DEVICE FOR COLLAGENOUS TISSUE TREATMENT

Abstract

A method of contraction of collagenous tissue between urethra and vagina includes positioning an RF active electrode between a urethra and a vagina and delivering RF energy into the collagenous tissue. The method includes using a mechanism to direct the active electrode into the safe position to avoid damage of important structures.

Claims

1. An apparatus for tissue treatment comprising: a directing mechanism comprising a guide formed with a lumen that extends through a longitudinal axis of said guide, said lumen being open at a distal end thereof; a connecting element coupled to said guide; a urethral positioning fixator coupled to said connecting element, a longitudinal axis of said urethral positioning fixator being offset from the longitudinal axis of said lumen of said guide, said ; an active electrode arranged to pass through said lumen and protrude past said distal end of said lumen; a return electrode offset from said longitudinal axis of said lumen of said guide such that said urethral positioning fixator and said return electrode are located on opposite sides of said guide; 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 said connecting element has an adjustable length that changes an amount said longitudinal axis of said urethral positioning fixator is offset from said longitudinal axis of said lumen of said guide.

3. The apparatus according to claim 1, wherein said connecting element is pivotable and lockable at any desired orientation with respect to said urethral positioning fixator or said guide.

4. The apparatus according to claim 1, wherein said urethral positioning fixator is parallel to said lumen of said guide.

5. The apparatus according to claim 1, wherein said urethral positioning fixator is parallel to said active electrode.

6. The apparatus according to claim 1, wherein said connecting element is perpendicular to said urethral positioning fixator.

7. The apparatus according to claim 1, wherein said connecting element is perpendicular to said guide.

8. A method for tissue treatment comprising using the apparatus of claim 1 and: inserting said urethral positioning fixator into a urethra of a patient; passing said active electrode through said distal end of said lumen so that said active RF electrode passes into tissue between the urethra and a vagina of the patient; inserting a return electrode into the vagina; and applying RF energy between said active electrode and said return electrode to create collagen contraction in a vicinity of said active electrode to contract collagenous tissue between the urethra and the vagina.

9. The method according to claim 8, wherein said active RF electrode has a distal conductive tip and an insulating shaft and the RF energy is delivered to said conductive tip.

10. The method according to claim 8, comprising using the RF energy to heat the tissue between the urethra and the vagina above 45° C.

11. The method according to claim 8, further comprising measuring temperature at said active electrode or said return electrode and using the temperature to control RF energy delivery to said active electrode.

12. The method according to claim 8, wherein the return electrode has a substantially larger area than a conductive area of the active electrode.

13. The method according to claim 8, further comprising adjusting a length of said connecting element so as to change an amount said longitudinal axis of said urethral positioning fixator is offset from said longitudinal axis of said lumen of said guide.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] In the accompanying drawings:

[0059] FIG. 1 illustrates a female urinary and reproductive system;

[0060] FIG. 2 illustrates an electro-surgical instrument with active and return electrodes, in accordance with an embodiment of the invention;

[0061] FIG. 3 illustrates a directing mechanism for aligning an internal electrode into the tissue, in accordance with an embodiment of the invention; and

[0062] FIG. 4 illustrates the electro-surgical instrument and directing mechanism applied to the patient's body.

DETAILED DESCRIPTION OF THE INVENTION

[0063] FIG. 1 illustrates anatomy of a female urinary and reproductive system. Urethra 2 is connected to the urinary bladder 3. The urethra 2 is located above the vagina 1 and is virtually parallel to the vagina 1. In order to achieve a desired therapeutic effect, the supporting tissue between urethra 2 and vagina 1 may be made firmer by contraction of collagen. The treatment may be performed in this delicate area to avoid damage to urethra 2, bladder 3 and vagina 1.

[0064] FIG. 2 illustrates an electro-surgical instrument 10 including a handle 24, an active electrode 22 and a return electrode 23. The shaft of active electrode 22 is coated with an insulating material and has a conductive tip 21 to deliver RF energy at the distal end of the electrode 22. The insulating material is thick enough to prevent significant RF leakage through capacitive coupling. Conductive tip 21 may have a length of 1 mm to 10 mm, without limitation. The diameter of active electrode 22 may be, without limitation, in a range of 0.7-2.5 mm to prevent physical damage to the patient during treatment. Return electrode 23 has a substantially larger area than the conductive area 21 of active electrode 22. Return electrode 23 may be connected to the handle 24 by means of a biasing device, such as a spring arm 25. The user may adjust the distance between the tip of active electrode 22 and return electrode 23 by adjusting spring arm 25. A thermistor or other temperature sensor 17 may be disposed on or in a tip of active electrode 22 to measure the temperature of tissue during treatment. Another thermistor or other temperature sensor 19 may be disposed on or in the return electrode 23 to monitor temperature of tissue coupled to the return electrode 23. RF energy and signals from both thermistors 17 and 19 may be delivered through a harness 26 to a main unit 60. The main unit 60 includes an RF generator 62, controller unit 64, power supply 66 and user interface 68. The main unit 60 delivers RF energy to the hand piece 24 according to user settings, RF impedance measurements and feedback obtained from both thermistors 17 and 19.

[0065] FIG. 3 illustrates a directing mechanism 45 that controls positioning of active electrode 22 between the urethra and vagina. The mechanism 45 includes a urethral positioning fixator 31 which can be inserted into the urethra. The fixator 31 may be, without limitation, a cylindrical pin with a diameter suitable for insertion into the urethra and a length longer than its diameter. A guide 32 is coupled to fixator 31 by a connecting element 33. Guide 32 has a lumen 34 for the active electrode 22 to pass through. Lumen 34 may be parallel to fixator 31. Active electrode 22 may be placed at any desired position along lumen 34 so that it is placed at a desired depth parallel to the urethra. The directing mechanism 45 avoids accidental damage to the urethra by active electrode 22.

[0066] The connecting element 33 may be telescopic, and may be pivotable and lockable at any desired orientation with respect to fixator 31 and/or guide 32, so as to accommodate different anatomical geometries the user may encounter.

[0067] FIG. 4 schematically illustrates a method of treatment using electro-surgical instrument 10 with directing mechanism 45. In one non-limiting embodiment, the method of treatment includes the following steps:

[0068] Inserting the fixator 31 of directing mechanism 45 into a urethra 43.

[0069] Positioning the lumen 34 of the directing mechanism 45 in front of (anterior to) the desired treatment volume between urethra 43 and vagina 41. The connecting element 33 may be adjusted to position lumen 34 at the correct place.

[0070] Inserting active electrode 22 into the tissue through the lumen 34 of directing mechanism 45 and applying return electrode 23 to the wall of the vagina 41.

[0071] Applying RF energy 47 between conductive tip 21 of active electrode 22 and return electrode 23 to create collagen contraction in vicinity of active electrode 22. Using the method of the invention to treat urethra supporting tissue, the following non-limiting parameter values of RF energy may be used:

[0072] RF frequency: 0.2-40 MHz.

[0073] Average output RF power: from about 0.5 to about 300 W.

[0074] Delivered energy creates a sufficiently high temperature to contract collagen in the vicinity of active electrode conductive tip.