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 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.

1 .- 29 . (canceled) 
     
     
         30 . An apparatus for remodeling a therapeutic zone within tissue underlying a mucosal epithelium of female genital tissue, the apparatus comprising:
 a handle; and   a treatment tip, the treatment tip comprising:
 a shaft comprising a longitudinal axis, 
 an energy delivery element having a thermally-conductive epithelium-contacting surface, 
 a plurality of temperature sensing elements, and 
 a controller configured to determine contact with a target tissue based on sensed temperature from the temperature sensing elements and time since last activation of the energy delivery element; 
 wherein the controller is configured to generate a contact map; and 
 wherein the controller is configured to determine a time since the energy delivery element of the treatment tip was last activated, take a temperature of one or more sites on the treatment tip, and determine if the energy delivery element is in contact with the tissue without applying RF energy to the tissue by comparing the temperature of the one or more sites on the treatment tip to a threshold function for the time since the treatment tip was last activated, and indicate if the energy delivery element is in contact with the tissue. 
   
     
     
         31 . The apparatus of  claim 30 , wherein the thermally-conductive epithelium-contacting surface is adapted to allow cooling of the epithelium. 
     
     
         32 . The apparatus of  claim 30 , wherein the plurality of temperature sensing elements are proximate the energy delivery element. 
     
     
         33 . The apparatus of  claim 30 , wherein the plurality of temperature sensing elements surround the energy delivery element. 
     
     
         34 . The apparatus of  claim 30 , further comprising an internal cooling chamber configured to internally cool the energy delivery element. 
     
     
         35 . The apparatus of  claim 34 , wherein the internal cooling chamber comprises a plurality of coolant nozzles configured to spray cooling fluid on an internal portion of the energy delivery element. 
     
     
         36 . The apparatus of  claim 34 , the internal cooling chamber further comprising:
 a first surface and an opposing second surface, the first surface comprising an inner surface of the epithelium-contacting surface; and   a plurality of cooling nozzles positioned on the opposing second surface, the cooling nozzles positioned centrally along a longitudinal axis of the treatment tip, the cooling nozzles angled to aim at longitudinally separated regions of the first surface and adapted to deliver coolant to the first surface.   
     
     
         37 . The apparatus of  claim 34 , further comprising a return coolant pathway extending proximally from the handle configured to channel the used coolant away from a patient. 
     
     
         38 . The apparatus of  claim 34 , further comprising a cable connecting the handle to the controller, the cable including a coolant delivery channel and a coolant return channel and at least one RF power line. 
     
     
         39 . The apparatus of  claim 30 , wherein the energy delivery element comprises at least one RF electrode. 
     
     
         40 . The apparatus of  claim 30 , wherein the plurality of temperature sensing elements comprise temperature sensors located in close proximity to the energy delivery element. 
     
     
         41 . The apparatus of  claim 30 , wherein the controller is configured to determine contact by comparing temperature of the energy delivery element to a temperature threshold that depends on time since last activation of the energy delivery element. 
     
     
         42 . The apparatus of  claim 30 , wherein the epithelium-contacting surface has a plurality of energy applicator regions. 
     
     
         43 . The apparatus of  claim 42 , wherein the contact map comprises a graphical map representing relative positions of the plurality of energy applicator regions on the energy delivery element, the graphical map showing contact status of each of the energy applicator regions. 
     
     
         44 . The apparatus of  claim 42 , further comprising a display configured to display the contact map. 
     
     
         45 . The apparatus of  claim 30 , wherein the thermally-conductive epithelium-contacting surface is adapted to allow cooling of the epithelium before transmitting RF energy to heat the target tissue, after transmitting RF energy to heat the target tissue, while transmitting RF energy to heat the target tissue, or combinations thereof. 
     
     
         46 . A method for remodeling a therapeutic zone within tissue underlying a mucosal epithelium of female genital tissue, the method comprising:
 providing an apparatus having a treatment tip, the treatment tip comprising:
 a shaft comprising a longitudinal axis, 
 an energy delivery element having a thermally-conductive epithelium-contacting surface, and 
 a controller, 
   sensing a temperature of a target tissue with a plurality of temperature sensing elements;   determining a time since last activation of the energy delivery element,   determining, with the controller, contact of the thermally-conductive epithelium-contacting surface with the target tissue based on the sensed temperature and the time since last activation of the energy delivery element; and   generating a contact map,   wherein the controller is configured to determine a time since the energy delivery element of the treatment tip was last activated, take a temperature of one or more sites on the treatment tip, and determine if the energy delivery element is in contact with the tissue without applying RF energy to the tissue by comparing the temperature of the one or more sites on the treatment tip to a threshold function for the time since the treatment tip was last activated, and indicate if the energy delivery element is in contact with the tissue.   
     
     
         47 . The method of  claim 46 , further comprising cooling the epithelium with the thermally-conductive epithelium-contacting surface. 
     
     
         48 . The method of  claim 46 , further comprising locating the plurality of temperature sensing elements proximate the energy delivery element. 
     
     
         49 . The method of  claim 46 , further comprising surrounding the energy delivery element with the plurality of temperature sensing elements. 
     
     
         50 . The method of  claim 46 , further comprising internally cooling the energy delivery element with an internal cooling chamber. 
     
     
         51 . The method of  claim 50 , further comprising spraying cooling fluid on an internal portion of the energy delivery element with a plurality of coolant nozzles in the internal cooling chamber. 
     
     
         52 . The method of  claim 50 , further comprising providing the internal cooling chamber with:
 a first surface and an opposing second surface, the first surface comprising an inner surface of the epithelium-contacting surface; and   a plurality of cooling nozzles positioned on the second surface, the cooling nozzles positioned centrally along a longitudinal axis of the treatment tip, the cooling nozzles angled to aim at longitudinally separated regions of the first surface and adapted to deliver coolant to the first surface.   
     
     
         53 . The method of  claim 50 , further comprising channeling used coolant away from a patient with a return coolant pathway extending proximally from a handle of the apparatus. 
     
     
         54 . The method of  claim 50 , further comprising connecting a handle of the apparatus to the controller with a cable, the cable including a coolant delivery channel and a coolant return channel and at least one RF power line. 
     
     
         55 . The method of  claim 46 , wherein the energy delivery element comprises at least one RF electrode. 
     
     
         56 . The method of  claim 46 , wherein the plurality of temperature sensing elements comprise temperature sensors located in close proximity to the energy delivery element. 
     
     
         57 . The method of  claim 46 , further comprising determining, with the controller, contact by comparing temperature of the energy delivery element to a temperature threshold that depends on time since last activation of the energy delivery element. 
     
     
         58 . The method of  claim 46 , wherein the epithelium-contacting surface has a plurality of energy applicator regions. 
     
     
         59 . The method of  claim 58 , wherein generating the contact map further comprises generating, with the controller, a graphical map representing relative positions of the plurality of energy applicator regions on the energy delivery element, and
 showing contact status of each of the energy applicator regions on the contact map.   
     
     
         60 . The method of  claim 58 , further comprising displaying the contact map on a display. 
     
     
         61 . The method of  claim 46 , further comprising indicating if the energy delivery element is in contact with the tissue. 
     
     
         62 . The method of  claim 46 , further comprising cooling, with the thermally-conductive epithelium-contacting surface, the epithelium before transmitting RF energy to heat the target tissue, after transmitting RF energy to heat the target tissue, while transmitting RF energy to heat the target tissue, or combinations thereof.