JP2015093035A - Puncture needle - Google Patents

Puncture needle Download PDF

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JP2015093035A
JP2015093035A JP2013233778A JP2013233778A JP2015093035A JP 2015093035 A JP2015093035 A JP 2015093035A JP 2013233778 A JP2013233778 A JP 2013233778A JP 2013233778 A JP2013233778 A JP 2013233778A JP 2015093035 A JP2015093035 A JP 2015093035A
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needle
inner needle
outer tube
tip
puncture needle
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一将 大原
Kazumasa Ohara
一将 大原
雄起 向井
Yuki Mukai
雄起 向井
一博 小澤
Kazuhiro Ozawa
一博 小澤
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Kaneka Corp
Maeda Sangyo Co Ltd
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Kaneka Corp
Maeda Sangyo Co Ltd
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Abstract

PROBLEM TO BE SOLVED: To provide a puncture needle improved in operability by an operator and safety of a patient.SOLUTION: A puncture needle includes: an outer cylindrical pipe having a curve-shaped tip part; and an inner needle inserted into the outer cylindrical pipe. The puncture needle includes a restriction part restricting relative movement between the outer cylindrical pipe and the inner needle by engagement between one end side of the outer cylindrical pipe and one end side of the inner needle with each other, and the restriction part includes: a linear engagement part formed in the one end side of the outer cylindrical pipe or the inner needle; and a point-like engagement part formed in the one end side of the inner needle or the outer cylindrical pipe, and guided along the linear engagement part. The linear engagement part includes a crossing guide part extending in a direction crossing a long direction of the outer cylindrical pipe or the inner needle.

Description

本発明は、穿刺針に関し、特に、生体管腔にカテーテル等の器具を誘導するために用いられる医療用の穿刺針に関する。   The present invention relates to a puncture needle, and more particularly to a medical puncture needle used for guiding an instrument such as a catheter into a living body lumen.

従来、医療分野において用いられる穿刺針（以下、「医療用穿刺針」と称する場合がある。）には、体内への薬剤等の投与に用いられるもの、血液、体液、組織等の採取に用いられるもの、カテーテル等の器具挿入に用いられるものなど、種々の手技に応じた穿刺針があり、例えば、硬膜外針、腰椎穿刺針などがある。硬膜外針は、硬膜外麻酔、硬膜外鎮痛法、すなわち、脊柱管の中にある硬膜の外側の硬膜外腔まで針管（硬膜外針）を穿刺して、麻酔薬や鎮痛剤を該硬膜外腔に注入する手技において使用されている（例えば、特許文献１、２、３参照）。   Conventionally, puncture needles used in the medical field (hereinafter sometimes referred to as “medical puncture needles”) are used for collecting drugs, etc. into the body, and used for collecting blood, body fluids, tissues, and the like. There are puncture needles according to various procedures such as those used for insertion of instruments such as catheters, and examples include epidural needles and lumbar puncture needles. Epidural needles are used for epidural anesthesia and epidural analgesia, that is, the needle tube (epidural needle) is punctured to the epidural space outside the dura mater in the spinal canal. It is used in procedures for injecting analgesics into the epidural space (see, for example, Patent Documents 1, 2, and 3).

特許文献１では、カテーテルは、カテーテルが硬膜外針を貫通して、硬膜外針に拘束されない段階で、カテーテルの先端が所定の方向に曲がり、あるいは向き易くするための断面形状を有する。この文献では、カテーテルの先端が所定方向に曲がるようにするための特徴を、硬膜外針にではなく、カテーテル自体に設けた技術を開示している。   In Patent Document 1, the catheter has a cross-sectional shape for allowing the distal end of the catheter to bend in a predetermined direction or to be easily oriented when the catheter passes through the epidural needle and is not restrained by the epidural needle. This document discloses a technique in which a feature for allowing the distal end of the catheter to bend in a predetermined direction is provided not on the epidural needle but on the catheter itself.

特許文献２、３に記載の発明では、カテーテルの先端が所定方向に曲がるようにするための特徴を、カテーテル自体にではなく、硬膜外針に設けた技術を開示している。この技術では、硬膜外針は、硬膜外腔にまで到達する穿刺針と、この針管を覆い、穿刺針とともに硬膜外腔に到達した後、留置されることでカテーテル等の導入路になる外筒管とを含んでいる。この硬膜外針において、穿刺針は、外針および内針からなる。外針は先端部が湾曲形状であり、先端刃面を有する。内針は先端刃面を有し、外針の内腔に着脱自在に摺動する。外筒管は可撓性樹脂製であり、外筒管全長の概ね半分程度の範囲で先端側が湾曲形状に癖付けされており、穿刺針が外筒管の内腔に着脱自在に摺動する。この穿刺針は、穿刺時には外筒管に挿着されて一体化した状態で用いられ、カテーテル等の器具挿入時には外筒管から抜去される。   The inventions described in Patent Documents 2 and 3 disclose a technique in which a feature for allowing the distal end of the catheter to bend in a predetermined direction is provided not on the catheter itself but on the epidural needle. In this technique, the epidural needle is covered with a puncture needle that reaches the epidural space, and after reaching the epidural space together with the puncture needle, the epidural needle is placed in an introduction path such as a catheter. And an outer tube. In this epidural needle, the puncture needle includes an outer needle and an inner needle. The outer needle has a curved tip end and a tip edge surface. The inner needle has a tip blade surface, and slides detachably in the lumen of the outer needle. The outer tube is made of a flexible resin, and the distal end side is brazed into a curved shape in the range of about half of the entire length of the outer tube, and the puncture needle slides detachably in the lumen of the outer tube. . This puncture needle is used in a state of being inserted into and integrated with the outer tube at the time of puncture, and is removed from the outer tube at the time of insertion of a device such as a catheter.

ところで、前記の手技では穿刺針の針先が所望の位置に到達したことを確認するため、穿刺針等を外筒管から抜去して体液が外筒管から漏出するか否かを指標の一つとしている。そして、体液の漏出が確認できない場合は、穿刺針を外筒管に再挿入し、さらに深く穿刺する場合がある。この場合、穿刺針を外筒管に再挿入する際に外筒管の先端部が湾曲している場合は、穿刺針の刃先が外筒管に突き当たり、穿刺針の外筒管への再挿入が困難になる場合があるという問題があった。また、再挿入の操作に手間取ることで、手術のリスクが増大し、患者にとっての安全性が低下するという問題もあった。   By the way, in the above procedure, in order to confirm that the tip of the puncture needle has reached a desired position, whether or not body fluid leaks from the outer cylinder tube by removing the puncture needle or the like from the outer cylinder tube is an index. I am trying. If leakage of body fluid cannot be confirmed, the puncture needle may be reinserted into the outer tube and punctured further deeply. In this case, when the tip of the outer tube is curved when the puncture needle is reinserted into the outer tube, the tip of the puncture needle hits the outer tube and the puncture needle is reinserted into the outer tube. There was a problem that may become difficult. In addition, taking time for the re-insertion operation increases the risk of surgery, and there is a problem that the safety for the patient decreases.

このような問題に対して特許文献２、３に記載の発明では、穿刺針の先端を湾曲させヒューバーポイントにすることで、外筒管の湾曲にヒューバーポイントの湾曲が接触して、刃先は接触しないとされている。しかしながら、生体管腔内の外筒管の状態は必ずしも一定ではなく、外筒管の湾曲状態も一定ではないことがある。また、外筒管に穿刺針を挿入する際に誤って勢いよく挿入した場合には、穿刺針と外筒管の湾曲形状だけでは穿刺針の刃先が外筒管に突き当たることを防止することが困難な場合がある。   With respect to such problems, in the inventions described in Patent Documents 2 and 3, by curving the tip of the puncture needle to be a Huber point, the curve of the Huber point is in contact with the curve of the outer tube, and the cutting edge is in contact It is said not to. However, the state of the outer tube in the living body lumen is not necessarily constant, and the curved state of the outer tube may not be constant. In addition, when the puncture needle is accidentally and vigorously inserted into the outer tube, the cutting edge of the puncture needle can be prevented from hitting the outer tube only with the curved shape of the puncture needle and the outer tube. It can be difficult.

また、特許文献２に記載の発明では、外針の基端部に接着される外針基には嵌合凸部が設けられ、外筒管の基端部に設けられた外筒基には嵌合凹部が設けられ、穿刺針と外筒管とを一体化する時に嵌合凸部と嵌合凹部とが嵌合して嵌合位置固定部となる。また、嵌合凹部は外筒管の湾曲方向（先端開口部）に合致するとともに、嵌合凸部は刃面方向に合致している。したがって、外筒管と穿刺針とを一体化する場合、外筒管の嵌合凹部と穿刺針の嵌合凸部とを一致させるように外筒管に穿刺針を略直進挿入することになる。特許文献３に記載の発明でも、概ね同様に、外筒管に穿刺針を略直進挿入する挿入操作を行うことになる。   Further, in the invention described in Patent Document 2, the outer needle base that is bonded to the proximal end portion of the outer needle is provided with a fitting convex portion, and the outer cylindrical base provided at the proximal end portion of the outer tubular tube A fitting concave portion is provided, and when the puncture needle and the outer tube are integrated, the fitting convex portion and the fitting concave portion are fitted to form a fitting position fixing portion. Further, the fitting concave portion matches the bending direction (tip opening portion) of the outer tube, and the fitting convex portion matches the blade surface direction. Therefore, when the outer tube and the puncture needle are integrated, the puncture needle is inserted substantially straight into the outer tube so that the fitting recess of the outer tube and the fitting protrusion of the puncture needle coincide with each other. . In the invention described in Patent Document 3, the insertion operation for inserting the puncture needle into the outer tube substantially linearly is performed in a similar manner.

このように、外筒管の湾曲方向がヒューバーポイントの湾曲方向と異なるような場合でも、術者は前記の嵌合凹部と嵌合凸部を目印に挿入操作を行うため、穿刺針の刃先が外筒管に突き当たる可能性がある。また、術者がある程度操作を行うことができたとしても、外筒管の湾曲とヒューバーポイントの湾曲を一致させることは困難であり、術者の操作は容易ではなく、穿刺針の刃先をヒューバーポイントにしただけでは、上記問題を解消するには至っていないのが現状である。   Thus, even when the bending direction of the outer tube is different from the bending direction of the Huber point, the operator performs the insertion operation using the fitting concave portion and the fitting convex portion as a mark. There is a possibility of hitting the outer tube. In addition, even if the operator can perform some operations, it is difficult to match the curve of the outer tube and the curve of the Huber point, and the operator's operation is not easy. The current situation is that the above-mentioned problems have not been solved by just making points.

特許第５０２００９４号公報Japanese Patent No. 5020094 特開２００５−２１１２６８号公報JP 2005-2111268 A 特開２０１１−１０４１４６号公報JP 2011-104146 A

そこで、本発明は、上記問題に鑑みてなされた。すなわち、本発明は、術者にとっての操作容易性、および患者にとっての安全性を向上させた穿刺針を提供することを目的とする。   Therefore, the present invention has been made in view of the above problems. That is, an object of the present invention is to provide a puncture needle that is easy to operate for an operator and safe for a patient.

