Positioning methods for intravascular electrode arrays for neuromodulation

1. A method for positioning an electrode array of a neuromodulation catheter at a target position along a posterior wall of a blood vessel for use in delivering therapeutic stimulus transvascularly to cardiac nerve fibers, the method comprising:

advancing the catheter into the blood vessel and positioning the electrode array into contact with the wall of the blood vessel in which a lead having lead insulation is positioned;

with the electrode array in contact with the wall of the blood vessel, selectively energizing electrodes of the array and measuring impedance between each of a plurality of electrode pairs of the array,

determining from the measured impedance which of the plurality of electrode pairs of the array has the highest measured impedance relative to the other of the plurality of electrode pairs to determine which of the plurality of electrode pairs are deployed in the presence of lead insulation of the lead, and

selecting pairs other than those determined to be in the presence of lead insulation; and

performing automatic response testing using each of the selected pairs by, for each of the selected pairs, energizing at least one electrode in the pair while monitoring the patient's heart rate, and determining whether said therapeutic energy results in a change to the patient's heart rate.

2. The method of claim 1 , wherein the step of performing automatic response testing includes

(a) determining the patient's heart rate;

(b) for each of said selected pairs, energizing said at least one electrode in the pair using stimulation parameters selected to capture the vagus nerve while determining the patient's heart rate and,

(c) if the heart rate determined in step (b) is not lower than the heart rate determined in step (a), repositioning the electrode array on the wall of the blood vessel and repeating step (b).

3. The method of claim 1 , wherein:

the method provides the catheter to have a catheter shaft, and the array comprises a pair of parallel elements having a space between them extending from the catheter, each element comprising a flexible substrate having electrodes thereon, each element further comprising a free end; and wherein

the method further comprises;

positioning the catheter shaft to run longitudinally along a wall of the blood vessel; and

positioning the array within the blood vessel so as to position the parallel elements longitudinally on opposite sides of the lead.

4. A method for positioning an electrode array of a neuromodulation catheter at a target position along a posterior wall of a blood vessel for use in delivering therapeutic stimulus transvascularly to cardiac nerve fibers, the method comprising:

advancing the catheter into the blood vessel and positioning the electrode array into contact with the wall of the blood vessel in which a CRM coil is positioned;

with the electrode array in contact with the wall of the blood vessel, selectively energizing electrodes of the array and measuring impedance between each of a plurality of electrode pairs of the array,

determining from the measured impedance which of the plurality of electrode pairs of the array have low measured impedance relative to the other of the plurality of electrode pairs to determine which of the plurality of electrode pairs are deployed in the presence of the CRM coil, and

selecting pairs other than those determined to be in the presence of the CRM coil; and

performing automatic response testing using each of the selected pairs by, for each of the selected pairs, energizing at least one electrode in the pair while monitoring the patient's heart rate, and determining whether said therapeutic energy results in a change to the patient's heart rate.

5. The method of claim 4 , wherein the step of performing automatic response testing includes

(a) determining the patient's heart rate;

(b) for each of said selected pairs, energizing said at least one electrode in the pair using stimulation parameters selected to capture the vagus nerve while determining the patient's heart rate and,

(c) if the heart rate determined in step (b) is not lower than the heart rate determined in step (a), repositioning the electrode array on the wall of the blood vessel and repeating step (b).

6. The method of claim 4 , wherein:

the method provides the catheter to have a catheter shaft and the array comprises a pair of parallel elements having a space between them extending from the catheter, each element comprising a flexible substrate having electrodes thereon, each element further comprising a free end; and wherein

the method further comprises;

positioning the catheter shaft to run longitudinally along a wall of the blood vessel; and

positioning the array within the blood vessel so as to position the parallel elements longitudinally on opposite sides of the CRM coil.