Medical Gloves

Flexible protective medical gloves and methods for their use

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Medical Gloves Abstract:
A flexible protective medical glove containing a non-liquid antiseptic composition and methods for its use are disclosed. The glove comprises a thin inner layer and a thin outer layer of material; preferably the outer layer is a more elastic and less plastic layer than the inner layer. A compartment between the layers of the glove is capable of providing a non-liquid antiseptic composition which comprises an antiseptic in a non-liquid composition. The non-liquid antiseptic composition may also contain a surface-active agent, an algesic agent, a colorant, a vasoconstrictive agent, an odorant, or a viscosity-modifying agent. An object puncturing the glove wall can become coated with the non-liquid antiseptic composition and can automatically transfer some of the antiseptic composition from the glove onto the hand and into a hand wound should the object cause a wound; useful as an immediate preventative antiseptic treatment to help to decontaminate the hand and hand wound of infectious pathogens that may have been transferred there by the object. The treatment can help to protect a gloved individual such as a surgeon, a medical doctor, a health care worker, a law enforcement officer, a dentist or any worker whose work may place them at some risk of becoming contaminated through the hands by an infectious pathogen including the AIDS virus or hepatitis B virus.

Medical Gloves Claims:
We claim:

1. A flexible protective glove with a liquid-impermeable wall having the capability to provide a non-liquid antiseptic composition treatment to a hand and to a hand wound should the wound occur underneath the glove while the glove is being worn when a wall of the glove is punctured by an object that may be contaminated with an infectious pathogen, comprising:

(a) a glove wall with a liquid-impermeable outer layer comprised of a first material having a thickness of about 1 mil to about 40 mils and a liquid-impermeable less elastic inner layer composed of a second material having a thickness of about 0.3 mils to about 30 mils wherein the first material and the second material form the walls of a compartment capable of providing a non-liquid antiseptic composition;

(b) wherein the non-liquid antiseptic composition in the compartment comprises an antiseptic or a number of substances that can form the non-liquid antiseptic composition when the object punctures the glove wall and causes a combination of a portion of the substances, wherein at least a portion of the glove wall contains the non-liquid antiseptic composition when the glove wall is punctured by the object;

(c) the glove wall capable of providing a physical barrier as a means of protection to the hand while the glove is being worn by an individual until a portion of the glove wall is punctured by an object;

(d) the glove wall capable of being punctured by the object while the glove is being worn on the hand;

(e) the glove wall having the flexibility to allow the hand of an individual in need of wearing the glove to easily and adequately perform delicate, dexterous and complex work including the work performed by a surgeon, a medical doctor, a dentist, a laboratory worker, a health care worker, a law enforcement worker, and a hospital worker;

(f) the glove having the capability to provide a coating to at least a portion of the object puncturing the glove wall; the coating comprising the non-liquid antiseptic composition; the coating on the object providing a means for immediately transfering some of the non-liquid antiseptic composition onto the hand and into the hand wound by the object puncturing the glove wall while the glove is being worn; the non-liquid antiseptic composition transferred to the hand and to the hand wound having the capability to provide an immediate non-liquid antiseptic composition treatment to the hand and hand wound;

(g) the glove having the additional capability to transfer some of the non-liquid antiseptic composition from a section of the glove wall having a hole resulting from the object puncturing the glove wall; the hole in the inner glove layer is relatively larger than the hole in the outer glove layer and may be used to help to direct a relatively larger transfer of non-liquid antiseptic composition from the glove to the hand and to the hand wound than from the glove to the outer surface of the glove; and

(h) the glove having the capability of treating the hand and the hand wound with the non-liquid antiseptic composition when the object punctures the glove wall, when the object contacts the hand, when the object may wound the hand, and when the object may contaminate the hand and the hand would with the infectious pathogen; wherein the non-liquid antiseptic composition transferred to the hand and the hand wound can help to protect the hand, the hand wound, and the systemic circulation of the individual by killing, inactivating, and otherwise destroying the infectious pathogen that may be contaminating the hand and the hand wound.

2. The glove according to claim 1, wherein the non-liquid antiseptic composition is capable of being redistributed within the compartment of the glove by massaging the glove to force the non-liquid antiseptic composition in the compartment to accumulate near the glove wall having the hole or is capable of being automatically or manually expelled from the wall having the hole onto the hand and into the hand wound providing additional non-liquid antiseptic composition to treat the skin and the hand wound resulting in additional protection of the skin and hand would from the infectious pathogen that may be contaminating the skin and the hand wound.

3. A glove according to claim 1, wherein the first material and the second material comprise:

a structural material selected from the group consisting of latex rubber, cis-1,4-polyisoprene, cis-polybutadiene, neoprene rubber, nitrile rubber, silicone rubber, case-hardened rubber, isobutylene-isoprene 1. butyl rubber, butadieneacrylonitrile 1. nitrile rubber, styrene-butadiene rubber, ethylene-propylene copolymer, ethylene-propylene diene terpolymer, polyisobutylene, chlorosulphonated polyeten, ester-type urethan rubber, polychlormethyloxyran epichlorhydrin rubber, epichlorhydrin copolymer with ethyleneoxydichlormethyloxyran copolymer cellulose acetate plastic, vinyl plastic, polyethylene plastic, polypropylene plastic, polyvinyl chloride plastic, polyvinyl acetate plastic, polystyrene plastic, polymethyl methyl-acrylate plastic, polyacrylonitrile plastic, vinyllite plastic, saran plastic, polytetrafluoroethylene plastic, polytrifluorochloroethylene plastic, polycaprolactam plastic, polyester plastic, urea formaldehyde plastic, polyurethane plastic, isotactic polypropylene plastic, nylon plastic, rayon plastic, polyamide plastic, phenolic plastic, silicone plastic, silk fiber, cotton fiber, cellulose fiber, wool fiber, animal skin, animal intestinal tissue, animal connective tissue, metallic fiber, mineral fiber and mixtures thereof.

4. A glove according to claim 3, wherein the first material comprises: a structural material selected from the group consisting of latex rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene rubber, neoprene rubber, and nitrile rubber, silicone rubber case-hardened rubber, isobutylene-isoprene 1. butyl rubber, butadieneacrylonitrile 1. nitrile rubber, styrene-butadiene rubber, ethylene-propylene copolymer, ethylene-propylene diene terpolymer, polyisobutylene, chlorosulphonated polyeten, ester-type urethan rubber, polychlormethyloxyran epichlorhydrin rubber, epichlorhydrin copolymer with ethyleneoxydichlormethyloxyran copolymer, and mixtures thereof; and wherein the second material comprises: a structural material selected from the group consisting of cellulose acetate plastic, vinyl plastic, polyethylene plastic, polypropylene plastic, polyvinyl chloride plastic, polyvinyl acetate plastic, polystyrene plastic, polymethyl methylacrylate plastic, polyacrylonitrile plastic, vinyllite plastic, saran plastic, polytetrafluoroethylene plastic, polycaprolactam plastic, rayon plastic, polytrifluorochloroethylene plastic, nylon plastic, polyester plastic, urea formaldehyde plastic, polyurethane plastic, isostactic polypropylene plastic, polyamide plastic, phenolic plastic, silicone plastic, silk fiber, cotton fiber, plant fiber, wool fiber, animal skin, animal intestinal tissue, animal connective tissue, metallic fiber, mineral fiber, and mixtures thereof.

5. A glove according to claim 1, wherein the antiseptic is selected from the group consisting of chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine hydrochloride, octoxynol, nonoxynol-9, methanol, ethanol, isopropanol, allyl alcohol, rubbing alcohol NF, sodium hypochlorite, potassium hypochlorite, calcium hypochlorite, magnesium hypochlorite, sodium dichloroisocyanurate, sodium perborate NF, sodium hydroxide, potassium hydroxide, magnesium hydroxide, calcium hydroxide, ammonia, ammonium hydroxide, lithium hydroxide, barium hydroxide, silver hydroxide, sodium tetradecyl sulfate, sulfur dioxide, pentationic acid, colloidal sulfur, sulfur, sulfurated potash, sublimed tyrothricin, hexachlorophene, hypochlorous acid, acetic acid, hydrochloric acid, sulfuric acid, sodium acetate, aluminum acetate, acetarsone, aluminum subacetate, cadmium sulfide, selenium sulfide, bacitracin, coilstin, chloramphenicol, tetracycline, erythromycin, gentamycin, tobramycin, mafenide acetate, neomycin sulfate, sulfisoxazole diolamine, sulfacetamide sodium, gentamycin sulfate, amphotericin B, calomel, chiniofon, creosote, diiodohydroxyquin, eucalyptol, eucalyptus oil, glycobiarsol, gramicidin, hexyl resorcinol, methylene blue, peppermint oil, phenylethyl alcohol, phenyl salicylate, methyl salicylate, pine tar, pine oil NF, alpha-terpineol, borneol, fenchyl alcohol, o-methylchavicol, polymixin B sulfate, salicylic acid, trichloroacetic acid, benzoic acid, pyrogallol NF X, pyrogallic acid, sodium benzoate, boric acid, sodium borate, lactic acid, sodium lactate, ohiofamine, chloramine T, silver nitrate, ammoniacal silver nitrate solution, eugenol, elemental iodine, sodium iodide, potassium iodide, calcium iodide, ammonium iodide, silver iodide, colloidal silver iodide in gelatin, silver lactate, ferrous iodide, mecuric iodide red, mecuric oxide red, strontium iodide, lithium iodide, magnesium iodide, zinc iodide, silver iodide, selenium iodide, thymol iodide NF X, dithymol diiodide, povidone-iodine, iodoform, iodol, iodopyrrol, chlorinated lime, potassium bromide, sodium bromide, merbromin NF, sodium fluoride, potassium fluoride, phenyl mercuric acetate, potassium mecuric iodide, proflavine hemisulfate, 3,6-diaminoacridine bisulfate, formaldehyde, glutaraldehyde, paraformaldehyde, butyl hydroxybenzoate, mercurous chloride, iodochlorhydroxyquin, zinc nitrate, zinc sulfate, cadmium sulfate, thimerosal NF, zinc oxide, zinc acetate, zinc chloride, silver nitrate, silver sulfadiazine, hydrogen peroxide, urea hydrogen peroxide, hydrogen peroxide carbamide, benzoyl peroxide, calcium peroxide, magnesium peroxide, barium peroxide, strontium peroxide, sodium peroxide, potassium perchlorite, sodium perchlorite, calcium perchlorite, magnesium perchlorite, zinc perchlorite, zinc peroxide, zinc carbonate, zinc hydroxide, zinc sulfate, succinyl peroxide, succinchlorimide NF IX, N-Chlorosuccinimide, potassium permanganate, sodium chlorate, potassium chlorate, phenol, camphorated phenol, phenol glycerin, chloroxylenol, 4-chloro-3,5-xylenol, sodium phenolate, domiphen bromide, salicylic acid, bismuth-formic-iodide, bismuth subgallate, bacitracin zinc, sodium lauryl sulfate, carbamide peroxide, oleic acid-iodine, pipetonyl butoxide, sodium peroxyborate monohydrate, ammonium ichthosulfonate, eucalyptol, menthol, Witch Hazel, camphor, tannic acid, chloroquinaldol, nalidixic acid, zinc phenolsulfonate, zinc sulfocarbolate, hydroxynalidixic acid, pipemidic acid, norfloxacin, norfloxacin hydrochloride, 8-hydroxyquinoline sulfate, sodium phenolate, thyme oil, o-cresol, m-cresol, metacresylacetate, p-cresol, cresol NF, 4-chloro-m-cresol, 4-chloro-3,5-xylenol, saponified cresol solution NF, methylphenol, ethyl phenol, other alkyl phenols, o-phenyl phenol, other aryl phenols, bisphenols, phenyl-mecuric chloride, phenylmecuric borate, resorcinol, resorcinol monoactetate NF, orthophenylphenol, chloroxylenol, hexylresorcinol, parachlorophenol, paratertiary-amylphenol, thymol, chlorothymol NF, butylparaban, ethylparaben, methylparaben, propylparaben, triclosan, bithionol NF, o-benzyl-p-chlorophenol, hexachlorophene, poloxamer 188, a benzalkonium chloride wherein the alkyl groups attached to the nitrogen represent an alkyl from CH.sub.3 to C.sub.18 H.sub.37, triclobisonium chloride, undecoylium chlorideiodine, coal tar solution, furazolidone, nifuroxime, nitrofurazone NF, nitromersol NF, oxychlorosene, sodium oxychlorosene, parachlorophenol NF, camphorated parachlorophenol NF, phenylmercuric nitrate NF, gentian violet USP, hexamethylpara-rosaniline chloride, rosaniline chloride, pentamethylpararosaniline chloride, methylrosaniline chloride, tetramethylpararosaniline chloride, nonylphenoxypolyethoxyethanol, methoxypolyoxyetheneglycol 550 laurate, oxyquinoline benzoate, p-triisopropylphenoxypolyethoxy-ethanol, halazone NF, dichloramine-T, benzethonium chloride, econazole, cetylpyridinium chloride, methylbenzethonium chloride, cetyldimethylbenzylammontum chloride, dichlorobenzalkonium chloride, domiphen bromide, triclocarban, clotrimazole, ciclopirox olamine, undecylenic acid, miconazole, tolnaftate, acriflavine, euflavine, 3,6-diamino-10-methylacridium chloride, 3,6-diamino-acridine, acid acr]flavine, 5-aminoacridine hydrochloride monohydrate, malachite green G, dodecyltrimethylammonium bromide, tetradecyltrimethyl-ammonium bromide, dequalinium chloride BP, dibromopropamidine isethionite, hexadecyltrimethylammmonium bromide, chloroazodin NF X, N-chloro-p-toluenesulfonamidosodium, 4-[(dichloroamino)sulfonyl]-benzoic acid, methenamine, methenamine mandelate, methenamine hippurate, octoxynol 9, phenazopyridine hydrochloride, 9-aminoacridine hydrochloride, bismuth tribromophenate, p-tert-butylphenol, cetyldimethylethylammonium bromide, chlorothymol, cloflucaban, clorophene, cloroxine, 8-hydroxyquinoline, merbromin, mercuric oxide yellow, ammoniated mercury, p-tert-pentylphenol, phenylmercuric acetate, phenylmercuric nitrate, propylene oxide, zinc pyrithione, triclocarban, zinc bacitracin, chlortetracycline hydrochloride, calcium chlortetracycline, oxytetracycline hydrochloride, beta-propiolactone, acyclovir, acyclovir sodium, amantadine hydrochloride, cytarabine, idoxuridine, interferon, gamma interferon, ribaviron, rifampin, suramin, trifluridine, vidarabine, zidovudine, methisazone, tumor necrosis factor, ampligen, ansamycin, (E)-5-(2-bromovinyl-2'-deoxyuridine, butylated hydroxytoluene, castamospermine, dextran sulfate, dideoxycytidine, dideoxyadenosine, dideoxylnosine, Peptide-T, dihydromethylpyridinylcarbonyloxyazidodideoxythymidine, ganciclovir, 2'-fluoro-2'-deoxy-5-iodo-ara C, phosphonoformate, rimantadine hydrochloride and mixtures thereof.

