JP5653655B2 - Puncture needle and blood vessel surface notch forming device - Google Patents
Puncture needle and blood vessel surface notch forming device Download PDFInfo
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Description
本発明は、血管に穿刺することにより、血管表面に穿刺痕を形成するための管状、あるいは円柱状の穿刺針及び血管表面切痕形成器具に関する。 The present invention relates to a tubular or columnar puncture needle and a blood vessel surface notch forming device for forming a puncture mark on a blood vessel surface by puncturing a blood vessel.
例えば血液透析などの血液浄化を行う際には、患者の皮下に針を刺し、当該針から採血と返血が行われている。この穿刺は、血液浄化時に毎回行う必要があるが、その都度患者に大きな痛みを与える。そこで、近年では、穿刺時の痛みを軽減するために、初回の穿刺時に鋭利な通常針を用いて、例えば図１９に示すように体の皮膚１００から血管１０１に通じる穿刺ルート１０２を形成し、それ以降に行われる穿刺時には、痂皮１０３を取り除き、鋭利性が低いダルニードルを穿刺ルート１０２に挿入して血管１０１に穿刺する、いわゆるボタンホール穿刺法が用いられている（特許文献１参照）。この方法によれば、穿刺ルート作製後は、新たに皮膚１００に穴を空ける必要がないので、患者の痛みが軽減される。 For example, when blood purification such as hemodialysis is performed, a needle is inserted into the patient's skin, and blood is collected and returned from the needle. This puncture needs to be performed every time the blood is purified, but each time it gives great pain to the patient. Therefore, in recent years, in order to reduce pain at the time of puncture, a puncture route 102 that leads from the skin 100 of the body to the blood vessel 101 is formed, for example, as shown in FIG. At the time of puncture performed thereafter, a so-called buttonhole puncture method is used in which the scab 103 is removed and a dull needle with low sharpness is inserted into the puncture route 102 to puncture the blood vessel 101 (see Patent Document 1). According to this method, it is not necessary to make a new hole in the skin 100 after creating the puncture route, so that the pain of the patient is reduced.
初回穿刺時に用いられる穿刺針１１０は、図２０に示すように先端側に傾斜した傾斜端面１１０ａを有し、且つ、当該傾斜端面１１０ａの先端には尖った尖端部１１０ｂが形成されている。穿刺針１１０により血管１０１に穿刺する場合には、まず、穿刺針１１０は、傾斜端面１１０ａを上にして、斜めに皮膚１００に挿入された後、血管１０１に向かって押し進められ、更に、尖端部１１０ｂが血管１０１の表面に到達した後は、そのままの姿勢で血管１０１内に挿入されるようになっている。 As shown in FIG. 20, the puncture needle 110 used at the time of the first puncture has an inclined end surface 110a inclined toward the distal end, and a sharp pointed portion 110b is formed at the distal end of the inclined end surface 110a. When puncturing the blood vessel 101 with the puncture needle 110, first, the puncture needle 110 is inserted into the skin 100 obliquely with the inclined end surface 110a facing upward, and then pushed forward toward the blood vessel 101. After 110b reaches the surface of the blood vessel 101, it is inserted into the blood vessel 101 as it is.
ところで、穿刺針１１０が血管１０１内に挿入される際には、血管１０１の表面には、図２１に示すような、挿入方向に対して手前側から奥側にＵ字状に開裂する穿刺口１０１ａが形成される。そして、二回目以降の穿刺時には、この穿刺口１０１ａの痕を通してダルニードルが血管１０１内に挿入されるようになっている。 By the way, when the puncture needle 110 is inserted into the blood vessel 101, the surface of the blood vessel 101 has a puncture opening that is cleaved in a U shape from the near side to the far side as shown in FIG. 101a is formed. In the second and subsequent punctures, the dull needle is inserted into the blood vessel 101 through the trace of the puncture port 101a.
図２２に示すように、穿刺ルート作製後はダルニードル１２０を穿刺ルート１０２に挿入し、ダルニードル１２０を血管１０１内に挿入しようとする場合には、ダルニードル１２０の先端を用いて、穿刺口１０１ａ上の最も弱い押圧力で穿刺口１０１ａが開く部位、所謂最適当接部１０１bが探られる。 As shown in FIG. 22, after the puncture route is prepared, when the dull needle 120 is inserted into the puncture route 102 and the dull needle 120 is to be inserted into the blood vessel 101, the tip of the dull needle 120 is used to A portion where the puncture opening 101a opens with the weakest pressing force, that is, a so-called optimum contact portion 101b is searched.
ところが、従来の穿刺針１１０により形成された穿刺口１０１ａにおいては、最適当接部１０１bは、穿刺口１０１ａのＵ字の底部付近に存在する。よって、穿刺ルート作製後にダルニードル１２０の先端で探られる最適当接部１０１bの位置は、ダルニードル１２０の挿入方向Ｘに対し手前側になる。 However, in the puncture port 101a formed by the conventional puncture needle 110, the optimum contact portion 101b exists near the bottom of the U-shape of the puncture port 101a. Therefore, the position of the optimum contact portion 101b that is searched for at the tip of the dull needle 120 after the puncture route is formed is on the near side with respect to the insertion direction X of the dull needle 120.
従って、ダルニードル１２０により最適当接部１０１ｂを探る際には、挿入方向Ｘに沿って手前側から奥側にダルニードル１２０をスライドさせることになるが、手前側にある最適当接部１０１ｂを一旦逃すと、ダルニードル１２０が最適当接部１０１ｂから離れていき、すぐに探り当てることができなくなる。また、探り当てた後も、最適当接部１０１ｂが手前側にあるために、ダルニードル１２０の挿入角度が相対的に大きくなり、その分穿刺口１０１ａを開けるための抵抗が大きくなるため、より強い力でダルニードル１２０を挿入させる必要がある。ダルニードル１２０の挿入に時間がかかったり、強い力が必要になると、血管を傷付けたり患者に痛みを与える恐れがある。 Therefore, when searching for the optimum contact portion 101b by the dull needle 120, the dull needle 120 is slid from the near side to the far side along the insertion direction X, but the optimum contact portion 101b on the near side is temporarily released. Then, the dull needle 120 moves away from the optimum contact portion 101b and cannot be immediately found. Moreover, since the optimum contact portion 101b is on the near side even after the detection, the insertion angle of the dull needle 120 becomes relatively large, and the resistance for opening the puncture port 101a increases accordingly, so that a stronger force Therefore, it is necessary to insert the dull needle 120. If it takes a long time to insert the dull needle 120 or a strong force is required, the blood vessel may be injured or pain may be given to the patient.
