Vaginal remodeling device and methods

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.

1 - 17 . (canceled) 
     
     
         18 . An apparatus for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying a mucosal epithelium of female genital tissue, the apparatus comprising:
 a treatment tip comprising:   an elongate shaft comprising a longitudinal axis, a proximal end, a distal end having a distal portion, and a narrow portion extending between the proximal end and the distal end, wherein the narrow portion narrows inwardly toward the longitudinal axis of the elongate shaft on a side of the elongate shaft; and   an energy delivery element on the elongate shaft and proximal to the distal end of the elongate shaft, the energy delivery element being disposed only along the same side of the elongate shaft as the narrow portion,   wherein the energy delivery element projects forward from the narrow portion on only a single side of the elongate shaft.   
     
     
         19 . The apparatus of  claim 18 , wherein the energy delivery element comprises an RF electrode. 
     
     
         20 . The apparatus of  claim 19 , wherein the RF electrode is curvilinear such that it curves radially with respect to the longitudinal axis while extending in parallel with the longitudinal axis 
     
     
         21 . The apparatus of  claim 20 , wherein the RF electrode is configured to have a radial curvature with respect to the longitudinal axis of the elongate shaft of up to 30 degrees. 
     
     
         22 . The apparatus of  claim 18 , wherein the energy delivery element is adapted to contact the epithelium. 
     
     
         23 . The apparatus of  claim 18 , wherein the treatment tip is configured to releasably couple and decouple to a hand piece. 
     
     
         24 . The apparatus of  claim 18 , further comprising a cooling system within the elongate shaft configured to cool the energy delivery element. 
     
     
         25 . The apparatus of  claim 24 , wherein the cooling system comprises cooling fluid and at least one nozzle, the nozzle configured to spray the cooling fluid on the energy delivery element. 
     
     
         26 . The apparatus of  claim 19 , wherein the RF electrode is a monopolar electrode. 
     
     
         27 . The apparatus of  claim 19 , wherein the RF electrode is one electrode of a bipolar electrode pair of the energy delivery element. 
     
     
         28 . The apparatus of  claim 19 , further comprising at least one thermistor located in close proximity to the RF electrode. 
     
     
         29 . The apparatus of  claim 18 , further comprising a programmable memory chip. 
     
     
         30 . The apparatus of  claim 18 , further comprising a hand piece adapted to be held by an operator, wherein the treatment tip is connected to or configured to connect to a distal end of the hand piece and the hand piece. 
     
     
         31 . The apparatus of  claim 18 , further comprising a connector portion at a proximal end of the treatment tip configured to removably connect the treatment tip to a hand piece. 
     
     
         32 . The apparatus of  claim 18 , further comprising a dielectric on an exterior of the energy delivery element. 
     
     
         33 . An apparatus for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying a mucosal epithelium of female genital tissue, the apparatus comprising:
 a treatment tip comprising:   an elongate shaft comprising a longitudinal axis, a proximal end, a distal end having a distal portion, and a narrow portion extending between the proximal end and the distal end, wherein the narrow portion narrows inwardly toward the longitudinal axis of the elongate shaft on a side of the elongate shaft,   a connector portion at the proximal end of the elongate shaft, and   an energy delivery element on a distal end region of the elongate shaft and proximal to the distal end of the elongate shaft, the energy delivery element being disposed only along the same side of the elongate shaft as the narrow portion; and   a hand piece adapted to be held by an operator and configured to releasably couple and decouple with the connector portion of the elongate shaft,   wherein the energy delivery element projects forward from the narrow portion on only a single side of the elongate shaft.   
     
     
         34 . The apparatus of  claim 33 , wherein the energy delivery element comprises an RF electrode. 
     
     
         35 . The apparatus of  claim 34 , wherein the RF electrode is a monopolar electrode. 
     
     
         36 . The apparatus of  claim 34 , wherein the RF electrode is curvilinear such that it curves radially with respect to the longitudinal axis while extending in parallel with the longitudinal axis. 
     
     
         37 . The apparatus of  claim 36 , wherein the RF electrode is configured to have a radial curvature with respect to the longitudinal axis of the elongate shaft of up to 30 degrees. 
     
     
         38 . The apparatus of  claim 33 , wherein the energy delivery element is adapted to contact the epithelium. 
     
     
         39 . The apparatus of  claim 33 , wherein the distal portion of the elongate shaft has a first surface and the narrow portion has a second surface, wherein the energy delivery element is only disposed on the first surface, wherein the first surface is substantially parallel to the second surface, and wherein the first surface is in a different plane than the second surface, allowing for the energy delivery element to make contact with the epithelium. 
     
     
         40 . The apparatus of  claim 33 , further comprising a cooling system within the elongate shaft configured to cool the energy delivery element. 
     
     
         41 . The apparatus of  claim 40 , wherein the cooling system comprises cooling fluid and at least one nozzle, the nozzle configured to spray the cooling fluid on the energy delivery element. 
     
     
         42 . The apparatus of  claim 34 , further comprising at least one thermistor located in close proximity to the RF electrode. 
     
     
         43 . The apparatus of  claim 33 , further comprising a programmable memory chip. 
     
     
         44 . The apparatus of  claim 33 , further comprising a dielectric on an exterior of the energy delivery element.