Devices for thermally-induced renal neuromodulation
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. A field generator comprising:
a processor configured to:
increase energy delivery, from the field generator to an electrode of an intravascular catheter intravascularly positioned at a target intravascular site within a renal artery of a patient, at a generally constant rate to a predetermined first power level over a first period of time;
maintain energy delivery to the electrode at the predetermined first power level for a second period of time; and
increase energy delivery to the electrode in variable increments after the second period of time and based on a difference between an average temperature at the target intravascular site and a maximum temperature threshold when a measured temperature is less than a preset temperature threshold and a measured impedance value is less than a predetermined impedance threshold, the increase in energy delivery after the second period of time continuing until the power level has reached a target maximum power threshold.
2. The field generator of claim 1 wherein the processor is further configured to maintain energy delivery to the electrode at the predetermined first power level if the measured temperature is greater than or equal to the preset temperature threshold.
3. The field generator of claim 1 wherein the preset temperature threshold is from 45 degrees Celsius to 90 degrees Celsius.
4. The field generator of claim 1 wherein the preset temperature threshold is from 60 degrees Celsius to 75 degrees Celsius.
5. The field generator of claim 1 wherein the preset temperature threshold is 65 degrees Celsius.
6. The field generator of claim 1 wherein the predetermined first power level is 5 watts.
7. The field generator of claim 1 wherein the first period of time is 15 seconds.
8. The field generator of claim 1 wherein the second period of time is 3 seconds.
9. The field generator of claim 1 wherein the target maximum power threshold is a second power level, and wherein the processor is configured to reduce energy delivery to the electrode positioned at the target intravascular site to a third power level less than the second power level if the measured temperature reaches a second temperature threshold.
10. The field generator of claim 9 the second power level is 6 watts.
11. The field generator of claim 9 wherein the second power level is 8 watts.
12. The field generator of claim 9 wherein the reduction in power occurs in increments.
13. The field generator of claim 9 wherein the second temperature threshold is 70 degrees Celsius.
14. The field generator of claim 1 wherein the processor is configured to terminate energy delivery if an interlock condition is satisfied.
15. The field generator of claim 14 wherein the interlock condition is satisfied when the measured temperature value reaches the maximum temperature threshold.
16. The field generator of claim 15 wherein the maximum temperature threshold is an average temperature or real time temperature from 70 degrees Celsius to 85 degrees Celsius.
17. The field generator of claim 15 wherein the maximum temperature threshold is an average temperature or real time temperature of 85 degrees Celsius.
18. The field generator of claim 15 wherein the maximum temperature threshold is a rate of change threshold.
19. The field generator of claim 14 wherein the interlock condition is satisfied when the measured impedance reaches the predetermined impedance threshold.
20. The field generator of claim 19 wherein the predetermined impedance threshold is a measured impedance below 20 Ohms or above 500 Ohms.
21. The field generator of claim 20 wherein the predetermined impedance threshold is a relative threshold.
22. The field generator of claim 1 wherein the processor is configured to prevent power from exceeding the target maximum power threshold.
23. The field generator of claim 22 wherein the target maximum power threshold is from 8 watts to 10 watts.
24. The field generator of claim 22 wherein the target maximum power threshold is 10 watts.