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

• US 9,636,258 B2
• Filed: 05/27/2015
• Issued: 05/02/2017
• 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., Goldfarb, Eric, Vrany, Julia D., Muni, Ketan P., Bolger, William E., Roberson, Joseph, Bright, II, Earl A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/722,300
• Publication Number:
  US 20150366716A1
• Time in Patent Office: 706 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. A method for providing a gas pathway and introducing a therapeutic substance in the middle ear region of a patient, comprising:

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

i. contains the therapeutic substance; and

ii. is configured to elute the therapeutic substance into tissue of the ET;

(b) providing an intermittent gas pathway between a lumen of the ET and the nasopharynx using the endoluminal implant; and

(c) eluting the therapeutic substance into the tissue of the ET that is adjacent to the endoluminal implant.

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

(a) a valve in fluid communication with the lumen of the ET, wherein the valve comprises;

i. a first valve portion; and

ii. a second valve portion;

(b) a first connector portion connected with the first valve portion to couple the endoluminal implant to adjacent cartilage; and

(c) a second connector portion connected with the second valve portion to further couple the implant to tensor villi palatine or levator villi palatine muscles.

3. The method of claim 2, wherein the first connector portion comprises a first tether configured to span across the adjacent cartilage and compress mucosa in the ET to secure the first valve portion to the adjacent cartilage.

4. The method of claim 2, wherein the valve is configured to modulate opening of the ET during swallowing due to movement of the tensor villi palatine or the levator villi palatine muscles.

5. The method of claim 1, wherein the endoluminal implant comprises a lumen.

6. The method of claim 5, wherein the lumen of the endoluminal implant contains the therapeutic substance.

7. The method of claim 6, wherein the therapeutic substance is configured to elute over time from the lumen of the endoluminal implant into the tissue of the ET.

8. The method of claim 1, wherein the therapeutic substance is configured to encourage tissue growth, limit stenosis of the ET and combinations thereof.

9. The method of claim 5, wherein the lumen of the endoluminal implant comprises a woven graft, expandable mesh or preformed lumen.

10. An endoluminal implant for providing a gas pathway between a nasopharynx and Eustachian Tube (ET) of a patient and introducing a therapeutic substance into the ET of the patient, the endoluminal implant comprising:

(a) a lumen dimensioned for insertion into the ET, the lumen containing the therapeutic substance;

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

(c) a first connector portion connected with the first valve portion to tether the implant to cartilage adjacent to the ET;

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

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

11. The endoluminal implant of claim 10, wherein the valve is configured to modulate the opening of the ET during swallowing due to movement of the tensor villi palatine or the levator villi palatine muscles.

12. The endoluminal implant of claim 10, wherein the therapeutic substance is configured to elute over time from the lumen of the endoluminal implant.

13. The endoluminal implant of claim 10, wherein the therapeutic substance is configured to encourage tissue growth, limit stenosis of the ET and combinations thereof.

14. The endoluminal implant of claim 10, wherein the lumen of the endoluminal implant comprises a woven graft, expandable mesh or preformed lumen.

15. An endoluminal implant for providing a gas pathway and introducing a therapeutic substance in the middle ear region of a patient, the endoluminal implant comprising an elongated spring member dimensioned for insertion into a Eustachian tube (ET) of the patient, wherein the elongated spring member comprises the therapeutic substance and is configured to:

(a) apply a force to modulate an opening in a gas pathway in communication with a lumen of a Eustachian Tube (ET) and a nasopharynx of the patient; and

(b) deliver the therapeutic substance to adjacent tissue.

16. The endoluminal implant of claim 15, wherein the therapeutic substance is embedded on the spring member, coated on the spring member or combinations thereof.

17. The endoluminal implant of claim 15, wherein the therapeutic substance is configured to encourage tissue growth, limit stenosis of the ET and combinations thereof.

18. The endoluminal implant of claim 15, wherein the therapeutic substance is configured to cause tissue to grow into or over the elongated spring member.

19. The endoluminal implant of claim 15, wherein the implant is configured to cause tissue ingrowth.

20. The endoluminal implant of claim 15, wherein the elongated spring member defines an elongated clam shell configuration.