US3755042A - Sterile packaging method for surgical devices - Google Patents

Sterile packaging method for surgical devices Download PDF

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Publication number
US3755042A
US3755042A US00180798A US3755042DA US3755042A US 3755042 A US3755042 A US 3755042A US 00180798 A US00180798 A US 00180798A US 3755042D A US3755042D A US 3755042DA US 3755042 A US3755042 A US 3755042A
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US
United States
Prior art keywords
sheet
package
cavity
heat
teflon fep
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.)
Expired - Lifetime
Application number
US00180798A
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English (en)
Inventor
G Robertson
L Breasbois
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.)
Dow Silicones Corp
Original Assignee
Dow Corning Corp
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Filing date
Publication date
Application filed by Dow Corning Corp filed Critical Dow Corning Corp
Application granted granted Critical
Publication of US3755042A publication Critical patent/US3755042A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses

Definitions

  • ABSTRACT Method of sterile packaging of a surgical device coinprising heat forming a sheet of Teflon FEP to form a blister having. shape and dimensions of the device, placing the device in the blister, covering it with a second sheet of Teflon FEP, heat sealing the edges of the package and dry heat sterilizing the packaged device.
  • This invention relates to the packaging of surgical devices, and more particularly relates to methods of packaging such devices to maintain the devices sterile until used.
  • a method of sterile packaging in which sterilization is accomplished in the final package and the package remains sealed, thereby retaining sterility, until the package is opened for use.
  • Teflon FEP fluorocarbon film a copolymer of tetrafluoroethylene and hexafluoropropylene, is used to form a blister package which is heat sealed around its edges after placement of the device to be packaged into the blister.
  • the closed package is then subjected to heat at a minimum of about 250 F. and a maximum of about other objects and advantages thereof will become'apparent to those skilled in the art from a consideration of the following detailed description when read in conjunction with the accompanying drawings wherein:
  • FIG. 1 is. a topview showing a mammary prosthesis packaged in accordance with the present invention.
  • FIG. 2 is a s ideview partially in cross-section of the embodiment shown in FIG. 1.
  • the prosthesis 11 is a surgically implantable body of silicone gel enclosed in a silicone rubber envelope having tissue ingrowth means 12 such as open mesh fabric or felt affixed to the rear portion thereof.
  • the prosthesis 11 is packaged in a blister package comprising a first sheet 13 of Teflon FEP having a cavity formed therein approximating the exterior dimensions of the prosthesis 1 l and a second sheet 14 of Teflon FEP which forms the closure of the cavity in the first sheet 13.
  • the two sheets are bonded together and sealed by a heat seal 15 around the entire periphery of the package.
  • Teflon FEP is a copolymer of tetrafluoroethylene and hexafluoroethylene available from E.I. Du Pont De Nemours & Co., Wilmington, Delaware. The material has a melting point of 500-535 F., a tensile strength of about 3,000 p.s.i., tensile elongation of about 300 percent, and tensile modulus of about 70,000 p.s.i. Other physical and thermal properties are described in Du Pont Technical Information Bulletin T-2B concerning Du Pont Teflon FEP Fluorocarbon Film and chemical propertiesare described in a similarly identified publication number T-3B.
  • the cavity for the prosthesis I1 is preferably formed in a sheet of Teflon FEP fluorocarbon film which is of 10 mil thickness.
  • the cavity is preferably formed by vacuum forming techniques using'a mold preheated between 200 F. and 300 F. and heating the film to 475 to 490 F. before vacuum drawing into the female mold. Pressure thermoforming techniques can also be used to mold the cavity.
  • the prosthesis 1 l is placed in the cavity and the second sheet 14 is placed over the cavity opening.
  • the second sheet is preferably a sheet of Teflon FEP fluorocarbon film which is of 5 mil thickness.
  • the two sheets 13 and 14 are then fused together around their periphery by means of a heated bar or other known heat sealing means to completely seal the prosthesis in the cavity.
  • the heat scaling is accomplished by heating the material to its melting point while the two sheets are held in contact.
  • the hot bar in .the preferred embodiment is of inch width and is heated to approximately 625 F.
  • the necessary dwell time is shortened by placing the heated baragainst the thinner sheet, or alternatively, double heated bars can be used to further shorten the necessary dwell time.
  • the package After the package has been sealed it is placed in an oven heated to at least 250? F. and not greater than about 490 F. (because melting of the package can occur) for sufficient time to sterilize the package contents. Since necessary time is dependent upon the thickness of the package, the volume of the blister, and the termal conductivity and reflectivity of the surgical device contained therein, no specific limits can be placed on sterilization time. However, for the mammary prosthesis described herein the present preferred sterilization cycle is maintenance of temperature be tween 280 F. and 290 F. for 5 hours. Dry heat is preferred to steam for ease in handling, although steam can also be used.
  • the Teflon FEP is an effective sterilization barrier.
  • the specific method described above should be considered as illustrative only, and it should be realized that the mammary prosthesis was chosen only as an example of surgical devices which can be packaged in the manner described.
  • One variation of the method described which is useful in further minimizing contamination after the package has finally been opened for use is the wrapping of the device to be packaged in a thin sheet of material which is thermally stable at the sterilization temperatures to be used, before the device is placed in the cavity of the sheet 13.
  • the thin sheet can be, for example, a further sheet of Teflon FEP fluorocarbon film having 0.5 mil thickness, which drapes easily to conform to the shape of the device being packaged.
  • the thin sheet becomes sterile with the device and allows handling of the device in order to remove it from the package without touching the device itself.
  • a method of sterile packaging of medical devices which comprises in sequence:

