BR112017025449A2 - método de embalagem para permitir a reesterilização do dispositivo médico - Google Patents
método de embalagem para permitir a reesterilização do dispositivo médicoInfo
- Publication number
- BR112017025449A2 BR112017025449A2 BR112017025449-2A BR112017025449A BR112017025449A2 BR 112017025449 A2 BR112017025449 A2 BR 112017025449A2 BR 112017025449 A BR112017025449 A BR 112017025449A BR 112017025449 A2 BR112017025449 A2 BR 112017025449A2
- Authority
- BR
- Brazil
- Prior art keywords
- gas
- gas permeable
- compartment
- medical device
- permeable material
- Prior art date
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
- B65B55/14—Sterilising contents prior to, or during, packaging by heat
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/06—Sterilising wrappers or receptacles prior to, or during, packaging by heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/02—Machines characterised by incorporation of means for making the containers or receptacles
- B65B5/022—Machines characterised by incorporation of means for making the containers or receptacles for making bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
- B65B55/18—Sterilising contents prior to, or during, packaging by liquids or gases
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
- B65B61/005—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for removing material by cutting
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/02—Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
- A61B2050/314—Flexible bags or pouches
- A61B2050/318—Multi-pouches, e.g. strips of side-by-side pouches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/18—Aseptic storing means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Packages (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Containers And Plastic Fillers For Packaging (AREA)
Abstract
é divulgado um método de embalagem de dispositivos médicos pré-preenchidos. o método compreende a produção de uma embalagem com um painel frontal e um painel traseiro que define um compartimento capaz de acomodar um ou mais dispositivos médicos em que pelo menos um painel frontal ou superior possui uma porção que contém um material permeável a gás enquanto a porção restante da bolsa é impermeável a gás. este material permeável a gás permite que o gás passe através do material e entre em contato com um ou mais artigos contidos no compartimento ou permite que o gás passe através do material permeável a gás do interior do compartimento para o exterior do recipiente. após a conclusão da esterilização, a bolsa é vedada e a porção permeável a gás é cortada deixando o dispositivo médico esterilizado fechado em uma bolsa completamente impermeável a gás.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562166766P | 2015-05-27 | 2015-05-27 | |
US62/166,766 | 2015-05-27 | ||
US15/164,269 | 2016-05-25 | ||
US15/164,269 US10293965B2 (en) | 2015-05-27 | 2016-05-25 | Packaging method to enable re-sterilization of medical device |
PCT/US2016/034280 WO2016191535A2 (en) | 2015-05-27 | 2016-05-26 | Packaging method to enable re-sterilization of medical device |
Publications (2)
Publication Number | Publication Date |
---|---|
BR112017025449A2 true BR112017025449A2 (pt) | 2018-08-07 |
BR112017025449B1 BR112017025449B1 (pt) | 2021-10-05 |
Family
ID=56098448
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112017025449-2A BR112017025449B1 (pt) | 2015-05-27 | 2016-05-26 | Método de embalo e esterilização de um dispositivo médico |
Country Status (9)
Country | Link |
---|---|
US (2) | US10293965B2 (pt) |
EP (1) | EP3302582A2 (pt) |
JP (2) | JP6861648B2 (pt) |
CN (2) | CN107921154B (pt) |
AU (2) | AU2016267149B2 (pt) |
BR (1) | BR112017025449B1 (pt) |
CA (1) | CA2986245C (pt) |
MX (2) | MX2017015152A (pt) |
WO (1) | WO2016191535A2 (pt) |
