JP4133867B2 - Medical needle - Google Patents
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- JP4133867B2 JP4133867B2 JP2004053622A JP2004053622A JP4133867B2 JP 4133867 B2 JP4133867 B2 JP 4133867B2 JP 2004053622 A JP2004053622 A JP 2004053622A JP 2004053622 A JP2004053622 A JP 2004053622A JP 4133867 B2 JP4133867 B2 JP 4133867B2
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Description
本発明は、医療用針に関する。 The present invention relates to a medical needle.
従来、吸引・排液用のカテーテル留置の目的で実施されている皮下トンネル法によるカテーテル留置において、カテーテルを一端に取り付けた状態で生体組織を貫通し、カテーテル留置のための貫通孔を形成するために、他端が針状又はメス状に鋭利な形状を成す穿刺針が広く使用されている。創傷部から吸引を要する皮下部位に、先端に複数個の吸引口を有する吸引・排液用のカテーテルを配置し、創傷部近くの皮膚組織内側より体外に向けて穿刺針を貫通させ、吸引・排液用のカテーテルを引き出す。切開部の縫合、チューブ固定をした後、ハサミ等で針と接続部付近の吸引・排液用のカテーテルを切断して、吸引器に接続し、吸引・排液排出を行う。穿刺針は、先端部は針状に尖り、その他端は吸引・排液用のカテーテル等を装着できるようにゴム止め状に段差が形成されている。針全体形状は一般に先端部付近で若干湾曲しているのが特徴である。 Conventionally, in the catheter placement by the subcutaneous tunnel method, which has been performed for the purpose of placing a catheter for suction and drainage, in order to penetrate a living tissue with the catheter attached to one end, and to form a through hole for catheter placement In addition, puncture needles whose other end has a sharp shape like a needle or a female are widely used. A suction / drainage catheter with a plurality of suction ports at the tip is placed in the subcutaneous site that requires suction from the wound part, and the puncture needle penetrates from the inside of the skin tissue near the wound part to the outside of the body. Pull out the catheter for drainage. After the incision is sutured and the tube is fixed, the needle and the catheter for suction / drainage near the connection part are cut with scissors and the like, connected to a suction device, and suction / drainage is performed. The tip of the puncture needle is pointed like a needle, and the other end is formed with a step like a rubber stopper so that a suction / drainage catheter or the like can be attached. The overall shape of the needle is generally slightly curved near the tip.
従来品では、針の穿刺性が悪いことから針穿刺性向上が求められる一方、手術時に血液や体液等が針表面に付着し、手が滑ることによる術者の指先や手の損傷、あるいは患者の臓器、皮膚の損傷の危険性があった。これらの問題を解決すべく針本体部の一部に凹みや段差の把持部を設けることで針を滑ることなく把持し、更に刃付け部の手元よりの部分を鈍状に仕上げ加工することで、万一、滑りを生じた場合でも術者の指先や手に傷を負わせることなく、刃先のみ鋭利で刃の手元側は切れ味を鈍らせているため、患者にも必要以上の侵襲を与えない針を開示している。（例えば特許文献１）しかしながら、この針仕様では昨今の針穿刺性向上の要求を満たすことが出来なく、穿刺性の点で問題であった。更に従来品は針とカテーテルの接続部において、カテーテルの肉厚を考慮した設計になっておらず、段差が出来るために針通過抵抗が高くなり、操作性が悪いという問題点もあった。
創傷部の術後吸引・排液用のカテーテルに取り付けて使用する生体組織貫通用の医療用針において、針穿刺抵抗、針抜去抵抗が低く、カテーテル留置操作が容易に行える医療用針を提供することである。 Provided is a medical needle for penetrating a living tissue that is used by attaching to a catheter for suction / drainage after surgery of a wound part, and provides a medical needle that has low needle puncture resistance and needle removal resistance and can be easily placed in a catheter. That is.
このような目的は、下記（１）〜（４）に記載の本発明により達成される。
（１）創傷部の術後・排液用のカテーテルに取り付けて使用する生体組織貫通用の先端部に穿刺部を有し、かつ前記穿刺部に刃付け終了部を有する医療用針にあって、前記穿刺部の刃付け終了部の断面積が４０〜６０％であると共に、前記穿刺部の後端側に外径２〜３ｍｍ、長さ１０〜２０ｍｍのストレート部と、該ストレート部の先端側及び後端側に各々設置されたテーパー部とから構成され素手で最適な穿刺の方向付けができる曲げ部を有していることを特徴とする医療用針。
（２）前記医療用針の後端部には、前記カテーテルを接続する手段を有するものである（１）に記載の医療用針。
（３）前記接続する手段が少なくとも１つの段差を有するものである（２）に記載の医療用針。
（４）前記接続する手段に、前記カテーテルを接続したカテーテル後端部の最大外径と医療用針の最大外径が、以下の式で表される（２）又は（３）に記載の医療用針。
−１０≧１００ｘ（Ａ−Ｂ）／Ｂ≦１０
Ａ：接続したカテーテル後端部の最大外径
Ｂ：医療用針の最大外径
Such objects are achieved by the present invention defined in the following (1) to (4).
