EP1592350A1 - Poche d'emballage d'un dispositif medical - Google Patents

Poche d'emballage d'un dispositif medical

Info

Publication number
EP1592350A1
EP1592350A1 EP03710170A EP03710170A EP1592350A1 EP 1592350 A1 EP1592350 A1 EP 1592350A1 EP 03710170 A EP03710170 A EP 03710170A EP 03710170 A EP03710170 A EP 03710170A EP 1592350 A1 EP1592350 A1 EP 1592350A1
Authority
EP
European Patent Office
Prior art keywords
pouch
gas
pouch according
medical device
pocket
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.)
Withdrawn
Application number
EP03710170A
Other languages
German (de)
English (en)
Inventor
Gerard Patrick Duffy
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.)
MASSN MEDICAL Ltd
Original Assignee
MASSN MEDICAL 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 MASSN MEDICAL Ltd filed Critical MASSN MEDICAL Ltd
Publication of EP1592350A1 publication Critical patent/EP1592350A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114—Packages or dispensers for needles or sutures
    • 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
    • A61L2/206—Ethylene oxide
    • 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • 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
    • A61B2050/3004—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments containing desiccant means, e.g. desiccant pouches
    • 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
    • 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
    • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
    • 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

Definitions

  • This invention relates to a pouch for packaging a medical device and, in particular, to a pouch for packaging an absorbable medical device to be sterilized by a gas sterilization process.
  • Certain types of medical devices such as surgical sutures, are designed to absorb when placed in the human body. These sutures are made from absorbable polymers such as polyglycolic acid and are moisture sensitive. Thus, it is necessary to package such devices in moisture impervious packaging.
  • Absorbable medical devices are usually supplied in a sterile state and the sterilization method of choice is the use of ethylene oxide gas.
  • One current packaging method for such medical devices is to double pack them.
  • the product is first placed in a foil pouch and then the foil pouch is over-wrapped in a secondary pouch, which is constructed from either TYVEK (TYVEK is a trade mark of E.I. du Pont de Nemours and Company) or a surgical grade kraft paper with a transparent gas impervious lid.
  • the outer pouch acts as a gas permeable microbe impermeable cover.
  • the outer pouch is sealed leaving the inner foil pouch open to allow the sterilization gas to circulate and sterilize the product.
  • the product then rests and degasses for a period of about five days before being returned to the manufacturer for sealing of the inner foil pouch. During this time the product can absorb water from the atmosphere. Upon return and prior to sealing the inner pouch, the package is placed in a vacuum oven and dried to below 0.2% water content. This process may take between 24- 48 hours. The inner pouch is then sealed through the outer pouch.
  • U.S. Patent No. 5,868,244 describes a vented package for a sterile medical device, in which the package is divided into two compartments.
  • One compartment contains the medical device to be sterilized and is sealed except for a channel joining it to the second compartment.
  • the second compartment is in turn sealed except for a gas permeable, microbe impermeable vent. During the sterilization process the gas enters into the second compartment through the vent and passes into the first compartment through the connecting channel.
  • the package may be stored in a humidity controlled storage area prior to further processing.
  • the package is then sealed across the connecting channel and the second compartment can be cut away.
  • the invention provides a pouch for packaging a medical device to be sterilized by a gas sterilization process, said pouch comprising a gas permeable microbe impermeable sealable pocket for receiving the medical device in use, the pocket being located within an outer gas impermeable sealable envelope, such that in use the medical device is placed within the pocket and sealed therein, and the sterilizing gas is then introduced into the outer envelope and from there circulates through the pocket to sterilize the medical device therein.
  • the outer envelope section provides a transient area through which the sterilizing gas must pass in order to access and sterilize the medical device within the sealable pocket.
  • a desiccant strip can be placed in the outer envelope, prior to sealing, and this prevents the suture from reabsorbing moisture post-sterilization.
  • the pocket is made from spun, bonded, olefin material.
  • the pocket is made from surgical grade coated kraft paper.
  • the outer envelope is internally divided into the pocket and a venting section by a gas permeable microbe impermeable partition, which is attached to the inner surface of the outer envelope.
  • An advantage of forming the pocket from a gas permeable microbe impermeable partition is that the pouch can be assembled by sandwiching the partition between two outer layers of material forming the outer envelope.
  • the venting section provides a transient area through which the sterilizing gas must pass in order to access and sterilize the medical device.
  • a desiccant strip can be placed in the venting section, prior to sealing, and this prevents the suture from reabsorbing moisture after sterilization.
  • the outer envelope is made from medical packaging film.
  • the medical packaging film is heat sealable.
  • the medical packaging film is transparent. It can be useful for one to be able to see through the outer envelope.
  • a transparent film such as ClearFoil (ClearFoil is a trade mark of Rollprint Packaging Products, Inc.) can be used to form part or all of the outer envelope.
