JP2013202068A

JP2013202068A - Valve body for medical device, medical device and manufacturing method of valve body for medical device

Info

Publication number: JP2013202068A
Application number: JP2012070787A
Authority: JP
Inventors: Yuta Narumi; 雄太鳴海; Atsushi Ogawa; 篤志小川
Original assignee: Kaneka Corp
Current assignee: Kaneka Corp
Priority date: 2012-03-27
Filing date: 2012-03-27
Publication date: 2013-10-07
Anticipated expiration: 2032-03-27
Also published as: JP5928064B2

Abstract

PROBLEM TO BE SOLVED: To provide a valve body for a medical device, which has a liquidtight property to a fluid such as a contrast medium, saline or blood at all times, and is capable of improving the liquidtight property and setting sliding resistance with an insert such as guide wire small, and to provide the medical device and a manufacturing method of the valve body for the medical device.SOLUTION: In a valve body 30 disposed in a body lumen part in a Y connector, at an insertion part 34 of the valve body to which an insert is to be inserted, a cut part 35 having a width extending from the insertion center of the insert to the outer side of a radial direction over the entire length extending from a distal end side to a proximal end side is formed. For at least a partial surface of the inner surface of the cut part 35, the minimum angle θ at which a plane in contact with the partial surface and the axial direction CL of the insertion center cross is set to be 0°<θ<90°.

Description

本発明は、Ｙアダプタ、カテーテル、シースイントロデューサ等の医療機器に組み込まれる医療機器用弁体、医療機器、および医療機器用弁体の製造方法に関するものである。 The present invention relates to a medical device valve body incorporated in a medical device such as a Y adapter, a catheter, and a sheath introducer, a medical device, and a method for manufacturing the medical device valve body.

現在、血管内病変に対する侵襲の少ない診断・治療法としてカテーテル等を使用する方法が知られている。この血管内治療法において使用されるＹコネクタ、カテーテル、シースイントロデューサ等には血液が体外に失われるのを防ぐために血液逆流防止用の弁体が組み込まれている。 Currently, a method using a catheter or the like is known as a diagnosis / treatment method with less invasiveness to an intravascular lesion. In order to prevent blood from being lost outside the body, a valve body for preventing blood backflow is incorporated in the Y connector, catheter, sheath introducer and the like used in this endovascular treatment method.

前記弁体を有する医療機器の１つとしてＹコネクタが知られており、例えば特許文献１に記載されているような、Ｙ字の筒状本体部材、カテーテル接続部、シリンジまたは三方活栓用接続部、筒状本体部材の基端側（近位側）に設けたキャップ部材、筒状本体部材内に組み付けた弁体を備えたものが提案されている。 A Y connector is known as one of the medical devices having the valve body. For example, as described in Patent Document 1, a Y-shaped cylindrical main body member, a catheter connection part, a syringe, or a three-way stopcock connection part A cap member provided on the base end side (proximal side) of the cylindrical main body member and a valve body assembled in the cylindrical main body member have been proposed.

前記弁体の中央部には、ガイドワイヤのような長尺部材を液密状に挿入したり抜き取ったりできるようにするためのスリットが形成され、Ｙコネクタに接続したシリンジからの注入液、Ｙコネクタ内の造影剤・生理食塩水あるいは血液等の流体が、弁体とガイドワイヤ間の隙間からＹコネクタ外に流出しないように構成されている。 A slit for allowing a long member such as a guide wire to be inserted and removed in a liquid-tight manner is formed in the central portion of the valve body, and an injection solution from a syringe connected to a Y connector, Y It is configured such that a contrast medium, physiological saline, blood or the like in the connector does not flow out of the Y connector from the gap between the valve body and the guide wire.

前記スリットとしては、弁体の中心線に対する直交断面が一文字や十文字やＹ字状で、弁体の中心線に沿って直線状に延びるように形成したスリットが提案されている（例えば、特許文献２参照。）。また、特許文献１には、弁体の中心線から半径方向に延びる幅を有し、弁体の一方の面側から弁体の内部へ延びる円弧状の第１スリットと、弁体の中心線から半径方向に延びる幅を有し、弁体の他方の面側から弁体の内部へ延びる円弧状の第２スリットとを備え、両スリットが弁体内において交差するように、弁体の中心線の周方向に対して両スリットを相互に角度を付けて配置させた弁体が提案されている。 As the slit, there has been proposed a slit formed so that a cross section orthogonal to the center line of the valve body is a single letter, a crossed letter, or a Y shape and extends linearly along the center line of the valve body (for example, Patent Documents). 2). Further, Patent Document 1 has a width extending in the radial direction from the center line of the valve body, an arc-shaped first slit extending from one surface side of the valve body to the inside of the valve body, and the center line of the valve body And a second arcuate slit extending from the other surface side of the valve body to the inside of the valve body, the center line of the valve body so that both slits intersect in the valve body A valve body has been proposed in which both slits are arranged at an angle with respect to the circumferential direction.

一方、前記筒状本体部材として、途中部に遠位側へ向けて縮径するテーパ面を有する環状の段差部を形成し、該段差部よりも遠位側に小径部を、また近位側に大径部を形成したものを用い、前記弁体として、遠位側と近位側とにテーパ部を形成し、中央部にガイドワイヤの外径よりも大径の貫通孔を形成したものを用いてなる、Ｙコネクタが実用化されている。このＹコネクタでは、筒状本体部材にキャップ部材が螺合されており、キャップ部材を締め付けることで、キャップ部材の先端部で弁体を段差部に圧接させて、弁体を縮径方向に弾性変形させ、弁体の貫通孔を閉鎖し、キャップ部材を緩めることで、弁体を拡径方向に弾性復帰させて、弁体の貫通孔を開口できるように構成されている。 On the other hand, as the cylindrical main body member, an annular stepped portion having a tapered surface whose diameter is reduced toward the distal side is formed in the middle portion, and a small diameter portion is disposed further to the distal side than the stepped portion, and the proximal side. The valve body is formed with a tapered portion at the distal side and the proximal side, and a through hole having a diameter larger than the outer diameter of the guide wire is formed at the central portion. A Y-connector made of is put to practical use. In this Y connector, the cap member is screwed onto the cylindrical main body member, and by tightening the cap member, the valve body is pressed against the stepped portion at the tip of the cap member, and the valve body is elastically reduced in the diameter reducing direction. By deforming, closing the through hole of the valve body, and loosening the cap member, the valve body is elastically returned in the diameter increasing direction so that the through hole of the valve body can be opened.

しかし、このＹコネクタでは、キャップ部材によって弁体が縮径方向に弾性変形されていないときには、造影剤・生理食塩水あるいは血液等の流体が弁体の外周部からＹコネクタ外に流出するという問題があった。例えば、単一管腔バルーンカテーテルに前記Ｙコネクタを適用すると、次のような問題が発生する。即ち、単一管腔バルーンカテーテルでは、ガイドワイヤのような長尺部材をカテーテル内腔に挿入し先端部をシールした上で造影剤を混合したバルーン拡張液を注入することでバルーンが拡張し、同時にＸ線下における視認性も得ることができるように構成されている。しかし、この単一管腔バルーンカテーテルに前記Ｙコネクタを適用すると、Ｙコネクタの弁体を開放したまま、バルーンカテーテル先端のシールを解除したときに、血圧によってカテーテル内腔に血液が流入する。そして、そのまま再度バルーンカテーテル先端をシールしバルーンを拡張すると、カテーテル内腔に流入した血液がバルーン内に流入し、血液が流入した分バルーンの視認性が低下するため、血管を損傷するリスクが大きくなるという問題が発生する。 However, in this Y connector, when the valve body is not elastically deformed in the direction of diameter reduction by the cap member, a fluid such as a contrast medium, physiological saline, or blood flows out of the Y connector from the outer peripheral portion of the valve body. was there. For example, when the Y connector is applied to a single lumen balloon catheter, the following problems occur. That is, in a single lumen balloon catheter, a long member such as a guide wire is inserted into the lumen of the catheter, the tip is sealed, and then the balloon is expanded by injecting a balloon expansion solution mixed with a contrast agent. At the same time, it is configured so that visibility under X-rays can also be obtained. However, when the Y connector is applied to this single lumen balloon catheter, blood flows into the catheter lumen by blood pressure when the seal of the balloon catheter tip is released while the valve body of the Y connector is opened. If the tip of the balloon catheter is sealed again and the balloon is expanded, the blood that has flowed into the catheter lumen flows into the balloon, and the visibility of the balloon decreases due to the blood flowing in, so there is a high risk of damaging the blood vessel. Problem arises.