(1) A medical needle having a puncture portion at a distal end portion for penetrating a living tissue to be used after being attached to a catheter for drainage after surgery of a wound portion, and having a cutting end portion at the puncture portion The cross-sectional area of the cutting end portion of the puncture portion is 40 to 60%, a straight portion having an outer diameter of 2 to 3 mm and a length of 10 to 20 mm on the rear end side of the puncture portion, and the tip of the straight portion A medical needle characterized in that it has a bent portion that is composed of a tapered portion that is installed on each of the side and rear end sides and that can be optimally oriented with a bare hand .
( 2 ) The medical needle according to (1), having means for connecting the catheter to a rear end portion of the medical needle.
( 3 ) The medical needle according to ( 2 ), wherein the connecting means has at least one step.
( 4 ) The medical device according to ( 2) or ( 3 ), wherein the maximum outer diameter of the rear end of the catheter connected to the catheter and the maximum outer diameter of the medical needle are connected to the connecting means. Needle.
−10 ≧ 100x (A−B) / B ≦ 10
A: Maximum outer diameter of connected catheter rear end B: Maximum outer diameter of medical needle
本発明の医療用針は、針断面積に対する刃付け終了部の断面積比率の最適化、及び刃面周囲の穿刺刃設置による針穿刺性の向上、更に、針とカテーテルの接続段差を無くすことで針の操作性が向上するという利点がある。 The medical needle of the present invention optimizes the cross-sectional area ratio of the end portion of the blade with respect to the cross-sectional area of the needle, improves the needle puncture property by installing the puncture blade around the blade surface, and eliminates the step difference between the needle and the catheter. This has the advantage that the operability of the needle is improved.
以下、図１〜３をもとに本発明を詳細に説明する。 Hereinafter, the present invention will be described in detail with reference to FIGS.
図１は、医療用針の正面図である。図２は、穿刺部の刃先角を示した正面図である。図３、医療用針後端部に設けられているカテーテルを接続する手段に、カテーテル（１１）を接続した状態を示す正面図である。
医療用針（１）は穿刺部（２）と曲げ部（３）とカテーテル接続部（４）からなる。穿刺部（２）は刃付け部（５）と刃面（６）とからなり、刃付け部（５）は実際に皮下組織を切り裂く役割を成し、刃面（６）の交線に位置し、鋭角になっているか、或いは鋭利な剃刀刃が設置されている。刃面（６）は医療用針（１）の先端部分に刃付け部（５）が設置できるよう、カットした面である。そして、刃付け部（５）末端には刃付け終了部（１２）がある。曲げ部（３）はテーパー部（７）とストレート部（８）からなる。カテーテル接続部（４）には段差（９）が設けられている。
刃先角（１０）は、医療用針長手方向に対する刃付け部（５）の穿刺角度である。
FIG. 1 is a front view of a medical needle. FIG. 2 is a front view showing the edge angle of the puncture portion. FIG. 3 is a front view showing a state in which the catheter (11) is connected to the means for connecting the catheter provided at the rear end of the medical needle.
The medical needle (1) includes a puncture portion (2), a bending portion (3), and a catheter connection portion (4). The puncture part (2) is composed of a bladed part (5) and a blade surface (6), and the bladed part (5) actually plays the role of tearing the subcutaneous tissue and is located at the intersection of the blade surface (6) However, it has an acute angle or a sharp razor blade. The blade surface (6) is a cut surface so that the blade attaching portion (5) can be installed at the distal end portion of the medical needle (1). And there exists a blade end part (12) in a blade attachment part (5) end. The bending part (3) consists of a taper part (7) and a straight part (8). The catheter connection (4) is provided with a step (9).
The blade edge angle (10) is the puncture angle of the blade attachment portion (5) with respect to the longitudinal direction of the medical needle.
