AU6139800A - An article of manufacture and a method of applying a protective glove - Google Patents

Description

WO 01/08541 PCT/AU00/00909 1 AN ARTICLE OF MANUFACTURE AND A METHOD OF APPLYING A PROTECTIVE GLOVE Technical Field The present invention relates to an article of manufacture and to a method of applying a protective glove. Background of the Invention Protective gloves such as medical gloves are used in many situations to protect hands from occupational hazards. In 1996, 20.8 billion medical gloves were imported into the US alone of which 90% were made of natural rubber latex and 10% nonlatex 0 synthetic. Side effects of using such gloves are prevalent including skin irritations and dry skin. When conducting operations in surgery and in particular for minimising health risks it is necessary for operating theatre personnel to prescrub hands and the lower arm prior Is to application of medical gloves. The typical scrub time for the first operation of the day is about five minutes. Subsequent scrubs may be shorter but must be sufficient to remove bacteria from the skin. Due to frequent washing with surgical skin cleansers and detergents over prolonged periods, it has been found that hands and arms tend to dry out, the presurgical scrub detergents typically removing natural greases and oils (sebum) such 2 as the cholesterol fraction from the body. The use of added moisturisers to the scrub detergent to rectify this problem has not been very effective. In addition the application of a sterile moisturising cream immediately before donning the gloves is not desirable due to the hands moving too freely within the glove, the hands being too slippery as the water phase has not had 25 sufficient time to evaporate. The direct application of a non-slippery anhydrous moisturiser (a cream base) is also undesirable as the cream base is thick and difficult to spread uniformly and areas of skin having a too thick layer of1 cream base applied are generally slippery within the surgical gloves. Without the use of such moisturisers or cream bases. medical gloves are generally difficult to apply resulting in loose glove material at the finger tips which is a hindrance in performing surgery. To overcome this problem, powdered gloves are known however such gloves are associated with latex allergy, and the dusting powders used can be rubbed off and become airborne in use. Cornstarch powders used have a propensity to bind natural latex proteins the powder becoming a means for the transport of natural latex 2> protein allergens. The use of powdered latex gloves is therefore being discontinued.

