JP4844259B2 - Method for manufacturing a needle assembly - Google Patents

Method for manufacturing a needle assembly Download PDF

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JP4844259B2
JP4844259B2 JP2006179180A JP2006179180A JP4844259B2 JP 4844259 B2 JP4844259 B2 JP 4844259B2 JP 2006179180 A JP2006179180 A JP 2006179180A JP 2006179180 A JP2006179180 A JP 2006179180A JP 4844259 B2 JP4844259 B2 JP 4844259B2
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needle
tip
hub
protector
assembly
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JP2008006050A (en
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裕之 中神
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Nipro Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3216—Caps placed transversally onto the needle, e.g. pivotally attached to the needle base

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

本発明は、針組立体に関し、より詳細には、血液などが付着した使用後の医療用針が、誤って人体に突き刺さることを防ぐための機構を備えた針組立体に関する。   The present invention relates to a needle assembly, and more particularly to a needle assembly provided with a mechanism for preventing a used medical needle to which blood or the like is attached from being accidentally stuck into a human body.

従来、注射針のような医療用針は、金属製の針と、金属針の基端側に設けられ、金属針を固定するためのハブと、該ハブに嵌合可能であり、針の針先を覆って使用前の誤穿刺を防止するためのキャップとから構成されている。前記医療用針は、その針先を覆うキャップを取り外した状態で使用する。そして、使用後、再びキャップにより患者の血液や体液により汚染された針先を覆い、術者や患者、針を廃棄する者等が誤って鋭利な針先に触れて傷を負ったり、また、それにより肝炎や各種伝染性疾患等に感染したりすることを防止する。   2. Description of the Related Art Conventionally, a medical needle such as an injection needle is provided on the proximal end side of a metal needle, a hub for fixing the metal needle, and can be fitted to the hub. A cap for covering the tip and preventing erroneous puncture before use. The medical needle is used in a state where a cap covering the needle tip is removed. And after use, the needle tip contaminated with the patient's blood and body fluid is again covered with the cap, the operator, the patient, the person discarding the needle, etc. accidentally touched the sharp needle tip and injured, This prevents infection with hepatitis or various infectious diseases.

使用済みの針を安全かつ容易に保護できる針組立体としては、従来、注射器の外筒を覆うように設けられた円筒状のシールドを、針の先端側へ摺動させることにより、針先を保護するものや、注射器にヒンジ止めされたシールドを、注射器に対して回転させることにより注射器先端の針を保護するもの、針に沿って軸線方向に移動可能なシールドにより針の先端を保護するものなどが開発された。
これらの針組立体は、両手による操作を必要とするため、操作者は片手で医療器具を保持し、もう一方の手でシールドを移動させて針先を保護する必要がある。また、いずれの針組立体も形状が大きいため、廃棄物量が極めて多くなる。 As a needle assembly that can safely and easily protect a used needle, conventionally, the needle tip is moved by sliding a cylindrical shield provided to cover the outer cylinder of the syringe toward the tip side of the needle. What protects, protects the needle at the tip of the syringe by rotating the shield hinged to the syringe relative to the syringe, protects the tip of the needle with a shield that can move in the axial direction along the needle Etc. were developed.
Since these needle assemblies require operation with both hands, the operator must hold the medical instrument with one hand and move the shield with the other hand to protect the needle tip. Also, since any needle assembly is large in shape, the amount of waste is extremely large.

一方、上記問題点を考慮して、片手で操作可能な針組立体も公知である（例えば、特許文献１参照）。この針組立体は、針の先端を保護しうる針ガードが針の軸方向に平行に設けられており、その基端は注射器まで延びている。針組立体の使用後、注射器を保持している手のいずれかの指で針ガードの基端側を先端に向けて押すことにより、針の先端を保護することができる。しかし、このような針組立体は、針ハブに針を挿入するための孔とは別に針ガードを挿入するための孔を形成したり、針ハブ上に針ガードを挿入するための孔を有する別の部材を設けたりする必要があるため形状が大きく、かつその組み立て方法も複雑である。   On the other hand, in consideration of the above problems, a needle assembly that can be operated with one hand is also known (see, for example, Patent Document 1). In this needle assembly, a needle guard capable of protecting the distal end of the needle is provided in parallel to the axial direction of the needle, and its proximal end extends to the syringe. After using the needle assembly, the tip of the needle can be protected by pressing the proximal end of the needle guard toward the tip with any finger of the hand holding the syringe. However, such a needle assembly forms a hole for inserting a needle guard separately from a hole for inserting a needle into the needle hub, or has a hole for inserting the needle guard on the needle hub. Since it is necessary to provide another member, the shape is large and the assembling method is complicated.

また、硬質樹脂からなる針ガードを有する注射器（例えば、特許文献２参照）は、片手で針先を保護する操作をより安定して行えるという利点は有するものの、針ガードが針に沿わず、針から距離をおいて平行に位置しており、形状が大きく使用しにくい。さらに針ガードが予期せぬ外力により引っ張られると、針先が針ガードから再度突出してしまうおそれもある。   In addition, a syringe having a needle guard made of a hard resin (see, for example, Patent Document 2) has the advantage that the operation of protecting the needle tip with one hand can be performed more stably, but the needle guard does not follow the needle, It is located in parallel at a distance from, and its shape is large and difficult to use. Furthermore, if the needle guard is pulled by an unexpected external force, the needle tip may protrude from the needle guard again.

