JP5860299B2

JP5860299B2 - Blood purifier plug

Info

Publication number: JP5860299B2
Application number: JP2012027602A
Authority: JP
Inventors: 田中　剛; 剛田中; 康久神内
Original assignee: Asahi Kasei Medical Co Ltd
Current assignee: Asahi Kasei Medical Co Ltd
Priority date: 2012-02-10
Filing date: 2012-02-10
Publication date: 2016-02-16
Anticipated expiration: 2032-02-10
Also published as: JP2013162898A

Description

本発明は、血液浄化器の流体の出入口を形成する管状の接続ポートに取り付けられる血液浄化器用栓体に関するものである。 The present invention relates to a blood purifier plug attached to a tubular connection port that forms a fluid inlet / outlet of a blood purifier.

内部に血液体液等の液体が流通される医療用具として、例えば、血液透析器、白血球除去器、血液成分吸着器、血漿分離機等の血液浄化器が知られている。これらは、分離剤が収容された容器の外面に体液等の循環のための一個以上の接続ポート（「液体ポート」とも言う）を備えている。 As medical devices through which liquids such as blood body fluids are circulated, blood purifiers such as hemodialyzers, leukocyte removers, blood component adsorbers, and plasma separators are known. These include one or more connection ports (also referred to as “liquid ports”) for circulation of body fluids or the like on the outer surface of a container in which a separating agent is accommodated.

例えば、血液透析器（「人工透析器」とも言う）では、筒状容器内に複数本の中空糸膜束が充填され、筒状容器の両端部において中空糸膜外周面と筒状容器内周面との間がポッティング剤により接着されることによって、各中空糸膜の内部で形成される血液側流路と、中空糸膜の外周面と筒状容器の内面との間および隣接する各中空糸膜間で形成される透析液側流路とを有している。血液側流路の両端には、血液を流通するための血液側ポート（接続ポート）を設けたヘッダーが取り付けられている。一方、透析液側流路の両端には、通常は筒状容器に透析液側ポート（接続ポート）が設けられている。使用時には、血液側ポートにおいては一方が血液導入口、他方が血液導出口となり、透析液ポートにおいては一方が透析液導入口、他方が透析液導出口となる。各ポートの形状は標準化されており、血液側ポートは内ネジタイプのポート形状をなし、透析側ポートは透析カプラーが脱着しやすい凹凸形状となっている（例えば、非特許文献１参照）。 For example, in a hemodialyzer (also referred to as “artificial dialyzer”), a cylindrical container is filled with a plurality of hollow fiber membrane bundles, and the hollow fiber membrane outer peripheral surface and the cylindrical container inner periphery are formed at both ends of the cylindrical container. By adhering the surface to each other with a potting agent, the blood-side flow passage formed inside each hollow fiber membrane, and each adjacent hollow between the outer peripheral surface of the hollow fiber membrane and the inner surface of the cylindrical container A dialysate side channel formed between the thread membranes. Headers provided with blood side ports (connection ports) for circulating blood are attached to both ends of the blood side flow path. On the other hand, a dialysate side port (connection port) is usually provided in the cylindrical container at both ends of the dialysate side channel. In use, one of the blood-side ports is a blood inlet and the other is a blood outlet, and one of the dialysate ports is a dialysate inlet and the other is a dialysate outlet. The shape of each port is standardized, the blood side port has an internal thread type port shape, and the dialysis side port has a concavo-convex shape to which the dialysis coupler is easily attached and detached (see, for example, Non-Patent Document 1).

特開平８−２８０７９５号公報JP-A-8-280795 特開平６−５４９０８号公報JP-A-6-54908

ＪＩＳ−Ｔ−３２５０：２００５（血液透析器、血液透析ろ（濾）過器、血液ろ（濾）過器及び血液濃縮器）JIS-T-3250: 2005 (hemodialyzer, hemodialysis filter, blood filter and blood concentrator)

本来、血液透析器では、滅菌時や輸送時あるいは使用前後での内部液体の漏出や外部との接触を防止する等の目的で、血液側ポートも透析側ポートも栓により封止した方が良い。特に、血液側ポートは、菌の侵入や異物混入を防ぐ必要が高く、生産工程では密閉栓で封止することが必要である。ところが、透析側ポートについては、生産工程で開放を必要とする場合がある。 Originally, in hemodialyzers, it is better to seal both the blood side port and the dialysis side port with stoppers for the purpose of preventing leakage of internal liquid and contact with the outside during sterilization, transportation or before and after use. . In particular, the blood-side port is highly required to prevent invasion of bacteria and foreign matters, and it is necessary to seal with a sealing plug in the production process. However, the dialysis side port may need to be opened in the production process.

例えば、特許文献１ではガス透過性のシリコン栓を用いて血液透析器をアルミラミネート袋に入れると同時に脱酸素剤を入れて袋内の酸素を吸着して袋内を不活性ガス雰囲気にする方法が記載されている。この方法では酸素濃度が目的の低濃度になるのに約21日必要であり、生産を前提に考えると中間製品在庫が膨大となり管理面や保管費用面での不利益が大きい。現在の市場に流通する血液透析器では、脱酸素を短時間で行うため密閉できない栓（開放状態の栓）が４つのポートの全部、もしくは一部に使われている状況にある。 For example, in Patent Document 1, a hemodialyzer is placed in an aluminum laminate bag using a gas-permeable silicon stopper, and at the same time an oxygen scavenger is adsorbed to adsorb oxygen in the bag to make the bag an inert gas atmosphere. Is described. With this method, it takes about 21 days for the oxygen concentration to reach the target low concentration. Considering production, the intermediate product inventory becomes enormous, and there are significant disadvantages in terms of management and storage costs. In hemodialyzers currently on the market, there is a situation in which all or a part of the four ports are used with stoppers (open stoppers) that cannot be sealed because deoxidation is performed in a short time.