6. A glove according to claim 1, wherein the non-liquid antiseptic composition contains a liquid component selected from the group consisting of water, methanol, ethanol, isopropanol, propanol, allyl alcohol, butanol, isobutanol, sec-butanol, tert-butanol, benzyl alcohol, 2-methoxyethanol, 2-ethoxyethanol, 2-octyl dodecanol, nonoxynol-9, n-octyl alchol, glycerol, propylene glycol, a polyethylene glycol of about 150 to about 700 molecular weight, urea, acetone, methyl ethyl ketone, ethyl ketone, methyl isopropyl ketone, 2-pentanone, ethyl acetate, 2-methoxyethyl acetate, ethyl propionate, ethyl butyrate, ethyl valerate, methyl acetate, propyl acetate, isopropyl acetate, 2-ethoxyethyl acetate, buryl acetate, sec-butyl acetate, tert-butyl acetate, amyl acetate, pentyl acetate, isopentyl acetate, benzyl acetate, mineral oil, silicone oil, hexamethyl disiloxane, glycerol trioctanoate, decyl oleate, cetearyl isononanoate, dimethicone, perfluropolymethyisopropyl ether of about 1500 to about 8800 molecular weight, olive oil, cottonseed oil, corn oil, soybean oil, wheat germ oil, linseed oil, pine oil, almond oil, macadamia oil, coconut oil, jojoba oil, peanut oil, persia oil, castor oil, cod liver oil, shark liver oil, mink oil, squalene and mixtures thereof.

7. A glove according to claim 1, wherein the non-liquid antiseptic composition contains a surface-active agent to facilitate the coating of the object with the non-liquid antiseptic composition, the surface active agent selected from the group consisting of dodecyldimethylamine oxide, lauryldimethylamine oxide, stearic acid, dibutyl adipate, octyl stearate, sodium cetearyl stearate, isopropyl myristrate, palmitic acid, stearyl alcohol, cetyl alcohol, colloidal magnesium aluminum silicate, caprylic triglyceride, captic triglyceride, cetostearyl alcohol, decyl-beta-D-glucopyranoside, nonyl-beta-D-glucopyranoside, octyl-beta-D-glucopyranoside, triethanolamine stearate, heptyl-beta-D-glucopyranoside, hexyl-beta-D-glucopyranoside, dodecyl-beta-D-maltoside, decyl-beta-D-maltoside, sodium dodecylsulfate, sodium oleate, potassium laurate, sodium laurate, sodium lauryl sulfate, glycerol monostearate, propylene glycol monostearate, bis(2-ethylhexyl)sodium sulfosuccinate, N-octylsulfobetaine, propylene glycol monolaurate, N-dodecylsulfatobetaine, octyl-beta-D-thioglucopyranoside, heptyl-beta-D-thioglucopyranoside, N-dodecyl-N,N-dimethylglycine, cetyl alcohol, N-decylsulfatobetaine, digitonin, N-hexyldecylsulfatobetaine, N-tetradecylsulfatobetaine, dioctyl sodium sulfosuccinate, N,N,bis(3-D-gluconamidopropyl)-cholamide, sodium deoxycholate, N,N,bis(3-D-gluconamidopropyl)-deoxycholamide, glycerol monostearate, sodium taurodeoxycholate, sodium cholate, sodium taurocholate, sodium glycocholate, cetyltrimethylammonium bromide, 3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate, 3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxypropane-1-sulfonate, octanoyl-N-methylglucamide, nonanoyl-N-methylglucamide, decanoyl-N-methylglucamide, nonyl-N-methylglucamide, lecithin, lysolecithin, nonaethylene glycol monododecyl ether, nonaethylene glycol octylphenol ether, nonaethylene glycol octylcyclohexyl ether, heptaethylene glycol octylphenyl ether, heptaethylene glycol octylcyclohexyl ether, polyoxyethylene (10) monolauryl ether, polyoxyethylene (8) isotridecyl ether, polyoxyethylene (10) isotridecyl ether, polyoxyethylene (15) isotridecyl ether, polyoxyethylene (9) lauryl ether, polyoxyethylene (23) lauryl ether, octaethylene glycol monododecyl ether, nonaethylene glycol monododecyl ether, polyethylene polypropylene glycol, sorbitan monopalmitate, sorbitan monooleate, sorbitan monostearate, polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monooleate, polyoxyethylene-4-lauryl ether, a polyethylene glycol of about 150 to about 600 molecular weight, polyoxyethylene glycol 400 molecular weight, polyoxyethylene glycol 1540 molecular weight, polyoxyethylene glycol 4000 molecular weight, polyoxyethylene glycol 8000 molecular weight, polyethylene glycol 400 monostearate, polyoxyethylene-4-sorbitan monolaurate, polyoxyethylene-20-sorbitan monooleate, polyoxyethylene-20-sorbitan monopalmitate, polyoxyethylene-20-sorbitan monolaurate, polyoxyethylene-40-stearate, dimethicone, simethicone, dimethylpolysiloxane, sorbitan trioleate, sorbitan tristreate, propylene glycol monostearate, sorbitan sesquioleate, diphenylmethylsilicone, lauryldimethylbenzylammonium chloride, a perfluoropolymethylisopropyl ether of about 1500 to about 6600 molecular weight, acacia, type A gelatin, type B Gelatin, egg yolk phospholipids, soybean phospholipids, cholesterol, colloidal aluminum silicate, colloidal magnesium hydroxide, and mixtures thereof.

8. A glove according to claim 1, wherein the non-liquid antiseptic composition contains an algesic agent to increase the pain sensation perceived from the hand, to alert the individual when the hand has been wounded, the algesic agent selected from the group consisting of formic acid, acetic acid, hydrochloric acid, phosphoric acid, sodium hydrogen phosphate, sodium phosphate, potassium hydrogen phosphate, potassium phosphate, citric acid, sodium hydrogen citrate, sodium citrate, sulfuric acid, sodium hydrogen sulfate, sodium sulfate, sodium hypochlorite, potassium hypochlorite, bradykinin, substance P, bee venom, wasp venom, ant venom, potassium chloride, potassium citrate, potassium sulfate, potassium phosphate, potassium carbonate, potassium bromide, potassium iodide, potassium fluoride, potassium hydroxide, potassium nitrate, and mixtures thereof.

9. A glove according to claim 1, wherein the non-liquid antiseptic composition further contains a colorant as a means for providing a colored visual signal to the individual when and where the glove wall has been punctured by the object, the colorant selected from the group consisting of a dye, an iron oxide, titanium dioxide, and mixtures thereof.

10. A glove according to claim 1, wherein the non-liquid antiseptic composition further contains a vasoconstricting agent in a concentration of about 1 vasoconstricting agent part in 200,000 parts of the non-liquid antiseptic composition to about 1 vasoconstricting agent part in 2,000 parts of the liquid antiseptic composition as a means for reducing blood flow in the hand wound as a means for reducing a systemic spreading of the infectious pathogen in the individual, the vasoconstricting agent selected from the group consisting of epinephrine, norepinephrine, phenylephrine, ephedrine, metaraminol, methoxamine, and mixtures thereof.

