JPH0666689U - Syringe - Google Patents
SyringeInfo
- Publication number
- JPH0666689U JPH0666689U JP1519093U JP1519093U JPH0666689U JP H0666689 U JPH0666689 U JP H0666689U JP 1519093 U JP1519093 U JP 1519093U JP 1519093 U JP1519093 U JP 1519093U JP H0666689 U JPH0666689 U JP H0666689U
- Authority
- JP
- Japan
- Prior art keywords
- gasket
- syringe
- airtightness
- chemical solution
- laminated
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M5/31513—Piston constructions to improve sealing or sliding
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0222—Materials for reducing friction
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
-
- 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
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (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)
Abstract
(57)【要約】
【目的】 1回の成形で経済的に熱可塑性フィルムのラ
ミネートが完了し、注射筒内壁とガスケット間の気密性
と滑動性の両方を満足するガスケットを有する注射器の
提供。
【構成】 プランジャー42先端に接続したガスケット
10を注射筒41内に嵌入して作成した注射器40にお
いて、プランジャー42の押し込みにともない、薬液を
加圧し、その反動圧によって凹面の薬液接触面18は受
圧してより平面状になり円縁側へと拡大され、第1の山
部13における注射筒内周面に対する接触圧力が高ま
り、気密性が向上し薬液が第1の山部13より以降に侵
入することがなく、薬液接触面18のみに耐薬品性のす
ぐれた熱可塑性樹脂フィルム17を積層ラミネートして
いるため、薬液中へ移行物がなく、すぐれた気密性を保
持しながら滑動性がよく極めて軽快な押し込み操作が可
能。
(57) [Summary] [PROBLEMS] To provide a syringe having a gasket that can be economically laminated with a thermoplastic film in one molding and that satisfies both airtightness and slidability between an inner wall of a syringe barrel and a gasket. In a syringe 40 made by fitting a gasket 10 connected to the tip of a plunger 42 into an injection cylinder 41, a chemical solution is pressurized as the plunger 42 is pushed, and a reaction surface pressure of the chemical solution causes a concave chemical solution contact surface 18 Receives pressure and becomes flatter and expands to the circular edge side, the contact pressure on the inner peripheral surface of the injection cylinder in the first crest portion 13 increases, the airtightness is improved, and the liquid medicine is discharged after the first crest portion 13. Since the thermoplastic resin film 17 having excellent chemical resistance is laminated and laminated only on the chemical solution contact surface 18 without invading, there is no migration into the chemical solution, and the sliding property is maintained while maintaining excellent airtightness. A very light pushing operation is possible.
Description
【0001】[0001]
この考案は、ディスポーサブル注射器、プレフィルドシリンジなどに使用する プランジャー摺動部の滑栓の改良に係り、薬液との接触面側を内容薬液の背圧に よって直径が拡大する凹形状となし、かつ薬液との接触面に薬液中へ移行物が少 ない耐薬品性のすぐれた熱可塑性樹脂フィルムを積層ラミネートして、収納医薬 品へ移行物のない、気密性、滑動性の良いプランジャー摺動部のガスケット構造 を有する注射器に関する。 This invention relates to the improvement of the stopper of the sliding part of the plunger used in disposable syringes, prefilled syringes, etc., in which the contact surface side with the drug solution has a concave shape whose diameter increases due to the back pressure of the drug solution, and Laminated thermoplastic resin film with excellent chemical resistance that has few migration products into the chemical solution is laminated on the contact surface with the chemical solution, and a plunger slide with no migration products, good airtightness and good sliding property. The present invention relates to a syringe having a gasket structure of the part.
【0002】[0002]
ガラス製またはプラスチック製注射筒とプランジャー(押棒)との間の気密性 を得るためにガスケット(滑栓、吸子)を用いた使い捨てのディスポーサブル注 射器や、また、最近は治療の簡便化を図り、過誤、汚染を防ぐために薬液が製造 過程で充填内蔵された容器兼用のプレフィルドシリンジと呼ばれる注射器が多用 されている。 Disposable disposable injectors with gaskets (sliding plugs, suckers) for airtightness between glass or plastic syringes and plungers (push rods), and more recently simplified treatment In order to prevent errors and contamination, a syringe called a prefilled syringe, which is also used as a container and filled with a drug solution in the manufacturing process, is often used.
