WO2015012206A1 - ガスケット及びこれを用いたプランジャー、シリンジ並びにプレフィルドシリンジ - Google Patents
ガスケット及びこれを用いたプランジャー、シリンジ並びにプレフィルドシリンジ Download PDFInfo
- Publication number
- WO2015012206A1 WO2015012206A1 PCT/JP2014/069137 JP2014069137W WO2015012206A1 WO 2015012206 A1 WO2015012206 A1 WO 2015012206A1 JP 2014069137 W JP2014069137 W JP 2014069137W WO 2015012206 A1 WO2015012206 A1 WO 2015012206A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- gasket
- plunger
- syringe
- shaft hole
- screw
- Prior art date
Links
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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
- 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
- A61M5/31515—Connection of piston with piston rod
-
- 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
- A61M5/3129—Syringe barrels
-
- 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
- A61M5/3129—Syringe barrels
- A61M2005/3131—Syringe barrels specially adapted for improving sealing or sliding
Definitions
- the present invention relates to a gasket and a plunger, a syringe, and a prefilled syringe using the gasket. More specifically, the present invention relates to a gasket provided with a screw hole anti-friction structure.
- a plunger rod is press-fitted into a gasket and assembled before being inserted into a barrel.
- a chemical solution that is, a so-called prefilled syringe
- the barrel is usually filled with the chemical solution and the plunger rod is joined to the gasket after the gasket is plugged. That is, a method in which a plunger rod is coupled to a syringe with a gasket plugged as a subsequent process is employed.
- Patent Document 1 As a method for connecting the gasket of the prefilled syringe and the plunger rod, as in Patent Document 1, a female screw of a gasket formed of a rubber elastic material such as an elastomer and a plunger rod formed of a plastic such as polypropylene, for example. The male thread is widely used. (Patent Document 1)
- the gasket inserted in the barrel is difficult to spread in the radial direction, when the plunger rod is press-fitted into the gasket like a normal syringe, the chemical may leak from the gasket or tip nozzle due to the pressure. Because.
- the gasket manufacturing methods it is manufactured by the following method.
- a rubber sheet is placed and pressed between upper and lower molds that can mold a plurality of gaskets.
- the upper mold refers to the front end side of the gasket
- the lower mold refers to the base end side (including the female screw hole) of the gasket.
- the rubber sheet becomes a sheet in which a plurality of gaskets are formed.
- the upper die is removed after pressing, the sheet on which a plurality of gaskets are formed remains on the lower die. Therefore, the sheet is peeled off from the lower die, and the gasket is separated from the sheet. Many are taken.
- Patent Document 1 when the sheet on which a plurality of gaskets are formed is peeled off from the lower mold, the female threads of the gasket may be messy or torn. In this case, there is a risk that the strength of the screw may be reduced, or dust may be generated and the chemical solution may be contaminated.
- the method of forming the gasket As for the method of forming the gasket, the method of forming the gasket by filling a rubber material into a mold in which a gasket-like space is formed, or the gasket from the rubber sheet at once, is not the method of forming from the sheet exemplified above.
- the problem to be solved by the present invention is a structure that prevents mussels and tears when a mold is pulled out by forming a screw during the manufacture of a gasket.
- the present inventor has come up with the present invention as a result of intensive studies to solve the above-described problems. That is, the present invention (1) A gasket provided with a female screw hole formed as a recess from a base end to a tip, wherein the female screw hole includes a shaft hole and a screw valley formed in the shaft hole, and the shaft hole is a base
- the gasket is characterized in that the diameter is gradually reduced from the end.
- this invention is utilized as a plunger which consists of (2) the plunger rod which has the external thread which engages with the internal thread hole of the gasket of said (1) description, and the said gasket, (3)
- a loosening prevention mechanism provided at a base end of the female screw hole and a base end of the male screw may be provided.
- FIG. 1 is a longitudinal sectional view of an embodiment of the gasket of the present invention.
- FIG. 2 is a bottom view of the gasket of FIG.
- FIG. 3 is a front view of an embodiment of the plunger rod of the present invention.
