Tethered Airway Implants and Methods of Using the Same

• US 20070246052A1
• Filed: 04/18/2007
• Published: 10/25/2007
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Pavad Medical, Inc.
• Inventors: Choi, George Y., Li, Kasey Kai-Chi, Kim, Doyeon, Hegde, Anant V., Bhat, Nikhil D.
• Granted Patent: US 7,909,037 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• 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
• CPC Class Codes: G02B 26/0841 the reflecting element being moved or deformed by electrostatic means
• CPC Class Codes: H02N 1/008 Laterally driven motors, e.g. of the comb-drive type
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices

Abstract

An airway implant device for maintaining and/or creating an opening in air passageways is disclosed. Methods of using the device are also disclosed. The airway implant device includes a deformable element to control the opening of an air passageway and a tether. Preferably the deformable element is an electroactive polymer element. Energizing of the electroactive polymer element provides support for the walls of an air passageway, when the walls collapse, and thus, completely or partially opens the air passageway. Also disclosed is an implant for stabilizing the tongue, the implant having an anchoring portion for securing a first end of the implant with the mandibula; a control portion connected with the anchoring portion, configured for selectively activating the implant; a flexible portion connected at its proximal end with the control portion, where the flexible portion has three-dimensional flexibility in a first state and where the flexible portion has a lesser three-dimensional flexibility in a second state, and where the flexible portion is selectively switchable between the first and second state by the control portion; and an anchoring portion for connecting the implant with the base of the tongue connected with the distal end of the flexible portion. Methods of treating airway disorders such as sleep apnea and snoring with the airway implant device are disclosed herein.

Claims

1. An airway implant device comprising a deformable element and a tether element, wherein said deformable element is adapted and configured to modulate an opening of an air passageway and said tether element is adapted and configured to fasten said deformable element to a bony structure.

2. The device of claim 1 wherein said deformable element comprises an actuator.

3. The device of claim 2 wherein said actuator comprises a magnet, a Nitinol, conducting polymer or an electroactive polymer.

4. The device of claim 1 wherein said deformable element comprises a magnetic material or an electroactive polymer element.

5. The device of claim 1 wherein said deformable element and said tether element comprise a polymeric material, wherein said polymeric material of said deformable element is an electroactive polymer.

6. The device of claim 1 wherein said deformable element comprises an electroactive polymer element.

7. The device of claim 6 further comprising an anode, a cathode, a first inductor, and a controller;

said anode and cathode being connected to said deformable element.

8. The device of claim 7 wherein said controller comprises a microprocessor, said microprocessor being adapted and configured to sense said opening of said air passageway and controlling an energizing of said deformable element.

9. The device of claim 6 further comprising a non-implanted portion.

10. The device of claim 9 wherein said non-implanted portion is a strip, said strip being adapted and configured to control said deformable element.

11. The device of claim 9 wherein said strip comprises a power supply and a second inductor.

12. The device of claim 11 wherein said second inductor is adapted and configured to interact with said first inductor.

13. The device of claim 1 wherein said deformable element is adapted and configured for implantation into a tongue.

14. The device of claim 6 wherein said electroactive polymer element comprises an ion-exchange polymer metal composite.

15. The device of claim 6 wherein said electroactive polymer element comprises a conducting polymer.

16. The device of claim 15 wherein said conducting polymer comprises a polypyrrole, a carbon nanotube or a polyaniline.

17. The device of claim 1 wherein said deformable element comprises a flat surface or a tube.

18. The device of claim 17 wherein said deformable element is adapted and configured to expand and contract like an accordion.

19. The device of claim 6 further comprising a power supply in electrical communication with the electroactive polymer element.

20. The device of claim 19 wherein application of electrical current to said electroactive polymer element opens an air passageway.

21. The device of claim 1 further comprising a coating to prevent tissue in-growth.

22. The device of claim 1 further comprising a coating to promote tissue in-growth.

23. The device of claim 6 further comprising an inductive coupling mechanism adapted to connect the electroactive polymer element to a power source.

24. The device of claim 1 further comprising a sensor element, wherein said sensor is adapted and configured to monitor a condition of an airway to determine likelihood of an apneic event.

25. The device of claim 24 wherein said condition monitored is an air passageway gap, air flow pressure, and/or wall tension.

26. The device of claim 24 wherein said sensor provides feedback to modulate said opening of said air passageway by said deformable element.

27. A method of treating a disease using an airway implant device comprising:

implanting in a subject'"'"'s airway an implant device comprising a deformable element and a tether element, the implanting step comprising fastening the deformable element to a bony structure of the subject with the tether element, wherein said deformable element is adapted and configured to modulate an opening of an air passageway.

29. The method of claim 27 or 28 wherein said disease is a sleep disorder.

30. The method of claim 29 wherein said sleep disorder is an obstructive sleep apnea or snoring.

28. A method of treating a disease using an airway implant device comprising:

implanting a deformable element in a tongue of a subject and tethering said deformable element to a jaw bone, said deformable element being adapted and configured to support the tongue upon being energized.

31. An implant for stabilizing the tongue, comprising:

a first anchoring portion for securing a first end of the implant with the mandibula;

a control portion connected with the anchoring portion, configured for selectively activating the implant;

a flexible portion connected at its proximal end with the control portion, said flexible portion having three-dimensional flexibility in a first state and said flexible portion having a lesser three-dimensional flexibility in a second state, said flexible portion being selectively switchable between said first and second state by said control portion; and

a second anchoring portion connected with the distal end of said flexible portion, said second anchoring portion being configured for connecting the implant with the base of the tongue.

32. The implant of claim 31 wherein said first anchoring portion includes an anchoring bracket.

33. The implant of claim 31 wherein said control portion comprises a spring-biased linear motor coupled with a flexible fiber, said fiber connected at its proximal end with a load movable by said motor and said fiber connected at its distal end with said second anchoring portion, said flexible fiber being configured to impart an axial load on said flexible portion.

34. The implant of claim 31 wherein said control portion is powered by a non-implanted inductively coupled power source.

35. The implant of claim 31 wherein said control portion comprises a shape memory alloy.

36. The implant of claim 31 wherein said control portion comprises an electro active polymer.

37. The implant of claim 31 wherein said flexible portion comprises a flexible helical spring.

38. The implant of claim 31 wherein said flexible portion comprises a bellows structure.

39. The implant of claim 31 wherein said flexible portion comprises an etched stent-like portion.

40. The implant of claim 31 wherein said flexible portion is coated with a hyaluronic acid coating.

41. The implant of claim 31 wherein said second anchoring portion comprises a first disc connected with the distal end of said flexible portion and a second disc connectible with the base of the tongue.

42. The implant of claim 41 wherein said first and second discs comprise suture holes disposed around their circumferences.

43. The implant of claim 41 wherein said first and second discs further comprise polyester rods having holes extending from the flat surfaces of the discs.