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JP2022151078A - PORT MEMBER AND CONTAINER FOR LIQUID CONTAINER AND LIQUID-FILLED CONTAINER FOR BIOLOGICAL ADMINISTRATION - Google Patents

PORT MEMBER AND CONTAINER FOR LIQUID CONTAINER AND LIQUID-FILLED CONTAINER FOR BIOLOGICAL ADMINISTRATION Download PDF

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JP2022151078A
JP2022151078A JP2021053985A JP2021053985A JP2022151078A JP 2022151078 A JP2022151078 A JP 2022151078A JP 2021053985 A JP2021053985 A JP 2021053985A JP 2021053985 A JP2021053985 A JP 2021053985A JP 2022151078 A JP2022151078 A JP 2022151078A
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port
annular
port member
container
liquid
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JP7689848B2 (en
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大貴 福山
Daiki Fukuyama
彦希 梅垣
Hikonori Umegaki
亮太 栗本
Ryota Kurimoto
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Terumo Corp
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Abstract

To provide a port member that is attached to a container for storing liquid and that can ensure sealing and opening property as well as ensuring insertion property of other member, and a liquid storage container and a liquid-filled container for living body administration.SOLUTION: A port member 30 includes a cylindrical base part 31, a cylindrical port body part 32 protruded in the distal direction from the base part 31, a closing part 33 extending in the distal direction from the port body part 32, and an annular concave part 35 provided between the port body part 32 and the closing part 33 and forming an annular thin wall part 34 for breaking. The port body part 32 has an annular inner peripheral surface corner part 36 formed on the inner peripheral surface. The annular concave part 35 has an annular inner edge corner part 37. The annular inner peripheral corner part 36 is provided at a position close to the annular inner edge corner part 37 and closer to the base part 31 than the annular inner edge corner part 37.SELECTED DRAWING: Figure 4

Description

本発明は、液状物を収納する容器に取り付けられるポート部材、ならびに液状物収納用容器および生体投与用液状物充填済み容器に関する。 TECHNICAL FIELD The present invention relates to a port member attached to a container for containing a liquid, a container for containing a liquid, and a container filled with a liquid for biological administration.

従来から、袋状の容器本体内に流動性の食品や薬液等の液状物が収納され、当該容器本体に液状物の排出用のポート部材が取り付けられている容器が知られている。そして、そのようなポート部材として、ポート本体部に一体的に形成された閉塞部を備え、閉塞部によって容器を密封するとともに、閉塞部を分離(破断)することによって容器を開封し、液状物を外部に排出するものが知られている。 2. Description of the Related Art Conventionally, there has been known a container in which a bag-shaped container main body contains a liquid substance such as a fluid food or a liquid medicine, and a port member for discharging the liquid substance is attached to the container main body. As such a port member, a closing portion integrally formed with the port main body portion is provided, and the container is sealed by the closing portion, and the container is opened by separating (breaking) the closing portion to open the liquid material. is known to be discharged to the outside.

例えば、特許文献1(特開2013-060213号公報)には、袋状容器に設けられ、内容物の注出具として使用されるワンピース製のスパウト(ポート部材)が開示されており、筒状本体の上端に破断可能な薄肉部を介して折り取り部材が連なっており、薄肉部を破断して折り取り部を取り除くことで、容器内容物の注出を行うことが可能となる。 For example, Patent Document 1 (Japanese Patent Application Laid-Open No. 2013-060213) discloses a one-piece spout (port member) that is provided in a bag-like container and used as a content pouring tool. A break-off member is connected to the upper end of the container through a breakable thin-walled portion, and by removing the broken-off portion by breaking the thin-walled portion, it is possible to pour out the contents of the container.

また、特許文献2(特開2014-091572号公報)には、筒部と弱化部を介して一体形成された折取部により流路が閉じられたスパウト(ポート部材)であって、スパウト本体の先端側から被せられ折取部を含んで覆うように別体に形成されたカバーを備えるスパウトが開示されており、これにより組立時や搬送時、保管時に弱化部が損傷して密封性が損なわれることを防止することが開示されている。 In addition, Patent Document 2 (Japanese Patent Application Laid-Open No. 2014-091572) discloses a spout (port member) in which a flow path is closed by a break-off portion integrally formed via a cylindrical portion and a weakened portion, and a spout body Disclosed is a spout provided with a cover that is separately formed so as to cover from the tip side of the spout and cover the break-off portion, which damages the weakened portion during assembly, transportation, and storage, resulting in poor sealing. It is disclosed to prevent damage.

特開2013-060213号公報JP 2013-060213 A 特開2014-091572号公報JP 2014-091572 A

上述のようなポート部材では、ポート部材(ひいてはポート部材が取り付けられる容器)の密封性を確保するために、破断可能な部分として形成される薄肉部の強度(肉厚)を確保する必要がある一方、当該強度(肉厚)が大きすぎると容器の開封性(閉塞部の分離し易さ)が損なわれたり、閉塞部の分離に伴ってポート本体部が変形してしまうという問題がある。また、破断部において生じるバリが容器内に混入することは避けなければならない。
さらに、例えば、近年、経腸栄養分野の胃瘻・経鼻チューブにおいて誤接続防止を目的として日本においても導入が決定したISO080369-3に規定されるメスコネクタ等においてこのような構造を採用する場合、閉塞部を除去した後の他部材(コネクタ部材)の挿入性を確保する(他部材の挿入を妨げない)ことが必要となる。
そこで、本発明の目的は、液状物を収納する容器に取り付けられるポート部材であって、密封性および開封性を確保するとともに、他部材の挿入性を確保できるポート部材、ならびに液状物収納用容器および生体投与用液状物充填済み容器を提供することにある。
In the port member as described above, it is necessary to ensure the strength (thickness) of the thin portion formed as a breakable portion in order to ensure the sealing performance of the port member (and thus the container to which the port member is attached). On the other hand, if the strength (thickness) is too large, there is a problem that the opening property of the container (the ease with which the closing portion can be separated) is impaired, or the port main body portion deforms as the closing portion is separated. In addition, it is necessary to avoid contamination of the container with burrs generated at the broken portion.
Furthermore, for example, in recent years, when adopting such a structure in a female connector specified in ISO 080369-3, which has been decided to be introduced in Japan for the purpose of preventing incorrect connection in gastrostomy and nasogastric tubes in the field of enteral nutrition. In addition, it is necessary to ensure the insertability of other members (connector members) after removing the blocking portion (not to hinder the insertion of other members).
SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a port member to be attached to a container for storing a liquid, which ensures sealing and unsealing properties, as well as ensuring insertability of other members, and a container for storing a liquid. and to provide a container filled with a liquid for biological administration.

上記目的を達成するものは、以下のものである。
(1) 液状物を収納する容器に取り付けられるポート部材であって、
前記ポート部材は、筒状のベース部と、前記ベース部より先端方向に突出した円筒状のポート本体部と、前記ポート本体部より先端方向に延びる閉塞部と、前記ポート本体部と前記閉塞部間に設けられ、破断用の環状薄肉部を形成する環状凹部とを備え、
前記ポート本体部は、内周面に形成された環状内周面角部を備え、
前記環状凹部は、環状内縁角部を備え、
前記環状内周面角部は、前記環状内縁角部に近接し、かつ前記環状内縁角部よりも前記ベース部側となる位置に設けられているポート部材。
What achieves the above objectives is the following.
(1) A port member attached to a container for storing a liquid,
The port member includes a cylindrical base portion, a cylindrical port main portion projecting from the base portion in the distal direction, a closing portion extending from the port main portion in the distal direction, and the port main portion and the closing portion. an annular recess provided between and forming an annular thinned portion for breaking,
The port main body has an annular inner peripheral surface corner formed on the inner peripheral surface,
The annular recess comprises an annular inner edge corner,
The annular inner peripheral surface corner portion is provided at a position closer to the annular inner edge corner portion and closer to the base portion than the annular inner edge corner portion.

