JP4826711B2 - Needle - Google Patents

Description

Translated fromJapanese

本発明は医療用の注射針に関し、特に、内痔核組織内への薬剤注射に好適な注射針に関する。  The present invention relates to a medical injection needle, and more particularly to an injection needle suitable for drug injection into an internal hemorrhoid tissue.

肛門部の血行障害（鬱血）により生じる痔の一種として、痔核がある。この痔核は、肛門部の歯状線よりも上部に発生する内痔核と、下部に発生する外痔核に分けられ、内痔核が全体の４０〜６０％を占めている。  Hemorrhoids are a type of hemorrhoid caused by blood circulation disorders (congestion) in the anus. This hemorrhoid is divided into an inner hemorrhoid that occurs above the tooth line of the anus and an outer hemorrhoid that occurs at the lower part, and the inner hemorrhoid accounts for 40-60% of the total.

現在の内痔核の治療では、軽症から中等症の場合には、薬剤治療等による保存療法が行われ、又、重症化した場合には、手術による根治療法が行われている。しかし、手術による場合には、術後の疼痛や出血の不安があると共に、１０日前後の入院が必要になることから、病院に行かずに、悩む患者が多いのが実情である。  In the present treatment of internal hemorrhoids, conservative therapy such as drug treatment is performed in cases of mild to moderate disease, and radical treatment by surgery is performed in the case of becoming severe. However, in the case of surgery, since there is anxiety about postoperative pain and bleeding, and hospitalization is required for about 10 days, there are many patients who suffer without going to the hospital.

この問題を解決するために、重症の内痔核の場合でも、手術ではなく、次のような薬剤治療が提案されている。この治療では、柔らかい内痔核組織内に薬剤（薬液）を直接注射して、内痔核組織を硬化退縮させる治療が行われる。ところで、上記治療では、薬剤が内痔核組織内ではなく、内痔核組織下の硬い直腸筋層に誤注射された場合には、重篤な副作用が懸念される。  In order to solve this problem, the following drug treatment is proposed instead of surgery even in the case of severe internal hemorrhoids. In this treatment, a drug (medical solution) is directly injected into a soft internal hemorrhoid tissue to cure the internal hemorrhoid tissue. By the way, in the above treatment, there is a concern that serious side effects may occur when the drug is erroneously injected not into the internal hemorrhoid tissue but into the hard rectal muscle layer under the internal hemorrhoid tissue.

そのため、上記治療に際しては、注射針を内痔核組織（痔患部層）に穿刺（刺通）した際には、その刺通抵抗が低く、注射針を内痔核組織下の直腸筋層に誤穿刺した際には、その刺通抵抗が大となる注射針、即ち、刺通抵抗が相違して、内痔核組織と直腸筋層を判別可能な注射針が必要となる。しかしながら、従来においては、上記のような注射針が存在しなかったのが実情である。  Therefore, during the above treatment, when the needle is punctured (pierced) into the internal hemorrhoid tissue (affected area layer), the puncture resistance is low, and the needle is erroneously punctured into the rectal muscle layer under the internal hemorrhoid tissue. In such a case, an injection needle whose piercing resistance is large, that is, an injection needle capable of discriminating the internal hemorrhoidal tissue from the rectal muscle layer is required. However, in the past, the actual situation is that there was no injection needle as described above.

解決しようとする問題点は、内痔核組織内への薬剤の注射時に、刺通抵抗の相違により、内痔核組織と、その組織下の直腸筋層を判別可能な注射針が存在しなかった点である。  The problem to be solved was that when a drug was injected into the internal hemorrhoid tissue, there was no injection needle that could distinguish the internal hemorrhoid tissue and the rectal muscle layer under the tissue due to the difference in piercing resistance. It is.

