JP5488868B2

JP5488868B2 - Disposable blood collection device

Info

Publication number: JP5488868B2
Application number: JP2009080544A
Authority: JP
Inventors: 弘三石倉; 賢鈴木; 健志山口
Original assignee: Nipro Corp
Current assignee: Nipro Corp
Priority date: 2009-03-27
Filing date: 2009-03-27
Publication date: 2014-05-14
Anticipated expiration: 2029-03-27
Also published as: JP2010227443A

Description

本発明は、皮膚を寸刺して少量の血液を採取するために用いられる採血器具に係り、特に、１回の使用で廃棄されるディスポーザブル型採血器具に関するものである。 The present invention relates to a blood collecting device used to puncture the skin and collect a small amount of blood, and more particularly to a disposable blood collecting device discarded after one use.

医療目的で、少量の血液を自己採取しなければならない場合がある。例えば糖尿病患者は、血糖レベルを定期的にチェック（血糖自己測定：ＳＭＢＧ）するために、患者自身が自己の血液を採取する必要がある。このような血液の自己採取を安全且つ確実に行なうことができるように、従来から、採血器具が用いられている。 For medical purposes, it may be necessary to self-collect a small amount of blood. For example, a diabetic patient needs to collect his / her own blood in order to periodically check the blood glucose level (blood glucose self-measurement: SMBG). Conventionally, blood collection instruments have been used so that such blood self-collection can be performed safely and reliably.

かかる採血器具は、一般に、穿刺針を有するランセットとばね部材がハウジングに収容された構造とされている。そして、ばね部材でランセットが付勢されてハウジングから穿刺針の先端が突出されることにより、皮膚表面を寸刺して少量の血液を滲出させるようになっている。特に近年では、使用後の穿刺針を介したＨＩＶやＢ型肝炎ウイルス等への感染を防止するために、１回限りの使用で廃棄されるディスポーザブル型の採血器具が広く用いられている。 Such a blood collection device generally has a structure in which a lancet having a puncture needle and a spring member are accommodated in a housing. Then, the lancet is urged by the spring member and the tip of the puncture needle protrudes from the housing, so that a small amount of blood is exuded by puncturing the skin surface. In particular, in recent years, disposable blood collection devices that are discarded after one-time use have been widely used in order to prevent infection with HIV, hepatitis B virus, and the like through the puncture needle after use.

ところで、このような採血器具では、穿刺針の無菌状態を使用時まで保持するために、穿刺針が予め樹脂製の保護キャップで覆われている（例えば、特許文献１参照）。このため、このような保護キャップは、使用時に、捩じ切られる等して採血器具から取り外される必要があり、保護キャップの取外し操作や取外し後の保護キャップの廃棄等、煩わしさを伴うものであった。 By the way, in such a blood collection device, the puncture needle is covered with a resin protective cap in advance in order to keep the sterilization state of the puncture needle until use (for example, refer to Patent Document 1). For this reason, such a protective cap needs to be removed from the blood collection device by being twisted off during use, and is accompanied by troublesome operations such as removal of the protective cap and disposal of the protective cap after removal. there were.

特表２００７−５２１０３１号公報JP-T 2007-521031 特表２００７−５３６００８号公報Special table 2007-536008 gazette 特表２００８−５２１５５１号公報Special table 2008-521551 gazette

本発明は上述の事情を背景として為されたものであって、その解決課題とするところは、穿刺針を覆う保護キャップをハウジングから取り外す必要のない、新規な構造のディスポーザブル型採血器具を提供することにある。 The present invention has been made in the background of the above-mentioned circumstances, and a problem to be solved thereof is to provide a disposable blood collection device having a novel structure that does not require removal of the protective cap covering the puncture needle from the housing. There is.

以下、前述の如き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, embodiments of the present invention made to solve the above-described problems will be described. In addition, the component employ | adopted in each aspect as described below is employable by arbitrary combinations as much as possible.

すなわち、本発明は、穿刺針を有するランセットとばね部材がハウジングに収容されており、該ばね部材で該ランセットが付勢され該穿刺針の先端が該ハウジングから突出して穿刺作動するディスポーザブル型採血器具において、前記穿刺針の針先を覆う保護キャップを設けると共に、前記ハウジングにより該保護キャップを該穿刺針から離隔可能に且つ回動可能に支持せしめて、該保護キャップが該ハウジングから取り外されることなく支持されたままの状態で該穿刺針から離脱して回動することにより該穿刺針の突出経路上に該保護キャップに設けられた貫通孔が位置されて、該保護キャップを前記ハウジングに支持した状態で前記穿刺作動が行われると共に、該穿刺作動後に該ハウジングが前記ランセットと前記ばね部材と該保護キャップを収容したまま廃棄されることを、特徴とする。 That is, according to the present invention, a lancet having a puncture needle and a spring member are accommodated in a housing, the lancet is urged by the spring member, and the tip of the puncture needle projects from the housing to perform a puncture operation. in, Rutotomoni a protective cap covering the needle tip of the puncture needle, and allowed spaced capable and rotatably supporting the protective cap from the puncture needle by the housing, that the protective cap is removed from the housing The through-hole provided in the protective cap is positioned on the projecting path of the puncture needle by turning away from the puncture needle and rotating while being supported, and supporting the protective cap to the housing wherein with the puncture operation is performed, the with the housing the lancet after the puncture operating spring member and the protective cab in a state To be discarded while accommodating the flop, characterized.

本発明によれば、穿刺針を覆う保護キャップをハウジングから取り外す必要がなく、取外し後の保護キャップの廃棄等の煩わしさもない。 According to the present invention, there is no need to remove the protective cap covering the puncture needle from the housing, and there is no troublesomeness such as disposal of the protective cap after removal.

また、本発明においては、前記保護キャップが、前記貫通孔が形成されたキャップ本体と、該キャップ本体に設けられ、該貫通孔の貫通方向に対して直角な方向に突出する支持軸とを有して構成される一方、前記ハウジングに、前記穿刺針の突出方向に延びる支持溝が設けられ、該ハウジングの支持溝に、該保護キャップの支持軸が支持されるようになっている態様が、好適に採用され得る。 In the present invention, the protective cap includes a cap main body in which the through hole is formed, and a support shaft provided in the cap main body and protruding in a direction perpendicular to the through direction of the through hole. On the other hand, an aspect in which the housing is provided with a support groove extending in the protruding direction of the puncture needle, and the support shaft of the protective cap is supported by the support groove of the housing, It can be suitably employed.

このようにすれば、ハウジングの支持溝にて支持された保護キャップの支持軸を回動させることにより、保護キャップ本体も回動されて、穿刺針の突出経路上に保護キャップの貫通孔を容易に位置させることが可能となる。 In this way, by rotating the support shaft of the protective cap supported by the support groove of the housing, the protective cap body is also rotated, so that the through hole of the protective cap can be easily formed on the protruding path of the puncture needle. It is possible to be located at.

さらに、上記態様を採用する場合には、前記保護キャップの支持軸に、前記貫通孔の貫通方向に突出する案内突片が設けられる一方、前記ハウジングの支持溝が、大幅部、小幅部、およびそれら大幅部と小幅部とを連結する傾斜部とを有して構成されており、該案内突片を該支持溝に取り付けて、該大幅部側から該小幅部側に移動させることにより、前記保護キャップが回動されるようになっている態様を、併せて採用することが出来る。 Further, when the above aspect is adopted, the support shaft of the protective cap is provided with a guide protrusion that protrudes in the penetrating direction of the through hole, while the support groove of the housing has a large portion, a small width portion, and It is configured to have an inclined portion that connects the large portion and the small width portion, and the guide projection piece is attached to the support groove and moved from the large portion side to the small width portion, A mode in which the protective cap is rotated can also be employed.

本態様によれば、ハウジングに設けられた支持溝に沿って保護キャップを移動させるだけの操作で、保護キャップを自動的に回動させることが出来る。 According to this aspect, the protective cap can be automatically rotated by simply moving the protective cap along the support groove provided in the housing.

また、本発明においては、採血部の皮膚表面に押し当てられる押当部材と該押当部材に対して移動可能に組み合わされた操作部材とを含んで前記ハウジングが構成されており、前記ばね部材で付勢された前記ランセットの該押当部材に対する係止状態を該操作部材で解除することにより、該押当部材から前記穿刺針が突出して穿刺作動されるようになっている態様も、採用可能である。 In the present invention, the housing includes a pressing member that is pressed against the skin surface of the blood collection unit and an operation member that is movably combined with the pressing member, and the spring member Also adopted is an aspect in which the puncture needle is protruded from the pressing member to be punctured by releasing the locking state of the lancet biased by the pressing member with the operating member. Is possible.

