Methods and devices for endovascular ablation of a splanchnic nerve
Systems, devices, and methods for transvascular ablation of target tissue. The devices and methods may, in some examples, be used for splanchnic nerve ablation to increase splanchnic venous blood capacitance to treat at least one of heart failure and hypertension. For example, the devices disclosed herein may be advanced endovascularly to a target vessel in the region of a thoracic splanchnic nerve (TSN), such as a greater splanchnic nerve (GSN) or a TSN nerve root. Also disclosed are methods of treating heart failure, such as HFpEF, by endovascularly ablating a thoracic splanchnic nerve to increase venous capacitance and reduce pulmonary blood pressure.
1. A system for ablating a greater splanchnic nerve from within an intercostal vein, the system comprising:
an ablation catheter, including:
an elongate shaft having a length such that at least a portion of a distal section of the elongate shaft can be positioned in a T9, T10, or T11 intercostal vein, the distal section having a linear configuration when radially unconstrained,
a guidewire lumen extending through the elongate shaft and including an exit port at a distal end of the distal section,
distal and proximal electrically conductive flexible and coiled ablation electrodes carried by and disposed circumferentially about the distal section,
the distal and proximal electrically conductive flexible and coiled ablation electrodes together having an axial length from 5 mm-25 mm and an axial spacing therebetween that is not more than 2.0 mm,
a plurality of distal electrode irrigation ports in a helical configuration disposed within the distal section and between windings in at least a central section of the distal electrode, wherein the windings in the at least a central section of the distal electrode are axially spaced apart such that the plurality of distal electrode irrigation ports are not radially underneath the windings and are visible in a side view of the distal section,
a plurality of proximal electrode irrigation ports in a helical configuration disposed within the distal section and between windings in at least a central section of the proximal electrode, wherein the windings in the at least a central section of the proximal electrode are axially spaced apart such that the plurality of proximal electrode irrigation ports are not radially underneath the windings and are visible in a side view of the distal section,
a plurality of distal irrigation ports distal to the distal electrode, the plurality of distal irrigation ports axially aligned and spaced circumferentially around the distal section,
a plurality of central irrigation ports axially between the distal electrode and proximal electrode, the plurality of central irrigation ports axially aligned and spaced circumferentially around the distal section; and
an external device or system adapted to be coupled to the ablation catheter so as to create operable communication with the ablation catheter, the external device or system including:
a power output module adapted to deliver a first waveform of ablative RF energy with an initial power from 15-50 W and a second waveform of ablative RF energy with an initial power from 15-50 W, and
a module adapted to receive information indicative of at least one of a sensed temperature or measured impedance and determine if at least one of the sensed temperature or the measured impedance is at or above a limit, and if at least one of the sensed temperature or the measured impedance is at or above a threshold limit, cause the power output module to decrease the power of at least one of the first waveform and the second waveform.
2. The system of claim 1 , wherein the module comprises at least one of a temperature limit module or an impedance limit module.
3. The system of claim 1 , wherein if at least one of the sensed temperature or the measured impedance is at or above a threshold limit, and a minimum therapy time has not yet passed, the module is adapted to cause the power output module to reduce the power of at least one of the first waveform and second waveform to a secondary power less than the initial power.
4. The system of claim 3 , wherein the secondary power is greater than zero and is from 5-10 W less than the initial power.
5. The system of claim 1 , wherein if at least one of the sensed temperature or the measured impedance is at or above a threshold limit, and a minimum therapy time has passed, the module is adapted to cause the power output module to reduce the power of at least one of the first waveform and second waveform to a secondary power between 0 W and 1 W.
6. The system of claim 1 , wherein the power output module is adapted to deliver cyclical asynchronous first and second waveforms.
7. The system of claim 1 , wherein the power output module is adapted to deliver the first waveform of ablative RF energy with an initial power of 25 W and the second waveform of ablative RF energy with an initial power of 25 W.
8. The system of claim 1 , wherein the module is adapted to determine if the sensed temperature is at or above 40° C. to 95° C., optionally at or above 90° C.
9. The system of claim 1 , wherein the module is adapted to determine if the measured impedance is at or above 200 to 500 ohms, optionally at or above 500 ohms.
10. The system of claim 1 , wherein the power output module is adapted with a default setting to deliver the ablative energy from 30 seconds to 180 seconds.
11. The system of claim 1 , wherein the power output module is adapted to deliver the first waveform of ablative RF energy with an initial power from 20 W to 50 W and the second waveform of ablative RF energy with an initial power from 20 W to 50 W.
12. The system of claim 1 , wherein the plurality of distal irrigation ports are equidistantly spaced circumferentially around the distal section, and wherein the plurality of central irrigation ports are equidistantly spaced circumferentially around the distal section.