JP4593906B2 - Heat seal mold for medical container and method for manufacturing medical container - Google Patents

Heat seal mold for medical container and method for manufacturing medical container Download PDF

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Publication number
JP4593906B2
JP4593906B2 JP2003406295A JP2003406295A JP4593906B2 JP 4593906 B2 JP4593906 B2 JP 4593906B2 JP 2003406295 A JP2003406295 A JP 2003406295A JP 2003406295 A JP2003406295 A JP 2003406295A JP 4593906 B2 JP4593906 B2 JP 4593906B2
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mold
sealing
soft bag
seal
target member
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JP2005160861A (en
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澄夫 明石
剛之 山口
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Terumo Corp
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Terumo Corp
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81411—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat
    • B29C66/81425—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being stepped, e.g. comprising a shoulder
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81431—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined comprising a single cavity, e.g. a groove
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832—Reciprocating joining or pressing tools
    • B29C66/8322—Joining or pressing tools reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7232—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer
    • B29C66/72321—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer consisting of metals or their alloys
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7232—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer
    • B29C66/72324—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer consisting of inorganic materials not provided for in B29C66/72321 - B29C66/72322
    • B29C66/72325—Ceramics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
    • B29C66/72341—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832—Reciprocating joining or pressing tools
    • B29C66/8322—Joining or pressing tools reciprocating along one axis
    • B29C66/83221—Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages
    • B29L2031/7148—Blood bags, medical bags

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Package Specialized In Special Use (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)

Description

本発明は、医療用容器用ヒートシール用金型及び医療用容器の製造方法に関する。 The present invention relates to a method of manufacturing a medical container heat sealing die and medical containers.

医療用容器には、例えば、点滴用の薬液を収納する輸液用容器、中心静脈に直接投与するために栄養分を収納するＩＶＨバッグ、経腸栄養剤を収納するバッグ、骨髄やリンパ球などの生体細胞を収納する細胞培養用バッグ、尿を収納する採尿バッグ、各種薬液を収納するバッグなど各種のバッグがある。これら医療用容器は、古くは硬質容器であったが、現在では、殆どが軟質容器となっている。
軟質容器は、軟質樹脂製シートにより構成された軟質バッグに、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材が取り付けられる。ポートとしては、排出ポート、混注ポート等がある。 Medical containers include, for example, infusion containers that store infusion drug solutions, IVH bags that store nutrients for direct administration to the central vein, bags that store enteral nutrients, and living organisms such as bone marrow and lymphocytes. There are various types of bags such as a cell culture bag for storing cells, a urine collection bag for storing urine, and a bag for storing various drug solutions. These medical containers have been hard containers in the past, but now most of them are soft containers.
In the soft container, at least one fixing target member selected from a port, a drug container, and a drug container mounting member is attached to a soft bag made of a soft resin sheet. Examples of the port include a discharge port and a mixed injection port.

軟質樹脂製シートにより作製された軟質バッグへの、ポート、薬剤容器、薬剤容器取付用部材などの固定対象部材の取付は、軟質樹脂製シート間に固定対象部材を挿入し、固定対象部材配置箇所及びその両側部分をヒートシールすることにより行われている。
しかしながら、従来のヒートシールによる取り付け方法は、ポートもしくは薬剤容器配置箇所の両側部分をほぼ平坦なシール面を有するシール用金型を用いてヒートシールしていたため、シール部のシール際の肉厚が薄く形成され強度が不十分なものとなったり、シール際に溶融バリが発生することがあった。
なお、本件出願人は、上記の問題点を解決する公知技術を現時点において取得していない。 The fixing target member such as the port, the drug container, and the drug container mounting member is attached to the soft bag made of the soft resin sheet by inserting the fixing target member between the soft resin sheets. And heat sealing the both side portions.
However, the conventional heat sealing attachment method heat seals both sides of the port or drug container placement location using a sealing mold having a substantially flat sealing surface. In some cases, the film is thin and has insufficient strength, or a melting burr is generated at the time of sealing.
In addition, the present applicant has not acquired a publicly known technique for solving the above problems at the present time.

このため、本発明は、上記問題点を解決するものであり、ポート、薬剤容器、薬剤容器取付用部材などの筒状固定対象部材の軟質バッグへの固定箇所の両側部分に形成されるシール部のシール際の肉厚を確保することができる医療用容器用シール用金型および医療用容器の製造方法を提供する。 For this reason, this invention solves the said problem, and the seal | sticker part formed in the both-sides part of the fixing location to the soft bag of cylindrical fixation target members, such as a port, a medicine container, and a medicine container attachment member A sealing mold for a medical container and a method for manufacturing the medical container capable of securing the thickness at the time of sealing are provided.

上記目的を達成するものは以下のものである。
（１）軟質樹脂製シートにより構成された軟質バッグに、前記軟質バッグと相溶性を有する樹脂かつ硬質材料を構成材料とする、排出ポート、混注ポートおよび薬剤容器より選択される少なくとも１つの筒状固定対象部材をヒートシールにより取り付けるための医療用容器用ヒートシール用金型であって、該シール用金型は、前記軟質バッグの一方の面に押しつけられる第１の金型と、前記軟質バッグの他方の面に押しつけられる第２の金型とを備え、前記第１の金型および前記第２の金型は、前記筒状固定対象部材の前記軟質バッグへのシール部分の外面形状に対応した表面形状を備える筒状固定対象部材外周部用シール面と、該筒状固定対象部材外周部用シール面と連続するとともにその両側に設けられ、前記軟質バッグの前記筒状固定対象部材の配置箇所の両側部分をシールするための筒状固定対象部材近接部用シール面を有し、前記筒状固定対象部材外周部用シール面は、一方の前記筒状固定対象部材近接部用シール面から他方の前記筒状固定対象部材近接部用シール面まで形成された半環状の突条部と、該半環状の突条部の前記軟質バッグの外縁側をシールする側に形成された半環状の傾斜面と、前記半環状の突条部の前記軟質バッグの薬剤収納部側をシールする側に形成された半環状の傾斜面を有し、前記各筒状固定対象部材近接部用シール面は、前記外周部用シール面の前記突条部と連続する平坦部分と、該平坦部分の前記外周部用シール面側を除く周囲に形成され、前記平坦部分を頂点とする傾斜面を備え、前記第１の金型及び第２の金型の周縁部分は、前記第１の金型及び前記第２の金型の前記平坦部分を近接する状態としたとき、該第１の金型及び該第２の金型の平坦部分より離間する形状となっているものであり、かつ、前記筒状固定対象部材近接部用シール面の前記軟質バッグの薬剤収納部側となる前記傾斜面の傾斜角度が、前記軟質バッグの外縁側となる前記傾斜面の傾斜角度に比べて、緩やかなものとなっている医療用容器用ヒートシール用金型。 The following objects are achieved.
(1) At least one cylindrical shape selected from a discharge port , a mixed injection port, and a drug container, comprising a soft bag made of a soft resin sheet and a resin and a hard material compatible with the soft bag. A heat sealing mold for a medical container for attaching a member to be fixed by heat sealing, the sealing mold including a first mold pressed against one surface of the soft bag, and the soft bag A second mold pressed against the other surface of the first and second molds, wherein the first mold and the second mold correspond to an outer surface shape of a seal portion of the cylindrical fixing target member to the soft bag. The cylindrical fixing target member outer periphery sealing surface having the above-described surface shape and the cylindrical fixing target member outer peripheral sealing surface are provided on both sides of the cylindrical fixing target member outer peripheral sealing surface. Has a cylindrical fixing subject member proximate portion sealing surface for sealing the side portions of the arrangement position of the elephant member, the cylindrical fixing subject member outer peripheral portion sealing surface is one of the cylindrical fixed object member near portion and protrusions of the semi-annular formed from use sealing surface to the other of the cylindrical fixing subject member proximate portion sealing surface, is formed on the side to seal the outer edge side of the soft bag protrusions of the half annular Each semi-annular inclined surface, and a semi-annular inclined surface formed on the side of the semi-annular ridge portion that seals the medicine storage portion side of the soft bag , and each cylindrical fixing target member proximity portion The sealing surface is formed on the periphery of the flat surface portion of the outer peripheral portion sealing surface excluding the protruding portion and on the periphery of the flat portion excluding the outer peripheral surface sealing surface side, and the inclined surface has the flat portion as a vertex. A peripheral portion of the first mold and the second mold is the first mold When the mold and the flat part of the second mold are brought close to each other, the mold is separated from the flat part of the first mold and the second mold, and , the inclination angle of the inclined surface as the drug accommodating portion side of the soft bag of the tubular fixing subject member proximate portion for sealing surface, as compared with the inclination angle of the inclined surface as the outer edge of the soft bag, gently A heat-sealing mold for medical containers.

（２） 前記平坦部分は、矩形状平坦部分である上記（１）に記載の医療用容器用ヒートシール用金型。
（３） 前記外周部用シール面の前記突条部の幅と、前記平坦部分の幅は、実質的に同一となっている上記（１）または（２）に記載の医療用容器用ヒートシール用金型。
（４） 前記近接部用シール面と前記外周部用シール面との境界部付近もしくは前記外周部用シール面には、樹脂溜まり形成用溝部もしくは樹脂溜まり形成用凹部が形成されている上記（１）ないし（３）のいずれかに記載の医療用容器用ヒートシール用金型。
（５） 前記外周部用シール面は、前記一方の近接部用シール面の前記平坦部分から前記他方の近接部用シール面の前記平坦部分まで延びる突条部を有している上記（１）ないし（４）のいずれかに記載の医療用容器用ヒートシール用金型。
（６） 前記外周部用シール面および／または前記近接部用シール面の外縁は、面取りされている上記（１）ないし（５）のいずれかに記載の医療用容器用ヒートシール用金型。 (2) The mold for heat sealing for medical containers according to (1), wherein the flat portion is a rectangular flat portion.
(3) The heat seal for a medical container according to (1) or (2) , wherein a width of the protruding portion of the sealing surface for the outer peripheral portion and a width of the flat portion are substantially the same. Mold.
(4) The resin reservoir forming groove or the resin reservoir forming recess is formed in the vicinity of the boundary between the proximity portion sealing surface and the outer peripheral portion sealing surface or in the outer peripheral portion sealing surface (1) ) A heat seal mold for medical containers according to any one of (3).
(5) The outer peripheral seal surface has a ridge that extends from the flat portion of the one proximity portion seal surface to the flat portion of the other proximity portion seal surface (1). Thru | or the metal mold | die for heat sealing for medical containers in any one of (4).
(6) The heat sealing mold for a medical container according to any one of (1) to (5), wherein an outer edge of the outer peripheral portion sealing surface and / or the proximity portion sealing surface is chamfered.

上記目的を達成するものは以下のものである。
（７） 軟質バッグと、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの筒状固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、軟質樹脂製シートにより構成された軟質バッグを準備する工程と、該軟質バッグの開口端部に前記筒状固定対象部材を配置しヒートシールすることにより取り付けるシール工程とを少なくとも備え、そして、該シール工程は、上記（１）ないし（６）のいずれかのシール用金型を用いて行う医療用容器の製造方法。 The following objects are achieved.
(7) A method of manufacturing a medical container having a soft bag and at least one cylindrical fixing target member selected from a port, a drug container, and a drug container mounting member, the manufacturing method being made of a soft resin At least a step of preparing a soft bag constituted by a sheet, and a sealing step of attaching the tubular fixing target member by placing and heat-sealing the cylindrical fixing target member at the opening end of the soft bag, and the sealing step includes: A method for producing a medical container, which is performed using the sealing mold according to any one of (1) to (6) above.

