Tongue Stabilization Device and Methods of Using the Same

• US 20080041398A1
• Filed: 08/29/2007
• Published: 02/21/2008
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Pavad Medical, Inc.
• Inventors: Hegde, Anant, Kim, Doyeon, Hallsten, Casidy, Bagley, Christopher, Bhat, Nikhil, Choi, George, Li, Kasey
• Granted Patent: US 7,909,038 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 2210/0038 electromagnetically
• 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: 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 implant 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; an anchoring portion for connecting the implant with the base of the tongue connected with the flexible portion, and a latch mechanism coupled with the control portion and configured to maintain the flexible portion in either of the first and second states. Methods of treating airway disorders such as sleep apnea and snoring with the airway implant device are disclosed herein.

Claims

1. 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 states by said control portion;

a second anchoring portion connected with said flexible portion, said second anchoring portion being configured for connecting the implant with the base of the tongue; and

a latch mechanism coupled with said control portion and configured to maintain said flexible portion in either of said first and second states.

2. The implant of claim 1 wherein said first anchoring portion includes an anchoring bracket.

3. The implant of claim 1 wherein said control portion comprises a shape memory actuator member coupled with a flexible fiber, said fiber connected at its proximal end with said shape memory actuator member and said fiber connected at its distal end with the distal end of said flexible member, said flexible fiber being configured to impart an axial load on said flexible portion.

4. The implant of claim 3 wherein said shape memory actuator member comprises a shape memory material configured to transition from a substantially martensitic phase to a substantially austenitic phase beginning at approximately 47 Deg. C.

5. The implant of claim 3 wherein said shape memory actuator member comprises a shape memory material configured to experience a contraction when its temperature is elevated above approximately 47 Deg. C.

6. The implant of claim 5 wherein said shape memory actuator member comprises a shape memory material configured to experience an expansion after said contraction when its temperature is lowered below approximately 52 Deg. C.

7. The implant of claim 3 wherein said latch mechanism is a normally closed latch mechanism, wherein said normally closed latch mechanism is configured to securely hold said flexible fiber when said latch mechanism is in a nonpowered state.

8. The implant of claim 7 wherein said latch mechanism comprises a retainer ring coupled with a retainer ring engaging member that is coupled with said flexible fiber.

9. The implant of claim 8 wherein said latch mechanism further comprises a shape memory actuator material connected with said retainer ring, said shape memory actuator material configured to open said retainer ring when powered to release said retainer ring engaging member.

10. The implant of claim 7 wherein said latch mechanism comprises a spring biased collet configured to securely hold said flexible fiber.

11. The implant of claim 10 further comprising a shape memory actuator material connected with said collet, said shape memory actuator material configured to urge said spring-biased collet away from the collet'"'"'s biased position when powered to release said flexible fiber from said collet.

12. The implant of claim 1 wherein said control portion is powered by a non-implanted inductively coupled power source.

13. The implant of claim 1 wherein said flexible portion comprises a flexible helical spring.

14. The implant of claim 1 wherein said flexible portion comprises a bellows structure.

15. The implant of claim 1 wherein said flexible portion comprises an etched stent-like portion.

16. The implant of claim 1 wherein said flexible portion is coated with a hyaluronic acid coating.

17. The implant of claim 1 wherein said second anchoring portion comprises a first disc connected with the distal end of said flexible portion and a second disc connectable with the base of the tongue.

18. The implant of claim 17 wherein said first and second discs comprise suture holes disposed around their circumferences.

19. The implant of claim 17 wherein said first and second discs further comprise polyester rods having holes extending from the flat surfaces of the discs.

20. The implant of claim 1 wherein said second anchoring portion comprises a first proximally extending anchor portion and a second distally extending anchor portion.

21. The device of claim 1 wherein said control portion comprises a microprocessor, said microprocessor being adapted and configured to sense an opening of the air passageway and controlling an energizing of said flexible portion.

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

23. The device of claim 1 further comprising a coating to promote tissue growth.

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 flexible portion.

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

implanting in a subject'"'"'s tongue a device 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;

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; and

a latch mechanism coupled with said control portion and configured to maintain said flexible portion in either of said first and second states, said device being adapted and configured to support the tongue upon being energized.

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

29. The method of claim 28 wherein said sleep disorder is an obstructive sleep apnea or snoring.

30. 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 states by said control portion;

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

31. The implant of claim 30 wherein said first anchoring portion includes an anchoring bracket.

32. The implant of claim 30 wherein said control portion comprises a shape memory actuator member coupled with a flexible fiber, said fiber connected at its proximal end with said shape memory actuator member and said fiber connected at its distal end with the distal end of said flexible member, said flexible fiber being configured to impart an axial load on said flexible portion.

33. The implant of claim 30 wherein said control portion is powered by a non-implanted inductively coupled power source.

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

implanting in a subject'"'"'s tongue a device 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;

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; and

an inductive powering mechanism coupled with said control portion and configured to maintain said flexible portion in either of said first and second states, said device being adapted and configured to support the tongue upon being energized; and

supporting the subject'"'"'s tongue by selectively activating the control portion of said implant using said inductive powering mechanism.