  • the outer envelope has a vent on a surface thereof, through which the sterilizing gas is introduced in use.
  • vent allows the outer envelope to be sealed prior to the gas sterilization process.
  • the vent is openable such that it moves between a closed state at ambient temperature and an open state at a raised temperature generated during the sterilization process.
  • the vent includes a layer of gas permeable microbe impermeable material through which the gas must pass in use.
  • the gas permeable microbe impermeable layer acts as a first microbial barrier for protecting the device. If this barrier is breached the gas permeable microbe impermeable pocket will still maintain the sterility of the device.
  • the layer of gas permeable microbe impermeable material is attached to the inside surface of the outer envelope under the vent.
  • the vent includes a layer of desiccant material through which the gas must pass in use.
  • the vent is a flap cut in the outer envelope material, the flap in use curling in response to the raised temperature generated during the sterilization process to uncover an aperture through which the sterilizing gas can enter the pouch.
  • a flap which is sensitive to temperature changes provides a simple method for opening and closing the vent.
  • the flap operates in accordance with natural mechanical laws of expansion and contraction.
  • the temperature at which the flap curls is in the range of 30°- 50° C.
  • the pouch has an adhesive patch for sealing the vent following the sterilizing process.
  • the or each section has an identifying tab associated therewith.
  • the pouch has an adhesive patch for sealing the vent following the sterilizing process.
  • the vent minimises the risk of moisture entering the pouch following the sterilization process
  • the addition of an adhesive patch provides a watertight seal and ensures that no moisture can enter through the vent.
  • the pouch does not have to be stored under aseptic or humidity controlled conditions.
  • Fig. 1 is a perspective view of a pouch according to the invention
  • Fig. 2 is an exploded view of the pouch of Fig. 1;
  • Fig. 3 is a cross-section on line III - III of Fig. 1, with the vent in the closed position;
  • Fig. 4 is the cross-section of Fig. 3, but with the vent in the open position.
  • a pouch for packaging a medical device to be sterilised by a gas sterilization process having a first surface 11 and a second surface 12, which are sealed together during assembly at edges 13, to form an outer envelope 14 having a sealable opening 16 along one side 17 thereof for receiving the medical device in use.
  • the pouch 10 is internally divided into a gas permeable microbe impermeable pocket 18 and a venting section 19 by a gas permeable microbe impermeable partition 20.
  • An openable vent 21 is located in the first surface 11 and is in communication with the venting section 19.
  • the vent 21 in use moves between a closed state at ambient temperature and an open state at a raised temperature generated during the sterilization process, thus allowing passage of a sterilizing gas into the venting section 19 and from there to the device receiving pocket 18 via the partition 20.
  • the vent 21 has a flap 22, which is cut in the first surface 11. This flap 22 curls in response to a raised temperature thus exposing an aperture 23 through which the sterilizing gas can enter the pouch 10. When the temperature returns to ambient the flap 22 flattens out and reseals the aperture 23.
  • a layer of gas permeable microbe impermeable material 24 (ghost outline) is attached to inside surface 25 of the first surface 11 so as to cover the aperture 23.
  • Tabs 26,27,28 on the first surface 11, the partition 20 and the second surface 12, respectively, permit positive identification of the device receiving pocket 18 and the venting section 19.
  • a flattened area 29 at an end 30 of the pouch 10 is used for opening the pouch by the user of the device contained therein.
  • a medical device to be packaged is placed in the device receiving pocket 18 of the pouch 10 and a desiccant strip, if required, is placed in the venting section 19.
  • the pouch 10 is then sealed along the edge 17 and the pouch is sterilized using an ethylene oxide gas sterilizing procedure.
  • the flap 22 opens to permit the sterilizing gas to circulate around the device.
  • the pouch 10 is allowed to return to ambient temperature and the flap reseals the aperture 23.
  • An adhesive patch (not shown) can then be placed over the flap 22 to provide a watertight seal.
  • the first surface 11 and the second surface 12 are made from a non-permeable heat sealable medical packaging film such as PerfecFlex EZ Peel film (PerfecFlex 35786-G High Barrier EZ Peel film), (PerfecFlex and EZ Peel are trade marks of Perfecseal, Inc.).
  • the gas permeable microbe impermeable partition 20 and the layer of gas permeable microbe material 24 are made from TYVEK material (CR27 1073B all over coated TYVEK) (TYVEK is a trade mark).
  • the pouch 10 is made up from three layers, the first surface 11, the second surface 12 and the gas permeable microbe impermeable partition 20, sandwiched therebetween. The three layers are joined together by heat sealing.
  • Ends 31,32,33 of first surface 11, partition 20, and second surface 12 are joined together to form the flattened area 29 of the assembled pouch.
  • a curved section 34 in end 33 facilitates the opening of the pouch 10 when the device contained therein is required, as the first surface 11 and the partition 20 can be gripped by the user and peeled away from the second surface 12.
  • the pouch 10 is illustrated containing a medical device 35 in the device receiving pocket 18 and a desiccant strip 36 in the venting section 19.
  • the arrows in Fig. 4 indicate the circulation of sterilizing gas through the aperture 23, around the venting section 19, through the partition 20 and around the medical device 35 in the device receiving pocket 18.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dentistry (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Packages (AREA)