本発明の医療用容器用シール用金型は、軟質樹脂製シートにより構成された軟質バッグに、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材をヒートシールにより取り付けるためのシール用金型であって、該シール用金型は、前記軟質バッグの一方の面に押しつけられる第１の金型と、前記軟質バッグの他方の面に押しつけられる第２の金型とを備え、前記第１の金型および前記第２の金型は、前記固定対象部材の前記軟質バッグへのシール部分の外面形状に対応した表面形状を備える固定対象部材外周部用シール面と、該固定対象部材外周部用シール面と連続するとともにその両側に設けられ、前記軟質バッグの前記固定対象部材の配置箇所の両側部分をシールするための固定対象部材近接部用シール面を有し、該固定対象部材近接部用シール面は、平坦部分と該平坦部分の前記外周部用シール面側以外の部分を囲む周縁部分を備え、前記第１の金型及び第２の金型の周縁部分は、前記第１の金型及び前記第２の金型の前記平坦部分を近接する状態としたとき、該第１の金型及び該第２の金型の平坦部分より離間する形状となっている。
このため、このシール用金型を用いることにより、軟質バッグの固定対象部材配置箇所の両側部分に形成されたシール部のシール際の肉厚を確保することができ、形成される医療用容器に十分なシール強度を備えるシール部を形成することができる。 The medical container sealing mold of the present invention attaches at least one fixing target member selected from a port, a medicine container, and a medicine container attaching member to a soft bag made of a soft resin sheet by heat sealing. A first mold that is pressed against one surface of the soft bag, and a second mold that is pressed against the other surface of the soft bag. The first mold and the second mold include a sealing surface for a fixing target member outer peripheral portion having a surface shape corresponding to an outer surface shape of a sealing portion of the fixing target member to the soft bag; A fixing target member proximity portion shim that is continuous with the sealing surface for the outer peripheral portion of the fixing target member and is provided on both sides thereof, and seals both side portions of the fixing portion of the soft bag. The fixing target member proximity portion sealing surface includes a flat portion and a peripheral portion surrounding the flat portion other than the outer peripheral portion sealing surface side, and includes the first mold and the second mold. The peripheral portion of the mold is closer to the flat portion of the first mold and the second mold when the flat portion of the first mold and the second mold are close to each other. It has a shape that is spaced apart.
For this reason, by using this mold for sealing, it is possible to secure the thickness at the time of sealing the sealing portion formed on both side portions of the fixing target member placement location of the soft bag, and to the formed medical container A seal portion with sufficient seal strength can be formed.

本発明の医療用容器の製造方法は、軟質バッグと、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、軟質樹脂製シートにより構成された軟質バッグを準備する工程と、該軟質バッグの開口端部に前記固定対象部材を配置しヒートシールすることにより取り付けるシール工程とを少なくとも備え、そして、該シール工程は、上記の医療容器用シール用金型を用いて行うものである。
このため、十分なシール強度を備える医療容器を確実に製造することができる。
また、本発明の医療用容器は、軟質樹脂製シートにより構成された軟質バッグと、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材を有する医療用容器であって、前記固定対象部材は、前記軟質バッグの前記軟質樹脂製シート間に配置され、該配置された固定対象部材の外周部分を被包する前記軟質バッグの固定対象部材被包部および該固定対象部材被包部と連続する固定対象部材配置部分の両側部分を融着することにより前記軟質バッグに取り付けられており、前記両側部分に形成された融着部の周辺部の肉厚は前記両側部分の内側部分の肉厚より厚くなっている。
このため、本発明の医療用容器は、軟質バッグの固定対象部材配置箇所の両側部分に形成されたシール部のシール際の肉厚が確保される。 The method for producing a medical container of the present invention is a method for producing a medical container having a soft bag and at least one member to be fixed selected from a port, a medicine container, and a medicine container mounting member. The method includes at least a step of preparing a soft bag made of a soft resin sheet, and a sealing step of attaching the fixing target member by placing and heat-sealing the fixing target member at an open end of the soft bag, and The sealing step is performed using the medical container sealing mold.
For this reason, a medical container provided with sufficient sealing strength can be manufactured reliably.
The medical container of the present invention is a medical container having a soft bag made of a soft resin sheet and at least one fixing target member selected from a port, a drug container, and a drug container mounting member. The fixing target member is disposed between the soft resin sheets of the soft bag, and the fixing target member encapsulating portion of the soft bag enclosing the outer peripheral portion of the arranged fixing target member and the fixing target member It is attached to the soft bag by fusing both side portions of the fixing target member arrangement portion continuous with the enveloping portion, and the thickness of the peripheral portion of the fusing portion formed on the both side portions is the thickness of the both side portions. It is thicker than the wall thickness of the inner part.
For this reason, the medical container of this invention ensures the thickness at the time of sealing of the seal part formed in the both sides of the fixation object member arrangement | positioning location of a soft bag.

本発明の実施例であるシール用金型について詳細に説明する。
図１は、本発明の一実施例のシール用金型の部分省略正面図である。図２は、図１に示すシール用金型を構成する第１の金型の底面図である。図３は、図１に示したシール用金型を構成する第１の金型の側面図である。図４は、図１に示すシール用金型の上面図である。図５は、シール用金型を構成する第１の金型の部分拡大斜視図である。図６は、図２に示す第１の金型のＡ−Ａ線における固定対象部材近接部用シール面部分の端面図である。図７は、図２に示す第１の金型のＢ−Ｂ線における固定対象部材外周部用シール面部分の端面図である。 The sealing mold that is an embodiment of the present invention will be described in detail.
FIG. 1 is a partially omitted front view of a sealing mold according to an embodiment of the present invention. FIG. 2 is a bottom view of a first mold constituting the sealing mold shown in FIG. FIG. 3 is a side view of a first mold constituting the sealing mold shown in FIG. FIG. 4 is a top view of the sealing mold shown in FIG. FIG. 5 is a partially enlarged perspective view of a first mold constituting the sealing mold. FIG. 6 is an end view of the sealing surface portion for the fixing target member proximity portion taken along line AA of the first mold shown in FIG. 2. FIG. 7 is an end view of the outer peripheral portion sealing surface portion of the fixing target member along the line BB of the first mold shown in FIG. 2.

本発明の医療用容器用シール用金型１は、軟質樹脂製シート１１ａ，１１ｂにより構成された軟質バッグ１１に、ポート１２，１３、薬剤容器１４および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材をヒートシールにより取り付けるためのシール用金型である。シール用金型１は、軟質バッグ１１の一方の面に押しつけられる第１の金型２と、軟質バッグ１１の他方の面に押しつけられる第２の金型３とを備える。第１の金型２および第２の金型３は、固定対象部材の軟質バッグ１１へのシール部分の外面形状に対応した表面形状を備える固定対象部材外周部用シール面４（５）と、固定対象部材外周部用シール面４（５）と連続するとともにその両側に設けられ、軟質バッグ１１の固定対象部材の配置箇所の両側部分をシールするための固定対象部材近接部用シール面６（７）を有し、固定対象部材近接部用シール面６（７）は、平坦部分６ａ（７ａ）と平坦部分６ａ（７ａ）の外周部用シール面４（５）側以外の部分を囲む周縁部分６ｂ（７ｂ）を備え、第１の金型及び第２の金型の周縁部分６ｂ（７ｂ）は、第１の金型２及び第２の金型３の平坦部分６ａ（７ａ）を近接する状態としたとき、第１の金型２及び第２の金型３の平坦部分６ａ（７ａ）より離間する形状となっている。   The medical container sealing mold 1 according to the present invention includes at least one selected from the ports 12 and 13, the drug container 14, and the drug container mounting member in the soft bag 11 constituted by the soft resin sheets 11 a and 11 b. It is the metal mold | die for sealing for attaching one fixing object member by heat sealing. The sealing mold 1 includes a first mold 2 that is pressed against one surface of the flexible bag 11 and a second mold 3 that is pressed against the other surface of the flexible bag 11. The first mold 2 and the second mold 3 include a fixing target member outer peripheral seal surface 4 (5) having a surface shape corresponding to the outer surface shape of the sealing portion of the fixing target member to the soft bag 11, and A fixing target member proximity portion sealing surface 6 (continuous to the fixing target member outer peripheral portion sealing surface 4 (5) and provided on both sides thereof for sealing both sides of the fixing portion of the flexible bag 11 to be fixed. 7) and the fixing target member proximity portion sealing surface 6 (7) is a peripheral portion surrounding a portion other than the flat portion 6a (7a) and the peripheral portion sealing surface 4 (5) side of the flat portion 6a (7a). A peripheral portion 6b (7b) of the first mold and the second mold is provided close to the flat portion 6a (7a) of the first mold 2 and the second mold 3 provided with a portion 6b (7b). The flat part 6a (7a) of the 1st metal mold | die 2 and the 2nd metal mold | die 3 when it is set as the state to carry out Ri and has a spaced apart to shape.

本発明のシール用金型１はシール装置本体に組み込まれて使用されるものである。
第１の金型２は、固定対象部材外周部用シール面４とこの外周部用シール面４の両側に形成された固定対象部材近接部用シール面６を有しており、第２の金型３も同様に、固定対象部材外周部用シール面５とこの外周部用シール面５の両側に形成された固定対象部材近接部用シール面７を有している。第１の金型２と第２の金型３はほぼ同じ構成をしているため、第１の金型２の図面（図２から図９）を用いて第２の金型３を説明する。また、第１の金型２、第２の金型３の軟質バッグ１１の外縁側をシールする側を一端側（図２の上側、図６の右側、図７の右側）とし、薬剤収納部側をシールする側を他端側（図２の下側、図６の左側、図７の左側）として説明する。 The sealing mold 1 of the present invention is used by being incorporated in a sealing device body.
The first mold 2 has a fixing target member outer peripheral part sealing surface 4 and a fixing target member proximity part sealing surface 6 formed on both sides of the outer peripheral part sealing surface 4. Similarly, the mold 3 has a fixing target member outer peripheral portion sealing surface 5 and fixing target member adjacent portion sealing surfaces 7 formed on both sides of the outer peripheral portion sealing surface 5. Since the first mold 2 and the second mold 3 have substantially the same configuration, the second mold 3 will be described with reference to the drawings of the first mold 2 (FIGS. 2 to 9). . Moreover, the side which seals the outer edge side of the soft bag 11 of the 1st metal mold | die 2 and the 2nd metal mold | die 3 is made into one end side (the upper side of FIG. 2, the right side of FIG. 6, the right side of FIG. 7), and a chemical | medical agent storage part The side that seals the side will be described as the other end side (the lower side in FIG. 2, the left side in FIG. 6, the left side in FIG. 7).

本発明の医療用容器用シール用金型１が製造時に用いられる医療用容器１０としては、例えば、図１０に示すように、軟質バッグ１１と、固定対象部材であり、軟質バッグ１１の一端部に取り付けられた排出ポート１２、混注ポート１３と、軟質バッグ１１の他端部に取り付けられた薬剤容器１４または薬剤容器取付部材（図示せず）を備える。この例の医療用容器１０では、軟質バッグ１１の排出ポート取付部１５、混注ポート取付部１６及び薬剤容器取付部１７にそれぞれ排出ポート１２，混注ポート１３，薬剤容器１４（または薬剤容器取付部材）がヒートシールにより取り付けられている。固定対象部材は、通常、筒状固定対象部材であり、上記の排出ポート、混注ポート、薬剤容器、薬剤容器取付部材は筒状部材である。   As the medical container 10 used at the time of manufacture of the medical container sealing mold 1 of the present invention, for example, as shown in FIG. 10, a soft bag 11 and a fixing target member, one end of the soft bag 11 is used. And a medicine container 14 or a medicine container attachment member (not shown) attached to the other end of the soft bag 11. In the medical container 10 of this example, the discharge port 12, the mixed injection port 13, and the drug container 14 (or the drug container mounting member) are respectively provided in the discharge port mounting portion 15, the mixed injection port mounting portion 16 and the drug container mounting portion 17 of the soft bag 11. Is attached by heat sealing. The fixation target member is usually a cylindrical fixation target member, and the discharge port, the mixed injection port, the drug container, and the drug container mounting member are cylindrical members.