本発明は、上記問題を解決できる注射針を提供することを目的とし、その目的を達成するために、本発明の特徴とするところは、内痔核組織内への薬剤の注射に使用されるものであって、針管の先端部がその軸心に対して斜めに研磨されて、その研磨面が刃面とされ、刃面が、基部側にある第１傾斜面と、先端部側の両側にある一対の第２傾斜面を有し、第２傾斜面と軸心のなす角度である第２傾斜角が、第１傾斜面と軸心のなす角度である第１傾斜角よりも大とされた注射針において、両第２傾斜面のなす角度である形成角が５０°〜９０°とされた点にある。
尚、第１傾斜角が８〜２０°とされることもある。
又、第２傾斜角が２１°〜３１°とされることもある。
更に、刃面の軸心方向の長さである刃面長Ｌ１が１．０〜５．０ｍｍとされることもある。
又、第２傾斜面の軸心方向の長さを脇取り長Ｌ２とした場合に、脇取り比Ｌ２／Ｌ１が０．２５〜０．６５とされることもある。
An object of the present invention is to provide an injection needle that can solve the above problems, and in order to achieve the object, the present invention is characterized in that it isused for injection of a drug into the internal hemorrhoid tissue. The tip ofthe needle tube is polished obliquely with respect to its axis, the polished surface is used as the blade surface, and the blade surface is provided on the first inclined surface on the base side and on both sides on the tip side. The second inclination angle that is an angle formed between the second inclined surface and the axial center is larger than the first inclination angle that is an angle formed between the first inclined surface and the axial center. In the injection needle, the formation angle which is an angle formed by both the second inclined surfaces is 50 ° to 90 °.
The first inclination angle may be 8 to 20 °.
Further, the second inclination angle may be set to 21 ° to 31 °.
Furthermore, the blade surface length L1, which is the length of the blade surface in the axial direction, may be 1.0 to 5.0 mm.
Further, when the length of the second inclined surface in the axial direction is set to the side cut length L2, the side cut ratio L2 / L1 may be set to 0.25 to 0.65.

本発明によれば、注射針を内痔核組織に穿刺（刺通）した際に、その刺通抵抗が低く、注射針を内痔核組織下の直腸筋層に誤穿刺した際には、その刺通抵抗が大となるので、薬剤（薬液）を内痔核組織内に確実に注入でき、内痔核組織下の直腸筋層等の不適切な部位に薬剤を誤って注入することを防止できる。  According to the present invention, when the injection needle is punctured (pierced) into the internal hemorrhoid tissue, the piercing resistance is low, and when the injection needle is erroneously inserted into the rectal muscle layer under the internal hemorrhoid tissue, the puncture is performed. Since the through resistance is increased, the drug (medicine solution) can be reliably injected into the internal hemorrhoid tissue, and the drug can be prevented from being erroneously injected into an inappropriate site such as the rectal muscle layer under the internal hemorrhoid tissue.

本発明は、内痔核組織内への薬剤（薬液）の注射時に、刺通抵抗の相違により、内痔核組織と、その組織下の直腸筋層を判別可能な注射針を提供する。  The present invention provides an injection needle capable of discriminating an internal hemorrhoid tissue and a rectal muscle layer under the tissue by a difference in piercing resistance when a drug (medical solution) is injected into the internal hemorrhoid tissue.

以下、本発明の一実施態様を図面に基づき説明するが、以下の説明では、便宜上、図１の左を前、図１の上下を左右、図２の上を上として説明する。本発明の注射針は下記のように形成されている。即ち、直管状の針管１の先端部がその軸心Ｃに対して斜めに研磨（研削）されて、前方に向かって先鋭状の先鋭部２が形成され、針管１の先鋭部２を除く部分が本体３とされている。先鋭部２の上面、即ち、上記斜めに研磨された面が刃面４とされ、先端が刃先５とされている。刃面４は、基部側の第１傾斜面（第１ベベル）６と、先端部側の左右両側にある一対の第２傾斜面（第２ベベル）７を有する。第２傾斜面７は第１傾斜面６に対し連設（連続）状に形成され、又、両第２傾斜面７は左右方向に並設（連続）状に形成されている。  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the following description, for the sake of convenience, the left of FIG. 1 will be described as the front, the top and bottom of FIG. 1 will be the left and right, and the top of FIG. The injection needle of the present invention is formed as follows. That is, the tip portion of the straighttubular needle tube 1 is polished (ground) obliquely with respect to the axis C thereof, and a sharpened sharpenedportion 2 is formed toward the front, and the portion excluding the sharpenedportion 2 of theneedle tube 1 Is themain body 3. The upper surface of the sharpenedportion 2, that is, the obliquely polished surface is theblade surface 4, and the tip is theblade edge 5. Theblade surface 4 has a first inclined surface (first bevel) 6 on the base side and a pair of second inclined surfaces (second bevel) 7 on both the left and right sides on the distal end side. The secondinclined surface 7 is formed in a continuous (continuous) shape with respect to the firstinclined surface 6, and both the secondinclined surfaces 7 are formed in a parallel (continuous) shape in the left-right direction.

