に平行な平面上に、しかも同一間隔で設けることが、均一な射出成形上好ましい。
なお、内部気体の排気孔が必要なことは通常の射出成形の場合と同様である。
【００２４】
次に本発明を図面を用いて説明する。しかし、本発明はこの図面の記載により制限されるものではない。
図１は、本発明に使用される円柱状ゴム栓１ａの縦断面図であり、図２は、図１のゴム栓と同じゴム栓１ｂをゴム栓外郭支持体２ｂで把持し、これを輸液容器４ｓに融着した状態の縦断面図であり、図３は、図１のゴム栓の底面及び胴部側面を合成樹脂製フィルムでラミネートしたゴム栓１ｃをゴム栓外郭支持体２ｃで把持し、これを輸液容器４ｓに融着した状態の縦断面図であり、図４は、図１のゴム栓の胴部側面に突出部が周設され、底面及び側面の一部に前記フィルムがラミネートされたゴム栓１ｄの断面図であり、図５は、図４のゴム栓と同じゴム栓１ｅをゴム栓外郭支持体２ｅで把持し、輸液容器４ｓに融着した状態の縦断面図であり、図６は、図１の円柱状ゴム栓の天面及び底面に環状凹溝が形成され、底面及び側面の一部には前記フィルムがラミネートされたゴム栓１ｆをゴム栓外郭支持体２ｆで把持し、輸液容器４ｓに融着した状態の縦断面図であり、図７は、図４のゴム栓の底面にさらに環状リブを形成したゴム栓１ｇの縦断面図であり、図８は図７に示したゴム栓と同じゴム栓１ｈをゴム栓外郭支持体２ｈで把持し、輸液容器４ｓに融着した状態の縦断面図であり、図９は図７に示したゴム栓と同じゴム栓１ｉを、該ゴム栓胴部側面にのみ位置するゴム栓外郭支持体２ｉで把持した状態の縦断面図であり、図１０は、図９に示した口栓体を輸液容器本体の開口部に嵌挿し、加熱器を配置した状態の縦断面図で示したものであり、図１１は、図１０に示した方法により嵌挿し、一体化した状態の縦断面図であり、図１２は、本発明に係る口栓体をインサート射出成形する場合の方法の一例を示す縦断面図であり、図１３は他の方法の実施例を示す縦断面図である。
【００２５】
以下、詳細に説明する。
図１に示すゴム栓は、単純な円柱状のゴム栓１ａの例であり、その縦断面図を示す。ゴム栓１ａは、天面１ａｐ、底面１ａｑ及び胴部側面１ａｒから構成されている。
【００２６】
図２は、図１と同じゴム栓１ｂを使用し、その胴部側面１ｂｒからゴム栓外郭支持体２ｂで圧縮下に把持した状態の口栓体を示す。該圧縮下にあるため、天面１ｂｐ及び底面１ｂｑは膨出変形している。このような変形が輸液用に刺通された針に強い圧力を与え、又針の引き抜き後の孔の強力な閉塞に貢献している。
一方、ゴム栓とゴム栓外郭支持体との一体性を向上させるために、ゴム栓外郭支持体２ｂはゴム栓の胴部側面１ｂｒに把持枠２ｂｒのみでなく、天面側外周縁部に補強枠２ｂｐが、また底面側外周縁部にも補強枠２ｂｑが形成されている。なお、底面側外周縁の補強枠２ｂｑは、輸液容器４ｓと融着させるために該輸液容器側に伸びて先端にフランジ２ｂｓが形成されているが、図２はその融着した状態を示す。
【００２７】
図３は、図１のゴム栓と同じゴム栓１ｃの底面（薬液接触面側）１ｃｑ及び胴部側面１ｃｒに合成樹脂製フィルム３がラミネートされたゴム栓を使用し、図２の場合とほぼ同様に、ゴム栓の胴部側面にはゴム栓外郭支持体２ｃの把持枠２ｃｒが、また底部外周縁部は補強枠２ｃｑが形成されている口栓体であるが、上記合成樹脂製フィルムを介してゴム栓１ｃとゴム栓外郭支持体２ｃが一体化しているため、ゴム栓の天面には補強枠はなくてもよい。ゴム栓外郭支持体２ｃが輸液容器４ｓ側にフランジ２ｃｓを有し、該容器と融着していることは図２の場合と同じである。胴部側面からの加圧により、天面１ｃｐは膨出変形している。底面側１ｃｑは膨出変形しない製造方法がとられているため、平坦である。
【００２８】
図４は、図１のゴム栓と同じゴム栓１ｄの胴部側面１ｄｒの中央部に、断面がほぼ台形の突出部１ｄｋが形成されたゴム栓１ｄであって、その底面１ｄｑの全面及び胴部側面の一部には、図３の場合同様の合成樹脂製フィルム３がラミネートされた状態を示す。１ｄｐは天面である。
【００２９】
図５は、図４と同じゴム栓１ｅであって、底面１ｅｑ及び胴部側面１ｅｒの一部に同様のフィルム３がラミネートされたものが使用され、胴部側面１ｅｒ側から加圧下にゴム栓外郭支持体２ｅで把持した口栓体を示し、ゴム栓とゴム栓外郭支持体とは強力に密着しているが、ラミネートフィルムがある部分は融着により一体化されている。ゴム栓の突出部１ｅｋは、ゴム栓外郭支持体２ｅの胴部側面の把持枠２ｅｒの上方把持枠２ｅｐ及び下方把持枠２ｅｑとかみ合い、投錨効果の下に強力に一体化している。ゴム栓は、図３の場合同様に天面１ｅｐ側に膨出変形しているが、底面１ｅｑ側は平坦である。ゴム栓外郭支持体のフランジ２ｅｓは輸液容器４ｓと融着している。
【００３０】
図６は、図１の円柱状ゴム栓と同じゴム栓１ｆの天面１ｆｐ及び底面１ｆｑの外周縁に環状凹溝１ｆｇをそれぞれ形成したゴム栓であって、底面及び胴部側面１ｆｒの一部には合成樹脂製フィルム３がラミネートされたものを、その胴部側面から、ゴム栓外郭支持体２ｆの把持枠２ｆｒで加圧下に把持して得られた口栓体を示す。ゴム栓外郭支持体２ｆには、ゴム栓の天面及び底面に沿って上記環状凹溝まで伸びる補強枠２ｆｐ及び２ｆｑが形成され、ゴム栓とゴム栓外郭支持体とは、該補強枠の環状凹溝への投錨効果及び上記フィルムを介した融着により強力に一体化し、液密なシールがされている。ゴム栓外郭支持体には、図５の場合同様に輸液容器４ｓに融着させるためのフランジ２ｆｓが形成され、融着されている。
【００３１】
図７は、図４のゴム栓と同じゴム栓１ｇにおいて底面１ｇｑ外周縁に環状リブ１ｇｍが形成されたものであり、天面１ｇｐ、底面１ｇｑ及び胴部側面１ｇｒから構成されるが、胴部側面には、図４の場合同様の突出部１ｇｋが形成されている。また胴部側面の一部及び底面は、環状リブを含め前記同様の合成樹脂製フィルム３がラミネートされている。この環状リブは、インサート射出成形時における金型面へのゴム栓の位置決め及び仮固定に有効に利用される他、針の刺通時等におけるゴム栓の異常変形防止にも効果的である。
【００３２】
図８は、図７に示したゴム栓と同じゴム栓１ｈに、合成樹脂製フィルム３が同様にラミネートされたものを、図５に示したゴム栓外郭支持体と同じ支持体２ｈで加圧下に把持して得られた口栓体を示すものである。ゴム栓は天面１ｈｐ、底面１ｈｑ、胴部側面１ｈｒから構成されるが、胴部側面には突出部１ｈｋ、底面には環状リブ１ｈｍがあり、底面及び胴部側面の一部は前記フィルム３がラミネートされている。また、上記突出部１ｈｋは、ゴム栓外郭支持体の把持枠２ｈｒの上方把持枠２ｈｐ及び下方把持枠２ｈｑとかみ合い、投錨効果の下に強力に一体化している。
なお、ゴム栓外郭支持体下方には図６等に示したものと同様にフランジ２ｈｓが形成され、輸液容器４ｓと融着一体化している。
【００３３】
図９は、ゴム栓外郭支持体が把持枠のみから構成され、図８に示すごとく輸液容器側には伸長していない場合の口栓体を示す。図７のゴム栓と同じゴム栓１ｉが使用され、天面１ｉｐ、底面１ｉｑ、胴部側面１ｉｒから構成され、胴部側面には前記同様の突出部１ｉｋ、底面には前記同様の環状リブ１ｉｍがそれぞれ形成されており、底面及び胴部側面の一部には前記同様にフィルム３がラミネートされている。
また、突出部１ｉｋはゴム栓外郭支持体２ｉを構成する把持枠２ｉｒの上方把持枠２ｉｐ及び下方把持枠２ｉｑとかみ合い、投錨効果の下に強力に一体化している。該上方把持枠２ｉｐの外周部には環状凸部２ｉｔが形成されているが、この環状凸部は後述の輸液容器の口部と溶融一体化する場合の溶融部分を構成している。
【００３４】
図１０は、図９に示したゴム栓１ｉに上記同様のフィルム３をラミネートしたものをゴム栓外郭支持体２ｉと一体化し、天面及び底面が膨出変形した口栓体を、輸液容器の口部に設けた口栓体受け口４ｔに嵌挿した状態を示すが、該口栓体受け口は、その下端に口栓体受け部４ｔｑ、上方にゴム栓外郭支持体の環状凸部２ｉｔよりも更に長く伸びた伸長部４ｔｐをそれぞれ有し、該伸長部は上記環状凸部とともに、口栓体と口栓体受け口との液密シールに寄与する部分である。
上記口栓体と口栓体受け口との液密シールは、図１０の上方に配置され、矢印方向に移動可能な溶融シーラー５を押し当てることにより達成される。即ち、該シーラーはヒーター５ｃを有するが、口栓体側にはゴム栓外郭支持体及び口栓体受け口とを溶融一体化するための凹部を有し、該凹部は底部５ａと傾斜した側面部５ｂとからなり、このシーラーの押し当てにより、口栓体受け口の伸長部４ｔｐは、内方に溶融状態で流され、一方、上方把持枠の環状凸部２ｉｔも溶融状態になり、両者は融着部分５ｔを形成する。
【００３５】
図１１は、この融着部分５ｔが形成された状態を示すものである。上記押し当て力が強い場合は図示のごとく、該融着部分が上方把持枠上面にまで拡がっているが、目的とする液密シール性を何ら損なうものではない。同図において、１ｉはゴム栓、３は合成樹脂製フィルム、２ｉはゴム栓外郭支持体、４ｔは口栓体受け口、５ｔは融着部分をそれぞれ示す。
【００３６】
図１２は、本発明に係る口栓体（図８に示す口栓体に類似するもの）を製造する方法の一例を示すものである。
割金型Ａ，Ｂ，Ｃ及びＤから構成されたインサート射出成形金型に、合成樹脂フィルムがラミネートされたゴム栓１ｇがインサートされ、キャビィティＣｃにゴム栓外郭支持体用樹脂が射出される前の状態を示す。
金型Ａには金型Ｂが入子金型として組み合わされているが、該金型Ａはゴム栓１ｇの天面の外周縁部に、摺動移動可能に接面しているが、金型Ｂは接面していないため、ゴム栓の天面側には偏平凹部状に空間Ｂｂが形成され、該天面の膨出変形を受け入れることができる状態にある。上記金型Ａとゴム栓１ｇの天面間の摺動移動可能性は、ゴム栓胴部側面に圧縮応力がかかり、天面が縮径する場合に必要な条件である。
なお、金型Ｂには排気のためのベント孔Ｂａが設けられ、上記膨出変形時に偏平凹部Ｂｂ内の空気を排出可能にしている。
【００３７】
金型Ｃは側面部にあり、矢印方向に樹脂が注入される射出ゲートＣｂが同じ高さで等間隔に設けられている。Ｃａは射出成形用ベント孔である。
金型Ｄはゴム栓底面側に配置された金型であり、環状溝Ｄａが設けられ、該環状溝にゴム栓の環状リブ１ｇｍが嵌挿されて位置決め及び仮固定がされている。しかし、ゴム栓胴部側面に圧縮応力を受けた場合、ゴム栓底面の縮径時に摺動、且つ縮径移動ができるように上記環状溝の巾は環状リブの巾よりも大にしておく必要があり、空間部Ｄｂを有し、上記嵌挿、位置決めは環状溝Ｄａ外側内壁と環状リブ１ｇｍの外壁面の間において行われることが最も好ましい。しかも環状リブと環状溝底面との間は摺動可能でなければならない。なお、ゴム栓の底面の縮径に伴う排気はベント孔Ｄｃを通じて行われるが、該ベント孔は、ゴム栓の仮固定用の吸引固定用としても利用される。
キャビティＣｃに射出された樹脂は、所定圧になればキャビティＣｄの部分においてゴム栓の胴部側面に圧縮応力を与え、縮径させることができる。
【００３８】
図１３は、本発明に係る口栓体（図９に示す口栓体に類似するもの）を製造する方法の他の一例を示すものである。
射出成形金型は、割金型Ｅ，Ｆ，Ｇ及びＨから構成されている。金型Ｅの中央部には金属粉粒体の焼結成形体である入子金型Ｈが組み込まれているが、該焼結成形体は微細な気体通路が形成されているため、図１２のベント孔Ｂａ，ベント用又は吸引用孔Ｄｃのような通気口を改めて形成する必要がない。
金型Ｈは、ゴム栓１ｄに対面する面には偏平凹部Ｈａが形成されているが、該偏平凹部外周辺はゴム栓に対しては摺動移動可能に接触している。この接触関係は、前記図１２の場合と同じ効果を期待するためのものである。ゴム栓胴部側面から圧縮応力を受け、天面は該偏平凹部に膨出変形するが、内部空気Ｕは金型Ｈ内の微細通路を通じて矢印方向に排出される。
【００３９】
金型Ｇは、ゴム栓に相対する面Ｇａには偏平凹部Ｇｂが形成されてなり、該凹部内底面に開口する固定吸引孔Ｇｃから吸引することにより、ゴム栓は金型Ｇ表面に仮固定されている。
金型Ｅ及びＦで形成された射出ゲートＥａからゴム栓外郭支持体を成形するためのキャビティＫに合成樹脂が射出され、所定圧以上にすれば、ゴム栓の胴部側面に圧縮応力が付加され、ゴム栓は縮径するが、それに相当する体積変化は偏平凹部Ｈａ及びＧｂに膨出変形することにより吸収される。
このような成形方法をとることにより、ゴム栓は天面及び底面が縮径し、該天面及び底面は膨出変形が起こる。
なお、Ｆａは射出成形用ベント孔である。
【００４０】
【発明の効果】
本発明によれば、ゴム栓の胴部全側面から圧縮応力を与えるが、ゴム栓の天面又は底面の対面する金型面に凹部を形成しておくことにより、この凹部への膨出変形が可能であり、これによって天面又は底面の縮径が可能になり、天面から底面に針を刺通したりしても液漏れが生じない程度に針締めつけ力が増大し、又、針を抜いても、その孔を直ちに、しかも強力に封止することのできる力が生じて液漏れのおそれがなくなる効果が発揮される。
【図面の簡単な説明】
【図１】円柱状ゴム栓の断面図。
【図２】図１のゴム栓をゴム栓外郭支持体で把持した口栓体を輸液容器に融着した状態の縦断面図。
【図３】フィルムでラミネートされ図１のゴム栓をゴム栓外郭支持体で把持した口栓体を輸液容器に融着した状態の縦断面図。
【図４】胴部側面に突出部を有し、フィルムがラミネートされた図１のゴム栓の縦断面図。
【図５】図４のゴム栓をゴム栓外郭支持体で把持した口栓体を輸液容器に融着した状態の縦断面図。
【図６】天面及び底面に環状凹溝を有し、フィルムがラミネートされた図１のゴム栓をゴム栓外郭支持体で把持した口栓体を輸液容器に融着した状態の縦断面図。
【図７】底面に環状リブを形成した図４のゴム栓縦断面図。
【図８】図７のゴム栓をゴム栓外郭支持体で把持した口栓体を輸液容器に融着した状態の縦断面図。
【図９】図７のゴム栓をゴム栓外郭支持体で把持した口栓体の縦断面図。
【図１０】図９の口栓体を輸液容器本体の開口部に嵌挿し、シーラーを配置した状態の縦断面図。
【図１１】図１０に示した方法により溶融一体化した状態の縦断面図。
【図１２】本発明に係る口栓体をインサート射出成形する場合の方法の一例を示す縦断面図。
【図１３】本発明に係る口栓体をインサート射出成形する場合の方法の他の一例を示す縦断面図。
【符号の説明】
１ａ，１ｂ，１ｃ，１ｄ，１ｅ，１ｆ，１ｇ，１ｈ，１ｉ・・・ゴム栓
１ａｐ，１ｂｐ，１ｃｐ，１ｄｐ，１ｅｐ，１ｆｐ，１ｇｐ，１ｈｐ，１ｉｐ・・・天面
１ａｑ，１ｂｑ，１ｃｑ，１ｄｑ，１ｅｑ，１ｆｑ，１ｇｑ，１ｈｑ，１ｉｑ・・・底面
１ａｒ，１ｂｒ，１ｃｒ，１ｄｒ，１ｅｒ，１ｆｒ，１ｇｒ，１ｈｒ，１ｉｒ・・・胴部側面
１ｄｋ，１ｅｋ，１ｇｋ，１ｈｋ，１ｉｋ・・・突出部
１ｆｇ・・・環状凹溝
１ｇｍ，１ｈｍ，１ｉｍ・・・環状リブ
２ｂ，２ｃ，２ｅ，２ｆ，２ｈ，２ｉ・・・ゴム栓外郭支持体
２ｂｒ，２ｃｒ，２ｅｒ，２ｆｒ，２ｈｒ，２ｉｒ・・把持枠
２ｂｐ，２ｂｑ，２ｃｑ，２ｆｐ，２ｆｑ・・・補強枠
２ｅｐ，２ｈｐ，２ｉｐ・・・上方把持枠
２ｅｑ，２ｈｑ，２ｉｑ・・・下方把持枠
２ｂｓ，２ｃｓ，２ｅｓ，２ｆｓ，２ｈｓ・・・フランジ
２ｉｔ・・・環状凸部
３・・・合成樹脂製フィルム
４ｓ・・・輸液容器口部
４ｔ・・・口栓体受け口
４ｔｐ・・・伸長部
４ｔｑ・・・口栓体受け部
５・・・溶融シーラー
５ａ・・・ヒーター凹部底面
５ｂ・・・ヒーター凹部側面
５ｃ・・・ヒーター
５ｔ・・・溶融部分
Ａ，Ｂ，Ｃ，Ｄ，Ｅ，Ｆ，Ｇ，Ｈ・・・割金型
Ｇａ・・・金型表面
Ｂｂ，Ｈａ，Ｇｂ・・・偏平凹部
Ｂａ，Ｃａ，Ｆａ・・・ベント孔
Ｃｂ，Ｅａ・・・射出ゲート
Ｇｃ・・・固定吸引孔
Ｃｃ，Ｃｄ，Ｋ・・・キャビティ
Ｄａ・・・環状溝
Ｄｂ・・・空間部
Ｄｃ・・・ベント孔又は固定吸引孔 [0001]
[Industrial application fields]
The present invention relates to a mouthpiece of an infusion container made of a synthetic resin used for drip infusion and the like, and a method for producing the same. The present invention relates to a plug body that does not leak even when it is pulled out or repeated, and a method for manufacturing the same.
[0002]
[Prior art]
In recent years, glass containers or synthetic resin bottles and bags are widely used as infusion containers for infusion injections, etc., but infusion containers are resistant to damage during transportation, storage, and use. The latter is preferably made of the latter synthetic resin.
On the other hand, for rubber stoppers for infusion containers, in addition to simple needle piercing for infusion, the needle for infusion of medicinal liquid for infusion while mixing other medicinal liquids, withdrawal of the needle when infusion is stopped, etc. It is susceptible to damage that impairs the inherent sealing properties of rubber plugs. That is, the contact surface between the infusion container and the rubber stopper is subjected to a large shear stress during needle piercing and withdrawal, particularly when repeated, and the contact state deteriorates, which is likely to cause liquid leakage. In addition, recovery of the rubber stopper after pulling out the needlesexIt is also important that if the needle insertion hole is not closed instantly after the needle is pulled out, the liquid will leak.