本発明は、湾曲形状の先端部を有する外筒管と、該外筒管の内部に挿入される内針とを含む穿刺針であって、
前記外筒管の一端側と前記内針の一端側とが互いに係合することによって、前記外筒管と前記内針との相対的な移動を規制する規制部を備え、
前記規制部は、
外筒管又は内針の前記一端側に設けられた線状係合部と、
内針又は外筒管の前記一端側に設けられ、前記線状係合部に沿って案内される点状係合部と、を含み、
前記線状係合部は、前記外筒管又は前記内針の長手方向に対して交差する方向に伸びる交差状案内部を含む、
穿刺針に関する。
この構成によれば、外筒管の内腔に沿って内針を挿入する際に、外筒管と内針との相対的な移動、例えば、外筒管の先端部側への内針の移動が勢いよくならないように規制されるため、煩雑な操作を要することなく、内針の針先が外筒管の湾曲形状の先端部の内腔部の内壁面に突き当たることによりその壁面が損傷することを防止できる。また、外筒管から内針を抜去する場合も同様に規制されるため、内針の先端部で外筒管の先端部を損傷することを防止し得る。 The present invention is a puncture needle including an outer tube having a curved tip and an inner needle inserted into the outer tube,
A restriction portion for restricting relative movement between the outer tube and the inner needle by engaging one end of the outer tube and one end of the inner needle;
The regulation part is
A linear engagement portion provided on the one end side of the outer tube or the inner needle;
A point-like engagement portion provided on the one end side of the inner needle or the outer tube and guided along the linear engagement portion,
The linear engagement portion includes a cross-shaped guide portion extending in a direction crossing the longitudinal direction of the outer tube or the inner needle.
It relates to a puncture needle.
According to this configuration, when the inner needle is inserted along the lumen of the outer tube, the relative movement between the outer tube and the inner needle, for example, the inner needle toward the distal end side of the outer tube Since the movement is restricted so that it does not become vigorous, the wall surface is damaged by the needle tip of the inner needle striking the inner wall surface of the curved distal end of the outer tube without requiring a complicated operation. Can be prevented. Further, when the inner needle is removed from the outer tube, it is similarly regulated, so that it is possible to prevent the tip of the inner needle from damaging the tip of the outer tube.

本発明では、前記内針は、長手方向中心軸上からずれた位置に針先が設けられており、前記線状係合部に沿って案内される点状係合部の動きに対応して前記内針の針先を移動させるのが好ましい。
この構成によれば、前記交差状案内部を点状係合部が移動する際に、針先の位置を規制部により制御することも可能になる。そのため、内針の先端部で外筒管の先端部を損傷することを効果的に防止し得る。 In the present invention, the inner needle is provided with a needle tip at a position deviated from the longitudinal central axis, and corresponds to the movement of the point-like engaging portion guided along the linear engaging portion. It is preferable to move the needle tip of the inner needle.
According to this configuration, the position of the needle tip can be controlled by the restricting portion when the point-like engaging portion moves on the intersecting guide portion. Therefore, it is possible to effectively prevent the distal end portion of the outer tube from being damaged by the distal end portion of the inner needle.

また、交差状案内部は、長手方向に対して巻回する螺旋形状を含んでいてもよい。
これにより、線状係合部が点状係合部を螺旋状に移動案内するため、例えば、外筒管の内部に内針を挿入する際に、外筒管と内針との相対的な移動がより規制され、外筒管の湾曲形状の先端部の内腔部の壁面が損傷することをより効果的に防止できる。 Further, the intersecting guide part may include a spiral shape wound around the longitudinal direction.
Thereby, since the linear engagement portion moves and guides the point engagement portion in a spiral manner, for example, when the inner needle is inserted into the outer tube, the relative relationship between the outer tube and the inner needle is increased. The movement is further restricted, and it is possible to more effectively prevent damage to the wall surface of the inner cavity of the curved distal end of the outer tube.

さらに、螺旋形状は、ピッチ間隔が２．０〜６．０ｍｍとなるように形成されていてもよい。
これにより、外筒管の内部に内針を挿入する際に、外筒管と内針との相対的な移動がより一層規制され、前述した外筒管の先端部の損傷をより効果的に防止できる。 Furthermore, the spiral shape may be formed such that the pitch interval is 2.0 to 6.0 mm.
As a result, when the inner needle is inserted into the outer cylindrical tube, the relative movement between the outer cylindrical tube and the inner needle is further restricted, and the above-described damage to the tip of the outer cylindrical tube is more effectively performed. Can be prevented.

また、線状係合部は、前記外筒管又は前記内針の長手方向に対する角度が変化する屈曲点を有し、該屈曲点に対し、前記外筒管の内部に内針を挿入する時に相対的に進行する側に位置する部分の前記角度が、進行する側とは反対側に位置する部分の前記角度より大きい屈曲部を有してもよい。
これにより、外筒管の内部に内針を挿入する際に、屈曲部を点状係合部が移動することで、外筒管の先端側への内針の移動が勢いよくなることをより効果的に規制し、前述した外筒管の先端部の損傷をより効果的に防止できる。 The linear engagement portion has a bending point where an angle with respect to the longitudinal direction of the outer tube or the inner needle changes, and when the inner needle is inserted into the outer tube with respect to the bending point. The angle of the portion located on the relatively advancing side may have a bent portion that is larger than the angle of the portion located on the side opposite to the advancing side.
As a result, when the inner needle is inserted into the outer cylindrical tube, the movement of the inner needle toward the distal end side of the outer cylindrical tube becomes more effective by the movement of the point-like engaging portion through the bent portion. Therefore, it is possible to more effectively prevent the above-described damage to the tip of the outer tube.

さらに、線状係合部は、抵抗要素を有していてもよい。
これにより、外筒管と内針との相対的な移動をより規制することができる。 Furthermore, the linear engaging part may have a resistance element.
Thereby, the relative movement of an outer cylinder pipe and an inner needle can be controlled more.

前記点状係合部の好ましい態様は、凸部であり、線状係合部の好ましい態様は外筒管又は前記内針の長手方向の所定範囲に連続して伸び、前記凸部を受け入れる凹部である。   A preferred embodiment of the point-like engaging portion is a convex portion, and a preferred embodiment of the linear engaging portion is a concave portion that continuously extends in a predetermined range in the longitudinal direction of the outer tube or the inner needle and receives the convex portion. It is.

また、凹部は前記外筒管の内部に内針を挿入する時に前記凸部を最初に受け入れる入口を有し、その幅が、凹部の他の部分の幅に比べて広くてもよい。
これにより、外筒管の内部に内針を挿入する際に、凹部が凸部を容易に受け入れることができるため、外筒管の内部に内針を容易に挿入することができる。 The concave portion may have an inlet that first receives the convex portion when the inner needle is inserted into the outer tube, and the width thereof may be wider than the width of the other portion of the concave portion.
Thereby, when inserting an inner needle into the inside of an outer cylinder pipe, since a crevice can receive a convex part easily, an inner needle can be easily inserted in the inside of an outer cylinder pipe.

凹部は、前記入口から前記凸部が凹部に対して相対的に進行する方向に向かうに従いその幅が狭くなる部分を含んでいてもよい。   The concave portion may include a portion whose width decreases from the inlet toward the direction in which the convex portion advances relative to the concave portion.

また、凹部には、前記凸部に係り合って、当該凸部を留める係留部が形成されてもよい。係留部の好ましい態様は、突起である。
係留部により、外筒管の内部に内針を挿入する際に、術者が挿入操作の終了位置を容易に知覚することができる。また、術者が必要以上に挿入操作を行うことを防止できるため、凹部および凸部の破損を防止できる。 Moreover, the anchoring part which engages with the said convex part and fastens the said convex part may be formed in a recessed part. A preferred embodiment of the mooring portion is a protrusion.
The anchoring portion allows the operator to easily perceive the end position of the insertion operation when inserting the inner needle into the outer tube. Further, since it is possible to prevent the surgeon from performing an insertion operation more than necessary, it is possible to prevent breakage of the concave and convex portions.

外筒管は、内針が挿着されると直線形状となり、当該内針が抜去されると元の湾曲形状となるのが好ましい。   The outer tube preferably has a linear shape when the inner needle is inserted, and has an original curved shape when the inner needle is removed.

本発明に係る穿刺針によれば、外筒管と内針との相対的な移動が勢いよくならないように規制されることで、内針の先端部で外筒管の先端部を損傷することを防止できるため、術者にとっての操作容易性、および患者にとっての安全性を向上させることができる。   According to the puncture needle of the present invention, the distal end portion of the outer cylinder tube is damaged at the distal end portion of the inner needle by restricting the relative movement between the outer tube and the inner needle so as not to become vigorous. Therefore, the ease of operation for the surgeon and the safety for the patient can be improved.

本発明に係る穿刺針の実施形態の一例を示す斜視図である。It is a perspective view which shows an example of embodiment of the puncture needle concerning this invention. 図１に示す実施形態の外筒管と内針を示す斜視図である。It is a perspective view which shows the outer cylinder pipe and inner needle of embodiment shown in FIG. （ａ）図２に示す内針の平面図である。（ｂ）図２に示す内針の正面図である。（ｃ）図２に示す内針の底面図である。（ｄ）図２に示す内針の左側面図である。（ｅ）図２に示す内針の右側面図である。(A) It is a top view of the inner needle shown in FIG. (B) It is a front view of the inner needle shown in FIG. (C) It is a bottom view of the inner needle shown in FIG. (D) It is a left view of the inner needle shown in FIG. (E) It is a right view of the inner needle shown in FIG. （ａ）図２に示す内針の背面図である。（ｂ）図３（ｂ）のＩ−Ｉ断面図である。(A) It is a rear view of the inner needle shown in FIG. (B) It is II sectional drawing of FIG.3 (b). （ａ）図２に示す外筒管の平面図である。（ｂ）図２に示す外筒管の正面図である。（ｃ）図２に示す外筒管の底面図である。（ｄ）図２に示す外筒管の左側面図である。（ｅ）図２に示す外筒管の右側面図である。(A) It is a top view of the outer cylinder pipe | tube shown in FIG. (B) It is a front view of the outer cylinder pipe shown in FIG. (C) It is a bottom view of the outer cylinder pipe shown in FIG. (D) It is a left view of the outer cylinder pipe shown in FIG. (E) It is a right view of the outer cylinder pipe | tube shown in FIG. （ａ）図２に示す外筒管の背面図である。（ｂ）図５（ｂ）のII−II断面図である。(A) It is a rear view of the outer cylinder pipe | tube shown in FIG. (B) It is II-II sectional drawing of FIG.5 (b). 図５（ｂ）の基端側の部分拡大図である。It is the elements on larger scale of the base end side of FIG.5 (b). 図１に示す実施形態の内針を図１に示す実施形態の外筒管に挿入し始めた状態を示す断面図である。It is sectional drawing which shows the state which began to insert the inner needle of embodiment shown in FIG. 1 in the outer cylinder pipe | tube of embodiment shown in FIG. （ａ）図８に示す状態の後、内針の内針基部の凸部が外筒管の外筒基部の凹部に受け入れられた当初の状態を示す断面図である。（ｂ）図９（ａ）に示す状態の後、内針を外筒管の先端側に進行させた時の状態を示す断面図である。（ｃ）図９（ｂ）に示す状態の後、内針を外筒管の先端側に進行させ、凸部が凹部の終端に到達した状態を示す断面図である。(A) It is sectional drawing which shows the initial state after which the convex part of the inner needle base part of the inner needle was received by the recessed part of the outer cylinder base part of an outer cylinder pipe after the state shown in FIG. (B) It is sectional drawing which shows a state when an inner needle is advanced to the front end side of an outer cylinder pipe after the state shown to Fig.9 (a). (C) It is sectional drawing which shows the state which made the inner needle advance to the front end side of an outer cylinder pipe after the state shown in FIG.9 (b), and the convex part reached | attained the terminal end of the recessed part.

以下、本発明に係る穿刺針の実施形態について、図面を参照しながら詳細に説明する。   Hereinafter, embodiments of a puncture needle according to the present invention will be described in detail with reference to the drawings.