11. A glove according to claim 1, wherein the non-liquid antiseptic composition further contains a viscosity-modifying polymer as a means for increasing the viscosity of the non-liquid antiseptic composition, the viscosity-modifying polymer selected from the group consisting of gum arabic, xantham gum, gum acacia, gum tragacanth, agar, glycyrrhiza, sodium alginate, bentonire, cellulose, methyl cellulose, carboxymethyl cellulose sodium, glycerol, propylene glycol, pyroxylin, polyoxyethylene glycols of about 150 to about 6000 molecular weight, gelatin, dimethicone of about 100 to about 3000 centistokes viscosity, simethicone, dimethylpolysiloxane, perfluropolymethyl-isopropyl ether of about 1500 to about 6600 molecular weight, starch, and mixtures thereof.

12. A glove according to claim 1, wherein a structural connection is made by using a third material to connect the first material to the second material, the third material comprising: a structural material selected from the group consisting of latex rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene rubber, neoprene rubber, nitrile rubber, silicone rubber, case-hardened latex rubber, isobutylene-isoprene 1. butyl rubber, butadieneacrylonitrile 1. nitrile rubber, styrene-butadiene rubber, ethylene-propylene copolymer, ethylene-propylene diene terpolymer, polyisobutylene, chlorosulphonated polyeten, ester-type urethan rubber, polychlormethyloxyran epichlorhydrin rubber, epichlorhydrin copolymer with ethyleneoxydichlormethyloxyran copolymer, cellulose acetate plastic, vinyl plastic, polyethylene plastic, polypropylene plastic, polyvinyl chloride plastic, polyvinyl acetate plastic, polystyrene plastic, polymethyl methylacrylate plastic, polyacrylonitrile plastic, vinyllite plastic, saran plastic, polytetrafluoroethylene plastic, polytrifluorochloro-ethylene plastic, nylon plastic, rayon plastic, polycaprolactam plastic, polyester plastic, urea formaldehyde plastic, polyurethane plastic, isostactic polypropylene plastic, polyamide plastic, phenolic plastic, silicone plastic, silk fiber, cotton fiber, plant fiber, wool fiber, animal skin, animal intestinal tissue, animal connective tissue, metallic fiber, mineral fiber, a glue comprising at least one of the aforementioned structural materials, and mixtures thereof.

13. A glove according to claim 12, wherein the structural connection reconfigures the compartment storing the non-liquid antiseptic composition into a plurality of compartments capable of storing the non-liquid antiseptic composition.

14. A glove according to claim 1, capable of providing a non-liquid antiseptic composition, which comprises: a quantity of povidone-iodine in a non-liquid composition.

15. A glove according to claim 1, capable of providing a non-liquid antiseptic composition, which comprises: a quantity of elemental iodine in a non-liquid composition.

16. A glove according to claim 1, capable of providing a non-liquid antiseptic composition, which comprises: a quantity of a hypochlorite salt antiseptic in a non-liquid composition.

17. A glove according to claim 1, capable of providing a non-liquid antiseptic composition, which comprises: a quantity of chlorhexidine gluconate.

18. A glove according to claim 1, capable of providing a non-liquid antiseptic composition, which comprises: a quantity of nonoxynol-9.

19. A method of using a flexible protective glove with a liquid-impermeable wall containing a non-liquid antiseptic composition or storing a number of substances that can form a non-liquid antiseptic composition when the substances are combined, the wall comprising an inner layer and an outer layer wherein the inner layer has a lower elasticity than the outer layer on a hand of an individual to protect the hand in the event that an object contaminated with an infectious agent punctures the glove, may wound the hand and may contaminate the hand and the hand wound with the infectious pathogen, comprising the steps of:

(a) using the glove initially as a liquid-impermeable physical barrier to infectious pathogens; using the glove to permit the hand to perform a delicate, dexterous and complex type of work that includes the type of work performed by a surgeon, medical doctor, a dentist, a laboratory worker, a hospital health care worker, a law enforcement worker, and a hospital worker;

(b) using the object to puncture the wall so that the wall has a hole;

(c) bringing the object into contact with the non-liquid antiseptic composition or using the object to cause some combination of the substances in the wall so that some non-liquid antiseptic composition is formed when the substances are combined in some portion of the wall that has been punctured by the object;

(d) coating a portion of the object puncturing the glove wall with the non-liquid antiseptic composition when the object punctures the glove wall;

(e) using the object puncturing the glove as a means for transfering a portion of the coating of the non-liquid antiseptic composition on the object, to the hand and into the hand wound when the object contacts the hand or the hand wound;

(f) promoting a larger transfer of the non-liquid antiseptic composition from the glove wall to the hand and hand wound, than from the glove to the outer surface of the glove wall, when the non-liquid antiseptic composition is dispersed from the hole in the punctured glove wall, by providing a smaller hole in the outer layer than in the inner layer of the glove wall after the object has been removed from the glove wall, by selecting a material composition for the inner glove layer that has a lower elasticity than the material composition selected for the outer glove layer; and

(g) using the non-liquid antiseptic composition transferred from and dispersed from the glove to the hand or to the hand wound to kill, to inactivate, and to otherwise destroy the infectious pathogen that may have been transferred to the skin and into the hand wound by the object.

20. A flexible protective glove with a liquid-impermeable wall having the capability to provide a non-liquid antiseptic composition treatment to a hand and to a hand wound should the wound occur underneath the glove while the glove is being worn when a wall of the glove is punctured by an object that may be contaminated with an infectious pathogen, comprising:

(a) a glove wall with a liquid-impermeable outer layer comprised of a first material having a thickness of about 1 mil to about 40 mils and a liquid-impermeable inner layer composed of a second material having a thickness of about 0.3 mils to about 30 mils wherein the first material and the second material form the walls of a compartment capable of providing a non-liquid antiseptic composition;

(b) wherein the non-liquid antiseptic composition in the compartment comprises an antiseptic and a vasoconstrictive agent, or a number of substances including a vasoconstrictive agent that can form the non-liquid antiseptic composition when the object punctures the glove wall and causes a combination of a portion of the substances, wherein at least a portion of the glove wall contains a non-liquid antiseptic composition when the glove wall is punctured by an object;

(c) the glove wall capable of providing a physical barrier as a means of protection to the hand while the glove is being worn by an individual until a portion of the glove wall is punctured by an object; the glove wall capable of being punctured by the object while the glove is being worn on the hand;

(d) the glove wall having the flexibility to allow the hand of an individual in need of wearing the glove to easily and adequately perform delicate, dexterous and complex work including the work performed by a surgeon, a medical doctor, a dentist, a laboratory worker, a health care worker, a law enforcement worker, and a hospital worker;

(e) the glove having the capability to provide a coating to at least a portion of the object puncturing the glove wall; the coating comprising the non-liquid antiseptic composition; the coating on the object providing a means for immediately transfering some of the non-liquid antiseptic composition onto the hand and into the hand wound contacted by the object; the non-liquid antiseptic composition transferred to the hand and to the hand wound having the capability to provide an immediate non-liquid antiseptic composition treatment to the hand and hand wound;

(f) the glove having the additional capability to disperse some of the non-liquid antiseptic composition from a section of the glove wall having a hole resulting from the object puncturing the glove wall; and

(g) the glove having the capability to help treat the hand and the hand wound with the non-liquid antiseptic composition when the object punctures the glove wall, when the object may contact the hand, when the object may wound the hand, and when the object may contaminate the hand and the hand would with the infectious pathogen; wherein the non-liquid antiseptic composition transferred or dispersed to the hand and the hand wound has the capability to help to protect the hand, the hand wound, and the systemic circulation of the individual by killing, inactivating, and otherwise destroying the infectious pathogen that may contaminate the hand and the hand wound.

Medical Gloves Description:
FIELD OF THE INVENTION

The present invention is a flexible protective medical glove that relates to the thin-walled medical glove that doctors, health care workers and other workers can wear on one or both hands as a physical barrier form of protection. In particular the present invention is a glove containing an antiseptic composition other than a liquid antiseptic composition within the glove wall;:the non-liquid antiseptic composition comprises an antiseptic in a non-liquid composition; for example, the composition may comprise a powder, a paste, a foam, a gel, a coating, a solid layer, a semi-solid foam, a putty or a state of matter that lacks the ability to flow like a liquid.

No useful medical glove is puncture-proof; when an individual wears a conventional medical glove, the thin glove wall can readily become punctured by an object and the hand underneath the glove may become wounded. If the object is contaminated with an infectious pathogen, then the hand and the hand wound may become contaminated and the individual may suffer a systemic pathogenic infection. A glove in accordance with the present invention can be used to help to prevent the hand and the hand wound from a contamination that might cause a systemic infection; the invention is urgently needed for example for use in medical work environments that may harbor the AIDS virus, the hepatitis B virus, or other infectious pathogens. When an object punctures a glove in accordance with the present invention, the object can contact and can then become coated with some of the antiseptic composition. If the object also causes a wound to the hand, then some of the antiseptic composition coating the object may be transferred to the hand and deposited into the hand wound, thereby helping to provide an immediate and automatic antiseptic treatment of the contaminated hand and hand wound. In general, the non-liquid antiseptic composition used in the present invention, lacking the ability to flow like a liquid can not leak from a glove wall puncture. For some embodiments of the present invention, manual massage of the gloved hand may be used as a means for causing extrusion of the non-liquid antiseptic composition from the glove wall puncture to increase the dispersion of the non-liquid antiseptic composition onto the hand and into hand wound as an additional treatment.

BACKGROUND OF THE INVENTION

In general, latex gloves are worn during a medical procedure to provide a physical barrier between the patient's body or tissues and the hands, wrist and arm regions of a health care practitioner such as a physician, nurse, phlebotomist and the like. The gloves must be flexible so that the manual dexterity of the health care practitioner or worker is not significantly decreased. The gloves are usually well-fitting and comfortable so that glove wear does not cause hand fatigue or discomfort.

Disposible sterile and nonsterile latex medical gloves are available. Sterile latex medical gloves are also known in the field as surgical gloves; they are sterilized at the glove factory; are made available typically as a pair in a specific size and are sealed in a sterile package. Surgical gloves are most often used for sterile field surgery to prevent a transfer of an infectious pathogen to a surface of a surgical wound from a surgeon's hands. Nonsterile latex medical gloves are also known in the field as examination gloves; they are used during non-sterile procedures; are made available usually in a size that can suitably fit either hand and are often packaged in bulk, for example in quanities of 50 per box. Non-sterile procedures include the medical examination of human body surfaces, body invaginations and body orifices; nonsterile medical gloves are also worn for protecting the hands of medical, research or hospital workers from contact with hazardous substances and surfaces. Examples of hazardous substances and surfaces include but are not limited to the following examples: biological waste products such as feces and urine, soiled wound dressings, garments or other materials, syringe needles, other medical devices, irritating or toxic liquids or chemicals, biological toxins, radioactive substances, and infectious pathogens. For the present invention, the term "infectious pathogens" is meant to include but is not limited to the following pathogens: viruses, bacteria, fungi, yeasts, rickettsia, prions, multicellular parasites, the spores of infectious pathogens, and the like.

At least three kinds of glove wall failure are known currently plague the currently known types of medical gloves. First, about two percent of standard latex gloves have inherent microscopic perforations after manufacturing that can be easily be permeated by small infectious pathogens such as a virus. Secondly, during their use, medical gloves may acquire additional perforations, small tears or small punctures which may go unnoticed but could provide a pathway for infectious pathogens to contact the hands of the glove wearer, particularly when the glove is contacted by bloody contaminated body fluids containing the infectious pathogen. If an infectious pathogen contacts human skin, the individual may eventually become systemically infected with the pathogen. Thirdly, if the glove is accidentally punctured by an object that is contaminated with an infectious pathogen, a gloved hand may become contaminated with an infectious pathogen. When a glove wall is punctured, the glove puncturing object may have a sharp edge like a hypodermic needle, suture needle, or scapel blade but an object with blunt edges can also puncture a glove wall. When the currently available medical gloves are worn on the hands, the gloves are not designed nor have the capacity to protect the hands when a glove is punctured by an object that is contaminated with an infectious pathogen.

