RF FRACTIONAL DEVICE FOR TREATMENT INSIDE OF NATURAL OPENINGS

Abstract

The invention relates to a device for medical treatment to restore shape and enhance functionality of body related to the natural opening structure.

Claims

1. A method for treatment inside the natural body openings for fractional tissue thermal damage and comprising the steps: Inserting applicator inside natural opening Pushing an array of conductive elements toward the treated surface to penetrate the tissue surface inside the natural body opening applying at least one pulse of RF energy to the array of conductive elements Retracting the array of conductive elements out of tissue after the end of RF energy delivery.

2. The method according to claim 1, wherein the conductive elements are needles.

3. The method according to claim 2, wherein the needle have length from 0.1 mm up to 10 mm.

4. The method according to claim 1, where RF voltage is applied between two or more groups of conductive elements in the array.

5. The method according to claim 1, where RF voltage is applied between conductive elements having one polarity and return electrode having larger area than total area of the conductive elements.

6. The method according to claim 5, wherein the return electrode is has one or more separate elements.

7. The method according to claim 5, wherein the return electrode is located on applicator.

8. The method according to claim 5, wherein the return electrode is separate from the applicator and is placed on the skin surface.

9. The method according to claim 1, where RF frequency is in the range of 100 kHz to 40 MHz

10. The method according to claim 1, where RF is delivered in pulse manner.

11. The method according to claim 1, where RF generator has power from 1 W up 500 W.

12. The method according to claim 1, where natural openings include but not limited by vagina, anus, nose, mouth, ears.

13. The method according to claim 1, where thermal damage is coagulation of the tissue.

14. The method according to claim 1, where thermal damage is ablation of the tissue.

15. The method according to claim 2, where part of the needle surface is coated by electrically non-conductive material.

16. A method for tissue thermal coagulation comprising the steps: Applying applicator to the treatment tissue surface Activating electro-mechanical mechanism to push the array of conductive elements through the tissue surface applying at least one pulse of RF energy to the array of conductive elements and return electrode located on the same applicator Activating electro-mechanical mechanism to retract the array of conductive elements out of tissue after the end of RF energy delivery.

17. The method according to claim 16, where part of the needle surface is coated by electrically non-conductive material.

18. The method according to claim 16, where amount of RF energy delivered to the tissue is high enough to create coagulation of tissue around the conductive element.

19. The method according to claim 16, where conductive elements are pushed into tissue to the depth of 0.5 mm to 10 mm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In the accompanying drawings:

[0029] FIG. 1a is a schematic depiction of one example of applicator with radial direction of conductive elements pushed out.

[0030] FIG. 1b is a schematic depiction of one example of applicator with radial direction of conductive elements retracted in.

[0031] FIG. 2 is a schematic depiction of one example of applicator with axial direction of conductive elements pushed out.

[0032] FIG. 3 is a schematic depiction of one example of RF current flowing between conductive elements and return electrode.

[0033] FIG. 4 is a schematic depiction of one example of applicator attached to the handle.

DETAILED DESCRIPTION

[0034] Referring first to FIG. 1, an applicator assembly is showing in the figure comprises housing 2. The array of conductive elements 1 is directed radial and is assembled to the movable part 3 with connector 4. Moving the movable part 3 the array of conductive elements may be hided inside the applicator and protruded out of the applicator to penetrate the tissue surface.

[0035] FIG. 1a show applicator when conductive elements are pushed outside of the applicator housing toward the treated tissue. FIG. 2b shows applicator where conductive elements are retracted into the applicator. RF current is delivered to the conductive elements through the connector 4 connecting to the RF generator.

[0036] Referring to FIG. 2, an alternative applicator assembly with the array of conductive elements 1 directed axially. Array of conductive elements 1 is assembled to the movable part 3 with connector 4. Moving the movable part 3 the array of conductive elements may be hided inside the applicator housing 2 and protruded out of the applicator to penetrate the tissue surface.

[0037] FIG. 3 show schematically cross section of the attached to the tissue 13. Array of conductive elements 1 shaped as a needle penetrates the tissue and RF current 14 flows from conductive elements 1 to the return electrode 12 having much larger area that whole are of array of conductive elements 1. RF current 14 is concentrated on the sharp conductive elements 1 and creates strong thermal effect in vicinity of needles while heating of tissue near the return electrode 12 much less. RF energy is high enough to create desired thermal effect as coagulation or ablation of the tissue.

[0038] FIG. 4 shows disposable applicator 20 attached intended to contact the tissue of patient and attached to handle 24 connected through harness to the platform. The handle comprises electro-mechanical linear actuator 21 transferring movement the movable part 3 in the disposable applicator to push the array of conductive elements 1 toward the tissue surface. When the linear actuator 21 is pulled back the spring 25 retracts conductive elements out of the tissue.

[0039] The preferred parameters for device are following:

[0040] 1. Applicator length is from 10 mm to 200 mm

[0041] 2. Applicator diameter (transversal dimension) is from 5 mm up to 40 mm.

[0042] 3. Number of conductive elements can be up to 200 but preferably from 4 up to 25 for easier penetration into the tissue.

[0043] 4. Time of pushing the array of conductive elements toward the tissue should be below 1 sec

[0044] 5. The penetration depth of conductive elements is from 0.1 mm up to 10 mm. For some application it can be predetermined while for other it should be adjustable

[0045] 6. RF voltage applied to the skin should be in the range of 10V up to 1000V

[0046] 7. Pulse repetition rate from 0.2 pps up 2 pps