医療用針（１）は金属加工品であり、その材質は特に限定されるものではないが、針の加工性と曲げ剛性を鑑み、ステンレスやアルミ等の金属類が好ましい。医療用針（１）の外径は接続する吸引・排液用のカテーテル（１１）外径に因り決まる。針断面積に対する刃付け終了部の断面積の比率は、４０〜６０％で、さらに好ましくは５０〜６０％である。針断面積に対する刃付け終了部の断面積の比率が６０％を超えると、2面の開角が大きくなり過ぎ、針挿入抵抗が大きくなり好ましくない。また、４０％未満では、２面の開角が小さくなり過ぎ、針先の耐久性能が低下するだけでなく、刃付け終了部（１２）以降、針径と同等断面積まで開口させる比率が大きく、抵抗が増し、好ましくない。また、針の穿刺性向上のため、医療用針（１）の穿刺部（２）の刃先角（１０）は、特に限定されないが、２０〜３０°が好ましく、２０〜２５がさらに好ましい。刃先角（１０）は３０°を超えると針先の針穿刺性能が低下するため、また２０°未満では針先の耐久性能の低下となり好ましくない。更に針穿刺性向上の点で、刃面周囲は面取り加工を行うのではなく、周囲にエッジを施す加工が好ましく、刃付けを行った穿刺刃（１３）とすることは更に好ましい。 The medical needle (1) is a metal processed product, and the material is not particularly limited, but metals such as stainless steel and aluminum are preferable in view of the workability and bending rigidity of the needle. The outer diameter of the medical needle (1) is determined by the outer diameter of the connected suction / drainage catheter (11). The ratio of the cross-sectional area of the cutting end portion to the needle cross-sectional area is 40 to 60%, more preferably 50 to 60%. If the ratio of the cross-sectional area of the cutting end portion to the cross-sectional area of the needle exceeds 60%, the opening angle of the two surfaces becomes too large, and the needle insertion resistance increases, which is not preferable. In addition, if it is less than 40%, the opening angle of the two surfaces becomes too small, and the durability performance of the needle tip not only decreases, but also the ratio of opening to the same cross-sectional area as the needle diameter after the blade end portion (12) is large. , Resistance is increased, which is not preferable. In order to improve the puncture property of the needle, the edge angle (10) of the puncture portion (2) of the medical needle (1) is not particularly limited, but is preferably 20 to 30 °, and more preferably 20 to 25. If the blade edge angle (10) exceeds 30 °, the needle puncture performance of the needle tip will deteriorate, and if it is less than 20 °, the durability performance of the needle tip will deteriorate, which is not preferable. Further, from the viewpoint of improving needle puncture performance, the periphery of the blade surface is preferably not chamfered, but is preferably processed to give an edge to the periphery, and a puncture blade (13) having a blade attached is more preferable.
また、体腔内は限られたスペースであるため、特に限定されないが、針先を穿刺方向へ折り曲げ、穿刺の方向付けができる仕様であることが望ましい。そのため、図１、図２、図３の針中央に針曲げ部（３）を設置した図を示した。更にその針曲げ部（３）を把持することで針を確実に把持出来るため、好ましい。その針曲げ部（３）の位置は、特に限定されないが、穿刺部（２）から１０ｍｍ以上離れた位置から針中央部までに位置するのが好ましい。針中央部から針後端の位置では、針先から離れ過ぎているため、穿刺の方向付け、及び針先に力が伝わり難いため、針穿刺が困難となる。また、穿刺部から１０ｍｍ未満の位置では刃付け部（５）に近いため、手が滑ることによる術者の指先や手の損傷、あるいは患者の臓器、皮膚の損傷の危険性あることから好ましくない。また、テーパー部（７）の長さは、特に限定されないが、３〜１０ｍｍが好ましい。１０ｍｍを超えるとテーパー角度が緩やかになり過ぎ、そのテーパー部（７）で針を滑ることなく把持できないことから好ましくなく、３ｍｍ未満ではテーパー角度が急になり、針挿入においてテーパー部（７）が引っ掛かる恐れがあるため穿刺性の点で好ましくない。また、引っ掛かりを防止するため、テーパー部（７）の形状は、特に限定されないが、丸加工や、図２のように複数段のテーパー形状とすることが好ましく、特に３段テーパー形状が好ましい。ストレート部（８）の径は、特に限定されないが、２〜３ｍｍが好ましい。３ｍｍを超えると剛性が増し、素手で曲げるのが困難となり、２ｍｍ未満では針穿刺の際に針先の方向性を保つのが困難となるため好ましくない。また、ストレート部（８）の長さは、特に限定されないが、１０〜２０ｍｍが好ましい。２０ｍｍを超えると針全体の剛性が低くなり針穿刺の際、針先の方向性が保てなくなるため好ましくない。１０ｍｍ未満ではその部分を持ち、把持するのが困難となるため好ましくない。 Further, since the inside of the body cavity is a limited space, it is not particularly limited. However, it is desirable that the specification is such that the needle tip can be bent in the puncture direction and the puncture direction can be directed. Therefore, the figure which installed the needle | hook bending part (3) in the needle | hook center of FIG.1, FIG.2, FIG.3 was shown. Furthermore, it is preferable because the needle can be securely gripped by gripping the needle bending portion (3). The position of the needle bending portion (3) is not particularly limited, but it is preferably located from the position 10 mm or more away from the puncture portion (2) to the center of the