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WO2003057290A1 - Appareil et procede de fabrication d'un dispositif de securite medical - Google Patents

Appareil et procede de fabrication d'un dispositif de securite medical Download PDF

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Publication number
WO2003057290A1
WO2003057290A1 PCT/SG2002/000261 SG0200261W WO03057290A1 WO 2003057290 A1 WO2003057290 A1 WO 2003057290A1 SG 0200261 W SG0200261 W SG 0200261W WO 03057290 A1 WO03057290 A1 WO 03057290A1
Authority
WO
WIPO (PCT)
Prior art keywords
assembly
sub
snap cap
cannula
assembling
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.)
Ceased
Application number
PCT/SG2002/000261
Other languages
English (en)
Inventor
Eng Hwa Chua
Kim Teng Lua
Han Chong Ng
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FA SYSTEMS AUTOMATION (S) Pte Ltd
Original Assignee
FA SYSTEMS AUTOMATION (S) Pte Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by FA SYSTEMS AUTOMATION (S) Pte Ltd filed Critical FA SYSTEMS AUTOMATION (S) Pte Ltd
Priority to AU2002348569A priority Critical patent/AU2002348569A1/en
Publication of WO2003057290A1 publication Critical patent/WO2003057290A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
    • B23P21/00—Machines for assembling a multiplicity of different parts to compose units, with or without preceding or subsequent working of such parts, e.g. with programme control
    • B23P21/004—Machines for assembling a multiplicity of different parts to compose units, with or without preceding or subsequent working of such parts, e.g. with programme control the units passing two or more work-stations whilst being composed
    • 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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston

Definitions

  • the present invention relates in general to a method of manufacturing medical safety devices. More particularly, the present invention relates to an apparatus and method for manufacturing a retractable needle syringe.
  • an example of a prior art retractable needle syringe is made of : a cannula 10, a hub 12, a snap cap 'O'-ring 14, a snap cap 16, a printed syringe barrel 18, a bungee 20, a mandrel O'-ring 22, a plunger seal 24, a plunger 26 and a needle cap 28.
  • the bungee 20 is made of a elastomer and provides the elastic force necessary to retract the needle into the syringe barrel 18.
  • the present invention provides a novel and efficient fully automated manufacturing system for assembling multi-component devices such as a retractable needle syringe having a cannula, a hub, a snap cap, a snap cap "0"-ring, a printed syringe barrel, a bungee, a mandrel "O'-ring, a plunger and a plunger seal.
  • the manufacturing system comprises a plurality of assembly modules. Each assembly module assembles one sub-assembly and together the assembly modules manufacture the completed article.
  • the assembly modules comprises at least two platforms, one fixed; the second capable of rotation about an axis. A variety of peripheral tools and devices are mounted on the fixed platform. While the second platform is mounted predominantly with jigs for holding the components.
  • peripheral tools and devices are actuated synchronously by a central gear cam mechanical linkage. While the second platform is rotated by a rotary indexing system, ensuring that the components held in the jigs are always aligned with the peripheral tools and devices of the first platform.
  • the process for installing and assembling the retractable needle syringe involves the steps of assembling cannula and hub together, mounting snap cap 'O'-ring onto cannula and hub, mounting snap cap onto syringe barrel, mounting mandrel 'O'-ring onto bungee, mounting plunger seal onto plunger, installing bungee into plunger and final assembly.
  • Fig.1 shows the components of a retractable needle syringe.
  • Fig.2 shows a top plan view of the system for assembling a retractable needle syringe.
  • Fig.3 is a block diagram showing the main steps for the manufacturing of a retractable needle syringe.
  • Fig.4 is a block diagram showing the detailed steps for the printing of the syringe barrel.
  • Fig.5 is a block diagram showing the detailed steps for the assembling of a syringe barrel snap cap assembly.
  • Fig.6 is a block diagram showing the detailed steps for the assembling of a plunger bungee assembly.
  • Fig.7 is a block diagram showing the detailed steps for the assembling of the final product and its packaging.
  • Fig.8 is a perspective view showing an example of a peripheral device and jig.
  • System 190 comprises of the following main modules: the Syringe Barrel Printing Module 30, the Snap cap 'O'-ring/Cannula & Hub Assembly Module 50, the Snap Cap/Cannula & Hub Assembly Module 80, the Syringe Barrel/Snap Cap Assembly Module 100, the Plunger & Bungee Assembly Module 120.
  • the Syringe Barrel printing Module 30 comprises a syringe barrel feeder 32, a orientator/singulation unit 34, a "Corona" treatment system 36, a printing unit 38, an inspection camera 40, a reject tray 42 and a collection hopper 44, for preparing syringe barrels for assembly.
  • the Snap cap O'-ring/Cannula & Hub Assembly Module 50 comprises a hub feeder 52, a hub jig 58, a Snap cap O'-ring feeder 54, a Snap cap 'O'- ring assembler 60, a cannula feeder 56, a cannula assembler 62, a sealant dispenser 64, ultra-violet(UV) lamps 66a, 66b, a leakage tester 68, an inspection camera 70, reject tray 72, a snap cap 'O'-ring/cannula & hub assembly feeder 74, and a flipper unit 75.
  • the Snap Cap/Cannula & Hub Assembly Module 80 comprises a Cannula & Hub assembly jig 82, snap cap assembler 83, a snap cap feeder 84, an inspection camera 85, a snap cap jig 86, a reject tray 90 and a snap cap/cannula & hub Assembly feeder 88.
  • the Syringe Barrel/Snap Cap Assembly Module 100 comprises a snap cap jig 102, an inspection camera 104, a syringe barrel jig 106, an assembler unit 108 and a syringe barrel assembly loader 110.
  • the Plunger & Bungee Assembly Module 120 comprises of a bungee feeder 122, a bungee jig 124, a mandrel 'O'-ring feeder 126, a mandrel 'O'- ring assembler 128, a plunger feeder 130, a plunger jig 132, an assembler unit 134, a plunger seal feeder 136, a plunger seal assembler 138, a bungee installation and air leakage tester 140, a reject tray 144 and a plunger and bungee assembly feeder 142.
  • the Final Assembly Module 150 comprises of a syringe barrel jig 152, a cannula washing unit 154, a blower unit 156, a lubricant dispenser 158, inspection cameras 160, 162, 168 a plunger jig 164, an assembler unit 166, a needle cap feeder 170, a needle cap assembler 172, a reject tray 174 and a Final Product feeder 176.
  • the main steps in the manufacturing of a retractable needle syringe comprises of : printing the syringe barrels 220, assembling syringe barrel assembly 230, assembling plunger bungee assembly 240 and the final assembly and packaging 250.
  • the syringe barrel printing module 30 performs the step of printing 220 the graduated scales onto the syringe barrel 18.
  • the unprinted syringe barrels 18 are placed into the syringe barrel feeder 32 and sent for orienting and singulating 310 in the orientator / singulator unit 34.
  • the syringe barrels then undergo the "Corona" treatment 320 to pre-treat the surface prior to printing.
