Partially erodable systems for treatment of obstructive sleep apnea

• US 8,707,960 B2
• Filed: 05/11/2009
• Issued: 04/29/2014
• Est. Priority Date: 05/12/2008
• Status: Expired due to Fees

• 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:
  US12/937,564
• Publication Number:
  US 20110144421A1
• Time in Patent Office: 1,814 Days
• Field of Search: 128/848, 128/897, 128/898, 623/9, 623/11.11, 623/14.11, 623/1.38, 623/13.18, 606/230
• 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. The method includes the steps of implanting a device into airway-forming tissue without affixing the device to the tissue and permitting a bioerodable portion of the device to bioerode to apply a force to the airway-forming tissue 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 having a stretched non-bioerodable portion into airway-forming tissue without affixing the device to the airway-forming tissue; and

permitting a plurality of separate bioerodable portions of the implanted device to bioerode, thereby permitting the stretched portion to unstretch to apply a force to the airway-forming tissue to maintain airway patency.

2. The method of claim 1 further comprising expanding the non-bioerodable portion of the device without affixing the device to the tissue.

3. The method of claim 1 wherein the anchors contain through holes.

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 portions bioerode.

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

9. The method of claim 7 wherein the changing step comprises changing a length and a width of the device.

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

11. The method of claim 1 wherein the bioerodable portions of the device comprise a bioactive agent when implanted, the method further comprising releasing the bioactive agent from the bioerodable portions as they bioerode.

12. The method of claim 1 further comprising permitting newly formed tissue to infiltrate the device.

13. The method of claim 12 wherein the newly formed tissue at least partially infiltrates the device prior to applying a force to the airway-forming tissue.

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

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

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

a body having an unstretched at-rest shape and a stretched, deformed shape, the body being adapted to be implanted into airway-forming tissue of the patient;

proximal and distal anchors adapted to be implanted into the airway-forming tissue without affixing the device to the airway-forming tissue and to be infiltrated by the airway-forming tissue to affix the anchors to the airway-forming tissue;

at least one bioerodable element maintaining the body in the stretched, deformed shape against a return force;

the body being configured to return toward the unstretched at-rest shape upon erosion of the at least one bioerodable element, wherein the at least one bioerodable element comprises a coil.

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

implanting a device into airway-forming tissue without affixing the device to the airway-forming tissue; and

permitting a plurality of separate bioerodable portions of the device to bioerode to apply a force to the airway-forming tissue to maintain airway patency, wherein the implanting step comprises inserting the device into epiglottis tissue.

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

a body having an unstretched at-rest shape and a stretched, deformed shape, the body being adapted to be implanted into airway-forming tissue of the patient;

proximal and distal anchors adapted to be implanted into the airway-forming tissue without affixing the device to the airway-forming tissue and to be infiltrated by the airway-forming tissue to affix the anchors to the airway-forming tissue;

at least one bioerodable element maintaining the body in the stretched, deformed shape against a return force;

the body being configured to return toward the unstretched at-rest shape upon erosion of the at least one bioerodable element, wherein the at least one bioerodable element comprises a C-shaped element.

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

a body having an unstretched at-rest shape and a stretched shape, the body being adapted to be implanted into airway-forming tissue of the patient;

spaced apart proximal and distal anchors coupled with the body and adapted to be implanted into the airway-forming tissue without affixing the device to the airway-forming tissue and to be infiltrated by the airway-forming tissue to affix the anchors to the airway-forming tissue;

a plurality of separate bioerodable elements maintaining the body in the stretched shape against a return force;

the body being configured to return toward the unstretched at-rest shape upon erosion of the separate bioerodable elements.

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

21. The device of claim 19 wherein the body is sized and shaped to be inserted into soft palate tissue.

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

23. The device of claim 19 wherein the stretched shape is longer and wider than the at-rest shape.

24. The device of claim 19 further comprising an elutable bioactive agent associated with the bioreodable elements such that the elutable bioactive agent is released when the bioerodable elements bioerode.

25. The device of claim 19 wherein at least one of the proximal and distal anchors is adapted to expand.

26. The device of claim 19 wherein at least one of the proximal and distal anchors is adapted to self-expand.

27. The device of claim 19 wherein at least one of the anchors comprises woven material.

28. The device of claim 19 wherein at least one of the anchors comprises non-woven material.

29. The device of claim 19 wherein the stretched shape is longer than the at-rest shape.

30. The device of claim 19 wherein at least one of the anchors comprises braided material.

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

implanting a device having a stretched non-bioerodable portion into airway-forming tissue without affixing the device to the tissue; and

permitting bioerodable portions of the implanted device to bioerode, thereby permitting the stretched portion to unstretch to apply a force to the airway-forming tissue to maintain airway patency,

wherein the bioerodable portions comprise a coil.