他にも医療機器の滅菌処理におけるエチレンオキサイドガス滅菌は、医療機器の隅々までエチレンオキサイドガスがいきわたることで滅菌効果を発現させるため、当該医療機器のポートを開放した状態で滅菌する方法や、高圧蒸気滅菌による圧力変化に対応させるためのポート開放状態処理、そのほか、電子線滅菌時の急激な帯電によるスパーク破壊などの要因からもポートを開放した状態で生産されるケースがある。 In addition, ethylene oxide gas sterilization in the sterilization treatment of medical devices is a method of sterilization with the port of the medical device opened in order to express the sterilization effect by spreading ethylene oxide gas to every corner of the medical device, There are cases in which the port is opened in the open state due to factors such as the port open state processing to cope with the pressure change due to high-pressure steam sterilization, and other factors such as spark destruction due to rapid charging during electron beam sterilization.

その一方、例えば上記血液透析器においては、アルミラミネート袋から取り出した後、血液透析器のプライミング操作（生理食塩水にて血液回路と接続される血液透析器を通液して洗浄する操作）が必要である。プライミング操作時には、透析側ポートからの液漏れを防ぐために、透析側ポートを封止することが必要である。よって開放状態の栓は、密閉栓に付け替えが必要となり、栓なし状態では、密閉栓を取り付ける作業が必要となる。 On the other hand, for example, in the above hemodialyzer, after removing from the aluminum laminate bag, the priming operation of the hemodialyzer (operation of washing by passing the hemodialyzer connected to the blood circuit with physiological saline) is performed. is necessary. During the priming operation, it is necessary to seal the dialysis side port in order to prevent liquid leakage from the dialysis side port. Therefore, the plug in the open state needs to be replaced with a hermetic plug, and in the state without the plug, the work of attaching the hermetic plug is necessary.

以上の血液透析器の例のように、血液浄化器においては、接続ポートで形成される流体の出入口を、処理に応じて開放したり閉鎖したりすることが必要な場合がある。そこで、本発明は、血液浄化器の流体の出入口を簡単な操作で開閉することができる血液浄化器用栓体を提供することを目的とする。 As in the example of the hemodialyzer described above, in the blood purifier, it may be necessary to open or close the fluid inlet / outlet formed by the connection port depending on the processing. Therefore, an object of the present invention is to provide a blood purifier plug that can open and close the fluid inlet / outlet of the blood purifier with a simple operation.

本発明の血液浄化器用栓体は、血液浄化器の流体の出入口を形成する管状の接続ポートに取り付けられる血液浄化器用栓体であって、接続ポートを挿入させる開口を下端に有し接続ポートの外側に嵌合する筒部と、筒部の上端の開口の近傍に設けられた蓋部と、筒部及び蓋部よりも肉薄に形成され筒部と蓋部とを接続する接続部と、を備え、筒部と、蓋部と、接続部と、は一体に形成されており、蓋部は、接続ポートから離間して出入口を開放する開放位置と、接続ポートの内側に嵌り込んで出入口を閉鎖する閉鎖位置と、の間で、接続部を変形させながら筒部に対して上下方向に移動可能であることを特徴とする。 The plug for blood purifier of the present invention is a plug for blood purifier attached to a tubular connection port that forms a fluid inlet / outlet of the blood purifier, and has an opening for inserting the connection port at the lower end. A cylindrical portion that fits outside, a lid portion provided in the vicinity of the opening at the upper end of the cylindrical portion, and a connecting portion that is formed thinner than the cylindrical portion and the lid portion and connects the cylindrical portion and the lid portion; The cylinder part, the lid part, and the connection part are integrally formed, and the lid part is spaced from the connection port to open the entrance and exit, and is fitted inside the connection port to provide the entrance and exit. Between the closed position and the closed position, it is possible to move in the vertical direction with respect to the cylindrical portion while deforming the connecting portion.

また、蓋部が筒部に対して移動するときには、接続部は、筒部との連結部である一端、及び蓋部との連結部である他端で屈曲されることとしてもよい。 Further, when the lid part moves relative to the cylinder part, the connection part may be bent at one end that is a connection part with the cylinder part and at the other end that is a connection part with the lid part.

またこの場合、接続部は、一端と他端との間に形成された肉薄部を有し、蓋部が筒部に対して移動するときには、接続部は、更に肉薄部で屈曲されることとしてもよい。 In this case, the connecting portion has a thin portion formed between one end and the other end, and when the lid portion moves relative to the cylindrical portion, the connecting portion is further bent at the thin portion. Also good.

また、蓋部が開放位置にあるときには、接続部と蓋部との連結部は、接続部と筒部との連結部よりも上方にあり、蓋部が閉鎖位置にあるときには、接続部と蓋部との連結部は、接続部と筒部との連結部よりも下方にあることとしてもよい。 Further, when the lid portion is in the open position, the connecting portion between the connecting portion and the lid portion is above the connecting portion between the connecting portion and the tube portion, and when the lid portion is in the closed position, the connecting portion and the lid portion are connected. The connecting portion with the portion may be located below the connecting portion between the connecting portion and the tubular portion.

また、蓋部が開放位置にあるときには、接続部は、筒部の筒軸線を含む断面で見て、筒部側に膨らむ湾曲形状をなすこととしてもよい。 Further, when the lid portion is in the open position, the connecting portion may have a curved shape that swells toward the tube portion when viewed in a cross section including the tube axis of the tube portion.

また、接続部は、筒部の周方向に所定の幅をもち周方向に互いに間隔を空けて配置された複数の薄板部を有することとしてもよい。 The connecting portion may include a plurality of thin plate portions having a predetermined width in the circumferential direction of the cylindrical portion and spaced from each other in the circumferential direction.