本発明に係る穿刺針は、湾曲形状の先端部を有する外筒管と、該外筒管の内部に挿入される内針とを含む穿刺針であって、
前記外筒管の一端側と前記内針の一端側とが互いに係合することによって、前記外筒管と前記内針との相対的な移動を規制する規制部を備え、
前記規制部は、
外筒管又は内針の前記一端側に設けられた線状係合部と、
内針又は外筒管の前記一端側に設けられ、前記線状係合部に沿って案内される点状係合部と、を含み、
前記線状係合部は、前記外筒管又は前記内針の長手方向に対して交差する方向に伸びる交差状案内部を含むものである。
このように、規制部は外筒管及び内針の一端側に設けられる。また、線状係合部は外筒管又は内針に設けられており、この線状係合部が外筒管に設けられた場合には、点状係合部は内針に設けられ、線状係合部が内針に設けられた場合には、点状係合部は外筒管に設けられる。以下では、規制部が後述する基端側に設けられ、線状係合部が外筒管に設けられ、点状係合部が内針に設けられた場合を例にして本発明の実施形態を説明するが、他の態様でも、同様の作用効果を奏することは勿論のことである。 The puncture needle according to the present invention is a puncture needle including an outer tube having a curved tip portion, and an inner needle inserted into the outer tube,
A restriction portion for restricting relative movement between the outer tube and the inner needle by engaging one end of the outer tube and one end of the inner needle;
The regulation part is
A linear engagement portion provided on the one end side of the outer tube or the inner needle;
A point-like engagement portion provided on the one end side of the inner needle or the outer tube and guided along the linear engagement portion,
The linear engagement portion includes a cross-shaped guide portion extending in a direction crossing the longitudinal direction of the outer tube or the inner needle.
As described above, the restricting portion is provided on one end side of the outer tube and the inner needle. Further, the linear engagement portion is provided on the outer tube or the inner needle, and when this linear engagement portion is provided on the outer tube, the point engagement portion is provided on the inner needle, When the linear engaging portion is provided on the inner needle, the dotted engaging portion is provided on the outer tube. In the following, the embodiment of the present invention will be described by taking as an example the case where the restricting portion is provided on the proximal end side, which will be described later, the linear engaging portion is provided on the outer tube, and the dotted engaging portion is provided on the inner needle. However, it is needless to say that the same effects can be obtained in other embodiments.

図１は、本発明に係る穿刺針の実施形態の一例の全体構成を示す斜視図である。図１に示すように、本実施形態の穿刺針１は、内針１０と外筒管４０とを備える。また、図２、８、９に示すように内針１０は外筒管４０の内腔部４２に挿入される。そして、内針１０が外筒管４０に挿着され、一体化されることで穿刺針１を構成する。また、内針１０と外筒管４０は着脱自在になっており、前述したように内針１０の外筒管４０に対する挿抜操作が可能になっている。本実施形態に示す穿刺針１をはじめとする本発明に係る穿刺針は、種々の医療用穿刺針として適用可能である。体内への薬剤等の投与に用いられるもの、血液、体液、組織等の採取に用いられるもの、カテーテル等の器具挿入に用いられるものなどに適用可能であり、例えば、腰椎穿刺針、硬膜外針等が挙げられるが、これに限定されるものではない。   FIG. 1 is a perspective view showing an overall configuration of an example of an embodiment of a puncture needle according to the present invention. As shown in FIG. 1, the puncture needle 1 of this embodiment includes an inner needle 10 and an outer tube 40. 2, 8, and 9, the inner needle 10 is inserted into the lumen 42 of the outer tube 40. And the puncture needle 1 is comprised by the inner needle 10 being inserted in the outer cylinder tube 40, and being integrated. Moreover, the inner needle 10 and the outer cylinder tube 40 are detachable, and the insertion / extraction operation of the inner needle 10 with respect to the outer cylinder tube 40 is possible as mentioned above. The puncture needle according to the present invention including the puncture needle 1 shown in the present embodiment can be applied as various medical puncture needles. Applicable to drugs used for the administration of drugs into the body, blood, bodily fluids, tissues, etc., and those used for insertion of catheters, etc., for example, lumbar puncture needles, epidural Although a needle etc. are mentioned, it is not limited to this.

図３（ａ）〜（ｅ）及び図４（ａ）は、穿刺針１を構成する内針１０の六面図であり、図４（ｂ）は、図３（ｂ）の正面図のＩ−Ｉ断面図を示したものである。   3 (a) to 3 (e) and FIG. 4 (a) are six views of the inner needle 10 constituting the puncture needle 1, and FIG. 4 (b) is a front view of FIG. 3 (b). -I shows a cross-sectional view.

内針１０は、針部３０と内針基部２０とを備える。内針１０は、その一端側には針部３０の針先３１を有し、もう一端側には内針基部２０を有する。本発明では、針先３１側を先端側、内針基部２０側を基端側と称することとする。   The inner needle 10 includes a needle portion 30 and an inner needle base portion 20. The inner needle 10 has a needle tip 31 of a needle portion 30 on one end side, and an inner needle base portion 20 on the other end side. In the present invention, the needle tip 31 side is referred to as the distal end side, and the inner needle base portion 20 side is referred to as the proximal end side.

図３、４に示すように、内針１０は、長手方向の中心軸１１が、針部３０の中心軸及び内針基部２０の中心軸に一致している。また、針部３０は、針先３１から内針基部２０側に亘り中心軸１１に沿って真直ぐな直線形状を有する。このように直線形状を有する場合、湾曲形状の先端部を有する場合に比べて、外筒管の内腔を損傷する可能性を低減することが容易になり、術者の操作性をより向上させることができ、ひいては、患者の安全性を向上させることができる。特許文献２や３に記載の内針のように先端部が湾曲形状を有する場合、刃面の周縁部の一部が、内針の直線状の部分から飛び出し、内針を外筒管に対して摺動移動させる操作、即ち、内針を外筒から抜去する操作及び内針を外筒に挿入する操作（以下、「挿抜操作」と称する。）の時に、その飛び出した周縁部が外筒管の直線形状になっている部分をも損傷する可能性が高くなる。この挿抜操作時に外筒管の内腔を傷つけないようにすることは容易ではなく、術者は煩雑な操作を余儀なくされることが多い。また、外筒管の内腔が傷ついてしまった場合、手術のリスクが増大し、患者の安全性が低下することになる。   As shown in FIGS. 3 and 4, the inner needle 10 has a longitudinal central axis 11 that coincides with the central axis of the needle portion 30 and the central axis of the inner needle base portion 20. The needle portion 30 has a straight linear shape along the central axis 11 from the needle tip 31 to the inner needle base portion 20 side. In this way, when it has a straight shape, it becomes easier to reduce the possibility of damaging the lumen of the outer tube than when it has a curved tip, and the operability of the operator is further improved. And by extension, the safety of the patient can be improved. When the tip has a curved shape like the inner needles described in Patent Documents 2 and 3, a part of the peripheral edge of the blade surface protrudes from the linear part of the inner needle, and the inner needle is moved away from the outer tube. And the sliding movement of the inner needle, that is, the operation of removing the inner needle from the outer cylinder and the operation of inserting the inner needle into the outer cylinder (hereinafter referred to as “insertion / removal operation”). The possibility of damaging the straight portion of the tube is also increased. It is not easy to avoid damaging the lumen of the outer tube during this insertion / extraction operation, and the operator is often forced to perform complicated operations. In addition, if the lumen of the outer tube is damaged, the risk of surgery increases and patient safety decreases.

また、針部３０の先端部の形状は特に限定はないが、針先３１が、図３（ａ）、（ｃ）、図４（ｂ）に示すように、中心軸上からずれた位置に設けられたものが好ましい。これにより、後述する規制部Ａの構成と相俟って、針先３１が外筒管４０の湾曲形状の先端部の内壁に突き当たることをより容易に防止することができる（図９参照）。このような内針の先端部の構成として、本実施形態では、図３（ｃ）に示すように中心軸１１に対する角度αが鋭角になるように刃面３２を形成し、刃の先端である針先３１が、中心軸１１上からずれた位置になるようにしている。   Further, the shape of the tip portion of the needle portion 30 is not particularly limited, but the needle tip 31 is at a position shifted from the central axis as shown in FIGS. 3 (a), 3 (c), and 4 (b). Those provided are preferred. This makes it possible to more easily prevent the needle tip 31 from striking against the inner wall of the curved distal end portion of the outer tube 40 in combination with the configuration of the restricting portion A described later (see FIG. 9). As a configuration of the tip portion of the inner needle, in this embodiment, the blade surface 32 is formed so that the angle α with respect to the central axis 11 is an acute angle as shown in FIG. The needle tip 31 is shifted from the center axis 11.

針部３０を構成する材料としては、適度な強度を有する材質であれば特に限定はなく、金属材料、高分子材料などが挙げられる。金属材料としては、例えば、ステンレス鋼、アルミニウム合金、銅系合金等が挙げられるが、これらに限定されるものではない。また、高分子材料としては、例えば、ナイロン等のポリアミド、ポリイミド等の樹脂材料が挙げられるが、これらに限定されるものではない。   The material constituting the needle portion 30 is not particularly limited as long as the material has an appropriate strength, and examples thereof include a metal material and a polymer material. Examples of the metal material include, but are not limited to, stainless steel, aluminum alloy, copper alloy, and the like. Examples of the polymer material include polyamide such as nylon and resin material such as polyimide, but are not limited thereto.

針部３０の大きさは、用途等に応じて適宜設定することができる。また、本実施形態では、針部３０は中実の円柱状であるが、これに限らず、例えば筒状の外針と中実の内針とで構成する等のような他の構造を有するものを採用しても良い。   The magnitude | size of the needle part 30 can be suitably set according to a use etc. In the present embodiment, the needle portion 30 has a solid columnar shape, but is not limited to this, and has another structure such as a cylindrical outer needle and a solid inner needle. A thing may be adopted.

内針基部２０の構造は特に限定はないが、針部３０の基端側を固定するとともに、後述する外筒管４０の外筒基部５０と組み合わされて規制部Ａを形成可能な構造を有するのが好ましい。本実施形態は、この規制部Ａを構成する点状係合部として内針基部２０に凸部２６を設けた例である。本発明における点状係合部は、線状係合部に沿って案内され移動可能な構造を有するものであればよい。ここで、「点状」とは、文字通り「点」を意味するものに限らず、線状係合部の「線状」に対する相対的な意味を有し、ある程度の大きさを有するものであるが、本発明の効果を奏する範囲で所定範囲の長さの線状係合部に沿ってその長さ方向に移動可能な大きさを有するものも含む概念である。   Although the structure of the inner needle base 20 is not particularly limited, the inner needle base 20 has a structure that can fix the proximal end side of the needle 30 and can form the restricting portion A in combination with an outer tube base 50 of the outer tube 40 described later. Is preferred. The present embodiment is an example in which a convex portion 26 is provided on the inner needle base portion 20 as a point-like engaging portion constituting the restricting portion A. The point-like engaging part in the present invention may be any one having a structure that is guided and movable along the linear engaging part. Here, “spot-like” is not limited to literally meaning “spot”, but has a relative meaning with respect to “line” of the linear engaging portion and has a certain size. However, it is a concept that includes a size that is movable in the length direction along the linear engagement portion having a predetermined length within a range in which the effect of the present invention is achieved.