国際公開第２００９／０９１０１８号パンフレットInternational Publication No. 2009/091018 Pamphlet 特開２００５−８７５７４号公報JP 2005-87574 A

ところで、前記特許文献１、２記載の弁体では、ガイドワイヤなどの挿入物をスリットに挿入していない状態では、スリットの内面同士が隙間なく密着することで、弁体が液密状に保持され、また挿入物をスリットに挿入した状態では、スリットの内面が挿入物の外面に隙間なく密着することで、弁体が液密状に保持されるので、ガイドワイヤの挿入の有無に関係なく弁体を常時液密状に保持できるという利点を有している。 By the way, in the valve body of the said patent documents 1 and 2, in the state which has not inserted inserts, such as a guide wire, in the slit, the inner surface of a slit closely_contact | adheres without a gap, and a valve body hold | maintains liquid-tight. In addition, in the state where the insert is inserted into the slit, the valve body is held in a liquid-tight state by closely contacting the inner surface of the slit with the outer surface of the insert, so that regardless of whether a guide wire is inserted or not. This has the advantage that the valve body can be kept liquid-tight at all times.

しかし、本件発明者は、前記特許文献１、２記載の弁体においても、挿入物の挿入中心の軸方向に沿って前記スリットを形成しているので、弁体よりも遠位側において筒状本体部材内に充填される造影剤・生理食塩水あるいは血液等の流体の液圧によって、弁体のうちのスリットからの挿入物の出口側端部に、スリット内面を挿入物から離間させる方向への力が作用して、スリット内面と挿入物間における液密性が低下することを見出した。そして、この液密性低下による液漏れを防止するため、スリット長さがどうしても長くなり、その分ガイドワイヤなどの挿入物に対する弁体の摺動抵抗が増えて、挿入物の操作性が低下するという問題があることを見出した。 However, since the present inventor forms the slit along the axial direction of the insertion center of the insert even in the valve body described in Patent Documents 1 and 2, the tubular body is formed on the distal side of the valve body. In the direction of separating the inner surface of the slit from the insert at the outlet side end of the insert from the slit of the valve body by the fluid pressure of the contrast medium, physiological saline or blood filled in the main body member It was found that the liquid tightness between the inner surface of the slit and the insert was lowered due to the above-mentioned force. In order to prevent liquid leakage due to this decrease in liquid tightness, the slit length is inevitably long, and the sliding resistance of the valve body with respect to the insert such as a guide wire is increased, and the operability of the insert is reduced. I found that there is a problem.

本発明の目的は、造影剤・生理食塩水あるいは血液等の流体に対する液密性を常に有し、しかも該液密性を高めて、ガイドワイヤのような挿入物との摺動抵抗を小さく設定可能な医療機器用弁体、医療機器、および医療機器用弁体の製造方法を提供することである。 It is an object of the present invention to always have liquid tightness to a fluid such as a contrast medium, physiological saline or blood, and to improve the liquid tightness and to set a sliding resistance with an insert such as a guide wire. A medical device valve body, a medical device, and a method for manufacturing a medical device valve body are provided.

本発明に係る医療機器用弁体は、医療機器における流体通路に配置される医療機器用弁体にあって、上記弁体は、挿入物が挿入される挿入部を含み、上記挿入部は、遠位側から近位側へと伸びる自身の全長に亘って、上記挿入物の挿入中心から半径方向の外側へ延びる幅を有する切込部を含み、上記切込部では、その切込部の内面の少なくとも一部の面が、下記条件式（１）を満たすものである。
０°＜θ＜９０°・・・・・（１）
ただし、θ：上記内面の少なくとも一部の面は、上記挿入物が挿入される軸における遠位側からみて、近位側に向かって角度を有しており、その一部の面に接する平面と、上記挿入中心の軸方向との交差する最小角である。なお、本明細書において、挿入物とは、切込部に挿入可能なものを意味し、ガイドワイヤなどの長尺部材は云うまでもなく、注射針などの短尺部材をも含むものとする。 The medical device valve body according to the present invention is a medical device valve body disposed in a fluid passage in a medical device, and the valve body includes an insertion portion into which an insert is inserted. A notch having a width extending radially outward from the insertion center of the insert over the entire length of the insert extending from the distal side to the proximal side. At least a part of the inner surface satisfies the following conditional expression (1).
0 ° <θ <90 ° (1)
However, θ: At least a part of the inner surface has an angle toward the proximal side when viewed from the distal side of the shaft into which the insert is inserted, and is a plane in contact with the part of the surface And the minimum angle that intersects the axial direction of the insertion center. In addition, in this specification, an insert means the thing which can be inserted in a notch part, Needless to say long members, such as a guide wire, shall also include short members, such as an injection needle.

この弁体では、ガイドワイヤなどの挿入物を切込部に挿入していない状態では、切込部の内面同士が隙間なく密着することで、弁体が液密状に保持され、また挿入物を切込部に挿入した状態では、切込部の内面が挿入物の外面に隙間なく密着することで、弁体が液密状に保持されるので、挿入物の有無に関係なく弁体を常時液密状に保持できる。しかも、切込部の内面の少なくとも一部を、挿入中心の軸方向に対して０°〜９０°の角度θで交差するように配置しているので、弁体よりも遠位側の流体通路内の液圧によって、弁体における切込部の遠位側部分が挿入物に圧接される方向に押されて、単に挿入中心の軸方向、即ち角度θが０°の切込を形成した従来の弁体と比較して、挿入物と弁体間における液密性が高められることになる。また、このように液密性が高められるので、弁体における挿入部の長さを短く設定して、挿入物に対する弁体の摺動抵抗を小さくでき、挿入物の操作性を向上できる。 In this valve body, when an insert such as a guide wire is not inserted into the notch, the inner surface of the notch is brought into close contact with the gap so that the valve is held in a liquid-tight state. Is inserted into the notch, the inner surface of the notch closely contacts the outer surface of the insert without any gaps, so that the valve body is held in a liquid-tight state. It can be kept liquid-tight at all times. Moreover, since at least a part of the inner surface of the cut portion is arranged to intersect at an angle θ of 0 ° to 90 ° with respect to the axial direction of the insertion center, the fluid passage on the distal side of the valve body The distal portion of the notch in the valve body is pushed in the direction in which it is pressed against the insert by the fluid pressure inside, and the axial direction of the insertion center, that is, the incision having an angle θ of 0 ° is simply formed. Compared with this valve body, the liquid tightness between the insert and the valve body is enhanced. In addition, since the liquid tightness is improved in this way, the length of the insertion portion in the valve body can be set short, the sliding resistance of the valve body with respect to the insert can be reduced, and the operability of the insert can be improved.

ここで、上記挿入中心の軸方向に対する交差断面での、上記切込部の形状は、上記軸方向における複数箇所において、変化することが好ましく、上記変化とは、上記軸方向における複数箇所での上記切込部の形状が、上記軸方向を中心に回転すること、または、上記軸方向からの乖離距離を変わることであることが好ましい実施の形態である。なお、軸方向を中心に回転する断面形状の切込部とは、例えば前記挿入物の挿入中心から半径方向外方側へ延びる幅を有し、該挿入中心の中心線に沿って螺旋状に周回する帯状の切込部のことを意味する。そして、このような切込部を形成すると、切込部により形成される挿入部の切片が挿入物の外形に沿って拡縮するので、挿入物と切込部の内面間における隙間を小さくして、液密性を一層向上することができる。 Here, it is preferable that the shape of the cut portion in the cross section with respect to the axial direction of the insertion center is changed at a plurality of locations in the axial direction, and the change is a plurality of locations in the axial direction. In a preferred embodiment, the shape of the notch is to rotate around the axial direction or to change the deviation distance from the axial direction. Note that the cut portion having a cross-sectional shape that rotates about the axial direction has, for example, a width extending radially outward from the insertion center of the insert, and spirally along the center line of the insertion center. It means a belt-shaped cut section that circulates. And when such a cut portion is formed, the section of the insert portion formed by the cut portion expands and contracts along the outer shape of the insert, so the gap between the insert and the inner surface of the cut portion is reduced. The liquid tightness can be further improved.

また、上記切込部は、全長における少なくとも一部を、非直線状に変化させることが好ましく、上記非直線状とは、上記挿入部の全長における近位側から遠位側に向かって、上記挿入部に対する上記切込部の進入角が、上記切込部の全長において部分的に異なることを意味する。 Further, it is preferable that the cut portion changes at least a part of the entire length in a non-linear manner, and the non-linear shape means that the insertion portion is moved from the proximal side to the distal side in the full length of the insertion portion. It means that the approach angle of the cut portion with respect to the insertion portion is partially different in the entire length of the cut portion.