(2) 前記ポート本体部は、内径が小径となった環状の内部段差部を備え、前記環状内周面角部は、前記内部段差部により形成されている上記(1)に記載のポート部材。
(3) 前記環状凹部は、前記ポート本体部の中心軸に対して直交するもしくは若干先端方向に傾斜した環状底面部と、前記環状底面部の内縁より、先端方向にかつ外方に延びる環状傾斜面部とを備え、前記環状内縁角部は、前記環状底面部と前記環状傾斜面部の内縁部により形成されている上記(1)または(2)に記載のポート部材。
(4) 前記環状内縁角部は、前記ポート本体部の内周面よりも外方に位置している上記(1)ないし(3)のいずれかに記載のポート部材。
(5) 前記ポート部材は、前記ポート本体部と前記閉塞部との連結部位において、前記環状内縁角部と前記環状内周面角部との間の肉厚が最小となっている上記(1)ないし(4)のいずれかに記載のポート部材。
(6) 前記環状内縁角部と前記環状内周面角部との間の肉厚は、0.10mm~0.35mmである上記(5)に記載のポート部材。
(7) 前記ポート部材は、前記閉塞部に固定された破断操作用部材を備え、前記破断操作用部材は、本体部と、前記本体部より外方に突出する操作部とを備え、前記ポート部材は、前記破断操作用部材の回転操作によって、前記環状薄肉部において前記閉塞部を前記ポート本体部から分離可能である上記(1)ないし(6)のいずれかに記載のポート部材。
(8) 前記液状物は、生体投与用液状物である上記(1)ないし(7)のいずれかに記載のポート部材。
(2) The port member according to (1) above, wherein the port main body includes an annular internal stepped portion with a small inner diameter, and the annular inner circumferential surface corner portion is formed by the internal stepped portion. .
(3) The annular concave portion has an annular bottom portion perpendicular to the central axis of the port body portion or slightly inclined in the distal direction, and an annular inclined portion extending in the distal direction and outward from the inner edge of the annular bottom portion. The port member according to the above (1) or (2), further comprising a surface portion, wherein the annular inner edge corner portion is formed by the annular bottom surface portion and the inner edge portion of the annular inclined surface portion.
(4) The port member according to any one of (1) to (3) above, wherein the annular inner edge corner portion is located outside the inner peripheral surface of the port body portion.
(5) In the above (1), the port member has a minimum wall thickness between the annular inner edge corner portion and the annular inner peripheral surface corner portion at the connecting portion between the port body portion and the closing portion. ) to (4).
(6) The port member according to (5) above, wherein the wall thickness between the annular inner edge corner portion and the annular inner peripheral corner portion is 0.10 mm to 0.35 mm.
(7) The port member includes a breaking operation member fixed to the closing portion, the breaking operation member includes a body portion and an operation portion projecting outward from the body portion, and the port member The port member according to any one of (1) to (6) above, wherein the closing portion can be separated from the port body portion at the annular thin portion by rotating the breaking operation member.
(8) The port member according to any one of (1) to (7) above, wherein the liquid is a liquid for biological administration.

また、上記目的を達成するものは、以下のものである。
(9) 排出口を有する容器本体と、前記排出口に、上記(1)ないし(8)のいずれかに記載のポート部材が取り付けられている液状物収納用容器。
Moreover, what achieves the above purpose is as follows.
(9) A container for storing liquid, comprising a container body having an outlet, and the port member according to any one of (1) to (8) above attached to the outlet.

また、上記目的を達成するものは、以下のものである。
(10) 上記(9)に記載の液状物収納用容器内に、生体投与用液状物が収納されている生体投与用液状物充填済み容器。
Moreover, what achieves the above purpose is as follows.
(10) A liquid-filled container for biological administration, wherein the liquid for biological administration is contained in the liquid-containing container according to (9) above.

本発明のポート部材は、筒状のベース部と、ベース部より先端方向に突出した円筒状のポート本体部と、ポート本体部より先端方向に延びる閉塞部と、ポート本体部と閉塞部間に設けられ、破断用の環状薄肉部を形成する環状凹部とを備え、ポート本体部は、内周面に形成された環状内周面角部を備え、環状凹部は、環状内縁角部を備え、環状内周面角部は、環状内縁角部に近接し、かつ環状内縁角部よりもベース部側となる位置に設けられている。これにより、ポート部材(ひいてはポート部材が取り付けられる容器)の密封性および開封性を確保するとともに、他部材の挿入性を確保できる。 The port member of the present invention includes a cylindrical base portion, a cylindrical port main portion projecting from the base portion in the distal direction, a closing portion extending from the port main portion in the distal direction, and a portion between the port main portion and the closing portion. an annular recess provided to form an annular thinned portion for breaking, the port body portion including an annular inner peripheral corner portion formed on the inner peripheral surface, the annular recess including an annular inner edge corner portion, The annular inner peripheral surface corner portion is provided at a position close to the annular inner edge corner portion and closer to the base portion side than the annular inner edge corner portion. As a result, it is possible to ensure the sealability and unsealability of the port member (and thus the container to which the port member is attached), and to ensure the insertability of other members.

本発明の液状物収納用容器は、排出口を有する容器本体と、排出口に、上記所定のポート部材が取り付けられている。これにより、ポート部材(ひいてはポート部材が取り付けられる容器)の密封性および開封性を確保するとともに、他部材の挿入性を確保できる。 A container for storing a liquid according to the present invention includes a container body having a discharge port, and the predetermined port member attached to the discharge port. As a result, it is possible to ensure the sealability and unsealability of the port member (and thus the container to which the port member is attached), and to ensure the insertability of other members.

本発明の生体投与用液状物充填済み容器は、上記所定の液状物収納用容器内に、生体投与用液状物が収納されている。これにより、ポート部材(ひいてはポート部材が取り付けられる容器)の密封性および開封性を確保するとともに、他部材の挿入性を確保できる。 In the liquid-filled container for bioadministration of the present invention, the liquid for bioadministration is stored in the predetermined liquid-storage container. As a result, it is possible to ensure the sealability and unsealability of the port member (and thus the container to which the port member is attached), and to ensure the insertability of other members.

図1は、本発明のポート部材を備える生体投与用液状物充填済み容器の実施例を示す正面図である。FIG. 1 is a front view showing an embodiment of a liquid-filled container for biological administration provided with a port member of the present invention. 図2は、図1のA部拡大説明図である。FIG. 2 is an enlarged explanatory view of part A in FIG. 図3は、図2に対応する部分の平面図である。3 is a plan view of a portion corresponding to FIG. 2. FIG. 図4は、図3のB-B断面を示す拡大断面部分説明図である。FIG. 4 is an enlarged cross-sectional partial explanatory view showing the BB cross section of FIG. 図5は、図4のC部拡大説明図である。FIG. 5 is an enlarged explanatory view of the C portion in FIG. 図6は、破断操作用部材を備える本発明のポート部材を備える生体投与用液状物充填済み容器の実施例を示す正面図である。FIG. 6 is a front view showing an embodiment of a liquid-filled container for biological administration comprising a port member of the present invention comprising a breaking operation member. 図7は、図6のE部に対応する部分の拡大平面図である。7 is an enlarged plan view of a portion corresponding to the E section of FIG. 6. FIG. 図8は、図7のF-F断面を示す拡大断面部分説明図である。FIG. 8 is an enlarged cross-sectional partial explanatory view showing the FF cross section of FIG. 図9は、本発明のポート部材において閉塞部を分離した状態を示す、拡大断面部分説明図である。FIG. 9 is an enlarged cross-sectional partial explanatory view showing a state in which the closing portion is separated in the port member of the present invention. 図10は、本発明のポート部材に接続可能なコネクタ部材の実施例を示す拡大断面部分説明図である。FIG. 10 is an enlarged cross-sectional partial explanatory view showing an embodiment of a connector member connectable to the port member of the present invention. 図11は、本発明のポート部材とコネクタ部材との接続態様を示す拡大断面部分説明図である。FIG. 11 is an enlarged cross-sectional partial explanatory view showing a connection mode between the port member and the connector member of the present invention. 図12は、本発明のポート部材に係る試験例の態様を示す説明図である。12A and 12B are explanatory diagrams showing aspects of test examples relating to the port member of the present invention. 図13は、本発明のポート部材に係る試験例の態様を示す断面写真である。FIG. 13 is a cross-sectional photograph showing an aspect of a test example relating to the port member of the present invention. 図14は、本発明のポート部材に係る試験例の態様を示す断面写真である。FIG. 14 is a cross-sectional photograph showing an aspect of a test example relating to the port member of the present invention. 図15は、本発明のポート部材に係る試験例の態様を示す断面写真である。FIG. 15 is a cross-sectional photograph showing an aspect of a test example relating to the port member of the present invention. 図16は、本発明のポート部材に係る試験例の態様を示す断面写真である。FIG. 16 is a cross-sectional photograph showing an aspect of a test example relating to the port member of the present invention. 図17は、本発明のポート部材の他の実施例を示す、図5に対応する拡大断面部分説明図である。FIG. 17 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 5, showing another embodiment of the port member of the present invention. 図18は、本発明のポート部材の他の実施例を示す、図5に対応する拡大断面部分説明図である。FIG. 18 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 5, showing another embodiment of the port member of the present invention. 図19は、本発明のポート部材の他の実施例を示す、図5に対応する拡大断面部分説明図である。FIG. 19 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 5, showing another embodiment of the port member of the present invention. 図20は、本発明のポート部材の他の実施例を示す、図5に対応する拡大断面部分説明図である。FIG. 20 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 5, showing another embodiment of the port member of the present invention. 図21は、本発明のポート部材の他の実施例を示す、図4に対応する拡大断面部分説明図である。21 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 4, showing another embodiment of the port member of the present invention; FIG. 図22は、本発明のポート部材の他の実施例を示す、図4に対応する拡大断面部分説明図である。22 is an enlarged cross-sectional partial explanatory view corresponding to FIG. 4, showing another embodiment of the port member of the present invention; FIG.

