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JP5500742B2 - Method for producing spinal subarachnoid anesthesia needle - Google Patents

Method for producing spinal subarachnoid anesthesia needle Download PDF

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JP5500742B2
JP5500742B2 JP2012062416A JP2012062416A JP5500742B2 JP 5500742 B2 JP5500742 B2 JP 5500742B2 JP 2012062416 A JP2012062416 A JP 2012062416A JP 2012062416 A JP2012062416 A JP 2012062416A JP 5500742 B2 JP5500742 B2 JP 5500742B2
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needle
opening
tip
anesthetic
anesthesia
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JP2012139529A (en
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英也 齋藤
徹 山崎
義雄 山之内
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Unisis Corp
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Description

本願発明は、脊椎くも膜下麻酔に用いる脊椎くも膜下麻酔針の製造方法に関する。   The present invention relates to a method for producing a spinal anesthesia needle used for spinal subarachnoid anesthesia.

脊椎くも膜下麻酔は、下半身局所麻酔として多用されている。通常のくも膜下麻酔針は、先端に刃先を有するものであるが、PDPHという術後に穿刺痕から流出した髄液圧の低下による頭痛が生じる場合がある。これは、麻酔針の刃先先端が鋭利なため、くも膜を穿刺したのちに髄液の流出がなかなか止まらないためと一般に解釈されている。これを回避するため、現在麻酔針を細くする傾向があるが、この他の方法として麻酔針先端に刃がついていないノンカット針(先端がペンシル状になっている)が開発され使用されている(特許文献1参照)。これは、一般に開発者の名前をとり、Whitacare・Sprotte と呼ばれるペンシルポイント針である。   Spinal subarachnoid anesthesia is frequently used as lower body local anesthesia. A normal subarachnoid anesthesia needle has a cutting edge at the tip, but a headache may occur due to a decrease in the cerebrospinal fluid pressure flowing out from the puncture mark after surgery called PDPH. This is generally interpreted as the outflow of cerebrospinal fluid does not stop easily after puncturing the arachnoid because the tip of the anesthetic needle is sharp. In order to avoid this, there is a current tendency to make the anesthetic needle thinner, but as another method, a non-cut needle (the tip of which is in a pencil shape) in which the tip of the anesthetic needle is not attached has been developed and used. (See Patent Document 1). This is a pencil point needle, generally named after the developer, called Whitcare / Sprotte.

図6、7は従来のくも膜下麻酔用の麻酔針11(ペンシルポイント針)の例を示し、図5は先端付近の平面図、図6は同じく側面図である。麻酔針11は、外径が一様な直管部12の先端に円錐状に先細りとなっている(ペンシル状)先端部13を備え、薬液を吐出する細長い開口14が形成されている。開口14は、全部又はほとんどの部分が直管部12に設けられている。麻酔針11の先端から開口14の先端までの距離aは2.0mm〜4.0mm程度、開口14の軸方向の長さbは3.0〜5.0mm程度である。ペンシルポイント針は、先端に刃がついていないため、くも膜の穿刺痕が小さく、髄液圧の低下が起こりにくいというメリットがある。また、刃先のついた麻酔針と比べて、くも膜を貫いた感覚が、術者にとってよくわかると一般にいわれている。   6 and 7 show an example of a conventional anesthetic needle 11 (pencil point needle) for subarachnoid anesthesia, FIG. 5 is a plan view of the vicinity of the tip, and FIG. 6 is a side view of the same. The anesthesia needle 11 is provided with a conical tapered (pencil-like) tip 13 at the tip of a straight tube portion 12 having a uniform outer diameter, and an elongated opening 14 for discharging a drug solution is formed. All or most of the opening 14 is provided in the straight pipe portion 12. The distance a from the tip of the anesthetic needle 11 to the tip of the opening 14 is about 2.0 mm to 4.0 mm, and the axial length b of the opening 14 is about 3.0 to 5.0 mm. Since the pencil point needle has no blade at the tip, there is a merit that the puncture mark of the arachnoid membrane is small and the decrease in cerebrospinal fluid pressure does not easily occur. In addition, it is generally said that the operator can easily understand the sense of penetrating the arachnoid membrane compared to an anesthetic needle with a blade edge.