As described above, the infusion container needs to be inserted with a rubber stopper for inserting a medicinal liquid extraction needle into the opening, and inserted or removed at the time of inserting or removing the medicinal liquid extraction needle. Therefore, there is a limit in the conventional technique for plugging to such an extent that no liquid leakage phenomenon is exhibited.
[0003]
Recently, various proposals have been made in order to meet the demand for the rubber plug.
For example, from the viewpoint of fusing and integrating a rubber stopper to the opening of a synthetic resin infusion container body, a rubber stopper laminated with a synthetic resin film is used, and the laminated portion is held by a synthetic resin support. In addition, a technique for preventing liquid leakage by fusing a plug body formed by fusing the laminate film and the support to the opening of the infusion container main body has been introduced (for example, Japanese Patent Laid-Open No. Hei 2). -1275, JP-A-3-205141, and JP-A-5-84275).
First, Japanese Patent Application Laid-Open No. 2-1275 discloses that a rubber stopper laminated with a synthetic resin film is provided with a concave portion at each of the upper and lower peripheral portions and sandwiched between outer support members having protruding ribs fitted into the concave portions. There is disclosed a plug body. In this case, as a sandwiching method, the rubber stopper is sandwiched from above and below by the outer support that is divided and formed into two upper and lower members in advance, and then the two members are fused and integrated, or the rubber stopper is placed in the injection mold. It is disclosed that the outer shell support is fixed and the outer shell support is injection-molded at once to create a state in which the rubber stopper is sandwiched between the outer shell support.
On the other hand, in Japanese Patent Laid-Open No. 3-205141 and Japanese Patent Laid-Open No. 5-84275, the synthetic rubber outer support is used to squeeze and integrate the upper and lower outer peripheral edges of the rubber plug laminated with a film. The outer shell support made of resin is divided into two cylindrical bodies inside and outside, and the laminated rubber stopper is sandwiched by the split outer shell support using the injection molding process and integrated by heat fusion. A method has been proposed.
[0004]
In the above conventional method, the outer peripheral edge of the rubber plug is sandwiched between the outer support members made of synthetic resin divided into two parts, both are heat-sealed to form a plug body, and the plug body is formed on the infusion container body. Since it can be liquid-tightly fixed at a position close to the opening, it achieves its purpose in terms of firmly fixing the rubber plug, but considering the various stresses received by the rubber plug in the plug body, first the rubber plug When the outer peripheral edge of the stopper is sandwiched from above and below by a closed annular outer support divided into two parts, it receives compressive stress due to the sandwiching, and this compressive stress is applied to the sandwiched part with respect to the rubber stopper. A tensile stress is generated from the center of the surrounded portion toward the sandwiched portion of the peripheral portion. This tensile stress is particularly great on the top and bottom surfaces of the rubber stopper, and tightens the needle when the needle for an infusion container is pierced, in a direction that reduces the elasticity for shrinkage inherent in the material of the rubber stopper. It is clear that it works.
Also, the rubber plug is used as an insert in an injection mold in advance, fixed with a pressure fixing mold having a smooth pressure surface, and a plastic resin for molding the outer support is injected into the mold cavity. In the method of molding the rubber plug outer support integrated with the rubber plug, the rubber plug outer support is received while receiving the compressive stress in the top / bottom direction to hold and fix the rubber plug, while the rubber plug remains slightly flattened. When the rubber plug is molded, a tensile stress is generated in the outer circumferential direction due to the compressive stress, and when the pin is sandwiched by the outer support composed of the two parts, such as a decrease in the piercing needle tightening force, etc. The same can be said.
[0005]
On the other hand, an attempt has been disclosed in which a ring is externally fitted to one end of a rubber plug, and the rubber plug is compressed and contracted by its compressive stress, thereby improving the holding ability of the pierced needle (Japanese Utility Model Laid-Open No. 2- 106236). However, this technology forcibly inserts a special ring for compressing and reducing the diameter of only the top surface of the rubber plug. In this method, a step is formed by cutting and the ring is fitted. Further, the material of the ring is required to have a fairly high rigidity, which causes problems such as thickening of the ring and easy removal. In any case, in this method, the rubber plug is abnormally deformed due to the compressive stress applied only to a part of the side of the top surface, for example, bulging of the side surface other than the top surface, deformation such as an increase in diameter, etc. In addition, it is difficult to plug the infusion container itself, the stability of the needle piercing property cannot be obtained, and the complexity associated with the ring fitting cannot be avoided, which is not a preferable method.
[0006]
[Problems to be solved by the invention]
According to these conventional methods, the inherent tightening force of the rubber stopper is reduced, specifically, the needle holding force in the piercing state of the needle for the infusion container or the strong occlusion force of the hole after the needle is removed. Problems such as lowering and lack of needle piercing stability have not been solved.
Therefore, the problem of the present invention is not only that the rubber stopper can be strongly attached to the opening portion of the infusion container body, but also does not impair the elasticity inherent in the rubber stopper, the tightening force against the piercing needle, An object of the present invention is to provide a rubber stopper in which the closing force of the hole generated by the passage is further increased. In addition, the present invention provides a method that does not involve abnormal deformation of the rubber plug despite the compressive stress from the side of the rubber plug.
[0007]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the present inventor has conducted intensive research, and as a result, integrated the rubber stopper and the outer support made of synthetic resin, and applied compressive stress in the center direction from the entire side surface of the body of the rubber stopper. By reducing the diameter of the rubber plug (reducing the diameter), it was found that the needle tightening force at the time of needle insertion or the strong closing force of the hole after needle removal increased, and the present invention was completed. That is, the gist of the present invention is as follows.
[0008]
