Vaginal remodeling device and method

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.

1 - 20 . (canceled) 
     
     
         21 . A device for remodeling the female genital tissue, comprising a treatment tip and a hand piece, wherein the treatment tip is connected to the distal end of the hand piece via a connection means, wherein the distal end of the treatment tip is rectangular, curved, conical, spherical, hemispherical, oval or circular in shape, and has a surface comprising one or more energy delivery elements, wherein said elements have an internal surface and an epithelium-contacting surface, and wherein the device further comprises one or more of the following:
 (a) one or more temperature sensors for measuring the temperature at or below the epithelium;   (b) one or more directional sensors; and   (c) one or more depth markers showing the depth of penetration of the treatment tip into the vagina.   
     
     
         22 . The device of  claim 21 , wherein said treatment tip is equipped with a finger holder. 
     
     
         23 . The device of  claim 21 , wherein the energy delivery elements can be turned on and off selectively. 
     
     
         24 . The device of  claim 21 , wherein the surface at the distal end of the treatment tip is fully or partially covered by energy delivery elements. 
     
     
         25 . The device of  claim 21 , wherein the surface at the distal end of the treatment tip is partially covered by insulated material. 
     
     
         26 . The device of  claim 21 , wherein the inside of said treatment tip comprises an internal cooling chamber having a supply line of coolant opposite to the internal surface of said one or more energy delivery elements, wherein the supply line of coolant comprises a plurality of nozzles configured to spray a coolant onto the internal surface of said one or more energy delivery elements. 
     
     
         27 . The device of  claim 21 , wherein the hand piece comprises one or more indicators for indicating the status and/or orientation of the device. 
     
     
         28 . The device of  claim 21 , wherein the treatment tip is removable from the hand piece. 
     
     
         29 . The device of  claim 21 , wherein the temperature sensors are thermocouples, each comprising a first and a second junction. 
     
     
         30 . The device of  claim 29 , wherein the first junction is located on the hand piece or between the energy delivery elements and said hand piece, and wherein the second junction is located at the distal end, proximal end, or middle of the one or more energy delivery elements. 
     
     
         31 . The device of  claim 29 , wherein the second junction comprises a blunt end that contacts the epithelium and measures its temperature, or a needle that penetrates the epithelium and measures the temperature below the epithelium. 
     
     
         32 . The device of  claim 21 , wherein one or more of said directional sensors employ electromagnetic or optical mechanisms to track the position of the treatment tip. 
     
     
         33 . The device of  claim 32 , wherein said directional sensors employing electromagnetic mechanisms are accelerometers or gyroscopes. 
     
     
         34 . The device of  claim 21 , wherein the directional sensors are mounted proximally or distally on the hand piece, or mounted close to the one or more energy delivery elements on the treatment tip. 
     
     
         35 . The device of  claim 21 , wherein the depth markers comprise raised lines, indented lines or numerical markers, and are located on the surface at the distal end of the treatment tip. 
     
     
         36 . A system for remodeling the female genital tissue, comprising
 i) a hand piece;   ii) a treatment tip, wherein the treatment tip is connected to the distal end of the hand piece via a connection, wherein the distal end of the treatment tip is rectangular, curved, conical, spherical, hemispherical, oval or circular in shape, and has a surface comprising one or more energy delivery elements, wherein said energy delivery elements have an internal surface and an epithelium-contacting surface, and wherein the device further comprises one or more of the following:
 (a) one or more temperature sensors for measuring the temperature at or below the epithelium; 
 (b) one or more directional sensors; and 
 (c) one or more depth markers showing the depth of penetration of the treatment tip into the vagina; and 
   iii) an integrated controller comprising
 (a) a housing; 
 (b) a radiofrequency power source within the housing; 
 (c) a cooling sub-system within the housing; 
 (d) a controller for controlling the operation of the system; and 
 (e) a display configured to display information about the system. 
   
     
     
         37 . The system of  claim 36 , wherein the energy delivery elements can be turned on and off selectively. 
     
     
         38 . The system of  claim 36 , further comprising a cable connecting the hand piece and the integrated controller, and/or a foot switch configured to connect to the integrated controller. 
     
     
         39 . A method of using the device of  claim 21  for remodeling a target tissue underlying a mucosal epithelium of the female genital tissue, comprising the step of cooling said epithelium and heating said target tissue with said energy delivery elements. 
     
     
         40 . The method of  claim 39 , wherein remodeling includes contracting the target tissue, tightening the introitus, tightening the vagina, denaturing collagen, or tightening collagen-rich sites of the target tissue.