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

• US 8,435,290 B2
• Filed: 03/24/2010
• Issued: 05/07/2013
• 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:
  US12/730,492
• Publication Number:
  US 20100305697A1
• Time in Patent Office: 1,140 Days
• Field of Search: 623/10, 606/109, 128/898
• US Class Current: 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. A method for providing a gas pathway in the middle ear region of a patient, comprising:

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

introducing an endoluminal ET ventilating implant via the patient'"'"'s nasopharynx along the guide wire into the Eustachian tube of the patient;

advancing the implant into the ET adjacent the cartilage and tensor villi palatine or the levator villi palatine muscles, said implant dimensioned for insertion into the ET adjacent the nasopharynx;

tethering the implant to the ET cartilage using a first connector;

tethering the implant to the tensor villi palatine or the levator villi palatine muscles using a second connector;

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 implant comprises a tube located in the ET lumen.

3. The method of claim 2, wherein the implant further comprises:

a valve in fluid communication with the lumen,

said valve having a first valve portion and a second valve portion, said first valve portion being connected with said first connector, and said second valve portion being connected with said second connector.

4. The method of claim 3, wherein said valve is configured to modulate the opening during swallowing due to movement of the tensor villi palatine or the levator villi palatine muscles.

5. The method of claim 1, wherein the guide wire includes at least one marking and wherein the method further comprises viewing a location of the marking relative to anatomy of the patient during the advancing method to determine how far to advance the guide wire into the ET.

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

a lumen dimensioned for insertion into the ET at an end adjacent the nasopharynx, through the patient'"'"'s nasopharynx;

a valve in fluid communication with the lumen, the valve having a first valve portion and a second valve portion;

a first connector portion connected with the first valve portion to tether the implant to the cartilage adjacent the ET; and

a second connector portion connected with the second valve portion to tether the implant to the adjacent tensor villi palatine or the levator villi palatine muscles;

wherein said first connector portion comprises a first tether configured to span across the cartilage and compress the mucosa of the ET lumen to secure the first valve portion with the cartilage.

7. The implant of claim 6, wherein the proximal end of said first connector portion has a T-shaped member to secure against the cartilage.

8. The implant of claim 6, wherein said valve is configured to modulate opening of the ET during swallowing.

9. The implant of claim 8, wherein the valve is configured to modulate opening of the ET in response to the movement of the tensor muscles.

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

introducing an endoluminal ET ventilating implant via the patient'"'"'s nasopharynx into a Eustachian tube (ET) of a patient;

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;

wherein the implant comprises an elongated spring member which applies a constant force against the ET and wherein the elongated spring member is arranged longitudinally within the ET.

13. The method of claim 10, wherein the elongated spring member defines an elongated claim shell configuration.

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

an elongated spring member dimensioned for insertion into the ET at an end adjacent the nasopharynx, through the patient'"'"'s nasopharynx;

wherein said elongated spring member applies a force to modulate an opening in a gas pathway in communication with the ET lumen and the nasopharynx and wherein said elongated spring member defines an elongated claim shell configuration.

12. The implant of claim 11, wherein the implant is configured to cause tissue ingrowth.