Eustachian tube device

• US 8,147,545 B2
• Filed: 06/26/2008
• Issued: 04/03/2012
• Est. Priority Date: 06/26/2007
• Status: Active Grant

• Current Assignee: Doya Medical Ltd.
• Original Assignee: Galit Avior
• Inventors: Avior, Galit
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/666,586
• Publication Number:
  US 20100174366A1
• Time in Patent Office: 1,377 Days
• Field of Search: 623/10
• US Class Current: 623/10
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

The present invention provides a device stenting the ET. The stent (device) provides enhanced ventilation and drainage to the middle ear. Also provided is a method for inserting the device into the Eustachian tube and through the isthmus of a human subject.

Claims

1. A device adapted for insertion into a Eustachian tube, said device comprising a shell, said shell comprising:

a proximal end and a distal end; and

a tube extending from said proximal end to said distal end, said tube being closed in a resting position, and opened by air pressure differential between said ends when air pressure exerted at the proximal end is higher than air pressure exerted at the distal end and when air pressure exerted at the distal end is higher than air pressure exerted at the proximal end; and

wherein said device is adapted for insertion into said Eustachian tube through a nasopharynx.

2. The device of claim 1, wherein an intermediate portion of the device fits within said Eustachian tube.

3. The device of claim 1, wherein at least a portion of the device is compressible.

4. The device of claim 1, further comprising an immobilizing means for immobilizing said device in a position in said Eustachian tube.

5. The device of claim 4, wherein said immobilizing means is located in said Eustachian tube when the device is positioned in said Eustachian tube.

6. The device of claim 1, further comprising a pharmacologically active agent.

7. The device as in claim 1, further comprising a pressure actuated artificial valve situated between said proximal end and said distal end, said valve serving to close said tube in said resting position and to open said tube upon occurrence of said air pressure differential.

8. The device of claim 7, wherein in closed position, said pressure actuated artificial valve blocks air flow and liquid flow through said Eustachian tube.

9. The device of claim 7, wherein said pressure actuated artificial valve is configured to open only upon occurrence of an air pressure differential of above 200 mmH₂O between said proximal and said distal ends.

10. The device of claim 7, wherein said pressure actuated artificial valve, in an open position, provides liquid flow through said Eustachian tube.

11. The device of claim 7, wherein said pressure actuated artificial valve, in an open position, provides gas flow through said Eustachian tube.

12. The device of claim 1, wherein said tube when opened provides unidirectional flow of liquid between said ends from a middle ear to said nasopharynx.

13. The device of claim 1, wherein said tube when opened provides bi-directional flow of air between said ends.

14. The device of claim 1, wherein said device occupies only a cartilaginous portion of the Eustachian tube.

15. The device of claim 1, wherein said tube is opened autonomously based on said air pressure differential and closed autonomously when said air pressure differential is equalized.

16. A method for insertion of a device into a Eustachian tube, comprising:

loading said device onto an insertion apparatus, said device comprising;

a proximal end, a distal end, an intermediate portion and a tube extending from said proximal end to said distal end through said intermediate portion, said tube being closed in a resting position, and opened by air pressure differential between said ends when air pressure exerted at the proximal end is higher than air pressure exerted at the distal end and when air pressure exerted at the distal end is higher than air pressure exerted at the proximal end;

wherein at least a portion of said device, upon said insertion is adapted to fit within said Eustachian tube;

inserting said device using said insertion apparatus into said Eustachian tube through a nasopharynx; and

releasing said device from said apparatus upon device insertion into said Eustachian tube.

17. The method of claim 16, further comprising fitting said intermediate portion of the device within an isthmus.

18. The method of claim 16, further comprising compressing at least a portion of said device to fit within an isthmus.

19. The method of claim 16, further comprising immobilizing said device upon said releasing.

20. The method of claim 16, wherein said tube is opened by opening a pressure actuated artificial valve situated between said proximal end and said distal end to equalize the air pressure differential between said distal end and said proximal end.

21. The method of claim 16, wherein said inserting is through a nostril.

22. The method of claim 16, wherein said inserting comprises locating said device wholly within a cartilaginous portion of the Eustachian tube.

23. The method of claim 16, further comprising releasing a pharmacologically active agent from said device.

24. The method of claim 16, further comprising adapting said tube to open only upon occurrence of an air pressure differential of above 200 mmH₂O between said proximal and said distal ends.

25. The method of claim 16, wherein the device is packed in a compressed form and extends along the Eustachian tube.