JP6506567B2 - Manufacturing method of all resin retractor - Google Patents
Manufacturing method of all resin retractor Download PDFInfo
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- JP6506567B2 JP6506567B2 JP2015030639A JP2015030639A JP6506567B2 JP 6506567 B2 JP6506567 B2 JP 6506567B2 JP 2015030639 A JP2015030639 A JP 2015030639A JP 2015030639 A JP2015030639 A JP 2015030639A JP 6506567 B2 JP6506567 B2 JP 6506567B2
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- 239000011347 resin Substances 0.000 title claims description 38
- 238000004519 manufacturing process Methods 0.000 title claims description 18
- 238000003780 insertion Methods 0.000 claims description 43
- 230000037431 insertion Effects 0.000 claims description 43
- 238000000465 moulding Methods 0.000 claims description 32
- 150000001875 compounds Chemical class 0.000 claims description 16
- 229920005992 thermoplastic resin Polymers 0.000 claims description 16
- 229920000049 Carbon (fiber) Polymers 0.000 claims description 14
- 239000004917 carbon fiber Substances 0.000 claims description 14
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 10
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- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 5
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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- 229910001220 stainless steel Inorganic materials 0.000 description 1
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Landscapes
- Surgical Instruments (AREA)
- Moulds For Moulding Plastics Or The Like (AREA)
Description
本発明は全樹脂製レトラクターの製造法に係り、特に低浸襲性切開部を通しての手術対象部位医療にあたり、X線観察の広域化を可能にしたオール樹脂製レトラクターの製造法に関するものである。 The present invention relates to a method for producing an all-resin retractor, and more particularly to a method for producing an all-resin retractor which enables wide-area X-ray observation for medical treatment of a surgical site through a low invasive incision. is there.
医療を施すべき箇所を覆う皮膚・筋肉などを切開した後に、その切開創から挿入され手術対象部位に至るまでの軟組織を圧排(器官の一部を切除することなく切り離す)または牽引する器具としてレトラクター(開創器)がある。最近では組織に与える損傷を軽減すべく低侵襲性が強まる傾向にあり、それゆえ切開部位の開口は可及的に小さくされ、その開口から処置を施そうとすると術野が狭小となるばかりでなく視野も狭くなる。このようなレトラクターは外科手術の補助具であって手術創を拡げておく器具として機能する。これは主として創内インサート部とハンドル部からなり、創内インサート部を創内に挿入して手術視野を確保するに都合がよく、また軟組織への損傷リスクを最小限にする器具であり、概ね先細で全体として偏平に形成される。 After incision of the skin, muscle, etc. covering the part where medical treatment is to be performed, it is used as an instrument for retracting (separating without removing a part of the organ) or pulling soft tissue from the incision wound up to the operation target site. There is a tractor (retractor). In recent years, there has been a tendency to intensify the low invasiveness in order to reduce the damage to the tissue, so the opening at the incision site is made as small as possible, and the operation field will only narrow if treatment is attempted from the opening. The field of view also narrows. Such a retractor is a surgical aid and functions as an instrument for spreading a surgical wound. This is an instrument consisting mainly of an insert and a handle, which is convenient for inserting the insert into the wound to secure a surgical field of view, and which minimizes the risk of damage to soft tissue. It is tapered and formed generally flat.
切開創が小さければ皮膚や筋肉などは復元しようとする作用を強く発揮するので、これら軟組織を牽引して積極的に開いておかねばならなくなる。その切開創に応じた形のレトラクターが必要となり、正面視が例えば「くの字状」に屈曲もしくは湾曲し、平面視はほぼストレートなシンプル形状のレトラクターが、他の複雑な形状のレトラクターとともにまたは単独で使用される。 If the incision is small, the skin, muscles, etc. exert a strong action to restore, so it becomes necessary to pull these soft tissues and keep them open. A retractor of a shape corresponding to the incisional is required, and a simple-shaped retractor with a front view that is bent or curved in, for example, a V shape, and a substantially straight plane view has other complicated shapes. Used with or without a tractor.
そのような略棒状のレトラクターは切開創の開口状態を保つだけでなく、その先端に爪状の突起などが形成されることも多く、術野深くに挿入された突起などによって処置対象域に存する組織に対処したり、硬組織を起こしたり引っ掛けるなどしてレトラクター自体の姿勢のロックをなさせる使われ方もする。 Such a substantially rod-shaped retractor not only maintains the open state of the incision wound, but often has a nail-like projection or the like formed at its tip, and the projection area etc. It is also used to deal with existing tissue, and to raise and lower hard tissue to lock the posture of the retractor itself.
ところで、レトラクターは人体に無害なものであり、また消毒が可能なものでなければならないことは言うまでもない。それゆえ、不錆鋼をはじめとした不錆性金属で製作されてきており、剛性を高くすることも極めて容易であることから信頼性の高い医療具として発展してきた経緯がある。しかし、上記したごとく低侵襲性の傾向(組織を侵す傾向が低い)が強まるにつれて術野のX線照射が不可避となり、その場合に金属製器具はX線の部分的不透過領域を生じさせる。 By the way, it goes without saying that the retractor must be harmless to the human body and must be disinfectable. Therefore, it has been made of rust-proof metal and other rust-proof metals, and it is extremely easy to increase its rigidity, so it has been developed as a highly reliable medical tool. However, as described above, as the tendency of minimally invasive (less likely to invade tissues) becomes stronger, X-ray irradiation of the operative field becomes inevitable, in which case the metallic instrument produces a partially opaque region of X-rays.
それゆえ、術野の視野を狭めることは否めず、処置の迅速化が妨げられたり屈曲度合いの異なるレトラクターに置き替えたりする事態が生じる。このような事情を勘案すると棒状レトラクターとはいえ創内挿入部の長さや角度、爪の形や向きなどに多種多様な形態が要求される。金属製である場合、キャスティングするなどして製造されるから形状に少しの違いがあっても、それごとに見合った成形金型が必要となり、レトラクター単価が上昇し治療費の高騰も招く。 Therefore, the view of the operative field can not be narrowed, and the treatment may not be speeded up, or a retractor with a different degree of flexion may occur. In consideration of such circumstances, although it is a rod-like retractor, various forms are required for the length and angle of the insertion portion in the wound, the shape and the direction of the claw, and the like. If it is made of metal, it is manufactured by casting, etc. Even if there is a slight difference in shape, a molding die appropriate for each is required, and the unit price of the retractor increases and the treatment cost also rises.