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)
US00180798A 1971-09-15 1971-09-15 Sterile packaging method for surgical devices Expired - Lifetime US3755042A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US18079871A 1971-09-15 1971-09-15

Publications (1)

Publication Number Publication Date
US3755042A true US3755042A (en) 1973-08-28

Family

ID=22661800

Family Applications (1)

Application Number Title Priority Date Filing Date
US00180798A Expired - Lifetime US3755042A (en) 1971-09-15 1971-09-15 Sterile packaging method for surgical devices

Country Status (6)

Country Link
US (1) US3755042A (enrdf_load_stackoverflow)
JP (1) JPS4837991A (enrdf_load_stackoverflow)
BE (1) BE788822A (enrdf_load_stackoverflow)
DE (1) DE2244812A1 (enrdf_load_stackoverflow)
FR (1) FR2152971B1 (enrdf_load_stackoverflow)
GB (1) GB1330819A (enrdf_load_stackoverflow)

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3912823A (en) * 1973-02-23 1975-10-14 Du Pont Vacuum skin-package for cooking food
US4119450A (en) * 1975-04-04 1978-10-10 Carlo Bianco Method for making a sanitary product
US5316147A (en) * 1992-09-11 1994-05-31 Dr. Helbig GmbH & Co Orthopadische Produkte KG Case for receiving a breast prosthesis
US5379895A (en) * 1993-09-13 1995-01-10 Minnesota Mining And Manufacturing Company Package for surgical device
US5623810A (en) * 1996-03-29 1997-04-29 Ethicon, Inc. Method for making sterile suture packages
WO1998000184A1 (en) * 1996-07-03 1998-01-08 Ultrafem, Inc. Method and system for manufacturing elastomeric articles
US20050079307A1 (en) * 2002-04-25 2005-04-14 Honeywell International Inc. Blister package
US20060186005A1 (en) * 2005-02-24 2006-08-24 Sina Ebnesajjad Terminally sterilizing pharmaceutical package
WO2006119053A1 (en) * 2005-04-29 2006-11-09 E. I. Du Pont De Nemours And Company Disposable vessel for the containment of biological materials and corrosive reagents
US20070031477A1 (en) * 2003-03-26 2007-02-08 Lavipharm S.A. Methods and devices for holding a composition
US20090065122A1 (en) * 2007-09-10 2009-03-12 Hui-Mei Chen Fluid Enveloping Device and Method for Enveloping fluid with Thin Films
US7722671B1 (en) * 1998-01-27 2010-05-25 St. Jude Medical, Inc. Medical devices with associated growth factors
US20100133133A1 (en) * 2008-12-01 2010-06-03 Ideal Implant Incorporated Packaging for Sterile Implant
US20130091805A1 (en) * 2011-10-14 2013-04-18 Applied Silicone Corporation System and method for curing, sterilization and aseptic packaging of medical devices
US9517873B1 (en) 2012-09-28 2016-12-13 Air Liquide Electronics U.S. Lp Clean storage packaging article and method for making and using
WO2018162345A1 (en) * 2017-03-07 2018-09-13 Gc Aesthetics (Manufacturing) Limited Packaging and delivery device for a breast implant
WO2019175468A1 (en) * 2018-03-14 2019-09-19 Grainsense Oy Sample containers for use inside integrating cavities, and tools
EP3597176A1 (en) 2014-08-19 2020-01-22 The Regents Of The University Of California Implants for localized drug delivery and methods of use thereof
USD883655S1 (en) * 2013-05-31 2020-05-12 Maria Lotosky-Compton Medical pouch for endoscopic tools
US11173291B2 (en) 2020-03-20 2021-11-16 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11338119B2 (en) 2020-03-20 2022-05-24 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11344526B2 (en) 2020-03-20 2022-05-31 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11446131B2 (en) 2017-04-10 2022-09-20 Gc Aesthetics (Distribution) Limited Soft prosthetic implant comprising macro-texturisation and method of manufacturing
US11648394B2 (en) 2017-11-03 2023-05-16 The Regents Of The University Of California Methods of implanting a device into a brain
US12102523B2 (en) 2018-04-04 2024-10-01 Gc Aesthetics (Distribution) Limited Implant
US12318291B2 (en) * 2007-01-19 2025-06-03 Edwards Lifesciences Corporation Method for implanting a cardiovascular valve

