Protective medical gloves and methods for their use

• US 5,335,373 A
• Filed: 11/29/1991
• Issued: 08/09/1994
• Est. Priority Date: 11/29/1991
• Status: Expired due to Fees

• Current Assignee: Edward A. Jazlowiecki, Karl P. Dresdner Jr, Kenneth H. Dangman
• Original Assignee: Edward A. Jazlowiecki, Karl P. Dresdner Jr, Kenneth H. Dangman
• Inventors: Dresdner, Karl P. Jr., Jazlowiecki, Edward A., Dangman, Kenneth H.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Current, Sara M.
• Application Number:
  US07/800,487
• Time in Patent Office: 984 Days
• Field of Search: 2/167, 2/168, 2/169, 2/164, 2/161 R, 2/159, 2/161.7, 2/901, 128/292, 128/306, 128/307, 604/292
• US Class Current: 2/161.7
• CPC Class Codes: A41D 19/0058 Three-dimensional gloves
• CPC Class Codes: A41D 19/0096 Means for resisting mechanical agressions, e.g. cutting or piercing
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 42/10 Surgical gloves
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A protective medical glove containing a liquid antiseptic composition and methods for its use are disclosed. The flexible glove comprises at least a thin inner layer and at least a thin outer layer of material; the outer layer is preferably the more elastic and less plastic layer. Between the layers of the glove, a liquid antiseptic composition is stored which comprises an antiseptic in a liquid. The liquid antiseptic composition may also contain a surface-active agent, an algesic agent, a colorant, a vasoconstrictive agent, a smell-causing chemical, and a viscosity-modifying agent. A glove puncture by an object may cause some transfer of liquid antiseptic composition from the glove onto the hand and into a hand wound should the wound occur; useful as an immediate treatment to help to prevent a possible systemic infection by a pathogen in the individual; the treatment can help to protect a gloved individual such as a surgeon, a medical doctor, a health care worker or another worker whose work may place them at risk of becoming contaminated by a glove-puncturing object contaminated with the AIDS virus, hepatitus B virus or another infectious pathogen.

Claims

1. A flexible protective glove with a liquid-impermeable wall having the capability to provide a 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 containing a liquid antiseptic composition;

(b) the liquid antiseptic composition in the compartment which comprises an antiseptic in a liquid;

(c) the glove wall capable of providing a physical barrier as a means of protective 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, a hospital worker, and other workers;

(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 liquid antiseptic composition;

the coating on the object providing a means for immediately transferring some of the 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 liquid antiseptic composition transferred to the hand and to the hand wound having the capability to provide an immediate liquid antiseptic composition treatment to the hand and hand wound;

(g) the glove having the additional capability to leak some of the 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 outer layer may shrink while the hole in the less elastic inner layer of the glove is not as capable of contracting to a small size;

the liquid antiseptic composition leaking from the hole having the capability of flowing onto the hand and into the hand wound as a means for providing a treatment of liquid antiseptic composition to the hand and to the hand wound;

more liquid antiseptic composition may leak from the glove wall onto the hand and into the hand wound than from the glove wall onto the outer surface of the glove; and

(h) the glove having the capability of treating the hand and the hand wound with the 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 wound with the infectious pathogen;

