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«2 United States Patent Abbott et al. ‘US011000545B2 US 11,000,545 B2 May 11, 2021 (10) Patent No.: (45) Date of Patent: (54) COPPER ION COMPOSITIONS AND METHODS OF TREATMENT FOR CONDITIONS CAUSED BY CORONAVIRUS AND INFLUENZA (71) Applicant: CDA Research Group, Inc, Pitsbu, PA(US) (72) laventors: ChunLim Abbott, Pitsburgh, PA (US): Dominic C, Abbott, Pitsbursh, PA. (us) (73) Assignee: CDA RESEARCH GROUP, INC., Pintshurgh, PA (US) (*) Notice: Subject to any disclaimer, the term ofthis, patent is extended or adjusted under 35. US.C. 154(b) by 0 days. (21) Appl. No: 160881,997 (22) Filed: May 22, 2020 (65) Prior Publication Data US 202010281972 Al Sep. 10, 2020 Related US. Application Data (63) Continuation-in-part of application No. 13°842,310, filed on Mar. 15, 2013, (51) Intl. AGIK 3834 (2006.01) AGIK 9700 (2006.01), A6IK 9/06, (2006.01) (52) US.Cl Pe AGIK 3324 (2013.01); AGIK 9/0014 (2013.01); A6IK 90078 (2013.01); AGIK 9/06 201301) (58) Field of Classification Search cre AGIK 3934 ‘Soe application file for complete search (56) References Cited US. PATENT DOCUMENTS. 2904602 S30.678 3803308 81961 Bossard T1968. Pacini 41974 Zinger S174 Gorton 1976 Courmat 81977 Sankey ea. U1979. Wallicek 1211980 Danning, Jc al TI98L Home ea PDPED DDD E o> rd ee>rrEe> LOI9SL Velosi 4332791 A 61982 Raat al 7983 Uragani 1011983 Drake ta 445790 A 7/1984 Tames 451849 A 1011986 Pollock eta 454220 4 21987 Whitehead eta 461,101 A 41987 ‘Sustnann 4695018 A GI9NT Sstnana eta 4680309 A 7/1987 Maurer 4999216 A 911990 Dauner S037 A 81901 Willams et a $1063.068 A L001. Batersca ea S165367 A 11/1992 Pickart S211'940 A $1992 Ishiguro eta S399.360 A 21098 Mobley ta S4I8866 A 91995 Zook Si2s862 A 6/1905 ‘Hartann ta 5458746 A 101995. Bumess eal SI816 A 81998. 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Burrell eta 2007 alien eta (Continued) FOREIGN PATENT DOCUMENTS au 04009672 guis73 ca, 2478137 AL 2/2006 (Continued) (OTHER PUBLICATIONS Google Search soppt salt fr sore throat “coronavins” Aug. 24, 2020 (Year: 2020)* “Assessment of the Safety and Flcacy of 3VMIOOL Cream for ‘Treatment of Chronic Pin Caused by KaceOsteoarttisClinalTei- alg hips iia gov 2 history NCTO2S321480 3d ‘AUB. 19,2015 (6 pages). “CDC No Longer Revommends Oral Drug for Gonodbea Trest- sent”, Centers for Disease Control Press Release, Aug, 9, 2012, 1 pase. “Copper Sulfate" extract from Extoxnet: Extension Toxicology ‘Network, , May 1994 ( pages), (Continued) Primary Examiner — Michael P Cohen (14) Attornes, Agent, or Firm — Wilmer Cutler Pickering Hale and Dorr LLP on ABSTRACT Provided herein are formulations coatsining copper ions and methods of treating underlying infections and conkitions caused by coronavirus, particularly COVID-19, and infiu- cenaas, particularly influenza A andor influenza B using such ‘ormulations. Methods of eating the underlying vieuses and their resultant conditions using topical copper ion treatments, are provided. topical treatment in is basic form comprises 1 biocompatible copper ion solution oF suspension ob by leaching of the eopper ions from copper metal. The copper ion solution or suspension may be combined with various carriers to form the copper ion treatment including creams or solutions, Methods of makiag the copper ion solution or suspension from solid copper metal ina biocom- patible solution are also provided. 12 Claims, 9 Drawing Sheets US 11,000,545 B2 Page 2 (56) 704819 76.015 857.961 08 siss.ae6 S1s.800 10398333, 20020114767 ao02 0136758 2003 0009718 do03 0163149 20030166510 200s0171519 oo 02sa097 oosiaoasta? 30060122095 20060210288 20060222622 00610283078 0070014839 0070053889 sooro1e7o71 20070187327 20070190175 20070283268 20070278073 20070276308 aoow 029915 2oso032119 008081077 20080125686 20080195033 20080274065 doowa20s883 duos 209155 2o0s0st116s 20080011218 20080317835 2009;0008258 2009;0018213 sooo 0148sa0 20090186071 200910246292 do0g.o2s7131 ooo 304813 200900311308 20100013998 ro1ov06sI61 0100068297 do1o1n01s D190 0158999 do1ouRsI78 do10028R248 aolous0Tsas O11 006a826 ou ooseoss 20120063262 ao12007 807 20120071888 201200085068 doiso12s7I6 ao1sox26061 2014x7495 ao14a271797 201410271798 aowsox71919 2016008272 2010000823 20170101609 20180071206 ao1801329 References Cited US. 