‘US 2009) cu») United States v2) Patent Application Publication Norton et al. (54) METHOD AND APPARATUS FOR, PRODUCING A STABILIZED ANTIMICROBIAL NON-TOXIC ELECTROLYZED SALINE SOLUTION EXHIBITING POTENTIAL THERAPEUTIC (75) Inventors: Verdis Norton, Sandy. UT (US): Gary L. Samuelson, Sandy, UT ws) Comespondenve Address MARCUS G THEODORE, PC 466 SOUTH 500 EAST SALT LAKE CITY, UT 84102 (US) (73) Assignees: (21) Appl.No: 12290298 (22) Filed ‘Oct 30, 2008, Related U.S. Application Data (©) Provisional application No. 61/001,010, fled on Oct. 30, 2007 103 (10) Pub. No.: US 2009/0110749 Al (43) Pub, Date Apr. 30, 2009 ication Classification (1) Ince AGIK 33/40 200501) BoD soto (2006.01) AOLP 31/00 (2006.01), C258 900 (200601), (2) Us.CL 4241616; 205/687; 204/230.2 on ABSTRACT AAn improved method and apparatus is disclosed for produe- ‘nga stable, non-toxic, antimicrobial electrolyzedsalinesol- ‘ion witha broad minge of antisinfeetive and therapeutic appli- cations. The resulting solution is balanced to normal and Lbypectonie saline ad hs heen shown to exhibit remarkable antimicrobial antiviral and therapeutic eha ‘ature ofthis solution makes it suitable for applications ia food safety animal health, agriculture and sterilization. The solution also exhibits a marked lack of toxicity upon intrave ‘ous, aspired, oral or topical application in mammals. The ‘therapeutic applications represent a heoad platform, possibly covering a varity of potential arcas of use, incising topical isinfection, antimicrobial application, wound treatment, ‘dative sre redvction and enhancement of immune func- ‘ion to beter detect malfunetioning cells, scterstes, ThePatent Application Publication Apr. 30, 2009 US 2009/0110749 AI 100 101 SS 102 104 103 107 106 Fig.1 Fig.2 106US 2009/0110749 AI METHOD AND APPARATUS FOR PRODUCING A STABILIZED ANTIMICROBIAL NON-TOXIC ELECTROLYZED SALINE SOLUTION EXHIBITING POTENTIAL AS. ‘THERAPEUTIC BACKGROUND OF THE INVENTION ovo) 1. Fietd [0002] This invention pertains fo an electrolytic method and apparatus for producing electolyzed saline redox-bal- ‘anced solutions. More particularly, i pertains a methodand ‘apparatus used to produce a stable, don-toxe, aatimierobial ‘eleciolyzed saline edox-balanced solution from pure saline ‘or hypertonic saline (NaCI and H,O), both refered to here afteras saline solution, exhibiting anti-infeetive and immune ‘eahaneing potential a a therapeutic employing a balanced mixture of chemically reduced and oxidized species incud- Jing Hypochlorous acid (HOC), Hypochlorites (OCT NaC 0), dissolved Oxygen (0,), Chlorine (C1) and Hydro- en (H,) gases, Hydrogen Peroxide (H,0,), Hydrogen ions (H, Hypochloride (CIO) and comesponding amounts of Superoxides (*0,-, HO,), Ozone (O,), Activated Hydrogen jons (17), Chloride fons (CT), Hydroxides (NaOH, OTF"), Singlet Oxygen (%0,) and other forms of Reactive Oxygen Spocies (ROS) (*0C1, *HO™) [0003] 2. Prioe Ast 10004} Elecirolysisof saline solutions has ong been usedto produce antimicrobial solutions that are compatible with ‘manumalian biology. Some examples include methods to pro- ‘duce chlorinated Water, bleach and hydrogen peroxide. Typ cally, the methods and apparatus used to eleetrolyze these Solutions employ ion-selective barriers between the ele. trodes inorder to efficiently isolate the target molecules and ‘eliminate unwanted byproducts. A fundamentally different ‘nd apparatus for producing @ non-ioxi antimicro= ial electolyzed saline solution is disclosed in eight United States patents, and two Japanese patentsanda Mexican patent based on these US. patents, all held bythe applicant, cover- ‘ng various other applications for intravenous injected elec- teolyzed saline solution (named MDI-P) the machinery that ‘manufactures it and the method by which it is manufctured. These US. patents are as follows 0008] "U.S. Pat No. 5.334.383, Morrow, dated Aug. 2, 1994 eiled [0006] “Flectrially Hydrolyzed Salines as In Vivo Microbicides for Treatment of Cardiomyopathy and ‘Mulkiple Sclerosis” This patent covers. method of treating antigen related infections related to cardiomy- ‘pathy and multiple sclerosis in humans and other warm blooded animals, Itdoes not cover the MDP Substance itself, but covers a panicular use of the substance. This ‘method of treatment includes the use ofan electrolyzed Saline solution in conjunction with one of