本発明の出願人は、これらの針組立体の問題点を解消することができる針組立体を先に提案している（例えば、特許文献３参照）。この針組立体は、針ハブとハブカバーとの間に形成される側孔に可撓性のプロテクターを挿通したものであり、プロテクターの形状が大きくなることがないため、片手で針先を保護する操作が容易であり、かつ組み立ても容易である。またプロテクターが針に沿うように配置されるため、いったんプロテクター先端の針先保護部に収容された針先が再度突出するおそれもない。   The applicant of the present invention has previously proposed a needle assembly that can solve the problems of these needle assemblies (see, for example, Patent Document 3). In this needle assembly, a flexible protector is inserted into a side hole formed between the needle hub and the hub cover, and the shape of the protector is not increased, so that the needle tip is protected with one hand. It is easy to operate and easy to assemble. Further, since the protector is arranged along the needle, there is no possibility that the needle tip once accommodated in the needle tip protecting portion at the tip of the protector will protrude again.

しかしこの針組立体は、組み立て時にまず針ハブの先端部に針の基端部を固定し、次いで針先をプロテクターの針先保護部の内腔に基端側から挿通させる必要がある。したがって、針先を針先保護部に挿通させる際に針先保護部の内壁で針先を痛めるおそれがある。針先を痛めない組み立て方法としては、針の基端部を針先保護部の内腔に先端側から挿通させた後に、針の基端部と針ハブの先端部を固定する方法が考えられるが、このような方法は針と針先保護部とを固定することなく針の基端部が針先保護部の基端部から露出した状態で保持する必要があり、非常に複雑である。また針ハブ、ハブカバーおよびプロテクターを先に組み立てた状態で、針の基端部を針先保護部の内腔へ先端側から挿入し、さらに針先保護部内に固定された針ハブの内腔へと挿入させることも考えられるが、このような組み立て方法もまた容易ではない。   However, in this needle assembly, it is necessary to fix the proximal end portion of the needle to the distal end portion of the needle hub at the time of assembly, and then to insert the needle tip from the proximal end side into the lumen of the needle tip protecting portion of the protector. Therefore, when the needle tip is inserted into the needle tip protection portion, the needle tip may be damaged by the inner wall of the needle tip protection portion. As an assembly method that does not damage the needle tip, a method is conceivable in which the proximal end portion of the needle and the distal end portion of the needle hub are fixed after the proximal end portion of the needle is inserted into the lumen of the needle tip protecting portion from the distal end side. However, such a method is very complicated because it is necessary to hold the base end portion of the needle exposed from the base end portion of the needle tip protection portion without fixing the needle and the needle tip protection portion. Also, with the needle hub, hub cover, and protector assembled first, insert the proximal end of the needle into the lumen of the needle tip protector from the distal end side, and further into the needle hub lumen fixed in the needle tip protector However, such an assembly method is also not easy.

特許第２７３９８４０号公報Japanese Patent No. 2739840 特開２００３−２２０１４０号公報JP 2003-220140 A 特開２００３−３３４３５号公報JP 2003-33435 A

そこで本発明は、組み立て方法が簡単で、かつ組み立て時に針先を痛めるおそれがない、使用後に片手で容易に針先を保護できる針組立体を提供することを目的とする。   SUMMARY OF THE INVENTION An object of the present invention is to provide a needle assembly that can be easily protected with one hand after use and has a simple assembling method and does not hurt the needle tip during assembly.

本発明者は、鋭意検討を行った結果、組み立ての工程の中で、針ハブの外周にハブカバーおよびプロテクター先端の針先保護部が固定され、針の取り付け時に針ハブの先端部が前記ハブカバーおよび針先保護部から先端部へ露出されるようにすることにより、上記課題を解決できることを見出し、本発明に到達した。   As a result of intensive studies, the inventor has fixed the hub cover and the tip of the protector at the tip of the protector to the outer periphery of the needle hub during the assembly process, and the tip of the needle hub is attached to the hub cover and the needle when the needle is attached. The inventors have found that the above-mentioned problems can be solved by exposing the needle tip protecting portion to the tip portion, and have reached the present invention.