The prevalence of vital disease caused by infectious pathogens in the human population has created an urgent need for more protective medical gloves that retain their medical utility. Currently, the most feared infectious pathogen is the human immunodeficiency virus (HIV). When a human is infected with HIV, a gradual destruction of the human immune system results over several years and this leads to Acquired Immune Deficiency Syndrome (AIDS), an illness which is generally ultimately fatal. In general, antiviral medical treatments are of limited utility. Vaccines are of limited utility because the HIV surface proteins mutate quickly and immunologically resistant strains of HIV evolve. Thus there is no known medical cure for HIV infection. A person who tests positive for HIV antibodies knows that they have been exposed to and probably harbor HIV in their body. Hepatitis B virus (HBV) is another virus that can lethally infect a human. There is an effective anti-HBV vaccine, but the vaccination treatment is a prolonged and expensive process. Better medical gloves could help to lessen the chance of vital infection. Likewise, better medical gloves would be useful to lessen the chance of infection from any infectious pathogen.

Medical gloves are commonly made from elastomeric materials such as latex rubber or plastic. Materials for a glove may also be obtained from a plant fiber such as cotton, from an animal secretion such as silk, from an animal tissue such as the skin or intestine, from a mineral or from a metal. The material(s) used to manufacture a medical glove should be flexible and should be capable of being made into a fiber or a thin sheet.

A second pair of gloves may be worn over the first pair of gloves to increase the thickness of their physical barrier protection. Multiple pairs of medical gloves can be worn provided that fine dexterous hand work can still be done. However, if two or more pairs of gloves are worn, the medical work by the gloved hand can become difficult and tiring.

Thick-walled work gloves have been constructed using the same materials that can be used to make thin-walled gloves. However, thick-walled gloves are inflexible and this property has generally limited their use by most medical doctors, health care workers, skilled workers and the like workers. A number of thick-walled work gloves have been developed to protect a hand from a serious cut or from a puncture wound by an object. For example, thick-walled cut-resistent gloves have been developed to protect the hands in animal slaughter houses where meat is manually cut (See U.S. Pat. No. 4,526,828 and PCT WO 91/10409). However, a puncture-resistant glove has not been developed that is also flexible to the degree needed by skilled medical personnel and the like who must use there hands skillfully and require protective gloves.

A glove in accordance with the present invention is relatively thin-walled and flexible so that the glove can be comfortably worn and easily used by medical personnel and the like workers as are conventional medical gloves. In addition, like a conventional medical glove, the present invention is capable of becoming punctured by an object.

The present invention has important, novel additional functions. Generally when an object punctures a glove in accordance with the present invention, the glove by a number of processes can immediately and automatically begin to help to protect the hand and any hand wound beneath the glove from becoming infected with an infectious pathogen should the object have been contaminated with an infectious pathogen.

A recent study of accidental blood contact during hospital surgical procedures in burn, trauma, orthopedic, general, gynecology, and plastic surgical services concluded that surgical gloves are an important means for preventing a substantial percentage of the blood contacts with the hands (Panlilo et al, 1991). Blood and body fluids can be contaminated with infectious pathogens such as HIV (also sometimes known as the AIDS virus) and the Hepatitis B virus. Because many substances or material objects can temporarily harbor an infectious pathogen, medical workers are made aware of the risks of becoming contaminated from contacting soiled objects and body fluids from infected individuals. Medical workers are advised to wear medical gloves in any environment which may contain infectious pathogens (Panlilo et al., 1991).

The United States Center For Disease Control (U.S. CDC) has issued guidelines for the prevention and control of nosocomial infections, for hospital environment control, and for control of surgical wound infections (See publications by Simmons, B. P., 1983). The U.S. CDC has reported that a clean wound (a wound that is initially pathogen-free) has only a 1 to 5 percent average risk of becoming infected whereas a contaminated wound (a wound exposed to an infectious pathogen) has a 15 to 17 percent average risk of becoming infected. Furthermore, it was found that a dirty wound (a wound exposed to biological or environmental liquid and solid waste which may be contaminated with an infectious pathogen) has more than a 27 percent average risk of becoming infected. Therefore, an infection is much more likely to occur in a dirty or contaminated wound than in a clean wound. Surgeons have administered an antiseptic solution directly into a wound as an irrigation solution (See also Maki, D. C, 1976). Furthermore the U.S. CDC guidelines advise doctors and health care workers to wash their hands with an antiseptic detergent to reduce the microbial (infectious pathogen) contamination on their hands before they wear medical gloves. Thus the cleaning of a wound and antiseptic decontamination of the hands are established treatment means for decreasing the risk of infection in a wound. The U.S. CDC has also suggested that antiseptics are more effective antimicrobial agents than soap and water, but has pointed out that frequent exposure of the skin with an antiseptic is often more irritating than skin exposure to soap and water. Thus, prolonged or repeated skin exposure to antiseptic compositions is ill-advised.

In 1987, the U.S. CDC issued the recommendation that medical examination gloves be worn as a "Universal Precaution". To adhere to the Universal Precaution Guidelines, doctors and other medical personnel are expected: (1) to assume that each patient is infected with human immunodeficiency virus (HIV) and thus to wear a new pair of gloves with each new patient, and (2) to remove their gloves and to wash their hands immediately if their hands appear to have become contaminated with blood or other body fluids (See Bartlett, J. G., 1988).

Although medical workers are well aware of the utility of an antiseptic in the prevention of skin infection and wound infection, medical glove wearers may not always be able to comply with the proposed U.S. CDC guidelines in a competent manner. It may be inconvenient or impossible for a glove wearer to immediately remove a damaged or contaminated glove during surgery or during a stressful medical emergency. Such a delay in glove removal may be dangerous for the glove wearer. The time delay may permit the blood circulation of the glove wearer to become more contaminated with an infectious pathogen. Delayed disinfection of the hand or hand wound with an antiseptic may be an ineffective means for preventing the systemic spread of an infectious pathogen in an individual. The glove wearer may delay glove removal and decontamination of the hand or hand wound with an antiseptic because the glove puncture was not perceived; the the wound may not be not felt immediately or bleeding from the wound may be so minor that it is not immediately noticed. It is thus a serious problem that some medical glove wearers may unwittingly delay a medical treatment of their gloved hands when a hand has become injured by a pathogen-contaminated object.

There has been an obvious increase in the wearing of medical gloves in many health care work environments following adoption of the Universal Precautions Guidelines and following the epidemic growth of AIDS in the human population. Because it is not known with certainty exactly which work environments can harbor an infectious pathogen such as HIV, medical gloves are now routinely worn by many medical or public workers whenever they suspect they may be at risk of any kind of accidental infection by any infectious pathogen. The present invention may be usefully worn in many work environments and during many kinds of work. The work environments and kinds of work in which gloves in accordance with the present invention may be used include but are not limited to the following examples: hospitals, medical clinics, private doctor offices, emergency medical work, medical ambulance work, fire rescue work, medical practice areas involving AIDS patients, surgery, gynecology, human fertility work, urology, general medicine, pathology, epidemiology, microbiology, neurology, orthopedics, radiology, ontology, nursing, dentistry, podiatry, psychiatry, psychiatric hospitals, hospices, other medical practices and specialties, kidney dialysis centers, diagnostic medical imaging-testing and operations facilities, hospital emergency waiting rooms, emergency hospital ambulatory care, clinics for drug rehabilitation, donor organ and tissue preservation banks and labs, blood banks, blood testing and related analytical chemistry labs, sperm banks, sperm testing labs, basic and clinical medical research labs, medical instrument cleaning, sharpening and repair facilities, hospital patient rooms, hospital operating rooms, cleaning and maintenance work, hospital laundries, hospital cafeterias, other hospital patient food service work, hospital morgues, funeral homes and related work areas that study or handle dead human bodies and tissues, medical and public waste or garbage collection areas, disposal areas and containers for human blood and disposible medical utensils, work with blood products, urine products or any human body products, hospital trash and other disposible waste areas which might contain medical waste, work with sharp contaminated objects such as needles, syringes, wires, catheters, and intravenous sets, plastic and glass tubes and pipettes, glass slides, scalpel blades, and the like; disposible medical instruments and work areas involved in surgical instrument handling, repair and cleaning, clothing and medical assist areas; areas of medical garbage removal and medical sanitation work, medical work in nursing or retirement homes, and cleaning or industrial operations in any building where there may be any risk of a pathogenic infection. Surgical gloves and/or examination gloves in accordance with the present invention may also be used in animal medicine and during general work with animals in research, on farms or ranches with animals, in veterinary and animal husbandry practices and pet stores, in work with zoo animals, and in similar work where there may be some risk of contact with an infectious pathogen. Gloves in accordance with the present invention may also provide useful protection from physical contact with infectious pathogens that may exist in potentially infectious, nonmedical technical areas, scientific areas and other work areas including but not limited to the following examples: industrial, military, or other research work that involves work with infectious pathogens used in molecular biology or molecular genetics, recombinant molecular genetics, fermentation and vaccine production; the facilities include any government, military, commercial, industrial, or biotechnological production, research and testing areas. Medical gloves in accordance with the present invention are also useful protective hand wear in areas or in work which may include but is not limited to the following examples: public and business building maintenance work and cleaning, outdoor public areas work, restaurant work, sports clubs, spas, health clubs, massage parlors, building rehabilitation and clean-up work; guard work in jails, prisons, and other crimminal confinement facilities. Gloves in accordance with the present invention may be useful during travel in public or private vehicles used to provide surface, underground, water, underwater, air, aerospace or even outer space transport conceivably may harbor infectious pathogens.

Conventional medical gloves are often worn to protect the hands of an individual from coming into physical contact with an infectious pathogen that infects another individual. Gloves in accordance with the present invention can provide superior protection for the glove wearer compared to conventional medical gloves when the glove wearer is within possible contact of individuals who are at risk of being infected with an infectious pathogen. Individuals who at risk of being infected with an infectious pathogen include but are not limited to the following examples: a person infected with the AIDS virus, a person infected with hepatitis B virus or other viruses, a person with a bacterial infection, a hospital patient, a health care patient, an intravenous drug user, a prostitute, a gang member, a homeless person, a mentally-ill person, a person suspected of or engaged in criminal activity, a captured or convicted or imprisoned criminal; an illegal immigrant, an immigrant from a known HIV-infested population, a new immigrant, a homosexual or bisexual individual, a sexually promiscuous individual, and a chronically-ill, elderly or incapacitated person who is at an increased risk of harboring an infectious pathogen. In addition, according to researchers based upon a U.S. survey of more than 11,000 students, it is believed that one in five American teenagers are at higher risk for acquiring AIDS because they have had sexual contact with several partners (four or more persons) during their teenage years (See The New York Times, Medical Science Section C3, dated Apr. 14, 1992 by Associated Press). Thus the risk among teenagers for acquiring AIDS may increase as more and more teenagers become carriers of the AIDS virus.