また、蓋部が開放位置にあるときには、蓋部の天板部は、筒部の上端の開口よりも上方に位置することとしてもよい。 Further, when the lid portion is in the open position, the top plate portion of the lid portion may be located above the opening at the upper end of the cylindrical portion.

また、蓋部が筒部に対して移動するときには、接続部は、筒部の筒軸線を含む断面で見て、接続部と筒部との連結部を中心として６０°以上回転することとしてもよい。 Further, when the lid part moves relative to the cylinder part, the connection part may be rotated by 60 ° or more around the connection part between the connection part and the cylinder part as seen in a cross section including the cylinder axis of the cylinder part. Good.

本発明によれば、血液浄化器の流体の出入口を簡単な操作で開閉することができる血液浄化器用栓体を提供することができる。 ADVANTAGE OF THE INVENTION According to this invention, the stopper for blood purifiers which can open and close the entrance and exit of the fluid of a blood purifier by simple operation can be provided.

本発明の血液浄化器用栓体が適用される人工透析器を示す断面図である。It is sectional drawing which shows the artificial dialyzer to which the plug for blood purifiers of this invention is applied. 本発明の血液浄化器用栓体の第１実施形態を示す斜視図である。It is a perspective view which shows 1st Embodiment of the stopper for blood purifiers of this invention. 図１の栓体を下方からみた斜視図である。It is the perspective view which looked at the stopper of FIG. 1 from the downward direction. 図１の栓体の平面図である。It is a top view of the stopper of FIG. 図１の栓体の開放状態を示す断面図である。It is sectional drawing which shows the open state of the plug body of FIG. 図１の栓体の閉鎖状態を示す断面図である。It is sectional drawing which shows the closed state of the plug body of FIG. 図５の薄板部近傍を拡大して示す断面図である。It is sectional drawing which expands and shows the thin-plate part vicinity of FIG. （ａ）〜（ｃ）は、図７の薄板部の変形順を示す断面図である。(A)-(c) is sectional drawing which shows the deformation | transformation order of the thin-plate part of FIG. 本発明の血液浄化器用栓体の第２実施形態を示す断面図である。It is sectional drawing which shows 2nd Embodiment of the stopper for blood purifiers of this invention. 図９の栓体の薄板部近傍を拡大して示す断面図である。It is sectional drawing which expands and shows the thin-plate part vicinity of the stopper of FIG.

以下、図面を参照しつつ本発明に係る血液浄化器用栓体の実施形態について詳細に説明する。まず、本発明の血液浄化器用栓体が用いられる血液浄化器の一例として、人工透析器５１について図１を参照し説明する。 Hereinafter, embodiments of a plug for a blood purifier according to the present invention will be described in detail with reference to the drawings. First, an artificial dialyzer 51 will be described with reference to FIG. 1 as an example of a blood purifier using the blood purifier plug of the present invention.

図１に示すように、人工透析器５１は、略円筒状の筒状容器５３と、筒状容器５３の長手方向に沿って装填された中空糸膜５４の束（中空子膜束）５５と、筒状容器５３の両端部内側で中空糸膜束５５の両端部を包囲するポッティング樹脂部５７と、を備えている。
ポッティング樹脂部５７には、中空糸膜束５５の両端部が埋設されて固定される。 As shown in FIG. 1, the artificial dialyzer 51 includes a substantially cylindrical tubular container 53 and a bundle (hollow membrane bundle) 55 of hollow fiber membranes 54 loaded along the longitudinal direction of the tubular container 53. And a potting resin portion 57 that surrounds both ends of the hollow fiber membrane bundle 55 inside both ends of the cylindrical container 53.
Both ends of the hollow fiber membrane bundle 55 are embedded and fixed in the potting resin portion 57.

人工透析器５１は、血液の出入口を形成する２つの血液ポート６１，６１を備えている。一方の血液ポート６１から導入された血液は、中空糸膜５４の内腔部を通過して他方の血液ポート６１から排出される。このとき血液中の不要物が中空糸膜５４を透過し中空糸膜５４と筒状容器５３との間の透析側流路５９に移動する。 The artificial dialyzer 51 includes two blood ports 61 and 61 that form a blood inlet / outlet. The blood introduced from one blood port 61 passes through the lumen of the hollow fiber membrane 54 and is discharged from the other blood port 61. At this time, unnecessary substances in the blood pass through the hollow fiber membrane 54 and move to the dialysis side channel 59 between the hollow fiber membrane 54 and the cylindrical container 53.

人工透析器５１は、上記透析側流路５９を筒状容器５３外に連通させる２つの管状の透析ポート（接続ポート）６３，６３を備えている。透析側流路５９には、上記不要物を筒状容器５３外に搬送するための透析液が流通する。透析ポート６３，６３は、透析液の出入口６３ａ，６３ａを形成する。また、透析ポート６３，６３は、上記透析液用のチューブが接続される接続ポートとして機能する。透析ポート６３，６３は、外径約１４．８５ｍｍの略円筒形状をなし、筒状容器５３の外側面から径方向に突出している。 The artificial dialyzer 51 includes two tubular dialysis ports (connection ports) 63 and 63 for communicating the dialysis side channel 59 to the outside of the cylindrical container 53. In the dialysis side channel 59, a dialysis solution for transporting the unnecessary matter out of the cylindrical container 53 flows. The dialysis ports 63 and 63 form dialysis fluid inlets and outlets 63a and 63a. The dialysis ports 63 and 63 function as connection ports to which the dialysis fluid tube is connected. The dialysis ports 63 and 63 have a substantially cylindrical shape with an outer diameter of about 14.85 mm, and protrude in the radial direction from the outer surface of the cylindrical container 53.

本発明の実施形態に係る血液浄化器用栓体１，２０１は、例えば、上記人工透析器５１の透析ポート６３に装着されて用いられるものである。 The blood purifier plugs 1, 201 according to the embodiment of the present invention are used by being mounted on the dialysis port 63 of the artificial dialyzer 51, for example.