needle. At the position from the center of the needle to the rear end of the needle, since it is too far from the needle tip, the direction of the puncture and the force is not easily transmitted to the needle tip, so that the needle puncture becomes difficult. Moreover, since it is close to the blade attachment portion (5) at a position less than 10 mm from the puncture portion, it is not preferable because there is a risk of damage to the operator's fingertips and hands due to slipping of hands, or damage to the patient's organs and skin. . Moreover, the length of a taper part (7) is although it does not specifically limit, 3-10 mm is preferable. If it exceeds 10 mm, the taper angle becomes too gentle, and the taper portion (7) is not preferable because the needle cannot be gripped without slipping. If it is less than 3 mm, the taper angle becomes steep, and the taper portion (7) is inserted during needle insertion. Since it may be caught, it is not preferable in terms of puncture. In order to prevent catching, the shape of the tapered portion (7) is not particularly limited, but it is preferably a round process or a multi-step tapered shape as shown in FIG. 2, and particularly a three-step tapered shape. Although the diameter of a straight part (8) is not specifically limited, 2-3 mm is preferable. If it exceeds 3 mm, the rigidity increases, making it difficult to bend with bare hands, and if it is less than 2 mm, it is difficult to maintain the direction of the needle tip during needle puncture, which is not preferable. Moreover, although the length of a straight part (8) is not specifically limited, 10-20 mm is preferable. If it exceeds 20 mm, the rigidity of the entire needle is lowered, and the needle tip directionality cannot be maintained during needle puncture, which is not preferable. If it is less than 10 mm, it will be difficult to hold that portion and grip it.
吸引・排液用のカテーテル（１１）をカテーテル接続部（４）の後端部の段差（９）に接続した際、その接続部におけるカテーテル最大外径（Ａ）と医療用針の最大外径（Ｂ）の関係が以下の式になるように、カテーテルの肉厚および／または段差の外径を設定することが好ましい。
−１０ ≦ １００ｘ（Ａ−Ｂ）／Ｂ ≦ １０
その最大外径が針外径の１０％を超えると、針穿刺時の通過抵抗が大きくなり過ぎ実使用上好ましくない。反対に−１０％未満では、留置カテーテルの径に比べ、針径が無意味に大きくなり、その分傷口が大きくなることから患者ＱＯＬの点で好ましくない。
段差（９）の数は、特に限定されるものではないが、２〜３段が好ましい。剛性のないシリコーン樹脂等の吸引・排液用のカテーテル（１１）との接続は、接着嵌合が望ましく、剛性のある塩化ビニル樹脂等のカテーテルは、段差部（４）の最大外径がカテーテル内腔に食い込みができる外径があり、垂直引張で３０Ｎ以上の嵌合強度があれば、嵌合のみで実用上の問題ない接続強度が得られる。また接着嵌合でないため、術者が接続することも可能である。
When the aspiration / drainage catheter (11) is connected to the step (9) at the rear end of the catheter connection part (4), the maximum catheter outer diameter (A) at the connection part and the maximum outer diameter of the medical needle It is preferable to set the thickness of the catheter and / or the outer diameter of the step so that the relationship of (B) becomes the following equation.
−10 ≦ 100x (A−B) / B ≦ 10
If the maximum outer diameter exceeds 10% of the needle outer diameter, the passage resistance at the time of needle puncture becomes too large, which is not preferable for practical use. On the other hand, if it is less than −10%, the needle diameter becomes meaninglessly larger than the diameter of the indwelling catheter, and the wound becomes larger by that amount, which is not preferable in terms of patient QOL.
The number of steps (9) is not particularly limited, but is preferably 2 to 3 steps. The connection with the catheter (11) for suction / drainage of non-rigid silicone resin or the like is desirably adhesive fitting, and the rigid vinyl chloride resin or the like has a stepped portion (4) having a maximum outer diameter of the catheter. If there is an outer diameter that can bite into the lumen and there is a fitting strength of 30 N or more by vertical tension, a connection strength with no practical problem can be obtained only by fitting. Moreover, since it is not adhesive fitting, an operator can also connect.