本実施形態では、内針基部２０は、図４に示すように、先端側には開口部２１を有し、基端側には基端面部２２を有し、基端面部２２から連続して基端側に伸びる筒状の側壁部２３を有する。そして、基端面部２２と側壁部２３とにより、開口部２１から外筒管４０の基部５０の一部を受け入れる内腔部２４が形成される。また、基端面部２２には、針部３０の基端部を受け入れて固定するための筒状部２５が内腔部２４側に向けて突設されている。
更に、側壁部２３の先端側端部において、内腔部２４に面する側に、点状の凸部２６が内腔部２４側に向けて突設されている。また、凸部２６の位置を外部から認識可能にするための窓部２７が基端面部２２に設けられている。この凸部２６が、前記のように外筒管４０の外筒基部５０に設けられた凹部５６とともに規制部Ａを形成する。本実施形態では、凸部２６は側壁部２３の先端側端部に設けられているが、これに限られず、外筒基部５０の構造に応じて、先端側端部以外の位置に設けてもよいし、外側に突出するように設けてもよい。
尚、図３、図４に示すように、筒状部２５は基端面部２２の中心に位置し、内針基部２０を把持して周方向に回動させた場合に内針１０の中心軸１１を中心にして回動させることができる。 In the present embodiment, as shown in FIG. 4, the inner needle base portion 20 has an opening 21 on the distal end side, a proximal end surface portion 22 on the proximal end side, and continues from the proximal end surface portion 22. It has a cylindrical side wall portion 23 extending to the base end side. The base end face portion 22 and the side wall portion 23 form a lumen portion 24 that receives a part of the base portion 50 of the outer tube 40 from the opening 21. In addition, a cylindrical portion 25 for receiving and fixing the proximal end portion of the needle portion 30 is provided on the proximal end surface portion 22 so as to project toward the lumen portion 24 side.
Furthermore, a dot-like convex portion 26 is provided projecting toward the lumen portion 24 side on the side facing the lumen portion 24 at the end portion on the distal end side of the side wall portion 23. In addition, a window portion 27 is provided on the base end surface portion 22 so that the position of the convex portion 26 can be recognized from the outside. This convex part 26 forms the restriction part A together with the concave part 56 provided in the outer cylinder base 50 of the outer cylinder pipe 40 as described above. In the present embodiment, the convex portion 26 is provided at the distal end side end portion of the side wall portion 23, but is not limited thereto, and may be provided at a position other than the distal end side end portion according to the structure of the outer cylinder base portion 50. It may be provided so as to protrude outward.
As shown in FIGS. 3 and 4, the cylindrical portion 25 is positioned at the center of the proximal end surface portion 22, and when the inner needle base portion 20 is gripped and rotated in the circumferential direction, the central axis of the inner needle 10. 11 can be turned around.

図３（ａ）〜（ｃ）、（ｅ）、図４（ａ）に示すように、内針基部２０の側壁部２３の外周面には、内針１０の中心軸１１方向に沿って伸びる滑り止め用のリブ部２８が外周面方向に沿って複数（本実施形態では８本）設けられている。また、側壁部２３の先端側の端部には外側に突出する２つのフランジ部２９が設けられ、その基端側に面する面部には、滑り止め用の曲線状のリブ部３３が形成されている。リブ部２８、３３の形状はこれに限らず適宜変更可能である。また、これらのリブ部は設けてもよいし、設けなくてもよい。   3A to 3C, 4E, and 4A, the outer peripheral surface of the side wall 23 of the inner needle base 20 extends along the direction of the central axis 11 of the inner needle 10. A plurality of (six in this embodiment) rib portions 28 for preventing slip are provided along the outer peripheral surface direction. Further, two flange portions 29 projecting outward are provided at the end portion on the distal end side of the side wall portion 23, and a curved rib portion 33 for preventing slip is formed on a surface portion facing the proximal end side. ing. The shape of the rib portions 28 and 33 is not limited to this, and can be changed as appropriate. Further, these rib portions may or may not be provided.

針部３０と内針基部２０との固定位置は、特に限定はないが、針部３０の針先３１の位置が内針基部２０により認識可能になるようにするのが好ましい。本実施形態では、図３（ｂ）、（ｄ）、（ｅ）に示すように、針先３１の位置と凸部２６の位置が同じ側で一致するように配置している。これにより、凸部２６（窓部２７）を介して針先３１の位置を把握することが容易になる。   The fixing position of the needle portion 30 and the inner needle base portion 20 is not particularly limited, but it is preferable that the position of the needle tip 31 of the needle portion 30 be recognized by the inner needle base portion 20. In this embodiment, as shown to FIG.3 (b), (d), (e), it arrange | positions so that the position of the needle point 31 and the position of the convex part 26 may correspond on the same side. Thereby, it becomes easy to grasp the position of the needle tip 31 via the convex part 26 (window part 27).

内針基部２０を構成する材質としては特に限定はなく、例えば、ＡＢＳ樹脂、ＡＳ樹脂（アクリロニトリルとスチレンのコポリマー）、ポリアミド、ポリブチレンテレフタレート（ＰＢＴ）、ポリカーボネート、ポリエチレンテレフタレート（ＰＥＴ）、ポリメチルメタクリレート（ＰＭＭＡ）、ポリアセタール（ＰＯＭ）、ポリエチレン、ポリプロピレン、ポリフェニレンオキシド（ＰＰＯ）、ポリフェニレンサルファイド、ポリスチレン等の熱可塑性樹脂が挙げられるが、これらに限定されるわけではない。   The material constituting the inner needle base 20 is not particularly limited. For example, ABS resin, AS resin (acrylonitrile and styrene copolymer), polyamide, polybutylene terephthalate (PBT), polycarbonate, polyethylene terephthalate (PET), polymethyl methacrylate Examples thereof include, but are not limited to, thermoplastic resins such as (PMMA), polyacetal (POM), polyethylene, polypropylene, polyphenylene oxide (PPO), polyphenylene sulfide, and polystyrene.

針部３０と内針基部２０の固定方法は特に限定はなく、例えば、内針基部２０の筒状部２５の内腔部に針部３０の基端部を挿入して、接着剤を介して固着しても良いし、接着剤を用いずに筒状部２５の内腔部に針部３０の基端部を圧入して物理的に固定しても良いし、他の方法を採用してもよい。   The method for fixing the needle part 30 and the inner needle base part 20 is not particularly limited. For example, the proximal end part of the needle part 30 is inserted into the inner cavity part of the cylindrical part 25 of the inner needle base part 20 and an adhesive is used. The proximal end of the needle part 30 may be press-fitted into the lumen part of the cylindrical part 25 without using an adhesive and may be physically fixed, or other methods may be employed. Also good.

図５（ａ）〜（ｅ）及び図６（ａ）は、穿刺針１を構成する外筒管４０の六面図であり、図６（ｂ）は、図５（ｂ）の正面図のII−II断面図を示したものである。   5 (a) to 5 (e) and FIG. 6 (a) are hexahedral views of the outer tube 40 constituting the puncture needle 1, and FIG. 6 (b) is a front view of FIG. 5 (b). II-II sectional drawing is shown.

外筒管４０は、外筒基部５０と筒状部６０とを備える。外筒管４０は、その一端側には筒状部６０の筒先６１を有し、もう一端側には外筒基部５０を有する。本発明では、筒先６１側を先端側、外筒基部５０側を基端側と称することとする。外筒管４０は、筒状部６０の先端開口部６２から外筒基部５０の基端開口部５１に亘り連通する内腔部４２を有し、内腔部４２を介してカテーテルを挿入したり、薬剤等を注入したり、体液を排出させたりすることができる。   The outer cylinder tube 40 includes an outer cylinder base 50 and a cylindrical part 60. The outer tube 40 has a tube tip 61 of the tubular portion 60 on one end side and an outer tube base 50 on the other end side. In the present invention, the cylinder tip 61 side is referred to as the distal end side, and the outer cylinder base 50 side is referred to as the proximal end side. The outer tube 40 has a lumen 42 that communicates from the distal end opening 62 of the cylindrical portion 60 to the proximal end opening 51 of the outer tube base 50, and a catheter can be inserted through the lumen 42. Drugs etc. can be injected and body fluids can be discharged.

図５、６に示すように、筒状部６０は、先端と基端で開口し、先端開口部６２から基端に亘り連通しており、湾曲形状の先端部６３を有する。先端部が湾曲形状を有することで、内腔部４２を介して挿入するカテーテルを湾曲した方向に誘導させ易くすることができる。一方、先端部６３を除き、外筒管４０は、長手方向の中心軸４１が筒状部６０及び外筒基部５０の中心軸に一致している。そして、本実施形態では、先端部６３は、筒状部６０の先端開口部６２の開口面側に向かってのみ緩やかに湾曲しており（特に図５（ｂ）、図６（ａ）参照）、先端部６３の中心軸４３はそれ以外部分の中心軸４１と同一平面上に存在する。また、図５（ｃ）に示すように、先端開口部６２の開口面は先端部６３以外の部分の中心軸４１に対する角度βが鋭角になるように形成している。これにより、内針１０を外筒管４０に挿着した時に、内針３０の刃面３２に対応した形状にすることができる。尚、本実施形態では図１、図９（ｃ）に示すように、内針１０を外筒管４０に挿着した時に、内針１０の先端部が外筒管４０の先端から少し飛び出した状態にしているが、内針１０の刃面３２と外筒管４０の先端開口部６２の開口面が一致するように形成してもよく、内針１０と外筒管４０を構成する材料等を考慮して適宜決定することができる。   As shown in FIGS. 5 and 6, the cylindrical portion 60 opens at the distal end and the proximal end, communicates from the distal opening 62 to the proximal end, and has a curved distal end portion 63. Since the distal end portion has a curved shape, the catheter to be inserted through the lumen portion 42 can be easily guided in the curved direction. On the other hand, except for the distal end portion 63, the outer tube 40 has a longitudinal central axis 41 that coincides with the central axes of the tubular portion 60 and the outer tube base 50. And in this embodiment, the front-end | tip part 63 is curving only toward the opening surface side of the front-end | tip opening part 62 of the cylindrical part 60 (refer especially FIG.5 (b) and FIG.6 (a)). The central axis 43 of the tip 63 is on the same plane as the central axis 41 of the other part. Further, as shown in FIG. 5C, the opening surface of the tip opening 62 is formed such that the angle β with respect to the central axis 41 of the portion other than the tip 63 is an acute angle. Thereby, when the inner needle 10 is inserted into the outer tube 40, the shape corresponding to the blade surface 32 of the inner needle 30 can be obtained. In the present embodiment, as shown in FIGS. 1 and 9C, when the inner needle 10 is inserted into the outer tube 40, the tip of the inner needle 10 protrudes slightly from the tip of the outer tube 40. Although it is in a state, it may be formed so that the blade surface 32 of the inner needle 10 and the opening surface of the distal end opening 62 of the outer cylindrical tube 40 coincide with each other, and the material constituting the inner needle 10 and the outer cylindrical tube 40, etc. Can be appropriately determined in consideration of the above.

筒状部６０を構成する材料としては特に限定はなく、金属材料、樹脂などが挙げられる。金属材料としては、例えば、ステンレス鋼、アルミニウム合金、銅系合金等が挙げられるが、これらに限定されるものではない。また、高分子材料としては、例えば、ポリエーテルエーテルケトン、非晶ポリアリレート、ポリサルフォン、ポリエーテルサルフォン、ポリフェニレンスルファイド、ポリイミド、ポリエーテルイミド、液晶ポリマー、ポリアミドイミド、フッ素樹脂（ポリテトラフルオロエチレン、ポリクロロトリフルオロエチレン、ポリフッ化ビニリデン等）が挙げられる。また、高分子材料を用いる場合は、強度を向上させるため、炭素繊維、ガラス繊維、ナノコンポジット等を含んでいてもよい。但し、真直ぐな直線状の内針１０を挿着させた時に、外筒管４０の筒状部６０の先端部６３をこれに追随させて真直ぐにするとともに、内針１０を抜去した時には湾曲形状に戻るようにする場合は、内針１０の針部３０よりも剛性の低い可撓性のある材料を用いるのが好ましく、針部３０に金属材料を用いる場合は、筒状部６０を構成する材料は高分子材料を用いるのが好ましい。   There is no limitation in particular as a material which comprises the cylindrical part 60, A metal material, resin, etc. are mentioned. Examples of the metal material include, but are not limited to, stainless steel, aluminum alloy, copper alloy, and the like. Examples of the polymer material include polyether ether ketone, amorphous polyarylate, polysulfone, polyether sulfone, polyphenylene sulfide, polyimide, polyetherimide, liquid crystal polymer, polyamideimide, fluororesin (polytetrafluoroethylene). , Polychlorotrifluoroethylene, polyvinylidene fluoride, etc.). Moreover, when using a polymeric material, in order to improve an intensity | strength, carbon fiber, glass fiber, a nanocomposite etc. may be included. However, when the straight linear inner needle 10 is inserted, the distal end portion 63 of the cylindrical portion 60 of the outer tube 40 is made to follow this straight, and when the inner needle 10 is removed, a curved shape is obtained. When returning to the above, it is preferable to use a flexible material having lower rigidity than the needle portion 30 of the inner needle 10, and when using a metal material for the needle portion 30, the cylindrical portion 60 is configured. The material is preferably a polymer material.

