Partially erodable systems for treatment of obstructive sleep apnea

• US 8,991,398 B2
• Filed: 12/11/2012
• Issued: 03/31/2015
• Est. Priority Date: 05/12/2008
• Status: Active Grant

• Current Assignee: ReVENT Medical, Inc.
• Original Assignee: ReVENT Medical, Inc.
• Inventors: Gillis, Edward M., Iancea, Octavian
• Primary Examiner(s): Nia, Alireza
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US13/711,537
• Publication Number:
  US 20130098374A1
• Time in Patent Office: 840 Days
• Field of Search: 128/848, 128897-898, 606/230, 623/1.38, 623/13.18
• US Class Current: 128/848
• 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

A method of maintaining airway patency in an airway of a patient which includes the steps of implanting a device into tissue adjacent an airway, the device having a bioerodable material wound around a resiliently deformable body to temporarily maintain the deformable body in a stretched, deformed state, and permitting the bioerodable material of the device to bioerode to apply a force to maintain airway patency. The invention also provides devices for practicing the method.

Claims

1. A method of maintaining airway patency in an airway of a patient, the method comprising:

implanting a device into tissue adjacent an airway, the device having at least one bioerodable fiber wound around a resiliently deformable body to temporarily maintain the deformable body in a stretched, deformed state, the device further having at least one tissue anchor configured to affix to the tissue adjacent the airway, wherein the at least one bioerodable fiber comprises a plurality of coil sections that each run generally transverse to a longitudinal direction of the resiliently deformable body, the coil sections abutting one another in the longitudinal direction to provide a column force to overcome a contracting force of the body until the at least one bioerodable fiber is permitted to bioerode; and

permitting the at least one bioerodable fiber of the device to bioerode to release the deformable body from its stretched, deformed state, thereby allowing the deformable body to contract to apply the contracting force from the at least one tissue anchor to affixed tissue adjacent the airway to maintain airway patency.

2. The method of claim 1 wherein the force is applied to airway-forming tissue.

3. The method of claim 1 further comprising expanding a portion of the device during the implanting step.

4. The method of claim 1 wherein the implanting step comprises inserting the device into the patient submandibularly.

5. The method of claim 1 wherein the implanting step comprises inserting the device into the patient sublingually.

6. The method of claim 1 wherein the implanting step comprises inserting the device into the patient intra-orally.

7. The method of claim 1 wherein the permitting step comprises changing a shape of the device when the bioerodable fiber bioerodes.

8. The method of claim 7 wherein the changing step comprises changing a length of the device.

9. The method of claim 1 further comprising permitting newly formed tissue to grow into open areas of anchors of the device prior to applying a force to airway-forming tissue.

10. The method of claim 1 wherein the implanting step comprises inserting the device into tongue tissue.

11. The method of claim 1 wherein the implanting step comprises inserting the device into soft palate tissue.

12. The method of claim 1 wherein the implanting step comprises inserting the device into pharyngeal wall tissue.

13. The method of claim 1 further comprising releasing a bioactive agent from the bioerodable fiber as it bioerodes.

14. A method of maintaining airway patency in an airway of a patient, the method comprising:

implanting a device into tissue adjacent an airway, the device having at least one bioerodable fiber wound around a resiliently deformable body to temporarily maintain the deformable body in a stretched, deformed state, wherein the at least one bioerodable fiber is wound within a first section of a resiliently deformable body between a second section and a third section of the body, the second and third sections having a greater width than the first section, the device having at least one tissue anchor configured to affix to the tissue adjacent the airway; and

permitting the bioerodable fiber of the device to bioerode to release the deformable body from its stretched, deformed state, thereby allowing the deformable body to contract to apply a contracting force from the at least one tissue anchor to the affixed tissue adjacent the airway to maintain airway patency.

15. The method of claim 14 wherein the at least one bioerodable fiber comprises a plurality of coil sections that each run generally transverse to a longitudinal direction of the resiliently deformable body, the coil sections abutting one another in the longitudinal direction to provide a column force to overcome the contracting force of the body until the at least one bioerodable fiber is permitted to bioerode.

