JP6857694B2 - Catheter assembly - Google Patents

Catheter assembly Download PDF

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JP6857694B2
JP6857694B2 JP2019143459A JP2019143459A JP6857694B2 JP 6857694 B2 JP6857694 B2 JP 6857694B2 JP 2019143459 A JP2019143459 A JP 2019143459A JP 2019143459 A JP2019143459 A JP 2019143459A JP 6857694 B2 JP6857694 B2 JP 6857694B2
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catheter
housing
support member
hub
support
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石田　昌弘
昌弘 石田
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TRUMO KABUSHIKI KAISHA
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Description

本発明は、例えば患者に対して輸液等を行うに際して血管に穿刺し、留置するカテーテル組立体に関する。 The present invention relates to a catheter assembly that punctures and indwells a blood vessel, for example, when infusing a patient.

従来、患者に対し輸液等を行う際には、例えば、カテーテル組立体が使用される。この種のカテーテル組立体は、中空のカテーテルと、カテーテルの基端に固着されたカテーテルハブと、カテーテル内に挿入され先端に鋭利な針先を有する中空の内針と、この内針の基端に固着された針ハブとを備える。 Conventionally, for example, a catheter assembly is used when infusing or the like to a patient. This type of catheter assembly consists of a hollow catheter, a catheter hub fixed to the base end of the catheter, a hollow inner needle that is inserted into the catheter and has a sharp tip, and the base end of the inner needle. It is equipped with a needle hub fixed to.

このようなカテーテル組立体では、カテーテルの先端から内針の先端が突出した初期状態でカテーテルハブが上下に分離可能なハウジング（針ハブ）内に収容されている（例えば、特許文献１参照）。初期状態では、上側ハウジングと下側ハウジングとは、カテーテルを支持するように互いに係合した状態でロックされている。一方、患者に内針を穿刺した後、カテーテルを内針に対して先端側に進出（前進）させる前に前記ロックが解除されて上側ハウジングと下側ハウジングが分離可能となる。そして、カテーテルを内針に対して前進させるときに上側ハウジングと下側ハウジングとが互いに分離してカテーテルハブがハウジングから離脱される。 In such a catheter assembly, the catheter hub is housed in a housing (needle hub) that can be separated vertically in an initial state in which the tip of the inner needle protrudes from the tip of the catheter (see, for example, Patent Document 1). In the initial state, the upper housing and the lower housing are locked in an engaged state so as to support the catheter. On the other hand, after the patient is punctured with the inner needle, the lock is released and the upper housing and the lower housing can be separated before the catheter is advanced (advanced) toward the tip side with respect to the inner needle. Then, when the catheter is advanced with respect to the inner needle, the upper housing and the lower housing are separated from each other, and the catheter hub is separated from the housing.

特表２０１３−５２９１１１号公報Japanese Patent Application Laid-Open No. 2013-529111

しかしながら、上述した特許文献１のようなカテーテル組立体では、カテーテルを内針に対して前進させる前に、上側ハウジングと下側ハウジングとの係合状態のロックが解除される。そのため、カテーテルを内針に対して前進させる際に、カテーテルが受ける抵抗力（カテーテルと患者の皮膚との間の摩擦抵抗力）によってカテーテル及び内針が撓み、ユーザが違和感を生じることがある。また、内針の先端が患者の皮膚から抜け出たり、皮膚から抜け出た内針の先端が復元力により前進した際にカテーテルを突き刺したりするおそれがある。 However, in a catheter assembly as described in Patent Document 1, the engaged state of the upper housing and the lower housing is unlocked before the catheter is advanced with respect to the inner needle. Therefore, when the catheter is advanced with respect to the inner needle, the catheter and the inner needle may be bent due to the resistance force (friction resistance force between the catheter and the patient's skin) received by the catheter, which may cause discomfort to the user. In addition, the tip of the inner needle may come out of the patient's skin, or the catheter may be pierced when the tip of the inner needle that comes out of the skin advances due to the restoring force.

本発明は、このような課題を考慮してなされたものであり、カテーテルを血管内に違和感なく円滑に挿入することができ、且つカテーテルハブをハウジングから容易に離脱させることができるカテーテル組立体を提供することを目的とする。 The present invention has been made in consideration of such a problem, and provides a catheter assembly capable of smoothly inserting a catheter into a blood vessel without discomfort and easily detaching a catheter hub from a housing. The purpose is to provide.

本発明の一態様は、中空のカテーテルと、前記カテーテルの基端部に固定されたカテーテルハブと、前記カテーテルに挿通された中空の内針と、前記内針を支持し、前記カテーテルの先端から前記内針の先端が突出した初期状態で前記カテーテルハブが配設されるハウジングと、前記カテーテルを支持する支持部材と、前記カテーテルハブに接続されて前記ハウジングに対して当該ハウジングの長手方向に沿って変位可能なカテーテル操作部材と、を備え、前記支持部材は、前記カテーテルハブとは接続しておらず、前記カテーテルが前記内針に対して先端側に進出する際に前記カテーテルを支持する第一状態と前記カテーテルハブの前記ハウジングからの離脱を許容する第二状態とに切り替え可能に前記ハウジングに設けられ、前記支持部材は、前記カテーテル操作部材が前記支持部材に接触して当該支持部材を押すことにより前記第一状態から前記第二状態に切り替わる、カテーテル組立体である。 One aspect of the present invention is to support a hollow catheter, a catheter hub fixed to the proximal end of the catheter, a hollow inner needle inserted through the catheter, and the inner needle from the tip of the catheter. A housing in which the catheter hub is arranged in an initial state in which the tip of the inner needle protrudes, a support member for supporting the catheter, and a support member connected to the catheter hub along the longitudinal direction of the housing with respect to the housing. A catheter operating member that is displaceable, the support member is not connected to the catheter hub, and supports the catheter when the catheter advances to the distal end side with respect to the internal needle. The housing is provided so as to be switchable between one state and a second state that allows the catheter hub to be detached from the housing, and the support member is such that the catheter operating member comes into contact with the support member to provide the support member. that switches from said first state to said second state by pushing a catheter assembly.

本発明によれば、支持部材を第一状態にすることによりカテーテルが内針に対して先端側に進出する際にカテーテルが支持されるため、カテーテルが受ける抵抗力によってカテーテル及び内針が撓むことを抑制することができる。これにより、カテーテルを血管内に違和感なく円滑に挿入することができる。また、カテーテルを血管内に挿入した後で、支持部材を第二状態にすることによりカテーテルハブをハウジングから容易に離脱させることができる。 According to the present invention, since the catheter is supported when the catheter advances to the distal end side with respect to the inner needle by putting the support member in the first state, the catheter and the inner needle are bent by the resistance force received by the catheter. Can be suppressed. As a result, the catheter can be smoothly inserted into the blood vessel without discomfort. Further, after the catheter is inserted into the blood vessel, the catheter hub can be easily detached from the housing by putting the support member in the second state.

本発明の第１実施形態に係るカテーテル組立体の斜視図である。It is a perspective view of the catheter assembly which concerns on 1st Embodiment of this invention. 図１のカテーテル組立体の分解斜視図である。It is an exploded perspective view of the catheter assembly of FIG. 図３Ａは図２のハウジングを斜め上方から見た斜視図であり、図３Ｂは図２の支持部材本体を斜め下方から見た斜視図である。3A is a perspective view of the housing of FIG. 2 viewed from diagonally above, and FIG. 3B is a perspective view of the support member main body of FIG. 2 viewed from diagonally below. 図１のカテーテル組立体の一部縦断面図である。It is a partial vertical sectional view of the catheter assembly of FIG. 図５Ａは図１の支持部材の第１の状態を示す断面図であり、図５Ｂは図１の支持部材の第２の状態を示す断面図である。5A is a cross-sectional view showing a first state of the support member of FIG. 1, and FIG. 5B is a cross-sectional view showing a second state of the support member of FIG. 図６Ａは図１のカテーテル組立体の使用方法を説明する第１の図であり、図６Ｂは図１のカテーテル組立体の使用方法を説明する第２の図である。FIG. 6A is a first diagram illustrating how to use the catheter assembly of FIG. 1, and FIG. 6B is a second diagram illustrating how to use the catheter assembly of FIG. 図７Ａは図１のカテーテル組立体の使用方法を説明する第３の図であり、図７Ｂは図１のカテーテル組立体の使用方法を説明する第４の図である。FIG. 7A is a third diagram illustrating how to use the catheter assembly of FIG. 1, and FIG. 7B is a fourth diagram illustrating how to use the catheter assembly of FIG. 図１の支持部材の変形例を示す断面図である。It is sectional drawing which shows the modification of the support member of FIG. 本発明の第２実施形態に係るカテーテル組立体の斜視図である。It is a perspective view of the catheter assembly which concerns on 2nd Embodiment of this invention. 図９のカテーテル組立体の分解斜視図である。FIG. 9 is an exploded perspective view of the catheter assembly of FIG. 図９のカテーテル操作部材及びカテーテル部材を下方から見た斜視図である。9 is a perspective view of the catheter operating member and the catheter member of FIG. 9 as viewed from below. 図１２Ａは図１０の支持部材を斜め下方から見た斜視図であり、図１２Ｂは図１０の支持部材を斜め上方から見た斜視図である。12A is a perspective view of the support member of FIG. 10 viewed from diagonally below, and FIG. 12B is a perspective view of the support member of FIG. 10 viewed from diagonally above. 図１３Ａは図９の支持部材が閉位置にある状態を下方から見た平面図であり、図１３Ｂは図９の支持部材が開位置にある状態を下方から見た平面図である。13A is a plan view of the support member of FIG. 9 in the closed position as viewed from below, and FIG. 13B is a plan view of the support member of FIG. 9 in the open position as viewed from below.

以下、本発明に係るカテーテル組立体について好適な実施形態を挙げ、添付の図面を参照しながら説明する。 Hereinafter, a suitable embodiment of the catheter assembly according to the present invention will be described with reference to the accompanying drawings.

（第１実施形態）
図１に初期状態を示す本実施形態に係るカテーテル組立体１０Ａは、患者（生体）に輸液や輸血等を行う場合に適用され、患者の体内に穿刺及び留置されて薬液等の導入部を構築する。カテーテル組立体１０Ａは、末梢静脈カテーテルよりも長さが長いカテーテル（例えば、中心静脈カテーテル、ＰＩＣＣ、ミッドラインカテーテル等）として構成され得る。なお、カテーテル組立体１０Ａは、末梢静脈カテーテルとして構成されてもよい。また、カテーテル組立体１０Ａは、静脈用カテーテルに限らず、末梢動脈カテーテル等の動脈用カテーテルとして構成されてもよい。 (First Embodiment)
The catheter assembly 10A according to the present embodiment, which shows the initial state in FIG. 1, is applied to perform infusion or blood transfusion to a patient (living body), and is punctured and indwelled in the patient's body to construct an introduction part for a drug solution or the like. To do. The catheter assembly 10A can be configured as a catheter (eg, central venous catheter, PICC, midline catheter, etc.) that is longer than the peripheral venous catheter. The catheter assembly 10A may be configured as a peripheral venous catheter. Further, the catheter assembly 10A is not limited to the intravenous catheter, and may be configured as an arterial catheter such as a peripheral arterial catheter.

カテーテル組立体１０Ａは、図１及び図２に示すように、カテーテル１２と、カテーテル１２を固定保持するカテーテルハブ１４と、カテーテル１２内に抜去可能に挿入される中空の内針１６と、内針１６を固定保持するハウジング１８と、カテーテルハブ１４の上側に装着されるカテーテル操作部材２０と、カテーテル１２と内針１６の間に抜去可能に挿入される補助部材２２と、補助部材２２を固定保持する補助部材ハブ２４と、カテーテルハブ１４及び補助部材ハブ２４の基端に接続される針保護部材２６と、ハウジング１８に設けられてカテーテル１２を支持する支持部材２７とを備える。なお、内針１６は、一部が軸方向に沿って切り欠かれていてもよい。また、内針１６は、中実針であってもよい。 As shown in FIGS. 1 and 2, the catheter assembly 10A includes a catheter 12, a catheter hub 14 that holds the catheter 12 fixedly, a hollow inner needle 16 that is retractably inserted into the catheter 12, and an inner needle. The housing 18 that holds 16 fixedly, the catheter operating member 20 that is mounted on the upper side of the catheter hub 14, the auxiliary member 22 that is detachably inserted between the catheter 12 and the inner needle 16, and the auxiliary member 22 are fixedly held. Auxiliary member hub 24, a needle protection member 26 connected to the catheter hub 14 and the proximal end of the auxiliary member hub 24, and a support member 27 provided in the housing 18 to support the catheter 12 are provided. A part of the inner needle 16 may be cut out along the axial direction. Further, the inner needle 16 may be a solid needle.

カテーテル組立体１０Ａは、使用前の初期状態で、カテーテル１２、補助部材２２及び内針１６を順に重ねた多重管構造（多重管部）を形成している。 The catheter assembly 10A forms a multi-tube structure (multi-tube portion) in which the catheter 12, the auxiliary member 22, and the inner needle 16 are sequentially stacked in the initial state before use.