本発明のポート部材、ならびに液状物収納用容器および生体投与用液状物充填済み容器を図面に示した実施例を用いて説明する。なお、図1ないし図5においては、説明の便宜のため、ポート部材について破断操作用部材を省略した態様で示している。 The port member of the present invention, a container for storing a liquid, and a container filled with a liquid for biological administration will be described with reference to the drawings. 1 to 5, for convenience of explanation, the port member is shown without the breaking operation member.

図1ないし図8に示すように、本発明のポート部材30は、液状物(生体投与用液状物20)を収納する容器(液状物収納容器10の容器本体11)に取り付けられるポート部材30である。ポート部材30は、筒状のベース部31と、ベース部31より先端方向に突出した円筒状のポート本体部32と、ポート本体部32より先端方向に延びる閉塞部33と、ポート本体部32と閉塞部33間に設けられ、破断用の環状薄肉部34を形成する環状凹部35とを備える。さらに、ポート本体部32は、内周面に形成された環状内周面角部36を備え、環状凹部35は、環状内縁角部37を備え、環状内周面角部36は、環状内縁角部37に近接し、かつ環状内縁角部37よりもベース部31側となる位置に設けられている。 As shown in FIGS. 1 to 8, the port member 30 of the present invention is a port member 30 attached to a container (container main body 11 of liquid container 10) for containing a liquid (liquid for biological administration 20). be. The port member 30 includes a cylindrical base portion 31 , a cylindrical port body portion 32 projecting in the distal direction from the base portion 31 , a blocking portion 33 extending in the distal direction from the port body portion 32 , and the port body portion 32 . An annular recess 35 is provided between the closing portions 33 and forms an annular thinned portion 34 for breaking. Further, the port body portion 32 includes an annular inner peripheral corner 36 formed on the inner peripheral surface, the annular recess 35 includes an annular inner peripheral corner 37, and the annular inner peripheral corner 36 includes an annular inner peripheral corner. It is provided at a position close to the portion 37 and closer to the base portion 31 than the annular inner edge corner portion 37 .

図1ないし図8に示すように、本発明の液状物収納容器10は、排出口12を有する容器本体11を備え、排出口12に、上記ポート部材30が取り付けられている。また、本発明の生体投与用液状物充填済み容器1は、上記液状物収納用容器10内に、液状物としての生体投与用液状物20が収納されている。そして、生体投与用液状物20としては、例えば、経腸栄養分野において用いられる流動性食品やその他の流動性食品、および点滴等に用いられる各種の薬液や輸液等が挙げられる。 As shown in FIGS. 1 to 8, the liquid material storage container 10 of the present invention includes a container body 11 having a discharge port 12, and the port member 30 is attached to the discharge port 12. FIG. Further, in the container 1 filled with a liquid for biological administration of the present invention, the liquid for biological administration 20 as a liquid is contained in the container 10 for containing a liquid. Examples of the liquid material for biological administration 20 include fluid foods and other fluid foods used in the field of enteral nutrition, and various drug solutions and infusion solutions used for drip infusion and the like.

容器本体11は、可撓性の袋状であり、内部に生体投与用液状物20が収納される。容器本体11の上部には、容器本体11の内部と外部とを連通させる(容器本体11の内部に収納された生体投与用液状物20を外部に排出する)ための排出口12が設けられている。容器本体11の排出口12にポート部材30が取り付けられている。 The container main body 11 is in the shape of a flexible bag, and contains the liquid substance for biological administration 20 therein. At the top of the container body 11, a discharge port 12 is provided for communicating the inside and the outside of the container body 11 (for discharging the liquid substance for biological administration 20 stored inside the container body 11 to the outside). there is A port member 30 is attached to the outlet 12 of the container body 11 .

図2および図3に示すように、ポート部材30は、筒状のベース部31を備える。ベース部31のさらに基端側(容器本体11側)には、菱形板状の板状部38、および船型状の取付部39(図2において破線で示す)が設けられている。ポート部材30は取付部39において容器本体11の排出口12に取り付けられている。より具体的には、取付部39は排出口12の内部に収納され、取付部39の外面部に、排出口12の内面部が液密に固定(接着や熱溶着等)されている。 As shown in FIGS. 2 and 3, the port member 30 has a tubular base portion 31 . A rhombus-shaped plate-like portion 38 and a boat-shaped mounting portion 39 (indicated by broken lines in FIG. 2) are provided on the base portion 31 further on the base end side (container body 11 side). The port member 30 is attached to the outlet 12 of the container body 11 at the attachment portion 39 . More specifically, the mounting portion 39 is housed inside the discharge port 12 , and the inner surface portion of the discharge port 12 is liquid-tightly fixed to the outer surface portion of the mounting portion 39 (adhesion, heat welding, or the like).

この実施例のポート部材30では、板状部38は、ベース部31の基端より、外方に延びる平板状のものとなっている。そして、この板状部38の下面が、容器本体11の排出口12の上面に当接し、排出口12を封止している。板状部38としては、この実施例のように略菱形状であることが好ましいが、円状、楕円状、多角形状であってもよい。 In the port member 30 of this embodiment, the plate-like portion 38 has a plate-like shape extending outward from the proximal end of the base portion 31 . The lower surface of the plate-like portion 38 contacts the upper surface of the discharge port 12 of the container body 11 to seal the discharge port 12 . The plate-like portion 38 preferably has a substantially rhombic shape as in this embodiment, but may have a circular, elliptical, or polygonal shape.

取付部39は、板状部38の下面よりさらに下方に所定長延びる筒状となっている。取付部39の上端の外縁形状は、板状部38の下面外縁形状よりも小さく、板状部38は、下面に取付部39より突出する環状突出部を有している。また、この実施例のポート部材30では、取付部39は、舟形、具体的には、軸方向に直交する断面が、菱形状のものとなっている。なお、取付部39は、円筒状、楕円筒状、多角筒状であってもよい。また、この実施例のポート部材30では、取付部39は、外面に凸部、凹部を備えている。 The mounting portion 39 has a tubular shape extending a predetermined length downward from the lower surface of the plate-like portion 38 . The outer edge shape of the upper end of the mounting portion 39 is smaller than the outer edge shape of the lower surface of the plate-like portion 38 , and the plate-like portion 38 has an annular projecting portion projecting from the mounting portion 39 on the lower surface. In addition, in the port member 30 of this embodiment, the attachment portion 39 has a boat shape, more specifically, a rhombic cross section perpendicular to the axial direction. The attachment portion 39 may have a cylindrical shape, an oval cylindrical shape, or a polygonal cylindrical shape. Further, in the port member 30 of this embodiment, the mounting portion 39 has a convex portion and a concave portion on the outer surface.

本実施例において、ポート部材30は、ベース部31から先端方向に向かって突出する円筒状のポート本体部32と、ポート本体部32から先端方向に延びる閉塞部33と、ポート本体部32と閉塞部33間に設けられ、破断用の環状薄肉部34を形成する環状凹部35とを備える。 In this embodiment, the port member 30 includes a cylindrical port body portion 32 projecting from the base portion 31 toward the distal direction, a closing portion 33 extending from the port body portion 32 toward the distal direction, and the port body portion 32 and the closing portion. An annular recess 35 provided between the portions 33 and forming an annular thinned portion 34 for breaking.

図4に示すように、ポート本体部32は中空の円筒形状であり、開放状態において液状物収納用容器10の内部を外部と連通可能(生体投与用液状物20を外部に排出可能)であるとともに、その内部には、後述するコネクタ部材50の第1筒状部51の先端部55(コネクタ部材先端部55)が挿入(進入)可能となっている。また、ポート本体部32の外周面には、螺合用リブ40が形成されている。螺合用リブ40は、外方に突出する螺旋状のリブであり、後述するコネクタ部材50の螺合用溝部53と螺合可能となっている。 As shown in FIG. 4, the port main body 32 has a hollow cylindrical shape, and in the open state, the inside of the liquid container 10 can communicate with the outside (the liquid for biological administration 20 can be discharged to the outside). In addition, a distal end portion 55 (connector member distal end portion 55) of a first cylindrical portion 51 of the connector member 50, which will be described later, can be inserted (entered) into the interior thereof. Further, a screwing rib 40 is formed on the outer peripheral surface of the port body portion 32 . The screwing rib 40 is a helical rib protruding outward, and can be screwed with a screwing groove 53 of the connector member 50 described later.

図4および図5に示すように、ポート本体部32は、内周面に形成された環状内周面角部36を備える。より具体的には、ポート本体部32は、内径が小径となった環状の内部段差部41を備え、環状内周面角部36は、内部段差部41により形成されている。言い換えれば、内部段差部41を挟んで、閉塞部33側の内径:dが、ポート本体部32の内径:Dよりも小径となっている。ここでは、内部段差部41(内部段差面)は、ポート本体部32の中心軸に対して直交する方向(略水平)に延びている。この実施例では、環状内周面角部36は、内周面の環状頂部(第1の環状頂部)と、この環状頂部より中心方向に延びる環状平面部との接続部により形成されている。環状内周面角部36は、尖った角部であることが好ましいが、若干の丸みを有するものであってもよい。 As shown in FIGS. 4 and 5, the port body portion 32 has an annular inner circumferential surface corner portion 36 formed on the inner circumferential surface. More specifically, the port body portion 32 has an annular internal stepped portion 41 with a small inner diameter, and the annular inner circumferential surface corner portion 36 is formed by the internal stepped portion 41 . In other words, with the internal stepped portion 41 interposed therebetween, the inner diameter: d of the closing portion 33 side is smaller than the inner diameter: D of the port body portion 32 . Here, the internal stepped portion 41 (internal stepped surface) extends in a direction perpendicular to the central axis of the port body portion 32 (substantially horizontally). In this embodiment, the annular inner peripheral surface corner portion 36 is formed by a connecting portion between an annular top portion (first annular top portion) of the inner peripheral surface and an annular flat portion extending from the annular top portion toward the center. The annular inner peripheral surface corner portion 36 is preferably a sharp corner portion, but may be slightly rounded.

