JP6813213B2 - forceps - Google Patents
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- JP6813213B2 JP6813213B2 JP2019549726A JP2019549726A JP6813213B2 JP 6813213 B2 JP6813213 B2 JP 6813213B2 JP 2019549726 A JP2019549726 A JP 2019549726A JP 2019549726 A JP2019549726 A JP 2019549726A JP 6813213 B2 JP6813213 B2 JP 6813213B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
Description
本発明は医療用の鉗子に関する。特に、樹脂を成型した鉗子に関する。 The present invention relates to medical forceps. In particular, it relates to forceps formed from resin.
鉗子は、刃のない鋏のような形状を有し、血管や組織などを挟み、牽引したり、圧迫したりするための医療器具である。鉗子は一般的に金属で形成されるが、繰り返して使用するためには、使用後の鉗子を滅菌処理する必要がある。滅菌処理時の作業者の感染防止の観点から、近年では樹脂製の使い捨ての鉗子が普及しつつある。 Forceps are medical devices that have a bladeless scissors-like shape and are used to pinch, pull, or compress blood vessels or tissues. The forceps are generally made of metal, but the forceps after use must be sterilized for repeated use. In recent years, disposable resin forceps have become widespread from the viewpoint of preventing infection of workers during sterilization.
しかし、樹脂製鉗子は、全長を長くした場合、枢軸と圧坐部や握り部との距離が長くなる。この場合、樹脂の可撓性に起因して、２つのアームの柄部が互いに離れる方向に変形して捩れてしまい、圧坐部での十分な把持力を得ることができない。このような樹脂製鉗子に必要な把持力を付与するために、例えば、特許文献１には、枢軸を介して互いに連結され、その枢軸回りに揺動自在な第１のアームと第２のアームとを有し、前記第１のアームおよび前記第２のアームには、前記枢軸から一方側に延びる圧坐部と、前記枢軸から他方側に延びる柄部の後端に前記圧坐部を開閉操作するための指環部とが設けられている鉗子において、前記柄部に前記第１のアームと前記第２のアームとが前記枢軸の軸方向に捩れることを防止する捩れ防止手段を備える樹脂製鉗子が記載されている。 However, when the total length of the resin forceps is increased, the distance between the pivot and the pressing portion or the grip portion becomes long. In this case, due to the flexibility of the resin, the handle portions of the two arms are deformed and twisted in the direction away from each other, and a sufficient gripping force at the seating portion cannot be obtained. In order to impart the necessary gripping force to such resin forceps, for example, in Patent Document 1, a first arm and a second arm which are connected to each other via a pivot axis and can swing around the pivot axis. The first arm and the second arm have a pressure seat portion extending from the Axis to one side and opening and closing the pressure seat portion at the rear end of a handle portion extending from the Axis to the other side. A resin provided with anti-twisting means for preventing the first arm and the second arm from twisting in the axial direction of the Axis in the forceps provided with a finger ring portion for operation. The forceps made are described.
また、樹脂製鉗子では、樹脂の可撓性に起因して、押付力を強くすると２つの握り部が上下方向に離れる方向に作用して、例えば、消毒用の綿球の保持ができなくなるという問題がある。このような樹脂製の鉗子に必要な押付力を付与するために、例えば、特許文献２には、中央部が枢軸を介して連結されその枢軸回りに揺動自在な一対のアームを有し、枢軸から一方側に延びる前側アーム先端につかみ部が設けられ、枢軸から他方側に延びる後側アーム後端につかみ部を開閉操作するための握り部が形成され、一対のアームが可撓性を有する樹脂からなり、後側アームに、枢軸部よりも高い位置に握り部が配置されるように曲げ部が形成され、この曲げ部は上向き勾配に形成されるとともに後側アームの中央部以降でその勾配が小さくなるように形成されている樹脂製鉗子が記載されている。 Further, in the case of resin forceps, due to the flexibility of the resin, when the pressing force is increased, the two grips act in the direction of separating in the vertical direction, for example, it becomes impossible to hold the cotton ball for disinfection. There's a problem. In order to apply the pressing force required for such resin forceps, for example, Patent Document 2 has a pair of arms in which a central portion is connected via a pivot axis and is swingable around the pivot axis. A grip is provided at the tip of the front arm extending from the Axis to one side, and a grip is formed at the rear end of the rear arm extending from the Axis to the other to open and close the grip, and the pair of arms is flexible. It is made of resin, and a bent portion is formed on the rear arm so that the grip portion is arranged at a position higher than the pivot portion, and this bent portion is formed with an upward gradient and after the central portion of the rear arm. A resin forceps formed so that the gradient is small is described.
しかし、特許文献１の樹脂製鉗子は、第１のアームと第２のアームを略Ｘ字状に交差して互いに連結させる枢軸がカシメ金具によって固定されているため、特許文献２にも記載されているように、廃棄時に材質の異なる連結ピンを分別する必要性には対処できない。また、特許文献１の樹脂製鉗子を含め、従来の樹脂製鉗子には、樹脂製鉗子に必要な把持力を付与するために、樹脂にガラス繊維等の補強材を含有させて強度を向上させた樹脂を用いるが、特許文献２の樹脂製鉗子では、アーム組立て時に枢軸を貫通孔に圧入することによる枢軸の破損を防止するため、枢軸を撓ませることを目的として、ガラス繊維等の補強材を含有しない樹脂を用いることを特徴としている。 However, the resin forceps of Patent Document 1 is also described in Patent Document 2 because the pivots that connect the first arm and the second arm so as to intersect each other in a substantially X shape are fixed by caulking metal fittings. As such, the need to separate connecting pins made of different materials at the time of disposal cannot be addressed. Further, the conventional resin forceps, including the resin forceps of Patent Document 1, are provided with a reinforcing material such as glass fiber in the resin to improve the strength in order to impart the necessary gripping force to the resin forceps. However, in the resin forceps of Patent Document 2, a reinforcing material such as glass fiber is used for the purpose of bending the pivot shaft in order to prevent damage to the pivot shaft due to press-fitting the pivot shaft into the through hole when assembling the arm. It is characterized by using a resin that does not contain.
