Devices and methods for treating sleep disordered breathing

• US 8,657,879 B2
• Filed: 12/02/2008
• Issued: 02/25/2014
• Est. Priority Date: 12/05/2007
• Status: Active Grant

• Current Assignee: Svip 7 LLC
• Original Assignee: Svip 7 LLC
• Inventors: Shalon, Tidhar, Kotlizky, Guy
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/745,896
• Publication Number:
  US 20100280626A1
• Time in Patent Office: 1,911 Days
• Field of Search: 128/848, 623 2364- 2372, 623/9
• US Class Current: 623/9
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/203 comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

Devices and methods of treating sleep disordered breathing are provided herein. The devices are designed capable of preventing collapse of an oral airway tissue during sleep while maintaining normal velopharyngeal functions.

Claims

1. A device for treating sleep disordered breathing comprising a tether having a first end attached to a device body configured as an open or closed tube, said tether being capable of suspending said device body within a pharyngeal airway when a second end thereof is anchored in a nasal cavity, to a nostril, or to tissue between nostrils, said device body being designed and configured for:

(a) maintaining patency of said airway or minimizing resistance to airflow during involuntary closure of said airway tissue; and

optionally

(b) enabling sealing of said airway during swallowing.

2. The device of claim 1, wherein said involuntary closure of said airway is caused by collapse of airway tissue during sleep.

3. The device of claim 1, wherein said tube is configured capable of being elastically closed by a radial force of about 30 grams or less.

4. The device of claim 1, wherein said tube is selected having a diameter of 3-12 mm.

5. The device of claim 1, wherein said device body has a C-shaped cross section.

6. The device of claim 1, wherein the tissue contacting surface of said device has a surface hardness of shore A5 or less.

7. The device of claim 1, wherein said pharyngeal airway is the nasopharyngeal airway.

11. The device of claim 1, wherein said suspending minimizes contact between a surface of said device body and said airway tissue when not maintaining patency of said airway or minimizing resistance to airflow during involuntary closure of said airway tissue.

15. The device of claim 1, wherein said device body has a non-tissue-contacting inner surface and a softer tissue-contacting outer surface.

8. A method of treating sleep disordered breathing comprising:

(a) inserting a device including a tether having a first end attached to a device body through a nostril;

(b) suspending said device body within a pharyngeal airway, said device being designed and configured for;

(i) maintaining patency of said airway or minimizing resistance to airflow during sleep; and

optionally

(ii) enabling sealing of said airway during swallowing; and

(c) anchoring a second end of said tether to said nostril, to tissue between nostrils or to tissue of a nasal cavity, thereby treating sleep disordered breathing.

9. The method of claim 8, wherein (a) is effected via an applicator attached to said device.

10. The method of claim 8, wherein the tissue contacting surface of said device body has a surface hardness of shore A5 or less.

16. The method of claim 8, wherein said device body is suspended behind the soft palate ending at or above the level of the uvula.

12. A device for treating sleep disordered breathing comprising a tether having a first end attached to a device body being elastically compressible and having an open cross section when uncompressed, said tether being capable of suspending said device body within a pharyngeal airway when a second end thereof is anchored in a nasal cavity, to a nostril, or to tissue between nostrils, said device body being designed and configured for:

(a) maintaining patency of said airway or minimizing resistance to airflow during involuntary closure of said airway tissue; and

optionally

(b) enabling sealing of said airway during swallowing.

13. A device for treating sleep disordered breathing comprising a tether having a first end attached to a device body at least a portion of said device body is configured as a sheet, closed tube or open tube coated with or fabricated from a hydrophobic material, said tether being capable of suspending said device body within a pharyngeal airway when a second end thereof is anchored in a nasal cavity, to a nostril, or to tissue between nostrils, said device body being designed and configured for:

(a) maintaining patency of said airway or minimizing resistance to airflow during involuntary closure of said airway tissue; and

optionally

(b) enabling sealing of said airway during swallowing.

14. A device for treating sleep disordered breathing comprising a device body configured as an open or closed tube for positioning within a pharyngeal lumen and being designed and configured for:

(a) maintaining an airway or minimizing resistance to airflow during involuntary closure of said pharyngeal lumen; and

optionally

(b) enabling sealing of said airway during swallowing;

wherein at least some portion of said device body contains gas.