Granted Patent B2

US 12,357,817 · App. 17/658,051 · Granted Jul 15, 2025

Inventor: Scott J. Wolf (Menlo Park, CA)

Assignee: Aerin Medical Inc.

A61N1/0546A61N1/36075A61N1/36189A61N1/40

Abstract

Claims (59)

1. A method for treating headaches, the method comprising:

identifying a patient suffering from headaches;

activating a console attached to a radiofrequency stylus;

advancing a distal tip of the radiofrequency stylus into a nasal cavity of the patient, wherein the distal tip comprises:

a first treatment element having a first treatment surface, the first treatment surface configured to include

a first plurality of bipolar radiofrequency electrodes disposed on the first treatment surface to treat a first tissue area of nasal mucosa; and

a second treatment element positioned distal of the first treatment element, the second treatment element having a second treatment surface configured to include a second plurality of bipolar radiofrequency electrodes to treat a second tissue area of the nasal mucosa;

contacting nasal mucosa lining the nasal cavity with the first treatment surface and the second treatment surface of the distal tip, to cause the first plurality of bipolar radiofrequency electrodes to contact the first tissue area and the second plurality of bipolar radiofrequency electrodes to contact the second tissue area of the nasal mucosa;

applying a pressure with the first treatment surface or the second treatment surface on the nasal mucosa;

determining, using the first treatment surface or the second treatment surface, if the pressure applied to the nasal mucosa is sufficient to confirm contact between the first treatment surface and the first tissue area or the second treatment surface and the second tissue area of the nasal mucosa;

activating at least one electrode pair from the first plurality of bipolar radiofrequency electrodes or the second plurality of bipolar radiofrequency electrodes when the pressure applied by the first treatment surface is sufficient to confirm contact between the first treatment surface and the first tissue area or the pressure applied by the second treatment surface is sufficient to confirm contact between the second treatment surface and the second tissue area of the nasal mucosa;

delivering radiofrequency energy to at least one electrode pair of the first plurality of bipolar radiofrequency electrodes to ablate at least one posterior nasal nerve underlying the first tissue area of the nasal mucosa; and

delivering radiofrequency energy from the at least one electrode pair of the second plurality of bipolar radiofrequency electrodes to disrupt at least one posterior nasal nerve underlying the second tissue area of the nasal mucosa,

wherein disrupting the at least one posterior nasal nerve ameliorates the headaches.

2. The method of claim 1 , further comprising:

moving the distal tip to multiple additional locations within the nasal cavity; and

delivering radiofrequency energy to the at least one posterior nasal nerve or a different nerve at the multiple additional locations.

3. The method of claim 1 , further comprising sensing a temperature of the nasal mucosa with a temperature sensing member located on the first treatment surface or the second treatment surface.

4. The method of claim 3 , further comprising automatically shutting off delivery of radiofrequency energy from the console to the radiofrequency stylus if the temperature is above a predefined acceptable maximum temperature.

5. The method of claim 1 , wherein the at least one posterior nasal nerve is selected from the group consisting of a sphenopalatine ganglion, a branch of a vidian nerve, a branch of the sphenopalatine ganglion, a trigeminal nerve, and an occipital nerve.

6. The method of claim 1 , further comprising bending a shaft of the radiofrequency stylus before advancing the distal tip into the nasal cavity.

7. The method of claim 1 , further comprising treating an additional tissue in the nasal cavity, wherein the additional tissue is selected from the group consisting of an inferior turbinate, a middle turbinate, a superior turbinate, a nasal septum, and a septal swell body.

8. The method of claim 1 , further comprising changing at least one of an orientation or a shape of the distal tip before or after advancing the distal tip into the nasal cavity.

9. The method of claim 8 , wherein the distal tip is changed to achieve a vertical or near vertical orientation relative to the nasal cavity.

10. The method of claim 1 , wherein the headaches comprise migraine headaches.

11. The method of claim 1 , further comprising confirming that the pressure is sufficient with the first treatment surface or the second treatment surface of the radiofrequency stylus against the first tissue area or the second tissue area of the nasal mucosa to confirm contact between the first treatment surface or the second treatment surface and the first tissue area or the second tissue area of the nasal mucosa.

12. A method for treating headaches, the method comprising:

identifying a patient suffering from headaches;

advancing a distal tip of a radiofrequency stylus into a nasal cavity, wherein the distal tip comprises:

a first treatment element having a first treatment surface, the first treatment surface configured to include

a first plurality of bipolar radiofrequency electrodes disposed on the first treatment surface to treat a first tissue area of nasal mucosa; and

a second treatment element configured to expand from a first configuration positioned inside the distal tip and a second configuration to contact a second tissue area of the nasal mucosa, the second treatment element having a second treatment surface configured to include a second plurality of bipolar radiofrequency electrodes to treat the second tissue area of the nasal mucosa;

contacting nasal mucosa lining the nasal cavity with the first treatment surface and the second treatment surface of the distal tip, to cause the first plurality of bipolar radiofrequency electrodes to contact the first tissue area and the second plurality of bipolar radiofrequency electrodes to contact the second tissue area of the nasal mucosa;