Families Citing this family (23)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2015122964A1 (en) * | 2014-02-11 | 2015-08-20 | Dexcom, Inc. | Packaging system for analyte sensors |
US20160152361A1 (en) * | 2014-12-02 | 2016-06-02 | Chandra Maurya Pte Ltd. | Apparatus for Wrapping a Napkin Around One or More Silverwares |
EP3791919A1 (en) | 2015-03-10 | 2021-03-17 | Regeneron Pharmaceuticals, Inc. | Aseptic piercing system |
WO2018142220A2 (en) * | 2017-02-03 | 2018-08-09 | Bee Sight Limited | Medical apparatus and method for sterilizing medical apparatus |
CN106742610B (zh) * | 2017-03-17 | 2020-03-17 | 山东华鲁制药有限公司 | 一种塑料安瓿瓶针剂双层无菌包装结构 |
WO2018182929A1 (en) | 2017-03-27 | 2018-10-04 | Regeneron Pharmaceuticals, Inc. | Sterilisation method |
WO2018204455A1 (en) | 2017-05-02 | 2018-11-08 | Medtronic Vascular Inc. | Assemblies and methods for sterilizing a wet stored prosthetic heart valve |
CN110603205B (zh) * | 2017-05-02 | 2022-08-09 | 美敦力瓦斯科尔勒公司 | 用于干组织假体心脏瓣膜的包装 |
MX2019012670A (es) | 2017-05-05 | 2020-07-13 | Regeneron Pharma | Autoinyector. |
AU2018289327B2 (en) | 2017-06-19 | 2021-07-01 | Dexcom, Inc. | Applicators for applying transcutaneous analyte sensors and associated methods of manufacture |
US20190167078A1 (en) * | 2017-12-04 | 2019-06-06 | Ethicon, Inc. | Sterilization package |
JP7285842B2 (ja) | 2017-12-13 | 2023-06-02 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 正確な用量の送達のためのデバイス及び方法 |
USD888252S1 (en) | 2018-06-18 | 2020-06-23 | Dexcom, Inc. | Transcutaneous analyte sensor applicator |
US11584558B2 (en) | 2018-12-12 | 2023-02-21 | Medtronic Vascular, Inc. | Shrink-formed package |
AU2020289563A1 (en) | 2019-06-05 | 2022-01-20 | Regeneron Pharmaceuticals, Inc. | Devices and methods for precision dose delivery |
CN111544608A (zh) * | 2020-05-15 | 2020-08-18 | 连云港佑源医药设备制造有限公司 | 一种手术用麻醉针灭菌消毒预处理装置 |
CN113306880A (zh) * | 2020-08-25 | 2021-08-27 | 美昕医疗器械(昆山)有限公司 | 一种组合包装及其灭菌方法 |
US11779748B2 (en) * | 2020-09-29 | 2023-10-10 | Codan Us Corporation | Medical coiled tubing |
KR20230118875A (ko) | 2020-12-31 | 2023-08-14 | 생-고뱅 퍼포먼스 플라스틱스 코포레이션 | 패키징 용기 및 이의 제조 및 사용 방법 |
WO2022259217A1 (en) | 2021-06-11 | 2022-12-15 | Cilag Gmbh International | Gas sterilizable syringes having apertures covered by gas permeable barriers for enabling ingress and egress of sterilization gases while preventing leakage of flowable materials |
USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
EP4260877A1 (fr) * | 2022-04-11 | 2023-10-18 | ELIS ITALIA S.p.A. | Emballage de sterilisation et procede de sterilisation correspondant |
CN115258239B (zh) * | 2022-08-01 | 2024-02-27 | 北京中泰邦医药科技有限公司 | 一种用于无菌凝胶药物的产品包装及其制备工艺 |
Family Cites Families (24)
Publication number | Priority date | Publication date | Assignee | Title |
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US3472369A (en) * | 1967-06-23 | 1969-10-14 | Samuel J Schuster | Readily opened package for storing items in bacteria-free condition |
JPS6274364A (ja) * | 1985-09-27 | 1987-04-06 | 株式会社 ニツシヨ− | 医療用具 |
US4660721A (en) | 1986-04-07 | 1987-04-28 | Cvp Systems, Inc. | Sterilization package |
CN1178476A (zh) * | 1995-03-13 | 1998-04-08 | 大正制药株式会社 | 预先填充注射器及预先填充注射液的灭菌方法 |
US5910138A (en) * | 1996-05-13 | 1999-06-08 | B. Braun Medical, Inc. | Flexible medical container with selectively enlargeable compartments and method for making same |
US6528017B2 (en) * | 1997-04-04 | 2003-03-04 | Ethicon, Inc. | System and method for sterilizing a lumen device |
US6066294A (en) * | 1997-08-21 | 2000-05-23 | Ethicon, Inc. | Multi-compartment sterilization system |
US5868244A (en) * | 1997-12-01 | 1999-02-09 | Ethicon, Inc. | Microbial barrier vented package for sterile medical devices and method of packaging |
US6098800A (en) | 1997-12-19 | 2000-08-08 | Rexam Medical Packaging, Inc. | Reinforced sterilizable containers |