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Biomaterials, 2417071907, 2003 (11 page). European Extended Seatch Report issued in European Patent p> sation No. 178514843, dated Jul. 10, 2020 (15 pages). “Ditference Between 304 vs 316 Stainless Ste”, Eagle Stiless ‘Tube & Fabrication. ln. hips: /caletube com abou-us news 304- vvs316stainlessstecl, un. 21,2018 2 pages) Inman Sesh Rpt an Wien Opinion ise yt Pr ant Tra Oe os Into Seahing ator isin totionl Aran No PCT US2020 1984 data Jun 23, 2020 (12 poss 10 Homemade Gls Tat Hea’, Reade’ Digs of Canada, Srtsfotige cb conlitons eles. Jan 008 Gms) “animobi Comper FAQS" CDA Plato 20, Copper Deel opment Associ Hemel Hempsed initelKingm, 210 8 3) Teer Reece Cent, tp mowesigmslich somite sens core-bioreges sgl lenin centr fefuenceceneriml, Ost. 26 208 (6 pas $20 Maal, -Mtisl pptons of tans ts 4 (UNS 30407 aom com Aisa LL s 2 5 3 3 ft © g i sry al a 3 a 8 FIG. 16 US. Patent May 11, 2021 Sheet 6 of 9 US 11,000,545 B2 FIG. 20 US. Patent May 11, 2021 Sheet 7 of 9 US 11,000,545 B2 FIG. 21 US. Patent May 11, 2021 Sheet 8 of 9 US 11,000,545 B2 US. Patent May 11, 2021 Sheet 9 of 9 US 11,000,545 B2 US 11,000,545 B2 1 COPPER ION COMPOSITIONS AND. METHODS OF TREATMENT FOR CONDITIONS CAUSED BY CORONAVIRUS AND INFLUENZA, (CROSS.REFERENCE TO RELATED ‘APPLICATIONS. ‘This application is a continvation-in-part of and claims priority t0 U.S. patent application Ser No. 13842.310, filed Mar, 15,2013, The entice contents of this patent application are hereby incorporated by reference in is entirety. FIELD OF THE DISCLOSURE ‘The technology pertains generally to topical treatments containing copper ions and to methods of treating respira tory and viral body conditions using topical treatments containing copper ions, More particularly, the technology pertains to treating respiratory conditions caused by viral infections andor the underlying viral infection using topical lreatments containing copper ions. In some aspects, the techaology pertains wo treating respiratory conditions caused bby corona vial infections, specifically infections by the COVID-19 virus, and/or the corona vial infection, specifi 2 cally infections by the COVID-19 virus, using topical treat- ments containing copper ions. In some aspects, the technol ‘ogy pertains to treating respiratory conditions caused by influenza viral infections, specifically infections by the influenza A or influenza B viruses, andor the influenza viral infection, specifically infections by the influenza A or infl- ‘iva BB viruses, using topical treatments containing copper ions. In some aspects, the technology pertains to inhalation therapy (aerosolized) delivery systems using an inhalation aerosol. BACKGROUND OF THE DISCLOSURE Many various sbnormal body contition are caused by ‘ham pathogens oF microbes, examples of which ined bacteria fang and viruses, Abnormal body conditions tht arse fom viral diseases include the endemic influenza, cause by influenza A andlor influenza B, and the pandemic ofthe novel SARS-CoV-2 coronaviss ("COVID-19"). The ‘CDC estimates that Inlvenza was associated with nearly $0 milion illnesses during inthe United States during 2017- 2018 season contibutng to 79400 deaths. Aditnaly the CDC estimates that in the fst four and a half months of 2020, COVID-19, which causes respiratory disease, had infected over 14 million poople in the United States and caused nearly 86,000 deaths. The global COVID-19_pan- demic has created an urgency in developing treatments for ‘is novel vial infection Adktional viral diseases ince herpes (Iypes I and 1), Jnuman papilloms virus (HPV) and HIN, al of which are sexually tansmitable. There is no eure for hemp or COVID-19. Antiviral drs are available to alleviate herpes symptoms and suppress the