すなわち、本発明は、
（１）先端に鋭利な針先を有する中空の針と、前記針が先端部に固着され針の内部と連通する内腔を有する針ハブと、細長い棒状の本体およびその先端側に設けられた前記針上を摺動する中空の筒体である針先保護部を有するプロテクターとを備え、前記針先保護部の先端部内周面には内部に収容された針先が先端側へ飛び出すことを防止しうるよう内方向へ突出した突起が設けられ、前記針ハブの外周には内部に針ハブ、プロテクター本体および針先保護部を収容可能な内部通路を有する筒状のハブカバーが固定され、前記ハブカバーは針ハブと接合されたときにプロテクター本体を摺動可能に挿通しうる側孔を形成し、前記プロテクターは本体が前記側孔に挿通された状態で、針および針ハブの先端部が針先保護部から先端側へ露出する第一の位置から、針先が針先保護部内に収容される第二の位置まで移動しうる針組立体の製造方法であって、
（ａ）針ハブの先端部をプロテクターの針先保護部の内腔に基端側から挿入し、前記針ハブの先端部が針先保護部から先端側へ露出した状態で針ハブと針先保護部とを固定する工程、
（ｂ）前記工程（ａ）で得られた組立体の先端部をハブカバーの内部通路に基端側から挿入し、前記ハブカバーと針ハブとを接合させてプロテクター本体を摺動可能に挿通した側孔を形成し、この状態で針ハブとハブカバーとを固定する工程、および
（ｃ）前記工程（ｂ）で得られた組立体の先端部から露出している針ハブの内腔に、針の基端部を先端側から挿入して固定する工程
を有してなることを特徴とする針組立体の製造方法、
（２）前記針ハブの外周面および前記針先保護部の先端部内周面の突起には、係合により前記プロテクターを第一の位置に位置決めするための第一位置決め手段が設けられている（１）記載の針組立体の製造方法、
（３）前記プロテクター本体の基端部には、ハブカバーとの係合により前記プロテクターを第二の位置に位置決めするための第二位置決め手段が設けられている（１）または（２）記載の針組立体の製造方法、
（４）前記プロテクター本体は、プロテクターが第一の位置に位置決めされるときに側孔に配置される部分に、外方向へ緩やかに湾曲する湾曲部が設けられている（１）〜（３）のいずれかに記載の針組立体の製造方法、
に関する。 That is, the present invention
(1) A hollow needle having a sharp needle tip at the tip, a needle hub having a lumen that is fixed to the tip and communicating with the inside of the needle, an elongated rod-shaped main body, and a tip side thereof e Bei a protector having a needle tip protective part is a hollow cylindrical body which slides on the needle, the needle tip housed inside pops out distally to the distal end portion inner peripheral surface of the needle tip protective part A protrusion projecting inwardly to prevent the needle hub, and a cylindrical hub cover having an internal passage capable of accommodating a needle hub, a protector body, and a needle tip protector is fixed to the outer periphery of the needle hub. The hub cover forms a side hole through which the protector body can be slidably inserted when the hub cover is joined to the needle hub, and the protector is in a state where the body and the tip end of the needle hub are inserted into the side hole. Exposed from the needle tip protector to the tip side From one position, the needle tip is a second method of manufacturing a needle assembly Ru bovine moved to a position to be accommodated in the needle tip protective portion,
(A) The tip of the needle hub is inserted into the lumen of the protector's needle tip protector from the proximal end side, and the needle hub and the needle tip are exposed with the tip of the needle hub exposed from the needle tip protector to the tip side. Fixing the protective part,
(B) The side where the distal end of the assembly obtained in the step (a) is inserted into the internal passage of the hub cover from the proximal end side, the hub cover and the needle hub are joined, and the protector body is slidably inserted. Forming a hole and fixing the needle hub and hub cover in this state; and
(C) A step of inserting and fixing the proximal end portion of the needle from the distal end side into the lumen of the needle hub exposed from the distal end portion of the assembly obtained in the step (b).
A method of manufacturing a needle assembly, comprising:
(2) to said needle hub outer circumference and protrusion of the needle tip protective tip inner peripheral surface of the first positioning means for positioning the protector in the first position is provided by the engagement ( 1) A method for producing the needle assembly according to the above,
(3) the proximal end portion of the protector body, the second positioning means for positioning the second position the protector by the engagement between the hub cover is provided (1) or (2) needle according Assembly manufacturing method ,
(4) the protector body, the portion that is disposed on the side hole when the protector is positioned in the first position, the curved portion gently curved outward direction are provided (1) to (3) A method of manufacturing the needle assembly according to any one of
About.

本発明の針組立体は、組み立ての工程の中で、針ハブの外周にハブカバーおよびプロテクター先端の針先保護部が固定され、針ハブの先端部が前記ハブカバーおよび針先保護部から先端側に露出される。したがって、針の取り付け時には、針の基端部を露出した針ハブの先端部からその内腔に挿入することができ、挿入後に針ハブの先端部と針とを接着などにより固定することが可能である。このような組み立て方法は非常に簡単で、かつ組み立て時に針先を痛めるおそれもない。   In the needle assembly of the present invention, the needle cover protecting portion at the tip of the hub cover and the protector is fixed to the outer periphery of the needle hub during the assembly process, and the tip of the needle hub is located on the tip side from the hub cover and the needle tip protecting portion. Exposed. Therefore, when attaching the needle, the proximal end of the needle can be inserted into the lumen from the exposed distal end of the needle hub, and after insertion, the distal end of the needle hub and the needle can be fixed by bonding or the like. It is. Such an assembling method is very simple and there is no fear of damaging the needle tip during assembling.

以下、図面を用いて本発明の好ましい実施態様を詳細に説明するが、本発明はこれらに限定されるものではない。
図１は本発明の針組立体の一実施例の針先保護前の状態を示す縦断面図であり、図２は図１に示される針組立体の針先保護後の状態を示す縦断面図である。
本発明の針組立体において、先端とは患者等に穿刺する側（図中、右側）を、基端とは先端の反対側（図中、左側）を指す。また、図示していないが、本発明の針組立体１は、基端側にシリンジやコネクター、輸液用チューブ等を接続して使用するものである。 Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings, but the present invention is not limited thereto.
FIG. 1 is a longitudinal sectional view showing a state of the needle assembly according to an embodiment of the present invention before protection of the needle tip, and FIG. 2 is a longitudinal sectional view showing a state of the needle assembly shown in FIG. 1 after protection of the needle tip. FIG.
In the needle assembly of the present invention, the distal end refers to the side that punctures a patient or the like (right side in the figure), and the proximal end refers to the opposite side of the distal end (left side in the figure). Although not shown, the needle assembly 1 of the present invention is used by connecting a syringe, a connector, an infusion tube or the like to the proximal end side.

本発明に用いられる針２は、中空の管であり、その先端部には鋭利な針先２１が形成されており、該針先２１は刺通抵抗を低くするために傾斜した刃面を有している。前記針２の材質としては、ステンレス鋼、アルミニウム、チタン、あるいはこれらの合金等の金属材料があげられる。   The needle 2 used in the present invention is a hollow tube, and a sharp needle tip 21 is formed at the tip of the tube. The needle tip 21 has an inclined blade surface to reduce piercing resistance. is doing. Examples of the material of the needle 2 include metal materials such as stainless steel, aluminum, titanium, and alloys thereof.

図１に示されるように、前記針２の基端部には、針ハブ３が固定されている。その固定方法としては、接着剤による接着や、熱による融着等があげられる。前記針ハブ３は、前記針２の内部と連通する内腔を有する中空の管体であり、該内腔は基端側に向かって内径が増加するテーパー状に形成されていてもよい。前記針ハブ３の基端部には、シリンジの先端部、コネクターや輸液チューブの接続部等が嵌合される。前記針ハブ３の材質としては、ポリカーボネート、アクリロニトリル−ブタジエン−スチレン共重合体、ポリスチレン、ポリエチレン、ポリプロピレン等の硬質材料が好ましく用いられる。   As shown in FIG. 1, a needle hub 3 is fixed to the proximal end portion of the needle 2. Examples of the fixing method include adhesion with an adhesive and fusion with heat. The needle hub 3 is a hollow tube body having a lumen communicating with the inside of the needle 2, and the lumen may be formed in a tapered shape whose inner diameter increases toward the proximal end side. A proximal end portion of the needle hub 3 is fitted with a distal end portion of a syringe, a connector, a connection portion of an infusion tube, and the like. As the material of the needle hub 3, a hard material such as polycarbonate, acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene, or polypropylene is preferably used.

