JP6805619B2 - Indwelling needle assembly - Google Patents

Indwelling needle assembly Download PDF

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JP6805619B2
JP6805619B2 JP2016157250A JP2016157250A JP6805619B2 JP 6805619 B2 JP6805619 B2 JP 6805619B2 JP 2016157250 A JP2016157250 A JP 2016157250A JP 2016157250 A JP2016157250 A JP 2016157250A JP 6805619 B2 JP6805619 B2 JP 6805619B2
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needle
tip
needle hub
peripheral surface
hub
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JP2018023587A (en
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慎吾 阪本
慎吾 阪本
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Nipro Corp
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Description

本発明は、輸液や採血、血液透析等を行う際に、血管に穿刺されて留置される留置針組立体に係り、特に、使用後の内針の針先を保護する針先プロテクタ部材を備えた留置針組立体に関するものである。 The present invention relates to an indwelling needle assembly that is punctured and indwelled in a blood vessel when performing infusion, blood collection, hemodialysis, etc., and particularly includes a needle tip protector member that protects the needle tip of the inner needle after use. It relates to an indwelling needle assembly.

従来から、外針と外針ハブとからなる外針ユニットに対して内針と内針ハブとからなる内針ユニットを挿通させて両ユニットを相互に組み付けた留置針組立体が知られている。このような留置針組立体では、外針が外挿された状態の内針を経皮的に血管へ穿刺した後、外針ユニットを穿刺方向前方へ押し出すことで、外針が内針により案内されつつ血管へ穿刺されることとなる。そして、外針の穿刺後、内針ユニットを外針ユニットから引き抜くことで、外針が血管に留置されるようになっている。 Conventionally, an indwelling needle assembly in which an inner needle unit consisting of an inner needle and an inner needle hub is inserted into an outer needle unit consisting of an outer needle and an outer needle hub and both units are assembled to each other has been known. .. In such an indwelling needle assembly, the outer needle is guided by the inner needle by percutaneously puncturing the blood vessel with the inner needle with the outer needle inserted and then pushing the outer needle unit forward in the puncture direction. It will be punctured into the blood vessel while being done. Then, after the outer needle is punctured, the inner needle unit is pulled out from the outer needle unit so that the outer needle is placed in the blood vessel.

また、かかる留置針組立体の内針ユニットは、穿刺後に外針ユニットから取り外した内針による誤穿刺を防止するために、内針の引抜き時に内針の針先を覆う針先プロテクタ部材を備えていることが望ましい。具体的には、特開２００３−１８０８３３号公報（特許文献１）に記載の留置針組立体では、内針を引き抜くことにより針先プロテクタ部材が内針の針先よりも先端側に移動して、内針の針先が保護されるようになっている。これにより、使用後の内針の誤穿刺が防止され得る。 Further, the inner needle unit of the indwelling needle assembly is provided with a needle tip protector member that covers the needle tip of the inner needle when the inner needle is pulled out in order to prevent erroneous puncture by the inner needle removed from the outer needle unit after puncture. It is desirable to have. Specifically, in the indwelling needle assembly described in Japanese Patent Application Laid-Open No. 2003-180833 (Patent Document 1), the needle tip protector member moves to the tip side of the needle tip of the inner needle by pulling out the inner needle. , The tip of the inner needle is protected. As a result, erroneous puncture of the inner needle after use can be prevented.

ところで、上記特許文献１に記載の留置針組立体では、外針ユニットから内針ユニットを引き抜いて外針ユニットを血管に留置する際には、外針ハブの外周面を手指で押さえて外針ユニットを患者の皮膚に固定させつつ内針を引き抜き、内針と外針とを相対移動させる。そして、内針の引抜きに伴い、針先プロテクタ部材が針軸上に移動して、内針の針先が針先プロテクタ部材で保護されるようになっている。 By the way, in the indwelling needle assembly described in Patent Document 1, when the inner needle unit is pulled out from the outer needle unit and the outer needle unit is placed in the blood vessel, the outer peripheral surface of the outer needle hub is pressed by a finger to hold the outer needle. The inner needle is pulled out while fixing the unit to the patient's skin, and the inner needle and the outer needle are moved relative to each other. Then, as the inner needle is pulled out, the needle tip protector member moves on the needle shaft, and the needle tip of the inner needle is protected by the needle tip protector member.

ところが、上記特許文献１に記載の留置針組立体では、外針ハブの外周面には手指を載置するための専用部分が形成されておらず、単に外針ハブの外周面が指置部とされていただけであった。それ故、外針ハブに置いた手指が滑って、安定して外針ハブを患者の皮膚に固定することが困難であった。それ故、内針の引抜時において外針に対して真っ直ぐ引き抜かれるべき内針がぶれて、内針の針先が針先プロテクタ部材によりうまく保護されなかったり、患者に穿刺されている外針が動いて患者が痛みを感じるおそれがあり、経験に加えて慎重な作業が必要であった。 However, in the indwelling needle assembly described in Patent Document 1, a dedicated portion for placing a finger is not formed on the outer peripheral surface of the outer needle hub, and the outer peripheral surface of the outer needle hub is simply the finger rest portion. It was just said. Therefore, the fingers placed on the outer needle hub slipped, and it was difficult to stably fix the outer needle hub to the patient's skin. Therefore, when the inner needle is pulled out, the inner needle that should be pulled out straight with respect to the outer needle is shaken, and the needle tip of the inner needle is not well protected by the needle tip protector member, or the outer needle punctured by the patient The patient could move and feel pain, which required careful work in addition to experience.

特開２００３−１８０８３３号公報Japanese Unexamined Patent Publication No. 2003-180833

本発明は、上述の事情を背景に為されたものであって、その解決課題は、外針から内針を安定して引き抜くことができる、新規な構造の留置針組立体を提供することにある。 The present invention has been made in the background of the above circumstances, and a solution thereof is to provide an indwelling needle assembly having a novel structure capable of stably pulling out an inner needle from an outer needle. is there.

以下、このような課題を解決するために為された本発明の態様を記載する。なお、以下に記載の各態様において採用される構成要素は、可能な限り任意の組み合わせで採用可能である。 Hereinafter, aspects of the present invention made to solve such problems will be described. The components adopted in each of the following aspects can be adopted in any combination as much as possible.

本発明の第１の態様は、外針ハブを基端側に有する外針に対して、内針ハブを基端側に有する内針が挿通されていると共に、針先プロテクタ部材が該内針に対して長さ方向で移動可能に装着された留置針組立体であって、前記針先プロテクタ部材において、該針先プロテクタ部材の前記外針ハブに対する基端側への移動を規制する規制部と、外部に露出する指置部と、該外針ハブの基端側開口部に挿入されて該指置部とは径方向反対側に位置する該外針ハブの周壁部の内周面に沿って先端側に延びて該内周面に当接する挿入部とが、一体的に設けられており、前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されていると共に、該雄ねじ部の外周側に延びだして前記指置部が設けられており、前記針先プロテクタ部材との移動を前記規制部で規制された該外針ハブが、該指置部へ加えられる操作力によって前記内針に対して該針先プロテクタ部材と共に先端側へ移動可能とされていることを特徴とするものである。 In the first aspect of the present invention, the inner needle having the inner needle hub on the proximal end side is inserted into the outer needle having the outer needle hub on the proximal end side, and the needle tip protector member is the inner needle. An indwelling needle assembly mounted so as to be movable in the length direction with respect to the needle tip protector member, which regulates the movement of the needle tip protector member toward the proximal end side with respect to the outer needle hub. On the inner peripheral surface of the peripheral wall portion of the outer needle hub, which is inserted into the opening on the base end side of the outer needle hub and is located on the side opposite to the finger rest portion in the radial direction. An insertion portion that extends along the tip side and abuts on the inner peripheral surface is integrally provided, and a male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub. The finger rest portion is provided so as to extend to the outer peripheral side of the male screw portion, and the outer needle hub whose movement with the needle tip protector member is restricted by the restrictor portion is added to the finger rest portion. It is characterized in that it can be moved toward the tip side together with the needle tip protector member with respect to the inner needle by an operating force.

本態様に従う構造とされた留置針組立体によれば、外針ハブとは別体とされた指置部が設けられていることから、当該指置部に手指を載置することで、内針の引抜時において、外針ハブを患者の皮膚に安定して位置決めすることができる。また、一般に、本態様の留置針組立体を使用する場合には、留置針組立体において指置部が設けられている側を周方向上側として、当該指置部に対して上方から手指が載置される。したがって、指置部とは径方向反対側に位置する挿入部は周方向下側に位置することとなり、指置部および挿入部を介して手指から及ぼされる押圧力が、外針ハブの周壁部の下側部分に直接的に作用する。これにより、外針ハブを皮膚に位置決め固定するための外力が及ぼされる箇所を従来より皮膚に近い位置とすることができて、手指からの押圧力を効率的に患者の皮膚および外針ハブに及ぼすことができる。この結果、外針ハブが、不用意なぐらつきを抑えられて患者の皮膚に安定して固定的に位置決めされることとなり、外針からの内針の引抜操作も容易に行なうことが可能になる。 According to the indwelling needle assembly having a structure according to this aspect, since the finger resting portion is provided separately from the outer needle hub, by placing the finger on the finger resting portion, the inner part can be placed. When the needle is pulled out, the outer needle hub can be stably positioned on the patient's skin. In general, when the indwelling needle assembly of this embodiment is used, the finger is placed on the indwelling needle assembly from above with the side where the finger rest is provided as the upper side in the circumferential direction. Be placed. Therefore, the insertion portion located on the radial side opposite to the finger rest portion is located on the lower side in the circumferential direction, and the pressing force exerted from the finger through the finger rest portion and the insertion portion is applied to the peripheral wall portion of the outer needle hub. It acts directly on the lower part. As a result, the place where the external force for positioning and fixing the outer needle hub to the skin can be located closer to the skin than before, and the pressing force from the fingers can be efficiently applied to the patient's skin and the outer needle hub. Can exert. As a result, the outer needle hub is stably and fixedly positioned on the patient's skin by suppressing inadvertent wobbling, and the inner needle can be easily pulled out from the outer needle. ..

本態様に従う構造とされた留置針組立体によれば、針先プロテクタ部材には、外針ハブに対する基端側への移動を規制する規制部が設けられている。一方、外針ハブの周壁部の内周面に沿って内方（先端側）に延びる挿入部が設けられていることから、当該挿入部と外針ハブとを係合させることも可能となる。そして、かかる挿入部が外針ハブに対して係合される場合には、これら規制部と挿入部とにより、針先プロテクタ部材と外針ハブとが周方向の複数箇所で係合される。それ故、外針ハブの押出操作時などに内針を相対的に引抜方向へ変位させた際にも、針先プロテクタ部材と外針ハブとの係合が意図せず解除されるおそれが低減され得て、内針の針先の露出が効果的に防止され得る。 According to the indwelling needle assembly having a structure according to this embodiment, the needle tip protector member is provided with a regulating portion for restricting movement toward the proximal end side with respect to the outer needle hub. On the other hand, since the insertion portion extending inward (tip side) along the inner peripheral surface of the peripheral wall portion of the outer needle hub is provided, it is possible to engage the insertion portion with the outer needle hub. .. When such an insertion portion is engaged with the outer needle hub, the needle tip protector member and the outer needle hub are engaged at a plurality of points in the circumferential direction by the restricting portion and the insertion portion. Therefore, even when the inner needle is relatively displaced in the pulling direction during the extrusion operation of the outer needle hub, the risk of unintentional disengagement between the needle tip protector member and the outer needle hub is reduced. The exposure of the needle tip of the inner needle can be effectively prevented.

本発明の第２の態様は、前記第１の態様に係る留置針組立体において、前記外針ハブの前記周壁部の周方向で部分的に位置して、前記挿入部が該外針ハブの該周壁部の内周面に沿って先端側に延びて設けられているものである。
本発明の第３の態様は、前記第１又は第２の態様に係る留置針組立体において、前記雄ねじ部の外周側に汚染防止部が設けられており、該汚染防止部と前記指置部とが一体的に設けられているものである。 A second aspect of the present invention is that in the indwelling needle assembly according to the first aspect, the outer needle hub is partially located in the circumferential direction of the peripheral wall portion, and the insertion portion is the outer needle hub. It is provided so as to extend toward the tip side along the inner peripheral surface of the peripheral wall portion.
A third aspect of the present invention is that in the indwelling needle assembly according to the first or second aspect, a contamination prevention portion is provided on the outer peripheral side of the male screw portion, and the contamination prevention portion and the finger placement portion are provided. Is provided integrally with.

本態様に従う構造とされた留置針組立体によれば、外針ハブの基端側開口部の外周面には雄ねじ部が形成されていることから、外針の留置後に、外針ハブに対してルアーロックタイプの外部流路などを接続することが可能となる。特に、かかる雄ねじ部の外周側に汚染防止部が設けられていることから、外針ハブの押出操作時などに施術者が雄ねじ部に接触して雄ねじ部に細菌などが付着することなどが効果的に防止され得る。それ故、外針ハブへの外部流路などの接続時に、外針ハブから患者の血管中に細菌が混入するなどのおそれが効果的に低減され得る。また、指置部と汚染防止部が一体的に設けられていることから、指置部に載置される手指が汚染防止部以外に接触することが効果的に回避されて、雄ねじ部に細菌などが付着することなどが一層効果的に防止され得る。 According to the indwelling needle assembly having a structure according to this embodiment, since a male screw portion is formed on the outer peripheral surface of the opening on the base end side of the outer needle hub, the outer needle hub is subjected to the placement of the outer needle. It is possible to connect a luer lock type external flow path. In particular, since the contamination prevention portion is provided on the outer peripheral side of the male screw portion, it is effective that the practitioner comes into contact with the male screw portion and bacteria or the like adhere to the male screw portion during the extrusion operation of the outer needle hub. Can be prevented. Therefore, when connecting the external flow path to the outer needle hub, the risk of bacteria being mixed into the patient's blood vessel from the outer needle hub can be effectively reduced. In addition, since the finger rest portion and the contamination prevention portion are integrally provided, it is effectively prevented that the fingers placed on the finger rest portion come into contact with other than the contamination prevention portion, and bacteria are formed on the male screw portion. It is possible to prevent the adhesion of such substances more effectively.

本発明の第４の態様は、前記第３の態様に係る留置針組立体において、前記指置部が前記雄ねじ部の外周側に位置して、該指置部により前記汚染防止部が構成されているものである。 In a fourth aspect of the present invention, in the indwelling needle assembly according to the third aspect, the finger rest portion is located on the outer peripheral side of the male screw portion, and the finger rest portion constitutes the contamination prevention portion. Is what you are doing.