また、金属製レトラクターの先端がセラミックインプラントに接触するなどすれば硬さの違いによってインプラントが傷つけられやすい。これがインプラントの機能低下や耐用年数の低減をきたすなどして、再施術の頻繁化をきたすなどの問題を生じさせる。 Also, if the tip of the metal retractor comes in contact with the ceramic implant, etc., the implant is easily damaged due to the difference in hardness. This causes problems such as deterioration of the function of the implant and a decrease in the service life, and the occurrence of frequent re-surgery.
ところで、特許文献1には、金属製レトラクターの組織と接触する部位(触接指)に樹脂をコーティングするなどして軟化させておけばよいことが記載されている。しかし、これではレトラクターによる組織やインプラントに対する保護性能は向上しても依然として多種多様な形状に対応させた成形金型の必要性は残されたままとなる。レトラクターを作用部と把持部に分割して成形し、これらの組み合わせにより成形金型の減少を図る提案もなされるが、接合機構が付加されるなどするから重量の大きいレトラクターの更なる重量増をきたす。 By the way, it is described in patent document 1 that resin may be coated to the site | part (touch finger) which contacts the structure | tissue of metal made retractor, and it may be made to soften. However, in this case, although the protection performance against tissues and implants by the retractor is improved, the need for molding dies corresponding to various shapes still remains. There is also a proposal to divide and form the retractor into the action part and the grip part and to reduce the number of molding dies by combining these, but since the joining mechanism is added, etc., the weight of the heavy retractor is further increased Increase.
それらの金属製に代えて樹脂製とすることもできると開示される。その樹脂はPEEKといったものを使用すればよいとも述べられている。しかし、単なるアイデアに止まるもので、今日まで実用化された樹脂製レトラクターは陽の目を見るに至っていない。問題はどのようにしてレトラクターを成形し仕上げるのかの具体的な技術が発展して来なかったからに外ならない。 It is disclosed that resin can be used instead of the metal. It is also stated that the resin may be such as PEEK. However, it is nothing more than an idea, and the resin-made retractors that have been put into practical use until today have not been able to see the sun. The problem lies in the fact that the concrete technology of how to shape and finish the retractor has not been developed.
レトラクターの把持部を樹脂で形成し、この把持部でのX線透過により、X線照射画像を見ながら創内処置を可能にすることが特許文献2に記載されている。これにはレトラクターの本体などを樹脂とすることも提案されている。しかし、これまたその製造手順に関する開示は見られるところでない。 Patent Document 2 describes that a grasping portion of the retractor is formed of resin, and X-ray transmission in this grasping portion enables an intra-corporeal treatment while viewing an X-ray irradiation image. It is also proposed that the main body of the retractor be made of resin for this. However, there is no disclosure of this nor its manufacturing procedures.
ところで、上でも触れたが、患者ごとに形の異なるレトラクターが必要となったり、施術部位に応じたレトラクターが必要となるわけであるが、200種ものレトラクターが要求される場合もあるという。しかし、代表的には、例えば本体形状で4種類、把持部形状で3種類、触接指形状で4種類に絞ったとしても48種類ものレトラクターが必要とされる。これらを製作するためにはたとえ樹脂製とする場合でも、成形金型は48種が必要となる。 By the way, as mentioned above, each patient needs a different type of retractor, or a retractor according to the operation site is needed, but as many as 200 types of retractor may be required. It is said. However, representatively, for example, four types of main body shapes, three types of holding portion shapes, and 48 types of tactile finger shapes require 48 types of retractors. In order to manufacture these, even if it is made of resin, 48 types of molding dies are required.
本発明は上記の問題に鑑みなされたもので、その目的は、X線透過を可能にして軟組織への損傷リスクを最小限にする低侵襲性に沿うべく全体の非金属化が図られかつ軽量化の推進がなされること、レトラクターを構成するコンポーネントの組み合わせを容易にして成形金型の種類数の抑制が図られ、製作コストの大いなる低減を期待できるようにすることを実現する全樹脂製レトラクターの製造法を提供することである。 The present invention has been made in view of the above problems, and its object is to achieve overall non-metallization and light weight along with minimally invasiveness which enables X-ray transmission and minimizes the risk of damage to soft tissue. All resin products that realize that the combination of components that make up the retractor can be facilitated to suppress the number of types of molding dies, and that a large reduction in manufacturing costs can be expected. It is to provide a manufacturing method of a retractor.
本発明は、切開創から挿入され手術対象部位に至るまでの軟組織を圧排または牽引等する触接指を本体胴の先端部位に備えた創内インサート部と、触接指に所望作用させるための操作手を備えたハンドル部とからなり、そのハンドル部に対して創内インサート部が一体化されているレトラクターの製造法に適用される。その特徴とするところは、図1を参照して、創内インサート部1はハンドル部2の爾後的な成形中に溶着される接続舌7を本体胴5の基端部位に備え、その本体胴5が接続舌7および触接指4と一体をなして炭素繊維強化熱可塑性樹脂のセミプレグシート8の積層により(図2の(b)を参照)、ハンドル部2とは独立して成形される(図5の(a)を参照)。
図3を参照して、下型9Dおよび上型9Uからなる成形金型9に刻設されたハンドル部2の形成用キャビティ10と連なり成形金型縁9eで開口する創内インサート部1の保持用キャビティ11に、接続舌7が操作手6の創内インサート部寄りに一体形成される連接胴成形域9sに臨まされるとともに本体胴5の触接指寄り部分が成形金型縁外に位置されるように、既に製作された創内インサート部1を収容保持する。そして、
少なくともいずれのキャビティ周りも熱可塑性樹脂溶融温度を超えない程度に加温された成形金型9内へ炭素繊維チップ配合の熱可塑性樹脂コンパウンドの融液を圧入して操作手6を注入成形するとともに、接続舌7の上または下もしくは上下もしくは周囲に流入したコンパウンド融液で接続舌表層を融解しつつ連接胴13を一体形成してハンドル部2を成形するようにしたことである。
According to the present invention, there is provided an intracorporeal insertion portion provided with a touch finger at an end portion of a main body trunk, which is provided with a touch finger for retracting or pulling soft tissue from an incision wound to a surgical target, The present invention is applied to a method of manufacturing a retractor which comprises a handle portion provided with an operating hand, and the insertion portion is integrated with the handle portion. As its feature, referring to FIG. 1, the endodontic insert portion 1 is provided with a connecting tongue 7 to be welded during subsequent shaping of the handle portion 2 at the proximal end portion of the main body barrel 5, and the main body 5 is formed independently of the handle portion 2 by laminating the semipreg sheet 8 of carbon fiber reinforced thermoplastic resin integrally with the connection tongue 7 and the touch finger 4 (see FIG. 2B) (See (a) of FIG. 5).
