JP2010537900A - Apparatus, sealing member, and fluid container - Google Patents

Apparatus, sealing member, and fluid container Download PDF

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JP2010537900A
JP2010537900A JP2010522854A JP2010522854A JP2010537900A JP 2010537900 A JP2010537900 A JP 2010537900A JP 2010522854 A JP2010522854 A JP 2010522854A JP 2010522854 A JP2010522854 A JP 2010522854A JP 2010537900 A JP2010537900 A JP 2010537900A
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sealing member
fluid container
opening
fluid
container
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JP5615176B2 (en
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トーンクヴィスト，ホーカン
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カルメル プハルマ アクチボラゲット
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Closures For Containers (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

密封部材（１４）を有する流体容器（１２）内部及び／又は外部へ流体（２２）を移送するための装置（２４）。装置（２４）は、密封部材（１４）を貫通するための穿刺部材（１６）と、流体（２２）が流体容器（１２）内部及び／又は外部へ流動し得る長手方向流路（１８）を画成する細長い胴部と、流路（１８）に連通する少なくとも一個の開口部（２０）と、を備える。少なくとも一個の開口部（２０）は、装置の使用中に、少なくとも一個の開口部（２０）の少なくとも一部が密封部材（１４）の最内側部（１４ｂ）に実質的に隣接して配置される状態を確保するために、穿刺部材（１６）の長さ（ｌ）の少なくとも１％にわたって広がっているようになっている。Device (24) for transporting fluid (22) into and / or out of fluid container (12) with sealing member (14). The device (24) comprises a piercing member (16) for penetrating the sealing member (14) and a longitudinal channel (18) through which the fluid (22) can flow into and / or out of the fluid container (12). And defining an elongated body and at least one opening (20) in communication with the flow path (18). The at least one opening (20) is disposed such that at least a portion of the at least one opening (20) is substantially adjacent to the innermost portion (14b) of the sealing member (14) during use of the device. In order to ensure that the puncture member (16) is at least 1% of the length (l) of the puncture member (16).

Description

本発明は、密封部材を有する流体容器内部及び／又は外部へ流体を移送するための装置に関する。本発明は、更に、密封部材及び流体容器に関する。本発明の装置、密封部材、及び流体容器は、限定的ではないが、特に、医療用物質を流体容器内部及び／又は外部へ移送することを対象とするけれども、任意の種類の流体、即ち、互いに自由に行き交う分子を有すると共に、その容器の形状を呈する傾向を有する任意の連続的な無定形物質を、流体容器内部及び／又は外部へ移送するために使用し得る。   The present invention relates to an apparatus for transferring a fluid inside and / or outside a fluid container having a sealing member. The present invention further relates to a sealing member and a fluid container. The device, sealing member, and fluid container of the present invention are not limited to any type of fluid, i.e., although specifically directed to transferring medical material into and / or out of the fluid container, i.e., Any continuous amorphous material that has molecules that freely flow around each other and that tends to assume the shape of the container can be used to transfer the fluid container into and / or out of the fluid container.

医療用の薬品及び溶媒は、ゴム、プラスチック、又はエラストマの栓、ストッパ、膜、又は穿刺可能なキャップにより密封された、バイアル、ボトル、又はバッグ等のガラス又はプラスチック容器に入れて供給される場合が多い。こうした密封部材は、薬品の劣化又は汚染を防止すると共に、揺動させることで容器の内容物を混合することを可能にし、更に容器の内容物が漏出して周囲を汚染することを防止する。通常は、流路と、流路に連通した開口部とを備えたカニューレ又は中空のスパイクを、こうした密封部材を介して挿入して、流体の容器への注入、及び容器からの流体の吸引を行う。   Medical drugs and solvents are supplied in glass or plastic containers, such as vials, bottles, or bags, sealed with rubber, plastic, or elastomeric stoppers, stoppers, membranes, or pierceable caps There are many. Such a sealing member prevents deterioration or contamination of the chemicals, and enables the contents of the container to be mixed by being swung, and further prevents the contents of the container from leaking out and contaminating the surroundings. Typically, a cannula or hollow spike with a flow path and an opening communicating with the flow path is inserted through such a sealing member to inject fluid into and into the container. Do.

注入流体容器が剛体又は半剛体材料製である場合、即ち、その壁部が圧壊不能である場合には、注入流体容器から医療用流体を吸引するための、及び内部に真空状態が出来るのを防止するために、空気入口が必要となる。したがって、剛体又は半剛体注入流体容器から流体を吸引する時には、通常は空気フィルタを備えた、医療用流体流路及び空気吸入路を有するスパイクが使用される。   If the infusion fluid container is made of a rigid or semi-rigid material, i.e. if its wall is not collapsible, a vacuum can be created to draw medical fluid from the infusion fluid container and to create an internal vacuum. In order to prevent, an air inlet is required. Thus, when aspirating fluid from a rigid or semi-rigid infusion fluid container, a spike having a medical fluid flow path and an air suction path, usually with an air filter, is used.