WO 01/08541 PCT/AU00/00909 2 In this regard health care workers are recognised as comprising a high-risk group for natural latex allergy. Studies of health care workers have demonstrated an appreciable prevalence of natural latex sensitisation as evidenced by natural latex-specific IgE antibodies and/or positive skin tests for natural latex allergy. Experimental studies report that powders such as cornstarch on medical gloves can damage tissue resistance to infection, enhance the development of infection, serve as a potential source of occupational asthma and other respiratory problems and provide a source of natural latex protein exposure to natural latex allergic individuals. Experimental and clinical data demonstrate that natural latex proteins are allergenic, natural latex proteins bind to in cornstarch, aerosolised powder on natural rubber latex gloves is allergenic and can cause respiratory allergic reactions. These published studies support the conclusion that airborne glove powder is a threat to individuals allergic to natural rubber latex and may represent an important agent for sensitizing non-allergic individuals. There is also limited published data and clinical experience that cornstarch powder on natural rubber latex 15is gloves may also be a contributing factor in the development of irritation and Type IV allergy. Cornstarch is a strong absorbing powder and has a tendency to cause dryness of the skin leading to cracking and itchiness. A more permanent method of reducing surface drag of medical gloves is by halogenation of the gloves for example by using chlorine. Such methods are not desirable 20 however as some of the mechanical and physical properties of the natural latex are compromised. Chlorination processes adversely affect shelf life, grip and in-use durability of the glove. In addition strong odours may be present and the gloves may irritate the skin. It would be desirable at least in preferred embodiments to solve the problem of dry 25 hands and arms of operating theatre personnel by providing a means for replacing skin oils and greases prior to applying protective gloves. It would also be desirable at least in preferred embodiments to provide a means for enabling easy application of protective gloves whilst preventing any allergic reactions to natural rubber latex among workers who use such gloves and other products containing latex. Object of the Invention It is the object of the present invention to overcome or substantially ameliorate at least one of the above disadvantages or at least provide a suitable alternative. Summary of the Invention According to a first aspect. the present invention consists in an article of S manufacture including a substrate impregnated or at least partially coated with a WO 01/08541 PCT/AU00/00909 3 moisturising cream base compatible with a protective glove material and containing little or no moisture. According to a second aspect, the present invention consists in a method of applying a protective glove comprising contacting the skin of at least part of the hands aind/or forearms of an individual with the article of manufacture of the first aspect such that at least a portion of said moisturising cream base is transferred to the skin prior to applying the protective glove. Detailed Description of the Preferred Embodiments Preferably the article of manufacture is in the form of wipe or towelette. n Preferably the article of manufacture is sterile. When sterile, the moisturising cream base and any optional ingredients should be compatible with the sterilisation process chosen. Accordingly moisturising cream bases which oxidise or become rancid during the sterilisation process are not suitable. Suitable sterilisation processes include gamma radiation and sterilisation with ethylene oxide gas. 5 Suitably the protective glove is made of rubber latex or a synthetic material such as vinyl (plasticised PVC), synthetic rubbers (such as neoprene and nitrile) or a synthetic polymer. Protective gloves made from materials other than latex and not containing natural allergens are available but none possess the unique mix of properties offered by natural rubber latex such as high elasticity, high tensile strength and excellent film f' orming characteristics, consequently rubber latex gloves are preferred. By little or no moisture is meant that the moisturising cream base has no water or an amount of water much lower than that of a typical moisturising cream for example 0 to 3 0wto of the usual moisture content. By compatible with a protective glove is meant that the mechanical and physical 5 properties of the glove are not compromised including for example shelf type, grip and in use durability. The moisturising cream base is suitably safe and effective and does not degrade the glove material. The moisturising cream base is suitably chosen on the basis of its compatibility with one or more of the surgical scrub solution used, the type of protective glove used and the end user (for example the end user may have hypersensitive skin). Commonly the moisturising cream base is formed from oils and/or greases such as mineral oils and petroleumn based materials. vegetable and animal fats and oils or silicone oils and waxes or a combination thereof. Unfortunately some mineral oils and petroleum products are not compatible with latex gloves and when such oils or products are used such cream 5 bases are only suitable for non-latex gloves. Preferably the moisturising cream base is not WO 01/08541 PCT/AU00/00909 4 oil based. Included as suitable components o1 moisturising cream bases are paraffinic hydrocarbons (straight or branched chain, saturated or unsaturated) and their common derivatives (fatty alcohols, acids and esters), silicone oils and waxes having chain lengths of from 16 to 60 carbon atoms. Specific examples include mineral oils; petrolatum; waxes including parraffin waxes: microcrystalline waxes: alkvl esters derived from monocarboxylic fatty acids having from 12 to 28 carbon atoms and short chain (C2 to CS) monohvdric alcohols such as isopropyl myristate. isopropyl palmnitate: alkyl esters derived 11from httv alcohols (C 1 2 to C2s) and short chain acids: fatty acids. fatty alcohols and fatty alcohol ethers having from 12 to 28 carbon atoms in at least one chain such as stearic S acid, cetyl alcohol. cetostearyl alcohol, and cetomacrogol 1000 (polyethylene glycol 1000 monoacetyl ether), ethoxylated and propoxylated fatty alcohols such as laureth-23 and steareth-2: glycerides, triglycerides, acetoglycerides and ethoxylated glycerides of CI, to