実使用において、まず、創傷部から吸引を要する皮下部位に、先端に複数個の吸引口を有する吸引・排液用のカテーテル（１１）を配置させる。術者は最適な針穿刺位置を決め、その方向に針先が向くよう、曲げ部（３）を折り曲げ、穿刺方向を決める。そして、曲げ部（３）を把持して、創傷部近くの皮膚組織内側より体外に向けて医療用針（１）を貫通させ、吸引・排液用のカテーテル（１１）を引き出す。そして、切開部の縫合、チューブの固定後、ハサミ等でカテーテル接続部（４）付近の吸引・排液用のカテーテル（１１）を切断して、吸引器に接続し、吸引・排液排出を行う。 In actual use, first, an aspiration / drainage catheter (11) having a plurality of suction ports at the tip is placed in a subcutaneous site requiring suction from a wound part. The surgeon determines the optimal needle puncture position, bends the bending portion (3) so that the needle tip is directed in that direction, and determines the puncture direction. Then, the bending part (3) is grasped, the medical needle (1) is penetrated from the inside of the skin tissue near the wound part to the outside of the body, and the suction / drainage catheter (11) is pulled out. After the incision is sutured and the tube is fixed, the suction / drainage catheter (11) in the vicinity of the catheter connection part (4) is cut with scissors or the like, and connected to the suction device to discharge the suction / drainage. Do.
本発明の医療用針は、創傷部の術後吸引・排液用のカテーテルに取り付けて使用する生体組織貫通用の医療用針において、針穿刺抵抗、針抜去抵抗が低く、カテーテル留置操作が容易に行える医療用針である。 The medical needle of the present invention is a medical needle for penetrating a living tissue that is used by attaching to a catheter for postoperative suction / drainage of a wound part, and has low needle puncture resistance and needle removal resistance, and easy catheter placement operation It is a medical needle that can be used in the future.
１ 医療用針
２ 穿刺部
３ 曲げ部
４ カテーテル接続部
５ 刃付け部
６ 刃面
７ テーパー部
８ ストレート部
９ 段差
１０ 刃先角
１１ 吸引・排液用のカテーテル
１２ 刃付け終了部
１３ 穿刺刃
DESCRIPTION OF SYMBOLS 1 Medical needle 2 Puncture part 3 Bending part 4 Catheter connection part 5 Cutting part 6 Blade surface 7
Claims (4)
−１０≧１００ｘ（Ａ−Ｂ）／Ｂ≦１０
Ａ：接続したカテーテル後端部の最大外径
Ｂ：医療用針の最大外径 The medical needle according to claim 2 or 3 , wherein the maximum outer diameter of the rear end of the catheter connected to the catheter and the maximum outer diameter of the medical needle are connected to the connecting means by the following formula.
−10 ≧ 100x (A−B) / B ≦ 10
A: Maximum outer diameter of connected catheter rear end B: Maximum outer diameter of medical needle
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2004053622A JP4133867B2 (en) | 2004-02-27 | 2004-02-27 | Medical needle |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2004053622A JP4133867B2 (en) | 2004-02-27 | 2004-02-27 | Medical needle |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2005237763A JP2005237763A (en) | 2005-09-08 |
| JP4133867B2 true JP4133867B2 (en) | 2008-08-13 |
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| JP2004053622A Expired - Fee Related JP4133867B2 (en) | 2004-02-27 | 2004-02-27 | Medical needle |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014167756A1 (en) | 2013-04-08 | 2014-10-16 | オリンパス株式会社 | Injection needle |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4801561B2 (en) * | 2006-10-11 | 2011-10-26 | 日本シャーウッド株式会社 | Medical needle puller |
| JP5352168B2 (en) * | 2008-09-12 | 2013-11-27 | 日本コヴィディエン株式会社 | Connection structure of medical needle and medical tube |
| JP6164698B2 (en) * | 2011-12-07 | 2017-07-19 | リサーチ メディカル プロプライエタリー リミテッドＲｅｓｅａｒｃｈ Ｍｅｄｉｃａｌ Ｐｔｙ Ｌｔｄ | Surgical trocar |
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2004
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014167756A1 (en) | 2013-04-08 | 2014-10-16 | オリンパス株式会社 | Injection needle |
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| JP2005237763A (en) | 2005-09-08 |
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