特許文献２の樹脂製鉗子では、押付力を付与するために、ガラス繊維等の補強材を含有しない樹脂を用いることにより、枢軸の破損を防止するとともに、カシメ金具等の材質の異なる材料を用いることによる廃棄時の問題を解決しているが、特許文献１の樹脂製鉗子のような十分な把持力を得ることができない。 In the resin forceps of Patent Document 2, in order to apply a pressing force, a resin that does not contain a reinforcing material such as glass fiber is used to prevent damage to the pivot axis and a material having a different material such as caulking metal fittings is used. Although the problem at the time of disposal is solved, it is not possible to obtain a sufficient gripping force as in the resin forceps of Patent Document 1.
上述の問題を解決するため、金属の部材を用いることなく、十分な把持力を有する樹脂製鉗子を提供する。または、オートクレーブによる複数回の滅菌が可能で、繰り返しの使用が可能な樹脂製鉗子を提供する。 In order to solve the above-mentioned problems, a resin forceps having a sufficient gripping force is provided without using a metal member. Alternatively, a resin forceps that can be sterilized multiple times by an autoclave and can be used repeatedly is provided.
本発明の一実施形態によると、第１のアームと第２のアームと、前記第１のアームと前記第２のアームとの一端にそれぞれ配置された把持部と、前記把持部を開閉可能に係合する枢軸と、前記第１のアームと前記第２のアームとの他端にそれぞれ配置された指環部と、を備え、前記第１のアームと前記第２のアームと前記指環部とは、樹脂とフィラーとを含む第１の層と、前記第１の層の表面に配置され、樹脂で構成された第２の層とを備える鉗子が提供される。 According to one embodiment of the present invention, the grip portions arranged at one ends of the first arm and the second arm, the first arm and the second arm, and the grip portion can be opened and closed. The first arm, the second arm, and the ring portion are provided with an engaging pivot and a ring portion arranged at the other ends of the first arm and the second arm, respectively. , A forceps comprising a first layer containing the resin and a filler and a second layer disposed on the surface of the first layer and composed of a resin is provided.
前記鉗子において、前記枢軸は、前記第１のアームに配置された凸部と、前記第２のアームに配置され、前記凸部と係合する凹部と、を備え、
前記凸部は、前記第２の層で構成された部分を含んでもよい。In the forceps, the pivot comprises a convex portion arranged on the first arm and a concave portion arranged on the second arm and engaged with the convex portion.
The convex portion may include a portion composed of the second layer.
前記凸部は、前記第２の層で構成されてもよい。 The convex portion may be composed of the second layer.
前記鉗子において、前記凸部は、前記凸部が配置された前記第１のアームから前記凸部の端部に向かって１°以上６°以下の角度で拡張する逆テーパ形状を有し、前記凹部は、前記第１のアームと接する前記第２のアームの面から、前記凹部の内部に向かって１°以上６°以下の角度で拡張する逆テーパ形状を有してもよい。 In the forceps, the convex portion has an inverted tapered shape that extends from the first arm on which the convex portion is arranged toward the end of the convex portion at an angle of 1 ° or more and 6 ° or less. The recess may have a reverse taper shape that extends from the surface of the second arm in contact with the first arm toward the inside of the recess at an angle of 1 ° or more and 6 ° or less.
前記第１のアームに配置された把持部と前記第２のアームに配置された第２の把持部とは、互いに噛合する歯形の形状を備え、前記歯形の形状を構成する凸部は、前記第２の層で構成された部分を含んでもよい。 The grip portion arranged on the first arm and the second grip portion arranged on the second arm have a tooth profile that meshes with each other, and the convex portion forming the tooth profile is described above. It may include a portion composed of a second layer.
前記歯形の形状を構成する凸部は、前記第２の層で構成されてもよい。 The convex portion forming the shape of the tooth profile may be formed by the second layer.
本発明によると、金属の部材を用いることなく、十分な把持力を有する樹脂製鉗子を提供することができる。または、オートクレーブによる複数回の滅菌が可能で、繰り返しの使用が可能な樹脂製鉗子を提供することができる。 According to the present invention, it is possible to provide a resin forceps having a sufficient gripping force without using a metal member. Alternatively, it is possible to provide a resin forceps that can be sterilized a plurality of times by an autoclave and can be used repeatedly.
以下に一実施形態に係る本発明の鉗子について、図を参照して説明する。なお、以下の実施形態は本発明の鉗子の一例であり、本発明の鉗子は以下の実施形態に限定されるわけではない。 The forceps of the present invention according to the embodiment will be described below with reference to the drawings. The following embodiment is an example of the forceps of the present invention, and the forceps of the present invention is not limited to the following embodiments.
図１は、本発明の一実施形態に係る鉗子１００の分解図である。図２は、鉗子１００を示す模式図である。また、図３は、鉗子１００を構成する第１のアーム１０と第２のアーム２０を図１に示した破線ＡＡ’で切断した断面構造を示す模式図である。鉗子１００は、第１のアーム１０と第２のアーム２０とを備える。第１のアーム１０の一端には第１の把持部１１が配置され、第２のアーム２０の一端には第２の把持部２１が配置される。また、第１のアーム１０と第２のアーム２０とは、枢軸３０により、第１の把持部１１及び第２の把持部２１を開閉可能に係合される。第１のアームの他端には第１の指環部１３が配置され、第２のアームとの他端には第２の指環部２３が配置される。第１の指環部１３及び第２の指環部２３は、使用者が指を通して、鉗子１００を把持するための環状構造である。 FIG. 1 is an exploded view of the forceps 100 according to an embodiment of the present invention. FIG. 2 is a schematic view showing the forceps 100. Further, FIG. 3 is a schematic view showing a cross-sectional structure in which the first arm 10 and the second arm 20 constituting the forceps 100 are cut by the broken line AA'shown in FIG. The forceps 100 includes a first arm 10 and a second arm 20. A first grip portion 11 is arranged at one end of the first arm 10, and a second grip portion 21 is arranged at one end of the second arm 20. Further, the first arm 10 and the second arm 20 are engaged with each other by the pivot 30 so that the first grip portion 11 and the second grip portion 21 can be opened and closed. The first ring portion 13 is arranged at the other end of the first arm, and the second ring portion 23 is arranged at the other end of the second arm. The first ring portion 13 and the second ring portion 23 have an annular structure for the user to grasp the forceps 100 through the finger.