herpes virus so that active infections recur less frequently and are of shorter daration, ‘ut these drugs are associate with significant side effets Infection with HPV is usally treated wit topical motica- tions, oral medications andor surgical removal of wart ‘Complications of HY infcton include increasod rik for cervical, rectal and vulvar cancers. Available treatments for HIV ave designed to suppress the views and boost the immune system in ope of avoiding opportunistic infections sand delaying or preventing the onset of fll-bowa acquired ” 4s © 2 ‘immune deficiency syndrome (AIDS), Viruses such as her- es, shingles and HPV ar also th cause of abnormal body conditions onthe skin. In particular, hepes causes cold sores (ever blisters), shingles causes painful erations, and HPV causes warts on the skin, ‘The oral-respiratory-otic areas of the body, ic. mouth, throat, nos, sinuses and ears are also common sites for normal body conditions duet te aforementioned pato- gens, microbes, and viruses, inching the COVID-19 and jnflcnza A and B viruses. Vira infections are responsible for maay uaanted symploms that appear in the oral- respratory-otic areas of the body inloing sore throat, ‘onslit,colds, bronchitis, sinusitis, shiaosinsits, wher ing, ear infections, earache, pressure in the ears, cold sores, mouth uleers, canker sores, cough, hoarseness or laryngitis, congestion, runay nose, sheczing, sore gums, periodontal disease, toth decay and halitosis (bad breath. Further, viral infections including COVID-19 and influenza A and B ‘infections can lead 10 serious, prolonged illnesses, hospital- jzaton, damage tothe respiratory sytem evea that remains neal even afer the viral infection is purged from the body, and, in some cases, death ‘A vast aray of presription and non-prescription drugs sed products re commercially available lo reat oral-respi- ratory.ate conditions. However, the prescription drgs and ‘even many of the non-prescription drugs or products used to treat the numerous body conditions described above have many drawbacks including undesirable or potentially harm fil side eats, high isk of ham in the eveat of overdose or improper vse, high cost, limited effetivenes, the need forclose maical monitoring, and inconvenience, Moreover, there is presently no single compound or product to teat COVID-19 infections or conditions aleting the oalrespi- ratory-otie that can include the mouth, thst, airway, nose, sinuses and ears eatsed by the COVID-10 infections. thas previously been established that copper postesses propetcs hy which tis capable of killing, newalizing and preventing the growth of pathogens. Its knowa that many bctera identifi as pathogens cannot survive on surfaces of copper metal. US. Pat, No 8.135.466 B2 to Fuller eta aisclsesa join prosthesis having an implant body with an external surfce containing an antimerobia metal where the ‘utimicrobal metal may be copper. U.S. Patent Application Publications No. US 201210071807 Al and No. US 2012/ (089068 AL to MoClure, J, disclose. wound dressings containing a meal-based antimicrobial agent where the metlcbased antimicrobial agent may be a mixture of silver ions and copper ions. Devies having. an exteral srfce of copper meal for insertion ia the vagina to treat abnormal biological conditions have been proposed by Applicans in US. patet application Ser. No. 12/157,823 filed Jun. 13, 2008 (ahandoned), Ser. No, 13/317,230 fled Oct. 12,2011, and Ser. No. 13/464,005 filed May 4, 2012, the entire disclosures of which are incorporated herein by reference. “Topical substances containing particles of copper or is alloys have boen proposed for eal suppart uses. Copper peides for use onthe skin are commer avaiable rd these regire peptides, i. small fragments of protein that have an affinity for copper to which they bind very tightly. US. Pat. No. 7.776915 B2 o Mora discloses topical composition containing, at & minimum, a ipic acid, caratine and a carpasine, where the carvsine may be chelated to zine or copper ions. The