図8は麻酔針11に開口14を形成する工程の説明図である。同図に示すように、開口14は、切削機の回転する円板状砥石15により麻酔針11の先端部分を切削して形成される。
実公平7−30031号公報
FIG. 8 is an explanatory diagram of the process of forming the opening 14 in the anesthetic needle 11. As shown in the figure, the opening 14 is formed by cutting the tip portion of the anesthetic needle 11 with a disk-shaped grindstone 15 rotated by a cutting machine.
No. 7-30031

前記のように、従来のペンシルポイント針は、開口がほとんど直管部に設けられている。このため、くも膜を貫いた後、針を開口全体がくも膜下に達するように十分に先に進めないと、所定部位まで針が到達したことを示す髄液のかえり(リコールバック)が確認できず、針を前進させすぎて神経を穿刺し、神経組織に損傷を与えるおそれがあった。
本発明は、ペンシルポイント針でありながら、くも膜を貫いた後、針を僅かに前進させるだけで、所定部位まで針が到達したことを示す髄液のかえり(リコールバック)を確認できるようにして、針を前進させすぎて神経組織に損傷を与えるおそれのない麻酔針を製造できるようにすることを目的としてなされたものである。
As described above, in the conventional pencil point needle, the opening is almost provided in the straight pipe portion. For this reason, after penetrating the arachnoid membrane, if the needle is not advanced sufficiently so that the entire opening reaches below the arachnoid, the cerebrospinal fluid return (recall back) indicating that the needle has reached the predetermined site cannot be confirmed. If the needle is advanced too much, the nerve may be punctured and the nerve tissue may be damaged.
Although the present invention is a pencil point needle, the needle can be slightly advanced after penetrating the arachnoid membrane, so that cerebrospinal fluid burr (recall back) indicating that the needle has reached a predetermined site can be confirmed. The purpose of the present invention is to make it possible to produce an anesthetic needle that does not cause the needle to be advanced too much and damage the nerve tissue.

本発明は、外径が一様な直管部の先端に円錐状に先細りとなっている先端部を備え、薬液を吐出する開口の全体が前記先端部に設けられている麻酔針の製造方法であって、該麻酔針の軸芯に対して25〜35°の角度で放電加工器の放電針を前記先端部に作用させることで、前記開口を開ける工程を有することを特徴とする脊椎くも膜下麻酔針の製造方法である。   The present invention provides a method for producing an anesthesia needle comprising a tip portion tapered in a conical shape at the tip of a straight tube portion having a uniform outer diameter, and an entire opening for discharging a drug solution is provided at the tip portion. A spinal arachnoid membrane comprising a step of opening the opening by causing a discharge needle of an electric discharge machine to act on the distal end portion at an angle of 25 to 35 ° with respect to the axis of the anesthetic needle. It is a manufacturing method of a lower anesthetic needle.

本発明方法で製造した麻酔針は、ペンシルポイント針であるので、くも膜の穿刺痕が小さく髄液圧の低下が起こりにくく、くも膜を貫いた感覚がわかりやすい。
また、開口全体が円錐状に先細りとなっている先端部に設けられているため、針先端がくも膜を穿刺した後、少ない前進量で直ちに開口全体がくも膜下に進入し、髄液のかえり(リコールバック)を速やかに確認することができ、針を前進させすぎて神経組織を穿刺してしまうおそれがない。
本発明は、麻酔針の軸芯に対して20〜40°の角度で放電加工器の放電針を先端部に作用させて開口を開けるようにすることで、前記効果を有する脊椎くも膜下麻酔針を容易に製造することができる。
Since the anesthesia needle manufactured by the method of the present invention is a pencil point needle, the puncture mark of the arachnoid membrane is small and the decrease in cerebrospinal fluid pressure does not easily occur, and the sense of penetrating the arachnoid membrane is easy to understand.
Further, since the entire opening is provided at the tip portion tapered in a conical shape, after the needle tip punctures the arachnoid, the entire opening immediately enters the subarachnoid with a small advance amount, and the cerebrospinal fluid is returned ( (Recall back) can be confirmed promptly, and there is no risk of puncturing the nerve tissue by advancing the needle too much.
The present invention provides a spinal subarachnoid anesthesia needle having the above-described effect by opening the opening by causing the discharge needle of the electric discharge machine to act on the tip at an angle of 20 to 40 ° with respect to the axis of the anesthetic needle. Can be easily manufactured.

本発明における麻酔針の太さは、従来のペンシルポイント針と同程度でよく、素材も従来のものと同等でよく、例えばステンレス製とすることができる。   The thickness of the anesthesia needle in the present invention may be the same as that of a conventional pencil point needle, and the material may be the same as that of a conventional one, and may be made of, for example, stainless steel.

本発明における麻酔針において、先端部の長さは1.5mm〜4.0mm程度が適当である。   In the anesthetic needle of the present invention, the length of the tip is suitably about 1.5 mm to 4.0 mm.