（第１実施形態）
以下、図２〜図８を参照し、本発明の第１実施形態に係る血液浄化器用栓体１について説明する。なお、以下の説明において「上」、「下」の概念を含む文言（例えば、「上端」、「下端」等）は、図２及び図５に示す状態の栓体１の上下に基づいて用いるものとする。 (First embodiment)
The blood purifier plug 1 according to the first embodiment of the present invention will be described below with reference to FIGS. In the following description, words including the concepts of “upper” and “lower” (for example, “upper end”, “lower end”, etc.) are used based on the top and bottom of the plug 1 in the state shown in FIGS. Shall.

詳細は後述するが、血液浄化器用栓体１は、透析ポート６３に装着されたままで、出入口６３ａを開放する「開放状態」、出入口６３ａを閉鎖する「閉鎖状態」といった２つの状態を取ることができる。図２〜図５は、開放状態の栓体１を示し、図６は、閉鎖状態の栓体１を示している。なお、図５〜図８はすべて、円筒部３の筒軸線Ａ（後述する）を含む断面を取った断面図である。 As will be described in detail later, the blood purifier plug body 1 can be in two states such as an “open state” in which the inlet / outlet 63a is opened and a “closed state” in which the inlet / outlet 63a is closed while being attached to the dialysis port 63. it can. 2 to 5 show the plug 1 in an open state, and FIG. 6 shows the plug 1 in a closed state. 5 to 8 are all cross-sectional views including a cross section including a cylinder axis A (described later) of the cylindrical portion 3.

まず、図２〜図５を参照しながら、開放状態の栓体１の構成について説明する。図に示すように、栓体１は、透析ポート６３全体を囲む円筒部３と、円筒部３の上端の開口３ａ近傍において当該円筒部３の中空部に設けられた蓋部５と、円筒部３の内壁面と蓋部５とを接続する接続部７と、を備えている。栓体１は、円筒部３の筒軸線Ａを透析ポート６３の筒軸線に一致させ、円筒部３の下端の開口３ｂから透析ポート６３を挿入させるようにして、透析ポート６３に取り付けられる。栓体１は樹脂製であり、円筒部３、蓋部５、及び接続部７は一体に成形されている。 First, the configuration of the plug 1 in an open state will be described with reference to FIGS. As shown in the figure, the plug 1 includes a cylindrical portion 3 surrounding the entire dialysis port 63, a lid portion 5 provided in a hollow portion of the cylindrical portion 3 in the vicinity of the opening 3a at the upper end of the cylindrical portion 3, and a cylindrical portion. 3, and a connecting portion 7 that connects the inner wall surface 3 and the lid portion 5. The plug 1 is attached to the dialysis port 63 so that the cylinder axis A of the cylindrical portion 3 coincides with the cylinder axis of the dialysis port 63 and the dialysis port 63 is inserted from the opening 3 b at the lower end of the cylindrical portion 3. The plug 1 is made of resin, and the cylindrical portion 3, the lid portion 5, and the connecting portion 7 are integrally formed.

円筒部３は、透析ポート６３の外側面６３ｓに嵌り込む形状をなしている。円筒部３が透析ポート６３の外側面６３ｓ（図５）に嵌り込むことにより、栓体１全体が透析ポート６３に固定される。円筒部３の内壁面には、透析ポート６３との間に隙間を形成するためのリブ３ｈ（図３）が形成されている。リブ３ｈは、内壁面から内側に突出する凸条をなしており、リブ３ｈがスペーサとして機能することで、円筒部３の内壁面と透析ポート６３の外側面６３ｓとの間に僅かに隙間が形成される。また、円筒部３の内壁面には、透析ポート６３の先端の段差部に当接するストッパ部３ｊが形成されている。透析ポート６３の先端の段差部がストッパ部３ｊに突き当たることで、透析ポート６３に対し栓体１が位置決めされる。また、円筒部３の外壁面にはローレットが形成されている。 The cylindrical portion 3 has a shape that fits into the outer surface 63 s of the dialysis port 63. The entire plug body 1 is fixed to the dialysis port 63 by fitting the cylindrical portion 3 into the outer surface 63 s (FIG. 5) of the dialysis port 63. A rib 3 h (FIG. 3) is formed on the inner wall surface of the cylindrical portion 3 to form a gap with the dialysis port 63. The rib 3h has a ridge protruding inward from the inner wall surface, and the rib 3h functions as a spacer, so that a slight gap is formed between the inner wall surface of the cylindrical portion 3 and the outer surface 63s of the dialysis port 63. It is formed. Further, a stopper portion 3 j that abuts on a step portion at the tip of the dialysis port 63 is formed on the inner wall surface of the cylindrical portion 3. The stopper 1 is positioned with respect to the dialysis port 63 by the stepped portion at the tip of the dialysis port 63 abutting against the stopper portion 3j. A knurling is formed on the outer wall surface of the cylindrical portion 3.

蓋部５は、平面視で円筒部３と同心円をなし、円筒部３の内壁面から離間して円筒部３の中空部に位置している。蓋部５の上面である天板部５ａは、円筒部３の上端である開口３ａよりも僅かに低い位置にある。蓋部５の下部は、透析ポート６３の内側面６３ｔに嵌り込む形状を成している。詳細は後述するが、蓋部５は、閉鎖状態（図６参照）において、透析ポート６３の内側面６３ｔに嵌り込み出入口６３ａを閉鎖する機能を有する。 The lid portion 5 is concentric with the cylindrical portion 3 in plan view, and is spaced from the inner wall surface of the cylindrical portion 3 and is located in the hollow portion of the cylindrical portion 3. The top plate portion 5 a that is the upper surface of the lid portion 5 is located slightly lower than the opening 3 a that is the upper end of the cylindrical portion 3. The lower portion of the lid portion 5 has a shape that fits into the inner side surface 63t of the dialysis port 63. Although the details will be described later, the lid 5 has a function of fitting into the inner side surface 63t of the dialysis port 63 and closing the entrance / exit 63a in the closed state (see FIG. 6).