医療用流体の入った容器が空に近い状態になった時、無駄を最小にし、容器の洗浄／廃棄を容易にするために、医療用流体（非常に高価及び／又は毒性である場合がある）の最後の数滴を容器から吸引するのに、カニューレ又はスパイクがよく使用される。カニューレ又はスパイクは、容器内に残存する医療用流体の吸引に際し、ゆっくりと慎重に密封部材から抜き取られる。しかしながら、毒性薬物は、こうした作業中に漏出して周囲を汚染する恐れがあり、又、塵、花粉、又はバクテリア等の望ましくない粒子を含有する未濾過空気が、カニューレ内に引き込まれ、これにより、内部の医療用流体が汚染される恐れがある。   When a container with medical fluid is nearly empty, medical fluid (which can be very expensive and / or toxic) to minimize waste and facilitate cleaning / disposal of the container A cannula or spike is often used to aspirate the last few drops of). The cannula or spike is slowly and carefully withdrawn from the sealing member as the medical fluid remaining in the container is aspirated. However, toxic drugs can escape during these operations and contaminate the environment, and unfiltered air containing unwanted particles such as dust, pollen, or bacteria can be drawn into the cannula, thereby The medical fluid inside may be contaminated.

場合によっては、容器から全ての薬品が吸引される訳ではないという事実を考慮して、実際、容器には余分な量の吸引対象薬品が入れられている。使用者は、これにより、推奨投与回数に渡って容器からの吸引が可能となるが、これを行うことにより、医療用流体の各容器のコストは増加し、無駄が多くなり、容器の洗浄又は廃棄に手間が増える。   In some cases, in view of the fact that not all drug is aspirated from the container, the container actually contains an extra amount of drug to be aspirated. This allows the user to aspirate from the container over the recommended number of doses, but doing so increases the cost of each container of medical fluid, increases waste, More time and effort for disposal.

密封部材は、多様な構成、サイズ、及び厚さのものが利用可能であるため、複数の異なる密封部材での使用に適合すると共に、医療用流体の最後の数滴を容器から安全且つ便利な形で吸引可能とするスパイクを設計することは困難である。   Sealing members are available in a variety of configurations, sizes, and thicknesses, making them suitable for use with a number of different sealing members and ensuring that the last few drops of medical fluid are safe and convenient from the container. It is difficult to design spikes that can be sucked in shape.

本発明の目的は、密封部材を有する流体容器内部及び／又は外部への流体の効率的な移送を可能にする装置を提供することである。   It is an object of the present invention to provide an apparatus that allows efficient transfer of fluid into and / or out of a fluid container having a sealing member.

この目的は、請求項１による装置により達成され、装置は、密封部材を貫通するための穿刺部材と、流体が流体容器内部又は外部へ流動し得る長手方向流路を画成する細長い胴部とを備える。装置は、流路に連通する少なくとも一個の開口部を備え、少なくとも一個の開口部は、装置の使用中に、少なくとも一個の開口部の少なくとも一部が密封部材の最内側部に実質的に隣接して配置される状態を確保するために、穿刺部材の長さの少なくとも１％、好ましくは少なくとも２％、又は少なくとも３％、又は少なくとも４％、又は少なくとも５％、又は少なくとも１０％、又は少なくとも２０％、又は少なくとも３０％、又は少なくとも５０％、又は最も好ましくは少なくとも７０％又は１００％にわたって、広がっているようになっている。   This object is achieved by a device according to claim 1, which comprises a piercing member for penetrating the sealing member and an elongated body defining a longitudinal channel through which fluid can flow into or out of the fluid container. Is provided. The device comprises at least one opening in communication with the flow path, wherein at least one opening is substantially adjacent to the innermost portion of the sealing member during use of the device. At least 1% of the length of the piercing member, preferably at least 2%, or at least 3%, or at least 4%, or at least 5%, or at least 10%, or at least It is spread over 20%, or at least 30%, or at least 50%, or most preferably at least 70% or 100%.

穿刺部材の長さは、穿刺部材の先端部から、底の無い流体容器の無限幅の密封部材に装置のその部分をより深く押し入れるために実質的に増加した力が必要となる量だけ装置の幅が増加する点までの距離として画成される。装置が全長に渡って実質的に均一な断面を有する場合、穿刺部材の長さは、穿刺部材の先端部から、装置の反対端部までの距離として画成される。   The length of the puncture member is the amount that the increased force is required to push the part of the device deeper from the tip of the puncture member into the infinite width sealing member of the bottomless fluid container Is defined as the distance to the point where the width of increases. If the device has a substantially uniform cross-section over its entire length, the length of the piercing member is defined as the distance from the tip of the piercing member to the opposite end of the device.

こうした装置により、流体容器の全ての内容物、或いは本質的に全ての内容物を、逆さにした流体容器から排出させることができる。   With such a device, all or essentially all of the contents of the fluid container can be drained from the inverted fluid container.