本態様に従う構造とされた留置針組立体によれば、指置部により汚染防止部が構成されていることから、指置部および汚染防止部が必要以上に大きくなることが回避されて、留置針組立体の取扱性が向上され得る。また、汚染防止部を、例えば周方向下側（患者の皮膚側）に設けなくすることもできて、留置針組立体の穿刺時に、汚染防止部が患者の皮膚に接触して患者が痛みを感じたり穿刺操作に悪影響を及ぼすおそれも回避され得る。 According to the indwelling needle assembly having a structure according to this aspect, since the contamination prevention portion is formed by the finger placement portion, it is possible to prevent the finger placement portion and the contamination prevention portion from becoming unnecessarily large and indwell. The handleability of the needle assembly can be improved. Further, it is possible not to provide the contamination prevention part on the lower side in the circumferential direction (the patient's skin side), for example, and when the indwelling needle assembly is punctured, the contamination prevention part comes into contact with the patient's skin and causes pain to the patient. The risk of feeling or adversely affecting the puncture operation can also be avoided.

本発明の第５の態様は、前記第３又は第４の態様に係る留置針組立体において、前記指置部が前記外針ハブの前記雄ねじ部よりも先端側にまで延びているものである。 A fifth aspect of the present invention is that in the indwelling needle assembly according to the third or fourth aspect, the finger rest portion extends to the tip end side of the male screw portion of the outer needle hub. ..

本態様に従う構造とされた留置針組立体によれば、指置部が外針ハブの雄ねじ部よりも先端側にまで延びていることから、施術者が雄ねじ部に接触するおそれが一層低減されて、患者の血管中に細菌などが混入することがより効果的に防止され得る。 According to the indwelling needle assembly having a structure according to this embodiment, since the finger rest portion extends to the tip side of the external needle hub from the male screw portion, the possibility that the practitioner comes into contact with the male screw portion is further reduced. Therefore, it is possible to more effectively prevent bacteria and the like from being mixed into the blood vessels of the patient.

本発明の第６の態様は、前記第１〜第５の何れかの態様に係る留置針組立体において、前記指置部の先端側に連続して外周側へ突出する指先押圧部が形成されているものである。 In a sixth aspect of the present invention, in the indwelling needle assembly according to any one of the first to fifth aspects, a fingertip pressing portion that continuously projects to the outer peripheral side is formed on the tip end side of the finger resting portion. Is what you are doing.

本態様に従う構造とされた留置針組立体によれば、指置部の先端側に連続して指先押圧部が形成されていることから、施術者が指置部に載置した手指に対して先端側に力を加えて指先押圧部を押圧することで、操作力を外針ハブに伝達させることができて、外針および外針ハブを安定して押し出すことができる。特に、留置針組立体の把持と外針ハブの押出操作を片方の手で行うことができることから、施術者の負担が軽減され得る。 According to the indwelling needle assembly having a structure according to this aspect, since the fingertip pressing portion is continuously formed on the tip side of the finger resting portion, the practitioner can refer to the finger placed on the finger resting portion. By applying a force to the tip side to press the fingertip pressing portion, the operating force can be transmitted to the outer needle hub, and the outer needle and the outer needle hub can be pushed out stably. In particular, since the indwelling needle assembly can be gripped and the outer needle hub can be extruded with one hand, the burden on the practitioner can be reduced.

さらに、外針ハブに、外周側に突出する指先押圧部が設けられないことから、患者の皮膚に外針ハブをテーピング固定する際に、指先押圧部が患者の皮膚に当接して患者が苦痛を感じるなどのおそれも軽減され得る。 Further, since the outer needle hub is not provided with the fingertip pressing portion protruding to the outer peripheral side, when the outer needle hub is taped and fixed to the patient's skin, the fingertip pressing portion comes into contact with the patient's skin and causes pain to the patient. The risk of feeling is also reduced.

本発明の第７の態様は、前記第６の態様に係る留置針組立体において、前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されていると共に、該雄ねじ部よりも先端側に位置して前記指先押圧部が設けられているものである。 According to a seventh aspect of the present invention, in the indwelling needle assembly according to the sixth aspect, a male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub, and the male screw portion is used. Is also located on the tip side and is provided with the fingertip pressing portion.

本態様に従う構造とされた留置針組立体によれば、指先押圧部が、外針ハブの基端側開口部の外周面に形成される雄ねじ部よりも先端側に設けられていることから、指置部が形成されるためのスペースを大きく確保することができて、施術者が指置部に手指を安定して載置することができる。 According to the indwelling needle assembly having a structure according to this embodiment, the fingertip pressing portion is provided on the tip side of the male screw portion formed on the outer peripheral surface of the base end side opening of the outer needle hub. A large space for forming the finger rest can be secured, and the practitioner can stably place the fingers on the finger rest.

本発明の第８の態様は、前記第６又は第７の態様に係る留置針組立体において、前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、該リテーナに対して前記指置部および前記指先押圧部が形成されていると共に、該リテーナには、該指置部および該指先押圧部に対して前記内針を挟んだ径方向反対側に位置して前記挿入部が形成されているものである。 An eighth aspect of the present invention is the indwelling needle assembly according to the sixth or seventh aspect, wherein the needle tip protector member is a protector body that covers the tip of the inner needle and a retainer that holds the protector body. The finger rest portion and the fingertip pressing portion are formed on the retainer, and the retainer has the inner needle on the finger rest portion and the fingertip pressing portion. The insertion portion is formed so as to be located on the opposite side in the radial direction across the.

本態様に従う構造とされた留置針組立体によれば、針先プロテクタ部材がプロテクタ本体とリテーナとを含んで構成されており、当該リテーナに対して指置部、指先押圧部および挿入部が形成されることから、プロテクタ本体の構造を簡単なものとすることができる。特に、プロテクタ本体とリテーナとが別体で形成されることから、プロテクタ本体とリテーナとの材質を相互に異ならせることができて、例えば内針の先端を覆うプロテクタ本体を金属などで形成する一方、複雑な形状のリテーナを合成樹脂などで形成することも可能となる。 According to the indwelling needle assembly having a structure according to this aspect, the needle tip protector member is configured to include a protector main body and a retainer, and a finger rest portion, a finger tip pressing portion and an insertion portion are formed on the retainer. Therefore, the structure of the protector main body can be simplified. In particular, since the protector body and the retainer are formed separately, the materials of the protector body and the retainer can be made different from each other. For example, the protector body covering the tip of the inner needle is formed of metal or the like. It is also possible to form a retainer having a complicated shape with a synthetic resin or the like.

本発明の第９の態様は、前記第６〜第８の何れかの態様に係る留置針組立体において、前記指置部および前記指先押圧部が、前記外針ハブに対して周方向に回転不能とされているものである。 A ninth aspect of the present invention is that in the indwelling needle assembly according to any one of the sixth to eighth aspects, the finger resting portion and the fingertip pressing portion rotate in the circumferential direction with respect to the outer needle hub. It is considered impossible.

本態様に従う構造とされた留置針組立体によれば、指置部および指先押圧部が、外針ハブに対して周方向に回転不能とされていることから、指置部に手指を載置しつつ指先押圧部を押し込んで外針ハブを押し出す際に、指置部および指先押圧部が外針ハブに対して回転することが防止されて、操作力が外針ハブに安定して伝達され得る。 According to the indwelling needle assembly having a structure according to this aspect, since the finger resting portion and the fingertip pressing portion cannot rotate in the circumferential direction with respect to the outer needle hub, the finger is placed on the finger resting portion. When the fingertip pressing part is pushed in and the outer needle hub is pushed out, the finger rest part and the fingertip pressing part are prevented from rotating with respect to the outer needle hub, and the operating force is stably transmitted to the outer needle hub. obtain.

本発明の第１０の態様は、前記第９の態様に係る留置針組立体において、前記指置部又は前記指先押圧部の内周面と前記外針ハブの外周面との間には、相互の係合作用で周方向に位置決めする周方向位置決め用の係合部が設けられているものである。 A tenth aspect of the present invention is that in the indwelling needle assembly according to the ninth aspect, the inner peripheral surface of the finger resting portion or the fingertip pressing portion and the outer peripheral surface of the outer needle hub are mutually connected. An engaging portion for circumferential positioning is provided for positioning in the circumferential direction by the engaging action of the above.

本態様に従う構造とされた留置針組立体によれば、指置部および指先押圧部と外針ハブとの周方向の位置決めが、指置部または指先押圧部の内周面と外針ハブの外周面との間に設けられた周方向位置決め用の係合部により安定して実現され得る。 According to the indwelling needle assembly having a structure according to this embodiment, the positioning of the finger rest portion and the fingertip pressing portion and the outer needle hub in the circumferential direction is performed by positioning the inner peripheral surface of the finger rest portion or the fingertip pressing portion and the outer needle hub. It can be stably realized by the engaging portion for circumferential positioning provided between the outer peripheral surface and the peripheral surface.

本発明の第１１の態様は、前記第６〜第１０の何れかの態様に係る留置針組立体において、前記指置部又は前記指先押圧部の内周面と前記外針ハブの外周面との間には、相互の係合作用で長さ方向に位置決めする長さ方向位置決め用の係合部が設けられているものである。 An eleventh aspect of the present invention relates to the inner peripheral surface of the finger resting portion or the fingertip pressing portion and the outer peripheral surface of the outer needle hub in the indwelling needle assembly according to any one of the sixth to tenth aspects. An engaging portion for positioning in the length direction for positioning in the length direction by mutual engagement is provided between the two.

本態様に従う構造とされた留置針組立体によれば、指置部および指先押圧部と外針ハブとが長さ方向で位置決めされることから、指置部および指先押圧部と外針ハブとが長さ方向で意図せず相対変位することが防止される。それ故、指先押圧部に対して先端側に外力を及ぼして指先押圧部を長さ方向に押し出すことで、外針ハブに対して押込方向の操作力を安定して及ぼすことができる。 According to the indwelling needle assembly having a structure according to this embodiment, since the finger rest portion, the fingertip pressing portion and the outer needle hub are positioned in the length direction, the finger rest portion, the fingertip pressing portion and the outer needle hub Is prevented from being unintentionally displaced relative to the length direction. Therefore, by applying an external force to the tip side of the fingertip pressing portion to push out the fingertip pressing portion in the length direction, it is possible to stably exert an operating force in the pushing direction on the outer needle hub.

本発明の第１２の態様は、前記第１〜第１１の何れかの態様に係る留置針組立体において、前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されており、該雄ねじ部の外周側に前記指置部が設けられている一方、該指置部の内周面には内周側に突出する下方突出部が設けられて、該下方突出部により前記規制部が構成されていると共に、該下方突出部の基端側面が長さ方向に対して傾斜しているものである。 In the twelfth aspect of the present invention, in the indwelling needle assembly according to any one of the first to eleventh aspects, a male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub. The finger resting portion is provided on the outer peripheral side of the male screw portion, while the inner peripheral surface of the finger resting portion is provided with a downward protruding portion projecting to the inner peripheral side, and the downward protruding portion regulates the above. The portion is configured, and the side surface of the base end of the downward projecting portion is inclined with respect to the length direction.

本態様に従う構造とされた留置針組立体によれば、指置部の内周面に設けられた下方突出部により規制部が構成されていることから、内針を引き抜く以前の初期状態では、下方突出部により針先プロテクタ部材の外針ハブに対する基端側への移動が規制されて、針先プロテクタ部材と外針ハブとが相互に連結されている。そして、外針から内針を引き抜くことで、針先プロテクタ部材と外針ハブとの連結が解除され得る。その際、下方突出部の基端側面が長さ方向に対して傾斜していることから、当該基端側面によって針先プロテクタ部材の移動がガイドされて、針先プロテクタ部材が外針ハブとの連結を解除する方向に安定して移動することができる。 According to the indwelling needle assembly having a structure according to this aspect, since the regulating portion is composed of the downward protruding portion provided on the inner peripheral surface of the finger resting portion, in the initial state before the inner needle is pulled out, The downward protrusion restricts the movement of the needle tip protector member to the proximal end side with respect to the outer needle hub, and the needle tip protector member and the outer needle hub are connected to each other. Then, by pulling out the inner needle from the outer needle, the connection between the needle tip protector member and the outer needle hub can be released. At that time, since the base end side surface of the downward protrusion is inclined with respect to the length direction, the movement of the needle tip protector member is guided by the base end side surface, and the needle tip protector member is brought into contact with the outer needle hub. It can move stably in the direction of breaking the connection.

本発明の第１３の態様は、前記第１〜第１２の何れかの態様に係る留置針組立体において、前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、該リテーナには、該プロテクタ本体の外周を囲む周壁部が設けられており、該周壁部が前記内針ハブに対して周方向に位置決めされて挿し入れられている一方、該周壁部から先端側に突出して前記挿入部が形成されているものである。 A thirteenth aspect of the present invention is the indwelling needle assembly according to any one of the first to twelfth aspects, wherein the needle tip protector member includes a protector body covering the tip of the inner needle and the protector body. It is configured to include a retainer to be held, and the retainer is provided with a peripheral wall portion surrounding the outer periphery of the protector main body, and the peripheral wall portion is positioned in the circumferential direction with respect to the inner needle hub and inserted. On the other hand, the insertion portion is formed so as to project from the peripheral wall portion toward the tip end side.

本態様に従う構造とされた留置針組立体によれば、針先プロテクタ部材がプロテクタ本体とリテーナとを含んで構成されており、当該リテーナには、プロテクタ本体における外周を囲む周壁部が設けられていることから、例えばリテーナの周壁部に対してプロテクタ本体を挿入することで、針先プロテクタ部材が容易に構成され得る。特に、周壁部が内針ハブに対して周方向で位置決めされることから、内針および内針ハブに対して針先プロテクタ部材が回転してしまうことが効果的に防止され得る。 According to the indwelling needle assembly having a structure according to this aspect, the needle tip protector member is configured to include a protector main body and a retainer, and the retainer is provided with a peripheral wall portion surrounding the outer periphery of the protector main body. Therefore, for example, by inserting the protector main body into the peripheral wall portion of the retainer, the needle tip protector member can be easily constructed. In particular, since the peripheral wall portion is positioned in the circumferential direction with respect to the inner needle hub, it is possible to effectively prevent the needle tip protector member from rotating with respect to the inner needle and the inner needle hub.

