JP2015160093A - puncture needle - Google Patents
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- JP2015160093A JP2015160093A JP2014038833A JP2014038833A JP2015160093A JP 2015160093 A JP2015160093 A JP 2015160093A JP 2014038833 A JP2014038833 A JP 2014038833A JP 2014038833 A JP2014038833 A JP 2014038833A JP 2015160093 A JP2015160093 A JP 2015160093A
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Abstract
Description
本発明は穿刺針に関し、詳しくはコアリングの防止に好適な穿刺針に関する。 The present invention relates to a puncture needle, and more particularly to a puncture needle suitable for preventing coring.
従来、穿刺針として様々な先端形状を有するものが知られ、例えば円筒状の針管の先端部分に、針管の軸心を斜めに交差する第１傾斜面と、当該第１傾斜面を切削して形成され、かつ上記軸心および第１傾斜面の中央を通過する中心面を挟んで形成された一対の第２傾斜面とを備えた穿刺針が知られている（特許文献１）。
この特許文献１の穿刺針は、例えば人工透析用の皮下埋め込み型カテーテルアクセスポートへの接続に使用する安全針組立体（特許文献２）に用いることが考えられ、上記穿刺針によって上記アクセスポートの内部空間を閉鎖するシリコーンゴム製等の蓋（セプタム）を貫通し、上記安全針組立体をアクセスポートの内部空間に連通させるようになっている。
そして特許文献１の穿刺針は、いわゆるコアリング、すなわち穿刺針が上記アクセスポートの蓋を貫通する際に、蓋の一部が断裂して微細な破片が穿刺針の内部通路等に残ってしまう問題を解決するための構成を有している。
すなわち上記特許文献１では、上記針管に形成された内部通路の開口部の一部を、ショットブラスト等によって丸形状に加工し、当該丸形状によって蓋を断裂させないようにしている。
Conventionally, puncture needles having various tip shapes are known. For example, a first inclined surface that obliquely intersects the axis of the needle tube at the tip portion of a cylindrical needle tube, and the first inclined surface are cut. A puncture needle is known that includes a pair of second inclined surfaces that are formed and sandwiched between the axis and a central surface that passes through the center of the first inclined surface (Patent Document 1).
The puncture needle of this Patent Document 1 is considered to be used for, for example, a safety needle assembly (Patent Document 2) used for connection to a subcutaneously implantable catheter access port for artificial dialysis. The safety needle assembly is communicated with the internal space of the access port through a lid (septum) made of silicone rubber or the like that closes the internal space.
The puncture needle of Patent Document 1 is a so-called coring, that is, when the puncture needle penetrates the lid of the access port, a part of the lid is torn and fine fragments remain in the internal passage or the like of the puncture needle. It has a configuration for solving the problem.
That is, in Patent Document 1, a part of the opening portion of the internal passage formed in the needle tube is processed into a round shape by shot blasting or the like so that the lid is not torn by the round shape.
しかしながら上記特許文献１の構成では、上記丸形状を開口部の一部にのみ形成するため、その加工が煩雑であって加工コストが高いという問題があり、また完全にはコアリングの発生を防止できていないという問題もあった。
このような問題に鑑み、本発明は低コストで製造することができ、またコアリングの発生をより抑制することが可能な穿刺針を提供するものである。
However, in the configuration of Patent Document 1, since the round shape is formed only in a part of the opening, there is a problem that the processing is complicated and the processing cost is high, and the generation of coring is completely prevented. There was also a problem that it was not done.
In view of such a problem, the present invention provides a puncture needle that can be manufactured at low cost and can further suppress the occurrence of coring.