With reference to FIG. 3, holding of the intracorporeal insert portion 1 connected with the forming cavity 10 of the handle portion 2 engraved on the forming mold 9 consisting of the lower mold 9D and the upper mold 9U and opened at the forming mold edge 9e The connecting tongue 7 faces the connecting barrel molding area 9s integrally formed in the cavity 11 so as to be integral with the insertion insert of the operating hand 6, and the contact finger portion of the main body 5 is positioned outside the molding die rim As described above, the intracorporeal insertion part 1 which has already been manufactured is accommodated and held. And
A melt of a thermoplastic resin compound blended with carbon fiber chips is pressed into a molding die 9 heated to such an extent that the thermoplastic resin melting temperature is not exceeded around at least any of the cavities, and the operator hand 6 is cast and formed. The connecting cylinder 13 is integrally formed while the connecting tongue surface layer is melted with the compound melt flowing into the upper and lower or upper and lower or around the connecting tongue 7 so that the handle portion 2 is formed.
本体胴5は屈曲もしくは湾曲して成形されているとよい。触接指4は本体胴5に対して屈曲または湾曲したフック片4A(図1の(b)を参照)もしくは反りを呈した起こし片4B(図7の(c)を参照)をなし、その触接指4および接続舌7は本体胴5に対して平面視略直線状をなして一体成形しておくことができる。 The body cylinder 5 may be bent or curved. The touch finger 4 is a hook piece 4A (see FIG. 1 (b)) bent or curved with respect to the main body 5 or a raised piece 4B (see FIG. 7 (c)) having a warp, The touch finger 4 and the connection tongue 7 can be integrally formed in a substantially linear shape in plan view with respect to the main body 5.
図7の(e)に示すように、触接指4を分岐爪14とするときは、創内インサート部1を成形後に機械加工することによって形成するとよい。 As shown in (e) of FIG. 7, when the touch finger 4 is a bifurcated claw 14, it may be formed by machining the intracorporeal insertion portion 1 after molding.
接続舌7の側方には以後に成形される連接胴13より幅方向にはみ出した左の拡幅域17および右の拡幅域18が形成され(図6を参照)、その拡幅域にはノッチ19を形成し、キャビティの対応箇所にはノッチ係合突起20が設けられ、コンパウンド融液加圧注入時に創内インサート部1のキャビティ抜けを阻止しておくようにする。 On the lateral side of the connecting tongue 7, a left widening area 17 and a right widening area 18 are formed which extend out in the width direction from the connecting cylinder 13 to be formed later (see FIG. 6). The notch engaging projection 20 is provided at the corresponding portion of the cavity so as to prevent the cavity of the endocardium insert 1 from being removed at the time of compound melt pressure injection.
本発明によれば、創内インサート部が炭素繊維強化熱可塑性樹脂のセミプレグシート積層によりハンドル部とは独立して成形される。創内インサート部の一部がその保持用キャビティに収容保持された状態で、触接指と一体をなす本体胴他端の接続舌がハンドル部の形成用キャビティにおける連接胴成形域に臨まされる。少なくともいずれのキャビティ周りも熱可塑性樹脂溶融温度を超えない程度に加温された成形金型内へ炭素繊維チップ配合の熱可塑性樹脂コンパウンドの融液が圧入されて操作手を注入成形する。接続舌の上または下もしくは上下もしくは周囲に流入したコンパウンド融液で接続舌表層を融解しつつ連接胴を一体形成してハンドル部が成形される。創内インサート部は一方向材繊維や織布材繊維に樹脂が含浸されたセミプレグシート積層体ゆえに、高強度高剛性が達成される。一方、ハンドル部は樹脂コンパウンドの固化物であるから手触りの優れた操作手が形成される。創内インサート部を形成する樹脂はハンドル部の樹脂とは同一種とされ、その樹脂が熱可塑性であることから加熱による軟化もしくは再溶融による溶着・融着で円滑に一体化が図られる。 According to the present invention, the wound insert portion is formed independently of the handle portion by the semipreg sheet lamination of the carbon fiber reinforced thermoplastic resin. The connecting tongue of the other end of the main body which is integral with the touch finger is exposed to the connecting cylinder forming area in the cavity for forming the handle portion in a state where a part of the insertion part in the wound is accommodated and held in the holding cavity. . The melt of the thermoplastic resin compound blended with the carbon fiber tip is pressed into the molding die heated to such an extent that the thermoplastic resin does not exceed the melting temperature of the thermoplastic resin at least around any of the cavities, and the operation hand is cast. The handle portion is formed by integrally forming the articulating cylinder while melting the connecting tongue surface layer with the compound melt flowing on or under the connecting tongue or up and down or around. Because the semi-preg sheet laminated body in which resin is impregnated into unidirectional fibers or woven fabric fibers, the wound insert portion achieves high strength and high rigidity. On the other hand, since the handle portion is a solidified product of the resin compound, an excellent handling hand is formed. The resin forming the intracorporeal insertion portion is the same as the resin of the handle portion, and since the resin is thermoplastic, it can be smoothly integrated by welding or fusion by softening or remelting due to heating.
創内インサート部のみならずハンドル部も樹脂製であるゆえオール樹脂製レトラクターとなる。このいずれの箇所にX線が照射されても術野の観察はほとんど妨げられなく、切開創の小形化すなわち低侵襲性が助成され、患者の肉体的精神的な負担も大いに軽減される。また、接続工程を含むとはいえ、一つのレトラクターとなった時点では一体品であるから、接続取外しといったためのジョイント機構は必要でなく、樹脂製であることも相まって軽量な医療器材となる。 Not only the insertion part but also the handle part is made of resin, so it becomes an all resin retractor. Irradiation of X-rays at any of these locations hardly prevents observation of the operative field, and the miniaturization of the incisional wound, that is, the low invasiveness is assisted, and the physical and mental burden on the patient is greatly reduced. Moreover, although it includes the connection process, since it is a one-piece product when it becomes a single retractor, a joint mechanism for connection removal is not necessary, and it is a lightweight medical equipment because it is made of resin. .
