DEVICE FOR CONTROLLING THE PRESENCE OF MICROORGANISMS AND PROCEDURE FOR DISINFECTION OF OBJECTS AND ENVIRONMENTS USING THIS DEVICE

Description

TITLE DEVICE FOR CONTROLLING THE PRESENCE OF MICROORGANISMS AND PROCEDURE FOR THE DISINFECTION OF OBJECTS AND ENVIRONMENTS USING THIS DEVICE INV. DES ABOUT THE YIJM PRIORITY USA DOM.BREV.N.06266318 DATED MAY 22, 1981 Rome, II. . A - v. prot. .67490A / 82 PROVINCIAL OFFICE OF INDUSTRY, COMMERCE AND CRAFTS OF TURIN Record of filing of patent application for industrial invention 1932 11 day tRKDIOI AFXX UK BODY RAISEMAHOM 9>O Λ« Mlll Reed, Pelo Alte, OA 94304 (SUU Vaiti d'l»wtoe) narioaaliU eUtuftlteaee The month of the month of the company represented by JACOBACCI CASETTA & PERANI S.p.A. with elective domicile in TURIN In via Alfieri n. 17 at JACOBACCI CASETTA & PERANI S.p.À. - submitted, signed to me, an application with stamp duty for the granting of an industrial invention patent for the Invention entitled: «Slides for the eootrollo of the jxroeea** dl Bloroor®eal«ai · prooodiaoato por le 61 alafedotte dt ««etti e aàblentl «UH «be such a «positive* Inventor* designated * π Priority: The right to priority has been claimed deriving from: a) previous patent application n. 06 / 266.313 filed in the U.S.A. 22 Acd&U 1931 Miscellaneous annotations The Buyer reports that the agent declares that he is not in possession of the applicant's title and acknowledges the declarations required by circular letter η. M9 deli'B November 1SBJ of the Centrajé / Bravetti Office. Attached documentation: a) description, In duplicate, dl η, Π writing pages; b) drawings, in duplicate, Legislative Decree no. 1 boards; c) letter of appointment, and<wwiw«Bw tfa^lwnwKiiRwpr» d) priority document with Italian translation; e) deed of assignment; (receives) f) Inventor designation; g) proof of payment (to the postal current account no. 00668004, made out to the Tax and Concession Register Office of Rome) of lira t^l / KX) issued by the Turin Post Office on 9.4.1932 n · h) revenue stamp of L. 3,000 The application, the description and the drawings listed above were signed by the interested parties and countersigned by me and stamped with the office stamp. A copy of this report was signed by me and delivered to the interested party. / •And ρ. The Depositor, JACOBACCI - CASETTA & P£R ALL.. THE COURT OFFICER * Àt'QÓi Q MINISTRY OF INDUSTRY, COMMERCE AND CRAFTS CENTRAL PATENT OFFICE - ROME RAISE CORPORATION 950 Page Mi 11 Road, Palo Alto, CA 94304 (United States of America) US nationality through agent JACOBACCI CASETTA & PERANl s.p.a. and electively domiciled for legal purposes in Turin, Via Alfieri, 17 i with the agent, requests the granting of a patent for the invention entitled: - - - - - ... ί Device for checking the presence of microorganisms and process for the disinfection of objects and environments using this device Designated Inventor: Su II YUM Priority — you claim the right deriving from: ARC 755 67430tì / 82 previous patent application No. 06 / 266.318 dated May 22nd l ” THE 1981, filed in the U.S.A. ATTACHED DOCUMENTATION Description in duplicate (17 pages of writing) Drawings in duplicate (number l plates) Letter of assignment Document by priority with Italian translation Deed of assignment (reserve) Inventor designation Proof of payment (on the c.c.p. N. 00668004) made out to the Registry Office and concessions of Rome of L. 141 .OOO issued by the Post Office of Turin On 9.4.1982 N. f / c N, 1 revenue stamp of L.z£O0O 3000 per order of Turin, April 13, 1982 ALZA CORPORATION JACOBACCI - HOUSE & χ^ *· x PERANl DESCRIPTION of the industrial invention entitled: Device for checking the presence of microorganisms and procedure for the disinfection of objects and environments using this device by: ALZA CORPORATION, US nationality, 950 Page Page Mili Road, Palo Alto, Ca 94304, United States of America Designated Inventor: Su II YUM Filed: APRIL 13, 1982 67490Δ / 82 SUMMARY Device for controlling the presence of unwanted microorganisms, comprising a polymer comprising a probiocide which produces the