本発明の装置は、更に、流体容器が逆さにされ、或いは直立位置にある時に、容器内部の流体の混合を良くする。例えば、逆さにした又は直立した流体容器において液体薬品を液体溶媒と混合する場合、複数の開口部又は細長くした開口部により、液体薬品／溶媒は、従来の装置を使用した場合よりも迅速に流体容器へ流入可能となり、入口部分が増加し、分散して、それにより発生する乱流が増加することにより混合がよくなるため、二種類の液体の混合が促進される。   The apparatus of the present invention further improves fluid mixing within the container when the fluid container is inverted or in an upright position. For example, when mixing a liquid chemical with a liquid solvent in an inverted or upright fluid container, multiple openings or elongated openings allow the liquid chemical / solvent to flow more quickly than with conventional equipment. It becomes possible to flow into the container, and the inlet portion increases, disperses, and the turbulence generated thereby increases, so that mixing is improved.

更に、流体容器及びその内容物が冷却されていた場合、逆さにした流体容器の密封部材を介して、流体容器の内容物より高い温度の流体を供給すれば、対流により、二種類の流体の混合を加速し得る。対流は、冷却された流体が、冷却された流体より高い温度の流体を収容する直立した流体容器の最上部に入る場合にも、混合を助長し得る。   Furthermore, when the fluid container and its contents are cooled, if a fluid having a temperature higher than that of the contents of the fluid container is supplied through the inverted sealing member of the fluid container, the two kinds of fluids are convected by convection. Mixing can be accelerated. Convection can also facilitate mixing when the cooled fluid enters the top of an upright fluid container that contains a higher temperature fluid than the cooled fluid.

本発明の装置は、少なくとも一個の開口部が装置が貫通するように設計された最も厚い密封部材の厚さより長く広がっている場合に、様々な厚さ（数ミリメートルから数センチメートルの範囲が可能）及び様々な構造（凹形、両凹形、又はＭ字形）の密封部材を備える複数の流体容器での使用に適している。   The device of the present invention can vary in thickness (ranging from a few millimeters to a few centimeters) when at least one opening extends longer than the thickness of the thickest sealing member designed to penetrate the device. ) And various structures (concave, biconcave, or M-shaped) sealing members.

本発明の一実施形態によれば、装置は、実質的に穿刺部材の全長に及ぶ一個の開口部を備える。   According to one embodiment of the invention, the device comprises a single opening that extends substantially over the entire length of the piercing member.

本発明の他の実施形態によれば、装置は、穿刺部材の長さにわたって均一又は不均一間隔に設けた複数の開口部を備える。   According to another embodiment of the invention, the device comprises a plurality of openings provided at uniform or non-uniform intervals over the length of the piercing member.

本発明の他の実施形態によれば、装置は、装置が流体容器の密封部材へ挿入される前に、少なくとも一個の開口部を少なくとも部分的に被覆及び密封するように配置された、ゴム、プラスチック、又はエラストマシース等の伸縮スリーブを備える。伸縮スリーブは、装置が流体容器の密封部材へ挿入された時に密封部材の最外側部に当接すると共に、装置の使用中に密封部材の最外側部の外部に位置した開口部の一部又は開口部群のみを被覆及び密封して、その開口部又は開口部群から医療用流体が漏出することを防止するように、穿刺部材が更に深く密封部材を貫通する際に収縮するように配置される。   According to another embodiment of the invention, the device comprises a rubber arranged to at least partially cover and seal at least one opening before the device is inserted into the sealing member of the fluid container. A telescopic sleeve such as plastic or elastomer sheath is provided. The telescopic sleeve abuts the outermost portion of the sealing member when the device is inserted into the sealing member of the fluid container, and a part or opening of the opening located outside the outermost portion of the sealing member during use of the device. The puncture member is arranged to contract as it penetrates the sealing member deeper so as to cover and seal only the group and prevent leakage of medical fluid from the opening or group of openings. .

本発明の一実施形態によれば、装置は、装置の使用中又は使用前後に装置が誤って流体容器からはずれないように流体容器へ装置を接続する接続手段を備える。   According to an embodiment of the invention, the device comprises connection means for connecting the device to the fluid container so that the device does not accidentally leave the fluid container during or before use of the device.

本発明の一実施形態によれば、装置は、例えば、流体容器の内部から外側へ密封部材に向かう方向に、開口部の最外縁部から延びる目盛り線を備える。装置の挿入点における密封部材の厚さが分かっている場合には、装置の使用中に開口部の最外縁部が密封部材の最内側部に実質的に隣接した位置になる状態を確保するには、装置を密封部材のどこまで挿入する必要があるかを使用者に指示するために目盛り線を使用することができる。目盛り線は、装置を挿入する前に、密封部材の厚さを計測するためにも使用できる。   According to an embodiment of the present invention, the device includes a scale line extending from the outermost edge of the opening, for example, in a direction from the inside of the fluid container to the outside toward the sealing member. If the thickness of the sealing member at the insertion point of the device is known, ensure that the outermost edge of the opening is substantially adjacent to the innermost portion of the sealing member during use of the device. Can use graduation lines to indicate to the user how far the device needs to be inserted into the sealing member. The graduation line can also be used to measure the thickness of the sealing member before inserting the device.