図４に示すように、接続部７は、複数枚（図の例では６枚）の薄板部９で構成されている。薄板部９は、円筒部３の周方向に所定幅をもち、周方向に等間隔を空けて配置されて、円筒部３と蓋部５との間を架橋している。すなわち、薄板部９の一端は蓋部５に連結され、薄板部９の他端は円筒部３の内壁面に連結されている。薄板部９は円筒部３及び蓋部５よりも肉薄に形成されているので、接続部７は、円筒部３及び蓋部５に比較して外力によって変形し易い。 As shown in FIG. 4, the connecting portion 7 is composed of a plurality of (six in the illustrated example) thin plate portions 9. The thin plate portion 9 has a predetermined width in the circumferential direction of the cylindrical portion 3 and is arranged at equal intervals in the circumferential direction, and bridges between the cylindrical portion 3 and the lid portion 5. That is, one end of the thin plate portion 9 is connected to the lid portion 5, and the other end of the thin plate portion 9 is connected to the inner wall surface of the cylindrical portion 3. Since the thin plate portion 9 is formed thinner than the cylindrical portion 3 and the lid portion 5, the connecting portion 7 is easily deformed by an external force as compared with the cylindrical portion 3 and the lid portion 5.

図５に示すように、栓体１の開放状態においては、蓋部５は透析ポート６３とは離れて位置している。よって、人工透析器５１の透析側流路５９（図１参照）は、出入口６３ａを通じ、リブ３ｈにより形成される上記の隙間や、薄板部９同士の間の間隙を通じて外部と連通している。 As shown in FIG. 5, the lid 5 is located away from the dialysis port 63 when the plug 1 is in an open state. Therefore, the dialysis side flow path 59 (see FIG. 1) of the artificial dialyzer 51 communicates with the outside through the above-mentioned gap formed by the rib 3h and the gap between the thin plate portions 9 through the inlet / outlet 63a.

続いて、図５〜図８を参照しながら、栓体１の開放状態から閉鎖状態への移行について説明する。 Next, the transition from the open state to the closed state of the plug 1 will be described with reference to FIGS.

前述のとおり、薄板部９は比較的変形し易い。よって、図５に示す開放状態の栓体１において、例えば、蓋部５が下方に向けてある程度の力で押されると、薄板部９が屈曲変形し、蓋部５が円筒部３に対して下方に平行移動する。そして、図６に示すように、蓋部５が下方に位置する閉鎖状態となる。この閉鎖状態においては、蓋部５の下部が透析ポート６３の内側面６３ｔに嵌り込むことで、出入口６３ａが閉鎖される。以下、開放状態における蓋部５の位置を「開放位置Ｐ１」と称し、閉鎖状態における蓋部５の位置を「閉鎖位置Ｐ２」と称する場合がある。なお、蓋部５を上方に向けてある程度の力で引くことにより、蓋部５を、閉鎖位置Ｐ２から開放位置Ｐ１に平行移動させることも可能である。 As described above, the thin plate portion 9 is relatively easily deformed. Therefore, in the plug 1 in the open state shown in FIG. 5, for example, when the lid portion 5 is pressed downward with a certain amount of force, the thin plate portion 9 is bent and deformed, and the lid portion 5 is deformed with respect to the cylindrical portion 3. Translate downwards. And as shown in FIG. 6, it will be in the closed state in which the cover part 5 is located below. In this closed state, the lower portion of the lid 5 is fitted into the inner side surface 63t of the dialysis port 63, whereby the entrance / exit 63a is closed. Hereinafter, the position of the lid 5 in the opened state may be referred to as “open position P1”, and the position of the lid 5 in the closed state may be referred to as “closed position P2”. It is also possible to translate the lid 5 from the closed position P2 to the open position P1 by pulling the lid 5 upward with a certain amount of force.

ここで、図７に示すように、薄板部９と蓋部５との連結部を蓋部連結部９ａ、薄板部９と円筒部３との連結部を円筒部連結部９ｂとすれば、開放状態から閉鎖状態への移行では、蓋部連結部９ａ及び円筒部連結部９ｂの少なくとも２箇所で薄板部９が屈曲される。そして、図５に示すように、蓋部５が開放位置Ｐ１にあるときには、蓋部連結部９ａは円筒部連結部９ｂよりも上方にあり、図６に示すように、蓋部５が閉鎖位置Ｐ２に移動したときには、蓋部連結部９ａは、円筒部連結部９ｂよりも下方の位置まで移動する。また、薄板部９は、筒軸線Ａを含む断面（図５及び図６の断面）内において、円筒部連結部９ｂを中心として下方に６０°以上回転することになる。すなわち、図８（ｃ）に示すように、開放状態における薄板部９（二点鎖線）と閉鎖状態における薄板部９（実線）とがなす角度αが６０°以上である。 Here, as shown in FIG. 7, if the connecting portion between the thin plate portion 9 and the lid portion 5 is a lid portion connecting portion 9a, and the connecting portion between the thin plate portion 9 and the cylindrical portion 3 is a cylindrical portion connecting portion 9b, it is opened. In the transition from the state to the closed state, the thin plate portion 9 is bent at at least two locations of the lid portion connecting portion 9a and the cylindrical portion connecting portion 9b. As shown in FIG. 5, when the lid portion 5 is in the open position P1, the lid portion connecting portion 9a is located above the cylindrical portion connecting portion 9b, and as shown in FIG. 6, the lid portion 5 is in the closed position. When moved to P2, the lid connecting portion 9a moves to a position below the cylindrical portion connecting portion 9b. Further, the thin plate portion 9 rotates downward by 60 ° or more around the cylindrical portion connecting portion 9b in the cross section including the cylinder axis A (the cross sections of FIGS. 5 and 6). That is, as shown in FIG. 8C, the angle α formed by the thin plate portion 9 (two-dot chain line) in the open state and the thin plate portion 9 (solid line) in the closed state is 60 ° or more.