図4に示すように、ポート部材30のポート本体部32は、内部段差部41の形成部位を除き(内部段差部41よりも下側の部分において)内径がほぼ同一となっている。言い換えれば、ポート本体部32の内部段差部41を除いた部分の内面は、軸方向に沿って略平行なストレート面(ほぼ同一径にて延びる円柱面)となっている。なお、ここで「内径がほぼ同一(軸方向に沿って略平行なストレート面)」とは、ポート部材30の成形に際して設定される抜き勾配程度の傾斜は許容することを指す。これにより、後に詳述する閉塞部33を備えるポート部材30をより容易に成形することができる。 As shown in FIG. 4, the port main body portion 32 of the port member 30 has substantially the same inner diameter (at the portion below the internal stepped portion 41) except for the portion where the internal stepped portion 41 is formed. In other words, the inner surface of the portion of the port main body 32 excluding the internal stepped portion 41 is a straight surface (cylindrical surface extending with substantially the same diameter) substantially parallel along the axial direction. Here, "the inner diameters are substantially the same (straight surfaces that are substantially parallel along the axial direction)" means that the port member 30 is allowed to have an inclination to the extent of a draft angle that is set when the port member 30 is molded. As a result, the port member 30 having the closing portion 33, which will be described in detail later, can be more easily molded.

ポート部材30は、ポート本体部32から先端方向に延びる閉塞部33を備える。図4に示すように、閉塞部33は、ポート本体部32の先端に連接され、先端側部分が閉塞した閉塞先端部を有する円筒形状である。閉塞部33が存在する状態において、ポート本体部32が閉塞(液状物収納用容器10が封止)されている。また、閉塞部33の外周面には外方に突出する破断操作用リブ42が形成されている。ここでは、閉塞部33に、互いに反対の方向に突出する一対の破断操作用リブ42,42が形成されている。 Port member 30 includes a blocking portion 33 extending distally from port body portion 32 . As shown in FIG. 4 , the blocking portion 33 is connected to the distal end of the port body portion 32 and has a cylindrical shape having a closed distal end with a distal end side portion blocked. In the state where the closing portion 33 exists, the port body portion 32 is closed (the liquid container 10 is sealed). A breaking operation rib 42 projecting outward is formed on the outer peripheral surface of the closing portion 33 . Here, the closing portion 33 is formed with a pair of breaking operation ribs 42, 42 protruding in mutually opposite directions.

そして、ポート本体部32と閉塞部33間には、破断用の環状薄肉部34を形成する環状凹部35が設けられている。環状凹部35は、環状内縁角部37を備える。本実施例では、図5に示すように、環状凹部35は、ポート本体部32の中心軸に対して直交する(もしくは若干先端方向に傾斜した)環状底面部43と、環状底面部43の内縁より、先端方向にかつ外方に延びる環状傾斜面部44とを備え、環状内縁角部37は、環状底面部43と環状傾斜面部44の内縁部により形成されている。なお、環状傾斜面部44は、環状底面部43の内縁より、先端方向にかつ外方に延びる環状湾曲面であってもよい。 An annular recess 35 forming an annular thin wall portion 34 for breaking is provided between the port body portion 32 and the closing portion 33 . The annular recess 35 has an annular inner edge corner 37 . In this embodiment, as shown in FIG. 5, the annular recessed portion 35 includes an annular bottom portion 43 perpendicular to the central axis of the port body portion 32 (or slightly inclined toward the distal direction) and an inner edge of the annular bottom portion 43. An annular inner edge corner portion 37 is formed by the annular bottom surface portion 43 and the inner edge portion of the annular inclined surface portion 44 . Note that the annular inclined surface portion 44 may be an annular curved surface extending outward from the inner edge of the annular bottom surface portion 43 in the distal direction.

環状底面部43は、ポート本体部32の中心軸に対して直交する面(水平面)に対して、0°(水平)~±10°で先端方向もしくは基端方向に傾斜していることが好ましい。また、環状底面部43と環状傾斜面部44とがなす角度:θは、40°~50°であることが好ましく、より好ましくは、45°である。 It is preferable that the annular bottom surface portion 43 is inclined at 0° (horizontal) to ±10° toward the distal direction or the proximal direction with respect to a plane (horizontal plane) perpendicular to the central axis of the port body portion 32 . . The angle θ between the annular bottom surface portion 43 and the annular inclined surface portion 44 is preferably 40° to 50°, more preferably 45°.

図5に示すように、環状内縁角部37は、ポート本体部32の内周面(ポート本体部32の内部段差部41を含む内周面)よりも外方に位置している。ここでは、環状内縁角部37が、ポート本体部32の内周面よりも、径方向外側にXで示す分だけ外方に位置している。なお、ここで示す、環状内縁角部37とポート本体部32の内周面との間の水平方向距離:Xは、0.17mm~0.25mmの範囲であることが好ましく、より好ましくは、0.19mm~0.21mmである。 As shown in FIG. 5, the annular inner edge corner portion 37 is positioned outward from the inner peripheral surface of the port body portion 32 (the inner peripheral surface of the port body portion 32 including the internal stepped portion 41). Here, the annular inner edge corner portion 37 is positioned radially outwardly by an amount indicated by X from the inner peripheral surface of the port body portion 32 . Note that the horizontal distance X between the annular inner edge corner portion 37 and the inner peripheral surface of the port body portion 32 shown here is preferably in the range of 0.17 mm to 0.25 mm, and more preferably, 0.19 mm to 0.21 mm.

そして、図5に示すように、ポート部材30においては、ポート本体部32と閉塞部33との連結部位(環状薄肉部34)において、環状内縁角部37と環状内周面角部36との間の肉厚(環状内縁角部37と環状内周面角部36間の距離):tが最小となっている。なお、肉厚:tは、0.10mm~0.35mmであることが好ましく、より好ましくは、0.15mm~0.30mmであり、特に、好ましくは、0.18mm~0.29mmである。肉厚:tが上記の範囲であれば、液状物収納用容器10の開封性(閉塞部33の分離し易さ)が損なわれるおそれがなく、不用意な破断もない。 As shown in FIG. 5, in the port member 30, the annular inner edge corner portion 37 and the annular inner peripheral surface corner portion 36 are formed at the connection portion (annular thin wall portion 34) between the port body portion 32 and the closing portion 33. The thickness between them (the distance between the annular inner edge corner portion 37 and the annular inner peripheral surface corner portion 36): t is minimized. The thickness t is preferably 0.10 mm to 0.35 mm, more preferably 0.15 mm to 0.30 mm, and particularly preferably 0.18 mm to 0.29 mm. If the thickness: t is within the above range, there is no risk of impairing the unsealability of the liquid container 10 (the ease with which the closing portion 33 can be separated), and there is no accidental breakage.

ポート部材30において、環状内周面角部36は、環状内縁角部37に近接し、かつ環状内縁角部37よりもベース部31側となる位置に設けられている。ここでは、図5に示すように、環状内周面角部36は、環状内縁角部37よりもYで示す分だけベース部31側(図5における下方)に位置している。なお、ここで示す、環状内縁角部37と環状内周面角部36との間の鉛直方向距離:Yは、0.0mm~0.2mmであることが好ましい。距離:Yが0.2mmよりも大きくなると、後に詳述するように、閉塞部33をポート本体部32から分離(破断)した際に生じるバリが、他部材(コネクタ部材50)の挿入性を悪化させる(他部材の挿入を妨げる)おそれがある。 In the port member 30 , the annular inner peripheral surface corner portion 36 is provided at a position close to the annular inner edge corner portion 37 and closer to the base portion 31 than the annular inner edge corner portion 37 . Here, as shown in FIG. 5, the annular inner peripheral surface corner portion 36 is located on the base portion 31 side (lower in FIG. 5) than the annular inner edge corner portion 37 by the amount indicated by Y. The vertical distance Y between the annular inner edge corner portion 37 and the annular inner peripheral surface corner portion 36 shown here is preferably 0.0 mm to 0.2 mm. If the distance Y is greater than 0.2 mm, burrs generated when the closing portion 33 is separated (broken) from the port body portion 32 impair the insertability of another member (connector member 50), as will be described in detail later. There is a risk of exacerbating the problem (obstructing insertion of other members).