カテーテル１２は、可撓性を有し、内部に内腔１３が貫通形成されている。内腔１３は、内針１６及び補助部材２２を収容可能且つ薬液や血液等を流動可能な直径に形成される。穿刺抵抗を減らすためにカテーテル１２の先端は縮径している。カテーテル１２の長さは、特に限定されず用途や諸条件等に応じて適宜設計可能であり、例えば、１４〜５００ｍｍ程度に設定され、あるいは３０〜４００ｍｍ程度に設定され、あるいは７６〜２００ｍｍ程度に設定される。 The catheter 12 is flexible and has a lumen 13 penetrating inside. The lumen 13 is formed to have a diameter capable of accommodating the inner needle 16 and the auxiliary member 22 and allowing the drug solution, blood, etc. to flow. The tip of the catheter 12 is reduced in diameter to reduce puncture resistance. The length of the catheter 12 is not particularly limited and can be appropriately designed according to the application, various conditions, etc., for example, it is set to about 14 to 500 mm, set to about 30 to 400 mm, or set to about 76 to 200 mm. Set.

カテーテル１２の構成材料は、特に限定されるものではないが、軟質樹脂材料が好適であり、例えば、ポリテトラフルオロエチレン（ＰＴＦＥ）、エチレン・テトラフルオロエチレン共重合体（ＥＴＦＥ）、ペルフルオロアルコキシフッ素樹脂（ＰＦＡ）等のフッ素系樹脂、ポリエチレン、ポリプロピレン等のオレフィン系樹脂又はこれらの混合物、ポリウレタン、ポリエステル、ポリアミド、ポリエーテルナイロン樹脂、オレフィン系樹脂とエチレン・酢酸ビニル共重合体との混合物等が挙げられる。 The constituent material of the catheter 12 is not particularly limited, but a soft resin material is preferable, for example, polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy alkane resin. Examples include fluororesins such as (PFA), olefin resins such as polyethylene and polypropylene, or mixtures thereof, polyurethanes, polyesters, polyamides, polyether nylon resins, olefin resins and ethylene / vinyl acetate copolymers, and the like. Be done.

カテーテル１２の基端部は、適宜の固着方法（かしめ、融着、接着等）によってカテーテルハブ１４内の先端部に固着される。カテーテル１２とカテーテルハブ１４により、カテーテル部材１７が構成されている。 The base end portion of the catheter 12 is fixed to the tip end portion in the catheter hub 14 by an appropriate fixing method (caulking, fusion, adhesion, etc.). The catheter member 17 is composed of the catheter 12 and the catheter hub 14.

カテーテルハブ１４は、カテーテル１２が血管内に挿入された状態で患者の皮膚上に露出され、テープ等により貼り付けられてカテーテル１２とともに留置される。カテーテルハブ１４は、先端方向に先細りの筒状に形成される。 The catheter hub 14 is exposed on the patient's skin with the catheter 12 inserted into the blood vessel, attached with tape or the like, and placed together with the catheter 12. The catheter hub 14 is formed in a tubular shape that tapers toward the tip end.

カテーテルハブ１４の構成材料は、特に限定されるものではないが、例えば、ポリプロピレン、ポリカーボネート、ポリアミド、ポリスルホン、ポリアリレート、メタクリレート−ブチレン−スチレン共重合体等の熱可塑性樹脂を適用するとよい。 The constituent material of the catheter hub 14 is not particularly limited, but for example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer may be applied.

カテーテルハブ１４の内部には、カテーテル１２の内腔１３に連通して輸液剤を流通可能な中空部１５が設けられている。この中空部１５には、内針１６の穿刺時に血液の逆流を防ぐとともに、輸液チューブのコネクタの挿入に伴い輸液を可能とする、図示しない止血弁やプラグ等が収容されてもよい。 Inside the catheter hub 14, a hollow portion 15 is provided so as to communicate with the lumen 13 of the catheter 12 and allow the infusion solution to flow. The hollow portion 15 may accommodate a hemostatic valve, a plug, or the like (not shown) that prevents backflow of blood when the inner needle 16 is punctured and enables infusion when the connector of the infusion tube is inserted.

図２に示すように、カテーテルハブ１４の外周面の先端寄りには、径方向外側に突出し、カテーテルハブ１４の周方向に周回する環状突起２８が形成されている。カテーテルハブ１４の基端側には径方向外方にフランジ状に突出し且つ周方向に延在するネジ部３０が設けられており、内針１６の離脱後に、図示しない輸液チューブのコネクタが接続される。 As shown in FIG. 2, an annular protrusion 28 is formed near the tip of the outer peripheral surface of the catheter hub 14 so as to project outward in the radial direction and circulate in the circumferential direction of the catheter hub 14. A threaded portion 30 that projects radially outward in a flange shape and extends in the circumferential direction is provided on the proximal end side of the catheter hub 14, and a connector of an infusion tube (not shown) is connected after the inner needle 16 is detached. To.

一方、カテーテル組立体１０Ａの内針１６は、生体の皮膚を穿刺可能な剛性を有する中空管に構成され、カテーテル１２の内腔１３及びカテーテルハブ１４の中空部１５に貫通配置される。内針１６は、カテーテル１２よりも長い全長に形成され、その先端には鋭利な針先１６ａが設けられる。 On the other hand, the inner needle 16 of the catheter assembly 10A is formed of a hollow tube having rigidity capable of puncturing the skin of a living body, and is arranged through the cavity 13 of the catheter 12 and the hollow portion 15 of the catheter hub 14. The inner needle 16 is formed to have a total length longer than that of the catheter 12, and a sharp needle tip 16a is provided at the tip thereof.

多重管部は、図１に示す初期状態で、カテーテル１２及び補助部材２２から針先１６ａを露出している。内針１６の内部には、内針１６の軸方向に貫通するルーメンが設けられ、このルーメンは、内針１６の先端開口に連通する。なお、内針１６の外周面には、軸方向に沿ってフラッシュバック確認用の溝部が設けられてもよい。 In the initial state shown in FIG. 1, the multi-tube portion exposes the needle tip 16a from the catheter 12 and the auxiliary member 22. Inside the inner needle 16, a lumen penetrating the inner needle 16 in the axial direction is provided, and this lumen communicates with the tip opening of the inner needle 16. The outer peripheral surface of the inner needle 16 may be provided with a groove for checking flashback along the axial direction.

内針１６の構成材料としては、例えば、ステンレス鋼、アルミニウム又はアルミニウム合金、チタン又はチタン合金のような金属材料、硬質樹脂、セラミックス等が挙げられる。内針１６は、適宜の固着方法（融着、接着、インサート成形等）により、ハウジング１８に強固に固着される。 Examples of the constituent material of the inner needle 16 include stainless steel, aluminum or aluminum alloy, metal material such as titanium or titanium alloy, hard resin, ceramics and the like. The inner needle 16 is firmly fixed to the housing 18 by an appropriate fixing method (fusion, adhesion, insert molding, etc.).

ハウジング１８には、初期状態で多重管部の一部、カテーテルハブ１４、カテーテル操作部材２０、補助部材ハブ２４、針保護部材２６、及び支持部材２７が配設（収容）される。ハウジング１８を構成する樹脂材料は、特に限定されるものではないが、例えば、カテーテルハブ１４で挙げた材料を適宜選択し得る。 A part of the multi-tube portion, a catheter hub 14, a catheter operating member 20, an auxiliary member hub 24, a needle protection member 26, and a support member 27 are arranged (accommodated) in the housing 18 in an initial state. The resin material constituting the housing 18 is not particularly limited, but for example, the material mentioned in the catheter hub 14 can be appropriately selected.

ハウジング１８は、図２に示すように、下壁３２と、下壁３２の先端側の側辺から上方に突出した一対の第１側壁３４ａ、３４ｂと、下壁３２の基端部の側辺から上方に突出した一対の第２側壁３５ａ、３５ｂと、下壁３２の基端部の上面から上方に突出して内針１６の基端部を固定支持する針保持部３６とを有する。 As shown in FIG. 2, the housing 18 includes a lower wall 32, a pair of first side walls 34a and 34b protruding upward from the side side of the lower wall 32 on the distal end side, and a side side of a base end portion of the lower wall 32. It has a pair of second side walls 35a and 35b projecting upward from the side, and a needle holding portion 36 projecting upward from the upper surface of the base end portion of the lower wall 32 to fix and support the base end portion of the inner needle 16.

図３Ａ及び図４に示すように、下壁３２は、その先端部が基端側よりも上方に延出しており、下壁３２の先端部の上面は円弧状に凹んでいる。下壁３２の先端部の上面の幅方向（ハウジング１８の長手方向と上下方向とに直交する方向）の中央には、カテーテル１２が配設される横断面形状が半円形状の第１支持溝３８が長手方向に沿って形成されている。第１支持溝３８の内面の長手方向中央には、横断面形状が半円形状の第１凹部４０が形成されている。これにより、カテーテル１２の外面と第１支持溝３８の内面との摺動抵抗を好適に抑えることができる。 As shown in FIGS. 3A and 4, the lower wall 32 has a tip extending upward from the base end side, and the upper surface of the tip of the lower wall 32 is recessed in an arc shape. A first support groove having a semicircular cross section in which the catheter 12 is arranged is located in the center of the upper surface of the tip of the lower wall 32 in the width direction (direction orthogonal to the longitudinal direction and the vertical direction of the housing 18). 38 is formed along the longitudinal direction. A first recess 40 having a semicircular cross-sectional shape is formed at the center of the inner surface of the first support groove 38 in the longitudinal direction. As a result, the sliding resistance between the outer surface of the catheter 12 and the inner surface of the first support groove 38 can be suitably suppressed.

第１支持溝３８及び第１凹部４０の横断面形状は半円形状に限られず、半円形状以外の円弧形状でもよい。また、カテーテル組立体１０Ａにおいて、第１支持溝３８及び第１凹部４０は設けられなくてもよい。この場合、カテーテル１２は、下壁３２の先端部の上面に接触する。 The cross-sectional shape of the first support groove 38 and the first recess 40 is not limited to the semicircular shape, and may be an arc shape other than the semicircular shape. Further, in the catheter assembly 10A, the first support groove 38 and the first recess 40 may not be provided. In this case, the catheter 12 comes into contact with the upper surface of the tip of the lower wall 32.

一対の第１側壁３４ａ、３４ｂは、下壁３２とともに長手方向に平行に延び、先端側の上下幅が基端側の上下幅よりも幅狭となるように形成されている。各第１側壁３４ａ、３４ｂの上下方向略中央には、先端側に開口する切欠部４２ａ、４２ｂが形成されている。また、一方の第１側壁３４ａの切欠部４２ａよりもやや基端側には、矩形状の嵌合孔４４が長手方向に延在している。切欠部４２ａ、４２ｂ及び嵌合孔４４は、支持部材２７をハウジング１８に対して保持するためのものである。一対の第２側壁３５ａ、３５ｂは、下壁３２とともに長手方向に平行に延び、上下幅が一定に形成されている。針保持部３６は、一対の第２側壁３５ａ、３５ｂの間に位置している。 The pair of first side walls 34a and 34b extend in parallel with the lower wall 32 in the longitudinal direction, and are formed so that the vertical width on the tip side is narrower than the vertical width on the base end side. Notches 42a and 42b that open to the tip side are formed at substantially the center of each of the first side walls 34a and 34b in the vertical direction. Further, a rectangular fitting hole 44 extends in the longitudinal direction slightly on the proximal end side of the notch 42a of the first side wall 34a. The cutouts 42a, 42b and the fitting hole 44 are for holding the support member 27 with respect to the housing 18. The pair of second side walls 35a and 35b extend parallel to the longitudinal direction together with the lower wall 32, and have a constant vertical width. The needle holding portion 36 is located between the pair of second side walls 35a and 35b.

ハウジング１８は、針保持部３６において内針１６を保持しているため、カテーテル１２に対してハウジング１８を基端方向に移動させると、ハウジング１８の移動に伴って内針１６もカテーテル１２に対して基端方向に移動させられる。すなわち、ハウジング１８は、内針１６の基端に固定された針ハブとしての機能も有する。なお、針保持部３６は、ハウジング１８とは別に成形し、ハウジング１８に接着固定してもよい。 Since the housing 18 holds the inner needle 16 in the needle holding portion 36, when the housing 18 is moved in the proximal direction with respect to the catheter 12, the inner needle 16 also moves with respect to the catheter 12 as the housing 18 moves. It is moved toward the base end. That is, the housing 18 also has a function as a needle hub fixed to the base end of the inner needle 16. The needle holding portion 36 may be formed separately from the housing 18 and adhesively fixed to the housing 18.

このカテーテル組立体１０Ａは、図１に示すように、初期状態でカテーテルハブ１４及び針保護部材２６がハウジング１８から露出している。なお、カテーテル組立体１０Ａは、ハウジング１８の長手方向中央に側壁を形成することによりカテーテルハブ１４や針保護部材２６等を囲う構成でもよく、ハウジング１８に上壁を形成したり、蓋体を取り付けたりしてカテーテルハブ１４や針保護部材２６等を覆う構成でもよい。 In the catheter assembly 10A, as shown in FIG. 1, the catheter hub 14 and the needle protection member 26 are exposed from the housing 18 in the initial state. The catheter assembly 10A may be configured to surround the catheter hub 14, the needle protection member 26, etc. by forming a side wall in the center of the housing 18 in the longitudinal direction, and may form an upper wall on the housing 18 or attach a lid. It may be configured to cover the catheter hub 14, the needle protection member 26, or the like.