【0003】 上記の注射器のガスケットは、加硫ゴムや弾性プラスチック等の成形品で作ら れるが、注射筒内壁と気密に嵌合して薬液を漏らすことなくかつプランジャーの 押し込み、引き出し等の摺動移動には簡便、軽滑性が必要である。 これらの要求特性は「厚生省告示412号ディスポーサブル注射筒基準」では 、「プランジャーの移動に要する力について(吸子の移動試験)、吸子は外筒内 面を滑らかに移動するものでなければならない。またこの場合、筒内に吸子のゴ ム片が残るものであってはならない」と規定している。The gasket of the above-mentioned syringe is made of a molded product such as vulcanized rubber or elastic plastic, but it does not leak the drug solution by airtightly fitting with the inner wall of the injection cylinder, and the plunger can be pushed in or pulled out. Dynamic movement requires simple and light sliding properties. These required characteristics are described in “Ministry of Health and Welfare Notification No. 412 Disposable Syringe Standard”, “Regarding the force required to move the plunger (sucker movement test), the sucker must move smoothly inside the outer cylinder. Also, in this case, there must be no gum pieces of the sucker remaining in the cylinder. "
【0004】 かかる要求特性を満たすべく、ディスポーサブル注射器の出現以来、慣習的な 技術としてガスケットの表面にシリコンオイルを塗布し、注射筒との間の気密維 持、潤滑が図られてきた。しかし、このような注射器は使用中にシリコンオイル が薬液中へ脱落混入し、薬液と共に人体内へ注射される危険がある。 近年、注射剤中の微粒子除去対策が進められると共に、容器器具に起因する微 粒子の混入防止が要望されている。In order to satisfy such required characteristics, since the advent of disposable syringes, as a conventional technique, silicone oil has been applied to the surface of a gasket to maintain airtightness and lubricate with a syringe barrel. However, such an injector has a risk that silicone oil may drop into the drug solution during use and be injected into the human body together with the drug solution. In recent years, countermeasures for removing fine particles from injectables have been promoted, and it has been desired to prevent contamination of fine particles caused by container devices.
【0005】[0005]
ディスポーサブル注射器、プレフィルドシリンジで使用されるゴムガスケット 材料は、ゴム加硫剤、加硫促進剤、可塑剤等が混合されていて、種々の不適当な 物質、異物が薬液中へ移行する恐れがある。 ゴムガスケットの表面を移行性のないフッ素樹脂、PP、PE等のフィルムで 被覆すれば、薬液との接触面にバリヤー効果が期待できるが、ゴム素材と比較し て表面が硬く、弾性が少なくなるため、注射筒内面との気密性が悪くなり漏洩が 起こる恐れがある。 図6に示す如く、従来のガスケット4を使用した注射器1において、注射筒2 とプランジャー3のガスケット4との間の気密性と滑動性は、その嵌合の強弱に よって非常に影響を受けやすいものであった。 Rubber gasket materials used in disposable syringes and prefilled syringes contain rubber vulcanizing agents, vulcanization accelerators, plasticizers, etc., which may cause various inappropriate substances and foreign substances to migrate into the chemical solution. . If the surface of the rubber gasket is covered with a film of non-migrating fluororesin, PP, PE, etc., a barrier effect can be expected on the contact surface with the chemical solution, but the surface is harder and less elastic than the rubber material. Therefore, airtightness with the inner surface of the syringe may be deteriorated and leakage may occur. As shown in FIG. 6, in the syringe 1 using the conventional gasket 4, the airtightness and slidability between the syringe barrel 2 and the gasket 4 of the plunger 3 are greatly affected by the strength of the fitting. It was easy.