筒状部６０の大きさは、針部３０の大きさを考慮して用途に応じて適宜設定することができる。尚、筒状部６０の内腔部６４の大きさは、内針１０の針部３０が摺動可能で、針部３０の先端部と外筒管４０の先端開口部６２の間に大きな隙間ができない程度にするのが好ましい。これにより穿刺時の患者の痛みを軽減することができる。また、筒状部６０の強度を確保する観点から、穿刺操作に影響しない程度に外径を大きくしたり、肉厚を大きくしてもよい。   The size of the cylindrical portion 60 can be appropriately set according to the application in consideration of the size of the needle portion 30. Note that the size of the lumen portion 64 of the cylindrical portion 60 is such that the needle portion 30 of the inner needle 10 is slidable, and a large gap is formed between the distal end portion of the needle portion 30 and the distal end opening portion 62 of the outer cylindrical tube 40. It is preferable to make such a degree that it cannot be performed. Thereby, the pain of the patient at the time of puncture can be reduced. Further, from the viewpoint of securing the strength of the tubular portion 60, the outer diameter may be increased or the wall thickness may be increased so as not to affect the puncture operation.

外筒基部５０の構造は特に限定はないが、筒状部６０を固定するとともに、内針１０の内針基部２０と組み合わされて規制部Ａを形成可能な構造を有するのが好ましい。本実施形態は、この規制部Ａを構成する線状係合部として外筒基部５０に線状の凹部５６を設けた例である。尚、前述のとおり、「線状」と「点状」とは相対的な意味を有し、「線状」とは「点状」よりも長さのあることを意味する。また、線状係合部は、点状係合部を案内移動させることが可能なものであればよい。   The structure of the outer cylinder base 50 is not particularly limited, but preferably has a structure capable of fixing the cylindrical part 60 and forming the restricting part A in combination with the inner needle base 20 of the inner needle 10. The present embodiment is an example in which a linear concave portion 56 is provided in the outer cylinder base 50 as a linear engaging portion constituting the restricting portion A. As described above, “linear” and “dot” have relative meanings, and “linear” means longer than “dot”. Moreover, the linear engaging part should just be a thing which can carry out guide movement of the dotted | punctate engaging part.

本実施形態では、外筒基部５０は、先端と基端で開口し、基端開口部５１から先端に亘り連通する内腔部５２を有する。内腔部５２の先端側には筒状部６０の基端部を受け入れて固定しており、内腔部５２の基端側は、内針基部２０の筒状部２５やシリンジの先端部を受け入れ可能になっている。外筒基部５０の基端外周部にはシリンジ等（図示せず）を螺合固定するためのねじ部５３が形成されている。
また、外筒基部５０の長手方向の中央部近辺に、中心軸４１に直交する方向に延びる２つの翼部５４が形成されている。この翼部５４を把持することにより、術者が穿刺操作を容易に行うことができる。この翼部５４は図５（ｄ）、（ｅ）に示すように、左側面視及び右側面視において略アレイ形状になっているが、これに限定されるものではなく、適宜決定することができる。翼部５４の基端側及び先端側に面する面部には、滑り止め用の直線状のリブ部５５が形成されている。リブ部５５の形状は直線状に限らず、曲線状、点状等適宜変更可能である。また、リブ部５５は形成してもよいし、しなくてもよい。 In the present embodiment, the outer cylinder base 50 has a lumen 52 that opens at the distal end and the proximal end and communicates from the proximal opening 51 to the distal end. The proximal end portion of the cylindrical portion 60 is received and fixed on the distal end side of the lumen portion 52, and the proximal end side of the lumen portion 52 is connected to the cylindrical portion 25 of the inner needle base portion 20 and the distal end portion of the syringe. It has become acceptable. A screw portion 53 for screwing and fixing a syringe or the like (not shown) is formed on the outer peripheral portion of the base end of the outer cylinder base portion 50.
In addition, two wing parts 54 extending in a direction orthogonal to the central axis 41 are formed in the vicinity of the center part in the longitudinal direction of the outer cylinder base part 50. By grasping the wing portion 54, the operator can easily perform the puncture operation. As shown in FIGS. 5D and 5E, the wing portion 54 has a substantially array shape in the left side view and the right side view, but is not limited to this and can be appropriately determined. it can. A linear rib portion 55 for preventing slippage is formed on a surface portion facing the proximal end side and the distal end side of the wing portion 54. The shape of the rib portion 55 is not limited to a linear shape, and can be changed as appropriate, such as a curved shape or a dotted shape. Further, the rib portion 55 may or may not be formed.

外筒基部５０の翼部５４より基端側の側壁の外周部には線状の凹部５６が形成されている。図５、６に示す実施形態では、凹部５６は、外筒管４０の長手方向基端側に形成された入口５７から、概ね先端側に向かうように進行した後、所定位置で先端側に向かいつつも概ね側壁面の周方向に沿うように進行するように伸び、入口５７のほぼ反対側の側壁面で終端６６になるように形成されている。入口５７から終端６６に至る部分のように所定長さに亘って連続して形成された凹部５６に、内針１０の内針基部２０に形成された点状の凸部２６が受け入れられて、凹部５６に沿って凹部２６が案内移動することで、外筒管４０と内針１０との相対的な移動が凹部５６の形状に概ね対応するように規制される。   A linear concave portion 56 is formed on the outer peripheral portion of the side wall on the proximal end side from the wing portion 54 of the outer cylinder base portion 50. In the embodiment shown in FIGS. 5 and 6, the recess 56 proceeds from the inlet 57 formed on the proximal end side in the longitudinal direction of the outer tube 40 toward the front end side, and then proceeds to the front end side at a predetermined position. However, it is formed so as to extend substantially along the circumferential direction of the side wall surface, and to be the end 66 on the side wall surface substantially opposite to the inlet 57. The point-like convex portion 26 formed on the inner needle base portion 20 of the inner needle 10 is received in the concave portion 56 continuously formed over a predetermined length like a portion from the inlet 57 to the terminal end 66, By the guide movement of the recess 26 along the recess 56, the relative movement between the outer tube 40 and the inner needle 10 is regulated so as to substantially correspond to the shape of the recess 56.

凹部５６は、外筒管４０の長手方向に対して交差する方向に伸びる交差状案内部５８を含む。交差状案内部５８は、外筒基部５０の中心軸４１に対して平行ではなく、所定の角度を有するように外筒基部５０の側壁面に沿うように伸びていればよい。また、中心軸４１に対する角度は、展開図において、交差状案内部５８の凹部の幅の中間点を結ぶ中心線又はその中間点から導き出される中心線に基づいて求めるとよい。このように交差状案内部５８を有することで、外筒管４０に対して内針１０を挿入する時に外筒管４０の中心軸４１に沿って移動させる速度を低下させ、外筒管４０の先端部６３側への内針１０の移動が勢いよくならないように規制することができる（以下、「移動速度の低減効果」等と称する。）。また、内針１０の針先３１を、中心軸１１、４１を中心として周方向にも移動させ得ることから、外筒管４０の筒状部６０の内腔部６４を構成する内壁面に針先３１が突き当たることを効果的に抑制することも可能である。   The recess 56 includes an intersecting guide portion 58 that extends in a direction intersecting the longitudinal direction of the outer tube 40. The cross-shaped guide part 58 should just be extended along the side wall surface of the outer cylinder base 50 so that it may have a predetermined angle instead of being parallel with respect to the central axis 41 of the outer cylinder base 50. In addition, the angle with respect to the central axis 41 may be obtained based on the center line connecting the intermediate points of the widths of the concave portions of the intersecting guide portions 58 or the center line derived from the intermediate points in the developed view. Thus, by having the cross-shaped guide part 58, when inserting the inner needle 10 with respect to the outer cylinder pipe 40, the speed moved along the central axis 41 of the outer cylinder pipe 40 is reduced, and The movement of the inner needle 10 toward the distal end portion 63 can be regulated so as not to become vigorous (hereinafter referred to as “movement speed reduction effect” or the like). Further, since the needle tip 31 of the inner needle 10 can be moved in the circumferential direction around the central axes 11 and 41, the needle is attached to the inner wall surface constituting the lumen portion 64 of the tubular portion 60 of the outer tubular tube 40. It is also possible to effectively prevent the tip 31 from striking.

交差状案内部５８の構成は、特に限定はなく、外筒管４０に対する内針１０の相対的な移動速度を任意の位置で任意の大きさに低下させることができるように、１箇所又は２箇所以上に設けてよく、また、交差角度の大きさも任意に設定すればよい。本実施形態では、図７に示すように、外筒管４０の中心軸４１に対する角度が異なる中心線４４、４５、４６、４７を有する凹部５６が形成されており、中心線４６以外の部分が交差状案内部５８を形成している。特に、中心線４７の部分の交差状案内部５８は、外筒管４０の長手方向（中心軸４１の方向）に対して巻回する螺旋形状を有している。このように螺旋形状を有していることで、外筒管４０に対する内針１０の移動速度の低減効果や内腔部６４の内壁面に対する針先３１の突き当たりの抑制効果がより向上する。さらに、螺旋形状のピッチ間隔が２．０〜６．０ｍｍとなるように形成することで、これらの効果がさらに向上する。ここで、ピッチ間隔とは、螺旋形状の凹部５６が外筒基部５０の外周部を１周した時の、中心軸４１に平行な直線上の、凹部５６の中心線４７の端点間距離を意味する。   The configuration of the intersecting guide portion 58 is not particularly limited, and it is possible to reduce the relative moving speed of the inner needle 10 with respect to the outer tube 40 to an arbitrary size at an arbitrary position or two. It may be provided at more than one place, and the size of the intersection angle may be set arbitrarily. In the present embodiment, as shown in FIG. 7, a recess 56 having center lines 44, 45, 46, 47 having different angles with respect to the center axis 41 of the outer tube 40 is formed, and portions other than the center line 46 are formed. An intersecting guide portion 58 is formed. In particular, the intersecting guide portion 58 at the center line 47 has a spiral shape wound around the longitudinal direction of the outer tube 40 (the direction of the center axis 41). By having such a spiral shape, the effect of reducing the moving speed of the inner needle 10 with respect to the outer tube 40 and the effect of suppressing the contact of the needle tip 31 with the inner wall surface of the lumen portion 64 are further improved. Furthermore, these effects are further improved by forming the spiral pitch so as to be 2.0 to 6.0 mm. Here, the pitch interval means the distance between the end points of the center line 47 of the recess 56 on a straight line parallel to the central axis 41 when the spiral recess 56 makes one round of the outer periphery of the outer cylinder base 50. To do.