針管１としては、従来と同様のものが使用されるが、表１に示すように、例えば、その長さＬは、１３〜７０ｍｍ、高い頻度で使用される値（高頻度値）としては、４４ｍｍ、その外径Ｏ．Ｄ．は０．３〜１．２５ｍｍ、高い頻度で使用される値（高頻度値）としては、０．５１ｍｍ、その内径Ｉ．Ｄ．は０．１６〜１．０４ｍｍ、高い頻度で使用される値（高頻度値）としては、０．２９ｍｍとされる。針管１の材料としては、ステンレス鋼を含む鉄鋼材料、アルミニウム、銅、チタンのような非鉄金属材料、ニッケル、コバルト、モリブテンのような耐熱材料、鉛、すずのような低融点金属、金、銀、白金のような貴金属材料およびこれらの合金が使用される。尚、針管１として、直管だけではなく、先端あるいは基端に向けてテーパー形状である筒体や、刃面４の軸心方向中途部からテーパー形状となる筒体が使用されることもある。  As theneedle tube 1, the same one as the conventional one is used. As shown in Table 1, for example, the length L is 13 to 70 mm, and the value used frequently (high frequency value) is: 44 mm, outer diameter O.D. D. Is 0.3 to 1.25 mm, a frequently used value (high frequency value) is 0.51 mm, its inner diameter I.V. D. Is 0.16 to 1.04 mm, and a frequently used value (high frequency value) is 0.29 mm. The material of theneedle tube 1 includes steel materials including stainless steel, non-ferrous metal materials such as aluminum, copper and titanium, heat resistant materials such as nickel, cobalt and molybdenum, low melting point metals such as lead and tin, gold, silver, Precious metal materials such as platinum and their alloys are used. As theneedle tube 1, not only a straight tube but also a cylindrical body having a tapered shape toward the distal end or the proximal end, or a cylindrical body having a tapered shape from a midway portion in the axial center direction of theblade surface 4 may be used. .

注射針は下記のようにして従来同様に製造される。即ち、針管１に曲がりや穴詰まり或いは全体の異常が無いように、針管１を所定の長さに切断し、針基側の切断面のバリを除去する。次に、刃面４の第１・第２傾斜面６，７を下記のように研磨により形成する。この研磨加工時には、針管１が研磨時の熱により損傷せず、バリが出にくいように、適切な研磨速度で研磨を行うと共に、刃面４の第１・第２傾斜面６，７をバランスのとれた形状に形成する。  The injection needle is manufactured in the conventional manner as follows. That is, theneedle tube 1 is cut to a predetermined length so that theneedle tube 1 is not bent, clogged, or has an overall abnormality, and the burr on the cut surface on the needle base side is removed. Next, the first and secondinclined surfaces 6 and 7 of theblade surface 4 are formed by polishing as follows. At the time of this polishing process, theneedle tube 1 is polished at an appropriate polishing rate and the first and secondinclined surfaces 6 and 7 of theblade surface 4 are balanced so that theneedle tube 1 is not damaged by the heat at the time of polishing and it is difficult to generate burrs. Formed in a well-shaped shape.

まず、第１段階の研磨として、円盤（円柱）状の回転砥石を針管１の先端部の上方側に配置して、図６（尚、図６では、説明の便宜上、回転砥石の軸心Ｄと針管１の距離を実際よりも小としてある。）に示すように、平面視において、回転砥石の回転軸心Ｄを針管１の軸心Ｃに対して直交状とした後、回転砥石の外周面で針管１の先端部を研磨して、まず、刃面４を概略形成する。次に、第２段階の研磨として、刃面４の先端部を回転砥石で更に研磨するのであるが、この際には、回転砥石を針管１の軸心Ｃを中心として上記研磨位置から左右にそれぞれ相対的に回動させて（尚、実際には、回転砥石を回動させずに、針管１を周方向の各方向に回動させる。以下、同様である。）、回転砥石の外周面により、刃面４の先端部の左右各側を研磨する。これにより、刃面４の内、第２段階で研磨されなかった部分が第１傾斜面６となり、第２段階で研磨された部分が第２傾斜面７となる。  First, as a first stage of polishing, a disk (column) -shaped rotating grindstone is disposed above the tip of theneedle tube 1, and FIG. 6 (in FIG. 6, the axis D of the rotating grindstone is used for convenience of explanation. And the distance between theneedle tube 1 and theneedle tube 1 is smaller than the actual distance.) In plan view, the rotational axis D of the rotating grindstone is perpendicular to the axis C of theneedle tube 1 and then the outer periphery of the rotating grindstone. The tip of theneedle tube 1 is polished with a surface to first roughly form theblade surface 4. Next, as the second stage of polishing, the tip of theblade surface 4 is further polished with a rotating grindstone. At this time, the rotating grindstone is moved left and right from the polishing position around the axis C of theneedle tube 1. The outer peripheral surface of the rotating grindstone is rotated relative to each other (actually, theneedle tube 1 is rotated in each circumferential direction without rotating the rotating grindstone. The same applies hereinafter). Thus, the left and right sides of the tip of theblade surface 4 are polished. Thus, the portion of theblade surface 4 that has not been polished in the second stage becomes the firstinclined surface 6, and the portion polished in the second stage becomes the secondinclined surface 7.