【0006】 そこで、ガスケットに積層ラミネートするフィルムの硬さ、厚さを調節したも の(実開昭62−139668号公報)、図7に示す如く、ガスケット5の摺動 部分(外径部分)の環状突起6の数を増加させ、樹脂フィルム7を積層ラミネー トしたもの(実開平1−138455号公報)、ガスケットの直径と長さの比率 を限定したもの(実開平1−138454号公報)等が提案されている。しかし 、ガスケットと注射筒間の気密性と滑動性は相反する要求特性であり、気密性を 上げればと滑動性が低下する問題がある。 また、図8に示す如く、ガスケット8の密封、滑動性を両立させるために、樹 脂フィルム9を第1山のみにラミネートする方法も提案(実公昭52−1943 5号公報、実公昭55−30602号公報)されている。しかし、環状突起の第 1山の全部をラミネートし、谷部にフィルムの端末を作る技術は煩雑で製造コス トが上昇するため、かかる構成からなるガスケットは未だ製品化されていない。Therefore, although the hardness and thickness of the film laminated and laminated on the gasket are adjusted (Japanese Utility Model Laid-Open No. 62-139668), as shown in FIG. 7, the sliding portion (outer diameter portion) of the gasket 5 is formed. The number of annular projections 6 is increased and the resin film 7 is laminated and laminated (Publication No. 1-138455), and the ratio of the diameter to the length of the gasket is limited (Publication No. 1-138454). Etc. have been proposed. However, the airtightness and slidability between the gasket and the syringe are contradictory requirements, and there is a problem that the slidability decreases with increasing airtightness. Further, as shown in FIG. 8, a method of laminating the resin film 9 only on the first mountain in order to achieve both the sealing property and the sliding property of the gasket 8 is also proposed (Japanese Utility Model Publication No. 52-19435, Japanese Utility Model Publication 55-55-). 30602 publication). However, since the technology of laminating the entire first peak of the annular protrusion and forming the end of the film in the valley is complicated and the manufacturing cost increases, a gasket having such a structure has not yet been commercialized.
【0007】 この考案は、上述の如く、既成の技術では樹脂を積層ラミネートしたガスケッ トにおいて注射筒内壁とガスケット間の気密性と滑動性の両方を満足させること が不充分で、折衷的に形状、材料などに特別の選択が必要であるなど、基本的な 問題解決になっていないことに鑑み、かかる問題を解消し、1回の成形で経済的 に熱可塑性フィルムのラミネートが完了して、バリヤー特性、気密性、滑動性の 全てを満足するガスケットを有する注射器の提供を目的としている。[0007] As described above, this invention is eclectic in the existing technology because it is not sufficient to satisfy both the airtightness and the slidability between the inner wall of the syringe barrel and the gasket in the gasket in which the resin is laminated and laminated. In view of the fact that basic problems have not been solved, such as the need for special selection of materials, etc., these problems have been resolved, and thermoplastic film lamination has been completed economically in one molding, It is an object of the present invention to provide a syringe having a gasket that satisfies all barrier properties, airtightness, and slidability.
【0008】[0008]
考案者らは、製造性がよく、バリヤー特性、気密性、滑動性の全てを満足する ガスケットを有する注射器を目的に、ガスケットの薬液との接触面の形状に着目 して種々検討した結果、ガスケットの薬液との接触面を皿状の凹形状となして、 同部のみに特定の熱可塑性樹脂フィルムを積層ラミネートすることにより、バリ ヤー特性を保持したままガスケットの押し込み時に内容薬液の背圧によってその 直径が拡大して弁効果により気密性が向上するとともに、ガスケットの注射筒内 周面との接触面は弾性ゴム素材が露出しており、ガスケット径を拡大させなくと も、十分な気密性と滑動性が得られることを知見し、この考案を完成した。 The inventors have conducted various studies, focusing on the shape of the contact surface of the gasket with the chemical solution, for the purpose of producing a syringe having a gasket that has good manufacturability, barrier properties, airtightness, and slidability. The contact surface with the chemical solution is made into a dish-shaped concave shape, and by laminating and laminating a specific thermoplastic resin film only on the same part, by back pressure of the content chemical solution when pushing the gasket while maintaining the barrier property. The diameter increases and the airtightness is improved by the valve effect, and the elastic rubber material is exposed on the contact surface of the gasket with the inner peripheral surface of the injection cylinder, so sufficient airtightness is achieved without increasing the gasket diameter. We have found that we can obtain smoothness and have completed this invention.