本発明は、かかる点に鑑みてなされたものであり、二回目以降の穿刺において、最適当接部を容易に探り当て、なおかつ血管に針をより小さい力で挿入可能にすることをその目的とする。 The present invention has been made in view of such points, and an object thereof is to easily find the optimum contact portion in the second and subsequent punctures and to insert the needle into the blood vessel with a smaller force. .
上記目的を達成する本発明は、血管に穿刺するための管状、或いは円柱状の穿刺針であって、針の先端に傾斜端面を有し、前記傾斜端面を下向きにして穿刺することによって、その穿刺方向に対して奥側を起点に手前側に放射状に開裂する穿刺痕が血管表面に形成され、前記傾斜端面の先端には、尖端部が形成され、当該尖端部が針の中心軸側に曲がっており、前記傾斜端面の背面には、背面刃面が形成されているものである。 The present invention that achieves the above object is a tubular or columnar puncture needle for puncturing a blood vessel, having a tilted end surface at the tip of the needle, and puncturing with the tilted end surface facing downward. A puncture mark is formed on the blood vessel surface that radiates toward the front side starting from the back side with respect to the puncture direction , a tip is formed at the tip of the inclined end surface, and the tip is on the central axis side of the needle. It is bent, and a back blade surface is formed on the back surface of the inclined end surface .
本発明によれば、血管表面に、奥側を起点に手前側に放射状に開裂する穿刺痕が形成されるので、いわゆる最適当接部が穿刺方向に対して奥側にできる。この結果、穿刺ルート作製後にダルニードルなどの針を血管内に挿入する際、最適当接部を探り易くなる。また、最適当接部が穿刺方向の奥側となるため、二回目以降の針の血管への挿入角度が相対的に小さくなり挿入のための抵抗が小さくなる。よって、針を血管内により小さい力で容易に挿入することができるようになる。
According to the present invention, since a puncture mark is formed on the blood vessel surface that is radially cleaved from the back side to the front side, a so-called optimum contact portion can be formed on the back side with respect to the puncture direction. As a result, when a needle such as a dull needle is inserted into the blood vessel after creating the puncture route, it is easy to find the optimum contact portion. In addition, since the optimum contact portion is on the back side in the puncture direction, the insertion angle of the second and subsequent needles into the blood vessel is relatively small, and the resistance for insertion is small. Therefore, the needle can be easily inserted into the blood vessel with a smaller force.
本発明において、前記傾斜端面の先端には、尖端部が形成され、当該尖端部が針の中心軸側に曲がっているので、穿刺針の傾斜端面側を下に向けた状態での血管への穿刺を適正に行うことができる。また、本発明においては、前記傾斜端面の背面には、背面刃面が形成されているので、尖端部を上側にした状態の穿刺針による穿刺をよりスムーズに行うことができる。
別の観点による本発明は、血管に穿刺するための管状、或いは円柱状の穿刺針であって、針の先端に傾斜端面を有し、前記傾斜端面を下向きにして穿刺することによって、その穿刺方向に対して奥側を起点に手前側に放射状に開裂する穿刺痕が血管表面に形成され、前記傾斜端面の先端には、尖端部が形成され、当該尖端部が針の中心軸側に曲がっており、前記傾斜端面の前記尖端部より後方側には、先端側に向いた他の尖端部が形成されている、穿刺針である。
In the present invention, a tip portion is formed at the tip of the inclined end surface, and the tip portion is bent toward the central axis side of the needle, so that the inclined end surface side of the puncture needle is directed to the blood vessel in a state of facing down. Puncture can be performed properly. In the present invention, since a back blade surface is formed on the back surface of the inclined end surface, puncture with a puncture needle with the pointed end on the upper side can be performed more smoothly.
Another aspect of the present invention is a tubular or cylindrical puncture needle for puncturing a blood vessel, and has a tilted end surface at the tip of the needle, and the puncture is performed by puncturing the tilted end surface downward. A puncture mark is formed on the blood vessel surface that radiates to the front side starting from the back side with respect to the direction, a tip is formed at the tip of the inclined end surface, and the tip is bent toward the central axis of the needle. And a puncture needle in which another pointed portion directed toward the tip side is formed on the rear side of the pointed end portion of the inclined end surface.
本発明においては、前記傾斜端面の少なくとも前記尖端部を含む部分には、刃面が形成されていてもよい。かかる場合、尖端部を上側にした状態の穿刺針による穿刺をよりスムーズに行うことができる。 In the present invention, a blade surface may be formed in a portion including at least the pointed portion of the inclined end surface. In such a case, the puncture with the puncture needle with the pointed portion on the upper side can be performed more smoothly.
本発明においては、前記刃面は、前記尖端部から前記傾斜端面の傾斜面まで形成されていてもよい。 In the present invention, the blade surface may be formed from the pointed end portion to the inclined surface of the inclined end surface.
本発明においては、前記背面刃面は、少なくとも前記尖端部に形成されていてもよい。また、前記背面刃面は、前記尖端部よりも後方側であって前記傾斜端面の背面の両側端に形成されていてもよい。 In the present invention, the back blade surface may be formed at least at the tip portion. Moreover, the said back blade surface may be formed in the both-sides end of the back surface of the said inclined end surface behind the said point part.
前記傾斜端面の前記尖端部より後方側には、先端側に向いた他の尖端部が形成されていてもよい。 On the rear side of the tip end portion of the inclined end surface, another tip end portion directed to the tip end side may be formed.
