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JP4511575B2 - Manufacturing method of medical cap - Google Patents

Manufacturing method of medical cap Download PDF

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JP4511575B2
JP4511575B2 JP2007185958A JP2007185958A JP4511575B2 JP 4511575 B2 JP4511575 B2 JP 4511575B2 JP 2007185958 A JP2007185958 A JP 2007185958A JP 2007185958 A JP2007185958 A JP 2007185958A JP 4511575 B2 JP4511575 B2 JP 4511575B2
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elastic plug
plug body
mold
needle
frame portion
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JP2009022371A (en
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鈴木  啓介
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Naigai Kasei Co Ltd
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Naigai Kasei Co Ltd
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Description

本発明は、輸液容器、採血管等の医療用キャップの製造方法に関する。特に、医療用において針刺し可能な栓体を備えた医療用キャップの製造方法に関する。 The present invention is an infusion container, a method of manufacturing a medical cap such as blood collection tubes. In particular, a method of manufacturing a medical cap having a needle stick can plug body in medical.

医療分野に用いられる薬液ボトルや点滴に用いられる輸液ボトルには、針でその薬液等を取り出せるようにするため、そのキャップとして、ゴム栓や、外枠体の内側に針指し用のゴムまたはエラストマー樹脂からなる栓体を設けたものが用いられている。この外枠体は、溶着などの方法により輸液容器に取り付けられる。そして、使用時には栓体に注射針を突き刺し、キャップ部を下にすることにより、容器内の輸液を取り出す。従って、この様な医療用キャップには、薬液や輸液の漏洩防止や空気に触れることによる変質防止のため、密閉性が求められる。   For medical solution bottles used in the medical field and infusion bottles used for infusions, rubber caps or rubber or elastomer for needle pointing on the inner side of the outer frame body are used as caps so that the chemicals can be taken out with a needle. What provided the plug body which consists of resin is used. This outer frame is attached to the infusion container by a method such as welding. In use, the infusion solution in the container is taken out by inserting a needle into the stopper and lowering the cap. Therefore, such a medical cap is required to have hermetic properties in order to prevent leakage of chemicals and infusions and to prevent deterioration due to contact with air.

例えば、医療用キャップの構造を栓体の接液面と外枠体の底面保持部の上部とが融着しており、かつ前記栓体の側面部と前記外枠体の側周部の内壁とは非融着状態で接触している状態にすることで、ゴム特性が改善され、再シール性に優れた医療用キャップが提案されている(下記特許文献1参照)。   For example, in the structure of the medical cap, the liquid contact surface of the plug body and the upper portion of the bottom surface holding portion of the outer frame body are fused, and the side wall of the plug body and the inner wall of the side periphery of the outer frame body Has been proposed to provide a medical cap that is improved in rubber characteristics and excellent in resealability by being brought into contact in a non-fused state (see Patent Document 1 below).

しかし、従来の医療用キャップであると、栓体と外枠体との密着が十分でない場合がある。このような医療用キャップにおいては、針刺しの際に栓体と外枠体の位置がずれて両者の間に空隙が生じたり、その為に第2本目の針を刺すこと、又は再度針刺しを行うことが困難になるという問題がある。   However, in the case of a conventional medical cap, the close contact between the plug body and the outer frame body may not be sufficient. In such a medical cap, the position of the plug body and the outer frame body shifts during needle sticking, and a gap is created between them, or the second needle is stuck for that purpose, or needle sticking is performed again. There is a problem that it becomes difficult.

特開2005−118185号公報JP-A-2005-118185

本発明は前記問題点に鑑みなされたものであり、その目的は、弾性栓体と、その周縁部を内壁で保持する外枠体との密着性に優れ、針刺しによって弾性栓体と外枠体の位置ずれがなく、密閉性の確保に優れた医療用キャップの製造方法を提供することにある。 The present invention has been made in view of the above-mentioned problems, and the object thereof is excellent in adhesiveness between the elastic plug body and the outer frame body holding the peripheral edge portion thereof by the inner wall, and the elastic plug body and the outer frame body by needle stick. no positional deviation of is to provide a method for producing superior medical cap to ensure tightness.

本願発明者等は、前記従来の問題点を解決すべく、医療用キャップの製造方法について検討した。その結果、下記構成を採用することにより、前記目的を達成できることを見出して、本発明を完成させるに至った。 The present inventors have, to solve the above conventional problems, and studied the manufacturing method of a medical cap. As a result, the inventors have found that the object can be achieved by adopting the following configuration, and have completed the present invention.

発明に係る医療用キャップの製造方法は、前記の課題を解決する為に、弾性栓体と、弾性栓体の周縁部を下面側から内壁で保持する下側枠部及び上面側から内壁で保持する上側枠部を備えた外枠体を有する医療用キャップの製造方法であって、第1上金型と共通下金型を用いて、前記弾性栓体の載置が可能な載置部を内壁に有する下側枠部を成形し、前記下側枠部の載置部上に、前記弾性栓体をその上面を上向きにして載置し、前記弾性栓体の直径よりも小さい直径を有する突起部を有し、かつ、前記共通下金型と組み合わせた際に前記上側枠部の成形用のキャビティを形成可能にする第2上金型を用いて、前記突起部が前記弾性栓体の中央部を押圧して下方に押し出すように前記共通下金型と型閉じし、前記キャビティ内に溶融樹脂を射出して上側枠部を成形し、前記外枠体を形成することを特徴とする。 In order to solve the above-described problems, the medical cap manufacturing method according to the present invention includes an elastic plug body, a lower frame portion that holds the peripheral edge portion of the elastic plug body from the lower surface side and the inner wall from the upper surface side. A method for manufacturing a medical cap having an outer frame body having an upper frame portion to hold, wherein the elastic plug body can be mounted using a first upper mold and a common lower mold A lower frame portion having an inner wall is molded, and the elastic plug body is placed on the placement portion of the lower frame portion with its upper surface facing upward, and the diameter is smaller than the diameter of the elastic plug body. A second upper die that has a projection portion and has a molding cavity for forming the upper frame portion when combined with the common lower die, and the projection portion is the elastic plug body. Close the common lower mold so that the center part of the mold is pushed down and push the molten resin into the cavity. And molding the upper frame portion, and forming the outer frame body.