【0009】 すなわち、この考案は、注射筒内にプランジャーによりガスケットを押し込み 、引き出し可能にした注射器において、ガスケットの薬液との接触面側を押し込 み時に内容薬液の背圧によって直径が拡大可能な凹形状となし、ガスケットの該 凹形状部に薬液中へ移行物が少ない耐薬品性のすぐれた熱可塑性樹脂フィルムを 積層ラミネートしたことを特徴とする注射器である。 また、この考案は、上記の構成おいて、熱可塑性樹脂フィルムを積層ラミネー トした薬液との接触面が注射筒内周面に対して鋭角に接触することを特徴とする 注射器である。That is, in the present invention, in a syringe in which a gasket is pushed into a syringe barrel by a plunger and can be pulled out, the diameter can be increased by back pressure of the content drug solution when the contact surface side of the gasket with the drug solution is pressed. The syringe is characterized in that the thermoplastic resin film having excellent chemical resistance and having few substances transferred into the chemical liquid is laminated and laminated on the concave portion of the gasket. The invention is also a syringe characterized in that, in the above-mentioned constitution, a contact surface with a drug solution obtained by laminating and laminating a thermoplastic resin film makes an acute angle contact with an inner peripheral surface of an injection cylinder.
【0010】 この考案において、注射器は前述のディスポーサブル注射器、プレフィルドシ リンジなど注射筒内にプランジャーによりガスケットを押し込み、引き出し可能 にした注射器であればいずれの構成にも適用できる。 また、この考案において、ガスケットには天然ゴム、IIR、IR、SiR、 URの軟質加硫ゴム、または約60℃以上の滅菌温度、γ線滅菌に耐え、高弾性 を有するTPE、SEBS等のサーモエラストマーを適宜選定できる。 さらに、積層ラミネートする熱可塑性樹脂フィルムには、フッ素樹脂、PE、 PP等の軟質プラスチックフィルムを適宜選定でき、フィルム厚さは弾性を維持 するために0.01〜0.1mmが望ましい。In the present invention, the syringe can be applied to any structure as long as it is a disposable syringe, a prefilled syringe, or the like in which a gasket is pushed by a plunger by a plunger and can be pulled out. Further, in this invention, the gasket is made of natural rubber, IIR, IR, SiR, UR soft vulcanized rubber, or a thermostable material such as TPE or SEBS that has a high elasticity and withstands sterilization temperature of about 60 ° C or more and γ ray sterilization. The elastomer can be appropriately selected. Further, as the thermoplastic resin film to be laminated and laminated, a soft plastic film such as fluororesin, PE or PP can be appropriately selected, and the film thickness is preferably 0.01 to 0.1 mm in order to maintain elasticity.