本発明においては、針の背面には、前記傾斜端面の先端側から血管の血液が入り込む溝が形成されていてもよい。これにより、穿刺針が血管に到達したか否かを視覚的に確認できる。 In the present invention, a groove into which blood in a blood vessel enters from the distal end side of the inclined end surface may be formed on the back surface of the needle. Thereby, it can be visually confirmed whether or not the puncture needle has reached the blood vessel.
以上の穿刺針は、皮膚から皮下の血管に通じる穿刺ルートを形成する際の穿刺に用いられるものであってもよい。 The above puncture needles may be used for puncture when forming a puncture route leading from the skin to a subcutaneous blood vessel.
別の観点による本発明は、皮膚表面及び血管表面に対して長軸が斜めになるように形成された、皮膚表面から血管表面に至る穿刺ルートに挿入されることにより、血管表面に、穿刺ルートの長軸に対して奥側を起点に手前側に放射状に開裂する切痕を形成するための管状あるいは円柱状の器具であって、血管表面に接する側の先端が傾斜端面を有し、該傾斜端面の先端には尖端部が形成され、該尖端部が器具の中心軸側に曲がっており、且つ、前記尖端部から、少なくとも前記傾斜端面の横径が最大となる位置まで該傾斜端面の周縁に沿って刃面が形成されており、前記傾斜端面の背面には、背面刃面が形成されている、血管表面切痕形成器具である。 According to another aspect of the present invention, there is provided a puncture route on a blood vessel surface by being inserted into a puncture route extending from the skin surface to the blood vessel surface so that the major axis is inclined with respect to the skin surface and the blood vessel surface. A tubular or cylindrical instrument for forming a notch that is radially cleaved from the back side to the long side with respect to the long axis of the tube, the tip on the side in contact with the blood vessel surface has an inclined end surface, A pointed end is formed at the tip of the inclined end surface, the pointed end is bent toward the central axis side of the instrument, and at least from the pointed end to the position where the lateral diameter of the inclined end surface is maximized. The blood vessel surface notch forming instrument has a blade surface formed along a peripheral edge, and a back blade surface is formed on the back surface of the inclined end surface .
前記血管表面切痕形成器具は、背面に、前記傾斜端面の先端側から血管の血液が入り込む溝が形成されていてもよい。 In the blood vessel surface notch forming device, a groove into which blood of the blood vessel enters from the distal end side of the inclined end surface may be formed on the back surface.
本発明によれば、穿刺ルート作製後に、血管にダルニードルなどの針をより小さい力で容易に挿入することができるので、血管を傷付けたり患者に痛みを与えることを防止できる。 According to the present invention, since a needle such as a dull needle can be easily inserted into a blood vessel with a smaller force after the puncture route is produced, it is possible to prevent the blood vessel from being damaged or painful to the patient.
以下、図面を参照して、本発明の好ましい実施の形態について説明する。図１は、本実施の形態に係る穿刺針（血管表面切痕形成器具）１を有する血液浄化処理用器具２の一例を示す説明図である。 Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an explanatory view showing an example of a blood purification treatment instrument 2 having a puncture needle (blood vessel surface notch forming instrument) 1 according to the present embodiment.
血液浄化処理用器具２は、例えば血液浄化処理時に患者の血管に穿刺される管状の穿刺針１と、穿刺針１が先端部に接続されたチューブ１０と、チューブ１０の後端部を他のチューブに接続するための接続部１１を有している。チューブ１０の穿刺針１に近い部分には、穿刺針１を動かす際に作業者が保持する保持部１２が設けられている。また、チューブ１０には、クランプ１３が取り付けられている。接続部１１には、キャップ１４が嵌められている。 The blood purification treatment instrument 2 includes, for example, a tubular puncture needle 1 that is punctured into a patient's blood vessel during blood purification treatment, a tube 10 to which the puncture needle 1 is connected to a distal end portion, and a rear end portion of the tube 10 to other portions. It has the connection part 11 for connecting to a tube. A holding portion 12 that is held by an operator when the puncture needle 1 is moved is provided in a portion of the tube 10 close to the puncture needle 1. A clamp 13 is attached to the tube 10. A cap 14 is fitted to the connection portion 11.
血液浄化処理用器具２は、例えば接続部１１により他のチューブに接続され、図示しない血液浄化器を有する血液浄化回路の一部を構成する。血液浄化処理用器具２は、血液浄化回路の採血側の端部区間と返血側の端部区間に取り付けられ、血液浄化処理時には穿刺針１を通じて採血や返血が行われる。なお、血液浄化処理には、例えば透析処理、血漿交換処理、血漿吸着処理、血液成分除去処理など含まれる。 The blood purification treatment instrument 2 is connected to another tube by, for example, the connecting portion 11 and constitutes a part of a blood purification circuit having a blood purifier (not shown). The blood purification treatment instrument 2 is attached to the blood collection side end section and the blood return side end section of the blood purification circuit, and blood collection and blood return are performed through the puncture needle 1 during the blood purification process. The blood purification processing includes, for example, dialysis processing, plasma exchange processing, plasma adsorption processing, blood component removal processing, and the like.
穿刺針１は、図２、図３及び図４に示すように先端側に傾斜端面２０を有し、傾斜端面２０は、針の中心軸Ａに対し傾斜している。この傾斜角度Ｂ（図３に示す）は、例えば５度〜２１度程度が好ましい。傾斜端面２０の先端には、尖端部２１が形成されている。尖端部２１は、針の中心軸Ａ側に曲がっている。なお、この曲がりは湾曲でも屈曲でもよい。また、尖端部２１の中心軸Ａ方向に対する曲がり角度Ｃ（図３に示す）は、例えば２度〜９０度程度が好ましく、８度〜６０度がより好ましい。 The puncture needle 1 has an inclined end surface 20 on the distal end side as shown in FIGS. 2, 3, and 4, and the inclined end surface 20 is inclined with respect to the central axis A of the needle. The inclination angle B (shown in FIG. 3) is preferably about 5 degrees to 21 degrees, for example. A tip portion 21 is formed at the tip of the inclined end surface 20. The tip 21 is bent toward the central axis A of the needle. This bend may be curved or bent. Further, the bending angle C (shown in FIG. 3) of the tip 21 with respect to the direction of the central axis A is preferably, for example, about 2 to 90 degrees, and more preferably 8 to 60 degrees.