カテーテル操作部材２０は、カテーテルハブ１４に装着されることで、内針１６及びハウジング１８に対しカテーテル１２及びカテーテルハブ１４を相対的に進退させる。詳細には、カテーテル操作部材２０は、先端及び基端方向に延びる平板部４６と、平板部４６の先端から上方やや基端方向に延出した操作部４８と、平板部４６の基端に一体成形されてカテーテルハブ１４に着脱自在なハブ装着部５０とを有する。 When the catheter operating member 20 is attached to the catheter hub 14, the catheter 12 and the catheter hub 14 are moved back and forth relative to the inner needle 16 and the housing 18. Specifically, the catheter operating member 20 is integrated with the flat plate portion 46 extending in the tip and proximal directions, the operating portion 48 extending slightly upward from the distal end of the flat plate portion 46 in the proximal direction, and the proximal end of the flat plate portion 46. It has a hub mounting portion 50 that is molded and can be attached to and detached from the catheter hub 14.

操作部４８は、ユーザの手指が接触され、カテーテル１２の進退操作がなされる部分である。平板部４６は、薄肉に形成されることにより、平板部４６の面方向と直交する方向に容易に湾曲可能な可撓性を有する。平板部４６（カテーテル操作部材２０）を構成する材料は、特に限定されるものではないが、例えば、カテーテルハブ１４で挙げた材料を適宜選択し得る。 The operation unit 48 is a portion where the user's fingers are touched and the catheter 12 is moved forward and backward. Since the flat plate portion 46 is formed to be thin, the flat plate portion 46 has flexibility that can be easily bent in a direction orthogonal to the surface direction of the flat plate portion 46. The material constituting the flat plate portion 46 (catheter operating member 20) is not particularly limited, but for example, the material mentioned in the catheter hub 14 can be appropriately selected.

平板部４６は、その先端から基端のやや手前まで一定の幅寸法で延在する幅広部（カム保持部）５２と、平板部４６の基端部を構成する一定の幅寸法の幅狭部（カム保持解除部）５４とを有している。 The flat plate portion 46 includes a wide portion (cam holding portion) 52 extending with a constant width dimension from the tip thereof to slightly in front of the base end, and a narrow portion having a constant width dimension constituting the base end portion of the flat plate portion 46. It has (cam holding release unit) 54.

幅狭部５４は、平板部４６の基端部のうち嵌合孔４４が位置する方向の側部が切り欠かれることにより形成されている。幅広部５２及び幅狭部５４の境界部のうち嵌合孔４４が位置する方向の側面には、先端方向に向かって嵌合孔４４が位置する側に傾斜する第１傾斜面５６が形成されている。ハブ装着部５０は、先端方向への操作によってカテーテルハブ１４を先端側に変位（前進）させることが可能に構成されている。なお、ハブ装着部５０は、カテーテルハブ１４に装着された状態でカテーテルハブ１４に対して周方向に回転可能となっている。 The narrow portion 54 is formed by cutting out a side portion of the base end portion of the flat plate portion 46 in the direction in which the fitting hole 44 is located. A first inclined surface 56 is formed on the side surface of the boundary portion between the wide portion 52 and the narrow portion 54 in the direction in which the fitting hole 44 is located so as to be inclined toward the tip end direction. ing. The hub mounting portion 50 is configured so that the catheter hub 14 can be displaced (advanced) toward the distal end side by operating in the distal end direction. The hub mounting portion 50 can rotate in the circumferential direction with respect to the catheter hub 14 in a state of being mounted on the catheter hub 14.

補助部材２２は、内針１６の先端によるカテーテル１２の内面の傷つき防止と、カテーテル１２を血管内に挿入する際のカテーテル１２の剛性強化のために、カテーテル１２の内側に離脱可能に挿通された可撓性を有する長尺状の部材である。具体的には、カテーテル組立体１０Ａの初期状態において、補助部材２２は、カテーテル１２と内針１６との間にカテーテル１２の延在方向に沿って配置されている。本実施形態において、補助部材２２はチューブ状に形成されており、補助部材２２の内腔に内針１６が挿通されている。 The auxiliary member 22 is removably inserted inside the catheter 12 in order to prevent the inner surface of the catheter 12 from being damaged by the tip of the inner needle 16 and to strengthen the rigidity of the catheter 12 when the catheter 12 is inserted into the blood vessel. It is a flexible and long member. Specifically, in the initial state of the catheter assembly 10A, the auxiliary member 22 is arranged between the catheter 12 and the inner needle 16 along the extending direction of the catheter 12. In the present embodiment, the auxiliary member 22 is formed in a tubular shape, and the inner needle 16 is inserted into the lumen of the auxiliary member 22.

本実施形態の場合、カテーテル組立体１０Ａの初期状態において、補助部材２２の最先端部は、カテーテル１２の最先端部よりも基端側に位置している。補助部材２２の最先端部は、カテーテル１２の最先端部と同じ位置、あるいは、カテーテル１２の最先端部よりも先端側に位置していてもよい。 In the case of the present embodiment, in the initial state of the catheter assembly 10A, the most advanced portion of the auxiliary member 22 is located closer to the proximal end side than the most advanced portion of the catheter 12. The most advanced portion of the auxiliary member 22 may be located at the same position as the most advanced portion of the catheter 12, or may be located on the distal end side of the most advanced portion of the catheter 12.

補助部材２２の形状は、チューブ状に限られず、円形の周方向の一部を切り欠いたＣ字状の断面を有する形状でもよく、あるいは、周方向に１８０°未満の弧状の断面を有する形状でもよい。また、補助部材２２は、補助部材２２の内外を貫通する隙間を有する構成、例えば、コイル状、メッシュ状等に構成されてもよい。 The shape of the auxiliary member 22 is not limited to a tubular shape, and may be a shape having a C-shaped cross section cut out in a part in the circumferential direction of a circle, or a shape having an arc-shaped cross section of less than 180 ° in the circumferential direction. But it may be. Further, the auxiliary member 22 may be configured to have a gap penetrating the inside and outside of the auxiliary member 22, for example, a coil shape or a mesh shape.

補助部材２２の構成材料としては、樹脂材料（例えば、カテーテル１２の構成材料として例示した樹脂材料から選択される１以上の材料）や金属材料（例えば、ステンレス鋼、超弾性合金等）が挙げられる。 Examples of the constituent material of the auxiliary member 22 include a resin material (for example, one or more materials selected from the resin materials exemplified as the constituent material of the catheter 12) and a metal material (for example, stainless steel, superelastic alloy, etc.). ..

補助部材ハブ２４は、例えば、カテーテルハブ１４と同様の硬質樹脂により構成され、補助部材２２の基端部に固定されている。補助部材ハブ２４は、中空状に形成されており、初期状態において、補助部材ハブ２４の先端部がカテーテルハブ１４の基端内周部に離脱可能に嵌合し、針保護部材２６の先端部が補助部材ハブ２４の基端内周部に嵌合するとともにカテーテルハブ１４の基端外周部（ネジ部３０）に離脱可能に係合している。 The auxiliary member hub 24 is made of, for example, the same hard resin as the catheter hub 14, and is fixed to the base end portion of the auxiliary member 22. The auxiliary member hub 24 is formed in a hollow shape, and in the initial state, the tip end portion of the auxiliary member hub 24 is detachably fitted to the inner peripheral portion of the base end of the catheter hub 14, and the tip end portion of the needle protection member 26 is detachably fitted. Is fitted to the inner peripheral portion of the proximal end of the auxiliary member hub 24 and is detachably engaged with the outer peripheral portion (threaded portion 30) of the proximal end of the catheter hub 14.

カテーテル組立体１０Ａにおいて、カテーテル１２の径が比較的大きく剛性強化のための内側からの補助（支持）の必要性が低い場合には、補助部材２２は設けられなくてもよい。この場合、補助部材ハブ２４をそのまま設けておく構成としておけば、針保護部材２６の構成は図示例のものと同じでよく、補助チューブが有る場合と無い場合とで針保護部材２６を成形する金型を２つ用意する必要がない。すなわち、どちらの場合も同一形状の金型で針保護部材２６を成形することができる。 In the catheter assembly 10A, when the diameter of the catheter 12 is relatively large and the need for assistance (support) from the inside for strengthening the rigidity is low, the auxiliary member 22 may not be provided. In this case, if the auxiliary member hub 24 is provided as it is, the structure of the needle protection member 26 may be the same as that of the illustrated example, and the needle protection member 26 is formed with or without the auxiliary tube. There is no need to prepare two molds. That is, in either case, the needle protection member 26 can be molded with a mold having the same shape.

また、カテーテル組立体１０Ａにおいて、補助部材ハブ２４は設けられなくてもよい。この場合、補助部材２２の基端部は直接、針保護部材２６に固定されるとともに、針保護部材２６の先端形状をカテーテルハブ１４の基端内周部に離脱可能に嵌合する形状に形成される。また、カテーテル組立体１０Ａにおいて、補助部材２２及び補助部材ハブ２４は設けられなくてもよい。この場合も、針保護部材２６の先端形状をカテーテルハブ１４の基端内周部に離脱可能に嵌合する形状に形成される。 Further, in the catheter assembly 10A, the auxiliary member hub 24 may not be provided. In this case, the base end portion of the auxiliary member 22 is directly fixed to the needle protection member 26, and the tip shape of the needle protection member 26 is formed so as to be detachably fitted to the inner peripheral portion of the base end of the catheter hub 14. Will be done. Further, in the catheter assembly 10A, the auxiliary member 22 and the auxiliary member hub 24 may not be provided. Also in this case, the tip shape of the needle protection member 26 is formed so as to be detachably fitted to the inner peripheral portion of the base end of the catheter hub 14.

針保護部材２６の内部には、板バネ状のシャッタ５８が配置されている。初期状態において、シャッタ５８は内針１６の外面によって押圧されて圧縮されている。一方、内針１６が針保護部材２６に対して後退し、内針１６の針先１６ａがシャッタ５８よりも基端側に移動すると、内針１６によるシャッタ５８に対する押圧が解除され、シャッタ５８は弾性復元力によって拡張する（開く）。これにより、針保護部材２６内の針挿通路が遮断される。なお、針保護部材２６から内針１６が基端方向に抜け出ないように、針保護部材２６の基端部内には抜け止め部材６０が設けられている。 A leaf spring-shaped shutter 58 is arranged inside the needle protection member 26. In the initial state, the shutter 58 is pressed and compressed by the outer surface of the inner needle 16. On the other hand, when the inner needle 16 retracts with respect to the needle protection member 26 and the needle tip 16a of the inner needle 16 moves toward the proximal end side of the shutter 58, the pressure on the shutter 58 by the inner needle 16 is released, and the shutter 58 is released. Expands (opens) by elastic restoring force. As a result, the needle insertion passage in the needle protection member 26 is blocked. A retaining member 60 is provided in the base end portion of the needle protection member 26 so that the inner needle 16 does not come out from the needle protection member 26 in the proximal direction.

図１及び図２に示すように、支持部材２７は、カテーテル１２を支持する部材であって、ハウジング１８の先端部に着脱可能である。支持部材２７を構成する樹脂材料は、特に限定されるものではないが、例えば、カテーテルハブ１４で挙げた材料を適宜選択し得る。 As shown in FIGS. 1 and 2, the support member 27 is a member that supports the catheter 12, and is removable from the tip of the housing 18. The resin material constituting the support member 27 is not particularly limited, but for example, the material mentioned in the catheter hub 14 can be appropriately selected.

支持部材２７は、ハウジング１８の長手方向に沿って延在したブロック状の支持部材本体６２と、支持部材本体６２をハウジング１８に対して保持するカム６４とを有している。支持部材本体６２のうち下壁３２に対向する下面は、下方に円弧状に突出している。支持部材本体６２の基端面の下側部分は、下方に向かって先端方向に傾斜している（図３Ｂ参照）。 The support member 27 has a block-shaped support member main body 62 extending along the longitudinal direction of the housing 18 and a cam 64 that holds the support member main body 62 with respect to the housing 18. The lower surface of the support member main body 62 facing the lower wall 32 projects downward in an arc shape. The lower portion of the base end surface of the support member main body 62 is inclined downward toward the tip end (see FIG. 3B).

支持部材本体６２の下面には、カテーテル１２が配設される横断面形状が半円形状の第２支持溝６６が長手方向に沿って支持部材本体６２の先端から基端面まで第１支持溝３８に対向するように形成されている。第２支持溝６６の内面の長手方向中央には、横断面形状が半円形状の第２凹部６８が形成されている。これにより、カテーテル１２の外面と第２支持溝６６の内面との摺動抵抗を好適に抑えることができる。 On the lower surface of the support member main body 62, a second support groove 66 having a semicircular cross-sectional shape in which the catheter 12 is arranged is provided along the longitudinal direction from the tip end surface to the proximal end surface of the support member main body 62. It is formed so as to face the. A second recess 68 having a semicircular cross-sectional shape is formed at the center of the inner surface of the second support groove 66 in the longitudinal direction. As a result, the sliding resistance between the outer surface of the catheter 12 and the inner surface of the second support groove 66 can be suitably suppressed.

第２支持溝６６及び第２凹部６８の横断面形状は半円形状に限られず、半円形状以外の円弧形状でもよい。また、カテーテル組立体１０Ａにおいて、第２支持溝６６及び第２凹部６８は設けられなくてもよい。この場合、カテーテル１２は、支持部材本体６２の下面に接触する。 The cross-sectional shape of the second support groove 66 and the second recess 68 is not limited to the semicircular shape, and may be an arc shape other than the semicircular shape. Further, in the catheter assembly 10A, the second support groove 66 and the second recess 68 may not be provided. In this case, the catheter 12 comes into contact with the lower surface of the support member main body 62.

