Granted Patent B2

US 12,636,073 · App. 17/454,561 · Granted May 26, 2026

Inventors: Charlton Yih (San Mateo, CA); Yen Hai Tieu (San Jose, CA); Andrew Frazier (Sunnyvale, CA); Scott J. Wolf (Menlo Park, CA); Fred Dinger (Austin, TX)

Assignee: Aerin Medical, Inc.

A61B18/1485A61B2017/00946A61B2017/248A61B2018/00017A61B2018/00023A61B2018/00047A61B2018/0016A61B2018/00327A61B2018/00791A61B2018/126A61B2018/1467

Abstract

Claims (58)

1 . A method of treating a soft palate in a patient, the method comprising:

advancing a tissue treatment portion of a soft palate treatment device through a mouth of the patient, the tissue treatment portion having an elongate portion and a hook-shaped distal end configured to fit around an end of the soft palate, and having a treatment surface, the treatment surface comprising:

a first longitudinal electrode positioned on a first lateral side of the tissue treatment portion and extending along a length of the tissue treatment portion from a proximal end of the tissue treatment portion to a distal end of the tissue treatment portion,

a second longitudinal electrode positioned on a second lateral side of the tissue treatment portion and extending along the length of the tissue treatment portion from the proximal end of the tissue treatment portion to the distal end of the tissue treatment portion; and

a cooling member positioned between the first and second longitudinal electrodes and extending along the length of the tissue treatment portion from the proximal end of the tissue treatment portion to the distal end of the tissue treatment portion;

contacting mucosal tissue with the tissue treatment portion, wherein an inferior surface of the soft palate is contacted with the elongate portion of the tissue treatment portion and a superior surface of the soft palate is contacted with the hook-shaped distal end of the tissue treatment portion;

delivering energy from the first longitudinal electrode of the tissue treatment portion through the mucosal tissue to a target tissue in the soft palate beneath the mucosal tissue, to change at least one property of the target tissue,

receiving, with the second longitudinal electrode, the energy delivered from the first longitudinal electrode,

cooling the mucosal tissue between the first and second longitudinal electrodes with the cooling member on the tissue treatment portion during delivery of energy such that the target tissue is treated at a selected tissue depth in a U-shaped energy delivery path from the first longitudinal electrode and through the target tissue to the second longitudinal electrode; and

removing the tissue treatment portion from the mouth.

2 . The method of claim 1 , wherein the change in the at least one property of the target tissue results in a reduction of at least one of snoring or sleep apnea in the patient.

3 . The method of claim 1 , further comprising applying force against the soft palate with the treatment surface while delivering the energy, to deform tissue of the soft palate, wherein changing the at least one property of the target tissue comprises reshaping the target tissue.

4 . The method of claim 1 , wherein changing the at least one property of the target tissue comprises at least one of reshaping, remodeling, stiffening, strengthening, tightening, shortening, thickening or ablating the target tissue.

5 . The method of claim 1 , wherein the energy is selected from the group consisting of radiofrequency, microwave, ultrasound, heat and cryogenic energy.

6 . The method of claim 1 , further comprising:

repositioning the tissue treatment portion to a new location on the soft palate; and

delivering the energy to the target tissue again, to form a treatment pattern in the target tissue.

7 . The method of claim 1 , wherein cooling the mucosal tissue comprises applying a suction force with the cooling member to suction air through the cooling member.

8 . The method of claim 1 , wherein cooling the mucosal tissue comprises circulating a cooling fluid through the cooling member.

9 . The method of claim 1 , wherein the cooling member comprises a thermoelectric cooler on the treatment surface, coupled with a heat pipe in a shaft of the soft palate treatment device, which is coupled with a heat sink in a handle of the soft palate treatment device.

10 . The method of claim 1 , further comprising:

measuring a temperature of the mucosal tissue with a temperature sensing member on the treatment surface of the tissue treatment portion; and

automatically controlling, with a controller coupled with the soft palate treatment device, at least one of energy delivery or cooling, based on the temperature.

11 . The method of claim 1 , wherein the target tissue is selected from the group consisting of muscle, cartilage, tendon, ligament, connective tissue, nerve and blood vessel.