A glove in accordance with the present invention may also usefully protect an individual under other circumstances. Animals, plants, soil, water, the air, and various forms of environmental pollution are capable of supporting colonies of infectious pathogens which may infect an individual. Thus workers in many nonmedical environments can also become contaminated with an infectious pathogen. Such nonmedical workers include but are not limited to the following workers: law enforcement workers, police, state trooper, national guard, military personnel, traffic police, transit police, jail and prison workers, park workers and park cleaners, sanitation workers, city morgue workers, hospital morgue workers, funeral home workers, and cemetery workers, waste and water treatment facility workers, street cleaners, sewer workers and other municipal workers, persons cleaning public bathrooms and portable toilet maintainance workers.

In addition, flexible protective medical gloves in accordance with the present invention can be used by any doctor, dentist, health care worker and the like or other individual who choses to continue working after they have tested seropositive with an infectious pathogen such as for example HIV or hepatitus B virus (See News York Times article by Jane Gross, dated Aug. 18, 1991). It is particularly important for infected medical personnel to wear protective medical gloves so that they do not transmit their infection to another person.

If an object cuts, or otherwise penetrates a thin medical glove wall while it is being worn on a hand, the physical barrier protection provided by the glove is immediately lost. Such an accident to a glove while it is being worn may also wound the hand and this wounding may expose the blood circulation of the individual to the surface of the glove-puncturing object; becoming wounded is particularly traumatic and serious if the surface of the glove-puncturing object may be contaminated with an infectious pathogen such as HIV.

Medical personnel know that wearing a conventional medical glove can not adequately protect a hand from a glove-puncturing object contaminated with HIV. HIV contamination to a gloved individual can take place if a syringe needle contaminated with AIDs-tainted blood punctures the glove and wounds the hand. A variety of medical objects have caused an instant HIV inoculation to the hands of health care workers wearing standard surgical or examination gloves (See Henderson et al., 1990; Beekman et al., 1990; Panlilo et al., 1991).

For the present invention, the term glove wall puncture is broadly defined to encompass a glove wall puncture caused by any object or by any process. A glove wall puncture may be caused by any physical object capable of cutting, biting, abrading, puncturing, stabbing, crushing, or otherwise physically penetrating the glove wall. When such objects are contaminated with an infectious pathogen, they can act as a carrier for the transfer of the infectious pathogen to the hand and the hand wound. Alternatively, the glove wall puncture may be caused in the absence of a solid physical object, for example by any process that helps to cause a hole in the glove. Processes that may help to cause a hole in a glove include but are not limited to the following: a chemical reaction with the glove wall material, a solvent dissolution of the glove wall, a change in the ambient gas pressure or liquid pressure on a glove wall surface, passage of a powerful electrical shock through the glove wall, a thermal melting or burning of the glove wall, or a low temperature freezing followed by fragmentation of the glove wall. In the forementioned examples, the process helping to or actually causing the glove wall puncture may not actually transfer an infectious pathogen to the hand or to the hand wound. In general a glove wall puncture always creates the access means through the glove wall for an infectious pathogen from the exterior surface of the glove to then contact the hand or a hand wound.

Health care workers and medical doctors in particular, know that hand wounding is a common accident, one that they often experience a number of times each year in their work environments because conventional medical gloves are not puncture-resistant and because this is a common risk in their work environments, particularily with sharp objects (Panlilio et al., 1991; see especially Wright et al., 1991). For the present invention, the term "hand" is broadly defined to encompass all portions of an arm and a hand that may be covered by a glove in accordance with the present invention; thus use of the term "hand" for some embodiments of the present invention may refer to the fingers, all surfaces of the hand, the wrist, the forearm, and may refer even to the surfaces of the arm up to the armpit and the shoulder.

Health care workers and other professionals who care for patients with AIDS know that they may become infected with the AIDS virus (HIV) from their work with AIDS patients. It is clear that as a result of the AIDS epidemic, medical doctors and health care workers now work with increased anxiety and fear of contracting AIDS (See "Fear of Disease Changes How Doctors Work, New York Times dated Apr. 7, 1992, page 1, by Lisa Belkin). Medical workers know that an accidental hand wound during their professional work may infect them with HIV and shorten their lives (Gerberding and Schecter, 1991). Each time a gloved hand is wounded by an object contaminated with blood or other body fluids, the wounded medical worker must psychologically deal with the possibility that the wound was contaminated with HIV, and that they are at some generally-unclear risk of acquiring an HIV infection. Thus, there is clearly an urgent need for a more protective medical glove than is currently available, that can provide superior protection for the glove wearer hand when their hand is wounded by an object that may be contaminated with an infectious pathogen such as HIV.

Some medical doctors and health care workers have indicated they would not disclose if their hand was wounded or injured during work by an object possibly contaminated with HIV nor would they disclose to their co-workers if their blood were to test positive for antibodies to HIV antigens because such disclosure would reveal to their co-workers that they might have a systemic HIV infection which could threaten their employment in health care (See Orentlicher, D., 1991; and New York Times article by Jane Gross, dated Aug. 18, 1991). Thus, there is a tendency for HIV infections to go unreported by medical workers and this would suggest that data gathered to estimate the incidence of accidental glove punctures among health care workers would be underestimated.

As mentioned, medical personnel work in environments having sharp medical instruments and needles which can readily puncture a standard medical glove on a hand and cause a hand wound (See Gerberding and Schecter, 1991). The reported incidence of accidental skin punctures to hospital surgical personnel in three major municipal hospitals (in San Francisco, Albuerque, and Atlanta) has averaged 2 to 5 injuries per 100 procedures (Panlilio et al., 1991; Gerberding et al., 1990; Gerberding and Schecter, 1991). These hospitals have also reported that occupational exposure to blood occurs often in surgical settings (Gerberding et al., 1990; Gerberding and Schecter, 1991; Panlilio et al., 1991). Accidental blood contact between a patient having HIV and workers in other more casual (nonsurgical) medical settings has been predicted to increase in view of the epidemic spread of HIV infection in the United States and in the World (Gerberding et al., 1990).

Three known factors that can affect the risk of a medical worker becoming infected with an infectious pathogen are (1) the prevalence of blood-borne infection in the patient population under treatment by the medical worker, (2) the frequency and types of hazardous exposure that the medical worker is subjected to, and (3) the risk of infection that accompanies each exposure to the medical worker (Gerberding and Schecter, 1991). It is thought unlikely that medical personnel can control the first two factors and still remain valid health care workers. It is one object of the present invention to help to lower the worker's risk from the third factor, namely a glove in accordance with the present invention may be used to try to help to lower the risk of infection that accompanies each hazardous exposure to a medical worker's hand.

The risk of systemic HIV infection to an individual wounded on a hand from a single hollow needle stick has recently been estimated to average roughly 0.4 percent (1 occurence in 250 events). This risk estimate was calculated from observations of documented needlestick wounds that were contaminated with blood from patients having an advanced stage of HIV infection during which their blood had an elevated HIV titer (Beckman et al., 1990; Henderson et al., 1990). This estimate is an underestimate because some hand injuries will not be reported and this study therefore underscores the real risk that medical workers experience.

An analysis of the risk of infection that accompanies each exposure of a hand and a hand wound to an infectious pathogen has been conducted, based upon an in vitro study of glove wall punctures by needles. The study found that the risk was influenced by several variables. An important variable was the volume of infectious blood transferred by the needlestick (See Mast and Gerberding, 1991). Other important variables included (1) the titer of the infectious pathogen in the contaminating blood, (2) the needle type and size, and (3) the depth of skin penetration by the pathogen contaminated object. Other observations have shown that wearing a standard medical glove on the hand can reduce the volume of blood transferred to the hand wound by about 50 percent (See Gerberding and Schecter, 1991). When two pairs of standard medical gloves were worn on the hand, the contamination of the hand wound by blood was further reduced to between 20 to 40 percent, (Gerberding and Schecter, 1991; Mandelbrot et al., 1990). Thus, studies have found that wearing two standard gloves on a hand can reduce, but does not adequately protect, a hand when it is wounded by a blood-tainted needle. The hand can become contaminated with a substantial fraction of the foreign blood, infectious pathogens or other substances present on the glove-puncturing blood-tainted needle. In view of the (a) incomplete protection that conventional gloves can provide, (b) the frequency of accidental hand wounds by gloved health care workers, and (c) the increasing incidence of HIV infection in the human population, it is likely that the probability of a health care worker becoming infected with HIV during work from HIV contamination of a hand wound will increase. The medical profession is concerned about their risk of HIV infection from a medical glove puncture and would like their risk to be reduced (See Orentlicher, 1991).

To have medical utility, a protective medical glove should retain the flexibility and the comfortability characteristics of conventional medical gloves. The prior art has not disclosed a flexible protective medical glove having a wall that is capable of storing a non-liquid antiseptic composition which comprises an antiseptic. The prior art has not disclosed the uses for a flexible protective medical barrier glove having a wall that stores a non-liquid antiseptic composition which comprises an antiseptic. When a glove puncture is caused by an object, the present invention can provide a non-liquid antiseptic composition capable of contacting and coating the object puncturing the flexible glove; useful as a treatment means for the hand and the hand wound that may occur when the flexible glove is punctured and/or the hand is wounded by the object puncturing the flexible glove; and particularily useful when the object may be contaminated with an infectious pathogen.

Related additional prior art is described below, but is not identical to the present invention. In view of the prior art, the subject matter of the present invention as a whole would not be obvious to persons of ordinary skill in the art pertaining to the subject matter of the present invention at the time of the invention.

A protective gel composition has been disclosed (U.S. Pat. No. 5,019,604 issued May 28, 1990 to G. M. Lemole) for coating the skin prior to covering the hands with standard surgical gloves. In one example, the composition contains lanolin, liquid silicone, polypropylene glycol monoleate, polytetrafluoroethylene powder in microspherical form, zinc oxide powder, anti-bacterial agents and antiviral agents with a preferred agent being nonoxynol-9. The composition forms a water repellent coating on the skin to prevent the skin contacting body fluids such as blood and blood products that may penetrate the gloves and otherwise expose the skin to harmful microbial and vital infections. The use of a protective gel to continuously contact the skin with chemicals may be irritating to the hands. After glove removal, the gel coating the skin must be washed off. Some individuals may also find that the number of steps required to use and remove the gel is time consuming or disagreeable. Use of the gel composition between two gloves was not suggested.

Use of antiseptic-coated gloves has been disclosed in a study of surgical hand hygiene (J. Hospit. Infect. 1988, 11 Supp. A:244-250 by Newsom et al.). Gloves were coated with solid cetylpyridinium chloride and surpressed skin flora counts after prolonged operations in comparison to standard gloves, but the solid antiseptic coating may cause hand irritation after prolonged contact. Use of such antiseptic between two gloves was not suggested.

Use of the antiseptic 4.0% chlorhexidine gluconate detergent formulation containing 4.0% isopropyl alcohol (Hibiclens/Hibiscrub) and the antiseptic 0.50% chlorhexidine gluconate in 70.0% isopropyl alcohol with emollients (Hibistat/Hibisol) as a skin treatment has been disclosed (J. Hospital Infection, 1990, 15:279-282 by Montefiori DC et al.). This antiseptic composition was found to inactivate HIV in experimental cell cultures after 15 seconds when used at 1:100 and 1:5 dilutions. Use of such antiseptic between two gloves was not suggested.