更に、上記切込部は、上記幅を、上記挿入物の挿入中心から外側に向けて湾曲状、または直線状、に延びること、上記切込部は、上記挿入物の挿入中心を中心として、周方向に間隔をあけて複数本形成したものであること、上記切込部としての幅の異なる複数種類の切込部を形成すること、などが好ましい実施の形態である。 Further, the cut portion extends in a curved shape or a straight shape from the insertion center of the insert toward the outside, and the cut portion is centered on the insertion center of the insert. It is a preferred embodiment that a plurality of slits are formed at intervals in the circumferential direction, and a plurality of types of slits having different widths as the slits are formed.

更にまた、前記医療機器の流体通路が、その途中部に形成した環状の段差部と、該段差部よりも遠位側に形成した小径部と、該段差部よりも近位側に形成した大径部とを有しており、前記弁体の近位側に大径部に内嵌される筒部を形成し、前記弁体の遠位側に遠位側へ行くにしたがって縮径するテーパ部を形成し、前記切込部をテーパ部の遠位部に該テーパ部の中心線を挿入中心として形成し、前記テーパ部の外周部に段差部に圧接可能な環状のシール部を遠位側へ向けて突出状に形成することが好ましい。この場合には、弁体のシール部を流体通路の段差部に圧接させることで、シール部と段差部とを確実に液密状にシールすることができ、しかも弁体を縮径方向へ弾性変形させて切込部を確実に液密状にシールすることができる。 Furthermore, the fluid passage of the medical device has an annular stepped portion formed in the middle thereof, a small diameter portion formed distal to the stepped portion, and a large step formed proximal to the stepped portion. And a taper that forms a cylindrical portion fitted into the large-diameter portion on the proximal side of the valve body, and decreases in diameter toward the distal side of the valve body. Forming a cut-out portion at the distal portion of the taper portion with the center line of the taper portion as the insertion center, and disposing an annular seal portion that can be pressed against the step portion on the outer peripheral portion of the taper portion It is preferable to form in a protruding shape toward the side. In this case, the sealing portion of the valve body is brought into pressure contact with the step portion of the fluid passage, so that the seal portion and the step portion can be reliably sealed in a liquid-tight manner, and the valve body is elastic in the reduced diameter direction. The cut portion can be reliably sealed in a liquid-tight manner by being deformed.

ここで、前記シール部の内周面を遠位側へ行くにしたがって拡径するテーパ面で構成することが好ましい実施の形態である。この場合には、シール部が段差部に圧接されて内側へ変形して突っ張ることにより、弁体が段差部を乗り越えて小径部側へ移動することを効果的に阻止できる。 Here, it is a preferred embodiment that the inner peripheral surface of the seal portion is configured with a tapered surface that increases in diameter toward the distal side. In this case, it is possible to effectively prevent the valve body from moving over the stepped portion and moving toward the small diameter portion by being pressed against the stepped portion and deformed inward.

本発明に係る医療機器は、前記医療機器用弁体を流体通路に内嵌して、該流体通路を閉鎖してなるものである。この医療機器では、弁体により流体通路を常時液密状に閉鎖でき、しかも切込部における液密性が高められるので、液密性を確保しつつ、切込部の長さを短くして、挿入物の摺動抵抗を少なくでき、挿入物の操作性を向上できる。 The medical device according to the present invention is formed by fitting the valve body for medical device into a fluid passage and closing the fluid passage. In this medical device, the fluid passage can always be closed in a liquid-tight manner by the valve body, and the liquid-tightness at the incision is increased, so that the length of the incision is shortened while ensuring the liquid-tightness. The sliding resistance of the insert can be reduced, and the operability of the insert can be improved.

本発明に係る医療機器用弁体の製造方法は、医療機器の流体通路に配置される医療機器用弁体の製造方法であって、弾性材料にて成形された弁体のうちの挿入物が挿入される挿入部に、加工ツールを用いて切込部を形成する切込工程を備え、前記切込工程において、前記加工ツールとして、回転中心軸から半径方向外方側へ延びる幅を有し、回転中心軸に沿って螺旋状に周回する帯状の切刃を備えた加工ツールを用い、前記加工ツールを回転させながら送り操作して、前記弁体の挿入部にその全長にわたって切込部を形成するものである。この製造方法では、切込部として、前記挿入物の挿入中心から半径方向外方側へ延びる幅を有し、該挿入中心に沿って螺旋状に周回する帯状の切込部を形成することができる。 A method for manufacturing a valve body for a medical device according to the present invention is a method for manufacturing a valve body for a medical device that is disposed in a fluid passage of the medical device, and an insert of the valve body formed of an elastic material is provided. The insertion portion to be inserted includes a cutting step for forming a cutting portion using a processing tool, and in the cutting step, the processing tool has a width extending radially outward from the rotation center axis. , Using a processing tool provided with a strip-shaped cutting blade that spirally circulates along the central axis of rotation, and feeding the rotary tool while rotating the processing tool, the insertion portion of the valve body over its entire length To form. In this manufacturing method, as the cut portion, a band-shaped cut portion having a width extending radially outward from the insertion center of the insert and spirally wound along the insertion center may be formed. it can.

本発明に係る医療機器用弁体によれば、ガイドワイヤなどの挿入物を切込部に挿入していない状態では、切込部の内面同士が隙間なく密着することで、弁体が液密状に保持され、また挿入物を切込部に挿入した状態では、切込部の内面が挿入物の外面に隙間なく密着することで、弁体が液密状に保持されるので、挿入物の有無に関係なく弁体を常時液密状に保持できる。しかも、切込部の内面の少なくとも一部を、挿入中心の軸方向に対して０°〜９０°の角度θで交差するように配置しているので、弁体よりも遠位側の流体通路内の液圧によって、弁体における切込部の遠位側部分が挿入物に圧接される方向に押されて、単に挿入中心の軸方向、即ち角度θが０°の切込を形成した従来の弁体と比較して、挿入物と弁体間における液密性が高められることになる。また、このように液密性が高められるので、弁体における挿入部の長さを短く設定して、挿入物に対する弁体の摺動抵抗を小さくでき、挿入物の操作性を向上できる。 According to the valve body for a medical device according to the present invention, in a state where an insert such as a guide wire is not inserted into the cut portion, the inner surface of the cut portion is in close contact with the gap portion, so that the valve body is liquid tight. In the state where the insert is inserted into the cut portion, the valve body is held in a liquid-tight state by closely contacting the inner surface of the cut portion with the outer surface of the insert without any gap. Regardless of the presence or absence of the valve, the valve body can be kept liquid-tight at all times. Moreover, since at least a part of the inner surface of the cut portion is arranged to intersect at an angle θ of 0 ° to 90 ° with respect to the axial direction of the insertion center, the fluid passage on the distal side of the valve body The distal portion of the notch in the valve body is pushed in the direction in which it is pressed against the insert by the fluid pressure inside, and the axial direction of the insertion center, that is, the incision having an angle θ of 0 ° is simply formed. Compared with this valve body, the liquid tightness between the insert and the valve body is enhanced. In addition, since the liquid tightness is improved in this way, the length of the insertion portion in the valve body can be set short, the sliding resistance of the valve body with respect to the insert can be reduced, and the operability of the insert can be improved.

図１は、本発明の弁体をＹコネクタの縦断面図である。FIG. 1 is a longitudinal sectional view of a Y connector of the valve body of the present invention. 図２は、本発明の弁体の斜視図である。FIG. 2 is a perspective view of the valve body of the present invention. 図３（ａ）は、本発明の弁体の左側面図、図３（ｂ）は、本発明の弁体の左側面図、図３（ｃ）は本発明の弁体の右側面図である。3A is a left side view of the valve body of the present invention, FIG. 3B is a left side view of the valve body of the present invention, and FIG. 3C is a right side view of the valve body of the present invention. is there. 図４は、本発明の弁体の縦断面図である。FIG. 4 is a longitudinal sectional view of the valve body of the present invention. 図５（ａ）は、図４のａ‐ａ線断面図、図５（ｂ）は、図４のｂ‐ｂ線断面図、図５（ｃ）は、図４のｃ‐ｃ線断面図5A is a cross-sectional view taken along the line aa in FIG. 4, FIG. 5B is a cross-sectional view taken along the line bb in FIG. 4, and FIG. 5C is a cross-sectional view taken along the line cc in FIG. 図６（ａ）は、本発明の弁体の切込部の正面図、図６（ｂ）は、本発明の弁体の切込部の平面図である。Fig.6 (a) is a front view of the notch part of the valve body of this invention, FIG.6 (b) is a top view of the notch part of the valve body of this invention. 図７（ａ）は、本発明の弁体の切込部を加工するための加工ツールの正面図、図７（ｂ）は同加工ツールの平面図である。Fig.7 (a) is a front view of the processing tool for processing the notch part of the valve body of this invention, FIG.7 (b) is a top view of the processing tool. 図８は、本発明の他の構成の弁体のスリットの斜視図である。FIG. 8 is a perspective view of a slit of a valve body having another configuration of the present invention. 、図９（ａ）は、本発明の他の構成の弁体のスリットの斜視図、図９（ｂ）は、同スリットの平面図である。FIG. 9A is a perspective view of a slit of a valve body having another configuration of the present invention, and FIG. 9B is a plan view of the slit. 図１０（ａ）は、本発明の他の構成の弁体のスリットの斜視図、図１０（ｂ）は、同スリットの平面図である。FIG. 10A is a perspective view of a slit of a valve body having another configuration of the present invention, and FIG. 10B is a plan view of the slit.