上記のような開放状態から閉鎖状態への移行を更に円滑にするため、図７に示すように、薄板部９の略中央の位置には、周囲よりも更に肉薄のくびれ部（肉薄部）９ｃが形成されている。開放状態から閉鎖状態への移行の際には、薄板部９は更にくびれ部９ｃで一時的に屈曲する。 In order to further facilitate the transition from the open state to the closed state as described above, a constricted portion (thin portion) 9c that is thinner than the surroundings is provided at a substantially central position of the thin plate portion 9 as shown in FIG. Is formed. In the transition from the open state to the closed state, the thin plate portion 9 is further bent temporarily at the constricted portion 9c.

上述のような接続部７及び薄板部９の構成に基づけば、開放状態から閉鎖状態に移行する際の薄板部９の変形の仕方は、図８に示すとおりである。図８（ａ）の開放状態から、例えばユーザが指で蓋部５の天板部５ａを押すなど、蓋部５に下向きの外力が作用すると、図８（ｂ）に示すように、蓋部連結部９ａとくびれ部９ｃとが最初に屈曲する。その後更に上記外力が作用すると、図８（ｃ）に示すように、円筒部連結部９ｂが下方に屈曲し、その状態で安定する。またこのとき、蓋部５の下部が透析ポート６３の内側面６３ｔに嵌り込む（図６参照）。 Based on the configuration of the connecting portion 7 and the thin plate portion 9 as described above, the manner of deformation of the thin plate portion 9 when shifting from the open state to the closed state is as shown in FIG. When a downward external force is applied to the lid 5 such as when the user presses the top plate 5a of the lid 5 with a finger from the opened state of FIG. 8A, the lid is shown in FIG. 8B. The connecting portion 9a and the constricted portion 9c are bent first. Thereafter, when the external force further acts, as shown in FIG. 8C, the cylindrical portion connecting portion 9b bends downward and stabilizes in that state. At this time, the lower portion of the lid 5 is fitted into the inner side surface 63t of the dialysis port 63 (see FIG. 6).

上記のような順序で円滑に薄板部９を変形させるためには、蓋部連結部９ａ、円筒部連結部９ｂ、及びくびれ部９ｃにおける板厚を適切に設計すればよい。また、上記のような薄板部９の変形を可能とするため、ある程度変形容易な樹脂を栓体１の材料として採用すればよい。このような樹脂の例としては、ポリエチレン、ポリプロピレン、ＡＢＳ樹脂などがある。また、器具を用いずに指で容易に蓋部５を押し下げることを可能にするため、円筒部３の開口３ａの直径が８〜３０ｍｍであり、天板部５ａの直径が７〜２９ｍｍであることが好ましい。 In order to smoothly deform the thin plate portion 9 in the order as described above, the plate thicknesses of the lid connecting portion 9a, the cylindrical portion connecting portion 9b, and the constricted portion 9c may be appropriately designed. Moreover, in order to enable the deformation of the thin plate portion 9 as described above, a resin that is easily deformable to some extent may be employed as the material of the plug body 1. Examples of such a resin include polyethylene, polypropylene, and ABS resin. Moreover, in order to be able to push down the cover part 5 easily with a finger | toe, without using an instrument, the diameter of the opening 3a of the cylindrical part 3 is 8-30 mm, and the diameter of the top-plate part 5a is 7-29 mm. It is preferable.

続いて、上記栓体１による作用効果について説明する。 Then, the effect by the said plug body 1 is demonstrated.

一般的に、人工透析器５１では、中空糸膜４の周囲に酸素が存在する状態でガンマ線による滅菌処理を行うと、中空糸膜４を劣化させしまう場合がある。そこで、人工透析器５１は、透析側流路５９内の酸素を除去すべく脱酸素剤と一緒に包装容器内に封入される。包装容器内では、透析側流路５９内の酸素が脱酸素剤に移動するように、出入口６３ａが開放されている必要がある。人工透析器５１の使用時には、包装容器の開封後に中空糸膜４の内腔を生理食塩水で洗浄する洗浄操作（プライミング操作）を行う。プライミング操作の際には、中空糸膜４を透過した生理食塩水が出入口６３ａから漏出しないように、出入口６３ａが閉鎖されている必要がある。すなわち、人工透析器５１の運用では、包装容器を開封した後、開放されていた出入口６３ａを閉鎖するといった作業が必要である。 Generally, in the artificial dialyzer 51, when sterilization treatment with gamma rays is performed in a state where oxygen is present around the hollow fiber membrane 4, the hollow fiber membrane 4 may be deteriorated. Therefore, the artificial dialyzer 51 is enclosed in a packaging container together with an oxygen scavenger so as to remove oxygen in the dialysis side channel 59. In the packaging container, the entrance / exit 63a needs to be opened so that oxygen in the dialysis side channel 59 moves to the oxygen scavenger. When the artificial dialyzer 51 is used, a washing operation (priming operation) for washing the lumen of the hollow fiber membrane 4 with physiological saline is performed after the packaging container is opened. In the priming operation, the entrance / exit 63a needs to be closed so that the physiological saline that has permeated through the hollow fiber membrane 4 does not leak from the entrance / exit 63a. That is, in the operation of the artificial dialyzer 51, after opening the packaging container, it is necessary to close the opened entrance 63a.