本発明の針組立体１の構成要件の一つであるプロテクター４は、細長い棒状の本体４１およびその先端側に設けられた中空の筒体である針先保護部４２を有している。前記プロテクター４は適度に柔軟であることが好ましく、その材料としてはポリプロピレン、ポリカーボネート、アクリロニトリル−ブタジエン−スチレン共重合体、ポリスチレン、ポリエチレン、ポリアセタール等が好ましく用いられる。前記針先保護部４２は、針２を内腔に挿通させ、該針２上を先端側または基端側へ摺動する。前記針先保護部４２の先端部内周面には、内部に収容された針先２１が先端側へ飛び出すことを防止しうるよう内方向へ突出した突起４３が設けられる。前記針先保護部４２の内径は、前記突起４３が設けられた部分で最も小さくなるが、この部分の内径が、針ハブ３の先端部が針先保護部４２から先端側へ露出することを許容するように、針ハブ３先端部の外径よりもわずかに大きく設定されていることが好ましい。   The protector 4 which is one of the constituent elements of the needle assembly 1 of the present invention has an elongated rod-like main body 41 and a needle tip protecting portion 42 which is a hollow cylindrical body provided on the distal end side thereof. The protector 4 is preferably moderately flexible, and polypropylene, polycarbonate, acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene, polyacetal and the like are preferably used as the material. The needle tip protecting portion 42 allows the needle 2 to be inserted into the lumen and slides on the needle 2 toward the distal end side or the proximal end side. A protrusion 43 projecting inward is provided on the inner peripheral surface of the distal end portion of the needle tip protecting portion 42 so as to prevent the needle tip 21 accommodated therein from jumping out toward the distal end side. The inner diameter of the needle tip protection portion 42 is the smallest at the portion where the projection 43 is provided, but the inner diameter of this portion indicates that the tip of the needle hub 3 is exposed from the needle tip protection portion 42 to the tip side. In order to allow, it is preferable that the outer diameter of the tip end portion of the needle hub 3 is set slightly larger.

前記針ハブ３の外周には、中空の管体であるハブカバー５が設けられている。前記ハブカバー５は、先端から基端へ貫通した内部通路５１を有している。前記内部通路５１には、針ハブ３、プロテクター本体４１および針先保護部４２が収容されうるよう、前記ハブカバー５の内径は該針先保護部４２の外径よりも若干大きく設定されている。前記ハブカバー５の全長は、針ハブ３の外周に配置されたときに、該針ハブ３の先端部がハブカバー５の先端側から露出しうる大きさであれば特に限定されない。前記ハブカバー５の材質もまた針ハブ３と同様、ポリカーボネート、アクリロニトリル−ブタジエン−スチレン共重合体、ポリスチレン、ポリエチレン、ポリプロピレン等の硬質材料が好ましく用いられる。   A hub cover 5 that is a hollow tube is provided on the outer periphery of the needle hub 3. The hub cover 5 has an internal passage 51 penetrating from the distal end to the proximal end. The inner diameter of the hub cover 5 is set to be slightly larger than the outer diameter of the needle tip protector 42 so that the needle hub 3, protector body 41 and needle tip protector 42 can be accommodated in the internal passage 51. The total length of the hub cover 5 is not particularly limited as long as the distal end portion of the needle hub 3 can be exposed from the distal end side of the hub cover 5 when arranged on the outer periphery of the needle hub 3. The material of the hub cover 5 is also preferably a hard material such as polycarbonate, acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene, polypropylene, etc., like the needle hub 3.

図１に示されるように、前記針ハブ３およびハブカバー５は、接合されて一体となったときに、外部とハブカバー５の内部通路５１とを連通しうる側孔６が形成される形状を有している。その接合方法としては、エポキシ樹脂、ＵＶ硬化接着剤等による接着、或いは超音波溶着による溶着等があげられる。   As shown in FIG. 1, the needle hub 3 and the hub cover 5 have a shape in which a side hole 6 is formed to allow the outside and the internal passage 51 of the hub cover 5 to communicate with each other when joined together. is doing. Examples of the bonding method include adhesion by an epoxy resin, a UV curable adhesive, or the like, or welding by ultrasonic welding.

前記側孔６には、プロテクター本体４１が摺動可能に挿通される。前記側孔６の形状および大きさは、プロテクター本体４１の摺動を妨げない限り特に限定されない。前記側孔６の外部へと開口する方向もまたプロテクター本体４１の摺動を妨げないものであればよい。プロテクター４を針２に沿って摺動するように配置するためには、前記側孔６は図１に示されるように、基端側へ向かって斜め外方向に開口したものであることが好ましい。   A protector body 41 is slidably inserted into the side hole 6. The shape and size of the side hole 6 are not particularly limited as long as the sliding of the protector body 41 is not hindered. The direction of opening to the outside of the side hole 6 may also be any as long as it does not prevent the protector body 41 from sliding. In order to arrange the protector 4 so as to slide along the needle 2, it is preferable that the side hole 6 is opened obliquely outward toward the base end as shown in FIG. .