本発明の第１４の態様は、前記第１〜第１３の何れかの態様に係る留置針組立体において、前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、該リテーナに対して前記挿入部が形成されていると共に、該挿入部の外周面が前記外針ハブの内周面に沿って周方向に広がる円弧状面とされているものである。 A fourteenth aspect of the present invention is the indwelling needle assembly according to any one of the first to thirteenth aspects, wherein the needle tip protector member includes a protector body covering the tip of the inner needle and the protector body. It is configured to include a retainer to be held, the insertion portion is formed with respect to the retainer, and the outer peripheral surface of the insertion portion is a circle extending in the circumferential direction along the inner peripheral surface of the outer needle hub. It is an arcuate surface.

本態様に従う構造とされた留置針組立体によれば、挿入部の外周面が外針ハブの内周面に対応する円弧状面とされていることから、例えば挿入部の外周面と外針ハブの内周面とをより確実に係合させることができて、意図せず針先プロテクタ部材と外針ハブとの係合が解除されるおそれが一層低減され得るだけでなく、外針ハブ内部が挿入部によって傷つけられるといった事態が防止され得る。 According to the indwelling needle assembly having a structure according to this aspect, the outer peripheral surface of the insertion portion is an arcuate surface corresponding to the inner peripheral surface of the outer needle hub. Therefore, for example, the outer peripheral surface of the insertion portion and the outer needle Not only can the inner peripheral surface of the hub be more reliably engaged, the risk of unintentional disengagement between the needle tip protector member and the outer needle hub can be further reduced, but also the outer needle hub. The situation where the inside is damaged by the insertion portion can be prevented.

本発明に従う構造とされた留置針組立体によれば、患者への穿刺状態において外針ハブを患者の皮膚に対してより安定して固定的に位置決めすることができ、内針の外針からの引抜操作も容易に且つ安定して行なうことが可能となる。 According to the indwelling needle assembly having a structure according to the present invention, the outer needle hub can be more stably and fixedly positioned with respect to the patient's skin in the state of being punctured by the patient, and the outer needle of the inner needle can be positioned from the outer needle. The withdrawal operation can be easily and stably performed.

本発明の１実施形態としての留置針組立体の全体を針先プロテクタ部材と外針ハブとが連結した状態で示す斜視図。The perspective view which shows the whole indwelling needle assembly as one Embodiment of this invention in the state which the needle tip protector member and the outer needle hub are connected. 図１に示された留置針組立体の縦断面図。The vertical sectional view of the indwelling needle assembly shown in FIG. 図２における要部を拡大して示す縦断面図。FIG. 2 is an enlarged vertical sectional view showing a main part in FIG. 図２における要部を拡大して示す縦断面斜視図。FIG. 2 is an enlarged vertical cross-sectional perspective view showing a main part in FIG. 図１に示された留置針組立体を内針の針先が針先プロテクタ部材で保護された状態で示す斜視図。FIG. 3 is a perspective view showing the indwelling needle assembly shown in FIG. 1 in a state where the needle tip of the inner needle is protected by the needle tip protector member. 図５に示された留置針組立体の要部を拡大して示す別方向からの斜視図。FIG. 5 is an enlarged perspective view of a main part of the indwelling needle assembly shown in FIG. 5 from another direction. 図５に示された留置針組立体の縦断面図。FIG. 5 is a vertical cross-sectional view of the indwelling needle assembly shown in FIG. 図７における要部を拡大して示す縦断面図。FIG. 7 is an enlarged vertical sectional view showing a main part in FIG. 7. 図７における要部を拡大して示す縦断面斜視図。FIG. 7 is an enlarged vertical cross-sectional perspective view showing a main part in FIG. 7.

以下、本発明の実施形態について、図面を参照しつつ説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.

先ず、図１〜４には、本発明の１実施形態としての留置針組立体１０が示されている。この留置針組立体１０は、内針ユニット１２と外針ユニット１４を含んで構成されている。すなわち、内針ユニット１２は、先端に針先１６を有する内針１８と、内針１８の基端側に設けられた内針ハブ２０とを備えており、さらに、内針１８に対して長さ方向で移動可能に外挿された針先プロテクタ部材２２が装着されている。一方、外針ユニット１４は、外針２４と、外針２４の基端側に設けられた外針ハブ２６とを備えており、かかる外針ユニット１４に対して内針ユニット１２の内針１８が基端側から挿通されることで、留置針組立体１０が構成されている。そして、留置針組立体１０の穿刺後に外針ユニット１４から内針１８が引き抜かれることにより、外針ユニット１４が患者の皮膚に留置される一方、針先プロテクタ部材２２が内針１８の先端側に移動して内針１８の針先１６が保護されるようになっている。なお、以下の説明において、長さ方向とは内針１８および外針２４の針軸方向となる図２中の左右方向をいう。また、先端側とは内針１８の針先１６側である図２中の左側をいう一方、基端側とは使用者が操作する側である図２中の右側をいう。さらに、上方向および下方向とは、それぞれ図２中の上方向および下方向をいう。 First, FIGS. 1 to 4 show an indwelling needle assembly 10 as an embodiment of the present invention. The indwelling needle assembly 10 includes an inner needle unit 12 and an outer needle unit 14. That is, the inner needle unit 12 includes an inner needle 18 having a needle tip 16 at the tip thereof and an inner needle hub 20 provided on the base end side of the inner needle 18, and is longer than the inner needle 18. A needle tip protector member 22 that is extrapolated so as to be movable in the longitudinal direction is attached. On the other hand, the outer needle unit 14 includes an outer needle 24 and an outer needle hub 26 provided on the base end side of the outer needle 24, and the inner needle 18 of the inner needle unit 12 is provided with respect to the outer needle unit 14. Is inserted from the proximal end side to form the indwelling needle assembly 10. Then, the inner needle 18 is pulled out from the outer needle unit 14 after the indwelling needle assembly 10 is punctured, so that the outer needle unit 14 is placed on the patient's skin, while the needle tip protector member 22 is on the tip side of the inner needle 18. The needle tip 16 of the inner needle 18 is protected by moving to. In the following description, the length direction refers to the left-right direction in FIG. 2, which is the needle axis direction of the inner needle 18 and the outer needle 24. The tip end side means the left side in FIG. 2 which is the needle tip 16 side of the inner needle 18, while the base end side means the right side in FIG. 2 which is the side operated by the user. Further, the upward direction and the downward direction refer to the upward direction and the downward direction in FIG. 2, respectively.

より詳細には、内針ユニット１２における内針１８は、鋭利な形状とされた針先１６を有する中空針であり、例えばステンレス鋼、アルミニウム、チタンまたはそれらの合金などの公知の材料から形成されている。すなわち、内針１８の針先１６には、軸方向に対して傾斜する方向に広がる刃面２７が形成されており、これにより、内針１８が患者の皮膚などに容易に穿刺されるようになっている。なお、本実施形態では、かかる刃面２７が上方を向くようになっている。また、内針１８の先端部分には、僅かに外径寸法が大きくされた大径部２８が形成されており、本実施形態では径方向１方向の両側（図２中の上下方向両側）に一対の大径部２８，２８が形成されている。なお、内針１８は中実針であってもよい。 More specifically, the inner needle 18 in the inner needle unit 12 is a hollow needle having a sharply shaped needle tip 16 and is formed of a known material such as stainless steel, aluminum, titanium or an alloy thereof. ing. That is, the needle tip 16 of the inner needle 18 is formed with a blade surface 27 that spreads in a direction that is inclined with respect to the axial direction, so that the inner needle 18 can be easily punctured into the skin of a patient or the like. It has become. In the present embodiment, the blade surface 27 faces upward. Further, a large diameter portion 28 having a slightly larger outer diameter is formed at the tip portion of the inner needle 18, and in the present embodiment, both sides in the radial direction (both sides in the vertical direction in FIG. 2) are formed. A pair of large diameter portions 28, 28 are formed. The inner needle 18 may be a solid needle.

さらに、内針１８の基端側に設けられた内針ハブ２０は、ポリプロピレン等の硬質の合成樹脂材料で形成されており、全体として長手の略円筒形状とされている。かかる内針ハブ２０の長さ方向中間部分における内周面には、内周側に突出する環状の中間壁部３０が設けられており、当該中間壁部３０の内周縁部からは、基端側に向かって筒状部３２が突出形成されている。この筒状部３２に対して内針１８の基端が挿通されて、必要に応じて接着などの処理が施されることにより内針１８の基端が筒状部３２に固着されており、これによって、内針１８の基端が内針ハブ２０に固定支持されている。 Further, the inner needle hub 20 provided on the base end side of the inner needle 18 is made of a hard synthetic resin material such as polypropylene, and has a substantially cylindrical shape as a whole. An annular intermediate wall portion 30 projecting to the inner peripheral side is provided on the inner peripheral surface of the intermediate portion of the inner needle hub 20 in the length direction, and a proximal end thereof is provided from the inner peripheral edge portion of the intermediate wall portion 30. The tubular portion 32 is formed so as to project toward the side. The base end of the inner needle 18 is inserted through the tubular portion 32, and the base end of the inner needle 18 is fixed to the tubular portion 32 by performing a process such as adhesion as necessary. As a result, the base end of the inner needle 18 is fixedly supported by the inner needle hub 20.

また、内針ハブ２０の基端側開口部には、略筒状とされたキャップ部材３４の先端部分が圧入されて固着されている。このキャップ部材３４の内部には、液体は通過不能とされるが気体は通過することのできるフィルタ３６が設けられている。なお、かかる内針ハブ２０やキャップ部材３４を透明な材質により形成することで、留置針組立体１０の穿刺時において、逆血（フラッシュバック）が容易に確認され得る。 Further, the tip portion of the cap member 34 having a substantially tubular shape is press-fitted and fixed to the opening on the base end side of the inner needle hub 20. Inside the cap member 34, a filter 36 is provided so that a liquid cannot pass through but a gas can pass through. By forming the inner needle hub 20 and the cap member 34 with a transparent material, back blood (flashback) can be easily confirmed at the time of puncturing the indwelling needle assembly 10.

さらに、内針ハブ２０における中間壁部３０より先端側は、内径寸法が大きくされたカバー筒部３８とされている。これにより、カバー筒部３８の内周側には先端側に開口する収容空所４０が形成されている。かかる収容空所４０は、幅寸法（図２中の紙面手前奥方向寸法）よりも上下方向寸法の方が大きくされた縦長の形状とされており、本実施形態では、略矩形状とされている。なお、カバー筒部３８の先端において、周上の一部（図２中の上部）には、切欠状の窓部４２が形成されている。 Further, the tip side of the inner needle hub 20 from the intermediate wall portion 30 is a cover cylinder portion 38 having an increased inner diameter. As a result, a storage space 40 that opens to the tip side is formed on the inner peripheral side of the cover cylinder portion 38. The accommodation space 40 has a vertically long shape in which the vertical dimension is larger than the width dimension (the dimension in the front-back direction of the paper surface in FIG. 2), and in the present embodiment, the accommodation space 40 has a substantially rectangular shape. There is. At the tip of the cover cylinder 38, a notch-shaped window 42 is formed in a part of the circumference (upper part in FIG. 2).

一方、外針ユニット１４において、外針２４はチューブ形状とされており、適度な可撓性を有する材料、例えばエチレン―テトラフルオロエチレン共重合体（ＥＴＦＥ）、ポリウレタン、ポリエーテルナイロン樹脂等の各種の軟質樹脂により形成されている。なお、外針２４の先端部分の外周面は、先細となるテーパ状外周面４４とされており、生体への穿刺抵抗が軽減されている。また、外針２４の先端部分の周壁に貫通孔を設けることで、外針２４に対する流体の流通効率の向上を図ることも可能である。 On the other hand, in the outer needle unit 14, the outer needle 24 has a tube shape, and various materials having appropriate flexibility, such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, and polyether nylon resin, are used. It is made of the soft resin of. The outer peripheral surface of the tip portion of the outer needle 24 is a tapered outer peripheral surface 44, which reduces the puncture resistance to the living body. Further, by providing a through hole in the peripheral wall of the tip portion of the outer needle 24, it is possible to improve the flow efficiency of the fluid with respect to the outer needle 24.

さらに、外針２４の基端側に設けられた外針ハブ２６は、ポリプロピレン等の硬質の合成樹脂材料で形成されており、全体として長さ方向に延びる周壁部４６を有する略円筒形状とされている。かかる外針ハブ２６の先端には、カシメピン４８が内挿されており、外針ハブ２６の周壁部４６とカシメピン４８との間で外針２４の基端を挟み込んで、必要に応じて接着などの処理が施されることにより、外針２４の基端が外針ハブ２６に固定支持されている。なお、かかるカシメピン４８よりも基端側では、外針ハブ２６の内周面４９および外周面５０のそれぞれが、先端側から基端側に向かって次第に内径寸法および外径寸法が大きくなるテーパ面とされている。 Further, the outer needle hub 26 provided on the base end side of the outer needle 24 is made of a hard synthetic resin material such as polypropylene, and has a substantially cylindrical shape having a peripheral wall portion 46 extending in the length direction as a whole. ing. A caulking pin 48 is inserted into the tip of the outer needle hub 26, and the base end of the outer needle 24 is sandwiched between the peripheral wall portion 46 of the outer needle hub 26 and the caulking pin 48, and if necessary, adhesion or the like is performed. The base end of the outer needle 24 is fixedly supported by the outer needle hub 26 by the treatment of. On the proximal end side of the caulking pin 48, each of the inner peripheral surface 49 and the outer peripheral surface 50 of the outer needle hub 26 is a tapered surface in which the inner diameter dimension and the outer diameter dimension gradually increase from the tip end side toward the proximal end side. It is said that.

また、外針ハブ２６の外周面５０における基端側開口部５２には、外周側に突出する雄ねじ部５４が形成されている。かかる雄ねじ部５４が形成されることで、外針ユニット１４が患者の皮膚に留置された後に、例えば外針ハブ２６の基端側開口部５２に対してルアーロックタイプのシリンジ等が接続され得るようになっている。なお、雄ねじ部５４には、周上の一部（図２中の上部）において切欠状の凹溝部５６が形成されており、当該凹溝部５６が外周側に開口して長さ方向に延びている。本実施形態では、凹溝部５６が略矩形断面を有しており、長さ方向の全長に亘って略一定の溝幅寸法とされている。 Further, a male screw portion 54 projecting to the outer peripheral side is formed in the proximal end side opening 52 on the outer peripheral surface 50 of the outer needle hub 26. By forming such a male screw portion 54, after the outer needle unit 14 is placed on the skin of the patient, for example, a luer lock type syringe or the like can be connected to the proximal end side opening 52 of the outer needle hub 26. It has become like. The male screw portion 54 is formed with a notched concave groove portion 56 in a part of the circumference (upper part in FIG. 2), and the concave groove portion 56 opens to the outer peripheral side and extends in the length direction. There is. In the present embodiment, the concave groove portion 56 has a substantially rectangular cross section, and has a substantially constant groove width dimension over the entire length in the length direction.