Abstract

Une poche (10) d'emballage d'un dispositif médical à stériliser, à l'aide d'un procédé de stérilisation gazeuse, présente une première surface (11) ainsi qu'une seconde surface (12), lesquelles sont scellées ensemble pendant l'assemblage aux bords (12) pour former une enveloppe extérieure (14) ayant une ouverture scellable (16) le long d'une face (17) de celle-ci, afin de recevoir le dispositif médical en utilisation. La poche (10) est divisée intérieurement en une poche (18) de réception du dispositif et une partie de ventilation (19) par une cloison (20) imperméable aux microbes et perméable au gaz. Un évent ouvrable (21) est situé dans la première surface (11). L'évent (21) présente un rabat (22) lequel est coupé dans la première surface (11). Ce rabat (22) s'enroule en réponse à une température élevée exposant ainsi une ouverture (23) par laquelle le gaz stérilisant peut pénétrer dans la poche (10). Lorsque la température revient à un niveau ambiant, le rabat (22) s'aplatit et referme hermétiquement l'ouverture (23). Lors de l'utilisation, un dispositif médical à emballer est placé dans le compartiment (18) recevant le dispositif de la poche (10) et une bande déshydratante, si nécessaire, est placée dans la section d'aération (19), la poche (10) est alors scellée le long du bord (17) puis elle est stérilisée. Une pièce adhésive (non illustrée) peut ensuite être placée sur le rabat (22) pour constituer un joint étanche à l'eau. Etant donné que la poche (17) est étanche à l'eau après stérilisation, il n'est pas nécessaire de la stocker dans des conditions d'asepsie ou d'humidité régulées.
EP03710170A 2003-02-13 2003-02-13 Poche d'emballage d'un dispositif medical Withdrawn EP1592350A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IE2003/000021 WO2004071308A1 (fr) 2003-02-13 2003-02-13 Poche d'emballage d'un dispositif medical

Publications (1)

Publication Number Publication Date
EP1592350A1 true EP1592350A1 (fr) 2005-11-09

Family

ID=32865991

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03710170A Withdrawn EP1592350A1 (fr) 2003-02-13 2003-02-13 Poche d'emballage d'un dispositif medical

Country Status (4)

Country Link
EP (1) EP1592350A1 (fr)
AU (1) AU2003214590A1 (fr)
NO (1) NO20054230L (fr)
WO (1) WO2004071308A1 (fr)