前記針ハブ３は、先端側がハブカバー５を外周に配置しうるように該ハブカバー５の内径よりも小さい外径を有し、基端側がハブカバー５の基端側への脱落を防止しうるように該ハブカバー５の内径よりも大きい外径を有していることが好ましい。この外径の変化する位置により、前記ハブカバー５の針ハブ３の外周での固定位置が決定されるが、該ハブカバー５はその内部通路５１から針ハブ３の先端部が先端側へ露出した状態で固定される。   The needle hub 3 has an outer diameter smaller than the inner diameter of the hub cover 5 so that the distal end side can arrange the hub cover 5 on the outer periphery, and the proximal end side can prevent the hub cover 5 from falling off to the proximal end side. It is preferable to have an outer diameter larger than the inner diameter of the hub cover 5. The fixing position of the hub cover 5 on the outer periphery of the needle hub 3 is determined by the position where the outer diameter changes. The hub cover 5 is in a state in which the distal end portion of the needle hub 3 is exposed from the inner passage 51 to the distal end side. It is fixed with.

図３は、図１に示される針組立体のＡ−Ａ線横断面図である。前記針ハブ３は、図３に示されるようにその外周に放射状に配置される複数のリブ３１を有していてもよい。前記リブ３１は針ハブ３がハブカバー５の内部通路５１に挿入されたときに、該リブ３１の先端が内部通路５１の壁面に接する大きさに形成されており、リブ３１がハブカバー５と接合することによって針ハブ３とハブカバー５は固定される。このとき、ハブカバー５の内部通路５１が前記リブ３１により複数の通路３２に分断されるため、前記プロテクター本体４１はそのうちの一つの通路３２内に配置されることになる。したがって、前記プロテクター本体４１の断面形状は、通路３２および側孔６内を摺動する際の摩擦を最小限にするために、前記通路３２および側孔６の形状に即したものであることが好ましい。
前記ハブカバー５の外周にもまた、図３に示されるような複数のリブ５２が設けられていてもよい。前記リブ５２は、針組立体１の使用前に針先２１を保護するために針２に被せられるキャップ（図示せず）を嵌合固定するために用いられる。 3 is a cross-sectional view taken along line AA of the needle assembly shown in FIG. The needle hub 3 may have a plurality of ribs 31 arranged radially on the outer periphery thereof as shown in FIG. The rib 31 is formed in such a size that the tip of the rib 31 comes into contact with the wall surface of the internal passage 51 when the needle hub 3 is inserted into the internal passage 51 of the hub cover 5, and the rib 31 is joined to the hub cover 5. As a result, the needle hub 3 and the hub cover 5 are fixed. At this time, since the internal passage 51 of the hub cover 5 is divided into a plurality of passages 32 by the ribs 31, the protector body 41 is disposed in one of the passages 32. Therefore, the cross-sectional shape of the protector body 41 may be in accordance with the shape of the passage 32 and the side hole 6 in order to minimize friction when sliding in the passage 32 and the side hole 6. preferable.
A plurality of ribs 52 as shown in FIG. 3 may also be provided on the outer periphery of the hub cover 5. The rib 52 is used to fit and fix a cap (not shown) that covers the needle 2 to protect the needle tip 21 before the needle assembly 1 is used.

前記プロテクター４は、針組立体１使用前および使用中、すなわち前記針先２１が保護される前には、図１に示されるように、針先保護部４２が針ハブ３の外周に配置される第一の位置に位置決めされる。前記第一の位置では、針２および針ハブ３の先端部は針先保護部４２から先端側へ露出している。針組立体１使用後、すなわち前記針先２１が保護される時には、前記プロテクター４は針組立体１を保持している手のいずれかの指でプロテクター本体４１が先端側へ押されることで先端側へと摺動し、図２に示されるように、前記針先２１が針先保護部４２内に収容される第二の位置で位置決めされる。   In the protector 4, before and during use of the needle assembly 1, that is, before the needle tip 21 is protected, as shown in FIG. 1, a needle tip protecting portion 42 is disposed on the outer periphery of the needle hub 3. Is positioned at the first position. In the first position, the distal end portions of the needle 2 and the needle hub 3 are exposed from the needle tip protecting portion 42 toward the distal end side. After the needle assembly 1 is used, that is, when the needle tip 21 is protected, the protector 4 is moved to the distal end by pushing the protector body 41 toward the distal end side with any finger of the hand holding the needle assembly 1. As shown in FIG. 2, the needle tip 21 is positioned at a second position where the needle tip 21 is accommodated in the needle tip protecting portion 42.

本発明の針組立体１には、前記プロテクター４を第一の位置に位置決めするための、第一位置決め手段が設けられることが好ましい。前記第一位置決め手段は、図１に示されるように、前記針先保護部４２が前記針ハブ３の外周に配置された第一の位置から、プロテクター４が容易に針組立体１の先端側または基端側へ移動しないように位置決めするためのものである。   The needle assembly 1 of the present invention is preferably provided with a first positioning means for positioning the protector 4 at the first position. As shown in FIG. 1, the first positioning means allows the protector 4 to easily move the tip end side of the needle assembly 1 from the first position where the needle tip protecting portion 42 is disposed on the outer periphery of the needle hub 3. Or it is for positioning so that it may not move to a base end side.

図４は、図１に示される針組立体１の、針ハブ３の先端部付近の部分拡大縦断面図である。前記第一位置決め手段は、例えば図５に示されるように、針ハブ３の先端部外周面に設けられた凸部３３と、前記プロテクター４の針先保護部４２の先端部内周面の突起４３に設けられた凹部４４との係合によるものがあげられる。前記第一位置決め手段は、前記針ハブ３の先端部外周面と前記針先保護部４２の先端部内周面の突起４３との係合によるものであれば、該針ハブ３に設けられるものが凹部であり、針先保護部４２の突起４３に設けられるものが凸部であっても差し支えない。   FIG. 4 is a partially enlarged longitudinal sectional view of the needle assembly 1 shown in FIG. 1 near the tip of the needle hub 3. For example, as shown in FIG. 5, the first positioning means includes a protrusion 33 provided on the outer peripheral surface of the distal end portion of the needle hub 3 and a protrusion 43 on the inner peripheral surface of the distal end portion of the needle tip protecting portion 42 of the protector 4. And the like by engagement with a recess 44 provided in the. If the first positioning means is based on the engagement between the outer peripheral surface of the distal end portion of the needle hub 3 and the protrusion 43 on the inner peripheral surface of the distal end portion of the needle tip protecting portion 42, the first positioning means is provided on the needle hub 3. Even if it is a recessed part and what is provided in the processus | protrusion 43 of the needlepoint protection part 42 is a convex part, it does not interfere.