本発明の製造方法は、弾性栓体の周縁部を下面側から内壁で保持する下側枠部を成形した後、上面側から内壁で保持する上側枠部を成形して、外枠体を形成する方法である。下側枠部は、第1上金型と共通下金型を用いて成形される。このとき、下側枠部の内壁には弾性栓体の載置が可能な載置部も形成される。   In the manufacturing method of the present invention, after forming the lower frame portion that holds the peripheral edge portion of the elastic plug body from the lower surface side by the inner wall, the upper frame portion that is held from the upper surface side by the inner wall is formed to form the outer frame body It is a method to do. The lower frame portion is formed using a first upper mold and a common lower mold. At this time, a mounting portion on which the elastic plug body can be mounted is also formed on the inner wall of the lower frame portion.

次に、下側枠部の載置部に弾性栓体をその上面が上向きとなる様に載置し、第2上金型と共通下金型を用いて、上側枠部を成形する。第2上金型は、共通下金型と組み合わせた際に、弾性栓体の中央部を押圧することが可能な突起部を備えている。このとき、弾性栓体下側の周縁部は前記載置部により支持されているが、中央部ではこれを支えるものがない。その為、突起部で押圧された中央部が下方に押し出された状態となる。この様な状態で、第2上金型と共通下金型との間に形成されたキャビティ内に溶融樹脂を射出して上側枠部を成形する。   Next, the elastic plug body is placed on the placement portion of the lower frame portion so that the upper surface thereof faces upward, and the upper frame portion is molded using the second upper mold and the common lower mold. The second upper mold includes a protrusion capable of pressing the central part of the elastic plug when combined with the common lower mold. At this time, the lower peripheral portion of the elastic plug is supported by the mounting portion described above, but there is nothing to support this in the central portion. For this reason, the central portion pressed by the protrusion is pushed downward. In such a state, the molten resin is injected into a cavity formed between the second upper mold and the common lower mold to mold the upper frame portion.

前記方法により成形された上側枠部は弾性栓体との接触面で融着した構造となっている。これにより、例えば上面側から針刺しをする際に弾性栓体と上側枠部の位置ずれにより空隙が生じるのを防止することができ、その結果、薬液の密閉性を確保することができる。また、上側枠部の成形は、弾性栓体は下側に押圧された状態で行われるので、上側枠部の成形後、弾性栓体の上面側に於ける中央部が上方に膨れあがるのを抑制することができる。   The upper frame portion formed by the above method has a structure fused at the contact surface with the elastic plug. Thereby, for example, when needle sticking is performed from the upper surface side, it is possible to prevent a gap from being generated due to the displacement of the elastic plug body and the upper frame portion, and as a result, it is possible to ensure the sealing property of the chemical solution. Further, since the upper frame portion is molded in a state where the elastic plug is pressed downward, the central portion on the upper surface side of the elastic plug body swells upward after the upper frame portion is molded. Can be suppressed.

前記方法に於いては、前記弾性栓体として、熱可塑性エラストマーを含み構成されるものを使用することが好ましい。これにより、復元力が向上し、輸液加療中の針保持力や針抜き後の再シール性に優れた医療用キャップを提供することができる。   In the said method, it is preferable to use what is comprised including a thermoplastic elastomer as said elastic plug. Thereby, a restoring force improves and it can provide the medical cap excellent in the needle holding force during infusion treatment and the resealability after needle removal.

本発明の実施の形態について、図を参照しながら以下に説明する。但し、説明に不要な部分は省略し、また説明を容易にする為に拡大又は縮小等して図示した部分がある。図1は、本実施の形態に係る医療用キャップの製造方法を説明するための断面図である。図2は、前記製造方法に於ける上側枠部の射出成形の様子を示す断面図である。   Embodiments of the present invention will be described below with reference to the drawings. However, parts that are not necessary for the description are omitted, and there are parts that are illustrated in an enlarged or reduced manner for ease of explanation. FIG. 1 is a cross-sectional view for explaining a method for manufacturing a medical cap according to the present embodiment. FIG. 2 is a cross-sectional view showing a state of injection molding of the upper frame portion in the manufacturing method.

図1(a)に示すように、第1上金型13と共通下金型11を用いて、下側枠部を射出成形する。本実施の形態では、第1上金型13は固定型であり、共通下金型11は可動型である。第1上金型13と共通下金型11は、型閉じをした際に、円筒状の下側枠部の成形が可能なキャビティが形成される構造となっている。   As shown in FIG. 1A, the lower frame portion is injection molded using the first upper mold 13 and the common lower mold 11. In the present embodiment, the first upper mold 13 is a fixed mold, and the common lower mold 11 is a movable mold. The first upper mold 13 and the common lower mold 11 have a structure in which a cavity capable of forming a cylindrical lower frame portion is formed when the mold is closed.

下側枠部の構成材料となる樹脂を溶融した溶融樹脂12は、第1上金型13内のスプル、ランナを通過し、キャビティ内に注入する。射出圧力としては特に限定されず、適宜必要に応じて設定され得る。射出された溶融樹脂12は所定時間冷却される。型開き後、図1(b)に示すように、下側枠部15が形成される。下側枠部15の内壁には、後述の弾性栓体を載置する為の載置部14が設けられている。   The molten resin 12 obtained by melting the resin as the constituent material of the lower frame portion passes through the sprue and runner in the first upper mold 13 and is injected into the cavity. The injection pressure is not particularly limited, and can be set as necessary. The injected molten resin 12 is cooled for a predetermined time. After the mold opening, as shown in FIG. 1B, the lower frame portion 15 is formed. On the inner wall of the lower frame portion 15, a mounting portion 14 for mounting an elastic plug body to be described later is provided.