12 . The method of claim 1 , further comprising bending a malleable shaft of the soft palate treatment device before advancing the tissue treatment portion.

13 . The method of claim 1 , further comprising applying force to the mucosal tissue with the tissue treatment portion to cause the tissue treatment portion to flex at at least one flex point along the tissue treatment portion.

14 . The method of claim 1 , wherein the cooling member includes an air vent.

15 . A device for treating a soft palate in a patient, the device comprising:

a handle;

a shaft having a proximal end attached to the handle and a distal end;

a treatment element extending from the distal end of the shaft, the treatment element having an elongate portion and a hook-shaped distal end configured to fit around an end of the soft palate, the treatment element comprising:

a treatment surface;

a first longitudinal electrode on the treatment surface; and

a second longitudinal electrode on the treatment surface;

a cooling mechanism positioned between the first longitudinal electrode and the second longitudinal electrode, the cooling mechanism configured to couple to a suction source for suctioning cooling fluid through the cooling mechanism,

wherein the first longitudinal electrode is configured to deliver radiofrequency energy to tissue, the second longitudinal electrode is configured to receive the energy delivered from the first longitudinal electrode, and the cooling mechanism is configured to cool the tissue between the first longitudinal electrode and the second longitudinal electrode such that the energy is delivered to the tissue in a U-shaped energy delivery path from the first longitudinal electrode to the second longitudinal electrode;

wherein the elongate portion of the treatment element is configured to contact an inferior surface of the soft palate and the hook-shaped distal end of the treatment element is configured to contact a superior surface of the soft palate; and

a connector for connecting the handle with a power source and a cooling source.

16 . The device of claim 15 , wherein the distal end of the shaft comprises a neck that is angled relative to a longitudinal axis of the shaft, and wherein the treatment element is attached to the neck.

17 . The device of claim 15 , wherein the first longitudinal electrode and the second longitudinal electrode comprise elongate bipolar radiofrequency electrodes.

18 . The device of claim 15 , wherein each of the first longitudinal electrode and the second longitudinal electrode comprises a protruding, non-penetrating electrode.

19 . The device of claim 15 , wherein the treatment surface has a convex shape for creating a concave deformity in the soft palate.

20 . The device of claim 15 , wherein the shaft is malleable.

21 . The device of claim 15 , further comprising at least one flex member on a top surface of the treatment element.

22 . The device of claim 15 , further comprising a temperature sensing member on the elongate-treatment element, for sensing a temperature of mucosal tissue in contact with the treatment surface.

23 . The device of claim 15 , wherein the cooling mechanism comprises a central channel extending from a proximal end of the treatment surface to a distal end of the treatment surface to couple to a lumen extending through the shaft and the handle to the suction source.

24 . A device for treating a soft palate in a patient, the device comprising:

a handle;

a shaft having a proximal end attached to the handle and a distal end;

a treatment element extending from the distal end of the shaft and having an elongate portion and a hook-shaped distal end configured to fit around an end of the soft palate, the treatment element comprising:

a treatment surface;

a first longitudinal electrode positioned on a first lateral side of the treatment surface and extending along a length of the treatment surface from a proximal end of the treatment surface to a distal end of the treatment surface;

a second longitudinal electrode positioned on a second lateral side of the treatment surface and extending along the length of the treatment surface from the proximal end of the treatment surface to the distal end of the treatment surface;

a cooling mechanism positioned between the first longitudinal electrode and the second longitudinal electrode,

wherein the first longitudinal electrode is configured to deliver radiofrequency energy to tissue, the second longitudinal electrode is configured to receive the energy delivered from the first longitudinal electrode, and the cooling mechanism is configured to cool the tissue between the first longitudinal electrode and the second longitudinal electrode such that the energy is delivered to the tissue in a U-shaped energy delivery path;

wherein the elongate portion of the treatment element is configured to contact an inferior surface of the soft palate and the hook-shaped distal end of the treatment element is configured to contact a superior surface of the soft palate; and

a connector for connecting the handle with a power source and a cooling source.

25 . The device of claim 24 , wherein the cooling mechanism includes an air vent.

Assignments (2)

Continuity (2)

References Cited (400)