more mod- lating agents such as ascorbic acid (Vitamin C), with or ‘without eancurtent colchicine, to mimic or enhance the body's naturally occurring immune response to bacte- ‘ial, Viral o fungal infection. The duration of this patent is until Aug. 2, 2011, subjectto patent term extension for clinical ial time. [0007] US, Pat. No, 5,507,932, dated Ape. 16, 1996 cntitld [0008] “Apparatus for Flectolyzing Plus.” Tis patent ‘covers equipment that exposes a liquid solution toa Apr. 30, 2009 lectical current, ereating aneectrolyzed solution, This ‘equipment may be used to produce an electrolyzed Saline solution, capable of killing bacterial, viral and fingal agents, foruseia medical applications such asthe ‘weatment of antigen related infections in humans and ‘other warm blooded animals, This patent covers the ‘equipment used t0 produce MDI-P, not the substance itself. The duration of this patent is until Aug. 26, 2014 [0009] "US. Pat. No. 560,816, Robinson, dated Oct. 1996 entitled [0010] “Method for Flectrotyzing Fluids” This patent ‘covers a method for electolying Mid, by using spe- alized equipment to expose liquid solutions toanelee- trical eurrent. Saline, forexample. may be treated hy this Process to yield an electolyzed sane solution, capable of killing bacterial, viral and fungal agents, for the teat ‘ment of antigen related infection in humans and other ‘warm blooded animals. This patent covers the method by which MDE-P is produced, not the substance itself, ‘The duration ofthispatent is until Aug. 26,2014, subject to patent term extension fr clinical tral time. [0011] US. Pat, No, 5,622,848, Morrow, dated Ape. 22, 1997 entitled [0012] “Flectically Hydrolyzed Saline Solutions As “Microbicides For In Vitro Treatment OF Contaminated Fluids Containing Blood.” This patent covers a method ‘oftreating whole blood and other blood products with an clectolyzed saline solution to reduceinection with bac- ‘eral, viral and fungal agents. This patent covers a par- ticular use of MDI-P, not substance itslt. The duration ‘of this patentis until Apr 22,2014, subject o patent erm ‘extension fr linia trial time [0013] "US. Pat. No. 5,674,537, Morrow, dated Oct. 7, 1997 eatitled| [0014] “An Flectrlyzed Saline Solution Containing ‘Concentrated Amounts OF Ozone And Chlorine Spe- cies” This patent covers a specific eleetolyzed saline Solution containing a regulated amount of microbicial ‘agents including ozone and active chlorine species. This soliton is intended forse inthe treatment of infections inthe body of humans and other warm blooded animals, ‘rin blood or blood produets. This patent covers the MDI-P substance. The duration of this patent is until (Got. 7, 2014, subjectto patent erm extension for einical ‘wal time, [0018] "US. Pat. No. $,731,008, Morrow, dated Mar. 24 1998 entitled 0016] “Electrically Hydolyzed Salines as. Microbi- cides." This patent covers a method of using a specific lectrolyzed. saline solution containing a regulated amount of microbicidal agents including ozone and active chlorine species forthe treatment of microbial infections, including HIV infection. The method inchades. intravenous administration of the solution ‘long with one or more modulating agents such ascorbic ‘cid (Vitamin C), with or without concurrent eolchicine This patent covers a method for using MDI-P not the substance itself. The duration of this patent is until May 23, 2010, subject to patent term extension for clinical tral time 0017] U.S. Pat. No. 6,007,686, Weleh etal, dated Dec. 28, 1999 entitled [0018] “System for Electolyzing Pluids for Useas Ant ‘mjerobial Agents.” This patent covers system for elee-US 2009/0110749 AI twolyzing fuids, such as a saline solution, for use is sterilizing dental and medical instruments and ot Dealt care equipment, The patent covers the necessary equipment for generating and circulating the elect Iyzad saline solution around the instruments to be ster= ilized, and includes specific claims for equipment designed for use with dental dll hand pieces and flex- ible tubing. This patent covers a process by which MDI-P may be made for a particular use, not the subs stance itself, The duration of this patent is until Aug 2, 201d. 0019] US. Pat No. 6.117.288, Weleh eta, dated Sep. 12, 2000 ented 0020] “System for Carrying Out Sterilization of Equip- ‘meni This patent covers @ system for cleaning