intended use for the topical composition is to improve the appearance of aged shia, US. Pateat Application Publication No, US2008 (0198033 Al to Bageson et al discloses use of a metal substance io teat diseases ia the body. The meal substance US 11,000,545 B2 eS is primarily a colloidal suspension and delivery of the substance to the body may require the vse of electricity. Prior othe present technology, it has not been recognized to provide a simple solution containing copper ions for use as ‘topical treatment o be appli direct to anatomical tissue to teat body conditions andor for use in conjunction with various carters including creams, gels, lotions, foams, pastes, other solutions, suppositories, tampons, body wipes, wound dressings, skin patches and suture material to form, topical treatments in which the carriers facilitate delivery of the copper ions to contact anatomical tissue depending on the anatomical area or areas of use on the body SUMMARY OF THE DISCLOSURE In one aspect, the technology involves a method of ‘treating at least one condition caused by a comonavirus or an influenza virus, the method comprising, administering a composition comprising copper jons to 8 subject in need thereof. In some embodiments, the atleast one condition is ceased by COVID-19. in some embodiments, the a east ‘one condition is caused by one or more of influenza A and influenza B. In some embodiments, the at last one condition alleets thera, respiratory, or atic tissues of the subject in need, and ‘the method comprises contacting the oral, respiratory, orotic tissues of the subject with the composition comprising copper ions, In some embodiments, the at least one condition com- prises cough, throat soreness, chest pain, or chest pressure Insome embodiments, the at least one condition comprises chest pain or chest pressure, the composition comprising ‘copper ions is a cream, and the composition comprising copper ions is administered by contocting the chest of the subject with the eam. In Some embodiments, the cream is administered to the subject's chest every’ three hours. In some embodiments, the cream is administered to the sub- jects chest as needed based on the subject's symptoms. In some embodiments, the composition comprising cop- per ious is a solution, a nebulizer, metered dose inkaler, erosolizer, vaporize, or atomizer delivers the solution in as 2 copper ion aerosolization mist, loud or spesy. and the ‘composition comprising copper ions is alministered by dllivering the copper ion mist, cloud, or spray tothe subject. In some embodiments, the copper ion mist, cloud, of spray is delivered to the Tongs of the subject. In some embodi- ‘ments, the nebulizer, metered dose inhaler, aerosolizer, ‘vaporizer, or atomizer is inserted into the subject's mouth, and the nebulizer, metered dose inhaler, aerosolizr, vapor: izer, or atomizer delivers the copper ion mis, clond, or spray into the subject's mouth. In some embodiments, the atleast, ‘one condition comprises throat soreness. In some embod ments, the nebulizer, metered dose inhaler, aemosolizer, ‘vaporizer, or alomizer delivers one, two, or three doses of the copper ion mist, cloud, or spray tothe subjet with each use. In some emboiments, the copper ion mist, cloud, or spray is administered to the subject every three hours. In Some embodiments, the copper ion mist, cloud, or spray is administered tothe subject as needed based on the subject's symptoms. In some embodiments, the at least one condition com prises chest pain or chest pressure, the composition com- prising copper ions is a solution, a nebulizer, metered dose inhaler, aerosolizer, vaporizer, or atomizer delivers the solu tion in as a copper ion mist, cloud or spray, and the ‘composition comprising copper ions is administered by delivering the copper ion mist, cloud, or spray to the subject, x0 ” 4s 0 © 4 and further a eream comprising copper ions is administering to the subject in need thereof, and the subject's chest is contated withthe ream, In some embodiments, the