また、本実施形態では、図７に示すように、線状係合部である凹部５６は、外筒管４０の長手方向（中心軸４１に平行な方向）に対する方向の角度が変化する屈曲点４８ａ、４８ｂ、４８ｃを有する。即ち、屈曲点４８ａ、４８ｂ、４８ｃでは、隣接する中心線４４、４５、４６、４７同士の連結点においてその角度が変化することで屈曲する。ここで、外筒管４０の長手方向（中心軸４１に平行な方向）に対する角度とは、展開図において、中心軸４１に平行な直線を基準線にして、この基準線と中心線４４、４５、４６、４７となす角度のうち小さい方の角度（基準線からの方向は問わない）を意味する。例えば、図７に示すように、中心線４７の場合は、外筒管４０の長手方向（中心軸４１に平行な方向）に対する角度は符号γで示した部分になる。また、中心線４６のように中心軸４１と平行な場合の角度は０°とする。
屈曲点４８ａ、４８ｂ、４８ｃのうち、屈曲点４８ｃのように、屈曲点４８ｃに対し、外筒管４０の内腔部４２に内針１０を挿入する時に相対的に内針１０が進行する側に位置する部分、すなわち、交差状案内部５８のうち中心線４７を有する凹部５６の角度γは、進行する側とは反対側に位置する部分、すなわち、中心線４６を有する凹部５６の角度（角度０°）より大きくなっている。凹部５６がこのような屈曲点４８ｃを含む屈曲部を有することで、屈曲部（屈曲点４８ｃ）での外筒管４０に対する内針１０の移動速度の低減効果を期待できる。このような角度としては特に限定はないが、角度γ（図７参照）が、６０°〜９０°であるのが好ましい。 Further, in the present embodiment, as shown in FIG. 7, the concave portion 56 that is a linear engagement portion is a bending point where the angle of the direction with respect to the longitudinal direction of the outer tube 40 (direction parallel to the central axis 41) changes. 48a, 48b, 48c. That is, the bending points 48a, 48b, and 48c are bent by changing the angle at the connection points between the adjacent center lines 44, 45, 46, and 47. Here, the angle with respect to the longitudinal direction (the direction parallel to the central axis 41) of the outer tube 40 is a straight line parallel to the central axis 41 in the developed view, and the reference line and the central lines 44, 45. 46, 47 means the smaller angle (the direction from the reference line does not matter). For example, as shown in FIG. 7, in the case of the center line 47, the angle with respect to the longitudinal direction of the outer tube 40 (direction parallel to the center axis 41) is a portion indicated by the symbol γ. In addition, the angle in the case of being parallel to the central axis 41 like the central line 46 is 0 °.
Of the bending points 48a, 48b, and 48c, the side where the inner needle 10 advances relative to the bending point 48c when the inner needle 10 is inserted into the inner cavity portion 42 of the outer tube 40 with respect to the bending point 48c. The angle γ of the concave portion 56 having the center line 47 in the portion located in the cross-shaped guide portion 58, that is, the angle of the portion 56 located on the opposite side to the traveling side, ie, the concave portion 56 having the center line 46 ( The angle is larger than 0 °. Since the recessed part 56 has such a bent part including the bent point 48c, an effect of reducing the moving speed of the inner needle 10 relative to the outer tube 40 at the bent part (bent point 48c) can be expected. Although there is no limitation in particular as such an angle, it is preferable that angle (gamma) (refer FIG. 7) is 60 degrees-90 degrees.

また、上述したように、本実施形態では、図５（ｂ）、図７に示すように、凹部５６には入口５７が設けられている。この入口５７は、凹部５６の他の部分に比べて幅が広くなっている。これにより、外筒管４０の内腔部４２に内針１０を挿入する時に、内針１０の凸部２６を外筒管４０の凹部５６に受け入れ易くすることができる。
また、凹部５６は、凸部２６が入口５７から凹部５６に対して相対的に進行する方向（先端側）に向かうに従いその幅が狭くなる部分を有する。本実施形態では、入口５７から先端側に向かって、先ず凹部５６の両壁面が漸次傾斜し、その後、一方の壁面は中心軸４１と平行な直線状としつつもう一方の壁面は漸次傾斜することで、先端側に向かうに従いその幅が狭くなっている。そして、中心線４６が形成される中心軸４１に平行で幅が一定の直線形状の凹部５６に連続し、屈曲部（屈曲点４８ｃ）において、さらに螺旋形状で幅が一定の交差状案内部５８に連続する。螺旋形状の螺旋の回転方向は、内針基部２０を右回りに回動させた場合に外筒管４０の筒先６１方向に進行するようになっている。このように、螺旋形状の螺旋の回転方向に合わせて、上記のように、一方の壁面を中心軸４１に平行な直線状とし、一方を漸次傾斜させる部分を形成することで、内針１０を外筒管４０に挿入する時に螺旋形状と同じ方向に回動させつつ、螺旋形状の回転方向とは反対方向の回動を抑制して術者の操作感を向上させることができる。 As described above, in this embodiment, as shown in FIGS. 5B and 7, the recess 56 is provided with the inlet 57. The inlet 57 is wider than other portions of the recess 56. Thereby, when the inner needle 10 is inserted into the inner cavity portion 42 of the outer cylindrical tube 40, the convex portion 26 of the inner needle 10 can be easily received in the concave portion 56 of the outer cylindrical tube 40.
Further, the concave portion 56 has a portion whose width becomes narrower as the convex portion 26 moves in the direction (the front end side) in which the convex portion 26 proceeds relative to the concave portion 56 from the inlet 57. In the present embodiment, first, both wall surfaces of the recess 56 gradually incline from the inlet 57 toward the front end side, and then one wall surface is linearly parallel to the central axis 41 and the other wall surface is gradually inclined. And the width becomes narrower toward the tip side. Then, the cross-shaped guide portion 58 that is continuous with the linear concave portion 56 that is parallel to the central axis 41 where the center line 46 is formed and has a constant width, and further has a spiral shape and a constant width at the bending portion (bending point 48c). It is continuous. The direction of rotation of the spiral helix advances in the direction of the tube tip 61 of the outer tube 40 when the inner needle base 20 is rotated clockwise. Thus, according to the rotational direction of the spiral of the spiral shape, as described above, one wall surface is formed in a straight line parallel to the central axis 41, and the inner needle 10 is While being inserted into the outer tube 40, it is possible to improve the operator's feeling of operation by rotating in the same direction as the spiral shape while suppressing the rotation in the direction opposite to the rotational direction of the spiral shape.

本実施形態では、中心線４６を有する凹部５６、屈曲部（屈曲点４８ｃ）、即ち、螺旋形状の交差状案内部５８の開始位置（外筒管４０に内針１０を挿入する場合の開始位置）が、筒状部６０の先端開口部６２の開口面が形成されている側に一致している。これにより、外筒管３０（筒状部６０）の湾曲している先端部６３とは反対側に内針１０の針先３１を位置させることができ、針先３１が内壁面に突き当たることを効果的に防止することができる。
また、先端開口部６２の開口面の向きを外部から認識することができるように、翼部５４のアレイ形状の窪み部分に突起４９を設けている。 In the present embodiment, the recessed portion 56 having the center line 46, the bent portion (bending point 48c), that is, the starting position of the spiral intersecting guide portion 58 (the starting position when the inner needle 10 is inserted into the outer tube 40). ) Coincides with the side where the opening surface of the distal end opening 62 of the cylindrical portion 60 is formed. As a result, the needle tip 31 of the inner needle 10 can be positioned on the opposite side of the distal end portion 63 of the outer tube 30 (cylindrical portion 60), and the needle tip 31 abuts against the inner wall surface. It can be effectively prevented.
In addition, a projection 49 is provided in the recessed portion of the array-shaped wing portion 54 so that the orientation of the opening surface of the tip opening 62 can be recognized from the outside.

本実施形態では、入口５７が形成されている外筒基部５０の側壁の外周部に階段状の段差５９を設けている。これにより、内針１０を外筒管４０に挿入する時に、入口５７以外の部分に凸部２６が位置する場合は、凸部２６が段差５９に当接して内針１０が外筒管４０に対して相対的に進行することを防止し、入口５７から凸部２６が凹部５６により確実に受け入れられるようにすることができる。   In the present embodiment, a stepped step 59 is provided on the outer periphery of the side wall of the outer cylinder base 50 where the inlet 57 is formed. Thus, when the convex portion 26 is located at a portion other than the inlet 57 when the inner needle 10 is inserted into the outer cylindrical tube 40, the convex portion 26 abuts on the step 59 and the inner needle 10 moves to the outer cylindrical tube 40. On the other hand, it is possible to prevent the protrusions 26 from being relatively moved and to ensure that the protrusions 26 are received by the recesses 56 from the inlets 57.

本実施形態では、凹部５６には、内針１０の凸部２６に係り合って、凸部２６を留める係留部６５が形成されている。係留部６５を設ける位置は特に限定はないが、内針１０を外筒管４０に挿入する際に、内針１０の凸部２６が外筒管４０の凹部５６の終端６６に到達したことを術者に知覚させて、外筒管４０に対する内針１０の相対移動を必要以上に行うことによる凸部２６及び凹部５６の損傷を防止する観点、終端６６とは反対側への凸部の不意の移動を抑制する観点から、凹部５６の終端６６の近傍に設けるのが好ましい。また、係留部６５の構造は特に限定はないが、凹部５６の側壁部から凹部５６に向けて突出する突起にすることが好ましい。
尚、本実施形態では、外筒管４０の翼部５４と内針１０のフランジ部２９の一部の形状を合致させることで、外観上から術者が視認して、外筒管４０に対する内針１０相対移動を必要以上に行うこと防止することもできる（図１参照）。 In the present embodiment, an anchoring portion 65 that engages with the convex portion 26 of the inner needle 10 and fastens the convex portion 26 is formed in the concave portion 56. The position where the mooring portion 65 is provided is not particularly limited, but when the inner needle 10 is inserted into the outer tube 40, the fact that the convex portion 26 of the inner needle 10 has reached the end 66 of the concave portion 56 of the outer tube 40. From the viewpoint of preventing the damage to the convex portion 26 and the concave portion 56 caused by making the operator perceive the relative movement of the inner needle 10 with respect to the outer tube 40 more than necessary, the unexpectedness of the convex portion on the side opposite to the end 66 From the viewpoint of suppressing the movement of the recess 56, it is preferable to provide it in the vicinity of the end 66 of the recess 56. The structure of the mooring portion 65 is not particularly limited, but is preferably a protrusion that protrudes from the side wall portion of the recessed portion 56 toward the recessed portion 56.
In the present embodiment, by matching the shapes of the wings 54 of the outer tube 40 and the flanges 29 of the inner needle 10, the operator can visually recognize the inner tube relative to the outer tube 40 from the appearance. It is also possible to prevent the needle 10 from moving more than necessary (see FIG. 1).

外筒基部５０を構成する材質としては特に限定はなく、内針基部２０と同様の材質を適宜選択して用いることができる。内針基部２０を構成する材質と同じでも、異なっていてもよい。   The material constituting the outer cylinder base 50 is not particularly limited, and the same material as that of the inner needle base 20 can be appropriately selected and used. The material constituting the inner needle base 20 may be the same or different.

本発明では、線状係合部が抵抗要素を有してもよい。抵抗要素は、点状係合部が線状係合部と係合しつつ移動する際に、その移動を規制するように作用する。これにより、内針１０を外筒管４０に対して挿入する際に、その移動速度を低下させることができる。このような抵抗要素としては、例えば、線状係合部及び／又は点状係合部を構成する部分を摩擦抵抗が大きくなる材質で構成したり、線状係合部の表面に凹凸が形成される部分を設けたりするなどが挙げられるが、これらに限定されない。また、摩擦抵抗が大きくなる材質で構成する方法の例としては、このような材質で構成されたコーティングを設けたり、線状係合部及び／又は点状係合部を形成する部分全体を前述の材質で構成したりする方法が挙げられるが、これらに限定されない。   In the present invention, the linear engaging portion may have a resistance element. The resistance element acts so as to restrict the movement of the dot-like engaging portion when moving while engaging the linear engaging portion. Thereby, when inserting the inner needle 10 with respect to the outer cylinder pipe 40, the moving speed can be reduced. As such a resistance element, for example, the portion constituting the linear engagement portion and / or the point engagement portion is made of a material that increases frictional resistance, or irregularities are formed on the surface of the linear engagement portion. However, the present invention is not limited to these. In addition, as an example of a method of forming with a material that increases the frictional resistance, the entire portion that forms a coating made of such a material or forms a linear engaging portion and / or a dotted engaging portion is described above. However, the present invention is not limited to these methods.