  • the "Corona" treatment system 36 uses high voltage electricity between 2 electrodes to produce an electrical arc resembling a 'blue mist'.
  • the syringe barrels 18 are exposed to this 'blue mist' during the "Corona” treatment process 315.
  • ink is dispensed onto a template, further transferred onto a silicon pad and a graduated scale is printed 320 onto the syringe barrel 18.
  • Hot air is then blown onto the syringe barrel 18 to cure the ink 325.
  • the newly printed scale on the syringe barrel 18 is then checked 330 by an inspection camera 40. Any smudging or unclear scales would result in the syringe barrel 18 being rejected 332 to the reject tray 42.
  • the Snap cap "0"-ring/Cannula & Hub Assembly module 50 performs the steps 230 in Fig.5.
  • a hub 12 is sent from the hub feeder 52 to a hub jig 58 where it is held securely.
  • the snap cap "0"-ring 14 is then mounted 410 onto the hub 12 by the snap cap O"-ring assembler 60.
  • the cannula 10 is then further inserted 415 into the hub 12 by the cannula assembler 62.
  • the sealant dispenser 64 then dispenses sealant 420 onto the cannula 10 and hub 12 interface.
  • Ultra Violet(UV) lamps 66a,66b are used to cure 425 the sealant.
  • the leakage tester 68 tests the cannula and hub assembly for leaks 430 at the cannula 10 and hub 12 interface.
  • the inspection camera 70 checks 435 the meniscus of the sealant for overflow or underfill.
  • the reject tray 72 collects the rejected 432 samples.
  • the assembled Snap Cap "O'- ring/Cannula & Hub assembly is oriented with the cannula pointing vertically upwards.
  • a flipper unit 75 flips the assembly over such that the cannula is now oriented pointing vertically downwards.
  • the Snap Cap "0"-ring/Cannula & Hub assembly is then sent to the Snap Cap/Cannula & Hub assembly module 80.
  • the snap cap jig 86 holds the snap cap 16 securely while the snap cap assembler 83 mounts 440 the cannula & hub assembly onto the snap cap 16.
  • the inspection camera 85 checks 445 to ensure presence of a cannula 10.
  • the reject tray 90 collects the rejected samples.
  • the snap cap/cannula & hub assembly is then sent to the Syringe Barrel/Snap Cap Assembly Module 100.
  • the snap cap assembly is held securely by the snap cap assembly jig 102.
  • the inspection camera 104 checks 445 for the presence of a cannula 10.
  • Printed syringe barrels 18 from the printing module 30 are picked up by the syringe barrel jig 106 and an assembler unit 108 mounts 450 the snap cap assembly onto the syringe barrel 18. The completed syringe barrel assembly is then sent to the Final Assembly module 150.
  • the steps for assembling 240 the plunger and bungee assembly is carried out in the plunger & bungee assembly module 120.
  • the bungee 20 is held securely by the bungee jig 124 and the mandrel "O'-ring assembler 128 mounts 510 the mandrel "O'-ring 22 onto the bungee 20.
  • the bungee jig 124 then arms 515 the bungee by stretching it to a predetermined length.
  • the plunger jig 132 holds the plunger 26 securely while the armed bungee 20 is installed 520 into the plunger 26 by the assembler unit 134.
  • the plunger seal assembler 138 then mounts 525 the plunger seal 24 onto the plunger 26.
  • the bungee installation and air leakage tester 140 then checks 530 the installed bungee 20 to ensure it has been installed properly in the plunger 26.
  • the tip of the bungee 20 protruding from the plunger seal 24 is subjected to a predetermined force not sufficient to activate the bungee. However, if the bungee 20 activates, then the installation has not been done correctly and the part is rejected 532.
  • the plunger and bungee assembly is also further subjected to an air leakage test to ensure that the bungee and plunger seal interface is airtight and not subject to any leakage. Rejected 532 samples are left in the reject tray 144.
  • the completed plunger bungee assembly is then sent to the Final Assembly Module 150.
  • the Final Assembly Module 150 receives the syringe barrel assembly and the plunger bungee assembly.
  • the syringe barrel jig 152 holds the syringe barrel assembly securely.
  • the cannula washing unit 154 then washes 610 the cannula 10. It then undergoes drying 615 at the blower unit 156.
  • a mist of silicon is sprayed 620 into the syringe barrel assembly by the lubricant dispenser 158.
  • Inspection cameras 160,162 then check the cannula length 625 and the bevel tip 630.
  • the rejected 627 samples are placed in the reject tray 174.
  • the plunger bungee assembly is received and held securely by the plunger jig 164.
  • the assembler unit 166 then inserts 635 the plunger bungee assembly into the syringe barrel assembly.
  • An inspection camera 168 checks 640 the height of the plunger 26 that protrudes out of the syringe barrel 18.
  • a needle cap is then mounted 645 over the cannula 10 and hub 12 by the needle cap assembler 172.
  • the retractable needle syringe is now completed.
  • the completed syringe is then placed in a Final Product feeder 176 to be sent to the packaging module 180 for packaging 650.
  • the present manufacturing system is made up of the 5 described assembly modules, the printing module and the packaging module.
  • Each assembly module assembles one of the described sub-assemblies and together the assembly modules manufacture the completed article.
  • Each of the assembly modules is controlled by a rotary indexing system with multiple synchronous action through a central gear cam mechanical linkage.