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2335239A1 (fr) * 1975-12-15 1977-07-15 Sanderson Roger Procede et appareil de sterilisation, notamment d'instruments chirurgicaux
JPH0427905U (enrdf_load_stackoverflow) * 1989-12-28 1992-03-05

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2917878A (en) * 1958-11-13 1959-12-22 American Cyanamid Co Method of sterile packing
US3189702A (en) * 1962-08-15 1965-06-15 Minnesota Mining & Mfg Package and method of making
US3389749A (en) * 1964-06-15 1968-06-25 Edward J. Towns Process for molding fluorocarbon resin material to an article
US3481100A (en) * 1966-11-23 1969-12-02 Anderson Bros Mfg Co Method and apparatus for packaging in protective atmosphere
US3613879A (en) * 1969-08-19 1971-10-19 Philip Morris Inc Suture packaging
US3649409A (en) * 1969-07-01 1972-03-14 Du Pont Process for lining a plastic cylinder with another plastic
US3673760A (en) * 1970-10-26 1972-07-04 American Can Co Packaging method and apparatus

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4513920Y1 (enrdf_load_stackoverflow) * 1966-09-24 1970-06-12

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2917878A (en) * 1958-11-13 1959-12-22 American Cyanamid Co Method of sterile packing
US3189702A (en) * 1962-08-15 1965-06-15 Minnesota Mining & Mfg Package and method of making
US3389749A (en) * 1964-06-15 1968-06-25 Edward J. Towns Process for molding fluorocarbon resin material to an article
US3481100A (en) * 1966-11-23 1969-12-02 Anderson Bros Mfg Co Method and apparatus for packaging in protective atmosphere
US3649409A (en) * 1969-07-01 1972-03-14 Du Pont Process for lining a plastic cylinder with another plastic
US3613879A (en) * 1969-08-19 1971-10-19 Philip Morris Inc Suture packaging
US3673760A (en) * 1970-10-26 1972-07-04 American Can Co Packaging method and apparatus