このようにすれば、操作部材を押当部材に対して移動させることにより、ランセットの係止状態を解除して穿刺作動させることができる。それ故、操作部材を持った片手だけで穿刺作動を行なわせることも可能となり、優れた操作性が発揮される。 In this way, by moving the operating member relative to the pressing member, the locked state of the lancet can be released and the puncture operation can be performed. Therefore, it is possible to perform the puncturing operation with only one hand having the operation member, and excellent operability is exhibited.

さらに、上記態様を採用する場合には、前記押当部材と前記操作部材が何れも有底の筒形状とされており、互いに開口部側で嵌め合わされて軸方向に相対移動可能に組み合わされることにより前記ハウジングが中空構造で形成されていると共に、該ハウジングの軸方向で移動可能に前記ランセットが収容されて、該ランセットの前記穿刺針が該押当部材の底部に向かって突設されていると共に、該押当部材の底部には穿刺用孔が形成されており、該押当部材の底部を採血部の皮膚表面に押し当てた状態で該操作部材を該押当部材に対して押圧操作することで、前記保護キャップが前記穿刺針から離脱され且つ回動されると共に、該ランセットの該押当部材に対する係止状態が解除されて、該ハウジングと該ランセットとの間に配設された前記ばね部材の付勢力によって該ランセットが該押当部材の底部に向かって移動し、該穿刺針の先端が該押当部材の該穿刺用孔から外部に突出して穿刺作動するようになっている態様を、併せて採用することが出来る。 Further, when the above aspect is adopted, the pressing member and the operation member are both formed in a bottomed cylindrical shape, and are fitted to each other on the opening side and combined so as to be relatively movable in the axial direction. The housing is formed with a hollow structure, the lancet is accommodated so as to be movable in the axial direction of the housing, and the puncture needle of the lancet projects toward the bottom of the pressing member. In addition, a puncture hole is formed at the bottom of the pressing member, and the operation member is pressed against the pressing member while the bottom of the pressing member is pressed against the skin surface of the blood collection unit. Thus, the protective cap is detached from the puncture needle and rotated, and the locked state of the lancet with respect to the pressing member is released, and the protective cap is disposed between the housing and the lancet. Above A mode in which the lancet is moved toward the bottom of the pressing member by the biasing force of the screw member, and the tip of the puncture needle projects to the outside from the puncture hole of the pressing member to perform a puncturing operation Can be used together.

本態様によれば、押当部材を皮膚表面に押し当てた状態で、操作部材を押当部材に対して皮膚表面に向けて押し込むという簡易な操作によって穿刺を行なうことが出来る。また、穿刺操作に際して、押当部材が皮膚表面から離れることも防止されて、穿刺深さの安定化も達成される。 According to this aspect, puncture can be performed by a simple operation of pushing the operating member toward the skin surface against the pressing member while the pressing member is pressed against the skin surface. Further, during the puncturing operation, the pressing member is prevented from separating from the skin surface, and stabilization of the puncture depth is achieved.

本発明によれば、穿刺針を覆う保護キャップをハウジングから取り外す必要がない。 According to the present invention, there is no need to remove the protective cap covering the puncture needle from the housing.

本発明の一実施形態としてのディスポーザブル型採血器具の側面図。The side view of the disposable blood-collecting device as one embodiment of the present invention. 同ディスポーザブル型採血器具の図１とは異なる方向の側面図。The side view of the direction different from FIG. 1 of the disposable blood collection instrument. 図１におけるＩＩＩ−ＩＩＩ断面図。III-III sectional drawing in FIG. 図２におけるＩＶ−ＩＶ断面図。IV-IV sectional drawing in FIG. 図１に示したディスポーザブル型採血器具の分解斜視図。FIG. 2 is an exploded perspective view of the disposable blood collection device shown in FIG. 1. 同ディスポーザブル型採血器具を構成する操作部材の断面斜視図。The cross-sectional perspective view of the operation member which comprises the same disposable blood-collecting instrument. 同ディスポーザブル型採血器具を構成するキャップ部材の正面図。The front view of the cap member which comprises the disposable blood-collecting instrument. 同キャップ部材の斜視図。The perspective view of the cap member. 図１に示したディスポーザブル型採血器具の穿刺作動を説明するための説明図であって、押当部材を操作部材に対して中心軸回りで回動させて、セーフティロック機構を解除させた状態を示す説明図。FIG. 2 is an explanatory diagram for explaining a puncturing operation of the disposable blood collection device shown in FIG. 1, wherein a state in which a safety member is released by rotating a pressing member around a central axis with respect to an operation member; FIG. 穿刺作動を説明するための図９に続く状態を示す説明図であって、ハウジング内で穿刺針が保護キャップから離脱した状態を示す説明図。It is explanatory drawing which shows the state following FIG. 9 for demonstrating puncture operation | movement, Comprising: Explanatory drawing which shows the state which the puncture needle removed from the protective cap within the housing. 穿刺作動を説明するための図１０に続く状態を示す説明図であって、ハウジング内で保護キャップが回動した状態を示す説明図。It is explanatory drawing which shows the state following FIG. 10 for demonstrating puncture operation | movement, Comprising: Explanatory drawing which shows the state which the protection cap rotated within the housing. 穿刺作動を説明するための図１１に続く状態を示す説明図であって、穿刺針で皮膚表面を穿刺している状態を示す説明図。It is explanatory drawing which shows the state following FIG. 11 for demonstrating a puncture operation | movement, Comprising: Explanatory drawing which shows the state which is puncturing the skin surface with a puncture needle. 穿刺作動を説明するための図１２に続く説明図であって、穿刺針がハウジング内に収容された状態を示す説明図。It is explanatory drawing following FIG. 12 for demonstrating a puncture operation | movement, Comprising: Explanatory drawing which shows the state in which the puncture needle was accommodated in the housing.

以下、本発明を更に具体的に明らかにするために、本発明の実施形態について、図面を参照しつつ、詳細に説明する。 Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

先ず、図１〜図５に、本発明の一実施形態としてのディスポーザブル型採血器具（以下、適宜に「採血器具」と略称する）１０を示す。採血器具１０は、操作部材１２と押当部材１４が組み合わされたハウジング１６を備えており、このハウジング１６にランセット１８と保護キャップ２０が収容されている。なお、以下の説明中、特に断りのない限り、前方とは図１の右方向、後方とは図１の左方向、軸方向とは図１の左右方向を言う。 First, FIG. 1 to FIG. 5 show a disposable blood collection device (hereinafter abbreviated as “blood collection device” as appropriate) 10 as one embodiment of the present invention. The blood collection device 10 includes a housing 16 in which an operation member 12 and a pressing member 14 are combined. A lancet 18 and a protective cap 20 are accommodated in the housing 16. In the following description, unless otherwise specified, the front means the right direction in FIG. 1, the rear means the left direction in FIG. 1, and the axial direction means the left and right direction in FIG.

より詳細には、操作部材１２は、有底の略円筒形状とされている。その底部２２には、中央部分を軸方向に貫通する係合孔２４が形成されている。 More specifically, the operation member 12 has a substantially cylindrical shape with a bottom. An engagement hole 24 is formed in the bottom portion 22 so as to penetrate the central portion in the axial direction.

また、操作部材１２の内部には、底部２２から軸方向内方に突出する収容筒部２６が一体形成されている。この収容筒部２６の後方側端部には、底部２２の係合孔２４が開口している。一方、収容筒部２６の前方側端部は、操作部材１２内に開口している。 In addition, a housing cylinder portion 26 that protrudes inward in the axial direction from the bottom portion 22 is integrally formed inside the operation member 12. An engagement hole 24 of the bottom portion 22 is opened at the rear side end portion of the accommodating cylinder portion 26. On the other hand, the front side end portion of the accommodation tube portion 26 is opened in the operation member 12.

更にまた、操作部材１２における開口部２７側の端部には、内周面上に突出して周方向に延びる係止突部２８が設けられている。そして、この係止突部２８における軸方向内方側の端面が、操作部材１２の内周面上に突出する抜止段差面２９とされている。 Furthermore, a locking protrusion 28 that protrudes on the inner peripheral surface and extends in the circumferential direction is provided at the end of the operation member 12 on the opening 27 side. An end surface on the inner side in the axial direction of the locking protrusion 28 is a removal step surface 29 protruding on the inner peripheral surface of the operation member 12.