copper jon mist, cloud, or spray and the cream are administered to the subject concurrent In an aspect, the technology involves a composition for treating at least one condition caused by a coronavirus or an influenza virus comprising a copper ion suspension, the copper ion suspension comprising copper ions, saline, and a bulle. In some embodiments, the copper ion suspension contains about 15 jim of copper In some embodiments, the copper ion suspension is Formed by a process comprising placing solid copper metal ina solution comprising saline and the bulla, allowing the solid copper metal 1 remain in the solution for a predeter- ‘ined period of ime, during which predetermined period of time the solid copper metal leaches into the solution, and removing the solid copper metal from the solution afer the predetermined period of time, BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view ofa bottle containing a copper ion treatment and having spray pump nozzle for dispensing the copper ion treatment. FIG. 2 isa side view ofa botle containing a copper ion treatment and having a spray pump nozzle with an elongate extension for dispensing the eopper ion treatment, FIG. 3 isa side view ofa botle containing a copper ion treatment wherein the bottle is squeezable tb dispense the copper ion treatment from a dropper oa the bole. FIG, 4 isa side view ofa batle containing a copper ion treatment and having a brush for applying the copper ion tweatment 0 anatomical tissue FIG. § is aside view of a tube containing « copper ion treatment wherein the tube is squeezable to dispense the copper ion treatment. FIG, 6 is a side view of an alternative bottle that is squeezable to dispense a copper ion treatment and showing the bottle in a dosed condition, FIG, 7 isa side view of the batle of FIG, 6 showing the boitle in an open condition, FIG, 8 isa side view ofa botle containing a copper ion treatment and having ® pump nozzle for dispensing the copper ion treatment inthe form of foam, FIG. 9 isa side view of an applicator for delivering a copper ion treatment tothe vagina, FIG. 10s side view ofthe applicator of FIG. 9 showing use of the applicator in conjuaction withthe tube of FIG. 5, FIG. 11 is a side view of an alternative applicator for applying a copper ion treatment onto anatomical tissue. 12 sa side view ofa tampon having a tampon body used as a cartier to deliver a copper ion treatment t0 the vagina FIG. 13 is a broken front view of a plurality of supposi- tories containing a copper ion treatment, the suppositories being insertable inthe vagina or rectum to deliver the copper jon treatment to the vagina oF rectum. FIG. 14 isa side view showing a suppository of EIG. 13. being removed from its package. FIG, 18 isa sie view of an applicator for delivering the suppositories of FIG. 13 to the Vagina or rectum. FIG, 16 isa front view of a package containing a body wipe carrying. a copper ion testment and showing the pockage partially open to eemove the body wipe therefrom, FIG. 17 is a perspective view of a wound dressing supplied with a copper ion teatment US 11,000,545 B2 5 FIG. 18 is plan view ofa skin patch carrying a copper jon treatment FIG. 19 is a perspective view of sunures created in anatomical tissue using suture material earryinga copper ion ‘treatment. FIG. 20 shows copper strips separated by using stainless steel rods in a phosphate bullered saline solution, FIG. 21 shows the bulk suspension obtained after incu ‘ating phosphate buffer saline with copper strips. FIG. 22 shows the tansfer of the bulk suspension to a measuring cup. IG. 23 shows the bulk suspension following transfer to ‘clean glass dish, DETAILED DESCRIPTION OF EMBODIMENTS Provided herein are topical fmulations comprising cop- per ions forthe treatment ofa variety of conditions, inlud- ing respiratory conditions. In particular, methods of treating respiratory conditions resulting from Viral infection using topical copper ion formulations such aa copper ion solution ‘of cream are provided. It is