biocide formaldehyde, an effervescent couple to evolve carbon dioxide, and optionally a surfactant. Field of invention This invention relates to a device useful for sterilizing medical, surgical, dental, laboratory and other manufacturing items, and for sterilizing selected environments of use: The device comprises (1) a polymer which houses (2) a probiocide which produces the biocide formaldehyde, (3) an effervescent pair, and (4) optionally a surfactant. Background of the invention ARO 755 •• ACCSACCI - HOUSE in PERANi THERE IS AD / f It is frequently recognized that it is very advantageous to substantially sterilize and maintain certain articles of manufacture substantially free from undesirable microorganisms, and also to control the presence of undesirable microorganisms in preselected environments of use. An agent! which is widely used for these purposes is a solution of formaldehyde, also known as formalin. The formaldehyde solution consists of about 37% by weight of gaseous formaldehyde in water (and methanol is usually added to it to prevent polymerization. This solution has full concentration, and is also known as formalin 100% or formalin 40. The latter designation Indicates that it contains 40 grams of formaldehyde in 100 milliliters of the solution. 0 1.0 Cj? Although formaldehyde solution is used > lf ξ? 1? by the medical and dental professions for the sterilization of medical, surgical and dental instruments, y 54' and by research and commercial users for the sterilization of other instruments and equipment, as well as for the disinfection of certain areas, the use of formaldehyde solution has disadvantages. For example, formaldehyde solution is commonly employed as a previously prepared stored solution, and this has the inherent disadvantage that formaldehyde vapors can continuously escape from the solution and, thus, render it less effective for its intended use. Another disadvantage is that the formaldehyde solution 2. it is heavy and expensive to ship, which increases its cost of use for the sterilization and disinfection of articles and environments. In addition, the formaldehyde solution is bulky, requiring bulky packaging, which is often damaged and leaks during transportation. In view of the above presentation, it will be understood that, due to the disadvantages associated with pre-prepared formaldehyde solutions, there is a critical need for a device that can provide formaldehyde solution on demand (useful for producing the expected results of sterilization and control of the presence of unwanted microorganisms. Brief description of the drawing In the drawing, which is not drawn to scale, but which illustrates one embodiment of the invention, the figure is as follows: the figure is a perspective view, with a part broken away, to illustrate the structure of a device provided by the invention. Detailed description of the invention The expression controlling the presence of microorganisms, as used herein, means in the context of this invention the killing, prevention and / or retardation of the presence ,or propagation (of microorganisms in a preselected environment of use. The environmental phrase 'OSACCI - CASETTA & FERAbii 3. of use includes the use of the device provided by this invention to control the presence of unwanted microorganisms in selected areas, such as hospital rooms, operating rooms, military dormitories, laboratories, homes, ships, railway carriages, stagnant water, animal baths» and similar. The terms biocide, sterilizer, and disinfectant, as used herein, refer to the ability of the device according to the invention to supply formaldehyde to kill, clean, prevent and / or delay the presence or spread of harmful unwanted microorganisms on tools and other items of manufacturing. The term instruments includes medical instruments, chirurir F ff gici , dental, laboratory and barber. The phrase articles of manufacture includes garbage cans, boxes, germ-free containers, contact lens containers, urine containers, and the like. The phrase unwanted microorganism, as used herein, includes