Double-sterile package for medical apparatus and method of making

• US 5,590,778 A
• Filed: 06/06/1995
• Issued: 01/07/1997
• Est. Priority Date: 06/06/1995
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Dutchik, Robert A.
• Primary Examiner(s): Gehman, Bryon P.
• Assistant Examiner(s): LUONG, SHIAN TINH NHAN
• Application Number:
  US08/470,851
• Time in Patent Office: 581 Days
• Field of Search: 206/438, 206/439, 206/370, 206/363, 206/570, 206/571, 206/484.1, 220/373, 220/374, 422/25, 422/34, 53/425, 53/426
• US Class Current: 206/439
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: B65D 77/04 Articles or materials enclosed in two or more containers disposed one within another
• CPC Class Codes: B65D 81/24 Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with thermal insulation B65D81/38

Abstract

A double-sterile package for critical-use medical apparatus includes an inner first container including an outer boundary wall impervious to microorganisms and being closed except for defining a hole. A patch of gas-permeable micro-porous sheet material is secured to the outer boundary wall spanning and closing the hole. The gas-permeable sheet material is sufficient to exclude environmental microorganisms from entering the inner first container. The first container is received into and nested within a conformal second container also having a boundary wall impervious to microorganisms and being closed except for defining a hole. This hole of the second container is also closed by a patch of the gas-permeable micro-porous sheet material, and the holes of the first and second containers are in gas-flow communication with one another. The medical apparatus within the nested containers is sterilized by evacuation of air and introduction of a sterilizing gas via the gas-permeable patches. Removal of the sterilizing gas provides a packaged sterile medical apparatus which may be transported, stored, and handled with no further need to additionally protect the sterility of the apparatus, or for further sterilization after the package is opened immediately prior to use of the apparatus.

Claims

1. A double-sterile package comprising:

an inner shape-retaining container including a boundary wall impervious to microorganisms and being closed except for defining a hole, said boundary wall bounding a package volume for receiving an article;

a patch of gas-permeable micro-porous sheet material sealingly secured to said boundary wall of said inner container, said patch spanning and closing said hole in said inner container boundary wall and being sufficient to exclude environmental microorganisms from entering said inner container;

a conformal shape-retaining outer container receiving and nesting with said inner container, said outer container also having a boundary wall impervious to microorganisms and being closed except for defining a respective hole;

a patch of gas-permeable micro-porous sheet material sealingly spanning and closing said hole of said outer container, said patch of micro-porous sheet material of said outer container also being sufficient to exclude environmental microorganisms from entering said outer container;

said holes of said first and second containers being in gas-flow communication with one another;

whereby a sterilizing gas may be introduced into said package volume via said holes and the gas flow communication therebetween through said gas-permeable patches of said inner and outer containers to sterilize said article, environmental microorganisms being excluded from said article after this sterilizing by said micro-porous patches to maintain sterility of said article.

2. The double-sterile package of claim 1 wherein said patch of gas-permeable micro-porous sheet material which is sealingly secured to said boundary wall of said inner container is free of heat sealing material and provides a permeability of substantially 20 seconds per 100 cubic centimeters per square inch.

3. The double-sterile package of claim 1 wherein said patch of gas-permeable micro-porous sheet material which is sealingly spanning and closing said hole of said outer container is free of heat sealing material and provides a permeability of substantially 20 seconds per 100 cubic centimeters per square inch.

4. The double-sterile package of claim 1 wherein said inner shape-retaining container includes a substantially rigid and shape-retaining tray-like member defining a recess therein, and a closure sheet spanning and closing said recess except for said hole which is defined by said closure sheet, said closure sheet and said tray-like member in said recess thereof cooperatively defining said package volume for receiving an article.

5. The double-sterile package of claim 4 wherein said substantially rigid and shape-retaining tray-like member of said inner shape-retaining container includes an outwardly extending planar flange portion circumscribing said recess, and said closure sheet sealingly engaging said flange portion to span and close said recess.

6. The double-sterile package of claim 4 wherein said closure sheet is impermeable except for said hole, and said closure sheet providing an area upon which printed matter is carried.

7. The double-sterile package of claim 1 wherein said conformal shape-retaining outer container includes a flexibly shape-retaining outer tray-like member receiving and nesting with said inner container.

8. The double-sterile package of claim 7 wherein said inner shape-retaining container includes a substantially rigid and shape-retaining tray-like member defining a recess therein, said tray-like member of said inner container defining an outwardly extending planar flange portion circumscribing said recess, and said closure sheet sealingly engaging said flange portion to span and close said recess, said flexibly shape-retaining outer tray-like member of said conformal shape-retaining outer container defining a stepped recess, a deeper recess portion of said stepped recess receiving a protruding portion of said inner substantially rigid and shape-retaining tray-like member, which protruding portion is complementary to said recess, and a shallower portion of said stepped recess receiving and nesting with said outwardly extending planar flange portion of said inner tray-like member.

9. The double-sterile package of claim 8 wherein said patch of gas-permeable micro-porous sheet material which is sealingly secured to said boundary wall of said inner container is congruent with said patch of gas-permeable micro-porous sheet material which is sealingly spanning and closing said hole of said outer container.

10. The double-sterile package of claim 8 wherein said flexibly shape-retaining outer tray-like member of said conformal shape-retaining outer container includes a lower wall portion downwardly closing said stepped recess, said lower wall portion of said conformal shape-retaining outer container including a plurality of downwardly extending protrusions cooperatively defining a fluid flow channel, whereby when two of said double-sterile packages are stacked one atop the other the package volume of the underlying one of said containers is ventilated via said channel.

11. The double-sterile package of claim 1 wherein said conformal shape-retaining outer container is sufficiently conformal with said inner container that no significant interstitial pocketed volume is defined within said outer container and outside of said inner container, whereby ventilation of gas to and from said package volume occurs via said gas flow communication between said holes but significant gas flow communication interstitially of said first and second containers is avoided.

12. A method of making a double-sterile package, said method comprising steps of:

providing an inner container having a boundary wall impervious to microorganisms and being closed except for defining a hole;

using said boundary wall of said inner container to define a volume for receiving an article;

providing a patch of gas-permeable micro-porous sheet material;

sealingly securing said patch of gas-permeable micro-porous material to said boundary wall of said inner container to span and close said hole in said inner container boundary wall;

insuring that said patch of gas-permeable micro-porous material is sufficient to exclude environmental microorganisms from entering said inner container via said hole;

providing an outer container receiving and nesting with said inner container, providing said outer container also with a respective boundary wall impervious to microorganisms and being closed except for defining a respective hole;

providing a respective patch of gas-permeable micro-porous sheet material;

sealingly securing said respective patch of gas-permeable micro-porous sheet material to said boundary wall of said outer container to span and close said respective hole of said outer container;

insuring that said patch of micro-porous sheet material of said outer container is also sufficient to exclude environmental microorganisms from entering said outer container;

providing gas flow communication between said holes of said first and second containers;

introducing a sterilizing gas into said volume via said holes and the gas flow communication therebetween through said gas-permeable patches of said inner and outer containers to sterilize said article; and

thereafter using said micro-porous patches to exclude environmental microorganisms from said article to maintain sterility of said article.