Films having a desiccant material incorporated therein and methods of use and manufacture

• US 8,003,179 B2
• Filed: 08/01/2006
• Issued: 08/23/2011
• Est. Priority Date: 06/20/2002
• Status: Active Grant

• Current Assignee: Alcan Packaging Flexible France
• Original Assignee: Alcan Packaging Flexible France
• Inventors: Sikorsky, James, Murray, Lee, Merical, Rick
• Primary Examiner(s): Ruthkosky; Mark
• Assistant Examiner(s): Kashnikow; Erik
• Application Number:
  US11/461,680
• Publication Number:
  US 20070160789A1
• Time in Patent Office: 1,848 Days
• Field of Search: 428/35.7, 428/35.2, 428/35.3, 428/35.8, 428/35.9, 428/458, 428/461, 428/469, 428/475.5, 428/476.1, 428/483, 428/515, 428/35.4, 206/204, 206/363, 534/00, 534/25, 534/34
• US Class Current: 428/35.9
• 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: B32B 15/08 of synthetic resin
• CPC Class Codes: B32B 2264/10 Inorganic particles
• CPC Class Codes: B32B 2264/102 Oxide or hydroxide
• CPC Class Codes: B32B 2264/104 Oxysalt, e.g. carbonate, sulfate, phosphate or nitrate particles
• CPC Class Codes: B32B 2264/12 Mixture of at least two particles made of different materials
• CPC Class Codes: B32B 2307/31 Heat sealable
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2307/728 Hydrophilic
• CPC Class Codes: B32B 2439/40 Closed containers
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/06 as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a layer of a particular substance B32B9/045; next to a bituminous or tarry layer B32B11/046; next to a water setting substance layer B32B13/12; next to a metal layer B32B15/08; next to a glass layer B32B17/10; next to a layer formed of natural mineral fibres or particles B32B19/045; next to a wood layer B32B21/08; next to a cellulosic plastic layer B32B23/08; next to a natural or synthetic rubber layer B32B25/08
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/304 comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
• CPC Class Codes: B32B 27/306 comprising vinyl acetate or vinyl alcohol (co)polymers
• CPC Class Codes: B32B 27/308 comprising acrylic (co)polymers
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 7/02 Physical, chemical or physicochemical properties
• CPC Class Codes: B32B 7/06 permitting easy separation
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1345 : Single layer [continuous layer]
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1359 : Three or more layers [continuous layer]
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]

Abstract

Film structures, packages, films and methods of making the same are provided wherein the film structures have a desiccant material incorporated into at least one layer of the film structures and further wherein the film structures can comprise a material for making a peelable seal when the film structures are heat sealed to other film structures. The film structures are utilized for a package to hold a product that may be sensitive to the presence of moisture. The product may preferably be pharmaceutical products, nutraceutical products, or devices such as absorbable sutures or medical stents, although any moisture-sensitive product is contemplated by the present invention.

Claims

1. A medical system comprising:

a desiccant package comprising a multilayer film comprising;

a first moisture barrier layer;

a first product contact layer comprising a material selected from the group consisting of polyvinylchloride, cyclo-olefin copolymer, high density polyethylene or a blend of cyclo-olefin copolymer and high density polyethylene; and

a first desiccant layer disposed between the first moisture barrier layer and the first product contact layer;

wherein when the medical system is subjected for at least about one hour at a temperature of at least 110°

Fahrenheit to an atmosphere comprising ethylene oxide and having a relative humidity of at least 30%, the first product contact layer allows the desiccant layer to survive the sterilization while retaining moisture scavenging efficacy of the desiccant layer, while allowing moisture to diffuse from the interior of the package and through the product contact layer after the package is sealed following ethylene oxide sterilization to lower the relative humidity of the interior of the package after the package is sealed and protect any product contained by the package from degradation by moisture present in the interior of the package while the sealed package is in storage, and

wherein the first desiccant layer comprises a chemical desiccant comprising one or more materials selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide and aluminum oxide, and

wherein regardless of the amount of humidity in the interior of the package when the package is sealed following subjection to ethylene oxide sterilization, the relative humidity in the interior of the package is less than approximately 20% within a time period of less than approximately 36 hours after the desiccant package is sealed.

2. The system of claim 1 wherein when the first desiccant layer has the capacity to alter the relative humidity in the interior of the package after the package is sealed from approximately more than 50% when the desiccant package is sealed, to less than approximately 10% within a time period of less than approximately 36 hours after the desiccant package was sealed.

3. The system of claim 1 wherein after approximately 36 hours after the desiccant package was sealed the relative humidity within the sealed desiccant package remains less than approximately 20% for at least approximately 12 months.

4. The system of claim 1 wherein the first desiccant layer comprises approximately 20-40% by weight desiccant and approximately 60-80% by weight polymeric material.

5. The system of claim 1 wherein the first desiccant layer further comprises a molecular sieve desiccant.

6. The system of claim 5 wherein said the first desiccant layer comprises approximately 5-35% by weight chemical desiccant, approximately 5-35% by weight molecular sieve desiccant, and approximately 30-90% by weight polymeric material.

7. The system of claim 1 wherein the first desiccant layer comprises calcium oxide blended with an extrudable olefin.

8. The system of claim 1 wherein said first product contact layer comprises high density polyethylene (HDPE).

9. A medical system comprising:

a package comprising a first multilayer film structure and a second multilayer film structure wherein the package is formed by sealing the first multilayer film structure to the second multilayer film structure around the edges of the first and second multilayer film structures,

wherein the first multilayer film structure comprises

a first polymeric layer comprising a material selected from the group consisting of polyvinylchloride, cyclo-olefin copolymer, high density polyethylene or a blend of cyclo-olefin copolymer and high density polyethylene;

a first moisture barrier layer, and

a first desiccant layer disposed between the first moisture barrier layer and the first polymeric layer, the first desiccant layer comprising a chemical desiccant comprising one or more materials selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide and aluminum oxide; and

wherein the second multilayer film structure comprises

a second polymeric layer comprising a material selected from the group consisting of polyvinylchloride, cyclo-olefin copolymer, high density polyethylene or a blend of cyclo-olefin copolymer and high density polyethylene;

a second moisture barrier layer, and

a second desiccant layer comprising a chemical desiccant, the second desiccant layer disposed between the second moisture barrier layer and the second polymeric layer;

wherein when the medical system is subjected to ethylene oxide sterilization conditions comprising an atmosphere comprising ethylene oxide and having a relative humidity of at least 30% at a temperature of at least 110°

Fahrenheit for at least about one hour, the first polymeric layer allows the desiccant layer to survive the sterilization while retaining moisture scavenging efficacy of the desiccant layer, and allowing moisture to diffuse from the interior of the package and through the first polymeric layer after the package is sealed following ethylene oxide sterilization to lower the relative humidity of the interior of the package after the package is sealed and protect any product contained by the package from degradation by moisture present in the interior of the package while the sealed package is in storage, and

wherein regardless of the amount of humidity within the package when the desiccant package is sealed following subjection to ethylene oxide sterilization, the relative humidity within the sealed package is less than approximately 20% approximately 36 hours after the desiccant package is sealed.

10. The system of claim 9 wherein, the first multilayer film structure further comprises a second desiccant layer.

11. The system of claim 9 wherein,

when the relative humidity within the system is at least approximately 50% when the desiccant package is sealed following subjection to ethylene oxide sterilization, the relative humidity within the sealed package is less than approximately 10% approximately 36 hours after the desiccant package was sealed.