すなわち本発明にかかる穿刺針は、円筒状の針管の先端部分に、針管の軸心を斜めに交差する第１傾斜面と、当該第１傾斜面を切削して形成され、かつ上記軸心および第１傾斜面の中央を通過する中心面を挟んで形成された一対の第２傾斜面とを備えた穿刺針において、
上記一対の第２傾斜面を上記針管に形成された内部通路の開口部の後側まで形成して、上記第１傾斜面と上記第２傾斜面とによって形成される稜線が、上記開口部の後部で該開口部と交差するようにし、かつ当該稜線の先端が、上記開口部を構成する上記第２傾斜面の縁部の最後端の位置よりも先端側に突出するようにしたことを特徴としている。
That is, the puncture needle according to the present invention is formed at the distal end portion of a cylindrical needle tube by forming a first inclined surface that obliquely intersects the axis of the needle tube, and cutting the first inclined surface. In a puncture needle comprising a pair of second inclined surfaces formed across a central surface passing through the center of the first inclined surface,
The pair of second inclined surfaces are formed to the rear side of the opening portion of the internal passage formed in the needle tube, and a ridge line formed by the first inclined surface and the second inclined surface is formed on the opening portion. The rear portion intersects with the opening, and the tip of the ridge line protrudes to the tip side from the position of the rear end of the edge of the second inclined surface constituting the opening. It is said.
上記発明によれば、針管に第１傾斜面および第２傾斜面を形成するだけでよく、特許文献１のようにショットブラスト等による加工が不要であり、安価に製造することができる。
また後述する実験結果からも明らかなように、本発明にかかる穿刺針を用いた場合、特許文献１の構成を有する穿刺針よりもコアリングの発生を抑制できることが確認できた。
According to the above-described invention, it is only necessary to form the first inclined surface and the second inclined surface on the needle tube, and processing such as shot blasting as in Patent Document 1 is unnecessary, and the needle tube can be manufactured at low cost.
Further, as is clear from the experimental results described later, it was confirmed that when the puncture needle according to the present invention was used, the occurrence of coring could be suppressed as compared with the puncture needle having the configuration of Patent Document 1.
以下図示実施例について説明すると、図１は穿刺針１の先端部分の拡大図を示し（ａ）は平面図を（ｂ）は側面図をそれぞれ示し、また図２は当該穿刺針１の先端部分の斜視図を示したものとなっている。
上記穿刺針１は、上記特許文献２に記載されるような安全針組立体に使用することができ、より具体的には皮下埋め込み型カテーテルアクセスポートに接続するためのフーバー針組立体に使用することができる。
このような安全針組立体では、上記穿刺針１を人体に穿刺することで、皮下に埋め込まれた上記アクセスポートの蓋（セプタム）を穿刺し、これにより安全針組立体を上記アクセスポートの内部空間に連通させるようになっている。
しかしながら、上記アクセスポートの蓋を穿刺針１が貫通する際に、上記蓋の一部が穿刺針１によって断裂して微細な破片となり、当該微細な破片が穿刺針の内部に流入する、いわゆるコアリングの問題があることから、穿刺針１の先端形状については当該コアリングを防止するための様々な形状が提案されてきた。
本実施例の穿刺針１は、上記コアリングを防止するために以下に述べる構成を有し、また後述する実験結果によって、良好にコアリングを防止できることを確認できた。
1 is an enlarged view of the distal end portion of the puncture needle 1, FIG. 1A is a plan view, FIG. 2B is a side view, and FIG. The perspective view is shown.
The puncture needle 1 can be used in a safety needle assembly as described in Patent Document 2, and more specifically, in a Hoover needle assembly for connection to a subcutaneously implantable catheter access port. be able to.
In such a safety needle assembly, the puncture needle 1 is punctured into a human body, thereby puncturing a cover (septum) of the access port embedded under the skin, whereby the safety needle assembly is placed inside the access port. It is designed to communicate with the space.
However, when the puncture needle 1 penetrates the lid of the access port, a part of the lid is torn by the puncture needle 1 to become a fine fragment, and the fine fragment flows into the puncture needle. Because of the ring problem, various shapes for preventing the coring have been proposed for the tip shape of the puncture needle 1.
The puncture needle 1 of this example has the following configuration in order to prevent the coring, and it has been confirmed that the coring can be satisfactorily prevented by the experimental results described later.
上記穿刺針１はステンレス合金などによって製造された円筒状の針管１ａを切削したものであり、当該針管１ａの肉厚は直径に対して１６〜３０％に設定されている。
そして上記針管１ａの先端部分には、当該針管１ａの軸心を斜めに交差するように切削した第１傾斜面２と、当該第１傾斜面２を切削した一対の第２傾斜面３と、針管１ａの内部通路１ｂが上記第１、第２傾斜面２、３に開口した開口部４とが形成されている。
なお以下の説明では、図１の図示右方を穿刺針１の先端、図示左方を後端と呼び、また上記針管１ａの軸心を通過して図１（ａ）の紙面に対して直交する平面を中心面Ｃとよぶ。
The puncture needle 1 is obtained by cutting a cylindrical needle tube 1a made of a stainless alloy or the like, and the thickness of the needle tube 1a is set to 16 to 30% with respect to the diameter.