研磨時に発生するバリの除去時には、刃先５が損傷しないように、刃先５を覆被した後、第１傾斜面６の全体と第２傾斜面７の基部側に、外径が数十μのガラスビーズを吹き付けて（ブラスト加工）、バリを除去する。刃先５のバリは電解研磨により除去して、稜線が明確に出るようにする。その後、針管１に対して酸による防錆加工をした後、洗浄処理を行う。  When removing burrs generated during polishing, after covering theblade edge 5 so that theblade edge 5 is not damaged, the outer diameter is several tens of μm on the entire firstinclined surface 6 and the base side of the secondinclined surface 7. Spray glass beads (blasting) to remove burrs. The burrs on theblade edge 5 are removed by electropolishing so that the ridge line appears clearly. Thereafter, theneedle tube 1 is subjected to a rust prevention treatment with an acid, and then subjected to a cleaning treatment.

ところで、注射針では、刃面４の軸心方向の長さＬ１が刃面長とされ、刃面長Ｌ１は、１．０〜５．０ｍｍとされ、好ましくは、１．７±０．４ｍｍとされる。  By the way, in the injection needle, the length L1 of theblade surface 4 in the axial direction is the blade surface length, and the blade surface length L1 is 1.0 to 5.0 mm, preferably 1.7 ± 0.4 mm. It is said.

又、第１傾斜面６は、針管の左右方向（水平方向）の径方向に平行とされると共に、全体に平坦又は略平坦とされている。第１傾斜面６と軸心Ｃのなす角度は第１傾斜角（第１ベベル角）αとされ、第１傾斜角αは、８〜２０°とされ、好ましくは、１３±２°とされる。  The firstinclined surface 6 is parallel to the radial direction of the left and right direction (horizontal direction) of the needle tube, and is flat or substantially flat as a whole. The angle formed between the firstinclined surface 6 and the axis C is a first inclination angle (first bevel angle) α, and the first inclination angle α is 8 to 20 °, preferably 13 ± 2 °. The

図５にも示すように、左右各側の第２傾斜面７は、軸心方向から見た際に、線対称とされて、同一形状とされており、第１傾斜面６と各第２傾斜面７の境目には、稜線９が形成されている。この稜線９は、径方向外方に向かうに従って、上位となるように、径方向に関して傾斜している。第２傾斜面７の軸心方向の長さは脇取り長Ｌ２とされて、脇取り比Ｌ２／Ｌ１が、０．２５〜０．６５とされ、好ましくは、０．４５±０．２とされる。  As shown in FIG. 5, the secondinclined surfaces 7 on the left and right sides are axisymmetric and have the same shape when viewed from the axial direction, and the firstinclined surface 6 and the secondinclined surfaces 6 are the same. Aridge line 9 is formed at the boundary of theinclined surface 7. Theridge line 9 is inclined with respect to the radial direction so as to be higher as it goes outward in the radial direction. The length of the secondinclined surface 7 in the axial center direction is set as a chamfering length L2, and a chamfering ratio L2 / L1 is set to 0.25 to 0.65, preferably 0.45 ± 0.2. Is done.

注射針を図２に示す状態から周方向の各方向に回動させ、図３及び図４に示すように、側面から見て、左右一方の第２傾斜面７が直線状に見える状態とした際に、第２傾斜面７と軸心Ｃのなす角度が第２傾斜角（第２ベベル角）βとされる。左右各側の第２傾斜角βは同一とされて、２１°〜３１°とされ、好ましくは、２６±２°とされる。  The injection needle is rotated in each direction in the circumferential direction from the state shown in FIG. 2, and as shown in FIGS. 3 and 4, when viewed from the side, the secondinclined surface 7 on one of the left and right sides appears to be linear. At this time, an angle formed between the secondinclined surface 7 and the axis C is set to a second inclination angle (second bevel angle) β. The second inclination angles β on the left and right sides are the same and are 21 ° to 31 °, preferably 26 ± 2 °.