固定対象部材外周部用シール面４（５）は、図２，図５，図６に示すように、排出ポート１２，混注ポート１３もしくは薬剤容器１４（または、薬剤容器固定用部材）などの固定対象部材の外周面に軟質バッグ１１（軟質樹脂製シート１１ａ，１１ｂ）を融着させることができるように、固定対象部材の固定対象外周面に対応した形状となっている。具体的に、外周部用シール面４（５）は、ほぼ半環状形状もしくは半円筒状となっている。このような構成により、固定対象部材の外周面に沿ってヒートシールすることができる。   As shown in FIGS. 2, 5, and 6, the sealing surface 4 (5) for the outer periphery of the member to be fixed is used to fix the discharge port 12, the mixed injection port 13, the drug container 14 (or the drug container fixing member), and the like. The shape corresponds to the outer peripheral surface of the fixing target member so that the soft bag 11 (soft resin sheets 11a and 11b) can be fused to the outer peripheral surface of the target member. Specifically, the outer peripheral seal surface 4 (5) is substantially semi-annular or semi-cylindrical. With such a configuration, heat sealing can be performed along the outer peripheral surface of the member to be fixed.

また、外周部用シール面４（５）には、一方の側辺付近から他方の側辺付近まで形成された突条部４ａ（５ａ）が形成されている。突条部４ａ（５ａ）は、半環状もしくは短い半円筒状の帯状突出部であり、本発明の実施例においては、外周部用シール面４（５）に対して平行に設けられ、後述する固定対象部材近接部用シール面６（７）の平坦部分６ａ（７ａ）と連続する。また、図２，図７に示すように、突条部４ａ（５ａ）の一端側には、半環状の傾斜面４ｂ（５ｂ）が形成され、傾斜面４ｂ（５ｂ）と連続して半環状もしくは半円筒状の平坦面４ｃ（５ｃ）が形成されている。突条部４ａ（５ａ）の他端側には、図２、図７に示すように、半環状の傾斜面４ｄ（５ｄ）と、傾斜面４ｄ（５ｄ）と連続する半環状もしくは半円筒状の平坦面４ｅ（５ｅ）と、平坦面４ｅ（５ｅ）と連続するとともに、高さが低くなるように形成された半環状の傾斜面４ｆ（５ｆ）が形成されている。   The outer peripheral seal surface 4 (5) is formed with a ridge 4a (5a) formed from the vicinity of one side to the vicinity of the other side. The protrusion 4a (5a) is a semi-annular or short semi-cylindrical belt-like protrusion, and is provided in parallel to the outer peripheral seal surface 4 (5) in the embodiment of the present invention, which will be described later. It is continuous with the flat portion 6a (7a) of the sealing surface 6 (7) for the fixing target member proximity portion. As shown in FIGS. 2 and 7, a semi-annular inclined surface 4b (5b) is formed on one end side of the protruding portion 4a (5a), and is continuous with the inclined surface 4b (5b). Alternatively, a semi-cylindrical flat surface 4c (5c) is formed. As shown in FIGS. 2 and 7, a semi-annular inclined surface 4d (5d) and a semi-annular or semi-cylindrical shape continuous with the inclined surface 4d (5d) are provided on the other end side of the protrusion 4a (5a). The flat surface 4e (5e) and the semi-annular inclined surface 4f (5f) formed so as to be continuous with the flat surface 4e (5e) and to have a low height are formed.

また、図７に示すように、外周部用シール面４（５）の一端及び他端は面取りされていることが好ましい。面取りはＲ面取りもしくは糸面取りであることが好ましい。これにより、シール際において、シール部の切れおよび剥離がより確実に防止される。また、上述した突条部４ａ（５ａ）、傾斜面４ｂ（５ｂ）、傾斜面４ｃ（５ｃ）との境界は面取りされていることが好ましい。   Moreover, as shown in FIG. 7, it is preferable that the one end and the other end of the outer peripheral seal surface 4 (5) are chamfered. The chamfering is preferably R chamfering or yarn chamfering. Thereby, at the time of sealing, cutting | disconnection and peeling of a seal part are prevented more reliably. Moreover, it is preferable that the boundary with the protrusion part 4a (5a) mentioned above, the inclined surface 4b (5b), and the inclined surface 4c (5c) is chamfered.

次に、固定対象部材近接部用シール面６（７）について説明する。
固定対象部材近接部用シール面６（７）は、図２，図５，図６に示すように、ポート１２，１３もしくは薬剤容器１４などの固定対象部材の外周部用シール面４，５の両側にほぼ左右対称に形成されている。固定対象部材近接部用シール面６（７）は、平坦部分６ａ（７ａ）と平坦部分６ａ（７ａ）の固定対象部材外周部用シール面側以外の部分を囲む周縁部分６ｂ（７ｂ）を備え、第１の金型２及び第２の金型３の周縁部分６ｂ（７ｂ）は、第１の金型２及び第２の金型３の平坦部分６ａ（７ａ）を近接する状態としたとき、第１の金型２及び第２の金型３の平坦部分６ａ（７ａ）より離間する形状となっている。シール用金型がこのような形状を備えるため、近接部用シール面６（７）により形成される医療用容器は、シール部のシール際のシートの引きつりが抑制されて肉厚が確保されるためシール際の強度が保持されるとともに、シール部外周に溶融バリが発生しにくくなり外観上も好ましいものとすることができる。 Next, the fixing target member proximity portion sealing surface 6 (7) will be described.
As shown in FIGS. 2, 5, and 6, the fixing target member proximity portion sealing surface 6 (7) is formed on the outer peripheral portion sealing surfaces 4, 5 of the fixing target member such as the ports 12, 13 or the drug container 14. It is formed symmetrically on both sides. The fixing target member proximity portion sealing surface 6 (7) includes a flat portion 6a (7a) and a peripheral portion 6b (7b) surrounding a portion other than the fixing target member outer peripheral portion sealing surface side of the flat portion 6a (7a). When the peripheral part 6b (7b) of the first mold 2 and the second mold 3 is in a state in which the first mold 2 and the flat part 6a (7a) of the second mold 3 are close to each other. The first mold 2 and the second mold 3 are separated from the flat portion 6a (7a). Since the sealing mold has such a shape, the medical container formed by the proximity portion sealing surface 6 (7) is prevented from being pulled when the sealing portion is sealed, and the wall thickness is secured. For this reason, the strength at the time of sealing is maintained, and it is difficult for molten burrs to be generated on the outer periphery of the seal portion, which is preferable in terms of appearance.

この実施例のシール用金型１では、近接部用シール面６（７）の周縁部分６ｂ（７ｂ）は、平坦部分６ａ（７ａ）と連続するとともに、この平坦部分６ａ（７ａ）を頂点とするように、周縁に向かって傾斜する傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）となっている。
具体的には、このシール用金型１では、近接部用シール面６（７）は、平坦部分６ａ（７ａ）と、平坦部分６ａ（７ａ）の外周部用シール面４（５）側を除く周囲に形成された傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）を有している。平坦部分６ａ（７ａ）は、外周部用シール面４（５）の突条部４ａ（５ａ）と連続するとともに、この突条部４ａ（５ａ）の両側にそれぞれ設けられている。特に、この実施例では、突条部４ａ（５ａ）の幅と平坦部分６ａ（７ａ）の幅は、実施的に同一となっており、図２に示すように、両者は、ずれることなく連続している。平坦部分６ａ（７ａ）は、矩形状、特に、図に示すような近接部シール面の横方向に長い長方形状が好ましい。しかし、平坦部分６ａ（７ａ）は、外周部シール面側が直線状である半円状、半楕円状、多角形状であってもよい。 In the sealing mold 1 of this embodiment, the peripheral portion 6b (7b) of the proximity portion sealing surface 6 (7) is continuous with the flat portion 6a (7a), and the flat portion 6a (7a) is the apex. As shown, the inclined surfaces 6b (7b), 6c (7c), and 6d (7d) are inclined toward the periphery.
Specifically, in this sealing mold 1, the proximity portion sealing surface 6 (7) has a flat portion 6 a (7 a) and an outer peripheral portion sealing surface 4 (5) side of the flat portion 6 a (7 a). It has the inclined surface 6b (7b), 6c (7c), 6d (7d) formed in the circumference | surroundings except. The flat portions 6a (7a) are continuous with the protrusions 4a (5a) of the outer peripheral seal surface 4 (5) and are provided on both sides of the protrusions 4a (5a). In particular, in this embodiment, the width of the protrusion 4a (5a) and the width of the flat portion 6a (7a) are practically the same. As shown in FIG. is doing. The flat portion 6a (7a) preferably has a rectangular shape, particularly a rectangular shape that is long in the lateral direction of the proximity seal surface as shown in the figure. However, the flat portion 6a (7a) may be semicircular, semielliptical, or polygonal in which the outer peripheral seal surface side is linear.

また、近接部用シール面６（７）の傾斜面６ｂ（７ｂ）は、外周部用シール面４（５）の傾斜面４ｄ（５ｄ）、平坦面４ｅ（５ｅ）、傾斜面４ｆ（５ｆ）からなる部分の両側にそれぞれ位置し、同様に、近接部用シール面６（７）の傾斜面６ｄ（７ｄ）は、外周部用シール面４（５）の傾斜面４ｂ（５ｂ）および平坦面４ｃ（５ｃ）からなる部分の両側にそれぞれ位置する。近接部用シール面６（７）の傾斜面６ｃ（７ｃ）は、平坦部分６ａ（７ａ）の外側側辺より、周縁に向かって傾斜する傾斜面である。また、傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）は、それぞれの表面形状が台形状となっている。平坦部分がシール面側が直線状である半円状、半楕円状、多角形状である場合は、傾斜面６ｂ（７ｂ）、６ｃ（７ｃ）、６ｄ（７ｄ）の平坦部分に隣接する部分は、平坦部分の外周形状に対応した形状となっている。近接部用シール面６（７）は、全体で、固定対象部材の固定部位の両側に略長方形状のシール部を形成する。   In addition, the inclined surface 6b (7b) of the proximity surface sealing surface 6 (7) includes the inclined surface 4d (5d), the flat surface 4e (5e), and the inclined surface 4f (5f) of the outer peripheral surface sealing surface 4 (5). Similarly, the inclined surface 6d (7d) of the seal portion 6 (7) for the proximity portion is formed on the inclined surface 4b (5b) and the flat surface of the seal surface 4 (5) for the outer peripheral portion. 4c (5c) is located on both sides of the part. The inclined surface 6c (7c) of the proximity portion sealing surface 6 (7) is an inclined surface inclined toward the periphery from the outer side of the flat portion 6a (7a). Further, the inclined surfaces 6b (7b), 6c (7c), and 6d (7d) each have a trapezoidal surface shape. When the flat portion is semicircular, semi-elliptical, or polygonal with the seal surface side being linear, the portion adjacent to the flat portion of the inclined surfaces 6b (7b), 6c (7c), 6d (7d) The shape corresponds to the outer peripheral shape of the flat portion. The seal portion 6 (7) for the proximity portion as a whole forms a substantially rectangular seal portion on both sides of the fixing portion of the fixing target member.

傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）は、直線状（言い換えれば、平面状）に傾斜していることが好ましい。また、図２，図６に示すように、他端側（使用時における軟質バッグの内側、言い換えれば、薬剤室側）に形成された傾斜面６ｂ（７ｂ）の傾斜角度が、一端側（使用時における軟質バッグの外側、言い換えれば、外縁側）形成された傾斜面６ｄ（７ｄ）の傾斜角度に比べて、緩やかなものとなっていることが好ましい。これにより、医療用容器１０に形成されたシール部の薬剤収納部側の肉厚が確保され、シール際の強度が十分なものとなる。本発明の実施例では、近接部用シール面６（７）の他端側の傾斜面６ｂ（７ｂ）が緩やかに形成され、外縁側の傾斜面６ｄ（７ｄ）が急なものとなっている。
また、このように平坦部分の周囲に傾斜面を設けることにより、突出した平坦部分と周囲との間に大きな段差があることにより生じるピンホールの発生を防止することができる。 The inclined surfaces 6b (7b), 6c (7c), and 6d (7d) are preferably inclined linearly (in other words, planar). As shown in FIGS. 2 and 6, the inclination angle of the inclined surface 6b (7b) formed on the other end side (inside the soft bag in use, in other words, the medicine chamber side) is the one end side (use It is preferable that the outer side of the soft bag at the time, in other words, the outer edge side) is gentler than the inclined angle of the inclined surface 6d (7d) formed. As a result, the thickness of the seal portion formed in the medical container 10 on the drug storage portion side is ensured, and the strength at the time of sealing is sufficient. In the embodiment of the present invention, the inclined surface 6b (7b) on the other end side of the seal surface 6 (7) for the proximity portion is gently formed, and the inclined surface 6d (7d) on the outer edge side is steep. .
Further, by providing the inclined surface around the flat portion in this way, it is possible to prevent the occurrence of pinholes caused by a large step between the protruding flat portion and the periphery.

平坦部分６ａ（７ａ）の長辺側の長さは、１〜１０ｍｍ、特に、３〜８ｍｍであることが好ましく、短辺側の長さは、０．５〜５ｍｍ、特に、１〜４ｍｍであることが好ましい。
傾斜面６ｂ（７ｂ）の軸方向の幅は、１〜１０ｍｍ、特に、２〜８ｍｍであることが好ましく、傾斜面６ｂ（７ｂ）の平坦部分６ａ（７ａ）に対する傾きは、０．５〜５°、特に、１〜４°であることが好ましい。傾斜面６ｃ（７ｃ）の軸方向と直交する方向の幅は、１〜１０ｍｍ、特に、３〜８ｍｍであることが好ましく、傾斜面６ｃ（７ｃ）の平坦部分６ａ（７ａ）に対する傾きは、０．５〜５°、特に、１〜４°であることが好ましい。傾斜面６ｄ（７ｄ）の軸方向の幅は、０．１〜５ｍｍ、特に、０．５〜４ｍｍであることが好ましく、傾斜面６ｄ（７ｄ）の平坦部分６ａ（７ａ）に対する傾きは、０．５〜１５°、特に、５〜１０°であることが好ましい。 The length of the long side of the flat portion 6a (7a) is preferably 1 to 10 mm, particularly preferably 3 to 8 mm, and the length of the short side is 0.5 to 5 mm, particularly 1 to 4 mm. Preferably there is.
The width of the inclined surface 6b (7b) in the axial direction is preferably 1 to 10 mm, particularly preferably 2 to 8 mm. The inclination of the inclined surface 6b (7b) with respect to the flat portion 6a (7a) is 0.5 to 5 mm. °, in particular 1 to 4 ° is preferred. The width of the inclined surface 6c (7c) in the direction orthogonal to the axial direction is preferably 1 to 10 mm, particularly 3 to 8 mm, and the inclination of the inclined surface 6c (7c) with respect to the flat portion 6a (7a) is 0. 5 to 5 °, particularly 1 to 4 ° is preferable. The width of the inclined surface 6d (7d) in the axial direction is preferably 0.1 to 5 mm, particularly preferably 0.5 to 4 mm, and the inclination of the inclined surface 6d (7d) with respect to the flat portion 6a (7a) is 0. 5 to 15 °, particularly preferably 5 to 10 °.

さらに、図６に示すように、近接部用シール面６（７）の周縁、すなわち周縁部分６ｂ（７ｂ）の外縁は、面取りされていることが好ましい。図６に示すものでは、近接部用シール面６（７）の傾斜面６ｂ（７ｂ）、傾斜面６ｃ（７ｃ）及び傾斜面６ｄ（７ｄ）の外縁は面取りされている。面取りは、Ｒ面取りもしくは糸面取りであることが好ましい。面取りすることによりシール際において、シール部の切れおよび剥離がより確実に防止される。また、近接部用シール面６（７）と外周部用シール面４（５）との境界部も面取りされていることが好ましい。また、傾斜面６ｃ（７ｃ）の角部と傾斜面６ｄ（７ｄ）の角部により形成されるコーナー部分も面取りされていることが好ましい。   Furthermore, as shown in FIG. 6, it is preferable that the peripheral edge of the proximity portion sealing surface 6 (7), that is, the outer edge of the peripheral edge portion 6 b (7 b) is chamfered. In the case shown in FIG. 6, the outer edges of the inclined surface 6b (7b), the inclined surface 6c (7c), and the inclined surface 6d (7d) of the proximity portion sealing surface 6 (7) are chamfered. The chamfering is preferably R chamfering or yarn chamfering. By chamfering, the sealing part is more reliably prevented from being cut off or peeled off during sealing. Moreover, it is preferable that the boundary part of the sealing surface 6 (7) for proximity parts and the sealing surface 4 (5) for outer peripheral parts is also chamfered. Moreover, it is preferable that the corner portion formed by the corner portion of the inclined surface 6c (7c) and the corner portion of the inclined surface 6d (7d) is also chamfered.

また、図２，図５に示すように、近接部用シール面６（７）と外周部用シール面４（５）との境界部付近もしくは外周部用シール面４（５）には、樹脂溜まり形成用溝部もしくは樹脂溜まり形成用凹部が形成されていることが好ましい。
この実施例のシール用金型１では、図２，図５に示すように、傾斜面６ｂ（７ｂ）の外周部用シール面４（５）と隣接する部分に沿って樹脂溜まり形成用溝部６ｅ（７ｅ）が形成されている。具体的には、樹脂溜まり形成用溝部６ｅ（７ｅ）は、固定対象部材配置箇所に形成された外周部用シール部と、この外周部用シール部の両側部分に形成された近接部用シール部との境界部もしくはその付近にそれぞれ一カ所ずつ設けられている。 As shown in FIGS. 2 and 5, a resin is not provided in the vicinity of the boundary between the proximity portion seal surface 6 (7) and the outer periphery seal surface 4 (5) or in the outer periphery seal surface 4 (5). It is preferable that a reservoir forming groove or a resin reservoir forming recess is formed.
In the sealing mold 1 of this embodiment, as shown in FIGS. 2 and 5, a resin reservoir forming groove 6e is formed along a portion adjacent to the outer peripheral sealing surface 4 (5) of the inclined surface 6b (7b). (7e) is formed. Specifically, the resin reservoir forming groove 6e (7e) includes an outer peripheral seal portion formed at a fixing target member arrangement portion, and a proximity portion seal portion formed on both side portions of the outer peripheral seal portion. There is one each at or near the boundary.

樹脂溜まり形成用溝部６ｅ（７ｅ）を有することにより、ヒートシールの際溶融した樹脂が樹脂溜まり形成用溝部６ｅ（７ｅ）内に流入して固まることにより、図１２に示すように、樹脂溜まり部が、固定対象部材（ポート１２，１３または薬剤容器１４）の外周面に形成されたすり抜け防止用環状溝部１２ａ，１３ａ，１４ａ内に形成され溝部１２ａ，１３ａ，１４ａに形成されたシール面と協働して、ポート１２，１３または薬剤容器１４の外周付近に生じるピンホールによるすり抜けを防止する。言い換えると、樹脂溜まり部は、ポート１２，１３もしくは薬剤容器１４の外周付近に形成された堤防のような役割を果たし、ピンホールによりすり抜けを防止する。また、樹脂溜まり部は、溝部１２ａ，１３ａ，１４ａの他端付近もしくは他端側に設けられていてもよい。この場合も、樹脂溜まり部と溝部１２ａ，１３ａ，１４ａに形成されたシール面が協働してすり抜けを防止する。   By having the resin reservoir forming groove 6e (7e), the resin melted at the time of heat sealing flows into the resin reservoir forming groove 6e (7e) and is solidified, as shown in FIG. Is formed in the annular groove portions 12a, 13a, 14a for slip-through prevention formed on the outer peripheral surface of the member to be fixed (port 12, 13 or drug container 14), and cooperates with the seal surface formed in the groove portions 12a, 13a, 14a. It works to prevent slipping due to pinholes that occur near the outer periphery of the ports 12, 13 or the drug container 14. In other words, the resin reservoir functions as a bank formed near the outer periphery of the ports 12 and 13 or the drug container 14 and prevents slipping through the pinhole. The resin reservoir may be provided near or at the other end side of the groove portions 12a, 13a, 14a. Also in this case, the resin reservoir and the seal surfaces formed in the grooves 12a, 13a, 14a cooperate to prevent slipping.

また、固定対象部材近接部用シール面における周縁部分は、上述した傾斜面に限定されるものではなく、第１の金型２及び第２の金型３の平坦部分６ａ，７ａを近接する状態としたときに、第１の金型２及び第２の金型３の周縁部分６ｂ，７ｂが、第１の金型２及び第２の金型３の平坦部分６ａ，７ａより離間する形状となっていればいかなる形状であってもよい。
例えば、上述したように一定の角度で傾斜している傾斜面により形成されているのではなく、図８に示すように、周縁部分が異なる角度で傾斜する傾斜面が連続するものであってもよい。図８に示す実施例では、近接部用シール面４０は、平坦部分６ａと、平坦部分６ａの周囲に形成された内側傾斜面４２と、内側傾斜面４２の周囲に設けられた外側傾斜面４３からなる。この実施例の場合、内側傾斜面４２より外側傾斜面４３の方が傾斜の傾きが大きくなるように形成されている。なお、外側の傾斜面より内側の傾斜面の傾きが大きくなっていてもよい。 Further, the peripheral edge portion of the fixing target member proximity portion sealing surface is not limited to the above-described inclined surface, and the flat portions 6a and 7a of the first mold 2 and the second mold 3 are close to each other. The peripheral portions 6b and 7b of the first mold 2 and the second mold 3 are separated from the flat portions 6a and 7a of the first mold 2 and the second mold 3 Any shape may be used.
For example, it is not formed by an inclined surface that is inclined at a constant angle as described above, but an inclined surface in which the peripheral edge portion is inclined at different angles as shown in FIG. 8 may be continuous. Good. In the embodiment shown in FIG. 8, the proximity portion sealing surface 40 includes a flat portion 6 a, an inner inclined surface 42 formed around the flat portion 6 a, and an outer inclined surface 43 provided around the inner inclined surface 42. Consists of. In the case of this embodiment, the outer inclined surface 43 is formed to have a larger inclination than the inner inclined surface 42. Note that the inclination of the inner inclined surface may be larger than that of the outer inclined surface.

また、図９に示すように、近接部用シール面４４は、平坦部分６ａを頂点とするとともに、平坦部分６ａから周縁に向かって階段状となる平坦面４６，４７により形成されていてもよい。また、近接部用シール面の周縁部分は、平坦部分６ａを頂点とする湾曲面となっているものであってもよい（図示せず）。
シール用金型の材質としては、熱伝導性が高いものが用いられ、銅、銅合金、ベリリウム鋼、アルミ、アルミ合金、亜鉛合金、ステンレス鋼等が用いられる。 Further, as shown in FIG. 9, the proximity portion sealing surface 44 may be formed by flat surfaces 46 and 47 having a flat portion 6a as a vertex and a stepped shape from the flat portion 6a toward the periphery. . Moreover, the peripheral part of the seal | sticker surface for proximity | contact parts may be a curved surface which makes the flat part 6a a vertex (not shown).
As the material of the sealing mold, a material having high thermal conductivity is used, and copper, copper alloy, beryllium steel, aluminum, aluminum alloy, zinc alloy, stainless steel and the like are used.