次に、図1(c)〜1(e)に示すように、下側枠部15の載置部14上に、弾性栓体17をその針刺面(上面)18が上向きとなる様に載置し、上側枠部の射出成形を行う。弾性栓体17は、その周縁部17aのみが載置部14によって下側から支えられている。また、弾性栓体17の直径は特に限定されず、通常は12〜30mmの範囲内で設定される。また、弾性栓体17の直径は、下側枠部15の開口部に於ける内径R1に対し、0.1mm〜0.5mm程度小さめに設定されていることが好ましい。これにより、下側枠部15内への弾性栓体17のインサートの容易性を確保している。更に、弾性栓体17の厚みは特に限定されず、通常は3〜10mmの範囲内で設定される。   Next, as shown in FIGS. 1 (c) to 1 (e), the elastic stopper 17 is placed on the mounting portion 14 of the lower frame portion 15 so that the needle piercing surface (upper surface) 18 faces upward. Place and perform injection molding of the upper frame. Only the peripheral edge portion 17 a of the elastic plug body 17 is supported by the mounting portion 14 from below. Moreover, the diameter of the elastic plug body 17 is not specifically limited, Usually, it sets within the range of 12-30 mm. The diameter of the elastic plug 17 is preferably set to be smaller by about 0.1 mm to 0.5 mm than the inner diameter R1 at the opening of the lower frame portion 15. Thereby, the ease of insertion of the elastic plug 17 into the lower frame portion 15 is ensured. Furthermore, the thickness of the elastic plug 17 is not particularly limited, and is usually set within a range of 3 to 10 mm.

ここで、上側枠部の射出成形の詳細を図2(a)〜2(c)に示す。上側枠部の成形には、第2上金型16と共通下金型11とを用いる。第2上金型16と共通下金型11は、型閉じをした際に、上側枠部の成形が可能なキャビティが形成される構造となっている。また、当該型閉じの際、弾性栓体17の中央部は、下側枠部15により支持されていない為、後述する突起部により押圧されて下方に押し出された状態となっている(図2(b)参照)。尚、弾性栓体17としては、針刺面18がフラットで、接液面20にのみ脱落防止の為の段差部17bが設けられたものを用いる。但し、本発明の弾性栓体としては、当該形状のものに限定されない。他の態様については、後段にて詳述する。   Here, the details of the injection molding of the upper frame part are shown in FIGS. The second upper mold 16 and the common lower mold 11 are used for molding the upper frame portion. The second upper mold 16 and the common lower mold 11 have a structure in which a cavity capable of molding the upper frame portion is formed when the mold is closed. Further, since the central portion of the elastic plug 17 is not supported by the lower frame portion 15 when the mold is closed, it is pressed by a protrusion described later and pushed downward (FIG. 2). (See (b)). In addition, as the elastic plug body 17, one having a flat needle stick surface 18 and a stepped portion 17 b for preventing dropout only on the liquid contact surface 20 is used. However, the elastic plug body of the present invention is not limited to the shape. Other aspects will be described in detail later.

前記第2上金型16には、カシメ入れ子19が設けられており、当該入れ子19は円柱状の突起部22aと段差部22bとを備えている。突起部22aの直径rは、弾性栓体17の直径よりも小さければ特に限定されず、成形する外枠体の形状、サイズに応じて適宜設定される。通常は、10.5〜29mmの範囲内であることが好ましく、11〜28mmの範囲内であることがより好ましい。内径Rが弾性栓体17の直径の80%を超えると、型締め時に下側枠部15が弾性栓体17を保持しにくくなる場合がある。その一方、内径Rが弾性栓体17の直径の45%未満であると、型締め時の弾性栓体17の変形が局部的になり、弾性栓体17の中央に向かう圧縮応力の発生が見られない場合がある。 The second upper mold 16 is provided with a caulking insert 19, and the insert 19 includes a columnar protrusion 22 a and a step 22 b. The diameter r of the protrusion 22a is not particularly limited as long as it is smaller than the diameter of the elastic plug body 17, and is appropriately set according to the shape and size of the outer frame body to be molded. Usually, it is preferably within a range of 10.5 to 29 mm, and more preferably within a range of 11 to 28 mm. The inner diameter R 2 exceeds 80% of the diameter of the elastic plug member 17, there is a case where the lower frame portion 15 at the time of mold clamping is unlikely to hold the elastic stopper 17. Meanwhile, if the inner diameter R 2 is less than 45% of the diameter of the elastic plug member 17, deformation of the elastic stopper 17 at the time of mold clamping is locally, generation of compressive stress towards the center of the elastic stopper 17 It may not be seen.

また、突起部22aの高さhは特に限定されず、弾性栓体17のサイズ、成形する外枠体の形状等に応じて適宜設定される。通常は、1〜5mmの範囲内であることが好ましく、1.5〜2.5mmの範囲内であることがより好ましい。高さhが5mmを超えると、第2上金型16と共通下金型11との型閉じが困難になる場合がある。その一方、高さhが1mm未満であると、弾性栓体17の中央部を下方に押し下げるのが不十分になり、弾性栓体17の中央に向かう圧縮応力の発生が見られない場合がある。   Further, the height h of the protrusion 22a is not particularly limited, and is appropriately set according to the size of the elastic plug 17 and the shape of the outer frame to be molded. Usually, it is preferably within a range of 1 to 5 mm, and more preferably within a range of 1.5 to 2.5 mm. If the height h exceeds 5 mm, it may be difficult to close the mold between the second upper mold 16 and the common lower mold 11. On the other hand, when the height h is less than 1 mm, it is insufficient to push down the central portion of the elastic plug body 17 downward, and there is a case where the generation of compressive stress toward the center of the elastic plug body 17 is not observed. .

尚、突起部の形状としては、本発明は前記円柱状の突起部22aに限定されない。例えば、図3(a)〜3(e)に示す種々の突起部を採用することもできる。即ち、中央部が窪んだ凹形状の突起部23(同図(a))や、中央部が所定の曲率で湾曲して膨らんだ凸形状の突起部24(同図(b))、リング状の突起部25(同図(c))、2段形状の突起部26(同図(d))、角が曲面となる様に面取りされた円柱状の突起部(同図(e))が例示できる。   In addition, as a shape of a projection part, this invention is not limited to the said cylindrical projection part 22a. For example, various protrusions shown in FIGS. 3A to 3E can be employed. That is, a concave-shaped projection 23 having a depressed central portion (FIG. 5A), a convex-shaped projection 24 having a curved central portion with a predetermined curvature (FIG. 5B), a ring shape Projection part 25 (FIG. (C)), two-stage projection part (FIG. (D)), and cylindrical projection part (FIG. (E)) chamfered so that the corners are curved. It can be illustrated.