envisioned thatthe treatment may include treating respiratory conditions resulting from COVID-19 or respiratory conditions resulting fron iaflu- ‘za A or influenza B, Addltionally, methods of treating Viral infection using topical eopper ion formulations such as ‘a copper ion solution of cream ae provided, I is envisioned that the treatment may include treating. vial infections ‘resulting fom COVID-19 o¢ viral infections resulting ftom influenza A or influenza B. In some embodiments, the solution is delivered to a subject in need thereof using a vaporizer. In some embod ‘ments, the solution is delivered to a subject in need thereof using an atomizer. In some embodiments, the solution is delivered {0 a subject in need thereof using a nebulizer. In some embodiments the solution is delivered to a subject in need thereof using a metered dose inhaler. In some emboci- ‘meats, the solution is delivered toa subject in need thereat using an aerosolizer. In some embodiments, the nebulizer, ‘metered dose inhaler, erosolizer, vaporizer, or the atomizer dllivers the solution into the lungs. In some embodiments the solution i provided asa mist or cloud, In some embocl- ‘ments, the nebulizer, metered dose inkaler, aerosolizet, ‘vaporizer, or atomizer is inserted into a subject's mouth and the nebulizer, metered dose inhaler, acosolizer, vaporizer, of atomizer dispenses the mist or cloud down the troat into the Jungs. In some embodiments the solution is provided once, twioe, or tree times as a mist or cloul tothe lungs each time the nebulizer, metered dose inhaler, aecosolizer, vaporizer, or atomizer is used. In some embodiments, the solution is provided as a spray. In some embodiments, the solution is provided as a spray to the back ofthe throat In some embodiments, the solution provided as @ mist, loud, or spray passes the throat as it enters the respiratory system of the subject. In some embodiments the solution ‘eats throat soreness a it passes the throat as a mist cloud, ‘orspray. In some embodiments, the solution is applied to the respiitory sysiem as a mist, eloud, or spray about once cevery three hous, In some embodiments, the solution is applied tothe respiratory system as « mis, cloud, or spray ‘8 needed based on a subject's sympioms, Insomeembodiments the solution may be administered to the mouth andor nasal passages of a subject. In some embodiments the solution is administered to the mouth andlor nasal passages concurrently with the solution being administered to the throats and respiratory system of the subject. ln some embodiments the concurreat administration x0 ” 4s 0 © 6 of the solution to the throats and respiratory system is dover as amis, cloud, o spray’ produced by a nebulizer, metered dose inhale, aerosolzer, atomizer, o vaporizer. In Some embodiments the administration ofthe soliton to one or more ofthe mouth, nasal pessages, throat, and respistory system inhibits viral infection ina subject. In some embo- ments, the viral infection being inhibited is a coronavirus, COVID-19, an influenza vn, nitenza A, andor influenza BB In some embodiment, the inhibitory benefit lasts for about 0. hours, f hour, LS hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hour, 8 hous, 12 hous, 24 hours, 36 hours, oF 48 hours. In some embodiments the inhibitory benefit lasts forabout 4 bourstoabout 12 hours. la some enbodiment the inhibitory benefit lasts for about 4 hours Ta some embodiment, the salution i applied tothe chest of subject. In some embodiment a formulation of the solution with a cream base is applied 10 the chest of @ subject. In some embodiments, pplication ofthe solution or ream the chest eieves pain or pressure in the chest of the subject. In some embovdimeas the solution or eream is applied to the chest concurrently with or just afer the application of the solution tothe expiratory system of the subject. In some embodiments the sootion of cream is applied tothe chest about once every three hours. In some embodiments the safution or cream is applied to the chest as