本発明の針組立体１には、さらに前記プロテクター４を第二の位置に位置決めするための、第二位置決め手段が備えられることが好ましい。前記第二位置決め手段は、図２に示されるように、前記針先保護部４２が前記針先２１を収納した第二の位置から、プロテクター４が容易に針組立体１の先端側および基端側へ移動しないように位置決めするためのものである。   It is preferable that the needle assembly 1 of the present invention further includes a second positioning means for positioning the protector 4 at the second position. As shown in FIG. 2, the second positioning means allows the protector 4 to easily move the distal end side and the proximal end of the needle assembly 1 from the second position where the needle tip protecting portion 42 houses the needle tip 21. It is for positioning so as not to move to the side.

前記第二位置決め手段のうち、プロテクター４の先端側への移動を防止するものは、例えば、前記プロテクター本体４１の基端部に設けられた係合アーム４５と前記ハブカバー５の基端部との係合によるものがあげられる。また、プロテクター本体４１の基端部に、図１に示されるように、側孔６に挿通不可能な程度に十分大きい指接触部４６が設けられる場合、該指接触部４６が前記ハブカバー５と係合するため、前記係合アーム４５を設けなくてもよい。   Of the second positioning means, the one that prevents the protector 4 from moving toward the distal end side is, for example, an engagement arm 45 provided at the proximal end portion of the protector body 41 and the proximal end portion of the hub cover 5. The thing by engagement is mention | raise | lifted. Further, as shown in FIG. 1, when a finger contact portion 46 that is sufficiently large so as not to be inserted into the side hole 6 is provided at the base end portion of the protector body 41, the finger contact portion 46 is connected to the hub cover 5. In order to engage, the engagement arm 45 may not be provided.

また、前記第二位置決め手段のうち、プロテクター４の基端側への移動を防止するものは、例えば、前記プロテクター本体４１基端部の係合アーム４５の先端部に内方向に向けて設けられた突起４７とハブカバー５の先端部との係合によるものがあげられる。また、プロテクター４の針先保護部４２の先端部内周面に設けられた突起４３と針先２１との係合によっても、プロテクター４の基端側への移動は防止される。   Of the second positioning means, the one for preventing the movement of the protector 4 toward the proximal end side is provided, for example, at the distal end portion of the engagement arm 45 at the proximal end portion of the protector body 41 facing inward. For example, the protrusion 47 may be engaged with the tip of the hub cover 5. Further, the movement of the protector 4 to the proximal end side is also prevented by the engagement of the protrusion 43 provided on the inner peripheral surface of the distal end portion of the needle tip protecting portion 42 of the protector 4 and the needle tip 21.

前記プロテクター本体４１は、プロテクター４が前記第一の位置に位置決めされるときに側孔６に配置される部分に、外方向へ緩やかに湾曲する湾曲部４８が設けられてもよい。この湾曲部４８が設けられることにより、前記側孔６が図１に示されるように基端側へ向かって斜め外方向に開口している場合には、プロテクター４の針先保護部４２がプロテクター本体４１の反発力を受けることなく第一の位置に位置決めされやすくなる。   The protector body 41 may be provided with a curved portion 48 that gently curves outwardly at a portion that is disposed in the side hole 6 when the protector 4 is positioned at the first position. By providing the curved portion 48, when the side hole 6 is opened obliquely outward toward the proximal end as shown in FIG. 1, the needle tip protecting portion 42 of the protector 4 is protected by the protector 4. It becomes easy to be positioned at the first position without receiving the repulsive force of the main body 41.

また前記湾曲部４８は、プロテクター本体４１が第二の位置に位置決めされたときに、図２に示されるように針先２１の針先保護部４２内に収容される位置を針先保護部４２の軸から偏心させる。これにより、針先２１は、プロテクター４が第二の位置から基端側へと移動しようとしたときに針先保護部４２の先端部内周面の突起４３と確実に係合し、該針先２１が針先保護部４２の先端側から突出することを確実に防止できる。   Further, when the protector main body 41 is positioned at the second position, the bending portion 48 has a position where the bending portion 48 is accommodated in the needle tip protection portion 42 of the needle tip 21 as shown in FIG. Eccentric from the axis. As a result, the needle tip 21 is reliably engaged with the protrusion 43 on the inner peripheral surface of the tip end portion of the needle tip protecting portion 42 when the protector 4 is about to move from the second position to the proximal end side. It is possible to surely prevent 21 from protruding from the tip side of the needle tip protection part 42.

本発明の針組立体１の組立方法であるが、まず、（ａ）針ハブ３の先端部をプロテクター４の針先保護部４２の内腔に基端側から挿入し、前記針ハブ３の先端部が針先保護部４２から先端側へ露出した状態で針ハブ３と針先保護部４２とを固定する。前記針ハブ３と針先保護部４２との固定は第一位置決め手段によるものである。   In the method of assembling the needle assembly 1 according to the present invention, first, (a) the distal end portion of the needle hub 3 is inserted into the lumen of the needle tip protection portion 42 of the protector 4 from the proximal end side, and the needle hub 3 The needle hub 3 and the needle tip protector 42 are fixed with the tip portion exposed from the needle tip protector 42 to the tip end side. The needle hub 3 and the needle tip protector 42 are fixed by the first positioning means.