【0011】[0011]
この考案による注射器の作用を図面に基づいて詳述する。図3と図4はこの考 案によるガスケットの構成を示す縦断説明図である。 図3に示すガスケット10は、所要直径、長さを有する円柱体からなり、外周 面には2本の環状溝部11,12を設けることにより、外周面に3つの山部13 ,14,15を形成してある。なお、環状溝部は2本以上、山部は3つ以上が好 ましい。また、図で右側端面にはプランジャー先端部との嵌合接続を行うための 嵌合穴16が形成され、さらに左側端面は凹面に形成されかつ熱可塑性樹脂フィ ルム17が積層ラミネートされた薬液接触面18である。 ガスケット10の薬液接触面18は、中央部が平坦でその周囲が傾斜した所謂 皿状の凹面に形成されて、薬液に接触表面のみに熱可塑性樹脂フィルム17が積 層ラミネートされており、最外縁部は嵌入される注射筒内周面2aに対して鋭角 に接触している。 The operation of the syringe according to the present invention will be described in detail with reference to the drawings. 3 and 4 are longitudinal explanatory views showing the structure of the gasket according to this idea. The gasket 10 shown in FIG. 3 is composed of a cylindrical body having a required diameter and length, and by providing two annular groove portions 11 and 12 on the outer peripheral surface, three peak portions 13, 14, 15 are formed on the outer peripheral surface. Has been formed. It is preferable that the number of annular grooves is two or more and the number of ridges is three or more. Further, in the figure, a right side end surface is formed with a fitting hole 16 for making a fitting connection with the tip of the plunger, a left side end surface is formed into a concave surface, and a thermoplastic resin film 17 is laminated and laminated. The contact surface 18. The chemical solution contact surface 18 of the gasket 10 is formed as a so-called dish-shaped concave surface having a flat central portion and a slanted periphery, and the thermoplastic resin film 17 is laminated on the chemical solution contact surface only. The portion is in contact with the inner peripheral surface 2a of the injection cylinder at an acute angle.
【0012】 ガスケット10が図示しないプランジャーにて左方向へ押し込まれると薬液を 加圧し、その反動圧によって凹面の薬液接触面18は受圧してより平面状になり 円縁側へと拡大されて、換言すれば弁的に直径が変化して円周が拡大されるため 、第1の山部13における注射筒内周面2aに対する接触圧力が高まり、気密性 が向上し薬液が第1の山部13より以降に侵入することがなくなる。 従って、ガスケット10の薬液接触面18は受圧により弁的に直径が変化し、 気密性が維持されるため、山部13,14,15を過大径にすることは不必要で 、注射筒内径に対し、0.05%〜2%程度拡径すれば気密性と滑動性が満足さ れる。 環状溝部11,12は山部13,14,15の弾性を助長させるための溝構造 であり、各山部に対し0.5〜2mm程度直径が小さければよい。また、第1の 山部13の軸方向幅は、弾性を維持するため、0.5〜2mmが望ましい。 これに対して、図6に示す従来のガスケット4の場合は、薬液接触面が凸面で 注射筒内周面2aに対し鈍角に接触しており、受圧した凸面に加わる圧力により 最外縁部は収縮する形状であり、プランジャーを押し込むことにより気密性が減 少する構成である。When the gasket 10 is pushed leftward by a plunger (not shown), the chemical liquid is pressurized, and the reaction pressure of the gasket 10 causes the concave chemical liquid contact surface 18 to receive a pressure and become more flat, and expand to the circular edge side. In other words, since the diameter changes valve-wise and the circumference is enlarged, the contact pressure on the inner peripheral surface 2a of the syringe barrel in the first crest portion 13 is increased, the airtightness is improved, and the liquid medicine is in the first crest portion. It will not invade after 13. Therefore, since the diameter of the liquid contact surface 18 of the gasket 10 changes like a valve due to pressure reception and the airtightness is maintained, it is unnecessary to make the peaks 13, 14, 15 excessively large, and On the other hand, if the diameter is expanded by about 0.05% to 2%, airtightness and slidability are satisfied. The annular groove portions 11 and 12 have a groove structure for promoting the elasticity of the ridge portions 13, 14 and 15, and the diameters of the ridge portions are preferably 0.5 to 2 mm. Further, the axial width of the first mountain portion 13 is preferably 0.5 to 2 mm in order to maintain elasticity. On the other hand, in the case of the conventional gasket 4 shown in FIG. 6, the chemical contact surface is a convex surface and is in contact with the inner peripheral surface 2a of the injection cylinder at an obtuse angle, and the outermost edge portion is contracted by the pressure applied to the convex surface that receives the pressure. The shape is such that the airtightness is reduced by pushing the plunger.