bacteria, spiroquettes, viruses, spores, fungi, mycobacteria, and the like. 1 microorganisms include Aspergillus niger, Aspergillus flavus, Rhizopus nigricans, Cladosporium herbarium, Epidermophyton floccosuin, Trichophyton mentagrophytes, Histoplasma capsulation and the like. The phrase also includes antibacterial activity against Pseudomonas aeruginosa, Escbericbia coli, Proteus •Ά20SAGGI - GASERÀ & PEKAft vulgaris, Staphy1ococcus aureus, Streptococcus faecalis, Klebsiella, Enterobacter aerogenes, Proteus mi / tabilis, and the like. The term also includes yeasts, such as Saccharomyces cerevislae, Candida albicans and the like. The device according to the invention, as exemplified by figure 1, and identified with the number 10, has at least one or more surfaces for dispensing the active agent, and it has a body 11 suitable, shaped and sized for placement in an environment of use, or for sterilization of an article of manufacture. The device 10 can comprise any shape, such as square, circle, rectangle, triangle, semicircle, and the like. The device 30 can be manufactured as a sheet, tape, casing, rod, matrix, sponge, prism of various cross-sections, such as cruciform or hexagonal, and the like. In the embodiment illustrated in figure 1 , the device 10 is in the form of a container and it has an inlet end 12 and an outlet end 13. The device 10 is seen in open section 14, and it comprises a polymer 15 containing dispersed therein a probiocide 16, an effervescent pair 17, and optionally, a surfactant 18. The device is optionally sized as needed, and may have various sizes. For example, the device when manufactured as a matrix ( may have a v F* OSACCÌ - HOUSE & WEIGHING& 5. length from 5mm to 20cm or more, a width from 5mm to 10cm or more, and a thickness from 1mm to 5mm or more. The device also may be designed and manufactured for immediate use, or for use over an extended period of time, such as 5 to 40 days or longer. Typical examples of polymers 15 used to manufacture the device 10 include polymers which permit the passage of fluid, primarily water. The polymers are exemplified by copolymers and acrylic polymers of methacrylate, ethyl acrylate, ethyl methacrylate and methacrylate; vinyl chloride homopolymers and copolymers, including vinyl chloride-vinyl acetate copolymers; dt chlorinated vinyl chloride; polyethylene, polypropylene; ethylene-propylene copolymer; chlorinated polyethylene; ethylene vinyl acetate copolymer; styrene-butadiene copolymer; acrylonitrile-styrene-butadiene copolymer; polyvinylidene chloride; vinyl chloride-vinylidene chloride copolymers; vinylidene chloride-acrylonitrile copolymer; vinyl chloride-1idene ester acrylate copolymer; polybutylene terephthalate; vinyl chloride-ester acrylate copolymer; polyvinyl-acetals, such as polyvinyl-formal, polyvinyl-acetal and polyvinyl-butyral; polyethers, polyesters, polyurethanes; halogenated-sulphonated polyolefins; polyisoprene; silicone and the like. 6. JAGOSACCI - CASETTA 4 PEAR The probiocides useful for the present purpose are materials which, in the presence of humidity, generate the biocide formaldehyde. A suitable probiocide for this purpose is paraformaldei.de. Paraformaldehyde is a member selected from the group consisting of the cyclic tripolymer of the general formula (CH O) , where n is 3, and the linear 2 n re polymer of the general formula HO(CH O) H, where m is 3 to 200 . m These polymers, in the presence of moisture entering the device, undergo depolymerization, providing the water-soluble biocide and disinfectant formaldehyde. The amount of paraformaldehyde, cyclic or linear, in a device is generally from about 2% to 80% by weight based on the total weight of the device, and more preferably about 30 to 60% of the device. p Another probiocide, useful for making the biocide that can be incorporated into the device, is methenamine, and its acid addition salts and quaternary salts. The biocidal activity of a methenamine salt results from the hydrolysis of methenamine to formaldehyde and the biocidal activity of the acid fraction of the salt. Exemplary compounds include methenamine mandelate, methenamine salicylate, methenamine sulfosa 1ycylate, and methenamine tetraiodide. The amount of methenamine salt in a device is generally from about 2% to 80% by weight based on the total weight of the device, and more preferably from about 'ACOSACC! - COTTAGE & PEARHi 7. 