傾斜端面２０には、刃面２２が形成されている。刃面２２は、左右方向（中心軸Ａに対して直角方向）の両端をカッティングして形成されている。刃面２２は、例えば尖端部２１から傾斜端面２０の傾斜面２０ａ（傾斜角度Ｂを有する部分）の横径が最大となる中央付近まで、傾斜面２０ａの周縁に沿って形成されている。なお、刃面２２は、さらに傾斜面２０ａの横径が最大となる位置よりも後方（傾斜面の上方）まで形成されていてもよい。 A blade surface 22 is formed on the inclined end surface 20. The blade surface 22 is formed by cutting both ends in the left-right direction (a direction perpendicular to the central axis A). The blade surface 22 is formed along the periphery of the inclined surface 20a, for example, from the pointed end portion 21 to the vicinity of the center where the horizontal diameter of the inclined surface 20a of the inclined end surface 20 (the portion having the inclination angle B) is maximum. In addition, the blade surface 22 may be formed further to the back (above the inclined surface) than the position where the horizontal diameter of the inclined surface 20a is maximum.
傾斜端面２０の背面３０には、背面刃面３１が形成されている。背面刃面３１は、例えば背面３０の両側端に尖端部２１から後方側に向けて形成されている。背面刃面３１は、例えば刃面２２より短く形成されている。 A back blade surface 31 is formed on the back surface 30 of the inclined end surface 20. For example, the back blade surface 31 is formed on both side ends of the back surface 30 from the pointed portion 21 toward the rear side. The back blade surface 31 is formed shorter than the blade surface 22, for example.
次に、以上のように構成された穿刺針１を用いて血液浄化処理時に血管に穿刺するプロセスについて説明する。 Next, a process of puncturing a blood vessel during blood purification using the puncture needle 1 configured as described above will be described.
先ず、初回の血液浄化処理時には、穿刺針１を有する血液浄化処理用器具２が、無菌袋から取り出され、血液浄化回路に接続される。 First, at the time of the first blood purification process, the blood purification processing instrument 2 having the puncture needle 1 is taken out of the sterile bag and connected to the blood purification circuit.
次に、図５に示すように穿刺針１が、尖端部２１側を上にし、傾斜端面２０を下に向けた状態で、皮膚１００の表面に対し斜め上方から所定角度で挿入される。穿刺針１が、皮膚１００から皮下に挿入されると、図６に示すように尖端部２１が血管１０１の表面に到達し、穿刺口１０１ａを開けて尖端部２１から血管１０１内に進入する。このとき、図７に示すように穿刺口１０１ａが、穿刺針１の挿入方向Ｘの水平成分方向Ｘ１に対して奥側を起点に手前側に放射状に開裂し、当該穿刺口１０１ａの奥側に最適当接部１０１ｂが形成される。その後、図８に示すようにさらに穿刺針１が進められ、穿刺針１の傾斜端面２０全体が血管１０１内に挿入される。 Next, as shown in FIG. 5, the puncture needle 1 is inserted into the surface of the skin 100 at a predetermined angle from the upper side with the tip end 21 side up and the inclined end face 20 facing down. When the puncture needle 1 is inserted subcutaneously from the skin 100, the tip 21 reaches the surface of the blood vessel 101 as shown in FIG. 6, opens the puncture port 101a, and enters the blood vessel 101 from the tip 21. At this time, as shown in FIG. 7, the puncture port 101a is radially cleaved from the back side with respect to the horizontal component direction X1 in the insertion direction X of the puncture needle 1, and is formed on the back side of the puncture port 101a. An optimum contact portion 101b is formed. Thereafter, as shown in FIG. 8, the puncture needle 1 is further advanced, and the entire inclined end surface 20 of the puncture needle 1 is inserted into the blood vessel 101.
その後、穿刺針１を通じて採血、返血が行われ、血液浄化処理が行われる。血液浄化処理が終了すると、穿刺針１が抜かれて、皮膚１００から血管１０１に通じる穿刺ルート１０２が形成される。また、穿刺口１０１ａが閉じて穿刺痕となる。 Thereafter, blood collection and blood return are performed through the puncture needle 1, and blood purification processing is performed. When the blood purification process is completed, the puncture needle 1 is removed, and a puncture route 102 that leads from the skin 100 to the blood vessel 101 is formed. Also, the puncture port 101a is closed to form a puncture mark.
穿刺ルート作製後の血液浄化処理では、ダルニードル１２０を用いて血管１０１への穿刺が行われる。図９に示すようにダルニードル１２０が穿刺ルート１０２に挿入され、ダルニードル１２０が血管１０１の表面に到達すると、最適当接部１０１ｂが探られる。このとき、ダルニードル１２０は、挿入方向Ｘに力が加えられているため、ダルニードル１２０が手前側から奥側にスライドし、穿刺痕の奥側の最適当接部１０１ｂに到達する。ダルニードル１２０が最適当接部１０１ｂに到達すると、最適当接部１０１ｂから穿刺口１０１ａが開口し、穿刺口１０１ａから血管１０１内にダルニードル１２０が挿入される。その後、ダルニードル１２０を通じて採血、返血が行われ、血液浄化処理が行われる。 In blood purification processing after creation of the puncture route, puncture of the blood vessel 101 is performed using the dull needle 120. As shown in FIG. 9, when the dull needle 120 is inserted into the puncture route 102 and the dull needle 120 reaches the surface of the blood vessel 101, the optimum contact portion 101b is searched. At this time, since force is applied to the dull needle 120 in the insertion direction X, the dull needle 120 slides from the near side to the far side and reaches the optimum contact portion 101b on the far side of the puncture mark. When the dull needle 120 reaches the optimum contact portion 101b, the puncture port 101a opens from the optimum contact portion 101b, and the dull needle 120 is inserted into the blood vessel 101 from the puncture port 101a. Thereafter, blood collection and blood return are performed through the dull needle 120, and blood purification processing is performed.