筒状部６０と外筒基部５０との固定方法は特に限定はなく、例えば、外筒基部５０の内腔部に筒状部６０の基端部を挿入して、接着剤を介して固着する方法等が挙げられるが、これに限定されるものではない。   The fixing method of the cylindrical part 60 and the outer cylinder base 50 is not particularly limited. For example, the proximal end part of the cylindrical part 60 is inserted into the inner cavity of the outer cylinder base 50 and is fixed through an adhesive. Although a method etc. are mentioned, it is not limited to this.

以下では、上述した内針１０と外筒管４０を用い、内針１０を外筒管４０に挿入する際に、内針１０の点状係合部である凸部２６と外筒管４０の線状係合部である凹部５６とで形成される規制部Ａの作用を、図８、９を参照しつつ説明する。   Hereinafter, when the inner needle 10 and the outer tube 40 are used and the inner needle 10 is inserted into the outer tube 40, the projection 26 and the outer tube 40, which are point-like engaging portions of the inner needle 10, are used. The operation of the restricting portion A formed by the concave portion 56 that is a linear engaging portion will be described with reference to FIGS.

図８に示すように、外筒管４０の外筒基部５０の側壁の外周側に設けられた凹部５６の入口５７の位置と、内針１０の内針基部２０の内腔部２４の内壁に設けられた凸部２６の位置とを合わせるようにして、外筒管４０の外筒基部５０の基端開口部５１に内針１０の針先３１を挿入する。この時、内針基部２０の基端面部２２に設けられている窓部２７によっても凸部２６の位置を確認することができる。尚、十分位置合わせをしなくても、外筒基部５０の段差５９が存在する場合は、段差５９に凸部２６が当接し、外筒管４０と内針１０の長手方向の相対移動が停止される。この場合、さらに、外筒管４０と内針１０を周方向に回動させることで、凸部２６を入口５７に誘導することができる。
また、特に、内針１０を外筒管４０に再挿入する場合は、外筒管４０の先端部分は体内に挿入されているため先端部分を直接確認することは困難であるが、外筒基部５０の翼部５４のアレイ形状の窪み部分に設けられている突起４９によっても、外筒管４０の筒状部６０の先端部６３が湾曲している方向、即ち、先端開口部６２が開口している方向を確認することができる。 As shown in FIG. 8, the position of the inlet 57 of the recess 56 provided on the outer peripheral side of the side wall of the outer cylinder base 50 of the outer tube 40 and the inner wall of the lumen 24 of the inner needle base 20 of the inner needle 10 The needle tip 31 of the inner needle 10 is inserted into the proximal end opening 51 of the outer tube base 50 of the outer tube 40 so as to match the position of the provided convex portion 26. At this time, the position of the convex portion 26 can also be confirmed by the window portion 27 provided on the proximal end surface portion 22 of the inner needle base portion 20. Even if the positioning is not performed sufficiently, if the step 59 of the outer cylinder base 50 exists, the convex portion 26 abuts on the step 59 and the relative movement in the longitudinal direction of the outer cylinder tube 40 and the inner needle 10 stops. Is done. In this case, the convex portion 26 can be guided to the inlet 57 by further rotating the outer tube 40 and the inner needle 10 in the circumferential direction.
In particular, when the inner needle 10 is reinserted into the outer tube 40, it is difficult to directly check the tip portion because the tip portion of the outer tube 40 is inserted into the body. The projection 49 provided in the array-shaped depression portion of the 50 wings 54 also opens the distal end 63 of the tubular portion 60 of the outer tube 40, that is, the distal end opening 62 opens. You can check the direction.

そして、外筒管４０の筒状部６０の内腔部６４（４２）に内針１０の針部３０を到達させるように外筒管４０に対して内針１０を進行させる。この時、針部３０が真直ぐな直線状を有する場合は、針先３１や刃面３２の周縁で内腔部６４の内壁面を損傷することが防止され、術者が迅速に操作を行うことができる。   Then, the inner needle 10 is advanced with respect to the outer tube 40 so that the needle portion 30 of the inner needle 10 reaches the lumen portion 64 (42) of the tubular portion 60 of the outer tube 40. At this time, when the needle part 30 has a straight straight line shape, it is possible to prevent the inner wall surface of the lumen part 64 from being damaged at the peripheral edge of the needle tip 31 and the blade surface 32, and the operator can quickly perform the operation. Can do.

筒状部６０の内腔部６４に内針１０の針部３０を摺動させて、更に進行させると、図９（ａ）に示すように、凸部２６が入口５７に到達し、凸部２６が凹部５６に受け入れられ、両者が互いに係合する。これにより、凸部２６が凹部５６に沿って移動し、外筒管４０と内針１０の相対的な移動が規制される。このように、凸部２６と凹部５６とが係合することで規制部Ａが形成される。入口５７の幅が凹部５６の他の部分より広くなっているため、凹部５６への凸部２６の係合を容易に行うことができる。   When the needle part 30 of the inner needle 10 is slid into the inner cavity part 64 of the cylindrical part 60 and further advanced, the convex part 26 reaches the inlet 57 as shown in FIG. 26 is received in the recess 56 and both engage each other. Thereby, the convex part 26 moves along the recessed part 56, and the relative movement of the outer cylinder pipe 40 and the inner needle 10 is controlled. In this way, the restricting portion A is formed by the engagement between the convex portion 26 and the concave portion 56. Since the width of the inlet 57 is wider than the other part of the concave portion 56, the convex portion 26 can be easily engaged with the concave portion 56.

凸部２６と凹部５６とを係合させた後、外筒管４０に対して内針１０を進行させると凹部５６に受け入れられた凸部２６が凹部５６に沿って移動させることができる。この時、内針基部２０に固着された針部３０の針先３１も凸部２６の動きに対応して移動させることができる。そして、図７に示すような中心線４４、４５、４６を有する凹部５６に沿って凸部２６を先端側に移動させると、この部分の凹部５６の幅の範囲で凸部２６の周方向の移動が規制されながら、針先３１もその動きに対応して周方向の移動が規制されながら先端側に向かって進行する。また、中心線４４、４５を有する凹部５６は、長手方向に交差する方向に延びる部分を有し得るため、外筒管４０に対して内針１０を進行させる時の進行速度を、中心軸４１に沿って進行させる場合よりも低下させ得る。また、ある程度の幅があり、針先３１をある程度回動させつつ進行させることができるため、針部３０の筒状部６０に対する摺動移動を安定して行うことができる。   After engaging the convex portion 26 and the concave portion 56, the convex portion 26 received in the concave portion 56 can be moved along the concave portion 56 when the inner needle 10 is advanced relative to the outer tube 40. At this time, the needle tip 31 of the needle portion 30 fixed to the inner needle base portion 20 can also be moved in accordance with the movement of the convex portion 26. Then, when the convex portion 26 is moved to the tip side along the concave portion 56 having the center lines 44, 45, and 46 as shown in FIG. 7, the circumferential direction of the convex portion 26 is within the range of the width of the concave portion 56 of this portion. While the movement is restricted, the needle tip 31 also advances toward the tip side while the movement in the circumferential direction is restricted corresponding to the movement. Moreover, since the recessed part 56 which has the centerlines 44 and 45 may have a part extended in the direction which cross | intersects a longitudinal direction, the advancing speed at the time of making the inner needle 10 advance with respect to the outer cylinder pipe 40 is made into the center axis 41. It can be lowered as compared with the case where it proceeds along the direction. Moreover, since there is a certain width and the needle tip 31 can be moved while being rotated to some extent, the sliding movement of the needle portion 30 relative to the cylindrical portion 60 can be performed stably.

そして、凸部２６が中心線４６を有する凹部５６に到達したときに、針先３１は、外筒管４０の先端部６３の湾曲の内側に位置するように案内される。そして、中心軸４１に平行な中心線４６を有する一定幅の凹部５６に沿って凸部２６を進行させ、図７に示す屈曲部（屈曲点４８ｃ）の位置に凸部２６を到達させた時に、針先３１が先端部６３の内壁面に突き当たることなく、先端開口部６２から針先３１を僅かに突出させることができる（図９（ｂ）参照。）。そして、筒状部６０が針部３０より剛性が低く可撓性を有する場合は、湾曲した先端部６３を直線状にすることができる（図９（ｂ）参照。）。尚、本実施形態では、屈曲部（屈曲点４８ｃ）の位置に凸部２６を到達させた時に針先３１が僅かに先端開口部６２から突出するようにしているが、例えば図９（ａ）に示すような針先３１と先端部６３の位置関係になるように、先端開口部６２から針先３１が突出しないように、凹部５６を形成してもよい。   And when the convex part 26 reaches | attains the recessed part 56 which has the centerline 46, the needle point 31 is guided so that it may be located inside the curve of the front-end | tip part 63 of the outer cylinder pipe | tube 40. FIG. And when the convex part 26 is advanced along the concave part 56 of a fixed width | variety which has the center line 46 parallel to the central axis 41, and the convex part 26 is reached at the position of the bending part (bending point 48c) shown in FIG. The needle tip 31 can be slightly projected from the tip opening 62 without the needle tip 31 hitting the inner wall surface of the tip portion 63 (see FIG. 9B). And when the cylindrical part 60 has flexibility lower than the needle part 30 and has flexibility, the curved front-end | tip part 63 can be made into linear form (refer FIG.9 (b)). In this embodiment, the needle tip 31 slightly protrudes from the tip opening 62 when the convex portion 26 reaches the position of the bent portion (bend point 48c). For example, FIG. The concave portion 56 may be formed so that the needle tip 31 does not protrude from the tip opening 62 so that the needle tip 31 and the tip portion 63 have a positional relationship as shown in FIG.

図９（ｂ）に示すように凸部２６が屈曲部（屈曲点４８ｃ）（図９には図示せず。図７を参照。）の位置に到達した後、螺旋形状の交差状案内部５８に沿って、凸部２６を進行させる。屈曲部（屈曲点４８ｃ）のように、中心軸４１に対して大きく屈曲させることで、先端部６３及びその近傍部での針先３１の長手方向（中心軸４１方向）の進行速度を低減して、先端部６３の内壁面に針先３１が勢いよく突き当たることを防止することができる。そのため、従来のような煩雑な操作を要することなく、湾曲形状の先端部６３の内壁面が損傷することを防止することができ、ひいては手術のリスクを低減することができる。
また、螺旋形状の交差状案内部５８に沿って凸部２６が移動することで、針先３１もそれに対応して周方向に回動しつつ先端側に低速で進行することで、針先３１の内壁面への突き当たりを防止するとともに、凸部２６が凹部５６の終端６６（図９には図示せず。図６（ａ）参照）に到達した時に、先端開口部６２の開口面の傾斜方向と針部３０の刃面３２の向きを一致させることができる（図９（ｃ）参照）。尚、終端６６の手前側に係留部６５（図９には図示せず。図６（ａ）参照）を設けることで、術者は凸部２６が終端６６に到達したことを知覚することができる。 As shown in FIG. 9B, after the convex portion 26 reaches the position of the bent portion (bend point 48c) (not shown in FIG. 9, refer to FIG. 7), the spiral cross-shaped guide portion 58 is formed. The convex part 26 is advanced along. Like the bent portion (bending point 48c), the needle shaft 31 is greatly bent with respect to the central axis 41 to reduce the traveling speed in the longitudinal direction (the central axis 41 direction) of the needle tip 31 at the tip 63 and its vicinity. Thus, the needle tip 31 can be prevented from strikingly striking the inner wall surface of the distal end portion 63. Therefore, it is possible to prevent the inner wall surface of the curved tip portion 63 from being damaged without requiring a complicated operation as in the prior art, thereby reducing the risk of surgery.
Further, as the convex portion 26 moves along the spiral intersecting guide portion 58, the needle tip 31 also rotates in the circumferential direction correspondingly and moves forward at a low speed, thereby the needle tip 31. Of the opening of the tip opening 62 when the protrusion 26 reaches the end 66 of the recess 56 (not shown in FIG. 9; see FIG. 6A). The direction and the direction of the blade surface 32 of the needle portion 30 can be matched (see FIG. 9C). In addition, by providing a mooring portion 65 (not shown in FIG. 9, see FIG. 6A) on the front side of the end 66, the operator can perceive that the convex portion 26 has reached the end 66. it can.

