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

• US 9,072,626 B2
• Filed: 05/06/2013
• Issued: 07/07/2015
• 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, Earl A. II, Goldfarb, Eric, Vrany, Julia D., Muni, Ketan P., Bolger, William E., Roberson, Joseph
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/887,618
• Publication Number:
  US 20130303968A1
• Time in Patent Office: 792 Days
• Field of Search: 623/10, 128/898
• US Class Current: 1/1
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: H01S 5/0602 which is an umpumped part of the active layer
• CPC Class Codes: H01S 5/06251 Amplitude modulation
• CPC Class Codes: H01S 5/06256 with DBR-structure

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. A method for providing a gas pathway in the middle ear region of a patient, the method comprising:

(a) advancing a guide catheter into the Eustachian tube (ET) of the patient via the patient'"'"'s nasopharynx;

(b) introducing an interventional device through the guide catheter into the ET of the patient to relieve obstruction or blockage in the ET;

(c) removing the interventional device from the ET;

(d) introducing an endoluminal ET ventilating implant into the ET of the patient through the guide catheter;

(e) advancing the implant into the ET adjacent the cartilage and tensor villi palatine or the levator villi palatine muscles, wherein the implant is dimensioned for insertion into the ET adjacent the nasopharynx;

(f) tethering the implant to tissue; and

(g) removing the guide catheter from the ET, leaving the implant tethered in the tissue;

thereby providing a gas pathway between the ET lumen and the nasopharynx using the implant, the implant being dimensioned and configured to modulate an opening in a gas pathway in communication with the ET lumen and the nasopharynx.

2. The method of claim 1 wherein the guide catheter has a bend on its distal tip that is greater than 30 degrees and less than 90 degrees.

3. The method of claim 1 wherein the implant further comprises a therapeutic substance.

10. The method of claim 1 wherein the act of tethering the implant to tissue comprises tethering the implant to the cartilage and tensor villi palatine or levator villi palatine muscles.

11. The method of claim 10 wherein the implant comprises a valve in fluid communication with the ET lumen, wherein the valve is configured to modulate the opening in the gas pathway in response to movement of the tensor villi palatine or the levator vili palatine muscles.

4. A kit for providing a gas pathway in the middle ear region of a patient, the kit comprising:

(a) a guide catheter having a bend on its distal tip;

(b) an interventional device for treating the Eustachian Tube (ET) to relieve obstruction or blockage in the ET; and

(c) an implant comprising a resiliently biased elongated member dimensioned for insertion into the ET at an end adjacent the nasopharynx, through the patient'"'"'s nasopharynx, wherein the elongated member is sized and configured to apply a force against the ET through the resilient bias to modulate fluid communication through the ET lumen.

5. The kit of claim 4 wherein the elongated member further comprises a therapeutic substance.

6. The kit of claim 5 wherein the therapeutic substance is configured to encourage tissue growth or limit stenosis of the ET.

7. The kit of claim 5 wherein the therapeutic substance is configured to elute over time.

8. The kit of claim 4 wherein the elongated member comprises an expandable mesh, a woven graft, or a preformed lumen.

12. The kit of claim 4 wherein the resiliently biased elongated member comprises a spring member.

13. The kit of claim 12 wherein the spring member has a clamshell configuration.

9. A kit for obtaining and maintaining proper functioning of the Eustachian Tube (ET), the kit comprising:

(a) a guide catheter having a bend on its distal tip;

(b) an interventional device for treating the Eustachian Tube (ET) to relieve obstruction or blockage in the ET; and

(c) an endoluminal implant dimensioned for insertion into the ET at an end adjacent to the nasopharynx, through the patient'"'"'s nasopharynx, wherein the endoluminal implant comprises a valve configured to modulate opening and closing of the ET lumen in response to movement of tissue associated with the ET.

14. The kit of claim 9 further comprising a plurality of tethers that are configured to tether the valve to tissue.

15. The kit of claim 14 wherein the valve comprises a first valve portion and a second valve portion, wherein the first valve portion is configured to be connected to ET cartilage using a first tether, wherein the second valve portion is configured to be connected to tensor villi palatine or the levator villi palatine muscles within the ET using a second tether.