And at the tip portion of the needle tube 1a, a first inclined surface 2 cut so as to obliquely intersect the axis of the needle tube 1a, a pair of second inclined surfaces 3 cut from the first inclined surface 2, and An opening 4 is formed in which the internal passage 1b of the needle tube 1a is opened in the first and second inclined surfaces 2 and 3.
In the following description, the right side in FIG. 1 is referred to as the tip of the puncture needle 1 and the left side in the drawing is referred to as the rear end, and passes through the axis of the needle tube 1a and is orthogonal to the paper surface of FIG. The plane to be called is the center plane C.
上記記第１傾斜面２は上記穿刺針１を製造する際に最初に切削され、図２に示すように上記中心面Ｃと直交する面に対して傾斜角１５〜１７°の範囲で切削されている。
次に、上記第２傾斜面３は上記中心面Ｃを挟んで対称となるように形成され、上記第１傾斜面２が加工された針管１ａをそれぞれ６０〜８０の範囲で正逆に回転させ、さらに上記中心面Ｃに直交した面に対して傾斜角１５〜１７°の範囲で上記第１傾斜面２を切削することで得られるようになっている。
これら一対の第２傾斜面３は、上記第１傾斜面２によって形成された開口部の範囲内で交差するように切削され、これにより上記一対の第２傾斜面３が上記開口部４の後側まで位置するようになっている。
その結果、上記開口部４の前側では、上記第２傾斜面３と第２傾斜面３とが交差することによって形成された第１稜線Ｒ１が上記中心面Ｃに沿って形成されるようになっている。
一方、上記開口部４の後側では、上記第１傾斜面２と上記第２傾斜面３とによって形成される第２稜線Ｒ２が、上記中心面Ｃを挟んで対称となるように形成されている。
これら第２稜線Ｒ２は、その先端が上記開口部４と交差しており、かつ当該
第２稜線Ｒ２の先端は、上記開口部４を構成する上記第２傾斜面３の縁部の最後端の位置（想像線で示す）よりも先端側に突出するようになっている。
The first inclined surface 2 is first cut when the puncture needle 1 is manufactured, and is cut within a range of an inclination angle of 15 to 17 ° with respect to a plane orthogonal to the central plane C as shown in FIG. ing.
Next, the second inclined surface 3 is formed so as to be symmetric with respect to the center plane C, and the needle tube 1a on which the first inclined surface 2 is processed is rotated in the forward and reverse directions in the range of 60 to 80, respectively. Furthermore, the first inclined surface 2 is obtained by cutting the first inclined surface 2 in a range of an inclination angle of 15 to 17 ° with respect to a plane orthogonal to the central plane C.
The pair of second inclined surfaces 3 are cut so as to intersect within the range of the opening formed by the first inclined surface 2, so that the pair of second inclined surfaces 3 are disposed behind the opening 4. It is located to the side.
As a result, on the front side of the opening 4, the first ridge line R1 formed by the intersection of the second inclined surface 3 and the second inclined surface 3 is formed along the center plane C. ing.
On the other hand, on the rear side of the opening 4, the second ridge line R2 formed by the first inclined surface 2 and the second inclined surface 3 is formed to be symmetric with respect to the center plane C. Yes.
The leading edges of the second ridge lines R2 intersect the opening 4 and the leading edges of the second ridge lines R2 are the rearmost ends of the edges of the second inclined surface 3 constituting the opening 4. It projects beyond the position (indicated by the imaginary line) toward the tip side.