次いで、（ｂ）前記工程（ａ）で得られた組立体の先端部をハブカバー５の内部通路に基端側から挿入し、前記ハブカバー５と針ハブ３とを接合させてプロテクター本体４１を摺動可能に挿通した側孔６を形成し、この状態で針ハブ３とハブカバー５とを固定する。このとき、前記針先保護部４２はハブカバー５の内部通路５１に配置されてもされなくてもよいが、針ハブ３の先端部はハブカバー５の先端側から露出している必要がある。   Next, (b) the distal end portion of the assembly obtained in the step (a) is inserted into the internal passage of the hub cover 5 from the proximal end side, the hub cover 5 and the needle hub 3 are joined, and the protector body 41 is slid. A side hole 6 movably inserted is formed, and the needle hub 3 and the hub cover 5 are fixed in this state. At this time, the needle tip protector 42 may or may not be disposed in the internal passage 51 of the hub cover 5, but the tip of the needle hub 3 needs to be exposed from the tip of the hub cover 5.

その後、（ｃ）前記工程（ｂ）で得られた組立体の先端部から露出している針ハブ３の内腔に、針２の基端部を先端側から挿入して固定し、本発明の針組立体１が完成する。前記針ハブ３の先端部はハブカバー５からもプロテクター４の針先保護部４２からも先端側に露出しているため、針２と針ハブ３とを固定する際、針ハブ３の先端部と針２とを接着あるいは融着することが非常に容易である。また、このような組立方法によれば、針先２１を他の部品の内腔に挿通する工程がないため、針先２１を痛めるおそれがない。   Thereafter, (c) the proximal end portion of the needle 2 is inserted and fixed from the distal end side into the lumen of the needle hub 3 exposed from the distal end portion of the assembly obtained in the step (b). The needle assembly 1 is completed. Since the distal end portion of the needle hub 3 is exposed to the distal end side from both the hub cover 5 and the needle tip protecting portion 42 of the protector 4, when the needle 2 and the needle hub 3 are fixed, the distal end portion of the needle hub 3 It is very easy to bond or fuse the needle 2. Further, according to such an assembling method, there is no step of inserting the needle tip 21 into the lumen of another component, and therefore there is no possibility that the needle tip 21 is damaged.

本発明の針組立体１の使用方法であるが、一般的に注射針を患者から引き抜く際に、操作者は片方の手で針組立体を保持して針を抜き、もう片方の手は患者の皮膚穿刺箇所を針の上からガーゼ等で押さえている。図１に示される本発明の針組立体１を使用する場合、操作者は針２を患者の皮膚から引き抜いた直後に、針組立体１を保持する手のいずれかの指で指接触部４６を針組立体１の先端側へ押すことで、図２に示されるように片手で容易に針先２１をプロテクター４の針先保護部４２内に収納することができる。   In the method of using the needle assembly 1 of the present invention, generally, when pulling out the injection needle from the patient, the operator holds the needle assembly with one hand and pulls out the needle, while the other hand is the patient. The skin puncture site is pressed from above the needle with gauze. When the needle assembly 1 of the present invention shown in FIG. 1 is used, an operator pulls out the needle 2 from the patient's skin, and immediately after that, the finger contact portion 46 is touched by any finger of the hand holding the needle assembly 1. 2 is pushed toward the distal end side of the needle assembly 1, the needle tip 21 can be easily housed in the needle tip protecting portion 42 of the protector 4 with one hand as shown in FIG. 2.

本発明の針組立体１は、上記した注射針組立体以外に、採血針組立体や留置針組立体の他、輸液セット用針、翼状針などの医療用針組立体などとしても使用できる。いずれも、基本的な構造およびそれによる効果は注射針組立体と同様であり、第一位置決め手段、第二位置決め手段および指接触部は、適宜好ましいものが組み合わせて設けられる。   In addition to the injection needle assembly described above, the needle assembly 1 of the present invention can be used as a medical needle assembly such as an infusion set needle and a winged needle in addition to a blood collection needle assembly and an indwelling needle assembly. In any case, the basic structure and the effects thereof are the same as those of the injection needle assembly, and the first positioning means, the second positioning means, and the finger contact portion are provided in combination as appropriate.

本発明の針組立体の一実施例の針先保護前の状態を示す縦断面図である。It is a longitudinal cross-sectional view which shows the state before needle-tip protection of one Example of the needle assembly of this invention. 図１に示される針組立体の針先保護後の状態を示す縦断面図である。It is a longitudinal cross-sectional view which shows the state after the needle tip protection of the needle assembly shown by FIG. 図１に示される針組立体のＡ−Ａ線横断面図である。FIG. 2 is a cross-sectional view taken along line AA of the needle assembly shown in FIG. 1. 図１に示される針組立体の針ハブの先端部付近の部分拡大縦断面図である。FIG. 2 is a partially enlarged longitudinal sectional view in the vicinity of a distal end portion of a needle hub of the needle assembly shown in FIG. 1.

符号の説明Explanation of symbols

１ 針組立体
２ 針
２１ 針先
３ 針ハブ
３１ リブ
３２ 通路
３３ 凸部
４ プロテクター
４１ プロテクター本体
４２ 針先保護部
４３ 突起
４４ 凹部
４５ 係合アーム
４６ 指接触部
４７ 突起
４８ 湾曲部
５ ハブカバー
５１ 内部通路
５２ リブ
６ 側孔 DESCRIPTION OF SYMBOLS 1 Needle assembly 2 Needle 21 Needle tip 3 Needle hub 31 Rib 32 Passage 33 Convex part 4 Protector 41 Protector main body 42 Needle point protection part 43 Protrusion 44 Concave 45 Engagement arm 46 Finger contact part 47 Protrusion 48 Bending part 5 Hub cover 51 Inside Passage 52 Rib 6 Side hole

Claims (4)