JP2001219976A (ja) * | 2000-02-09 | 2001-08-14 | Terumo Corp | 医療用包装体の製造方法および医療用包装体 |
FR2816925B1 (fr) * | 2000-11-20 | 2003-02-14 | Becton Dickinson France | Emballage pour produits a steriliser a l'aide d'un fluide sterilisant a haute temperature |
ATE383119T1 (de) * | 2000-11-20 | 2008-01-15 | Becton Dickinson Co | Durchsichtige medizinische produktverpackung |
US6996952B2 (en) * | 2003-09-30 | 2006-02-14 | Codman & Shurtleff, Inc. | Method for improving stability and effectivity of a drug-device combination product |
US20050268573A1 (en) | 2004-01-20 | 2005-12-08 | Avantec Vascular Corporation | Package of sensitive articles |
DE102004027923A1 (de) | 2004-06-09 | 2005-12-29 | Reto Artusi | Vorrichtung zum Behandeln eines Gutes mit Gas |
US8367099B2 (en) * | 2004-09-28 | 2013-02-05 | Atrium Medical Corporation | Perforated fatty acid films |
JP2006271781A (ja) * | 2005-03-30 | 2006-10-12 | Toppan Printing Co Ltd | 医療品用滅菌包装袋の製造方法 |
WO2007047028A1 (en) | 2005-10-14 | 2007-04-26 | Atrium Medical Corporation | Packaging and sterilization of medical devices |
CN101195426A (zh) * | 2006-12-05 | 2008-06-11 | 天津百畅医疗器械科技有限公司 | 一种用于环氧乙烷消毒的双面薄膜包装 |
US7631760B2 (en) * | 2008-02-07 | 2009-12-15 | Amcor Flexibles Healthcare, Inc. | Dual compartment pouch |
JP5332958B2 (ja) * | 2009-06-29 | 2013-11-06 | 大日本印刷株式会社 | プレフィルドシリンジ包装体及びプレフィルドシリンジ用パック |
AR078060A1 (es) * | 2009-07-14 | 2011-10-12 | Novartis Ag | Descontaminacion de superficie de contenedores previamente llenados en empaque secundario |
JP2011030727A (ja) * | 2009-07-31 | 2011-02-17 | Manii Kk | 医療用品の包装袋、医療用品を収容した包装袋および医療用品の包装方法 |
CA2846939A1 (en) * | 2009-08-20 | 2010-10-26 | Ar Medicom Inc. | Sterilizable pouch |
-
2016
- 2016-05-25 US US15/164,269 patent/US10293965B2/en active Active
- 2016-05-26 MX MX2017015152A patent/MX2017015152A/es unknown
- 2016-05-26 CA CA2986245A patent/CA2986245C/en active Active
- 2016-05-26 EP EP16727119.6A patent/EP3302582A2/en active Pending
- 2016-05-26 WO PCT/US2016/034280 patent/WO2016191535A2/en active Application Filing
- 2016-05-26 CN CN201680037816.9A patent/CN107921154B/zh active Active
- 2016-05-26 AU AU2016267149A patent/AU2016267149B2/en active Active
- 2016-05-26 BR BR112017025449-2A patent/BR112017025449B1/pt active IP Right Grant
- 2016-05-26 JP JP2017561711A patent/JP6861648B2/ja active Active
- 2016-05-26 CN CN202110978803.4A patent/CN113650883B/zh active Active
-
2017
- 2017-11-24 MX MX2021010161A patent/MX2021010161A/es unknown
-
2018
- 2018-11-07 AU AU2018260861A patent/AU2018260861B2/en active Active
-
2019
- 2019-05-16 US US16/414,131 patent/US10710759B2/en active Active
-
2021
- 2021-03-30 JP JP2021057477A patent/JP2021118851A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
MX2017015152A (es) | 2018-06-20 |
AU2018260861B2 (en) | 2020-06-11 |
CN113650883A (zh) | 2021-11-16 |
CN107921154A (zh) | 2018-04-17 |
JP6861648B2 (ja) | 2021-04-21 |
CA2986245C (en) | 2021-07-06 |
JP2018518262A (ja) | 2018-07-12 |
CN113650883B (zh) | 2023-01-31 |
WO2016191535A2 (en) | 2016-12-01 |
US10710759B2 (en) | 2020-07-14 |
MX2021010161A (es) | 2021-09-14 |
US20190270533A1 (en) | 2019-09-05 |
CA2986245A1 (en) | 2016-12-01 |
WO2016191535A3 (en) | 2017-01-12 |
JP2021118851A (ja) | 2021-08-12 |
US20160347492A1 (en) | 2016-12-01 |
AU2016267149A1 (en) | 2017-12-07 |
US10293965B2 (en) | 2019-05-21 |
CN107921154B (zh) | 2021-08-20 |
AU2018260861A1 (en) | 2018-11-29 |
EP3302582A2 (en) | 2018-04-11 |
AU2016267149B2 (en) | 2018-11-08 |
BR112017025449B1 (pt) | 2021-10-05 |
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Legal Events
Date | Code | Title | Description |
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B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
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