本実施形態において、第１のアーム１０、第２のアーム２０及び指環部は、樹脂とフィラーとを含むコア層である第１の層９１と、第１の層９１の表面に配置され、樹脂で構成されたスキン層である第２の層９３とを備える。第１のアーム１０、第１の把持部１１及び第１の指環部１３は、一体で構成される。また、第２のアーム２０、第２の把持部２１及び第２の指環部２３は、一体で構成される。なお、本発明に係る鉗子１００は、図１及び図２に示したペアン鉗子に限定されない。例えば、コッヘル鉗子、ミクリッツ鉗子、マギール鉗子、ケリー鉗子、リンパ節鉗子、アリス鉗子、胃鉗子及び腸鉗子等、公知の鉗子であってもよい。この場合、鉗子の種類に応じて、第１のアーム１０及び第２のアーム２０の長さや形状が変更される。また、第１の把持部１１及び第２の把持部２１が先端部に向かって真っ直ぐな直型の鉗子であってもよく、先端部に向かって湾曲する曲型の鉗子であってもよい。また、第１の指環部１３と第２の指環部２３の近傍には、第１の係止部１５と第２の係止部２５がそれぞれ配置される。第１の係止部１５と第２の係止部２５には、対向する位置にラチェット歯１が配置される。第１の係止部１５と第２の係止部２５とは、ラチェット歯１が噛み合うことにより、第１の把持部１１及び第２の把持部２１の開閉をロックするラチェット３を構成する。 In the present embodiment, the first arm 10, the second arm 20, and the ring portion are arranged on the surfaces of the first layer 91, which is a core layer containing the resin and the filler, and the first layer 91, and the resin. It includes a second layer 93, which is a skin layer composed of. The first arm 10, the first grip portion 11, and the first ring portion 13 are integrally formed. Further, the second arm 20, the second grip portion 21, and the second ring portion 23 are integrally formed. The forceps 100 according to the present invention is not limited to the Pean forceps shown in FIGS. 1 and 2. For example, known forceps such as Kochel forceps, Miklitz forceps, Magill forceps, Kelly forceps, lymph node forceps, Alice forceps, gastric forceps and intestinal forceps may be used. In this case, the length and shape of the first arm 10 and the second arm 20 are changed according to the type of forceps. Further, the first grip portion 11 and the second grip portion 21 may be straight forceps that are straight toward the tip portion, or may be curved forceps that are curved toward the tip portion. Further, a first locking portion 15 and a second locking portion 25 are arranged in the vicinity of the first ring portion 13 and the second ring portion 23, respectively. Ratchet teeth 1 are arranged at positions opposite to each other in the first locking portion 15 and the second locking portion 25. The first locking portion 15 and the second locking portion 25 form a ratchet 3 that locks the opening and closing of the first grip portion 11 and the second grip portion 21 by engaging the ratchet teeth 1.
組立状態で第２の把持部２１と対向する第１の把持部１１の面及び第１の把持部１１と対向する第２の把持部２１の面は、鉗子の種類に応じた形状を有する。図１及び図２には、一例として、ペアン鉗子を示している。図４は、本発明の一実施形態に係る鉗子１００を構成する第２のアーム２０を図１に示した破線ＢＢ’で切断した断面構造を示す模式図である。ペアン鉗子は、対向する第１の把持部１１の面及び第２の把持部２１の面に互いに噛合する歯形の形状を有する。なお、本発明に係る鉗子１００は、図１及び図２に示したペアン鉗子に限定されない。鉗子の種類に応じて、第１の把持部１１及び第２の把持部２１の形状が変更される。例えば、コッヘル鉗子である場合には、ペアン鉗子と同様に、第１の把持部１１の面及び第２の把持部２１の面に互いに噛合する歯形の形状２２を有するとともに、第１の把持部１１及び第２の把持部２１の先端部には、第１の把持部１１と第２の把持部２１とを血管や組織を把持・圧挫した状態（把持部を閉じた状態）にロックするための鈎を有する。 The surface of the first grip portion 11 facing the second grip portion 21 and the surface of the second grip portion 21 facing the first grip portion 11 in the assembled state have shapes according to the type of forceps. FIG. 1 and FIG. 2 show Pean forceps as an example. FIG. 4 is a schematic view showing a cross-sectional structure in which the second arm 20 constituting the forceps 100 according to the embodiment of the present invention is cut by the broken line BB'shown in FIG. The Pean forceps have a tooth profile that meshes with each other on the surfaces of the first grip 11 and the second grip 21 that face each other. The forceps 100 according to the present invention is not limited to the Pean forceps shown in FIGS. 1 and 2. The shapes of the first grip portion 11 and the second grip portion 21 are changed according to the type of forceps. For example, in the case of Kocher forceps, similarly to Pean forceps, the surface of the first grip portion 11 and the surface of the second grip portion 21 have a tooth profile 22 that meshes with each other, and the first grip portion At the tips of the 11 and the second grip portion 21, the first grip portion 11 and the second grip portion 21 are locked in a state of gripping and crushing a blood vessel or tissue (a state in which the grip portion is closed). Have a hook for.
なお、一実施形態において、歯形の形状２２は第２の層９３で構成されてもよい。第２の層９３はフィラーを含まない樹脂で構成されるため、フィラーを含む第１の層９１より剛性が低い。このため、歯形の形状２２を第２の層９３で構成することにより、フィラーを含む第１の層９１で歯形の形状２２を構成する場合よりも弾性が大きくなり、血管や組織又は縫合針等を把持する際の密着性を高めることができる。また、一実施形態において、第１の層９１ａで歯形の形状２２ａを構成し、さらに第２の層９３ａで歯形の形状２２ａに追従する被膜を構成してもよい。歯形の形状２２ａがこのような構造を有することにより、歯形の形状２２ａ自体の強度を高めるとともに、歯形の形状２２ａの表面に弾性を付与して、血管や組織又は縫合針等を把持する際の密着性を高めることができる。 In one embodiment, the tooth profile shape 22 may be composed of a second layer 93. Since the second layer 93 is made of a resin containing no filler, the rigidity of the second layer 93 is lower than that of the first layer 91 containing a filler. Therefore, by forming the tooth profile shape 22 with the second layer 93, the elasticity becomes larger than that when the tooth profile shape 22 is formed by the first layer 91 containing the filler, and the blood vessel, tissue, suture needle, etc. It is possible to improve the adhesion when gripping the. Further, in one embodiment, the first layer 91a may form the tooth profile shape 22a, and the second layer 93a may further form a coating film that follows the tooth profile shape 22a. When the tooth profile shape 22a has such a structure, the strength of the tooth profile shape 22a itself is increased, and elasticity is imparted to the surface of the tooth profile shape 22a to grip a blood vessel, a tissue, a suture needle, or the like. Adhesion can be improved.