ポート部材30の形成材料としては、硬質の合成樹脂、例えば、ポリプロピレン、ポリエチレンなどのポリオレフィン、ポリカーボネート、ポリエステル(PET)、ポリスチレン、ポリアミド、硬質ポリ塩化ビニル、ABS樹脂等の樹脂材料を挙げることができる。ポート部材30の形成材料としては、高密度ポリエチレン(HDPE)が好ましい。ポート部材30は、例えば、射出成形により一体成形することができる。また、ポート部材30は、ISO80369-3に対応するものであることが好ましい。 Materials for forming the port member 30 include hard synthetic resins, for example, resin materials such as polyolefins such as polypropylene and polyethylene, polycarbonate, polyester (PET), polystyrene, polyamide, rigid polyvinyl chloride, and ABS resin. . A preferred material for forming the port member 30 is high density polyethylene (HDPE). The port member 30 can be integrally molded, for example, by injection molding. Also, the port member 30 preferably conforms to ISO80369-3.

図6ないし図8に示すように、ポート部材30は、閉塞部33に固定された破断操作用部材(キャップ)60を備える。破断操作用部材60は、本体部61と、本体部61より外方に突出する操作部62とを備える。ポート部材30は、破断操作用部材60の回転操作によって、環状薄肉部34において閉塞部33をポート本体部32から分離可能である。 As shown in FIGS. 6 to 8 , the port member 30 includes a breaking operation member (cap) 60 fixed to the closing portion 33 . The breaking operation member 60 includes a body portion 61 and an operation portion 62 projecting outward from the body portion 61 . The port member 30 can separate the closing portion 33 from the port body portion 32 at the annular thin portion 34 by rotating the breaking operation member 60 .

より具体的には、図8に示すように、破断操作用部材60の本体部61は、円筒形状であり、内部にポート部材30の上側部分[閉塞部33、環状凹部35(環状薄肉部34)、ポート本体部32、およびベース部31の一部]を収納可能となっている。本体部61の内周面には、閉塞部33に形成された破断操作用リブ42,42と係合するキャップ側リブ63,63が、内方に向かって突出するように形成されている。キャップ側リブ63は、それぞれ、2つのリブからなり(図8においては、それぞれ、1つのみ図示)、周方向において破断操作用リブ42を挟み込むように係合する。破断操作用部材60は、キャップ側リブ63,63が破断操作用リブ42,42に係合された状態で、閉塞部33の先端部に熱溶着等によって固定されている(溶着部64)。この実施例では、破断操作用部材60の本体部61は、ポート部材30の上述した環状薄肉部34、環状凹部35を被包している。このため、破断操作用部材60に衝撃が付与された場合などにおける、環状薄肉部34の破損を防止している。 More specifically, as shown in FIG. 8, the body portion 61 of the breaking operation member 60 has a cylindrical shape, and the upper portion of the port member 30 [the closing portion 33, the annular concave portion 35 (the annular thin portion 34 ), the port main body 32, and part of the base portion 31]. Cap-side ribs 63, 63 that engage with the breaking operation ribs 42, 42 formed on the closing portion 33 are formed on the inner peripheral surface of the body portion 61 so as to protrude inward. Each of the cap-side ribs 63 is composed of two ribs (only one of each is shown in FIG. 8), and engages so as to sandwich the breaking operation rib 42 in the circumferential direction. The breaking operation member 60 is fixed to the distal end portion of the closing portion 33 by heat welding or the like with the cap-side ribs 63, 63 engaged with the breaking operation ribs 42, 42 (welding portion 64). In this embodiment, the body portion 61 of the breaking operation member 60 covers the annular thin wall portion 34 and the annular concave portion 35 of the port member 30 described above. Therefore, the annular thin portion 34 is prevented from being damaged when an impact is applied to the breaking operation member 60 .

破断操作用部材60は、本体部61から外方に突出する操作部62を備える。破断操作用部材60は、本体部61から互いに反対の方向に突出する一対の操作部62,62を備える。ポート部材30は、破断操作用部材60の回転操作によって、環状薄肉部34において閉塞部33をポート本体部32から分離可能である。操作部62を利用して破断操作用部材60の回転操作を行うことにより、より大きな力(モーメント)を環状薄肉部34に作用させることができ、閉塞部33をより容易にポート本体部32から分離する(捻り取る)ことができる。 The breaking operation member 60 includes an operation portion 62 projecting outward from a body portion 61 . The breaking operation member 60 includes a pair of operation portions 62, 62 projecting from the main body portion 61 in opposite directions. The port member 30 can separate the closing portion 33 from the port body portion 32 at the annular thin portion 34 by rotating the breaking operation member 60 . By rotating the breaking operation member 60 using the operation portion 62 , a larger force (moment) can be applied to the thin annular portion 34 , and the closing portion 33 can be more easily removed from the port body portion 32 . It can be separated (twisted off).

破断操作用部材60の形成材料としては、ポート部材30の形成材料と同じく硬質の合成樹脂、例えば、ポリプロピレン、ポリエチレンなどのポリオレフィン、ポリカーボネート、ポリエステル(PET)、ポリスチレン、ポリアミド、硬質ポリ塩化ビニル、ABS樹脂等の樹脂材料を挙げることができる。破断操作用部材60の形成材料としては、高密度ポリエチレン(HDPE)が好ましい。 As the material for forming the breaking operation member 60, the same hard synthetic resin as the material for forming the port member 30, for example, polyolefins such as polypropylene and polyethylene, polycarbonate, polyester (PET), polystyrene, polyamide, rigid polyvinyl chloride, and ABS. A resin material such as a resin can be used. High-density polyethylene (HDPE) is preferable as the material for forming the breaking operation member 60 .

なお、ポート部材は、破断操作用部材を備えないものであってもよい。その場合、閉塞部を、直接、回転操作することにより、ポート本体部から分離する(捻り取る)ことができる。このとき、閉塞部に形成された一対の破断操作用リブを利用して、閉塞部を回転操作することもできる。また、閉塞部に横方向(軸方向に略直交する方向)の力を作用させることにより、閉塞部を分離する(折り取る)こともできる。なお、閉塞部は折り取るよりも捻り取る方が好ましく、破断操作用部材を備えることにより、閉塞部を意図せずに破損するないし折り取ることを防止できる。また、破断操作用部材を備えることにより、破断操作用部材を備えない場合(閉塞部を直接操作する場合)に比べて、容易に、かつ適切に閉塞部をポート本体部から分離する(捻り取る)ことができる。 In addition, the port member may not be provided with the breaking operation member. In that case, the closure can be separated (twisted) from the port body by direct rotational manipulation. At this time, the closing portion can also be rotated using a pair of breaking operation ribs formed on the closing portion. Moreover, the blocking part can be separated (break off) by applying a force in the lateral direction (in a direction substantially perpendicular to the axial direction) to the blocking part. It should be noted that it is preferable to twist off the blocking portion rather than breaking it off, and by providing the breaking operation member, it is possible to prevent the blocking portion from being unintentionally damaged or broken off. In addition, by providing the breaking operation member, the closing portion can be easily and properly separated from the port main body (twisted off) compared to the case where the breaking operation member is not provided (when the closing portion is directly operated). )be able to.

図9に示すように、ポート部材30において、閉塞部33をポート本体部32から分離することで、ポート本体部32を開放する(液状物収納用容器10を開封する)ことができる。これにより、液状物収納用容器10(容器本体11)に収納された生体投与用液状物20をポート部材30を介して外部に排出可能になるとともに、ポート部材30に他部材(例えば、後述するコネクタ部材50)を接続可能となる。そして、図9に示すように、閉塞部33が分離されたポート部材30には、環状薄肉部34部分が破断することにより形成された環状破断端70が形成される。この実施例のポート部材30では、環状破断端70は、上方に向かって拡径する傾斜面を有するものとなっている。 As shown in FIG. 9, in the port member 30, the closing portion 33 is separated from the port body portion 32, thereby opening the port body portion 32 (opening the liquid container 10). As a result, the liquid for biological administration 20 stored in the container 10 (container main body 11) can be discharged to the outside through the port member 30, and the port member 30 can be connected to another member (for example, to be described later). The connector member 50) can be connected. Then, as shown in FIG. 9, the port member 30 from which the closing portion 33 is separated is formed with an annular broken end 70 formed by breaking the annular thin portion 34 portion. In the port member 30 of this embodiment, the annular fracture end 70 has an inclined surface whose diameter increases upward.

図10に示すように、ポート部材30に接続可能なコネクタ部材50は、ポート部材30に接続可能な第1筒状部51と、第1筒状部51を被包する第2筒状部(ロックアダプタ)52と、第2筒状部52の内周面に形成され、螺合用溝部53を形成する螺合用突出部54とを備える。特に、図10に示すコネクタ部材50は、先端に開口を有する第1筒状部51と、第1筒状部51を被包する第2筒状部52と、後端に開口を有するチューブ接続用のコネクタ部57と、第1筒状部51とチューブ接続用のコネクタ部57間に設けられたフランジ部58とを備えている。そして、図11に示すように、コネクタ部57には、液体注入用チューブ72が接続可能である。 As shown in FIG. 10, the connector member 50 connectable to the port member 30 includes a first cylindrical portion 51 connectable to the port member 30 and a second cylindrical portion ( lock adapter) 52 , and a threading protrusion 54 formed on the inner peripheral surface of the second tubular portion 52 and forming a threading groove 53 . In particular, the connector member 50 shown in FIG. 10 includes a first tubular portion 51 having an opening at the front end, a second tubular portion 52 covering the first tubular portion 51, and a tube connection portion having an opening at the rear end. and a flange portion 58 provided between the first tubular portion 51 and the connector portion 57 for tube connection. Then, as shown in FIG. 11 , a liquid injection tube 72 can be connected to the connector portion 57 .