- 4 is a cross-sectional view of the threaded portion in FIG.
- FIG. 5 shows a plunger combining a gasket and a plunger rod.
- FIG. 6 shows a prefilled syringe in which a plunger and a barrel are combined.
- An internal thread hole 2 is formed as a recess in the gasket body 1 from the proximal end to the distal end, and the internal thread hole 2 includes a shaft hole 22 and a thread valley 23 formed in the shaft hole 22.
- the shaft hole 22 has a substantially truncated cone shape that is gradually reduced in diameter from the proximal end toward the distal end, and the depth of the thread valley 23 is formed constant from the shaft hole. Note that the tip of the shaft hole is processed so that the thread valley gradually becomes shallower as in the conventional screw.
- an engaged portion 33 that is a part of a later-described loosening prevention mechanism 3 is provided at the base end of the gasket 1.
- the engaged portion 33 is composed of a cylindrical space 21 provided continuously at the base end of the female screw hole 2 and four concave portions 31 integrally provided at an interval of 90 degrees on the outer periphery thereof. It is provided to intrude into.
- Examples of the material for forming the gasket 1 include butyl rubber, silicone rubber, thermoplastic elastomer, silicone elastomer, and the like. Especially, if the material has been used as a medical device and has been conventionally used as a material for forming a gasket, It is not limited.
- the gasket 1 can be connected to the plunger rod 4 and used as the plunger 6.
- the plunger rod will be described with reference to FIGS.
- the plunger rod 4 is formed with a male screw 5 that is screwed with the female screw 2 of the gasket 1, and the male screw 5 includes a shaft 52 and a screw thread 53 formed on the shaft 52.
- the shaft 52 is gradually reduced in diameter from the proximal end toward the distal end, and the height of the screw thread 53 is the same as the depth of the screw valley 23.
- An engaging portion 34 that is a part of a later-described loosening prevention mechanism 3 is formed at the proximal end of the male screw 5.
- the engaging part 34 is provided substantially continuously with the base end of the male screw 5, and is substantially the same as the pedestal 51 having substantially the same shape as the columnar space 21 and the four recesses 31 integrally provided at intervals of 90 degrees on the outer periphery thereof. It consists of four convex portions 32 having a shape, and the convex portions 32 protrude toward the tip of the male screw 5.
- the material for forming the plunger rod 4 is a plastic material such as polyethylene or polypropylene, but is not particularly limited as long as it has been used as a medical device and has been conventionally used as a material for forming a plunger rod. .
- FIG. 5 shows a plunger 6 in which the gasket 1 and the plunger rod 4 are combined.
- the loosening prevention mechanism 3 provided on the gasket 1 and the plunger rod 4 includes a concave portion 31 provided on the base end of the gasket 1 and a convex portion 32 provided on the base end of the male screw 5 of the plunger rod 4. It is a configuration that matches. With this configuration, rotation in the direction in which the gasket 1 and the plunger rod 4 are loosened is prevented from being loosened.
- the example provided with the loosening prevention mechanism is illustrated, but the loosening prevention mechanism is not necessarily provided, and there is no problem even if it is not provided.
- the depth of the thread root 23 of the internal thread 2 and the height of the thread 53 of the external thread 5 are both constant, and the depth of the thread valley 23 and the height of the thread 53 are Therefore, even if the shaft hole and the shaft have a gradually reduced shape, the strength of the screw is sufficiently secured. Note that the depth of the screw valley 23 and the height of the screw thread 53 may not be constant.
- the gasket 1 of the present invention is connected to a plunger rod 4 to form a plunger 6, and the gasket 1 of the plunger 6 is slidably accommodated in the barrel 7 so that a syringe or It can also be used as a prefilled syringe.
- the gasket of the present invention can improve the stuffiness and tearing of the screw hole, and thus can be suitably used for medical treatment.