さらに、収容筒部２６には、その周壁部分に一対のスリット状の挿通溝３０，３０が形成されている。この一対のスリット状の挿通溝３０，３０は、収容筒部２６の軸方向に延びており、収容筒部２６の先端部側に開放している。また、収容筒部２６は、周上で部分的に、操作部材１２の周壁部と一体的な厚肉の壁構造とされている。即ち、収容筒部２６と操作部材１２の周壁部との間には、両者を一体的に連結する一対の連結部３１，３１が、周上で部分的に形成されている。なお、一対の挿通溝３０，３０の対向方向と、一対の連結部３１，３１の対向方向は、何れも収容筒部２６の軸直角方向とされており、且つ互いに直交している。 Further, the accommodating cylinder portion 26 is formed with a pair of slit-like insertion grooves 30 and 30 on the peripheral wall portion thereof. The pair of slit-like insertion grooves 30, 30 extend in the axial direction of the housing cylinder part 26 and open to the distal end side of the housing cylinder part 26. In addition, the accommodating cylinder portion 26 has a thick wall structure that is partly integrated with the peripheral wall portion of the operation member 12 on the circumference. That is, a pair of connecting portions 31, 31 that integrally connect the accommodating cylinder portion 26 and the peripheral wall portion of the operation member 12 are partially formed on the circumference. Note that the opposing direction of the pair of insertion grooves 30 and 30 and the opposing direction of the pair of connecting portions 31 and 31 are both perpendicular to the axis of the housing tube portion 26 and are orthogonal to each other.

また、操作部材１２の外周面には、突起部からなる複数の指標３２、３４ａ、３４ｂ、３４ｃが形成されている。その一つである初期指標３２は、開口部２７側の端縁部近くに設けられており、後述する押当部材１４の操作部材１２に対する初期回動位置を示すものである。また、第１指標３４ａ、第２指標３４ｂ、第３指標３４ｃは、何れも、後述する穿刺針６２の突出量を選択設定するためのものであり、操作部材１２の開口部２７側の端縁部から軸方向に延びる線状突起から構成されている。 A plurality of indicators 32, 34 a, 34 b, 34 c made of protrusions are formed on the outer peripheral surface of the operation member 12. One of the initial indicators 32 is provided near the edge on the opening 27 side, and indicates an initial rotation position of the pressing member 14 described later with respect to the operation member 12. Each of the first index 34a, the second index 34b, and the third index 34c is for selecting and setting a protruding amount of a puncture needle 62 described later, and is an edge of the operation member 12 on the opening 27 side. It is comprised from the linear protrusion extended in an axial direction from a part.

なお、第１指標３４ａは一本の線状突起、第２指標３４ｂは２本の線状突起、第３指標３４ｃは３本の線状突起から構成されており、相互に識別可能とされている。特に第１指標３４ａから第２指標３４ｂ更に第３指標３４ｃとなるに従って次第に線状突起が長くされており、穿刺針６２の突出量が次第に大きく設定されることを視覚的にイメージできるようになっている。また、初期指標３２と第１〜第３指標３４ａ、３４ｂ、３４ｃは、操作部材１２の周方向で略一定の間隔を隔てて設けられている。 The first index 34a is composed of one linear protrusion, the second index 34b is composed of two linear protrusions, and the third index 34c is composed of three linear protrusions, which can be distinguished from each other. Yes. In particular, as the first index 34a, the second index 34b, and the third index 34c, the linear protrusions are gradually lengthened, so that it is possible to visually imagine that the protruding amount of the puncture needle 62 is gradually increased. ing. The initial indicator 32 and the first to third indicators 34a, 34b, 34c are provided at a substantially constant interval in the circumferential direction of the operation member 12.

さらに、図６に示すように、操作部材１２の内周面には、複数の溝３６、３８ａ、３８ｂ、３８ｃが形成されている。これらの溝３６、３８ａ、３８ｂ、３８ｃは、何れも、操作部材１２の開口部２７側の端縁部から軸方向に延びる凹溝によって構成されている。その一つである初期嵌合溝３６が、初期指標３２の内周面に位置している。また、第１案内溝３８ａが第１指標３４ａの内周面に位置していると共に、第２案内溝３８ｂが第２指標３４ｂの内周面に位置しており、第３案内溝３８ｃが第３指標３４ｄの内周面に位置している。 Further, as shown in FIG. 6, a plurality of grooves 36, 38 a, 38 b, 38 c are formed on the inner peripheral surface of the operation member 12. All of these grooves 36, 38 a, 38 b, and 38 c are constituted by concave grooves that extend in the axial direction from the edge of the operation member 12 on the opening 27 side. One of the initial fitting grooves 36 is located on the inner peripheral surface of the initial indicator 32. The first guide groove 38a is located on the inner peripheral surface of the first indicator 34a, the second guide groove 38b is located on the inner peripheral surface of the second indicator 34b, and the third guide groove 38c is the second guide groove 38c. It is located on the inner peripheral surface of the 3 index 34d.

また、第１〜第３案内溝３８ａ〜３８ｃの軸方向長さは略同じとされており、操作部材１２内で収容筒部２６の開口端部近くまで延びている。一方、初期嵌合溝３６は、第１〜第３案内溝３８ａ〜３８ｃに比して短い。 Further, the axial lengths of the first to third guide grooves 38 a to 38 c are substantially the same, and extend within the operation member 12 to the vicinity of the opening end portion of the accommodation tube portion 26. On the other hand, the initial fitting groove 36 is shorter than the first to third guide grooves 38a to 38c.

一方、押当部材１４は、有底の略円筒形状とされている。その筒壁部の外径寸法は、操作部材１２に内挿可能な大きさとされている。また、押当部材１４の底部４０には、中央部分を貫通する穿刺用孔４２が形成されている。 On the other hand, the pressing member 14 has a substantially cylindrical shape with a bottom. The outer diameter dimension of the cylindrical wall portion is a size that can be inserted into the operation member 12. Further, a puncture hole 42 penetrating the center portion is formed in the bottom portion 40 of the pressing member 14.

また、押当部材１４の筒壁部には、一対の支持溝４４，４４が形成されている。各支持溝４４は、筒壁部を貫通するスリット形状で、押当部材１４の開口部４５側端部から底部４０近くまで軸方向（後述する穿刺針６２の突出方向）に延びている。また、各支持溝４４の幅寸法は、長さ方向の中間部分で変化している。即ち、各支持溝４４の一方の側壁には、長さ方向中間部分に傾斜部４６が設けられており、この傾斜部４６よりも開口部４５側が大幅部４８とされていると共に、傾斜部４６よりも底部４０側が小幅部５０とされている。 A pair of support grooves 44 and 44 are formed in the cylindrical wall portion of the pressing member 14. Each support groove 44 has a slit shape penetrating the cylindrical wall portion, and extends in the axial direction (projection direction of a puncture needle 62 described later) from the opening 45 side end portion of the pressing member 14 to the vicinity of the bottom portion 40. Further, the width dimension of each support groove 44 changes in the middle portion in the length direction. In other words, an inclined portion 46 is provided at one side wall of each support groove 44 in the middle portion in the longitudinal direction. The inclined portion 46 has a large portion 48 on the opening 45 side of the inclined portion 46. The bottom 40 side is a narrow portion 50.

なお、一対の支持溝４４，４４は、押当部材１４の筒壁部の径方向で対向位置して形成されている。また、一対の支持溝４４，４４における傾斜部４６，４６は、押当部材１４の側方視（図２参照）において互いに重なり合っている。 The pair of support grooves 44 and 44 are formed to face each other in the radial direction of the cylindrical wall portion of the pressing member 14. Further, the inclined portions 46, 46 in the pair of support grooves 44, 44 overlap each other in a side view of the pressing member 14 (see FIG. 2).

さらに、押当部材１４の外周面には、突起状のリブ５２が形成されており、一対の支持溝４４，４４の周方向中間部分を軸方向に延びている。このリブ５２は、後述するように、操作部材１２の指標３２，３４ａ，３４ｂ，３４ｃと協働して、採血器具１０の作動状態を表示する。 Further, a projecting rib 52 is formed on the outer peripheral surface of the pressing member 14, and extends in the axial direction between the pair of support grooves 44, 44 in the circumferential direction. As will be described later, the rib 52 displays the operating state of the blood collection device 10 in cooperation with the indicators 32, 34a, 34b, and 34c of the operation member 12.