図６に示すように、刃面４が上側となる状態で、第２傾斜面７を軸心方向から見た際には、各第２傾斜面７は、径方向外方に向かうに従って、下位となるように、径方向に関しても傾斜している。第２傾斜面７及び上記稜線９の径方向に関する傾斜は、回転砥石の径及び研磨時に回転砥石が左右に回動される角度（回動角度）により定まる。両第２傾斜面７のなす角度である形成角θは、５０〜９０°とされ、好ましくは、７０±１０°とされる。この場合、回動角度は、９０°〜１３０°（左右には、４５°〜６５°）、好ましくは、１１０±１０°（左右には、５５±１０°）となる。  As shown in FIG. 6, when the secondinclined surface 7 is viewed from the axial direction with theblade surface 4 on the upper side, each secondinclined surface 7 becomes lower as it goes radially outward. It is also inclined in the radial direction so that The inclination of the secondinclined surface 7 and theridgeline 9 in the radial direction is determined by the diameter of the rotating grindstone and the angle (rotation angle) by which the rotating grindstone is rotated left and right during polishing. The formation angle θ, which is an angle formed by both the secondinclined surfaces 7, is 50 to 90 °, and preferably 70 ± 10 °. In this case, the rotation angle is 90 ° to 130 ° (45 ° to 65 ° on the left and right), preferably 110 ± 10 ° (55 ± 10 ° on the left and right).

上記のように構成した実施態様によれば、重症化した内痔核を薬剤（薬液）により治療する際には、シリンジ（図示省略）に本発明の注射針を接続すると共に、シリンジ内に薬剤を吸引した後、注射針を内痔核に穿刺（刺通）する。  According to the embodiment configured as described above, when treating severe internal hemorrhoids with a medicine (medicine solution), the syringe needle of the present invention is connected to a syringe (not shown), and the medicine is placed in the syringe. After aspiration, the needle is punctured (pierced) into the inner hemorrhoid.

この際、注射針の先鋭部２の先端部における、両第２傾斜面７の形成角θが５０〜９０°とされて、従来の１１０°よりも小とされ、これにより、先鋭部２の先端部側の横断面積が従来よりも小であると共に、内痔核自体も柔らかいため、内痔核に注射針を小さな刺通抵抗で容易に穿刺（刺通）できる。  At this time, the formation angle θ of the secondinclined surfaces 7 at the distal end of the sharpenedportion 2 of the injection needle is set to 50 to 90 °, which is smaller than the conventional 110 °. Since the cross-sectional area on the distal end side is smaller than that of the prior art and the inner hemorrhoid itself is soft, the injection needle can be easily punctured (pierced) into the inner hemorrhoid with a small puncture resistance.

尚、刺通抵抗が小であり過ぎると、注射針を内痔核に穿刺したことが明瞭に施術者に伝わり難い場合もあるため、第２傾斜面７の第２傾斜角βが２１°〜３１°というように、大とされて、これにより、刺通抵抗の増大が図られている。尚、第２傾斜面７の第２傾斜角βを上記よりも小さな値として、刺通抵抗の増大を図らない場合もある。  If the piercing resistance is too small, it may be difficult to clearly tell the practitioner that the injection needle has been pierced into the inner hemorrhoid, so the second inclination angle β of the secondinclined surface 7 is 21 ° to 31. As a result, the piercing resistance is increased. In some cases, the second inclination angle β of the secondinclined surface 7 is set to a value smaller than the above, and the piercing resistance is not increased.

ところで、注射針を内痔核に穿刺して、注射針の先鋭部２の先端部だけではなく、その基部も内痔核の組織内に挿入していくと、この挿入されていく部分の横断面積が次第に大となるため、注射針の刺通抵抗も次第に大となる。  By the way, when the injection needle is punctured into the inner hemorrhoid and not only the distal end portion of the sharpenedportion 2 of the injection needle but also the base portion thereof is inserted into the tissue of the inner hemorrhoid, the cross-sectional area of the inserted portion is increased. Since it gradually increases, the piercing resistance of the injection needle also gradually increases.

この際、注射針を挿入し過ぎると、まず、第１段階として、注射針の先鋭部２の先端部が、内痔核組織下の直腸筋層に挿入され、第２段階として、注射針の先鋭部２の基部が、内痔核組織下の直腸筋層に挿入されることになる。  At this time, if the injection needle is inserted too much, first, as the first step, the tip of the sharpenedportion 2 of the injection needle is inserted into the rectal muscle layer under the internal hemorrhoid tissue, and as the second step, the sharpened portion of the injection needle is inserted. The base ofpart 2 will be inserted into the rectal muscle layer under the internal hemorrhoidal tissue.