ハウジング１８の第１支持溝３８と支持部材本体６２の第２支持溝６６とで構成される空間にカテーテル１２が摺動可能に配置される（図４参照）。すなわち、カテーテル１２は、第１支持溝３８の内面と第２支持溝６６の内面の両方に摺動可能に接触することにより、ハウジング１８と支持部材本体６２の間で支持されている。 The catheter 12 is slidably arranged in the space formed by the first support groove 38 of the housing 18 and the second support groove 66 of the support member main body 62 (see FIG. 4). That is, the catheter 12 is supported between the housing 18 and the support member main body 62 by slidably contacting both the inner surface of the first support groove 38 and the inner surface of the second support groove 66.

支持部材本体６２のうち各第１側壁３４ａ、３４ｂに対向する各側面には、切欠部４２ａ、４２ｂに挿入される凸部７０ａ、７０ｂが設けられている。凸部７０ａ、７０ｂが切欠部４２ａ、４２ｂに挿入されることにより、支持部材本体６２のハウジング１８に対する基端方向への変位及び上下方向の変位が規制される。これにより、支持部材本体６２がハウジング１８に対して強固に保持されるため、支持部材本体６２によりカテーテル１２を一層安定して支持することができる。 Convex portions 70a and 70b to be inserted into the notches 42a and 42b are provided on the side surfaces of the support member main body 62 facing the first side walls 34a and 34b. By inserting the convex portions 70a and 70b into the notch portions 42a and 42b, the displacement of the support member main body 62 with respect to the housing 18 in the proximal direction and the displacement in the vertical direction are regulated. As a result, the support member main body 62 is firmly held against the housing 18, so that the support member main body 62 can support the catheter 12 more stably.

カテーテル組立体１０Ａにおいて、一対の凸部７０ａ、７０ｂの少なくともいずれか１つは設けられなくてもよい。この場合、これら凸部７０ａ、７０ｂに対応する切欠部４２ａ、４２ｂについても設けられなくてもよい。このような構成であっても、カム６４により支持部材本体６２をハウジング１８に対して保持することができる。 In the catheter assembly 10A, at least one of the pair of protrusions 70a and 70b may not be provided. In this case, the notches 42a and 42b corresponding to the convex portions 70a and 70b may not be provided. Even with such a configuration, the support member main body 62 can be held against the housing 18 by the cam 64.

図３Ｂ〜図５Ａに示すように、支持部材本体６２には、カテーテル操作部材２０の平板部４６が挿通する挿通孔７２と、挿通孔７２に連通する第１配設孔７４と、第１配設孔７４に連通して支持部材本体６２の側面に開口する第２配設孔７６とが形成されている。挿通孔７２は、支持部材本体６２の先端面から基端面まで長手方向に沿って延在しており、支持部材本体６２の先端部において支持部材本体６２の上面に開口している。これにより、初期状態でカテーテル操作部材２０の操作部４８の一部を挿通孔７２に配置することができる。 As shown in FIGS. 3B to 5A, the support member main body 62 has an insertion hole 72 through which the flat plate portion 46 of the catheter operating member 20 is inserted, a first arrangement hole 74 communicating with the insertion hole 72, and a first arrangement. A second arrangement hole 76 that communicates with the hole 74 and opens on the side surface of the support member main body 62 is formed. The insertion hole 72 extends from the tip end surface of the support member main body 62 to the base end surface along the longitudinal direction, and is opened on the upper surface of the support member main body 62 at the tip end portion of the support member main body 62. As a result, a part of the operating portion 48 of the catheter operating member 20 can be arranged in the insertion hole 72 in the initial state.

第１配設孔７４と第２配設孔７６とにより、カム６４が配設される１つの配設孔７８が形成されている。第１配設孔７４は、支持部材本体６２の長手方向略中央から基端面まで延在している。第２配設孔７６は、支持部材本体６２の側面に矩形状に開口しており、支持部材本体６２がハウジング１８に装着された状態で嵌合孔４４に連通する。支持部材本体６２の長手方向において、第２配設孔７６は、第１配設孔７４よりも短く且つ嵌合孔４４よりも長く形成されている。 The first arrangement hole 74 and the second arrangement hole 76 form one arrangement hole 78 in which the cam 64 is arranged. The first arrangement hole 74 extends from substantially the center in the longitudinal direction of the support member main body 62 to the proximal end surface. The second arrangement hole 76 has a rectangular opening on the side surface of the support member main body 62, and communicates with the fitting hole 44 in a state where the support member main body 62 is mounted on the housing 18. In the longitudinal direction of the support member main body 62, the second arrangement hole 76 is formed shorter than the first arrangement hole 74 and longer than the fitting hole 44.

また、支持部材本体６２のうち挿通孔７２よりも上方には、長手方向に沿って貫通した一対の貫通孔８０ａ、８０ｂが支持部材本体６２の幅方向（ハウジング１８の幅方向）に互いに離間して形成されている。 Further, above the insertion holes 72 of the support member main body 62, a pair of through holes 80a and 80b penetrating along the longitudinal direction are separated from each other in the width direction of the support member main body 62 (width direction of the housing 18). Is formed.

カム６４は、嵌合孔４４に嵌合する第１位置と嵌合孔４４から離脱した第２位置とに変位可能に配設孔７８に配設されている。カム６４が嵌合孔４４に嵌合することにより、支持部材本体６２は、ハウジング１８に対して保持される。 The cam 64 is displaceably arranged in the arrangement hole 78 at a first position where the cam 64 is fitted into the fitting hole 44 and a second position where the cam 64 is separated from the fitting hole 44. By fitting the cam 64 into the fitting hole 44, the support member main body 62 is held with respect to the housing 18.

カム６４は、Ｔ字状の平板部材であって、第１配設孔７４に配設されるストッパ部８２と、ストッパ部８２から第２配設孔７６に向かって突出した突出部８４とを有している。支持部材本体６２の長手方向において、ストッパ部８２は、第２配設孔７６よりも長く形成されている。これにより、支持部材本体６２がハウジング１８から離脱した場合であっても、カム６４が配設孔７８から抜け出ることが阻止（防止）される。 The cam 64 is a T-shaped flat plate member, and has a stopper portion 82 arranged in the first arrangement hole 74 and a protruding portion 84 protruding from the stopper portion 82 toward the second arrangement hole 76. Have. In the longitudinal direction of the support member main body 62, the stopper portion 82 is formed longer than the second arrangement hole 76. As a result, even when the support member main body 62 is detached from the housing 18, the cam 64 is prevented (prevented) from coming out of the arrangement hole 78.

ストッパ部８２における平板部４６に対向する面には、カテーテル１２の先端側に向かって突出部８４側に傾斜した第２傾斜面８６が形成されている。第２傾斜面８６の傾斜角度は、平板部４６の第１傾斜面５６の傾斜角度と同一に設定されている。 On the surface of the stopper portion 82 facing the flat plate portion 46, a second inclined surface 86 inclined toward the protruding portion 84 side toward the distal end side of the catheter 12 is formed. The inclination angle of the second inclined surface 86 is set to be the same as the inclination angle of the first inclined surface 56 of the flat plate portion 46.

突出部８４のうちカテーテル１２の先端方向を指向する面には、平板部４６とは反対側に向かってカテーテル１２の基端方向に傾斜した案内面８８が形成されている。すなわち、突出部８４の先端部は、その先端に向かって徐々に幅狭に形成されているため、嵌合部に嵌合（挿入）可能となっている。 On the surface of the protruding portion 84 that points toward the tip of the catheter 12, a guide surface 88 that is inclined toward the proximal end of the catheter 12 is formed toward the side opposite to the flat plate portion 46. That is, since the tip portion of the protruding portion 84 is gradually formed to be narrower toward the tip end, it can be fitted (inserted) into the fitting portion.

図５Ａに示すように、挿通孔７２に幅広部５２が位置する状態において、カム６４は、ストッパ部８２が幅広部５２に接触することにより、突出部８４が嵌合孔４４に嵌合する第１位置に保持される。すなわち、支持部材本体６２は、カテーテル１２の支持を維持するロック状態となる。従って、カテーテル操作部材２０をハウジング１８に対して先端側に変位させてカテーテル１２の先端部を血管内に挿入する際に、カテーテル１２に抵抗力が作用しても支持部材本体６２がハウジング１８から離脱することを抑制することができる。 As shown in FIG. 5A, in a state where the wide portion 52 is located in the insertion hole 72, in the cam 64, the stopper portion 82 comes into contact with the wide portion 52, so that the protruding portion 84 fits into the fitting hole 44. It is held in one position. That is, the support member main body 62 is in a locked state for maintaining the support of the catheter 12. Therefore, when the catheter operating member 20 is displaced toward the distal end side with respect to the housing 18 and the distal end portion of the catheter 12 is inserted into the blood vessel, the support member main body 62 is moved from the housing 18 even if a resistance force acts on the catheter 12. It is possible to suppress withdrawal.

カム６４が第１位置に保持されているロック状態において、案内面８８は、嵌合孔４４を構成する壁面と第１側壁３４ａ、３４ｂの内面との境界部（角部９０）に接触している。 In the locked state in which the cam 64 is held in the first position, the guide surface 88 comes into contact with the boundary portion (corner portion 90) between the wall surface forming the fitting hole 44 and the inner surfaces of the first side walls 34a and 34b. There is.

一方、図５Ｂに示すように、挿通孔７２に幅狭部５４が位置する状態において、ストッパ部８２と幅広部５２との接触が解除されるため、カム６４は、第１位置から嵌合孔４４から離脱した第２位置に変位可能となる。すなわち、支持部材本体６２は、ハウジング１８から離脱可能な（カテーテルハブ１４のハウジング１８からの離脱を許容する）アンロック状態となる。 On the other hand, as shown in FIG. 5B, when the narrow portion 54 is located in the insertion hole 72, the contact between the stopper portion 82 and the wide portion 52 is released, so that the cam 64 has a fitting hole from the first position. It can be displaced to the second position away from 44. That is, the support member main body 62 is in an unlocked state in which it can be detached from the housing 18 (allowing the catheter hub 14 to be detached from the housing 18).

従って、アンロック状態でハウジング１８に対してカテーテル操作部材２０及びカテーテル部材１７を相対的に先端方向に変位させると、支持部材２７（支持部材本体６２及びカム６４）がハウジング１８に対して先端方向に変位するとともに案内面８８が上記角部９０によって幅狭部５４側に押されることによりカム６４が第１位置から第２位置に変位して嵌合孔４４から離脱する。この第２位置では、カム６４のストッパ部８２は、幅狭部５４に接触している。そして、ハウジング１８に対してカテーテル操作部材２０及びカテーテル部材１７を相対的に先端方向に変位させることにより支持部材２７がハウジング１８から離脱される。 Therefore, when the catheter operating member 20 and the catheter member 17 are displaced in the distal direction relative to the housing 18 in the unlocked state, the support member 27 (support member main body 62 and cam 64) is displaced in the distal direction with respect to the housing 18. When the guide surface 88 is pushed toward the narrow portion 54 by the corner portion 90, the cam 64 is displaced from the first position to the second position and is separated from the fitting hole 44. At this second position, the stopper portion 82 of the cam 64 is in contact with the narrow portion 54. Then, the support member 27 is separated from the housing 18 by displacing the catheter operating member 20 and the catheter member 17 relative to the housing 18 in the distal direction.

次に、上記のように構成されたカテーテル組立体１０Ａの作用及び効果について説明する。 Next, the action and effect of the catheter assembly 10A configured as described above will be described.

図１に示す初期状態のカテーテル組立体１０Ａでは、カテーテルハブ１４、補助部材ハブ２４及び針保護部材２６が接続されるとともに、カテーテル操作部材２０のハブ装着部５０にカテーテルハブ１４が装着されて、ハウジング１８に一体的に配設されている。 In the catheter assembly 10A in the initial state shown in FIG. 1, the catheter hub 14, the auxiliary member hub 24, and the needle protection member 26 are connected, and the catheter hub 14 is mounted on the hub mounting portion 50 of the catheter operating member 20. It is integrally arranged in the housing 18.

また、初期状態では、カテーテル１２、補助部材２２及び内針１６が同心状に重なる多重管部が、支持部材２７により支持されている。具体的には、カテーテル１２がハウジング１８の第１支持溝３８と支持部材２７の第２支持溝６６とで構成される空間に配設されることによりハウジング１８及び支持部材２７の両方に接触した状態で支持されている。このとき、支持部材本体６２の挿通孔７２にはカテーテル操作部材２０の幅広部５２が位置しているため、カム６４が嵌合孔４４に嵌合する第１位置に保持されている。すなわち、支持部材本体６２は、カテーテル１２の支持を維持するロック状態になっている。 Further, in the initial state, the multi-tube portion in which the catheter 12, the auxiliary member 22, and the inner needle 16 are concentrically overlapped is supported by the support member 27. Specifically, the catheter 12 came into contact with both the housing 18 and the support member 27 by being arranged in the space composed of the first support groove 38 of the housing 18 and the second support groove 66 of the support member 27. It is supported in the state. At this time, since the wide portion 52 of the catheter operating member 20 is located in the insertion hole 72 of the support member main body 62, the cam 64 is held at the first position where it is fitted into the fitting hole 44. That is, the support member main body 62 is in a locked state for maintaining the support of the catheter 12.