A sterile glove has been disclosed in which the antibacterial agent zeolite is immobilized in a plastic film on one or both surfaces of the glove; useful for handling food, for work in a kitchen or for medical purposes (U.S. Pat. No. 5,003,638 issued Apr. 2, 1991 by T. Miyake and T. Yamamoto). According to the Merck Index (8th Edition), zeolite is a hydrated dust or powder of alkali aluminum silicate. An immobilized thin layer of antibacterial agent can not help to prevent a hand wound infection.

A glove has been disclosed which was made by first immobilizing an anti-microbial agent into rubber and by then solidifying the mixture into a glove (U.S. Pat. No. 5,031,245, issued Jul. 18, 1991 by Milner, R.). The glove was reported to be an improved barrier to HIV. A non-ionic, sparingly water-soluble antimicrobial agent that does not coagulate natural rubber latex such as chlorophene, dichloroxylenol, hexachloraphane was used; diphenyl derivatives may be halogenated and used such as 0.1% to 10% by wt. 2,4,4'-trichloro-2'-hydroxyphenyl ether, diacetylaminoazotoluene, triclocarban and triclosan. The surface of the glove was dusted with a powder containing an anti-microbial agent such as chlorhexidine digluconate and cyclodextrin. The antiseptic dust on the glove surface contacts the hand while the glove is worn and may irritate the skin.

A multilaminar hybrid glove has been disclosed having at least an outer rubber layer, an inner rubber layer and at least one intermediate (cotton or Kevlar plastic) material layer layer impregnated with a gel containing 4 percent nonoxynol-9; regions of the glove may be protected with an armor of fungicide-coated, puncture-resistant Kevlar plastic fabric (Infect. Control Hospital Epidemiol. 1991, 12(7): 435-438 by Johnson et al., 1991). In vitro tests found that the glove with Kevlar resisted some needlestick punctures. In vitro tests found that the glove reduced the transfer of HIV from a solid needle tip to a culture dish by chemical inactivation of the virus on the needle when the needle contacted the gel containing nonoxynol-9 in the cotton layer. Results using "hollow" syringe needles were not obtained and the authors indicated they could not predict such results without additional study. The authors disclosed that their gloves were too stiff and too thick-walled to function on the dominant hand of a surgeon; they suggested that thinner, more surgically acceptable intermediate gloves were needed; but these three-layer gloves containing nonoxynol-9 gel antiseptic were not flexible enough for the needs of a medical worker performing manual skilled work.

The present invention is directed toward providing novel flexible protective medical glove designs and methods for their use. A glove in accordance with the present invention can provide a non-liquid antiseptic composition treatment to a hand when the glove wall is punctured. The subject matter of the present invention as a whole has not been made obvious nor has it been suggested by the prior art for medical gloves or for antiseptic compositions used on the hands. The flexible protective medical gloves comprising the present invention are provide a major improvement in medical glove protection technology because the present invention may be useful as an automatic means for helping to protect a hand from becoming infected by a glove-puncturing object when the object is contaminated with an infectious pathogen. Use of the gloves does not constantly expose the hands to a potentially irritating antiseptic. The non-liquid antiseptic composition in the gloves can not flow from a glove wall puncture as a liquid could. However, for some embodiments of the present invention the non-liquid antiseptic composition may be capable of automatically expanding following a glove wall puncture so that non-liquid antiseptic composition is expelled from the glove wall puncture onto the hand and into a hand wound should one occur.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a flexible protective medical glove having a thin flexible glove wall comprising at least an outer glove layer of a first material having a thickness of between about 1 mil (1 mil is one-thousandth of an inch) to about 40 mils and at least an inner glove layer of a second material having a thickness of between about 0.3 mils to about 30 mils wherein the first material and the second material form at least the walls of a compartment storing a non-liquid antiseptic composition or at least some of the material components capable of comprising the non-liquid antiseptic composition. The compartment(s) storing the non-liquid antiseptic composition, or its components in some separate fashion, may become mixed together to some degree during a glove wall puncture. Thus the present invention has the capability to provide some non-liquid antiseptic composition in the compartment along at least some portion of the glove wall puncture. As a result of a glove wall puncture a suitable amount of the non-liquid antiseptic composition is formed. The compartment(s) generally has a thickness of less than 100 mils; it is expected that the compartment(s) may become temporarily compressed during glove wear so that compartment(s) thickness is capable of varying; in addition, the compartment(s) in some portions of the glove may be expanded due to glove design, or during the wearing of a glove to a thickness exceeding 500 mils. At the back end of a glove where the hands are first inserted, the compartment(s) may be open or may be closed. Alternatively, the glove compartment may be optionally capable of being opened or closed using for example a zip-lock sealing mechanism or other sealing seam mechanism, to allow the glove wearer to increase or reduce the amount of non-liquid antiseptic composition in the glove. Preferably the compartment(s) is closed. A glove in accordance with the present invention can be as flexible a conventional medical glove; this is important because glove flexibility permits a gloved hand to easily and adequately perform delicate, dexterous and complex hand work including for example, the hand work of a surgeon, a medical doctor, a dentist, a laboratory worker, a health care worker, a law enforcement worker, a hospital worker and like workers. It is envisioned that the glove wall could be constructed from almost any material or combination of materials provided that at least the surface of the inner glove layer and at least the surface of the outer glove layer are not liquid permeable. Most preferably at least the inner and the outer glove wall layers are made of thin flexible layers of rubber and/or plastic materials.

The non-liquid antiseptic composition comprises an antiseptic in a non-liquid composition. Preferably the antiseptic comprises at least one of the following antiseptics: povidone-iodine, elemental iodine, sodium iodide, potassium iodide, sodium hypochlorite, nonoxynol-9, and chlorhexidine gluconate. For the present invention the antiseptic composition is termed a "non-liquid antiseptic composition" to distinguish its physical properties from the physical properties of a liquid antiseptic compositions. Once formed, the non-liquid antiseptic composition behaves as a non-liquid meaning that the complete antiseptic composition is incapable of flowing like a liquid from a glove wall puncture. For the present invention, the term "non-liquid antiseptic composition" is not meant to imply that any of the components which comprise the non-liquid antiseptic composition are necessarily non-liquid. Rather, the final assembled or activated, non-liquid antiseptic composition will have the inability to flow like a liquid. Thus, one or more liquids may be used to form the non-liquid antiseptic composition, such as for example ethanol, water, isopropanol, or a mixture thereof. Preferably the non-liquid antiseptic composition further includes at least one surface active agent. The non-liquid antiseptic composition may also contain one or more of the following substances: an organic silicone, an organic solvent, a salt, an acid, a base, a pH buffer, a preservative that can help to stabilize the antiseptic activity, a metal ion chelator, a catalyst, a sticky chemical additive, a gelling agent, a thickening agent, a hardening or stiffening agent, a humectant, an emulsifier, a viscosity-modifying agent that may be used to increase the coating of the glove puncturing object by the the liquid antiseptic composition, a chemical scent that can help to increase the smell or render the odor of the liquid antiseptic composition more pleasant, a gas generation system, a foaming agent that can help to better mix the non-liquid antiseptic composition with the contaminants on the hand and in the hand wound containing infectious pathogen, glycerin, a soap, a detergent, a pain-causing agent (algesic), a coloring agent, and/or a vasoconstricting agent.

The present invention also provides a new method for protecting a gloved hand from an infectious pathogen in the event of glove damage while the glove is being worn.

It is another object of the present invention to also provide methods for the use of the present invention. Gloves in accordance with the present invention, like standard medical gloves, can provide a useful thin physical barrier form of protection to the hands. It is an object of the present invention to minimize contact between the hand and the non-liquid antiseptic composition to reduce unnecessary irritation of the hand by the antiseptic, until such time that the wall of the glove is punctured by an object, and then antiseptic is needed to contact the hand. For some embodiments of the present invention, when an object punctures a glove wall of the invention, the present invention has the capability to automatically begin a non-liquid antiseptic composition treatment of the hand or the hand wound should a wound occur.

The treatment of non-liquid antiseptic composition from the glove should be capable of inactivating, killing, and/or otherwise destroying the infectious pathogen that the non-liquid antiseptic composition may contact. The non-liquid antiseptic composition should be capable of disabling the contacted infectious pathogen so that the infectious pathogen from the object is no longer a danger to the hand and the hand wound of the contaminated individual. For the present invention, the term "infectious pathogan" has a broad meaning intended to encompass known and to be discovered pathogenic microorganisms which would include prions and viruses as well as the biochemical cofactors or molecular fragments that can be synthesized or released by an infectious pathogen or by other biological cells or that may arise by other biosynthetic means that could be considered to be infective; the term is intended to include biochemical cofactors and chemical fragments including but not limited to the following examples of infective materials as well as their related biochemical machinery: deoxyribonucleic acids (DNA), ribonucleic acids (RNA, mRNA, tRNA and the like), protein cofactors, and the enzymes that act upon DNA, RNA, mRNA, tRNA and like nucleic acids in any form or conformation which may alter the potency of a pathogenic infection. The non-human proteins that help HIV to inhibit the human immune system are considered for the present invention to be protein cofactors and are considered relevant infective materials. Some of these proteins may affect the binding of HIV to human cells. Damage to these proteins by the non-liquid antiseptic composition may have anti-infective utility. Thus, the term "infectious pathogen" for the present invention is broadly defined to include at least the following infectious pathogens in any of their physical forms: viruses, bacteria, yeasts, molds, algae, other fungi, multicellular parasites, rickettsia, prions, the spores of infectious pathogens, and includes any of the biochemical molecular fragments of an infectious pathogen (i.e., DNA, the various RNA molecules, associated DNA and RNA enzymes and associated proteins) that could contribute to the infectivity of an infectious pathogen. For some embodiments of present invention, it is a preferred object that the non-liquid antiseptic composition has potent antiviral or viricidal activity against the human immunodeficiency virus (HIV), and/or the Hepatitis B virus.

An object of the present invention is to help to protect the hand and a hand wound from becoming infected by a glove puncturing object that is contaminated with an infectious pathogen should the object puncture the glove wall and contact or wound the hand. When the glove wall is punctured by an object, the object may then wound the hand and come into contact with the blood circulation of the individual. In passing through the glove wall, the object can become coated with non-liquid antiseptic composition and can carry some non-liquid antiseptic composition along with the infectious pathogen contamination that may be present on the object, to the hand and into the hand wound; useful as a automatic and immediate non-liquid antiseptic composition treatment to the hand and the hand wound that may help to immediately provide a protective treatment to the gloved individual so that the individual does not acquire a systemic infection from the infectious pathogen on the glove-puncturing object.