このように、上記第２稜線Ｒ２の先端を上記第２傾斜面３の縁部の最後端の位置よりも先端側に突出させることで、穿刺針１を穿刺した場合におけるコアリングを防止することが可能となっている。
図３は本発明にかかる穿刺針１を用いた実験の結果を示す写真となっており、このうち（ａ）は直径が１．０５ｍｍ、肉厚が０．３１ｍｍの針管であり、直径に対する肉厚の割合を３０％とした穿刺針１を、（ｂ）は直径が１．０５ｍｍ、肉厚が０．１７ｍｍの針管であり、上記肉厚の割合を１６％とした穿刺針１を示している。
上記実験では、シリコーンゴム製のシートに各穿刺針１を複数回ずつ穿刺し、シリコーンゴムの微細な破片が内部通路に認められるか否かを測定し、その結果、本発明にかかる（ａ）（ｂ）の穿刺針１はいずれも良好にコアリングの発生を抑制するものであることが確認された。
In this way, by causing the distal end of the second ridge line R2 to protrude further toward the distal end side than the position of the rearmost end of the second inclined surface 3, coring when the puncture needle 1 is punctured is prevented. Is possible.
FIG. 3 is a photograph showing the results of an experiment using the puncture needle 1 according to the present invention, in which (a) is a needle tube having a diameter of 1.05 mm and a wall thickness of 0.31 mm. A puncture needle 1 with a thickness ratio of 30% is shown, (b) is a needle tube with a diameter of 1.05 mm and a wall thickness of 0.17 mm, and the puncture needle 1 with the thickness ratio of 16% is shown. Yes.
In the above experiment, each puncture needle 1 is punctured a plurality of times in a silicone rubber sheet, and it is measured whether or not fine debris of silicone rubber is observed in the internal passage. As a result, the present invention is applied to (a). It was confirmed that the puncture needle 1 of (b) satisfactorily suppressed the occurrence of coring.
上記実験結果に基づいて推察すると、上記第１稜線Ｒ１の形成された先端部分が最初にシートに刺入されると、その後（ａ）（ｂ）に示す本発明にかかる穿刺針１では、上記第２稜線Ｒ２の先端部分が上記第１、第２傾斜面２、３の縁部における最後端の位置よりも先にシートに接触することとなる。
その結果、この第２稜線Ｒ２の先端部分がシートを押さえ、その後この押さえられたシートの内側に穿刺針１が侵入し、結果として当該第２稜線Ｒ２の先端部の間に形成された上記第１傾斜面２の開口部４の縁部ではシートを断裂させず、コアリングが発生しないものと推察される。
そして、本発明にかかる穿刺針１においても、直径に対する肉厚の割合が高い（ａ）の穿刺針１のほうが、肉厚の割合が低い（ｂ）の穿刺針１よりもコアリングの発生が抑えられたことが確認でき、肉厚の割合を高くしたほうが望ましいことが判明した。
これは、直径に対する肉厚の割合が高い（ａ）の穿刺針１のほうが、上記第２稜線Ｒ２の先端部分をより第２傾斜面３の縁部の最後端の位置よりも先端側に突出させることができ、上記シートをより効果的に抑えることができたからであると推察される。
As inferred based on the experimental results, when the tip portion formed with the first ridge line R1 is first inserted into the sheet, the puncture needle 1 according to the present invention shown in (a) and (b) below The leading edge portion of the second ridgeline R2 comes into contact with the sheet before the position of the rearmost edge at the edge of the first and second inclined surfaces 2 and 3.
As a result, the distal end portion of the second ridge line R2 presses the sheet, and then the puncture needle 1 enters the inside of the pressed sheet, and as a result, the second ridge line R2 is formed between the distal end portions of the second ridge line R2. It is surmised that the sheet is not torn at the edge of the opening 4 of the inclined surface 2 and no coring occurs.
In the puncture needle 1 according to the present invention, coring is more likely to occur in the puncture needle 1 having a higher thickness ratio with respect to the diameter than in the puncture needle 1 having a lower thickness ratio (b). It was confirmed that it was suppressed, and it was found that it is desirable to increase the ratio of the wall thickness.
This is because the puncture needle 1 of (a) having a higher thickness ratio with respect to the diameter more protrudes the distal end portion of the second ridge line R2 to the distal end side than the position of the rearmost end of the edge of the second inclined surface 3. This is presumably because the sheet was more effectively suppressed.