以上の実施の形態によれば、傾斜端面２０の尖端部２１が針の中心軸Ａ側に曲がっている。このため、傾斜端面２０側を下に向けて尖端部２１側を上にした状態で、穿刺針１を血管１０１に穿刺したときに、例えば尖端部２１と血管１０１表面との角度が十分に確保される。よって、尖端部２１を上にしたいわゆる逆さ刺しを行っても、穿刺針１が血管１０１に適正に穿刺される。 According to the above embodiment, the pointed portion 21 of the inclined end surface 20 is bent toward the central axis A side of the needle. For this reason, when the puncture needle 1 is punctured into the blood vessel 101 with the inclined end surface 20 facing down and the pointed end 21 side up, for example, a sufficient angle between the pointed end 21 and the surface of the blood vessel 101 is secured. Is done. Therefore, the puncture needle 1 is properly punctured into the blood vessel 101 even if so-called upside-down puncture is performed with the tip portion 21 facing upward.
また、いわゆる逆さ刺しにより、穿刺針１の斜めの挿入方向Ｘに対して血管１０１の穿刺口１０１ａの奥側に最適当接部１０１ｂが形成される。このため、穿刺ルート作製後に、ダルニードル１２０を挿入する力を利用して、ダルニードル１２０が奥側の最適当接部１０１ｂに誘導されるので、最適当接部１０１ｂを探り易くなる。また、奥側の最適当接部１０１ｂから穿刺口１０１ａが開口するので、ダルニードル１２０の血管１０１への挿入角度が相対的に小さくなり挿入のための抵抗が小さくなる。これにより、血管１０１にダルニードル１２０をより小さい力で容易に挿入することができるので、血管１０１を傷付けたり患者に痛みを与えることを防止できる。 Moreover, the optimal contact part 101b is formed in the back | inner side of the puncture opening | mouth 101a of the blood vessel 101 with respect to the diagonal insertion direction X of the puncture needle 1 by what is called inverted stab. For this reason, after the puncture route is created, the dull needle 120 is guided to the optimum contact portion 101b on the back side by using a force for inserting the dull needle 120, so that the optimum contact portion 101b can be easily found. Moreover, since the puncture port 101a opens from the optimal contact portion 101b on the back side, the insertion angle of the dull needle 120 into the blood vessel 101 becomes relatively small, and the resistance for insertion becomes small. Thereby, since the dull needle 120 can be easily inserted into the blood vessel 101 with a smaller force, it is possible to prevent the blood vessel 101 from being damaged or painful to the patient.
以上の実施の形態では、傾斜端面２０に、刃面２２が尖端部２１から傾斜端面２０の傾斜面２０ａの途中まで形成されているので、尖端部２１を上にした状態の穿刺針１によるいわゆる逆さ刺しをよりスムーズに行うことができる。 In the above embodiment, since the blade surface 22 is formed on the inclined end surface 20 from the pointed end portion 21 to the middle of the inclined surface 20a of the inclined end surface 20, so-called the puncture needle 1 with the pointed end portion 21 facing upward. Upside-down stab can be performed more smoothly.
また、傾斜端面２０の背面３０の尖端部２１に背面刃面３１が形成されているので、尖端部２１を上にした状態の穿刺針１によるいわゆる逆さ刺しをよりスムーズに行うことができる。 In addition, since the back blade surface 31 is formed on the pointed portion 21 of the back surface 30 of the inclined end surface 20, so-called upside-down piercing with the puncture needle 1 with the pointed portion 21 facing up can be performed more smoothly.
以上の実施の形態では、背面刃面３１が尖端部２１に形成されていたが、図１０、図１１及び図１２に示すように尖端部２１よりも後方側であって傾斜端面２０の背面３０の両側端に形成されていてもよい。かかる場合も、尖端部２１を上にした状態の穿刺針１による穿刺をよりスムーズに行うことができる。なお、背面刃面３１は、尖端部２１付近と、その尖端部２１よりも後方側の両方に形成されていてもよい。 In the above embodiment, the back blade surface 31 is formed on the pointed end portion 21, but as shown in FIGS. 10, 11, and 12, it is on the rear side of the pointed end portion 21 and the back surface 30 of the inclined end surface 20. It may be formed on both side ends. In such a case as well, puncturing with the puncture needle 1 with the tip portion 21 facing upward can be performed more smoothly. In addition, the back blade surface 31 may be formed both near the tip portion 21 and on the rear side of the tip portion 21.
以上の実施の形態で記載した穿刺針１において、図１３に示すように穿刺針１の背面３０に、傾斜端面２０の先端側から血管１０１の血液が入り込む溝４０が形成されていてもよい。かかる場合、溝４０は、例えば尖端部２１付近から後方側に向けて直線状に形成されている。溝４０の幅は、例えば０．１ｍｍ〜２ｍｍ程度が好ましく、深さは、例えば１５μｍ〜５００μｍ程度が好ましい。これにより、穿刺針１の傾斜端面２０が血管１０１内に入ると、血液が毛細管現象により溝４０に入り込むので、穿刺針１が血管１０１内に到達したか否かを視覚的に確認できる。 In the puncture needle 1 described in the above embodiment, a groove 40 into which blood in the blood vessel 101 enters from the distal end side of the inclined end surface 20 may be formed on the back surface 30 of the puncture needle 1 as shown in FIG. In such a case, the groove 40 is formed, for example, in a straight line from the vicinity of the tip portion 21 toward the rear side. The width of the groove 40 is preferably about 0.1 mm to 2 mm, for example, and the depth is preferably about 15 μm to 500 μm, for example. Thereby, when the inclined end face 20 of the puncture needle 1 enters the blood vessel 101, blood enters the groove 40 by capillary action, so that it can be visually confirmed whether or not the puncture needle 1 has reached the blood vessel 101.