30%, at ÓO% of the device. The device may also accommodate both para-formaldehyde and methenamine in a total amount of about 40 to 80% of the device. The device may also contain polyoxymethylene esters and polyoxymethyl lenic diesters. (qua 1) polyoxymethylene diacetate and mixtures thereof which have recurring oxymethylene groups, which esters liberate formaldehyde in the presence of moisture and of the effervescent pair. The effervescent pair includes an acidic member, which member acts as an acid catalyst on compounds with groups recurring oxymethylenes, leading to the production of formaldehyde. The effervescent pair (useful for the purpose of 6« This invention is a gas generating means for producing physical activity by vigorous generation of gaseous carbon dioxide. The pair, in the presence of the probiocide and an aqueous medium entering the device, produces gaseous activity to help the formaldehyde generated in the device move out of the device. The gas generated by the couple also provides physical activity to mix the formaldehyde in a solution or environment to perform its biocidal activities. The effervescent pair comprises at least one acidic material. preferably solid, and a basic material (preferably solid) which dissolve and react in the presence of OSACCF - CASETTA & PERANl 8. □n aqueous fluid entering the device, or they react in the presence of an aqueous fluid, after diffusion from the device to produce effervescence due to carbon dioxide. The pair is mixed with the probiocide in powder, crystalline or granular form, and the composition formed is formulated in a polymeric matrix. The acidic member of the pair comprises an organic acid ! such as malic, fumaric, tartaric, itaconic, maleic, citric, oedipal, succinic and mesaconic acids, and mixtures thereof. Inorganic acids and salts of acids, such as monosodium citrate, potassium acid tartrate and potassium bitartrate can also be used in the device. The basic components include metal carbonates and bicarbonates, such as alkali metal carbonates and bicarbonates, or alkaline earth carbonates and bicarbonates (and mixtures thereof. Exemplary materials include the alkali metal carbonates and bicarbonates lithium, sodium, and potassium, and the alkali compounds -earth carbonate or bicarbonate of magnesium and calcium.Ammonium carbonate, ammonium sesquicarbonate are also useful.Combination of some of these acids and bases results in gassing, or more rapid effervescence when in contact with water; in particular, citric acid or a mixture of citric acid and tartaric acid and sodium bicarbonate, give a rapid reaction IR v P 4CO3AGC! * HOUSE 4 PERANi 9. gaseous, which is useful for delivering the probiocide for its intended results. The effervescent pair is mixed with the probiocide in any anhydrous or dry state, preferably in substantially stoichiometric equilibrium, to produce a combination which generates carbon dioxide. The amount of effervescent pair is from about 1% to 40 g of the device, more preferably from 57. to 207. of the device. Surfactants useful for the purpose of the invention include those having wetting, soluble and mixing properties which assist the probiocide and the gaseous carbon dioxide generated to enhance their beneficial results. 