(1) It has a cylindrical rubber stopper and a rubber stopper outer support attached to the main body opening of the synthetic resin infusion container.Manufactured by insert injection molding with rubber plug insertedIn the plug body, at least the entire side surface of the outer peripheral edge of the top surface and bottom surface of the rubber plug and the entire side surface of the body portion is subjected to compressive stress from the rubber plug outer support made of synthetic resin.The rubber plug shell support andThe rubber plug is in close contact, and at least one of the top and bottom diameters of the rubber plug isThe resin injected during molding and the compression stress applied to the side of the barrel of the rubber plug from the molded rubber plug outer support as a result of the injection1-10% diameter reduction, top air contact areaas well as/Alternatively, the liquid contact portion on the bottom surface is a bulging and deforming mouthpiece for an infusion container.
(Second)The infusion container plug according to the first aspect, wherein the resin is injected from an injection gate provided outside the body of the inserted rubber stopper.
(No.3) The stopper for an infusion container according to the second aspect, wherein the injection of the resin is performed from an injection gate provided at the same interval outside the body of the inserted rubber stopper.
(4th)4. The mouthpiece for an infusion container according to any one of the first to third aspects, wherein the compressive stress is compressive stress from the side surface of the body portion of the rubber plug toward the center.
(5th)5. The mouthpiece for an infusion container according to any one of the first to fourth aspects, wherein a needle is pierced from the top surface to the bottom surface so that no liquid leaks and the hole can be immediately sealed even if the needle is removed. .
(Sixth)6. The mouthpiece for an infusion container according to any one of the first to fifth aspects, wherein at least one of the top and bottom diameters of the rubber stopper is reduced in diameter by 2 to 8%.
(Seventh)7. The mouthpiece for an infusion container according to any one of the first to sixth aspects, wherein at least one of the top and bottom diameters of the rubber stopper is reduced in diameter by 3 to 6%.
(No.8) In the center of the side surface of the body portion of the rubber plug, there is provided a protrusion that is larger than the diameter of the top surface and the bottom surface.Or any of 7A mouthpiece for an infusion container as described.
(No. 9)The mouthpiece for an infusion container according to the eighth aspect, wherein the protrusion has a trapezoidal cross section.
(No.10) The first liquid ring having an annular rib on the outer peripheral edge of the liquid contact portion on the bottom surface of the rubber stopper or on the outer peripheral edge of the air contact portion on the top surface.Or any of 9A mouthpiece for an infusion container as described.
(No.11) An annular groove is formed in the outer peripheral edge of at least one surface of the top or bottom surface of the rubber plug, and the outer peripheral edge of the top and bottom surfaces of the rubber plug, and the entire side surface of the body portion are rubber plug outer supports. 1st thru | or which are receiving the compressive stress from10The mouthpiece for an infusion container according to any one of the above.
(No.12) The first to thirteenth aspects, wherein the rubber plug and the rubber plug outer support are fused.11The mouthpiece for an infusion container according to any one of the above.
(No.13) A synthetic resin film is laminated on at least the bottom surface of the rubber plug and the side surface of the body portion, and at least a part of the adhesion between the rubber plug and the rubber plug shell support is at least partially supported by the film and the rubber plug shell support. 1st thru | or the said which is a melt | fusion with a body12The mouthpiece for an infusion container according to any one of the above.
(No.14) The mouthpiece for an infusion container according to the thirteenth aspect, wherein a synthetic resin film is laminated on the bottom and the side of the body of the rubber stopper.
(15) The rubber plug shell support according to any one of the first to 14th aspects, wherein the rubber plug shell support body does not have an extended portion from the bottom surface along the side surface of the rubber plug and is formed only on the side surface of the rubber plug. A mouthpiece for an infusion container according to 1.
(No.16) The rubber plug outer support does not have an extended portion from the bottom surface along the side surface of the rubber plug body, and further extends from the side surface of the rubber plug and the side surface of the rubber plug to the top and bottom surfaces of the rubber plug. The mouthpiece for an infusion container according to any one of the first to fifteenth aspects, further comprising a reinforcing frame extending in a rib shape along the outer peripheral edge thereof.
[0009]
Hereinafter, the contents of the present invention will be described in detail.
The rubber stopper used in the present invention is sufficient if it has resistance to the chemical solution used, including those conventionally used for mouthpieces of infusion containers, but the method for testing plastic containers for infusion according to the Japanese Pharmacopoeia In addition, those that conform to the standards of the rubber stopper test method for infusion are used in practice.
[0010]
Adhesion between the rubber plug and the rubber plug shell support can also be achieved by the rubber plug receiving the compressive stress of the rubber plug shell support from all sides of the barrel, but it is laminated with a synthetic resin film. If the rubber plug is used and heat fusion is achieved between the film and the rubber plug outer support, the above-mentioned adhesion is more effective.
This synthetic resin film is effective in terms of liquid-tight sealing by fusing the rubber plug and the rubber plug outer support as described above, but if it is present on the bottom surface, that is, the surface in contact with the chemical liquid, Since leaching of the rubber plug component is suppressed, this is also a useful means in this respect.
[0011]
A method for producing a rubber stopper laminated with the synthetic resin film is not particularly limited, but an uncrosslinked rubber material is sandwiched between synthetic resin films (for example, as described in JP-A-2-1275). Method) or a method of casting on a film and forming a rubber plug simultaneously with crosslinking is simple and preferred. However, in consideration of the contact relationship between the rubber plug and the rubber plug outer support and the liquid contact relationship between the rubber plug and the chemical solution, it is preferable that at least the bottom surface is laminated. Furthermore, it is more preferable from the point of liquid-tight sealing property to laminate on the side surface of the body portion of the rubber plug.
The synthetic resin film used here is required to be resistant to the rubber plug shell support and the chemical solution or to the chemical solution, but the former fusibility is particularly required. When it is used, polyethylene, polypropylene, ethylene / vinyl acetate copolymer and the like can be exemplified, but when the latter chemical resistance is particularly required, polyester, polytetrafluoroethylene and the like are preferably used. When both are required, polyethylene, polypropylene and the like are particularly suitable.
The thickness of the laminating film is not particularly limited, but is preferably about 10 to 100 μm in view of easiness of laminating and fusion force.
[0012]
Since the contact surface between the rubber plug and the rubber plug shell support is constantly subjected to shear peeling stress when the needle is inserted or pulled out, a method for mechanical integration of the rubber plug and the rubber plug shell support is also preferably employed. The
