Method and device for the treatment of obstructive sleep apnea and snoring

• US 8,408,213 B2
• Filed: 09/30/2011
• Issued: 04/02/2013
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: LinguaFlex, Inc.
• Original Assignee: LinguaFlex, Inc.
• Inventors: Sanders, Ira
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): Hicks, Victoria J
• Application Number:
  US13/250,867
• Publication Number:
  US 20120017920A1
• Time in Patent Office: 550 Days
• Field of Search: 128/848, 128/846, 602/902, 600/237, 600/235, 600/240, 600/201
• US Class Current: 128/848
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

The device relates to methods and devices for the treatment of obstructive sleep apnea syndrome.

Claims

1. A method for treatment of a breathing disorder using a tissue retractor, the method comprising:

inserting a shaft into a soft tissue located in a patient'"'"'s oral cavity or pharynx thereby forming a tract through the soft tissue;

connecting an anchor member at or near a second end of the shaft; and

adjusting at least one of the shaft, the anchor member, or a retractor member disposed at or near a first end of the shaft, to alter the pressure exerted on the soft tissue,

wherein at least one of the retractor member or the anchor member is positionable on an external surface of the soft tissue and at least one of the shaft, the retractor member or the anchor member interact to exert a tension force to establish a pressure sufficient to prevent a deformation of the external surface by bringing the soft tissue toward another soft tissue located in the patient'"'"'s oral cavity or pharynx,

the tissue retractor configured for subsequent retensioning by noninvasively adjusting the anchor member after the tract matures.

2. The method of claim 1 wherein the soft tissue is a tongue.

3. The method of claim 2 wherein the anchor member is adjusted under the tongue after the tract matures.

4. The method of claim 2 wherein the inserting step further comprises:

positioning the shaft in a needle bore;

inserting the needle bore at or near the junction of the frenulum and the tongue blade with a tip of the needle bore oriented toward the tongue curve;

advancing the needle bore through the tongue; and

removing the needle bore while maintaining the shaft in the patient'"'"'s tongue.

5. The method of claim 2 wherein the shaft is hollow and the inserting step further comprises:

positioning the hollow shaft over a needle;

inserting the needle at or near the junction of the frenulum and the tongue blade with a tip of the needle oriented toward the tongue curve;

advancing the needle through the tongue; and

removing the needle while maintaining the shaft in the patient'"'"'s tongue.

6. The method of claim 1 wherein the pressure is between 0.01 and 1000 grams per cm².

7. The method of claim 6 wherein the pressure is between 0.1 and 100 grams per cm².

8. The method of claim 7 wherein the pressure is between 10 and 100 grams per cm².

9. The method of claim 1 wherein the subsequent retensioning is performed by the patient.

10. The method of claim 1 wherein the anchor member is in communication with a muscle that is active during sleep.

11. The method of claim 1 wherein the pressure is a counterforce pressure that creates an indentation in the external surface, the pressure stiffens the soft tissue to prevent deformation of the external surface, or the pressure is a counterforce pressure that prevents deformation of the external surface.

12. The method of claim 1 wherein at least a portion of at lest one of the shaft, the retractor member or the anchor member is positioned in the patient'"'"'s epiglottis.

13. The method of claim 1 further comprising positioning the tissue retractor on a needle and inserting the needle to a desired depth within the soft tissue.

14. The method of claim 1 wherein the shaft is flexible.

15. The method of claim 1 wherein the retractor member and the shaft are made of a single continuous flexible structure.

16. The method of claim 1 wherein the tissue retractor is removable from the soft tissue.