1 surfactants can be cationic, * V anionic or nonionic. Exemplary cationic surfactants include laur1-dimethyl1-benzi1-ammonium chloride, p-diisobutylphenoxy-ethoxyethyl-dimethyl-benzyl-ammonium chloride, alkyl 1-dimethyl1-benzi1-ammonium chloride, laur1-isoquinolinium bromide, cetyl-ethyl bromide -dimethyl-ammonium, stearyl-dimethyl-benzyl-ammonium chloride, N-soybean-N-ethyl-morpholinium ethosulfate, N(acyl-cholaminoformyl-methyl)pyridinium chloride, a mixture including alkyl chloride (CH to C2 H3) to 1 1-methyl 1-trimet 1-ammonium and laur1-isoquinolinium bromide, coamidoalkyl-betaine, and N-laur1-amino-propionic acid. Exemplary anionic surfactants include AiTOSACCI - CASETTA & PERANÌ 10. linear alkylaryl sulfonates prepared by the Frlede 1-Cra£ts reaction of an olefin and benzene, wherein the olefin has 10 to 18 atoms, and their alkali metal salts, and other anionic surfactants such as alkyl laurels 1-sulfonate, capryl-imidazoline derivatives, sodium sulfosuccinic acid dioctyl ester, sodium laurel sulfate, sodium aryl salt in Ichi. lacto-polyether sulfate, triethanolamine salt of lauryl sulfate, triethanolamine salt of alkylaryl sulfate, and mixtures thereof. Exemplary nonionic surfactants include alkylated aryl-polyether-alcohol, polyethylene glycol-tert-dodecyl-thioether, fatty acid amide condensates, aromatic polyglycol-ether condensates, lauric acid secondary amide, fatty acid alkanolamine condensates , sorbitan monolaurate, polyoxyethylene sorbitan monolaurate, sorbitan monooleate, polyoxyethylene sorbitan monooleate derivative, polyoxyethylene manni.de-monooleate lauryl ether, polyoxyethylene esters of mixed resins and acids fats, and mixtures thereof, and surfactants generally comprising the condensation product of a linear aliphatic alcohol having from 8 to 22 carbon atoms in its aliphatic moiety and an alkylene oxide, wherein the oxide constitutes from about 55 to 80% by weight of the surfactant molecule. Examples of surfactants identified by i. trademarks include lACOBACCI * CASETTA & PERAKì Igepal CO-170, a nonionic consisting essentially of nonyl phenol condensed with 10 to 11 moles of ethylene oxide; Pluronic P-65, a nonionic consisting essentially of hydrophilic polyoxyethylene groups and a hydrophobic polyhyoxypropylene group, having an average molecular weight of 3500 (with 50% ethylene oxides; Pluronic® P-123 a nonionic with a molecular weight of about 5650, with 30% ethylene oxide groups; Deriphat 160, an ampholytic disodium N-lauryl-yft-imino-dipropionate; and similar. The amount of surfactant employed is an amount sufficient to obtain the expected results, usually the amount will range from 0.01% to about 5% by weight, based on the total weight of all components in the device. The following examples will serve to further illustrate the present invention, but the invention is not intended to be limited thereto. Example 1 A device is prepared as follows: first, grams of white solid polymeric paraformaldehyde, powder, 5 grams of citric acid and 10 grams of sodium bicarbonate (are mixed at room temperature of 21°C in a dry, moisture-free environment, to 30 minutes, to give a homogeneous mixture.Then, 40 grams of the mixture are fed, over a period of 5 to IT V ( 'OSAGCI - CASETTA & PERAWl 12. minutes, to a two-roll mill, previously charged with ethylene-vinyl acetate copolymer having a vinyl acetate content of 407%, and milling continued for 5 to 10 minutes to thoroughly mix the blend into the copolymer. Then, the ground product is passed through a four-roll calender to form a film. The film is then cut into a square shape for use in a chosen environment. Example 2 A device is prepared by mixing, in an anhydrous environment, 107" of citric acid, 197" of sodium bicarbonate, 17" of surfactant Igepal and 707" of paraiormalde ide, to give a homogeneous mixture, which is mixed with the poii( olefin) polyethylene), commercially available(§), by mixing on a Brabender Plastograph, with moderate heating for 7 to 14 minutes. Then, the mixed mass is removed from the machine ( and pressed 2 to 15,000 1ibre / square inch (1,055 kg / cm ) ( forming a rectangular shaped matrix, useful for checking for the presence of unwanted organisms. The device is stored in a dry to prevent premature contact with humidity.The package consists of two sheets of aluminum foil facing each other, defining an internal space, the sheets being joined on their one OSAGCI - HOUSE 4 PERANi. moisture-tight suburbs. Example 3 A dispenser system is prepared by mixing, according to the example described above, 40 grams of