Apparatus for treatment of ménière's disease and similar conditions

• US 6,629,938 B1
• Filed: 03/14/2001
• Issued: 10/07/2003
• Est. Priority Date: 07/06/1998
• Status: Expired due to Term

• Current Assignee: LiNA Medical ApS
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nilsson, Anders, Engvall, Daniel
• Primary Examiner(s): DeMille, Danton D.
• Assistant Examiner(s): Thanh, Quang D
• Application Number:
  US09/743,168
• Time in Patent Office: 937 Days
• Field of Search: 601/76, 601/77, 601/10, 601/148, 601/149, 600/559, 607/105
• US Class Current: 601/76
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing

Abstract

An apparatus for treatment of Ménière'"'"'s disease by intermittently increasing air (gas) pressure, in an air (gas) pressure chamber in communication with an outwardly sealed external ear volume bordering the tympanic membrane, comprises a peripherally fixed flexible circular diaphragm forming a wall of the chamber and being displaceable in a perpendicular direction essentially without being tensioned. Displacement of the diaphragm away from the chamber is effected by air pressure built up in the chamber, not by a separate displacement device. The apparatus further comprises a linear electromagnetic device for displacing the diaphragm. The apparatus may include systems for gas pressure sensing; chamber pressure equalizing; and microprocessor control, for controlling the displacement of the diaphragm and the pressure equalizing device by a signal input from the pressure sensing device.

Claims

1. An apparatus for treatment of Mé

niè

re'"'"'s disease by intermittently increasing air (gas) pressure, in an air (gas) pressure chamber being in communication with an outwardly sealed external ear volume bordering to the tympanic membrane, the apparatus comprising a flexible diaphragm forming a wall of the chamber and being displaceable in the direction toward the chamber, the apparatus further comprising an actuator which when actuated displaces the diaphragm in the direction toward the chamber and when not actuated, passively permits the diaphragm to displace in an opposite direction.

2. The apparatus of claim 1, wherein the actuator comprises a linear electromagnetic device.

3. The apparatus according to claim 2, wherein the diaphragm actuator comprises an elongate actuating member having an axis and being fixed to the diaphragm at its one end and to a core of a ferromagnetic magnetic material;

and an electric coil for displacement of the core along said axis in the direction toward the chamber.

4. The apparatus of claim 1, further comprising:

a pressure sensor for monitoring pressure in the chamber;

a pressure equalising conduit for equalising the pressure in the chamber with ambient air pressure; and

a control system comprising a microprocessor, for controlling the displacement of the diaphragm and the pressure equalising conduit by a signal input from the pressure sensor.

5. The apparatus of claim 4, wherein the pressure equalising conduit comprises a valve.

6. The apparatus of claim 5, wherein the valve is in an open position except during the generation of said signal.

7. The apparatus of claim 5, further comprising a safety circuit for breaking the current to the pressure equalising valve and the actuator if the pressure exceeds ambient pressure by 25 cm H₂O or more.

8. The apparatus of claim 4, wherein the diaphragm actuator comprises an elongate actuating member having an axis and being fixed to the diaphragm at its one end and to a core of a ferromagnetic magnetic material;

an electric coil for displacement of the core along said axis in the direction of the chamber; and

a device for energising the coil controlled by the control system.

9. The apparatus of claim 4, wherein the pressure equalising conduit comprises an on/off valve working at below a sound pressure level of 20 dB.

10. The apparatus of claim 9, wherein the valve is provided with sealing faces comprising a resilient polymer.

11. The apparatus of claim 9, wherein the valve is controlled to open, at the end of said signal, during from about 0.5 seconds to 1.5 seconds, preferably during about one second, from a fully closed position to a fully opened position.

12. The apparatus of claim 9, wherein the valve is controlled to be in an open position except during the generation of said signal.

13. The apparatus of claim 4, wherein variable information for control of the apparatus is stored in a storage medium associated with said microprocessor in the form of a parameter set in an E²PROM or other suitable storage medium.

14. The apparatus of claim 13, wherein the storage medium is associated with an input device with which a parameter set is replaceable by another parameter set.

15. The apparatus of claim 14, wherein the input device comprises an IR input device.

16. The apparatus according to claim 4, wherein the pressure equalising conduit comprises a valve.

17. The apparatus according to claim 16, wherein the valve is controlled to open, at the end of said signal, during from about 0.5 seconds to 1.5 seconds, preferably during about one second, from a fully closed position to a fully opened position.

18. The apparatus according to claim 16, wherein the valve is controlled to be in an open position except during the generation of said signal.

19. The apparatus of claim 1, comprising a mechanical safety valve for protection of the patient against negative pressure.

20. The apparatus according to claim 1, wherein the force required to displace the diaphragm by a given distance with said air (gas) pressure chamber in a closed state is five or more times greater than the force required for a corresponding displacement with the chamber in an open state.

21. The apparatus according to claim 20, wherein the force required to displace the diaphragm by a given distance with said air (gas) pressure chamber in a closed state is ten or more times greater than the force required for a corresponding displacement with the chamber in an open state.

22. The apparatus according to claim 20, wherein the displacement is about 3 mm.

23. The apparatus according to claim 21, wherein the displacement is about 3 mm.

24. The apparatus according to claim 1, wherein the diaphragm is displaceable in the direction toward the chamber substantially without being tensioned.

25. The apparatus according to claim 1, wherein the displacement of the diaphragm is below 5 mm, said displacement defining the working range of the apparatus.

26. The apparatus according to claim 25, wherein a chamber pressure/diaphragm displacement ratio is about constant within the working range of the apparatus.

27. The apparatus according to claim 25, wherein a coil voltage/diaphragm displacement ratio is about constant within the working range of the invention.

28. The apparatus according to claim 1, wherein a displacement of the diaphragm is below 3 mm, said displacement defining the working range of the apparatus.

29. The apparatus according to claim 28, wherein a chamber pressure/diaphragm displacement ratio is about constant within the working range of the apparatus.

30. The apparatus according to claim 28, wherein a coil voltage/diaphragm displacement ratio is about constant within the working range of the invention.

31. The apparatus according to claim 1, wherein the diaphragm actuator comprises an elongate actuating member having an axis and being fixed to the diaphragm at its one end and to a core of a ferromagnetic magnetic material;

and an electric coil for displacement of the core along said axis in the direction toward the chamber.