以上、添付図面を参照しながら本発明の好適な実施の形態について説明したが、本発明はかかる例に限定されない。当業者であれば、特許請求の範囲に記載された思想の範疇内において、各種の変更例または修正例に想到し得ることは明らかであり、それらについても当然に本発明の技術的範囲に属するものと了解される。 The preferred embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to such examples. It is obvious for those skilled in the art that various modifications or modifications can be conceived within the scope of the idea described in the claims, and these naturally belong to the technical scope of the present invention. It is understood.
例えば以上の形態で記載した穿刺針１の尖端部２１の形状は、針の中心軸Ａ側に曲がっていれば、他の形状であってもよい。また、刃面２２、背面刃面３１の形状、位置や数もこれに限られない。また、以上の実施の形態の穿刺針１は、内部に血液が通る環状のものであったが、図１４、図１５に示すように血液が通らない円柱状のものであってもよい。
管状でない為穿刺時の面積が増え穿刺抵抗は増すが、細工しやすく製造上の利点がある。
この穿刺針１は、穿刺ルート１０２を形成するためのものになる。かかる場合、初めにいわゆる逆刺しの状態で穿刺針１が血管１０１に挿入され、穿刺口１０１ａと、穿刺ルート１０２が形成され、その後ダルニードル１２０が穿刺ルート１０２及び穿刺口１０１ａを通じて血管１０１に挿入され、当該ダルニードル１２０を通じて採血、返血が行われ、血液浄化処理が行われる。
For example, the shape of the tip 21 of the puncture needle 1 described in the above form may be other shapes as long as it is bent toward the central axis A of the needle. Further, the shape, position, and number of the blade surface 22 and the back blade surface 31 are not limited thereto. Moreover, although the puncture needle 1 of the above embodiment was an annular shape through which blood passes, it may be a cylindrical shape through which blood does not pass as shown in FIGS.
Since it is not tubular, the area at the time of puncture increases and puncture resistance increases, but it is easy to work and has an advantage in manufacturing.
This puncture needle 1 serves to form a puncture route 102. In such a case, the puncture needle 1 is first inserted into the blood vessel 101 in a so-called reverse puncture state, and the puncture port 101a and the puncture route 102 are formed, and then the dull needle 120 is inserted into the blood vessel 101 through the puncture route 102 and the puncture port 101a. Blood is collected and returned through the dull needle 120, and blood purification processing is performed.
また、以上の実施の形態で記載した穿刺針１において、図１６、図１７に示すように傾斜端面２０の尖端部２１より後方側に、先端側に向いた他の尖端部５０が形成されていてもよい。他の尖端部５０は、側面から見て例えば３０度程度の鋭角に形成されている。他の尖端部５０の上面には、刃面５１が形成されている。
一般的には、刃面２２の傾斜角度が鋭角に成る程、穿刺性は向上するが、一方、傾斜端面長が長くなり、針傾斜面が血管幅よりはみ出し、血液が漏れる危険性が増加する。図１６、図１７に示す様な二段構造することにより、刃面を鋭角にして穿刺性を向上させ、且つ血液が漏れる危険性が少ない穿刺針が作製できる。
Moreover, in the puncture needle 1 described in the above embodiment, as shown in FIGS. 16 and 17, another pointed portion 50 directed toward the distal end side is formed on the rear side of the pointed portion 21 of the inclined end surface 20. May be. The other pointed portion 50 is formed at an acute angle of, for example, about 30 degrees when viewed from the side. A blade surface 51 is formed on the upper surface of the other pointed portion 50.
In general, the sharper the angle of inclination of the blade surface 22, the better the puncture property. On the other hand, the length of the inclined end surface becomes longer, the needle inclined surface protrudes beyond the blood vessel width, and the risk of blood leakage increases. . The two-stage structure as shown in FIGS. 16 and 17 makes it possible to produce a puncture needle with an acute angle of the blade surface to improve the puncture property and less risk of blood leakage.
また、上記実施の形態では、穿刺針１が血液浄化処理時に用いられるものであったが、例えば注射器により薬液を投与する時や採血を行う時に用いられる穿刺針にも、本発明は適用できる。 Moreover, in the said embodiment, although the puncture needle 1 was used at the time of blood purification processing, this invention is applicable also to the puncture needle used when administering a chemical | medical solution with a syringe or performing blood collection, for example.
また、穿刺針１が留置針の一部として用いられる場合にも本発明は適用できる。かかる場合、例えば図１８に示すように留置針５０は、外針部５１と、内針部５２を有している。外針部５１は、外針６０と、当該外針６０の後端側に取り付けられた接続部６１を有している。内針部５２は、内針としての穿刺針１と、穿刺針１の後端側に取り付けられたフィルタ等を備えた保持部７０等を有している。穿刺針１を外針６０に差し込んで外針６０の先端から尖端部２１を突出させた状態で、上記実施の形態と同様に尖端部２１を上にして穿刺針１を血管１０１に穿刺する。その後、外針６０を血管１０１内に挿入し、その後穿刺針１のみを血管１０１から抜いて、外針６０を残す。外針６０の接続部６１にチューブ等を接続し、外針６０から採血や返血を行って、血液浄化処理などを行う。なお、穿刺針１が留置針の場合も、穿刺針１が円柱状のものであってもよい。 The present invention can also be applied when the puncture needle 1 is used as part of an indwelling needle. In such a case, for example, as shown in FIG. 18, the indwelling needle 50 has an outer needle portion 51 and an inner needle portion 52. The outer needle portion 51 has an outer needle 60 and a connecting portion 61 attached to the rear end side of the outer needle 60. The inner needle portion 52 has a puncture needle 1 as an inner needle, a holding portion 70 provided with a filter or the like attached to the rear end side of the puncture needle 1 and the like. In a state where the puncture needle 1 is inserted into the outer needle 60 and the pointed end portion 21 protrudes from the tip of the outer needle 60, the puncture needle 1 is punctured into the blood vessel 101 with the pointed end portion 21 facing up as in the above embodiment. Thereafter, the outer needle 60 is inserted into the blood vessel 101, and then only the puncture needle 1 is removed from the blood vessel 101 to leave the outer needle 60. A tube or the like is connected to the connection portion 61 of the outer needle 60, blood is collected or returned from the outer needle 60, and blood purification processing is performed. In addition, when the puncture needle 1 is an indwelling needle, the puncture needle 1 may be cylindrical.
