FILMS HAVING A DESICCANT MATERIAL INCORPORATED THEREIN AND METHODS OF USE AND MANUFACTURE

• US 20070160789A1
• Filed: 08/01/2006
• Published: 07/12/2007
• Est. Priority Date: 06/20/2002
• Status: Active Grant

• Current Assignee: Alcan Packaging Flexible France
• Original Assignee: Alcan Packaging Flexible France
• Inventors: Murray, Lee, Merical, Rick, Sikorsky, James
• Granted Patent: US 8,003,179 B2
• Time in Patent Office: Days
• US Class Current: 428/35.700
• 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 moisture sensitive drug eluting stent and

a desiccant package comprising a multilayer film comprising;

a first heat seal layer;

a first desiccant layer;

a first barrier layer; and

a first laminating layer,

wherein the drug eluting stent is inside the desiccant package.

2. The system of claim 1 wherein the relative humidity within the desiccant package is approximately more than 50% at a first time and wherein the relative humidity within the desiccant package is less than approximately 20% approximately 36 hours after the first time.

3. The system of claim 2 wherein after approximately 36 hours after the first time the relative humidity within the 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 multilayer film comprises a second desiccant layer.

6. The system of claim 5 wherein said the first desiccant layer comprises approximately 20-40% by weight desiccant and approximately 60-80% by weight polymeric material and the second desiccant layer comprises approximately 20-40% by weight desiccant and approximately 60-80% 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 5 wherein the first desiccant layer comprises a molecular sieve desiccant and the second desiccant layer comprises a chemical desiccant.

9. The system of claim 1 wherein said first polymeric layer comprises one or more materials selected from the following group consisting of:

high density polyethylene (HDPE), polyvinylchloride (PVC), cyclo-olefin copolymer (COC), or a blend of COC and HDPE

10. A medical system comprising:

a stent and

a package comprising a first multilayer film structure and a second multilayer film structure,

wherein the first multilayer film structure comprises

a first polymeric layer;

a first desiccant layer; and

a first barrier layer, and

wherein the second multilayer film structure comprises

a first polymeric layer;

a first desiccant layer; and

a first barrier layer,

wherein the drug eluting stent is inside the desiccant package, and

wherein a portion of the first multilayer film structure is heat sealed to a portion of the second multilayer film structure.

11. The system of claim 10 wherein,

the first multilayer film structure further comprises a second desiccant layer.

12. The system of claim 10 wherein,

the relative humidity within the system is at least approximately 50% at a first time and wherein the relative humidity within the package is less than approximately 20% approximately 36 hours after the first time.

13. A method of increasing the sterilization of a product, the method comprising:

a) exposing a package in an open configuration and exposing the product while it is in the package in the open configuration to an atmosphere with a relative humidity of at least approximately 30% and a temperature of at least approximately 110 degrees Fahrenheit and wherein the atmosphere comprises ethylene oxide gas;

b) removing a substantial majority of the ethylene oxide gas from the atmosphere;

c) closing the package;

wherein the package comprises a multilayer film comprising;

a first polymeric layer;

a first desiccant layer; and

a first barrier layer.

14. The method of claim 13 wherein the product is a moisture sensitive stent selected from the group consisting of:

drug eluting stents, cardiovascular stents, or surgical stents.

15. The method of claim 13 wherein the package further comprises a vacuum vent.

16. The method of claim 13 wherein the multilayer film further comprises a second desiccant layer.

17. The method of claim 13 wherein the relative humidity of the atmosphere is at least approximately 60%.

18. The method of claim 17 wherein the temperature of the atmosphere is approximately 125 degrees Fahrenheit.

19. The method of claim 13 wherein the first desiccant layer comprises calcium oxide.

20. The method of claim 19 wherein the first desiccant layer further comprises an extrudable olefin.

21. The method of claim 16 wherein the first desiccant layer comprises a molecular sieve desiccant and wherein the second desiccant layer comprises a chemical desiccant.

22. A method of packaging a moisture-sensitive product in a humid environment comprising:

a) exposing an open package containing the product to the humid environment, the package comprising;

a multilayer film comprising;

a first heat seal layer;

a first desiccant layer;

a second desiccant layer;

a first barrier layer; and

a first laminating layer; and

b) closing the open package such that gas is present in the package after it is closed, wherein the relative humidity of the gas in the package is less than approximately 20% approximately 36 hours after the package has been closed.

23. The method of claim 22 wherein the humid environment has a relative humidity of at least approximately 50% and wherein the first desiccant layer comprises a molecular sieve desiccant and the second desiccant layer comprises a chemical desiccant.