【0013】 図4に示すガスケット20は、図3に示すガスケット10と同様構成であり、 所謂皿状の凹面に形成された薬液接触面21の中央部が僅かに凸面となることが 異なるが、薬液接触面21の最外縁部は嵌入される注射筒内周面2aに対して鋭 角に接触し、上述の作用効果を奏する。 なお、図3と図4の例では、薬液接触面18,21の最外縁部が嵌入される注 射筒内周面2aに対して鋭角に接触している例を示したが、受圧して注射筒内周 面2aに対する接触圧力が高まる直角以下であれば、接触角度は適宜選定すれば よい。The gasket 20 shown in FIG. 4 has the same configuration as that of the gasket 10 shown in FIG. 3, except that the central portion of the chemical liquid contact surface 21 formed on a so-called dish-shaped concave surface is slightly convex. The outermost edge of the drug solution contact surface 21 makes an acute contact with the inner peripheral surface 2a of the injection cylinder into which it is inserted, and the above-described effects are achieved. In the examples of FIGS. 3 and 4, the outermost edges of the chemical liquid contact surfaces 18 and 21 are in contact with the inner peripheral surface 2a of the injection cylinder at an acute angle, but when receiving pressure, The contact angle may be appropriately selected as long as the contact pressure with respect to the inner peripheral surface 2a of the syringe is equal to or less than a right angle.
【0014】[0014]
実施例1 上述の図3に示すガスケットを製造するため、図5のゴム用金型の断面説明図 に示すように下金型30に形成した所要形状のキャビティ31内に軟質ゴム32 を入れ、その上側へフッ素樹脂、PP、PEなどの樹脂フィルム33をコロナ、 スッパタリング等の物理処理を施した表面をゴム側にして置き、上金型34を重 ね、通常の圧縮成形法により、加熱加硫してラミネート接着させ、加硫後はパン チングによりガスケット外径に合わせてゴムバリト過剰フィルムの除去を行うこ とにより、一回の成形により簡単に製造することができた。 得られたガスケットを用いてディスポーサブル注射器を作成した。図1に示す 如く、プランジャー42先端に接続した図3のガスケット10を注射筒41内に 嵌入して注射器40を作成した。 図6の従来の注射器1とこの考案による注射器40のガスケットの滑動性を比 較したところ、この考案の場合、すぐれた気密性を保持しながら極めて軽快な押 し込み操作が可能であった。 Example 1 In order to manufacture the above-mentioned gasket shown in FIG. 3, as shown in the cross-sectional explanatory view of the rubber mold of FIG. 5, the soft rubber 32 is put in the cavity 31 of the required shape formed in the lower mold 30, A resin film 33 made of fluororesin, PP, PE or the like is placed on the upper side with the surface subjected to physical treatment such as corona and spattering on the rubber side, and the upper mold 34 is overlaid and heated by a usual compression molding method. By vulcanizing and laminating and adhering, and after vulcanizing, by removing the excess rubber ballit film according to the gasket outer diameter by punching, it was possible to easily manufacture by one molding. A disposable syringe was prepared using the obtained gasket. As shown in FIG. 1, the gasket 40 of FIG. 3 connected to the tip of the plunger 42 was fitted into the syringe barrel 41 to prepare the syringe 40. Comparing the slipperiness of the gasket of the conventional syringe 1 of FIG. 6 with the syringe 40 of the present invention, it was found that the present invention was capable of extremely light pushing operation while maintaining excellent airtightness.