上記第１段階では、両第２傾斜面７の形成角θが５０〜９０°であって、先鋭部２における、直腸筋層に穿刺された先端部の横断面積が従来よりも小であるため、両第２傾斜面７のなす角度に起因する刺通抵抗は小である。しかし、第２傾斜面７の第２傾斜角βが２１°〜３１°というように大とされて、第２傾斜角βに起因する刺通抵抗が大であると共に、直腸筋層自体が硬いこともあって、注射針の刺通抵抗が増大する。  In the first stage, the formation angle θ of both the secondinclined surfaces 7 is 50 to 90 °, and the cross-sectional area of the tip portion pierced into the rectal muscle layer at the sharpenedportion 2 is smaller than before. The piercing resistance due to the angle formed by the secondinclined surfaces 7 is small. However, the second inclination angle β of the secondinclined surface 7 is set to be as large as 21 ° to 31 °, the piercing resistance due to the second inclination angle β is large, and the rectal muscle layer itself is hard. In some cases, the piercing resistance of the injection needle increases.

上記第２段階では、第１傾斜面６の第１傾斜角αは８〜２０°と第２傾斜面７の第２傾斜角βよりも小であるため、第２傾斜角に起因する刺通抵抗は小である。しかし、上記第１段階では、両第２傾斜面７の形成角θが５０〜９０°であると共に、これに起因して、先鋭部２における、直腸筋層に穿刺された先端部の横断面積が従来よりも小である。これに対し、第２段階では、第１傾斜面６が針管１の左右方向（水平方向）の径方向と平行であって、第１傾斜面６が第２傾斜面７、即ち、第１段階よりも上方側及び左右両側（径方向外方側）に大きく出っ張ると共に、これに起因して、先鋭部２における、直腸筋層に穿刺される部分の横断面積が、第１段階よりも急激に増大する。これにより、直腸筋層自体が硬いこともあって、注射針の刺通抵抗が一挙に増大する。  In the second stage, since the first inclination angle α of the firstinclined surface 6 is 8 to 20 °, which is smaller than the second inclination angle β of the secondinclined surface 7, the piercing caused by the second inclination angle is performed. Resistance is small. However, in the first stage, the formation angle θ of both the secondinclined surfaces 7 is 50 to 90 °, and due to this, the cross-sectional area of the tip portion pierced into the rectal muscle layer at the sharpenedportion 2 Is smaller than before. On the other hand, in the second stage, the firstinclined surface 6 is parallel to the radial direction of theneedle tube 1 in the left-right direction (horizontal direction), and the firstinclined surface 6 is the secondinclined surface 7, that is, the first stage. Bulges to the upper side and the left and right sides (radially outward), and as a result, the cross-sectional area of the portion to be punctured into the rectal muscle layer in the sharpenedportion 2 is sharper than in the first stage. Increase. Thereby, the rectal muscle layer itself may be hard, and the piercing resistance of the injection needle increases at a stroke.

尚、注射針の直腸筋層への穿刺を上記のように２段階に分けて説明したが、第２傾斜面７の脇取り長Ｌ２が小であるため、実際の注射では、上記第１・第２段階は略同時に起こり、これにより、内痔核組織下の直腸筋層への注射針の穿刺時には、刺通抵抗が飛躍的に増大する。  Although the puncture of the rectal muscle layer of the injection needle has been described in two stages as described above, since the chamfer length L2 of the secondinclined surface 7 is small, in actual injection, the first The second stage occurs substantially simultaneously, which dramatically increases the penetration resistance when the injection needle is punctured into the rectal muscle layer under the internal hemorrhoidal tissue.

上記のようにして、注射針を内痔核組織内に確実に穿刺した後、薬剤を内痔核組織内に注入する。  As described above, after the needle is reliably punctured into the internal hemorrhoid tissue, the drug is injected into the internal hemorrhoid tissue.

上記のように、注射針を内痔核組織に穿刺した際に、その刺通抵抗が低く、注射針を内痔核組織下の直腸筋層に誤穿刺した際には、その刺通抵抗が大となるので、薬剤を内痔核組織内に確実に注入でき、内痔核組織下の直腸筋層等の不適切な部位に薬剤を誤って注入することを防止できる。  As mentioned above, when the needle is punctured into the internal hemorrhoid tissue, its puncture resistance is low, and when the needle is accidentally punctured into the rectal muscle layer under the internal hemorrhoid tissue, the puncture resistance is large. Therefore, the drug can be reliably injected into the internal hemorrhoid tissue, and the drug can be prevented from being erroneously injected into an inappropriate site such as the rectal muscle layer under the internal hemorrhoid tissue.