続いて、図2(b)に示すように、第2上金型16と共通下金型11との型閉じを行う。このとき、弾性栓体17の針刺面18に於ける中央部が突起部22aにより押圧され、接液面(下面)20が下方に押し下げられる。また、弾性栓体17の針刺面18の周縁部の一部が段差部22bと接触する。   Subsequently, as shown in FIG. 2B, the second upper mold 16 and the common lower mold 11 are closed. At this time, the central portion of the needle plug surface 18 of the elastic plug 17 is pressed by the protrusion 22a, and the liquid contact surface (lower surface) 20 is pressed downward. Further, a part of the peripheral edge portion of the needle piercing surface 18 of the elastic plug 17 is in contact with the stepped portion 22b.

次に、型閉じにより形成されたキャビティ28内に、上側枠部の構成材料となる樹脂を溶融した溶融樹脂31を注入する。射出圧力としては特に限定されず、適宜必要に応じて設定され得る。射出された溶融樹脂31は所定時間冷却される。型開き後、図2(c)に示すように、上側枠部32が形成される。弾性栓体17と上側枠部32の接触部分は融着した状態となっている。   Next, a molten resin 31 in which a resin as a constituent material of the upper frame portion is melted is injected into the cavity 28 formed by mold closing. The injection pressure is not particularly limited, and can be set as necessary. The injected molten resin 31 is cooled for a predetermined time. After the mold opening, as shown in FIG. 2C, the upper frame portion 32 is formed. The contact portion between the elastic plug 17 and the upper frame portion 32 is in a fused state.

以上により、上側枠部32と下側枠部15とが一体となった外枠体27が形成され、本実施の形態に係る医療用キャップ30が得られる(図1(e)、1(f)参照)。   As described above, the outer frame body 27 in which the upper frame portion 32 and the lower frame portion 15 are integrated is formed, and the medical cap 30 according to the present embodiment is obtained (FIGS. 1 (e) and 1 (f). )reference).

前記製造方法により得られる医療用キャップ30において、弾性栓体17には、上側枠部32によって、図2(c)の矢印で示す方向、すなわち弾性栓体17の中央部の下方に向かって圧縮応力(カシメ力)が働いている。この圧縮応力の作用により、弾性栓体17自身が有する復元力が弾性栓体17の側周部の方向に働き拡張しようとする結果、下側枠部15との密閉性が向上する。これにより、針抜けに対する保持力、及び復元力が向上し、針抜け後の再シール性にも優れたものにできる。   In the medical cap 30 obtained by the manufacturing method, the elastic plug body 17 is compressed by the upper frame portion 32 toward the direction indicated by the arrow in FIG. 2C, that is, below the central portion of the elastic plug body 17. Stress (caulking force) is working. Due to the action of the compressive stress, the restoring force of the elastic plug body 17 itself acts in the direction of the side peripheral portion of the elastic plug body 17 and attempts to expand, so that the sealing performance with the lower frame section 15 is improved. As a result, the holding force and the restoring force against needle removal are improved, and the resealability after needle removal can be improved.

また、圧縮押力の作用により、弾性栓体17における針刺面18の中央部が上方に膨れあがるのを抑制することができる。より詳細には、弾性栓体17の中央部の高さを、その周縁部を基準として1.5mm以下に抑制することができる。これにより、上側枠部32に、弾性栓体を密封する為のピールフィルム29を貼り付ける際にも、当該ピールフィルム29が弾性栓体17と接触するのを防止できる。また、弾性栓体17とピールフィルム29の隙間を小さくし、かつ、ピールフィルム29により密封された空気の体積を小さくできるので、例えば、滅菌の際、密封された空気の体積変化によるピールフィルム29の変形破壊を防止することができる。更に、弾性栓体17の針刺面18での膨らみを防止出きる結果、上側枠部32に於ける貼付部26aと前記中央部との段差を2mm以下に抑制できるので、当該上側枠部32に阻害されずに針の刺し込みを行うことができ、作業性が向上する。   Moreover, it can suppress that the center part of the needle stab surface 18 in the elastic plug body 17 bulges upwards by the effect | action of compression pressing force. More specifically, the height of the central portion of the elastic plug body 17 can be suppressed to 1.5 mm or less with reference to the peripheral edge portion. Thereby, when the peel film 29 for sealing the elastic plug body is attached to the upper frame portion 32, the peel film 29 can be prevented from coming into contact with the elastic plug body 17. Further, since the gap between the elastic plug 17 and the peel film 29 can be reduced and the volume of the air sealed by the peel film 29 can be reduced, for example, the peel film 29 due to the volume change of the sealed air during sterilization. Can be prevented from being deformed. Further, as a result of preventing the elastic stopper body 17 from bulging on the needle piercing surface 18, the step difference between the affixing portion 26a and the central portion in the upper frame portion 32 can be suppressed to 2 mm or less. The needle can be inserted without being hindered by this, and workability is improved.

また、弾性栓体17と下側枠部15との接触部分は非融着状態である。これにより、使用時の針抜けや液漏れを防止することができる。即ち、弾性栓体側面部は下側枠部15に固定されずに自由な状態にあるので、針を刺した場合に弾性栓体17が外側に押しやられる力を吸収することができる。このとき刺した針には、反作用で下側枠部15から弾性栓体17と通して針を保持する力が生じるので、針抜けを防止できる。また、針を抜いたときには、弾性栓体17は下側枠部15から内側に押しやられる力を受けるので、針で生じた穴を閉塞し、再シール性を向上させることができる。弾性栓体17の接液面20は、下側枠部の下方側に向かって凸状になっている(図2(c)参照)。凸状となっている接液面20の頭頂部と、段差部17bの段差面を含む面との距離sは、0.1mm〜3mmであることが好ましく、0.1mm〜2.5mmであることがより好ましい。   The contact portion between the elastic plug 17 and the lower frame portion 15 is in a non-fused state. Thereby, needle omission and liquid leakage during use can be prevented. That is, the side surface portion of the elastic plug body is not fixed to the lower frame portion 15 and is in a free state, so that it is possible to absorb the force that the elastic plug body 17 is pushed outward when a needle is stabbed. At this time, a force that holds the needle through the elastic plug 17 from the lower frame portion 15 is generated in the pierced needle as a reaction, so that needle removal can be prevented. Further, when the needle is pulled out, the elastic plug body 17 receives a force pushed inward from the lower frame portion 15, so that the hole generated by the needle can be closed and the resealability can be improved. The liquid contact surface 20 of the elastic plug body 17 is convex toward the lower side of the lower frame portion (see FIG. 2C). The distance s between the top of the liquid contact surface 20 that is convex and the surface including the stepped surface of the stepped portion 17b is preferably 0.1 mm to 3 mm, and preferably 0.1 mm to 2.5 mm. It is more preferable.