更にまた、外針ハブ２６の内径は、挿通される内針１８の外径よりも大きくされており、外針ハブ２６の内部には止血弁機構５８が収容されている。この止血弁機構５８の構造は何等限定されるものではないが、本実施形態では、止血弁本体６０と押し子６２と押し子ガイド６４とから構成されている。 Furthermore, the inner diameter of the outer needle hub 26 is made larger than the outer diameter of the inner needle 18 to be inserted, and the hemostatic valve mechanism 58 is housed inside the outer needle hub 26. The structure of the hemostatic valve mechanism 58 is not limited in any way, but in the present embodiment, it is composed of a hemostatic valve main body 60, a pusher 62, and a pusher guide 64.

止血弁本体６０は中央にスリット６６（図８参照）が形成されたディスク弁とされており、弾性を有するゴム弾性体やエラストマーにより形成されている。なお、本実施形態の止血弁本体６０は、基端面の外周端から基端側に突出する筒状支持部６８が設けられているとともに、当該基端面における筒状支持部６８よりも内周側には、基端側に開口する環状凹部７０が形成されている。 The hemostatic valve main body 60 is a disc valve having a slit 66 (see FIG. 8) formed in the center, and is formed of an elastic rubber elastic body or an elastomer. The hemostatic valve main body 60 of the present embodiment is provided with a tubular support portion 68 projecting from the outer peripheral end of the proximal end surface to the proximal end side, and is on the inner peripheral side of the tubular support portion 68 on the proximal end surface. Is formed with an annular recess 70 that opens to the proximal end side.

また、押し子６２は全体として略筒状とされており、内径寸法が内針１８の外径寸法より大きくされている。一方、押し子６２の長さ方向中間部分における外周面には、外径寸法が小さくされた環状凹溝７２が、軸方向で所定寸法をもって形成されている。 Further, the pusher 62 has a substantially tubular shape as a whole, and the inner diameter dimension is larger than the outer diameter dimension of the inner needle 18. On the other hand, an annular groove 72 having a reduced outer diameter is formed on the outer peripheral surface of the intermediate portion of the pusher 62 in the length direction with a predetermined dimension in the axial direction.

さらに、押し子ガイド６４は全体として略筒状とされており、基端には、内周側に突出する環状突部７４が形成されている。なお、本実施形態の押し子ガイド６４の先端面には、先端側に突出する先端筒部７６が形成されている。 Further, the pusher guide 64 has a substantially tubular shape as a whole, and an annular protrusion 74 protruding toward the inner peripheral side is formed at the base end. A tip cylinder portion 76 projecting toward the tip is formed on the tip surface of the pusher guide 64 of the present embodiment.

かかる止血弁本体６０が、外針ハブ２６の内部に径方向（例えば図２中の上下方向）で圧縮状態とされて収容配置されているとともに、止血弁本体６０の基端側に押し子６２と押し子ガイド６４が位置しており、押し子ガイド６４が、押し子６２と外針ハブ２６との径方向間に配置されている。また、押し子ガイド６４の環状突部７４が押し子６２の環状凹溝７２に嵌め入れられており、押し子６２が押し子ガイド６４に対して長さ方向に摺動して移動可能とされている。さらに、本実施形態では、止血弁本体６０の基端面に設けられた環状凹部７０に、押し子ガイド６４の先端筒部７６が挿入されており、環状凹部７０の底面と先端筒部７６の先端面とが相互に当接している。 The hemostatic valve main body 60 is housed and arranged inside the outer needle hub 26 in a radial direction (for example, in the vertical direction in FIG. 2) in a compressed state, and a pusher 62 is placed on the proximal end side of the hemostatic valve main body 60. And the pusher guide 64 are located, and the pusher guide 64 is arranged between the pusher 62 and the outer needle hub 26 in the radial direction. Further, the annular protrusion 74 of the pusher guide 64 is fitted into the annular recess 72 of the pusher 62 so that the pusher 62 can slide and move in the length direction with respect to the pusher guide 64. ing. Further, in the present embodiment, the tip cylinder portion 76 of the pusher guide 64 is inserted into the annular recess 70 provided on the base end surface of the hemostatic valve main body 60, and the bottom surface of the annular recess 70 and the tip of the tip cylinder portion 76. The surfaces are in contact with each other.

そして、図１などに示される初期状態では、内針１８が止血弁本体６０に挿通されている一方、後述するように、留置針組立体１０の穿刺後、内針１８を基端側に引き抜くことで止血弁本体６０のスリット６６が閉塞するようになっている。また、外針ユニット１４が患者の皮膚に留置された後に、外針ハブ２６の基端側開口部５２からシリンジなどの雄ルアーが挿入されることにより、雄ルアーの先端が押し子６２を先端方向に押し込み、止血弁本体６０のスリット６６を開放させるようになっている。これにより、外針２４の内部と外針ハブ２６の内部（押し子６２の内部）とシリンジの内部とが連通されて、例えばシリンジ内の薬液などが外針ユニット１４を通じて患者の血管内に注入されるようになっている。なお、薬液の注入後や注入の中断時において、外針ユニット１４からシリンジを抜き取ることにより、止血弁本体６０の弾性復元作用により押し子６２が初期位置まで押し戻されるとともに、スリット６６が速やかに閉鎖されるようになっている。 Then, in the initial state shown in FIG. 1 and the like, the inner needle 18 is inserted through the hemostatic valve main body 60, while the inner needle 18 is pulled out toward the proximal end side after the indwelling needle assembly 10 is punctured, as will be described later. As a result, the slit 66 of the hemostatic valve main body 60 is closed. Further, after the outer needle unit 14 is placed on the skin of the patient, a male lure such as a syringe is inserted from the base end side opening 52 of the outer needle hub 26, so that the tip of the male lure pushes the pusher 62. It is pushed in the direction to open the slit 66 of the hemostatic valve main body 60. As a result, the inside of the outer needle 24, the inside of the outer needle hub 26 (the inside of the pusher 62), and the inside of the syringe are communicated with each other, and for example, a drug solution in the syringe is injected into the patient's blood vessel through the outer needle unit 14. It is supposed to be done. By removing the syringe from the outer needle unit 14 after injecting the drug solution or when the injection is interrupted, the pusher 62 is pushed back to the initial position by the elastic restoration action of the hemostatic valve body 60, and the slit 66 is quickly closed. It is supposed to be done.

また、内針ユニット１２において、内針１８には針先プロテクタ部材２２が外挿装着されている。この針先プロテクタ部材２２は、内針１８の引抜時において、内針１８の針先１６を覆って保護するプロテクタ本体７８と、当該プロテクタ本体７８を保持するリテーナ８０とを含んで構成されている。 Further, in the inner needle unit 12, a needle tip protector member 22 is extrapolated and attached to the inner needle 18. The needle tip protector member 22 includes a protector main body 78 that covers and protects the needle tip 16 of the inner needle 18 when the inner needle 18 is pulled out, and a retainer 80 that holds the protector main body 78. ..

プロテクタ本体７８は、例えばステンレス鋼などの薄肉の金属板に対して複数回プレス加工などを施して折り曲げた形状とされている。すなわち、プロテクタ本体７８の基端には、上下方向に広がる略矩形状の基端壁部８２が設けられており、当該基端壁部８２の中央には板厚方向で貫通する貫通孔８４が形成されている。なお、当該貫通孔８４の内径寸法は、内針１８の大径部２８，２８以外の部分の外径寸法より大きくされているとともに、大径部２８，２８における最大外径寸法よりも小さくされている。 The protector main body 78 has a shape in which a thin metal plate such as stainless steel is pressed a plurality of times and bent. That is, a substantially rectangular base end wall portion 82 extending in the vertical direction is provided at the base end of the protector main body 78, and a through hole 84 penetrating in the plate thickness direction is provided in the center of the base end wall portion 82. It is formed. The inner diameter of the through hole 84 is larger than the outer diameter of the inner needle 18 other than the large diameter portions 28 and 28, and is smaller than the maximum outer diameter of the large diameter portions 28 and 28. ing.

また、基端壁部８２の上下両端部には、それぞれ先端側に延び出す上方壁部８６および下方壁部８８が形成されている。この上方壁部８６は、下方壁部８８よりも先端側まで延び出すアーム状とされており、上方壁部８６の先端には、内周側に屈曲する屈曲部９０が設けられている。一方、下方壁部８８の先端は基端側に折り返されており、当該折返部分が、プロテクタ本体７８とリテーナ８０との組付時においてプロテクタ本体７８からリテーナ８０が抜け出すことを防止する抜止部９２とされている。 Further, an upper wall portion 86 and a lower wall portion 88 extending toward the tip end are formed at both upper and lower ends of the base end wall portion 82, respectively. The upper wall portion 86 has an arm shape extending from the lower wall portion 88 to the tip end side, and the tip end of the upper wall portion 86 is provided with a bent portion 90 that bends to the inner peripheral side. On the other hand, the tip of the lower wall portion 88 is folded back toward the base end side, and the folded-out portion prevents the retainer 80 from coming out of the protector main body 78 when the protector main body 78 and the retainer 80 are assembled. It is said that.

さらに、上方壁部８６と下方壁部８８とが上下方向で対向する部分において、プロテクタ本体７８の幅方向（図３中の紙面手前奥方向）両側には、上方壁部８６から連続して延びて、且つ長さ方向に延びる一対の側方壁部９４，９４が設けられている。そして、一方（本実施形態では、図３中の紙面奥側）の側方壁部９４の先端は折り曲げられて、長さ方向と直交する方向（紙面直交方向）に広がる縦壁部９６が形成されている。かかる縦壁部９６の中央には、板厚方向で貫通する貫通孔９８が形成されている。なお、当該貫通孔９８の内径寸法は、内針１８の大径部２８，２８における最大外径寸法よりも大きくされている。 Further, in the portion where the upper wall portion 86 and the lower wall portion 88 face each other in the vertical direction, the protector main body 78 extends continuously from the upper wall portion 86 on both sides in the width direction (the front-back direction of the paper surface in FIG. 3). A pair of side wall portions 94, 94 extending in the length direction are provided. Then, the tip of the side wall portion 94 on one side (in the present embodiment, the back side of the paper surface in FIG. 3) is bent to form a vertical wall portion 96 extending in a direction orthogonal to the length direction (paper surface orthogonal direction). Has been done. A through hole 98 penetrating in the plate thickness direction is formed in the center of the vertical wall portion 96. The inner diameter of the through hole 98 is larger than the maximum outer diameter of the large diameter portions 28, 28 of the inner needle 18.

なお、上方壁部８６における下方壁部８８よりも先端側に延びる部分において、プロテクタ本体７８の幅方向両側には、上方壁部８６から連続して延びる一対の側方壁部１００，１００が設けられている。これら側方壁部１００，１００により、後述する内針１８の針先１６保護時には、内針１８の先端側だけでなく幅方向両側も保護されるようになっている。 A pair of side wall portions 100, 100 extending continuously from the upper wall portion 86 are provided on both sides of the protector main body 78 in the width direction in a portion of the upper wall portion 86 extending toward the tip side of the lower wall portion 88. Has been done. These side wall portions 100, 100 protect not only the tip end side of the inner needle 18 but also both sides in the width direction when the needle tip 16 of the inner needle 18 described later is protected.

一方、リテーナ８０は、全体として長さ方向に延びる略矩形筒状とされており、例えば硬質の合成樹脂により形成される。すなわち、それぞれ長さ方向に延びる上壁部１０２と下壁部１０４と一対の側壁部１０６，１０６とから構成される周壁部１０８を備えている。当該周壁部１０８を構成する側壁部１０６，１０６は、下壁部１０４よりも先端側まで延び出しており、下壁部１０４よりも先端側には、両側壁部１０６，１０６の下端を相互に連結する連結部１１０が形成されている。なお、当該連結部１１０と下壁部１０４との長さ方向間には所定寸法の隙間１１２が形成されている。また、連結部１１０の外周面（下面）１１４は、外針ハブ２６の内周面４９に沿って周方向に広がる円弧状面とされている。更にまた、連結部１１０の内周面（上面）には、内周側に開口して長さ方向に延びる溝状凹所１１５が形成されている。 On the other hand, the retainer 80 has a substantially rectangular tubular shape extending in the length direction as a whole, and is formed of, for example, a hard synthetic resin. That is, it is provided with a peripheral wall portion 108 composed of an upper wall portion 102 extending in the length direction, a lower wall portion 104, and a pair of side wall portions 106, 106, respectively. The side wall portions 106, 106 constituting the peripheral wall portion 108 extend to the tip side from the lower wall portion 104, and the lower ends of both side wall portions 106, 106 are mutually extended to the tip side from the lower wall portion 104. A connecting portion 110 to be connected is formed. A gap 112 having a predetermined dimension is formed between the connecting portion 110 and the lower wall portion 104 in the length direction. Further, the outer peripheral surface (lower surface) 114 of the connecting portion 110 is an arcuate surface extending in the circumferential direction along the inner peripheral surface 49 of the outer needle hub 26. Furthermore, on the inner peripheral surface (upper surface) of the connecting portion 110, a groove-shaped recess 115 that opens on the inner peripheral side and extends in the length direction is formed.

さらに、周壁部１０８を構成する上壁部１０２の上方には、留置針組立体１０を把持する際や外針ハブ２６を押し出す際に施術者が手指を載置するための指置部１１６が形成されている。 Further, above the upper wall portion 102 constituting the peripheral wall portion 108, a finger rest portion 116 for the practitioner to place a finger when gripping the indwelling needle assembly 10 or pushing out the outer needle hub 26 is provided. It is formed.

すなわち、指置部１１６は略矩形板形状とされており、所定の長さ寸法および幅寸法を有している。なお、操作性を考慮すると、指置部１１６の長さ寸法（軸方向寸法）は１〜２０ｍｍ、幅寸法は５〜１０ｍｍであることが好ましい。 That is, the finger rest portion 116 has a substantially rectangular plate shape, and has a predetermined length dimension and width dimension. In consideration of operability, the length dimension (axial dimension) of the finger rest portion 116 is preferably 1 to 20 mm, and the width dimension is preferably 5 to 10 mm.