本発明は、更に、流体容器の出口を密封するための、ゴム、プラスチック、又はエラストマの栓、ストッパ、膜、又は穿刺可能なキャップ等の密封部材に関し、密封部材は、本発明の実施形態の何れかによる装置を備え、装置は、密封部材と一体的に形成されるか、或いは、密封部材に取り外し可能／取り外し不可能に接続される。   The present invention further relates to a sealing member, such as a rubber, plastic, or elastomeric plug, stopper, membrane, or pierceable cap, for sealing the outlet of the fluid container, the sealing member being an embodiment of the present invention. And the device is formed integrally with the sealing member or removably / non-removably connected to the sealing member.

本発明の一実施形態によれば、装置は、装置を密封部材に対して前後に摺動させることにより装置の少なくとも一個の開口部を開閉し得るように、密封部材に摺動可能に装着される。   According to an embodiment of the present invention, the device is slidably mounted on the sealing member such that at least one opening of the device can be opened and closed by sliding the device back and forth relative to the sealing member. The

本発明は、更に、本発明の実施形態の何れかによる密封部材を備えた流体容器に関する。   The invention further relates to a fluid container comprising a sealing member according to any of the embodiments of the invention.

流体容器の内部及び／又は外部へ流体を移送するための従来の装置を示す図である。FIG. 2 shows a conventional device for transferring fluid to and / or outside of a fluid container. 本発明の実施形態による、流体容器の内部及び／又は外部へ流体を移送するための装置を示す図である。FIG. 3 shows an apparatus for transferring fluid to and / or outside of a fluid container according to an embodiment of the present invention. 本発明の実施形態による、流体容器の内部及び／又は外部へ流体を移送するための装置を示す図である。FIG. 3 shows an apparatus for transferring fluid to and / or outside of a fluid container according to an embodiment of the present invention. 本発明の実施形態による、流体容器の内部及び／又は外部へ流体を移送するための装置を示す図である。FIG. 3 shows an apparatus for transferring fluid to and / or outside of a fluid container according to an embodiment of the present invention. 本発明の実施形態による、流体容器の内部及び／又は外部へ流体を移送するための装置を示す図である。FIG. 3 shows an apparatus for transferring fluid to and / or outside of a fluid container according to an embodiment of the present invention. 本発明の実施形態による、密封部材を密封することを示す図である。FIG. 6 shows sealing a sealing member according to an embodiment of the present invention. 本発明の実施形態による、密封部材を密封することを示す図である。FIG. 6 shows sealing a sealing member according to an embodiment of the present invention.

以下、非限定的な例により、次の各添付図を参照して本発明を更に説明する。
図面は一定の縮尺で描かれておらず、特定の特徴部の寸法は、明快にするために誇張されていることに留意されたい。
更に、各添付図の例示が剛体、半剛体、又は柔軟性の容器であるかに関係なく、本発明は、密封部材を有する任意の種類の流体容器での使用に適していることに留意されたい。 The invention will now be further described by way of non-limiting examples with reference to the following accompanying figures.
Note that the drawings are not drawn to scale, and the dimensions of certain features are exaggerated for clarity.
Furthermore, it is noted that the present invention is suitable for use with any type of fluid container having a sealing member, regardless of whether the illustration in each attached figure is a rigid, semi-rigid, or flexible container. I want.

図１は、流体容器１２の内容物２２を密封する密封部材１４を有する逆さにした流体容器１２の内部及び／又は外部へ流体を移送するための従来の装置１０を示す。装置１０は、密封部材１４を貫通するための穿刺部材１６と、流体容器の内容物が流体容器１２内部及び／又は外部へ流動し得る長手方向流路１８を画成する細長い胴部と、流路１８と連通する一個の横向きの開口部とを備える。   FIG. 1 shows a conventional apparatus 10 for transferring fluid into and / or out of an inverted fluid container 12 having a sealing member 14 that seals the contents 22 of the fluid container 12. The device 10 includes a piercing member 16 for penetrating the sealing member 14, an elongated body defining a longitudinal channel 18 through which the contents of the fluid container can flow into and / or out of the fluid container 12, and a flow. A lateral opening that communicates with the path 18.

密封部材１４は厚さ及び強靱性が様々であるため、密封部材１４を介して装置を挿入する際に使用者が加える力の大きさにより、又、装置が流体容器１２の長手方向軸に対して実質的に垂直に挿入されるか、角度を成して挿入されるかによって、装置の開口部２０は、流体容器１２内の無数の位置のどこにでも配置され得る。流体容器１２の内容物２２が開口部の最外縁部２０ａの真下の高さまで排出されると、装置を僅かに引き出さなければ、それ以上の流体を流体容器から排出させることができなくなる。   Because the sealing member 14 varies in thickness and toughness, depending on the amount of force applied by the user when inserting the device through the sealing member 14, the device may also be relative to the longitudinal axis of the fluid container 12. Depending on whether it is inserted substantially vertically or at an angle, the opening 20 of the device can be located anywhere in a myriad of locations within the fluid container 12. When the contents 22 of the fluid container 12 are discharged to a height just below the outermost edge 20a of the opening, no further fluid can be discharged from the fluid container unless the device is pulled slightly.

