Partially erodable systems for treatment of obstructive sleep apnea

• US 8,327,854 B2
• Filed: 10/07/2011
• Issued: 12/11/2012
• 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): Bianco, Patricia
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US13/269,520
• Publication Number:
  US 20120024298A1
• Time in Patent Office: 431 Days
• Field of Search: 128/848, 128/897, 128/898, 623/9, 623/11.11, 623/14.11
• 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 a bioerodable material helically 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 release the deformable body from its stretched, deformed state, thereby allowing the deformable body to apply a force to maintain airway patency.

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

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

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

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

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

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

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

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

10. 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.

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

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

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

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 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 release the deformable body from its stretched, deformed state, thereby allowing the deformable body to apply a force to maintain airway patency,

wherein the implanting step further comprises a device having a bioerodable material helically wound within a narrow section of a resiliently deformable body between wide sections of the body.

15. The method of claim 14 wherein the implanting step further comprises a device having a plurality of bioerodable material portions, a plurality of narrow sections and a plurality of wide sections, each of the plurality of bioerodable material portions being helically wound within one of the narrow sections of the resiliently deformable body between two of the wide sections of the body.

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 material portion helically wound around a portion of the body, the bioerodable material 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 material portion,

wherein the bioerodable material portion is a fiber.

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

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

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

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

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

22. 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.

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

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

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

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;

at least one bioerodable material portion wound around a portion of the body, the bioerodable material 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 material portion,

wherein the at least one bioerodable material portion is helically wound within a narrow section of the body between wide sections of the body.

27. The device of claim 26 wherein the device comprises a plurality of bioerodable material portions, a plurality of narrow sections and a plurality of wide sections, each of the plurality of bioerodable material portions being helically wound within one of the narrow sections of the body between two of the wide sections of the body.

28. 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;

at least one bioerodable material portion helically wound around a portion of the body, the bioerodable material 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 material portion,

wherein the at least one bioerodable material portion is formed from a polymer.