Method and System for Preventing Migraine Headaches, Cluster Headaches and Dizziness

• US 20170100329A1
• Filed: 12/20/2016
• Published: 04/13/2017
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Seed Health, Inc.
• Original Assignee: Joseph E. Kovarik, Katherine Rose Kovarik
• Inventors: Kovarik, Joseph E., Kovarik, Katherine Rose
• Granted Patent: US 9,987,224 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 39/39541 against normal tissues, cells
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: C07K 16/2869 against hormone receptors for antibodies against neuromediator receptors C07K16/286

Abstract

A method and system for addressing the avoidance of migraines, cluster headaches and dizziness by adjusting an individual'"'"'s microbiome, and in particular, to the provision of beneficial oral and gut microbes at particular times to enhance a person'"'"'s oral health, including through the use of oral strips that adhere to surfaces in the oral cavity.

Claims

1. A method of reducing the likelihood of migraine headaches, comprising:

providing to an individual in need thereof a buccal bioadhesive strip, said strip having a first and second side, said first side having a surface comprising a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 .mu.m in at least a portion of said surface, the second side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip includes xylitol and at least one encapsulated feature containing a bacteria selected from the group consisting of Lachnospira, Veillonella, Faecalibacterium and Rothia.

2. The method as set forth in claim 1, further comprising including on said strip an antibody that selectively inhibits the human calcitonin gene-related peptide (CGRP) receptor.

3. The method as set forth in claim 1, further comprising including Lactobacillus spp. on said strip.

4. The method as set forth in claim 1, further comprising administering at least 6 g/fibre/day to the individual to increase the numbers of bifidobacteria in the gut microbiome of the individual.

5. The method as set forth in claim 1, further comprising including increasing in an oral cavity of the individual the number of both Bifidobacteriaceae and Lactobacteriaceae bacteria.

6. The method as set forth in claim 1, further comprising providing a high fibre diet that includes acetate.

7. The method as set forth in claim 6, wherein the amount of acetate is sufficient to decrease the ratio of bacteria in the individual'"'"'s oral cavity from the phylum Firmicutes compared to Bacteroidetes.

8. The method as set forth in claim 1, further comprising including Enterococcus faecium on the strip.

9. The method as set forth in claim 1, further comprising removing from the oral cavity of the individual gram negative bacteria associated with periodontitis, and within 2 hours thereof, providing the individual with the strip as set forth in claim 1.

11. The method as set forth in claim 1, further comprising retarding in the oral cavity of the individual the growth conditions for spirochetes and P. gingivalis.

12. The method as set forth in claim 1, further comprising including Veillonella on the strip.

13. The method as set forth in claim 1, wherein said strip includes at least one polymer selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof.

14. The method as set forth in claim 1, wherein said strip includes at least 0.2% xylitol by weight.

15. The method as set forth in claim 1, wherein said strip further comprises bioluminescent material.

16. The method as set forth in claim 1, wherein said strip is dissolvable in a person'"'"'s mouth within a period of 1 hour.

17. The method as set forth in claim 1, wherein the strip comprises at least one encapsulated feature that contains an agent selected from the group consisting of an antibiotic;

lactic acid bacteria; and

xylitol.

18. The method as set forth in claim 1, wherein said strip includes at least 200 mg of xylitol.

19. The method as set forth in claim 17, wherein said agent further comprises Prevotella bacteria.

20. The strip of claim 1 wherein said strip has at least one active ingredient encapsulated inside a frangible capsule that may be broken by the individual pressing against said strip with the individual'"'"'s tongue.

10. A method of reducing the likelihood of migraine headaches, comprising:

providing to an individual in need thereof a buccal bioadhesive strip, said strip having a first and second side, said first side having a surface comprising a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 .mu.m in at least a portion of said surface, the second side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip includes Lactobacillus reuteri bacteria to induce a sustained induction of oxytocin, and providing the individual, prior to the use of the strip, with an amount of antibiotic sufficient to reduce the number of undesired bacteria in the oral cavity said antibiotic selected from the group consisting of tetracycline hydrochloride, doxycycline, and minocycline.