  • the various modules are linked up to each other by a variety of conveying and transporting means. Some examples of these conveying means are : conveyor belts, rollers, rails and movable jigs
  • the assembly modules are made up of a variety of peripheral tools and devices mounted on a first circular platform 46.
  • This first circular platform 46 is fixed and immovable.
  • the peripheral devices 49 such as the assembler units and sealant dispensers are actuated by a central gear cam mechanical linkage 45 in tandem with a rotary indexing system.
  • the peripheral devices 49 are designed to have similar interfacing mechanical linkages. This allows for the configuration of the first circular platform 46 to be easily changed to adapt the assembly module to different products.
  • the peripheral devices 49 are also designed with similar footprints and standard mounting interfaces. This allows for rapid mounting and dismounting of peripheral devices 49 which decreases downtime during maintenance. A faulty peripheral device 49 may be readily dismounted and a serviceable one replaced simply by using simple hand tools.
  • a second circular platform 47 rotates about an axis and is controlled by the rotary indexing system.
  • Mounted on this second platform 47 are the jigs 48 that are designed to hold the components of the unassembled retractable needle syringe.
  • the second platform 47 rotates and ensures each mounted jig 48 is aligned to a predetermined peripheral device 49 on the first circular platform 46. After the peripheral devices 49 have performed their intended action, the second circular platform 47 then rotates to a next index according to the rotary indexing system.
  • the central gear cam mechanical linkage 45 works together with the rotary indexing system to actuate the peripheral devices 49.
  • peripheral devices 49 An example of a peripheral devices 49 is the "0"-ring assembler.
  • the assembler units as mentioned like the "0"-ring assembler are inherently pick and place units.
  • the pick and place units pick up components and mount them individually onto other components being held by the jigs.
  • This method of assembling such low cost devices does not appear to be cost effective and feasible as compared to conventional manufacturing systems. In the conventional systems, large numbers can be produced in short periods of time, but the quality levels are not high.
  • the present invention advantageously allows for every sub-assembly to be inspected before each sub-assembly proceeds to the next assembly module. If required, each component and uncompleted sub-assembly may be inspected before the next peripheral device is actuated. This provides for an almost 100% good parts output at the packaging module of the entire system.
  • the peripheral devices 49 further allow for different dimensions of syringes to be manufactured.
  • the jigs 48 and assembler units have extra allowances to handle parts having a predetermined range of dimensions, thus allowing the same equipment to manufacture a variety of size of syringes.
  • the assembly modules each being driven by a central gear cam mechanical linkage 45 results in a high speed assembling action.
  • the central gear cam linkage 45 actuates the peripheral devices 49 on the first circular platform 46 of each assembly module synchronously.
  • the Rotary Indexing system ensures that each peripheral device 49 carries out its action synchronously. It also ensures that the succeeding peripheral device 49 takes over the action on a component at the next index after rotation. This results in an assembling action that is smooth and rapid.
  • the use of the circular platform according to the present invention reduces the overall footprint of the assembling modules making them more compact.
  • Such equipment for manufacturing medical devices are inevitably located in a clean room.
  • Such a manufacturing system thus requires a smaller clean room, which ultimately translates into lower costs.
  • a smaller clean room is also easier to manage and it reduces the possibility and avenues for contamination.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention porte sur un système de fabrication nouveau et efficace permettant d'assembler des dispositifs à plusieurs composants tels qu'une seringue à aiguille rétractable. Le système de fabrication comprend une pluralité de modules d'assemblage qui comportent au moins deux plates-formes, l'une fixe et la seconde capable de tourner autour d'un axe. Divers outils et dispositifs périphériques sont montés sur la plate-forme fixe, la seconde plate-forme étant montée principalement avec des gabarits pour retenir les composants. Les outils et dispositifs périphériques sont actionnés de manière synchrone par une liaison mécanique centrale à came et engrenage. La seconde plate-forme tourne sous l'action d'un système d'indexage rotatif, permettant ainsi que les composants retenus dans les gabarits soient toujours alignés sur les outils et dispositifs périphériques de la première plate-forme.
PCT/SG2002/000261 2002-01-11 2002-11-08 Appareil et procede de fabrication d'un dispositif de securite medical Ceased WO2003057290A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002348569A AU2002348569A1 (en) 2002-01-11 2002-11-08 An apparatus and process for manufacturing a medical safety device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SG200200160A SG117401A1 (en) 2002-01-11 2002-01-11 An apparatus and process for manufacturing a medical safety device
SG200200160-0 2002-01-11