以下に、上記実施の形態で記載したダルニードル１の性能評価実験の結果を示す。評価実験１及び評価実験２は、穿刺針の穿刺性能を評価する実験である。 Below, the result of the performance evaluation experiment of the dull needle 1 described in the said embodiment is shown. Evaluation experiment 1 and evaluation experiment 2 are experiments for evaluating the puncture performance of the puncture needle.
（評価実験１）
評価実験１では、荷重測定器（MODEL-1605N：アイコーエンジニアリング社製）を用い、厚み１．０５ｍｍ、４０ｍｍΦのシリコンゴム（ＳＲ-50；タイガーポリマー社製）に対し各サンプルの穿刺針を、傾斜端面を下（尖端部を上）にした状態で、傾斜角３０度で刺通させ、そのときの必要荷重を測定した。実験条件として、室温２６℃にて刺通スピードは５０ｍｍ/ｍｉｎで行った。この評価実験１の結果を表１に示す。
(Evaluation Experiment 1)
In evaluation experiment 1, a load measuring instrument (MODEL-1605N: manufactured by Aiko Engineering Co., Ltd.) was used to tilt the puncture needle of each sample against silicon rubber (SR-50; manufactured by Tiger Polymer Co., Ltd.) having a thickness of 1.05 mm and 40 mmΦ. In a state where the end face is down (pointed portion is up), piercing was performed at an inclination angle of 30 degrees, and the required load at that time was measured. As experimental conditions, the piercing speed was 50 mm / min at a room temperature of 26 ° C. The results of this evaluation experiment 1 are shown in Table 1.
実施例１のサンプルは、上記実施の形態で記載した背面刃面３１が尖端部２１に形成されている穿刺針（図２〜図４に示したタイプ）であり、実施例２のサンプルは、上記実施の形態で記載した背面刃面３１が尖端部２１より後方側に形成されている穿刺針（図１０〜図１２に示したタイプ）である。実施例３のサンプルは尖端部２１が中心軸側に曲がっており、背面刃面３１が形成されている円柱状の穿刺針（（図１４〜図１５に示したタイプ）である。比較例は、傾斜端面の尖端部が曲がっていない従来の穿刺針である。なお、この従来の穿刺針の傾斜端面の針の中心軸に対する傾斜角は、１５度である。 The sample of Example 1 is a puncture needle (the type shown in FIGS. 2 to 4) in which the back blade surface 31 described in the above embodiment is formed at the pointed portion 21, and the sample of Example 2 is This is a puncture needle (the type shown in FIGS. 10 to 12) in which the back blade surface 31 described in the above embodiment is formed on the rear side of the pointed portion 21. The sample of Example 3 is a cylindrical puncture needle (the type shown in FIGS. 14 to 15) in which the tip 21 is bent toward the central axis and the back blade surface 31 is formed. This is a conventional puncture needle in which the tip of the inclined end face is not bent, and the inclination angle of the inclined end face of the conventional puncture needle with respect to the central axis of the needle is 15 degrees.
（評価実験２）
ナイロン不織布/ウレタンラミネイト（横74×縦115×厚さ30ｍｍ：スコッチ社製）のナイロン不織布面にセルロース製シート（約150μｍ）を貼り付け、モデル血管を作製した。セルロースシート面に対して、実施例１として本発明の穿刺針（先端バックカットの図２〜図４のタイプ）、実施例２として本発明の穿刺針（サイドバックカットの図１０〜図１２のタイプ）を約３０度の角度で、傾斜端面が下向きになる様に穿刺を行った。同様に、比較例として従来の１７G穿刺針（テルモ社製）を用いて、通常方法に従い、約３０度の角度で傾斜端面が上向きになる様に穿刺を行った。
更に、１７Ｇダルニードル（ニプロ社製）を穿刺跡の手前からセルロース表面をなぞるように推し進めて穿刺状況を評価した。
(Evaluation Experiment 2)
A cellulose sheet (about 150 μm) was attached to the nylon nonwoven fabric surface of nylon nonwoven fabric / urethane laminate (width 74 × length 115 × thickness 30 mm: manufactured by Scotch) to prepare a model blood vessel. As for Example 1, the puncture needle of the present invention (tip back-cut type of FIGS. 2 to 4) is used as Example 1, and the puncture needle of the present invention (Side-back cut of FIGS. 10 to 12) is used as Example 2. Puncture was performed at an angle of about 30 degrees with the inclined end face facing down. Similarly, using a conventional 17G puncture needle (manufactured by Terumo Corp.) as a comparative example, puncture was performed according to a normal method so that the inclined end face was upward at an angle of about 30 degrees.
Furthermore, a 17G dull needle (manufactured by Nipro Co., Ltd.) was pushed forward from the front of the puncture trace to trace the cellulose surface, and the puncture situation was evaluated.
本発明は、二回目以降の穿刺において、血管に針をより小さい力で容易に挿入する際に有用である。 The present invention is useful when a needle is easily inserted into a blood vessel with a smaller force in the second and subsequent punctures.
１ 穿刺針
２ 血液浄化処理用器具
１０ チューブ
１１ 接続部
１２ 保持部
１３ クランプ
１４ キャップ
２０ 傾斜端面
２１ 尖端部
２２ 刃面
３０ 背面
３１ 背面刃面
４０ 溝
１００ 皮膚
１０１ 血管
１０１ａ 穿刺口
１０１ｂ 最適当接部
１０２ 穿刺ルート
Ａ 針の中心軸
Ｂ 傾斜角度
Ｃ 尖端部の曲がり角度
DESCRIPTION OF SYMBOLS 1 Puncture needle 2 Blood purification processing instrument 10 Tube 11 Connection portion 12 Holding portion 13 Clamp 14 Cap 20 Inclined end surface 21 Pointed end portion 22 Blade surface 30 Rear surface 31 Rear blade surface 40 Groove 100 Skin 101 Blood vessel 101a Puncture port 101b Optimal contact portion 102 Puncture route A Center axis of the needle B Inclination angle C Bend angle of the tip
Claims (10)
針の先端に傾斜端面を有し、
前記傾斜端面を下向きにして穿刺することによって、その穿刺方向に対して奥側を起点に手前側に放射状に開裂する穿刺痕が血管表面に形成され、
前記傾斜端面の先端には、尖端部が形成され、当該尖端部が針の中心軸側に曲がっており、
前記傾斜端面の背面には、背面刃面が形成されている、穿刺針。 A tubular or cylindrical puncture needle for puncturing a blood vessel,
It has an inclined end surface at the tip of the needle,
By puncturing with the inclined end face downward, a puncture mark is formed on the blood vessel surface that is radially cleaved from the back side to the front side with respect to the puncturing direction ,
A tip portion is formed at the tip of the inclined end surface, and the tip portion is bent toward the central axis side of the needle,
A puncture needle having a back blade surface formed on the back surface of the inclined end surface .