図２は、密封部材１４を有する逆さにした流体容器１２の内部及び／又は外部へ流体を移送するための本発明による装置２４を示す。装置２４は、密封部材１４を貫通するための傾斜先端部を有する穿刺部材１６を備え、更に、円形、正方形、六角形、又は八角形等の、対称又は非対称断面形状の細長いチューブ状の胴部２４ａを任意に備えることができる。細長い胴部２４ａは、穿刺部材１６の幅よりも大きな幅を有し、流体容器１２の密封部材１４を貫通して挿入されることを目的としていない。細長い胴部２４ａは、落下室を備えることができる。装置２４は、更に、空気／液体入口２４ｂを任意に備えることができる。   FIG. 2 shows a device 24 according to the invention for transferring fluid into and / or out of an inverted fluid container 12 having a sealing member 14. The device 24 comprises a piercing member 16 having an inclined tip for penetrating the sealing member 14, and further an elongated tubular body having a symmetrical or asymmetrical cross-sectional shape, such as a circular, square, hexagonal or octagonal shape. 24a can optionally be provided. The elongated body portion 24a has a width larger than that of the puncture member 16, and is not intended to be inserted through the sealing member 14 of the fluid container 12. The elongated body 24a can include a drop chamber. The device 24 can further optionally include an air / liquid inlet 24b.

穿刺部材１６は、流体容器の内容物が流体容器１２の内部及び／又は外部へ流動し得る実質的に長手方向の流路（図示せず）と、流路に連通する、長方形、正方形、円形、楕円形といった任意の形状にすることが可能な一個の細長い開口部２０とを画成する。開口部２０は、穿刺部材の先端部から、或いは穿刺部材の先端部より数ミリメートルの所から、穿刺部材１６の長さＬの約５０％にわたって長手方向に広がり、装置１０の使用中、少なくとも一個の開口部の少なくとも一部が密封部材１４の最内側部１４ａに実質的に隣接する状態を確保する。開口部２０の最大幅は、穿刺部材１６の最大幅の少なくとも２０％、好ましくは穿刺部材１６の最大幅の少なくとも５０％である。   The piercing member 16 has a substantially longitudinal channel (not shown) through which the contents of the fluid container can flow into and / or out of the fluid container 12, and a rectangular, square, or circular shape communicating with the channel. And an elongated opening 20 that can be any shape, such as an oval. The opening 20 extends longitudinally from the tip of the puncture member or from a few millimeters from the tip of the puncture member over a length L of about 50% of the length L of the puncture member 16, and at least one is in use during use of the device 10. The state in which at least part of the opening is substantially adjacent to the innermost part 14 a of the sealing member 14 is ensured. The maximum width of the opening 20 is at least 20% of the maximum width of the puncture member 16, preferably at least 50% of the maximum width of the puncture member 16.

図示した例において、密封部材１４の最内側部１４ａは、装置の使用中、細長い開口部２０に重なり合う。装置２４は、更に、目盛り線２６を備え、装置２４の挿入点における密封部材１４の厚さが分かっている場合に、使用者が開口部２０の最外縁部２０ａを正確に位置決めすることを可能にする。   In the illustrated example, the innermost portion 14a of the sealing member 14 overlaps the elongated opening 20 during use of the device. The device 24 further comprises a scale line 26 that allows the user to accurately position the outermost edge 20a of the opening 20 when the thickness of the sealing member 14 at the insertion point of the device 24 is known. To.

装置２４は、熱可塑性プラスチック材等のプラスチック、金属、ガラス、又はセラミック材で構成することが出来る。穿刺部材１６の長さは、０．５乃至５．０ｃｍ以上の範囲にしてよく、これにより、穿刺部材の長さは、好ましくは、その最大幅の５乃至２０倍である。   The device 24 can be composed of a plastic such as a thermoplastic material, a metal, a glass, or a ceramic material. The length of the puncture member 16 may be in the range of 0.5 to 5.0 cm or more, whereby the length of the puncture member is preferably 5 to 20 times its maximum width.

図２にはガラス瓶のような剛体又は半剛体の流体容器１２を図示しているが、本発明の装置２４は、輸液バッグ等の非剛体流体容器での使用にも等しく適していることに留意されたい。更に、剛体又は半剛体流体容器から流体を排出する時には空気入口が必要になるが、空気入口及び空気通路は、図をわかり易くするために何れの図面にも図示していない。しかしながら、本発明の装置は、任意の数の空気又は他の流体用の通路を備えることができる。   Although FIG. 2 illustrates a rigid or semi-rigid fluid container 12 such as a glass bottle, it should be noted that the device 24 of the present invention is equally suitable for use with non-rigid fluid containers such as infusion bags. I want to be. In addition, an air inlet is required when discharging fluid from a rigid or semi-rigid fluid container, but the air inlet and air passage are not shown in any of the drawings for clarity of illustration. However, the device of the present invention can include any number of passages for air or other fluids.