Publications (1)

Publication Number Publication Date
WO2003057290A1 true WO2003057290A1 (fr) 2003-07-17

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PCT/SG2002/000261 Ceased WO2003057290A1 (fr) 2002-01-11 2002-11-08 Appareil et procede de fabrication d'un dispositif de securite medical

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AU (1) AU2002348569A1 (fr)
SG (1) SG117401A1 (fr)
WO (1) WO2003057290A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102430924A (zh) * 2011-10-19 2012-05-02 苏州奥兰迪尔自动化设备有限公司 针管自动组装机及其自动组装方法
CN102500018A (zh) * 2011-10-19 2012-06-20 苏州奥兰迪尔自动化设备有限公司 一种注射器的胶塞芯杆自动组装装置
JP2013018091A (ja) * 2011-07-13 2013-01-31 Honda Sun Co Ltd 部品組付け装置および部品組付け方法
CN104400422A (zh) * 2014-11-18 2015-03-11 湖南千山制药机械股份有限公司 采血针组装设备
CN105857664A (zh) * 2016-05-26 2016-08-17 上海睿通机器人自动化股份有限公司 一种动物芯片注射器全自动组装包装机及其组装方法
CN109227109A (zh) * 2018-08-21 2019-01-18 北京南格尔生物科技有限公司 一种采血器自动组装系统及方法
EP3448187B1 (fr) 2016-04-29 2021-06-23 RAI Strategic Holdings, Inc. Systèmes et procédés d'assemblage d'une pluralité de cartouches pour un dispositif de distribution d'aérosol

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108044333B (zh) * 2017-12-06 2019-09-10 中船重工鹏力（南京）智能装备系统有限公司 一种计量表机械式数字计数器全自动装配设备及方法

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Publication number Priority date Publication date Assignee Title
US5784932A (en) * 1996-06-20 1998-07-28 Gilberti; Joseph J. Rotary indexing table
US6050977A (en) * 1996-11-15 2000-04-18 Futura Medical Technologies Inc. Syringe with retractable needle assembly
JP2000308682A (ja) * 1999-02-22 2000-11-07 Chugai Pharmaceut Co Ltd プランジャロッド付きシリンジ製剤及びその製造方法並びにその組付装置
TW425365B (en) * 1999-11-08 2001-03-11 Huang Ying Shr A device for assembling plunger and piston and making process thereof
TW429231B (en) * 1999-12-10 2001-04-11 Huang Ying Shr Process and device for assembling needle hub and O-ring
WO2001041843A1 (fr) * 1999-12-13 2001-06-14 Futura Medical Technologies, Inc. Seringue à ensemble aiguille rétractable

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5784932A (en) * 1996-06-20 1998-07-28 Gilberti; Joseph J. Rotary indexing table
US6050977A (en) * 1996-11-15 2000-04-18 Futura Medical Technologies Inc. Syringe with retractable needle assembly
JP2000308682A (ja) * 1999-02-22 2000-11-07 Chugai Pharmaceut Co Ltd プランジャロッド付きシリンジ製剤及びその製造方法並びにその組付装置
TW425365B (en) * 1999-11-08 2001-03-11 Huang Ying Shr A device for assembling plunger and piston and making process thereof
TW429231B (en) * 1999-12-10 2001-04-11 Huang Ying Shr Process and device for assembling needle hub and O-ring
WO2001041843A1 (fr) * 1999-12-13 2001-06-14 Futura Medical Technologies, Inc. Seringue à ensemble aiguille rétractable

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DATABASE WPI Derwent World Patents Index; Class B07, AN 2001-439972/47 *
DATABASE WPI Derwent World Patents Index; Class Q31, AN 2002-024607/03 *
PATENT ABSTRACTS OF JAPAN *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013018091A (ja) * 2011-07-13 2013-01-31 Honda Sun Co Ltd 部品組付け装置および部品組付け方法
CN102430924A (zh) * 2011-10-19 2012-05-02 苏州奥兰迪尔自动化设备有限公司 针管自动组装机及其自动组装方法
CN102500018A (zh) * 2011-10-19 2012-06-20 苏州奥兰迪尔自动化设备有限公司 一种注射器的胶塞芯杆自动组装装置
CN102430924B (zh) * 2011-10-19 2013-07-24 苏州奥兰迪尔自动化设备有限公司 针管自动组装机及其自动组装方法
CN104400422A (zh) * 2014-11-18 2015-03-11 湖南千山制药机械股份有限公司 采血针组装设备
EP3448187B1 (fr) 2016-04-29 2021-06-23 RAI Strategic Holdings, Inc. Systèmes et procédés d'assemblage d'une pluralité de cartouches pour un dispositif de distribution d'aérosol
US12005184B2 (en) 2016-04-29 2024-06-11 Rai Strategic Holdings, Inc. Methods for assembling a cartridge for an aerosol delivery device, and associated systems and apparatuses
CN105857664A (zh) * 2016-05-26 2016-08-17 上海睿通机器人自动化股份有限公司 一种动物芯片注射器全自动组装包装机及其组装方法
CN109227109A (zh) * 2018-08-21 2019-01-18 北京南格尔生物科技有限公司 一种采血器自动组装系统及方法

Also Published As

Publication number Publication date
AU2002348569A1 (en) 2003-07-24
SG117401A1 (en) 2005-12-29

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