また、枢軸３０は、第１のアーム１０に配置された凸部３１と、第２のアーム２０に配置され、凸部３１と係合する凹部３３と、を備える。凸部３１は第２の層９３で構成される部分を含み、図３を参照すると、一実施形態において、凸部３１は第２の層９３で構成される。また、凸部３１と係合する凹部３３の表面は第２の層９３で構成される。凸部３１を第２の層９３で構成することにより、フィラーを含む第１の層９１で凸部３１を構成する場合よりも弾性が大きくなり、組立時に凹部３３との係合がしやすくなるとともに、係合後に凸部３１が凹部３３から脱離しにくくなる。また、凹部３３の表面を第２の層９３で構成することにより、組立時に凸部３１との係合がしやすくなるとともに、係合後に凸部３１が脱離しにくくなる。 Further, the pivot 30 includes a convex portion 31 arranged on the first arm 10 and a concave portion 33 arranged on the second arm 20 and engaged with the convex portion 31. The convex portion 31 includes a portion composed of the second layer 93, and referring to FIG. 3, in one embodiment, the convex portion 31 is composed of the second layer 93. Further, the surface of the concave portion 33 that engages with the convex portion 31 is composed of a second layer 93. By forming the convex portion 31 with the second layer 93, the elasticity becomes larger than when the convex portion 31 is formed with the first layer 91 containing the filler, and it becomes easier to engage with the concave portion 33 at the time of assembly. At the same time, it becomes difficult for the convex portion 31 to be detached from the concave portion 33 after engagement. Further, by forming the surface of the concave portion 33 with the second layer 93, it becomes easy to engage with the convex portion 31 at the time of assembly, and it becomes difficult for the convex portion 31 to come off after engagement.
図５は、本発明の一実施形態に係る第１のアーム１０に配置された凸部３１及び第２のアーム２０に配置された凹部３３の形状を説明する模式図である。一実施形態において、凸部３１は概略円筒状の形状を有し、凸部３１が配置された第１のアーム１０から凸部３１の端部に向かって径が拡張するように、凸部３１の断面が逆テーパ形状を有する。ここで、凸部３１は、第１のアーム１０から凸部３１の端部に向かって、即ち、凸部３１が配置された第１のアーム１０の面と直行する線に対して、１°以上６°以下の角度αで傾斜する。凹部３３は凸部３１を収容するように、凸部３１に対応する形状を有し、第１のアーム１０と接する第２のアーム２０の面から、凹部３３の内部に向かって径が拡張するように、凹部３３の断面が逆テーパ形状を有する。ここで、凹部３３は、第２のアーム２０から凹部３３の内部に向かって、即ち、凹部３３が配置された第２のアーム２０の面と直行する線に対して、１°以上６°以下の角度αで傾斜する。凸部３１と凹部３３とがこのような逆テーパ形状を有することにより、組立時に凸部３１との係合がしやすくなるとともに、係合後に凸部３１が脱離しにくくなる。 FIG. 5 is a schematic view illustrating the shapes of the convex portion 31 arranged on the first arm 10 and the concave portion 33 arranged on the second arm 20 according to the embodiment of the present invention. In one embodiment, the convex portion 31 has a substantially cylindrical shape, and the convex portion 31 has a diameter that expands from the first arm 10 on which the convex portion 31 is arranged toward the end of the convex portion 31. The cross section of is inverted tapered. Here, the convex portion 31 is 1 ° with respect to a line perpendicular to the surface of the first arm 10 on which the convex portion 31 is arranged, from the first arm 10 toward the end portion of the convex portion 31. Tilt at an angle α of 6 ° or less. The concave portion 33 has a shape corresponding to the convex portion 31 so as to accommodate the convex portion 31, and the diameter expands from the surface of the second arm 20 in contact with the first arm 10 toward the inside of the concave portion 33. As described above, the cross section of the recess 33 has an inverted tapered shape. Here, the recess 33 is 1 ° or more and 6 ° or less with respect to a line perpendicular to the surface of the second arm 20 in which the recess 33 is arranged, from the second arm 20 toward the inside of the recess 33. Tilt at the angle α of. Since the convex portion 31 and the concave portion 33 have such an inverted tapered shape, the convex portion 31 can be easily engaged with the convex portion 31 at the time of assembly, and the convex portion 31 is less likely to be disengaged after the engagement.
図５において、凸部３１が配置された第１のアーム１０の面と凸部３１との接続部Ｒ1は、第１のアーム１０の面から凸部３１に向かって径が縮小するＲ形状を有することが好ましい。凸部３１と第１のアーム１０の面との接続部Ｒ1はＲ０．３以上であることが好ましい。このような形状を有することにより、凸部３１と第１のアーム１０の面との接続部の強度を得ることができる。また、概略円柱形状の凸部３１の側面と凸部３１の円形の端部の面のとの接続部Ｒ2は、側面から端部の面に向かって径が縮小するＲ形状を有することが好ましい。凸部３１の側面と端部の面との接続部Ｒ2はＲ０．３以上であることが好ましいが、組立時や使用時での欠けを防止できれば、これに限定されるものではない。このような形状を有することにより、凸部３１を凹部３３に挿入しやすくすることができる。また、接続部Ｒ1と凸部３１の側面との変曲点の径φ1と凸部３１の側面と接続部Ｒ2との変曲点の径φ2とは、上記の角度αの範囲で設定される。なお、径φ1は、凸部３１が配置される第１のアーム１０の面の幅、即ち枢軸３０の回転軸ＣＣ’と直交する第１のアーム１０の面の幅をＷとしたとき、φ1＜Ｗ／２とすることが好ましい。5, the connecting portion R 1 of the surface and the convex portion 31 of the first arm 10 of the convex portion 31 is arranged, R shape diameter toward the protrusion 31 from the surface of the first arm 10 is reduced It is preferable to have. The connecting portion R 1 between the convex portion 31 and the surface of the first arm 10 is preferably R0.3 or more. By having such a shape, the strength of the connecting portion between the convex portion 31 and the surface of the first arm 10 can be obtained. Further, the connecting portion R 2 between the side surface of the convex portion 31 having a substantially cylindrical shape and the surface of the circular end portion of the convex portion 31 may have an R shape whose diameter decreases from the side surface toward the end surface. preferable. The connecting portion R 2 between the side surface and the end surface of the convex portion 31 is preferably R0.3 or more, but is not limited to this as long as it can prevent chipping during assembly or use. By having such a shape, the convex portion 31 can be easily inserted into the concave portion 33. Further, the connecting portion R 1 and the diameter phi 2 of the inflection point of the diameter phi 1 and the side surface of the protrusion 31 of the inflection point and the connecting portion R 2 of the side surface of the convex portion 31, the range of the angle α Set in. The diameter φ 1 is when the width of the surface of the first arm 10 on which the convex portion 31 is arranged, that is, the width of the surface of the first arm 10 orthogonal to the rotation axis CC'of the pivot 30, is W. It is preferable that φ 1 <W / 2.