図３は、流体容器の密封材に装置が挿入される前の本発明の別の実施形態による装置２４を示す。装置は、穿刺部材の固い傾斜先端部の後ろから穿刺部材１６の反対端部までの実質的に穿刺部材１６の全長Ｌにわたる一個の開口部２０を備える。開口部２０の長さは、当然ながら、貫通しようとする最も厚い密封部材１４の厚さにより決まる。   FIG. 3 shows a device 24 according to another embodiment of the present invention before the device is inserted into a fluid container seal. The device comprises a single opening 20 that extends over the entire length L of the piercing member 16 from behind the rigid slanted tip of the piercing member to the opposite end of the piercing member 16. The length of the opening 20 is naturally determined by the thickness of the thickest sealing member 14 to be penetrated.

装置２４は、装置が流体容器に挿入される前に、少なくとも一個の開口部２０を少なくとも部分的に被覆及び密封するようにし、例えばシリコンゴムで構成される密着した弾性伸縮スリーブ２８を備える。伸縮スリーブ２８は、装置が流体容器１２に挿入された時に密封部材１４の最外側部１４ｂに当接し、穿刺部材１６が密封部材１４を更に深く貫通する際に収縮するようになっている。   The device 24 comprises an intimate elastic telescopic sleeve 28, for example made of silicone rubber, so as to at least partially cover and seal at least one opening 20 before the device is inserted into the fluid container. The telescopic sleeve 28 contacts the outermost part 14b of the sealing member 14 when the apparatus is inserted into the fluid container 12, and contracts when the puncture member 16 penetrates the sealing member 14 further deeply.

図４は、流体容器１２の密封部材１４に挿入された後の図３の装置２４を示す。密封部材１４の最内側部１４ａの内側にある開口部２０の一部が流体容器の内部に露出される一方、密封部材１４の最外側部１４ｂの外側にある開口部２０の部分は密封され、これにより、流体容器１２の内容物の劣化又は汚染が防止され、流体容器１２の内容物を揺動により混合することが可能となり、流体容器１２の内容物が漏出して周囲を汚染することが防止されることがわかる。   FIG. 4 shows the device 24 of FIG. 3 after being inserted into the sealing member 14 of the fluid container 12. A portion of the opening 20 inside the innermost portion 14a of the sealing member 14 is exposed inside the fluid container, while the portion of the opening 20 outside the outermost portion 14b of the sealing member 14 is sealed, As a result, deterioration or contamination of the contents of the fluid container 12 can be prevented, the contents of the fluid container 12 can be mixed by rocking, and the contents of the fluid container 12 can leak and contaminate the surroundings. It can be seen that it is prevented.

図３及び４に示した装置２４は、更に、流体容器１２の縁に把持する形で係合して、流体容器１２上の所定位置に装置２４を堅固に保持する接続手段３０を備える。接続手段３０は、流体容器の密封部材１４を貫通して装置２４を押し込んだ時に、流体容器１２の縁に摺動可能に係合する湾曲端部領域を含む二本の手動操作可能な弾性アームを備える。   The device 24 shown in FIGS. 3 and 4 further comprises connecting means 30 that grips and engages the edge of the fluid container 12 to hold the device 24 firmly in place on the fluid container 12. The connecting means 30 includes two manually operable elastic arms including a curved end region that slidably engages the edge of the fluid container 12 when the device 24 is pushed through the fluid container sealing member 14. Is provided.

接続手段３０は、スナップフィット機構、ルアーロック、又は他の任意の機械的又は非機械的接続手段であってもよく、接続手段を係合させた際に、装置の穿刺部材１６を流体容器１２の密封部材１４に貫通させ、これにより、流体容器１２の内部と装置２４の流路との間に流体連通をもたらすように、即ち、例えば、ルアーロックをロック位置へ捻った時に流体連通がもたらされるようになされている。   The connecting means 30 may be a snap fit mechanism, a luer lock, or any other mechanical or non-mechanical connecting means, and when the connecting means is engaged, the piercing member 16 of the device is connected to the fluid container 12. The sealing member 14 so as to provide fluid communication between the interior of the fluid container 12 and the flow path of the device 24, ie, for example, when the luer lock is twisted to a locked position. It is made to be.

本発明の別の実施形態によれば、装置は、使用者が穿刺部材１６により負傷することを防止すると共に、穿刺部材１６の汚染を防止するために、穿刺部材シールド／ガードを備える。図３及び４に示した実施形態において接続手段３０は、穿刺部材シールド／ガードとしても機能する。   According to another embodiment of the present invention, the device includes a piercing member shield / guard to prevent a user from being injured by the piercing member 16 and to prevent contamination of the piercing member 16. In the embodiment shown in FIGS. 3 and 4, the connecting means 30 also functions as a piercing member shield / guard.

本発明の装置２４の少なくとも一個の開口部２０は、必ずしも装置２４の長手方向軸線に平行に又は同一線上に延びている必要はなく、穿刺部材１６の長さに沿ってジグザグのパターンで延びてもよく、或いは、装置２４の長手方向軸に対して横方向に延びる複数の開口部により構成されてもよいことに留意されたい。   The at least one opening 20 of the device 24 of the present invention does not necessarily extend parallel to or collinear with the longitudinal axis of the device 24, but extends in a zigzag pattern along the length of the piercing member 16. Note that it may alternatively be constituted by a plurality of openings extending transverse to the longitudinal axis of the device 24.