needed based on a subject’ symptoms Sympioms which may infonn the application of the solution to a subject in need thereof include, but are not limited to, sore that, cough, chest pain, and chest pressure In some embodiments, a solution containing copper ions, ie. copper ion-contaning solution, for use as topical teeatmen containing copper ions, ie. topical copper ion teeatmient, to eat body conditions is produced according a process or method by which copper ions fom copper meta ar leached into an appropriate biocompatible soltion. As sed herein, “copper meta” means pure copper (995% or seater copper affer processing) and copper alloys such as basses, bronzes, copper-ickels and coppericke-zncs. Preferably, pore copper is seas the copper metal. Example 1 describes the steps involved in prodcing an amount of copper ioa-contining solution equal or substantially equal to 7.4 ounces. In other embodiments suspension contsining a copper salt precipitate is combined with a ream base to create a copper ion cream, wherein a substantial proportion of the copper ions ae found in te quid phase ofthe cream. In certain embovtimests at east Spin, 7g. 9 wpa. or 11 pg/ml of coppers found inthe soluble phase. In some embodiments, the Liguid phase ofthe cream contains about 115 ypiml. of copper. Example 34 describes the steps involved in preparing a cream with bout 1.5 ygiml. of copper in the soluble phase. In some embodiments, the liquid phase of the eream contains about 15 yy of copper In some embodiments, the solution containing copper dons is produced sing substantially pure copper. In emboi- ment, the solton consining copper ions is produced by adding an appropriate amount of solution in & vessel with copper. In some embodiments, additonal safution is placed inthe vesel to decrease the concentration ofthe copper ions Jeached ito the solution. In some embotiments, less solt- tio is plced in the vesel to increase te concentration of the copper ions leached into the sation. In some embodiments, the solution i buered. In some bodiment, the buller comprises a least one of acetate, acetic acd, phosphate, a phosphoric acd, orat lest oe salt of acetate, acetic aid, phosphate or phosphoric acd. In US 11,000,545 B2 7 some embodiments, the solution requires no baie, or the solution is substantially free of buffers or buffering agen In some embodiments, the solution i a saline solution, Insome embodiments, the copper lad is disposed into the solution fora predetermined time between about 0.5 hours and several days eg, 1, 2,3, 4, 5, 67, oF 10 days), several ‘weeks (eg. 1,2,3,4,5,or 6 weeks), or several months (eg, 1, 2, 3,4, 5,6, or 12 months). In some embodiments the predetermined time is between about 0.5 hours and about 72 hours In some embodiments, the time is about 0.5, about 1, about 1.S,about 2, about 2.5, bout 3, about 4, about S, about 6, about 12, about 18, about 24, bout 36, abou 48, about 60, or about 72 hours. In some embodiments, the solution with the copper load dlisposed in it is heated or cooled to a predetermined tem- perature. In some embodiments, the temperature is brought to between about 20° C. (ie. about room temperature) to about 100° C. In some embodiments, the temperature is Drought to between about 20°C. and 70° C, In some cemboxtiments, the temperature is brought to between about 35°C. and 70° C. In some embodiments, the temperature is Drought to between about 35° C. and 50” C. In some ‘embodiments, the temperature is brought to about 37° C. and maintained for a predetermined period of time. In some ‘embodiments, the temperatures brought to about SO” C. and naintained for a predetermined period of time, In some ‘embodiments, the temperature is brought to between about 20° C. and 35° C. In some embodiments, the temperature is ‘brought to between about SO” C. and 70° C. In some ‘embodiments, the temperature is brought to between about 70° C. andl 100" C, Inasmuch as the preseat disclosure is subject to many ‘variations, modifications and changes in deal, iti intended