次に、本発明の医療用容器の製造方法及び医療用容器について上記図面を用いて説明する。
本発明の医療用容器１０の製造方法は、軟質バッグ１１と、ポート１２，１３、薬剤容器１４および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材とを有する医療用容器の製造方法であって、この製造方法は、軟質樹脂製シート１１ａ，１１ｂにより構成された軟質バッグ１１を準備する工程と、軟質バッグ１１の開口端部に固定対象部材を配置しヒートシールすることにより取り付けるシール工程とを少なくとも備え、そして、このシール工程は、上述したシール用金型１を用いて行うものである。 Next, a method for manufacturing a medical container and a medical container according to the present invention will be described with reference to the drawings.
The method for manufacturing a medical container 10 according to the present invention is a method for manufacturing a medical container having a soft bag 11 and at least one member to be fixed selected from ports 12, 13, a drug container 14, and a drug container mounting member. The manufacturing method includes a step of preparing a soft bag 11 composed of soft resin sheets 11a and 11b, and a seal to be attached by placing a fixing target member on the opening end of the soft bag 11 and performing heat sealing. The sealing step is performed using the sealing mold 1 described above.

本発明の医療用容器１０は、軟質樹脂製シート１１ａ，１１ｂにより構成された軟質バッグ１１と、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの固定対象部材を有する医療用容器であって、固定対象部材は、軟質バッグ１１の軟質樹脂製シート１１ａ，１１ｂ間に配置され、配置された固定対象部材の外周部分を被包する軟質バッグ１１の固定対象部材被包部および固定対象部材被包部と連続する固定対象部材配置部分の両側部分を融着することにより軟質バッグ１１に取り付けられており、両側部分に形成された融着部の周辺部の肉厚は両側部分の内側部分の肉厚より厚くなっている。   The medical container 10 of the present invention has a soft bag 11 formed of soft resin sheets 11a and 11b, and a medical container having at least one fixing target member selected from a port, a drug container, and a drug container mounting member. The fixing target member is disposed between the soft resin sheets 11a and 11b of the soft bag 11, and the fixing target member enclosing portion and fixing of the soft bag 11 that encloses the outer peripheral portion of the arranged fixing target member. It is attached to the soft bag 11 by fusing both side portions of the fixed target member arrangement portion continuous with the target member enveloping portion, and the thickness of the peripheral portion of the fusion portion formed on both side portions is the It is thicker than the wall thickness of the inner part.

まず、軟質樹脂製シート１１ａ、１１ｂにより構成された軟質バッグ１１を準備する工程について説明する。
本発明の実施例における軟質バッグ１１は、図１０に示すように、内部に薬剤収納部３４，３５を有し外周全体がシールされている医療容器用バッグである。そして、軟質バッグ１１の一端部及び他端部は幅広にシールされ、両側辺は幅狭にシールされ、軟質バッグ１１の一端部には排出ポート取付部１５、混注ポート取付部１６が設けられ、他端部には薬剤容器取付部１７が設けられている。また、軟質バッグ１１（医療用容器１０）は、剥離可能な仕切部３３により２室の薬剤室３４，３５に区分されている。 First, the process for preparing the soft bag 11 composed of the soft resin sheets 11a and 11b will be described.
The soft bag 11 in the Example of this invention is a bag for medical containers which has the chemical | medical agent storage parts 34 and 35 inside, and the whole outer periphery is sealed, as shown in FIG. And the one end part and other end part of the soft bag 11 are sealed wide, both sides are sealed narrowly, and the discharge port attaching part 15 and the mixed injection port attaching part 16 are provided at one end part of the soft bag 11, A drug container mounting portion 17 is provided at the other end portion. Further, the soft bag 11 (medical container 10) is divided into two drug chambers 34 and 35 by a detachable partition 33.

軟質バッグ１１は、軟質合成樹脂により作製されている。軟質バッグ１１は、インフレーション成形法により筒状に成形されたものが好ましい。なお、軟質バッグ１１は、例えば、Ｔダイ法、ブロー成形法、ドライラミネート法、ホットメルトラミネート法、共押出インフレーション法、共押出Ｔダイ法、ホットプレス法等の種々の方法により製造されたものでもよい。そして、軟質バッグ１１は、製造過程において折り曲げられることにより２つの側辺が形成される。また、必要により軽くプレスすることにより、折り曲げられた側辺を形成してもよい。
また、軟質バッグ１１は、ガスバリヤー性を有することが好ましい。ガスバリヤー性の程度としては、水蒸気透過度が、５０ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下であることが好ましく、より好ましくは１０ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下であり、さらに好ましくは１ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下である。この水蒸気透過度は、ＪＩＳＫ７１２９（Ａ法）に記載の方法により測定される。 The soft bag 11 is made of a soft synthetic resin. The flexible bag 11 is preferably formed into a cylindrical shape by an inflation molding method. The soft bag 11 is manufactured by various methods such as T-die method, blow molding method, dry laminating method, hot-melt laminating method, co-extrusion inflation method, co-extrusion T-die method, and hot pressing method. But you can. And the flexible bag 11 is bent in a manufacturing process, and two sides are formed. Moreover, you may form the bent side by lightly pressing as needed.
The soft bag 11 preferably has gas barrier properties. As the degree of gas barrier property, the water vapor permeability is preferably 50 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less, more preferably 10 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. More preferably, it is 1 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. This water vapor permeability is measured by the method described in JISK7129 (Method A).

このように軟質バッグ１１がガスバリヤー性を有することにより、医療用容器１０の内部からの水分の蒸散が防止できる。その結果、充填される液体の減少、濃縮を防止することができる。また、医療用容器１０の外部からの水蒸気の侵入も防止することができる。
このような軟質バッグ１１の形成材料としては、例えばポリエチレン（ＰＥ）、ポリプロピレン（ＰＰ）、ポリブタジエン、エチレン−酢酸ビニル共重合体（ＥＶＡ）のようなポリオレフィン、オレフィン系エラストマー、スチレン系エラストマー等の各種熱可塑性エラストマーあるいはこれらを任意に組み合わせたもの（ブレンド樹脂、ポリマーアロイ、積層体等）が挙げられる。そして、使用する樹脂材料は、高圧蒸気滅菌（オートクレーブ滅菌）に耐えられる耐熱性、耐水性を有していることが好ましい。 Thus, since the soft bag 11 has gas barrier properties, the evaporation of moisture from the inside of the medical container 10 can be prevented. As a result, it is possible to prevent a decrease in liquid filling and concentration. Moreover, the invasion of water vapor from the outside of the medical container 10 can be prevented.
As a material for forming such a flexible bag 11, for example, polyethylene (PE), polypropylene (PP), polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), olefin elastomer, styrene elastomer, and the like. Thermoplastic elastomers or those arbitrarily combined (blend resin, polymer alloy, laminate, etc.) can be mentioned. And it is preferable that the resin material to be used has the heat resistance and water resistance which can endure high pressure steam sterilization (autoclave sterilization).

また、軟質バッグ１１の形成材料として、ポリオレフィンが含有されるとき、本発明の有用性が大きいものとなる。したがって、本発明においては、軟質バッグ１１の形成材料として、ポリオレフィンを含むものであるのが好ましい。軟質バッグ１１の形成材料として、特に好ましいものとして、ポリエチレンまたはポリプロピレンに、スチレン−ブタジエン共重合体やスチレン−エチレン−ブチレン−スチレンブロック共重合体等のスチレン系熱可塑性エラストマーをブレンドし柔軟化した軟質樹脂を挙げることができる。この材料は、高強度で柔軟性に富み、耐熱性（特に滅菌時の耐熱性）、耐水性が高い他、加工性が特に優れ、製造コストの低減を図れる点で好ましい。   Moreover, when polyolefin is contained as a forming material of the flexible bag 11, the usefulness of the present invention is great. Therefore, in the present invention, it is preferable that the material for forming the flexible bag 11 includes polyolefin. As a material for forming the flexible bag 11, as a particularly preferable material, softened softened by blending styrene-based thermoplastic elastomer such as styrene-butadiene copolymer or styrene-ethylene-butylene-styrene block copolymer with polyethylene or polypropylene. Resins can be mentioned. This material is preferable in that it has high strength and flexibility, heat resistance (particularly heat resistance during sterilization) and water resistance, and is particularly excellent in workability and can reduce manufacturing costs.

また、軟質バッグは、前述したような材料よりなる単層構造のもの（単層体）であってもよいし、また種々の目的で、複数の層（特に異種材料の層）を重ねた多層積層体であってもよい。多層積層体の場合、複数の樹脂層を重ねたものであってもよいし、少なくとも１層の樹脂層に金属層を積層したものであってもよい。複数の樹脂層を重ねたものの場合、それぞれの樹脂の利点を併有することができ、例えば、軟質バッグ１１の耐衝撃性を向上させたり、対ブロッキング性を付与したりすることができる。また、金属層を有するものの場合、軟質バッグ１１のガスバリヤー性等を向上させることができる。例えば、アルミ箔等のフィルムが積層された場合、ガスバリヤー性の向上とともに、遮光性を付与したりすることができる。また、酸化チタン、酸化アルミニウム、酸化ケイ素等の酸化物からなる層を形成した場合、ガスバリヤー性の向上とともに、シート状筒状体の透明性を維持することができ、内部の視認性を確保することができる。なお、軟質バッグ１１が多層積層体である場合、その内表面部分を形成する材料が、前述した材料であるのが好ましい。   In addition, the soft bag may have a single layer structure (single layer body) made of the material as described above, or a multilayer in which a plurality of layers (particularly layers of different materials) are stacked for various purposes. A laminated body may be sufficient. In the case of a multilayer laminate, a plurality of resin layers may be stacked, or a metal layer may be stacked on at least one resin layer. In the case where a plurality of resin layers are stacked, the advantages of the respective resins can be obtained together. For example, the impact resistance of the soft bag 11 can be improved, or anti-blocking properties can be imparted. Moreover, in the case of a thing with a metal layer, the gas barrier property etc. of the soft bag 11 can be improved. For example, when a film such as an aluminum foil is laminated, the gas barrier property can be improved and the light shielding property can be imparted. In addition, when a layer made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide is formed, the gas barrier property can be improved and the transparency of the sheet-like cylindrical body can be maintained, and the internal visibility is ensured. can do. In addition, when the soft bag 11 is a multilayer laminated body, it is preferable that the material which forms the inner surface part is the material mentioned above.

軟質バッグ１１を構成するシート材（単層または多層積層体）１１ａ，１１ｂ厚さは、その層構成や用いる素材の特性（柔軟性、強度、水蒸気透過性、耐熱性等）等に応じて適宜決定され、特に限定されるものではないが、通常は、１００〜５００μｍ程度であるのが好ましく、２００〜３００μｍ程度であるのがより好ましい。
また、医療用容器１０の容積は、内部に収納する液体の種類等によって異なるが、通常は、２００〜５０００ｍｌ程度であるのが好ましく、１０００〜５０００ｍｌ程度であるのがより好ましい。 The thickness of the sheet material (single layer or multilayer laminate) 11a, 11b constituting the flexible bag 11 is appropriately determined according to the layer configuration and the characteristics of the material used (flexibility, strength, water vapor permeability, heat resistance, etc.), etc. Although it is determined and is not particularly limited, it is usually preferably about 100 to 500 μm, more preferably about 200 to 300 μm.
Moreover, although the volume of the medical container 10 changes with kinds etc. of the liquid accommodated in an inside, it is preferable normally that it is about 200-5000 ml, and it is more preferable that it is about 1000-5000 ml.

軟質バッグの軟質バッグ１１の一端部に形成されたシール部３１には排出ポート取付部１５、混注ポート取付部１６が設けられ、他端部に形成されたシール部３２には、薬剤容器取付部１７が設けられている。
軟質バッグ１１の外周に形成されたシールは、熱融着（ヒートシール）、高周波融着等により形成されることが好ましく、特に、熱融着により行うことが好ましい。 A discharge port mounting portion 15 and a mixed injection port mounting portion 16 are provided in the seal portion 31 formed at one end portion of the soft bag 11 of the soft bag, and a drug container mounting portion is provided in the seal portion 32 formed at the other end portion. 17 is provided.
The seal formed on the outer periphery of the flexible bag 11 is preferably formed by heat fusion (heat sealing), high frequency fusion, or the like, and particularly preferably by heat fusion.