レトラクターの完成品は永久一体性のあるものとなるが、製作の段階では創内インサート部はハンドル部から独立して作られる。創内インサート部はハンドル部の形状に左右されることなく成形できるから、そのための成形金型の種類分だけ準備しておけばよい。創内インサート部の接続舌およびその近傍の本体胴形状や寸法を共通化しておけば、ハンドル部の成形ならびに創内インサート部との一体化をするための成形金型の準備数も抑制される。レトラクターの単価の低下に大きく寄与する。 The finished product of the retractor will be permanently integrated, but in the manufacturing stage the endodontic insert will be made independent of the handle. Since the intracorporeal insertion portion can be molded without being influenced by the shape of the handle portion, it is sufficient to prepare only the type of molding die for that purpose. If the shape and dimensions of the body tongue and the connecting tongue of the intracorporeal insertion part are made common, the number of preparation molds for forming the handle part and integrating with the intracorporeal insertion part is also suppressed . It greatly contributes to the fall of the unit price of the retractor.
本体胴を屈曲もしくは湾曲して成形しておけば、小切開創においてもレトラクターの操作が容易となるが、屈曲もしくは湾曲の程度が異なったものを成形するにおいてもハンドル部の成形に特別な拘束や制限を及ぼすことが可及的に少なくなる。 If the main body is bent or curved, the retractor can be easily operated even in a small incision, but it is particularly useful for forming the handle even when molding those with different degrees of bending or bending. There are as few restraints and restrictions as possible.
触接指は本体胴に対して屈曲または湾曲したフック片もしくは反りを呈した起こし片をなし、この触接指および接続舌が本体胴に対して平面視略直線状をなして一体成形されるようにしておけば、セミプレグシートの積層による成形が極めて円滑になされ、強度や剛性の確保も容易となる。 The touch finger is a hooked piece or bent up and bent piece bent or curved with respect to the main body, and the touch finger and the connection tongue are integrally formed in a substantially linear shape in plan view with respect to the main body. By doing so, the forming by laminating the semi-preg sheets becomes extremely smooth, and it becomes easy to secure strength and rigidity.
触接指を分岐爪とするときは、創内インサート部を成形後に機械加工することによって形成することができる。したがって、分岐爪の形成自体はセミプレグシート積層による成形に何ら関連性を有しないから、創内インサート部は、幅の複数倍もしくはそれ以上の寸法を持つ数個取り成形品なるかたちで成形することができる。これを所定幅に切断するなどすればよく、分岐爪の違いによる金型の増加は回避され。創内インサート部の数個分成形手法によれば、触接指の形状にとらわれることがないから多量生産も可能となる。 When the touch finger is used as a bifurcated nail, it can be formed by machining after molding the intracorporeal insertion portion. Therefore, since the formation of the bifurcated claws has no relevance to the formation by semipreg sheet lamination, the intracorporeal insertion part is formed in a form of a few-piece molded article having dimensions of a multiple or more of the width be able to. This may be cut to a predetermined width, etc., and the increase in the mold due to the difference between the branched claws is avoided. According to the method of forming a few insert portions in the wound creation, mass production is also possible because the shape of the touch finger is not involved.
接続舌の側方には以後に成形される連接胴より幅方向にはみ出した左の拡幅域および右の拡幅域が形成され、その拡幅域にはノッチを形成し、キャビティの対応箇所にノッチ係合突起が設けられると、コンパウンド融液加圧注入時に創内インサート部のキャビティ抜けを阻止しておくことができる。 On the lateral side of the connecting tongue, a left widening area and a right widening area extending in the width direction from the connecting cylinder to be formed later are formed, and a notch is formed in the widening area, and a notch is engaged at the corresponding location of the cavity. The provision of the interlocking projections can prevent the cavity insertion of the intracorporeal insertion part from being injected at the time of compound melt pressure injection.
以上いずれの手法で製造されようともレトラクターはオール樹脂であり、軽量であって術者の操作負担を少なくし、X線照射により患部の確認においても遮られるものがなくなり、施術の円滑化・正確化の増進に大きく寄与する。 Whether manufactured by any of the above methods, the retractor is all resin, is lightweight, reduces the operation burden on the operator, and there is no obstruction in the confirmation of the affected area by X-ray irradiation, and the treatment is smoothened. It greatly contributes to the enhancement of accuracy.
以下に、本発明に係る全樹脂製レトラクターの製造法を、その実施の形態を表した図面に基づいて詳細に説明する。図1は創内インサート部1とハンドル部2とからなり、そのハンドル部に対して創内インサート部が一体化されているレトラクター3の一例である。創内インサート部1は、図示しない切開創から挿入され手術対象部位に至るまでの軟組織を圧排または牽引等する触接指4を本体胴5の先端部位に備える。ハンドル部2は触接指に所望作用させるための操作手6を備える。 Below, the manufacturing method of the all-resins retractor which concerns on this invention is demonstrated in detail based on the drawing showing the embodiment. FIG. 1 shows an example of a retractor 3 which is composed of an extracorporeal insertion part 1 and a handle part 2 and in which the extracorporeal insertion part is integrated with the handle part. The intracorporeal insert portion 1 includes a touch finger 4 at the distal end portion of the main body barrel 5 for retracting or pulling soft tissue from an incision (not shown) to a surgical target site. The handle portion 2 is provided with an operating hand 6 for causing a touch finger to perform a desired action.
