Stock material or miscellaneous articles – Hollow or container type article – Polymer or resin containing
Reexamination Certificate
2001-12-19
2004-08-03
Nolan, Sandra M. (Department: 1772)
Stock material or miscellaneous articles
Hollow or container type article
Polymer or resin containing
C428S036700, C428S036800, C428S447000
Reexamination Certificate
active
06770342
ABSTRACT:
BACKGROUND
The present invention relates to a gas- and odour-barrier multi-layer film with good properties of noiselessness as well as of softness and flexibility, and to the flexible containers intended for human drainage in medical applications made therewith.
For certain medical applications, containers, such as bags or pouches, are required for use in contact with the skin, under the patient's garments, for collecting excretion products from patients whose excretive apparatus has been deviated or reconstructed surgically following traumatic or pathological events. These containers or bags are generally referred to as “ostomy” pouches.
Films suitable for such a specific end use should meet a number of requirements: they must be gas- and odour-barrier; have mechanical properties that afford a good degree of protection against wear, abrasion and puncturing; possess quietness features that render the sound emission, particularly when the patients moves around, almost impossible to be perceived by a human ear; and softness and “feel” features that make them suited to applications involving compatibility with human skin. Furthermore they should be sealable, e.g. heat or RF sealable, so that no leakage, even minimal, occurs at the seal, and easily processable without giving any sticking problem.
Currently available from a number of manufacturers are excretion product collecting containers which meet some of the requirements set forth above.
In particular commercially available ostomy pouches, such as those with a PVDC gas- and odour-barrier core layer and outer layers of e.g. ethylene-vinyl acetate copolymers, typically have good mechanical and gas- and odour-barrier properties, good sealability and easily processable while they are generally poor in noiselessness and softness so that the patient is never allowed to at least occasionally “forget” his/her disabled condition, with obvious disturbing consequences of a psychological nature.
U.S. Pat. No. 5,043,205 describes a method to improve the softness and noiselessness of films for medical use by employing ethylene-butyl acrylate copolymers or blends of ethylene-butyl acrylate copolymers with an elastomeric polyolefin for the skin layers thereof.
BE-A-899,649 also describes films particularly suitable for use in ostomy applications wherein the outer skin layers comprise a mixture of ethylene-vinyl acetate copolymer, an elastomeric copolymer of ethylene and propylene and a hydrocarbon processing aid.
In these cases the improvement in softness and noiselessness is remarkable but the film is difficult to process and owing to the low Vicat temperature of the elastomer contained in the outer skin layers, it may easily stick to itself when wound up.
It has now been found that it is possible to obtain a film having high mechanical and gas- and odour-barrier properties, good sealability, good processability, and remarkable softness and noiselessness features, that can suitable be employed for ostomy applications, by providing a multi-layer film comprising a gas- and odour-barrier layer and at least an exterior layer comprising a blend of ethylene-vinyl acetate copolymer, ethylene-alkyl(meth)acrylate copolymer and at least 1% by weight of a silicone elastomer.
SUMMARY OF THE INVENTION
The first object of the present invention is a multi-layer gas- and odour-barrier film comprising a gas- and odour-barrier layer a) and at least one outer layer b) comprising a blend of an ethylene-vinyl acetate copolymer, an ethylene-alkyl-acrylate or alkyl-methacrylate copolymer and from about 1 to about 15% by weight calculated on the overall weight of the blend of a silicone elastomer.
A second object of the present invention is a bag or container intended in particular for human draining and collecting excretion products from patients having a deviated reconstructed excretive apparatus made with the film of the first object.
REFERENCES:
patent: 4535113 (1985-08-01), Foster et al.
patent: 4687711 (1987-08-01), Vietto et al.
patent: 5043205 (1991-08-01), Perazzo et al.
patent: 5091453 (1992-02-01), Davidson et al.
Lagaly Thomas C.
Nolan Sandra M.
Sealed Air Corporation
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