Methods and systems for thermally-induced renal neuromodulation

Abstract

Methods and system are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

1 - 117 . (canceled) 
   
   
       118 . A catheter for delivering energy to a treatment site within or adjacent to a wall of a body lumen of a patient, the catheter comprising:
 a shaft having a longitudinal axis;   an electrode spaced apart from the shaft;   a sensor located proximate to or within the electrode; and   an intermediate section between the electrode and the shaft, wherein the intermediate section is configured to vary between an uncompressed state and a compressed state, and wherein the electrode is offset from the longitudinal axis of the shaft when the intermediate section is in the uncompressed state.   
   
   
       119 . The catheter of  claim 118  wherein the electrode includes a band and a conductive fill material at least partially within the band, and wherein the band comprises a first metal and the conductive fill material comprises a second metal. 
   
   
       120 . The catheter of  claim 119  wherein the conductive fill material comprises a dome-shaped geometry. 
   
   
       121 . The catheter of  claim 119  wherein the first metal is platinum. 
   
   
       122 . The catheter of  claim 118  wherein the electrode is comprised of a radiopaque material. 
   
   
       123 . The catheter of  claim 118  wherein the intermediate section is comprised of a radiopaque material. 
   
   
       124 . The catheter of  claim 118  wherein the catheter has a working length of from about 55 cm to about 140 cm. 
   
   
       125 . The catheter of  claim 118  wherein the catheter has a working length of from about 60 cm to about 80 cm. 
   
   
       126 . The catheter of  claim 118  wherein the catheter has a working length of from about 95 cm to about 120 cm. 
   
   
       127 . The catheter of  claim 118  wherein the catheter has a working length of about 108 cm. 
   
   
       128 . The catheter of  claim 118  wherein approximately all of the shaft is generally flexible 
   
   
       129 . The catheter of  claim 118  wherein a distal portion of the shaft is more flexible than a proximal portion of the shaft. 
   
   
       130 . The catheter of  claim 129  wherein the proximal portion of the shaft comprises a braided shaft with reinforcement. 
   
   
       131 . The catheter of  claim 130  wherein the distal portion of the shaft comprises a braided shaft without reinforcement. 
   
   
       132 . The catheter of  claim 129  wherein the distal portion of the shaft is adjacent to the intermediate section. 
   
   
       133 . The catheter of  claim 132  wherein the distal portion of the shaft has a length of about 7 cm. 
   
   
       134 . The catheter of  claim 118  wherein the intermediate section is comprised of at least one of stainless steel, shape memory alloy, and plastic. 
   
   
       135 . The catheter of  claim 118 , further comprising a thermocouple wire carried by the intermediate section. 
   
   
       136 . The catheter of  claim 118  wherein the intermediate section is configured to position the electrode into contact with the wall of the body lumen. 
   
   
       137 . The catheter of  claim 118  wherein the intermediate section in its uncompressed state offsets the electrode from the longitudinal axis of the shaft by about 2 mm to about 20 mm. 
   
   
       138 . The catheter of  claim 118  wherein the intermediate section in its uncompressed state offsets the electrode from the longitudinal axis of the shaft by about 10 mm to about 20 mm. 
   
   
       139 . The catheter of  claim 118  wherein the intermediate section in its uncompressed state offsets the electrode from the longitudinal axis of the shaft by about 16 mm. 
   
   
       140 . The catheter of  claim 118  wherein the shaft has an outer diameter of from about 0.014 inches to about 0.085 inches. 
   
   
       141 . The catheter of  claim 118  wherein the shaft has an outer diameter of about 0.040 inches. 
   
   
       142 . The catheter of  claim 118  wherein the electrode has a cross-sectional dimension of from about 0.020 inches to about 0.085 inches. 
   
   
       143 . The catheter of  claim 118  wherein the electrode has a cross-sectional dimension of about 0.049 inches. 
   
   
       144 . The catheter of  claim 118  wherein the sensor comprises a temperature sensor for sensing the temperature of the tissue site, the wall of the body lumen and/or the electrode. 
   
   
       145 . The catheter of  claim 144 , further comprising a first wire and a second wire, wherein both the first wire and second wire are electrically connected to the electrode and/or the sensor and configured to concurrently deliver energy to the electrode and transmit the sensed temperature. 
   