そして、指置部１１６の幅方向両端と側壁部１０６，１０６の先端における上端部（上壁部１０２の先端における幅方向両端部）とが、一対の接続部１１８，１１８により相互に接続されている。 Then, both ends in the width direction of the finger rest portion 116 and the upper end portions at the tips of the side wall portions 106, 106 (both ends in the width direction at the tip of the upper wall portion 102) are connected to each other by a pair of connecting portions 118, 118. There is.

また、かかる指置部１１６よりも先端側には、後述する外針ハブ２６の押出操作時に施術者が外針ハブ２６を指先で押し出すための指先押圧部１２０が設けられている。この指先押圧部１２０は、外周側に突出する略板形状とされており、本実施形態では、針先プロテクタ部材２２のリテーナ８０において、指置部１１６から先端側に連続して一体的に形成されている。すなわち、指置部１１６の先端（指先押圧部１２０の基端）には、先端になるにつれて上方に湾曲する（長さ方向に対する傾斜角度が大きくなる）湾曲部分１２２が形成されており、指置部１１６と指先押圧部１２０とが滑らかに連続している。なお、本実施形態では、指先押圧部１２０が、長さ方向に対して略直交する方向（上下方向）に突出している。 Further, on the tip side of the finger rest portion 116, a fingertip pressing portion 120 is provided for the practitioner to push out the outer needle hub 26 with his / her fingertip during the extrusion operation of the outer needle hub 26 described later. The fingertip pressing portion 120 has a substantially plate shape protruding toward the outer peripheral side, and in the present embodiment, the retainer 80 of the needle tip protector member 22 is continuously and integrally formed from the finger rest portion 116 to the tip end side. Has been done. That is, at the tip of the finger rest portion 116 (the base end of the fingertip pressing portion 120), a curved portion 122 that curves upward (the inclination angle with respect to the length direction increases) is formed toward the tip, and the finger rest portion 122 is formed. The portion 116 and the fingertip pressing portion 120 are smoothly continuous. In the present embodiment, the fingertip pressing portion 120 projects in a direction (vertical direction) substantially orthogonal to the length direction.

一方、これら指置部１１６および指先押圧部１２０の内周面（下面）における幅方向中央部分には、長さ方向に延びる係合突部１２４が形成されている。この係合突部１２４は、略一定の幅方向寸法をもって指置部１１６および指先押圧部１２０の長さ方向略全長に亘って延びており、すなわち指置部１１６の幅方向両側に設けられた接続部１１８，１１８の間を延びている。また、係合突部１２４の下端面は長さ方向に対して略平行に延びており、すなわち係合突部１２４の上下寸法が先端側に向かって次第に大きくなるようにされている。なお、かかる係合突部１２４の幅方向寸法は、外針ハブ２６の雄ねじ部５４に設けられた凹溝部５６の溝幅寸法よりも小さくされている。 On the other hand, an engaging protrusion 124 extending in the length direction is formed at the central portion in the width direction on the inner peripheral surface (lower surface) of the finger rest portion 116 and the fingertip pressing portion 120. The engaging protrusion 124 extends over substantially the entire length of the finger rest portion 116 and the fingertip pressing portion 120 with substantially a constant width direction dimension, that is, is provided on both sides of the finger rest portion 116 in the width direction. It extends between the connections 118 and 118. Further, the lower end surface of the engaging protrusion 124 extends substantially parallel to the length direction, that is, the vertical dimension of the engaging protrusion 124 gradually increases toward the tip side. The width direction dimension of the engaging protrusion 124 is smaller than the groove width dimension of the concave groove portion 56 provided in the male screw portion 54 of the outer needle hub 26.

さらに、指置部１１６の内周面には、下方に突出して幅方向（図３中の紙面手前奥方向）に延びる下方突出部としての係合突起１２６が形成されている。この係合突起１２６は、所定の突出寸法（上下方向寸法）と幅方向寸法を有しており、接続部１１８，１１８に対して所定の離隔距離をもって先端側に形成されている。なお、本実施形態では、係合突起１２６の幅方向寸法が係合突部１２４の幅方向寸法より大きくされており、外針ハブ２６の雄ねじ部５４に設けられた凹溝部５６の溝幅寸法よりも大きくされている。また、係合突起１２６が略三角形断面をもって形成されており、即ち係合突起１２６の先端側面１２８が、下方になるにつれて次第に基端側に傾斜する（長さ方向に対して傾斜する）傾斜面とされている一方、基端側面１３０が、下方になるにつれて次第に先端側に傾斜する（長さ方向に対して傾斜する）傾斜面とされている。そして、係合突起１２６の突出先端が、係合突部１２４の下端面よりも下方まで突出している。 Further, on the inner peripheral surface of the finger rest portion 116, an engaging protrusion 126 is formed as a downward protruding portion that protrudes downward and extends in the width direction (the front-back direction of the paper surface in FIG. 3). The engaging projection 126 has a predetermined protruding dimension (vertical dimension) and a width direction dimension, and is formed on the tip side with a predetermined separation distance from the connecting portions 118 and 118. In the present embodiment, the width direction dimension of the engagement protrusion 126 is larger than the width direction dimension of the engagement protrusion 124, and the groove width dimension of the concave groove portion 56 provided in the male screw portion 54 of the outer needle hub 26. Has been made larger than. Further, the engaging protrusion 126 is formed with a substantially triangular cross section, that is, the tip side surface 128 of the engaging protrusion 126 gradually inclines toward the base end side (inclines in the length direction) as it goes downward. On the other hand, the base end side surface 130 is an inclined surface that gradually inclines toward the tip end side (inclines in the length direction) as it goes downward. Then, the protruding tip of the engaging protrusion 126 protrudes below the lower end surface of the engaging protrusion 124.

かかる構造とされたプロテクタ本体７８とリテーナ８０とが相互に組み付けられることで針先プロテクタ部材２２が構成されている。すなわち、例えばプロテクタ本体７８における下方壁部８８の先端が折り曲げられることなく真っ直ぐとされた状態で、リテーナ８０の周壁部１０８における基端側開口部からプロテクタ本体７８が挿入される。その際、プロテクタ本体７８の下方壁部８８と側方壁部９４，９４との上下方向間にリテーナ８０の下壁部１０４が挿入されて、その後下方壁部８８の先端を、下壁部１０４と連結部１１０との軸方向間の隙間１１２において、基端側に折り返して抜止部９２を形成することで、プロテクタ本体７８とリテーナ８０とが相互に組み付けられる。かかる組付状態では、プロテクタ本体７８の基端部分が、下方壁部８８を除いて、外周側からリテーナ８０の周壁部１０８により囲まれている。すなわち、プロテクタ本体７８が外周側からリテーナ８０により囲まれて針先プロテクタ部材２２が構成されていることから、リテーナ８０の外周側に位置する指置部１１６および指先押圧部１２０が、針先プロテクタ部材２２の外周側に位置している。 The needle tip protector member 22 is formed by assembling the protector main body 78 and the retainer 80 having such a structure to each other. That is, for example, the protector main body 78 is inserted from the proximal end side opening in the peripheral wall portion 108 of the retainer 80 in a state where the tip of the lower wall portion 88 in the protector main body 78 is straightened without being bent. At that time, the lower wall portion 104 of the retainer 80 is inserted between the lower wall portion 88 of the protector main body 78 and the side wall portions 94, 94 in the vertical direction, and then the tip of the lower wall portion 88 is inserted into the lower wall portion 104. In the gap 112 between the connecting portion 110 and the connecting portion 110 in the axial direction, the protector main body 78 and the retainer 80 are assembled to each other by folding back to the base end side to form the retaining portion 92. In such an assembled state, the base end portion of the protector main body 78 is surrounded by the peripheral wall portion 108 of the retainer 80 from the outer peripheral side except for the lower wall portion 88. That is, since the protector main body 78 is surrounded by the retainer 80 from the outer peripheral side to form the needle tip protector member 22, the finger rest portion 116 and the fingertip pressing portion 120 located on the outer peripheral side of the retainer 80 are the needle tip protector. It is located on the outer peripheral side of the member 22.

また、かかる組付状態では、リテーナ８０の下壁部１０４が、プロテクタ本体７８の抜止部９２と基端壁部８２との長さ方向間で位置決めされるとともに、下方壁部８８と側方壁部９４，９４との上下方向間で位置決めされる。さらに、プロテクタ本体７８の幅方向両端部（側方壁部９４，９４）がリテーナ８０の側壁部１０６，１０６に当接することで、プロテクタ本体７８がリテーナ８０に対して幅方向で位置決めされる。これらのことから、プロテクタ本体７８とリテーナ８０との組付状態では、それぞれが相対変位することなく安定して組み付けられる。 Further, in such an assembled state, the lower wall portion 104 of the retainer 80 is positioned between the retaining portion 92 of the protector main body 78 and the base end wall portion 82 in the length direction, and the lower wall portion 88 and the side wall. It is positioned between the parts 94 and 94 in the vertical direction. Further, both end portions (side wall portions 94, 94) of the protector main body 78 in the width direction come into contact with the side wall portions 106, 106 of the retainer 80, so that the protector main body 78 is positioned in the width direction with respect to the retainer 80. From these facts, in the assembled state of the protector main body 78 and the retainer 80, they can be stably assembled without relative displacement.

かかる針先プロテクタ部材２２が内針１８に外挿されて、内針１８の基端が内針ハブ２０に固定されることで内針ユニット１２が構成されている。すなわち、内針１８の大径部２８，２８より基端側が、プロテクタ本体７８における基端壁部８２における貫通孔８４と縦壁部９６における貫通孔９８に挿通される。 The inner needle unit 12 is formed by extrapolating the needle tip protector member 22 to the inner needle 18 and fixing the base end of the inner needle 18 to the inner needle hub 20. That is, the proximal end side of the inner needle 18 from the large diameter portions 28, 28 is inserted into the through hole 84 in the proximal end wall portion 82 and the through hole 98 in the vertical wall portion 96 in the protector main body 78.

なお、プロテクタ本体７８は、内針１８が挿通されていない単体の状態では、上方壁部８６の先端部分が下方に傾斜しており、長さ方向の投影において、上方壁部８６の先端に設けられた屈曲部９０が貫通孔８４および貫通孔９８と重なるように位置している（図８参照）。かかるプロテクタ本体７８に対して内針１８が挿通されることで、内針１８の先端部分が外周側（上方）へ弾性変形せしめられて、屈曲部９０の先端が内針１８の外周面に当接するようになっている。すなわち、プロテクタ本体７８に対して内針１８が挿通された状態では、上方壁部８６の先端部分（屈曲部９０）に対して、常時内周側（下方）へ向かう付勢力が及ぼされており、屈曲部９０の先端と内針１８の外周面とが相互に当接することで、上方壁部８６の先端部分（屈曲部９０）における内周側への変形が制限されるようになっている。 The protector body 78 is provided at the tip of the upper wall portion 86 in the projection in the length direction because the tip portion of the upper wall portion 86 is inclined downward in the state where the inner needle 18 is not inserted. The bent portion 90 is positioned so as to overlap the through hole 84 and the through hole 98 (see FIG. 8). When the inner needle 18 is inserted through the protector main body 78, the tip portion of the inner needle 18 is elastically deformed toward the outer peripheral side (upward), and the tip of the bent portion 90 hits the outer peripheral surface of the inner needle 18. It is designed to come into contact. That is, in a state where the inner needle 18 is inserted through the protector main body 78, a urging force is always exerted on the tip portion (bending portion 90) of the upper wall portion 86 toward the inner peripheral side (downward). The tip of the bent portion 90 and the outer peripheral surface of the inner needle 18 are in contact with each other, so that the deformation of the tip portion (bent portion 90) of the upper wall portion 86 toward the inner circumference is restricted. ..

以上の如き構造とされた内針ユニット１２と外針ユニット１４とが相互に組み付けられることで、留置針組立体１０が構成されている。すなわち、針先プロテクタ部材２２の基端部分（リテーナ８０）が内針ハブ２０の先端に設けられた収容空所４０に収容されるとともに、内針１８の針先１６が外針ユニット１４を貫通して外針２４よりも先端側に位置している。なお、本実施形態では、内針ハブ２０の収容空所４０およびリテーナ８０の周壁部１０８がそれぞれ略矩形状とされていることから、内針ハブ２０と針先プロテクタ部材２２との相対回転が防止され得る。 The indwelling needle assembly 10 is configured by assembling the inner needle unit 12 and the outer needle unit 14 having the above-mentioned structure to each other. That is, the base end portion (retainer 80) of the needle tip protector member 22 is housed in the storage space 40 provided at the tip of the inner needle hub 20, and the needle tip 16 of the inner needle 18 penetrates the outer needle unit 14. It is located on the tip side of the outer needle 24. In the present embodiment, since the accommodation space 40 of the inner needle hub 20 and the peripheral wall portion 108 of the retainer 80 are each substantially rectangular, the relative rotation between the inner needle hub 20 and the needle tip protector member 22 is caused. Can be prevented.

かかる内針ユニット１２と外針ユニット１４との組付状態では、リテーナ８０の上壁部０２および側壁部１０６，１０６から上方に突出する接続部１１８，１１８が、内針ハブ２０におけるカバー筒部３８の上方に設けられた窓部４２に対して周方向で位置合わせされている。それ故、接続部１１８，１１８が窓部４２を通じて内針ハブ２０の外周側に突出しているとともに、接続部１１８，１１８に接続された指置部１１６および指先押圧部１２０が留置針組立体１０の外周面に露出している。なお、このように、接続部１１８，１１８が窓部４２を通じて外周側に突出することによっても、内針ハブ２０と針先プロテクタ部材２２との相対回転が防止され得る。 In the assembled state of the inner needle unit 12 and the outer needle unit 14, the connecting portions 118 and 118 protruding upward from the upper wall portion 02 and the side wall portions 106 and 106 of the retainer 80 are the cover cylinder portions of the inner needle hub 20. It is aligned in the circumferential direction with respect to the window portion 42 provided above the 38. Therefore, the connecting portions 118 and 118 project to the outer peripheral side of the inner needle hub 20 through the window portion 42, and the finger resting portion 116 and the fingertip pressing portion 120 connected to the connecting portions 118 and 118 are the indwelling needle assembly 10. It is exposed on the outer peripheral surface of. In this way, even if the connecting portions 118, 118 project to the outer peripheral side through the window portion 42, the relative rotation between the inner needle hub 20 and the needle tip protector member 22 can be prevented.