and Sterilizing medical aad dental instruments to prevent the spread of infection from one patient to another. The ‘covered system baths the instrument inan elect patent covers a particular use of MDI-P, not the sub- Stance itself, The duration of this patent i until Aug. 26, 2014. [021] The two Japanese and one Mexican patents pro- vide corresponding coverage in those countries for sev- cml of the US. patents. Applicant also has pending applications wit the US Patent and Trademark Office for patents on MDI-P asa pharmaceutical treatment for cystic fibrosis, sepsis and asthma, 10022] The above embodiments ofthese prioe patents yp cally have produced measurably different variations of elo twolyzed saline solution. Eaeh Variation, however, exhibited sonte antimicrobial ation and many of these devices pro- ‘duced solutions with measurable amounts ofthe components (chlorine, pH, ozone, etc) within the rnge ofthe disclosed regulated amounts, The resulting electoyzed saline compo- sitions, however, have not historically been satisfactorily con- sistent or controllable, specifically regarding the eoncentra- tions of Reactive Oxygen Species (ROS). In addition, these prior inventions could produce toxic chemicals (chlorates) in the process of elecimolyzing the saline solution. Conse- ‘quently, there is 8 need foe an improved manufacturing ‘method and apparatus, such as that described below, to con- sistently produce solutions suitable for therapeutic aplica- Fons in bans and warm-blooded animals SUMMARY OF THE INVENTION 10023] The improved method and apparatus described below provides an improved electrolyzing fluid containing regulated amounts of stable reactive oxygen spocies (ROS) particularly suited for stable, nontoxie antimicrobial appli- ‘ations and to aid the immune system in identifying and ‘destroying malfunctioning eels. The invention comprises & ‘method for making an electrolyzed saline solution for use as fn in vivo treatment of human or warm-blooded animal. Spectiealy, it comprises 10024] 2, placing a saline solution having a saline eoncen- tration ofa least abot 0.15% within a container [0025] 6. activating a uid circulation device to maintain 2 Flow of the saline solution between the elecizde surfaces, Apr. 30, 2009 [0026] c. adjusting the temperature ofthe eireulating saline at preferred level to prevent production of ehlortes and ‘regulate the relative concentrations of resulting components [0027] a. placing in the saline solution an anode and a cathode associated with a power source, and [0028] e. applying an effective voltage potential less than about thirty volts between the cathode and the anode sufi tient to produce a balanced mixture of chemical redox bal- anced species including Hypochlorous acid (HOC), Hypochlortes (OCT, NaC 10) dissolved Oxygen (0). Chle- rine (CI) and Hydrogen (H,) gases, Hydrogen Pecoxide (8,03) Hydrogen ions (H™, Flypochloride (CIO) and eorre- sponding amounts of peroxides *O.", HO.), Ozone (0,), Aetivated Flydrogen ions (11), Chloride ons (CI), Hydrox- ides (NaOH, OF), Singlet Oxygen (?O. ) and other forms of Reoctive Oxygen Species (ROS) (20C1, *HO") utilizing electron and proton donation, jon and dssolved-gas transport to produce a specific redox balanced set of molectles and ‘ons. Tis edox-halanced set of molecules and ions in com- bination area potent ant-infotive and help the immune sys- tem identify and destroy malfunetioning eels. [0029] This elecwolyzed saline solution is then adm {ered ios himen or warm-blooded animal for therapeutic Preferably, the electolyzed sine solution is administered by injection, orl or anal ingestion, applied topically, used as a bath, applied in a wound deessng, oF inhaled in atomized form. [0030] ‘Tae container for producing the eleetolyzed saline solutions is fabricated from a biologically compatible mate- ‘ial. In addition, the anode is made of a ase metal selected ‘rom the group consisting of platinum, niobium, titanium or Any metal compatible with platinum bonding with an outer Jayer of platioum bonded tothe base metal The shape ofthe anode has a cylindrical, or fat (planar) shaped structure. The ‘anode is preferably permeable to fui flow. [0031] Usually the eathode is positioned coaxially or in parallel in felaion to the anode, This cathode is made of @ base metal selected from the group consisting of platinum, siobium, titanium