なお、押当部材１４の開口側端部には、外径寸法が大きな厚肉部が設けられている。そして、この厚肉部の外周面が開口部４５側に向かって小径化したテーパ面５３とされている。また、かかる厚肉部における大径側の軸方向端面は、押当部材１４の外周面上に突出する係止段差面５４とされている。 A thick wall portion having a large outer diameter is provided at the opening side end of the pressing member 14. And the outer peripheral surface of this thick part is made into the taper surface 53 which became small diameter toward the opening part 45 side. Further, the axial end surface on the large diameter side of the thick wall portion is a locking step surface 54 protruding on the outer peripheral surface of the pressing member 14.

そして、かかるテーパ面５３によって、押当部材１４の操作部材１２への挿し込みが容易とされている。また、挿し込みに際して、押当部材１４のテーパ面５３が操作部材１２の係止突部２８を超えると、押当部材１４の係止段差面５４が操作部材１２の抜止段差面２９に係止されることにより、押当部材１４の操作部材１２からの抜け出しが阻止されるようになっている。 The tapered surface 53 facilitates the insertion of the pressing member 14 into the operation member 12. Further, when the tapered surface 53 of the pressing member 14 exceeds the locking projection 28 of the operation member 12 during insertion, the locking step surface 54 of the pressing member 14 is locked to the retaining step surface 29 of the operation member 12. As a result, the pressing member 14 is prevented from coming off from the operation member 12.

一方、ランセット１８は、ランセットハブ６０と穿刺針６２を含んで構成されている。ランセットハブ６０はポリプロピレンやポリエチレン、ポリカーボネート、ＡＢＳ樹脂、アクリル樹脂等の合成樹脂から形成されており、円板部６４と、円板部６４の中心軸上に突出する筒状の針保持部６６を有している。また、円板部６４における針保持部６６の突出面上には、一対の当接部６８，６８が一体形成されている。かかる一対の当接部６８，６８は、円板部６４の径方向で対称に、それぞれ扇形状で突出形成されている。そして、穿刺針６２の基端部分が、インサート成形や接着等によってランセットハブ６０の針保持部６６に固定されており、穿刺針６２の針先６９がランセットハブ６０の中心軸上で外方に突出している。 On the other hand, the lancet 18 includes a lancet hub 60 and a puncture needle 62. The lancet hub 60 is made of a synthetic resin such as polypropylene, polyethylene, polycarbonate, ABS resin, acrylic resin, and the like. The lancet hub 60 includes a disc portion 64 and a cylindrical needle holding portion 66 that projects on the central axis of the disc portion 64. Have. In addition, a pair of contact portions 68 and 68 are integrally formed on the protruding surface of the needle holding portion 66 in the disc portion 64. The pair of abutting portions 68 and 68 are formed so as to protrude in a fan shape symmetrically in the radial direction of the disc portion 64. The proximal end portion of the puncture needle 62 is fixed to the needle holding portion 66 of the lancet hub 60 by insert molding or adhesion, and the needle tip 69 of the puncture needle 62 is outward on the central axis of the lancet hub 60. It protrudes.

また、円板部６４の外周部分には、一対の外周壁７０，７０が形成されており、円板部６４から針保持部６６とは反対の軸方向に向かって突出している。また、各外周壁７０の外周面上には、係止爪７２が形成されている。なお、係止爪７２の外周面は、穿刺針６２の突出方向に向けて次第に拡径するテーパ面７３とされている。 A pair of outer peripheral walls 70, 70 are formed on the outer peripheral portion of the disc portion 64, and project from the disc portion 64 toward the axial direction opposite to the needle holding portion 66. Further, a locking claw 72 is formed on the outer peripheral surface of each outer peripheral wall 70. The outer peripheral surface of the locking claw 72 is a tapered surface 73 that gradually increases in diameter in the protruding direction of the puncture needle 62.

さらに、円板部６４には、ばね部材としてのばね部７４が一体形成されている。本実施形態のばね部７４は、葛折れ様の屈曲形状を有する樹脂製の板ばねにて構成されており、その一方の端部が円板部６４に連結されている。そして、ばね部７４は、円板部６４から、針保持部６６と反対の軸方向に向かって突出している。また、ばね部７４の他方の端部には、取付板部７６が一体形成されている。この取付板部７６には、一対の係合爪７８，７８が、ばね部７４と反対側の面上に突設されている。 Further, a spring portion 74 as a spring member is integrally formed with the disc portion 64. The spring portion 74 of the present embodiment is configured by a resin plate spring having a bent-like bent shape, and one end portion thereof is connected to the disc portion 64. The spring portion 74 protrudes from the disc portion 64 in the axial direction opposite to the needle holding portion 66. A mounting plate portion 76 is integrally formed at the other end of the spring portion 74. A pair of engaging claws 78, 78 project from the mounting plate portion 76 on the surface opposite to the spring portion 74.

さらに、ばね部７４および取付板部７６には、ばね部７４の幅方向両側に突出する挿通ピン８０が複数形成されている。これら挿通ピン８０は、何れも、円板部６４の中心線に交差してばね部７４および取付板部７６の幅方向に延びる直線上に突設されている。なお、取付板部７６に形成された挿通ピン８０の突出寸法は、ばね部７４に形成された挿通ピン８０よりも大きくされている。そして、これら挿通ピン８０が、葛折れ様の屈曲形状とされたばね部７４の稜線と谷線の中間部分をばね部７４の屈曲方向に延びる直線上に整列配置して形成されている。 Further, the spring portion 74 and the mounting plate portion 76 are formed with a plurality of insertion pins 80 protruding on both sides in the width direction of the spring portion 74. Each of these insertion pins 80 protrudes on a straight line that intersects the center line of the disc portion 64 and extends in the width direction of the spring portion 74 and the mounting plate portion 76. The protruding dimension of the insertion pin 80 formed on the mounting plate portion 76 is larger than that of the insertion pin 80 formed on the spring portion 74. These insertion pins 80 are formed by aligning and arranging the middle part of the ridge line and the valley line of the spring part 74 having a bent-like bent shape on a straight line extending in the bending direction of the spring part 74.

また、保護キャップ２０は、図７および図８にも示すように、厚肉の略円筒形状の（内径寸法は全長で略一定とされているが、外径寸法が軸方向一方に向かって変化する略半球形状とされた）キャップ本体８６を備えている。そして、このキャップ本体８６の中心に設けられた貫通孔によって針挿通孔８７が構成されている。また、キャップ本体８６の外周面は、軸方向一方の端部から他方の端部に向かって次第に小径化しており、略半球形状の湾曲外周面とされている。更に、キャップ本体８６の大径側端部には、針挿通孔８７の貫通方向に対して直角な方向（軸直角方向）に突出する一対の支持軸８８，８８が一体形成されている。また、キャップ本体８６の大径側端部近くの外周面には、針収容孔９２が形成されており、一対の支持軸８８，８８の突出方向に直交する方向で、針挿通孔８７に至らない程度に延び出されている。即ち、保護キャップ２０において、支持軸８８，８８、針挿通孔８７、針収容孔９２は、直交三軸方向に延びている。 Further, as shown in FIGS. 7 and 8, the protective cap 20 has a thick and substantially cylindrical shape (the inner diameter is substantially constant over the entire length, but the outer diameter changes toward one side in the axial direction. A cap body 86). A needle insertion hole 87 is constituted by a through hole provided in the center of the cap body 86. Further, the outer peripheral surface of the cap body 86 is gradually reduced in diameter from one end portion in the axial direction toward the other end portion, and has a substantially hemispherical curved outer peripheral surface. Further, a pair of support shafts 88 projecting in a direction perpendicular to the penetrating direction of the needle insertion hole 87 (a direction perpendicular to the axis) is integrally formed at the large-diameter side end of the cap body 86. Further, a needle housing hole 92 is formed on the outer peripheral surface near the large-diameter end of the cap body 86, and reaches the needle insertion hole 87 in a direction perpendicular to the protruding direction of the pair of support shafts 88, 88. There is no extension. That is, in the protective cap 20, the support shafts 88, 88, the needle insertion hole 87, and the needle accommodation hole 92 extend in the orthogonal three-axis direction.