C

2 s fatty acids; other fatty esters of polyhydroxy alcohols: lanolin and its derivatives; polysiloxanes such as dimethicone and other conventional emollients such as glycerin and S propylene glycol and other polyols. More specific examples of moisturising cream bases include (a) Temovate (Glaxo Wellcome) Emollient Cream (a mixture of cetostearyl alcohol, isopropyl myristate. propylene glycol, cetomacrogol 1000, dimethicone 360. citric acid. sodium citrate and imidurea as a preservative, (b) Moisturel® (Westwood-Squibb) Emollient-Moisturizer (a Mixture of white petrolatum 30%, dimethicone 1% 0 , carbomer 934. cetvil alcohol. diazolidinyl urea, glycerin, Kathon CG, laureth-23, magnesium aluminium silicate. PVP hexadecane copolymer. PG dioctanoate, sodium hydroxide and steareth-2). (c) Hyderm cream (a mixture of cetostearyl alcohol, purified water, propylene glycol and sodium laurel sulfate), (d) Sorbolene with Glycerin 10% cream (contains cetomacrogol cream. 25 aqueous B.P., glycerin (glycerol) 10%. preserved \with methyl hydroxybenzoate B.P. 0.2% and propyl hydroxybenzoate B.P. 0.1%) and (e) Microshield® (Johnson& Johnson medical) moisturising lotion base containing stearic acid, glycol stearate, isopropyl palmitate. parrafin liquid, collagen amino acids. dl-alpha tocopherol acetate. aloe barbadensis gel, cocamrnidopropyl PG-dimonium chloride phosphate. PEG-75 lanolin J imethicone. cetyl alcohol, propyl hydrobenzoate. carbomer, triethanolamine. LLIaterlium-15, triclosan and methvlhvdrobenzoate (this lotion base is compatible with latex and chlorhexidinc, a common surgical scrub component. and is suitable for gamma radiation). lPrelferred moisturising cream bases are those containing pure cholesterol and/or S\\ool alcohols (with not less than 28% cholesterol) including Ointment of Wool Alcohols WO 01/08541 PCT/AU00/00909 5 (B.P.) containing wool alcohols 6% with hard paraffin, white soft paraffin, yellow soft paraffin and liquid paraffin. Another preferred cream base is Eucerin (anhydrous) available from Beiersdorf Australia Ltd which is a wool alcohol ointment B.P containing highly purified wool alcohol prepared from the unsaponifible fraction of wool fat and containing free alcohols consisting of approximately 30% cholesterol (and typically not less than 28% cholesterol) with the triterpine alcohols lanosterol and agnosterol, and other aliphatic alcohols. In any of these cream bases it may be desirable to reduce or substitute any paraffin content with for example a suitable vegetable oil for latex compatibility. As a preferred example of a moisturising cream base is cholesterol dissolved in a vegetable oil S such as jojoba oil with an antioxidant such as vitamin E. Suitably the moisturising cream base is impregnated in or coated on the substrate in an amount sufficient to enable it to be transferred to the skin and in an amount less than that which would cause the skin to become too slippery and cause undue movement of the protective glove on the fingers. Most preferably the substrate is impregnated with up to .5 four times its weight in moisturising cream base, even more preferably up to three times its weight. Suitably the substrate is paper-like and can be made from a non-woven material, paper, cotton, rayon, a woven material, wadding, felt, sponge or a mixture thereof. Suitably the substrate is chosen on its stability with respect to the sterilisation process 20 chosen. For radiation stability compounds are chosen for the substrate that preferably contain benzene rings which can be part or a branch to a main chain (compounds are avoided with contain triple bonds, double bonds in a main chain and high energy (stable) side branches). Suitable polymers for forming the substrate which are capable of being irradiated include polystyrene and its copolymers such as ABS (thermoplastic terpolymer 3 from acrylonitrile). SAN (thermoplastic copolymer from styrene and acrylonitrile). HIPS (high impact polystyrene), polyethylene, low density polyethylene (LDPE). linear low density polyethylene (LLDPE), high density polyethylene (HDPE), polyesters and PETG (polyethylene terepthalate glycol). polycarbonate and alloys, polysulfone. PVC (polyvinylchloride) flexible and semi-rigid (colour corrected), polyurethanes. "high-end" engineering resins, PEK (polyether ketone). PEEK (polyether ester ketone), polyetherimides, thermosets such as epoxies. phenolics, polyimides. polyurethanes, polyesters. elastomers such as TPE (dthermoplastic elastomner). SEBS (styrene ethvlene/butvlene-stvrene triblock polymer). TPO (thermoplastic olefinic elastomer), natural isoprene. EPDM (elastomneric terpolymer from ethylene. propylene and a nonconjugated diene), silicone, urethane and nitrile, polvamides such as nylons especially WO 01/08541 PCT/AU00/00909 6 12. 11. 6/12 and 6/10, polypropylenes and copolymers (radiation stabilised), fluoroplastics (other than PTFE (polytetrafluoroethylene) and FEP (thermoplastic copolymer from tetrafluoroethylene and hexafluoroethylene)) such as PVDF (polyvinvlidene fluoride), PCTFE (polychlorotrifluoroethylene) and PETFE (polyethylene-tetra-fluoroethylene). The moisturising cream base may also suitably contain optional ingredients such as an antiseptic. Alternatively an antiseptic may be included in the prescrub solution, such antiseptics remain as a residue on the skin. In either situation it is desirable that the moisturising cream base is compatible with the antiseptic residue or the antiseptic S included in the moisturising cream base. Other optional ingredients include emulsifiers, skin conditioners, thickeners, pH adjusting agents, hemectants, colourants, fragrances, preservatives and antioxidants. A suitable antioxidant is Vitamin E. The article of manufacture can be prepared in a clean sterile environment. For example the substrate can be immersed in the cream moisturizing base and any excess 5 suitably removed. Alternatively the moisturising cream base may be in the form of a solution which is allowed to evaporate. The article of manufacture can be presented in a peel-apart pack. Suitably the article of manufacture in the form of a wipe or towelette is folded into a compact form prior to being sealed within a package. Preferably the towelette is interleaved with sheets of grease-proof paper, folded and placed in a peel open pouch (preferably a plastic pouch), packaged and gamma irradiated for a shelf life of up to 5 years. Alternatively the towelette may be placed in a pervious envelope and sterilised with ethylene oxide. The article of manufacture can be applied to a user' s skin as soon as possible and preferably immediately after washing and hand drying and rubbed over the hands and 25 forearms resulting in a uniform thin layer of the moisturising cream base on the skin. The gloves and where necessary sterile gown can then be donned. By use of the invention it is possible to apply a uniform thin layer of a moisturising cream base to skin prior to donning medical gloves which gloves are then easier to apply. The pharmaceutical composition of the present invention produces a mnoisturising effect on the skin because the gloves are applied as soon as possible after application. If gloves were not applied the moisturising effect would be inferior to that of a standard moisturising cream which contains more water. Use of the invention results in the misturising cream base being applied to the skin which is then occluded by gloves and o \\n. Occlusion of the skin promotes absorption of the cream base into the skin.