or any metal compatible with platinum bonding with an outer layer of platinam bonded 4 the base peta and has a eylindrical, or flat (plana) shaped stucture similarto that of thesnode and ial preferably permesblet iid fow, [0032] Thespacing between the surfaces ofthe cathode and the anode is typically not greater than about one inch. This invention has means to cireulate and regulate the temperatore of fluids during production, has appropriate electrode design and as methods that effectively stabilize the compesition of the resulting solution, [0033] The tempersture, fd flow and effective voltae are ‘hose as to climinate production of cblonites and to create the desired mixture of components. These parameters are {termined by experimentation. Theresuting solution is con- ‘istetly stable and suitable for in vivo therapeutic appica- ‘ions. The sable ROS concentration, forexample, hat Vara ‘ion of Tes than 5% from batch to batch and from device 10 device when the same set of parameters are employed by each, [0034] Theeffetive voltage may be applied by direct eut- rent, altemating enetent, o various combinations of lternat- ing current and diroct current power sources, resulting in a combined effective voltaze ranging anywhere between Oand 30 volts. The effective voltage is chosen to eliminate the production of ehlorates and to create the desired mixture ofUS 2009/0110749 AI ‘components containing stable ROS. For example, a typical temperature mange ofthe saline solution i fom 30 deg. F. 40 100.dey F. Inthe lower temperature range, kssO, isabsorbed by the fluid and the uid has smaller electrical conductivity, therefore higher effective voltages can be tilizedto maintain ‘adequate electrical current required 1o provide regulated ‘amounts of stable ROS without significantly increasing the probability of creating chlorates and while maintaining a pll Of720 75, 10035] | Thoeffective voltage may be adjusted, as desired, t0 regulate the concenttation ofthe components and the pH of the resulting solution over a lange variety of temperatures and fluid ows, Wherein tis dificult to theoretically determine the concentrations ofall the various resulting chemscal com ponents when given any specific set of parameters, the opti. imal effective voltage, Hil temperature and flow are deter mined by experimentation, This methodology allows forthe intentional regation of eoncentrations ofthe specific chemi ‘cal components in these stable ROS enriched solutions, allowing forthe optimization of solutions intended for spe- Cite purposes [0036] ‘The method and apparatus thus provides a stable, ROS enriched, antimicrobial, non-toxic electolyzed saline solutions, hercinater referred to as Reoxeyn, with a specific redox-halanced set af molecules a ons in slution that has the ability to attack infective microbes and enhances the abil- ity of the immune system to recognize and destroy damaged ‘oF malfnetioning cells. 10037] Reoxcyn solutions are balanced 10 normal and hypertonic saline and have been shown through extensive, repeatable research by accredited laboratories To be stable non-toxic and exhibit remarkable antimicrobial, antiviral and therapeutic characterises, Besides the therapeutic appli tions, the nature of these solutions also makes them suitable {or applications in food safety, animal health, agsieulture and sterilization, The solutions exhibit a marked lack of toxicity up nro. espe rl rtp appiinin nam 10038] | Reoxcyn solutions provide a broad platform for anti-infective and therapeutic applications covering several Potential urews of use, including topical disinZetion ‘robial application, wound treatment, oxidative stress redue~ tion and enhancement of immune funtion, Reoxeyn solt- tions, being that they contain regulated amounts of stable reactive oxygen species (ROS), are particularly suited for ‘enhancing the ability ofthe immune sYstem to recognize and ‘destroy damaged or malfunctioning cells. Such solutions ean also be administered in a number of eilferent ways appropri- ‘ate forthe desired therapeutic application. [0029] Furthemore, all of the ound in these sou 2 scientific investigation eateporized as redox messaging and regulation of genes, Soch molecular components, being & balanced set of reduced species (RS) and reactive oxygen species (ROS), are the same molecules and ions tht mieror those found