   
       146 . The catheter of  claim 145  wherein the shaft further comprises a lumen through which the first wire and second wire are routed. 
   
   
       147 . The catheter of  claim 145  wherein the first wire is configured to deliver energy to the electrode and the second wire is configured to transmit the sensed temperature. 
   
   
       148 . The catheter of  claim 143  wherein the sensor further comprises an impedance sensor for monitoring tissue impedance and wherein the first and second wire are further configured to transmit the sensed impedance in concurrence with the delivery of energy. 
   
   
       149 . The catheter of  claim 118  wherein the sensor is configured to monitor at least one parameter selected from the group consisting of temperature, impedance, voltage, current and resistance. 
   
   
       150 . The catheter of  claim 118  wherein the intermediate section in its uncompressed shape comprises an arch. 
   
   
       151 . The catheter of  claim 118 , further comprising a sheath configured to hold the intermediate section in the compressed state. 
   
   
       152 . The catheter of  claim 118 , further comprising an actuator wire configured to hold the intermediate section in the compressed state. 
   
   
       153 . A probe for delivering energy to a tissue site within or adjacent to a wall of a body lumen of a patient, the probe comprising:
 a shaft;   an electrode spaced apart from the shaft, wherein the electrode is configured to concurrently deliver energy, monitor impedance, and monitor a temperature of the tissue site, the wall of the body lumen, and/or electrode;   an intermediate section between the electrode and the shaft, wherein the intermediate section is configured to position the electrode in contact with the wall of the body lumen; and   a thermal protection element configured to protect non-target tissue from undesirable thermal exposure.   
   
   
       154 . The probe of  claim 153  wherein the intermediate section is shaped like an arch. 
   
   
       155 . The probe of  claim 153  wherein the intermediate section comprises a positioning element. 
   
   
       156 . The probe of  claim 155  wherein the positioning element comprises a wire-actuated deflectable tip. 
   
   
       157 . The probe of  claim 155  wherein the positioning element comprises an expandable member. 
   
   
       158 . The probe of  claim 157  wherein the expandable member comprises a balloon. 
   
   
       159 . The probe of  claim 157  wherein the expandable member comprises a wire basket. 
   
   
       160 . The probe of  claim 157  wherein the expandable member is self-expanding. 
   
   
       161 . The probe of  claim 157  wherein the expandable member is mechanically expandable. 
   
   
       162 . The probe of  claim 153  wherein the thermal protection element comprises a cooling element. 
   
   
       163 . The probe of  claim 153  wherein the shaft comprises an infusion lumen, and wherein the thermal protection element comprises a thermal fluid infused through the infusion lumen. 
   
   
       164 . The probe of  claim 163  wherein the intermediate section comprises a positioning element, and wherein the positioning element is configured to receive the thermal fluid from the infusion lumen. 
   
   
       165 . The probe of  claim 163  wherein the infusion lumen extends through the intermediate section and/or electrode. 
   
   
       166 . A probe for delivering energy to a tissue site within or adjacent to a wall of a body lumen of a patient, the probe comprising:
 a shaft;   an electrode spaced apart from the shaft, wherein the electrode is configured to concurrently deliver energy, monitor impedance, and monitor a temperature of the tissue site, the wall of the body lumen, and/or electrode;   an intermediate section between the electrode and the shaft, wherein the intermediate section is configured to position the electrode in contact with the wall of the body lumen; and   thermal protection means for protecting non-target tissue from undesirable thermal exposure.   
   
   
       167 . A probe for delivering energy to a wall of a body lumen and/or cavity of a patient, the probe comprising:
 a shaft;   an electrode spaced apart from the shaft, wherein the electrode is configured to concurrently deliver energy to the wall of the body lumen, monitor impedance of the wall of the body lumen, and monitor a temperature of the wall of the body lumen and/or electrode;   an intermediate section between the electrode and the shaft; and   an elongate member extending along the shaft, wherein the elongate member is configured to position the electrode in contact with the wall of the body lumen.   
   
   
       168 . The probe of  claim 167  wherein the elongate member is further configured to be self expanding. 
   
   
       169 . The probe of  claim 167  wherein the elongate member is further configured to be mechanically expanding. 
   
   
       170 . The probe of  claim 167  wherein the intermediate section comprises a wire-actuated deflectable tip.