さらに、キャップ本体８６における小径側の軸方向端面には、ストッパ部９４が形成されている。ストッパ部９４は、キャップ本体８６の軸方向に突出する第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃによって構成されている。これら第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃは、それぞれ、針挿通孔８７の軸方向視においてキャップ本体８６の径方向で対向する一対の扇状突部の先端面によって形成されている。本実施形態における第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃは、それぞれ、中心角が略４５°の扇形状とされている。また、これら第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃはキャップ本体８６の軸方向外方への突出高さが互いに異なっており、第１のストッパ面９６ａ、第２のストッパ面９６ｂ、第３のストッパ面９６ｃの順に、突出寸法が次第に小さくされている。 Further, a stopper portion 94 is formed on the axial end surface of the cap body 86 on the small diameter side. The stopper portion 94 includes first to third stopper surfaces 96a, 96b, and 96c that protrude in the axial direction of the cap body 86. Each of the first to third stopper surfaces 96a, 96b, 96c is formed by the distal end surfaces of a pair of fan-shaped protrusions that face each other in the radial direction of the cap body 86 when the needle insertion hole 87 is viewed in the axial direction. Each of the first to third stopper surfaces 96a, 96b, 96c in the present embodiment has a fan shape with a central angle of about 45 °. The first to third stopper surfaces 96a, 96b, and 96c are different from each other in the protruding height of the cap main body 86 in the axial direction, and the first stopper surface 96a, the second stopper surface 96b, In the order of the third stopper surface 96c, the protruding dimension is gradually reduced.

また、一対の支持軸８８，８８は、押当部材１４の支持溝４４，４４における小幅部５０に挿通可能な外径寸法とされている。更に、各支持軸８８のキャップ本体８６側の部位には、各支持軸８８からストッパ部９４側に向かって突出する案内突片９８が、それぞれ形成されている。なお、案内突片９８の突出高さは、その突出方向を押当部材１４の支持溝４４の幅方向に向けた状態で、支持軸８８を支持溝４４の大幅部４８に差し入れることは可能だが、小幅部５０に差し入れることは出来ないように設定されている。 In addition, the pair of support shafts 88 and 88 have an outer diameter dimension that can be inserted into the small width portion 50 in the support grooves 44 and 44 of the pressing member 14. Further, guide protrusions 98 that protrude from the support shafts 88 toward the stopper portions 94 are formed on the portions of the support shafts 88 on the cap body 86 side. The protruding height of the guide protrusion 98 is such that the support shaft 88 can be inserted into the large portion 48 of the support groove 44 in a state in which the protrusion direction is directed in the width direction of the support groove 44 of the pressing member 14. However, it is set so that it cannot be inserted into the narrow portion 50.

保護キャップ２０は、通常、穿刺針６２をセットした成形キャビティを用いたインサート成形により、ランセット１８と一体成形され得る。これにより、穿刺針６２の針先６９が保護キャップ２０によって保護されると共に、上記針収容孔９２が、保護キャップ２０に形成される。 The protective cap 20 can be integrally formed with the lancet 18 by insert molding using a molding cavity in which the puncture needle 62 is set. Thereby, the needle tip 69 of the puncture needle 62 is protected by the protective cap 20, and the needle accommodation hole 92 is formed in the protective cap 20.

そして、ランセット１８の針保持部６６に穿刺針６２が取り付けられることによって構成されたランセット構造体９９を、操作部材１２の収容筒部２６に挿入して、係合爪７８を操作部材１２の係合孔２４と係合させる。これにより、ランセット構造体９９は、取付板部７６を操作部材１２の底部２２の内面に重ね合わせて固定した状態で操作部材１２に組み付けられる。また、ばね部７４に突設された挿通ピン８０を、収容筒部２６の挿通溝３０に挿通させる。これにより、ばね部７４の傾きを防止しつつ伸縮弾性変形を許容して、目的とする弾性変形の安定化が図られている。 Then, a lancet structure 99 configured by attaching the puncture needle 62 to the needle holding portion 66 of the lancet 18 is inserted into the accommodating cylinder portion 26 of the operation member 12, and the engaging claw 78 is engaged with the operation member 12. Engage with the joint hole 24. As a result, the lancet structure 99 is assembled to the operation member 12 in a state where the mounting plate 76 is overlapped and fixed to the inner surface of the bottom 22 of the operation member 12. Further, the insertion pin 80 protruding from the spring portion 74 is inserted into the insertion groove 30 of the housing cylinder portion 26. Thus, the elastic elastic deformation is allowed while preventing the inclination of the spring portion 74 and the intended elastic deformation is stabilized.

なお、保護キャップ２０は、上述のようにインサート成形でランセット１８と一体形成される他、ランセット１８とは別に形成されてもよい。後者の場合には、穿刺針６２への保護キャップ２０の装着は、ランセット構造体９９を操作部材１２に組み付ける前に行なっても、組み付けた後で行っても良い。また、穿刺針６２へ保護キャップ２０を装着するに際しては、後述する滅菌状態を保持するために、保護キャップ２０の針収容孔９２内に、穿刺針６２を保持する針保持部６６の先端部が嵌入するまで、挿し入れることが好ましい。 The protective cap 20 may be formed separately from the lancet 18 in addition to being integrally formed with the lancet 18 by insert molding as described above. In the latter case, the protective cap 20 may be attached to the puncture needle 62 before or after the lancet structure 99 is assembled to the operation member 12. Further, when the protective cap 20 is attached to the puncture needle 62, the distal end portion of the needle holding portion 66 that holds the puncture needle 62 is placed in the needle accommodation hole 92 of the protective cap 20 in order to maintain a sterilized state to be described later. It is preferable to insert until it is inserted.

その後、押当部材１４を、操作部材１２の開口部から嵌め入れて組み付ける。その際、保護キャップ２０の支持軸８８を、押当部材１４の支持溝４４に差し入れる。そして、押当部材１４のテーパ面５３が操作部材１２の抜止段差面２９よりも軸方向後方に位置するまで、押当部材１４を操作部材１２に押し入れる。これにより、押当部材１４の係止段差面５４が抜止段差面２９に係止されて、押当部材１４が操作部材１２に対する同心軸上で抜け出し不能の挿入状態で組み付けられる。 Thereafter, the pressing member 14 is fitted and assembled from the opening of the operation member 12. At that time, the support shaft 88 of the protective cap 20 is inserted into the support groove 44 of the pressing member 14. Then, the pressing member 14 is pushed into the operation member 12 until the tapered surface 53 of the pressing member 14 is positioned rearward in the axial direction from the retaining step surface 29 of the operation member 12. As a result, the locking step surface 54 of the pressing member 14 is locked to the retaining step surface 29, and the pressing member 14 is assembled in a state where it cannot be pulled out on the concentric shaft with respect to the operation member 12.

このようにして組み立てられた採血器具１０のハウジング１６内には、ランセット構造体９９と保護キャップ２０が収容されている。かかる組立状態では、穿刺針６２の針先６９が押当部材１４の底部４０に向けられていると共に、ばね部７４が操作部材１２の底部２２とランセット１８の間に配設されている。 The lancet structure 99 and the protective cap 20 are accommodated in the housing 16 of the blood collection device 10 assembled in this way. In such an assembled state, the needle tip 69 of the puncture needle 62 is directed toward the bottom portion 40 of the pressing member 14, and the spring portion 74 is disposed between the bottom portion 22 of the operation member 12 and the lancet 18.

なお、採血器具１０は、少なくとも穿刺針６２の針先６９とそれを保護するキャップ本体８６が滅菌状態となるように処理される。具体的には、例えば穿刺針６２にキャップ本体８６を装着する前或いは後に放射線や高圧蒸気滅菌等で滅菌処理が施される。なお、穿刺針６２をセットした成形キャビティを用いてランセット１８と保護キャップ２０を一体成形することによって、穿刺針６２の針先６９を滅菌状態に保持させるようにしても良い。 The blood collection device 10 is processed so that at least the needle tip 69 of the puncture needle 62 and the cap body 86 that protects it are in a sterilized state. Specifically, for example, before or after mounting the cap body 86 on the puncture needle 62, sterilization is performed by radiation, high-pressure steam sterilization, or the like. The lancet 18 and the protective cap 20 may be integrally molded using a molding cavity in which the puncture needle 62 is set, so that the needle tip 69 of the puncture needle 62 may be held in a sterilized state.

これら操作部材１２と押当部材１４は、中心軸回りで互いに回動可能に組み付けられている。そして、本実施形態における採血器具１０は、図１〜図４に示したように、押当部材１４のリブ５２が操作部材１２の周方向で初期指標３２と重なって位置されて、初期嵌合溝３６と嵌合された状態を初期状態として使用者に提供される。 The operation member 12 and the pressing member 14 are assembled so as to be rotatable around a central axis. As shown in FIGS. 1 to 4, the blood collection device 10 according to the present embodiment is configured such that the rib 52 of the pressing member 14 is positioned so as to overlap the initial indicator 32 in the circumferential direction of the operation member 12. The state fitted with the groove 36 is provided to the user as an initial state.