上記栓体１によれば、人工透析器５１の包装時には、透析ポート６３，６３にそれぞれ開放状態の栓体１を装着して、脱酸素剤と一緒に包装容器内に封入すればよい。これにより、人工透析器５１の保管時や輸送時、滅菌操作などにおける状況で出入口６３ａの開放状態が保たれ、透析側流路５９の脱酸素が行われる。そして、包装容器の開封後には、栓体１の蓋部５を指で押し下げるといった簡単な操作により、出入口６３ａを閉鎖することができる。すなわち、人工透析器５１の使用前もしくは使用時にワン操作で出入口６３を閉鎖して透析側流路５９の気密性を保つことができる。 According to the plug 1, when the artificial dialyzer 51 is packaged, the open plug 1 may be attached to the dialysis ports 63 and 63, respectively, and sealed together with the oxygen scavenger in the packaging container. As a result, the entrance / exit 63a is kept open during storage, transportation, sterilization, etc. of the artificial dialyzer 51, and the dialysis side passage 59 is deoxygenated. And after opening a packaging container, the entrance-and-exit 63a can be closed by simple operation of pushing down the cover part 5 of the stopper 1 with a finger | toe. That is, before or during use of the artificial dialyzer 51, the inlet / outlet 63 can be closed by one operation to maintain the airtightness of the dialysis side channel 59.

ここで、従来の医療機器用の栓体としては「気密させる機能のみの栓」「開放させる機能のみの栓」「内圧を受けて膨らむバルーン栓」「ガス透過素材を用いた栓」「２種以上の構成部品で組まれた操作型の栓（特許文献２等参照）」などがある。このような栓体を透析ポート６３に装着する栓体に適用することも考えられる。 Here, as a plug for a conventional medical device, “a plug with only an airtight function”, “a plug with only a function to open”, “a balloon plug inflated by internal pressure”, “a plug using a gas permeable material”, “two types” There is an operation-type stopper assembled with the above-described components (see Patent Document 2, etc.). It is also conceivable to apply such a plug to a plug mounted on the dialysis port 63.

しかしながら、「気密させる機能のみの栓」では、人工透析器５１の滅菌時前の容器内脱酸素やEOGガスの供給ができない。また、人工透析器５１の蒸気滅菌時の容器内外圧変化による容器破壊を回避できない。「開放させる機能のみの栓」では、透析ポート６３への手指の接触を防止することはできるが、プライミング操作時に透析ポート６３からの液漏れを防ぐことはできない。「内圧を受けて膨らむバルーン栓」は高圧蒸気滅菌に用いられる栓であるが、柔軟性があり耐熱性も有する原材料が高価なことからコスト高である。「ガス透過素材を用いた栓」を適用すると、透析側流路５９を目的の酸素濃度にするのに時間がかかる。「２種以上の構成部品で組まれた操作型の栓」は、医療従事者が手でワン操作を行い密閉できる構造にはなっていないことと、栓構成材料が３つ以上あり、コスト高である。 However, with the “stopper only for airtight function”, it is not possible to deoxidize the container before the artificial dialyzer 51 is sterilized or supply EOG gas. In addition, it is not possible to avoid the destruction of the container due to a change in the internal / external pressure of the artificial dialyzer 51 during steam sterilization. With the “plug having only a function to be opened”, it is possible to prevent finger contact with the dialysis port 63, but it is not possible to prevent liquid leakage from the dialysis port 63 during the priming operation. “Balloon plugs that swell under internal pressure” are stoppers used for high-pressure steam sterilization, but they are expensive due to the high cost of raw materials that are flexible and heat resistant. When “a plug using a gas permeable material” is applied, it takes time to bring the dialysis side channel 59 to the target oxygen concentration. “Operation-type stoppers assembled with two or more types of component parts” are not designed to be sealed by medical personnel with one operation by hand, and there are three or more plug component materials, resulting in high costs. It is.

これに対し、上述の栓体１によれば、上記の製造時や滅菌時等の問題を解決することができ、また、製造コストも抑えることができる。 On the other hand, according to the plug 1 described above, the above-described problems such as manufacturing and sterilization can be solved, and the manufacturing cost can be reduced.

（第２実施形態）
続いて、図９及び図１０を参照し、本発明の第２実施形態に係る血液浄化器用栓体２０１について説明する。本実施形態の栓体２０１において、前述の栓体１と同一又は同等の構成要素には図面に同一の符号を付して重複する説明を省略する。 (Second Embodiment)
Next, a blood purifier plug 201 according to a second embodiment of the present invention will be described with reference to FIGS. 9 and 10. In the plug body 201 of the present embodiment, the same or equivalent components as those of the plug body 1 described above are denoted by the same reference numerals in the drawings, and redundant description is omitted.

図９に示すように、開放状態の栓体２０１では、開放位置Ｐ１にある蓋部２０５の天板部２０５ａが、円筒部３の開口３ａの位置よりも僅かに上方に位置している。このように、円筒部３の上端の開口３ａから、蓋部２０５の上端が僅かに突出しているので、蓋部２０５を指で押し下げる動作が容易になる。 As shown in FIG. 9, in the plug body 201 in the open state, the top plate portion 205 a of the lid portion 205 at the open position P <b> 1 is positioned slightly above the position of the opening 3 a of the cylindrical portion 3. Thus, since the upper end of the cover part 205 protrudes slightly from the opening 3a of the upper end of the cylindrical part 3, the operation | movement which pushes down the cover part 205 with a finger | toe becomes easy.