以下、本発明の実施の形態について、図面を参照しながら詳細に説明する。
図１は本発明に係る弁体３０を組み込んだＹコネクタ１の断面図である。本実施の形態では、図１に示すＹコネクタ１を基準に、図１の左側を「先端側」、右側を「基端側」と定義して説明する。 Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
FIG. 1 is a cross-sectional view of a Y connector 1 incorporating a valve body 30 according to the present invention. In the present embodiment, the Y connector 1 shown in FIG. 1 is used as a reference, and the left side in FIG. 1 is defined as “distal side” and the right side is defined as “proximal side”.

図１に示すように、Ｙコネクタ１は、例えば、カテーテル２のハブ等とカテーテル接続部４を接続して使用される。これにより、Ｙコネクタ１を通じてカテーテル２内に、ガイドワイヤのような長尺部材からなる挿入物３を挿入できるように構成されている。 As shown in FIG. 1, the Y connector 1 is used by connecting a hub or the like of the catheter 2 and the catheter connecting portion 4, for example. As a result, an insert 3 made of a long member such as a guide wire can be inserted into the catheter 2 through the Y connector 1.

Ｙコネクタ１は、Ｙ字状の筒状本体部材１０と、筒状本体部材１０の先端部（遠位側）に設けたカテーテル接続部４と、筒状本体部材１０の基端側（近位側）に設けたキャップ部材２０と、筒状本体部材１０内に組み込んだ弁体３０とを有している。以下、各部の構成について説明する。 The Y connector 1 includes a Y-shaped cylindrical main body member 10, a catheter connecting portion 4 provided at the distal end (distal side) of the cylindrical main body member 10, and a proximal end side (proximal) of the cylindrical main body member 10. And a valve body 30 incorporated in the cylindrical main body member 10. Hereinafter, the structure of each part is demonstrated.

図１に示すように、Ｙ字状の筒状本体部材１０は、先端から基端にわたって貫通するチューブ状の本体部１１と、本体部１１の途中部から斜めに分岐するチューブ状の分岐部１２とを有し、分岐部１２の外端部にはシリンジまたは三方活栓を接続するための接続部１３が形成され、本体部１１の基端部の外周部にはキャップ部材２０を取付けるための雄ネジ１４が形成されている。 As shown in FIG. 1, a Y-shaped cylindrical main body member 10 includes a tubular main body portion 11 that penetrates from the distal end to the proximal end, and a tubular branch portion 12 that branches obliquely from a middle portion of the main body portion 11. A connecting portion 13 for connecting a syringe or a three-way stopcock is formed at the outer end portion of the branching portion 12, and a male portion for attaching the cap member 20 to the outer peripheral portion of the base end portion of the main body portion 11. A screw 14 is formed.

本体部１１内には本体内腔部１５が形成され、分岐部１２内には本体内腔部１５に連通する分岐内腔部１６が形成され、シリンジまたは三方活栓により分岐内腔部１６に供給した造影剤や生理食塩水は、分岐内腔部１６及び弁体３０よりも先端側の本体内腔部１５を経て、Ｙコネクタ１に接続したカテーテル２に注入されるように構成されている。なお、Ｙコネクタ１が医療機器に相当し、本体内腔部１５が医療機器の流体通路に相当する。 A main body lumen portion 15 is formed in the main body portion 11, and a branch lumen portion 16 communicating with the main body lumen portion 15 is formed in the branch portion 12, and supplied to the branch lumen portion 16 by a syringe or a three-way cock. The contrast medium and physiological saline thus prepared are configured to be injected into the catheter 2 connected to the Y connector 1 through the branch lumen 16 and the main body lumen 15 on the distal side of the valve body 30. The Y connector 1 corresponds to a medical device, and the main body lumen 15 corresponds to a fluid passage of the medical device.

本体内腔部１５は、分岐内腔部１６の連通部よりも基端側の途中部に形成した、先端側へ向けて縮径するテーパ面からなる環状の段差部１５ａと、段差部１５ａよりも先端側（遠位側）に形成した小径部１５ｂと、段差部１５ａよりも基端側（近位側）に形成した大径部１５ｃとを有している。 The main body cavity portion 15 includes an annular step portion 15a formed in a middle portion on the proximal side of the communication portion of the branch lumen portion 16 and having a tapered surface with a diameter reduced toward the distal end side, and a step portion 15a. Also has a small-diameter portion 15b formed on the distal end side (distal side) and a large-diameter portion 15c formed on the proximal end side (proximal side) with respect to the stepped portion 15a.

キャップ部材２０は、本体部１１の雄ネジ１４に螺合する雌ネジ２１を形成したキャップ本体２２と、キャップ本体２２の中央部から先端側へ突出する円筒状の操作筒部２３とを有し、操作筒部２３を本体内腔部１５の大径部１５ｃに内嵌させて、筒状本体部材１０の雄ネジ１４に雌ネジ２１を螺合させることによって、筒状本体部材１０に組み付けられている。 The cap member 20 includes a cap main body 22 in which a female screw 21 that is screwed into the male screw 14 of the main body portion 11 is formed, and a cylindrical operation cylinder portion 23 that protrudes from the center portion of the cap main body 22 toward the distal end side. The operation cylinder portion 23 is fitted into the large diameter portion 15 c of the main body lumen portion 15, and the female screw 21 is screwed into the male screw 14 of the cylindrical main body member 10, thereby being assembled to the cylindrical main body member 10. ing.

弁体３０は、操作筒部２３の先端側において本体内腔部１５の大径部１５ｃに液密状に内嵌され、本体部１１の雄ネジ１４に対するキャップ部材２０の雌ネジ２１のねじ込み量に応じて、操作筒部２３の先端部で大径部１５ｃの先端側へ押し操作されるように構成されている。また、弁体３０の先端側への移動は段差部１５ａにより規制され、これにより小径部１５ｂ内に弁体３０が押し出されないように構成されている。更に、弁体３０が段差部１５ａに圧接されることで、弁体３０の外周部と本体内腔部１５とが液密状に保持されるとともに、段差部１５ａのテーパ面により弁体３０が縮径方向に圧縮変形するように構成されている。 The valve body 30 is liquid-tightly fitted into the large-diameter portion 15 c of the main body lumen portion 15 on the distal end side of the operation cylinder portion 23, and the screwing amount of the female screw 21 of the cap member 20 with respect to the male screw 14 of the main body portion 11. Accordingly, it is configured such that the distal end portion of the operation cylinder portion 23 is pushed to the distal end side of the large diameter portion 15c. Further, the movement of the valve body 30 toward the distal end side is restricted by the step portion 15a, so that the valve body 30 is not pushed out into the small diameter portion 15b. Furthermore, when the valve body 30 is pressed against the step portion 15a, the outer peripheral portion of the valve body 30 and the main body lumen 15 are held in a liquid-tight state, and the valve body 30 is held by the tapered surface of the step portion 15a. It is comprised so that it may compress-deform in a diameter reducing direction.

