Partially erodable systems for treatment of obstructive sleep apnea

• US 8,523,760 B2
• Filed: 04/10/2012
• Issued: 09/03/2013
• Est. Priority Date: 01/03/2008
• Status: Active Grant

• Current Assignee: ReVENT Medical, Inc.
• Original Assignee: ReVENT Medical, Inc.
• Inventors: Gillis, Edward M.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US13/443,839
• Publication Number:
  US 20120197070A1
• Time in Patent Office: 511 Days
• Field of Search: 128/848, 128/897, 128/898, 600/37
• US Class Current: 600/37
• 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

The invention relates to devices and methods for reforming tissue surrounding the airway of a subject suffering from obstructive sleep apnea so as to open the airway and alleviate the occurrence of apneic events. Devices comprise a combination of resiliently deformable material and bioerodible material. The deformable portion of the device has a preferred shape that corresponds to the desired final shape of the device once placed in an airway. In making a transplant-ready device, however, the deformable portion is placed into a deformed shape and constrained in that shape by the bioerodible material. After implantation, the device gradually assumes the preferred shape as the constraining bioerodible material erodes. As the device gradually reforms toward the preferred shape, it reforms the tissue into the therapeutically desirable configuration. The gradual nature of the shape change generally stabilizes the device in the tissue, and supports tissue reforming into a stable configuration.

Claims

1. A method of alleviating airway restriction comprising:

implanting a device at a site in the tissue, the device comprising a resiliently expandable inner portion having an axially expanded configuration in which the inner portion is stretched into axial tension and an axially unexpanded configuration in which the inner portion is not stretched in axial tension, and a plurality of discrete bioerodible outer portions maintaining the expandable inner portion in the axially expanded configuration, the device sized and shaped to conform to an airway-forming tissue site in a manner compatible with normal physiological function of the site; and

bioeroding the plurality of discrete bioerodible outer portions, thereby allowing the expandable inner portion to return toward the axially unexpanded configuration to alleviate restriction of the airway.

2. The method of claim 1 wherein the bioeroding occurs over a time that ranges from days to months.

3. The method of claim 2 wherein the bioeroding step occurs over time at a rate that varies in relation to the ratio of biologically-exposed surface area of the bioerodible portions to the volume of the bioerodible portions.

4. The method of claim 1 wherein the bioeroding occurs at a rate sufficiently slow for the tissue site to recover from the implanting prior to the device substantially changing shape.

5. The method of claim 4 wherein the tissue site recovery from the implanting includes forming fibrotic tissue around the device.

6. The method of claim 1 further including changing the shape of the device.

7. The method of claim 1 wherein to alleviate restriction of the airway includes remodeling the airway-forming tissue such that the airway is unobstructed during sleep.

8. The method of claim 7 wherein remodeling the airway-forming tissue is such that the airway is unobstructed during sleep and frequency of apneic events is diminished.

9. The method of claim 1 further comprising, after the implanting step, infiltrating newly formed fibrotic tissue into interstices in the device.

10. The method of claim 1, further comprising releasing a bioactive agent from the bioerodible portions during the bioeroding step.

11. The method of claim 1 wherein the implanting step includes implanting into soft palate tissue.

12. The method of claim 1 wherein the implanting step includes implanting into tongue tissue.

13. The method of claim 1 wherein implanting step includes implanting into pharyngeal wall tissue.

14. The method of claim 1 wherein the expandable portion is linearly and resiliently stretched in the expanded configuration.

15. The method of claim 1 wherein the bioerodible portions comprise at least two different materials that bioerode at different rates.

16. The method of claim 1 wherein the device comprises a plurality of resiliently expandable inner portions each having an axially expanded configuration in which the inner portion is stretched into axial tension and an axially unexpanded configuration in which the inner portion is not stretched in axial tension.