先端に鋭利な針先を有する中空の針と、前記針が先端部に固着され針の内部と連通する内腔を有する針ハブと、細長い棒状の本体およびその先端側に設けられた前記針上を摺動する中空の筒体である針先保護部を有するプロテクターとを備え、前記針先保護部の先端部内周面には内部に収容された針先が先端側へ飛び出すことを防止しうるよう内方向へ突出した突起が設けられ、前記針ハブの外周には内部に針ハブ、プロテクター本体および針先保護部を収容可能な内部通路を有する筒状のハブカバーが固定され、前記ハブカバーは針ハブと接合されたときにプロテクター本体を摺動可能に挿通しうる側孔を形成し、前記プロテクターは本体が前記側孔に挿通された状態で、針および針ハブの先端部が針先保護部から先端側へ露出する第一の位置から、針先が針先保護部内に収容される第二の位置まで移動しうる針組立体の製造方法であって、
（ａ）針ハブの先端部をプロテクターの針先保護部の内腔に基端側から挿入し、前記針ハブの先端部が針先保護部から先端側へ露出した状態で針ハブと針先保護部とを固定する工程、
（ｂ）前記工程（ａ）で得られた組立体の先端部をハブカバーの内部通路に基端側から挿入し、前記ハブカバーと針ハブとを接合させてプロテクター本体を摺動可能に挿通した側孔を形成し、この状態で針ハブとハブカバーとを固定する工程、および
（ｃ）前記工程（ｂ）で得られた組立体の先端部から露出している針ハブの内腔に、針の基端部を先端側から挿入して固定する工程
を有してなることを特徴とする針組立体の製造方法。 A hollow needle having a sharp needle tip at the tip, a needle hub having a lumen that is fixed to the tip and communicating with the inside of the needle, an elongated rod-like body, and the needle provided on the tip side e Bei a protector having a needle tip protective part is a hollow cylindrical body which slides, needle tip contained therein the tip end inner peripheral surface of the needle tip protective part can be prevented from jumping out toward the distal end A protrusion that protrudes inwardly is provided, and a cylindrical hub cover having an inner passage capable of accommodating a needle hub, a protector body, and a needle tip protecting portion is fixed to the outer periphery of the needle hub. A side hole is formed through which the protector body can be slidably inserted when joined to the needle hub, and the tip of the needle and the needle hub is protected by the needle with the body inserted into the side hole. First exposed from the front to the tip Placed al, needlepoint method for manufacturing a second needle assembly Ru bovine moved to a position which is accommodated in the needle tip protective portion,
(A) The tip of the needle hub is inserted into the lumen of the protector's needle tip protector from the proximal end side, and the needle hub and the needle tip are exposed with the tip of the needle hub exposed from the needle tip protector to the tip side. Fixing the protective part,
(B) The side where the distal end of the assembly obtained in the step (a) is inserted into the internal passage of the hub cover from the proximal end side, the hub cover and the needle hub are joined, and the protector body is slidably inserted. Forming a hole and fixing the needle hub and hub cover in this state; and
(C) A step of inserting and fixing the proximal end portion of the needle from the distal end side into the lumen of the needle hub exposed from the distal end portion of the assembly obtained in the step (b).
A method of manufacturing a needle assembly comprising: 前記針ハブの先端部外周面および前記針先保護部の先端部内周面の突起には、係合により前記プロテクターを第一の位置に位置決めするための第一位置決め手段が設けられている請求項１記載の針組立体の製造方法。 Wherein the needle hub distal end portion outer peripheral surface and the projection of the needle tip protective part tip inner peripheral surface of the claim the first positioning means for positioning the protector in the first position by engagement is provided A method for manufacturing the needle assembly according to claim 1. 前記プロテクター本体の基端部には、ハブカバーとの係合により前記プロテクターを第二の位置に位置決めするための第二位置決め手段が設けられている請求項１または２記載の針組立体の製造方法。 The protector proximal end portion of the body, the method of manufacturing the needle assembly of claim 1 or 2, wherein the second positioning means for positioning the protector in the second position by the engagement of the hub cover is provided . 前記プロテクター本体は、プロテクターが第一の位置に位置決めされるときに側孔に配置される部分に、外方向へ緩やかに湾曲する湾曲部が設けられている請求項１〜３のいずれかに記載の針組立体の製造方法。 The protector body, the portion that is disposed on the side hole when the protector is positioned in a first position, according to claim 1, the curved portion gently curved outward direction is provided Method for manufacturing a needle assembly.
JP2006179180A 2006-06-29 2006-06-29 Method for manufacturing a needle assembly Expired - Fee Related JP4844259B2 (en)

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CN105128327A (en) * 2015-09-30 2015-12-09 迈得医疗工业设备股份有限公司 Rubber plug and needle tube assembling device

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WO2013065370A1 (en) * 2011-11-02 2013-05-10 テルモ株式会社 Method for manufacturing needle-equipped outer tube, and needle-equipped outer tube
JP6242879B2 (en) * 2013-05-02 2017-12-06 テルモ株式会社 Outer cylinder with needle and method for manufacturing the same

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US5466223A (en) * 1994-06-20 1995-11-14 Becton, Dickinson And Company Needle assembly having single-handedly activatable needle barrier
EP1604700B1 (en) * 1996-02-27 2010-09-15 B. Braun Melsungen AG Needle tip guard for hypodermic needles
JP3956385B2 (en) * 2001-01-25 2007-08-08 ニプロ株式会社 Needle assembly
JP2003220140A (en) * 2002-01-31 2003-08-05 Yoshino Kogyosho Co Ltd Syringe

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Publication number Priority date Publication date Assignee Title
CN105128327A (en) * 2015-09-30 2015-12-09 迈得医疗工业设备股份有限公司 Rubber plug and needle tube assembling device
CN105128327B (en) * 2015-09-30 2017-03-22 迈得医疗工业设备股份有限公司 Rubber plug and needle tube assembling device

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