ガイドワイヤなどの挿入物３は、操作筒部２３の貫通孔２４に挿入されて、Ｙコネクタ１内に導入され、弁体３０の切込部３５及び本体内腔部１５の小径部１５ｂを通って、Ｙコネクタ１に接続されたカテーテル２内に挿入されている。そして、挿入物３が弁体３０の切込部３５に常時液密状に挿入されることで、キャップ部材２０の螺合を緩めた状態においても、弁体３０に挿入物３を挿入した状態で、本体内腔部１５の先端側と基端側とが弁体３０を介して液密状に常時仕切られるように構成されている。ただし、キャップ部材２０を締め付けると、弁体３０の外周部が段差部１５ａに圧接されるとともに、弁体３０が縮径方向に圧縮変形して、弁体３０の内面が挿入物３に強く圧接されるので、挿入物３の移動が規制されるとともに、本体内腔部１５の先端側に大きな流体圧が作用した場合でも、弁体３０の外周部と本体内後部１５間が液密状に保持されるとともに、挿入物３と弁体３０間が液密状に保持される。なお、本体内腔部１５の先端側に作用する流体圧としては、Ｙコネクタ１先端側からうける血圧やＹコネクタ１に接続されたシリンジからの流体の注入圧などがある。 An insert 3 such as a guide wire is inserted into the through hole 24 of the operation tube portion 23 and introduced into the Y connector 1, and passes through the cut portion 35 of the valve body 30 and the small diameter portion 15 b of the body lumen portion 15. And inserted into the catheter 2 connected to the Y connector 1. And the state which inserted the insert 3 in the valve body 30 also in the state which loosened the screwing of the cap member 20 by always inserting the insert 3 in the notch part 35 of the valve body 30 in the liquid-tight state. Thus, the distal end side and the proximal end side of the main body lumen portion 15 are always partitioned in a liquid-tight manner via the valve body 30. However, when the cap member 20 is tightened, the outer peripheral portion of the valve body 30 is pressed against the stepped portion 15a, and the valve body 30 is compressed and deformed in the direction of diameter reduction, so that the inner surface of the valve body 30 is pressed strongly against the insert 3. Therefore, the movement of the insert 3 is restricted, and even when a large fluid pressure acts on the distal end side of the main body lumen portion 15, the space between the outer peripheral portion of the valve body 30 and the rear portion 15 in the main body is liquid-tight. While being held, the space between the insert 3 and the valve body 30 is held in a liquid-tight manner. The fluid pressure acting on the distal end side of the main body lumen 15 includes blood pressure received from the distal end side of the Y connector 1 and fluid injection pressure from a syringe connected to the Y connector 1.

なお、筒状本体部材１０及びキャップ部材２０の素材としては、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、ポリカーボネート、アクリル樹脂、ポリアミドのような各種合成樹脂を好適に採用できるが、これに限定されるものではない。 In addition, as a raw material of the cylindrical main body member 10 and the cap member 20, various synthetic resins such as polyvinyl chloride, polyethylene, polypropylene, polycarbonate, acrylic resin, and polyamide can be suitably used, but the material is not limited thereto. Absent.

次に、弁体３０の具体的構成について説明する。
図１〜図６に示すように、弁体３０は、本体内腔部１５の大径部１５ｃに液密状に内嵌する円筒状の筒部３１と、筒部３１の先端部に連なって弁体３０の先端側部分に本体内腔部１５の先端側へ突出状に形成した先端へ行くにしたがって縮径するテーパ部３２と、筒部３１及びテーパ部３２の内側に形成したガイドワイヤなどの挿入物３よりも大径のガイド孔３３と、挿入物３が挿入されるテーパ部３２の先端部の挿入部３４に形成した切込部３５と、テーパ部３２の外周部に先端側へ突出状に形成した環状のシール部３６とを備えている。ただし、弁体３０の構成は、適用するＹコネクタ１の構成などに応じて適宜に変更することが可能で、例えば円板状の弁体を採用することも可能である。 Next, a specific configuration of the valve body 30 will be described.
As shown in FIGS. 1 to 6, the valve body 30 is connected to a cylindrical tube portion 31 that fits in a liquid-tight manner in the large-diameter portion 15 c of the main body lumen portion 15, and a distal end portion of the tube portion 31. A tapered portion 32 that decreases in diameter as it goes to the distal end of the valve body 30 that protrudes toward the distal end of the main body lumen 15, a guide wire that is formed inside the cylindrical portion 31 and the tapered portion 32, etc. The guide hole 33 having a diameter larger than that of the insert 3, the notch 35 formed in the insertion portion 34 at the tip of the tapered portion 32 into which the insert 3 is inserted, and the outer periphery of the taper 32 toward the distal side And an annular seal portion 36 formed in a protruding shape. However, the configuration of the valve body 30 can be changed as appropriate according to the configuration of the Y connector 1 to be applied. For example, a disc-shaped valve body can be adopted.

弁体３０を構成する素材としては、シリコーンゴム、ウレタンゴム、フッ素ゴム、アクリルゴム等の各種剛性ゴム、天然ゴム、またはポリアミド系、ポリエステル系等の各種熱可塑性エラストマーのような弾性材料を採用できる。 As a material constituting the valve body 30, various rigid rubbers such as silicone rubber, urethane rubber, fluorine rubber, and acrylic rubber, natural rubber, or elastic materials such as various thermoplastic elastomers such as polyamide and polyester can be adopted. .

弁体３０の外径は本体内腔部１５の大径部１５ｃよりも大きい寸法に形成され、弁体３０を縮径方向に圧縮しながら大径部１５ｃに内嵌することで、弁体３０と大径部１５ｃ間における液密性が得られるように構成されている。 The outer diameter of the valve body 30 is formed to be larger than the large diameter portion 15c of the main body lumen portion 15, and the valve body 30 is fitted into the large diameter portion 15c while compressing the valve body 30 in the diameter reducing direction. The liquid-tightness between the large-diameter portion 15c is obtained.

テーパ部３２の先端側には第１テーパ面３２ａが形成され、テーパ部３２の基端側には第１テーパ面３２ａよりも中心線とのなす角度の大きい第２テーパ面３２ｂが形成されている。テーパ部３２の先端部の挿入部３４には挿入物３を挿入可能とする切込部３５が形成され、第１テーパ面３２ａにより本体内腔部１５の先端側に作用する流体圧によって弁体３０は中心方向に押し込まれる。これらの圧力によっても弁体３０内に設けられる切込部３５が閉鎖されて、Ｙコネクタ１の液密性が保たれる。 A first tapered surface 32a is formed on the distal end side of the tapered portion 32, and a second tapered surface 32b having a larger angle with the center line than the first tapered surface 32a is formed on the proximal end side of the tapered portion 32. Yes. The insertion portion 34 at the distal end portion of the tapered portion 32 is formed with a cut portion 35 through which the insert 3 can be inserted, and the valve element is caused by the fluid pressure acting on the distal end side of the body lumen portion 15 by the first tapered surface 32a. 30 is pushed in the center direction. The cut portion 35 provided in the valve body 30 is also closed by these pressures, and the liquid tightness of the Y connector 1 is maintained.

弁体３０の基端側に形成される第２テーパ面３２ｂは、中心線に対する角度が本体内腔部１５の段差部１５ａのテーパ面と同じになるように形成され、キャップ部材２０を締め込んだときに、弁体３０が本体内腔部１５の先端側へ押し出されることを防止できるように構成されている。 The second taper surface 32b formed on the proximal end side of the valve body 30 is formed so that the angle with respect to the center line is the same as the taper surface of the step portion 15a of the body lumen portion 15, and the cap member 20 is tightened. At this time, the valve body 30 is configured to be prevented from being pushed out toward the distal end side of the main body lumen portion 15.

シール部３６の内周面には先端側へ行くにしたがって拡径するテーパ面が形成され、これによりシール部３６が本体内腔部１５の先端側に作用する流体圧で大径部１５ｃの内面に押し付けられるため、弁体３０の外周面からの造影剤や生理食塩水のような流体の流出を防止できるように構成されている。 The inner peripheral surface of the seal portion 36 is formed with a taper surface that increases in diameter as it goes to the distal end side, whereby the seal portion 36 is subjected to the fluid pressure acting on the distal end side of the main body lumen portion 15 and the inner surface of the large diameter portion 15c. Therefore, the fluid such as the contrast medium or the physiological saline from the outer peripheral surface of the valve body 30 can be prevented from flowing out.

図４〜図６に示すように、弁体３０の先端部の挿入部３４には、挿入部３４の先端側から基端側への全長に亘って、挿入物３の挿入中心から半径方向の外側へ延びる幅Ｗを有する切込部３５が形成され、切込部３５の内面の少なくとも一部の面は、その一部の面に接する平面と、挿入中心の中心線ＣＬの方向（弁体３０の中心線の方向）との交差する最小角θが、０°＜θ＜９０°になるように構成されている。 As shown in FIGS. 4 to 6, the insertion portion 34 at the distal end portion of the valve body 30 extends in the radial direction from the insertion center of the insert 3 over the entire length from the distal end side to the proximal end side of the insertion portion 34. A notch 35 having a width W extending outward is formed, and at least a part of the inner surface of the notch 35 has a plane in contact with the part and a direction of the center line CL of the insertion center (valve element). The minimum angle θ intersecting with the direction of the center line of 30 is configured to satisfy 0 ° <θ <90 °.