尚、前記外枠体27を構成する下側枠部15及び上側枠部32に用いる材料としては、合成樹脂のうち、医療用途としての安全性が確立されたものであれば足りる。中でも熱可塑性樹脂を用いるのが一般的である。具体的には、ポリエチレン、ポリプロピレン、PET(ポリエチレンテレフタレート)樹脂等の従来医療用途に用いられている樹脂が好ましいが、これらに限定されるものではない。下側枠部15と上側枠部32は、両者を融着させて外枠体27を構成するため、それぞれ用いられる成分は、同一の成分または相溶性のある成分であることが好ましい。また、下側枠部15または上側枠部32の一方または両方に、着色剤などの任意の成分を添加してもよい。   In addition, as a material used for the lower frame part 15 and the upper frame part 32 which comprise the said outer frame body 27, the safety | security for medical use is sufficient among synthetic resins. Of these, a thermoplastic resin is generally used. Specifically, resins conventionally used for medical use such as polyethylene, polypropylene, and PET (polyethylene terephthalate) resin are preferable, but are not limited thereto. Since the lower frame portion 15 and the upper frame portion 32 are fused together to form the outer frame body 27, the components used are preferably the same component or compatible components. Moreover, you may add arbitrary components, such as a coloring agent, to one or both of the lower frame part 15 or the upper frame part 32. FIG.

前記弾性栓体17に用いる材料としては、例えば、ゴムや熱可塑性エラストマーが挙げられる。前記ゴムとしては特に限定されず、例えば、天然ゴム、イソプレンゴム、ブタジエンゴム、スチレン−ブタジエンゴム、イソプレン−イソブチレンゴム等が例示できる。また、熱可塑性エラストマーとしては特に限定されず、例えば、オレフィン系、スチレン系、ポリウレタン系、ポリエステル系、ポリ塩化ビニル系、ポリブタジエン系等が例示できる。中でも共役ジエン系の熱可塑性エラストマーに水素添加した熱可塑性エラストマー(SEBS、SEPS、HSBR、SEBR、CEBC)が好適である。   Examples of the material used for the elastic plug body 17 include rubber and thermoplastic elastomer. The rubber is not particularly limited, and examples thereof include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and isoprene-isobutylene rubber. Moreover, it does not specifically limit as a thermoplastic elastomer, For example, an olefin type, a styrene type, a polyurethane type, a polyester type, a polyvinyl chloride type, a polybutadiene type etc. can be illustrated. Among them, thermoplastic elastomers (SEBS, SEPS, HSBR, SEBR, CEBC) obtained by hydrogenating conjugated diene-based thermoplastic elastomers are preferable.

また、熱可塑性エラストマー材料は、ゴム材料に比べて極めて衛生的な素材であるが、使用する薬液によっては、弾性栓体17の接液面20に、ラミネート加工を行ってもよい。ラミネート加工には、下側枠部15または取り付けるべき容器本体と同一種類の樹脂が一般に用いられる。これにより、薬液が接触する容器内や弾性栓体17の接液面20と同一又は類似した性質の材料とすることができる。   The thermoplastic elastomer material is an extremely hygienic material compared to the rubber material. However, depending on the chemical solution used, the liquid contact surface 20 of the elastic plug body 17 may be laminated. For laminating, the same type of resin as the lower frame portion 15 or the container body to be attached is generally used. Thereby, it can be set as the material of the same or similar property in the container which a chemical | medical solution contacts, and the liquid-contacting surface 20 of the elastic plug body 17.

また、弾性栓体17の断面形状は、適宜必要に応じて変形可能である。具体的には、例えば図4(a)に示すように、針刺面41a及び接液面41bの双方に、脱落防止の為の段差部41cが設けられた弾性栓体41が挙げられる。また、図4(b)に示すように、針刺面42a及び接液面42bの両方ともフラットの弾性栓体42であってもよい。更に、図4(c)に示すように、針刺面46a側に、第2上金型16の突起部22aの直径よりも大きい径を有する環状溝46cを備え、接液面46bはフラットな構成の弾性栓体46であってもよい。更に、図4(d)に示すように、針刺面47a側に第2上金型16の突起部22aの直径よりも大きい径を有する環状溝47cを備え、接液面47b側に脱落防止の為の段差部47dを備えた弾性栓体47であってもよい。更に、図4(e)に示すように、針刺面44a側に環状の突条部44cが設けられ、接液面42b側に脱落防止の為の段差部44dが設けられた弾性栓体44であってもよい。更に、図4(f)に示すように、針刺面45aにのみ脱落防止の為の段差部45cが設けられ、接液面45bはフラットの弾性栓体45であってもよい。   In addition, the cross-sectional shape of the elastic plug body 17 can be appropriately modified as necessary. Specifically, for example, as shown in FIG. 4A, there is an elastic plug body 41 in which a stepped portion 41c is provided on both the needle stick surface 41a and the liquid contact surface 41b to prevent the dropout. Further, as shown in FIG. 4B, both the needle stick surface 42a and the liquid contact surface 42b may be flat elastic plugs 42. Further, as shown in FIG. 4C, an annular groove 46c having a diameter larger than the diameter of the protrusion 22a of the second upper mold 16 is provided on the needle puncture surface 46a side, and the liquid contact surface 46b is flat. The elastic plug 46 may be configured. Further, as shown in FIG. 4 (d), an annular groove 47c having a diameter larger than the diameter of the protrusion 22a of the second upper mold 16 is provided on the needle puncture surface 47a side, and is prevented from falling off on the liquid contact surface 47b side. The elastic plug body 47 provided with the level | step-difference part 47d for this may be sufficient. Further, as shown in FIG. 4 (e), an elastic plug body 44 is provided with an annular protrusion 44c on the needle puncture surface 44a side and a stepped portion 44d for preventing the dropout on the liquid contact surface 42b side. It may be. Further, as shown in FIG. 4 (f), a stepped portion 45c may be provided only on the needle puncture surface 45a, and the liquid contact surface 45b may be a flat elastic plug 45.

