Endovascular Nerve Monitoring Devices and Associated Systems and Methods

Abstract

Endovascular nerve monitoring devices and associated systems and methods are disclosed herein. A nerve monitoring system configured in accordance with a particular embodiment of the present technology can include a shaft having a proximal portion and a distal portion and a nerve monitoring assembly at the distal portion. The shaft is configured to locate the distal portion intravascularly at a treatment site. The nerve monitoring assembly can include a bipolar stimulation electrode array and a bipolar recording electrode array disposed distal to the bipolar stimulation electrode assembly.

1 - 27 . (canceled) 
     
     
         28 . A system, comprising:
 a shaft including a proximal portion and a distal portion, wherein the shaft is configured to intravascularly locate the distal portion at a treatment site within a renal blood vessel of a human patient;   a balloon at the distal portion of the shaft, wherein the balloon is configured to provide non-target tissue with protection from neuromodulation;   a lumen extending distally from a proximal portion of the shaft to an opening positioned along a portion of the shaft within the balloon;   a first electrode positioned on the outer surface of the balloon and extending about at least a portion of the circumference of the balloon;   a second electrode positioned on the outer surface of the balloon and extending about at least a portion of the circumference of the balloon, wherein the first electrode is spaced apart from and electrically isolated from the second electrode along the balloon;   wherein the first and second electrodes are configured to—
 deliver therapeutic neuromodulation to renal nerves proximate the treatment site, and 
 stimulate nerves and/or record nerve activity at the treatment site. 
   
     
     
         29 . The system of  claim 28  wherein the first electrode is configured to stimulate renal nerves proximate the treatment site and the second electrode is configured to record nerve activity at the treatment site during and/or after the therapeutic neuromodulation. 
     
     
         30 . The system of  claim 29  wherein the second electrode is configured to record nerve signals less than 1.5 μV. 
     
     
         31 . The system of  claim 28 , further comprising an insulated portion between the first electrode and the second electrode on the outer surface of the balloon. 
     
     
         32 . The system of  claim 28  wherein:
 the first electrode comprises a conductive strip configured for monopolar stimulation; and 
 the second electrode comprises two conductive strips configured for bipolar recording of renal nerve activity before, during, and/or after therapy. 
 
     
     
         33 . The system of  claim 28  wherein the lumen is a first lumen, and wherein the shaft further includes a second lumen extending distally to a second opening positioned along a portion of the shaft within the balloon. 
     
     
         34 . The system of  claim 28  wherein at least one of the first and second electrodes includes a multi-electrode loop having at least two electrodes spaced circumferentially about the loop. 
     
     
         35 . The system of  claim 28  wherein at least one of the first electrode and the second electrode is configured to deliver radio frequency (RF) energy sufficient to ablate the renal nerves proximate the treatment site. 
     
     
         36 . The system of  claim 28  wherein the balloon is transformable between a delivery state and a deployed state and wherein, in the deployed state, the balloon is sized and shaped to occlude the renal blood vessel. 
     
     
         37 . The system of  claim 28  wherein the balloon is transformable between a delivery state and a deployed state and wherein, in the deployed state, the balloon is sized and shaped to place the first electrode and second electrode in apposition with an inner wall of the renal blood vessel. 
     
     
         38 . A method, comprising:
 intravascularly deploying a treatment device in a renal blood vessel of a human patient at a treatment site, wherein the treatment device includes an elongated shaft, a balloon at a distal portion of the shaft, and first and second electrodes on an outer surface of the balloon;   transforming the balloon from a delivery state to a deployed state by inflating the balloon with a thermally protective inflation medium such that the balloon makes contact with an inner wall of the renal blood vessel and thereby provides thermal protection of non-target tissue;   ablating the renal nerves via radio frequency (RF) energy delivered from the first electrode and/or the second electrode;   before ablation, stimulating the renal nerves proximate the treatment site and recording the resulting nerve activity; and   after ablation, stimulating the renal nerves and recording the resulting nerve activity.   
     
     
         39 . The method of  claim 38 , further comprising confirming the effectiveness of the ablation on the nerves proximate the treatment site based on the post-ablation recording. 
     
     
         40 . The method of  claim 38  wherein stimulating the renal nerves proximate the treatment site before and/or after ablation is performed by the first electrode and recording nerve activity before and/or after ablation is performed with the second electrode. 
     
     
         41 . The method of  claim 38  wherein:
 stimulating the renal nerves proximate the treatment site before and after ablation comprises providing monopolar stimulation to the nerves; and 
 recording nerve activity before and after ablation comprises providing bipolar recording of the nerve activity with the second electrode, wherein the second electrode is distal to the first electrode. 
 
     
     
         42 . The method of  claim 38  wherein:
 stimulating nerves before and/or after ablation comprises delivering a plurality of stimulus pulses with the first electrode, each stimulus pulse having an intensity of about 20-60 mA at a pulse length of about 100-400 μs; 
 recording nerve activity before and after ablation is performed by the second electrode, wherein recording comprises recording an electrogram of the second electrode and that corresponds to the nerve activity resulting from the corresponding stimulus pulses. 
 
     
     
         43 . The method of  claim 38  wherein deploying the treatment device includes deploying the first electrode proximal to the second electrode, wherein the first and second electrodes each comprise a loop electrode. 
     
     
         44 . The method of  claim 38  wherein deploying the treatment device in the renal blood vessel comprises deploying the first electrode proximal to the second electrode. 
     
     
         45 . The method of  claim 38  wherein deploying the treatment device in the renal blood vessel comprises inflating the balloon within a renal artery, wherein the inflated balloon, the first electrode, and the second electrode contact an inner wall of the renal artery. 
     
     
         46 . The method of  claim 38  wherein:
 stimulating nerves after ablation and recording the resulting nerve activity is performed after delivering a first cycle of ablation to renal nerves proximate the treatment site; and 
 the method further comprises delivering a second cycle of ablation to renal nerves proximate the treatment site with the first and/or second electrodes when the recorded post-ablation nerve activity from the first cycle is above a predetermined threshold.