そして、指置部１１６および指先押圧部１２０は、内針ハブ２０の先端部分から外針ハブ２６の基端部分に跨って延びており、本実施形態では、指置部１１６が外針ハブ２６の基端側開口部５２に設けられた雄ねじ部５４の外周側に位置して、且つ雄ねじ部５４よりも先端側にまで延びているとともに、指先押圧部１２０が雄ねじ部５４よりも先端側に位置している。すなわち、本実施形態では、雄ねじ部５４の外周側に位置して、雄ねじ部５４への接触などを阻止する汚染防止部が、指置部１１６によって構成されており、かかる汚染防止部（指置部）１１６が設けられることで、雄ねじ部５４における細菌の付着などが効果的に防止され得る。 The finger rest portion 116 and the fingertip pressing portion 120 extend from the tip end portion of the inner needle hub 20 to the base end portion of the outer needle hub 26, and in the present embodiment, the finger rest portion 116 extends from the outer needle hub 26. It is located on the outer peripheral side of the male screw portion 54 provided in the base end side opening 52 of the above, extends to the tip side from the male screw portion 54, and the fingertip pressing portion 120 is closer to the tip side than the male screw portion 54. positioned. That is, in the present embodiment, the contamination prevention portion 116 is located on the outer peripheral side of the male screw portion 54 and prevents contact with the male screw portion 54, and the contamination prevention portion (finger placement) is formed. By providing the portion) 116, the adhesion of bacteria on the male screw portion 54 can be effectively prevented.

上記の如き組付状態では、指置部１１６と指先押圧部１２０の内周面に設けられた、長さ方向に延びる係合突部１２４と、外針ハブ２６の外周面５０に設けられた雄ねじ部５４の凹溝部５６とが周方向で位置決めされて、係合突部１２４が凹溝部５６に入り込んでいる。これにより、係合突部１２４と雄ねじ部５４とが相互に当接することで、針先プロテクタ部材２２（内針ユニット１２）と外針ハブ２６（外針ユニット１４）との相対回転が防止されて、周方向で位置決めされている。したがって、本実施形態では、これら係合突部１２４と雄ねじ部５４とにより、相互の係合作用で周方向に位置決めする周方向位置決め用の係合部が構成されている。 In the assembled state as described above, the engaging protrusion 124 extending in the length direction provided on the inner peripheral surface of the finger rest portion 116 and the fingertip pressing portion 120, and the outer peripheral surface 50 of the outer needle hub 26 are provided. The concave groove portion 56 of the male screw portion 54 is positioned in the circumferential direction, and the engaging protrusion 124 is inserted into the concave groove portion 56. As a result, the engaging protrusion 124 and the male screw portion 54 come into contact with each other, thereby preventing the relative rotation of the needle tip protector member 22 (inner needle unit 12) and the outer needle hub 26 (outer needle unit 14). It is positioned in the circumferential direction. Therefore, in the present embodiment, the engaging protrusion 124 and the male screw portion 54 form an engaging portion for circumferential positioning that positions in the circumferential direction by mutual engagement.

また、かかる組付状態では、指置部１１６の内周面に設けられた接続部１１８，１１８と係合突起１２６との長さ方向間に、外針ハブ２６の外周面５０に設けられた雄ねじ部５４が入り込んでいる。これにより、雄ねじ部５４と係合突起１２６とが相互に当接することで、針先プロテクタ部材２２（内針ユニット１２）が、外針ハブ２６（外針ユニット１４）に対して基端側に変位することが阻止される。すなわち、本実施形態では、雄ねじ部５４と係合突起１２６とにより、針先プロテクタ部材２２の外針ハブ２６に対する基端側への移動を規制する規制部が構成されている。 Further, in such an assembled state, it is provided on the outer peripheral surface 50 of the outer needle hub 26 between the connecting portions 118, 118 provided on the inner peripheral surface of the finger rest portion 116 and the engaging protrusion 126 in the length direction. The male screw portion 54 is inserted. As a result, the male screw portion 54 and the engaging protrusion 126 come into contact with each other, so that the needle tip protector member 22 (inner needle unit 12) is moved to the proximal end side with respect to the outer needle hub 26 (outer needle unit 14). Displacement is prevented. That is, in the present embodiment, the male screw portion 54 and the engaging protrusion 126 form a regulating portion that regulates the movement of the needle tip protector member 22 toward the proximal end side with respect to the outer needle hub 26.

それに加えて、雄ねじ部５４と、接続部１１８，１１８および係合突起１２６とが相互に当接することで、針先プロテクタ部材２２（内針ユニット１２）と外針ハブ２６（外針ユニット１４）との長さ方向での相対変位が防止されて、長さ方向で位置決めされている。したがって、本実施形態では、これら接続部１１８，１１８と係合突起１２６と雄ねじ部５４とにより、相互の係合作用で長さ方向に位置決めする長さ方向位置決め用の係合部が構成されている。 In addition, the male screw portion 54, the connecting portions 118, 118, and the engaging protrusion 126 come into contact with each other, so that the needle tip protector member 22 (inner needle unit 12) and the outer needle hub 26 (outer needle unit 14) come into contact with each other. Relative displacement in the length direction with and is prevented, and positioning is performed in the length direction. Therefore, in the present embodiment, the connecting portions 118 and 118, the engaging projection 126, and the male screw portion 54 form an engaging portion for positioning in the length direction by mutual engagement action. There is.

さらに、かかる内針ユニット１２と外針ユニット１４との組付状態では、上記のように、指置部１１６および指先押圧部１２０が、外針ハブ２６の雄ねじ部５４に対して外側から係合している一方、針先プロテクタ部材２２におけるプロテクタ本体７８の上方壁部８６の先端部分、およびリテーナ８０の下方において先端側に延び出す連結部１１０が、外針ハブ２６の基端側開口部５２から内方（先端側）に挿入されるようになっている。すなわち、針先プロテクタ部材２２における指置部１１６に対して内針１８を挟んで径方向反対側（下方）に位置する部分（リテーナ８０の下方）から延び出して、外針ハブ２６の内方に挿入される挿入部が、連結部１１０によって構成されている。そして、かかる連結部１１０が、外針ハブ２６の周壁部４６の下方における内周面４９に沿って外針ハブ２６の内方に延びており、特に、本実施形態では、連結部１１０の外周面１１４が、外針ハブ２６における下方の内周面４９に当接している。なお、挿入部（連結部）１１０の外周面１１４は円弧状面であることが好ましいが、何等限定されるものではない。すなわち、例えば挿入部の外周面に複数の突起を設けて、当該突起と外針ハブ２６における下方の内周面４９とが当接するようにしてもよい。 Further, in the assembled state of the inner needle unit 12 and the outer needle unit 14, the finger rest portion 116 and the fingertip pressing portion 120 are engaged with the male screw portion 54 of the outer needle hub 26 from the outside as described above. On the other hand, the tip portion of the upper wall portion 86 of the protector main body 78 in the needle tip protector member 22 and the connecting portion 110 extending toward the tip side below the retainer 80 are connected to the base end side opening 52 of the outer needle hub 26. It is designed to be inserted inward (tip side) from. That is, the needle tip protector member 22 extends from a portion (below the retainer 80) located on the opposite side (lower side) of the inner needle 18 with respect to the finger rest portion 116 in the radial direction, and extends inside the outer needle hub 26. The insertion portion to be inserted into is configured by the connecting portion 110. The connecting portion 110 extends inward of the outer needle hub 26 along the inner peripheral surface 49 below the peripheral wall portion 46 of the outer needle hub 26. In particular, in the present embodiment, the outer circumference of the connecting portion 110 The surface 114 is in contact with the lower inner peripheral surface 49 of the outer needle hub 26. The outer peripheral surface 114 of the insertion portion (connecting portion) 110 is preferably an arcuate surface, but is not limited in any way. That is, for example, a plurality of protrusions may be provided on the outer peripheral surface of the insertion portion so that the protrusions and the lower inner peripheral surface 49 of the outer needle hub 26 come into contact with each other.

したがって、本実施形態では、規制部（係合突起）１２６と指置部１１６と挿入部（連結部）１１０とが、同一の部材（リテーナ８０）に設けられて、一体的に形成されている。また、本発明において限定される構造ではないが、本実施形態では外針ハブ２６の内方に挿入される挿入部（連結部）１１０が指置部１１６と同一の部品（リテーナ８０）に形成されていることから、指置部１１６に大きな力が作用した場合でも、外針ハブ２６と針先プロテクタ部材２２との係合が解除されて内針１８の針先１６が意図せず露出してしまうことがより確実に防止され得る。 Therefore, in the present embodiment, the regulation portion (engagement protrusion) 126, the finger rest portion 116, and the insertion portion (connecting portion) 110 are provided on the same member (retainer 80) and are integrally formed. .. Further, although the structure is not limited in the present invention, in the present embodiment, the insertion portion (connecting portion) 110 inserted inside the outer needle hub 26 is formed in the same component (retainer 80) as the finger rest portion 116. Therefore, even when a large force is applied to the finger rest portion 116, the engagement between the outer needle hub 26 and the needle tip protector member 22 is released, and the needle tip 16 of the inner needle 18 is unintentionally exposed. It can be prevented more reliably.

なお、かかる組付状態において、プロテクタ本体７８の上方壁部８６と外針ハブ２６における上方の内周面４９とは、相互に当接していてもよいが、本実施形態では、僅かな離隔距離をもって径方向（上下方向）で対向している。かかるプロテクタ本体７８の上方壁部８６と外針ハブ２６における上方の内周面４９との離隔距離は、指置部１１６の内周面に設けられた係合突起１２６が雄ねじ部５４を乗り越えるために必要な上下方向寸法より小さくされており、プロテクタ本体７８の上方壁部８６と外針ハブ２６における上方の内周面４９とが相互に当接することで、外針ハブ２６（外針ユニット１４）からの針先プロテクタ部材２２（内針ユニット１２）の抜出しが防止されている。 In such an assembled state, the upper wall portion 86 of the protector main body 78 and the upper inner peripheral surface 49 of the outer needle hub 26 may be in contact with each other, but in the present embodiment, a slight separation distance may be provided. They face each other in the radial direction (vertical direction). The separation distance between the upper wall portion 86 of the protector main body 78 and the upper inner peripheral surface 49 of the outer needle hub 26 is because the engaging protrusion 126 provided on the inner peripheral surface of the finger rest portion 116 gets over the male screw portion 54. The upper wall portion 86 of the protector main body 78 and the upper inner peripheral surface 49 of the outer needle hub 26 are in contact with each other, so that the outer needle hub 26 (outer needle unit 14) is smaller than the vertical dimension required for the above. ), The needle tip protector member 22 (inner needle unit 12) is prevented from being pulled out.

かかる構造とされた留置針組立体１０は、施術者が内針ハブ２０を把持しつつ指置部１１６に手指（例えば人差指）を載置した状態で、外針２４および内針１８の先端部分が患者の血管に経皮的に穿刺される。そして、逆血（フラッシュバック）を確認した後、施術者が指置部１１６に載置している手指で指先押圧部１２０を穿刺方向前方へ押圧することにより、内針１８に案内されて外針２４が患者の血管に穿刺される。かかる状態において、図５〜９に示されるように、外針ユニット１４から内針１８を引き抜くことで、内針１８の針先１６が針先プロテクタ部材２２で保護されつつ、外針ハブ２６と針先プロテクタ部材２２との係合が解除されて、外針ユニット１４から内針ユニット１２が取り外されるようになっている。 The indwelling needle assembly 10 having such a structure has the tip portions of the outer needle 24 and the inner needle 18 in a state where the practitioner holds the inner needle hub 20 and places the fingers (for example, the index finger) on the finger rest portion 116. Is percutaneously punctured into the patient's blood vessels. Then, after confirming the back blood (flashback), the practitioner presses the fingertip pressing portion 120 forward in the puncture direction with the finger placed on the finger rest portion 116, and is guided by the inner needle 18 to the outside. The needle 24 is punctured into the patient's blood vessel. In such a state, as shown in FIGS. 5 to 9, by pulling out the inner needle 18 from the outer needle unit 14, the needle tip 16 of the inner needle 18 is protected by the needle tip protector member 22, and the outer needle hub 26 The engagement with the needle tip protector member 22 is released, and the inner needle unit 12 is removed from the outer needle unit 14.

すなわち、内針１８を基端側に引き抜いて、プロテクタ本体７８における上方壁部８６の屈曲部９０と内針１８の外周面との係合が解除されることで、付勢力に従い上方壁部８６の先端部分（屈曲部９０）は、図６，９における白矢印の方向（内周側、即ち下方）に変位する。なお、下方に変位した上方壁部８６の先端部分（屈曲部９０および側方壁部１００，１００）は、連結部１１０の内周面に設けられた溝状凹所１１５に入り込むようになっている。これにより、図７，８に示されるように、内針１８における針先１６の周囲が、上方壁部８６の先端部分（屈曲部９０および側方壁部１００，１００）および連結部１１０により覆われて保護されるようになっている。 That is, the inner needle 18 is pulled out toward the base end side, and the engagement between the bent portion 90 of the upper wall portion 86 of the protector main body 78 and the outer peripheral surface of the inner needle 18 is released, so that the upper wall portion 86 follows the urging force. The tip portion (bent portion 90) of the above is displaced in the direction of the white arrow in FIGS. 6 and 9 (inner peripheral side, that is, downward). The tip portions (bent portion 90 and side wall portions 100, 100) of the upper wall portion 86 displaced downward come into the groove-shaped recess 115 provided on the inner peripheral surface of the connecting portion 110. There is. As a result, as shown in FIGS. 7 and 8, the periphery of the needle tip 16 in the inner needle 18 is covered by the tip portion (bending portion 90 and the side wall portions 100, 100) and the connecting portion 110 of the upper wall portion 86. It is designed to be protected.

