Stock material or miscellaneous articles – Hollow or container type article – Polymer or resin containing
Reexamination Certificate
2000-02-29
2004-03-23
Kelly, Cynthia H. (Department: 1774)
Stock material or miscellaneous articles
Hollow or container type article
Polymer or resin containing
C428S216000, C002S168000
Reexamination Certificate
active
06709725
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to elastomeric articles which exhibit enhanced lubricity with respect to both dry and damp surfaces and in particular to flexible elastomeric articles such as films and gloves which are powder free and exhibit enhanced lubricity with respect to both dry and damp surfaces such as skin.
Elastomeric articles such as medical gloves are generally required to be tight fitting. This requirement makes donning the gloves difficult unless they are lubricated. It has been common practice to utilise powder lubricants such as modified corn starch or talc applied to the inner surface of medical gloves to facilitate donning. However, certain post-operative complications including adhesions, peritonitis and granuloma formation have been attributed to the use of loose powder as a lubricant on gloves and other items used in surgery.
Much effort has been devoted to developing medical gloves which may be readily donned but which do not utilise a powder lubricant. Approaches which have been tried include depositing a granular material on the inner surface of the gloves, bonding to the outer elastomeric layer an inner layer comprising embedded particles, halogenating the gloves and bonding a lubricating hydrogel polymer to the inner surface of the glove and treating the surface with a surfactant.
Although each of the above approaches has its merits, none provide a medical glove which may be as readily donned as a powdered glove, especially when the hands are damp or wet.
We have now found an elastomeric article comprising a coating which provides the article with enhanced lubricity with respect to both dry and wet or damp surfaces.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides an elastomeric article having a first layer of natural or synthetic rubber and at least one layer of a coating of a polymer blend comprising at least one film forming polymer and at least one wax.
In another aspect, the present invention also provides a process for making an elastomeric article comprising forming a first layer of natural or synthetic rubber followed by coating at least one surface of the first layer with a layer of a polymer blend comprising a film forming polymer and a wax.
DETAILED DESCRIPTION OF THE INVENTION
Preferred elastomeric articles according to the invention are medical gloves and the present invention is described primarily with reference to surgeons' gloves. However, the elastomeric articles of the invention may include other elastomeric articles and particularly elastomeric articles which may have contact with skin or other tissue. Such articles include: films, sheets, examination gloves used by doctors, veterinary practitioners, dentists, nurses and other personnel coming into contact with animals or animal fluids; finger stalls; condoms; catheters, ureters, and sheath type incontinence devices.
Suitable elastomers which may be used for the first or rubber layer of the elastomeric articles of the present invention include natural rubber latex, nitrile rubber latex, polychloroprene, styrene-butadiene rubber or a polyurethane. Preferably the first or rubber layer of the elastomeric article comprises natural latex rubber and more preferably, the first or rubber layer of the elastomeric article comprises natural latex rubber glove.
In the elastomeric article of the present invention, the film forming polymer component of the polymer blend coating may be selected from a range of film forming polymers including acrylic polymers and copolymers, methacrylate polymers and copolymers, polyurethane polymers and carboxylated styrene-butadiene copolymers.
Preferably the film forming polymer of the polymer blend is a polyurethane. Suitable polyurethanes include aliphatic polyurethanes and aromatic polyurethanes. Preferably the polyurethane is used in the form of an aqueous dispersion. Examples of suitable commercially available polyurethanes include, but are not limited to, BEETAFIN™ L9009, Witcobond™ W-506, and Neorez™ R-972.
In the elastomeric article of the present invention, the wax component is preferably a synthetic polymer or copolymer wax and more preferably a polyethylene wax, high density polyethylene wax, an oxidised or modified polyethylene wax or high density polyethylene wax or a mixture of such waxes. Preferably, the wax has a melting point equal to or above 80° C. and more preferably the wax is a polyethylene wax having a melting point equal to or above 80° C. Examples of suitable commercially available polyethylene waxes include, but are not limited to, AQUAMAT™ 213, MICHEM LUBE™ 61335 and AQUACER™ 502.
The polymer blend coating used in the present invention may also comprise conventional additives and modifiers including surfactants, antioxidants, antistatic agents, bactericidal or bacteriostatic agents and hardness modifiers. Suitable bactericidal and/or bacteriostatic agents may be selected from the known group of quaternary amine compounds. Suitable hardness modifiers may be selected from polymeric compounds including, but not limited to, poly(2-hydroxyethylmethacrylate), acrylic polymers and melamine-formaldehyde resins. Preferably, the hardness modifier is a polymer or copolymer having a glass transition temperature (Tg) higher than that of the film forming polymer.
In the elastomeric article of the present invention, the ratio of film forming polymer to wax in the polymer blend is preferably at least 0.5 to 1 and more preferably between 0.5 to 1 and 20 to 1.
Preferably the polymer blend is applied to the first layer of natural or synthetic rubber in the form of an aqueous dispersion or emulsion. For example, the film forming polymer and the wax are dispersed in water in the presence of one or more suitable surfactants. Suitable surfactants may be chosen from a range of commercially available non-ionic and anionic surfactants including for example, those sold under the trade marks DARVAN™ and SYNPERONIC™. Typically the aqueous dispersion of the polymer blend comprises 3 to 30% by weight solids and more preferably 5 to 20% by weight solids. The concentration of the surfactant(s) is preferably 0.01 to 0.10% (w/v), most preferably 0.02 to 0.05% (w/v).
The elastomeric articles of the present invention may be made by forming the first layer of natural or synthetic rubber and then applying to at least one surface of the first layer, a coating of a polymer blend comprising at least one film forming polymer and at least one wax.
Between formation of the first layer and coating with the polymer blend, the first layer of natural or synthetic rubber optionally may be heated until the layer is gelled or the surface of the first layer to be coated may be leached.
Optionally the surface of the first layer which is to be coated with the polymer blend may be treated to improve adhesion between the first layer and the polymer blend. Suitable methods for surface treatment of the first layer may include treatment with an oxidising agent such as an aqueous solution of an alkali metal or alkaline earth metal hypochlorite followed by leaching in water, preferably hot water. Alternatively, the surface of the first layer which is to be coated with the polymer blend may be treated with an agent, such as a dilute aqueous solution of aluminium sulfate or calcium nitrate, to promote deposition of the polymer blend onto the surface of the first layer.
For convenience, the process of the present invention may be illustrated by reference to surgeons' gloves. In such a process a conventional method for preparing latex rubber gloves, such as described in a bulletin “Dipping With Natural Rubber Latex” by the Malaysian Rubber Producers' Research Association, Hertford, England, 1980, is employed. For example, a former coated with a coagulant is first dipped into natural or synthetic latex. After withdrawal, the glove on the former is heated until the film is significantly gelled. The glove may then be subjected to leaching.
The polymer blend may then be applied to the first layer of natural or synthetic rubber by dipping the
Cacioli Paul
Husin Yunus
Kassim Adeli
Kwan Soo-Hwa
Lai Hee-Meng
Ansell Medical Sdn, Bhd.
Gardner & Carton & Douglas LLP
Kelly Cynthia H.
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