Buccal bioadhesive strip and method of treating snoring and sleep apnea

• US 9,549,842 B2
• Filed: 06/26/2015
• Issued: 01/24/2017
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Seed Health, Inc.
• Original Assignee: Joseph E. Kovarik
• Inventors: Kovarik, Joseph E.
• Primary Examiner(s): BROWN, MICHAEL A
• Application Number:
  US14/752,192
• Publication Number:
  US 20150290026A1
• Time in Patent Office: 578 Days
• Field of Search: 128/848.857, 128859-862, 602/902
• US Class Current: 1/1
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

A method, system and device for addressing the reduction of snoring includes a removable or dissolvable strip of material that adhere to mucosal tissue of a person'"'"'s soft palate to provide stiffening support therefore, thus reducing the occurrence of vibration of such tissue during sleep. Preferred embodiments include of a specially textured surface, either one both or at least the outer side of an adhesive strip (the side facing away from the mucosal tissue to which it is attached) that has anti-microbial characteristics, bioluminescent expressions, etc. and a surface topography that resists bioadhesion of undesired bacteria that are typically present in a human'"'"'s mouth.

Claims

1. A buccal bioadhesive strip that when applied to the tissue of the soft palate, stiffens the tissue to reduce vibration, comprising:

at least one surface of said strip has 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 at least one surface, a strip having a first and second side, the first 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 extends over a majority of the soft palate,

said strip including breath freshening components;

said strip adapted to persist in a mouth of a user for at least 3 hours; and

wherein said strip includes between 0.2 and 0.9% xylitol by weight.

2. The strip of claim 1 wherein said strip further includes a toxic substance associated with the strip that is effective to kill undesired bacteria in the mouth.

3. The strip of claim 1 wherein said strip comprises bioluminescent material.

4. The strip of claim 1 wherein said strip comprises a cyclodextrin component.

5. The strip of claim 1 wherein said strip is devoid of paper, rice or hemp products.

6. The strip of 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.

7. The strip of claim 1 wherein said strip comprises structural features that direct airflow in a manner that further reduces the occasion of throat tissue vibration, such features selected from the group consisting of grooves, hollow structures and curved, elevated surfaces.

8. The film as set forth in claim 1, wherein the first side has adhesive material associated therewith and the second side does not.

9. The strip of claim 1 wherein said strip has compounds residing thereon to facilitate the growth of desired bacteria beneficial to a person'"'"'s health.

10. A buccal bioadhesive strip that when applied to the tissue of the soft palate, stiffens the tissue to reduce vibration, comprising:

at least one surface of said strip has 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 at least one surface.

11. The strip of claim 10 wherein said strip is non-dissolvable in a person'"'"'s mouth.

12. The strip of claim 10 wherein said strip is dissolvable in a person'"'"'s mouth within a period of 3 hours.

13. A method of treating snoring and/or obstructive sleep apnea in a subject in need of such treatment, comprising:

providing to a subject a buccal bioadhesive strip adapted to bind a mucosal membrane by applying said strip to the subject'"'"'s tissue of the soft palate to stiffen the tissue and to reduce vibration of the tissue, the strip having a first and second side, the first 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 has at least one layer comprising a polymer and extends over a majority of the soft palate, said second side resisting bioadhesion as compared to said first side and having a textured surface that has an anti-microbial characteristic comprising a textured surface having a topography that resists bioadhesion of bacteria present in a human'"'"'s mouth, and wherein said strip includes at least about 200 mg xylitol and one of bacterial and helminth components, and wherein the strip is porous, biodegradable and does not result in permanent tissue changes that affect the physical characteristics of the soft palate.

14. The film as set forth in claim 13, wherein the first side has adhesive material associated therewith and the second side does not.

15. The film as set forth in claim 13, wherein said strip includes between 0.2 and 0.9% xylitol by weight.

16. The film as set forth in claim 13, wherein said strip comprises a cyclodextrin component.

17. The film as set forth in claim 13, wherein said strip includes helminth components effective to trigger an immune response in a user.

18. The method as set forth in claim 13, 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.

19. The method as set forth in claim 13, wherein said strip comprises collagen selected from the group of collagen Type I, II and III, and a cyclodextrin component.

20. The method as set forth in claim 13, wherein said strip comprises a biodegradable polyester comprising polycaprolactone.