〔試験例１及び比較例１〕
次に、本発明を実施した試験例１と、比較例１により、本発明を更に説明するが、本発明は試験例により限定されるものではない。[Test Example 1 and Comparative Example 1]
Next, the present invention will be further described with reference to Test Example 1 in which the present invention was implemented and Comparative Example 1. However, the present invention is not limited to the test examples.

外径Ｏ．Ｄ．を０．５１ｍｍ、肉厚を０．１０ｍｍ、刃面長Ｌ１を１．７ｍｍ、第１傾斜角αを１３°、第２傾斜角βを２６°、両第２傾斜面の形成角θを７０°とした注射針を５本製作し、試験例１とした。又、外径Ｏ．Ｄ．及び肉厚を上記と同一とし、刃面長Ｌ１を２．４ｍｍ、第１傾斜角αを１０°、第２傾斜角βを１８°、両第２傾斜面の形成角θを１１０°とした注射針を５本製作し、比較例１とした。  O.D. D. Is 0.51 mm, the wall thickness is 0.10 mm, the blade surface length L1 is 1.7 mm, the first inclination angle α is 13 °, the second inclination angle β is 26 °, and the formation angle θ of both second inclination surfaces is 70. Five injection needles with an angle of 0 were produced and designated as Test Example 1. Also, the outer diameter O.D. D. And the wall thickness L1 is the same as described above, the blade face length L1 is 2.4 mm, the first inclination angle α is 10 °, the second inclination angle β is 18 °, and the formation angle θ of both the second inclination surfaces is 110 °. Five injection needles were produced and used as Comparative Example 1.

試験には、図７に示す痔核モデルを使用した。この痔核モデルはシリコーンゴムから成る円盤（円柱）状とされ、内痔核組織を模した上側円盤１１と、内痔核組織下の直腸筋層を模した下側円盤１２と、これら上側・下側円盤１１，１２が嵌入されるリング状枠体１３を有する。上側円盤１１の上面は平坦面とされているが、この上面には、上方に突出する隆起部１４が、周方向に間隔を置いて、形成されている。この隆起部１４を形成した理由は、注射針の刺通部分の長さを調整するためである。  The hemorrhoid model shown in FIG. 7 was used for the test. This hemorrhoid model is a disc (column) made of silicone rubber, and includes anupper disc 11 that imitates the inner hemorrhoid tissue, alower disc 12 that imitates the rectal muscle layer under the inner hemorrhoid tissue, and these upper and lower discs. 11 and 12 has a ring-shapedframe 13 into which the 12 and 12 are inserted. The upper surface of theupper disk 11 is a flat surface. On this upper surface, raisedportions 14 protruding upward are formed at intervals in the circumferential direction. The reason for forming the raisedportion 14 is to adjust the length of the piercing portion of the injection needle.

上記内痔核モデルの上側・下側円盤１１，１２に上方から、試験例１の各注射針を、２０ｍｍ／ｍｉｎの刺通速度で、垂直に刺通して、その刺通抵抗を万能試験機（インストロン社製：型番５５６５）で測定し、その測定結果を平均して、図８の実線で示すように、注射針の痔核モデルに対する挿入量（ｍｍ）と刺通抵抗（Ｎ）の関係を示すグラフを得た。比較例１の各注射針についても、上記同様に測定し、図８の点線で示すように、注射針の痔核モデルに対する挿入量（ｍｍ）と刺通抵抗（Ｎ）の関係を示すグラフを得た。  From above the upper andlower disks 11 and 12 of the inner hemorrhoid model, the injection needles of Test Example 1 were pierced vertically at a piercing speed of 20 mm / min, and the piercing resistance was measured using a universal testing machine (instrument Ron, Inc .: Model No. 5565), and the measurement results are averaged, and as shown by the solid line in FIG. 8, the relationship between the insertion amount (mm) and the penetration resistance (N) with respect to the hemorrhoid model of the injection needle is shown. A graph was obtained. Each of the injection needles of Comparative Example 1 was measured in the same manner as described above, and a graph showing the relationship between the insertion amount (mm) of the injection needle with respect to the hemorrhoid model and the penetration resistance (N) was obtained as shown by the dotted line in FIG. It was.