創内インサート部1はハンドル部2の爾後的な成形中に溶着される接続舌7を本体胴5の基端部位に備え、本体胴5が接続舌7および触接指4と一体をなして、炭素繊維強化熱可塑性樹脂のセミプレグシート8の積層により(図2(b)を参照)、図1中の(c),(d),(e)に示すように、全体として偏平な断面形を有して、後述するごとくハンドル部2とは独立して成形される。セミプレグシート8は強化用の炭素繊維間の一部にまたは全部に樹脂が含浸された状態にあって、予めオートクレーブなどによって加熱加圧された後徐冷されるなどした薄い補強済み樹脂板である。これは、プリプレグ、セミプレグ、部分含浸プリプレグなどとも呼ばれ、また時として樹脂半含浸基材、半含浸プリプレグとも称されるものである。 The insertion insert portion 1 has a connecting tongue 7 to be welded during subsequent shaping of the handle portion 2 at the proximal end portion of the main body barrel 5, and the main body barrel 5 is integral with the connecting tongue 7 and the touch finger 4 And by laminating the carbon fiber reinforced thermoplastic resin semipreg sheet 8 (refer to FIG. 2 (b)), as shown in (c), (d) and (e) in FIG. It has a shape and is formed independently of the handle portion 2 as described later. The semipreg sheet 8 is a thin reinforced resin plate which is in a state in which a resin is impregnated in part or all of the reinforcing carbon fibers and which is heated and pressurized in advance by an autoclave or the like and then gradually cooled. is there. This is also referred to as a prepreg, semipreg, partially impregnated prepreg, etc., and sometimes also referred to as a resin semi-impregnated base, semi-impregnated prepreg.
熱可塑性樹脂としては人体に無害であるとともに300℃を超える温度にならないと軟化も溶融もしないポリエーテルエーテルケトン(PEEK)やポリエーテルイミド(PEI)といったものが使用される。これらは強靱で吸湿せず耐候性に優れている。いずれにしても例えば200〜650GPaの高弾性炭素繊維で強化されるからステンレススチールやチタンといった高価な不錆金属に十分代替しえるものである。したがって、生体に対する毒性やアレルギー誘発性のないレトラクター3とすることができる。 As the thermoplastic resin, polyetheretherketone (PEEK) and polyetherimide (PEI) which are harmless to the human body and which neither soften nor melt unless the temperature exceeds 300 ° C. are used. They are tough and do not absorb moisture and are excellent in weatherability. In any case, since it is reinforced with, for example, 200 to 650 GPa high elastic carbon fiber, it can be sufficiently substituted for expensive non-rust metal such as stainless steel or titanium. Therefore, it can be set as the Retractor 3 which is not toxic to the living body or allergenicity.
ちなみに、複合の材料のうちの補強用繊維としては、炭素繊維、セラミックス繊維、ガラス繊維、アラミド繊維などを例示することができ、それら繊維を長繊維として、糸状、簾状、織布、不織布などとしたものや、短繊維としてチョップ状にしたものなどのかたちで使用することができる。特に、炭素繊維が好ましく、なかでも高弾性炭素繊維を用いることが最も好ましい。また、樹脂としては、上記したポリエーテルエーテルケトン、ポリエーテルイミドのほかに、ポリエーテルケトン、ポリアクリルエーテルケトン、ポリフェニレンサルフィド、ポリサルフォンなどを挙げることもできる。なお、炭素繊維に樹脂との接着性を高めるためのサイジング処理を予め施しておくなどすれば更によい。 Incidentally, carbon fibers, ceramic fibers, glass fibers, aramid fibers and the like can be exemplified as reinforcing fibers among composite materials, and those fibers are long fibers such as filiform, scaly, woven, non-woven, etc. It is possible to use it in the form of what was or what was chopped as a short fiber. In particular, carbon fibers are preferable, and among them, highly elastic carbon fibers are most preferable. Further, as the resin, in addition to the above-mentioned polyether ether ketone and polyether imide, polyether ketone, poly acrylic ether ketone, polyphenylene sulfide, polysulfone and the like can also be mentioned. In addition, it is further better to apply a sizing process to carbon fiber in advance to improve the adhesiveness with the resin.
一方向繊維材を含むセミプレグシートや織布繊維材を含むセミプレグシートが例えば交互に重ねて積層されるので(図2の(b)を参照)、図1中に示したように偏平な断面形であっても高強度・高剛性の創内インサート部1を形成することができる。ましてや触接指4も接続舌7も本体胴5に対して平面視略直線状をなしていると(図1(a)や(f)を参照)、一体成形するにあたってはセミプレグシート8を直線的に裁断しておくだけでよいから、図示しない成形金型内に短冊状積層することも簡単となる。ちなみに、接続舌7におけるセミプレグシート積層数は本体胴5の他部における積層数よりも徐々に少なくされる。触接指4における積層数は本体胴5の他部における積層数に略等しく、先端のみが急激に減らされるなどする。 Since semipreg sheets containing unidirectional fibers and semipreg sheets containing woven fibers are laminated alternately, for example (see FIG. 2 (b)), as shown in FIG. Even in the cross-sectional shape, it is possible to form a high strength and high rigidity intra-wound insertion portion 1. If the touch finger 4 and the connection tongue 7 are both substantially linear in plan view with respect to the main body 5 (see FIGS. 1 (a) and 1 (f)), the semi-preg sheet 8 is integrally formed. Since it is only necessary to cut linearly, it is also easy to laminate strip-like in a molding die not shown. Incidentally, the number of laminated semipreg sheets in the connection tongue 7 is gradually reduced from the number of laminated layers in the other part of the main body 5. The number of stacks in the touch finger 4 is substantially equal to the number of stacks in the other part of the main body barrel 5, and only the tip is sharply reduced.