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
Description
(1)基端から先端に向かって凹みとして形成された雌ねじ穴を設けたガスケットであって、前記雌ねじ穴は軸穴と、前記軸穴に形成されたねじ谷を含み、前記軸穴は基端から漸次縮径することを特徴とするガスケットである。この構成とすることにより金型から抜く際、ゴムシートを引っ張ることで生じるネジの変形が抑制され、金型を抜く際のムシレや裂けを回避することができ、ムシレや裂けに起因する、ネジの強度が低下する恐れや、ゴミが生じ薬液を汚染することがない。
2 雌ねじ
21 円柱状空間
22 軸穴
23 ねじ谷
3 緩み防止機構
31 凹部
32 凸部
33 被係合部
34 係合部
4 プランジャーロッド
5 雄ねじ
51 台座
52 軸
53 ねじ山
6 プランジャー
7 バレル
Claims (5)
- 基端から先端に向かって凹みとして形成された雌ねじ穴を設けたガスケットであって、前記雌ねじ穴は軸穴と、前記軸穴に形成されたねじ谷を含み、前記軸穴は基端から漸次縮径することを特徴とするガスケット。
- 請求項1記載のガスケットの前記雌ねじ穴と係合する雄ねじを先端に有するプランジャーロッドと、前記ガスケットと、からなるプランジャー。
- 請求項2に記載のプランジャーにおいて、前記雌ねじ穴の基端と前記雄ねじの基端に設けられた緩み防止機構を備えたプランジャー。
- 請求項2および3記載のプランジャーと、前記プランジャーのガスケットを内部に摺動可能に挿入するバレルと、を含むシリンジ。
- 請求項2および3記載のプランジャーと、前記プランジャーのガスケットを内部に摺動可能に挿入するバレルと、を含むプレフィルドシリンジ。
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14830272.2A EP3025746A4 (en) | 2013-07-22 | 2014-07-18 | Gasket, and plunger, syringe, and prefilled syringe which use same |
US14/906,665 US20160193418A1 (en) | 2013-07-22 | 2014-07-18 | Gasket and plunger using the same, syringe, and prefilled syringe |
JP2015528261A JPWO2015012206A1 (ja) | 2013-07-22 | 2014-07-18 | ガスケット及びこれを用いたプランジャー、シリンジ並びにプレフィルドシリンジ |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013151242 | 2013-07-22 | ||
JP2013-151242 | 2013-07-22 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2015012206A1 true WO2015012206A1 (ja) | 2015-01-29 |
Family
ID=52393247
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2014/069137 WO2015012206A1 (ja) | 2013-07-22 | 2014-07-18 | ガスケット及びこれを用いたプランジャー、シリンジ並びにプレフィルドシリンジ |
Country Status (4)
Country | Link |
---|---|
US (1) | US20160193418A1 (ja) |
EP (1) | EP3025746A4 (ja) |
JP (1) | JPWO2015012206A1 (ja) |
WO (1) | WO2015012206A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108472455A (zh) * | 2016-01-15 | 2018-08-31 | W.L.戈尔及同仁股份有限公司 | 注射器柱塞组件 |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10058658B1 (en) * | 2017-05-26 | 2018-08-28 | Precision Polymer Products, Inc. | Film faced articles and methods of manufacturing the same |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB741604A (en) * | 1952-10-16 | 1955-12-07 | S & R J Everett & Co Ltd | Improvements relating to hypodermic syringes |
US4180069A (en) * | 1976-06-01 | 1979-12-25 | The West Company | Plunger rod and piston for a syringe |
JP2000140103A (ja) | 1998-11-05 | 2000-05-23 | Daikyo Seiko Ltd | 注射器用プランジャ |
JP2001025506A (ja) * | 1999-05-10 | 2001-01-30 | Material Eng Tech Lab Inc | 薬液入り注射器 |
JP2004092671A (ja) * | 2002-08-29 | 2004-03-25 | Terumo Corp | シリンジ用ガスケット、ガスケット付プランジャー、シリンジ及びプレフィルドシリンジ |
WO2009128265A1 (ja) * | 2008-04-16 | 2009-10-22 | 味の素株式会社 | シリンジ |
WO2010103919A1 (ja) * | 2009-03-09 | 2010-09-16 | テルモ株式会社 | ガスケットおよびシリンジ |
