US20050079093A1 - Sterilization wraps and methods for sterilizing articles - Google Patents

Sterilization wraps and methods for sterilizing articles Download PDF

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Publication number
US20050079093A1
US20050079093A1 US10/685,545 US68554503A US2005079093A1 US 20050079093 A1 US20050079093 A1 US 20050079093A1 US 68554503 A US68554503 A US 68554503A US 2005079093 A1 US2005079093 A1 US 2005079093A1
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US
United States
Prior art keywords
sheet
sterilization
article
set forth
wrap
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.)
Abandoned
Application number
US10/685,545
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English (en)
Inventor
Clay Cannady
Michael Duski
Brian Hoge
Greg Stecklein
James Whitaker
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Allegiance Corp
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Allegiance Corp
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 Allegiance Corp filed Critical Allegiance Corp
Priority to US10/685,545 priority Critical patent/US20050079093A1/en
Assigned to ALLEGIANCE CORPORATION reassignment ALLEGIANCE CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HOGE, BRIAN G., WHITAKER, JAMES F., DUSKIE, MICHAEL, STECKLEIN, GREG, CANNADY, CLAY
Priority to JP2006535637A priority patent/JP4738341B2/ja
Priority to NZ588688A priority patent/NZ588688A/en
Priority to CA2540333A priority patent/CA2540333C/en
Priority to AU2004281759A priority patent/AU2004281759B2/en
Priority to NZ588719A priority patent/NZ588719A/en
Priority to EP04795047.2A priority patent/EP1682189B1/de
Priority to NZ547116A priority patent/NZ547116A/en
Priority to NZ582009A priority patent/NZ582009A/en
Priority to EP14179915.5A priority patent/EP2845611B1/de
Priority to US10/966,354 priority patent/US7560082B2/en
Priority to NZ588766A priority patent/NZ588766A/en
Priority to MXPA06003980A priority patent/MXPA06003980A/es
Priority to PCT/US2004/033829 priority patent/WO2005037333A1/en
Priority to ES04795047.2T priority patent/ES2675351T3/es
Publication of US20050079093A1 publication Critical patent/US20050079093A1/en
Priority to US12/482,931 priority patent/US20090246079A1/en
Priority to US12/482,897 priority patent/US7906070B2/en
Priority to JP2010250745A priority patent/JP2011078795A/ja
Priority to US13/910,929 priority patent/US8821808B2/en
Priority to US14/472,004 priority patent/US20150147512A1/en
Abandoned 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • 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
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • 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
    • A61B50/3001—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for sharps
    • 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
    • A61B50/31—Carrying cases or bags, e.g. doctors' bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/05—Interconnection of layers the layers not being connected over the whole surface, e.g. discontinuous connection or patterned connection
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/04—Articles or materials wholly enclosed in single sheets or wrapper blanks
    • B65D75/06—Articles or materials wholly enclosed in single sheets or wrapper blanks in sheets or blanks initially folded to form tubes
    • B65D75/08—Articles or materials wholly enclosed in single sheets or wrapper blanks in sheets or blanks initially folded to form tubes with the ends of the tube closed by folding
    • 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
    • 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
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/03—3 layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B32B2250/242—All polymers belonging to those covered by group B32B27/32
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/02—Open containers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/19—Sheets or webs edge spliced or joined
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24942—Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31909—Next to second addition polymer from unsaturated monomers
    • Y10T428/31913—Monoolefin polymer