For the rubber plug, mechanical integration that can considerably counter the above-mentioned shear peeling stress by providing a protrusion with a desired width, which is larger than the diameter of the top and bottom surfaces, at the center of the body side surface. Is obtained. In addition, the trunk | drum side surface center here means that the center of this protrusion part exists in the center vicinity of the trunk | drum side surface substantially, and does not need to be an exact center position. Further, the width and height of the protruding portion are not particularly limited, but a protruding portion having a trapezoidal cross section is particularly preferable in terms of shear peeling resistance.
The rubber plug shell support may be formed only on the side surface of the barrel portion of the rubber plug, but further extends from the side surface of the barrel portion to the top and / or bottom outer peripheral edge of the rubber plug, By forming a reinforcing frame that reaches the annular groove formed in the periphery, the integration of both is further improved.
If an annular rib is provided along the outer periphery of the liquid contact portion on the bottom surface of the rubber plug or the outer periphery of the air contact portion on the top surface, the annular rib is useful for positioning the rubber plug on the mold surface during insert injection molding described later. However, the formation of the annular rib itself acts as a rib for preventing deformation of the rubber plug, which is a preferred embodiment.
[0013]
The method of making the rubber plug receive a compressive stress from the outer support body of the rubber plug on the entire side surface of the barrel and reducing the diameter of the top or bottom surface of the rubber plug is not particularly limited. In the method of forcibly inserting the rubber plug into the rubber plug shell support having a smaller inner diameter, the larger the difference between the two diameters, the more difficult the insertion work is. However, so-called insert molding, in which a rubber plug is inserted in a split mold in advance and a rubber plug outer support is injection-molded on the entire side surface of the barrel portion or on the outer peripheral edge of the barrel side surface and the top and bottom surfaces. This method can be achieved easily and is preferable.
In this case, even if the rubber plug is subjected to compressive stress on the entire side surface or the like of the trunk portion, the volume of the rubber plug itself is not changed, so that only the reduced diameter of at least one of the top surface or the bottom surface according to the present invention is involved. It is impossible to deform the rubber plug by reducing the volume. In order to reduce the volume of the top surface or bottom surface by reducing the diameter, the volume of the other part of the rubber plug must be increased, that is, accompanied by a volume displacement. Don't be.
[0014]
In the present invention, the rubber plug causes the volume decrease based on the compressive stress from the entire side surface of the trunk portion, etc., to generate a phenomenon of volume increase in the vertical direction on the top surface or the bottom surface, that is, a phenomenon of bulging deformation. It is something to be solved.
However, in the present invention, from the viewpoint of preventing liquid leakage when the needle is pierced, pulled out, or repeated, which is the original purpose of the present invention, the higher the compressive stress is, the more preferable, If the diameter of the rubber plug becomes large and the tightening force becomes excessive, the needle piercing and drawing work itself becomes difficult, which may hinder the infusion work.
Considering these points, in the present invention, the range of the diameter reduction of the top surface or the bottom surface of the rubber plug needs to be 1 to 10%, preferably 2 to 8%, and more preferably 3 to 6%. However, in this case, if it is less than 1%, the desired effect cannot be obtained, and a liquid leakage phenomenon is observed as in the conventional case. On the other hand, if it exceeds 10%, a considerable amount of force is required to pierce the needle into the rubber stopper or to pull out the needle, which hinders the infusion work as described above, which is not preferable. The case of 2 to 8% is more effective in terms of liquid leakage resistance and workability. When the diameter reduction is 3 to 6%, it is the most preferable range from the overall viewpoint.
[0015]
The mouthpiece for an infusion container according to the present invention includes a rubber stopper laminated with a rubber stopper or a synthetic resin film and a rubber stopper outer support.bodyThe rubber plug outer shell supportbodyIf the rubber plug is further extended from the bottom surface along the side of the body of the rubber plug and an annular rib protruding outward is formed as a flange at the tip, a flange is also provided at the opening of the synthetic resin infusion body This facilitates the coupling between the two. For bonding between the two, ultrasonic bonding and other fusion methods usually performed in synthetic resin moldings can be applied. In addition, rubber plug shell support as described abovebodyWithout plug, or a rib plug formed only on the side of the body of the rubber plug, or in the form of a rib from the side of the body and the side of the body to the top and bottom surfaces of the rubber plug to the outer periphery. It is also possible to form a plug body that extends to form a reinforcing frame, in which case the plug body is inserted into a plug body receiving portion formed in advance in the synthetic resin infusion body opening, A method in which the two are fused in a liquid-tight manner by various known heat fusion means can be adopted as an effective method.
[0016]
The present invention also provides a manufacturing method of a plug having a rubber plug and a rubber plug shell support, and in particular, a rubber plug is inserted in a split mold in advance, A method of injection molding is disclosed.
According to the manufacturing method of the plug according to the present invention, the rubber plug is inserted in the mold in advance, and the top surface or the bottom surface is temporarily fixed to the mold surface in order to position the rubber plug. As a temporary fixing method for this positioning, a rubber plug fixing suction hole is opened on the mold surface facing the top or bottom of the rubber plug, and the rubber plug is sucked and fixed at a predetermined position on the mold surface. Although there is a method, an annular groove is provided at a predetermined position of the mold and an annular rib provided along the outer peripheral edge of the top surface or the bottom surface of the rubber plug is inserted and is preferable because positioning is easier. In the present invention, since the rubber plug is compressed from the entire surface of the barrel and reduced in diameter, the annular groove is formed so that the annular rib can also be reduced in diameter when the insertion method of the annular rib is adopted. It is necessary to widen slightly in the center direction of the ring.
[0017]
The positional relationship between the mold surface on which the rubber stopper is positioned and the mold surface facing the mold surface may be in a position that leaves a gap of about 0.2 to 0.4 mm when there is no flat recess described later. preferable. This is because it is preferable to leave a deformation space of the rubber plug when the rubber plug is compressed from the side surface of the body portion. This is because there is no risk of intrusion.
When there is the flat recess, it may be in contact with the opposing mold surface.
[0018]