determining a pressure applied to the nasal mucosa the nasal cavity by the first treatment surface or the second treatment surface;

activating at least one electrode pair from the first plurality of bipolar radiofrequency electrodes or the second plurality of bipolar radiofrequency electrodes, using a console in electrical communication with the at least one electrode pair, when the pressure applied by the first treatment surface is sufficient to confirm contact between the first treatment surface and the first tissue area or the pressure applied by the second treatment surface is sufficient to confirm contact between the second treatment surface and the second tissue area of the nasal mucosa; and

delivering radiofrequency energy to the at least one electrode pair of the first plurality of bipolar radiofrequency electrodes on the first treatment surface to ablate at least one posterior nasal nerve underlying the first tissue area of the nasal mucosa and delivering radiofrequency energy to the at least one electrode pair of the second plurality of bipolar radiofrequency electrodes on the second treatment surface to ablate at least one posterior nasal nerve underlying the second tissue area of the nasal mucosa,

wherein ablating the at least one posterior nasal nerve ameliorates the headaches.

13. The method of claim 12 , further comprising:

moving the distal tip to multiple additional locations within the nasal cavity; and

delivering radiofrequency energy to the at least one posterior nasal nerve or a different nerve at the multiple additional locations.

14. The method of claim 12 , further comprising sensing a temperature of the nasal mucosa with a temperature sensing member located on the first treatment surface or the second treatment surface.

15. The method of claim 14 , further comprising automatically shutting off delivery of radiofrequency energy from the console to the radiofrequency stylus if the temperature is above a predefined acceptable maximum temperature.

16. The method of claim 12 , wherein the at least one posterior nasal nerve is selected from the group consisting of a sphenopalatine ganglion, a branch of a vidian nerve, a branch of the sphenopalatine ganglion, a trigeminal nerve, and an occipital nerve.

17. The method of claim 12 , further comprising confirming the sufficient pressure with the first treatment surface or the second treatment surface of the radiofrequency stylus against the first tissue area or the second tissue area of the nasal mucosa to confirm contact between the first treatment surface or the second treatment surface and the first tissue area or the second tissue area of the nasal mucosa.

18. A method for treating headaches, the method comprising:

identifying a patient suffering from headaches;

activating a console attached to a radiofrequency stylus;

advancing a distal tip of a radiofrequency stylus into a nasal cavity, wherein the distal tip comprises:

a first treatment element having a first treatment surface, the first treatment surface configured to include

a first plurality of bipolar radiofrequency electrodes disposed on the first treatment surface to treat a first tissue area of nasal mucosa; and

a second treatment element positioned distal of the first treatment element, the second treatment element having a second treatment surface configured to include a second plurality of bipolar radiofrequency electrodes to treat a second tissue area of the nasal mucosa;

contacting the nasal mucosa of the nasal cavity with the first treatment surface and the second treatment surface, to cause at least one electrode pair of the first plurality of bipolar radiofrequency electrodes to contact the first tissue area and at least one electrode pair of the second plurality of bipolar radiofrequency electrodes to contact the second tissue area of the nasal mucosa;

applying a pressure with the first treatment surface or the second treatment surface on the first tissue area or the second tissue area of the nasal mucosa;

determining, using the first treatment surface or the second treatment surface, if the pressure applied to the nasal mucosa is sufficient to confirm contact between the first treatment surface and the first tissue area or the second treatment surface and the second tissue area of the nasal mucosa;

activating at least one electrode pair from the first plurality of bipolar radiofrequency electrodes or the second plurality of bipolar radiofrequency electrodes when the pressure applied by the first treatment surface is sufficient to confirm contact between the first treatment surface and the first tissue area or the pressure applied by the second treatment surface is sufficient to confirm contact between the second treatment surface and the second tissue area of the nasal mucosa;

measuring impedance with the at least one electrode pair from the first plurality of bipolar radiofrequency electrodes or the second plurality of bipolar radiofrequency electrodes;

determining, via the console, that the impedance is within a desired range that indicates sufficient contact of the at least one electrode pair from the first plurality of bipolar radiofrequency electrodes with the first tissue area or the at least one electrode pair from the second plurality of bipolar radiofrequency electrodes with the second tissue area of the nasal mucosa;

delivering radiofrequency energy to the at least one electrode pair of the first plurality of bipolar radiofrequency electrodes on the first treatment surface to ablate at least one posterior nasal nerve underlying the first tissue area of the nasal mucosa and delivering radiofrequency energy to the at least one electrode pair of the second plurality of bipolar radiofrequency electrodes on the second treatment surface to ablate at least one posterior nasal nerve underlying the second tissue area of the nasal mucosa;

wherein ablating the at least one posterior nasal nerve ameliorates the headaches.

Assignments (2)

Continuity (3)

References Cited (400)

Cited By (4)

US 12,527,618 US 12,636,058 US 12,636,073 US 12,678,212