Definitions

  • This invention relates to sterilization wrap. More particularly, it relates to sterilization wrap utilizing two layers or sheets of material.
  • Reusable medical instruments must be sterilized prior to each use. Normally, these instruments are exposed to a sterilant to achieve sterilization.
  • steriliant is meant to refer to the sterilization effectors that are conventionally utilized with sterilization wrap, sterilization techniques, including but not limited to steam, ethylene-oxide, plasma, or the like.
  • sterilization wrap In order for the instruments to remain sterile after the sterilization procedure, the instruments must be wrapped in a material called sterilization wrap prior to the sterilization procedure.
  • the most common type of sterilization wrap is a three-ply laminate consisting of a layer of melt blown polypropylene sandwiched between two layers of spun bond polypropylene.
  • the wrap includes bond points all across the face of the material so that the material is held together, i.e., laminated.
  • This three-ply material is commonly referred to as “SMS”, which is short for spun bond-melt blown-spun bond.
  • SMS is sufficiently porous to permit steam, ethylene-oxide and other sterilization materials to penetrate through the material to the surgical instruments, but has filtration properties sufficient to prevent the passage of most pathogens therethrough so as to maintain sterility after the sterilization process.
  • the wrap also protects articles during sterilization, and acts as a filtration medium for the sterilant.
  • Kimberly-Clark Corporation has developed a product called “One Step® Sterilization Wrap.”
  • One Step® Sterilization Wrap is made by bonding two separate sheets of sterilization wrap together near two of the edges of the adjacent sheets.
  • the Kimberly-Clark One Step® product is described in U.S. Pat. Nos. 5,635,134 and 5,688,476.
  • FIG. 1 herein shows one of the Kimberly-Clark One Step® products described in these Kimberly-Clark patents.
  • Sterilization wrap 10 includes a top sheet 12 made of SMS and a bottom sheet 14 also made of SMS.
  • the lengths and widths of top sheet 12 and bottom sheet 14 are identical and the outside edges of each layer align with one another.
  • the two layers of SMS are bonded together near two opposing edges 16 and 18 , as illustrated by bond lines 20 and 22 .
  • the method of bonding the two sheets together may be ultrasonic bonding.
  • the other two opposing edges 24 and 26 are not bonded together so there is a visible gap 28 between sheets 12 and 14 so that the user of the sterilization wrap visually distinguishes the fact that there are, indeed, two sheets.
  • Simul-Wrap® which overcomes the problems of the Kimberly-Clark One Step® product described above.
  • the Simul-Wrap® product is made of two identical sheets of SMS sterilization material which are bonded together along all four edges.
  • the Cardinal Health Simul-Wrap® product is shown in U.S. Pat. No. 6,517,916.
  • both the One Step® product and the Simul-Wrap® product have certain drawbacks. Neither product is specifically engineered to wick moisture away from the article to be sterilized after sterilization takes place. In addition, neither product provides an indication that adequate sterilization has been achieved.
  • a sterilization wrap for wrapping an article to be sterilized.
  • At least one sheet, and preferably two sheets, of sterilization material and a sheet of absorbent material are provided.
  • the sheet of absorbent material is bonded to a sheet of sterilization material.
  • the sheet of absorbent material is adapted to receive the article to be sterilized.
  • the sheet of absorbent material (a) provides sterility protection for the article in addition to the sheet of sterilization material, and (b) wicks moisture away from the article after sterilization has taken place.
  • the sheet of absorbent material may be made of cellulose or other absorbent matter which is capable of being formed into a sheet or layer.
  • the sheet of absorbent material is smaller than the sheet of sterilization material.
  • one side of the sheet of sterilization material has a central portion and the sheet of absorbent material is bonded to the central portion of the sheet of sterilization material.
  • the sheet of sterilization material may be a different color from the sheet of absorbent material so that the user may readily differentiate between the two sheets and thus distinguish where to place the article being packaged.
  • the sheet of absorbent material is thicker or heavier than the sheet of sterilization material.
  • a chemical visual indicator which changes color in the presence of a sterilant, such as steam, may be attached to either sheet near the article to be sterilized to indicate whether or not the article has been exposed to adequate sterilization conditions.
  • a sterilization wrap for wrapping an article to be sterilized. At least one sheet, and preferably two sheets, of sterilization material, and a sheet of reinforcement material are provided.
  • the sheet of reinforcement material is bonded to a sheet of sterilization material.
  • the sheet of reinforcement material is adapted to receive the article to be sterilized.
  • the sheet of reinforcement material is preferably made of SMS and preferably has a higher basis weight than the sheet or either of the sheets of sterilization material.
  • a sterilization wrap for wrapping an article to be sterilized in which at least one sheet, and preferably two sheets bonded together at their outer peripheries, of sterilization material are provided.