On the mold surface on which the rubber plug is temporarily fixed or on the opposite mold surface, a flat recess having a size that can be covered with the bottom surface or the top surface of the reduced diameter rubber plug is formed. This constitutes a place where the rubber plug bulges and deforms due to compression from the side surface of the rubber plug body.
The flat recess can achieve its purpose if it exists in at least one of the upper and lower molds. However, when it is desired to increase the degree of diameter reduction of the top surface or the bottom surface, the metal on both sides is made larger than the volume of the recess. Forming a flat recess in the mold can easily cause deformation of the rubber plug such as a reduced diameter and bulge.
The rubber stopper fixing suction hole may be open on the inner surface of the flat recess. Further, when a flat concave portion is formed on the mold surface opposite to the mold surface on which the rubber plug is temporarily fixed, it is desirable to provide a vent hole for discharging air accompanying the bulging deformation of the rubber plug.
[0019]
The volume of the above-described flat recess needs to be sufficient to absorb the rubber plug thickness increase (the top surface or bottom surface side bulging deformation) based on the reduced diameter of the bottom surface or top surface of the rubber plug. The increase in the thickness of the rubber plug (bulging deformation) due to the injection pressure is easier to cause over the widest possible area of the top or bottom surface. Therefore, the larger the inner diameter of the flat recess, the deeper the depth. Small is enough.
Therefore, the depth of the recess is determined by the desired degree of diameter reduction, and cannot be specified in general. However, in order to reduce the diameter of the top or bottom surface of the rubber plug by 1 to 10%, the material of the rubber plug Considering the deformability based on the above, about 0.2 to 5 mm is preferable. If the thickness is less than 0.2 mm, it is difficult to sufficiently bulge the rubber plug, and the degree of diameter reduction becomes insufficient, which makes it difficult to achieve the intended purpose. On the other hand, bulging deformation exceeding 5 mm is usually difficult to occur, and a depth exceeding 5 mm is not very meaningful.
[0020]
The simplest way to increase the injection molding pressure of the rubber plug shell support is to apply a compressive stress to the side surface of the body of the rubber plug to reduce the diameter of the top or bottom surface. There is also a method of utilizing the molding shrinkage characteristics of the synthetic resin by forming the top surface or bottom surface of the rubber plug thick so that it can be used preferably.
[0021]
In order to control the diameter of the top or bottom of the rubber plug to take a desired value within the range of 1 to 10% reduction, in addition to the method by controlling the injection resin pressure, the degree of deformation of the top or bottom The most convenient method is to use a strain gauge. The relationship between the resin pressure in the mold and the reduced diameter, and the strain received by the gauge terminal in the recess by the rubber plug bulging in the recess of the mold are obtained in advance, and the setting of the predetermined resin pressure or strain value during injection molding is maintained. The desired degree of diameter reduction can be easily obtained through the steps of maintaining the holding pressure and cooling.
[0022]
By setting the mold surface in contact with or opposite to the top or bottom surface of the rubber plug to be a nested mold, it becomes easy to install the fixed suction hole or the vent hole of the rubber plug. In addition, when a sintered compact of air-permeable metal powder is used for the insert mold, the above-described fixed suction hole or vent hole can be easily installed and is preferably employed.
[0023]
The cavity of the injection mold is composed of the top and bottom side molds of the rubber plug and the mold surrounding the barrel part, but the injection gate is outside the barrel part of the rubber plug and on the top and bottom surfaces. It is preferable for uniform injection molding to provide them on a parallel plane and at the same interval.
It is to be noted that an internal gas exhaust hole is necessary as in the case of normal injection molding.
[0024]
Next, the present invention will be described with reference to the drawings. However, the present invention is not limited by the description of the drawings.
FIG. 1 is a longitudinal sectional view of a cylindrical rubber plug 1a used in the present invention, and FIG. 2 shows a rubber plug 1b which is the same as the rubber plug of FIG. FIG. 3 is a longitudinal sectional view showing a state where the rubber plug is fused to the container 4s. FIG. 3 shows a rubber plug 1c obtained by laminating the bottom surface and the body side surface of the rubber plug of FIG. 1 with a synthetic resin film. FIG. 4 is a longitudinal sectional view showing a state in which this is fused to the infusion container 4s. FIG. 4 shows a protrusion provided on the side surface of the body portion of the rubber plug of FIG. FIG. 5 is a longitudinal sectional view showing a state where the rubber stopper 1e same as the rubber stopper of FIG. 4 is held by the rubber stopper outer support 2e and fused to the infusion container 4s. FIG. 6 shows an annular groove formed on the top and bottom surfaces of the cylindrical rubber plug of FIG. FIG. 7 is a longitudinal sectional view showing a state in which the rubber stopper 1f laminated with the film is held by the rubber stopper outer support 2f and fused to the infusion container 4s. FIG. 8 is a vertical cross-sectional view of the rubber plug 1g formed, and FIG. 8 is a vertical cross-section in a state where the same rubber plug 1h as the rubber plug shown in FIG. 7 is held by the rubber plug outer support 2h and fused to the infusion container 4s. FIG. 9 is a longitudinal sectional view showing a state where the same rubber plug 1i as the rubber plug shown in FIG. 7 is gripped by the rubber plug outer support 2i located only on the side surface of the rubber plug body. 9 is a longitudinal cross-sectional view of the state in which the mouth plug shown in FIG. 9 is inserted into the opening of the infusion container main body and the heater is arranged, and FIG. 11 is fitted by the method shown in FIG. FIG. 12 is a longitudinal sectional view showing a state where the plug is inserted and integrated, and FIG. It is a longitudinal sectional view showing an example of the method when the form, FIG. 13 is a longitudinal sectional view showing an example of another method.
[0025]
Details will be described below.
The rubber plug shown in FIG. 1 is an example of a simple cylindrical rubber plug 1a, and shows a longitudinal sectional view thereof. The rubber plug 1a includes a top surface 1ap, a bottom surface 1aq, and a body side surface 1ar.
[0026]
FIG. 2 shows a mouth plug body using the same rubber plug 1b as in FIG. 1 and gripped under compression by a rubber plug outer support 2b from the trunk side surface 1br. Because of the compression, the top surface 1bp and the bottom surface 1bq are bulged and deformed. Such deformation applies a strong pressure to the needle pierced for infusion, and contributes to a strong blockage of the hole after the needle is withdrawn.
On the other hand, in order to improve the integrity between the rubber plug and the rubber plug outer support, the rubber plug outer support 2b is reinforced not only on the grip frame 2br but also on the outer peripheral edge of the top surface on the barrel side surface 1br of the rubber plug. A reinforcing frame 2bq is formed on the frame 2bp and also on the bottom peripheral edge. The reinforcing frame 2bq on the outer peripheral edge on the bottom side extends to the infusion container side to be fused with the infusion container 4s and has a flange 2bs formed at the tip. FIG. 2 shows the fused state.
[0027]