以上のように、本発明にかかる（ａ）（ｂ）の穿刺針１は良好にコアリングを防止することができ、また上記穿刺針１は上記針管１ａに第１、第２傾斜面２、３を切削するだけであり、ショットブラスト等の別途の加工が不要であることから、安価に製造することが可能となっている。 As described above, the puncture needle 1 of (a) and (b) according to the present invention can satisfactorily prevent coring, and the puncture needle 1 is connected to the needle tube 1a by the first and second inclined surfaces 2, 3 is only cut, and no separate processing such as shot blasting is required, so that it can be manufactured at low cost.
なお、上記実施例では上記穿刺針１を上記アクセスポートの蓋（セプタム）に穿刺するための安全針組立体に用いているが、その他バイアルの蓋等を穿刺するための穿刺針１としても利用することが可能である。 In the above embodiment, the puncture needle 1 is used as a safety needle assembly for puncturing the lid (septum) of the access port. However, the puncture needle 1 is also used as a puncture needle 1 for puncturing a lid of a vial or the like. Is possible.
１ 穿刺針１ １ａ 針管１ａ
２ 第１傾斜面２ ３ 第２傾斜面３
４ 開口部４ Ｒ２ 第２稜線Ｒ２
1 Puncture needle 1 1a Needle tube 1a
2 First inclined surface 2 3 Second inclined surface 3
4 opening 4 R2 2nd ridgeline R2
Claims (3)
上記一対の第２傾斜面を上記針管に形成された内部通路の開口部の後側まで形成して、上記第１傾斜面と上記第２傾斜面とによって形成される稜線が、上記開口部の後部で該開口部と交差するようにし、かつ当該稜線の先端が、上記開口部を構成する上記第２傾斜面の縁部の最後端の位置よりも先端側に突出するようにしたことを特徴とする穿刺針。 A first inclined surface that obliquely intersects the axis of the needle tube and a first inclined surface that is formed by cutting the first inclined surface at the distal end portion of the cylindrical needle tube, and passes through the axis and the center of the first inclined surface. In the puncture needle provided with a pair of second inclined surfaces formed across the center surface,
The pair of second inclined surfaces are formed to the rear side of the opening portion of the internal passage formed in the needle tube, and a ridge line formed by the first inclined surface and the second inclined surface is formed on the opening portion. The rear portion intersects with the opening, and the tip of the ridge line protrudes to the tip side from the position of the rear end of the edge of the second inclined surface constituting the opening. A puncture needle.
上記第２傾斜面を、上記針管を上記軸心を中心に回転角度６０〜８０°の範囲で正逆に回転させて、当該回転した状態における上記第１傾斜面を上記中心面に直交する面に対して傾斜角１５〜１７°の範囲で切削して形成したことを特徴とする請求項１に記載の穿刺針。 The first inclined surface is provided in a range of 15 to 17 ° with respect to a surface orthogonal to the center surface,
The second inclined surface is a surface orthogonal to the central plane in the rotated state by rotating the needle tube in the forward and reverse directions within a rotation angle range of 60 to 80 degrees around the axis. The puncture needle according to claim 1, wherein the puncture needle is formed by cutting in a range of an inclination angle of 15 to 17 °.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014038833A JP6226134B2 (en) | 2014-02-28 | 2014-02-28 | Puncture needle |
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| JP2014038833A JP6226134B2 (en) | 2014-02-28 | 2014-02-28 | Puncture needle |
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| JP2015160093A true JP2015160093A (en) | 2015-09-07 |
| JP6226134B2 JP6226134B2 (en) | 2017-11-08 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006280503A (en) * | 2005-03-31 | 2006-10-19 | Nipro Corp | Needle for syringe |
| JP2007501062A (en) * | 2003-08-05 | 2007-01-25 | ベクトン・ディキンソン・アンド・カンパニー | Syringe with multiple beveled needles |
| CN202477967U (en) * | 2012-04-01 | 2012-10-10 | 蔡敏 | Disposable injection needle |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007501062A (en) * | 2003-08-05 | 2007-01-25 | ベクトン・ディキンソン・アンド・カンパニー | Syringe with multiple beveled needles |
| JP2006280503A (en) * | 2005-03-31 | 2006-10-19 | Nipro Corp | Needle for syringe |
| CN202477967U (en) * | 2012-04-01 | 2012-10-10 | 蔡敏 | Disposable injection needle |
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| JP6226134B2 (en) | 2017-11-08 |
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