wherein the 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 liquid antiseptic composition is capable of being redistributed within the compartment of the glove by massaging the glove to force the liquid antiseptic composition in the compartment to accumulate near the glove wall having the hole and to leak at an increased rate from the wall having the hole onto the hand and into the hand wound providing additional liquid antiseptic composition to treat the skin and the hand wound resulting in additional protection of the skin and hand wound 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) a structural material selected from the group consisting of latex rubber, cis-1,4-polyisoprene, cis-polybutadiene, neoprene rubber, nitrile rubber, silicone rubber, 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 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, isotactic polypropylene plastic, polyamide plastic, phenolic plastic, silicon 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, sodium dichloroisocyanurate, octoxynol, nonoxynol-9, ethanol, isopropanol, propanol, benzyl alcohol, allyl alcohol, methanol, sodium hypochlorite, potassium hypochlorite, hypochlorous acid, acetic acid, trichloroacetic acid, benzoic acid, sodium benzoate, boric acid, sodium borate, lactic acid, chloramine, elemental iodine, sodium iodide, potassium iodide, calcium iodide, ammonium iodide, ferrous iodide, strontium iodide, lithium iodide, magnesium iodide, zinc iodide, silver iodide, selenium iodide, povidone-iodine, formaldehyde, glutaraldehyde, mercurous chloride, zinc nitrate, zinc sulfate, zinc oxide, zinc acetate, zinc chloride, silver nitrate, silver sulfadiazine, hydrogen peroxide, benzoyl peroxide, phenol, sodium phenolate, cresol, methylphenol, resorcinol, orthophenylphenol, chloroxylenol, hexyl-resorcinol, parachlorophenol, para-tertiaryamylphenol, thymol, butylparaban, ethylparaben, methylparaben, propylparaben, triclosan, o-benzyl-p-chlorophenol, hexachlorophene, poloxamer 188, benzalkonium chloride, benzethonium chloride, cetylpridinium chloride, econazole, methylbenzethonium chloride, cetyldimethylbenzylammonium chloride, triclocarban, clotrimazole, ciclopirox olamine, undecylenic acid, miconazole, tolnaftate, and mixtures thereof.

6. A glove according to claim 1, wherein the liquid medium is selected from the group consisting of water, methanol, ethanol, isopropanol, propanol, allyl alcohol, butanol, isobutanol, sec-butanol, tert-butanol, benzyl alcohol, 2-octyl dodecanol, glycerol, propylene glycol, a polyethylene glycol of about 150 to about 600 molecular weight, urea, acetone, methyl ethyl ketone, ethyl ketone, methyl isopropyl ketone, 2-pentanone, ethyl acetate, ethyl propionate, ethyl butyrate, ethyl valerate, methyl acetate, propyl acetate, buryl 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 6600 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 liquid antiseptic composition contains a surface-active agent to facilitate the coating of the object with the 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, colloidal magnesium aluminum silicate, caprylic triglyceride, capric triglyceride, cetostearyl alcohol, decyl-beta-D-glucopyranoside, nonyl-beta-D-glucopyranoside, octylbeta-D-glucopyranoside, triethanolamine stearate, sodium lauryl sulfate, 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, 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 perfluropolymethylisopropyl 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 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 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 liquid antiseptic composition further contains a vasoconstricting agent in a concentration of about 1 vasoconstricting agent part in 200,000 parts of the 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 liquid antiseptic composition further contains a viscosity-modifying polymer as a means for adjusting the viscosity of the liquid antiseptic composition to between about 1 centipoise and about 5000 centipoise at a temperature of between about 10 to about 45 degrees centigrade, the viscosity-modifying polymer selected from the group consisting of xantham gum, gum acacia, gum tragacanth, agar, glycyrrhiza, sodium alginate, cellulose, methyl cellulose, carboxymethylcellulose sodium, glycerol, propylene glycol, pyroxylin, polyoxyethylene glycols of about 150 to about 600 molecular weight, gelatin, dimethicone of about 100 to about 1000 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) 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, 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, polytrifluorochloroethylene plastic, nylon plastic, rayon plastic, polycaprolactam plastic, polyester plastic, urea formaldehyde plastic, polyurethane plastic, isotactic 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 liquid antiseptic composition into a plurality of compartments capable of storing the liquid antiseptic composition.

14. A glove according to claim 1, wherein the liquid antiseptic composition comprises:

(a) about 0.02 to about 20 parts of povidone-iodine,

(b) about 0.1 to about 90 parts of water,

(c) about 0.05 to about 30 parts of a polyethylene glycol of about 150 to about 600 molecular weight, and

(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected from the group consisting of ethanol, isopropanol, propanol, n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and mixtures thereof.