第1筒状部51は、外径が先端方向に向かって縮径するテーパ形状を有している。具体的には、第1筒状部51は、ISO594に準拠した6%ルアーテーパを有するノズル形状を備えている。第1筒状部51は、本発明のポート部材のみならず、他の医療器具(例えば、コネクタ、三方活栓)を接続可能である。 The first cylindrical portion 51 has a tapered shape in which the outer diameter decreases toward the distal end. Specifically, the first cylindrical portion 51 has a nozzle shape with a 6% luer taper conforming to ISO594. The first tubular portion 51 can be connected not only to the port member of the present invention but also to other medical instruments (for example, a connector, a three-way stopcock).

第2筒状部52は、筒状部材であり、第1筒状部51に装着されており、第1筒状部51の先端部は、第2筒状部52の先端部より突出している。また、第2筒状部52は、その基端部に設けられ、中心方向に延びる環状リブを有している。この環状リブが、第1筒状部51の外周面に設けられた環状凹部に進入している。このため、第2筒状部52は、第1筒状部51に回転可能に装着されている。 The second tubular portion 52 is a tubular member and is attached to the first tubular portion 51 , and the tip of the first tubular portion 51 protrudes from the tip of the second tubular portion 52 . . The second tubular portion 52 has an annular rib provided at its proximal end portion and extending toward the center. This annular rib enters an annular recess provided on the outer peripheral surface of the first tubular portion 51 . Therefore, the second tubular portion 52 is rotatably attached to the first tubular portion 51 .

そして、第2筒状部52の内周面には、螺合用溝部53を形成する螺合用突出部54が形成されている。螺合用突出部54は、内方に向かって突出する螺旋状の突出部(所謂ネジの山部)である。螺合用突出部54によって螺合用溝部53(所謂ネジの谷部)が形成される。螺合用溝部53は、ポート部材30の螺合用リブ40と螺合可能である。 A threaded projection 54 forming a threaded groove 53 is formed on the inner peripheral surface of the second tubular portion 52 . The screwing protrusion 54 is a helical protrusion (so-called screw thread) that protrudes inward. A screwing groove portion 53 (a so-called thread root portion) is formed by the screwing projection portion 54 . The screwing groove portion 53 can be screwed with the screwing rib 40 of the port member 30 .

コネクタ部材50の形成材料としては、ポート部材30と同じく硬質の合成樹脂、例えば、ポリプロピレン、ポリエチレンなどのポリオレフィン、ポリカーボネート、ポリエステル(PET)、ポリスチレン、ポリアミド、ポリエチレン、硬質ポリ塩化ビニル、ABS樹脂等の樹脂材料を挙げることができる。コネクタ部材50の形成材料としては、高密度ポリエチレン(HDPE)が好ましい。コネクタ部材50は、例えば、射出成形により一体成形することができる。また、コネクタ部材50は、ISO80369-3に対応するものであることが好ましい。 As a material for forming the connector member 50, the same hard synthetic resin as the port member 30, for example, polyolefin such as polypropylene and polyethylene, polycarbonate, polyester (PET), polystyrene, polyamide, polyethylene, rigid polyvinyl chloride, ABS resin, and the like can be used. A resin material can be mentioned. A preferred material for forming the connector member 50 is high density polyethylene (HDPE). The connector member 50 can be integrally formed by injection molding, for example. Also, the connector member 50 preferably conforms to ISO80369-3.

閉塞部33が分離された後、ポート部材30とコネクタ部材50とを接続する態様について説明する。図11に示すように、ポート本体部32にコネクタ部材50の第1筒状部51の先端部55を進入させるとともに、ポート部材30とコネクタ部材50とを相対的に回転させることで、ポート部材30の螺合用リブ40とコネクタ部材50の螺合用溝部53とを螺合させる。 A mode of connecting the port member 30 and the connector member 50 after the blocking portion 33 is separated will be described. As shown in FIG. 11, by inserting the distal end portion 55 of the first cylindrical portion 51 of the connector member 50 into the port body portion 32 and relatively rotating the port member 30 and the connector member 50, the port member The screwing rib 40 of 30 and the screwing groove 53 of the connector member 50 are screwed together.

ポート部材30(螺合用リブ40)とコネクタ部材50(螺合用溝部53)との螺合の進行により、コネクタ部材50がポート部材30側に移動(先端部55がポート本体部32内を進行)する。ここで、コネクタ部材50の第1筒状部51の先端部55がテーパ形状となっているため、当該先端部55の外面部と、ポート部材30のポート本体部32の内面部とが接触(ないしは圧接)し、液密に係合する。これにより、ポート部材30(ポート本体部32)とコネクタ部材50(第1筒状部51)とが連通し、液状物収納用容器10(容器本体11)内の液状物(生体投与用液状物20)を、ポート部材30およびコネクタ部材50を介して、患者に供給可能となる。 As the screwing between the port member 30 (screw rib 40) and the connector member 50 (screw groove 53) progresses, the connector member 50 moves toward the port member 30 (the distal end portion 55 advances in the port body portion 32). do. Here, since the distal end portion 55 of the first cylindrical portion 51 of the connector member 50 is tapered, the outer surface portion of the distal end portion 55 and the inner surface portion of the port body portion 32 of the port member 30 contact ( or pressure contact) to engage in a liquid-tight manner. As a result, the port member 30 (port body portion 32) and the connector member 50 (first cylindrical portion 51) are communicated with each other, and the liquid material (liquid material for biological administration) in the liquid material storage container 10 (container body 11) is communicated. 20) can be delivered to the patient via port member 30 and connector member 50.

ポート部材30においては、ポート本体部32の内周面に形成された環状内周面角部36が、環状凹部35の環状内縁角部37に近接し、かつ環状内縁角部37よりもベース部31側となる位置に設けられている。これにより、ポート部材30(ひいてはポート部材30が取り付けられる液状物収納用容器10)の密封性および開封性を確保するとともに、他部材の挿入性を確保できる。 In the port member 30 , the annular inner peripheral corner portion 36 formed on the inner peripheral surface of the port body portion 32 is closer to the annular inner edge corner portion 37 of the annular recessed portion 35 and is closer to the base than the annular inner edge corner portion 37 . It is provided at a position on the 31 side. As a result, it is possible to secure the sealability and unsealability of the port member 30 (and the liquid container 10 to which the port member 30 is attached), and to secure the insertability of other members.

すなわち、ポート部材30は、破断用の環状薄肉部34(環状内周面角部36および環状内縁角部37を含む)が所定の形態を備えるため、ポート部材30の密封性と開封性という相反する特性が両立できる。 That is, since the port member 30 has a predetermined shape of the annular thin-walled portion 34 (including the annular inner peripheral surface corner portion 36 and the annular inner edge corner portion 37) for breaking, there is a contradiction between the sealing performance and the opening performance of the port member 30. characteristics to be compatible.

また、例えば、ポート部材30を射出成形により一体成形する場合、成形時の変形(ヒケ等)を抑制する[またはそのような変形による密封性の低下(変形部分の強度低下)を抑制する]ために、保圧条件を高く設定して、成形品(ポート部材30全体)の樹脂の充填密度が上昇した場合でも、環状薄肉部34の強度を適切に設定して、密封性と開封性とを確保することができる。さらに、開封時(閉塞部33をポート本体部32から分離する際)に必要以上の力(モーメント)を要することがないため、開封時のポート部材30の変形を回避できる。 In addition, for example, when the port member 30 is integrally molded by injection molding, to suppress deformation (sink marks, etc.) during molding [or to suppress deterioration in sealing performance due to such deformation (reduction in strength of the deformed portion)]. In addition, even if the holding pressure condition is set high and the packing density of the resin in the molded product (the entire port member 30) increases, the strength of the annular thin portion 34 is appropriately set to improve sealing and unsealing properties. can be secured. Furthermore, since no excessive force (moment) is required when unsealing (when separating the closing portion 33 from the port body portion 32), deformation of the port member 30 during unsealing can be avoided.