カテーテル組立体１０Ａを使用する場合、まず、カテーテル組立体１０Ａを患者の皮膚に穿刺する穿刺操作を行う。穿刺操作において、ユーザ（医師、看護師等）は、ハウジング１８を把持しつつ、カテーテル組立体１０Ａの先端部（内針１６が挿通されたカテーテル１２の先端部）を患者に押し当てるようにして、穿刺目標の血管に向かって皮膚に穿刺する。これにより、内針１６及びカテーテル１２の先端部が皮膚に穿刺される。この穿刺時には、上述したように、支持部材２７によりカテーテル１２を支持していることで、穿刺に伴う抵抗力を受けても、ハウジング１８内での多重管部の撓みが抑制される。これにより、ユーザは違和感なく穿刺を行うことができる。 When the catheter assembly 10A is used, first, a puncture operation is performed to puncture the catheter assembly 10A into the skin of the patient. In the puncture operation, the user (doctor, nurse, etc.) holds the housing 18 and presses the tip of the catheter assembly 10A (the tip of the catheter 12 through which the inner needle 16 is inserted) against the patient. , Puncture the skin toward the target blood vessel. As a result, the tips of the inner needle 16 and the catheter 12 are punctured into the skin. At the time of this puncture, as described above, since the catheter 12 is supported by the support member 27, the bending of the multi-tube portion in the housing 18 is suppressed even if the resistance force due to the puncture is received. As a result, the user can perform the puncture without discomfort.

次に、ユーザは、図６Ａのように、ハウジング１８の位置を固定しつつ、カテーテル操作部材２０を先端方向に操作してカテーテル部材１７（カテーテル１２及びカテーテルハブ１４）を前進させる。この場合、ユーザは、例えば、カテーテル操作部材２０の操作部４８に手指を当てて、ハウジング１８と相対的にカテーテル操作部材２０を先端方向に進出させる。図６Ａではカテーテル操作部材２０は直線状のままであるが、実際には、カテーテル操作部材２０が患者の皮膚に接触しないように、カテーテル操作部材２０の平板部４６を上方に湾曲させながら、カテーテル操作部材２０を前進させる。 Next, as shown in FIG. 6A, the user operates the catheter operating member 20 in the distal direction while fixing the position of the housing 18 to advance the catheter member 17 (catheter 12 and catheter hub 14). In this case, for example, the user puts his / her finger on the operation unit 48 of the catheter operation member 20 to advance the catheter operation member 20 in the distal direction relative to the housing 18. In FIG. 6A, the catheter operating member 20 remains linear, but in reality, the catheter while bending the flat plate portion 46 of the catheter operating member 20 upward so that the catheter operating member 20 does not come into contact with the patient's skin. The operating member 20 is advanced.

このとき、上述したように、支持部材本体６２は、カテーテル１２の支持を維持するロック状態となっているため、カテーテル１２の挿入に伴う抵抗力を受けても、カテーテル１２及び内針１６等の多重管部が撓むことを抑制することができる。これにより、カテーテル１２を血管内に違和感なく円滑に挿入することができる。 At this time, as described above, since the support member main body 62 is in the locked state for maintaining the support of the catheter 12, the catheter 12 and the inner needle 16 and the like are subjected to the resistance force due to the insertion of the catheter 12. It is possible to prevent the multi-tube portion from bending. As a result, the catheter 12 can be smoothly inserted into the blood vessel without any discomfort.

なお、このとき、ユーザの好みによっては、カテーテル操作部材２０をハウジング１８に対して進退させてもよい。このような場合であっても、支持部材本体６２によりカテーテル１２の支持が維持されているので、多重管部が撓むことを抑制することができる。 At this time, the catheter operating member 20 may be moved back and forth with respect to the housing 18 depending on the preference of the user. Even in such a case, since the support of the catheter 12 is maintained by the support member main body 62, it is possible to suppress the multi-tube portion from bending.

カテーテル１２の先端を血管内の所定位置まで挿入すると、支持部材本体６２の挿通孔７２にはカテーテル操作部材２０の幅狭部５４が位置する。この状態で、ストッパ部８２と幅広部５２との接触が解除されるため、カム６４は、第１位置から第２位置に変位可能になる。すなわち、支持部材本体６２は、ハウジング１８から離脱可能なアンロック状態となっている。 When the tip of the catheter 12 is inserted to a predetermined position in the blood vessel, the narrow portion 54 of the catheter operating member 20 is located in the insertion hole 72 of the support member main body 62. In this state, the contact between the stopper portion 82 and the wide portion 52 is released, so that the cam 64 can be displaced from the first position to the second position. That is, the support member main body 62 is in an unlocked state in which it can be detached from the housing 18.

次に、ユーザは、カテーテル操作部材２０及びカテーテル部材１７の位置を保持しつつ、ハウジング１８を基端方向に引っ張る。そうすると、ハウジング１８が支持部材２７に対して相対的に基端方向に変位するとともに案内面８８が第１側壁３４ａ、３４ｂの角部９０によって幅狭部５４側に押されることによりカム６４が嵌合孔４４から離脱して第２位置に変位する。この状態で、カム６４のストッパ部８２は幅狭部５４に接触している。また、一対の凸部７０ａ、７０ｂは切欠部４２ａ、４２ｂから離脱する。 Next, the user pulls the housing 18 toward the proximal end while holding the positions of the catheter operating member 20 and the catheter member 17. Then, the housing 18 is displaced relative to the support member 27 in the proximal direction, and the guide surface 88 is pushed toward the narrow portion 54 by the corners 90 of the first side walls 34a and 34b, so that the cam 64 is fitted. It separates from the hole 44 and is displaced to the second position. In this state, the stopper portion 82 of the cam 64 is in contact with the narrow portion 54. Further, the pair of convex portions 70a and 70b are separated from the notched portions 42a and 42b.

なお、ユーザの好みによっては、ハウジング１８の位置を保持しつつ、カテーテル操作部材２０をハウジング１８に対して先端側にさらに変位させてもよい。この場合であっても、ハブ装着部５０が支持部材本体６２の基端面に接触して支持部材本体６２を先端方向に押すため、支持部材２７がハウジング１８に対して相対的に先端方向に変位するとともに案内面８８が角部９０によって幅狭部５４側に押されることによりカム６４が嵌合孔４４から離脱して第２位置に変位する。 Depending on the preference of the user, the catheter operating member 20 may be further displaced toward the tip end side with respect to the housing 18 while maintaining the position of the housing 18. Even in this case, since the hub mounting portion 50 contacts the base end surface of the support member main body 62 and pushes the support member main body 62 toward the tip end, the support member 27 is displaced in the tip direction relative to the housing 18. At the same time, the guide surface 88 is pushed toward the narrow portion 54 by the corner portion 90, so that the cam 64 is separated from the fitting hole 44 and displaced to the second position.

そして、ハウジング１８を基端方向にさらに引っ張ると、図６Ｂのように、ハブ装着部５０により先端方向に押された支持部材本体６２及びカム６４（支持部材２７）がハウジング１８から離脱し、カテーテル部材１７及びカテーテル操作部材２０がハウジング１８から完全に抜け出るとともに、ハウジング１８に固定された内針１６がカテーテル１２から抜去される。このとき、支持部材本体６２の長手方向においてストッパ部８２が第２配設孔７６よりも長く形成されているため、カム６４が配設孔７８から抜け出ることはない。 Then, when the housing 18 is further pulled toward the proximal end, as shown in FIG. 6B, the support member main body 62 and the cam 64 (support member 27) pushed in the distal end direction by the hub mounting portion 50 are separated from the housing 18, and the catheter The member 17 and the catheter operating member 20 are completely removed from the housing 18, and the inner needle 16 fixed to the housing 18 is removed from the catheter 12. At this time, since the stopper portion 82 is formed longer than the second arrangement hole 76 in the longitudinal direction of the support member main body 62, the cam 64 does not come out of the arrangement hole 78.

また、針保護部材２６及びシャッタ５８によるセーフティ機能が発現する。すなわち、針先１６ａが針保護部材２６内でシャッタ５８よりも基端側に移動することに伴って、シャッタ５８が針保護部材２６内の針挿通路を遮断する。これにより、針保護部材２６の先端からの内針１６の再突出が阻止される。また、抜け止め部材６０により、針保護部材２６の基端側から内針１６が抜け出ることが阻止されるため、針保護部材２６による針先１６ａの保護が好適に維持される。 Further, the safety function by the needle protection member 26 and the shutter 58 is exhibited. That is, as the needle tip 16a moves toward the proximal end side of the shutter 58 in the needle protection member 26, the shutter 58 blocks the needle insertion passage in the needle protection member 26. As a result, the re-projection of the inner needle 16 from the tip of the needle protection member 26 is prevented. Further, since the retaining member 60 prevents the inner needle 16 from coming out from the base end side of the needle protecting member 26, the protection of the needle tip 16a by the needle protecting member 26 is preferably maintained.

また、図６Ｂの状態からさらにハウジング１８を基端方向に引っ張ると、カテーテルハブ１４と針保護部材２６との連結が解除される。これにより、図７Ａのように、針保護部材２６がカテーテルハブ１４から分離する。このとき、補助部材ハブ２４と針保護部材２６とは連結されているため、針保護部材２６によって補助部材ハブ２４が基端方向に引っ張られ、補助部材２２もカテーテル１２から抜去されるに至る。 Further, when the housing 18 is further pulled toward the proximal end from the state of FIG. 6B, the connection between the catheter hub 14 and the needle protection member 26 is released. As a result, as shown in FIG. 7A, the needle protection member 26 is separated from the catheter hub 14. At this time, since the auxiliary member hub 24 and the needle protection member 26 are connected, the auxiliary member hub 24 is pulled toward the proximal end by the needle protection member 26, and the auxiliary member 22 is also removed from the catheter 12.

次に、ユーザは、図７Ｂのように、カテーテル操作部材２０をカテーテルハブ１４から離脱させる。これにより、カテーテル部材１７は患者に留置される。なお、ユーザの好みによっては、カテーテル操作部材２０をカテーテルハブ１４に取り付けたままにしてもよい。 Next, the user detaches the catheter operating member 20 from the catheter hub 14, as shown in FIG. 7B. As a result, the catheter member 17 is placed in the patient. The catheter operating member 20 may be left attached to the catheter hub 14 depending on the user's preference.

次に、内針１６及び補助部材２２が抜き取られた状態のカテーテル部材１７の基端側（カテーテルハブ１４の基端部）に、図示しない輸液チューブのコネクタを接続し、輸液チューブから患者への輸液剤（薬液）の投与を実施する。 Next, a connector of an infusion tube (not shown) is connected to the base end side (base end portion of the catheter hub 14) of the catheter member 17 in a state where the inner needle 16 and the auxiliary member 22 are removed, and the infusion tube is transferred to the patient. Administer an infusion solution (drug solution).

上記の説明では、支持部材２７がハウジング１８から離脱した後、カテーテル部材１７及びカテーテル操作部材２０をハウジング１８から離脱させた。しかしながら、ユーザの好みによっては、ハウジング１８から一度離脱させた支持部材２７を再度ハウジング１８に装着し、カテーテル１２を内針１６に対して進退させてもよい。 In the above description, after the support member 27 is detached from the housing 18, the catheter member 17 and the catheter operating member 20 are detached from the housing 18. However, depending on the preference of the user, the support member 27 once detached from the housing 18 may be reattached to the housing 18 and the catheter 12 may be advanced and retracted with respect to the inner needle 16.

この場合、ユーザは、カテーテル操作部材２０及びカテーテル部材１７の位置を保持しつつハウジング１８を先端側に変位させることにより、支持部材本体６２の基端をハウジング１８の先端側から挿入する。これにより、各凸部７０ａ、７０ｂが各切欠部４２ａ、４２ｂに挿入されて第２配設孔７６が嵌合孔４４に連通する（対向する）。 In this case, the user inserts the base end of the support member main body 62 from the tip end side of the housing 18 by displacing the housing 18 toward the tip end side while holding the positions of the catheter operating member 20 and the catheter member 17. As a result, the convex portions 70a and 70b are inserted into the notch portions 42a and 42b, and the second arrangement hole 76 communicates with (opposes) the fitting hole 44.

そして、この状態でハウジング１８の位置を保持しつつカテーテル操作部材２０を基端方向にスライドさせる。そうすると、第２傾斜面８６が第１傾斜面５６によって嵌合孔４４側に押されることによりカム６４が第２位置から第１位置に変位して嵌合孔４４に嵌合する。この状態で挿通孔７２に位置する幅広部５２とストッパ部８２とが接触するため、カム６４が第１位置に保持される。 Then, in this state, the catheter operating member 20 is slid toward the proximal end while maintaining the position of the housing 18. Then, the second inclined surface 86 is pushed toward the fitting hole 44 by the first inclined surface 56, so that the cam 64 is displaced from the second position to the first position and fitted into the fitting hole 44. In this state, the wide portion 52 located in the insertion hole 72 and the stopper portion 82 come into contact with each other, so that the cam 64 is held in the first position.