図3に示すように、ハンドル部2の成形のための金型9は下型9Dおよび上型9Uからなり、金型内にはハンドル部2の形成用キャビティ10が刻設される。このキャビティに連なるように創内インサート部1の保持用キャビティ11も形成される。これは成形金型縁9eで開口するもので十分であるが、既に成形されている創内インサート部1の接続舌7が操作手6の創内インサート部寄りに一体形成される連接胴成形域9sに臨まされる。なお、本体胴5の触接指寄り部分は成形金型縁外に位置される。そして、少なくともいずれのキャビティ周りも熱可塑性樹脂溶融温度を超えない程度に加温された成形金型内へ炭素繊維チップ配合の同種の熱可塑性樹脂のコンパウンド融液が図4中の通路12を経て圧入され、操作手6が注入成形される。ちなみに、図示は2個どり用であり、通路12は左右に枝分かれしている。接続舌7の上または下もしくは上下もしくは周囲に流入したコンパウンド融液で接続舌7の表層を融解しつつ連接胴13が一体形成され、ハンドル部2を成形する(図3(c)を参照)。 As shown in FIG. 3, a mold 9 for molding the handle portion 2 is composed of a lower mold 9D and an upper mold 9U, and a cavity 10 for forming the handle portion 2 is engraved in the mold. The holding cavity 11 of the endoprosthesis insert 1 is also formed to be continuous with the cavity. Although it is sufficient that the opening is made by the molding die edge 9e, the connecting cylinder forming area in which the connecting tongue 7 of the already formed wound insertion portion 1 is integrally formed closer to the wound insertion portion of the operating hand 6 I will come to 9s. The touching finger portion of the main body 5 is located outside the molding die rim. Then, a compound melt of the same kind of thermoplastic resin of the carbon fiber chip mix is passed through the passage 12 in FIG. 4 into the molding die heated so as not to exceed the thermoplastic resin melting temperature around at least any of the cavities. The press-in is performed, and the operating hand 6 is casted. Incidentally, the illustration is for two pieces, and the passage 12 is branched into right and left. The connecting cylinder 13 is integrally formed while melting the surface layer of the connecting tongue 7 with the compound melt flowing into the upper, lower, upper or lower or around the connecting tongue 7, and the handle portion 2 is formed (see FIG. 3C). .
なお、本体胴5は図5(a)〜(c)に示すように屈曲もしくは湾曲して成形しておくことができる。このような形状にしておけば、小切開創においてもレトラクターの操作が容易となり、屈曲もしくは湾曲の程度が異なったものを成形するにおいても(後述する図7を参照)ハンドル部2の成形に特別な拘束や制限などの影響を与えることが可及的に少なくなる。このような創内インサート部1には、その触接指4を本体胴5に対して屈曲または湾曲したフック片4A(図1(b)を参照)もしくは反りを呈した起こし片4B(図7(c)や(e)などを参照)として形成しておくことができる。軟組織を圧排または牽引等するほかに硬組織への係留性も高められる。この触接指4および接続舌は本体胴5に対して平面視略直線状をなして一体成形しておくようにすれば、すでに述べたごとくセミプレグシート8の積層による成形が極めて円滑になされ、強度や剛性の確保も容易となる。 In addition, as shown to Fig.5 (a)-(c), the main body trunk | drum 5 can be bent or curved and shape | molded. Such a shape facilitates the operation of the retractor even in a small incisional wound, and the molding of the handle portion 2 even when molding ones with different degrees of bending or bending (see FIG. 7 described later). The impact of special restraints and restrictions will be reduced as much as possible. In such a healing insert 1, a hook piece 4A (see FIG. 1 (b)) or a raised piece 4B (see FIG. 7) in which the touch finger 4 is bent or curved with respect to the main body barrel 5. See (c) and (e). In addition to restricting or pulling soft tissue, the ability to anchor to hard tissue is also enhanced. If this touch finger 4 and the connection tongue are integrally formed in a substantially linear shape in plan view with respect to the body barrel 5, as described above, the formation by laminating the semipreg sheets 8 is extremely smooth. Also, it is easy to secure strength and rigidity.
触接指4はへら状とされたり、図7(c)に示すように単独爪としたり、図7(e)に示すように分岐爪14としておくことができる。単独爪であれ分岐爪であれ、創内インサート部1の完成後に機械加工することによって形成することができる。したがって、分岐爪の形成自体はセミプレグシート積層による成形に何ら関連しないから、創内インサート部1は、図5の(a),(b)に示すように幅の複数倍もしくはそれ以上の寸法を持つ数個取り成形品15なるかたちで成形することができ、これを所定幅に切断するなどすればよく(図5(c)を参照)、爪の形状の違いによる金型の増加は回避され、コストダウンも促進することができる。なお、分岐爪とする場合にかぎらず、へら状の触接指4とする場合も同様となる。したがって、創内インサート部1の数個分成形手法によれば、触接指4の形状にとらわれることなくコストダウンが図られ、多量生産も可能となる。 The touch finger 4 may be formed into a spatula, may be a single nail as shown in FIG. 7 (c), or may be a branch nail 14 as shown in FIG. 7 (e). A single claw or a branched claw can be formed by machining after the completion of the endodontic insert portion 1. Therefore, since the formation of the bifurcated claws itself is not related at all to the formation by semipreg sheet lamination, the wound insertion portion 1 has dimensions of a multiple or more of the width as shown in (a) and (b) of FIG. It can be molded in the form of a few-piece molded product 15 having a shape, which may be cut to a predetermined width (see FIG. 5 (c)), and the increase in the mold due to the difference in the shape of the nail is avoided. Cost reduction can also be promoted. The same applies to the case of using the spatula-like touch finger 4 as well as the case of using a branched nail. Therefore, according to the formation method for the several generational insertion parts 1, cost reduction can be achieved without being restricted by the shape of the touch finger 4, and mass production becomes possible.
以上の説明から分かるように、創内インサート部1が炭素繊維強化熱可塑性樹脂のセミプレグシート積層によりハンドル部2とは独立して図5(a)に示す金型16で成形される。この成形の一例は後で述べる。図3(b)に示すごとく、創内インサート部1の一部がその保持用キャビティ11に収容保持された状態で、触接指4と一体をなす本体胴他端の接続舌7がハンドル部2の形成用キャビティ10における連接胴成形域9sに臨まされる。少なくともいずれのキャビティ周りも熱可塑性樹脂溶融温度を超えない程度に加温された成形金型9内へカーボンファイバ(チョップドファイバ)、カーボンナノファイバ、カーボンナノチューブといった短炭素繊維配合の熱可塑性樹脂コンパウンドの融液が圧入されて操作手6を注入成形する。接続舌7の上または下もしくは上下もしくは周囲に流入したコンパウンド融液で接続舌表層を融解しつつ連接胴13を一体形成してハンドル部2が成形される。 As can be understood from the above description, the healing insert portion 1 is molded by the mold 16 shown in FIG. 5A independently of the handle portion 2 by semipreg sheet lamination of a carbon fiber reinforced thermoplastic resin. An example of this shaping will be described later. As shown in FIG. 3 (b), the connection tongue 7 of the other end of the main body barrel integrally formed with the touch finger 4 is a handle portion in a state where a part of the creation insert 1 is accommodated and held in the holding cavity 11. The connecting cylinder molding area 9s in the second forming cavity 10 is exposed. Thermoplastic resin compound containing carbon fiber (chopped fiber), carbon nano fiber, carbon nanotube such as carbon nano fiber, carbon nanotube (carbon fiber), carbon nanotube, carbon nanotube (carbon fiber), carbon nano tube, carbon nano fiber, carbon nano fiber The melt is pressed in and the operator hand 6 is injected and formed. The connecting cylinder 13 is integrally formed while the connecting tongue surface layer is melted with the compound melt flowing into the upper, lower, upper or lower or around the connecting tongue 7, and the handle portion 2 is formed.