3 uses a rubber plug in which a synthetic resin film 3 is laminated on the bottom surface (chemical solution contact surface side) 1cq and the body side surface 1cr of the same rubber plug 1c as in FIG. Similarly, a gripping frame 2cr of the rubber plug shell support 2c is formed on the side surface of the body portion of the rubber plug and a reinforcing plug 2cq is formed on the outer peripheral edge of the bottom portion. Since the rubber plug 1c and the rubber plug outer support 2c are integrated with each other, there is no need for a reinforcing frame on the top surface of the rubber plug. The rubber plug shell support 2c has a flange 2cs on the side of the infusion container 4s and is fused to the container as in the case of FIG. The top surface 1cp is bulged and deformed by pressurization from the side surface of the body portion. The bottom side 1cq is flat because a manufacturing method that does not bulge and deform is employed.
[0028]
FIG. 4 shows a rubber plug 1d having a protrusion 1dk having a substantially trapezoidal cross section at the center of the barrel side surface 1dr of the same rubber plug 1d as that of FIG. The same synthetic resin film 3 as in the case of FIG. 3 is laminated on a part of the side surface. 1 dp is the top surface.
[0029]
FIG. 5 shows the same rubber plug 1e as in FIG. 4, in which the same film 3 is laminated on the bottom surface 1eq and a part of the body side surface 1er, and the rubber plug is pressed under pressure from the body side surface 1er side. The mouth plug body gripped by the outer shell support 2e is shown, and the rubber plug and the rubber plug outer shell support are in close contact with each other, but the portion with the laminate film is integrated by fusion. The protruding part 1ek of the rubber plug meshes with the upper gripping frame 2ep and the lower gripping frame 2eq of the gripping frame 2er on the side surface of the body part of the rubber plug shell support 2e, and is strongly integrated under the anchoring effect. The rubber stopper bulges and deforms toward the top surface 1ep as in the case of FIG. 3, but the bottom surface 1eq side is flat. The flange 2es of the rubber plug shell support is fused to the infusion container 4s.
[0030]
FIG. 6 is a rubber plug in which annular concave grooves 1fg are respectively formed on the outer peripheral edges of the top surface 1fp and the bottom surface 1fq of the same rubber plug 1f as the cylindrical rubber plug of FIG. 1, and a part of the bottom surface and the body side surface 1fr. Shows a plug body obtained by gripping a laminate of the synthetic resin film 3 from the side surface of the body portion under pressure with the grip frame 2fr of the rubber plug shell support 2f. Reinforcing frames 2fp and 2fq extending to the annular groove along the top and bottom surfaces of the rubber plug are formed on the rubber plug outer support 2f, and the rubber plug and the rubber plug outer support are formed in an annular shape of the reinforcing frame. It is strongly integrated by a throwing effect in the concave groove and fused via the film, and a liquid-tight seal is achieved. As in the case of FIG. 5, a flange 2fs for fusing to the infusion container 4s is formed and fused to the rubber plug shell support.
[0031]
FIG. 7 shows an example in which an annular rib 1gm is formed on the outer peripheral edge of the bottom surface 1gq in the same rubber plug 1g as that of FIG. 4, and is composed of a top surface 1gp, a bottom surface 1gq, and a body side surface 1gr. On the side surface, a protrusion 1gk similar to that shown in FIG. 4 is formed. Moreover, the synthetic resin film 3 similar to the above is laminated on a part of the side surface and the bottom surface of the body portion including the annular rib. The annular rib is effectively used for positioning and temporarily fixing the rubber stopper to the mold surface during insert injection molding, and is effective for preventing abnormal deformation of the rubber stopper during needle insertion.
[0032]
FIG. 8 shows the same rubber plug 1h as shown in FIG. 7 and a synthetic resin film 3 laminated in the same manner under pressure on the same support 2h as the rubber plug outer support shown in FIG. The plug body obtained by gripping is shown. The rubber plug is composed of a top surface 1hp, a bottom surface 1hq, and a body side surface 1hr. The rubber side surface has a protrusion 1hk on the side surface of the body portion and an annular rib 1hm on the bottom surface. Is laminated. The protrusion 1hk meshes with the upper gripping frame 2hp and the lower gripping frame 2hq of the gripping frame 2hr of the rubber plug shell support, and is strongly integrated under the anchoring effect.
A flange 2hs is formed below the rubber plug shell support, similarly to the one shown in FIG. 6 and the like, and is fused and integrated with the infusion container 4s.
[0033]
FIG. 9 shows a mouth plug when the rubber plug shell support is composed only of a gripping frame and does not extend to the infusion container side as shown in FIG. The same rubber plug 1i as the rubber plug of FIG. 7 is used, and is composed of a top surface 1ip, a bottom surface 1iq, and a body side surface 1ir. Are formed, and the film 3 is laminated on the bottom surface and part of the side surface of the body portion in the same manner as described above.
Further, the protruding portion 1ik meshes with the upper gripping frame 2ip and the lower gripping frame 2iq of the gripping frame 2ir constituting the rubber plug shell support 2i, and is strongly integrated under the anchoring effect. An annular convex portion 2it is formed on the outer peripheral portion of the upper gripping frame 2ip, and this annular convex portion constitutes a melting portion when it is fused and integrated with a mouth portion of an infusion container described later.
[0034]
FIG. 10 shows a structure in which a rubber plug 1i shown in FIG. 9 laminated with the same film 3 as above is integrated with a rubber plug outer support 2i. A state in which the plug is inserted into a plug receiving hole 4t provided in the mouth is shown. The plug receiving hole is lower than the plug receiving part 4tq at the lower end, and above the annular convex part 2it of the rubber plug outer support. Each of the elongated portions 4tp has a portion that contributes to a liquid-tight seal between the plug body and the plug body receptacle.
The liquid-tight seal between the plug body and the plug body receptacle is achieved by pressing a melt sealer 5 that is disposed above the position shown in FIG. That is, the sealer has a heater 5c, but has a recess on the side of the plug body for melting and integrating the rubber plug shell support and the plug body receptacle, and the recess has a side surface 5b inclined with the bottom 5a. By the pressing of the sealer, the extension part 4tp of the plug body receiving port is caused to flow in the melted state inward, while the annular convex part 2it of the upper gripping frame is also melted, and both are fused. A portion 5t is formed.
[0035]
FIG. 11 shows a state in which the fused portion 5t is formed. When the pressing force is strong, as shown in the drawing, the fused portion extends to the upper surface of the upper gripping frame, but this does not impair the intended liquid-tight sealability. In the drawing, 1i is a rubber plug, 3 is a synthetic resin film, 2i is a rubber plug shell support, 4t is a plug body receiving port, and 5t is a fused portion.
[0036]
FIG. 12 shows an example of a method for producing a plug body according to the present invention (similar to the plug body shown in FIG. 8).
A rubber plug 1g laminated with a synthetic resin film is inserted into an insert injection mold composed of split molds A, B, C and D, and before the rubber plug outer support resin is injected into the cavity Cc. Shows the state.