針の先端に傾斜端面を有し、
前記傾斜端面を下向きにして穿刺することによって、その穿刺方向に対して奥側を起点に手前側に放射状に開裂する穿刺痕が血管表面に形成され、
前記傾斜端面の先端には、尖端部が形成され、当該尖端部が針の中心軸側に曲がっており、
前記傾斜端面の前記尖端部より後方側には、先端側に向いた他の尖端部が形成されている、穿刺針。 A tubular or cylindrical puncture needle for puncturing a blood vessel,
It has an inclined end surface at the tip of the needle,
By puncturing with the inclined end face downward, a puncture mark is formed on the blood vessel surface that is radially cleaved from the back side to the front side with respect to the puncturing direction ,
A tip portion is formed at the tip of the inclined end surface, and the tip portion is bent toward the central axis side of the needle,
A puncture needle in which another pointed portion directed toward the tip side is formed on the rear side of the pointed portion of the inclined end surface .
血管表面に接する側の先端が傾斜端面を有し、該傾斜端面の先端には尖端部が形成され、該尖端部が器具の中心軸側に曲がっており、且つ、前記尖端部から、少なくとも前記傾斜端面の横径が最大となる位置まで該傾斜端面の周縁に沿って刃面が形成されており、前記傾斜端面の背面には、背面刃面が形成されている、血管表面切痕形成器具。 Inserted into the puncture route from the skin surface to the blood vessel surface, formed so that the major axis is oblique to the skin surface and the blood vessel surface, the back side of the major axis of the puncture route on the blood vessel surface A tubular or columnar device for forming a notch that radially radiates to the near side starting from
The tip on the side in contact with the blood vessel surface has an inclined end surface, a tip is formed at the tip of the inclined end surface, the tip is bent toward the central axis of the instrument, and at least from the tip A blood vessel surface notch forming instrument , wherein a blade surface is formed along a peripheral edge of the inclined end surface up to a position where the lateral diameter of the inclined end surface is maximized, and a rear blade surface is formed on the back surface of the inclined end surface. .
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| JP2010126885A JP5653655B2 (en) | 2010-06-02 | 2010-06-02 | Puncture needle and blood vessel surface notch forming device |
| US13/115,275 US20110295152A1 (en) | 2010-05-25 | 2011-05-25 | Puncture method, incision needle, puncture needle, needle cap and instrument for blood purification treatment |
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| KR101321051B1 (en) | 2012-05-03 | 2013-10-23 | 한국기계연구원 | Biopsy needle having multiple micro cutting edge and inner cannular manufacturing method of the same |
| EP2862585B1 (en) * | 2012-06-14 | 2018-02-28 | Asahi Kasei Medical Co., Ltd. | Puncture needle |
| JP6215018B2 (en) * | 2013-11-26 | 2017-10-18 | 株式会社日立ハイテクノロジーズ | Automatic analyzer |
| KR20170113547A (en) * | 2015-01-16 | 2017-10-12 | 아사히 가세이 메디컬 가부시키가이샤 | Needle and method for manufacturing same |
| CN107847670B (en) * | 2015-07-30 | 2020-09-04 | 泰尔茂株式会社 | Medical puncture needle and method for manufacturing puncture needle |
| JP2018143630A (en) * | 2017-03-08 | 2018-09-20 | テルモ株式会社 | Puncture needle |
| KR20200038268A (en) * | 2017-08-04 | 2020-04-10 | 백톤 디킨슨 앤드 컴퍼니 | Method and apparatus for introducing a needle for catheter placement |
| CN109223000A (en) * | 2018-11-14 | 2019-01-18 | 威海永欣医疗科技有限公司 | The antipollution visual elbow blood taking needle of one kind and production method |
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| JPS5822751Y2 (en) * | 1979-03-14 | 1983-05-16 | 川澄化学工業株式会社 | indwelling needle |
| DE3013384A1 (en) * | 1980-04-05 | 1981-10-15 | Günter van Dr.med. 4000 Düsseldorf Endert | CANNULA |
| JPS6272649U (en) * | 1985-10-24 | 1987-05-09 | ||
| JPH02121038U (en) * | 1989-03-17 | 1990-10-01 | ||
| NO173261C (en) * | 1990-09-07 | 1993-11-24 | Bent Heimreid | Intravenously! Skanyle |
| JPH1094601A (en) * | 1996-09-24 | 1998-04-14 | Nippon Sherwood Kk | Intravenous cannula |
| JP2004041492A (en) * | 2002-07-12 | 2004-02-12 | Scitec Kk | Medical needle |
| JP2004358016A (en) * | 2003-06-06 | 2004-12-24 | Nipro Corp | Puncture needle easily inserted along puncture route |
| FR2881353B1 (en) * | 2005-02-03 | 2008-12-05 | Vygon Sa | IMPROVEMENT TO PUNCTURAL BITS AND CATHETER TUBES |
| JP2009045124A (en) * | 2007-08-15 | 2009-03-05 | Nextier:Kk | Blood vessel fixing kit |
| WO2009157289A1 (en) * | 2008-06-27 | 2009-12-30 | テルモ株式会社 | Indwelling needle and method of manufacturing the same |
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