【0015】 実施例2 実施例1で得られたガスケットを用いてプレフィルドシリンジを作成した。す なわち図2に示す如く、先端をゴム栓54にて封止し他方端を開放したインナー コンテナ53内に薬液55を収納し、プランジャー56先端に接続したガスケッ ト10をインナーコンテナ53内に嵌入して収納薬液を封止し、このインナーコ ンテナ53を両刃の刺針52を装着した注射筒51内に嵌入してプレフィルドシ リンジ50をを作成した。 ガスケット10の薬液接触面は収納薬液を封止する際の受圧により弁的に直径 が変化して気密性が向上維持され、かつ薬液中へ移行物が少ない耐薬品性のすぐ れた熱可塑性樹脂フィルムを積層ラミネートしているため、インナーコンテナ5 3の収納薬液55を長期間にわって汚染より保護できる。 また、使用時はプランジャー56を押し込むことにより、まずインナーコンテ ナ53が注射筒51内を移動して、刺針52の内側刃でゴム栓54が刺通され、 さらにプランジャー56を押し込むことによりガスケット10が移動し、すぐれ た気密性を保持しながら極めて軽快な押し込み操作が可能となる。Example 2 A prefilled syringe was produced using the gasket obtained in Example 1. That is, as shown in FIG. 2, the chemical solution 55 is stored in an inner container 53 whose tip is sealed with a rubber stopper 54 and whose other end is open, and the gasket 10 connected to the tip of the plunger 56 is placed inside the inner container 53. The inner container 53 was inserted into an injection cylinder 51 equipped with a double-edged pricking needle 52 to form a prefilled syringe 50. The gasket 10 has a chemical contact surface that changes in valve-like diameter due to the pressure received when the stored chemical is sealed and maintains airtightness, and is a thermoplastic resin with excellent chemical resistance with little migration into the chemical. Since the films are laminated and laminated, the stored chemical liquid 55 in the inner container 53 can be protected from contamination over a long period of time. When the plunger 56 is pushed during use, the inner container 53 first moves inside the injection cylinder 51, the rubber plug 54 is pierced by the inner blade of the puncture needle 52, and the plunger 56 is pushed further. The gasket 10 moves, and extremely light pushing operation is possible while maintaining excellent airtightness.
【0016】[0016]
この考案による注射器は、ガスケットの薬液との接触面を皿状の凹形状となし て、同部のみに特定の熱可塑性樹脂フィルムを積層ラミネートすることにより、 バリヤー特性を保持したままガスケットの押し込み時に内容薬液の背圧によって その直径が拡大して気密性が向上するとともに、ガスケットの注射筒内周面との 接触面はガスケット素材が露出しており、十分な滑動性が得られるとともに、製 造性がよく、バリヤー特性、気密性、滑動性の全てを満足するため、ディスポー サブル注射器のみならず、プレフィルドシリンジにも最適である。 The syringe according to the present invention has a dish-shaped concave surface on the gasket that contacts the liquid medicine, and by laminating and laminating a specific thermoplastic resin film only on the same part, when the gasket is pushed in while maintaining the barrier properties. The back pressure of the drug solution expands its diameter to improve airtightness, and the gasket material is exposed at the contact surface of the gasket with the inner peripheral surface of the injection cylinder, providing sufficient sliding properties and manufacturing. It is suitable for not only disposable syringes but also prefilled syringes because it has good properties and satisfies all barrier properties, airtightness and slidability.
【図1】この考案によるディスポーサブル注射器の構成
を示す縦断説明図である。FIG. 1 is a vertical cross sectional view showing the structure of a disposable syringe according to the present invention.
【図2】この考案によるプレフィルドシリンジの構成を
示す縦断説明図である。FIG. 2 is a vertical cross sectional view showing the structure of a prefilled syringe according to the present invention.
【図3】この考案によるガスケットの構成を示す縦断説
明図である。FIG. 3 is a vertical cross sectional view showing a structure of a gasket according to the present invention.
【図4】この考案によるガスケットの他の構成を示す縦
断説明図である。FIG. 4 is a vertical cross sectional view showing another structure of the gasket according to the present invention.
【図5】この考案によるガスケットを製造するためのゴ
ム用金型の断面説明図である。FIG. 5 is an explanatory cross-sectional view of a rubber mold for manufacturing a gasket according to the present invention.