そして、上記のように、上方壁部８６の先端部分が下方に変位することで、上方壁部８６と外針ハブ２６の内周面４９との間に隙間が発生する。この隙間の大きさは、指置部１１６の内周面に設けられた係合突起１２６が雄ねじ部５４を乗り越えるために必要な上下方向寸法よりも大きくされており、外針ハブ２６に対して針先プロテクタ部材２２（指置部１１６および指先押圧部１２０）を上方（外周側）に変位させることで、長さ方向位置決め用の係合部（雄ねじ部５４ならびに接続部１１８，１１８および係合突起１２６）による長さ方向の位置決めが解除されて、外針ハブ２６（外針ユニット１４）から針先プロテクタ部材２２（内針ユニット１２）を取り外すことができるようになっている。なお、係合突起１２６の基端側面１３０が、下方になるにつれて次第に先端側に傾斜する（軸方向に対して傾斜する）傾斜面とされていることから、外針ハブ２６に対して内針ユニット１２（針先プロテクタ部材２２）を基端側に水平に引き抜くことで、雄ねじ部５４と基端側面１３０とが当接して、当該基端側面１３０により針先プロテクタ部材２２の外針ハブ２６に対する上方への変位がガイドされるようになっている。 Then, as described above, the tip portion of the upper wall portion 86 is displaced downward, so that a gap is generated between the upper wall portion 86 and the inner peripheral surface 49 of the outer needle hub 26. The size of this gap is larger than the vertical dimension required for the engaging protrusion 126 provided on the inner peripheral surface of the finger rest portion 116 to get over the male screw portion 54, with respect to the outer needle hub 26. By displacing the needle tip protector member 22 (finger resting portion 116 and fingertip pressing portion 120) upward (outer peripheral side), the engaging portion (male screw portion 54 and connecting portions 118, 118 and engaging portion) for positioning in the length direction are engaged. The positioning in the length direction by the protrusion 126) is released, and the needle tip protector member 22 (inner needle unit 12) can be removed from the outer needle hub 26 (outer needle unit 14). Since the base end side surface 130 of the engaging projection 126 is an inclined surface that gradually inclines toward the tip end side (inclines in the axial direction) as it goes downward, the inner needle with respect to the outer needle hub 26. By pulling out the unit 12 (needle tip protector member 22) horizontally to the proximal end side, the male screw portion 54 and the proximal end side surface 130 come into contact with each other, and the outer needle hub 26 of the needle tip protector member 22 is brought into contact with the proximal end side surface 130. The upward displacement with respect to is guided.

上記の如き構造とされた留置針組立体１０では、外針ハブ２６と連結する針先プロテクタ部材２２の外周側には指置部１１６が設けられていることから、留置針組立体１０の穿刺後に指置部１１６を手指で押さえることで、外針ハブ２６ひいては外針２４を患者の皮膚に安定して固定することができる。加えて、外針ハブ２６の雄ねじ部５４と針先プロテクタ部材２２のリテーナ８０に設けられた指置部１１６とが周方向の一方（上方）で係合しているとともに、リテーナ８０に設けられた挿入部（連結部１１０）と外針ハブ２６の内周面４９とが周方向の他方（下方）で係合している。すなわち、外針ハブ２６と針先プロテクタ部材２２とが周上の複数箇所で係合していることから、指先押圧部１２０に操作力を及ぼして外針ユニット１４を穿刺方向前方に押し出す際に、外針ハブ２６と針先プロテクタ部材２２とをより確実に係合させた状態で押し出すことができる。これにより、外針ユニット１４の押出操作時に、意図せず外針ハブ２６と針先プロテクタ部材２２との係合が解除されて内針１８の針先１６が保護されていない状態で露出してしまうことが効果的に防止され得る。 In the indwelling needle assembly 10 having the above-mentioned structure, since the finger resting portion 116 is provided on the outer peripheral side of the needle tip protector member 22 connected to the outer needle hub 26, the indwelling needle assembly 10 is punctured. By later pressing the finger rest 116 with a finger, the outer needle hub 26 and thus the outer needle 24 can be stably fixed to the patient's skin. In addition, the male screw portion 54 of the outer needle hub 26 and the finger rest portion 116 provided on the retainer 80 of the needle tip protector member 22 are engaged with each other in one (upward) direction in the circumferential direction, and are provided on the retainer 80. The insertion portion (connecting portion 110) and the inner peripheral surface 49 of the outer needle hub 26 are engaged with each other (downward) in the circumferential direction. That is, since the outer needle hub 26 and the needle tip protector member 22 are engaged at a plurality of points on the circumference, when an operating force is applied to the fingertip pressing portion 120 to push the outer needle unit 14 forward in the puncture direction. , The outer needle hub 26 and the needle tip protector member 22 can be extruded in a more securely engaged state. As a result, when the outer needle unit 14 is extruded, the outer needle hub 26 and the needle tip protector member 22 are unintentionally disengaged, and the needle tip 16 of the inner needle 18 is exposed in an unprotected state. It can be effectively prevented from getting stuck.

特に、本実施形態では、挿入部（連結部１１０）の外周面１１４が、外針ハブ２６の内周面４９に対応した円弧状面とされていることから、挿入部（連結部１１０）と外針ハブ２６の内周面４９との係合が安定して実現され得る。また、挿入部（連結部１１０）の外周面１１４により、外針ハブ２６の内周面４９が損傷するおそれも効果的に低減され得る。特に、かかる挿入部（連結部１１０）が合成樹脂製とされていることから、外針ハブ２６の内周面４９が損傷するおそれが一層効果的に低減され得る。 In particular, in the present embodiment, since the outer peripheral surface 114 of the insertion portion (connecting portion 110) is an arcuate surface corresponding to the inner peripheral surface 49 of the outer needle hub 26, the insertion portion (connecting portion 110) and the outer peripheral surface 114 Engagement of the outer needle hub 26 with the inner peripheral surface 49 can be stably realized. Further, the possibility that the inner peripheral surface 49 of the outer needle hub 26 is damaged by the outer peripheral surface 114 of the insertion portion (connecting portion 110) can be effectively reduced. In particular, since the insertion portion (connecting portion 110) is made of synthetic resin, the risk of damage to the inner peripheral surface 49 of the outer needle hub 26 can be further effectively reduced.

さらに、係合突起１２６の基端側面１３０が傾斜面とされていることから、外針ユニット１４から内針ユニット１２を引き抜くに際して、針先プロテクタ部材２２を外針ハブ２６との連結が解除される方向にガイドすることができて、内針ユニット１２を水平に引き抜くことができる。これにより、内針１８の引抜動作時において、内針ユニット１２や外針ユニット１４のぶれを小さく抑えることができる。 Further, since the base end side surface 130 of the engaging protrusion 126 is an inclined surface, the connection of the needle tip protector member 22 with the outer needle hub 26 is released when the inner needle unit 12 is pulled out from the outer needle unit 14. The inner needle unit 12 can be pulled out horizontally by being able to guide in the direction of the needle. As a result, the shake of the inner needle unit 12 and the outer needle unit 14 can be suppressed to be small when the inner needle 18 is pulled out.

また、指先押圧部１２０が、針先プロテクタ部材２２のリテーナ８０に設けられていることから、外針ハブ２６の外周面５０に、外周側に大きく突出する突部などが設けられることが回避される。それ故、外針ユニット１４を患者の血管に留置して外針ハブ２６をテーピング固定するときなどに、患者の皮膚に指先押圧部が強く押し当たり患者が痛みを感じるおそれが回避され得る。 Further, since the fingertip pressing portion 120 is provided on the retainer 80 of the needle tip protector member 22, it is possible to prevent the outer peripheral surface 50 of the outer needle hub 26 from being provided with a protrusion or the like that greatly protrudes toward the outer peripheral side. To. Therefore, when the external needle unit 14 is placed in the blood vessel of the patient and the external needle hub 26 is taped and fixed, the possibility that the fingertip pressing portion strongly presses against the patient's skin and the patient feels pain can be avoided.

さらに、指置部１１６と指先押圧部１２０とが一体的に形成されていることから、施術者が指置部１１６に載置した手指で穿刺方向前方に操作力を及ぼすことにより、外針ユニット１４を押し出す操作を行うことができる。 Further, since the finger rest portion 116 and the fingertip pressing portion 120 are integrally formed, the practitioner exerts an operating force forward in the puncture direction with the fingers placed on the finger rest portion 116, thereby causing the external needle unit. The operation of pushing out 14 can be performed.

特に、施術者の手指が載置される指置部１１６が汚染防止部を構成して、外針ハブ２６の雄ねじ部５４よりも先端側まで延びていることから、施術者の手指が雄ねじ部５４に接触して、外針ハブ２６の基端側開口部５２にシリンジなどを接続する際に細菌などが混入するおそれが低減され得る。そして、このように、汚染防止部が指置部１１６により構成されることで、汚染防止部が必要以上に大きく形成されることも回避され得る。 In particular, since the finger rest portion 116 on which the practitioner's fingers are placed constitutes a contamination prevention portion and extends to the tip side of the external needle hub 26 from the male screw portion 54, the practitioner's fingers are the male screw portion. It is possible to reduce the possibility that bacteria or the like are mixed when the syringe or the like is connected to the proximal end side opening 52 of the outer needle hub 26 in contact with the 54. Further, by forming the contamination prevention portion by the finger rest portion 116 in this way, it is possible to avoid that the contamination prevention portion is formed larger than necessary.

また、指先押圧部１２０も雄ねじ部５４よりも先端側に位置していることから、指置部の大きさを十分に確保することができて、施術者による外針ユニット１４の押出操作が、良好な操作感をもって行われ得る。 Further, since the fingertip pressing portion 120 is also located on the tip side of the male screw portion 54, the size of the finger rest portion can be sufficiently secured, and the practitioner can extrude the outer needle unit 14. It can be performed with a good feeling of operation.

さらに、指先押圧部１２０の基端側には、基端側に向かって長さ方向に対する傾斜角度が次第に小さくされた湾曲部分１２２が設けられて、指先押圧部１２０と指置部１１６とが滑らかに接続されていることから、施術者の手指が良好なフィット感をもって載置され得る。それ故、施術者からの操作力を安定して外針ユニット１４に伝達させることができる。 Further, on the base end side of the fingertip pressing portion 120, a curved portion 122 whose inclination angle with respect to the length direction is gradually reduced toward the base end side is provided, so that the fingertip pressing portion 120 and the finger rest portion 116 are smooth. Since it is connected to, the practitioner's fingers can be placed with a good fit. Therefore, the operating force from the practitioner can be stably transmitted to the outer needle unit 14.

また、針先プロテクタ部材２２が、それぞれ別部材とされたプロテクタ本体７８とリテーナ８０とによって形成されていることから、例えば内針１８の針先１６を直接覆うプロテクタ本体７８を金属により形成して、複雑な形状であるリテーナ８０を合成樹脂で形成することなども可能となる。 Further, since the needle tip protector member 22 is formed by the protector main body 78 and the retainer 80, which are separate members, for example, the protector main body 78 that directly covers the needle tip 16 of the inner needle 18 is formed of metal. It is also possible to form the retainer 80, which has a complicated shape, with a synthetic resin.

特に、リテーナ８０に設けられる接続部１１８，１１８および係合突起１２６ならびに係合突部１２４により、リテーナ８０が外針ハブ２６に対して長さ方向および周方向で位置決めされる。それ故、外針ユニット１４の押出操作時に、外針ハブ２６に対して針先プロテクタ部材２２が回転したり長さ方向で変位したりすることがなく、指先押圧部１２０（針先プロテクタ部材２２）から及ぼされる操作力を安定して外針ユニット１４に伝達することができる。 In particular, the retainer 80 is positioned in the longitudinal direction and the circumferential direction with respect to the outer needle hub 26 by the connecting portions 118, 118, the engaging protrusion 126, and the engaging protrusion 124 provided on the retainer 80. Therefore, during the extrusion operation of the outer needle unit 14, the needle tip protector member 22 does not rotate or displace in the length direction with respect to the outer needle hub 26, and the fingertip pressing portion 120 (needle tip protector member 22) does not rotate. ) Can be stably transmitted to the outer needle unit 14.

更にまた、本実施形態では、内針ハブ２０における収容空所４０の形状が略矩形状とされているとともに、リテーナ８０の基端部分の形状も略矩形状とされている。それ故、リテーナ８０の周壁部１０８が、収容空所４０の周壁であるカバー筒部３８に当接することで、内針ハブ２０と針先プロテクタ部材２２との相対回転が防止される。それに加えて、カバー筒部３８に設けられた窓部４２を通じてリテーナ８０の接続部１１８，１１８が突出することでも、内針ハブ２０と針先プロテクタ部材２２との相対回転が防止され得る。かかる内針ハブ２０と針先プロテクタ部材２２との相対回転防止機構の少なくとも一つが採用されることで、内針ハブ２０と針先プロテクタ部材２２との相対回転が防止されて、例えば内針１８の針先１６に設けられる刃面２７を上方に向けた状態で留置針組立体１０を穿刺することができる。 Furthermore, in the present embodiment, the shape of the accommodation space 40 in the inner needle hub 20 is substantially rectangular, and the shape of the base end portion of the retainer 80 is also substantially rectangular. Therefore, the peripheral wall portion 108 of the retainer 80 comes into contact with the cover cylinder portion 38 which is the peripheral wall of the accommodation space 40, so that the relative rotation between the inner needle hub 20 and the needle tip protector member 22 is prevented. In addition, the relative rotation of the inner needle hub 20 and the needle tip protector member 22 can be prevented by projecting the connecting portions 118 and 118 of the retainer 80 through the window portion 42 provided in the cover cylinder portion 38. By adopting at least one of the relative rotation prevention mechanisms between the inner needle hub 20 and the needle tip protector member 22, the relative rotation between the inner needle hub 20 and the needle tip protector member 22 is prevented, for example, the inner needle 18 The indwelling needle assembly 10 can be punctured with the blade surface 27 provided on the needle tip 16 of the above facing upward.

以上、本発明の実施形態について説明してきたが、本発明はかかる実施形態における具体的な記載によって限定的に解釈されるものでなく、当業者の知識に基づいて種々なる変更、修正、改良などを加えた態様で実施可能である。 Although the embodiments of the present invention have been described above, the present invention is not limitedly interpreted by the specific description in the embodiments, and various changes, modifications, improvements, etc. are made based on the knowledge of those skilled in the art. It can be carried out in the form of adding.

たとえば、前記実施形態では、規制部（係合突起）１２６と指置部１１６と挿入部（連結部）１１０とが、同一の部材（リテーナ８０）に一体成形されることによって一体的に形成されていたが、かかる態様に限定されるものではない。すなわち、規制部と指置部と挿入部のうちの１つまたは２つは他のものとは別体として形成されて、必要に応じて接着や溶着、係止などの各種固定構造をもって相互に組み付けられることで一体的に設けられていてもよい。 For example, in the above embodiment, the regulation portion (engagement protrusion) 126, the finger rest portion 116, and the insertion portion (connecting portion) 110 are integrally formed by being integrally molded into the same member (retainer 80). However, the present invention is not limited to this mode. That is, one or two of the regulation part, the finger rest part, and the insertion part are formed as separate bodies from the others, and have various fixing structures such as adhesion, welding, and locking as necessary. It may be integrally provided by being assembled.