図９（ｃ）に示すように、凸部２６が凹部５６の終端６６に到達した段階で、内針１０と外筒管４０が一体化され、穿刺針として機能させることができる。このように、凸部２６と凹部５６とを備える規制部Ａにより、外筒管４０と内針１０との相対的な移動を規制することができ、さらには、外筒管４０の外筒基部５０と内針１０の内針基部２０との相対的な移動を制御することで、内針１０の針先３１と外筒管４０の先端部６３の相対的な位置関係を制御することができる。   As shown in FIG. 9C, when the convex portion 26 reaches the end 66 of the concave portion 56, the inner needle 10 and the outer tube 40 are integrated and can function as a puncture needle. Thus, the relative movement between the outer tubular tube 40 and the inner needle 10 can be restricted by the restricting portion A including the convex portion 26 and the concave portion 56, and further, the outer cylindrical base portion of the outer cylindrical tube 40. By controlling the relative movement of 50 and the inner needle base 20 of the inner needle 10, the relative positional relationship between the needle tip 31 of the inner needle 10 and the distal end portion 63 of the outer tube 40 can be controlled. .

また、本実施形態では、内針１０を外筒管４０に挿着させ、穿刺針を構成する時には、筒状部６０の先端部６３が湾曲形状から直線形状に変形され、穿刺針１は、針先１から筒状部６０及び針部３０の基端側端部に亘り直線形状を有する。このように穿刺針が直線形状の場合は、従来の特許文献２、３に示すように先端部が湾曲形状の場合と異なり、この湾曲方向を考慮した最適な方向への穿刺を行う必要がなく、術者の技量に大きく左右されることなく、より安全に穿刺を行うことができる。そのため、従来より手術のリスクが低減され、患者にとっての安全性をより向上することができる。   In the present embodiment, when the inner needle 10 is inserted into the outer tube 40 to form a puncture needle, the distal end portion 63 of the tubular portion 60 is deformed from a curved shape to a linear shape, and the puncture needle 1 is It has a linear shape from the needle tip 1 to the cylindrical portion 60 and the proximal end of the needle portion 30. In this way, when the puncture needle has a linear shape, unlike the conventional cases of Patent Documents 2 and 3, there is no need to perform puncturing in an optimal direction in consideration of the bending direction. The puncture can be performed more safely without being greatly affected by the skill of the operator. Therefore, the risk of surgery can be reduced as compared with the prior art, and the safety for the patient can be further improved.

また、本実施形態では、穿刺針１を適切に生体管腔に穿刺し、挿入した後、穿刺針１から内針１０を抜去した後は、外筒管４０の先端部６３は湾曲形状に戻るため、湾曲して方向づけられた先端開口部６２を介してカテーテルを挿入することができ、カテーテルを安全に生体管腔の所望の方向に挿入することができる。   In the present embodiment, after the puncture needle 1 is properly punctured and inserted into the living body lumen, the inner needle 10 is removed from the puncture needle 1, and then the distal end portion 63 of the outer tube 40 returns to a curved shape. Therefore, the catheter can be inserted through the distal opening 62 that is curved and oriented, and the catheter can be safely inserted in a desired direction of the biological lumen.

上述した実施形態の構成は、一例を示したものであり、本発明の構成はこれに限定されない。本発明の効果を奏する範囲において、例えば、規制部を構成する点状係合部である凸部を外筒管に、同じく線状係合部である凹部を内針に設ける等、種々改変された構成も含む。
尚、規制部が形成される外筒管および内針において、一方に雄ねじ、他方に雌ねじを形成し、雄ねじと雌ねじのはまり合いによって、外筒管と内針との相対的移動を規制することも可能である。 The configuration of the above-described embodiment is an example, and the configuration of the present invention is not limited to this. In the range where the effects of the present invention are exhibited, various modifications are made, for example, a convex portion that is a point-like engaging portion constituting the restricting portion is provided on the outer tube, and a concave portion that is also a linear engaging portion is provided on the inner needle. Including the configuration.
In the outer tube and the inner needle where the restricting portion is formed, a male screw is formed on one side and a female screw is formed on the other, and the relative movement between the outer tube and the inner needle is restricted by the engagement of the male screw and the female screw. Is also possible.

１ 穿刺針
１０ 内針
１１、４１、４３、４４、４５、４６、４７ 中心軸
２０ 内針基部
２１ 開口部
２２ 基端面部
２３ 側壁部
２４ 内腔部
２５ 筒状部
２６ 凸部
２７ 窓部
２８、３３、５５ リブ部
２９ フランジ部
３０ 針部
３１ 針先
３２ 刃面
４０ 外筒管
４２ 内腔部
４８ａ、４８ｂ、４８ｃ 屈曲点
４９ 突起
５０ 外筒基部
５１ 基端開口部
５２ 内腔部
５３ ねじ部
５４ 翼部
５６ 凹部
５７ 入口
５８ 交差状案内部
５９ 段差
６０ 筒状体
６１ 筒先
６２ 先端開口部
６３ 先端部
６４ 内腔部
６５ 係留部
６６ 終端
Ａ 規制部 DESCRIPTION OF SYMBOLS 1 Puncture needle 10 Inner needle 11, 41, 43, 44, 45, 46, 47 Center axis 20 Inner needle base 21 Opening part 22 Base end face part 23 Side wall part 24 Lumen part 25 Tubular part 26 Projection part 27 Window part 28 , 33, 55 Rib portion 29 Flange portion 30 Needle portion 31 Needle tip 32 Blade surface 40 Outer tube 42 Inner lumen portion 48a, 48b, 48c Bending point 49 Projection 50 Outer cylinder base portion 51 Base end opening portion 52 Inner lumen portion 53 Screw Portions 54 Wings 56 Recesses 57 Entrances 58 Crossing guides 59 Steps 60 Tubular bodies 61 Tube tips 62 Tip openings 63 Tips 64 Lumens 65 Anchors 66 Terminations A Restrictions

Claims (12)

湾曲形状の先端部を有する外筒管と、該外筒管の内部に挿入される内針とを含む穿刺針であって、
前記外筒管の一端側と前記内針の一端側とが互いに係合することによって、前記外筒管と前記内針との相対的な移動を規制する規制部を備え、
前記規制部は、
外筒管又は内針の前記一端側に設けられた線状係合部と、
内針又は外筒管の前記一端側に設けられ、前記線状係合部に沿って案内される点状係合部と、を含み、
前記線状係合部は、前記外筒管又は前記内針の長手方向に対して交差する方向に伸びる交差状案内部を含む、
穿刺針。 A puncture needle including an outer tube having a curved tip and an inner needle inserted into the outer tube,
A restriction portion for restricting relative movement between the outer tube and the inner needle by engaging one end of the outer tube and one end of the inner needle;
The regulation part is
A linear engagement portion provided on the one end side of the outer tube or the inner needle;
A point-like engagement portion provided on the one end side of the inner needle or the outer tube and guided along the linear engagement portion,
The linear engagement portion includes a cross-shaped guide portion extending in a direction crossing the longitudinal direction of the outer tube or the inner needle.
Puncture needle. 前記内針は、長手方向中心軸上からずれた位置に針先が設けられており、
前記線状形状部に沿って案内される点状係合部の動きに対応して前記内針の針先を移動させる、請求項１に記載の穿刺針。 The inner needle is provided with a needle tip at a position displaced from the longitudinal central axis,
The puncture needle according to claim 1, wherein the needle tip of the inner needle is moved in accordance with the movement of the point-like engagement portion guided along the linear shape portion. 前記交差状案内部が、前記長手方向に対して巻回する螺旋形状を含む、請求項１または２に記載の穿刺針。   The puncture needle according to claim 1 or 2, wherein the intersecting guide portion includes a spiral shape wound around the longitudinal direction. 前記螺旋形状は、ピッチ間隔が２．０〜６．０ｍｍとなるように形成された、請求項３に記載の穿刺針。   The puncture needle according to claim 3, wherein the spiral shape is formed so that a pitch interval is 2.0 to 6.0 mm. 前記線状係合部が、前記外筒管又は前記内針の長手方向に対する角度が変化する屈曲点を有し、該屈曲点に対し、前記外筒管の内部に内針を挿入する時に相対的に進行する側に位置する部分の前記角度が、進行する側とは反対側に位置する部分の前記角度より大きい屈曲部を有する、請求項１〜４のいずれかに記載の穿刺針。   The linear engaging portion has a bending point at which an angle with respect to the longitudinal direction of the outer tube or the inner needle changes, and is relative to the bending point when the inner needle is inserted into the outer tube. The puncture needle according to any one of claims 1 to 4, wherein the angle of the portion located on the side of the progressive movement has a bent portion larger than the angle of the portion located on the opposite side of the progression side. 前記線状係合部は、抵抗要素を有する、請求項１〜５のいずれかに記載の穿刺針。   The puncture needle according to any one of claims 1 to 5, wherein the linear engagement portion includes a resistance element. 前記点状係合部は、凸部であり、前記線状係合部は、前記外筒管又は前記内針の長手方向の所定範囲に連続して伸び、前記凸部を受け入れる凹部である、請求項１〜６のいずれかに記載の穿刺針。   The point-like engaging portion is a convex portion, and the linear engaging portion is a concave portion that continuously extends in a predetermined range in the longitudinal direction of the outer tube or the inner needle and receives the convex portion. The puncture needle according to any one of claims 1 to 6. 前記凹部は、前記外筒管の内部に内針を挿入する時に前記凸部を最初に受け入れる入口を有し、その幅が、凹部の他の部分の幅に比べて広い、請求項７に記載の穿刺針。   The said recessed part has an entrance which receives the said convex part first when inserting an inner needle into the inside of the said outer cylinder pipe | tube, The width | variety is wider compared with the width | variety of the other part of a recessed part. Puncture needle. 前記凹部は、前記入口から前記凸部が凹部に対して相対的に進行する方向に向かうに従いその幅が狭くなる部分を含む、請求項８に記載の穿刺針。   The puncture needle according to claim 8, wherein the concave portion includes a portion whose width becomes narrower from the entrance toward the direction in which the convex portion advances relative to the concave portion. 前記凹部には、前記凸部に係り合って、当該凸部を留める係留部が形成される、請求項７〜９のいずれかに記載の穿刺針。   The puncture needle according to any one of claims 7 to 9, wherein an anchoring portion that engages with the convex portion and fastens the convex portion is formed in the concave portion. 前記係留部は、突起である、請求項１０に記載の穿刺針。   The puncture needle according to claim 10, wherein the anchoring portion is a protrusion. 前記外筒管は、前記内針が挿着されると前記湾曲形状の先端部が直線形状となり、当該内針が抜去されると先端部が湾曲形状に戻る、１〜１１のいずれかに記載の穿刺針。   The outer cylindrical tube has any one of 1 to 11, wherein the curved tip portion is linear when the inner needle is inserted, and the tip portion returns to a curved shape when the inner needle is removed. Puncture needle.
JP2013233778A 2013-11-12 2013-11-12 Puncture needle Pending JP2015093035A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190000135U (en) * 2017-07-06 2019-01-16 이현우 Drainage set of medical suction unit
JP2022500150A (en) * 2018-09-14 2022-01-04 マンセル、ジョン Implantable nerve block intervention

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190000135U (en) * 2017-07-06 2019-01-16 이현우 Drainage set of medical suction unit
KR200488954Y1 (en) 2017-07-06 2019-04-09 이현우 Drainage set of medical suction unit
JP2022500150A (en) * 2018-09-14 2022-01-04 マンセル、ジョン Implantable nerve block intervention
JP7491908B2 (en) 2018-09-14 2024-05-28 マンセル、ジョン Implantable nerve blocking interventions

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