創内インサート部1は一方向材繊維や織布材繊維に樹脂が含浸されたセミプレグシート積層体ゆえに、高強度高剛性が達成される。一方、ハンドル部2は樹脂コンパウンドの固化物であるから手触りの優れた操作手6が形成される(ファイバ混入量の調整により弾性率を変えることができる)。創内インサート部1を形成する樹脂とハンドル部2の樹脂とは同一種とされ、その樹脂が熱可塑性であることから加熱による軟化もしくは再溶融による溶着・融着で円滑に一体化が図られる。多くの場合、連接胴の接続舌との一体部位は接続舌を上下から挟むように重合した形となり、連接胴13には二股に割れた上片と下片からなる鰐口が形成された恰好となる(図1(c)を参照)。この接続舌7の挟み込みによれば、その一体化は一層強固なものとなる。 The intracorporeal insertion portion 1 achieves high strength and high rigidity because it is a semi-preg sheet laminate in which resin is impregnated into unidirectional fibers or woven fabric fibers. On the other hand, since the handle portion 2 is a solidified product of the resin compound, an excellent operating hand 6 with a good touch is formed (the elastic modulus can be changed by adjusting the amount of the mixed fiber). The resin forming the intracorporeal insertion portion 1 and the resin of the handle portion 2 are made of the same type, and since the resin is thermoplastic, integration can be smoothly achieved by welding or fusion due to softening or remelting due to heating. . In many cases, the integral part of the connecting cylinder with the connecting tongue is formed so as to sandwich the connecting tongue from above and below, and the connecting cylinder 13 is formed with a fork having an upper piece and a lower piece split into forks. (See FIG. 1 (c)). According to the pinching of the connection tongue 7, the integration becomes even stronger.
創内インサート部1のみならずハンドル部2も樹脂製であるゆえオール樹脂製レトラクター3となるから、これのいずれの箇所にX線が照射されても術野の観察はほとんど妨げられなくなり、切開創の小形化すなわち低侵襲性が助成され、患者の肉体的精神的な負担も大いに軽減される。すなわち術者の視界が妨げられることは極めて少なくなる。また、接続舌を介した接続工程を含むとはいえ、一つのレトラクターとなった時点では一体品であるから、接続取外しといったためのジョイント機構は必要でなく、樹脂製であることも相まって軽量な医療器材となる。 Since not only the wound insertion portion 1 but also the handle portion 2 is made of resin, it becomes an all-resin retractor 3. Therefore, even if X-rays are irradiated to any of these portions, observation of the operative field is hardly hindered. The miniaturization of the incision, that is, the low invasiveness is assisted, and the physical and mental burden on the patient is greatly reduced. In other words, the visual field of the operator is hardly disturbed. Moreover, although it includes a connection process via a connection tongue, since it is an integral part when it becomes one retractor, a joint mechanism for connection removal is not necessary, and it is lightweight because it is made of resin. Medical equipment.
レトラクター3の完成品は永久一体性のあるものとなるが、製作の段階では創内インサート部1はハンドル部2から独立して作られる。創内インサート部1はハンドル部2の形状に左右されることなく成形できるから、図5(a)に示すような創内インサート部のための成形金型16の種類分だけ準備しておけばよい(例えば金型の樹脂フィルムバッグ被覆式真空成形などにより造形される)。創内インサート部1の接続舌7およびその近傍の本体胴5の形状や寸法を共通化しておけば、ハンドル部2の成形ならびに創内インサート部1との一体化をするための成形金型9の準備数も抑制される。すでに述べたごとくの全48種類のレトラクターを所望する場合でも、金型は48種類を必要とすることがなく、創内インサート部用を12個、ハンドル部用を4個の計16すなわち1/3の数の金型の準備で済ませることができる。これはレトラクター3の単価の低下に大きく寄与する。なお、操作手6には丸孔6A、長円孔6Bなどの指掛けもしくは牽引具係止輪が形成されるが(図1(a)を参照)、その有無や組み合わせのために成形金型が急増するということもない。 Although the finished product of the retractor 3 is permanently integrated, in the production stage, the insertion insert 1 is made independently of the handle 2. Since the intracorporeal insertion part 1 can be molded without being influenced by the shape of the handle part 2, if only the kind of the molding die 16 for the intracorporeal insertion part as shown in FIG. 5A is prepared Good (for example, molded by resin film bag-covered vacuum forming of a mold or the like). If the shape and dimensions of the connecting tongue 7 of the endodontic insert 1 and the body barrel 5 in the vicinity thereof are made common, a molding die 9 for molding the handle 2 and integrating with the endocardial insert 1 is provided. The number of preparations is also reduced. Even if all 48 types of retractors as described above are desired, 48 types of molds are not required, and a total of 16 pieces, ie 12 pieces for the insert in the wound area and 4 pieces for the handle part are required. It is possible to do with the preparation of the mold of the number of / 3. This greatly contributes to the decrease in the unit price of the retractor 3. The operator hand 6 is formed with a finger hook or pull tool locking ring such as a round hole 6A and an oval hole 6B (see FIG. 1 (a)). There is no such thing as a surge.
