Method of treating snoring and obstructive sleep apnea

• US 9,445,936 B2
• Filed: 03/26/2014
• Issued: 09/20/2016
• 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
• Application Number:
  US14/225,503
• Publication Number:
  US 20140238411A1
• Time in Patent Office: 909 Days
• Field of Search: 128/846, 128/848, 128859-862, 602/902, 245/5
• 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 method of treating snoring and/or obstructive sleep apnea in a subject in need of such treatment, comprising:

providing to the subject a buccal bioadhesive strip adapted to bind a mucosal membrane by applying said strip to the tissue of the soft palate to stiffen the tissue to reduce vibration, said strip comprising at least one coating layer having a surface topography for resisting bioadhesion, said at least one layer comprising a polymer, said coating layer having a pattern defined by a plurality of spaced apart features attached to or projected into a base surface, said plurality of 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 μ

m in at least a portion of said coating layer, said coating layer resisting bioadhesion as compared to said base surface.

2. The method of claim 1, wherein the strip is non-biodegradable and is porous.

3. The method of claim 1, wherein the strip has a surface adapted to promote tissue in-growth.

4. The method of claim 1, wherein the strip is biodegradable and comprises a salt selected from the group consisting of a water soluble salt of a co-polymer of methyl vinyl ether and maleic acid, sodium hyaluronate, sodium alginate, and calcium alginate.

5. The method of claim 1, wherein said strip includes a bioadhesive selected from the group consisting of a carboxylated polymer, poly(acrylic acid) and crosslinked poly(acrylic acid).

6. The method of claim 1, wherein said strip does not result in permanent tissue changes that affect the physical characteristics of the soft palate.

7. The method of claim 1, wherein the strip is coated with one or more layers of crosslinked polyvinyl pyrrolidones and crosslinked polyacrylic acids.

8. The method as set forth in claim 1, wherein said strip has 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, and 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.

9. 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 bioadhesive is selected from the group consisting of a carboxylated polymer, poly(acrylic acid), crosslinked polyvinyl pyrrolidone, crosslinked poly(acrylic acid), polycarbophil, carbomer, and a water soluble salt of a co-polymer of methyl vinyl ether and maleic acid.

10. The method of claim 9, wherein the strip is non-biodegradable and is porous and includes breath freshening components.

11. The method of claim 9, wherein said strip comprises at least one polymer selected from the group consisting of a cellulose ether, methyl acrylate, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose, polysulfone, polyvinyl alcohol, polyethylene oxide and polyethylene glycol.

12. The method of claim 9, wherein the strip is biodegradable and comprises a salt selected from the group consisting of a water soluble salt of a co-polymer of methyl vinyl ether and maleic acid, sodium hyaluronate, sodium alginate, and calcium alginate.

13. The method of claim 9, 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, and casein, and wherein the strip comprises a hydrocolloid comprising at least between about 10% to about 50% by dry weight of the strip, said hydrocolloid selected from the group consisting of natural seaweeds, natural seed gum, natural plant exudates, natural fiber extracts, biosynthetic gums, gelatins, biosynthetic process starch or cellulosic materials, alginates, calcium alginate, marine colloids, natural gums, polysaccharides, sodium alginate, carrageenan, xanthan gum, gum acacia, gum arabic, guar gum, pullulan, agar, chitin, chitosan, pectin, karaya gum, zein, hordein, gliadin, carob meal, tragacanths, polysaccharides, maltodextrin, amylose, amylopectin, maize starch, potato starch, rice starch, tapioca starch, pea starch, sweet potato starch, barley starch, wheat starch, maize starch, dextrins, levan, elsinan, gluten, collagen, whey protein, casein, milk protein, soya protein, gelatine, colophony, and bees wax.

14. The method of claim 9, wherein said strip does not result in permanent tissue changes that affect the physical characteristics of the soft palate.

15. The method of claim 9, wherein said strip has an anti-microbial surface that reduces noxious odors arising from foul smelling agents produced by bacteria in the subject'"'"'s mouth.

16. The method of claim 9, wherein said strip has no active drug.

17. The method of claim 9, wherein said strip has separate layers having different structural characteristics selected from the group of flexibility, dissolution rate, pliability and tensile strength.

18. The method of claim 9, wherein said strip comprises collagen selected from the group of collagen Type I, II and III.

19. The method of claim 9, wherein said strip is dissolvable and comprises a biodegradable polyester comprising polycaprolactone.

20. 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 at least one textured surface that has an anti-microbial characteristic that comprises a textured surface having a topography that resists bioadhesion of bacteria present in a human'"'"'s mouth;

wherein the strip is non-biodegradable and is porous, and wherein said bioadhesive is selected from the group consisting of a carboxylated polymer, poly(acrylic acid), crosslinked polyvinyl pyrrolidone, and crosslinked poly(acrylic acid); and

wherein said strip does not result in permanent tissue changes that affect the physical characteristics of the soft palate.