Partially erodable systems for treatment of obstructive sleep apnea

• US 8,747,296 B2
• Filed: 07/30/2013
• Issued: 06/10/2014
• Est. Priority Date: 01/03/2008
• Status: Expired due to Fees

• 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:
  US13/954,589
• Publication Number:
  US 20130312767A1
• Time in Patent Office: 315 Days
• Field of Search: 600/37, 128/848, 128/897, 128/898, 623/23.64, 623 2371- 2376
• 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 obstructive collapse of an airway-forming tissue comprising:

implanting a device at an airway-forming tissue site, the device comprising a first end, a second end, and an elastomeric medial portion extending between the first and second ends, the medial portion having a linear configuration, a curvilinear configuration, and a site adapted to receive a plurality of bioerodible segments, the device sized and shaped to conform to the airway-forming tissue site in a manner compatible with normal physiological function of the airway-forming site; and

bioeroding the bioerodible segments of the device to remodel the airway-forming tissue, wherein the bioeroding step further comprises moving the device from the curvilinear configuration toward the linear configuration to thereby remodel the airway-forming tissue.

2. The method of claim 1, after the implanting step, infiltrating newly formed fibrotic tissue into one or more holes, pores, or interstices in the device.

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

4. The method of claim 1, wherein the bioeroding step comprises eroding the bioerodible segments from openings in the site that are filled with the bioerodible segments.

5. The method of claim 1, wherein the curvilinear configuration comprises a serpentine shape.

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

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

8. A method of alleviating obstructive collapse of an airway-forming tissue comprising:

implanting a device at an airway-forming tissue site, the device comprising a first end, a second end, and an elastomeric medial portion extending between the first and second ends, the medial portion having a linear configuration, a curvilinear configuration, and a site adapted to receive a plurality of bioerodible segments, the device sized and shaped to conform to the airway-forming tissue site in a manner compatible with normal physiological function of the airway-forming site; and

bioeroding the bioerodible segments of the device to remodel the airway-forming tissue,

wherein the bioeroding step further comprises straightening the curvilinear configuration of the device to thereby exert a force on the airway-forming tissue.