Use of physiologically balanced, ionized, acidic solution in wound healing

• US 6,426,066 B1
• Filed: 01/12/2000
• Issued: 07/30/2002
• Est. Priority Date: 01/12/2000
• Status: Expired due to Term

• Current Assignee: NovaBay Pharmaceuticals, Inc.
• Original Assignee: California Pacific Labs, Inc.
• Inventors: Najafi, Ramin, Bernard, Suzanne M.
• Primary Examiner(s): Fay, Zohreh
• Assistant Examiner(s): KWON, YONG SOK
• Application Number:
  US09/482,159
• Time in Patent Office: 930 Days
• Field of Search: 424/78.04, 424/78.06, 424/78.07, 424/613, 424/661, 205/701, 205/742, 204/228, 204/229
• US Class Current: 424/78.04
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 33/40 Peroxides
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 27/04 Artificial tears; Irrigation solutions
• CPC Class Codes: A61P 31/02 Local antiseptics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: C02F 1/4618 for producing "ionised" acidic or basic water
• CPC Class Codes: C02F 2001/46185 only anodic or acidic water, e.g. for oxidizing or sterilizing
• CPC Class Codes: C02F 2103/026 Treating water for medical or cosmetic purposes
• CPC Class Codes: C02F 2201/46115 Electrolytic cell with membranes or diaphragms
• CPC Class Codes: C02F 2201/4618 Supplying or removing reactants or electrolyte
• CPC Class Codes: C02F 2209/04 Oxidation reduction potential [ORP]
• CPC Class Codes: C02F 2209/06 pH
• CPC Class Codes: C02F 2303/04 Disinfection
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A physiologically-balanced, ionized, acidic solution. The solution may be prepared by the electrolysis of a solution comprising a mixture of inorganic salts in physiologically balanced proportions. A mixture of inorganic salts and, optionally, minerals (such as metallic elements, for example, and not by way of limitation) is used in order to mimic the electrolyte concentration and mixture of body fluid in an isotonic state. The solution typically comprises halide salts of sodium, potassium, calcium, and other cations. Typically the halide is fluoride, chloride, bromide, or iodide; and most typically chloride. The halide-comprising acidic solution is physiologically balanced by the inclusion of elements such as sodium, potassium, magnesium, zinc, lithium, and beryllium in the solution. The composition of the invention is nontoxic and has antibacterial properties. The composition is useful in any application in which antimicrobial properties are desirable, particularly in the topical application to wounds, burns, etc., and can be incorporated into a bandage or wound dressing.

Claims

1. A method of promoting wound healing, or tissue repair, or tissue regeneration, in a subject in need of such treatment comprising:

applying to a wound, or a damaged tissue, or a combination thereof, with an effective amount of a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of halide-comprising salts including about 0.3 to about 14 g/L sodium halide, about 0.02 to about 0.8 g/L potassium halide, and about 0.01-0.5 g/L magnesium halide; and

having a total concentration of halide-comprising salts in the range of about 0.4 g/L to about 16 g/L, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

a titratable halide content ranging from about 20 ppm to about 100 ppm;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

3. The method of claim 1, wherein said method further, comprising exposing the area of damaged tissue to be irrigated to a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of halide-comprising salts including about 0.3 to about 14 g/L sodium halide, about 0.02 to about 0.8 g/L potassium halide, and about 0.01-0.5 g/L magnesium halide;

and having a total concentration of halide-comprising salts in the range of about 0.4 g/L to about 16 g/L, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

a titratable halide content ranging from about 20 ppm to about 100 ppm;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

4. The method of claim 1, wherein said method further comprising applying to a dermal tissue a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of halide-comprising salts including about 0.3 to about 14 g/L sodium halide, about 0.02 to about 0.8 g/L potassium halide, and about 0.01-0.5 g/L magnesium halide;

and having a total concentration of halide-comprising salts in the range of about 0.4 g/L to about 16 g/L, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

a titratable halide content ranging from about 20 ppm to about 100 ppm;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

5. The method of claim 1, 2, 3, or 4, wherein the concentration of halide-comprising salts ranges from about 4 g/l to about 12 g/l.

6. The method of claim 5, wherein the halide comprising salts are chloride salts.

7. The method of claim 5, wherein the halide-comprising salts further include at least one salt selected from the group consisting of calcium halide, zinc halide, lithium halide, and beryllium halide.

2. A method of treating a burn in a subject in need of such treatment, comprising application of an effective amount of a physiologically-balanced, acidic composition to an affected site of the damaged tissues wherein said composition comprises an electrolyzed aqueous solution of halide-comprising salts including about 0.3 to about 14 g/L sodium halide, about 0.02 to about 0.8 g/L potassium halide, and about 0.01-0.5 g/L magnesium halide;

and having a total concentration of halide-comprising salts in the range of about 0.4 g/L to about 16 g/L, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

a titratable halide content ranging from about 20 ppm to about 100 ppm;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

8. A method of promoting wound healing, or tissue repair, or tissue regeneration in a subject in need of such treatment, comprising:

applying to a wound, or a damaged tissue, or a combination thereof with an effective amount of a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of salts, including sodium cations at a concentration of about 0.005 to about 7 g/L, potassium cations at a concentration of about 0.005 to about 0.6 g/L, and magnesium cations at a concentration of about 0.005 to about 0.1 g/L; and

, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

10. The method of claim 8, wherein said method further comprising exposing the area of damaged tissue to be irrigated to a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of salts, including sodium cations at a concentration of about 0.005 to about 7 g/L, potassium cations at a concentration of about 0.005 to about 0.6 g/L, and magnesium cations at a concentration of about 0.005 to about 0.1 g/L;

and, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

11. The method of claim 8, wherein said method further comprising applying to said dermal tissue a physiologically-balanced, acidic composition comprising an electrolyzed aqueous solution of salts, including sodium cations at a concentration of about 0.005 to about 7 g/L, potassium cations at a concentration of about 0.005 to about 0.6 g/L, and magnesium cations at a concentration of about 0.005 to about 0.1 g/L;

and, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.

12. The method of claim 8, 9, 10, or 11, further comprising halide-comprising salts.

13. The method of claim 12, wherein the concentration of halide-comprising salts ranges from about 4 g/l to about 12 g/l.

14. The method of claim 12, wherein the halide comprising salts are chloride salts.

15. The method of claim 12, wherein the halide-comprising salts further include at least one salt selected from the group consisting of calcium halide, zinc halide, lithium halide, and beryllium halide.

9. A method of treating a burn in a subject in need of such treatment, comprising application of an effective amount of a physiologically-balanced, acidic composition to an affected area of the damaged tissue, wherein said composition comprises an electrolyzed aqueous solution of salts, including sodium cations at a concentration of about 0.005 to about 7 g/L, potassium cations at a concentration of about 0.005 to about 0.6 g/L, and magnesium cations at a concentration of about 0.005 to about 0.1 g/L;

and, a pH ranging from about 2 to about 6, an oxidation reduction potential ranging from about +600 mV to about +1200 mV;

an O₃ concentration ranging from about 0.001 ppm to about 5 ppm;

an O₂ concentration ranging from about 5 ppm to about 30 ppm; and

, a HClO concentration ranging from about 0.1 ppm to about 1000 ppm.