  • the first sheet has an outer periphery and a central portion.
  • an additional sheet of reinforcement material that is bonded to the central portion of the first sheet of sterilization material.
  • the perimeter of the reinforcement sheet is smaller than the perimeter of the first sheet.
  • a sterilization wrap for wrapping an article to be sterilized, including at least one sheet of sterilization material and a sheet of absorbent material attached to the sheet of sterilization material.
  • the sheet of absorbent material is adapted to contact the article to be sterilized.
  • the sheet of absorbent material is also capable of wicking moisture away from the article after sterilization has taken place.
  • a sterilization wrap for wrapping an article to be sterilized, including at least one sheet, and preferably two sheets bonded together, of sterilization material, and a chemical visual indictor responsive to the presence of sterilant.
  • the chemical visual indicator will indicate whether the article has been exposed to adequate sterilization conditions.
  • methods for sterilizing an article including the steps of providing an article to be sterilized, and wrapping the article to be sterilized with the sterilization wraps described above, and applying sterilant to the wrapped article.
  • FIG. 1 is a perspective view of a prior art sterilization wrap
  • FIG. 2 is a perspective view of the sterilization wrap, in accordance with one embodiment of the subject invention.
  • FIG. 3 is a plan view of the sterilization wrap of FIG. 2 with an article to be sterilized received thereon;
  • FIG. 4 is a sectional view of the sterilization wrap of FIG. 2 taken through section line 4 - 4 .
  • FIG. 5 is a plan view of another embodiment of the sterilization wrap in accordance with the subject invention.
  • FIG. 6 is a sectional view of the sterilization wrap of FIG. 5 taken through section lines 6 - 6 .
  • FIG. 7 is a plan view of yet another embodiment of the sterilization wrap in accordance with the subject invention.
  • FIG. 8 is a sectional view of the sterilization wrap of FIG. 7 taken through section lines 8 - 8 .
  • FIG. 9 is a plan view of yet another embodiment of the sterilization wrap in accordance with the subject invention.
  • FIG. 10 is a sectional view of the sterilization wrap of FIG. 9 taken through section lines 10 - 10 .
  • FIG. 11 is a plan view of yet another embodiment of the sterilization wrap in accordance with the subject invention.
  • FIG. 12 is a sectional view of the sterilization wrap of FIG. 11 taken through section lines 12 - 12 .
  • sterilization wrap 30 having a first sheet or layer 32 and a second layer or sheet 34 .
  • the first layer 32 which is the outside layer, is made of SMS.
  • the first layer 32 is sometimes referred to herein as a sheet of sterilization material.
  • the second layer 34 which is the inside layer, may be made of cellulose or some other absorbent material, which absorbs liquids and aids in drying and which also permits a sterilant, such as steam or ethylene-oxide, to pass therethrough, but inhibits pathogens from passing therethrough.
  • absorbent materials could include, but are not limited to, absorbent synthetics such as hydrophillic spunmelt polyolefins, polyester, nylon, as well as polyrayons and bicomponent fibers.
  • the second layer 34 is sometimes referred to herein as a sheet of absorbent material.
  • the second or inside layer 34 has a smaller perimeter than the first or outside layer 32 . It is preferred that the perimeter of the inside layer 34 be at least 25% less than the outside layer 32 .
  • the inside layer 34 receives the article to be sterilized 36 thereon.
  • the article to be sterilized is a tray containing surgical instruments.
  • inside layer 34 has a smaller perimeter than outside layer 32 , it should be large enough so that when the article to be sterilized 36 is wrapped by sterilization wrap 30 , both the bottom and sides of the article to be sterilized 36 is covered by inside layer 34 .
  • Outside layer 32 includes a central portion 38 .
  • Inside layer 34 is adhered to the central portion 38 by means of gluing, ultrasonic bonding or some other form of adherence. Glue spots 40 are illustrated in FIG. 4 .
  • inside layer 34 may be made of SMS which does not have the liquid absorbent properties of cellulose. The structure of inside layer 34 when it is made of SMS is discussed below in reference to FIG. 9 . In any event, this inside layer provides abuse resistance and containment properties over the prior art sterilization wrap described above.
  • the inner layer 34 may be made of a moisture absorbent material, such as cellulose, which provides an enhanced moisture absorption function.
  • a moisture absorbent material such as cellulose
  • the material for layer 34 By using an absorbent material, i.e., absorption material, as the material for layer 34 , this moisture tends to be wicked away from the article to be sterilized 36 and more effectively dried. Thus the chances of pathogen growth on or around the article to be sterilized is greatly reduced.
  • outer layer 32 be of a different color from inner layer 34 . Since inner layer 34 is always within the sterile field, this color differential will inform the sterile clinician that it is okay to touch any portion of the sterile field formed by the inside surface of outer layer 32 and inside layer 34 .
  • a sterilization chemical visual indicator 42 which may also be an integrator or emulator, be adhered to inside layer 34 or to the inside surface 41 of outside layer 32 in the vicinity of inside layer 34 .