In one embodiment according to the present invention, the glove is comprised of a liquid-impermeable outer layer of a first material and a liquid-impermeable inner glove layer of a second material wherein the first material and the second material form the walls of a compartment(s) capable of containing a non-liquid antiseptic composition; the compartment(s) contain or may store the non-liquid antiseptic composition. The glove also has the capability to provide a coating to at least a portion of the object puncturing the glove wall; the coating comprising the non-liquid antiseptic composition; the coating on the object providing a means for automatically and immediately transfering some of the non-liquid antiseptic composition onto the hand and into the hand wound resulting from the object puncturing the glove while the glove is being worn; the non-liquid antiseptic composition transferred to the hand and the hand wound having the capability to provide a treatment of non-liquid antiseptic composition to the hand and the hand wound which may have become contaminated with an infectious pathogen transferred from the glove-puncturing object. It is desirable that the non-liquid antiseptic composition have some capability to dissolve into or become liquified upon contact with the hand or upon contact with the glove-puncturing object or upon contact with hand fluids or blood of the hand wound due. The glove has the additional capability of treating the hand and the hand wound with the non-liquid antiseptic composition when the object punctures the glove wall, when the object contacts the hand, if and when the object wounds the hand and whether or not the object actually contaminates the hand and the hand wound with the infectious pathogen. The non-liquid antiseptic composition automatically and immediately transferred by the glove-puncturing object from the glove to the hand and the wound on the hand, may be useful by beginning to help to protect the hand, the hand wound, and thus the systemic circulation of an individual by killing, inactivating and/or otherwise destroying without undue delay the infectious pathogen that may have contaminated the hand and the hand wound as a result of a glove-puncture by an object that may be contaminated with an infectious pathogen.

In a second embodiment according to the present invention, the glove can provide a non-liquid antiseptic composition such as a foam, a paste, a gel, an ointment or other greasy composition which is capable of optionally being redistributed within the compartment(s) of the glove by the manual application of pressure to the glove wall compartment(s) in order to force the non-liquid antiseptic composition in the compartment(s) to accumulate near the glove wall having the hole should one be caused by a glove-puncturing object. As a result, the non-liquid antiseptic compostion can then optionally be forcibly extruded from the punctured glove wall having the hole onto the hand and into the hand wound; the additional non-liquid antiseptic composition contacting the hand and the hand wound may be used to help to provide additional protection to the hand, the hand wound, and the systemic circulation of an individual from an infectious pathogen that may have contaminated the hand and the hand wound when the glove-puncturing object contacted the hand and caused a hand wound. A hand wound is defined for the present invention as at least a degree of damage to the skin that increases the probability that an individual can become infected by an infectious pathogen. A hand wound may or may not cause bleeding of body fluids or blood from the individual.

In another embodiment according to the present invention, the glove contains a non-liquid antiseptic composition which may also contain a pain-causing chemical (algesic agent) such as a potassium salt, formic acid, bradykinin or substance P. One object of the pain-causing chemical is to provide enhanced pain sensation at the hand wound to better warn the glove wearer that they may have suffered a hand wound.

According to another embodiment of the present invention, the glove contains a non-liquid antiseptic composition which may also contain a colored substance such as a dye or an opacifier that can help to visually signal when and where a glove wall has been punctured or damaged; useful particularily for distracted, preoccupied, or overly-stressed individuals needing to wear a medical glove.

According to another embodiment of the present invention, the glove contains a non-liquid antiseptic composition which may also contain a chemical capable of producing a distinctive chemical smell or odor which can be either bad smelling or pleasant smelling. A sudden release of the distinctive chemical odor from a glove puncture can be a useful means for increasing a glove wearer's awareness that a glove may be damaged.

According to another embodiment of the present invention, the glove contains a non-liquid antiseptic composition which may also contain a vasoconstricting agent; preferably a catecholamine such as epinephrine or norepinephrine. An object of the vasoconstricting agent is to reduce blood flow in the hand wound area as a means for limiting the systemic dispersion of the infectious pathogen away from the hand wound by the blood circulation or by the lymphatic circulation of the individual.

According to another embodiment of the present invention, the glove contains a non-liquid antiseptic composition which may also contain a viscosity-modifying agent that can be used to alter the physical properties of the liquid antiseptic composition; this additive can be particularly useful as a means for influencing the thickness of the coating of non-liquid antiseptic composition that can form on the object that punctures the glove wall.

According to another embodiment of the present invention, the non-liquid antiseptic composition may have adhesive properties that allow the non-liquid antiseptic composition to coat or "gum-up" the surfaces of the object that contact the composition as the object punctures the glove;useful so that the contamination including infectious pathogen on the object is less readily spread from the glove-puncturing object when the object contacts the hand or causes a hand wound.

According to another embodiment of the present invention the glove wall has a plurality of glove layers that can act as a structural connection which reconfigures the compartment storing the non-liquid antiseptic composition into a plurality of compartments capable of storing the non-liquid antiseptic composition; useful as a means for selectively partitioning the non-liquid antiseptic composition in the glove wall.

According to another embodiment of the present invention, the glove wall comprises a sponge-like wall structure capable of acting as a structural connection which reconfigures the compartment storing the non-liquid antiseptic composition into a plurality of compartments capable of storing the non-liquid antiseptic composition; the outer and inner surfaces of the glove wall can be coated with a liquid-impermeable coating of a rubber or a plastic material. The actual number of pore-sized compartments, the degree of segmentation of the glove wall into the compartments, and the volume of each subcompartment are not critical limitations for the present invention and may be highly variable.

According to another embodiment of the present invention, the compartment storing the non-liquid antiseptic composition is subdivided into a number of smaller compartments as a means for controlling the distribution and capacity for redistribution of the non-liquid antiseptic composition within the glove wall. Each smaller compartment may be connected to another small compartment by at least one hole so that the non-liquid antiseptic composition can be dispersed between the compartments if desired using a pressure gradient. Some of the subdivided compartments may be closed.

According to another embodiment of the present invention, the compartment storing the non-liquid antiseptic composition is subdivided into a plurality of closed compartments as a means for controlling the distribution or thickness of the non-liquid antiseptic composition within the glove wall.

According to another embodiment of the present invention, the compartment of the glove storing the non-liquid antiseptic composition is connected to an additional compartment of non-liquid antiseptic composition using a tube with an opening whose aperature can be varied as desired or closed entirely.

The subject matter which we regard as our invention is more particularily pointed out and distinctly claimed in the concluding portion of this specification. Other features and advantages are inherent in the protective glove and method claimed and disclosed for its use or will become apparent to those skilled in the art from the following detailed description in conjunction with the accompanying diagrammatic drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view and a partial enlarged view illustrating a glove containing a non-liquid antiseptic composition between an outer layer of a first material and the inner layer of a second material in accordance with the present invention;

FIG. 1B is a partial enlarged view of the section of a glove wall shown circled in FIG. 1A;

FIG. 2A is an enlarged sectional view of a glove wall taken along line 5--5 in FIG. 1A, illustrating one edge of an object which is puncturing a glove in accordance with the present invention; in this example, the object is puncturing the glove wall along line 5--5 and the non-liquid antiseptic composition in the glove wall is in the process of coating the object;

FIG. 2B illustrates the situation of FIG. 2A at a later point in time, after a portion of the glove-puncturing object has fully punctured the glove wall and has then wounded the hand; in the process the non-liquid antiseptic composition coating or smearing on the glove-puncturing the object has been transferred to the hand and hand wound as an immediate automatic antiseptic treatment to the hand and to the hand wound; and

FIG. 2C illustrates the situation of FIG. 2B at a later point in time, following either the optional application of external manual pressure to the damaged glove or for some embodiments of the present invention after glove damage has occurred and initiated internal gas production by the non-liquid antiseptic composition and created an internal positive pressure within the compartment that can expand or expell some forms of the non-liquid antiseptic composition from the glove out of the hole caused by the glove-puncturing object; the result is both useful for increasing the amount of non-liquid antiseptic composition in the glove wall near the glove puncture hole, and is useful for extruding or expelling a suitable amount of non-liquid antiseptic composition from the glove wall through the glove wall puncture hole and onto the hand and into the hand wound;

FIG. 3 illustrates a perspective view of a glove in accordance with the present invention, and a partial expanded view of a finger and a partial expanded view of the wrist area; the compartment storing non-liquid antiseptic composition is enlarged in the wrist area of the glove;

FIG. 4 illustrates a perspective view of a glove in accordance with the present invention with a partial expanded view of the glove wall; the glove has several structural connections between the innner layer and the outer layer of the glove.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1A illustrates a glove in accordance with the present invention; the glove indicated generally at 1 is composed of flexible materials forming a liquid-impermeable wall having the capability to provide a non-liquid antiseptic composition treatment to a hand and to a hand wound underneath the glove while the glove is being worn when the wall of the glove is punctured and/or when the hand is wounded by an object that may be contaminated with an infectious pathogen.

It is an object of the present invention to provide a glove having any conceivable arm length, up to and including a glove having an arm length that can protect the entire arm of an individual up to about the shoulder region of the individual. Whereas the normal length of the glove is between about 8 inches and about 12 inches, the arm-length long glove may be up to 36 inches in length.

A glove in accordance with the present invention can have elastic walls so that one size of the glove may be worn on several different sized hands as can a conventional medical examination glove. Alternatively, a glove in accordance with the present invention can be made available in a number of different sizes as are some conventional medical surgical gloves, so that the glove does not need to be substantially stretched or unduly stressed by the glove wearer in order for the glove to closely fit their hand.

FIG. 1B is an enlarged view of a representative section of the glove wall shown circled in FIG. 1A. FIG. 1B illustrates that the glove wall comprises an outer layer 2 of a first material and an inner layer 3 of a second material. Together the first material and the second material can be used to form the walls of a compartment 4 that is capable of containing or storing a non-liquid antiseptic composition.

A glove in accordance with the present invention contains or is capable of containing a non-liquid antiseptic composition in compartment 4. Not depicted in the figures is the feature that compartment 4 for some embodiments of the present invention can optionally be configured into any shape or size within reasonable limits of utility. Furthermore, compartment 4 may be subdivided into a plurality of compartments; each of these may be termed a subcompartment for the present invention. A variety of open, porous, partly closed, and/or closed additional partitions or walls within the compartment may be used to form the subcompartments. The non-liquid antiseptic composition is symbolized in all figures by stippling the area in the figure with dots. The non-liquid antiseptic composition comprises an antiseptic in a non-liquid composition. For some embodiments of the present invention, the antiseptic may be used in a solid form and may be the only ingredient comprising the non-liquid antiseptic composition. For example, a powder of sodium iodide or potassium permanganate might be used as a non-liquid antiseptic composition.

It is another object of the present invention to provide a flexible glove wall capable of providing a physical barrier means of protecting the hand while the glove is being worn by an individual. The glove can provide a useful physical barrier until a portion of the glove wall is punctured by an object. When a glove in accordance with the present invention is to be worn on the hand of a person such as a surgeon, a medical doctor, health care worker, or other worker, the glove wall needs to be flexible so that the the gloved hand can easily and adequately perform delicate, dexterous and complex work without causing the hand to become tired.

It is another object of the present invention to provide the method of using a flexible protective medical glove in accordance with the present invention wall on a hand of an individual to protect the hand in the event that an object that may be contaminated with an infectious agent punctures the glove, comprising the steps of:

(a) using the glove initially as a liquid-impermeable physical barrier to infectious pathogens; during which the glove can be used to permit the hand to perform a delicate, dexterous and complex type of work that includes the type of work performed by a surgeon, a medical doctor, a dentist, a laboratory worker, a hospital health care worker, a law enforcement worker, and a hospital worker; and during which the glove can be used to store a non-liquid antiseptic composition in the glove wall;

(b) using the glove to coat a portion of an object that may puncture the glove wall with the non-liquid antiseptic composition while the object punctures the compartment in the glove storing the non-liquid antiseptic composition;

(c) using the object puncturing the glove to transfer a portion of the non-liquid antiseptic composition coating the object from the glove to the hand and into the hand wound; and

(d) using the non-liquid antiseptic composition that is transferred to the hand and into the hand wound to help to kill, inactivate, and to otherwise destroy any infectious pathogen transferred to the skin and into the hand wound by the glove-puncturing object.