なお、支持部材２７のハウジング１８への装着操作は、ハウジング１８の位置を保持しつつカテーテル操作部材２０及びカテーテル部材１７を基端方向にスライドさせることにより、支持部材本体６２の基端をハウジング１８の先端側から挿入するようにしてもよい。 In the operation of attaching the support member 27 to the housing 18, the catheter operating member 20 and the catheter member 17 are slid toward the proximal end while maintaining the position of the housing 18, so that the proximal end of the support member main body 62 is attached to the housing 18. It may be inserted from the tip side of the.

ハウジング１８から離脱した支持部材２７を再度ハウジング１８に装着する場合には、カテーテル組立体１０Ａは、カム６４を第２位置で保持する保持手段９１を有していてもよい（図８参照）。保持手段９１としては、例えば、カム６４に設けた凸部９２を、配設孔７８を構成する壁面に形成した凹部９４に嵌合させる構成を採用し得る。 When the support member 27 detached from the housing 18 is reattached to the housing 18, the catheter assembly 10A may have holding means 91 for holding the cam 64 in the second position (see FIG. 8). As the holding means 91, for example, a configuration may be adopted in which the convex portion 92 provided on the cam 64 is fitted into the concave portion 94 formed on the wall surface forming the arrangement hole 78.

また、保持手段９１は、配設孔７８を構成する壁面に凸部を設けカム６４に凹部を形成する構成でもよいし、配設孔７８を構成する壁面とカム６４に互いに係合する凸部を設ける構成でもよい。なお、保持手段９１は、第１傾斜面５６により第２傾斜面８６が嵌合孔４４側に押された際に、カム６４の第２位置の保持が解除される程度の保持力に設定されている。このような保持手段９１を設けた場合、配設孔７８からカム６４の一部が突出すること（カム６４が邪魔になること）が抑制されるため、支持部材２７をハウジング１８に対して円滑に挿入することができる。 Further, the holding means 91 may have a configuration in which a convex portion is provided on the wall surface forming the arrangement hole 78 to form a concave portion in the cam 64, or the wall surface forming the arrangement hole 78 and the convex portion that engages with the cam 64. It may be configured to provide. The holding means 91 is set to a holding force such that when the second inclined surface 86 is pushed toward the fitting hole 44 by the first inclined surface 56, the holding of the second position of the cam 64 is released. ing. When such a holding means 91 is provided, it is suppressed that a part of the cam 64 protrudes from the arrangement hole 78 (the cam 64 becomes an obstacle), so that the support member 27 is smoothly attached to the housing 18. Can be inserted into.

また、上記の説明では、針保護部材２６をカテーテルハブ１４から分離する際に、補助部材ハブ２４を針保護部材２６につなげたままとし、補助部材２２をカテーテル１２から抜去した。但し、ユーザの好みによっては、針保護部材２６をカテーテルハブ１４から分離する際に、針保護部材２６と補助部材ハブ２４との切り離しも行い、補助部材２２とカテーテル１２の組立体を血管内に挿入してもよい。 Further, in the above description, when the needle protection member 26 is separated from the catheter hub 14, the auxiliary member hub 24 is left connected to the needle protection member 26, and the auxiliary member 22 is removed from the catheter 12. However, depending on the user's preference, when the needle protection member 26 is separated from the catheter hub 14, the needle protection member 26 and the auxiliary member hub 24 are also separated, and the assembly of the auxiliary member 22 and the catheter 12 is inserted into the blood vessel. You may insert it.

以上説明したように、本実施形態において、支持部材２７は、カテーテル１２が内針１６に対して先端側に進出する際にカテーテル１２の支持を維持するロック状態とカテーテルハブ１４のハウジング１８からの離脱を許容するアンロック状態とに切り替え可能にハウジング１８に設けられている。これにより、カテーテル１２を血管内に違和感なく円滑に挿入することができ、且つカテーテルハブ１４をハウジング１８から容易に離脱させることができる。 As described above, in the present embodiment, the support member 27 is in a locked state for maintaining the support of the catheter 12 when the catheter 12 advances toward the distal end side with respect to the inner needle 16 and from the housing 18 of the catheter hub 14. The housing 18 is provided so as to be switchable to an unlocked state that allows detachment. As a result, the catheter 12 can be smoothly inserted into the blood vessel without discomfort, and the catheter hub 14 can be easily detached from the housing 18.

また、ユーザは、カテーテル操作部材２０をハウジング１８に対してカテーテル１２の先端側に変位させるだけで支持部材２７をロック状態からアンロック状態に切り替えることができるので、カテーテル組立体１０Ａの操作性を向上させることができる。さらに、ロック状態でハウジング１８に対する支持部材２７の変位が規制されているので、支持部材２７によってカテーテル１２及び内針１６等の多重管部を安定して支持することができる。 Further, since the user can switch the support member 27 from the locked state to the unlocked state simply by displacing the catheter operating member 20 toward the tip end side of the catheter 12 with respect to the housing 18, the operability of the catheter assembly 10A can be improved. Can be improved. Further, since the displacement of the support member 27 with respect to the housing 18 is restricted in the locked state, the support member 27 can stably support the multi-tube portion such as the catheter 12 and the inner needle 16.

さらにまた、アンロック状態でカテーテル操作部材２０がハウジング１８に対してカテーテル１２の先端側に相対的に変位することにより支持部材２７がハウジング１８から離脱されるので、カテーテルハブ１４及びカテーテル操作部材２０をハウジング１８から容易に離脱させることができる。 Furthermore, since the support member 27 is separated from the housing 18 by the catheter operating member 20 being displaced relative to the tip end side of the catheter 12 with respect to the housing 18 in the unlocked state, the catheter hub 14 and the catheter operating member 20 Can be easily detached from the housing 18.

本実施形態によれば、挿通孔７２に幅広部５２が位置している間、カム６４は嵌合孔４４に嵌合する第１位置に保持されて支持部材２７がロック状態となるため、支持部材本体６２によってカテーテル１２を安定して支持することができる。また、カテーテル操作部材２０をハウジング１８に対してカテーテル１２の先端側に相対的に変位させて挿通孔７２に幅狭部５４を位置させることにより、カム６４は第１位置から嵌合孔４４から離脱する第２位置に変位可能になり支持部材２７がアンロック状態となる。そのため、簡易な構成で支持部材２７をロック状態とアンロック状態とに切り替えることができる。さらに、カム６４に形成した案内面８８の作用によりカム６４を第１位置から第２位置に容易に変位させることができる。 According to the present embodiment, while the wide portion 52 is located in the insertion hole 72, the cam 64 is held in the first position where the cam 64 is fitted in the fitting hole 44, and the support member 27 is locked. The catheter 12 can be stably supported by the member body 62. Further, by displacing the catheter operating member 20 relative to the tip end side of the catheter 12 with respect to the housing 18 and locating the narrow portion 54 in the insertion hole 72, the cam 64 is moved from the first position to the fitting hole 44. The support member 27 is unlocked because it can be displaced to the second position where it is disengaged. Therefore, the support member 27 can be switched between the locked state and the unlocked state with a simple configuration. Further, the cam 64 can be easily displaced from the first position to the second position by the action of the guide surface 88 formed on the cam 64.

本実施形態によれば、カム６４が配設孔７８から分離することをストッパ部８２により防止することができるので、カテーテル組立体１０Ａの操作性を向上させることができる。 According to the present embodiment, the stopper portion 82 can prevent the cam 64 from separating from the arrangement hole 78, so that the operability of the catheter assembly 10A can be improved.

（第２実施形態）
次に、本発明の第２実施形態に係るカテーテル組立体１０Ｂについて図９〜図１３Ｂを参照しながら説明する。なお、第２実施形態に係るカテーテル組立体１０Ｂにおいて、第１実施形態に係るカテーテル組立体１０Ａと同一の構成要素には同一の参照符号を付し、詳細な説明を省略する。 (Second Embodiment)
Next, the catheter assembly 10B according to the second embodiment of the present invention will be described with reference to FIGS. 9 to 13B. In the catheter assembly 10B according to the second embodiment, the same components as the catheter assembly 10A according to the first embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.

図９及び図１０に示すように、本実施形態に係るカテーテル組立体１０Ｂは、カテーテル１２、カテーテルハブ１４、内針１６、ハウジング１００、カテーテル操作部材１０２、補助部材２２、補助部材ハブ２４、針保護部材２６及び支持部材１０４を備えている。 As shown in FIGS. 9 and 10, the catheter assembly 10B according to the present embodiment includes a catheter 12, a catheter hub 14, an inner needle 16, a housing 100, a catheter operating member 102, an auxiliary member 22, an auxiliary member hub 24, and a needle. It includes a protective member 26 and a support member 104.

ハウジング１００は、第１実施形態で説明したハウジング１８と同様の材料で構成され、下壁１０６と、下壁１０６の側辺から上方向に突出する一対の側壁１０８ａ、１０８ｂと、下壁１０６の上面から上方に突出して内針１６の基端部を固定支持する針保持部１１０を有する。 The housing 100 is made of the same material as the housing 18 described in the first embodiment, and is formed of a lower wall 106, a pair of side walls 108a and 108b protruding upward from the side sides of the lower wall 106, and a lower wall 106. It has a needle holding portion 110 that projects upward from the upper surface and fixes and supports the base end portion of the inner needle 16.

下壁１０６及び一対の側壁１０８ａ、１０８ｂで囲う内側には、多重管部の一部、カテーテルハブ１４、補助部材ハブ２４及び針保護部材２６を収容する収容空間１１２が形成される。 An accommodation space 112 for accommodating a part of the multi-tube portion, the catheter hub 14, the auxiliary member hub 24, and the needle protection member 26 is formed inside the lower wall 106 and the pair of side walls 108a and 108b.

一対の側壁１０８ａ、１０８ｂは、下壁１０６とともに長手方向に平行に延び、基端側及び中間側の上下幅が一定であり、中間側に対し先端側の上下幅が幅広となるように形成されている。各側壁１０８ａ、１０８ｂの先端側上部には、側壁１０８ａ、１０８ｂの内面を直線状に切り込んだ溝状のレール部１１４が設けられている。レール部１１４は、カテーテル操作部材１０２の左右の側縁を収容して、カテーテル操作部材１０２の進退をガイドする。一方の側壁１０８ａには、支持部材１０４を取り付けるための配置用凹部１１６が設けられる。 The pair of side walls 108a and 108b are formed so as to extend in parallel with the lower wall 106 in the longitudinal direction, the vertical widths of the base end side and the intermediate side are constant, and the vertical width of the tip side is wider than that of the intermediate side. ing. A groove-shaped rail portion 114 in which the inner surfaces of the side walls 108a and 108b are cut in a straight line is provided on the upper portion of the side walls 108a and 108b on the tip end side. The rail portion 114 accommodates the left and right side edges of the catheter operating member 102 and guides the advance / retreat of the catheter operating member 102. One side wall 108a is provided with an arrangement recess 116 for attaching the support member 104.

配置用凹部１１６は、側壁１０８ａの先端から基端方向に向かって切り欠かれて、下壁１０６とレール部１１４の間に位置している。配置用凹部１１６の形成位置の下壁１０６及び側壁１０８ａには、支持部材１０４を回転自在に取り付ける上下一対の支承孔部１１８が設けられる。レール部１１４に重なる位置（上側の支承孔部１１８と配置用凹部１１６の間）には、後述する支持部材１０４のカム凸部１５２が収容される窓１２０が設けられている（図１２Ｂ参照）。下壁１０６には、支持部材１０４の支持本体部１４８が開位置（図１３Ｂの位置）に移動した際に、係止凸部１６４が挿入される係止凹部１２２が形成されている。 The placement recess 116 is cut out from the tip of the side wall 108a toward the proximal end and is located between the lower wall 106 and the rail portion 114. A pair of upper and lower bearing holes 118 for rotatably attaching the support member 104 are provided on the lower wall 106 and the side wall 108a at the position where the arrangement recess 116 is formed. At a position overlapping the rail portion 114 (between the upper support hole portion 118 and the arrangement recess 116), a window 120 in which the cam convex portion 152 of the support member 104 described later is housed is provided (see FIG. 12B). .. The lower wall 106 is formed with a locking recess 122 into which the locking convex portion 164 is inserted when the support main body portion 148 of the support member 104 moves to the open position (position in FIG. 13B).

カテーテル操作部材１０２は、第１実施形態で説明したカテーテル操作部材２０と同様の材料で構成され、カテーテル１２を直接保持するとともにカテーテルハブ１４に装着されることで、内針１６及びハウジング１００に対しカテーテル１２及びカテーテルハブ１４を相対的に進退させる。詳細には、カテーテル操作部材１０２は、先端及び基端方向に延びる操作板部１２４と、操作板部１２４の基端に一体成形されてカテーテルハブ１４に着脱自在に装着されるハブ装着部１２５とを有する。 The catheter operating member 102 is made of the same material as the catheter operating member 20 described in the first embodiment, and by directly holding the catheter 12 and attaching it to the catheter hub 14, the catheter operating member 102 is attached to the inner needle 16 and the housing 100. The catheter 12 and the catheter hub 14 are relatively advanced and retracted. Specifically, the catheter operating member 102 includes an operation plate portion 124 extending in the direction of the tip end and the proximal end, and a hub mounting portion 125 integrally molded at the proximal end of the operation plate portion 124 and detachably attached to the catheter hub 14. Has.

