Device and method for treatment of sleep disorders

Abstract

A method includes inserting a distal end of an applicator and delivering RF energy inside a mouth, applying one or more electrodes to a treatment area inside the mouth, and applying RF energy to the treatment area to increase its temperature. The method includes measuring tissue surface temperature in the treatment area with a temperature sensor; and adjusting RF energy automatically to achieve collagen remodeling and avoid tissue coagulation or ablation and thereby treat a sleep obstructing disorder.

Claims

1. A method comprising: applying an applicator to a treatment area inside a mouth, said applicator comprising a central electrode which has a first polarity and left and right side electrodes which have a polarity opposite to the first polarity, wherein said central electrode is disposed flush on a flat mouth-tissue contacting surface of said applicator and all portions of said left and right side electrodes are disposed flush on respective left and right flat surfaces that are tilted with respect to a plane defined by said flat mouth-tissue contacting surface, and said applicator further comprises respective left and right arcuate surfaces, both tilted with respect to the plane defined by said flat mouth-tissue contacting surface, which respectively separate said left and right flat surfaces from said flat mouth-tissue contacting surface; using said electrodes to apply RF energy to the treatment area to increase its temperature; measuring tissue surface temperature in the treatment area with a temperature sensor; and adjusting RF energy to achieve collagen remodeling and avoid tissue coagulation or ablation and thereby treat a sleep obstructing disorder.

2. The method according to claim 1 wherein the treatment area is a tongue or a soft palate.

3. The method according to claim 1 wherein the sleep obstructing disorder is snoring or sleep apnea.

4. The method according to claim 1, wherein tissue of the treatment area is heated up to 40° C. to 50° C.

5. The method according to claim 1, wherein frequency of the RF energy is in a range of 100 kHz to 10 MHz.

6. The method according to claim 1, wherein the RF energy is applied in CW manner.

7. The method according to claim 1, wherein average RF power is 1-50 W.

8. The method according to claim 1, wherein the collagen remodeling causes tissue contraction.

9. The method according to claim 1, wherein the temperature sensor comprises a thermistor, a thermocouple or an optical sensor.

10. The method according to claim 1, wherein a thermal response time of the temperature sensor is in a range of 0.1 sec to 2 sec.

11. The method according to claim 1, wherein said central electrode has a larger area than said side electrodes.

12. The method according to claim 1, wherein said central electrode is made from a metal sheet having a contact surface and a flexible printed circuit board is attached to said central electrode on a side opposite to said contact surface, and said temperature sensor is part of circuitry of said flexible printed circuit board.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the accompanying drawings:

(2) FIG. 1 is a schematic illustration of a hand piece with a disposable tip, in accordance with a non-limiting embodiment of the invention.

(3) FIG. 2 is a schematic illustration of electrodes, in accordance with a non-limiting embodiment of the invention.

(4) FIG. 3 is a cross-sectional illustration of a disposable tip, in accordance with a non-limiting embodiment of the invention.

(5) FIG. 4 is a schematic illustration of RF energy between electrodes, in accordance with a non-limiting embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

(6) Referring first to FIG. 1, an applicator assembly includes a handle 11. A disposable tip 12 is connected to the handle 11. Handle 11 has a locking mechanism 13 fixing the disposable tip 12 to handle 11. All communication of signals and power between handle 11 and an external device (which includes RF power source and processing circuitry) may be via a cable 14. The RF power source provides RF power to the handle 11 through the cable 14, and a temperature sensor signal from the disposable tip is delivered to the processing circuitry through the same cable 14 or by wireless communication.

(7) FIG. 2 illustrates the electrode geometry on the disposable tip 12. In the non-limiting illustrated embodiment, there are three electrodes: a central electrode 21 has one polarity while two side electrodes 22, 23 have the opposite polarity. The size of the electrodes and the distance between them are designed to have virtually uniform distribution of RF energy in the tissue. Size and shape of the tip are optimized to have good contact with treated tissue, such as the soft palate and tongue.

(8) Referring to FIG. 3, a cross-section of the disposable tip is shown. Without limitation, the electrode 31 may be made from thin stainless steel sheet with a thickness of about 0.2 mm. Electrode 31 contacts the tissue, delivering RF energy to the treated site. A flexible PCB 32 is attached to the opposite side of electrode 31 having good thermal contact with the electrode 31. The thickness of flexible PCB 32 may be, without limitation, about 100 microns. A miniature SMD (surface mount device) thermistor 33 may be soldered to the opposite side of PCB 32 and senses skin temperature through the thin electrode 31 and PCB 32. Thermistor 33 is fast enough to prevent tissue overheating. Typical response time is, without limitation, about 0.3 sec.

(9) FIG. 4 illustrates RF energy distribution 41 between electrodes. RF current goes from central electrode 21 having one polarity to the side electrodes 22, 23 having opposite polarity. Central electrode 21 may have a larger area than side electrodes 22, 23 to have uniform current density and heating in the treated tissue 42.

(10) Non-limiting parameters for the device are as follows:

(11) 1. Length of disposable tip may be 7-20 cm

(12) 2. Tip treatment area may be 0.5-5 cm.sup.2

(13) 3. Number of electrodes on the tip may be two or more for bipolar design. Alternatively, a mono-polar design can be used with a separate return electrode.

(14) 4. Average RF power may be in the range of 5 W to 40 W which can be delivered in CW or quasi-CW mode

(15) 5. Frequency of RF may be from 0.2 M Hz up to 10 MHz

(16) 6. Treatment time may be in the range of 10 sec up to 20 min.

(17) 7. RF voltage may be applied to the skin in the range of 10V up to 1000V

(18) 8. Temperature sensor response time may be from 0.1 sec up to 2 sec.