paraiormaldehyde, grams of methenamine mandelate, 5 grams of citric acid and 15 grams of potassium bicarbonate, and adding it slowly, over a period of 5 minutes ^with continuous milling (to a heated two-roller mill (previously loaded with ethylene-ethyl acrylate copolymer). The ground formulation is removed from the mill, and then extruded into a solid rod-like system which is useful for sterilizing articles of manufacture. In one embodiment, the procedure for v Checking for the presence of unwanted microorganisms* on an item of manufacture, such as barber scissors, is accomplished by submerging the item in a solution, freshly formed, adding a dispensing system, comprising paraformaldehyde, an effervescent pair in a polymeric carrier, and water. In the presence of water the dispenser system releases paraformaldehyde which generates formaldehyde, and releases the pair which generates gaseous carbon dioxide which mixes the formaldehyde into the solution to produce the desired results. Those skilled in the art of disinfectants will appreciate that, in light of the present disclosure and the 14. 'A'OSACCf - GASETTA & PERAN In the annexed claims, many embodiments of the invention can be carried out without departing from the spirit of the invention.

Claims

1. CLAIMS 1. In a process for the disinfection of an article of manufacture, the process comprising disposing the article in the presence of a polymer containing a probiocide and an effervescent pair, said probiocide upon its release from the polymer, producing the biocide formaldehyde , and the effervescent couple generating carbon dioxide to mix the biocide with the liquid, thereby bringing the article into contact with the biocide to disinfect it, The process for disinfecting the manufacturing article according to claim 1, wherein the liquid is water. The process for disinfecting the article of manufacture according to claim 1, wherein the probiocide is paraformaldehyde. The process for disinfecting the manufactured article according to claim 1, wherein the probiocide is methenamine and its salts. The method for disinfecting the manufacturing article according to claim 1. The polymer additionally contains a surfactant. V t* AJO8ACCI - CASETTA & PERAòi , in which the 1 5. The process for disinfecting the article of manufacture according to claim 1, wherein the effervescent pair comprises an inorganic or organic acid, and a compound capable of evolving carbon dioxide in the presence of the acid and the liquid, the compound being a alkali metal carbonate, an alkali metal bicarbonate, an alkaline earth carbonate, or an alkaline earth bicarbonate.

7. A device for checking for the presence of microorganisms, the device comprising a polymer containing a probiocide and an effervescent pair, the probiocide, upon its release from the polymer producing the biocide formaldehyde, and the effervescent pair, upon its release from the polymer, being capable of developing carbon dioxide t* (to bring the biocide into contact with the organisms, thus controlling their presence. The device for checking for the presence of microorganisms according to claim 7, wherein the probiocide is paraformaldehyde. The device for checking for the presence of microorganisms according to claim 7, wherein the probiocide has recurring oxymethylene groups. The device for checking for the presence of microorganisms according to claim 7, wherein the probiocide is methenamine and its salts. 08 / ÌCCI - CASETTA & PERAN; 16.

11. Device for checking the presence of microorganisms sin ί according to claim 7, wherein the polymer furthermore contains a surfactant.

12. A device for checking for the presence of microorganisms according to claim 7, wherein the effervescent pair comprises an acid and an alkali metal carbonate, an alkali metal bicarbonate > an alkaline earth carbonate (or an alkaline-earth bicarbonate. i / 3100 'A'OrSACCI - CASETTA 4 PERANi 67490Α / 82 JACOBACCI - CASERA & PERANI s. p. a. 67490 Δ / 82 MINISTRY OF INDUSTRY, COMMERCE AND CRAFTS Central Office for Patents, Models and Trademarks #*# **» #»#