in biological systems and are intimately involved in the ability of the immune system to recognize, detect, ‘eliminate and hea infected, dameged or mutated tissues in, ‘mammal, [0040] The measurement of concentrations of ROS inside the solations hasbeen done by meansofa uorospectrometer, Nanodrop 3300, and three varieties of Muorescent dyes, -Phycoerytherin (R-PE), Hydroxypheny fluorescein (HPF) ‘and Aminophenyl Muorescein (APF), that are commonly sed Apr. 30, 2009 to determine relative ROS concentrations inside setive bio- logical systems and cells, The molecules in these dyes change shape, and therefore fluoresce only when exposed te molec Jareomponents in ROS, The resulling change in uorescence can then be detected by the Mluorospeetrometer and ean be ‘elated fo the concentration of ROS present. ROS concent ‘ions in Reoxeyn are verified and detected by either APF oF R-PE fiorescent dyes, both of which produce entirely com- sistent messurements of relative concentrations of ROS in various concentrations ad dilutions of Reoxeyn. Dr, James (Claget has linked the ROS measurements in Reoxeyn, using RPE fluorescent dye, tothe reaction ofthis dye wo regula fons of 2/2-Axobis(2-methyIpopionamide) hidroebloride, a molecule that produces known amounts of ROS, This snot an absolute measurement, ut itrlates ROS in Reoxeya itto amounts of a known producer of ROS, [041] These fuoresceat dyes are often used in eombina- ‘on with fluorescence microscope to create high-resolution ‘mages ofthe build-up of ROS (oxidative stress) inside ind Vinal living cells. These dyes have boon shown to speci cally be sensitive 10 concentrations of ROS regardless of ‘complex surrounding chemical environments, [042] Although APF and R-PE dyes ate capable of mea- suring relative ROS concentrations ia Reoxcyn, no know absolute standard concentration for stabilized ROS in pure saline soluions exists, Furthermore, discrepancies in the decay time of these floorescent dyes make measuring stan- ‘ardized amounts of ROS in other solutions incompatible ‘with measuring those found in Reoxeyn. This may be due, in part, to the molecular complexes in Reoxeyn that keep the ROS concentration stable, elfectvely shielding the fe radi cals from readily reacting with the dyes. The standant for ROS concentration in Reoxeyn therefore measured relative to the ROS concentration ina standardized solution that has ben used in all ofthe antimicrobial and toxicity stadies to ate, both published and unpublished. Methods to meastre hsolite ROS cancentratons in Reoxcyn are actively being pursued. [0043] The regulated amounts of ROS, thus measured. inside a variety of the Reoxeyn solutions producedby various ‘embodiments ofthis invention have been shown wo be stable, consistent and predictable, sufficient for therapeutic applica. DESCRIPTION OF THE DRAWING [0044] FIG. Lisaside view ofonepretered embodiment of the invention. [0048] FIG. 2 isa top view ofthe prefered embodiment of the invention shown in FIG. DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS, [0046] FIG. 1isaside view ofan embodiment ofthe inven- ‘ion. It has @ container 101, which holds a saline solution having a saline concentration of at least about 0.15% to 1.0% bby weight. The container may be fitted with a id 100. The container 101 has cylindrical anode 104a anda surounding ‘encentrie cylindrical esthode 101 positioned on is bottom 105, The anode 1012 and cathode 101) are operably associ- ated with a power supply 107. The power supply 107 provides 4 source of electrical current with an effective voltage of ‘under 30 volts via wires 106 affixed tothe anode 10La and 2 cathode 1018US 2009/0110749 AI 10047] The anode 104 is a prised of titanium with an outer layer ofp thetitaninm base. The cathode 1014 isa eylindeical mesh ring ‘comprised of titanium with an outer layer of pltinurs bonded to the titanium base that is positioned coaxially about the ‘anode 10a, The spacing between the ealhode 1016 and the anode 1044, at the preferred flow rate Below, is typically not ‘greater than about one inch. Moreover, the effective voltage Potential between the eathode 101A and the anode 1012 is not treater than a preferred amount typically under 30 volts {0048} temperature regulation device, such as 2 combi nation heating/cooling deviee, is positioned along the sides 104 inside the container 101 to exchange