具体的には、図６に示すように、挿入物３の挿入中心から半径方向外方側へ延びる幅Ｗを有し、該挿入中心の中心線ＣＬに沿って螺旋状に周回する帯状の２個の切込部３５を、挿入中心を挟んで半径方向両側に設けることができる。図５は、図６のａ-ａ線、ｂ-ｂ線、ｃ-ｃ線での断面図で、切込部３５の内面は自然状態で常に閉塞しており、その断面は一文字状に形成されている。 Specifically, as shown in FIG. 6, a band-shaped 2 having a width W extending radially outward from the insertion center of the insert 3 and spirally wrapping around the center line CL of the insertion center. The notches 35 can be provided on both sides in the radial direction with the insertion center interposed therebetween. FIG. 5 is a cross-sectional view taken along the lines aa, bb, and cc of FIG. 6, and the inner surface of the cut portion 35 is always closed in a natural state, and the cross section is formed in a single character. Has been.

切込部３５の幅Ｗの寸法は特に限定されないが、挿入物３の外径に応じて設定することが好ましく、例えば、挿入物３としてガイドワイヤをＹコネクタ１内に導入するために用いるガイドワイヤインサータを用いる場合には、最大外径が０．９ｍｍであれば、幅Ｗを０．４５ｍｍ以上に設定することで、挿入物３による切込部３５の損傷を抑制できる。なお、幅Ｗは、大きく設定するほど摺動性は向上する。 The dimension of the width W of the notch 35 is not particularly limited, but is preferably set according to the outer diameter of the insert 3, for example, a guide used for introducing a guide wire into the Y connector 1 as the insert 3. When the wire inserter is used, if the maximum outer diameter is 0.9 mm, damage to the cut portion 35 due to the insert 3 can be suppressed by setting the width W to 0.45 mm or more. Note that as the width W is set larger, the slidability is improved.

図６に示すような形状の切込部３５は、例えばドリル状の加工ツール４０を用いて加工できる。具体的には、図７に示すように、加工ツール４０として、回転中心ＲＣから半径方向外方側へ延びる幅を有し、回転中心ＲＣに沿って螺旋状に周回する２枚の帯状の切刃４１を備えたものを用いることになる。加工ツール４０及び弁体３０を同軸上に配置して、加工ツール４０を回転させながら送り操作して、弁体３０の挿入部３４全長にわたって切込部３５を形成し、その後加工ツール４０を逆回転させながら、弁体３０の挿入部３４から加工ツール４０を引き抜くことで、切込部３５を形成することになる。加工ツールではなく弁体を回転させて同様に形成してもよい。より具体的には、加工ツール４０を挿入部３４に挿入することで、弾性材料で形成されている弁体３０は加工ツール４０の挿入とともに延伸される。そして、徐々に加工ツール４０を推し進めると弁体３０は加工ツール４０の形状に密着しながら引き裂かれ、これにより切込部３５が形成されることになる。また、延伸された状態で形成された切込部３５は、加工ツール４０を引き戻すと弾性によって弁体３０の中心方向に収縮するため、図６に示すように、自然状態では閉塞された切込部３５が形成される。 The cut portion 35 having a shape as shown in FIG. 6 can be processed using, for example, a drill-like processing tool 40. Specifically, as shown in FIG. 7, as the processing tool 40, two strip-shaped cuts having a width extending radially outward from the rotation center RC and spirally wound along the rotation center RC. The thing provided with the blade 41 is used. The machining tool 40 and the valve body 30 are arranged on the same axis, and the feeding operation is performed while rotating the machining tool 40 to form the cut portion 35 over the entire length of the insertion portion 34 of the valve body 30, and then the machining tool 40 is reversed. The cutting part 35 is formed by pulling out the processing tool 40 from the insertion part 34 of the valve body 30 while rotating. You may form similarly by rotating a valve body instead of a processing tool. More specifically, by inserting the processing tool 40 into the insertion portion 34, the valve body 30 formed of an elastic material is stretched along with the insertion of the processing tool 40. Then, when the processing tool 40 is gradually advanced, the valve body 30 is torn while being in close contact with the shape of the processing tool 40, thereby forming the cut portion 35. Further, since the cut portion 35 formed in the stretched state contracts in the center direction of the valve body 30 by elasticity when the processing tool 40 is pulled back, the cut portion which is closed in the natural state as shown in FIG. A portion 35 is formed.

なお、弁体３０の切込部３５を加工する際にシリコーンオイルを添加することで切込部３５の内面にシリコーン層を形成してもよい。この場合には、切込部３５の内面に摩擦係数が小さいシリコーン層が形成されることによって、切込部３５に対する挿入物３の摺動性が向上する。またシリコーン層によって切込部３５の内面同士の隙間が密になるため、切込部３５における液密性を向上させることができる。また、加工ツール４０の先端部に先鋭部を突出状に形成し、弾性材料からなる挿入部３４を圧縮変形させながら、切込みを入れるように構成することも好ましい。更に、図８のような４個の切込部３５を十文字状に配置したものや、３個の切込部３５をＹ字状に配置したものなどは、切込部３５に適合する形状及び大きさの切刃を有する加工ツールを用いて上記と同様に加工することができる。 Note that a silicone layer may be formed on the inner surface of the cut portion 35 by adding silicone oil when the cut portion 35 of the valve body 30 is processed. In this case, the slidability of the insert 3 with respect to the cut portion 35 is improved by forming a silicone layer having a small friction coefficient on the inner surface of the cut portion 35. Moreover, since the clearance gap between the inner surfaces of the notch part 35 becomes dense with a silicone layer, the liquid-tightness in the notch part 35 can be improved. Further, it is also preferable that a sharpened portion is formed in a protruding shape at the distal end portion of the processing tool 40 and the insertion portion 34 made of an elastic material is compressed and deformed to make a cut. Further, the shape in which the four cut portions 35 as shown in FIG. 8 are arranged in a cross shape, the shape in which the three cut portions 35 are arranged in a Y shape, etc. It can process similarly to the above using the processing tool which has a cutting blade of a size.

また、弁体３０が組み込まれる医療機器に挿入される長尺部材の材質・外径・硬度によって摺動性は異なるため、加工ツール４０の外径や切込部３５の挿通中心の軸方向の長さを調整することで実施形態と同様の作用・効果が得られる。 In addition, since the slidability varies depending on the material, outer diameter, and hardness of the long member inserted into the medical device in which the valve body 30 is incorporated, the outer diameter of the processing tool 40 and the axial direction of the insertion center of the cut portion 35 are different. By adjusting the length, the same actions and effects as in the embodiment can be obtained.