図５は、本発明の別の実施形態による装置を示す。装置２４は、実質的に穿刺部材１６の全長に及ぶ距離ｄにわたって均一間隔に設けた複数の開口部２４を備える。穿刺部材の長さが３ｃｍである場合、装置２４は、例えば、穿刺部材１６の長手方向に長さ２ｍｍで、それぞれの間隔が１ｍｍの十個の均等間隔の開口部２０を備えることができる。図示した実施形態において、穿刺部材１６は、薄い中心部分を有する密封部材１４を穿刺するために、或いは前もってスリットを入れた穿刺部材１４を穿刺するために使用できる尖っていない端部を有している。当然ながら、本実施形態に関連して尖った穿刺部材も使用し得ることを理解されたい。   FIG. 5 shows an apparatus according to another embodiment of the invention. The device 24 comprises a plurality of openings 24 provided at even intervals over a distance d that extends substantially over the entire length of the piercing member 16. When the length of the puncture member is 3 cm, the device 24 may include ten equally spaced openings 20 that are 2 mm long in the longitudinal direction of the puncture member 16 and each 1 mm apart. In the illustrated embodiment, the piercing member 16 has a non-pointed end that can be used to pierce a sealing member 14 having a thin central portion, or to pierce a previously slit puncture member 14. Yes. Of course, it should be understood that pointed piercing members may also be used in connection with this embodiment.

図６及び７は、本発明の一実施形態による密封部材３２を示す。密封部材３２は、例えば、天然又は合成ゴム、或いは他の任意のエラストマ、プラスチック、又はガラスで構成される。密封部材３２は、本発明の実施形態の何れかによる装置２４を備え、装置２４は、密封部材３２と一体的に形成されるか、或いは、取り外し可能／取り外し不可能に接続される。装置２４は、図６に示すような閉位置から、図７に示すような開位置へ、装置を密封部材に対して前後に摺動させることにより、装置の少なくとも一個の開口部２０を開閉し得るように、密封部材３２に摺動可能に装着される。装置２４は、当然ながら、図示した完全開位置及び完全閉位置に加えて、任意の位置において停止するようにすることができる。   6 and 7 illustrate a sealing member 32 according to one embodiment of the present invention. The sealing member 32 is made of, for example, natural or synthetic rubber, or any other elastomer, plastic, or glass. The sealing member 32 comprises a device 24 according to any of the embodiments of the present invention, the device 24 being formed integrally with the sealing member 32 or detachably / non-removably connected. The device 24 opens and closes at least one opening 20 of the device by sliding the device back and forth with respect to the sealing member from the closed position as shown in FIG. 6 to the open position as shown in FIG. As is obtained, the sealing member 32 is slidably mounted. The device 24 can of course be stopped at any position in addition to the fully open and fully closed positions shown.

図７では、装置の肩部３４が密封部材３２の最外縁部３２ａに当接するまで、装置２４の穿刺部材１６全体が密封部材３２を貫通して押し込まれている。この位置において、開口部の下縁部２０ａは、密封部材３２の最内縁部３２ｂと同一線上になり、密封部材が挿入された流体容器の内部に開口部２０全体が露出されるようになる。   In FIG. 7, the entire puncture member 16 of the device 24 is pushed through the sealing member 32 until the shoulder 34 of the device contacts the outermost edge 32 a of the sealing member 32. At this position, the lower edge portion 20a of the opening portion is collinear with the innermost edge portion 32b of the sealing member 32, and the entire opening portion 20 is exposed inside the fluid container in which the sealing member is inserted.

本発明の密封部材３２は、流体容器１２の入口／出口へ挿入してよく、或いは、例えば、流体容器への取り付けを可能にするために、ねじ等の手段を備えてもよい。
特許請求の範囲に含まれる本発明の別の変形は、当業者には明らかとなろう。 The sealing member 32 of the present invention may be inserted into the inlet / outlet of the fluid container 12 or may comprise means such as screws, for example, to allow attachment to the fluid container.
Other variations of the invention that fall within the scope of the claims will be apparent to those skilled in the art.