また、筒軸線Ａを含む断面（図９及び図１０の断面）で見て、栓体２０１の薄板部２０９は、円筒部３側に膨らむ湾曲形状をなしている。この形状によれば、ユーザが指で蓋部２０５を押し下げたときに、くびれ部９ｃ及び蓋部連結部９ａを屈曲させる力が作用し易く、くびれ部９ｃ及び蓋部連結部９ａがより円滑に屈曲する。よって、ユーザが指で蓋部２０５を押し下げたときに、開放状態から閉鎖状態へより円滑に移行する。 Further, when viewed in a cross section including the cylinder axis A (the cross sections in FIGS. 9 and 10), the thin plate portion 209 of the plug 201 has a curved shape that swells toward the cylindrical portion 3. According to this shape, when the user pushes down the lid portion 205 with a finger, a force for bending the constricted portion 9c and the lid portion connecting portion 9a is likely to act, and the constricted portion 9c and the lid portion connecting portion 9a are smoother. Bend. Therefore, when the user presses down the cover 205 with a finger, the smooth transition from the open state to the closed state occurs.

以上、本発明の実施形態について説明したが、本発明は、上記実施形態に限られるものではなく、各請求項に記載した要旨を変更しない範囲で変形したものであってもよい。例えば、本発明は、血液透析器用の栓体に限らず、白血球除去器、血液成分吸着器、血漿分離機等の他の血液浄化器用の栓体にも適用することができる。また、本発明は、特に、ドライタイプの血液浄化器の栓体に好適に適用することができる。 As mentioned above, although embodiment of this invention was described, this invention is not restricted to the said embodiment, You may change in the range which does not change the summary described in each claim. For example, the present invention is not limited to a stopper for a hemodialyzer, but can also be applied to a stopper for other blood purifiers such as a leukocyte remover, a blood component adsorber, and a plasma separator. Further, the present invention can be suitably applied particularly to a plug of a dry type blood purifier.

また、第１及び第２実施形態においては、筒軸線Ａを含む断面で見て、薄板部９，２０９の中央付近にくびれ部９ｃが設けられているが、くびれ部９ｃは省略してもよい。すなわち、本発明の栓体においては、筒軸線Ａを含む断面で見て、一様な厚みをもつ薄板部（接続部）を採用してもよい。また、以上説明した栓体の各構成要素を、適宜組み合わせて採用することも可能である。 In the first and second embodiments, the constricted portion 9c is provided near the center of the thin plate portions 9 and 209 when viewed in a cross section including the cylinder axis A, but the constricted portion 9c may be omitted. . That is, in the plug of the present invention, a thin plate portion (connection portion) having a uniform thickness as viewed in a cross section including the cylinder axis A may be employed. Moreover, it is also possible to employ | adopt combining suitably each component of the plug body demonstrated above.

１…血液浄化器用栓体、３…円筒部（筒部）、３ａ…上端の開口、３ｂ…下端の開口、５…蓋部、５ａ…天板部、７…接続部、９…薄板部、９ａ…蓋部連結部（一端）、９ｂ…円筒部連結部（他端）、９ｃ…くびれ部（肉薄部）、５１…人工透析器（血液浄化器）、６３…透析ポート（接続ポート）、６３ａ…出入口、Ａ…筒軸線、Ｐ１…開放位置、Ｐ２…閉鎖位置。 DESCRIPTION OF SYMBOLS 1 ... Blood purifier stopper, 3 ... Cylindrical part (cylinder part), 3a ... Upper end opening, 3b ... Lower end opening, 5 ... Lid part, 5a ... Top plate part, 7 ... Connection part, 9 ... Thin plate part, 9a ... Lid connecting part (one end), 9b ... Cylindrical part connecting part (the other end), 9c ... Constriction part (thin part), 51 ... Artificial dialyzer (blood purifier), 63 ... Dialysis port (connection port), 63a ... entrance / exit, A ... cylinder axis, P1 ... open position, P2 ... closed position.

Claims

A plug for a blood purifier attached to a tubular connection port that forms a fluid inlet / outlet of the blood purifier,
A cylindrical portion that has an opening for inserting the connection port at the lower end and fits outside the connection port;
A lid provided in the vicinity of the opening at the upper end of the cylindrical portion;
A connecting portion that is formed thinner than the cylindrical portion and the lid portion and connects the cylindrical portion and the lid portion;
The tube portion, the lid portion, and the connection portion are integrally formed,
The lid is
Between the open position that opens the doorway apart from the connection port and the closed position that fits inside the connection port and closes the doorway, while deforming the connection portion, movable der in the up-and-down direction Te is,
The connecting portion is
A plug for a blood purifier having a plurality of thin plate portions having a predetermined width in the circumferential direction of the cylindrical portion and spaced apart from each other in the circumferential direction .

When the lid part moves relative to the cylinder part,
The connecting portion is
The plug for a blood purifier according to claim 1, wherein the plug is bent at one end that is a connecting portion with the cylinder portion and at the other end that is a connecting portion with the lid portion.

The connecting portion has a thin portion formed between the one end and the other end,
When the lid part moves relative to the cylinder part,
The connecting portion is
The blood purifier plug according to claim 2, further bent at the thin portion.

When the lid is in the open position,
The connecting portion between the connecting portion and the lid portion is above the connecting portion between the connecting portion and the cylindrical portion,
When the lid is in the closed position,
The connection part of the said connection part and the said cover part exists in the downward direction rather than the connection part of the said connection part and the said cylinder part, The blood purifier for any one of Claims 1-3 characterized by the above-mentioned. Plug body.

When the lid is in the open position,
The connecting portion is
The plug for blood purifier according to any one of claims 1 to 4, wherein the plug for blood purifier according to any one of claims 1 to 4, which has a curved shape that swells toward the cylinder part when viewed in a cross section including the cylinder axis of the cylinder part.

When the lid is in the open position,
The plug for a blood purifier according to any one of claims 1 to 5 , wherein the top plate portion of the lid portion is positioned above the opening at the upper end of the cylindrical portion.

When the lid part moves relative to the cylinder part,
The connecting portion is
Viewed in cross section including the cylinder axis of the cylindrical portion, according to any one of claim 1 to 6, wherein the rotating least 60 ° around the connection portion between the cylindrical portion and the connecting portion Blood purifier plug.