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. An ablation catheter adapted for ablating a greater splanchnic nerve from within an intercostal vein, comprising:
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 the 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 equidistantly spaced circumferentially around the distal section; and
a plurality of central irrigation ports axially between the distal electrode and proximal electrode, the plurality of central irrigation ports axially aligned and equidistantly spaced circumferentially around the distal section.
2. The ablation catheter of claim 1 , wherein the plurality of distal irrigation ports consists of three irrigation ports spaced 120 degrees circumferentially around the linear distal section.
3. The ablation catheter of claim 1 , wherein the plurality of central irrigation ports consists of three irrigation ports spaced 120 degrees circumferentially around the linear distal section.
4. The ablation catheter of claim 1 , wherein the plurality of distal electrode irrigation ports are arranged in a helical pattern having the same pitch as the coiled distal electrode.
5. The ablation catheter of claim 4 , wherein the plurality of proximal electrode irrigation ports are arranged in a helical pattern having the same pitch as the coiled proximal electrode.
6. The ablation catheter of claim 1 , wherein the plurality of proximal electrode irrigation ports are arranged in a helical pattern having the same pitch as the coiled proximal ablation electrode.
7. The ablation catheter of claim 1 , wherein the linear distal section is void of irrigation ports proximal to the proximal ablation electrode.
8. The ablation catheter of claim 1 , wherein windings at distal and proximal ends of at least one of the proximal and distal electrodes do not have an irrigation port therebetween.
9. The ablation catheter of claim 1 , wherein the distal and proximal ends of each of the distal and proximal ablation elements have a varying pitch.
10. The ablation catheter of claim 1 , wherein the plurality of distal irrigation ports are within 2 mm of a distal end of the distal ablation electrode.
11. The ablation catheter of claim 1 , wherein the plurality of distal electrode irrigation ports, the plurality of proximal electrode irrigation ports, the plurality of distal irrigation ports, and the plurality of central irrigation ports together define a plurality of irrigation ports having a combined and total area in a range of 1.51e-4 to 1.08e-3 in 2 .
12. The ablation catheter of claim 1 , wherein the number of the plurality of irrigation ports is in a range of 17 to 344.
13. The ablation catheter of claim 12 , wherein the plurality of irrigation ports have a size and quantity such that a Weber number is in a range of 0.4-53 when irrigation fluid is delivered from the plurality of irrigation ports at a rate from 15 ml/min to 50 ml/min.
14. The ablation catheter of claim 1 , the distal section, in the linear configuration when radially unconstrained, having a distal length from 60 mm to 100 mm and sufficiently flexible to be advanced from an azygous vein into an intercostal vein, the elongate shaft having a central section proximal to the distal section, the central section having a central length from 15 mm to 25 mm and having a central stiffness and that is greater than a distal stiffness of the distal section.
15. The ablation catheter of claim 1 , wherein the distal section has a length from 60 mm to 100 mm and sufficiently flexible to be advanced from an azygous vein into an intercostal vein, and wherein the ablation catheter, at the location of the distal section and including the distal and proximal electrodes carried by and disposed circumferentially about the distal section, has an outer dimension that is not greater than 3 mm.
16. The ablation catheter of claim 1 , wherein the distal and proximal electrically conductive flexible and coiled ablation electrodes are the only electrodes carried by the ablation catheter.
17. The ablation catheter of claim 1 , wherein the distal and proximal electrically conductive flexible and coiled ablation electrodes together have an axial length from 10 mm-25 mm.
18. An ablation catheter adapted for ablating a greater splanchnic nerve from within an intercostal vein, comprising:
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, wherein the distal and proximal electrically conductive flexible and coiled ablation electrodes are the only electrodes carried by the ablation catheter,
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 the 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 equidistantly spaced circumferentially around the distal section; and
a plurality of central irrigation ports axially between the distal electrode and proximal electrode, the plurality of central irrigation ports axially aligned and equidistantly spaced circumferentially around the distal section.
19. The ablation catheter of claim 18 , wherein the distal and proximal electrically conductive flexible and coiled ablation electrodes together have an axial length from 10 mm-25 mm.