【図6】従来のディスポーサブル注射器の構成を示す縦
断説明図である。FIG. 6 is a vertical cross-sectional explanatory view showing the configuration of a conventional disposable syringe.
【図7】従来のガスケットの構成を示す縦断説明図であ
る。FIG. 7 is a vertical cross sectional view showing the structure of a conventional gasket.
【図8】従来のガスケットの他の構成を示す縦断説明図
である。FIG. 8 is a vertical cross-sectional explanatory view showing another configuration of the conventional gasket.
1 注射器 2 注射筒 2a 注射筒内周面 3 プランジャー 4,5,8 ガスケット 6 環状突起 7,9 樹脂フィルム 10,20 ガスケット 11,12 環状溝部 13,14,15 山部 16 嵌合穴 17 熱可塑性樹脂フィルム 18,21 薬液接触面 30 下金型 31 キャビティ 32 軟質ゴム 33 フッ素樹脂フィルム 34 上金型 40 注射器 41,51 注射筒 42,56 プランジャー 50 プレフィルドシリンジ 52 刺針 53 インナーコンテナ 54 ゴム栓 55 薬液 1 Syringe 2 Injection Cylinder 2a Injection Cylinder Inner Surface 3 Plunger 4,5,8 Gasket 6 Annular Protrusion 7,9 Resin Film 10,20 Gasket 11,12 Annular Groove 13,14,15 Crest 16 Fitting Hole 17 Heat Plastic resin film 18,21 Chemical contact surface 30 Lower mold 31 Cavity 32 Soft rubber 33 Fluororesin film 34 Upper mold 40 Syringe 41,51 Syringe 42,56 Plunger 50 Prefilled syringe 52 Needle 53 Inner container 54 Rubber stopper 55 Liquid medicine
Claims (2)
トを押し込み、引き出し可能にした注射器において、ガ
スケットの薬液との接触面側を押し込み時に内容薬液の
背圧によって直径が拡大可能な凹形状となし、ガスケッ
トの該凹形状部に薬液中へ移行物が少ない耐薬品性のす
ぐれた熱可塑性樹脂フィルムを積層ラミネートしたこと
を特徴とする注射器。1. A syringe in which a gasket is pushed into a syringe barrel by a plunger so that the syringe can be pulled out, and when the contact surface side of the gasket with the chemical liquid is pushed, the concave shape is formed so that the diameter can be expanded by the back pressure of the chemical liquid. A syringe characterized by laminating and laminating a thermoplastic resin film having excellent chemical resistance with less migration into the chemical liquid on the concave portion of the gasket.
した薬液との接触面が注射筒内周面に対して鋭角に接触
することを特徴とする請求項1記載の注射器。2. The syringe according to claim 1, wherein a contact surface with a drug solution obtained by laminating and laminating a thermoplastic resin film is in contact with the inner peripheral surface of the injection cylinder at an acute angle.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP1519093U JPH0666689U (en) | 1993-03-05 | 1993-03-05 | Syringe |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP1519093U JPH0666689U (en) | 1993-03-05 | 1993-03-05 | Syringe |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH0666689U true JPH0666689U (en) | 1994-09-20 |
Family
ID=11881937
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP1519093U Pending JPH0666689U (en) | 1993-03-05 | 1993-03-05 | Syringe |
Country Status (1)
Country | Link |
---|---|
JP (1) | JPH0666689U (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7111848B2 (en) | 2000-09-14 | 2006-09-26 | Terumo Kabushiki Kaisha | Gasket and method of manufacturing the gasket |
JP2022081491A (en) * | 2012-06-01 | 2022-05-31 | ノバルティス アーゲー | Injection syringe |
-
1993
- 1993-03-05 JP JP1519093U patent/JPH0666689U/en active Pending
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7111848B2 (en) | 2000-09-14 | 2006-09-26 | Terumo Kabushiki Kaisha | Gasket and method of manufacturing the gasket |
JP2022081491A (en) * | 2012-06-01 | 2022-05-31 | ノバルティス アーゲー | Injection syringe |
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