なお、挿入中心の中心線ＣＬに直交する断面での切込部３５の形状は、直線状だけでなく、湾曲状などの非直線状に形成することもできる。また、切込部３５の個数は任意に設定することが可能で、１個だけ形成することもできるし、挿入中心の中心線ＣＬを中心に周方向に間隔をあけて３個以上設けることもできる。例えば、図８に示すように、４個の切込部３５を周方向に９０°の間隔をあけて形成し、挿入中心の中心線に直交する断面での切込部３５の形状を十文字状に形成することができる。更に、複数の切込部３５を形成する場合には、切込部３５の幅Ｗを同じに設定することもできるが、異なる幅の切込部３５を設け、中心線ＣＬからの乖離距離が変化するように構成することも可能である。更にまた、切込部３５の内面の少なくとも一部の面が、その一部の面に接する平面と、挿入中心の中心線ＣＬの方向との交差する最小角θが、０°＜θ＜９０°になるように構成されていれば、任意の形状の切込部を形成することが可能であり、弁体３０の挿入部３４における切込部３５を形成した位置に、切込部３５に代えて、例えば図９、図１０に示すような、三角波状の切込部３５Ａや、正弦波状の切込部３５Ｂを形成することも可能である。また、この切込部３５Ａ、３５Ｂにおいては、中心線ＣＬからの乖離距離ＥＬが変化するとともに、中心線ＣＬに対する進入角が変化することになる。なお、「乖離距離ＥＬが変化する」とは、図９（ｂ）、図１０（ｂ）に示すように、挿入中心の中心線ＣＬに対する交差断面での切込部３５Ａ、３５Ｂの形状が、中心線ＣＬ方向の複数箇所において、中心線ＣＬからの乖離距離ＥＬを変えることを意味する。また、「進入角が変化する」とは、図９、図１０に示すように、切込部３５Ａ、３５Ｂが、中心線ＣＬ方向に沿うことなく（０°ではなく）、進入角度を有しており、その進入角度を切込部３５Ａ、３５Ｂにおける中心線ＣＬ方向の複数箇所において変えることを意味する。例えば、図９に示す切込部３５Ａのように、進入角度を交互に変化させたり、図１０に示す切込部３５Ｂのように、進入角度を連続的に変化させることになる。 Note that the shape of the cut portion 35 in a cross section orthogonal to the center line CL of the insertion center can be formed not only in a straight line but also in a non-linear shape such as a curved line. Further, the number of the cut portions 35 can be arbitrarily set, and can be formed only one, or three or more can be provided at intervals in the circumferential direction around the center line CL of the insertion center. it can. For example, as shown in FIG. 8, four notches 35 are formed at intervals of 90 ° in the circumferential direction, and the shape of the notches 35 in a cross section perpendicular to the center line of the insertion center is a cross shape. Can be formed. Furthermore, in the case of forming a plurality of cut portions 35, the width W of the cut portions 35 can be set to be the same, but the cut portions 35 having different widths are provided, and the separation distance from the center line CL is increased. It can also be configured to change. Furthermore, the minimum angle θ at which at least a part of the inner surface of the cut portion 35 intersects the plane in contact with the part and the direction of the center line CL of the insertion center is 0 ° <θ <90. It is possible to form a cut portion having an arbitrary shape as long as the cut portion 35 is formed at the position where the cut portion 35 is formed in the insertion portion 34 of the valve body 30. Instead, for example, a triangular wave-shaped cut portion 35A or a sine wave-shaped cut portion 35B as shown in FIGS. 9 and 10 can be formed. In addition, in the cut portions 35A and 35B, the divergence distance EL from the center line CL changes, and the approach angle with respect to the center line CL changes. In addition, as shown in FIG. 9B and FIG. 10B, “the deviation distance EL changes” means that the shapes of the cut portions 35A and 35B in the cross section with respect to the center line CL of the insertion center are as follows. This means that the deviation distance EL from the center line CL is changed at a plurality of locations in the direction of the center line CL. In addition, as shown in FIGS. 9 and 10, “the entry angle changes” means that the notches 35A and 35B have an entry angle without being along the direction of the center line CL (not 0 °). It means that the approach angle is changed at a plurality of locations in the direction of the center line CL in the cut portions 35A and 35B. For example, the approach angle is alternately changed like the cut portion 35A shown in FIG. 9, or the approach angle is continuously changed like the cut portion 35B shown in FIG.

このような構成の切込部３５を形成した弁体３０では、切込部３５の内面が自然状態で常に閉塞されており、しかも切込部３５の形状が複雑なので、造影剤・生理食塩水または血液等の流体が切込部３５を通ってＹコネクタ１外へ流出しにくくなる。また、切込部３５に挿入物３を挿入した状態で、切込部３５の内面が、弁体３０を構成する素材の弾性により、挿入物３の外面に圧接されるので、弁体３０と挿入物３間における液密性が保たれる。しかも、最小角θを０°＜θ＜９０°に設定しているので、弁体３０よりも先端側の本体内腔部１５の流体圧によって、弁体３０における切込部３５の先端側部分が挿入物３に圧接される方向に押されて、単に挿入中心の軸方向、即ち最小角θが０°の切込みを形成した従来の弁体３０と比較して、挿入物３と弁体３０間における液密性が高められることになる。また、このように液密性が高められるので、切込部３５の中心線方向の長さを短く設定して、挿入物３に対する弁体３０の摺動抵抗を小さくでき、挿入物３の操作性を向上できる。しかも、図６に示す切込部３５のように、挿入中心の中心線ＣＬに沿って螺旋状に周回するように形成すると、切込部３５により形成される挿入部３４の切片が、切込部３５に挿入される挿入物３の外形に沿って拡縮するので、挿入物３と切込部３５の内面間における隙間を小さくして、液密性を一層向上することができる。 In the valve body 30 in which the cut portion 35 having such a configuration is formed, the inner surface of the cut portion 35 is always closed in a natural state, and the shape of the cut portion 35 is complicated. Or, fluid such as blood is less likely to flow out of the Y connector 1 through the notch 35. Further, with the insert 3 inserted into the notch 35, the inner surface of the notch 35 is pressed against the outer surface of the insert 3 by the elasticity of the material constituting the valve 30. Liquid tightness between the inserts 3 is maintained. Moreover, since the minimum angle θ is set to 0 ° <θ <90 °, the tip side portion of the notch 35 in the valve body 30 is caused by the fluid pressure in the body lumen 15 on the tip side of the valve body 30. Is pushed in the direction pressed against the insert 3, and the insert 3 and the valve body 30 are simply compared with the conventional valve body 30 in which an axial direction of the insertion center, that is, a cut having a minimum angle θ of 0 ° is formed. The liquid tightness between the two will be improved. In addition, since the liquid tightness is improved in this way, the length of the cut portion 35 in the center line direction can be set short to reduce the sliding resistance of the valve body 30 with respect to the insert 3, and the operation of the insert 3 can be reduced. Can be improved. In addition, as in the case of the notch portion 35 shown in FIG. 6, when it is formed so as to spiral around the center line CL of the insertion center, the section of the insert portion 34 formed by the notch portion 35 becomes the notch. Since it expands / contracts along the outer shape of the insert 3 inserted into the portion 35, the gap between the inner surface of the insert 3 and the cut portion 35 can be reduced to further improve the liquid tightness.

なお、本実施の形態では、Ｙコネクタ１に本発明の弁体３０を適用した場合について説明したが、これに限定されず、シースイントロデューサ、マイクロカテーテルおよびバルーンカテーテル等の各カテーテル等の医療機器に対しても本発明の弁体３０を適用することができる。例えばガイドワイヤルーメンと造影剤を含むバルーン拡張用流体が通過する内腔が併用される単一管腔バルーンカテーテルに組み入れた場合、弁体３０によってカテーテル内腔には生体内からの血液の流入が抑制されるため、Ｘ線下におけるバルーンの視認性低下が抑制される。 In the present embodiment, the case where the valve body 30 of the present invention is applied to the Y connector 1 has been described. However, the present invention is not limited to this, and medical devices such as sheath introducers, microcatheters, balloon catheters, and other catheters. The valve body 30 of the present invention can also be applied to the above. For example, when incorporated in a single lumen balloon catheter in which a lumen through which a balloon-expanding fluid containing a guide wire lumen and a contrast medium passes is used in combination, the valve body 30 causes blood from the living body to flow into the catheter lumen. Since it is suppressed, the visibility fall of the balloon under X-ray | X_line is suppressed.

また、挿入物３としては、適用する医療機器に応じて、ガイドワイヤのような長尺部材以外に、注射針などの短尺物や、薬液などの流体を挿入することもできる。 In addition to the long member such as a guide wire, a short object such as an injection needle or a fluid such as a drug solution can be inserted as the insert 3 depending on the medical device to be applied.

次に、弁体３０の作用効果を確認するために行った評価試験について説明する。 Next, an evaluation test performed for confirming the effect of the valve body 30 will be described.

＜評価試験１＞
切込部の挿入中心の軸方向の長さに関する評価試験を下記の通り行った。 <Evaluation test 1>
An evaluation test on the axial length of the insertion center of the cut portion was performed as follows.

１．弁体
弁体として、切込部の挿入中心の軸方向の長さが、０．５ｍｍ、１．０ｍｍ、１．５ｍｍの３種の弁体をシリコーンゴムで作製した。そして、弁体の先端部に、外径０．９ｍｍの加工ツール４０で切込部を加工した。 1. Valve body Three types of valve bodies having axial lengths of 0.5 mm, 1.0 mm, and 1.5 mm in the insertion center of the cut portion were made of silicone rubber. And the notch part was processed into the front-end | tip part of the valve body with the processing tool 40 with an outer diameter of 0.9 mm.

２．弁性能評価
作製した３種の弁体をＹコネクタ１に組み込み、Ｙコネクタ１内に水を満たした上で２００ｍｍＨ₂Ｏの内圧を付与した。水圧下でＹコネクタ１内からの水の流出を確認するとともに、外径０．２５ｍｍのガイドワイヤを挿入したときの水漏れの有無を確認した。その結果を表１に示す。ただし、水漏れの発生しなかった弁体は「○」で示し、水漏れの発生した弁体は「×」で示した。 2. Valve performance evaluation The three types of produced valve bodies were assembled in the Y connector 1 and the Y connector 1 was filled with water, and then an internal pressure of 200 mmH ₂ O was applied. While confirming the outflow of water from the Y connector 1 under water pressure, the presence or absence of water leakage when a guide wire having an outer diameter of 0.25 mm was inserted was confirmed. The results are shown in Table 1. However, a valve element that did not cause water leakage was indicated by “◯”, and a valve element that caused water leakage was indicated by “x”.