Cited By (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3912823A (en) * 1973-02-23 1975-10-14 Du Pont Vacuum skin-package for cooking food
US4119450A (en) * 1975-04-04 1978-10-10 Carlo Bianco Method for making a sanitary product
US5316147A (en) * 1992-09-11 1994-05-31 Dr. Helbig GmbH & Co Orthopadische Produkte KG Case for receiving a breast prosthesis
US5379895A (en) * 1993-09-13 1995-01-10 Minnesota Mining And Manufacturing Company Package for surgical device
US5623810A (en) * 1996-03-29 1997-04-29 Ethicon, Inc. Method for making sterile suture packages
WO1998000184A1 (en) * 1996-07-03 1998-01-08 Ultrafem, Inc. Method and system for manufacturing elastomeric articles
US7722671B1 (en) * 1998-01-27 2010-05-25 St. Jude Medical, Inc. Medical devices with associated growth factors
US7337593B2 (en) * 2002-04-25 2008-03-04 Honeywell International Inc. Method of forming a blister package including a fluoropolymer layer
US20050079307A1 (en) * 2002-04-25 2005-04-14 Honeywell International Inc. Blister package
US20070031477A1 (en) * 2003-03-26 2007-02-08 Lavipharm S.A. Methods and devices for holding a composition
US20060186005A1 (en) * 2005-02-24 2006-08-24 Sina Ebnesajjad Terminally sterilizing pharmaceutical package
WO2006119053A1 (en) * 2005-04-29 2006-11-09 E. I. Du Pont De Nemours And Company Disposable vessel for the containment of biological materials and corrosive reagents
US12318291B2 (en) * 2007-01-19 2025-06-03 Edwards Lifesciences Corporation Method for implanting a cardiovascular valve
US20090065122A1 (en) * 2007-09-10 2009-03-12 Hui-Mei Chen Fluid Enveloping Device and Method for Enveloping fluid with Thin Films
US7887655B2 (en) * 2007-09-10 2011-02-15 Hui-Mei Chen Fluid enveloping device and method for enveloping fluid with thin films
US20100133133A1 (en) * 2008-12-01 2010-06-03 Ideal Implant Incorporated Packaging for Sterile Implant
US9084668B2 (en) * 2008-12-01 2015-07-21 Ideal Implant Incorporated Packaging for sterile implant
US20130091805A1 (en) * 2011-10-14 2013-04-18 Applied Silicone Corporation System and method for curing, sterilization and aseptic packaging of medical devices
EP2766052A4 (en) * 2011-10-14 2015-09-09 Applied Silicone Corp SYSTEM AND METHOD FOR CURING, STERILIZING AND CLEANING PACKAGING OF MEDICAL DEVICES
US10370170B1 (en) 2012-09-28 2019-08-06 Air Liquide Electronics U.S. Lp Clean storage packaging article and method for making and using
US9517873B1 (en) 2012-09-28 2016-12-13 Air Liquide Electronics U.S. Lp Clean storage packaging article and method for making and using
USD883655S1 (en) * 2013-05-31 2020-05-12 Maria Lotosky-Compton Medical pouch for endoscopic tools
US10912933B2 (en) 2014-08-19 2021-02-09 The Regents Of The University Of California Implants for localized drug delivery and methods of use thereof
EP3597176A1 (en) 2014-08-19 2020-01-22 The Regents Of The University Of California Implants for localized drug delivery and methods of use thereof
US11918770B2 (en) 2014-08-19 2024-03-05 The Regents Of The University Of California Implants for localized drug delivery and methods of use thereof
US11324935B2 (en) 2014-08-19 2022-05-10 The Regents Of The University Of California Implants for localized drug delivery and methods of use thereof
KR20190123320A (ko) * 2017-03-07 2019-10-31 지씨 에스테틱스 (매뉴팩처링) 리미티드 유방 주입물 용 패키징 및 전달 장치
WO2018162345A1 (en) * 2017-03-07 2018-09-13 Gc Aesthetics (Manufacturing) Limited Packaging and delivery device for a breast implant
RU2754387C2 (ru) * 2017-03-07 2021-09-01 ДжиСи ЭСТЕТИКС (МЭНЬЮФЭКЧУРИНГ) ЛИМИТЕД Упаковка для грудного импланта,упакованный грудной имплант и способ введения грудного импланта
US11583382B2 (en) 2017-03-07 2023-02-21 Gc Aesthetics (Distribution) Limited Packaging and delivery device for a breast implant
US11446131B2 (en) 2017-04-10 2022-09-20 Gc Aesthetics (Distribution) Limited Soft prosthetic implant comprising macro-texturisation and method of manufacturing
US12168123B2 (en) 2017-11-03 2024-12-17 The Regents Of The University Of California Methods of implanting a device into a brain
US11648394B2 (en) 2017-11-03 2023-05-16 The Regents Of The University Of California Methods of implanting a device into a brain
CN111867730A (zh) * 2018-03-14 2020-10-30 格兰森斯股份公司 在积分腔内使用的样品容器和工具
AU2019235471B2 (en) * 2018-03-14 2022-03-31 Grainsense Oy Sample containers for use inside integrating cavities, and tools
US11975331B2 (en) 2018-03-14 2024-05-07 Grainsense Oy Sample containers for use inside integrating cavities, and tools
RU2753446C1 (ru) * 2018-03-14 2021-08-16 Грейнсенс Ой Контейнеры для образцов для применения внутри интегрирующих камер и соответствующие приспособления
WO2019175468A1 (en) * 2018-03-14 2019-09-19 Grainsense Oy Sample containers for use inside integrating cavities, and tools
US12102523B2 (en) 2018-04-04 2024-10-01 Gc Aesthetics (Distribution) Limited Implant
US11344526B2 (en) 2020-03-20 2022-05-31 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11338119B2 (en) 2020-03-20 2022-05-24 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11173291B2 (en) 2020-03-20 2021-11-16 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery

Also Published As

Publication number Publication date
BE788822A (fr) 1973-03-14
GB1330819A (en) 1973-09-19
JPS4837991A (enrdf_load_stackoverflow) 1973-06-04
DE2244812A1 (de) 1973-03-22
FR2152971B1 (enrdf_load_stackoverflow) 1976-01-23
FR2152971A1 (enrdf_load_stackoverflow) 1973-04-27

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