また、前記実施形態では、指置部１１６と指先押圧部１２０とが一体的に形成されていたが、指置部と指先押圧部とは、相互に独立して形成されてもよい。なお、指先押圧部は、指置部より先端側にあることが好適であり、例えば外針ハブに設けられてもよい。尤も、指先押圧部は、本発明において必須なものではない。 Further, in the above-described embodiment, the finger rest portion 116 and the fingertip pressing portion 120 are integrally formed, but the finger rest portion and the fingertip pressing portion may be formed independently of each other. The fingertip pressing portion is preferably located on the tip side of the finger resting portion, and may be provided on, for example, an outer needle hub. However, the fingertip pressing portion is not essential in the present invention.

さらに、前記実施形態では、内針１８を引き抜く以前の初期状態では、指置部１１６の内周面に設けられた規制部としての係合突起１２６が外針ハブ２６の雄ねじ部５４に対して係止されるとともに、かかる係止が内針１８の引抜きに伴い解除されるようになっていたが、かかる態様に限定されるものではない。すなわち、例えば外針ハブの雄ねじ部に対して係止されて、且つかかる係止が内針の引抜きに伴い解除されるような係止部（規制部）を指置部とは別に設けてもよい。 Further, in the above-described embodiment, in the initial state before the inner needle 18 is pulled out, the engaging projection 126 as a regulating portion provided on the inner peripheral surface of the finger rest portion 116 is attached to the male screw portion 54 of the outer needle hub 26. At the same time as being locked, the locking is released when the inner needle 18 is pulled out, but the present invention is not limited to this mode. That is, for example, even if a locking portion (regulating portion) that is locked to the male screw portion of the outer needle hub and is released when the inner needle is pulled out is provided separately from the finger rest portion. Good.

更にまた、前記実施形態では、長さ方向に延びる係合突部１２４が、指置部１１６および指先押圧部１２０の内周面において長さ方向の略全長に亘って延びていたが、指置部と指先押圧部の何れか一方の内周面においてのみ延びていてもよい。また、前記実施形態では、幅方向に延びる係合突起１２６が、指置部１１６の内周面に設けられていたが、指先押圧部の内周面に設けられてもよい。尤も、これら係合突部や係合突起は、本発明において必須なものではない。 Furthermore, in the above-described embodiment, the engaging protrusion 124 extending in the length direction extends over substantially the entire length in the length direction on the inner peripheral surfaces of the finger rest portion 116 and the fingertip pressing portion 120. It may extend only on the inner peripheral surface of either the portion or the fingertip pressing portion. Further, in the above-described embodiment, the engaging protrusion 126 extending in the width direction is provided on the inner peripheral surface of the finger rest portion 116, but may be provided on the inner peripheral surface of the fingertip pressing portion. However, these engaging protrusions and engaging protrusions are not essential in the present invention.

また、前記実施形態では、汚染防止部が指置部１１６によって構成されていたが、例えば汚染防止部と指置部とは別体として形成されて、相互に組み付けられるなどして一体的に設けられるようになっていてもよい。あるいは、汚染防止部は指置部とは独立して形成されてもよく、例えば周方向の全周に亘って連続して延びる筒状の汚染防止部が設けられてもよい。尤も、かかる汚染防止部は、本発明において必須なものではない。 Further, in the above-described embodiment, the contamination prevention portion is composed of the finger rest portion 116, but for example, the contamination prevention portion and the finger rest portion are formed as separate bodies and are integrally provided by being assembled to each other. You may be able to do it. Alternatively, the contamination prevention portion may be formed independently of the finger rest portion, and for example, a tubular contamination prevention portion that extends continuously over the entire circumference in the circumferential direction may be provided. However, such a pollution control unit is not essential in the present invention.

さらに、前記実施形態では、針先プロテクタ部材２２が、金属製のプロテクタ本体７８と合成樹脂製のリテーナ８０により構成されていたが、プロテクタ本体およびリテーナの材質は何等限定されるものではない。すなわち、プロテクタ本体が合成樹脂製とされる一方、リテーナが金属製とされてもよいし、またはプロテクタ本体とリテーナの両方が金属製または合成樹脂製とされてもよい。尤も、針先プロテクタ部材は、プロテクタ本体とリテーナにより構成される必要はなく、金属や合成樹脂により一体的に形成されてもよい。 Further, in the above embodiment, the needle tip protector member 22 is composed of a metal protector main body 78 and a synthetic resin retainer 80, but the materials of the protector main body and the retainer are not limited in any way. That is, the protector body may be made of synthetic resin, while the retainer may be made of metal, or both the protector body and the retainer may be made of metal or synthetic resin. However, the needle tip protector member does not have to be composed of the protector body and the retainer, and may be integrally formed of metal or synthetic resin.

１０：留置針組立体、１６：針先（先端）、１８：内針、２０：内針ハブ、２２：針先プロテクタ部材、２４：外針、２６：外針ハブ、４６：周壁部、４９：内周面、５０：外周面、５２：基端側開口部、５４：雄ねじ部（規制部、周方向位置決め用の係合部、長さ方向位置決め用の係合部）、７８：プロテクタ本体、８０：リテーナ、１０８：周壁部、１１０：連結部（挿入部）、１１４：外周面、１１５：溝状凹所、１１６：指置部（汚染防止部）、１１８：接続部（長さ方向位置決め用の係合部）、１２０：指先押圧部、１２２：湾曲部分、１２４：係合突部（周方向位置決め用の係合部）、１２６：係合突起（規制部、長さ方向位置決め用の係合部、下方突出部）、１３０：基端側面 10: Indwelling needle assembly, 16: Needle tip (tip), 18: Inner needle, 20: Inner needle hub, 22: Needle tip protector member, 24: Outer needle, 26: Outer needle hub, 46: Peripheral wall, 49 : Inner peripheral surface, 50: Outer peripheral surface, 52: Base end side opening, 54: Male threaded part (regulating part, engaging part for circumferential positioning, engaging part for lengthwise positioning), 78: Protector body , 80: retainer, 108: peripheral wall part, 110: connecting part (insertion part), 114: outer peripheral surface, 115: groove-shaped recess, 116: finger rest part (contamination prevention part), 118: connecting part (length direction) (Engaging part for positioning), 120: fingertip pressing part, 122: curved part, 124: engaging protrusion (engaging part for circumferential positioning), 126: engaging protrusion (regulating part, for positioning in length direction) Engagement part, downward protrusion), 130: Base end side surface

Claims (14)

外針ハブを基端側に有する外針に対して、内針ハブを基端側に有する内針が挿通されていると共に、針先プロテクタ部材が該内針に対して長さ方向で移動可能に装着された留置針組立体であって、
前記針先プロテクタ部材において、該針先プロテクタ部材の前記外針ハブに対する基端側への移動を規制する規制部と、外部に露出する指置部と、該外針ハブの基端側開口部に挿入されて該指置部とは径方向反対側に位置する該外針ハブの周壁部の内周面に沿って先端側に延びて該内周面に当接する挿入部とが、一体的に設けられており、
前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されていると共に、該雄ねじ部の外周側に延びだして前記指置部が設けられており、前記針先プロテクタ部材との移動を前記規制部で規制された該外針ハブが、該指置部へ加えられる操作力によって前記内針に対して該針先プロテクタ部材と共に先端側へ移動可能とされていることを特徴とする留置針組立体。 The inner needle having the inner needle hub on the base end side is inserted into the outer needle having the outer needle hub on the base end side, and the needle tip protector member can move in the length direction with respect to the inner needle. It is an indwelling needle assembly attached to
In the needle tip protector member, a regulating portion that regulates the movement of the needle tip protector member toward the proximal end side with respect to the outer needle hub, a finger rest portion that is exposed to the outside, and a proximal end side opening portion of the outer needle hub. The insertion portion that is inserted into the needle and extends to the tip side along the inner peripheral surface of the peripheral wall portion of the outer needle hub located on the opposite side of the finger rest portion in the radial direction and abuts on the inner peripheral surface is integrated. It is provided in
A male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub, and the finger rest portion is provided so as to extend to the outer peripheral side of the male screw portion, and the needle tip protector member and the needle tip protector member. The outer needle hub whose movement is restricted by the regulating portion is characterized in that the outer needle hub can be moved toward the tip side together with the needle tip protector member with respect to the inner needle by an operating force applied to the finger resting portion. Indwelling needle assembly. 前記外針ハブの前記周壁部の周方向で部分的に位置して、前記挿入部が該外針ハブの該周壁部の内周面に沿って先端側に延びて設けられている請求項１に記載の留置針組立体。 1. A claim 1 in which the insertion portion is partially located in the circumferential direction of the peripheral wall portion of the outer needle hub, and the insertion portion extends toward the tip end side along the inner peripheral surface of the peripheral wall portion of the outer needle hub. The indwelling needle assembly described in. 前記雄ねじ部の外周側に汚染防止部が設けられており、該汚染防止部と前記指置部とが一体的に設けられている請求項１又は２に記載の留置針組立体。 The pollution section on the outer peripheral side of the male screw portion is provided, the indwelling needle assembly according to claim 1 or 2, and the finger portion and said contamination preventing portion is integrally provided. 前記指置部が前記雄ねじ部の外周側に位置して、該指置部により前記汚染防止部が構成されている請求項３に記載の留置針組立体。 The indwelling needle assembly according to claim 3, wherein the finger rest portion is located on the outer peripheral side of the male screw portion, and the contamination prevention portion is formed by the finger rest portion. 前記指置部が前記外針ハブの前記雄ねじ部よりも先端側にまで延びている請求項３又は４に記載の留置針組立体。 The indwelling needle assembly according to claim 3 or 4, wherein the finger rest portion extends to the tip end side of the male screw portion of the outer needle hub. 前記指置部の先端側に連続して外周側へ突出する指先押圧部が形成されている請求項１〜５の何れか１項に記載の留置針組立体。 The indwelling needle assembly according to any one of claims 1 to 5, wherein a fingertip pressing portion that continuously projects to the outer peripheral side is formed on the tip end side of the finger resting portion. 前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されていると共に、該雄ねじ部よりも先端側に位置して前記指先押圧部が設けられている請求項６に記載の留置針組立体。 The sixth aspect of claim 6, wherein a male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub, and the fingertip pressing portion is provided located on the tip side of the male screw portion. Indwelling needle assembly. 前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、
該リテーナに対して前記指置部および前記指先押圧部が形成されていると共に、
該リテーナには、該指置部および該指先押圧部に対して前記内針を挟んだ径方向反対側に位置して前記挿入部が形成されている請求項６又は７に記載の留置針組立体。 The needle tip protector member includes a protector main body that covers the tip of the inner needle and a retainer that holds the protector main body.
The finger resting portion and the fingertip pressing portion are formed on the retainer, and the fingertip pressing portion is formed.
The indwelling needle set according to claim 6 or 7, wherein the retainer is formed with the insertion portion located on the side opposite to the finger rest portion and the fingertip pressing portion in the radial direction with the inner needle sandwiched. Three-dimensional. 前記指置部および前記指先押圧部が、前記外針ハブに対して周方向に回転不能とされている請求項６〜８の何れか１項に記載の留置針組立体。 The indwelling needle assembly according to any one of claims 6 to 8, wherein the finger resting portion and the fingertip pressing portion cannot rotate in the circumferential direction with respect to the outer needle hub. 前記指置部又は前記指先押圧部の内周面と前記外針ハブの外周面との間には、相互の係合作用で周方向に位置決めする周方向位置決め用の係合部が設けられている請求項９に記載の留置針組立体。 Between the inner peripheral surface of the finger rest or the fingertip pressing portion and the outer peripheral surface of the outer needle hub, an engaging portion for circumferential positioning is provided for positioning in the circumferential direction by mutual engagement action. The indwelling needle assembly according to claim 9. 前記指置部又は前記指先押圧部の内周面と前記外針ハブの外周面との間には、相互の係合作用で長さ方向に位置決めする長さ方向位置決め用の係合部が設けられている請求項６〜１０の何れか１項に記載の留置針組立体。 An engaging portion for positioning in the length direction is provided between the inner peripheral surface of the finger rest portion or the fingertip pressing portion and the outer peripheral surface of the outer needle hub to position in the length direction by mutual engagement action. The indwelling needle assembly according to any one of claims 6 to 10. 前記外針ハブの基端側開口部の外周面には雄ねじ部が形成されており、該雄ねじ部の外周側に前記指置部が設けられている一方、該指置部の内周面には内周側に突出する下方突出部が設けられて、該下方突出部により前記規制部が構成されていると共に、該下方突出部の基端側面が長さ方向に対して傾斜している請求項１〜１１の何れか１項に記載の留置針組立体。 A male screw portion is formed on the outer peripheral surface of the base end side opening of the outer needle hub, and the finger rest portion is provided on the outer peripheral side of the male screw portion, while the inner peripheral surface of the finger rest portion. Is provided with a downward protruding portion protruding to the inner peripheral side, the restricting portion is formed by the downward protruding portion, and the base end side surface of the downward protruding portion is inclined with respect to the length direction. Item 2. The indwelling needle assembly according to any one of Items 1 to 11. 前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、
該リテーナには、該プロテクタ本体の外周を囲む周壁部が設けられており、該周壁部が前記内針ハブに対して周方向に位置決めされて挿し入れられている一方、該周壁部から先端側に突出して前記挿入部が形成されている請求項１〜１２の何れか１項に記載の留置針組立体。 The needle tip protector member includes a protector main body that covers the tip of the inner needle and a retainer that holds the protector main body.
The retainer is provided with a peripheral wall portion that surrounds the outer periphery of the protector main body, and the peripheral wall portion is positioned and inserted in the circumferential direction with respect to the inner needle hub, while the tip side from the peripheral wall portion. The indwelling needle assembly according to any one of claims 1 to 12, wherein the insertion portion is formed so as to project from the indwelling needle assembly. 前記針先プロテクタ部材は、前記内針の先端を覆うプロテクタ本体と、該プロテクタ本体を保持するリテーナとを含んで構成されており、
該リテーナに対して前記挿入部が形成されていると共に、
該挿入部の外周面が前記外針ハブの内周面に沿って周方向に広がる円弧状面とされている請求項１〜１３の何れか１項に記載の留置針組立体。 The needle tip protector member includes a protector main body that covers the tip of the inner needle and a retainer that holds the protector main body.
The insertion portion is formed with respect to the retainer, and at the same time,
The indwelling needle assembly according to any one of claims 1 to 13, wherein the outer peripheral surface of the insertion portion is an arcuate surface extending in the circumferential direction along the inner peripheral surface of the outer needle hub.
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