Heated balloon having rotary fluid impeller

An apparatus for thermal coagulation of the endometrium of a uterus, the apparatus comprising:

• (a) a balloon catheter assembly including
• an elongate tubular member having a proximal end and a distal end, the tubular member having a first lumen in fluid communication with the proximal end and the distal end, and
• a distensible bladder secured proximate the distal end of the elongate tubular member, the distensible bladder in fluid communication with the first lumen of the tubular member;
• (b) a heating assembly including
• a tubular core having a surface, a distal end and a proximal end secured to the distal end of the elongate tubular member of the balloon catheter assembly, the tubular core being disposed within the distensible bladder and configured with a spiral groove forming a plurality of crests and troughs along the surface of the core,
• a resistive wire wound about the core member and disposed in the spiral groove, such that the resistive wire is prevented from contacting the distensible bladder,
• at least one thermocouple having a plurality of thermocouple wires, and
• an electrical connector in electrical communication with lead wires partially disposed within a second lumen of the elongate tubular member, the lead wires being in electrical communication with the resistive wire and the plurality of thermocouple wires;
• (c) a circulation assembly including
• an impeller having at least two blades positioned distal of the core of said heating assembly,
• a cage secured to the distal end of the core, wherein the impeller is disposed within the cage such that the impeller blades will not contact said distensible bladder, and
• a cable having a distal end secured to the impeller and a proximal end secured to a rotation connector such that the cable is partially disposed within a lumen of the core and within a third lumen of the tubular member of said balloon catheter assembly, wherein axial rotation of the connector rotates the blades of the impeller;
• (d) a handle assembly including
• a body secured to the proximal end of the elongate tubular member of said balloon catheter assembly,
• a fluid fill port in fluid communication with the first lumen of the elongate tubular member and the distensible bladder,
• a valve positioned between and in fluid communication with the first lumen of the tubular member and the fluid fill port, and
• a pressure conduit having a distal end in fluid communication with the first lumen of the tubular member and a proximal end secured to a pressure connector;
• and
• (e) an umbilical cable connected to the body of said handle assembly, wherein the lead wires of said heating assembly, the cable of said circulation assembly and the pressure conduit of said handle assembly are partially disposed within said umbilical cable.

A system for applying heat to the endometrium of a human uterus, the system comprising:

• (a) a balloon catheter assembly including
• an elongate tubular member having a proximal end and a distal end, the tubular member having a first lumen in fluid communication with the proximal end and the distal end, and
• a distensible bladder secured proximate the distal end of the elongate tubular member, the distensible bladder in fluid communication with the first lumen of the tubular member;
• (b) a heating assembly including
• a tubular core having a surface, a distal end and a proximal end secured to the distal end of the elongate tubular member of the balloon catheter assembly, the tubular core being disposed within the distensible bladder and configured with a spiral groove forming a plurality of crests and troughs along the surface of the core,
• a filament wound about the core member and disposed in the spiral groove such that the filament is prevented from contacting the distensible bladder, wherein heat is generated when an electric current is applied to the filament,
• at least one thermocouple having a plurality of thermocouple wires, and
• an electrical connector in electrical communication with lead wires partially disposed within a second lumen of the elongate tubular member, the lead wires being in electrical communication with the resistive wire and the plurality of thermocouple wires;
• (c) a circulation assembly including
• an impeller having at least two blades positioned distal of the core of said heating assembly,
• a cage secured to the distal end of the core, wherein the impeller is disposed within the cage such that the impeller blades will not contact said distensible bladder, and
• a cable having a distal end secured to the impeller and a proximal end secured to a rotation connector such that the cable is partially disposed within a lumen of the core and within a third lumen of the tubular member of said balloon catheter assembly, wherein axial rotation of the connector rotates the blades of the impeller;
• (d) a handle assembly including
• a body secured to the proximal end of the elongate tubular member of said balloon catheter assembly,
• a fluid fill port in fluid communication with the first lumen of the elongate tubular member and the distensible bladder,
• a valve positioned between and in fluid communication with the first lumen of the tubular member and the fluid fill port, and
• a pressure conduit having a distal end in fluid communication with the first lumen of the tubular member and a proximal end secured to a pressure connector;
• and
• (e) an umbilical cable connected to the body of said handle assembly, wherein the lead wires of said heating assembly, the cable of said circulation assembly and the pressure conduit of said handle assembly are partially disposed within said umbilical cable;
• and
• (f) a controller configured to accept said electrical connector for providing and regulating electrical current to the heating element, wherein the controller is configured to accept the rotational connector for rotating the impeller cable and the controller is further configured to accept the pressure connector for monitoring the pressure of the fluid in the distensible bladder.