The mold B is combined with the mold A as a nested mold, and the mold A is in contact with the outer peripheral edge of the top surface of the rubber plug 1g so as to be slidable. Since the mold B is not in contact with the surface, a space Bb is formed in a flat concave shape on the top surface side of the rubber plug, and the bulging deformation of the top surface can be received. The possibility of sliding movement between the mold A and the top surface of the rubber plug 1g is a necessary condition when compressive stress is applied to the side surface of the rubber plug body and the top surface is reduced in diameter.
The mold B is provided with a vent hole Ba for exhausting air so that the air in the flat recess Bb can be discharged during the bulging deformation.
[0037]
The mold C is on the side surface, and injection gates Cb into which resin is injected in the direction of the arrow are provided at the same height and at equal intervals. Ca is a vent hole for injection molding.
The mold D is a mold disposed on the bottom side of the rubber plug, and is provided with an annular groove Da, and an annular rib 1gm of the rubber plug is fitted into the annular groove to be positioned and temporarily fixed. However, the width of the annular groove needs to be larger than the width of the annular rib so that it can slide and move when the rubber plug bottom surface is compressed when the rubber plug barrel side surface is compressed. Most preferably, the space Db is provided, and the insertion and positioning are performed between the outer inner wall of the annular groove Da and the outer wall surface of the annular rib 1gm. Moreover, it must be slidable between the annular rib and the annular groove bottom. In addition, although the exhaust accompanying the diameter reduction of the bottom face of the rubber plug is performed through the vent hole Dc, the vent hole is also used for suction fixing for temporarily fixing the rubber plug.
When the resin injected into the cavity Cc reaches a predetermined pressure, the resin can be reduced in diameter by applying a compressive stress to the side surface of the body portion of the rubber plug at the cavity Cd.
[0038]
FIG. 13 shows another example of a method for producing a plug body according to the present invention (similar to the plug body shown in FIG. 9).
The injection mold is composed of split molds E, F, G and H. An insert mold H, which is a sintered compact of metal powder particles, is incorporated in the center of the mold E. Since the sintered compact has a fine gas passage, the vent shown in FIG. There is no need to newly form a vent such as the hole Ba, vent or suction hole Dc.
The mold H has a flat recess Ha formed on the surface facing the rubber plug 1d, and the outer periphery of the flat recess is in contact with the rubber plug so as to be slidable. This contact relationship is for expecting the same effect as in the case of FIG. The top surface of the rubber plug body receives compressive stress from the side surface of the rubber plug body and bulges and deforms into the flat concave portion.
[0039]
The mold G has a flat recess Gb formed on the surface Ga facing the rubber stopper, and the rubber stopper is temporarily fixed on the surface of the mold G by suction from a fixed suction hole Gc opened in the bottom surface of the recess. Has been.
Synthetic resin is injected from the injection gate Ea formed by the molds E and F into the cavity K for molding the rubber plug shell support, and if the pressure exceeds a predetermined pressure, compressive stress is applied to the side surface of the body of the rubber plug Although the diameter of the rubber plug is reduced, the volume change corresponding to the diameter is absorbed by bulging and deforming into the flat recesses Ha and Gb.
By adopting such a molding method, the top surface and the bottom surface of the rubber plug are reduced in diameter, and the top surface and the bottom surface are bulged and deformed.
Note that Fa is an injection molding vent hole.
[0040]
【The invention's effect】
According to the present invention, compressive stress is applied from the entire side surface of the barrel portion of the rubber plug. By forming a concave portion on the mold surface facing the top surface or the bottom surface of the rubber plug, the bulge deformation into the concave portion is achieved. This makes it possible to reduce the diameter of the top surface or bottom surface, increasing the needle tightening force to the extent that no liquid leaks even if a needle is inserted from the top surface to the bottom surface, and the needle is removed. However, there is an effect that a force capable of sealing the hole immediately and powerfully is generated and there is no risk of liquid leakage.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view of a cylindrical rubber stopper.
FIG. 2 is a longitudinal sectional view of a state in which a mouth plug holding the rubber plug of FIG. 1 with a rubber plug shell support is fused to an infusion container.
3 is a longitudinal sectional view of a state in which a mouth plug body laminated with a film and gripping the rubber plug of FIG. 1 with a rubber plug shell support is fused to an infusion container.
4 is a vertical cross-sectional view of the rubber stopper of FIG. 1 having a protrusion on the side surface of the body and laminated with a film.
5 is a longitudinal sectional view showing a state in which a mouth plug body in which the rubber plug of FIG. 4 is held by a rubber plug shell support is fused to an infusion container.
6 is a longitudinal cross-sectional view of a state in which a mouth plug body, which has an annular groove on the top and bottom surfaces and is laminated with a film, is held by a rubber plug shell support and is fused to an infusion container. FIG. .
7 is a vertical cross-sectional view of the rubber plug of FIG. 4 in which an annular rib is formed on the bottom surface.
8 is a longitudinal sectional view of a state in which a mouth plug body in which the rubber plug of FIG. 7 is held by a rubber plug shell support is fused to an infusion container.
9 is a longitudinal sectional view of a mouth plug body in which the rubber plug of FIG. 7 is gripped by a rubber plug shell support.
FIG. 10 is a longitudinal sectional view showing a state in which the stopper of FIG. 9 is fitted into the opening of the infusion container main body and a sealer is disposed.
FIG. 11 is a longitudinal sectional view showing a state of being fused and integrated by the method shown in FIG.
FIG. 12 is a longitudinal sectional view showing an example of a method in the case of insert injection molding of a plug according to the present invention.
FIG. 13 is a longitudinal sectional view showing another example of the method in the case of insert injection molding of the plug according to the present invention.
[Explanation of symbols]
1a, 1b, 1c, 1d, 1e, 1f, 1g, 1h, 1i ... rubber stopper
1ap, 1bp, 1cp, 1dp, 1ep, 1fp, 1gp, 1hp, 1ip ... top surface
1 aq, 1 bq, 1 cq, 1 dq, 1 eq, 1 fq, 1 gq, 1 hq, 1 iq.
1ar, 1br, 1cr, 1dr, 1er, 1fr, 1gr, 1hr, 1ir ...
1dk, 1ek, 1gk, 1hk, 1ik ... projecting part
1fg ... annular groove
1gm, 1hm, 1im ... annular rib
2b, 2c, 2e, 2f, 2h, 2i ... rubber stopper outer support
2br, 2cr, 2er, 2fr, 2hr, 2ir ...
2bp, 2bq, 2cq, 2fp, 2fq ... Reinforcing frame
2ep, 2hp, 2ip ... Upper gripping frame
2eq, 2hq, 2iq ... lower gripping frame
2bs, 2cs, 2es, 2fs, 2hs ... flange
2it ... annular convex part
3 ... Synthetic resin film
4s ... Infusion container mouth
4t ... Mouthpiece receptacle
4tp ... extension part
4tq ... plug body receiving part
5 ... Molten sealer
5a ... Heater recess bottom
5b ... Heater recess side
5c ... Heater
5t ... Molten part
A, B, C, D, E, F, G, H ... Split mold
Ga ... mold surface
Bb, Ha, Gb ... flat recess
Ba, Ca, Fa ... vent hole
Cb, Ea ... Injection gate
Gc: Fixed suction hole
Cc, Cd, K ... cavity
Da ... annular groove
Db Space part
Dc ... Vent holes or fixed suction holes

