FRACTIONAL TREATMENT OF URINARY INCONTINENCE

Abstract

A method of creating multiple thermal lesions in tissue around urethra using needle electrodes inserted essentially parallel to urethra.

Claims

1. Apparatus for tissue treatment comprising: a central blunt urethra fixator; an array of electrodes positioned circumferentially about said central blunt urethra fixator and distance radially from said central blunt urethra fixator, at least one of said electrodes being an active electrode, and wherein said central blunt urethra fixator and said electrodes protrude from a housing; a return electrode offset from said active electrode; and a main unit comprising an RF generator, a controller unit, a power supply and a user interface, said main unit configured to deliver RF energy between said return electrode and a conductive tip of said active electrode to create collagen contraction in a vicinity of said active electrode.

2. The apparatus according to claim 1, wherein another one of said electrodes is said return electrode.

3. The apparatus according to claim 1, wherein said central blunt urethra fixator is said return electrode.

4. The apparatus according to claim 1, wherein said central blunt urethra fixator protrudes further out of said housing than said electrodes.

5. The apparatus according to claim 1, wherein said electrodes are substantially parallel to said central blunt urethra fixator.

6. A method for tissue treatment comprising using the apparatus of claim 1 and: inserting said urethra fixator into a urethra of a patient; inserting said electrodes into tissue near said urethra; and applying RF energy between one of said electrodes and a return electrode to create collagen contraction in a vicinity of said active electrode to contract collagenous tissue near the urethra.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0043] FIG. 1 shows a hand piece design;

[0044] FIG. 2 shows hand piece tips with needle electrodes, return electrode and urethra fixator;

[0045] FIG. 3 shows hand piece tips without return electrode;

[0046] FIG. 4 shows the hand piece tip applied to the urethral tissue;

[0047] FIG. 5a shows the needle electrode.

[0048] FIG. 5b shows a partially isolated needle electrode.

DETAILED DESCRIPTION

[0049] FIG. 1 shows a hand piece 11 having a handle 13 and a disposable tip 12 used for applying RF energy to the patient.

[0050] FIG. 2 shows the disposable tip 12 wherein a urethra fixator 21 has a diameter of 3-6 mm. Needle electrodes 22 surround fixator 21 at a distance. This enables creating a thermal lesion around the needles without risk of urethra damage. RF energy is applied between the needle electrodes 22 and return electrode 23 is applied to the tissue surface. The needle electrodes 22 are pushed out of the tip when the user activates the pulse. When the needle electrodes 22 are moved out to a predetermined depth, the pulse of RF energy is applied between the needle electrodes 22 and return electrode 23. Because the conductive area of needle electrodes 22 is smaller than the area of return electrode 23, the thermal effect is stronger around the needles 22.

[0051] FIG. 3 shows alternative tips 33 design without an external electrode. The RF energy is applied between one of the needle electrodes 22 acting as an active electrode and other needle electrodes acting as a return electrode. Then RF energy can be switched to connect another needle as the active electrode. Energy is switched between needle electrodes to create a thermal lesion in the vicinity of each lesion.

[0052] Alternatively, urethra fixator 31 can be made from a conductive material and act as an return electrode. RF energy is applied between needle electrodes 22 and urethral fixator 31.

[0053] FIG. 4 demonstrates schematically a disposable tip 40 applied to the tissue. The urethral fixator 41 is inserted into the urethra 44. Needle electrodes 42 are inserted into the tissue around the urethra 44. Depth of needle electrode insertion is limited to avoid damage of the bladder 45. Typically, insertion depth should not exceed 25 mm. RF energy is applied to the needle electrodes 42 to create thermal lesions 43 in vicinity of the needle electrodes. The size of lesions 43 should be small enough to avoid damage of urethra 44. Size of the thermal lesions 43 is controlled by an amount of RF energy applied to the needle electrodes 42 and by duration of RF pulses.

[0054] The needle electrodes can be made from conductive materials as shown in FIG. 5a to apply RF energy along the entire length of the needle electrode 52 and the sharp end of needle electrode 51.

[0055] In order to minimize damage near the tissue surface, the electrode can be partially coated by an insulating material as shown in FIG. 5b. Sharp end 51 and uncoated shaft 52 at the distal end of the needle electrode are uncoated to deliver RF energy. The proximal part 53 of the needle electrode is coated with a thin layer of insulating material to prevent RF energy delivery and minimize damage near the tissue surface.

[0056] The method of treatment includes the following steps: [0057] Inserting the fixator 41 into the urethra 43. [0058] Pushing needle electrodes 42 out of the tip into the tissue to predetermined depth. [0059] Applying predetermined amount of RF energy to the needle electrodes 42 to create thermal lesions 43 in vicinity of needle electrodes 42. [0060] Retracting the needle electrodes 42 out of the tissue.

[0061] Using the method of the invention to treat urethra supporting tissue, the following exemplary parameter values of RF energy may be used: [0062] RF frequency: 0.2-40 MHz. [0063] Average output RF power: from about 0.5 to about 500 W. [0064] RF energy delivered during a time of 1 millisecond to 3 seconds.