heat withthe saline solution inorder to mainiin the saline solution ata desied temperature between 30 deg. F. 10 100 dog. F. 10049] A cieulation tube 102 is mounted on the exterior of the container 101 with openings coanecting and in com nication withthe top and bottom interior ofthe container 101 The cicculation tube 102 is associated witha fluid pump 103, to provide for fluid circulation and flow inside the contsiner 101. This allows saline solution inthe container 101 to flow through the anode 101g and cathode 1016 assembly at @ proferad flow rate, typically between 0.1 0 50 ce/em sec [0080] FIG. 1 also shows. second circulation tube 102 and {lv pamp 103 similarly structured and mounted om the exte- Fior of the opposite side ofthe container 101 that performs @ similar uid eicultion funtion. Ths two tube 102 crcula- tion structure and flow pattem insures complete mixing and ‘electrolysis f the sane solution to produce ROS concentra tions aleufate to be between 0.05 and 50 pp [0051] FIG. 2isatop view ofthe preferred embodiment of the invention shown ia FIG. 10052] "Although this refereace has made reference to the iustrated emboxtiments, its nt intended to limit he seape ‘of the claims. The claims themselves recite those features ‘decined essential tothe invention We claim: 1A method for prodvcing a stable, n-toxi, antmicro~ bial electolyzed saline solution exhibiting ant-infective and ‘mmune-enhancing potential as a therapeutic containing regulated amounts of stable reactive oxygen species (ROS), ‘comprising: ‘a. preparing a saline solution having a saline concentration ‘of at least about 0.15% > inserting within the saline solution an inert anode and a spaced part corresponding inert cathode associated witha power source, «regulating the temperature ofthe saline solution to main- {nina soliton emipersare sufficient to prevent proic= tioa of chlorate al regulate relative concentrations of ‘resulting components during electrolysis, 4. cirenlatng the saline soktion to maintain a flow ofthe Saline soition between the anode and eathode, and applying an effective voltaze potetial less than about *iety wots erwaen the cathode andthe anode sufficient to produce a balanced mixture of chemically reduced and oxidized. species including Hypochlorous acid (HOCH, Hypochlortes (OCF, NaCIO), dissolved Oxy- agen (0;), Chlorine (C1) between 1 10 200 ppm and Hydrogen (H1,) gases, Hydrogen Peroxide (H,0,), Hydrogen ions (H"), Hypochloride (CIO) and corre sponding amounts of Superoxides *0,-, HO.) Ozone (O,) from 110 50 ppm, Activated Flydrogen ions (H), CCoride ions (Cr, Hydroxides (NaOH, O17), Singlet Apr. 30, 2009 ‘Oxygen (?0,) and other forms of Reative Oxygen Spe cies (ROS) “OCI, "HO", and total ROS between 0.05 16-30 ppm, utilizing electron and proton danaton, ion snd disslved-gos transport the empersture, anode and cathode spacing, saline solution circulation rate, and fleive vollge combination selected to achieve ‘desired eletrolysseficioncies and stale specie com> positions containing stable ROS conspounds while pre ‘eating production of chlorate. 2. A sable, non-oxie, antimicrobial electolyzed saline solution exbibitng antidafective and insane enhancing potential a8 a therapettie contsining regulated amounts of ble reactive oxygen species (ROS), comprising s balanced mixture of chemically reduced and oxidized species inelud- dng Hiypochlorois acid (HOC), ypochlontes (OCT. NaCl} solved Oxygen (O.), Chlorine Cl, between t0 200 ppm and Hydrogen (H.) gases, Hydrogen Peroxide (G05, Hydrogen ions (H°), lyposhlorde (CTO) and eomre ‘sponding amounts of Superoxides (*0,”, HO), Ozone (Os) From L to 50 ppm, Activated Hydrogen ions (F-), Chloride fons (CI), Hyroxides (NOH, OF), Singlet Oxygen (*0,) and other forms of Reactive Oxygen Spevies (ROS) C*OCi, S110") an oa stable ROS compovnds between 0.05 to 50 om. 3. A method for using a stable, non-toxie, antimicrobial clecoyaed saline solution exhibiting aatcinfevtve and Jmmune-enhancing potential for use a an i vivo treatment {ora hima oF war-hloedd animal, compesing 4 prcparing saline soltion hiving a saline concentration fF a least about 0.15%, +s insecting within the saline sok spaced apart coresponding inert cathode asso ‘ith apotier sour, regulating the temperature ofthe saline solution to min- tain a solution temperate sulin wo prevent produc tion of chlorates and