Flexible monolayer elastomer films and bag for medical use

• US 7,569,262 B2
• Filed: 01/31/2002
• Issued: 08/04/2009
• Est. Priority Date: 02/01/2001
• Status: Expired due to Term

• Current Assignee: Renolit AG (Jakob Mã¼Ller GmbH & Company KG)
• Original Assignee: Renolit AG (Jakob Mã¼Ller GmbH & Company KG)
• Inventors: Elcik, Robert, Gelfand, Daniel, Szabo, Emery
• Primary Examiner(s): Sample; David R
• Assistant Examiner(s): Wood; Ellen S
• Application Number:
  US10/470,691
• Publication Number:
  US 20040146671A1
• Time in Patent Office: 2,742 Days
• Field of Search: 428/35.7, 428/36.92, 525/222, 525/240, 604/408
• US Class Current: 428/35.2
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: B29C 67/24 characterised by the choice of material
• CPC Class Codes: C08J 2353/00 Characterised by the use of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives of such polymers
• CPC Class Codes: C08J 5/18 Manufacture of films or sheets
• CPC Class Codes: C08L 23/0815 Copolymers of ethene with aliphatic 1-olefins
• CPC Class Codes: C08L 23/0853 Vinylacetate
• CPC Class Codes: C08L 23/10 Homopolymers or copolymers of propene
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 2666/04 Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 2666/06 Homopolymers or copolymers of unsaturated hydrocarbons; Derivatives thereof
• CPC Class Codes: C08L 53/00 Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 53/02 of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: C08L 53/025 modified
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/31855 Of addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31909 Next to second addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31913 Monoolefin polymer

Abstract

Soft, flexible films suitable for human skin contact are required for disposable medical devices. Soft, flexible monolayer elastomer films have been developed that are suitable for human skin contact and provide improved low-temperature flexibility and improved strength to weight ratio over conventional polyvinyl chloride films for medical uses. Embodiments of the flexible monolayer elastomer film include styrene-ethylene-propylene-styrene block copolymers (SEPS), SEPS/polyolefin mixtures, SEPS/polyolefin/ethylene-vinyl acetate (EVA) copolymer mixtures, and EVA/polyolefin mixtures.

Claims

1. A flexible monolayer elastomer film consisting essentially of from about 55% to about 75% by weight of an ethylene-vinyl acetate copolymer and from about 25% to about 45% by weight of a metallocene catalyzed ethylene-octene copolymer, the film having a texture, the texture being substantially that of plasticized polyvinyl chloride, and wherein the film is essentially free of leachable material.

2. A flexible monolayer bag for storing medical products, wherein the bag is formed from the flexible monolayer elastomer film of claim 1.

3. The flexible monolayer elastomer film of claim 1, wherein the film has an oxygen transmission rate of from about 100 cm³/100 in²/24 hours to about 600 cm³/100 in²/24 hours, a carbon dioxide transmission rate of from about 1000 cm³/100 in²/24 hours to about 5000 cm³/100 in²/24 hours, and a water vapor transmission rate of from about 1.7 g/100 in²/24 hours to about 2.7 g/100 in²/24 hours;

for 0.006″

thick films.

4. The flexible monolayer elastomer film of claim 1, wherein the film has an oxygen transmission rate of from about 300 cm³/100 in²/24 hours to about 400 cm³/100 in²/24 hours and a carbon dioxide transmission rate of from about 2500 cm³/100 in²/24 hours to about 3500 cm³/100 in²/24 hours;

for 0.006″

thick films.

5. A flexible monolayer elastomer film consisting essentially of from about 55% to about 75% by weight of an ethylene-vinyl acetate copolymer, from about 25% to about 45% by weight of a metallocene catalyzed ethylene-octene copolymer, and optionally 5% to 20% by weight of one or more of a styrene-ethylene-propylene-styrene block copolymer, a syndiotactic polypropylene, a polypropylene homopolymer, a polypropylene copolymer, a metallocene catalyzed isotactic polypropylene, a low-density polyethylene, and a linear low-density polyethylene, the film having a texture, the texture being substantially that of plasticized polyvinyl chloride, and wherein the film is essentially free of leachable material.

6. A flexible monolayer bag for storing medical products, wherein the bag is formed from the flexible monolayer elastomer film of claim 5.

7. The flexible monolayer elastomer film of claim 5, wherein the film has an oxygen transmission rate of from about 100 cm³/100 in²/24 hours to about 600 cm³/100 in²/24 hours, a carbon dioxide transmission rate of from about 1000 cm³/100 in²/24 hours to about 5000 cm³/100 in²/24 hours, and a water vapor transmission rate of from about 1.7 g/100 in²/24 hours to about 2.7 g/100 in²/24 hours;

for 0.006″

thick films.

8. The flexible monolayer elastomer film of claim 5, wherein the film has an oxygen transmission rate of from about 300 cm³/100 in²/24 hours to about 400 cm³/100 in²/24 hours and a carbon dioxide transmission rate of from about 2500 cm³/100 in²/24 hours to about 3500 cm³/100 in²/24 hours;

for 0.006″

thick films.