15. A glove according to claim 1, wherein the liquid antiseptic composition comprises:

(a) about 0.1 to about 20 parts of elemental iodine,

(b) about 0.1 to about 20 parts of sodium iodide

(c) about 0.1 to about 30 parts of water,

(d) about 0.05 to about 30 parts of a polyethylene glycol of about 150 to about 600 molecular weight, and

(e) about 0.1 to about 90 parts of an alcohol, the alcohol selected from the group consisting of ethanol, isopropanol, propanol, n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and mixtures thereof.

16. A glove according to claim 1, wherein the liquid antiseptic composition comprises:

(a) about 0.1 to about 35 parts of sodium hypochlorite,

(b) about 50 to 99 parts of water,

(c) about 0.05 to about 30 parts of a polyethylene glycol of about 150 to about 600 molecular weight, and

(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected from the group consisting of ethanol, isopropanol, propanol, n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and mixtures thereof.

17. A glove according to claim 1, wherein the liquid antiseptic composition comprises;

(a) about 0.1 to about 25 parts of chlorhexidine gluconate,

(b) about 0.1 to about 90 parts of water,

(c) about 0.05 to about 30 parts of a polyethylene glycol of about 150 to about 600 molecular weight, and

(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected from the group consisting of ethanol, isopropanol, propanol, n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and mixtures thereof.

18. A glove according to claim 1, wherein the liquid antiseptic composition comprises;

(a) about 0.1 to about 50 parts of nonoxynol-9,

(b) about 0.1 to about 95 parts of water,

(c) about 0.05 to about 30 parts of a polyethylene glycol of about 150 to about 600 molecular weight, and

(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected from the group consisting of ethanol, isopropanol, propanol, n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and mixtures thereof.

19. A method of using a flexible protective glove with a liquid-impermeable wall 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; and

storing a liquid antiseptic composition in the glove wall;

(b) using the object to puncture the glove wall;

(c) using the glove to coat a portion of the object puncturing the glove wall with the liquid antiseptic composition when the object punctures the compartment storing the liquid antiseptic composition;

(d) using the object puncturing the glove to transfer a portion of the coating of the liquid antiseptic composition on the object, to the hand and into the hand wound when the object contacts the hand;

(e) using the glove wall having the hole formed by the object as a means for leaking more liquid antiseptic composition from the glove wall onto the hand and into the hand wound than from the glove wall onto the outer surface of the glove;

(f) controlling the relative size of the holes in the outer and inner glove layers to bias the direction of liquid antiseptic composition from the glove so that most of the leakage occurs across the inner glove layer onto the hand and into the hand wound rather than across the outer glove layer by selecting a material composition for the inner glove layer that is less elastic than the material composition selected for the outer glove layer; and

(g) using the liquid antiseptic composition transferred from the glove to the hand and 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 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 mil to about 30 mils wherein the first material and the second material form the layers of a compartment capable of storing a liquid antiseptic composition;

(b) the liquid antiseptic composition which contains a vasoconstrictive agent;

(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;

the glove wall capable of being punctured by the object;

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

(e) the glove having the capability to provide a coating of liquid antiseptic composition to at least a portion of the object puncturing the glove wall;

the coating of liquid antiseptic composition on the object providing a means for immediately transferring some liquid antiseptic composition onto the hand and into the hand wound contacted by the object;

the liquid antiseptic composition transferred to the skin and to the hand wound having the capability to help to provide an immediate treatment of liquid antiseptic composition to the hand and to the hand wound;

(f) the glove having the additional capability of leak some of the liquid antiseptic composition from a section of the glove wall having a hole resulting from the object puncturing the glove wall;

the liquid antiseptic composition leaking from the hole having the capability to flow onto the hand and into the hand wound as a means for providing a treatment of liquid antiseptic composition to the hand and to the hand wound; and

(g) the glove having the capability to help to treat the hand and the hand wound with a liquid antiseptic composition when the object punctures the glove wall, when the object may contact, when the object may wound the hand, and when the object may contaminate the hand and the hand wound with the infectious pathogen;

wherein the liquid antiseptic composition transferred to the hand and to 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.