Claims

In the plug body manufactured by insert injection molding with a rubber plug inserted, and having a cylindrical rubber plug and a rubber plug shell support attached to the body opening of the synthetic resin infusion container, the injection of the resin is an insert. The outer surface of the rubber plug is formed by injection gates on the plane parallel to the top and bottom surfaces and at the same interval on the plane parallel to the top and bottom surfaces. At least the whole body side surface of the peripheral part and the whole body side surface is in close contact with the rubber plug shell support body under compressive stress from the synthetic resin rubber plug shell support body, and the top and bottom surfaces of the rubber plug At least one of the diameters of the resin is reduced in diameter by 1 to 10% by the compressive stress applied to the side surface of the barrel part of the rubber plug from the resin injected during molding and the rubber plug outer support molded as a result of the injection. Air contact and / or bottom Liquid contact portion infusion container spout body, characterized in that bulges deformation.

The mouthpiece for an infusion container according to claim 1, wherein the compressive stress is a compressive stress from the side surface of the body portion of the rubber plug toward the center.

3. The mouthpiece for an infusion container according to claim 1 or 2, wherein a needle is pierced from the top surface to the bottom surface to prevent liquid leakage, and even if the needle is removed, the hole can be immediately sealed.

4. The mouthpiece for an infusion container according to any one of claims 1 to 3, wherein at least one of the top and bottom diameters of the rubber stopper is reduced in diameter by 2 to 8%.

5. The mouthpiece for an infusion container according to any one of claims 1 to 4, wherein at least one of the top and bottom diameters of the rubber stopper is reduced in diameter by 3 to 6%.

6. The mouthpiece for an infusion container according to any one of claims 1 to 5, wherein a protrusion that is larger than the diameter of the top and bottom surfaces is provided around the center of the side surface of the body portion of the rubber plug.

7. The mouthpiece for an infusion container according to claim 6 , wherein the protrusion has a trapezoidal cross section.

The mouth plug for an infusion container according to any one of claims 1 to 7, wherein an annular rib is provided on the outer peripheral edge of the liquid contact portion on the bottom surface of the rubber stopper or the outer peripheral edge of the air contact portion on the top surface.

An annular concave groove is formed in the outer peripheral edge of at least one surface of the top or bottom of the rubber plug, and the outer peripheral edge of the top and bottom of the rubber plug and the entire side surface of the trunk are formed from the rubber plug outer support. The mouthpiece for an infusion container according to any one of claims 1 to 8, which is subjected to compressive stress.

10. The mouthpiece for an infusion container according to any one of claims 1 to 9, wherein adhesion between the rubber stopper and the rubber stopper outer support is fusion.

A synthetic resin film is laminated on at least the bottom surface of the bottom surface and the body side surface of the rubber plug, and at least a part of the close contact between the rubber plug and the rubber plug shell support is the film and the rubber plug shell support. The mouthpiece for an infusion container according to any one of claims 1 to 10, wherein the mouthpiece is a fusion-bonded material.

The mouthpiece for an infusion container according to claim 11, wherein a synthetic resin film is laminated on the bottom of the rubber stopper and the side of the trunk.

The infusion solution according to any one of claims 1 to 12, wherein the rubber plug shell support body does not have an extended portion from the bottom surface along the side surface of the body portion of the rubber plug and is formed only on the side surface of the body portion of the rubber plug. Cap for container.

The rubber plug shell support does not have an extended portion from the bottom surface along the side surface of the rubber plug body, and further along the top surface and bottom surface of the rubber plug from the body side surface of the rubber plug and the body side surface. The mouthpiece for an infusion container according to any one of claims 1 to 13, further comprising a reinforcing frame extending in a rib shape up to the outer peripheral edge.