System and method for treatment of non-ventilating middle ear by providing a gas pathway through the nasopharynx

• US 10,376,416 B2
• Filed: 05/01/2017
• Issued: 08/13/2019
• Est. Priority Date: 03/31/2009
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Clifford, Anton G., Makower, Joshua, Chang, John Y., Morriss, John H., Bright, II, Earl A., Goldfarb, Eric, Vrany, Julia D., Muni, Ketan P., Bolger, William E., Roberson, Joseph
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/583,053
• Publication Number:
  US 20170296387A1
• Time in Patent Office: 834 Days
• Field of Search: 623 10
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for

Abstract

Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

Claims

1. An endoluminal implant for providing a gas pathway between a nasopharynx and a Eustachian tube (ET) of a patient, the endoluminal implant comprising:

(a) a body dimensioned for insertion into the ET, wherein the body defines a lumen; and

(b) a valve configured to modulate opening and closing of the lumen in response to movement of tissue associated with the ET, wherein the valve comprises;

(i) a first valve portion; and

(ii) a second valve portion,

wherein the first and second valve portions are movable relative to one another between a closed state in which the valve portions are configured to sealingly engage one another to thereby restrict flow of gas through the lumen, and an open state in which the valve portions are configured to separate to thereby permit flow of gas through the lumen.

2. The endoluminal implant of claim 1, wherein the endoluminal implant further comprises:

(i) a first coupling member configured to couple the first valve portion to tissue adjacent to the ET, and

(ii) a second coupling member configured to couple the second valve portion to tissue adjacent to the ET.

3. The endoluminal implant of claim 2, wherein the first coupling member comprises a first tether and the second coupling member comprises a second tether, wherein the first and second tethers are configured to extend transversely through a wall of the ET to couple to respective tissue.

4. The endoluminal implant of claim 2, wherein the first coupling member is configured to couple the first valve portion to cartilage, wherein the second coupling member is configured to couple the second valve portion to a tensor villi palatine muscle or a levator villi palatine muscle.

5. The endoluminal implant of claim 2, wherein the first and second coupling members are configured to compress mucosa of the ET and thereby reduce an inner diameter of the ET.

6. The endoluminal implant of claim 2, wherein the first coupling member includes a first anchoring member configured to anchor the first coupling member to tissue, wherein the second coupling member includes a second anchoring member configured to anchor the second coupling member to tissue.

7. The endoluminal implant of claim 6, wherein each of the first and second anchoring members is configured to assume a T-shaped configuration.

8. The endoluminal implant of claim 1, wherein a portion of the lumen is configured to expand from a first cross-sectional width when the first and second valve portions are in the closed state, to a larger second cross-sectional width when the first and second valve portions are in the open state.

9. The endoluminal implant of claim 8, wherein the portion of the lumen comprises a flexible material.

10. The endoluminal implant of claim 1, wherein the lumen contains a therapeutic substance configured to elute into tissue surrounding the lumen.

11. The endoluminal implant of claim 10, wherein the therapeutic substance is configured to at least one of:

(i) promote growth of tissue into exterior portions of the lumen, or (ii) prevent growth of tissue into interior portions of the lumen.

12. The endoluminal implant of claim 1, wherein the lumen comprises at least one of an expandable mesh, a woven graft, or a molded structure.

13. The endoluminal implant of claim 1, wherein the first valve portion has a first sealing surface, wherein the second valve portion has a complementary shaped second sealing surface configured to sealingly engage the first sealing surface when the first and second valve portions are in the closed state.

14. The endoluminal implant of claim 1, wherein the lumen is configured to receive a guidewire longitudinally therethrough.

15. The endoluminal implant of claim 14, wherein the lumen is further configured to receive a catheter over the guidewire.

16. An endoluminal implant for providing a gas pathway between a nasopharynx and a Eustachian tube (ET) of a patient, the endoluminal implant comprising a body dimensioned for insertion into the ET, wherein the body comprises:

(i) a first body portion,

(ii) a second body portion movably coupled to the first body portion, and

(iii) an open interior defined between the first and second body portions,

wherein the first and second body portions are resiliently biased away from one another and are configured to exert an outwardly directed force on the ET to thereby bias the ET toward an open state.

17. The endoluminal implant of claim 16, wherein the first and second body portions are coupled together in an elongate clamshell configuration.

18. The endoluminal implant of claim 16, wherein the first body portion is configured to be positioned behind a posterior wall of the ET, wherein the second body portion is configured to be positioned behind an anterior wall of the ET.

19. An endoluminal implant for providing a gas pathway between a nasopharynx and a Eustachian tube (ET) of a patient, the endoluminal implant comprising:

(a) an elongate body defining a lumen, wherein the elongate body is dimensioned for insertion into the ET;

(b) a first movable portion; and

(c) a second movable portion,

wherein the first and second movable portions are configured to move transversely toward one another to thereby restrict flow of gas longitudinally through the lumen, wherein the movable portions are configured to move transversely away from one another to thereby permit flow of gas longitudinally through the lumen.

20. The endoluminal implant of claim 19, wherein the first and second movable portions are configured to move relative to one another in response to movement of at least one of a tensor villi palatine muscle or a levator villi palatine muscle.