regulate relative consentatons oF ‘esting components during eeetlysis, 4 ciulating the saline softion to maintain a ow ofthe Ssline soltion between the anode ad cathode ad applying an effetve voltage potential less than about thiny vals betwcenthcathode andthe anode siliciot to pradice a balanced mixture of chemically reduced and. oxidized. species including Hypochlorous acid (HOCH, Hypoetortes (OCT, NaCIO). dissolved Oxy sen (02), Chlorine (C1) between 1 200 ppm and Hydrogen (H,) pases, Hydrogen Peroxide (H,0,) Hydrogen ions (1°), Hypachloride (CIO) and corr sponding amounts of Supeoxides °0, HO), Ozone (O.) fom 11050 ppm, Activate Lyd gca ions (1). Chloride tons (CI), Hdroxides (NaOH, OH), Singlet ‘Oxyucn (70, and ther forms of Reactive yen Spe- cies (ROS) OCI, °HO>), and total ROS between 0.05 to 30 pp, wtiirng electron and proton donation, io and disslved-gis transport the temperature, anode and silhode spacing sli solution creulation rate and ctctve vollge combination selectad 0 achieve ‘lesired electrolysis eficiccics ad stable specie com positions containing stable ROS compounds while pre ‘ting prodiction of chlrates ad {ministering the eecirolyzd saline sotuonbalaneed tixtre to a human or waem blooded anim for ther- peut se fo attack infective mimes and enhance the Eblity ofthe immune sytem to recognize and desty damaged oF malfunctioning cells man inert anode and a tdUS 2009/0110749 AI 4.4 method for using a stable, electolyzed saline solution exhibiting ant-infective and Jmmune-enhancing potential for use as an in vivo treatanent ora human or warm bloodes/-animel aeconling to elim 3 ‘wherein the electrolyzed saline solution balanced mixture is ‘administeredby injection, orl or anal ingestion applied 1p cally, used as 8 bath, applied ina wound dressing or inhaled in atomized form. 8. A method for using a stable, non-toxic, animierobial ‘electolyzed saline solution exhibiting antiinfeotive and Jmmune-enbancing potential for use as an in vivo treataient fora human oe warm-blooded animal according 1 claim 3, ‘wherein the sine solution balanced mixture is placed in ‘container means fabricated from a biologically compatible material. 6. A method for using a stable, non-toxic, antimicrobial ‘electolyzed saline solution exhibiting antinfeotive and jmmune-enhancing potential for use as an in vivo treatment foe a human oe waem blooded-animal according to claim 3, ‘wherein the anode is made ofa hase mctalsclcted from the roup consisting of patina, niobium, titanium or any metal ‘compatible with platinum bonding andis costed with anonter layer of platinum bonded the base metal 7. A method for using a stable, non-toxic, animirobial ‘lectrolyzed saline solution exhibiting ant-infective and Jmanne-enhancing potential for use an in vivo treatment fora human or warm-blooded animal acconting to claim 6 ‘wherein the anode has a eylindrieal, or fat (planar) shaped 8. A mothod for using a stable, non-toxic, antimierobial electolyzed saline solution exhibiting antiinfootive and jmmune-enhancing potential for use as an in vivo treatment fora human oe warm-blooded animal according to claim 3, ‘wherein the cathode is positioned coaxially o¢ in parallel in relation tthe anode. 9. A method for using a stable, non-toxic, animierobial loctolyzed. saline solution exhibiting. ant-infoctive and Jmmune-enhancing potential for use as an in vivo tretanent ora human or warm-blooded animal according to claim 3, “wherein the eathode is made ofa base metal selected from the _aroup consisting of platinum, niobium, titanium or any metal ‘compatible wth platinum bonding ands plated withan outer layer of platinum bonded to the base metal 10, A method for using a stable, non-toxic, antimicrobial ‘lectolyzed saline solution exhibiting antiinfootive and jimmune-enhancing potential for use as an in vivo treatment ora human oe warm-blooded animal aecorling to elim 7, swherein the cathode has #eylinrical, or ft (planar shaped Structure 11, A method for using a stable, non-toxic, antimicrobial ‘lectrolyzed saline solution exhibiting ant-infective and Jmaine-enhancing potential for use a-an in vivo treatment ora human or warm-blooded animal according to claim 3, wherein thespacing between thecathode and the nade is ess than about one inch 12. An apparatus for producing stable, non-toxic, anti ‘robial elecrolyzed saline solution exhibiting