  • the sterilization indicator could be of a chemistry which meets or exceeds the requirements of Class 1-Class 6 chemical indicators as defined by ISO-11140-1.
  • the sterilization indicator turns color in the presence of steam or ethylene-oxide or other sterilant and will remain at that color after sterilization has taken place. This informs the clinician that the article to be sterilized has, indeed, been exposed to adequate sterilization conditions at the time that the clinician opens the wrapped article.
  • Sterilization indicators are known and two such indicators are described in U.S. Pat. No. 4,514,361 issued to Hirsch and U.S. Pat. No. 2,889,799 issued to Korpman, which are hereby incorporated herein by reference.
  • Sterilization integrators are known and one such integrator is described in U.S. Pat. No. 4,448,548, which is hereby incorporated herein by reference.
  • the sterilization wrap described above can be manufactured using conventional equipment and techniques readily available to those skilled in the medical fabric field.
  • the sterilization wrap described above may be used as set forth below.
  • the article to be sterilized 36 as shown in FIG. 3 , is placed on the outside surface of inner layer 34 .
  • the article to be sterilized 36 is then wrapped utilizing standard sterilization wrapping techniques so that a portion of the inside layer 34 covers the bottom and sides of the article to be sterilized 36 , and a portion of the outside layer 32 also covers the top of the article to be sterilized 36 .
  • the wrapped package is then exposed to a sterilization process.
  • the wrapped package is subjected to sterilants, such as steam, ethylene-oxide or plasma, for a predetermined period of time so that substantially all of the pathogens which may be present on the article to be sterilized 36 are killed.
  • the package is then stored for usage.
  • the package is unwrapped by the clinician.
  • the sterile clinician will know it is all right to touch the sterile field formed by the inner layer 34 because the inner layer 34 and the outside layer 32 are different colors.
  • the clinician will then observe the status of sterilization indicator, integrator, or emulator 42 to determine whether or not the article 36 has been exposed to adequate sterilization conditions.
  • the article to be sterilized 36 may then be used.
  • the above-described improved sterilization wrap provides the two layers of protection and ease of use associated with Kimberly-Clark's One Step® and Cardinal Health's Simul-Wrap®, while having the added features of increased protection in the central area adjacent to the article to be sterilized and further providing an ability to wick moisture away from the article to be sterilized, particularly in the case of steam sterilization, and in addition, visually informs the clinician that the inside of the wrap is the sterile field and visually informs the clinician that the article has, indeed, been exposed to adequate sterilization conditions.
  • FIGS. 2 through 4 show absorbent layer 34 attached to a single sheet of sterilization material, it is preferred that two (2) layers of sterilization material are utilized.
  • two-layer sterilization wrap 44 is provided and includes outside layer 46 and inside layer 48 , each made of SMS.
  • the two layers 46 and 48 each have four edges 49 , 51 , 53 and 55 and are bonded together at the four edges about their outer peripheries 50 , preferably by heat and pressure.
  • the bonded two-layer sterilization material 44 may be the Simul-Wrap® product which is commercially available from Cardinal Health (1500 Waukegan Road, McGaw Park, Ill. 60085) and which is described in U.S. Pat. No. 6,517,916, the disclosure of which is hereby incorporated herein by reference.
  • Absorbent layer 52 which may be made of cellulose or another moisture absorbing substance, is bonded to the outside of inner layer 48 by gluing or another bonding technique, as illustrated by bond sites 54 .
  • layer 52 may be made of SMS as discussed in reference to FIGS. 2 and 9 .
  • a sterilization indicator device 56 is attached to absorbent layer 52 .
  • the absorbent layer 52 has been replaced with a reinforcement panel 58 made of SMS.
  • Panel 58 has an equal to or higher basis weight than either layer 46 or 48 .
  • the basis weight of panel 58 may range from 1.0 ounces per square yard (osy) to 3.0 osy.
  • the basis weight for each of layers 46 and 48 may range from 0.75 osy to 2.9 osy.
  • reinforcement panel 58 does not provide the moisture wicking function of absorption layer 52 , it provides additional protection for the article to be sterilized 36 as shown in FIG. 5 , which is to be placed on reinforcement panel 58 .
  • the embodiment shown in FIGS. 9 and 10 results in a more cost effective product than the use of two full sheets of SMS, but is equal functionally, since less material is used.
  • FIG. 9 also shows a sterilization indicator 56 having been placed on the outside surface of inner panel 48 .
  • FIGS. 11 and 12 represents a combination of the embodiments of FIGS. 7 and 9 . That is, reinforcement panel 58 is attached to inside SMS layer 48 . Absorbent layer 52 is, in turn, attached to reinforcement layer 58 . Chemical visual indicator 56 is attached to absorbent layer 52 . Alternatively, indicator 56 may be attached to reinforcement layer 58 or to inside layer 48 . In addition, in the embodiment of FIGS. 11 and 12 , outside SMS layer could be eliminated.

