Apparatus and methods for treating sleep apnea

• US 9,265,649 B2
• Filed: 12/13/2011
• Issued: 02/23/2016
• Est. Priority Date: 12/13/2010
• Status: Expired due to Fees

• Current Assignee: Quiescence Medical, Inc.
• Original Assignee: Quiescence Medical, Inc.
• Inventors: Pflueger, D. Russell, Thompson, Christopher Paul, Bacich, Steven R., Quick, Richard L., Yurek, Matthew
• Primary Examiner(s): Hawthorne, Ophelia A
• Application Number:
  US13/324,764
• Publication Number:
  US 20120180799A1
• Time in Patent Office: 1,533 Days
• Field of Search: 128/848, 128859-862, 433 6- 7, 602/902
• US Class Current: 1/1
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

Apparatus and methods are provided for treating sleep apnea, snoring, and the like using an implant within an oropharyngeal region adjacent an anterior longitudinal ligament. The implant may include a relatively narrow central region between first and second relatively wide outer regions. In one embodiment, one of the outer regions is compressible to allow the outer region to be directed through or behind the ligament such that the central region is disposed within or behind the ligament, the outer region being resiliently expandable after passing through or behind the ligament. In another embodiment, the implant may include one or more tines or other features that may be directed into adjacent tissue to secure the implant within the oropharyngeal region.

Claims

1. A system for implantation within an oropharyngeal region, comprising:

an implant formed from a flat sheet comprising a central region between first and second outer regions generally defining a plane in a substantially flat configuration, the outer regions defining lobes surrounding respective open interior spaces on either side of the central region, the outer regions displaceable out of the plane such that the implant defines a curved configuration, the central region comprising one or more apertures sized for receiving a fastener therethrough; and

one or more fasteners sized for insertion through the one or more apertures orthogonal to the plane for securing the central region to tissue adjacent the oropharyngeal region,

wherein the central region comprises a strut extending between the first and second outer regions, and a tab extending from the strut, the tab comprising an aperture therethrough for receiving a fastener therethrough.

2. The system of claim 1, wherein the one or more apertures are sized for receiving a shaft of the one or more fasteners.

3. The system of claim 1, wherein the central region comprises a pair of struts extending between the first and second outer regions, each strut comprising a tab extending therefrom and an aperture therethrough for receiving a respective fastener therethrough.

4. The system of claim 1, wherein each of the first and second outer regions comprises a loop enclosing the interior open space.

5. The system of claim 1, wherein each of the fasteners comprises a clip.

6. The system of claim 1, wherein the one or more fasteners comprise a screw.

7. A method for treating an oropharyngeal region of a patient comprising:

directing an implant comprising first and second outer regions separated by a central region into the oropharyngeal region in a curved configuration;

positioning the central region adjacent a posterior wall of the oropharyngeal region such that the outer regions are oriented towards opposite lateral walls of the oropharyngeal region;

directing one or more fasteners through the central region into tissue adjacent the posterior wall; and

releasing the implant within the oropharyngeal region such that the outer regions contact the opposite lateral walls to apply a force to dilate tissue adjacent the oropharyngeal region.

8. The method of claim 7, wherein directing one or more fasteners comprises directing first and second fasteners through the central region into tissue adjacent the posterior wall.

9. The method of claim 8, wherein the fasteners are aligned along an axis extending substantially parallel to an anterior longitudinal ligament of the patient.

10. The method of claim 7, wherein the one or more fasteners comprise one or more clips, screws, or sutures.

11. The method of claim 7, wherein the one or more fasteners are directed into the anterior longitudinal ligament of the oropharyngeal region of the patient.

12. The method of claim 7, wherein the one or more fasteners are directed into a vertebra of the patient.

13. An apparatus for implantation within an oropharyngeal region, comprising:

an implant comprising a central region between first and second outer regions generally defining a plane in a substantially flat configuration and displaceable to a curved configuration to facilitate introduction into an oropharyngeal region, the outer regions defining lobes surrounding respective open interior spaces on either side of the central region;

one or more apertures extending through the central region for receiving respective fasteners to secure the central region to tissue adjacent the oropharyngeal region within which the implant is introduced in the curved configuration; and

a pair of tabs on the central region, each tab comprising one of the one or more apertures.

14. The apparatus of claim 13, wherein the outer regions are displaceable towards one another such that the implant defines a generally “

C”

shaped curved configuration, the outer regions being biased towards the substantially flat configuration to apply a force to dilate tissue adjacent the oropharyngeal region when the implant is disposed within the oropharyngeal region.

15. The apparatus of claim 13, further comprises one or more fasteners receivable through respective one or more apertures.

16. The apparatus of claim 15, wherein each fastener comprises a clip.

17. A method for treating an oropharyngeal region of a patient comprising:

directing an implant comprising first and second outer regions separated by a central region into the oropharyngeal region in a curved configuration, wherein the first outer region comprises a first loop, the second outer region comprises a second loop and the central region comprises one or more struts extending between the first and second loops;

positioning the central region adjacent a posterior wall of the oropharyngeal region;

directing one or more fasteners through respective one or more apertures on the one or more struts into tissue adjacent the posterior wall; and

releasing the implant within the oropharyngeal region such that the outer regions apply a force to dilate tissue adjacent the oropharyngeal region.

18. An implant for implantation within an oropharyngeal region adjacent a ligament, comprising:

a first loop surrounding a first interior open space;

a second loop surrounding a second interior open space;

a first strut extending between the first and second loops thereby defining a major axis between the first and second loops; and

a tab extending from the first strut and comprising an aperture therethrough sized to receive a fastener therethrough,

wherein the first and second loops are deflectable to a curved configuration to apply a force to dilate tissue adjacent the oropharyngeal region when the implant is disposed within the oropharyngeal region and a fastener is directed through the aperture to secure the first strut within the oropharyngeal region.