図５において、凹部３３が配置された第２のアーム２０の面と凹部３３との接続部Ｃ1は、第２のアーム２０の面から凹部３３に向かって径が縮小するＣ面取りを有することが好ましい。凹部３３と第２のアーム２０の面との接続部Ｃ1は接続部Ｒ1に追従する形状であればよい。このような形状を有することにより、凸部３１を凹部３３に挿入しやすくすることができる。また、凹部３３の側面と凹部３３の円形の端部の面のとの接続部Ｒ3は、側面からの面に向かって径が縮小するＲ形状を有することが好ましい。凹部３３の側面と端部の面との接続部Ｒ3はＲ０．３以上であることが好ましい。このような形状を有することにより、凸部３１を凹部３３に挿入した際に接続部Ｒ3に生じる応力を緩和することができる。また、接続部Ｃ1と凹部３３の側面との変曲点の径φ3と凹部３３の側面と接続部Ｒ3との変曲点の径φ4とは、上記の角度αの範囲で設定される。5, the connecting portion C 1 of the face and the concave portion 33 of the second arm 20 a recess 33 is arranged, having a C chamfer diameter toward the recess 33 from the surface of the second arm 20 is reduced Is preferable. The connecting portion C 1 between the recess 33 and the surface of the second arm 20 may have a shape that follows the connecting portion R 1 . By having such a shape, the convex portion 31 can be easily inserted into the concave portion 33. Further, it is preferable that the connecting portion R 3 between the side surface of the recess 33 and the surface of the circular end portion of the recess 33 has an R shape whose diameter decreases toward the surface from the side surface. The connection portion R 3 between the side surface of the recess 33 and the end surface is preferably R 0.3 or more. By having such a shape, the stress generated in the connecting portion R 3 when the convex portion 31 is inserted into the concave portion 33 can be relaxed. Further, the diameter φ 3 of the inflection point between the connection portion C 1 and the side surface of the recess 33 and the diameter φ 4 of the inflection point between the side surface of the recess 33 and the connection portion R 3 are set within the above angle α. Will be done.
また、一実施形態において、第１の層９１ａで凸部３１ａを構成し、さらに第２の層９３ａで凸部３１ａに追従する被膜を構成してもよい。凸部３１ａがこのような構造を有することにより、第１のアーム１０ａにおいて、凸部３１ａ自体の強度を高めることができる。さらに、凸部３１ａの表面に弾性を付与して、組立時に凹部３３との係合がしやすくなるとともに、係合後に凸部３１が凹部３３から脱離しにくくなる。なお、凸部３１ａ及び凹部３３ａは、凸部３１及び凹部３３と同様の形状を採ることができるため、詳細な説明は省略する。 Further, in one embodiment, the first layer 91a may form the convex portion 31a, and the second layer 93a may further form a coating film that follows the convex portion 31a. When the convex portion 31a has such a structure, the strength of the convex portion 31a itself can be increased in the first arm 10a. Further, elasticity is imparted to the surface of the convex portion 31a, so that the convex portion 31 can be easily engaged with the concave portion 33 at the time of assembly, and the convex portion 31 is difficult to be detached from the concave portion 33 after engagement. Since the convex portion 31a and the concave portion 33a can have the same shape as the convex portion 31 and the concave portion 33, detailed description thereof will be omitted.
ここで、コア層である第１の層９１を構成する材料は、樹脂とフィラーとを含む。第１の層９１に利用可能な樹脂としては、例えば、ポリアミド、ポリフタルアミド等のポリアミド系樹脂、ポリエチレン、ポリプロピレン等のポリオレフィン系樹脂及びポリエステル系樹脂からなる群から選択される。また、第１の層９１に利用可能なフィラーとしては、例えば、ガラス繊維、炭素繊維及びセルロースナノファイバからなる群から選択される。 Here, the material constituting the first layer 91, which is the core layer, contains a resin and a filler. The resin that can be used for the first layer 91 is selected from the group consisting of, for example, a polyamide resin such as polyamide and polyphthalamide, a polyolefin resin such as polyethylene and polypropylene, and a polyester resin. Further, as the filler that can be used for the first layer 91, for example, it is selected from the group consisting of glass fiber, carbon fiber and cellulose nanofiber.
スキン層である第２の層９３を構成する樹脂としては、例えば、ポリアミド、ポリフタルアミド等のポリアミド系樹脂、ポリエチレン、ポリプロピレン等のポリオレフィン系樹脂及びポリエステル系樹脂からなる群から選択される。また、第２の層９３には、鉗子１００の意匠性も考慮して、例えば、アルミフィラー又はその他の高輝度フィラーを含むメタリック調の樹脂材料を用いることができる。さらに、医療従事者が鉗子の種類を明確に区別できるように、鉗子の種類等に応じて第２の層９３を着色してもよい。または、術野での視認性の向上や、レーザーメスのレーザー光の反射を低減する目的から、第２の層９３を光透過性又は透明なポリエステル系樹脂で構成してもよい。 The resin constituting the second layer 93, which is the skin layer, is selected from the group consisting of, for example, a polyamide resin such as polyamide and polyphthalamide, a polyolefin resin such as polyethylene and polypropylene, and a polyester resin. Further, in consideration of the design of the forceps 100, a metallic resin material containing, for example, an aluminum filler or another high-intensity filler can be used for the second layer 93. Further, the second layer 93 may be colored according to the type of forceps and the like so that the medical staff can clearly distinguish the type of forceps. Alternatively, the second layer 93 may be made of a light-transmitting or transparent polyester-based resin for the purpose of improving visibility in the surgical field and reducing the reflection of the laser light of the laser scalpel.