JP2013070789A (ja) * | 2011-09-27 | 2013-04-22 | Terumo Corp | シリンジ用プランジャー、シリンジおよびプレフィルドシリンジ |
Family Cites Families (10)
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US5370621A (en) * | 1992-12-14 | 1994-12-06 | Mallinckrodt Medical, Inc. | Insert device for facilitating limited aspiration of a delivery apparatus |
JP3296025B2 (ja) * | 1993-05-21 | 2002-06-24 | ニプロ株式会社 | 薬液充填式注射器 |
DE10122959A1 (de) * | 2001-05-11 | 2002-11-21 | West Pharm Serv Drug Res Ltd | Pharmazeutischer Spritzenkolben sowie Verfahren und Vorrichtung zu dessen Herstellung |
JP4401779B2 (ja) * | 2001-12-06 | 2010-01-20 | ノボ・ノルデイスク・エー/エス | 医療用投薬システム |
JP2004121344A (ja) * | 2002-09-30 | 2004-04-22 | Terumo Corp | シリンジ用ガスケット、ガスケット付プランジャー、シリンジ及びプレフィルドシリンジ |
JP3978785B2 (ja) * | 2003-09-10 | 2007-09-19 | ニプロ株式会社 | 外れ防止機構を備えたプランジャー |
KR101316487B1 (ko) * | 2005-08-01 | 2013-10-08 | 니프로 가부시키가이샤 | 주사기용 플런저와 이것을 이용한 시린지 및 프리필드시린지 |
JP4848784B2 (ja) * | 2006-02-02 | 2011-12-28 | ニプロ株式会社 | プランジャーとこれを用いたシリンジ及びプレフィルドシリンジ |
JP2008264256A (ja) * | 2007-04-20 | 2008-11-06 | Nipro Corp | プレフィルドシリンジ及びプレフィルドシリンジの製造方法 |
JP5639769B2 (ja) * | 2010-03-09 | 2014-12-10 | 大成化工株式会社 | プランジャーロッド及びシリンジ |
-
2014
- 2014-07-18 US US14/906,665 patent/US20160193418A1/en not_active Abandoned
- 2014-07-18 WO PCT/JP2014/069137 patent/WO2015012206A1/ja active Application Filing
- 2014-07-18 JP JP2015528261A patent/JPWO2015012206A1/ja active Pending
- 2014-07-18 EP EP14830272.2A patent/EP3025746A4/en not_active Withdrawn
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB741604A (en) * | 1952-10-16 | 1955-12-07 | S & R J Everett & Co Ltd | Improvements relating to hypodermic syringes |
US4180069A (en) * | 1976-06-01 | 1979-12-25 | The West Company | Plunger rod and piston for a syringe |
JP2000140103A (ja) | 1998-11-05 | 2000-05-23 | Daikyo Seiko Ltd | 注射器用プランジャ |
JP2001025506A (ja) * | 1999-05-10 | 2001-01-30 | Material Eng Tech Lab Inc | 薬液入り注射器 |
JP2004092671A (ja) * | 2002-08-29 | 2004-03-25 | Terumo Corp | シリンジ用ガスケット、ガスケット付プランジャー、シリンジ及びプレフィルドシリンジ |
WO2009128265A1 (ja) * | 2008-04-16 | 2009-10-22 | 味の素株式会社 | シリンジ |
WO2010103919A1 (ja) * | 2009-03-09 | 2010-09-16 | テルモ株式会社 | ガスケットおよびシリンジ |
JP2013070789A (ja) * | 2011-09-27 | 2013-04-22 | Terumo Corp | シリンジ用プランジャー、シリンジおよびプレフィルドシリンジ |
Non-Patent Citations (1)
Title |
---|
See also references of EP3025746A4 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108472455A (zh) * | 2016-01-15 | 2018-08-31 | W.L.戈尔及同仁股份有限公司 | 注射器柱塞组件 |
Also Published As
Publication number | Publication date |
---|---|
EP3025746A1 (en) | 2016-06-01 |
JPWO2015012206A1 (ja) | 2017-03-02 |
US20160193418A1 (en) | 2016-07-07 |
EP3025746A4 (en) | 2017-03-29 |
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