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 transformable between a delivery state and a deployed state, and wherein, in the deployed state, 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, in the deployed state, the balloon is sized and shaped to place the first electrode and the second electrode in apposition with an inner wall of the renal blood vessel; and   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 pV. 
     
     
         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, in the deployed state, is sized and shaped to occlude the renal blood vessel. 
     
     
         37 . 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;   an outer balloon at the distal portion of the shaft, wherein the outer balloon is transformable between a first delivery state and a first deployed state, and wherein, in the first deployed state, the outer balloon is configured to provide non-target tissue with protection from neuromodulation;   an inner balloon positioned within the outer balloon, wherein the inner balloon is transformable between a second delivery state and a second deployed state, and wherein, in the second deployed state, the inner balloon is configured to provide therapeutic neuromodulation to nerves proximate the treatment site;   a first electrode positioned on the outer surface of the outer balloon and extending about at least a portion of the circumference of the outer balloon; and   a second electrode positioned on the outer surface of the outer balloon and extending about at least a portion of the circumference of the outer balloon,   wherein the first electrode is spaced apart from and electrically isolated from the second electrode along the outer balloon,   wherein the first and second electrodes are configured to stimulate nerves and/or record nerve activity at the treatment site.   
     
     
         38 . The system of  claim 37  wherein the inner balloon, when in the second deployed state, is positioned between the first electrode and the second electrode. 
     
     
         39 . The system of  claim 37  wherein the outer balloon is configured to receive an insulating inflation medium and the inner balloon is configured to receive a thermal fluid. 
     
     
         40 . The system of  claim 37  wherein:
 the outer balloon is configured to receive an insulating inflation medium via a first lumen extending distally from a proximal portion of the shaft to a first opening positioned along a portion of the shaft within the outer balloon; and 
 the inner balloon is configured to receive a thermal fluid via a second lumen extending distally from a proximal portion of the shaft to a second opening positioned along a portion of the shaft within the inner balloon. 
 
     
     
         41 . The system of  claim 37  wherein the outer balloon, in the first deployed state, is sized and shaped to occlude the renal blood vessel. 
     
     
         42 . The system of  claim 37  wherein the inner balloon, in the second deployed state, is sized and shaped to contact the outer balloon at an interface extending around a full circumference of the inner balloon. 
     
     
         43 . The system of  claim 37  wherein the inner balloon has a smaller diameter in the second deployed state than the diameter of the outer balloon in the first deployed state. 
     
     
         44 . The system of  claim 43  wherein the inner balloon is attached to an interior surface of the outer balloon. 
     
     
         45 . The system of  claim 37  wherein the first and second electrodes are configured to monitor the strength of the nerve signal before, during, and/or after neuromodulation. 
     
     
         46 . The system of  claim 37  wherein the first electrode is one of a plurality of point electrodes and/or the second electrode is one of a plurality of point electrodes. 
     
     
         47 . The system of  claim 46  wherein the plurality of point electrodes are configured to provide monopolar and/or bipolar nerve stimulation and recording at the treatment site.