かかる初期状態において、保護キャップ２０は、支持軸８８および案内突片９８が押当部材１４における支持溝４４の大幅部４８内に挿入されて、案内突片９８の突出方向を支持溝４４の延び出し方向に直交する方向（図２中、上下方向）に向けた状態で収容される。なお、案内突片９８は、大幅部４８内において支持軸８８からの突出先端が傾斜部４６側に位置される。これにより、保護キャップ２０は、針収容孔９２が支持軸８８に対する穿刺針６２側に位置されて押当部材１４の中心軸上を延びる状態で位置される。そして、穿刺針６２における針保持部６６からの突出部分が針収容孔９２内に挿入されて、針先６９が針収容孔９２内に位置されることによって保護キャップ２０に覆われて保護される。 In such an initial state, the protective cap 20 has the support shaft 88 and the guide protrusion 98 inserted into the large portion 48 of the support groove 44 in the pressing member 14, and the support groove 44 extends in the protruding direction of the guide protrusion 98. It is accommodated in a state directed in a direction (vertical direction in FIG. 2) orthogonal to the ejection direction. The guide protrusion 98 has a protruding tip from the support shaft 88 in the large portion 48 and is positioned on the inclined portion 46 side. Accordingly, the protective cap 20 is positioned in a state where the needle accommodation hole 92 is positioned on the puncture needle 62 side with respect to the support shaft 88 and extends on the central axis of the pressing member 14. The protruding portion of the puncture needle 62 from the needle holding portion 66 is inserted into the needle accommodation hole 92 and the needle tip 69 is positioned in the needle accommodation hole 92 so as to be covered and protected by the protective cap 20. .

また、初期状態においては、リブ５２の軸方向後端面が初期嵌合溝３６の軸方向後端面に係止されることによって、操作部材１２の押当部材１４に対する軸方向の押し込みが阻止されており、これらリブ５２と初期嵌合溝３６によって、セーフティロック機構が構成されている。 Further, in the initial state, the axial rear end surface of the rib 52 is locked to the axial rear end surface of the initial fitting groove 36, thereby preventing the operation member 12 from being pushed in the pressing member 14 in the axial direction. The rib 52 and the initial fitting groove 36 constitute a safety lock mechanism.

このような構造とされた採血器具１０は、押当部材１４において支持溝４４が軸方向後方に開口する切欠形状をもって形成されていることから、押当部材１４の軸方向後方における僅かな縮径方向の変形が可能とされており、これにより、押当部材１４の操作部材１２に対する中心軸回りの回動が許容されている。そして、採血器具１０を使用する際には、先ず、図９（ａ）および（ｂ）に示すように、押当部材１４を操作部材１２に対して中心軸回りで回動させて、リブ５２を第１〜第３指標３４ａ，３４ｂ, ３４ｃの所望の何れかと重ね合わせることによって、リブ５２を第１〜第３案内溝３８ａ，３８ｂ，３８ｃの何れかに嵌合させる。なお、図９においては、リブ５２を第２指標３４ｂに合わせて、第２案内溝３８ｂに嵌め合わせた状態を示す。 The blood collection device 10 having such a structure has a slightly reduced diameter in the axially rearward direction of the pressing member 14 because the support groove 44 is formed in the pressing member 14 with a notch shape that opens rearward in the axial direction. The direction can be deformed, and the rotation of the pressing member 14 around the central axis with respect to the operation member 12 is allowed. When using the blood collection instrument 10, first, as shown in FIGS. 9A and 9B, the pressing member 14 is rotated around the central axis with respect to the operation member 12, and the rib 52 Is overlapped with any desired one of the first to third indicators 34a, 34b, 34c, thereby fitting the rib 52 into any one of the first to third guide grooves 38a, 38b, 38c. FIG. 9 shows a state in which the rib 52 is fitted in the second guide groove 38b in accordance with the second index 34b.

かかる回動操作によって、押当部材１４と共に保護キャップ２０がランセット１８に対して中心軸回りで回動されることとなる。また、第１〜第３案内溝３８ａ，３８ｂ，３８ｃは初期指標３２の位置に形成された初期嵌合溝３６よりも操作部材１２の軸方向後方に延び出されていることによって、リブ５２を第１〜第３案内溝３８ａ，３８ｂ，３８ｃの何れかに嵌合させた状態で、操作部材１２の押当部材１４に対する軸方向相対変位が許容される。 With this turning operation, the protective cap 20 together with the pressing member 14 is turned around the central axis with respect to the lancet 18. Further, the first to third guide grooves 38a, 38b, and 38c extend rearward in the axial direction of the operation member 12 with respect to the initial fitting groove 36 formed at the position of the initial indicator 32, whereby the rib 52 is formed. An axial relative displacement of the operating member 12 with respect to the pressing member 14 is allowed in a state where the operating member 12 is fitted in any of the first to third guide grooves 38a, 38b, and 38c.

次に、図１０（ａ）および（ｂ）に示すように、押当部材１４の底部４０をモデル的に図示する採血部の皮膚表面１００に押し当てつつ、操作部材１２を押当部材１４に向けて軸方向で押し込む。そこにおいて、保護キャップ２０は、支持軸８８が押当部材１４の支持溝４４から押当部材１４の径方向外方にそれぞれ突出されて、操作部材１２の開口端面１０２と当接されることによって操作部材１２から押圧力が及ぼされて、支持溝４４に沿って、押当部材１４の軸方向前方に移動される。一方、ランセット１８は、係止爪７２の押当部材１４の軸方向後端面に対する係止状態が維持される。これにより、保護キャップ２０がランセット１８に対して穿刺針６２の突出方向で前方に移動されて穿刺針６２から離脱すると共に、ばね部７４の圧縮変形が開始される。 Next, as shown in FIGS. 10A and 10B, the operating member 12 is pressed against the pressing member 14 while pressing the bottom portion 40 of the pressing member 14 against the skin surface 100 of the blood collection portion schematically illustrated. Push in the axial direction. In this case, the protective cap 20 is configured such that the support shaft 88 protrudes from the support groove 44 of the pressing member 14 outward in the radial direction of the pressing member 14 and abuts against the opening end surface 102 of the operation member 12. A pressing force is exerted from the operation member 12, and is moved forward in the axial direction of the pressing member 14 along the support groove 44. On the other hand, the lancet 18 is maintained in the locked state of the locking claw 72 with respect to the axial rear end surface of the pressing member 14. As a result, the protective cap 20 is moved forward in the protruding direction of the puncture needle 62 with respect to the lancet 18 and detached from the puncture needle 62, and the compression deformation of the spring portion 74 is started.

続いて、図１１（ａ）および（ｂ）に示すように、操作部材１２が更に押し込まれることによって、保護キャップ２０の案内突片９８が、支持溝４４の傾斜部４６に当接される。なお、案内突片９８の傾斜部４６への当接は、保護キャップ２０が穿刺針６２から離脱された後に行なわれるように、傾斜部４６の押当部材１４の軸方向での位置が設定される。そして、案内突片９８が傾斜部４６で案内されることによって、支持軸８８と案内突片９８が、小幅部５０に入るように支持軸８８の中心軸回りで回動されて、保護キャップ２０が、支持軸８８回り（図１１においては、図中反時計回り）で略９０°だけ回動される。これにより、針挿通孔８７がその軸方向を穿刺針６２の突出経路上に位置されて、保護キャップ２０が針挿通孔８７を通じて穿刺針６２の突出経路上で貫通されることによって、保護キャップ２０が穿刺針６２の突出経路から外れた位置で押当部材１４に支持される。それと共に、ランセット１８の変位方向でストッパ部９４がランセット１８の当接部６８と対向位置される。 Subsequently, as shown in FIGS. 11A and 11B, when the operation member 12 is further pushed, the guide projection piece 98 of the protective cap 20 is brought into contact with the inclined portion 46 of the support groove 44. The position of the inclined portion 46 in the axial direction of the pressing member 14 is set so that the contact of the guide protrusion 98 with the inclined portion 46 is performed after the protective cap 20 is detached from the puncture needle 62. The When the guide protrusion 98 is guided by the inclined portion 46, the support shaft 88 and the guide protrusion 98 are rotated around the central axis of the support shaft 88 so as to enter the small width portion 50, and the protective cap 20. However, it is rotated by about 90 ° around the support shaft 88 (counterclockwise in FIG. 11). Accordingly, the needle insertion hole 87 is positioned on the protruding path of the puncture needle 62 in the axial direction, and the protective cap 20 is penetrated on the protruding path of the puncture needle 62 through the needle insertion hole 87, thereby the protective cap 20. Is supported by the pressing member 14 at a position deviating from the protruding path of the puncture needle 62. At the same time, the stopper portion 94 is opposed to the contact portion 68 of the lancet 18 in the displacement direction of the lancet 18.