It is another object of the present invention to provide a flexible protective medical glove that can be worn to protect an individual from an infectious pathogen; such a glove is particularily useful for a worker who ordinarily needs to wear a pair of standard medical or standard surgical gloves in order to protect their hands during their work. Gloves in accordance with the present invention can provide antiseptic chemical protection in addition to the barrier protection provided by conventional medical gloves. Thus, the present invention should be useful for medical personnel such as doctors, surgeons, dentists, laboratory workers, health care workers, and other hospital workers; the gloves should be particularily useful for medical personnel and other individuals who care for or may come into potentially infectious contact with AIDS infected or Hepatitis B infected patients.

FIG. 2A, FIG. 2B, and FIG. 2C illustrate the function of the present invention when an object causes a glove puncture while the glove is being worn on a hand. In most instances, a glove in accordance with the present invention is thin-walled like a standard medical examination glove or like a standard surgical glove. Thus, a glove wall of the present invention is capable of being punctured by an object when it contacts the glove wall with sufficient force. For the present invention, the definition of a glove-puncturing object is meant to include objects capable of puncturing, tearing, penetrating, cutting, abrading, shredding, chopping, biting, or otherwise disrupting the physical integrity of the glove wall. The wounding of a gloved hand is a common accident with health care workers. The glove puncturing object may be blunt or sharp edged. Typical objects that may cause an accidental glove puncture include the following objects: hypodermic syringe needles, suture needles, other needles, glass fragments, sharp metal fragments, scapel blades, mechanical devices, surgical instruments, medical instruments, blunt forceps, glass slides, glass capillary tubes, and accessory medical objects such drill tips, chisels, saws, wires and other glass objects. The edge of the glove-puncturing object depicted in FIG. 2A, FIG. 2B, and FIG. 2C is sharp. However, a sharp object is depicted here only for illustrative purposes and is not meant to be a limiting example. The glove puncturing object may be a blunt-edged object. For any glove-puncturing object, the interactions between glove-puncturing object 6, glove layer 2, glove layer 3, non-liquid antiseptic composition 4 and hand 8 as illustrated in the figures, are expected to be similar as will become readily apparent from the following detailed description of these interactions.

FIG. 2A illustrates a cross-section of a glove wall along Line 5--5 as shown in FIG. 1A. A glove-puncturing object 6 is shown puncturing a glove on a hand 8 at a glove wall puncture 10. Object 6 may be contaminated with an infectious pathogen. In addition, object 6 may be contaminated with blood, other body fluids, other solids and mixtures therof. The contamination of the glove-puncturing object 6 has not been depicted in these figures. The three arrows in FIG. 2A indicate the direction of motion for object 6. The contact angle of object 6 with the glove wall is not critical for function of the present invention.

It is another object of the present invention to provide a coating 7 of non-liquid antiseptic composition on the puncturing portion of object 6. When object 6 punctures outer glove layer 2 and contacts compartment 4 storing the non-liquid antiseptic composition, the contact may provide object 6 with a coating 7 of non-liquid antiseptic composition.

It is another object of the present invention to transfer a portion of coating 7 from object 6 for example, to the space between inner glove layer 3 and hand 8. In FIG. 2B, object 6 is puncturing inner glove layer 3 and thus has completely punctured the glove wall. If the non-liquid antiseptic composition is an essentially dry solid, a granular, a crystalline, a powder or the like dry composition, then coating 7 of non-liquid antiseptic composition on object 6 may deposit some of the dry composition in a small portion of the space between inner glove layer 3 and hand 8. Fluid matter on object 6 may cause the dry non-liquid antiseptic composition to adhere to some degree on object 6. If the non-liquid antiseptic composition contains in part some liquid and/or the antiseptic is solvated to some extent, as occurs with a number of non-liquid compositions such as foams, pastes, gels, ointments, greases, bases and the like compositions, then coating 7 is more likely to smear, stick, film or provide an even or more complete coating on the puncturing surfaces of object 6; preferable as a means for allowing a portion of the non-liquid antiseptic composition to be transferred on object 6 from compartment 4 to the space between inner glove layer 3 and hand 8.

It is another object of the present invention to have the capability to transfer a portion of coating 7 to hand wound 9, should a hand wound occur when the glove is punctured by object 8. Depending upon the depth of penetration of object 6 into hand 8, the hand wound 9 may have a shallow or a deep depth and variable bleeding. Prior to contacting the gloved hand, object 6 may have been contaminated; the contamination may include an infectious pathogen, blood, other body fluids, other solids and mixtures thereof. The infectious pathogens transferred from object 6 to hand 8 or hand wound 9 can cause a hand infection and/or a systemic infection in a human. As mentioned above, it is known that the risk of an infection in the gloved individual may be significantly lowered by immediately treating the potentially contaminated hand and the hand wound with an antiseptic. If object 6 contamination includes HIV virus or Hepatitis B virus, then contamination of hand 8 or hand wound 9 by object 6 can be very dangerous. Thus, a particularily important capability of a glove in accordance with present invention is to use the glove puncturing object 6 to transfer some of the non-liquid antiseptic composition from the glove to the hand and into hand wound as a preventative antiseptic treatment at the same time that object 6 may be contaminating the hand and a hand wound with an infectious pathogen. Providing an immediate treatment of non-liquid antiseptic composition to the hand and to the hand wound may be critical to help to prevent the establishment of a pathogenic systemic infection in individuals.

It is another object of the present invention as illustrated in FIG. 2C, to optionally enable the glove wearer or any other individual observing the gloved hand to more quickly see puncture site 10. To accomplish this objective, the non-liquid antiseptic composition may contain a colorant. The colorant may consist of one or more dyes and/or one or more opacifiers or any combination therein. Some examples of the colorants that may be used in the liquid antiseptic composition include but are not limited to one or a combination of the more than one of the following dyes: FD&C Yellow No. 5, FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Red No. 40, FD&C Red No. 40, D&C Red No. 28, D&C Red No. 30, D&C Red No. 33, FD&C Blue No. 1, FD&C Blue No. 2., FD&C Green No. 3, D&C Green No. 5, yellow iron oxide, black iron oxide, red iron oxide brown iron oxide and mixtures thereof. Any suitable dye may be used. The colorant may be combined with one or more of the following opacifiers: white titanium dioxide, white calcium carbonate, white zinc sulfate, white zinc oxide, yellow iron oxide, black iron oxide red iron oxide brown iron oxide and mixtures thereof. Other acceptable opacifiers may be used.

Optionally, after a glove has been punctured by an object, another object of the present invention is to provide a smaller hole in outer glove layer 2 than in inner glove layer 3, after the glove-puncturing object has been removed from the glove wall at puncture 10. The relatively larger hole in inner glove layer 3 can help to promote a relatively larger transfer of non-liquid antiseptic composition from the glove to the hand and hand wound than from the glove to the outer surface of the glove wall. In other words, the difference in outer and inner glove layer puncture holes may be used to direct the non-liquid antiseptic composition toward the hand where it is needed to provide a treatment and may help reduce antiseptic contamination of the external surface of the glove. External antiseptic contamination of a doctor's gloves may be undesirable for example around medical patients or for a surgeon during internal surgery when the internal tissues of patient's body should not be exposed to an antiseptic.

Whether or not the glove-puncturing object is known to be contaminated with an infectious pathogen, it is another object of the present invention to provide a prophylactic treatment of non-liquid antiseptic composition to the hand and to the hand wound when a glove wall puncture 10 is caused by any object. The non-liquid antiseptic composition transferred to the hand and the hand wound can contact the hand and can dissolve or liquify in the hand wound. An immediate and non-delayed mixing of the antiseptic composition with any biological or infectious pathogen contamination that may be present in hand wound 9 may be useful for effective disinfection by inactivating, killing and/or otherwise destroying any infectious pathogen transferred to the hand wound. Thus, use of gloves in accordance with the present invention is envisioned as a particularily important preventative measure when there is any anticipated risk that the glove wearer could become exposed through the hands to HIV hepatitis B virus.

For some embodiments of the present invention the glove may be designed so that the non-liquid antiseptic composition in compartment 4 is capable of some redistribution. Providing the present invention with the capability for some redistribution of the non-liquid antiseptic composition may help meet the needs of the glove wearer following an accidental glove wall puncture. When the risk of infectious pathogen contamination to hand 8 and hand wound 9 has been perceived, then reflex glove massage by the gloved individual may be a particularily effective method of using a glove in accordance with the present invention to mobilize additional non-liquid antiseptic composition onto the hand and into the hand wound where it can be useful. Optionally, the glove wearer can massage (rub or apply constant pressure) to the glove wall near the puncture wound to force the non-liquid antiseptic composition in compartment 4 to accumulate near the glove wall having the hole (the hole in glove wall puncture 10). The thickness of compartment 4 in the glove wall in FIG. 2C is expanded compared to its thickness in FIG. 2B to illustrate the point that a local accumulation of the non-liquid antiseptic composition may occur in compartment 4 near glove wall puncture 10 as a result of glove massage. The local accumulation of non-liquid antiseptic composition in the glove wall can be further massaged or pressured by a hand or other means to force the non-liquid antiseptic composition in compartment 4 to become expelled, moved or extruded from the puncture hole in the glove, onto the hand and into the hand wound. This redistribution of the non-liquid antiseptic composition is only feasible when for example the non-liquid antiseptic composition is in a distensible or moldable state such as a foam, gel, paste, ointment, grease, putty, base and the like combinations of gas, liquid, and/or solids.

For some embodiments of the present invention, the non-liquid antiseptic compositions may be capable of providing a gas with antiseptic properties; examples of such antiseptic gases include but are not limited to the following gases: oxygen, chlorine, fluorine, bromine, iodine, chlorine dioxide, ozone, other halogen-oxygen compound gases, aldehyde gases, ethylene oxide, propylene oxide, propiolactone, sulfur, and the like and mixtures thereof. The antiseptic gas may be formed before, during or after the act of glove puncture by an object, or for example at the discretion of the glove wearer. The gas may be formed or provided by from the combination and/or chemical reaction and/or decomposition of a substance or substances(s) present in compartment 4 which may be singular or multicompartmental. Gas-producing substances may readily diffuse to the hand and hand wound treatment area through the glove puncture hole caused by the glove-puncturing object.

For some embodiments of the present invention, a dry solid antiseptic composition may be provided in compartment 4. Effective massage and/or redistribution of a dry solid antiseptic composition in compartment 4 may be difficult.

It is envisioned that for some embodiments of the present invention, a combination of substances in the glove or at the treatment area(s) may provide during the use of the present invention suitable antiseptic gases and/or non-liquid antiseptic compositions that are capable of being dispersed from the glove puncture. Dispersion may be accomplished by glove massage or other manually applied pressure or chemical generation of pressure and/or expanding antiseptic composition volume within compartment 4 may expell the non-liquid antiseptic composition from the glove wall puncture to the hand to inactivate or kill infectious pathogens that may be present on the hand or in the hand wound or other treatment areas. Treatment areas include but are not limited to the following: any surfaces of the glove puncturing object including the inner barrel of the syringe needle, any surfaces of the glove and/or its compartment(s), and any portions of