本発明に係る鉗子１００は、第１のアーム１０及び第２のアーム２０をコア層である第１の層９１と、第１の層９１の表面に配置されるスキン層である第２の層９３とで構成している。上述したように、アーム組立て時に枢軸を貫通孔に圧入することによる枢軸の破損を防止するためには、ガラス繊維等の補強材を含有しない樹脂を用いる事が考えられるが、ガラス繊維等の補強材を含有しない樹脂を用いる特許文献２の樹脂製鉗子では、十分な把持力を得ることができなかった。コア層である第１の層９１と、第１の層９１の表面に配置されるスキン層である第２の層９３とで第１のアーム１０及び第２のアーム２０を構成することにより、本発明に係る鉗子１００においては、組立時に凸部３１と凹部３３との係合がしやすくなるとともに、係合後に凸部３１が凹部３３から脱離しにくくなる。また、フィラーを含む第１の層９１のみで把持部を構成する場合よりも、樹脂で構成される第２の層９３を用いることにより、弾性が大きくなり、血管や組織又は縫合針等を把持する際の密着性を高めることができる。 The forceps 100 according to the present invention has a first arm 10 and a second arm 20 as a core layer, a first layer 91, and a second layer, which is a skin layer on the surface of the first layer 91. It is composed of 93. As described above, in order to prevent damage to the pivot due to press-fitting the pivot into the through hole when assembling the arm, it is conceivable to use a resin that does not contain a reinforcing material such as glass fiber, but reinforcement of glass fiber or the like. With the resin forceps of Patent Document 2 using a resin containing no material, a sufficient gripping force could not be obtained. By forming the first arm 10 and the second arm 20 by the first layer 91 which is a core layer and the second layer 93 which is a skin layer arranged on the surface of the first layer 91. In the forceps 100 according to the present invention, the convex portion 31 and the concave portion 33 are easily engaged with each other during assembly, and the convex portion 31 is difficult to be detached from the concave portion 33 after engagement. Further, by using the second layer 93 made of resin, the elasticity becomes larger than in the case where the grip portion is formed only by the first layer 91 containing the filler, and the blood vessel, the tissue, the suture needle or the like is gripped. It is possible to improve the adhesion when performing.
争乱や近年の大規模な自然災害での医療活動では、輸送性の観点から、軽量な樹脂製鉗子が望まれるが、患者に対して十分な量の樹脂製鉗子を準備できるとは限らない。このような場合、オートクレーブによる滅菌が行える樹脂製鉗子が望まれるが、カシメ金具を必須とする特許文献１の樹脂製鉗子では材質による熱膨張率の違いから、高圧蒸気滅菌時に枢軸が破損する恐れがある。本発明に係る鉗子１００においては、凸部３１は第２の層９３で構成される部分を含み、金属を用いない。このため、高圧蒸気滅菌時での枢軸の破損を防止することができる。 In medical activities in conflicts and large-scale natural disasters in recent years, lightweight resin forceps are desired from the viewpoint of transportability, but it is not always possible to prepare a sufficient amount of resin forceps for a patient. In such a case, a resin forceps that can be sterilized by an autoclave is desired, but the resin forceps of Patent Document 1 that requires caulking metal fittings may damage the pivot during high-pressure steam sterilization due to the difference in the coefficient of thermal expansion depending on the material. There is. In the forceps 100 according to the present invention, the convex portion 31 includes a portion composed of the second layer 93 and does not use metal. Therefore, it is possible to prevent damage to the pivot during high-pressure steam sterilization.
また、本発明に係る鉗子１００は、樹脂で構成され、金属の部材を含まないため、金属探知機で検出されないため、緊急輸送時での手荷物検査を簡便にすることができる。 Further, since the forceps 100 according to the present invention is made of resin and does not contain a metal member, it is not detected by a metal detector, so that baggage inspection at the time of emergency transportation can be simplified.
フィラーを含む第１の層９１のみで第１のアーム１０及び第２のアーム２０をした場合、繰り返しの使用における摩耗や繰り返しの加熱滅菌により、フィラーが表面から突出して患者や医療従事者が思わぬ怪我をする懸念がある。しかし、本発明に係る鉗子１００は、フィラーを含む第１の層９１の表面に樹脂で構成される第２の層９３を配置することにより、フィラーが表面から突出するのを防ぐことができ、より高い安全性を付与することもできる。 When the first arm 10 and the second arm 20 are made only of the first layer 91 containing the filler, the filler protrudes from the surface due to wear in repeated use and repeated heat sterilization, and the patient or medical staff thinks. There is a risk of serious injury. However, the forceps 100 according to the present invention can prevent the filler from protruding from the surface by arranging the second layer 93 made of resin on the surface of the first layer 91 containing the filler. It is also possible to give higher safety.
また、第２の層９３にメタリック調の樹脂材料を用いることにより、鉗子１００に意匠性を付与することもできる。樹脂製鉗子はディスポーザブルでの利用が一般的であるため、患者や医療従事者による信頼性が低いという心理的側面がある。しかし、第２の層９３にメタリック調の樹脂材料を用いることにより、金属製鉗子のような意匠性を付与して、樹脂製鉗子への心理的な信頼性を高めることができる。さらに、医療従事者が鉗子の種類を明確に区別できるように、鉗子の種類等に応じて第２の層９３を着色することもできる。金属性鉗子を着色する方法としては、塗料の使用やめっきが考えられる。しかし、金属性鉗子はディスポーザブルでの利用を前提としないため、繰り返しの使用により塗料やめっきが剥がれるリスクがあり、一般には金属性鉗子の着色は行われてこなかった。本発明に係る鉗子１００は樹脂製鉗子であり、数回の使用では第２の層９３が欠落するリスクはほとんどない。このため、第２の層９３を着色することにより、医療従事者が鉗子の種類を明確に区別できるため、鉗子の取り違えによる医療事故を防止することができる。 Further, by using a metallic resin material for the second layer 93, it is possible to impart designability to the forceps 100. Since resin forceps are generally used in a disposable manner, they have a psychological aspect of being unreliable by patients and medical staff. However, by using a metallic resin material for the second layer 93, it is possible to impart a design like a metal forceps and enhance the psychological reliability of the resin forceps. Further, the second layer 93 can be colored according to the type of forceps and the like so that the medical staff can clearly distinguish the type of forceps. As a method of coloring the metallic forceps, the use of paint or plating can be considered. However, since the metal forceps are not supposed to be used in a disposable manner, there is a risk that the paint or plating may come off due to repeated use, and the metal forceps have not been generally colored. The forceps 100 according to the present invention is a resin forceps, and there is almost no risk that the second layer 93 will be missing after several uses. Therefore, by coloring the second layer 93, the medical worker can clearly distinguish the type of forceps, and it is possible to prevent a medical accident due to the wrong forceps.