本発明における麻酔針は、針先端から前記開口の先端までの距離aが0.5mm〜1.5mmであることが望ましい。0.5mm未満にすることは困難なばかりでなく、針先端の強度が弱くなる。1.5mmを越えると少ない穿刺量で直ちに開口がくも膜下に進入し、髄液のかえり(リコールバック)を速やかに確認することができるという効果が低減する。なお、この場合の距離は、図1に示すように、軸芯に平行な方向に測定した距離である。   In the anesthetic needle according to the present invention, the distance a from the needle tip to the tip of the opening is desirably 0.5 mm to 1.5 mm. Not only is it difficult to make it less than 0.5 mm, but the strength of the needle tip is weakened. When the diameter exceeds 1.5 mm, the opening immediately enters the subarachnoid with a small amount of puncture, and the effect that the cerebrospinal fluid bounce (recall back) can be quickly confirmed is reduced. The distance in this case is a distance measured in a direction parallel to the axis as shown in FIG.

本発明における麻酔針は、開口の軸方向長さb(開口先端から後端までの長さ)は0.4mm〜1.0mm程度が適当である。   In the anesthetic needle according to the present invention, the axial length b of the opening (the length from the opening front end to the rear end) is suitably about 0.4 mm to 1.0 mm.

開口を形成する場合、従来は、麻酔針の軸芯に対して直角方向から円板状砥石15で切削加工していたが、本発明の製造方法においては、放電加工器を用いる。その放電針を麻酔針先端部に作用させる角度は、麻酔針の軸芯に対して20〜40°が適当である。この角度範囲をはずれると、開口の形状が不規則になりやすく、放電針の制御が難しくなる。   In the case of forming the opening, conventionally, the disk-shaped grindstone 15 was used to cut from the direction perpendicular to the axis of the anesthetic needle. However, in the manufacturing method of the present invention, an electric discharge machine is used. A suitable angle for causing the discharge needle to act on the tip of the anesthetic needle is 20 to 40 ° with respect to the axis of the anesthetic needle. Outside this angular range, the shape of the opening tends to be irregular, making it difficult to control the discharge needle.

以下、本発明を実施するための形態を図面に基づいて説明する。図1は本発明方法で製造した脊椎くも膜下麻酔針1の先端部付近の平面図、図2は同じく側面図、図3は図1における中央横断面図である。   Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. FIG. 1 is a plan view of the vicinity of the tip of a spinal subarachnoid anesthetic needle 1 manufactured by the method of the present invention, FIG. 2 is a side view, and FIG. 3 is a central cross-sectional view in FIG.

麻酔針1は、外径が一様な直管部2の先端に円錐状に先細りとなっている先端部3を備える。開口4は、その全体が先端部3に設けられている。直管部2の外径は0.72±0.01mm、内径は0.49±0.01mm、針先端から開口先端までの距離aは0.78mm、開口先端から後端までの長さbは0.62mm、先端部の長さは2.18mmである。開口4の幅は、当該部分の麻酔針の内径とほぼ等しくなるようにした。   The anesthesia needle 1 includes a distal end portion 3 that is tapered conically at the distal end of a straight tube portion 2 having a uniform outer diameter. The opening 4 is entirely provided at the tip 3. The straight pipe 2 has an outer diameter of 0.72 ± 0.01 mm, an inner diameter of 0.49 ± 0.01 mm, a distance a from the needle tip to the opening tip of 0.78 mm, and a length b from the opening tip to the rear end. Is 0.62 mm, and the tip length is 2.18 mm. The width of the opening 4 was set to be substantially equal to the inner diameter of the anesthetic needle in this portion.

図4は麻酔針1に開口を開ける方法の説明図である。まず、外径0.72±0.01mm、内径0.49±0.01mmのステンレス製管の先端をペンシルポイント状に加工し、円錐状に先細りとなっている先端部を設ける。ペンシルポイント状の加工は、従来周知の方法で行うことができる(例えば特開平11−207427号公報参照)。ペンシルポイント状に加工した針1を支持台5の載置板5aの上に固定する。載置台5aは水平面に対して60°傾いている。支持台5に固定した針1に対し、放電加工器の放電針6を垂直に下降させる。これにより、針1の軸芯に対して30°の角度で放電針6を麻酔針1の先端部3に作用させ、開口4を形成することができる。   FIG. 4 is an explanatory diagram of a method of opening an opening in the anesthetic needle 1. First, the tip of a stainless steel tube having an outer diameter of 0.72 ± 0.01 mm and an inner diameter of 0.49 ± 0.01 mm is processed into a pencil point shape, and a tip portion tapered in a conical shape is provided. The pencil point processing can be performed by a conventionally known method (for example, see Japanese Patent Application Laid-Open No. 11-207427). The needle 1 processed into a pencil point shape is fixed on the mounting plate 5 a of the support base 5. The mounting table 5a is inclined by 60 ° with respect to the horizontal plane. The discharge needle 6 of the electric discharge machine is lowered vertically with respect to the needle 1 fixed to the support base 5. As a result, the discharge needle 6 can act on the distal end portion 3 of the anesthetic needle 1 at an angle of 30 ° with respect to the axis of the needle 1 to form the opening 4.