また、カテーテル操作部材１０２は、操作板部１２４に設けられて一定の幅寸法で延在する幅広部（カム保持部）１２６と、ハブ装着部１２５に設けられて一定の幅寸法の幅狭部（カム保持解除部）１２８とを有している。幅広部１２６及び幅狭部１２８の境界部には段差１３０が形成されている。 Further, the catheter operating member 102 is provided in a wide portion (cam holding portion) 126 provided on the operation plate portion 124 and extending with a constant width dimension, and a narrow portion having a constant width dimension provided on the hub mounting portion 125. It has a (cam holding / releasing unit) 128. A step 130 is formed at the boundary between the wide portion 126 and the narrow portion 128.

操作板部１２４は、ユーザの指が接触され、カテーテル１２の進退操作がなされる部分である。操作板部１２４の長手方向に沿って延びる左右の側縁は、一対の側壁１０８ａ、１０８ｂの上面と一対のレール部１１４に配置される。操作板部１２４は、充分に薄肉に形成されることにより、操作板部１２４の面方向と直交する方向に容易に湾曲可能な可撓性を有する。 The operation plate portion 124 is a portion where the user's finger is touched and the catheter 12 is moved forward and backward. The left and right side edges extending along the longitudinal direction of the operation plate portion 124 are arranged on the upper surfaces of the pair of side walls 108a and 108b and the pair of rail portions 114. The operation plate portion 124 is formed to be sufficiently thin, so that the operation plate portion 124 has flexibility that can be easily bent in a direction orthogonal to the surface direction of the operation plate portion 124.

図９〜図１１に示すように、操作板部１２４の上面には、上側リブ１３２及びタブ１３４、１３６が設けられ、操作板部１２４の先端には、先端反り部１３８が設けられ、操作板部１２４の下面には、保持部１４０及び下側リブ１４２が設けられる。上側リブ１３２及び下側リブ１４２は、操作板部１２４の長手方向に沿って複数設けられる。これら上側リブ１３２及び下側リブ１４２は、上下にそれぞれ突出し、操作板部１２４の幅方向に沿って直線状に延びることで、操作板部１２４の幅方向の強度を高める。これにより操作板部１２４は、外部から外力がかかってもハウジング１００内での折れ曲りや撓み等が抑止され、一対の側壁１０８ａ、１０８ｂの上面及びレール部１１４に沿ってスムーズに進退する。 As shown in FIGS. 9 to 11, upper ribs 132 and tabs 134 and 136 are provided on the upper surface of the operation plate portion 124, and a tip warp portion 138 is provided at the tip of the operation plate portion 124. A holding portion 140 and a lower rib 142 are provided on the lower surface of the portion 124. A plurality of upper ribs 132 and lower ribs 142 are provided along the longitudinal direction of the operation plate portion 124. The upper rib 132 and the lower rib 142 project vertically and extend linearly along the width direction of the operation plate portion 124, thereby increasing the strength of the operation plate portion 124 in the width direction. As a result, the operation plate portion 124 is prevented from bending or bending in the housing 100 even when an external force is applied from the outside, and smoothly advances and retreats along the upper surfaces of the pair of side walls 108a and 108b and the rail portion 114.

タブ１３４、１３６は、ユーザの指が直接当てられることを想定した部位であり、上側リブ１３２よりも高く突出している。タブ１３４、１３６の設置数は、図９に示す２つに限定されず、１つ又は３つ以上設けられてもよい。 The tabs 134 and 136 are portions where the user's finger is assumed to be directly touched, and protrude higher than the upper rib 132. The number of tabs 134 and 136 installed is not limited to the two shown in FIG. 9, and one or three or more tabs may be installed.

図１１に示すように、保持部１４０は、カテーテル１２を含む上記多重管部を離脱可能に保持する。なお、図１１では、説明に必要な構成要素のみを示している。保持部１４０は、左右で一組の突片１４４を操作板部１２４の長手方向に複数組（図示例では５組）有する。各突片１４４は操作板部１２４の下面から下方向に突出している。５組の突片１４４は、操作板部１２４の長手方向に沿って等間隔に設けられ、各箇所でカテーテル１２に接触して保持する。なお、保持部１４０には、一組の突片１４４のみ設けられてもよい。あるいは、保持部１４０は設けられなくてもよい。 As shown in FIG. 11, the holding portion 140 holds the multi-tube portion including the catheter 12 in a detachable manner. Note that FIG. 11 shows only the components necessary for the explanation. The holding portion 140 has a plurality of sets of projecting pieces 144 on the left and right in the longitudinal direction of the operation plate portion 124 (five sets in the illustrated example). Each projecting piece 144 projects downward from the lower surface of the operation plate portion 124. The five sets of projecting pieces 144 are provided at equal intervals along the longitudinal direction of the operation plate portion 124, and are held in contact with the catheter 12 at each location. The holding portion 140 may be provided with only one set of projecting pieces 144. Alternatively, the holding portion 140 may not be provided.

図１２Ａ及び図１２Ｂに示すように、支持部材１０４は、円柱状の軸棒部１４６と、軸棒部１４６から横方向（軸棒部１４６の軸心と直交方向）に突出する支持本体部１４８とを有する。軸棒部１４６は、上下方向に短く延びて、その上端部と下端部が配置用凹部１１６の上下一対の支承孔部１１８にそれぞれ挿入される。支持部材１０４は、この軸棒部１４６を基点にハウジング１００に回転自在に組み付けられる。 As shown in FIGS. 12A and 12B, the support member 104 has a columnar shaft rod portion 146 and a support main body portion 148 projecting laterally (in a direction orthogonal to the axis of the shaft rod portion 146) from the shaft rod portion 146. And have. The shaft rod portion 146 extends shortly in the vertical direction, and its upper end portion and lower end portion are inserted into a pair of upper and lower support hole portions 118 of the arrangement recess 116, respectively. The support member 104 is rotatably assembled to the housing 100 with the shaft rod portion 146 as a base point.

軸棒部１４６の下側には、支持部材１０４のハウジング１００の組付状態で、配置用凹部１１６の上下幅に対応した連結補強部１５０が膨出形成されている。支持本体部１４８は、この連結補強部１５０に連結される。また、軸棒部１４６の上側には、一対のカム凸部１５２が一体成形されている。一対のカム凸部１５２は、所定位置（ハウジング１００の組付状態で窓１２０に収容される位置）に設けられ、軸棒部１４６を挟んで互いに反対方向且つ同程度に突出している。 On the lower side of the shaft rod portion 146, a connecting reinforcing portion 150 corresponding to the vertical width of the arrangement recess 116 is formed to bulge in the assembled state of the housing 100 of the support member 104. The support main body portion 148 is connected to the connection reinforcing portion 150. Further, a pair of cam convex portions 152 are integrally molded on the upper side of the shaft rod portion 146. The pair of cam convex portions 152 are provided at predetermined positions (positions accommodated in the window 120 in the assembled state of the housing 100), and project in opposite directions and to the same extent with the shaft rod portion 146.

支持部材１０４は、軸棒部１４６及び一対のカム凸部１５２の支持本体部１４８を臨む位置に操作部材用溝部１５４を有する。操作部材用溝部１５４は、図９に示す初期状態で、先端側のカム凸部１５２の最先端から基端側のカム凸部１５２の最基端まで直線状に延在している。この操作部材用溝部１５４は、レール部１１４に対応する位置に配置されて、レール部１１４とともにカテーテル操作部材１０２の側縁を摺動可能に収容する。 The support member 104 has a groove portion 154 for an operation member at a position facing the support main body portion 148 of the shaft rod portion 146 and the pair of cam convex portions 152. In the initial state shown in FIG. 9, the groove portion 154 for the operating member extends linearly from the tip end of the cam convex portion 152 on the distal end side to the most proximal end of the cam convex portion 152 on the proximal end side. The operating member groove portion 154 is arranged at a position corresponding to the rail portion 114, and slidably accommodates the side edge of the catheter operating member 102 together with the rail portion 114.

一方、支持部材１０４の支持本体部１４８は、ハウジング１００の組付状態で、上記の軸棒部１４６を基点とした回転により移動する部位である。具体的には、支持本体部１４８は、収容空間１１２内に位置してカテーテル１２を接触支持可能な閉位置（図１３Ａ参照）と、閉位置と異なりハウジング１００の外部及び配置用凹部１１６に位置してカテーテル１２に非接触となる開位置（図１３Ｂ参照）とに変位する。軸棒部１４６を軸心周りとした閉位置と開位置の角度は、カテーテルハブ１４、補助部材ハブ２４及び針保護部材２６が容易に抜けるように９０°以上であることが好ましい。本実施形態では、開位置においてカム凸部１５２がレール部１１４内に位置するように９０°に設定している。 On the other hand, the support main body portion 148 of the support member 104 is a portion that moves by rotation with the shaft rod portion 146 as a base point in the assembled state of the housing 100. Specifically, the support main body 148 is located in the closed position (see FIG. 13A) where the catheter 12 can be contact-supported by being located in the accommodation space 112, and is located outside the housing 100 and in the placement recess 116 unlike the closed position. Then, the catheter 12 is displaced to an open position (see FIG. 13B) that is not in contact with the catheter 12. The angle between the closed position and the open position around the shaft rod portion 146 is preferably 90 ° or more so that the catheter hub 14, the auxiliary member hub 24, and the needle protection member 26 can be easily pulled out. In the present embodiment, the cam convex portion 152 is set to 90 ° so as to be located in the rail portion 114 in the open position.

支持本体部１４８は、正面視で、配置用凹部１１６の上下幅に略一致する大きさのＳ字状に形成され、上下方向に弾性変形可能なバネ力を有している。支持本体部１４８の上面には、僅かに上方に隆起する隆起部１５６が設けられる。この隆起部１５６は、支持本体部１４８の閉位置で、カテーテル操作部材１０２に保持されたカテーテル１２（多重管部）を下方から接触支持する。 The support main body portion 148 is formed in an S shape having a size substantially matching the vertical width of the arrangement recess 116 when viewed from the front, and has a spring force that can be elastically deformed in the vertical direction. A raised portion 156 that slightly rises upward is provided on the upper surface of the support main body portion 148. The raised portion 156 contacts and supports the catheter 12 (multi-tube portion) held by the catheter operating member 102 at the closed position of the support main body portion 148 from below.

また、支持本体部１４８の上部先端側には、先端方向且つ下方に傾斜する先端傾斜面１５８が形成され、支持本体部１４８の上部基端側には、基端方向且つ下方に傾斜する基端傾斜面１６０が形成される。さらに、支持本体部１４８の隆起部１５６に連なる端部には、軸棒部１４６から離れる幅方向外側且つ下側に向かって傾斜して突出するウイング１６２が一体成形されている。 Further, a tip inclined surface 158 that is inclined in the tip direction and downward is formed on the upper tip side of the support main body 148, and a base end that is inclined in the proximal direction and downward is formed on the upper base end side of the support main body 148. An inclined surface 160 is formed. Further, at the end portion of the support main body portion 148 connected to the raised portion 156, a wing 162 is integrally formed so as to be inclined outward and downward in the width direction away from the shaft rod portion 146.

支持本体部１４８の下面には、係止凸部１６４が下方に向かって突出形成される。係止凸部１６４は、支持本体部１４８の開位置でハウジング１００の係止凹部１２２に挿入される。また、支持本体部１４８の下部側の基端には、基端方向に突出する接触用突起１６６が設けられる。この接触用突起１６６は、カテーテル操作部材１０２の進出時にハブ装着部１２５に接触して、支持本体部１４８の閉位置から９０°離れた開位置への変位を誘導する。 On the lower surface of the support main body portion 148, a locking convex portion 164 is formed so as to project downward. The locking convex portion 164 is inserted into the locking recess 122 of the housing 100 at the open position of the support main body portion 148. Further, a contact protrusion 166 projecting in the direction of the base end is provided at the base end on the lower side of the support main body portion 148. The contact protrusion 166 contacts the hub mounting portion 125 when the catheter operating member 102 advances, and induces a displacement of the support main body portion 148 to an open position 90 ° away from the closed position.

支持部材１０４を構成する材料は、特に限定されるものではなく、例えば、カテーテルハブ１４で挙げた材料を適宜選択し得る。なお、支持部材１０４は、ハウジング１００に対して別体に設けられるだけでなく、ハウジング１００に一体成形されてもよい。また、支持部材１０４は、ハウジング１００の一方の側壁１０８ａのみに設けられるものではなく、他方の側壁１０８ｂに設けられてもよく、これら側壁１０８ａ、１０８ｂの両方に一対設けられてもよい。また支持本体部１４８の回転方向は、ハウジング１００の平面方向に限らず、上下を含む側面方向でもよい。 The material constituting the support member 104 is not particularly limited, and for example, the material mentioned in the catheter hub 14 can be appropriately selected. The support member 104 is not only provided separately from the housing 100, but may be integrally molded with the housing 100. Further, the support member 104 is not provided only on one side wall 108a of the housing 100, but may be provided on the other side wall 108b, or may be provided as a pair on both of these side walls 108a and 108b. Further, the rotation direction of the support main body portion 148 is not limited to the plane direction of the housing 100, but may be a side surface direction including the vertical direction.

次に、上記のように構成されたカテーテル組立体１０Ｂの作用及び効果について説明する。本実施形態に係るカテーテル組立体１０Ｂの使用方法は、上述した第１実施形態に係るカテーテル組立体１０Ａの使用方法と基本的に同じであるため、詳細な説明を省略する。 Next, the action and effect of the catheter assembly 10B configured as described above will be described. Since the method of using the catheter assembly 10B according to the present embodiment is basically the same as the method of using the catheter assembly 10A according to the first embodiment described above, detailed description thereof will be omitted.