ati-infective nd immune-enhancing potential as a therapeutic contining regulated amounts of stable reactive oxygen species (ROS), ‘comprising: 4. container filled with saline solution having a saline ‘eancentration ofa least about 0.15%, fan inert anode and a spaced apart corresponding inert cathode placed within the saline solution, Apr. 30, 2009 «a temperature regulator for regulating the temperature of the saline solution t maintain a solution temperature sulicient to prevent production of chlorates and regulate ‘lative concentrations of resulting components daring electrolysis, 4. circulation means associated withthe container fr cit. culating te saline solution to maintain a flow of the saline solution between the anode and cathode, a power source associated withthe anode and eathode to apply anelfective voltage potential less than about tiny vols between the cathode and the anode sulicient produce a balanced mixture of chemically reduced and ‘oxidized species including Hypochlorous acid (HOCD, Hypochlorite (OCI, NaCIO), dissolved Oxygen (O:), (Chlorine (Cl, between Ito 200 ppmand Hydrogen (H,) ‘ges, Hydrogen Peroxide (H,0), Hydrogen ions (H), Hypochloride (C10) and comesponding amounts of Superoxides (°0,-, HO,), Ozone(O,) from 1050 ppm, Activated Hydrogen ions (H), Chloride ions (Ct Hyydroxides (NaOH, OH"), Singlet Oxygen (*0,) and ‘ther forms of Reactive Oxygen Species (ROS) POC, "10>, and total ROS between 105 10 50 ppm, wilizing electron and proton donation, ion and dissolved-gas transport; dhe temperature, anode and cathode spacing, saline solution citculation rate, and effective voltage combination selected 10 achieve desired electrolysis ‘ffciences and stable specie compositions containing Stable ROS compounds while preventing production of chlorate, 13. An apparatus for producing a stable, non-toxie, anti crobialclotrolyzed saline safution exhibiting antivinfoctive and immune-enbancing potential as. therapeutic containing ‘epulated amounts of stable reactive oxygen species (ROS) ‘aevording to claim 12, wherein the container is fabricated {fom a biologically compatible material, 14. An apparatus for producing a stable, non-toxie, antimi- crobial electrolyzed saline solution exhibiting an-infetive ‘and inumuine-enbancing potential as a Uaerapeutic containing regulated amounts of stable reactive oxygen spocies (ROS) according to elsim 12, wherein the anode ix made of a base metal selected from the group consisting of platinum, nio- bium, titanium or any metal compatible with platinum bond- ing and is coated with an outer layer of platinum bonded tothe base metal 18. An apparatus for producing a stable, non-toxie, anti crobialeloctrolyzed saline solution exhibiting anti-infective ‘and imimune-enbancing potential as a Uaerapeutic containing regulated amounts of stable roaetive oxygen species (ROS) ‘according to claim 14, wherein the anode has ncylindrical, oF fat (planar) shaped structure. 16, An apparatus for producing a stable, non-toxie, antimi crobialeloctrolyzed saline solution exhibiting antivinfcetive and immune-enlancing potential asa therapeutic containing ‘regulated amounts of stable reactive oxygen species (ROS) according to claim 18, wherein the cathode as a cylindrical, orflat (plana) shaped structure ands positioned coaxially oF in parallel in relation tothe anode, 17. An apparatus for producing a stable, non-toxie, anti crobialelocrolyzed saline soution exhibiting antiinfotive And immune-enlancing potential as a therapeutic containing ‘regulated amounts of stable reactive oxygen species (ROS) ccording to claim 16, wherein the cathode is made ofa ase netal selected from the group consisting of platinum, noUS 2009/0110749 AI bium, titanium or any metal compatible with platinum bond- Jing and is plated with anouter layer of platinum bonded to the base metal 18. An apparatus for producing a stable, non-toxie, ais ‘robialelectolyzed saline soltion exhibiting aniinfective ‘and immune-enhaneing potential asa therapeutie containing regulated amounts of stable reactive oxygen spocies (ROS) Apr. 30, 2009 ‘aecording to claim 12, wherein the spacing between the eath- ‘de and he anodes less than one inch and is dependent upon fon transfer rates and electric fields to achieve desired elec- trolyss efficiencies to produce different varctes of soliton ‘components all containing stable ROS compounds