US2020155240A1PendingUtilityA1

Implantable Electrode Positioning

Assignee: SALUDA MEDICAL PTY LTDPriority: Dec 11, 2014Filed: Jan 24, 2020Published: May 21, 2020
Est. expiryDec 11, 2034(~8.3 yrs left)· nominal 20-yr term from priority
A61B 2562/046A61B 2505/05A61B 5/686A61B 5/4893A61N 1/36185A61B 5/407A61N 1/36071A61N 1/0553A61N 1/3614A61N 1/372A61B 2034/2053A61B 5/04001A61N 1/36135A61B 34/20A61B 5/24A61N 1/3605A61B 5/4029A61B 5/388A61B 5/1118
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Claims

Abstract

A method of surgically positioning an electrode array at a desired implantation location relative to a nerve. A temporary probe electrode is temporarily positioned adjacent to the nerve and at a location which is caudorostrally separate to the desired implantation location of the electrode array. The implanted position of the probe electrode is temporarily fixed relative to the nerve. During implantation of the electrode array, electrical stimuli are applied from one of the temporarily fixed probe electrode and the electrode array, to evoke compound action potentials on the nerve. Compound action potentials evoked by the stimuli are sensed from at least one electrode of the other of the temporarily fixed probe electrode and the electrode array. From the sensed compound action potentials a position of the electrode array relative to the nerve is determined.

Claims

exact text as granted — not AI-modified
1 . A method of surgically positioning an electrode array at a desired implantation location relative to a nerve, the method comprising:
 implanting a temporary probe electrode adjacent to the nerve and at a location which is caudorostrally separate to the desired implantation location of the electrode array;   temporarily fixing the implanted position of the probe electrode relative to the nerve;   during implantation of the electrode array, applying electrical stimuli from one of the temporarily fixed probe electrode and the electrode array, to evoke compound action potentials on the nerve;   sensing, from at least one electrode of the other of the temporarily fixed probe electrode and the electrode array, the compound action potentials evoked by the stimuli; and   determining from the sensed compound action potentials a position of the electrode array relative to the nerve.   
     
     
         2 . The method of  claim 1  wherein the probe electrode is surgically introduced via the same incision as the electrode array. 
     
     
         3 . The method of  claim 1  wherein the desired positioning of the electrode array is relative mediolaterally to a physiologic midline of the nerve. 
     
     
         4 . The method of  claim 3  wherein the probe electrode is configured to simultaneously stimulate an even distribution of fibres mediolaterally across the nerve. 
     
     
         5 . The method of  claim 3  wherein identification of the physiologic midline of the nerve, and positioning of the electrode array relative to the identified midline, is achieved by providing two laterally spaced apart sense electrodes on the electrode array, and monitoring a relative strength of the compound action potential sensed by each of the sense electrodes. 
     
     
         6 . The method of  claim 1  wherein a radial spacing of the electrode array from the nerve is determined. 
     
     
         7 . The method of  claim 6  wherein the probe electrode comprises first and second stimulus electrodes each at distinct radii away from the nerve, used to deliver stimuli of equal intensity, at different times. 
     
     
         8 . The method of  claim 1  wherein the probe electrode is fixed by being temporarily anchored upon a vertebra, within the epidural space. 
     
     
         9 . The method of  claim 1  wherein the probe electrode is a peripheral nerve stimulator delivering transcutaneous stimuli, to evoke CAPs on peripheral nerve(s) at a location of interest. 
     
     
         10 . The method of  claim 9  wherein an array location at which sense electrodes sense a maximal collision of CAPs evoked by spinal cord stimulus electrodes with CAPs evoked by the peripheral nerve stimulator is taken to be an optimal caudorostral position of the spinal stimulus electrodes relative to the location of interest. 
     
     
         11 . A system for positioning an electrode array at a desired implantation location relative to a nerve, the system comprising:
 a temporary probe electrode configured to be implanted adjacent to the nerve at a location which is caudorostrally separate to the desired implantation location of the electrode array, and configured to be temporarily fixed relative to the nerve while implanted;   an electrode array configured to be implanted adjacent to the nerve at the desired implantation location, and comprising at least one electrode configured to evoke or sense compound action potentials; and   a controller configured to:   
       cause electrical stimuli to be applied from one of the temporarily fixed probe electrode and the electrode array to evoke compound action potentials on the nerve during implantation of the electrode array; 
       sense from at least one electrode of the other of the temporarily fixed probe electrode and the electrode array the compound action potentials evoked by the stimuli; and 
       determine from the sensed compound action potentials a position of the electrode array relative to the nerve. 
     
     
         12 . A non-transitory computer readable medium for surgically positioning an electrode array at a desired implantation location relative to a nerve, comprising instructions which, when executed by one or more processors, causes performance of the following:
 computer program code means for, during implantation of the electrode array, applying electrical stimuli from one of the electrode array and a probe electrode which is temporarily fixed adjacent to the nerve at a location which is caudorostrally separate to the desired implantation location of the electrode array, to evoke compound action potentials on the nerve;   computer program code means for sensing, from at least one electrode of the other of the electrode array and the probe electrode, the compound action potentials evoked by the stimuli; and   computer program code means for determining from the sensed compound action potentials a position of the electrode array relative to the nerve.

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