本実施形態のカテーテル組立体１０Ｂの初期状態では、ハウジング１００の先端部に組み付けられた支持部材１０４の支持本体部１４８が閉位置に待機し、図９及び図１３Ａに示すように、カテーテル操作部材１０２の複数の保持部１４０に保持された多重管部が支持本体部１４８により接触支持されている。このとき、操作部材用溝部１５４には、カテーテル操作部材１０２の幅広部１２６が位置しているため、カム凸部１５２の回転が規制されている。すなわち、支持本体部１４８は、カテーテル１２の支持を維持するロック状態となっている。また、各保持部１４０は、カテーテル１２の外周面を軸方向の各箇所において弱い係合力で保持し、全体としてカテーテル１２を強固に保持している。 In the initial state of the catheter assembly 10B of the present embodiment, the support main body 148 of the support member 104 assembled to the tip of the housing 100 stands by in a closed position, and as shown in FIGS. 9 and 13A, the catheter operating member The multi-tube portion held by the plurality of holding portions 140 of 102 is contact-supported by the support main body portion 148. At this time, since the wide portion 126 of the catheter operating member 102 is located in the groove portion 154 for the operating member, the rotation of the cam convex portion 152 is restricted. That is, the support main body 148 is in a locked state for maintaining the support of the catheter 12. Further, each holding portion 140 holds the outer peripheral surface of the catheter 12 with a weak engaging force at each position in the axial direction, and firmly holds the catheter 12 as a whole.

カテーテル組立体１０Ｂの穿刺時には、支持部材１０４によりカテーテル１２を支持するとともに保持部１４０がカテーテル１２を保持していることで、穿刺に伴う抵抗力を受けても、ハウジング１００内での多重管部の撓みが防止される。これにより、ユーザは違和感なく穿刺を行うことができる。また、カテーテル組立体１０Ｂは、内針１６の強度を弱めて一層細く形成することも可能となり、患者の負担を軽減することができる。 When the catheter assembly 10B is punctured, the support member 104 supports the catheter 12 and the holding portion 140 holds the catheter 12, so that the multi-tube portion in the housing 100 is subjected to the resistance force due to the puncture. Bending is prevented. As a result, the user can perform the puncture without discomfort. Further, the catheter assembly 10B can be formed thinner by weakening the strength of the inner needle 16, and the burden on the patient can be reduced.

カテーテル１２の進出操作では、ユーザは、ハウジング１００の位置を固定しつつ、カテーテル操作部材１０２の上側リブ１３２やタブ１３４、１３６に指を当てて、ハウジング１００に対しカテーテル操作部材１０２を先端方向に進出（相対移動）させる。カテーテル組立体１０Ｂでは、保持部１４０による多重管部の保持が継続して、カテーテル１２がスムーズに進出する。 In the advance operation of the catheter 12, the user puts a finger on the upper rib 132 or the tabs 134 and 136 of the catheter operating member 102 while fixing the position of the housing 100, and moves the catheter operating member 102 toward the tip of the housing 100. Advance (relative movement). In the catheter assembly 10B, the holding portion 140 continues to hold the multi-tube portion, and the catheter 12 smoothly advances.

このとき、上述したように、支持本体部１４８は、カテーテル１２の支持を維持するロック状態となっているため、カテーテル１２の挿入に伴う抵抗力を受けても、カテーテル１２及び内針１６等の多重管部が撓むことを抑制することができる。これにより、カテーテル１２を血管内に違和感なく円滑に挿入することができる。 At this time, as described above, since the support main body 148 is in the locked state for maintaining the support of the catheter 12, the catheter 12 and the inner needle 16 and the like are subjected to the resistance force due to the insertion of the catheter 12. It is possible to prevent the multi-tube portion from bending. As a result, the catheter 12 can be smoothly inserted into the blood vessel without any discomfort.

なお、ユーザの好みによっては、カテーテル操作部材１０２をハウジング１００に対して進退させてもよい。このような場合であっても、支持本体部１４８によりカテーテル１２の支持が維持されているので、多重管部が撓むことを抑制することができる。 The catheter operating member 102 may be moved back and forth with respect to the housing 100 depending on the user's preference. Even in such a case, since the support of the catheter 12 is maintained by the support main body portion 148, it is possible to suppress the multi-tube portion from bending.

カテーテル１２の先端を血管内の所定位置まで挿入すると、操作部材用溝部１５４にはカテーテル操作部材１０２の幅狭部１２８が位置する。この状態で、カム凸部１５２の回転の規制が解除されて回転可能となるため、支持本体部１４８は、閉位置から開位置への変位が可能となる。すなわち、支持本体部１４８は、カテーテルハブ１４及びカテーテル操作部材１０２がハウジング１００から離脱可能なアンロック状態となっている。 When the tip of the catheter 12 is inserted to a predetermined position in the blood vessel, the narrow portion 128 of the catheter operating member 102 is located in the groove portion 154 for the operating member. In this state, the restriction on the rotation of the cam convex portion 152 is released and the cam convex portion 152 can rotate, so that the support main body portion 148 can be displaced from the closed position to the open position. That is, the support main body 148 is in an unlocked state in which the catheter hub 14 and the catheter operating member 102 can be detached from the housing 100.

この状態で、カテーテル操作部材１０２及びカテーテル部材１７をハウジング１００に対して先端方向に相対的に変位させると、ハブ装着部１２５が支持本体部１４８の接触用突起１６６に接触して先端方向に押すことで、支持本体部１４８及びカム凸部１５２が軸棒部１４６を基点に回転する。 In this state, when the catheter operating member 102 and the catheter member 17 are displaced relative to the housing 100 in the distal end direction, the hub mounting portion 125 comes into contact with the contact projection 166 of the support main body portion 148 and pushes in the distal end direction. As a result, the support main body portion 148 and the cam convex portion 152 rotate with the shaft rod portion 146 as the base point.

そして、支持本体部１４８が所定の回転角度（９０°）回転した時に、支持本体部１４８の係止凸部１６４がハウジング１００の係止凹部１２２に挿入され、支持本体部１４８が開位置に保持される。これにより、カテーテルハブ１４及びカテーテル操作部材１０２をハウジング１００から容易に離脱させることができる。 Then, when the support main body 148 is rotated by a predetermined rotation angle (90 °), the locking convex portion 164 of the support main body 148 is inserted into the locking recess 122 of the housing 100, and the support main body 148 is held in the open position. Will be done. As a result, the catheter hub 14 and the catheter operating member 102 can be easily separated from the housing 100.

カテーテル組立体１０Ｂの使用において、ユーザの好みによっては、ハウジング１００から離脱させたカテーテル操作部材１０２を再度ハウジング１００に装着し、カテーテル１２を内針１６に対して進退させてもよい。 In the use of the catheter assembly 10B, the catheter operating member 102 detached from the housing 100 may be reattached to the housing 100 and the catheter 12 may be moved back and forth with respect to the inner needle 16 depending on the preference of the user.

この場合、ユーザは、ハウジング１００をカテーテル操作部材１０２及びカテーテル部材１７に対して先端方向に相対的に変位させることにより、カテーテル操作部材１０２の基端をハウジング１００の先端側から挿入する。そうすると、操作板部１２４の側縁がレール部１１４に挿入され、操作板部１２４の段差１３０がカム凸部１５２に接触してカム凸部１５２を基端方向に押すことにより係止凸部１６４が係止凹部１２２から抜け出る。 In this case, the user inserts the proximal end of the catheter operating member 102 from the distal end side of the housing 100 by displacing the housing 100 relative to the catheter operating member 102 and the catheter member 17 in the distal end direction. Then, the side edge of the operation plate portion 124 is inserted into the rail portion 114, and the step 130 of the operation plate portion 124 comes into contact with the cam convex portion 152 and pushes the cam convex portion 152 in the proximal direction to push the locking convex portion 164. Comes out of the locking recess 122.

これにより、カム凸部１５２及び支持本体部１４８が軸棒部１４６を基点に回転（カテーテル１２の進出時とは逆回転）するため、支持本体部１４８が開状態から閉状態に切り替わる。このとき、ウイング１６２が斜め下側に延出しているので、支持本体部１４８の逆回転時にウイング１６２がカテーテル１２に接触してカテーテル１２が横方向にずれることを回避することができる。そして、カテーテル操作部材１０２をハウジング１００に対して基端方向に引っ張ることにより、カテーテル１２が支持本体部１４８に下方から支えられた状態で保持部１４０に保持される。 As a result, the cam convex portion 152 and the support main body portion 148 rotate about the shaft rod portion 146 as a base point (rotation opposite to that when the catheter 12 advances), so that the support main body portion 148 switches from the open state to the closed state. At this time, since the wing 162 extends diagonally downward, it is possible to prevent the wing 162 from coming into contact with the catheter 12 and the catheter 12 to be laterally displaced when the support main body portion 148 is rotated in the reverse direction. Then, by pulling the catheter operating member 102 in the proximal direction with respect to the housing 100, the catheter 12 is held by the holding portion 140 in a state of being supported from below by the supporting main body portion 148.

本実施形態によれば、ユーザは、カテーテル操作部材１０２をハウジング１００に対してカテーテル１２の先端側に変位させるだけで支持部材１０４をロック状態からアンロック状態に切り替えることができる。これにより、カテーテル組立体１０Ｂの操作性を向上させることができる。また、ロック状態でハウジング１００に対する支持部材１０４の変位が規制されているので、支持部材１０４によってカテーテル１２及び内針１６等の多重管部を安定して支持することができる。 According to the present embodiment, the user can switch the support member 104 from the locked state to the unlocked state simply by displacing the catheter operating member 102 toward the tip end side of the catheter 12 with respect to the housing 100. Thereby, the operability of the catheter assembly 10B can be improved. Further, since the displacement of the support member 104 with respect to the housing 100 is restricted in the locked state, the support member 104 can stably support the multi-tube portion such as the catheter 12 and the inner needle 16.

本実施形態では、カテーテル操作部材１０２をハウジング１００に対して先端側に進出させることにより支持部材１０４が閉状態から開状態に変位して保持される。これにより、カテーテルハブ１４をハウジング１００から離脱させる際にカテーテルハブ１４と支持本体部１４８とが干渉することを抑えることができるので、カテーテルハブ１４をハウジング１００から容易に離脱させることができる。 In the present embodiment, the support member 104 is displaced and held from the closed state to the open state by advancing the catheter operating member 102 toward the distal end side with respect to the housing 100. As a result, it is possible to prevent the catheter hub 14 from interfering with the support main body portion 148 when the catheter hub 14 is detached from the housing 100, so that the catheter hub 14 can be easily detached from the housing 100.

１０Ａ、１０Ｂ…カテーテル組立体 １２…カテーテル
１４…カテーテルハブ １６…内針
１６ａ…針先 １８、１００…ハウジング
２０、１０２…カテーテル操作部材 ２７、１０４…支持部材
５２、１２６…幅広部 ５４、１２８…幅狭部
６２…支持部材本体 ６４…カム
７８…配設孔 ８２…ストッパ部
８８…案内面 ９１…保持手段 10A, 10B ... Catheter assembly 12 ... Catheter 14 ... Catheter hub 16 ... Inner needle 16a ... Needle tip 18, 100 ... Housing 20, 102 ... Catheter operating member 27, 104 ... Support member 52, 126 ... Wide part 54, 128 ... Narrow portion 62 ... Support member body 64 ... Cam 78 ... Arrangement hole 82 ... Stopper portion 88 ... Guide surface 91 ... Holding means

Claims (1)

中空のカテーテルと、
前記カテーテルの基端部に固定されたカテーテルハブと、
前記カテーテルに挿通された中空の内針と、
前記内針を支持し、前記カテーテルの先端から前記内針の先端が突出した初期状態で前記カテーテルハブが配設されるハウジングと、
前記カテーテルを支持する支持部材と、
前記カテーテルハブに接続されて前記ハウジングに対して当該ハウジングの長手方向に沿って変位可能なカテーテル操作部材と、を備え、
前記支持部材は、前記カテーテルハブとは接続しておらず、前記カテーテルが前記内針に対して先端側に進出する際に前記カテーテルを支持する第一状態と前記カテーテルハブの前記ハウジングからの離脱を許容する第二状態とに切り替え可能に前記ハウジングに設けられ、
前記支持部材は、前記カテーテル操作部材が前記支持部材に接触して当該支持部材を押すことにより前記第一状態から前記第二状態に切り替わる、カテーテル組立体。 With a hollow catheter
A catheter hub fixed to the base end of the catheter and
A hollow inner needle inserted through the catheter and
A housing that supports the inner needle and is arranged with the catheter hub in an initial state in which the tip of the inner needle protrudes from the tip of the catheter.
A support member that supports the catheter and
A catheter operating member connected to the catheter hub and displaceable with respect to the housing along the longitudinal direction of the housing.
The support member is not connected to the catheter hub, and the first state of supporting the catheter when the catheter advances to the distal side with respect to the inner needle and the detachment of the catheter hub from the housing. Is provided in the housing so that it can be switched to a second state that allows
Said support member, said that switches catheter manipulation member is brought into contact with said support member from said first state by pressing the support member to the second state, the catheter assembly.
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