また、一実施形態において、第２の層９３を光透過性又は透明な樹脂で構成してもよい。従来は金属で形成されていたため、術野での視認性が悪く、レーザーメスのレーザー光を反射する懸念がある。一方、本発明に係る鉗子１００は、第２の層９３を光透過性又は透明な樹脂で構成することにより、術野での視認性を向上させることができる。また、第２の層９３を光透過性又は透明な樹脂で構成することにより、レーザーメスのレーザー光の反射を低減するができ、レーザー光を透過させることもできる。 Further, in one embodiment, the second layer 93 may be made of a light-transmitting or transparent resin. Since it was conventionally made of metal, it has poor visibility in the surgical field, and there is a concern that it may reflect the laser beam of the laser scalpel. On the other hand, in the forceps 100 according to the present invention, the visibility in the surgical field can be improved by forming the second layer 93 with a light-transmitting or transparent resin. Further, by forming the second layer 93 with a light-transmitting or transparent resin, the reflection of the laser light of the laser scalpel can be reduced, and the laser light can be transmitted.
本発明に係る鉗子１００は、１５Ｎ以上の把持力を有する。本明細書において、鉗子の把持力は、以下の評価方法を用いて評価することとする。ショアＤ硬度が１８〜２５のゴムの試験片（４０×４０ｍｍ，ｔ＝０．５）を用い、鉗子で試験片を把持し、鉗子を精密万能試験機に固定する。精密万能試験機により、試験片を引っ張り、把持力を測定する。 The forceps 100 according to the present invention has a gripping force of 15 N or more. In the present specification, the gripping force of the forceps is evaluated by using the following evaluation method. Using a rubber test piece (40 × 40 mm, t = 0.5) having a shore D hardness of 18 to 25, grasp the test piece with forceps and fix the forceps to the precision universal testing machine. The test piece is pulled by a precision universal testing machine and the gripping force is measured.
本発明に係る鉗子１００の製造方法は、上述した構造を形成できる限り、特に限定されない。例えば、２材成形による射出成形法を用いることができる。一実施形態において、本発明に係る鉗子１００は、スキン層である第２の層９３を金型に射出し、第２の層９３の内部にフィラーを含む第１の層９１を射出して成型することができるが、これに限定されるものではない。 The method for manufacturing the forceps 100 according to the present invention is not particularly limited as long as the above-mentioned structure can be formed. For example, an injection molding method using two-material molding can be used. In one embodiment, the forceps 100 according to the present invention is molded by injecting a second layer 93, which is a skin layer, into a mold, and injecting a first layer 91 containing a filler inside the second layer 93. However, it is not limited to this.
（実施例）
実施例として、コア層である第１の層９１にガラス短繊維を３０ｗｔ％含有するナイロン６（ユニチカ製、ユニチカナイロン６、Ａ１０３０ＧＦＬ）を用い、スキン層である第２の層９３にはナイロン６（ユニチカ製、ユニチカナイロン６、Ｍ１０３０ＤＨ）を用いた。ペアン鉗子用の金型に樹脂を射出し、樹脂の内部にガラス短繊維を３０ｗｔ％含有する樹脂を射出して、第１の層９１と、第１の層９１の表面に配置された第２の層９３とを有する第１のアーム１０及び第２のアーム２０を成形した。凸部３１は、第２の層９３で構成された。第１のアーム１０の凸部３１と第２のアーム２０の凹部３３に係合して、実施例のペアン鉗子を作製した。枢軸３０の中心から把持部の先端までの長さは、４７．５ｍｍであった。(Example)
As an example, nylon 6 (manufactured by Unitica, Unitica nylon 6, A1030GFL) containing 30 wt% of short glass fibers is used in the first layer 91 which is the core layer, and nylon 6 is used in the second layer 93 which is the skin layer. (Made by Unitica, Unitica Nylon 6, M1030DH) was used. A resin is injected into a mold for Pean forceps, a resin containing 30 wt% of glass short fibers is injected into the resin, and a second layer 91 and a second layer 91 are arranged on the surface of the first layer 91. The first arm 10 and the second arm 20 having the layer 93 of the above were molded. The convex portion 31 is composed of a second layer 93. The convex portion 31 of the first arm 10 and the concave portion 33 of the second arm 20 were engaged with each other to prepare the Pean forceps of the example. The length from the center of the pivot 30 to the tip of the grip was 47.5 mm.
（比較例）
比較例として、ナイロン６（ユニチカ製、ユニチカナイロン６、Ｍ１０３０ＤＨ）のみを用いて第１のアーム１０及び第２のアーム２０を射出成形し、実施例と同様の形状を有する比較例の第１のアーム及び第２のアームを作製した。比較例の第１のアームの凸部と第２のアームの凹部に係合して、比較例のペアン鉗子を作製した。(Comparison example)
As a comparative example, the first arm 10 and the second arm 20 are injection-molded using only nylon 6 (manufactured by Unitika, Unitika nylon 6, M1030DH), and the first arm of the comparative example having the same shape as the example. An arm and a second arm were made. Pean forceps of Comparative Example were produced by engaging with the convex portion of the first arm of Comparative Example and the concave portion of the second arm.