that all subject matter discussed above or shown in the ‘accompanying drawings be interpreted as illustrative only and not be taken in a limiting sense. EXAMPLES Example 1 7.44 ounces of biocompatible saline solution bullered with acetic acid and sodium acetate to a pH of S (20.4) is placed ina container r vessel witha tight, removable lid to ‘minimize evaporation, The container is placed in an inen- batar or oven ata temperature of 37° Celsius (21° C.). When the saline solution has reached 37° Celsius, 102 grams of pure copper metal in solid form is placed in the heated solution within the container, and the container with the tight lid thereon is placed in the incubator at 37° Celsius for 24 hours. During the 24-hour period, copper ions from the ‘copper metal leach into the solution, At the end of the 24-hour period, the containers removed from the incubator fand the copper metal is removed o¢ separated from the solution. The amount of solution remaining after removal or separation of the copper metal therefrom constitutes the copper ion-contaning solution and should be essentially 7.44 ounces with minimal evaporation, The copper ion= containing solution produced according to this process con- tains copper ions in an amount equa or substantially equal to 46 milligrams when analyzed for copper content by inductively coupled plasma/optcal emission spectroscopy ICP/OES), The copper ion-containing solution is stored at oom temperature and i ready for use in this fom as a topical copper ion twatment to he applied to anatomical tissue to treat body conditions. In addition, the copper ion-containing solution is ready for use in conjunction With x0 ” 4s 0 © 8 various carriers including creams, gels, lotions, foams, pastes, oer solutions, suppositories, tampons, body wipes, ‘wound dressings skin patches and suture materials o foam topical capper on treatments in which the carers facilitate delivery ofthe copper ioa treatments to contact anatomical tissue to teat body conditions ‘The solié pure copper metal in Example 1 may be inthe form of one or more sheets of pure copper metal typically in the range of 0.03 10006 inc thick, of appropiate length and width o provide the 102 grams of pure copper meta. a practice the process described in Example 1 has been aed out using asthe copper metal four vaginal therapeu tic devices made of pure copper in accordance with Appi- cans" prior patent application Ser. No. 13464005 previ- ously incorporated herein by reference in is entre. In this case, each vaginal therapentie device used was 3.28 Inches Jong by 0.70 inch wide with a wall thickness of 0.031 iach proving 25.5 grams of pure copper, The biocompatible Saline solution usa inthe process described in Example 1 is commenially availble from B. Braun Medica. As an aematve to the biocompatible sine, vaginal simulating ‘uid (VS) bleed with acetic acid a pl ofS (204) can be used as the biocompatible solution, but wil produce less leaching of copper ions from copper metal ove the 24 hour petiod. The VSF can be prepared in accordance with pub lished iterate, eg. Owen, D.H,, Katz, DF, “A Vaginal Fo Simulant, Contraception, pages 91-95 (1999). The proces described in Example I canbe modified to eliminate the step of heating the solution prior to placement of the copper metal therein. In the later eas, the copper metal and unheated solution are placed inthe container, the container with the ight Tid theron is placed in the Inubator at 37° Celsius and, once the solution has reached 37° Celsius, the container withthe heated solution and copper metal therein js allowed to remia inthe oven for 24 hours. The copper metal ean be removed or separated from the solation in ‘various ways, such as by iting the metal out ofthe solution or pouring the solution alone into another container. OF course, the quantities of biocompatible sine and solid copper mental used in Example | can be proportionately Increased to produce a greater amount of copper ion-

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