尚、痔核モデルでは、図８の直線Ａよりも左側部分、即ち、直線Ａよりも注射針の痔核モデルに対する挿入量が小であって、注射針が上側円盤１１のみに穿刺されている場合には、注射針が内痔核組織に穿刺されていると見做され、直線Ａよりも右側部分、即ち、直線Ａよりも注射針の痔核モデルに対する挿入量が大であって、注射針が上側円盤１１だけでなく、下側円盤１２にも穿刺されている場合には、注射針が直腸筋層に穿刺されていると見做される。  In the hemorrhoid model, when the insertion amount of the injection needle into the hemorrhoid model is smaller than the straight line A in FIG. 8, that is, the straight line A, and the injection needle is punctured only in theupper disk 11. Is considered that the injection needle is pierced into the internal hemorrhoid tissue, the insertion amount of the injection needle into the hemorrhoid model is larger than the straight line A, that is, the injection needle is inserted into the upper disc. When not only 11 but also thelower disc 12 is punctured, it is considered that the injection needle is pierced into the rectal muscle layer.

図８を見れば、注射針が直腸筋層に穿刺された際には、試験例１の刺通抵抗は、比較例１よりも急激に増大する。従って、本発明の注射針を使用すれば、内痔核組織下の直腸筋層等の不適切な部位に薬剤を誤って注入することを防止できる。  Referring to FIG. 8, when the injection needle is punctured into the rectal muscle layer, the puncture resistance in Test Example 1 increases more rapidly than in Comparative Example 1. Therefore, by using the injection needle of the present invention, it is possible to prevent the drug from being erroneously injected into an inappropriate site such as the rectal muscle layer under the internal hemorrhoid tissue.

本発明の一実施態様を示す平面図である。It is a top view which shows one embodiment of this invention.図１の側面図である。It is a side view of FIG.図２の注射針を軸心回りに回動させた側面図である。It is the side view which rotated the injection needle of FIG. 2 around the shaft center.図２の注射針を軸心回りに回動させた側面図である。It is the side view which rotated the injection needle of FIG. 2 around the shaft center.図１の正面図である。It is a front view of FIG.図２のＡ−Ａ線矢視断面図である。FIG. 3 is a cross-sectional view taken along line AA in FIG. 2.内痔核モデルの縦側断面図である。It is a longitudinal cross-sectional view of an inner hemorrhoid model.試験結果を示すグラフである。It is a graph which shows a test result.

符号の説明Explanation of symbols

１ 針管
２ 先鋭部
４ 刃面
６，７ 第１・第２傾斜面
Ｃ 軸心
Ｌ１ 刃面長
Ｌ２ 脇取り長
α，β 第１・第２傾斜角
θ 形成角DESCRIPTION OFSYMBOLS 1Needle tube 2Sharp part 4Blade surface 6,7 1st, 2nd inclined surface C Axis center L1 Blade surface length L2 Side-cutting length α, β 1st, 2nd inclined angle θ Formation angle

Claims (5)

Translated fromJapanese

内痔核組織内への薬剤の注射に使用されるものであって、
針管の先端部がその軸心に対して斜めに研磨されて、その研磨面が刃面とされ、
刃面が、基部側にある第１傾斜面と、先端部側の両側にある一対の第２傾斜面を有し、 第２傾斜面と軸心のなす角度である第２傾斜角が、第１傾斜面と軸心のなす角度である第１傾斜角よりも大とされた注射針において、
両第２傾斜面のなす角度である形成角が５０°〜９０°とされた注射針。Used to inject drugs into the internal hemorrhoid tissue,
The tip of the needle tube is polished obliquely with respect to its axis, and the polished surface is used as the blade surface.
The blade surface has a first inclined surface on the base side and a pair of second inclined surfaces on both sides on the distal end side, and the second inclined angle, which is an angle formed by the second inclined surface and the axis, In the injection needle that is made larger than the first inclination angle that is an angle formed by one inclined surface and the axis,
An injection needle having a formation angle of 50 ° to 90 °, which is an angle formed by both second inclined surfaces. 第１傾斜角が８〜２０°とされた請求項１記載の注射針。  The injection needle according to claim 1, wherein the first inclination angle is 8 to 20 °. 第２傾斜角が２１°〜３１°とされた請求項１又は２記載の注射針。  The injection needle according to claim 1 or 2, wherein the second inclination angle is 21 ° to 31 °. 刃面の軸心方向の長さである刃面長Ｌ１が１．０〜５．０ｍｍとされた請求項１〜３の何れかに記載の注射針。  The injection needle according to any one of claims 1 to 3, wherein a blade surface length L1 which is a length of the blade surface in the axial direction is 1.0 to 5.0 mm. 第２傾斜面の軸心方向の長さを脇取り長Ｌ２とした場合に、脇取り比Ｌ２／Ｌ１が０．２５〜０．６５とされた請求項４記載の注射針。  The injection needle according to claim 4, wherein when the length of the second inclined surface in the axial direction is set to the side cut length L2, the side cut ratio L2 / L1 is set to 0.25 to 0.65.

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