Abstract: Methods for treating urinary stress incontinence by non-invasively delivering energy to one or more submucosal regions of vaginal tissue to induce remodeling within the vaginal tissue are provided. In some embodiments, the energy delivery results in heating of the target tissue to a temperature that ranges from about 38° C. to about 46° C. In some embodiments, the subject methods involve cooling a mucosal epithelial layer over the vaginal tissue. In some embodiments, a reverse thermal gradient is produced as the mucosal epithelium is cooled while energy is delivered to the underlying vaginal tissue.

Abstract: This invention relates generally to apparatus and methods for tightening tissue of the female genitalia by heating targeted connective tissue with radiant energy, while cooling the mucosal epithelial surface over the target tissue to protect it from the heat. Embodiments include a handle and treatment tip that has both an energy delivery element and a cooling mechanism. The handle may be a two-handed handle allowing control even while rotating and maneuvering the treatment around the genital opening. The apparatus or system may also include an integrated controller, which may confirm tissue contact without applying RF energy, based only on the temperature of the applicator and the time since the last application of energy from the applicator.

Abstract: The systems and methods in accordance with the principles of the invention can treat urinary stress incontinence by treating target tissue in proximity to the urethra and/or bladder neck. A method for treating urinary stress incontinence in a subject can included non-invasively heating a subsurface region of a target tissue to induce remodeling of the subsurface region at the anterior and/or posterior regions of the vagina. The system can include: a controller and a probe having a distal end configured for non-invasive contact with a surface of a target tissue to transfer energy to the target tissue based on treatment parameters. The probe distal end can have two treatment surfaces spaced apart a distance equal to at least a width of a urethra.

Abstract: This invention relates generally to apparatus and methods for tightening tissue of the female genitalia by heating targeted connective tissue with radiant energy, while cooling the mucosal epithelial surface over the target tissue to protect it from the heat. Embodiments include a treatment tip that comprises both an energy delivery element and a cooling mechanism. As the treatment tip contacts the epithelial mucosa, the tip cools the mucosa by contact, and delivers energy through the epithelium to the underlying tissue, thereby creating a reverse thermal gradient. The effect of the applied heat is to remodel genital tissue by tightening it. Such remodeling may include a tighter vagina and a tighter introitus. The tightening may be a consequence of thermal denaturation of collagen as well as a longer term healing response in the tissue that includes an increased deposition of collagen.

Abstract: This invention provides devices and methods for remodeling the female genital tissue, the device comprising a treatment tip, wherein the distal end of the treatment tip is conical, spherical, hemispherical, oval or circular in shape. The device further comprises one or more energy delivery elements for simultaneous cooling of the vaginal epithelium and transmission of energy for heating the tissues underneath the epithelium. In one embodiment, said device may further comprise one or more of the following: one or more temperature sensors for measuring the temperature at or below the epithelium; one or more directional sensors mounted on the hand piece or treatment tip; and one or more depth markers to show the depth of penetration of the treatment tip into the vagina. In another embodiment, this invention provides a device having a finger holder with electrodes for remodeling the female genital tissue.