また、ポート部材30では、閉塞部33の分離部分、すなわち、閉塞部33が分離された後のポート本体部32の先端部におけるバリの発生が抑制されるとともに、バリが内方に向かって発生することが抑制される。これにより、ポート部材30を介して液状物収納用容器10から排出される生体投与用液状物20にバリが混入することを抑制できるとともに、ポート部材30に他部材(コネクタ部材50等)を接続する場合にバリが妨げになり難く、他部材の挿入性を確保することができる。 In addition, in the port member 30, the occurrence of burrs at the separation portion of the closing portion 33, that is, at the distal end portion of the port main body portion 32 after the closing portion 33 is separated, is suppressed, and burrs are generated toward the inside. is suppressed. As a result, burrs can be prevented from entering the liquid substance for biological administration 20 discharged from the liquid substance container 10 via the port member 30 , and other members (such as the connector member 50 ) can be connected to the port member 30 . The burr is unlikely to hinder the insertion of the other members, and the insertability of other members can be ensured.

ここで、本発明のポート部材の効果を確認するために、いくつかの試験例を示す。以下に示す、試験例1ないし試験例4のポート部材は、上記の実施例のポート部材30と同様の構成を備え、上記の実施例においてYで示す、環状内縁角部37と環状内周面角部36との間の鉛直方向距離:Y[言い換えれば、環状内縁角部37に対する環状内周面角部36(内部段差部41)の形成位置]が、それぞれ、図12に示すように、異なっている。また、最小肉厚部の態様および肉厚が以下に示すように、異なっている。 Here, some test examples are shown to confirm the effect of the port member of the present invention. The port members of Test Examples 1 to 4 shown below have the same configuration as the port member 30 of the above embodiment, and have an annular inner edge corner portion 37 and an annular inner peripheral surface indicated by Y in the above embodiment. The vertical distance from the corner 36: Y [in other words, the formation position of the annular inner peripheral surface corner 36 (internal stepped portion 41) with respect to the annular inner edge corner 37] is, as shown in FIG. different. Also, the form and thickness of the minimum thickness portion are different as shown below.

試験例1のポート部材においては、距離:Yが0.18mmであり、試験例2のポート部材においては、距離:Yが0.2mmであった。また、試験例1および試験例2のポート部材においては、環状内縁角部と環状内周面角部との間の肉厚(環状内縁角部と環状内周面角部との間の距離)が、最小肉厚部(最短距離部)であり、当該最小肉厚部の肉厚(環状内縁角部と環状内周面角部との間の肉厚:t)が、試験例1のポート部材においては、0.27mmであり、試験例2のポート部材においては、0.29mmであった。 In the port member of Test Example 1, the distance Y was 0.18 mm, and in the port member of Test Example 2, the distance Y was 0.2 mm. Further, in the port members of Test Examples 1 and 2, the wall thickness between the annular inner edge corner portion and the annular inner peripheral surface corner portion (the distance between the annular inner edge corner portion and the annular inner peripheral surface corner portion) is the minimum thickness portion (shortest distance portion), and the thickness of the minimum thickness portion (thickness between the annular inner edge corner and the annular inner peripheral corner: t) is the port of Test Example 1 In the member, it was 0.27 mm, and in the port member of Test Example 2, it was 0.29 mm.

試験例1および試験例2のポート部材(30)は、開封性は良好で、図13(試験例1)および図14(試験例2)に示すように、閉塞部の分離部[閉塞部を分離した後のポート本体部(32)の先端部]に発生したバリ(71)の発生量は少なく、また、バリ(71)が内方に向かって発生していないことが確認された。 The port members (30) of Test Examples 1 and 2 had good unsealability, and as shown in Figs. It was confirmed that the amount of burrs (71) generated at the tip of the port main body (32) after separation] was small, and that the burrs (71) were not generated inward.

試験例3のポート部材においては、距離:Yが0.21mmであり、試験例4のポート部材においては、距離:Yが0.22mmであり、環状内周面角部(内部段差部)の位置が試験例1および試験例2のポート部材よりもある程度下方に設定されていた。また、試験例3のポートおよび試験例4のポート部材では、環状内縁角部と環状内周面角部との間の肉厚(環状内縁角部と環状内周面角部との間の距離)が、最小肉厚部(最短距離部)であり、当該最小肉厚部の肉厚(環状内縁角部と環状内周面角部との間の肉厚:t)が、試験例3のポート部材においては、0.30mmであり、試験例4のポート部材においては、0.31mmであった。なお、試験例3および試験例4において、環状内縁角部の側部の肉厚は、いずれも0.36mmであった。 In the port member of Test Example 3, the distance Y was 0.21 mm, and in the port member of Test Example 4, the distance Y was 0.22 mm. The position was set to some extent lower than the port members of Test Examples 1 and 2. In the port of Test Example 3 and the port member of Test Example 4, the wall thickness between the annular inner edge corner and the annular inner peripheral corner (the distance between the annular inner edge corner and the annular inner peripheral corner) ) is the minimum thickness portion (shortest distance portion), and the thickness of the minimum thickness portion (thickness between the annular inner edge corner and the annular inner peripheral surface corner: t) is the thickness of Test Example 3 The port member was 0.30 mm, and the port member of Test Example 4 was 0.31 mm. In addition, in Test Examples 3 and 4, the thickness of the side portion of the annular inner edge corner portion was 0.36 mm.

試験例3および試験例4のポート部材(30)は、環状内縁角部の側部が最小肉厚部となっている従来のポート部材に比べれば開封時(閉塞部の分離時)に要する力は小さいものの、試験例1および試験例2のポート部材に比べて、開封時(閉塞部の分離時)に大きな力が必要であった。また、図15(試験例3)および図16(試験例4)に示すように、閉塞部の分離部[閉塞部を分離した後のポート本体部(32)の先端部]に発生したバリ(71)の発生量が試験例1および試験例2のポート部材に比べて多く、一部においてバリ(71)が内方に向かって発生するおそれがあることが認められた。 The port member (30) of Test Example 3 and Test Example 4 has a smaller force required for opening (separation of the closed portion) than the conventional port member in which the side portion of the annular inner edge corner portion has the smallest wall thickness. was small, but a larger force was required at the time of unsealing (at the time of separation of the closed portion) compared to the port members of Test Examples 1 and 2. Further, as shown in FIG. 15 (Test Example 3) and FIG. 16 (Test Example 4), burrs (the tip of the port main body (32) after separating the blocking portion) generated at the separation portion of the blocking portion ( 71) was generated in a larger amount than in the port members of Test Examples 1 and 2, and it was recognized that burrs (71) may be generated inwardly in part.

図17ないし図22には、それぞれ、本発明のポート部材の別の実施形態が示されている。これらの実施例では、上述した実施例(ポート部材30)に対してポート本体部(環状内周面角部、内部段差部)および/または環状凹部の形態が異なっている。これらの実施例では、特に記載のない限り、上述した実施例と共通する構成については、同一の名称および符号(符号の末尾にアルファベットを付す場合がある)を用いて、詳細な説明を省略する。 Figures 17-22 each show another embodiment of the port member of the present invention. These embodiments differ from the above-described embodiment (port member 30) in the form of the port main body portion (annular inner circumferential surface corner portion, internal stepped portion) and/or the annular concave portion. In these embodiments, unless otherwise specified, the same names and symbols (alphabet may be added to the end of the symbols) are used for configurations common to the above-described embodiments, and detailed descriptions thereof are omitted. .

図17に示すポート部材30aにおいては、環状凹部35a(環状薄肉部34a)を構成する環状底面部43aが、ポート本体部32の中心軸に対して直交する方向よりも若干先端方向に傾斜している。 In the port member 30a shown in FIG. 17, the annular bottom portion 43a forming the annular recess 35a (annular thin-walled portion 34a) is slightly inclined toward the distal end from the direction orthogonal to the central axis of the port body portion 32. there is

図18に示すポート部材30bにおいては、環状凹部35b(環状薄肉部34b)が、ポート本体部32の中心軸に対して直交する方向に延びる環状底面部43と、環状底面部43の内縁より、先端方向にかつ外方に延びる環状湾曲面部45とを備える。ポート部材30bでは、環状内縁角部37bが、環状底面部43と環状湾曲面部45の内縁部により形成されている。環状湾曲面部45は、下に湾曲するものであってもよい。 In the port member 30b shown in FIG. 18, the annular recess 35b (annular thin-walled portion 34b) is formed by an annular bottom portion 43 extending in a direction perpendicular to the central axis of the port body portion 32 and an inner edge of the annular bottom portion 43. and an annular curved surface portion 45 extending distally and outwardly. In the port member 30 b , an annular inner edge corner portion 37 b is formed by the inner edges of the annular bottom surface portion 43 and the annular curved surface portion 45 . The annular curved surface portion 45 may be curved downward.

図19に示すポート部材30cにおいては、環状凹部35c(環状薄肉部34c)が、ポート本体部32の中心軸に対して直交する方向に延びる環状底面部43と、環状底面部43の内縁より先端方向に延びる環状垂直面部46と、環状垂直面部46の上縁より外方(ここでは、環状底面部43に略平行)に延びる環状天面部47とを備える。ポート部材30cでは、環状内縁角部37cが、環状底面部43と環状垂直面部46の内縁部により形成されている。 In a port member 30c shown in FIG. 19, an annular recess 35c (annular thin-walled portion 34c) has an annular bottom portion 43 extending in a direction orthogonal to the central axis of the port body portion 32 and a tip from the inner edge of the annular bottom portion 43. and an annular top surface portion 47 extending outward from the upper edge of the annular vertical surface portion 46 (here, substantially parallel to the annular bottom surface portion 43). In the port member 30 c , an annular inner edge corner portion 37 c is formed by the inner edges of the annular bottom surface portion 43 and the annular vertical surface portion 46 .