排出ポート取付部１５及び混注ポート取付部１６は、軟質バッグ１１の一端部に形成されたシール部３１の一部をシールしないことにより設けられ、薬剤容器取付部１７は、他端部に形成されたシール部３２の一部をシールしないことにより設けられている。排出ポート取付部１５、混注ポート取付部１６、薬剤容器取付部１７は、それぞれ薬剤収納部側から軟質バッグ１１の外縁に向かって拡径している。両側辺に形成されたシール部３７の中央付近は幅広に作製され内側に向かって突出するように形成されている。この部分は、後述する仕切部３３と接合する部分となっている。
なお、本発明の実施例の軟質バッグ１１は、上述したようにシート状筒状体の外周全体をシールしたものであるが、シート状筒状体の一端部及び他端部のみシールし、両側辺に融着部を形成しないものであってもよい。 The discharge port mounting portion 15 and the mixed injection port mounting portion 16 are provided by not sealing a part of the seal portion 31 formed at one end portion of the soft bag 11, and the drug container mounting portion 17 is formed at the other end portion. The seal portion 32 is provided by not sealing a part thereof. The discharge port mounting portion 15, the mixed injection port mounting portion 16, and the drug container mounting portion 17 are each expanded in diameter from the drug storage portion side toward the outer edge of the soft bag 11. The vicinity of the center of the seal portion 37 formed on both sides is formed so as to be wide and protrude inward. This portion is a portion to be joined to a partition portion 33 described later.
The soft bag 11 according to the embodiment of the present invention has the entire outer periphery of the sheet-like tubular body sealed as described above, but only one end and the other end of the sheet-like tubular body are sealed, and both sides are sealed. You may not form a melt | fusion part in a side.

仕切部３３は、軟質バッグ１１の中央付近に形成された弱シール部である。弱シール部は帯状のシール部であり、両端部が両側辺シール部３７の中央付近の幅広部と接合している。弱シール部３３は、液体収納部に液体が充填された状態の医療用容器１０を指等で押圧すること等により、剥離可能な程度のシール強度を備える。このように仕切部３３により軟質バッグ１１内を２つに区分することにより、反応等による変質、劣化を生じる物質を含有する液体を使用するまでは別々に保存でき、使用に際し、両液を混合することが好ましいとき等に適用することができる。このような液体としては、例えば、アミノ酸電解質液とブドウ糖液、ブドウ糖液と重曹液等の組み合わせが挙げられる。また、上記のような弱シール部を備えない場合には、どのような液体を充填してもよく、例えば、生理食塩水、電解質溶液、リンゲル液、高カロリー輸液、ブドウ糖液、注射用水、腹膜透析液、経口栄養剤等が挙げられる。
なお、軟質バッグ１１（医療用容器１０）は、弱シール部を備えるものに限定されるものではない。また、軟質バッグ１１の一端部に設けられたシール部３１、他端部に設けられたシール部３２には、ハンガー等に吊り下げるための孔（吊り下げ部）３６が設けられている。 The partition portion 33 is a weak seal portion formed near the center of the soft bag 11. The weak seal portion is a belt-like seal portion, and both end portions are joined to the wide portion near the center of the side seal portions 37. The weak seal portion 33 has a seal strength that can be peeled off by pressing the medical container 10 filled with the liquid in the liquid storage portion with a finger or the like. By dividing the inside of the soft bag 11 into two parts by the partition part 33 as described above, it can be stored separately until a liquid containing a substance that causes alteration or deterioration due to reaction or the like is used, and both liquids are mixed in use. It can be applied when it is preferable to do so. Examples of such a liquid include a combination of an amino acid electrolyte solution and a glucose solution, a glucose solution and a sodium bicarbonate solution, and the like. In addition, when the weak seal portion as described above is not provided, any liquid may be filled, for example, physiological saline, electrolyte solution, Ringer's solution, high calorie infusion solution, glucose solution, water for injection, peritoneal dialysis. Liquids, oral nutrients and the like.
In addition, the soft bag 11 (medical container 10) is not limited to a thing provided with a weak seal part. Moreover, a hole (hanging portion) 36 for hanging on a hanger or the like is provided in the seal portion 31 provided at one end portion of the soft bag 11 and the seal portion 32 provided at the other end portion.

また、本発明で使用される排出ポート１２としては公知のものを使用することが好ましく、例えば、筒状ポート部材とその外側開口を封止するとともに針管を挿通可能なシール部材を備えるものが好ましい。また、混注ポート１３としては、公知のものを使用することが好ましく、例えば、筒状ポート部材とその外側開口を封止するとともに針管を挿通可能なシール部材を備えるものが好ましい。また、混注ポート１３としては、公知のものを使用することが好ましい。また、本発明の実施例の排出ポート１２および混注ポート１３の外周面には先端側部分に環状のすり抜け防止用溝部１２ａ，１３ａが形成されている。シール材としては、排出用針を刺通可能なものであることが好ましい。   Moreover, it is preferable to use a well-known thing as the discharge port 12 used by this invention, For example, what has a sealing member which can insert a needle tube while sealing a cylindrical port member and its outer side opening is preferable. . Moreover, as the mixed injection port 13, it is preferable to use a well-known thing, for example, a thing provided with the sealing member which can insert a needle tube while sealing a cylindrical port member and its outer side opening is preferable. Moreover, it is preferable to use a well-known port as the mixed injection port 13. In addition, annular slip-out preventing grooves 12a and 13a are formed on the outer peripheral surfaces of the discharge port 12 and the co-injection port 13 of the embodiment of the present invention at the tip side portion. As the sealing material, it is preferable that the discharging needle can be pierced.

また、シール材は、自己閉塞性を有し、針管を弾性体から抜き取った後は、その穿刺孔が閉塞し、薬液の漏れを防止するものであることが好ましい。シール材の構成材料としては、例えば、ポリエチレン、ポリプロピレン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体、架橋型エチレン−酢酸ビニル共重合体等のポリオレフィン、ポリエステル、ポリ塩化ビニル、ポリウレタン、ポリアミドなどの可撓性高分子材料、ポリアミドエラストマー、ポリエステルエラストマー等の熱可塑性樹脂（熱可塑性エラストマー）、天然ゴム、イソプレンゴム、シリコーンゴム、ブタジエンゴム、スチレン−ブタジエンゴムのような各種ゴム材料等の弾性材料、あるいはこれらのうちの任意の２以上を組み合わせたものが挙げられ、シール性、再シール性の点からは弾性材料を含有しているものが好ましい。また、ポートとしては、円筒状、楕円筒状の成形品であることが好ましい。   Moreover, it is preferable that the sealing material has a self-occlusion property, and after the needle tube is extracted from the elastic body, the puncture hole thereof is blocked to prevent leakage of the chemical solution. Examples of the constituent material of the sealing material include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer, polyester, polyvinyl chloride, polyurethane, Flexible polymer materials such as polyamide, thermoplastic resins such as polyamide elastomer and polyester elastomer (thermoplastic elastomer), natural rubber, isoprene rubber, silicone rubber, butadiene rubber, various rubber materials such as styrene-butadiene rubber, etc. An elastic material or a combination of any two or more of these materials can be used, and those containing an elastic material are preferable from the viewpoint of sealing performance and resealability. Moreover, as a port, it is preferable that it is a cylindrical and elliptical cylinder-shaped molded article.

また、本発明で使用される薬剤容器１４としては、公知のものを使用することが好ましく、本発明の実施例では、薬剤収納部と薬剤収納部の端部に設けられ軟質バッグ１１内部において薬剤収納部が軟質バッグ内と連通可能な連通規制部を有するものが使用されている。本発明の実施例において、連通規制部は薬剤収納部の端部と連続する脆弱部と連続して設けられた操作部からなり、操作部を折り曲げることにより脆弱部が破断可能して薬剤収納部と軟質バッグ内部が開封するものとなっている。また、薬剤容器１４の外周面には、環状のすり抜け防止用溝部１４ａが形成されている。   Moreover, it is preferable to use a well-known thing as the chemical | medical agent container 14 used by this invention. In the Example of this invention, it is provided in the edge part of a chemical | medical agent storage part and a chemical | medical agent storage part, and a chemical | medical agent is contained in the soft bag 11 inside. What has a communication control part in which a storage part can communicate with the inside of a soft bag is used. In the embodiment of the present invention, the communication restricting portion is composed of an operation portion provided continuously with the weak portion continuous with the end portion of the medicine storage portion, and the weak portion can be broken by bending the operation portion, so that the medicine storage portion. The inside of the soft bag is opened. Further, an annular slip-preventing groove 14 a is formed on the outer peripheral surface of the medicine container 14.

薬剤収納部１４内に充填される薬剤としては、粉末、顆粒状などの固体状、液体状等のいかなるものでもよい。薬剤としては、輸液剤に配合・溶解させるものであって、例えば抗生物質、ビタミン剤（総合ビタミン剤）、各種アミノ酸、ヘパリン等の抗血栓剤、インシュリン、抗腫瘍剤、鎮痛剤、強心剤、静注麻酔剤、抗パーキンソン剤、潰瘍治療剤、副腎皮質ホルモン剤、不整脈用剤、補正電解質、抗ウィルス薬、免疫賦活剤等が挙げられる。また、薬剤収納部は、常圧でもよいが、減圧または真空状態としてもよい。このように、薬剤収納部が減圧または真空状態であると、薬剤の変質分解・劣化等の防止効果が向上するとともに、連通規制部の破断時に、輸液剤を吸引し、より迅速に薬剤収納部へ導入することができる。   The drug filled in the drug container 14 may be any powder, granular or other solid, liquid or the like. Drugs are formulated and dissolved in infusions. For example, antibiotics, vitamins (general vitamins), various amino acids, antithrombotics such as heparin, insulin, antitumor agents, analgesics, cardiotonics, statics Note: Anesthetic agents, anti-Parkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction electrolytes, antiviral agents, immunostimulants, and the like. Moreover, although a chemical | medical agent storage part may be a normal pressure, it is good also as a pressure reduction or a vacuum state. Thus, when the medicine container is in a reduced pressure or vacuum state, the effect of preventing degradation, degradation, degradation, etc. of the drug is improved, and when the communication restriction part is broken, the infusion is sucked and the medicine container is more quickly Can be introduced.

排出ポート１２、混注ポート１３及び薬剤容器１４の構成材料としては、軟質バッグ１１と相溶性を有する樹脂であることが好ましい。また、硬質材料であることが好ましい。例えば、硬質ポリ塩化ビニル、ポリエチレン、ポリプロピレン、ポリブタジエン、環状ポリオレフィン（具体的には、ＺＥＯＮＥＸ（登録商標、日本ゼオン株式会社）、ＡＰＥＬ（登録商標、三井化学株式会社製））、ポリプロピレン、ポリプロピレンホモポリマー、高密度ポリエチレンのようなポリオレフィン、ポリスチレン、ポリ−（４−メチルペンテン−１）、ポリカーボネート、ＡＢＳ樹脂、アクリル樹脂、ポリメチルメタクリレート（ＰＭＭＡ）、ポリアセタール、ポリアリレート、ポリアクリロニトリル、ポリフッ化ビニリデン、アイオノマー、アクリロニトリル−ブタジエン−スチレン共重合体、ポリエチレンテレフタレート（ＰＥＴ）、ポリブチレンテレフタレート（ＰＢＴ）のようなポリエステル、ブタジエン−スチレン共重合体、芳香族または脂肪族ポリアミド等の各種樹脂、あるいはこれらを任意に組みあわせたものが挙げられる。   The constituent material of the discharge port 12, the mixed injection port 13, and the drug container 14 is preferably a resin that is compatible with the soft bag 11. Moreover, it is preferable that it is a hard material. For example, rigid polyvinyl chloride, polyethylene, polypropylene, polybutadiene, cyclic polyolefin (specifically, ZEONEX (registered trademark, Nippon Zeon Co., Ltd.), APEL (registered trademark, manufactured by Mitsui Chemicals, Inc.)), polypropylene, polypropylene homopolymer , Polyolefin such as high density polyethylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile, polyvinylidene fluoride, ionomer , Acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), butadiene-styrene Polymer, various resins such as aromatic or aliphatic polyamide, or include a combination of these as desired.