弾性栓体17の製造方法としては特に限定されず、例えば、熱可塑性エラストマーを圧潰しながら行うコンプレッション成形や射出成形により製造可能である。   The method for producing the elastic plug body 17 is not particularly limited, and for example, it can be produced by compression molding or injection molding performed while crushing the thermoplastic elastomer.

(その他の事項)
本発明は前記に示した態様に限定されるものではなく、当該発明の効果を奏する範囲で種々の変更が可能である。例えば、前記実施の形態では、下側枠部として弾性栓体に近づくに従い、その内径が大きくなる態様を例にして説明したが、例えば、図5に示すように、弾性栓体41が載置された位置より下方では、その内径が均一となった下側枠部52有するポート一体タイプのキャップにも適用可能である。また、図5(b)に示すように、フランジを有する下側枠部53であって、容器口部とフランジ同士が溶着したタイプのキャップにも適用可能である。更に、図5(c)に示すように、容器口部に落とし込み、その上部外周を溶着させて用いるインサートタイプのキャップであってもよい。更に、図5(d)に示すように、同図(c)に示すインサートタイプと同様であるが、下側枠部55の周縁部に環状凹部55aが設けられ、当該環状凹部55aにおいて嵌合する様に上側枠部56とが成形された外枠体を有するキャップであってもよい。この場合、弾性栓体57の直径は通常よりも小さく、具体的には、12〜24mmの範囲内である。
(Other matters)
The present invention is not limited to the embodiment described above, and various modifications can be made within the scope of the effects of the present invention. For example, in the above-described embodiment, an example has been described in which the inner diameter increases as the lower frame portion approaches the elastic plug body. However, for example, as illustrated in FIG. Below the position, it is also applicable to a port-integrated cap having a lower frame portion 52 having a uniform inner diameter. Moreover, as shown in FIG.5 (b), it is the lower frame part 53 which has a flange, Comprising: It is applicable also to the cap of the type which the container opening part and the flange welded. Furthermore, as shown in FIG.5 (c), it may be an insert type cap that is used by dropping into the container mouth and welding the upper outer periphery thereof. Furthermore, as shown in FIG. 5D, the insert type is the same as the insert type shown in FIG. A cap having an outer frame body formed with the upper frame portion 56 may be used. In this case, the diameter of the elastic plug body 57 is smaller than usual, specifically, within a range of 12 to 24 mm.

以下に、この発明の好適な実施例を例示的に詳しく説明する。但し、この実施例に記載されている材料や配合量等は、特に限定的な記載がない限りは、この発明の範囲をそれらのみに限定する趣旨のものではなく、単なる説明例に過ぎない。   Hereinafter, preferred embodiments of the present invention will be described in detail by way of example. However, the materials, blending amounts, and the like described in the examples are not intended to limit the scope of the present invention only to them, but are merely illustrative examples, unless otherwise specified.

(実施例1)
本実施例では、前述の図1(a)〜1(f)に示した方法に従い、図7(a)に示す医療用キャップ60の製造を行った。外枠体の材料としてはLDPE(低密度ポリエチレン、MFR=1)を用い、弾性栓体61の材料としてはスチレン系熱可塑性エラストマーを用いた。また、成形機としては、日精樹脂工業(株)製の二色射出成形機(商品名;DC100−200)を使用した。
Example 1
In this example, the medical cap 60 shown in FIG. 7A was manufactured according to the method shown in FIGS. 1A to 1F described above. LDPE (low density polyethylene, MFR = 1) was used as the material of the outer frame body, and styrene thermoplastic elastomer was used as the material of the elastic plug body 61. As a molding machine, a two-color injection molding machine (trade name; DC100-200) manufactured by Nissei Plastic Industry Co., Ltd. was used.

下側枠部62の成形条件は下記の通りである。
射出成形温度:240℃
射出圧力 :40kgf/cm
射出時間 :3.2秒
第1上金型温度及び共通下金型温度 :43℃
The molding conditions for the lower frame portion 62 are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 40 kgf / cm 2
Injection time: 3.2 seconds First upper mold temperature and common lower mold temperature: 43 ° C

また、上側枠部63の成形条件は下記の通りである。
射出成形温度:240℃
射出圧力 :39kgf/cm
射出時間 :2.8秒
第2上金型温度及び共通下金型温度 :43℃
The molding conditions for the upper frame portion 63 are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 39kgf / cm 2
Injection time: 2.8 seconds Second upper mold temperature and common lower mold temperature: 43 ° C

(比較例1)
先ず、予め成形した上側枠部101上に、弾性栓体102をその接液面が上向きとなる様に載置した(図6(a)参照)。次に、上金型103及び下金型104を用いて型閉じし(図6(b)参照)、キャビティ内に溶融樹脂を注入して射出成形を行った(図6(c))。これにより、本比較例に係る医療用キャップ100を製造した(図7(b)参照)。外枠体の材料としてはLDPE(低密度ポリエチレン、MFR=1)を用い、弾性栓体102の材料としてはスチレン系熱可塑性エラストマーを用いた。また、成形機としては、日精樹脂工業(株)製の二色射出成形機(商品名;DC100−200)を使用した。
(Comparative Example 1)
First, the elastic plug body 102 was placed on the pre-formed upper frame portion 101 so that the liquid contact surface faced upward (see FIG. 6A). Next, the upper mold 103 and the lower mold 104 were used to close the mold (see FIG. 6B), and molten resin was injected into the cavity to perform injection molding (FIG. 6C). This manufactured the medical cap 100 which concerns on this comparative example (refer FIG.7 (b)). LDPE (low density polyethylene, MFR = 1) was used as the material of the outer frame body, and styrene thermoplastic elastomer was used as the material of the elastic plug body 102. As a molding machine, a two-color injection molding machine (trade name; DC100-200) manufactured by Nissei Plastic Industry Co., Ltd. was used.