ところで、図6(a)に示すように、接続舌7の側方には以後に成形される連接胴より幅方向にはみ出した左の拡幅域17および右の拡幅域18が形成され、その拡幅域にはノッチ19を形成し、キャビティの対応箇所にはノッチ係合突起20(図6(b)を参照)を設けておくとよい。こうしておけば、コンパウンド融液加圧注入時に創内インサート部1のキャビティ抜け(金型からの抜け出し)を阻止しておくことができる。なお、左右の拡幅域17,18はハンドル部成形後にグラインディングするなどにより除去され、連接胴13と本体胴5とが滑らかに連なる外形をなさせるとともに、操作手6における把持の違和感や患者の皮膚等との無用の接触を著しく減らすことができる。 By the way, as shown in FIG. 6 (a), on the side of the connection tongue 7, a left widening area 17 and a right widening area 18 protruding in the width direction from the connecting cylinder to be formed later are formed. Notches 19 may be formed in the area, and notch engaging projections 20 (see FIG. 6 (b)) may be provided at corresponding locations of the cavities. In this way, it is possible to prevent the cavity insertion (extraction from the mold) of the creation insert portion 1 at the time of compound melt pressure injection. The left and right widening zones 17 and 18 are removed by grinding after forming the handle portion, and the connecting barrel 13 and the body barrel 5 form a smooth continuous outer shape, and the sense of incongruity in gripping with the operating hand 6 or the patient. Unwanted contact with the skin etc. can be significantly reduced.
以上いずれの手法で製造されたものであってもレトラクターはマトリックス全てを樹脂とするものであり、軽量であって術者の操作負担を少なくし、小切開創を開く方向に牽引すれば軟組織が圧排、牽引による術野の視野が確保される。X線照射により患部の確認においてもオール樹脂ゆえに遮られるものがなく、施術の円滑化・正確化の増進に大きく寄与する。上記したごとく金型の数は少なくなるが、図7に示したように、本体胴5の長さを違えたり、屈曲や湾曲度合いを変えたり、ハンドル部2の形を所望のものにするなどでき、特に術者の好みに応じたレトラクターを少ない金型形態でもって実現することができる。 No matter whether manufactured by any of the above methods, the retractor uses the entire matrix as resin, is lightweight, reduces the operation burden on the operator, and pulls the small incision in the direction to open it. There is a view of the surgical field by exclusion and traction. There is nothing that is blocked because of the all-resin in the confirmation of the affected area by X-ray irradiation, which greatly contributes to the promotion of smoothing and accuracy of the treatment. As described above, although the number of molds is reduced, as shown in FIG. 7, the length of the main body cylinder 5 may be different, the degree of bending or bending may be changed, or the shape of the handle portion 2 may be desired. In particular, it is possible to realize a retractor according to the preference of the operator with a small number of mold forms.
1…創内インサート部、2…ハンドル部、3…レトラクター、4…触接指、4A…フック片、4B…起こし片、5…本体胴、6…操作手、6A…丸孔、7…接続舌、8…セミプレグシート、9…金型、9e…成形金型縁、9s…連接胴成形域、9D…下型、9U…上型、10…形成用キャビティ、11…保持用キャビティ、13…連接胴、14…分岐爪、15…数個取り成形品、16…創内インサート部成形金型、17…左の拡幅域、18…右の拡幅域、19…ノッチ、20…ノッチ係合突起。 DESCRIPTION OF SYMBOLS 1 ... Insertion part in a wound, 2 ... Handle part, 3 ... Retractor, 4 ... Touching finger, 4A ... Hook piece, 4B ... Uplift piece, 5 ... Body body, 6 ... Operation hand, 6A ... Round hole, 7 ... Connecting tongue, 8: Semipreg sheet, 9: mold, 9e: molding die edge, 9s: connecting cylinder molding area, 9D: lower mold, 9U: upper mold, 10: forming cavity, 11: holding cavity, 13: Articulating cylinder, 14: bifurcated claw, 15: several-piece molded article, 16: insert for insertion part molding die, 17: left widening area, 18: right widening area, 19: notch, 20: notch engagement Alignment.
Claims (5)
前記創内インサート部は前記ハンドル部の爾後的な成形中に溶着される接続舌を前記本体胴の基端部位に備え、該本体胴が接続舌および前記触接指と一体をなして炭素繊維強化熱可塑性樹脂のセミプレグシート積層により、前記ハンドル部とは独立して成形され、
下型および上型からなる成形金型に刻設された前記ハンドル部の形成用キャビティと連なり成形金型縁で開口する創内インサート部の保持用キャビティに、前記接続舌が前記操作手の創内インサート部寄りに一体形成される連接胴成形域に臨まされるとともに前記本体胴の触接指寄り部分が成形金型縁外に位置されるように、既に製作された前記創内インサート部を収容保持し、
少なくとも前記いずれのキャビティ周りも前記熱可塑性樹脂溶融温度を超えない程度に加温された成形金型内へ炭素繊維チップ配合の熱可塑性樹脂コンパウンドの融液を圧入して前記操作手を注入成形するとともに、前記接続舌の上または下もしくは上下もしくは周囲に流入したコンパウンド融液で接続舌表層を融解しつつ前記連接胴を一体形成してハンドル部を成形するようにしたことを特徴とする全樹脂製レトラクターの製造法。 An intracorporeal insertion section provided with a touch finger at the tip of the body trunk for retracting or pulling soft tissue from the incision wound up to the operation target site, and an operation hand for desired action on the touch finger In a method of manufacturing a retractor, comprising: a handle portion provided, wherein the intracorporeal insertion portion is integrated with the handle portion,
The endoprosthesis insert comprises a connecting tongue at the proximal end of the body barrel which is welded during subsequent shaping of the handle portion, the body barrel being integral with the connecting tongue and the touch finger and carbon fiber Molded independently of the handle portion by semi-preg sheet lamination of reinforced thermoplastic resin,
The connecting tongue is connected to the holding cavity of the wound insert portion which is continuous with the forming cavity of the handle portion engraved in the forming die consisting of the lower mold and the upper die and opened at the forming die edge. The above-mentioned wound insert portion is manufactured so as to face the connecting cylinder forming area integrally formed closer to the inner insert portion and to position the touch and touch portion of the main body cylinder outside the molding die rim. Contain and hold,
The operation hand is injected and formed by pressing a melt of a thermoplastic resin compound blended with carbon fiber chips into a molding die heated so as not to exceed the melting temperature of the thermoplastic resin at least around any of the cavities. In addition, the connecting cylinder is integrally formed while the connecting tongue surface layer is melted with a compound melt flowing into the upper, lower, upper or lower or around the connecting tongue, and the handle portion is formed. Manufacturing method of a made retractor.
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