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US10/685,545 2003-10-14 2003-10-14 Sterilization wraps and methods for sterilizing articles Abandoned US20050079093A1 (en)

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Application Number Priority Date Filing Date Title
US10/685,545 US20050079093A1 (en) 2003-10-14 2003-10-14 Sterilization wraps and methods for sterilizing articles
ES04795047.2T ES2675351T3 (es) 2003-10-14 2004-10-13 Envoltorios de esterilización
US10/966,354 US7560082B2 (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
MXPA06003980A MXPA06003980A (es) 2003-10-14 2004-10-13 Cubiertas de esterilizacion y metodos para esterilizar articulos.
CA2540333A CA2540333C (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
AU2004281759A AU2004281759B2 (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
NZ588719A NZ588719A (en) 2003-10-14 2004-10-13 Sterilization wrap with an additional panel of absorbent material attached to the panel of sterilization material
EP04795047.2A EP1682189B1 (de) 2003-10-14 2004-10-13 Sterilisationswickel
NZ547116A NZ547116A (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
NZ582009A NZ582009A (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
EP14179915.5A EP2845611B1 (de) 2003-10-14 2004-10-13 Sterilisationswickel und Verfahren zur Sterilisation von Gegenständen
JP2006535637A JP4738341B2 (ja) 2003-10-14 2004-10-13 物品を殺菌するための殺菌ラップ及び方法
NZ588766A NZ588766A (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles where the wrap has a visual chemical indicator which is visible when the wrap is opened
NZ588688A NZ588688A (en) 2003-10-14 2004-10-13 Multi layer sterilization wrap with the corners of the additional panel attached to the edges of the first panel of sterilzation material
PCT/US2004/033829 WO2005037333A1 (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
US12/482,897 US7906070B2 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
US12/482,931 US20090246079A1 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
JP2010250745A JP2011078795A (ja) 2003-10-14 2010-11-09 物品を殺菌するための殺菌ラップ及び方法
US13/910,929 US8821808B2 (en) 2003-10-14 2013-06-05 Sterilization wraps and methods for sterilizing articles
US14/472,004 US20150147512A1 (en) 2003-10-14 2014-08-28 Sterilization wraps and methods for sterilizing articles

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US13/910,929 Continuation US8821808B2 (en) 2003-10-14 2013-06-05 Sterilization wraps and methods for sterilizing articles

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US10/966,354 Expired - Lifetime US7560082B2 (en) 2003-10-14 2004-10-13 Sterilization wraps and methods for sterilizing articles
US12/482,931 Abandoned US20090246079A1 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
US12/482,897 Expired - Lifetime US7906070B2 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
US13/910,929 Expired - Lifetime US8821808B2 (en) 2003-10-14 2013-06-05 Sterilization wraps and methods for sterilizing articles
US14/472,004 Abandoned US20150147512A1 (en) 2003-10-14 2014-08-28 Sterilization wraps and methods for sterilizing articles

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US12/482,931 Abandoned US20090246079A1 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
US12/482,897 Expired - Lifetime US7906070B2 (en) 2003-10-14 2009-06-11 Sterilization wraps and methods for sterilizing articles
US13/910,929 Expired - Lifetime US8821808B2 (en) 2003-10-14 2013-06-05 Sterilization wraps and methods for sterilizing articles
US14/472,004 Abandoned US20150147512A1 (en) 2003-10-14 2014-08-28 Sterilization wraps and methods for sterilizing articles

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US (6) US20050079093A1 (de)
EP (2) EP2845611B1 (de)
JP (2) JP4738341B2 (de)
AU (1) AU2004281759B2 (de)
CA (1) CA2540333C (de)
ES (1) ES2675351T3 (de)
MX (1) MXPA06003980A (de)
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EP1682189A1 (de) 2006-07-26
US7560082B2 (en) 2009-07-14
EP1682189B1 (de) 2018-05-09
NZ588766A (en) 2012-02-24
EP2845611B1 (de) 2020-03-11
WO2005037333A1 (en) 2005-04-28
JP4738341B2 (ja) 2011-08-03
NZ588719A (en) 2012-04-27
US20090257913A1 (en) 2009-10-15
MXPA06003980A (es) 2006-06-27
NZ588688A (en) 2012-04-27
US20090246079A1 (en) 2009-10-01
US8821808B2 (en) 2014-09-02
NZ582009A (en) 2011-07-29
JP2007508120A (ja) 2007-04-05
CA2540333C (en) 2011-12-06
EP2845611A1 (de) 2015-03-11
US20050163654A1 (en) 2005-07-28
JP2011078795A (ja) 2011-04-21
US7906070B2 (en) 2011-03-15
US20150147512A1 (en) 2015-05-28
US20130340394A1 (en) 2013-12-26
ES2675351T3 (es) 2018-07-10
NZ547116A (en) 2010-07-30
AU2004281759A1 (en) 2005-04-28
AU2004281759B2 (en) 2010-12-09
CA2540333A1 (en) 2005-04-28

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