上側枠部101の成形条件は下記の通りである。
射出成形温度:240℃
射出圧力 :42kgf/cm
射出時間 :3.2秒
第1上金型温度及び共通下金型温度 :43℃
The molding conditions for the upper frame portion 101 are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 42 kgf / cm 2
Injection time: 3.2 seconds First upper mold temperature and common lower mold temperature: 43 ° C

また、下側枠部の成形条件は下記の通りである。
射出成形温度:240℃
射出圧力 :50kgf/cm
射出時間 :3.4秒
第2上金型温度及び共通下金型温度 :43℃
The molding conditions for the lower frame part are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 50 kgf / cm 2
Injection time: 3.4 seconds Second upper mold temperature and common lower mold temperature: 43 ° C

(穿刺針の穿刺試験)
前記実施例1及び比較例1で得られた医療用キャップをそれぞれ用意し、プラスチック製輸液針を弾性栓体に刺したときの外枠体の状態を調べた。その結果、実施例1に係る医療用キャップ60については、図7(a)に示すように、弾性栓体61が上側枠部63とその接触面で融着固定されているので位置ズレが起こらず、空隙が生じなかった。その一方、比較例1に係る医療用キャップでは、図7(b)に示す様に、上側枠部101と弾性栓体102との接触部分が融着していないため、当該上側枠部101にリブ104を設けていても、めくれが発生した。
(Puncture test of puncture needle)
Each of the medical caps obtained in Example 1 and Comparative Example 1 was prepared, and the state of the outer frame when the plastic infusion needle was inserted into the elastic stopper was examined. As a result, with respect to the medical cap 60 according to the first embodiment, as shown in FIG. 7A, the elastic plug body 61 is fused and fixed at the upper frame portion 63 and its contact surface, so that the positional displacement occurs. In addition, no voids were formed. On the other hand, in the medical cap according to Comparative Example 1, as shown in FIG. 7B, the contact portion between the upper frame portion 101 and the elastic plug body 102 is not fused. Even if the rib 104 was provided, turning occurred.

(穿刺針の保持力試験)
前記実施例及び比較例で得られた医療用キャップに対し、オートクレーブにより106℃で25分間の滅菌処理を行った。その様な医療用キャップを40サンプル用意し、金属針(16G金属針)及び樹脂針(400樹脂針)をそれぞれ弾性栓体に刺したときの保持力について調べた。各医療用キャップを引っ張り圧縮試験機にセットし、弾性栓体の中央部に、前記試験機に取り付けた下記の穿刺針を垂直に突き刺した後、該穿刺針を200mm/minの速度で上昇させ、該穿刺針が弾性栓体から抜けるときの力(単位;kgf)を測定した。穿刺針としては、前記2種類の針を用いて行い、それぞれ最大値、最小値、平均値及び標準偏差を求めた。結果を下記表1に示す。
(Puncture needle holding force test)
The medical caps obtained in the examples and comparative examples were sterilized at 106 ° C. for 25 minutes using an autoclave. Forty samples of such medical caps were prepared, and the holding force when each of the metal needle (16G metal needle) and the resin needle (400 resin needle) was stabbed into the elastic stopper was examined. Each medical cap was pulled and set in a compression tester, and the following puncture needle attached to the tester was vertically punctured in the center of the elastic stopper, and then the puncture needle was raised at a speed of 200 mm / min. The force (unit: kgf) when the puncture needle was removed from the elastic plug was measured. As the puncture needle, the two kinds of needles were used, and the maximum value, the minimum value, the average value, and the standard deviation were obtained, respectively. The results are shown in Table 1 below.

Figure 0004511575
Figure 0004511575

(穿刺針の液漏れ試験)
前記実施例及び比較例で得られた医療用キャップに対し、オートクレーブにより106℃で25分間の滅菌処理を行った。次に、各医療用キャップを試験用圧力缶体に取り付け、その点滴部位にテルモ株式会社製連結管(商品名;TC−00503B)を穿刺し4時間放置した。その後、抜針し、液漏れするかを調べた。尚、検体数は200個とした。
(Puncture needle leak test)
The medical caps obtained in the examples and comparative examples were sterilized at 106 ° C. for 25 minutes using an autoclave. Next, each medical cap was attached to a test pressure can body, and a connection tube (trade name: TC-00503B) manufactured by Terumo Corporation was punctured at the drip site, and left for 4 hours. Thereafter, the needle was removed and checked for liquid leakage. The number of specimens was 200.

次に、前記と同様にして滅菌処理を行った各医療用キャップを試験用圧力缶体に取り付け、その点滴部位にテルモ株式会社製輸液セット(商品名;TK−A400LK)を穿刺し4時間放置した。その後、抜針し、液漏れするかを調べた。尚、検体数は200個とした。   Next, each medical cap sterilized in the same manner as described above is attached to a test pressure can body, and an infusion set (trade name; TK-A400LK) manufactured by Terumo Corporation is punctured at the drip site and left for 4 hours. did. Thereafter, the needle was removed and checked for liquid leakage. The number of specimens was 200.

更に、前記と同様にして滅菌処理を行った各医療用キャップを試験用圧力缶体に取り付け、その混注部位に、18G金属針をシリンジにセットし水10mlを入れて垂直に穿刺した。その後、18G金属針を針刺面に対し傾斜させた状態にし、水を試験用圧力缶体に3回注入吸引を繰り返した。続いて、2本目の18G金属針の穿刺し、水の注入吸引の操作を繰り返した。更に、1時間後の液漏れ量を測定した。結果を下記表2に示す。また、検体回数は200個とした。   Furthermore, each medical cap sterilized in the same manner as described above was attached to a test pressure can body, and an 18G metal needle was set in a syringe at the mixed injection site, and 10 ml of water was added and punctured vertically. Thereafter, the 18G metal needle was inclined with respect to the needle puncture surface, and water was injected and sucked into the test pressure can body three times. Subsequently, the second 18G metal needle was punctured and the operation of injecting and sucking water was repeated. Furthermore, the amount of liquid leakage after 1 hour was measured. The results are shown in Table 2 below. The number of specimens was 200.

Figure 0004511575
Figure 0004511575

本発明の実施の一形態に係る医療用キャップの製造方法を説明するための断面図である。It is sectional drawing for demonstrating the manufacturing method of the medical cap which concerns on one Embodiment of this invention. 前記製造方法に於ける上側枠部の射出成形の様子を示す断面図である。It is sectional drawing which shows the mode of injection molding of the upper side frame part in the said manufacturing method. 前記製造方法に用いる各種の第2上金型を示す断面図である。It is sectional drawing which shows the various 2nd upper metal mold | die used for the said manufacturing method. 前記医療用キャップに用いる各種の弾性栓体を示す断面図である。It is sectional drawing which shows the various elastic stoppers used for the said medical cap. 本発明の他の実施の形態に係る医療用キャップを示す断面図である。It is sectional drawing which shows the medical cap which concerns on other embodiment of this invention. 比較例1の医療用キャップの製造方法を説明するための断面図である。6 is a cross-sectional view for explaining a method for manufacturing the medical cap of Comparative Example 1. FIG. 穿刺針の穿刺試験の様子を示す断面図である。It is sectional drawing which shows the mode of the puncture test of a puncture needle.