（把持力の評価）
実施例及び比較例の鉗子について、把持力を評価した。把持力の評価方法は以下のとおりである。
試験機：島津製作所 精密万能試験機
試験環境：２３±２℃
試験モード：シングル
試験種類：引張り
試験片：一般ゴム
試験片の硬度：１８〜２５（ショアＤ）
試験片の寸法：４０×４０ｍｍ ｔ＝０．５
試験方法：鉗子で試験片を把持し、鉗子を精密万能試験機に固定し、試験片を引っ張り、把持力を測定した。(Evaluation of gripping force)
The gripping force was evaluated for the forceps of Examples and Comparative Examples. The method for evaluating the gripping force is as follows.
Testing machine: Shimadzu Precision universal testing machine Testing environment: 23 ± 2 ° C
Test mode: Single Test type: Tension
Test piece: General rubber Test piece hardness: 18 to 25 (Shore D)
Specimen dimensions: 40 x 40 mm t = 0.5
Test method: The test piece was gripped with forceps, the forceps were fixed to a precision universal testing machine, the test piece was pulled, and the gripping force was measured.
実施例及び比較例の鉗子それぞれについて、２０本の把持力を測定し、その平均値を得た。測定に用いた試料の長手方向の把持力と短手方向の把持力の平均値を表１に示す。
表１の結果より、実施例の鉗子は、比較例の鉗子に対して、試料の長手方向で把持力が２．０３倍となり、試料の短手方向で把持力が２．４２倍であった。この結果より、本実施例に係る鉗子が十分な把持力を有することが明らかとなった。 From the results in Table 1, the forceps of the example had a gripping force of 2.03 times in the longitudinal direction of the sample and 2.42 times in the lateral direction of the sample as compared with the forceps of the comparative example. .. From this result, it was clarified that the forceps according to this example have a sufficient gripping force.
１ ラチェット歯、３ ラチェット、１０ 第１のアーム、１０ａ 第１のアーム、１１ 第１の把持部、１３ 第１の指環部、１５ 第１の係止部、２０ 第２のアーム、２１ 第２の把持部、２２ 形状、２２ａ 形状、２３ 第２の指環部、２５ 第２の係止部、３０ 枢軸、３１ 凸部、３１ａ 凸部、３３ 凹部、３３ａ 凹部、９１ 第１の層、９１ａ 第１の層、９３ 第２の層、９３ａ 第２の層、１００ 鉗子 1 ratchet tooth, 3 ratchet, 10 first arm, 10a first arm, 11 first gripping part, 13 first ring part, 15 first locking part, 20 second arm, 21 second Grip, 22 shape, 22a shape, 23 2nd ring part, 25 2nd locking part, 30 Axis, 31 convex part, 31a convex part, 33 concave part, 33a concave part, 91 1st layer, 91a th 1st layer, 93 2nd layer, 93a 2nd layer, 100 forceps
Claims (6)
前記第１のアームと前記第２のアームと前記指環部とは、樹脂とフィラーとを含む第１の層と、前記第１の層の表面に配置され、前記フィラーを含まない樹脂で構成された第２の層とを備えることを特徴とする鉗子。A first arm and a second arm, a grip portion arranged at one end of the first arm and the second arm, a pivot axis that engages the grip portion so as to be openable and closable, and the first arm. And a ring portion arranged at the other end of the second arm, respectively.
The first arm, the second arm, and the ring portion are composed of a first layer containing a resin and a filler, and a resin arranged on the surface of the first layer and containing no filler. A forceps characterized by comprising a second layer.
前記凸部は、前記第２の層で構成された部分を含むことを特徴とする請求項１に記載の鉗子。The pivot comprises a convex portion arranged on the first arm and a concave portion arranged on the second arm and engaged with the convex portion.
The forceps according to claim 1, wherein the convex portion includes a portion composed of the second layer.
前記凹部は、前記第１のアームと接する前記第２のアームの面から、
前記凹部の内部に向かって１°以上６°以下の角度で拡張する逆テーパ形状を有することを特徴とする請求項２又は３に記載の鉗子。The convex portion has a reverse taper shape that extends from the first arm on which the convex portion is arranged toward the end of the convex portion at an angle of 1 ° or more and 6 ° or less.
The recess is formed from the surface of the second arm in contact with the first arm.
The forceps according to claim 2 or 3, wherein the forceps have an inverted tapered shape that expands at an angle of 1 ° or more and 6 ° or less toward the inside of the recess.
前記歯形の形状を構成する凸部は、前記第２の層で構成された部分を含むことを特徴とする請求項１乃至４の何れか一に記載の鉗子。The grip portion arranged on the first arm and the second grip portion arranged on the second arm have a tooth profile shape that meshes with each other.
The forceps according to any one of claims 1 to 4, wherein the convex portion forming the shape of the tooth profile includes a portion formed of the second layer.
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| PCT/JP2017/038405 WO2019082284A1 (en) | 2017-10-24 | 2017-10-24 | Forceps |
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| US20210085893A1 (en) * | 2019-09-25 | 2021-03-25 | Danielle T. Abramson | Device and methodology for preparing skin for self-injection |
| JP2021065515A (en) * | 2019-10-25 | 2021-04-30 | Ｓ・Ｃａｓｔｅｍ株式会社 | Synthetic resin grasping instrument |
| JP2021065607A (en) * | 2019-10-28 | 2021-04-30 | 日精産業株式会社 | Surgical instrument |
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| US20020111624A1 (en) * | 2001-01-26 | 2002-08-15 | Witt David A. | Coagulating electrosurgical instrument with tissue dam |
| US7909823B2 (en) * | 2005-01-14 | 2011-03-22 | Covidien Ag | Open vessel sealing instrument |
| JP4411227B2 (en) * | 2005-02-25 | 2010-02-10 | 川本産業株式会社 | Resin forceps |
| JP5328421B2 (en) * | 2009-02-27 | 2013-10-30 | 株式会社ホギメディカル | forceps |
| JP5633877B2 (en) * | 2010-11-30 | 2014-12-03 | 良造 戸谷 | Delivery forceps |
| JP2013103039A (en) * | 2011-11-16 | 2013-05-30 | Adachi Kogyo:Kk | Characteristic structure of handle of scissors and forceps, and method for manufacturing the same |
| JP5990083B2 (en) * | 2012-10-19 | 2016-09-07 | 株式会社フジコー | Manufacturing method of dental medical equipment |
| US10045798B2 (en) * | 2012-11-11 | 2018-08-14 | Carbofix Orthopedics Ltd. | Composite implant coating |
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