図20に示すポート部材30dにおいては、環状内周面角部36dを形成する内部段差部41d(内部段差面)が、ポート本体部32dの中心軸に対して直交する方向よりも先端方向に傾斜している。 In the port member 30d shown in FIG. 20, the internal stepped portion 41d (internal stepped surface) forming the annular inner peripheral corner portion 36d is inclined more toward the distal direction than the direction orthogonal to the central axis of the port body portion 32d. is doing.

図21に示すポート部材30eにおいては、ポート部材30eの環状内周面角部36eの上側部分(閉塞部33e部分)が中実部48となっている。言い換えれば、ポート部材30eでは、環状内周面角部36eは形成されているが、内部段差部が形成されていない。なお、図22に示すポート部材30fのように、ポート部材30fの環状内周面角部36fの上側部分(閉塞部33f部分)を中実部48とした上で、ポート部材30f(閉塞部33f部分)の成形性を向上させるために、凹部49を設けてもよい。 In the port member 30e shown in FIG. 21, a solid portion 48 is formed in the upper portion (closed portion 33e portion) of the annular inner circumferential surface corner portion 36e of the port member 30e. In other words, in the port member 30e, the annular inner circumferential surface corner portion 36e is formed, but the internal stepped portion is not formed. Note that, like the port member 30f shown in FIG. 22, the upper portion (blocking portion 33f portion) of the annular inner circumferential surface corner portion 36f of the port member 30f is formed into a solid portion 48, and then the port member 30f (blocking portion 33f) is formed into a solid portion 48. A recess 49 may be provided in order to improve the moldability of the part).

1 生体投与用液状物充填済み容器
10 液状物収納用容器
11 容器本体
12 排出口
20 生体投与用液状物
30 ポート部材
31 ベース部
32 ポート本体部
33 閉塞部
34 環状薄肉部
35 環状凹部
36 環状内周面角部
37 環状内縁角部
50 コネクタ部材
60 破断操作用部材
1 Liquid substance-filled container for biological administration 10 Container for liquid substance storage 11 Container body 12 Discharge port 20 Liquid substance for biological administration 30 Port member 31 Base portion 32 Port body portion 33 Closing portion 34 Annular thin portion 35 Annular concave portion 36 Annular interior Peripheral surface corner portion 37 Annular inner edge corner portion 50 Connector member 60 Breaking operation member

Claims (10)

液状物を収納する容器に取り付けられるポート部材であって、
前記ポート部材は、筒状のベース部と、前記ベース部より先端方向に突出した円筒状のポート本体部と、前記ポート本体部より先端方向に延びる閉塞部と、前記ポート本体部と前記閉塞部間に設けられ、破断用の環状薄肉部を形成する環状凹部とを備え、
前記ポート本体部は、内周面に形成された環状内周面角部を備え、
前記環状凹部は、環状内縁角部を備え、
前記環状内周面角部は、前記環状内縁角部に近接し、かつ前記環状内縁角部よりも前記ベース部側となる位置に設けられていることを特徴とするポート部材。
A port member attached to a container for storing a liquid,
The port member includes a cylindrical base portion, a cylindrical port main portion projecting from the base portion in the distal direction, a closing portion extending from the port main portion in the distal direction, and the port main portion and the closing portion. an annular recess provided between and forming an annular thinned portion for breaking,
The port main body has an annular inner peripheral surface corner formed on the inner peripheral surface,
The annular recess comprises an annular inner edge corner,
The port member, wherein the annular inner peripheral surface corner portion is provided at a position close to the annular inner edge corner portion and closer to the base portion than the annular inner edge corner portion.
前記ポート本体部は、内径が小径となった環状の内部段差部を備え、前記環状内周面角部は、前記内部段差部により形成されている請求項1に記載のポート部材。 2. The port member according to claim 1, wherein the port main body portion has an annular internal stepped portion with a reduced inner diameter, and the annular inner circumferential surface corner portion is formed by the internal stepped portion. 前記環状凹部は、前記ポート本体部の中心軸に対して直交するもしくは若干先端方向に傾斜した環状底面部と、前記環状底面部の内縁より、先端方向にかつ外方に延びる環状傾斜面部とを備え、前記環状内縁角部は、前記環状底面部と前記環状傾斜面部の内縁部により形成されている請求項1または2に記載のポート部材。 The annular recess has an annular bottom surface perpendicular to the central axis of the port body or slightly inclined in the distal direction, and an annular inclined surface portion extending in the distal direction and outward from the inner edge of the annular bottom surface. 3. The port member according to claim 1, wherein said annular inner edge corner portion is formed by said annular bottom surface portion and said annular inclined surface portion's inner edge portion. 前記環状内縁角部は、前記ポート本体部の内周面よりも外方に位置している請求項1ないし3のいずれかに記載のポート部材。 The port member according to any one of claims 1 to 3, wherein the annular inner edge corner portion is positioned outward from the inner peripheral surface of the port body portion. 前記ポート部材は、前記ポート本体部と前記閉塞部との連結部位において、前記環状内縁角部と前記環状内周面角部との間の肉厚が最小となっている請求項1ないし4のいずれかに記載のポート部材。 5. The port member according to any one of claims 1 to 4, wherein the wall thickness between the annular inner edge corner portion and the annular inner circumferential surface corner portion is the smallest at the connecting portion between the port body portion and the closing portion. A port member according to any one of the preceding claims. 前記環状内縁角部と前記環状内周面角部との間の肉厚は、0.10mm~0.35mmである請求項5に記載のポート部材。 6. The port member according to claim 5, wherein the wall thickness between the annular inner edge corner portion and the annular inner peripheral corner portion is 0.10 mm to 0.35 mm. 前記ポート部材は、前記閉塞部に固定された破断操作用部材を備え、前記破断操作用部材は、本体部と、前記本体部より外方に突出する操作部とを備え、前記ポート部材は、前記破断操作用部材の回転操作によって、前記環状薄肉部において前記閉塞部を前記ポート本体部から分離可能である請求項1ないし6のいずれかに記載のポート部材。 The port member includes a breaking operation member fixed to the closing portion, the breaking operation member includes a main body portion and an operation portion projecting outward from the main body portion, and the port member includes: 7. The port member according to claim 1, wherein the closing portion can be separated from the port body portion at the annular thin portion by rotating the breaking operation member. 前記液状物は、生体投与用液状物である請求項1ないし7のいずれかに記載のポート部材。 8. The port member according to any one of claims 1 to 7, wherein said liquid is a liquid for bioadministration. 排出口を有する容器本体と、前記排出口に、請求項1ないし8のいずれかに記載のポート部材が取り付けられていることを特徴とする液状物収納用容器。 A container for storing a liquid, comprising a container body having a discharge port, and the port member according to any one of claims 1 to 8 attached to the discharge port. 請求項9に記載の液状物収納用容器内に、生体投与用液状物が収納されている生体投与用液状物充填済み容器。 10. A liquid-filled container for biological administration, wherein the liquid for biological administration is contained in the liquid-containing container according to claim 9.
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JP2001340427A (en) * 2000-06-02 2001-12-11 Kawasumi Lab Inc Mouth of medical bag and medical bag
JP2006062752A (en) * 2004-07-30 2006-03-09 Otsuka Pharmaceut Factory Inc Mouth member and container using the same
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JP2013060213A (en) * 2011-09-13 2013-04-04 Orihiro Engineering Co Ltd Spout
JP2014091571A (en) * 2012-11-07 2014-05-19 Nippon Closures Co Ltd Breakable spout
JP2017001732A (en) * 2015-06-15 2017-01-05 大日本印刷株式会社 Bung hole combinational body, container with bung hole combinational body, and charging body
JP2020050412A (en) * 2018-09-28 2020-04-02 日本クロージャー株式会社 Spout with cover member

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3061262U (en) * 1999-02-05 1999-09-17 川澄化学工業株式会社 Infusion port cap of medical bag and medical bag
JP2001340427A (en) * 2000-06-02 2001-12-11 Kawasumi Lab Inc Mouth of medical bag and medical bag
JP2006062752A (en) * 2004-07-30 2006-03-09 Otsuka Pharmaceut Factory Inc Mouth member and container using the same
EP1980498A1 (en) * 2007-04-12 2008-10-15 Rexam Home and Personal Care One-piece dispensing spout with a cap attached to a tube with a breakable web of material
JP2013060213A (en) * 2011-09-13 2013-04-04 Orihiro Engineering Co Ltd Spout
JP2014091571A (en) * 2012-11-07 2014-05-19 Nippon Closures Co Ltd Breakable spout
JP2017001732A (en) * 2015-06-15 2017-01-05 大日本印刷株式会社 Bung hole combinational body, container with bung hole combinational body, and charging body
JP2020050412A (en) * 2018-09-28 2020-04-02 日本クロージャー株式会社 Spout with cover member

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