Vaginal remodeling device and methods

摘要

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.

主权项

1. An apparatus for remodeling a therapeutic zone within tissue underlying a mucosal epithelium of female genital tissue, the apparatus comprising:
an elongate handle configured to be held; a treatment tip, the tip comprising:
a shaft comprising a longitudinal axis;an energy delivery element having an epithelium-contacting surface, the epithelium-contacting surface having a plurality of energy applicator regions; andan internal cooling chamber configured to internally cool the energy delivery element,wherein the energy delivery element comprises a thermally-conductive surface that is adapted to allow cooling of the epithelium while transmitting RF energy to heat the target tissue; a controller configured to determine contact with a target tissue and generate a contact map comprising 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; 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 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 treatment energy delivery element is in contact with the tissue; and a display configured to display the contact map.