前記の麻酔針1と、図5の従来の麻酔針11(外径0.72±0.01mm、内径0.49±0.01mm、a=2mm、b=3.1mm)について、リコールバックにかかる時間を測定した。
図5は、麻酔針1に内針7(スタイレット)を入れた状態でゴム管8を穿刺した状態を示している。
ビーカーに赤インクを3滴垂らし、100mlの精製水で希釈して試験液9を作成した。外径10mm、内径8mmのゴム管に90mmの水圧がかかるように試験液を満たした。麻酔針を、内針を入れた状態でゴム管に対して直角に穿刺し、開口が完全にゴム管内に挿入された状態にする。実施例の麻酔針1はゴム管内に少なくとも1.4mm挿入すればよいが、従来の麻酔針11は少なくとも5.1mm挿入する必要がある。
麻酔針の内針を測定者Aが声を掛けて抜くと同時に、測定者Bがストップウォッチで時間測定を開始する。麻酔針の後端から試験液が流出し始めたとき測定者Bがディテクションタイムを測定する。ディテクションタイムは、麻酔針1、11共に約2秒であった。本発明の麻酔針のリコールバックにかかる時間は、従来の麻酔針と遜色ないことが実証された。
The anesthetic needle 1 and the conventional anesthetic needle 11 (outer diameter 0.72 ± 0.01 mm, inner diameter 0.49 ± 0.01 mm, a = 2 mm, b = 3.1 mm) shown in FIG. 5 are recalled. This time was measured.
FIG. 5 shows a state where the rubber tube 8 is punctured with the inner needle 7 (stylet) inserted into the anesthetic needle 1.
Three drops of red ink were dropped in a beaker and diluted with 100 ml of purified water to prepare Test Solution 9. The test solution was filled so that a water pressure of 90 mm was applied to a rubber tube having an outer diameter of 10 mm and an inner diameter of 8 mm. The anesthesia needle is punctured at right angles to the rubber tube with the inner needle inserted, and the opening is completely inserted into the rubber tube. The anesthetic needle 1 of the embodiment may be inserted at least 1.4 mm into the rubber tube, but the conventional anesthetic needle 11 needs to be inserted at least 5.1 mm.
At the same time that the measurer A pulls out the inner needle of the anesthesia needle, the measurer B starts measuring time with a stopwatch. When the test liquid begins to flow out from the rear end of the anesthetic needle, the measurer B measures the detection time. The detection time for both the anesthetic needles 1 and 11 was about 2 seconds. It was demonstrated that the time required for recalling the anesthetic needle of the present invention is comparable to that of a conventional anesthetic needle.

本発明方法で製造した脊椎くも膜下麻酔針1の平面図である。It is a top view of the spinal subarachnoid anesthesia needle 1 manufactured by the method of the present invention. 麻酔針1の側面図である。1 is a side view of an anesthetic needle 1. FIG. 図1における中央横断面図である。It is a center cross-sectional view in FIG. 麻酔針1に開口を開ける方法の説明図である。It is explanatory drawing of the method of opening an opening in the anesthetic needle. リコールバックにかかる時間測定の説明図である。It is explanatory drawing of the time measurement concerning a recall back. 従来の麻酔針11の平面図である。It is a top view of the conventional anesthesia needle 11. FIG. 従来の麻酔針11の側面図である。It is a side view of the conventional anesthetic needle 11. 従来の麻酔針11に開口14を形成する工程の説明図である。It is explanatory drawing of the process of forming the opening 14 in the conventional anesthesia needle 11. FIG.

1 麻酔針
2 直管部
3 先端部
4 開口
5 支持台
6 放電針
7 内針
8 ゴム管
9 試験液
11 麻酔針
12 直管部
13 先端部
14 開口
15 砥石
DESCRIPTION OF SYMBOLS 1 Anesthetic needle 2 Straight pipe part 3 Tip part 4 Opening 5 Support stand 6 Discharge needle 7 Inner needle 8 Rubber tube 9 Test solution 11 Anesthetic needle 12 Straight pipe part 13 Tip part 14 Opening 15 Grinding stone

Claims (1)

外径が一様な直管部の先端に円錐状に先細りとなっている先端部を備え、薬液を吐出する開口の全体が前記先端部に設けられている麻酔針の製造方法であって、該麻酔針の軸芯に対して20〜40°の角度で放電加工器の放電針を前記先端部に作用させることで、前記開口を開ける工程を有することを特徴とする脊椎くも膜下麻酔針の製造方法。   An anesthesia needle manufacturing method comprising a tip portion tapered in a conical shape at the tip of a straight tube portion having a uniform outer diameter, and an entire opening for discharging a drug solution provided in the tip portion, A spinal anesthesia needle comprising a step of opening the opening by causing a discharge needle of an electric discharge machine to act on the tip at an angle of 20 to 40 ° with respect to the axis of the anesthetic needle. Production method.
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