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CA2560788A1 (fr) 2004-03-26 2005-10-06 Unomedical A/S Dispositif d'injection pour necessaire de perfusion
US8062250B2 (en) 2004-08-10 2011-11-22 Unomedical A/S Cannula device
ATE422852T1 (de) 2004-12-08 2009-03-15 Perfecseal Inc Sterilisierbares paket mit hoher sauerstoffbarriere
US7985199B2 (en) 2005-03-17 2011-07-26 Unomedical A/S Gateway system
ATE480278T1 (de) 2005-09-12 2010-09-15 Unomedical As Einfürungssystem für ein infusionsset mit einem ersten und zweiten federeinheit
CA2634335A1 (fr) 2005-12-23 2007-06-28 Unomedical A/S Appareil pour administration
KR20080104342A (ko) 2006-02-28 2008-12-02 우노메디컬 에이/에스 바늘 보호구를 구비하는 주입부와 주입부용 인서터
EP2023818A2 (fr) 2006-06-07 2009-02-18 Unomedical A/S Appareil à insérer
BRPI0712361A2 (pt) 2006-06-09 2012-06-19 Unomedical As suporte de montagem
MX2009001119A (es) 2006-08-02 2009-06-02 Unomedical As Canula y dispositivo de administracion.
EP1917990A1 (fr) 2006-10-31 2008-05-07 Unomedical A/S Ensemble de perfusion
DK2150195T3 (da) * 2007-06-06 2010-12-06 Unomedical As Emballage, der kan gassteriliseres
DE202008017390U1 (de) 2007-06-20 2009-08-13 Unomedical A/S Katheter und Vorrichtung zum Herstellen eines solchen Katheters
RU2010103450A (ru) 2007-07-03 2011-08-10 Уномедикал А/С (Dk) Устройство введения с бистабильными равновесными состояниями
CN101790394B (zh) 2007-07-10 2012-10-17 优诺医疗有限公司 具有两个弹簧的插入器
JP2010533524A (ja) 2007-07-18 2010-10-28 ウノメディカル アクティーゼルスカブ 枢動作用を持つ挿入デバイス
US7631760B2 (en) 2008-02-07 2009-12-15 Amcor Flexibles Healthcare, Inc. Dual compartment pouch
CA2713485A1 (fr) 2008-02-13 2009-08-20 Unomedical A/S Joint d'etancheite entre une partie canule et un trajet de fluide
AU2009216703A1 (en) 2008-02-20 2009-08-27 Unomedical A/S Insertion device with horizontally moving part
US9095324B2 (en) 2008-06-20 2015-08-04 Boston Scientific Scimed, Inc. Package assembly
BRPI0923489A2 (pt) 2008-12-22 2016-01-26 Unomedical As dispositivo médico compreendendo almofada adesiva
AU2010214150B2 (en) * 2009-02-13 2014-07-10 Mhm Ip Limited A sterilisation bag
CA2766475A1 (fr) 2009-07-30 2011-02-03 Unomedical A/S Dispositif introducteur avec partie mobile horizontale
CA2766961A1 (fr) 2009-08-07 2011-02-10 Unomedical A/S Dispositif d'administration avec capteur et une ou plusieurs canules
CN102844060A (zh) 2010-03-30 2012-12-26 犹诺医药有限公司 医疗装置
US8517174B2 (en) 2010-06-22 2013-08-27 Ethicon, Inc. Dispensing packages for medical devices having two components that are mechanically interlocked and methods therefor
US8235209B2 (en) 2010-08-11 2012-08-07 Boston Scientific Scimed, Inc. Medical device packaging and methods for preparing and packaging medical devices
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EP2436412A1 (fr) 2010-10-04 2012-04-04 Unomedical A/S Canule d'arroseur
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US11197689B2 (en) 2011-10-05 2021-12-14 Unomedical A/S Inserter for simultaneous insertion of multiple transcutaneous parts
EP2583715A1 (fr) 2011-10-19 2013-04-24 Unomedical A/S Système de tube de perfusion et procédé de fabrication
US9440051B2 (en) 2011-10-27 2016-09-13 Unomedical A/S Inserter for a multiplicity of subcutaneous parts
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Also Published As

Publication number Publication date
NO20054230L (no) 2005-09-12
AU2003214590A1 (en) 2004-09-06
WO2004071308A1 (fr) 2004-08-26

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