WO 01/08541 PCT/AU00/00909 7 Examples Example 1 Towellettes in accordance with the present invention containing wool alcohols were prepared on a small scale as follows. Paper was slit to 12cm width and rolled. The paper roll was then placed on an appropriate manufacturing station where it was unrolled and passed through a vat of the wool alcohol which had previously been melted by heating to about 80'C. The oiled paper was then passed through rollers to remove excess oil and then onto a lamination stage where a 13cm wide strip of grease-proof paper was applied to both the top and bottom surfaces, overlapping at each edge. The trilaminate was then passed through motorised rollers to a guillotine station where it was cut to 10cm lengths, the lengths falling on a fast moving conveyor belt and then to a paper folding station. The fblded portions were then stacked inside a tubular container and when full passed to the next station where individual folded portions were removed and placed on another conveyor bearing a bilaminar plastic film. The timing of the placement of the folded 5 portion was controlled by timing marks printed on the plastic film passing over a light sensing diode. A second bilaminar plastic film was applied to the top surface and the composite layers passed onto the next station where the laminate was heat fused and cut into pouches each containing a single folded towelette. The pouches were then placed in boxes and gamma irradiated. Example 2 An article of manufacture according to the invention was prepared as follows. A cellulose paper Dextex Ultrawrap towellette (Dexter Corporation of Connecticut) supplied by Drdiger Australia and measuring 12cm by 10 cm was weighed and found to have a dry weight of 0.5gms. The towellette was then immersed in a molten wool alcohol 5 ointment (Eucerin) which had been melted at a temperature of about 80 0 C (Eucerin has a melting point of not below 58'C). The towellette impregnated weight was 1.4gmn. The ttvellette was then applied by a user to the hands and lower arms and reweighed. The to\\ellette alier use had a weight of 1.2 gins. The user then applied a powder-free surgical glove. It was found that the glove was easy to put on and easy to use. No additional lubrication was required and the hands were not slippery within the gloves It will be appreciated by those skilled in the art that the invention can be embodied in other tbforms. For example the invention is not limited to use in surgical situations but WO 01/08541 PCT/AU00/00909 8 can be used in non-sterile situations where it is necessary to use protective gloves for example in dental surgeries and childcare centres. Industrial Applicability The present invention provides an article of manufacture including a substrate impregnated or at least partially coated with a moisturising cream base compatible with a protective glove material and containing little or no moisture. A method of applying a protective glove is also disclosed.

Claims (9)

1. An article of manufacture including a substrate impregnated or at least partially coated with a moisturising cream base compatible with a protective glove material and containing little or no moisture.

2. An article of manufacture according to claim 1 in the form of a wipe or towellette.

3. An article of manufacture according to claim 1 which is sterile.

4. An article of manufacture according to claim 1 which is compatible with rubber latex or a synthetic glove material.

5. An article of manufacture according to claim I wherein the moisturising cream base 0 is formed from oils and/or greases.

6. An article of manufacture according to claim 5 wherein the oils and/or greases are mineral oils. petroleum products, vegetable oils or waxes, animal oils or waxes, silicone oils or waxes or a combination thereof.

7. An article of manufacture according to claim 5 wherein the moisturising cream base 5 is formed from cholesterol and/or wool alcohols.

8. An article of manufacture according to claim 7 wherein the moisturising cream base is formed from cholesterol, jojoba oil and vitamin E.

9. An article of manufacture according to claim 1 wherein the substrate is impregnated with up to lour times its weight in moisturising cream base. I U. An article of manufacture according to claim I wherein the substrate is made from a non-woven material, paper, cotton, a woven material, wadding. felt. sponge or a mixture thereof. I 1. A method of applying a protective glove comprising contacting the skin of at least part of the hands and/or forearms of an individual with the article of manufacture 25 according to any one of the preceding claims such that at least a portion of said moisturising cream base is transferred to the skin prior to applying the protective glove. 2. A method according to claim 11 wherein the article of manufacture is applied immnediatelyv after washing and hand drying.