次に、軟質バッグ１１の端部にポート１２，１３もしくは薬剤容器１４（または薬剤容器取付部材）を配置しシール用金型１を用いてヒートシールすることにより取り付けるシール工程について上記図面を用いて説明する。
シール工程は、上述したシール用金型１を用いて行われる。シール工程は、軟質バッグ１１の排出ポート１２，混注ポート１３，薬剤容器１４（または、薬剤容器取付部材）を、それぞれ、軟質バッグ１１の排出ポート取付部１５、混注ポート１６、薬剤容器取付部１７に配置して、上述した第１の金型２と第２の金型３により軟質バッグ１１のシール対象部分を挟んで熱プレスすることにより行われる。具体的に、排出ポート１２、混注ポート１３、薬剤容器１４の外周面に設けられたすり抜け防止用溝部１２ａ，１３ａ，１４ａに、第１の金型２と第２の金型３の外周部用シール面４（５）に設けられた突条部４ａ（５ａ）があたるように配置される。なお、排出ポート１２および混注ポート１３は、完全に組み立てられた排出ポート１２および混注ポート１３の形態ではなく、筒状ポート部材のみを軟質バッグにヒートシールし、その後、シール部材を取り付けるものであってもよい。 Next, with reference to the above drawings, a sealing process in which the ports 12 and 13 or the drug container 14 (or the drug container mounting member) is arranged at the end of the soft bag 11 and heat sealed using the sealing mold 1 will be described. explain.
The sealing step is performed using the sealing mold 1 described above. In the sealing step, the discharge port 12, the mixed injection port 13, and the drug container 14 (or drug container mounting member) of the soft bag 11 are respectively connected to the discharge port mounting portion 15, the mixed injection port 16, and the drug container mounting portion 17 of the soft bag 11. It arrange | positions, and it heat-presses by pinching | interposing the sealing object part of the soft bag 11 with the 1st metal mold | die 2 and the 2nd metal mold | die 3 which were mentioned above. Specifically, for the outer peripheral portions of the first mold 2 and the second mold 3 in the slip-through preventing grooves 12a, 13a, 14a provided on the outer peripheral surface of the discharge port 12, the mixed injection port 13, and the medicine container 14. It arrange | positions so that the protrusion 4a (5a) provided in the sealing surface 4 (5) may hit. The discharge port 12 and the mixed injection port 13 are not the form of the completely assembled discharge port 12 and the mixed injection port 13, but only the cylindrical port member is heat-sealed to the soft bag, and then the seal member is attached. May be.

ヒートシールする際のシール用金型１の温度は、軟質バッグ１１の形成材料の溶融温度より５℃以上高いものとして行うことが好ましく、特に、１０〜３０℃高いものとすることが好ましい。また、軟質バッグ１１が積層体により形成されている場合には、内側層を形成する形成材料の溶融温度より５℃以上高いものとすることが好ましく、特に、３０〜８０℃高いものとすることが好ましい。また、シール工程におけるシール圧は、軟質バッグ１１の形成材料等によっても相違するが、１５〜１００ｋｇ／ｃｍ2であるのが好ましく、３０〜８０ｋｇ／ｃｍ2であることがより好ましい。
本発明の実施例の第１の金型２及び第２の金型３でヒートシールすることにより、排出ポート１２、混注ポート１３及び薬剤容器１４が軟質バッグ１１の一端部及び他端部に液密に取り付けられる。上述したヒートシールにより、排出ポート１２、混注ポート１３、薬剤容器１４の外周面及びその両側部分には帯状のシール部２２，２３，２４が形成され、排出ポート１２等が軟質バッグ１１に液密に取り付けられる。 The temperature of the sealing mold 1 at the time of heat sealing is preferably 5 ° C. or more higher than the melting temperature of the forming material of the soft bag 11, and particularly preferably 10 to 30 ° C. higher. Moreover, when the soft bag 11 is formed with a laminated body, it is preferably 5 ° C. or more higher than the melting temperature of the forming material forming the inner layer, and particularly 30 to 80 ° C. higher. Is preferred. Further, sealing pressure on the seal step, which varies depending on the material for forming the soft bag 11 or the like, is preferably from 15~100kg / cm 2, more preferably 30~80kg / cm 2.
By heat-sealing with the first mold 2 and the second mold 3 of the embodiment of the present invention, the discharge port 12, the mixed injection port 13, and the drug container 14 are liquid at one end and the other end of the soft bag 11. Closely attached. By the heat sealing described above, strip-shaped seal portions 22, 23, and 24 are formed on the outer peripheral surface of the discharge port 12, the mixed injection port 13, and the medicine container 14 and on both sides thereof, and the discharge port 12 and the like are liquid-tight to the soft bag 11. Attached to.

具体的には、軟質バッグ１１は排出ポート１２、混注ポート１３、薬剤容器１４の外周面のすり抜け防止用溝部１２ａ，１３ａ，１４ａ及びその付近に沿って融着し、排出ポート１２等の配置箇所の両側部分に軟質樹脂製シート１１ａ，１１ｂ同士が融着して長方形状の融着部２２，２３，２４が形成される。軟質バッグ１１は、排出ポート１２、混注ポート１３、薬剤容器１４の外周面に形成されたすり抜け防止用溝部に沿って融着しているため排出ポート１２等の軟質バッグ１１からのすり抜けが防止される。 Specifically, the flexible bag 11 is fused along the discharge port 12, the mixed injection port 13, the groove portions 12a, 13a, and 14a for preventing slipping of the outer peripheral surface of the drug container 14, and the vicinity thereof, and the arrangement place of the discharge port 12, etc. The flexible resin sheets 11a and 11b are fused to both sides of the sheet to form rectangular fused portions 22, 23 and 24 . Since the soft bag 11 is fused along the slip-out preventing groove formed on the outer peripheral surface of the discharge port 12, the mixed injection port 13, and the medicine container 14, the slip-out from the soft bag 11 such as the discharge port 12 is prevented. The

ポート等配置箇所の両側部分の形成されたシール部は、図１０，図１１，図１２に示すように、近接部用シール面６（７）の平坦部分６ａ（７ａ）により形成された一定の肉厚の長方形状のシール部２５ａ，２６ａ，２７ａと、このシール部２５ａ，２６ａ，２７ａの周囲に形成された近接部用シール面６（７）の傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）により形成された３つの台形状シール部（２５ｂ，２６ｂ，２７ｂ），（２５ｃ，２６ｃ，２７ｃ），（２５ｄ，２６ｄ，２７ｄ）からなる。また、図１１，図１２に示すように、台形状シール部（２５ｃ，２６ｃ，２７ｃ），（２５ｄ，２６ｄ，２７ｄ）の隣接部分の先端部は面取りされた形状となっている。傾斜面６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ）により形成されたシール部（２５ｂ，２６ｂ，２７ｂ），（２５ｃ，２６ｃ，２７ｃ），（２５ｄ，２６ｄ，２７ｄ）は、周縁に向かって肉厚が厚くなるように形成されている。このため、シール際の強度が十分なものとなるとともに、シール際に溶融バリが生じにくくなる。また、近接部用シール面６（７）の傾斜面６ｂ（７ｂ）により形成された台形状シール部２５ｄ，２６ｄ，２７ｄは比較的に緩やかに肉厚が増加するものとなっており、傾斜面６ｄ（７ｄ）により形成されたシール部２５ｂ，２６ｂ，２７ｂは比較的急に肉厚が増加するものとなっている。 As shown in FIGS. 10, 11, and 12, the seal portions formed on both side portions of the ports and the like are fixed portions formed by the flat portions 6a (7a) of the seal surface 6 (7) for the proximity portion. Thick rectangular seal portions 25a, 26a, 27a and inclined surfaces 6b (7b), 6c (7c) of the seal portion 6 (7) for the proximity portion formed around the seal portions 25a, 26a, 27a , 6d (7d) and three trapezoidal seal portions (25b, 26b, 27b), (25c, 26c, 27c), (25d, 26d, 27d). Further, as shown in FIGS. 11 and 12, tip portions of adjacent portions of the trapezoidal seal portions (25c, 26c, 27c) and (25d, 26d, 27d) are chamfered. The seal portions (25b, 26b, 27b), (25c, 26c, 27c), (25d, 26d, 27d) formed by the inclined surfaces 6b (7b), 6c (7c), 6d (7d) face the periphery. The wall thickness is increased. For this reason, the strength at the time of sealing becomes sufficient, and a melting burr is hardly generated at the time of sealing. Further, the trapezoidal seal portions 25d, 26d, and 27d formed by the inclined surfaces 6b (7b) of the proximity portion seal surface 6 (7) are relatively gently increased in thickness. The thickness of the seal portions 25b, 26b, and 27b formed by 6d (7d) is relatively abruptly increased.

また、図８に示すようなシール用金型によりヒートシールした場合は、ポート等配置箇所の両側部分の形成されたシール部は、近接部用シール面の内側部分により形成された平坦面により形成された一定の肉厚の長方形状のシール部と、このシール部の周囲に形成されたシール面の傾斜面により形成された３つの台形状シール部と、３つの台形状シール部の周囲に形成された３つの台形状シール部からなり、内側に形成された台形状シール部の肉厚は、外側に形成されたシール部の肉厚より緩やかに肉厚が増加しするものとなっている。
また、図９に示すようなシール用金型によりヒートシールした場合は、ポート等配置箇所の両側部分に形成されたシール部の内側部分から周辺に向かって段階的に肉厚が増加するものとなる。 In addition, when heat sealing is performed using a sealing mold as shown in FIG. 8, the seal portion formed on both side portions of the place where the port is disposed is formed by a flat surface formed by the inner portion of the proximity portion seal surface. A rectangular seal portion having a constant thickness, three trapezoidal seal portions formed by the inclined surface of the seal surface formed around the seal portion, and formed around the three trapezoidal seal portions The thickness of the trapezoidal seal portion formed on the inner side is gradually increased from the thickness of the seal portion formed on the outer side.
In addition, when heat sealing is performed with a sealing mold as shown in FIG. 9, the wall thickness gradually increases from the inner portion of the seal portion formed on both side portions of the port or the like to the periphery. Become.

また、図１１，図１２に示すように、ポート等配置箇所の両側部分に形成されたシール部とポート配置箇所との境界部付近には樹脂溜まり部２５ｅ，２６ｅ，２７ｅが一カ所ずつ形成されている。樹脂溜まり部２５ｅ，２６ｅ，２７ｅは、排出ポート１２，混注ポート１３，薬剤容器１４の外周面に形成されたすり抜け防止用溝部１４ａ，１５ａ，１６ａと係合して、排出ポート１２，混注ポート１３，薬剤容器１４の軟質バッグ１１からのすり抜けを防止する。   Further, as shown in FIGS. 11 and 12, resin reservoirs 25e, 26e, and 27e are formed one by one in the vicinity of the boundary between the seal portion formed on both sides of the port placement portion and the port placement portion. ing. The resin reservoirs 25e, 26e, and 27e are engaged with the discharge port 12, the mixed injection port 13, and the slip-through preventing grooves 14a, 15a, and 16a formed on the outer peripheral surface of the medicine container 14, and the discharge port 12, the mixed injection port 13 and the like. , Prevents the drug container 14 from slipping out of the soft bag 11.