16. A device for maintaining patency of an airway of a patient comprising:

a resiliently deformable body having an at-rest shape and a deformed shape, the body being adapted to be implanted into tissue adjacent an airway of the patient;

proximal and distal anchors adapted to be implanted into the tissue and adapted to affix to the tissue; and

at least one bioerodable fiber portion wound around a portion of the body, the bioerodable fiber portion maintaining the body in the deformed shape against a return force;

the body being configured to return toward the at-rest shape upon erosion of the bioerodable fiber portion such that the return force is applied to the proximal and distal anchors in opposite directions, wherein the at least one bioerodable fiber portion comprises a plurality of coil sections that each run generally transverse to a longitudinal direction of the resiliently deformable body, the coil sections abutting one another in the longitudinal direction, the bioerodable fiber portion thereby maintaining the body in the deformed shape with a column force that acts against the return force of the body until the bioerodible fiber portion erodes.

17. The device of claim 16 wherein the body is sized and shaped to be inserted into tongue tissue.

18. The device of claim 16 wherein the body is sized and shaped to be inserted into soft palate tissue.

19. The device of claim 16 wherein the body is sized and shaped to be inserted into pharyngeal tissue.

20. The device of claim 16 wherein the proximal and distal anchors are adapted to be implanted into the tissue without affixing the device to the tissue upon implantation, and wherein the anchors are adapted to allow newly formed tissue to grow into open areas of the anchors to affix the anchors to the tissue adjacent the airway.

21. The device of claim 16 wherein at least one of the proximal and distal anchors is adapted to expand.

22. The device of claim 16 wherein at least one of the proximal and distal anchors is adapted to self-expand.

23. The device of claim 16 wherein at least one of the anchors contains a through hole.

24. The device of claim 16 wherein the deformed shape is longer than the at-rest shape.

25. The device of claim 16 further comprising an elutable bioactive agent associated with the bioerodable fiber portion.

26. A device for maintaining patency of an airway of a patient comprising:

a resiliently deformable body having an at-rest shape and a deformed shape, the body being adapted to be implanted into tissue adjacent an airway of the patient;

proximal and distal anchors adapted to be implanted into the tissue and adapted to affix to the tissue; and

at least one bioerodable fiber portion wound around a portion of the body, the bioerodable fiber portion maintaining the body in the deformed shape against a return force;

the body being configured to return toward the at-rest shape upon erosion of the bioerodable fiber portion such that the return force is applied to the proximal and distal anchors in opposite directions,

wherein the at least one bioerodable fiber portion is wound within a first section of the body between a second section and a third section of the body, the second and third sections having a greater width than the first section.

27. The device of claim 26 wherein the bioerodable fiber portion comprises a plurality of coil sections that each run generally transverse to a longitudinal direction of the resiliently deformable body, the coil sections abutting one another in the longitudinal direction, thereby maintaining the body in the deformed shape with a column force that acts against the return force of the body until the bioerodible fiber portion erodes.

28. The device of claim 26 wherein the at least one bioerodable fiber portion is formed from a polymer.

29. A device for maintaining patency of an airway of a patient comprising:

a resiliently deformable body having an at-rest shape and a deformed shape, the body being adapted to be implanted into tissue adjacent an airway of the patient;

proximal and distal anchors adapted to be implanted into the tissue and adapted to affix to the tissue; and

a plurality of bioerodable fiber portions wound around a portion of the body, the bioerodable fiber portion maintaining the body in the deformed shape against a return force;

the body being configured to return toward the at-rest shape upon erosion of the bioerodable fiber portion such that the return force is applied to the proximal and distal anchors in opposite directions,

wherein the body comprises a plurality of narrow sections and a plurality of wide sections, each of the plurality of bioerodible fiber portions being wound within one of the narrow sections of the body between two of the wide sections of the body.

30. A method of maintaining airway patency in an airway of a patient, the method comprising:

implanting a device into tissue adjacent an airway, the device having a plurality of bioerodable fiber portions wound around a resiliently deformable body to temporarily maintain the deformable body in a stretched, deformed state, wherein each of the plurality of bioerodable fibers wound within one of a plurality of narrow sections of a resiliently deformable body between two of a plurality of wide sections of the body, the device having at least one tissue anchor configured to affix to the tissue adjacent the airway; and

permitting the bioerodable fiber of the device to bioerode to release the deformable body from its stretched, deformed state, thereby allowing the deformable body to contract to apply a force from the at least one tissue anchor to the affixed tissue adjacent the airway to maintain airway patency.