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Claims for Patent: 5,954,703

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Claims for Patent: 5,954,703

Title: Method and apparatus for applying 5-aminolevulinic acid
Abstract:A method and apparatus for storing, mixing and applying ALA as a treatment for lesions. The apparatus comprises a deformable container enclosing a hermetically sealed compartment of essentially anhydrous ALA which is shielded from exposure to air and moisture, and a liquid diluent. The liquid diluent may be in a second compartment. The deformable container is squeezed to crush the compartments and mix the essentially anhydrous ALA with the liquid diluent. The ALA may be delivered from the deformable container through a point applicator for controlling and precisely directing the application during treatment.
Inventor(s): Golub; Allyn (Miramar, FL)
Assignee: Dusa Pharmaceuticals, Inc. (Ontario, CA)
Application Number:08/962,294
Patent Claims: 1. A method of storing, mixing and applying 5-aminolevulinic acid which inhibits exposure of the 5-aminolevulinic acid to air and moisture until just prior to application, said method comprising:

hermetically sealing essentially anhydrous 5-aminolevulinic acid within a first essentially frangible compartment;

disposing said first compartment within a deformable container, said container having an applicator;

deforming said container to crush said first compartment and mix said essentially anhydrous 5-aminolevulinic acid with a liquid diluent in said container; and

topically applying 5-aminolevulinic acid from said container through said applicator.

2. The method as defined in claim 1, wherein said applicator comprises a point applicator for controlling topical application of 5-aminolevulinic acid.

3. The method as defined in claim 1, further comprising:

sealing said liquid diluent in a second essentially frangible compartment; and,

disposing said second compartment within said container.

4. The method as defined in claim 3, wherein said step of deforming said container crushes said second compartment prior to crushing said first compartment.

5. A method of treating rapidly proliferating cells with 5-aminolevulinic acid, said method comprising:

providing a deformable container containing a first essentially frangible compartment of essentially anhydrous 5-aminolevulinic acid and a second essentially frangible compartment of a liquid diluent, said essentially anhydrous 5-aminolevulinic acid being hermetically sealed in said first compartment;

deforming said container to crush said first and second compartments within said container;

mixing said essentially anhydrous 5-aminolevulinic acid and said liquid diluent; and

topically applying 5-aminolevulinic acid to the rapidly proliferating cells.

6. The method as defined in claim 5, wherein said topical application of 5-aminolevulinic acid is controlled by a point applicator.

7. An applicator for dispensing 5-aminolevulinic acid, said applicator comprising:

a first essentially frangible compartment containing essentially anhydrous 5-aminolevulinic acid;

a deformable container enclosing said first compartment and a liquid diluent for 5-aminolevulinic acid; and

a topical applicator dispersing 5-aminolevulinic acid from said container;

wherein said first essentially frangible compartment is interposed between said liquid diluent and said topical applicator.

8. The applicator as defined in claim 7, wherein said first compartment is essentially hermetically sealed.

9. The applicator as defined in claim 7, further comprising:

a second essentially frangible compartment containing said liquid diluent, said deformable container enclosing said second essentially frangible compartment.

10. The applicator as defined in claim 7,

wherein said topical applicator includes a point applicator for controlling dispersion of 5-aminolevulinic acid from said container.

11. The applicator as defined in claim 10, wherein said point applicator includes:

a tubular body having an inner cylindrical surface and an outer cylindrical surface, said outer cylindrical surface contiguously confronting an inner cylindrical surface of said container;

a resiliently biased valve for normally occluding a first end of said tubular body; and

a liquid permeable cover for covering said first end of said tubular body;

wherein depressing said cover creates a gap between said valve and said tubular body for distributing the 5-aminolevulinic acid.

12. The applicator as defined in claim 11, further comprising:

a seal interposed between said first essentially frangible compartment and said container.

13. The applicator as defined in claim 12, wherein said seal includes a raised annular rib on at least one of said tubular body outer surface and said container inner cylindrical surface.

14. The applicator as defined in claim 7, wherein said liquid diluent comprises an alcohol/water solution.

15. The applicator as defined in claim 14, wherein said liquid diluent further comprises a wetting agent.

16. The applicator as defined in claim 15, wherein said wetting agent is a surfactant.

17. The applicator as defined in claim 14, wherein said liquid diluent further comprises a humectant.

18. The applicator as defined in claim 17, wherein said humectant is a polyalcohol.

19. The applicator as defined in claim 17, wherein said humectant is selected from the group consisting of polyethylene glycol, propylene glycol and glycerin.
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