図１は、本発明の一実施例の医療容器用シール用金型の部分省略正面図である。FIG. 1 is a partially omitted front view of a medical container sealing mold according to an embodiment of the present invention. 図２は、図１に示すシール用金型を構成する第１の金型の底面図である。FIG. 2 is a bottom view of a first mold constituting the sealing mold shown in FIG. 図３は、図１に示したシール用金型を構成する第１の金型の側面図である。FIG. 3 is a side view of a first mold constituting the sealing mold shown in FIG. 図４は、図１に示すシール用金型の上面図である。FIG. 4 is a top view of the sealing mold shown in FIG. 図５は、シール用金型を構成する第１の金型の部分拡大斜視図である。FIG. 5 is a partially enlarged perspective view of a first mold constituting the sealing mold. 図６は、図２に示す第１の金型のＡ−Ａ線における固定対象部材近接部用シール面部分の端面図である。FIG. 6 is an end view of the sealing surface portion for the fixing target member proximity portion taken along line AA of the first mold shown in FIG. 2. 図７は、図２に示す第１の金型のＢ−Ｂ線における固定対象部材外周部用シール面部分の端面図である。FIG. 7 is an end view of the outer peripheral portion sealing surface portion of the fixing target member along the line BB of the first mold shown in FIG. 2. 図８は、他の実施例であるシール用金型の部分拡大斜視図である。FIG. 8 is a partially enlarged perspective view of a sealing mold according to another embodiment. 図９は、他の実施例であるシール用金型の部分拡大斜視図である。FIG. 9 is a partially enlarged perspective view of a sealing mold according to another embodiment. 図１０は、本発明の医療用容器を輸液用容器に応用した実施例の正面図である。FIG. 10 is a front view of an embodiment in which the medical container of the present invention is applied to an infusion container. 図１１は、図１０に示す輸液用容器の一端部側の部分拡大図である。FIG. 11 is a partially enlarged view of one end side of the infusion container shown in FIG. 図１２は、図１０に示す輸液用容器の他端部側の部分拡大図である。12 is a partially enlarged view of the other end portion side of the infusion container shown in FIG.

符号の説明Explanation of symbols

１ 医療用容器用シール用金型
４，５ 固定対象部材外周部用シール面
６，７ 固定対象部材近接部用シール面
６ａ（７ａ） 矩形状平坦面部分
６ｂ（７ｂ），６ｃ（７ｃ），６ｄ（７ｄ） 周縁部分
１１ 軟質バッグ
１２ 排出ポート
１３ 混注ポート
１４ 薬剤容器 DESCRIPTION OF SYMBOLS 1 Sealing metal mold | die for medical containers 4,5 Sealing surface 6a (7a) for fixation object member outer peripheral part 6a (7a) Rectangular flat surface part 6b (7b), 6c (7c), 6d (7d) Peripheral portion 11 Soft bag 12 Discharge port 13 Mixed injection port 14 Drug container

Claims (7)

軟質樹脂製シートにより構成された軟質バッグに、前記軟質バッグと相溶性を有する樹脂かつ硬質材料を構成材料とする、排出ポート、混注ポートおよび薬剤容器より選択される少なくとも１つの筒状固定対象部材をヒートシールにより取り付けるための医療用容器用ヒートシール用金型であって、該シール用金型は、前記軟質バッグの一方の面に押しつけられる第１の金型と、前記軟質バッグの他方の面に押しつけられる第２の金型とを備え、前記第１の金型および前記第２の金型は、前記筒状固定対象部材の前記軟質バッグへのシール部分の外面形状に対応した表面形状を備える筒状固定対象部材外周部用シール面と、該筒状固定対象部材外周部用シール面と連続するとともにその両側に設けられ、前記軟質バッグの前記筒状固定対象部材の配置箇所の両側部分をシールするための筒状固定対象部材近接部用シール面を有し、
前記筒状固定対象部材外周部用シール面は、一方の前記筒状固定対象部材近接部用シール面から他方の前記筒状固定対象部材近接部用シール面まで形成された半環状の突条部と、該半環状の突条部の前記軟質バッグの外縁側をシールする側に形成された半環状の傾斜面と、前記半環状の突条部の前記軟質バッグの薬剤収納部側をシールする側に形成された半環状の傾斜面を有し、前記各筒状固定対象部材近接部用シール面は、前記外周部用シール面の前記突条部と連続する平坦部分と、該平坦部分の前記外周部用シール面側を除く周囲に形成され、前記平坦部分を頂点とする傾斜面を備え、前記第１の金型及び第２の金型の周縁部分は、前記第１の金型及び前記第２の金型の前記平坦部分を近接する状態としたとき、該第１の金型及び該第２の金型の平坦部分より離間する形状となっているものであり、かつ、前記筒状固定対象部材近接部用シール面の前記軟質バッグの薬剤収納部側となる前記傾斜面の傾斜角度が、前記軟質バッグの外縁側となる前記傾斜面の傾斜角度に比べて、緩やかなものとなっていることを特徴とする医療用容器用ヒートシール用金型。 At least one cylindrical fixing target member selected from a discharge port , a co-infusion port, and a drug container, comprising a resin and a hard material compatible with the soft bag as a constituent material in a soft bag made of a soft resin sheet A heat seal mold for medical containers for attaching the first bag to the first surface of the soft bag, and the other mold of the soft bag. A second mold that is pressed against a surface, and the first mold and the second mold have a surface shape corresponding to an outer surface shape of a seal portion of the cylindrical fixing target member to the soft bag. A cylindrical fixing target member outer peripheral part sealing surface comprising the cylindrical fixing target member outer peripheral part sealing surface and provided on both sides of the cylindrical fixing target member outer peripheral sealing surface; Has a cylindrical fixing subject member proximate portion sealing surface for sealing the side portions of the arrangement position of
The cylindrical fixing target member outer peripheral seal surface is a semi-annular ridge formed from one cylindrical fixing target member proximity portion sealing surface to the other cylindrical fixing target member proximity portion sealing surface . When, sealed and semi-annular inclined surface of the outer edge is formed on the side of the seal, the medicine container portion side of the soft bag of the semi-annular ridges of the soft bag protrusions of the half annular an inclined surface of the semi-annular formed in the side, each cylindrical fixing subject member proximate portion sealing surface has a flat portion continuous with the protruding portion of the outer peripheral portion sealing surface, of the flat portions It is formed in the circumference excluding the outer peripheral seal surface side, and includes an inclined surface having the flat portion as an apex, and the peripheral portions of the first mold and the second mold are the first mold and When the flat portion of the second mold is brought into a close state, the first mold and the second mold Is intended has a shape away from the flat portion of the die, and the inclination angle of the inclined surface as the drug accommodating portion side of the soft bag of the tubular fixing subject member proximate portion for sealing surface, wherein compared to the inclination angle of the inclined surface as the outer edge of the flexible bag, heat sealing die for a medical container, characterized in that has a gentle. 前記平坦部分は、矩形状平坦部分である請求項１に記載の医療用容器用ヒートシール用金型。 The mold for heat sealing for medical containers according to claim 1, wherein the flat portion is a rectangular flat portion. 前記外周部用シール面の前記突条部の幅と、前記平坦部分の幅は、実質的に同一となっている請求項１または２に記載の医療用容器用ヒートシール用金型。 The mold for heat sealing for medical containers according to claim 1 or 2, wherein a width of the protruding portion of the outer peripheral sealing surface and a width of the flat portion are substantially the same. 前記近接部用シール面と前記外周部用シール面との境界部付近もしくは前記外周部用シール面には、樹脂溜まり形成用溝部もしくは樹脂溜まり形成用凹部が形成されている請求項１ないし３のいずれかに記載の医療用容器用ヒートシール用金型。 4. A resin reservoir forming groove or a resin reservoir forming recess is formed in the vicinity of the boundary between the proximity portion seal surface and the outer periphery seal surface or in the outer periphery seal surface. The heat seal mold for medical containers according to any one of the above. 前記外周部用シール面は、前記一方の近接部用シール面の前記平坦部分から前記他方の近接部用シール面の前記平坦部分まで延びる突条部を有している請求項１ないし４のいずれかに記載の医療用容器用ヒートシール用金型。 The said outer peripheral part seal surface has a protrusion part extended from the said flat part of said one proximity part seal surface to the said flat part of said other proximity part seal surface. A mold for heat sealing for medical containers according to claim 1. 前記外周部用シール面および／または前記近接部用シール面の外縁は、面取りされている請求項１ないし５のいずれかに記載の医療用容器用ヒートシール用金型。 The heat sealing mold for a medical container according to any one of claims 1 to 5, wherein an outer edge of the outer peripheral portion sealing surface and / or the proximity portion sealing surface is chamfered. 軟質バッグと、ポート、薬剤容器および薬剤容器取付用部材より選択される少なくとも１つの筒状固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、軟質樹脂製シートにより構成された軟質バッグを準備する工程と、該軟質バッグの開口端部に前記筒状固定対象部材を配置しヒートシールすることにより取り付けるシール工程とを少なくとも備え、そして、該シール工程は、請求項１ないし６のいずれかのシール用金型を用いて行うことを特徴とする医療用容器の製造方法。 A method for manufacturing a medical container having a soft bag and at least one cylindrical fixing target member selected from a port, a drug container, and a drug container mounting member, the manufacturing method comprising a soft resin sheet At least a step of preparing the soft bag and a sealing step of attaching the tubular fixing target member by placing and heat-sealing the cylindrical fixing target member at the opening end of the soft bag, and the sealing step includes: A method for producing a medical container, which is performed using any one of the sealing molds.
JP2003406295A 2003-12-04 2003-12-04 Heat seal mold for medical container and method for manufacturing medical container Expired - Fee Related JP4593906B2 (en)

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* Cited by examiner, † Cited by third party
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JPS58165867A (en) * 1982-03-26 1983-09-30 テルモ株式会社 Medical bag and production thereof
JPS61173327U (en) * 1984-12-14 1986-10-28
JPS6234563A (en) * 1985-08-07 1987-02-14 川澄化学工業株式会社 Production of medical bag
JPS63249633A (en) * 1987-04-07 1988-10-17 川澄化学工業株式会社 Manufacture of bag for medical care
JPH03132307A (en) * 1989-10-18 1991-06-05 Nissho Corp Mold for manufacturing medical bag
JPH04242545A (en) * 1991-04-08 1992-08-31 Kawasumi Lab Inc Bag for medical treatment
JPH0586344U (en) * 1991-05-23 1993-11-22 川澄化学工業株式会社 Medical bag
JPH09248327A (en) * 1996-03-13 1997-09-22 Kawasumi Lab Inc Bag for medical treatment and its production
JP2000237280A (en) * 1999-02-18 2000-09-05 Kawasumi Lab Inc Manufacture of bag for medical use and mouth part mold
JP2001269389A (en) * 2000-03-24 2001-10-02 Terumo Corp Method of manufacturing for medical container and medical container
JP2004187948A (en) * 2002-12-11 2004-07-08 Terumo Corp Method of manufacturing medical container, and medical container

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58165867A (en) * 1982-03-26 1983-09-30 テルモ株式会社 Medical bag and production thereof
JPS61173327U (en) * 1984-12-14 1986-10-28
JPS6234563A (en) * 1985-08-07 1987-02-14 川澄化学工業株式会社 Production of medical bag
JPS63249633A (en) * 1987-04-07 1988-10-17 川澄化学工業株式会社 Manufacture of bag for medical care
JPH03132307A (en) * 1989-10-18 1991-06-05 Nissho Corp Mold for manufacturing medical bag
JPH04242545A (en) * 1991-04-08 1992-08-31 Kawasumi Lab Inc Bag for medical treatment
JPH0586344U (en) * 1991-05-23 1993-11-22 川澄化学工業株式会社 Medical bag
JPH09248327A (en) * 1996-03-13 1997-09-22 Kawasumi Lab Inc Bag for medical treatment and its production
JP2000237280A (en) * 1999-02-18 2000-09-05 Kawasumi Lab Inc Manufacture of bag for medical use and mouth part mold
JP2001269389A (en) * 2000-03-24 2001-10-02 Terumo Corp Method of manufacturing for medical container and medical container
JP2004187948A (en) * 2002-12-11 2004-07-08 Terumo Corp Method of manufacturing medical container, and medical container

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