Claims (10)

密封部材（１４）を有する流体容器（１２）内部及び／又は外部へ流体（２２）を移送するための装置（２４）であって、該装置（２４）は、前記密封部材（１４）を貫通するための穿刺部材（１６）と、流体（２２）が前記流体容器（１２）内部及び／又は外部へ流動し得る長手方向流路（１８）を画成する細長い胴部と、前記流路（１８）に連通する少なくとも一個の開口部（２０）と、を備え、前記少なくとも一個の開口部（２０）は、前記装置の使用中に、前記少なくとも一個の開口部（２０）の少なくとも一部が密封部材（１４）の最内側部（１４ｂ）に実質的に隣接して配置される状態を確保するために、前記穿刺部材（１６）の長さ（ｌ）の少なくとも１％にわたって広がっているようになっていることを特徴とする装置（２４）。   A device (24) for transporting fluid (22) into and / or out of a fluid container (12) having a sealing member (14), said device (24) passing through said sealing member (14) A piercing member (16) for defining the body, an elongated body defining a longitudinal channel (18) through which fluid (22) can flow into and / or out of the fluid container (12), and the channel ( 18) at least one opening (20) in communication with the at least one opening (20), wherein at least a portion of the at least one opening (20) is in use during use of the device. To ensure a state of being disposed substantially adjacent to the innermost part (14b) of the sealing member (14), it extends over at least 1% of the length (l) of the puncture member (16). A device (2) characterized by ). 前記少なくとも一個の開口部（２０）は、前記穿刺部材（１６）の長さ（Ｌ）の少なくとも２％、又は少なくとも３％、又は少なくとも４％、又は少なくとも５％、又は少なくとも１０％、又は少なくとも２０％、又は少なくとも３０％、又は少なくとも５０％、又は最も好ましくは少なくとも７０％又は１００％にわたって広がっているようになっていることを特徴とする、請求項１記載の装置（２４）。   The at least one opening (20) is at least 2%, or at least 3%, or at least 4%, or at least 5%, or at least 10%, or at least of the length (L) of the piercing member (16) Device (24) according to claim 1, characterized in that it is spread over 20%, or at least 30%, or at least 50%, or most preferably at least 70% or 100%. 前記穿刺部材（１６）の全長（Ｌ）に実質的にわたって広がる一個の開口部（２０）を備えることを特徴とする、請求項１又は２記載の装置（２４）。   Device (24) according to claim 1 or 2, characterized in that it comprises a single opening (20) extending substantially over the entire length (L) of the piercing member (16). 前記穿刺部材（１６）の長さ（ｌ）にわたって均一又は不均一間隔で設けた複数の開口部（２０）を備えることを特徴とする、請求項１又は２記載の装置（２４）。   Device (24) according to claim 1 or 2, characterized in that it comprises a plurality of openings (20) provided at uniform or non-uniform intervals over the length (l) of the puncture member (16). 前記装置が流体容器（１２）の密封部材（１４）に挿入されていない時に、前記少なくとも一個の開口部（２０）を少なくとも部分的に被覆及び密封するようになされた伸縮スリーブ（２８）を備え、該スリーブ（２８）は、前記装置が流体容器（１２）の密封部材（１４）へ挿入された時に前記密封部材（１４）の最外側部（１４ａ）に当接すると共に、前記穿刺部材（１６）が更に深く前記密封部材（１４）を貫通する際に収縮するようになっていることを特徴とする、請求項１〜４の何れか１に記載の装置（２４）。   A telescopic sleeve (28) adapted to at least partially cover and seal the at least one opening (20) when the device is not inserted into the sealing member (14) of the fluid container (12); The sleeve (28) contacts the outermost part (14a) of the sealing member (14) when the device is inserted into the sealing member (14) of the fluid container (12), and the puncture member (16). 5. The device (24) according to any one of claims 1 to 4, characterized in that it contracts as it penetrates the sealing member (14) deeper. 前記流体容器（１２）に接続するための接続手段（３０）を備えることを特徴とする、請求項１〜５の何れか１に記載の装置（２４）。   Device (24) according to any one of the preceding claims, characterized in that it comprises connection means (30) for connecting to the fluid container (12). 目盛り線（２６）を備えることを特徴とする、請求項１〜６の何れか１に記載の装置（２４）。   Device (24) according to any one of the preceding claims, characterized in that it comprises a graduation line (26). 流体容器（１２）の入口／出口を密封するための、ゴム、プラスチック、又はエラストマの栓、ストッパ、膜、又は穿刺可能なキャップ等の密封部材（３２）であって、前記密封部材（１４）と一体的に形成された、或いは、取り外し可能／取り外し不可能に接続された、請求項１乃至６の何れかによる装置（２４）を備えることを特徴とする密封部材（３２）。   A sealing member (32), such as a rubber, plastic or elastomeric plug, stopper, membrane, or pierceable cap, for sealing the inlet / outlet of the fluid container (12), said sealing member (14) 7. Sealing member (32), characterized in that it comprises a device (24) according to any of claims 1 to 6, which is formed integrally with or detachably / non-removably connected. 前記装置（２４）は、前記装置（２４）を前記密封部材（１４）に対して前後に摺動させることにより前記装置（２４）の前記少なくとも一個の開口部（２０）を開閉し得るように、前記密封部材（１４）に摺動可能に装着されることを特徴とする、請求項８記載の密封部材（３２）。   The device (24) can open and close the at least one opening (20) of the device (24) by sliding the device (24) back and forth with respect to the sealing member (14). 9. Sealing member (32) according to claim 8, characterized in that it is slidably mounted on the sealing member (14). 請求項８又は９記載の密封部材（３２）を備えることを特徴とする流体容器（１２）。   A fluid container (12) comprising a sealing member (32) according to claim 8 or 9.
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