HYDROGEL-BASED BIOMEDICAL DEVICES FOR THERAPEUTIC HYDROGEN TREATMENT OF SKIN AND TISSUES AND METHODS OF USING THEM

1 . A product of manufacture capable of delivering a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen to a tissue in need thereof, the product of manufacture comprising:

(a) a hydrated hydrogel, and

(b) at least one cathode electrode and at least one anode electrode implanted within or upon the hydrogel, wherein the cathode and the anode electrode are spaced sufficiently apart to generate an electrical current in the hydrogel sufficient to cause a hydrolysis reaction in the hydrogel, thereby generating the hydrogen, metastable hydrogen peroxide and oxygen,

and optionally (c), a power source operatively linked to the at least one cathode electrode and at least one anode electrode able to generate a current sufficient to cause a hydrolysis reaction in the hydrogel.

2 . The product of manufacture of claim 1 , wherein the hydrogel comprises a glycosaminoglycan, an anionic glycosaminoglycan, or an anionic non-sulfated glycosaminoglycan, wherein optionally the glycosaminoglycan comprises a hyaluronic acid, and optionally the hydrogel is at least about 75%, 80% or 85% wt (by weight) hydrated.

3 . The product of manufacture of claim 1 or claim 2 , wherein the hydrogel comprises a crosslinked polyethylene oxide, a crosslinked poly(2-acrylamido-2-methyl-1-propanesulfonic acid) or poly AMPS, a crosslinked polyvinylpyrrolidone, a polyvinyl alcohol, a sodium polyacrylate, an acrylate polymer, an agarose or a cellulose, optionally a methylcellulose, and optionally the hydrogel is at least about 85%, 90% or 95% hydrated, or is 100% hydrated.

4 . The product of manufacture of any of the preceding claims , wherein the cathode and the anode electrode are spaced 0.5 to 3 cm, or 1 to 2 cm, apart; or, the cathode and the anode electrode are made of a material comprising a conductive material, optionally a flexible conductive material, and optionally the conductive material comprises a graphite or a metal, wherein optionally the metal comprises platinum or gold.

5 . The product of manufacture of any of the preceding claims , fabricated in the form of a pad, a dressing or a patch, or a skin pad or skin patch.

6 . The product of manufacture of any of the preceding claims , comprising a power source operatively linked to the at least one cathode electrode and at least one anode electrode, wherein optionally the power source comprises a battery or a microbattery, wherein optionally the battery or microbattery can deliver a current of between about 1 μA to 10 3 μA.

7 . The product of manufacture of any of the preceding claims , further comprising a flexible supportive material, and optionally the hydrogel is completely or partially encased in or is supported by the flexible supportive material, and optionally the flexible supportive material comprises an acrylic, a nylon or a polyester.

8 . A method for treating or ameliorating, or accelerating the healing of, or slowing the progression of, or lessening the symptoms of, a wound, a disease or a condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen, the method comprising: topically administering to a tissue or skin in need thereof a product of manufacture of any of the preceding claims ,

wherein optionally the wound, disease or condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen comprises or is: a wound, a granuloma, an ulcer (optionally a diabetic ulcer), a burn, a skin condition (optionally the skin condition is a dermatitis or eczema), or a cancer (optionally the cancer is a melanoma or a carcinoma),

and optionally the condition comprises a cosmetic condition, and the product of manufacture is applied for cosmetic purposes, wherein optionally the cosmetic purposes comprise application for removal, treatment of or amelioration of bruises, acne, scars and/or unwanted pigmentation.

9 . The method of claim 8 , wherein the wound, a disease or a condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen is: an autoimmune disease or a condition of the skin or mucosa,

and optionally the autoimmune disease or a condition of the skin or mucosa is: alopecia, urticaria, pemphigoid (optionally, bullous pemphigoid or cicatricial pemphigoid), pemphigus (optionally, pemphigus vulgaris), lupus eythematosus, erythema (optionally, erythema nodosum) lichen planus or lichen sclerosus, psoriasis, scleroderma, or vitiligo.

10 . A kit comprising: a product of manufacture of any of the preceding claims , and optionally comprising instructions for practicing a method of any of the preceding claims ,

wherein optionally the kit further comprises leads for connecting the at least one cathode electrode and at least one anode electrode to an external power source if the product of manufacture does not contain its own internal power source,

wherein optionally the kit further comprises software for downloading or loading onto a phone, a computer or an equivalent device for allowing or enabling interaction between a user and the product of manufacture, and data transmission from the product of manufacture to the phone, computer or equivalent device, and presentation of the transmitted data to the user, wherein optionally the software is packaged as an app for the phone or equivalent device.

11 . Use of a product of manufacture of any of the preceding claims , or a kit of any of the preceding claims , for treating or ameliorating, or accelerating the healing of, or slowing the progression of, or lessening the symptoms of, a wound, a disease or a condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen, the use comprising: topically administering to a tissue or skin in need thereof a product of manufacture of any of the preceding claims ,

wherein optionally the product of manufacture is fabricated in the form of a pad, a dressing or a patch,

wherein optionally the wound, disease or condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen is: an autoimmune disease or a condition of the skin or mucosa,

and optionally the autoimmune disease or a condition of the skin or mucosa is: alopecia, urticaria, pemphigoid (optionally, bullous pemphigoid or cicatricial pemphigoid), pemphigus (optionally, pemphigus vulgaris), lupus eythematosus, erythema (optionally, erythema nodosum) lichen planus or lichen sclerosus, psoriasis, scleroderma, or vitiligo,

and optionally the condition comprises a cosmetic condition, and the product of manufacture is applied for cosmetic purposes, wherein optionally the cosmetic purposes comprise application for removal, treatment of or amelioration of bruises, acne, scars and/or unwanted pigmentation.

12 . A product of manufacture for use in treating or ameliorating, or accelerating the healing of, or slowing the progression of, or lessening the symptoms of, a wound, a disease or a condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen, the product of manufacture as set forth in any of the preceding claims ,

wherein optionally the product of manufacture is fabricated in the form of a pad, a dressing or a patch,

wherein optionally the wound, disease or condition response to administration of a therapeutically effective amount of hydrogen, metastable hydrogen peroxide and/or oxygen is: an autoimmune disease or a condition of the skin or mucosa,

and optionally the autoimmune disease or a condition of the skin or mucosa is: alopecia, urticaria, pemphigoid (optionally, bullous pemphigoid or cicatricial pemphigoid), pemphigus (optionally, pemphigus vulgaris), lupus eythematosus, erythema (optionally, erythema nodosum) lichen planus or lichen sclerosus, psoriasis, scleroderma, or vitiligo,

and optionally the condition comprises a cosmetic condition, and the product of manufacture is applied for cosmetic purposes, wherein optionally the cosmetic purposes comprise application for removal, treatment of or amelioration of bruises, acne, scars and/or unwanted pigmentation.