３．摺動性評価
作製した３種の弁体をＹコネクタ１に配置し、Ｙコネクタ１内に外径０．２５ｍｍのガイドワイヤ(ポリテトラフルオロエチレンコーティング)を挿入して、摺動性を触感にて評価した。その結果を表１に示す。ただし、摺動抵抗の大きな弁体は「×」で示し、摺動抵抗の小さい弁体は「○」で示した。 3. Evaluation of sliding property Three kinds of manufactured valve bodies are arranged in the Y connector 1 and a guide wire (polytetrafluoroethylene coating) having an outer diameter of 0.25 mm is inserted into the Y connector 1 so that the sliding property is tactile. And evaluated. The results are shown in Table 1. However, a valve element having a large sliding resistance is indicated by “x”, and a valve element having a small sliding resistance is indicated by “◯”.

＜評価試験例２＞
切込部の加工径に関する評価試験を下記の通り行った。 <Evaluation Test Example 2>
An evaluation test on the machining diameter of the cut portion was performed as follows.

１．弁体
弁体として、外径が０．９ｍｍ、１．１ｍｍの２種類の加工ツールを用いて切込部３５を形成した２種の弁体と、外径が１．１ｍｍの加工ツールを用いて、シリコーンオイル付与して切込部を形成した弁体の計３種の弁体をシリコーンゴムで作製した。 1. Valve body As the valve body, two kinds of valve bodies in which the cut portion 35 is formed using two kinds of machining tools having an outer diameter of 0.9 mm and 1.1 mm, and a machining tool having an outer diameter of 1.1 mm are used. Then, a total of three types of valve bodies, which were provided with silicone oil and formed a cut portion, were made of silicone rubber.

２．弁性能評価
作製した３種の弁体をＹコネクタ１に配置し、Ｙコネクタ１内に水を満たした上で２００ｍｍＨ₂Ｏの内圧を付与した。水圧下でＹコネクタ１内からの水の流出を確認するとともに、外径０．２５ｍｍのガイドワイヤを挿入したときの水漏れの有無を確認した。その結果を表２に示す。ただし、水漏れの発生しなかった弁体は「○」で示した。 2. Valve performance evaluation The produced three types of valve bodies were arranged in the Y connector 1, and after filling the Y connector 1 with water, an internal pressure of 200 mmH ₂ O was applied. While confirming the outflow of water from the Y connector 1 under water pressure, the presence or absence of water leakage when a guide wire having an outer diameter of 0.25 mm was inserted was confirmed. The results are shown in Table 2. However, the valve body where no water leak occurred is indicated by “◯”.

３．摺動性評価
作製した２種の弁体が配置されたＹコネクタ１内に生理食塩水と造影剤の混合液（体積比１：１）を満たし、外径０．３５ｍｍのガイドワイヤを挿入して摺動させて摺動荷重をフォースゲージ(日本電産シンポ社製)で測定した。ガイドワイヤは速度１０ｍｍ／ｓｅｃ、ストローク２０ｍｍで５往復摺動し、押込み時と引き戻し時のそれぞれのピーク荷重の平均値を測定した。その結果を表２に示す。 3. Sliding performance evaluation The Y connector 1 in which the prepared two types of valve bodies are arranged is filled with a mixed solution of physiological saline and contrast medium (volume ratio 1: 1), and a guide wire having an outer diameter of 0.35 mm is inserted. The sliding load was measured with a force gauge (manufactured by Nidec Symposium). The guide wire was slid 5 reciprocations at a speed of 10 mm / sec and a stroke of 20 mm, and the average value of each peak load at the time of pushing and pulling was measured. The results are shown in Table 2.

表１と表２から、Ｙコネクタ１に挿入されるカテーテルの外径によって切込部の挿入中心の軸方向の長さと加工方法を設定することで、弁性能と摺動性を両立できることを確認した。 From Table 1 and Table 2, it is confirmed that both the valve performance and slidability can be achieved by setting the axial length of the insertion center of the incision and the processing method according to the outer diameter of the catheter inserted into the Y connector 1 did.

１Ｙコネクタ２カテーテル
３挿入物４カテーテル接続部
１０筒状本体部材１１本体部
１２分岐部１３接続部
１４雄ネジ１５本体内腔部
１５ａ段差部１５ｂ小径部
１５ｃ大径部１６分岐内腔部
２０キャップ部材２１雌ネジ
２２キャップ本体２３操作筒部
２４貫通孔
３０弁体３１筒部
３２テーパ部３２ａ第１テーパ面
３２ｂ第２テーパ面３３ガイド孔
３４挿入部３５切込部
３６シール部
３５Ａ切込部３５Ｂ切込部
４０加工ツール４１切刃
DESCRIPTION OF SYMBOLS 1 Y connector 2 Catheter 3 Insert 4 Catheter connection part 10 Tubular main body member 11 Main body part 12 Branch part 13 Connection part 14 Male screw 15 Body cavity part 15a Step part 15b Small diameter part 15c Large diameter part 16 Branch lumen part 20 Cap member 21 Female screw 22 Cap body 23 Operation cylinder portion 24 Through hole 30 Valve body 31 Tube portion 32 Taper portion 32a First taper surface 32b Second taper surface 33 Guide hole 34 Insertion portion 35 Cut portion 36 Seal portion 35A Cut Part 35B Cutting part 40 Processing tool 41 Cutting blade

Claims

In the valve body for a medical device arranged in a fluid passage in the medical device,
The valve body includes an insertion portion into which an insert is inserted,
The insert includes a notch having a width extending radially outward from the insertion center of the insert over its entire length extending from the distal side to the proximal side,
In the said notch part, the valve body for medical devices in which at least one surface of the inner surface of the notch part satisfy | fills the following conditional expression (1).
0 ° <θ <90 ° (1)
However,
θ: At least a part of the inner surface has an angle toward the proximal side when viewed from the distal side in the axis in which the insert is inserted, and a plane in contact with the part of the surface; This is the minimum angle that intersects the axial direction of the insertion center.

The medical device valve body according to claim 1, wherein a shape of the cut portion in a cross section with respect to the axial direction of the insertion center changes at a plurality of locations in the axial direction.

3. The change is that the shape of the cut portion at a plurality of locations in the axial direction rotates around the axial direction or changes a deviation distance from the axial direction. The valve body for medical equipment as described.

The said cutting part is a valve body for medical devices of any one of Claims 1-3 which change at least one part in a full length non-linearly.

The non-linear shape means that the approach angle of the cut portion with respect to the insert portion is partially different in the full length of the cut portion from the proximal side to the distal side in the full length of the insert portion. The medical device valve body according to claim 4.

The said notch part is a valve body for medical devices of any one of Claims 1-5 extended in the said curved shape or linear shape toward the outer side from the insertion center of the said insert.

The valve body for a medical device according to any one of claims 1 to 6, wherein a plurality of the cut portions are formed at intervals in the circumferential direction around the insertion center of the insert.

The valve body for medical devices according to claim 7, wherein a plurality of types of cut portions having different widths as the cut portion are formed.

An annular stepped portion formed in the middle of the fluid passage of the medical device, a small-diameter portion formed distal to the stepped portion, and a large-diameter portion formed proximal to the stepped portion. A cylindrical portion fitted into the large-diameter portion is formed on the proximal side of the valve body, and a tapered portion that is reduced in diameter toward the distal side is formed on the distal side of the valve body. The cut portion is formed at the distal portion of the tapered portion with the center line of the tapered portion as the insertion center, and an annular seal portion capable of being pressed against the stepped portion on the outer peripheral portion of the tapered portion is directed to the distal side. The valve body for medical devices of any one of Claims 1-8 formed in the protruding shape.

The medical device valve body according to claim 9, wherein the valve body for a medical device is configured with a tapered surface whose diameter increases toward the distal side on an inner peripheral surface of the seal portion.

A medical device formed by fitting the valve body for medical device according to any one of claims 1 to 10 into a fluid passage and closing the fluid passage.

A method for manufacturing a valve body for a medical device disposed in a fluid passage of the medical device,
The insertion part into which the insert of the valve body formed of an elastic material is inserted includes a cutting process for forming a cutting part using a processing tool,
In the cutting step, as the processing tool, using a processing tool having a band-shaped cutting blade having a width extending radially outward from the rotation center axis and spirally wound along the rotation center axis, A feed operation is performed while rotating the processing tool, and a cut portion is formed over the entire length of the insertion portion of the valve body.
The manufacturing method of the valve body for medical devices characterized by the above-mentioned.