ここにおいて、ランセット１８の当接部６８は、保護キャップ２０の第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃのそれぞれと略同じ形状とされており、押当部材１４の操作部材１２に対する回動位置に応じて、対向位置されるようになっている。具体的には、ランセット１８の当接部６８は、リブ５２を第１指標３４ａに合わせて第１案内溝３８ａと嵌合させた位置では第１のストッパ面９６ａと、リブ５２を第２指標３４ｂに合わせて第２案内溝３８ｂと嵌合させた位置では第２のストッパ面９６ｂと、リブ５２を第３指標３４ｃに合わせて第３案内溝３８ｃと嵌合させた位置では第３のストッパ面９６ｂと穿刺針６２の突出方向で対向位置されるようになっている。なお、図１１においては、リブ５２が第２指標３４ｂに合わされていることによって、当接部６８が穿刺針６２の突出方向で第２のストッパ面９６ｂと対向位置される。 Here, the contact portion 68 of the lancet 18 has substantially the same shape as each of the first to third stopper surfaces 96a, 96b, 96c of the protective cap 20, and the rotation of the pressing member 14 relative to the operation member 12 is performed. Depending on the movement position, the position is opposed. Specifically, the abutment portion 68 of the lancet 18 has the first stopper surface 96a and the rib 52 as the second index at a position where the rib 52 is fitted to the first guide groove 38a in alignment with the first index 34a. The second stopper surface 96b is positioned at the position where the second guide groove 38b is fitted to 34b and the third stopper is positioned at the position where the rib 52 is fitted to the third guide groove 38c so as to be aligned with the third index 34c. The face 96b and the puncture needle 62 are opposed to each other in the protruding direction. In FIG. 11, the rib 52 is aligned with the second index 34 b, so that the contact portion 68 is positioned opposite the second stopper surface 96 b in the protruding direction of the puncture needle 62.

また、第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃは、その突出量が大きい程、穿刺針６２の突出方向で当接部６８に対する離隔距離が小さくされることとなり、本実施形態においては、最も突出量の大きい第１のストッパ面９６ａが当接部６８と対向された場合にランセット１８との離隔距離が最も小さく、最も突出量の小さい第３のストッパ面９６ｃが当接部６８と対向された場合にランセット１８との離隔距離が最も大きくなるようにされている。 In addition, in the present embodiment, the first to third stopper surfaces 96a, 96b, and 96c have a smaller distance from the contact portion 68 in the protruding direction of the puncture needle 62 as the protruding amount increases. When the first stopper surface 96 a having the largest protrusion amount is opposed to the contact portion 68, the separation distance from the lancet 18 is the smallest, and the third stopper surface 96 c having the smallest protrusion amount is the contact portion 68. When facing each other, the distance from the lancet 18 is maximized.

また、ばね部７４は、圧縮変形に伴って挿通ピン８０が収容筒部２６の挿通溝３０に順に挿通されることによって、圧縮変形が穿刺針６２の突出方向で円滑に行なわれると共に、圧縮変形時においてもハウジング１６内で安定位置されるようになっている。 In addition, the spring portion 74 is smoothly deformed in the protruding direction of the puncture needle 62 by the insertion pin 80 being sequentially inserted into the insertion groove 30 of the accommodating tube portion 26 along with the compression deformation, and the compression deformation. Even at times, the housing 16 is positioned stably.

そして、操作部材１２を更に押し込むと、押当部材１４が操作部材１２の更に軸方向後方に移動されることによって、ランセット１８のテーパ面７３が操作部材１２の連結部３１で案内されて、ランセット１８における係止爪７２の形成部位が縮径方向に変形される。これにより、ランセット１８の係止爪７２と押当部材１４の軸方向後端面との係合状態が解除されて、ランセット１８は、ばね部７４の弾性復元力によって押当部材１４の底部４０に向けて移動され、穿刺針６２がハウジング１６の中心軸上で軸方向前方に移動される。 When the operation member 12 is further pushed in, the pressing member 14 is moved further axially rearward of the operation member 12, whereby the tapered surface 73 of the lancet 18 is guided by the connecting portion 31 of the operation member 12 and the lancet. 18 is deformed in the direction of diameter reduction. Thereby, the engagement state between the locking claw 72 of the lancet 18 and the axial rear end surface of the pressing member 14 is released, and the lancet 18 is applied to the bottom portion 40 of the pressing member 14 by the elastic restoring force of the spring portion 74. The puncture needle 62 is moved forward in the axial direction on the central axis of the housing 16.

図１２（ａ）および（ｂ）に示すように、ばね部７４は、弾性復元力によって瞬間的に自由長よりも伸張し、ばね部７４によって付勢されたランセット１８は、当接部６８が、第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃのうち穿刺針６２の突出方向で対向位置された何れかに当接することによって、軸方向前方への移動が阻止される。これにより、針先６９が、保護キャップ２０の針挿通孔８７および押当部材１４の穿刺用孔４２を通じてハウジング１６から所定量だけ突出されて、皮膚表面１００を穿刺する。 As shown in FIGS. 12A and 12B, the spring portion 74 is instantaneously extended beyond the free length by the elastic restoring force, and the lancet 18 biased by the spring portion 74 The first to third stopper surfaces 96a, 96b, and 96c are brought into contact with any one of the first and third stopper surfaces 96a, 96b, and 96c that are opposed to each other in the protruding direction of the puncture needle 62, thereby preventing the forward movement in the axial direction. As a result, the needle tip 69 protrudes from the housing 16 by a predetermined amount through the needle insertion hole 87 of the protective cap 20 and the puncture hole 42 of the pressing member 14 to puncture the skin surface 100.

そこにおいて、ランセット１８の前方への移動端位置で規定される穿刺針６２のハウジング１６からの突出量は、第１〜第３のストッパ面９６ａ，９６ｂ，９６ｃの突出量に応じて設定されることとなり、本実施形態においては、第１のストッパ面９６ａに当接する場合が最も小さく、第３のストッパ面９６ｃに当接する場合が最も大きくされる。図１２においては、当接部６８が第２のストッパ面９６ｂに当接されることから、第１のストッパ面９６ａに当接される場合よりも大きく、第３のストッパ面９６ｃに当接される場合よりも小さな突出量とされる。 In this case, the amount of protrusion of the puncture needle 62 defined by the forward movement end position of the lancet 18 is set according to the amount of protrusion of the first to third stopper surfaces 96a, 96b, 96c. In other words, in the present embodiment, the contact with the first stopper surface 96a is the smallest, and the contact with the third stopper surface 96c is the largest. In FIG. 12, since the contact portion 68 is in contact with the second stopper surface 96b, it is larger than that in contact with the first stopper surface 96a and is in contact with the third stopper surface 96c. The amount of protrusion is smaller than that of the case.

そして、図１３（ａ）および（ｂ）に示すように、ストッパ部９４で前方への移動が阻止されたランセット１８は、ばね部７４が自然長に復帰することによって、針先６９がハウジング１６内に再び収容される。これにより、針先６９のハウジング１６外への露出と誤穿刺が防止されると共に、採血器具１０の再利用が不可能とされて、使用後の採血器具１０は廃棄される。 Then, as shown in FIGS. 13A and 13B, the lancet 18 whose forward movement is prevented by the stopper portion 94 returns the spring portion 74 to the natural length, so that the needle tip 69 is moved to the housing 16. Housed again inside. As a result, exposure of the needle tip 69 to the outside of the housing 16 and erroneous puncture are prevented, and the blood collection device 10 cannot be reused, and the blood collection device 10 after use is discarded.