11 共通下金型
12 溶融樹脂
13 上金型
14 載置部
15 下側枠部
16 上金型
17 弾性栓体
17a 周縁部
17b 段差部
18 針刺面
19 入れ子
20 接液面
22a 突起部
22b 段差部
23 突起部
24 突起部
25 突起部
26 突起部
26a 貼付部
27 外枠体
28 キャビティ
29 ピールフィルム
30 医療用キャップ
31 溶融樹脂
32 上側枠部
41 弾性栓体
41a 針刺面
41b 接液面
41c 段差部
42 弾性栓体
42a 針刺面
42b 接液面
44 弾性栓体
44a 針刺面
44c 突条部
44d 段差部
45 弾性栓体
45a 針刺面
45b 接液面
45c 段差部
46 弾性栓体
46a 針刺面
46b 接液面
46c 環状溝
47 弾性栓体
47a 針刺面
47b 接液面
47c 環状溝
47d 段差部
52 下側枠部
53 下側枠部
55 下側枠部
55a 環状凹部
55a 当該環状凹部
56 上側枠部
57 弾性栓体
60 医療用キャップ
61 弾性栓体
62 下側枠部
63 上側枠部
DESCRIPTION OF SYMBOLS 11 Common lower metal mold | die 12 Molten resin 13 Upper metal mold | die 14 Mounting part 15 Lower frame part 16 Upper metal mold | die 17 Elastic plug 17a Peripheral part 17b Step part 18 Needle stick surface 19 Nesting 20 Liquid contact surface 22a Protrusion part 22b Level difference Part 23 Projection part 24 Projection part 25 Projection part 26 Projection part 26a Adhering part 27 Outer frame body 28 Cavity 29 Peel film 30 Medical cap 31 Molten resin 32 Upper frame part 41 Elastic plug body 41a Needle stick surface 41b Liquid contact surface 41c Step Portion 42 Elastic stopper 42a Needle stick surface 42b Liquid contact surface 44 Elastic stopper body 44a Needle stick surface 44c Projection 44d Stepped portion 45 Elastic stopper body 45a Needle stick surface 45b Liquid contact surface 45c Step portion 46 Elastic stopper 46a Needle stick Surface 46b Liquid contact surface 46c Annular groove 47 Elastic stopper 47a Needle stick surface 47b Liquid contact surface 47c Annular groove 47d Stepped portion 52 Lower frame portion 53 Side frame 55 the lower frame portion 55a an annular recess 55a the annular recess 56 upper frame section 57 elastic plug body 60 medical cap 61 elastic plug body 62 the lower frame portion 63 upper frame section

Claims (2)

弾性栓体と、弾性栓体の周縁部を下面側から内壁で保持する下側枠部及び上面側から内壁で保持する上側枠部を備えた外枠体を有する医療用キャップの製造方法であって、
第1上金型と共通下金型を用いて、前記弾性栓体の載置が可能な載置部を内壁に有する下側枠部を成形し、
前記下側枠部の載置部上に、前記弾性栓体をその上面を上向きにして載置し、
前記弾性栓体の直径よりも小さい直径を有する突起部を有し、かつ、前記共通下金型と組み合わせた際に前記上側枠部の成形用のキャビティを形成可能にする第2上金型を用いて、前記突起部が前記弾性栓体の中央部を押圧して下方に押し出すように前記共通下金型と型閉じし、
前記キャビティ内に溶融樹脂を射出して上側枠部を成形し、前記外枠体を形成する医療用キャップの製造方法。
A method for producing a medical cap having an elastic plug body, and an outer frame body having a lower frame portion that holds the peripheral edge portion of the elastic plug body from the lower surface side with the inner wall and an upper frame portion that holds the peripheral edge portion from the upper surface side with the inner wall. And
Using a first upper mold and a common lower mold, a lower frame part having a mounting part on the inner wall on which the elastic plug body can be mounted is molded,
On the mounting portion of the lower frame portion, the elastic plug body is placed with its upper surface facing upward,
A second upper mold having a protrusion having a diameter smaller than the diameter of the elastic plug body and capable of forming a molding cavity of the upper frame when combined with the common lower mold; Using, closing the common lower mold and the mold so that the protruding portion presses the central portion of the elastic plug body and pushes downward,
A method for manufacturing a medical cap, comprising injecting molten resin into the cavity to form an upper frame portion to form the outer frame body.
前記弾性栓体として、熱可塑性エラストマーを含み構成されるものを使用する請求項に記載の医療用キャップの製造方法。 The method for manufacturing a medical cap according to claim 1 , wherein the elastic plug body includes a thermoplastic elastomer.
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JPH03169537A (en) * 1989-11-29 1991-07-23 Kyoraku Co Ltd Manufacture of stopper body including rubber stopper
JPH0488942U (en) * 1991-06-21 1992-08-03
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JPH021275A (en) * 1988-03-03 1990-01-05 Daikyo Rubber Seiko:Kk Plug body of plastic container for medicines
JPH03169537A (en) * 1989-11-29 1991-07-23 Kyoraku Co Ltd Manufacture of stopper body including rubber stopper
JPH0488942U (en) * 1991-06-21 1992-08-03
JPH08317961A (en) * 1995-05-25 1996-12-03 Showa Denko Kk Stopper unit for infusion container and its manufacture
JP2001129055A (en) * 1999-11-09 2001-05-15 Otsuka Pharmaceut Factory Inc Cap and drug container using the same
JP2005199031A (en) * 2003-12-19 2005-07-28 Naigai Kasei Kk Medical cap, and production method therefor
JP2007175171A (en) * 2005-12-27 2007-07-12 Otsuka Pharmaceut Factory Inc Cylindrical member for flowing out/in of chemical, and chemical container

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