このような構造とされた採血器具１０によれば、使用時に、穿刺針を覆う保護キャップをハウジングから取り外す必要がない。また、保護キャップ２０にストッパ部９４を設けたことによって、穿刺針６２の保護機構と、穿刺針６２の突出量の調節機構とを、少ない部品点数と簡易な構造をもって実現することが出来る。これにより、製造コストの低減や、採血器具１０の小型化を図ることも出来る。 According to the blood collection device 10 having such a structure, it is not necessary to remove the protective cap that covers the puncture needle from the housing during use. Further, by providing the protective cap 20 with the stopper portion 94, a protection mechanism for the puncture needle 62 and a mechanism for adjusting the protruding amount of the puncture needle 62 can be realized with a small number of parts and a simple structure. Thereby, reduction of manufacturing cost and size reduction of the blood collection instrument 10 can also be achieved.

さらに、本実施形態においては、保護キャップ２０に設けられた支持軸８８および案内突片９８、操作部材１２の開口端面１０２、押当部材１４に設けられた支持溝４４および傾斜部４６を含んで、保護キャップ２０を穿刺針６２から離脱させてストッパ部９４を穿刺針６２の突出方向でランセット１８と対向位置させる連動機構が構成されることによって、これら２つの動作を、操作部材１２を皮膚表面１００に対して押し付ける単一の動作によって自動的に行なわせることが可能とされており、より優れた操作性を実現することが出来る。 Furthermore, in this embodiment, the support shaft 88 and the guide protrusion 98 provided on the protective cap 20, the opening end surface 102 of the operation member 12, the support groove 44 and the inclined portion 46 provided on the pressing member 14 are included. The interlocking mechanism is configured to disengage the protective cap 20 from the puncture needle 62 and position the stopper portion 94 to face the lancet 18 in the projecting direction of the puncture needle 62. It is possible to automatically perform the operation by a single operation of pressing against 100, and it is possible to realize better operability.

また、本実施形態においては、ストッパ部９４を複数の段差面形状として、穿刺針６２の突出量を段階的に調節することによって、かかる突出量を精度良く安定的に設定することが出来て、安全性の向上も図られ得る。更に、穿刺針６２の突出量の調節は、押当部材１４を操作部材１２に対して回転させるという簡易な操作で行なうことが可能とされている。 Further, in the present embodiment, the amount of protrusion can be accurately and stably set by adjusting the protrusion amount of the puncture needle 62 stepwise by forming the stopper portion 94 into a plurality of stepped surface shapes. Safety can also be improved. Further, the amount of protrusion of the puncture needle 62 can be adjusted by a simple operation of rotating the pressing member 14 relative to the operation member 12.

以上、本発明の一実施形態について詳述してきたが、これはあくまでも例示であって、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、何等、限定的に解釈されるものではない。 As mentioned above, although one Embodiment of this invention was explained in full detail, this is an illustration to the last, Comprising: This invention is not limited at all by the specific description in this Embodiment.

例えば、前記実施形態においては、保護キャップ２０のストッパ部９４が段差面形状とされていたが、ストッパ部９４をランセットハブ６０に形成されていた当接部６８と同形状とする一方、ランセットハブ６０における当接部６８を、ストッパ部９４と同様の段差面形状とする等しても良い。また、穿刺針の突出量を段階的に設定するに際して、その段階数は適宜に設定可能であって、前記実施形態よりも多くしても良いし、少なくしても良い。また、例えば保護キャップをネジ調節などによって穿刺針の突出方向で無段階に前後させる等して、穿刺針の突出量を無段階に調節可能とする等しても良い。 For example, in the above-described embodiment, the stopper portion 94 of the protective cap 20 has a stepped surface shape, but the stopper portion 94 has the same shape as the contact portion 68 formed on the lancet hub 60, while the lancet hub The contact portion 68 in 60 may have the same stepped surface shape as the stopper portion 94. Moreover, when setting the protrusion amount of a puncture needle in steps, the number of steps can be set as appropriate, and may be larger or smaller than in the above embodiment. Further, for example, the protrusion amount of the puncture needle may be adjusted steplessly by moving the protective cap back and forth steplessly in the protruding direction of the puncture needle by adjusting a screw or the like.

また、前記実施形態においては、ランセットハブ６０とばね部材としてのばね部７４が一体形成されていたが、これらを別体成形することも可能であり、ばね部材として、金属製の板ばねやコイルスプリング等を採用しても良い。更にまた、前記実施形態においては、ばね部７４が操作部材１２に固定されていたが、ばね部材は必ずしも操作部材に固定されている必要は無い。 Moreover, in the said embodiment, although the lancet hub 60 and the spring part 74 as a spring member were integrally formed, these can also be shape | molded separately, and metal leaf | plate springs and coils can be used as a spring member. A spring or the like may be employed. Furthermore, in the above-described embodiment, the spring portion 74 is fixed to the operation member 12, but the spring member is not necessarily fixed to the operation member.

さらに、保護キャップを穿刺針から離脱させてストッパ部を構成する位置に導く連動機構は必ずしも必要ではなく、例えば穿刺操作とは別の手操作で保護キャップを穿刺針から離脱させた後に、保護キャップを手操作でストッパとしてセットする等しても良い。 Further, an interlocking mechanism for separating the protective cap from the puncture needle and guiding it to the position constituting the stopper portion is not necessarily required. For example, after the protective cap is detached from the puncture needle by a manual operation different from the puncture operation, the protective cap is not required. May be manually set as a stopper.

１０：採血器具、１２：操作部材、１４：押当部材、１６：ハウジング、１８：ランセット、２０：保護キャップ、６２：穿刺針、６８：当接部、６９：針先、７４：ばね部、９４：ストッパ部、９６ａ：第１のストッパ面、９６ｂ：第２のストッパ面、９６ｃ：第３のストッパ面 10: Blood collection instrument, 12: Operation member, 14: Pushing member, 16: Housing, 18: Lancet, 20: Protection cap, 62: Puncture needle, 68: Abutment part, 69: Needle tip, 74: Spring part, 94: stopper portion, 96a: first stopper surface, 96b: second stopper surface, 96c: third stopper surface

Claims

In a disposable blood collection device in which a lancet having a puncture needle and a spring member are accommodated in a housing, the lancet is urged by the spring member, and the tip of the puncture needle protrudes from the housing to perform a puncture operation.
Wherein the protective cap the needle tip to cover the puncture needle provided Rutotomoni and allowed spaced capable and rotatably supporting the protective cap from the puncture needle by the housing,
The through-hole provided in the protective cap is positioned on the protruding path of the puncture needle by rotating away from the puncture needle while the protective cap is supported without being removed from the housing. The puncturing operation is performed with the protective cap supported by the housing, and the housing is discarded after the puncturing operation while the lancet, the spring member, and the protective cap are accommodated. Disposable blood collection device.

While the protective cap is configured to include a cap body in which the through hole is formed, and a support shaft provided in the cap body and protruding in a direction perpendicular to the through direction of the through hole,
The housing is provided with a support groove extending in the protruding direction of the puncture needle,
The disposable blood collection device according to claim 1, wherein the support shaft of the protective cap is supported in the support groove of the housing.

On the support shaft of the protective cap is provided with a guide protrusion that protrudes in the through direction of the through hole,
The support groove of the housing is configured to include a large portion, a small width portion, and an inclined portion that connects the large portion and the small width portion,
The disposable blood collection device according to claim 2, wherein the protective cap is rotated by attaching the guide protrusion to the support groove and moving the guide protrusion from the large portion side to the small width portion side. .

The housing is configured to include a pressing member pressed against the skin surface of the blood collection unit and an operation member that is movably combined with the pressing member,
The puncture needle protrudes from the pressing member and is punctured by releasing the locked state of the lancet biased by the spring member with respect to the pressing member by the operating member. The disposable blood collection device according to any one of Items 1 to 3.

The pressing member and the operating member are both cylindrical with a bottom, and the housing is formed in a hollow structure by being fitted to each other on the opening side and combined so as to be relatively movable in the axial direction. With
The lancet is accommodated so as to be movable in the axial direction of the housing, and the puncture needle of the lancet protrudes toward the bottom of the pressing member, and a puncture hole is formed in the bottom of the pressing member. Is formed,
The protective cap is detached from the puncture needle and rotated by pressing the operating member against the pressing member with the bottom of the pressing member pressed against the skin surface of the blood collection unit. At the same time, the latched state of the lancet with respect to the pressing member is released, and the lancet is moved toward the bottom of the pressing member by the urging force of the spring member disposed between the housing and the lancet. 5. The disposable blood collection device according to claim 4, wherein the disposable blood collection device is moved and moved so that the tip of the puncture needle protrudes from the puncture hole of the pressing member to the outside.