US2021361947A1PendingUtilityA1

Systems and methods for selecting stimulation parameters based on stimulation target region, effects, or side effects

Assignee: BOSTON SCIENT NEUROMODULATION CORPPriority: Jun 29, 2015Filed: Aug 4, 2021Published: Nov 25, 2021
Est. expiryJun 29, 2035(~8.9 yrs left)· nominal 20-yr term from priority
G16H 40/63A61N 1/37247A61N 1/36071G16H 20/30G16H 50/50A61N 1/36082A61N 1/0551A61N 1/37241A61N 1/3787A61N 1/36135
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Claims

Abstract

A system or method for identifying sets of stimulation parameters can include receiving at least one image of a region of a patient; registering the at least one image with an anatomical or physiological atlas that identifies different anatomical or physiological structures; identifying a desired stimulation region using the at least one image; comparing the desired stimulation region with each of a plurality of predetermined estimated stimulation regions, where each of the estimated stimulation regions is a calculated estimate of a stimulation volume for a corresponding set of electrical stimulation parameters; selecting one of the predetermined estimated stimulation regions based on the comparing; and providing the corresponding set of electrical stimulation parameters for the selected one of the predetermined estimated stimulation regions to a user or an electrical stimulation device. Other systems or methods use functional maps or subregions of a region of synchronous neural activity to identify stimulation parameters.

Claims

exact text as granted — not AI-modified
What is claimed as new and desired to be protected by Letters Patent of the United States is: 
     
         1 . A method of providing electrical stimulation of a patient, the method comprising:
 providing at least one functional map identifying anatomical or physiological volumes that, when stimulated, produce at least one stimulation effect or at least one stimulation side effect in at least one patient, wherein the at least one functional map includes an estimate of a likelihood that the anatomical or physiological volumes will produce the at least one stimulation effect or the at least one stimulation side effect;   identifying at least one desired stimulation effect or at least one undesired stimulation side effect;   using the at least one functional map, identifying a desired stimulation region that produces the at least one desired stimulation effect at a first predetermined threshold likelihood or avoids the at least one undesired stimulation side effect at a second predetermined threshold likelihood;   based on the desired stimulation region, identifying an estimated stimulation region that is an estimate of a stimulation volume for a corresponding set of electrical stimulation parameters using an electrical stimulation lead; and   delivering electrical stimulation to the patient according to the corresponding set of electrical stimulation parameters for the estimated stimulation region.   
     
     
         2 . The method of  claim 1 , further comprising providing the corresponding set of electrical stimulation parameters for the selected one of the estimated stimulation regions to an electrical stimulation device. 
     
     
         3 . The method of  claim 2 , wherein the electrical stimulation device comprises an implantable pulse generator and an electrical stimulation lead that is coupled to the implantable pulse generator and comprises a plurality of electrodes, wherein the delivering the electrical stimulation comprises delivering the electrical stimulation by the implantable pulse generator through at least one of the electrodes of the electrical stimulation lead according to the corresponding set of electrical stimulation parameters for the estimated stimulation region. 
     
     
         4 . The method of  claim 2 , wherein the electrical stimulation device comprises an external trial stimulator and an electrical stimulation lead that is coupled to the external trial stimulator and comprises a plurality of electrodes, wherein the delivering the electrical stimulation comprises delivering the electrical stimulation by the external trial stimulator through at least one of the electrodes of the electrical stimulation lead according to the corresponding set of electrical stimulation parameters for the estimated stimulation region. 
     
     
         5 . The method of  claim 1 , wherein the identifying the at least one desired stimulation effect or the at least one undesired stimulation side effect comprises identifying both the at least one desired stimulation effect and the at least one undesired stimulation side effect. 
     
     
         7 . The method of  claim 1 , wherein the providing at least one functional map comprises providing the at least one functional map with scores associated with the anatomical or physiological volumes, each score being associated with at least one of the at least one stimulation effect or the at least one stimulation side effect. 
     
     
         7 . The method of  claim 1 , wherein the identifying the estimated stimulation region comprises
 comparing the desired stimulation region with each of a plurality of potential estimated stimulation regions, wherein each of the potential estimated stimulation regions is an estimate of a stimulation volume for a corresponding set of electrical stimulation parameters using an electrical stimulation lead; and   selecting one of the potential estimated stimulation regions as the estimated stimulation region based on the comparing.   
     
     
         8 . The method of  claim 7 , further comprising receiving at least one selection criterion, wherein the selecting the one of the potential estimated stimulation regions comprises selecting the one of the potential estimated stimulation regions based on the at least one selection criterion. 
     
     
         9 . The method of  claim 7 , further comprising automatically rejecting any of the potential estimated stimulation regions that fails to have a predetermined amount of overlap with the desired stimulation region. 
     
     
         10 . The method of  claim 7 , further comprising obtaining the plurality of possible estimated stimulation regions by calculating each of the possible estimated stimulation regions. 
     
     
         11 . The method of  claim 7 , further comprising obtaining the plurality of possible estimated stimulation regions from a memory of a device. 
     
     
         12 . The method of  claim 7 , wherein the comparing comprises determining a difference between the desired stimulation region and each of the plurality of possible estimated stimulation regions. 
     
     
         13 . The method of  claim 1 , further comprising determining an amount or percentage of the estimated stimulation region outside the desired stimulation region. 
     
     
         14 . The method of  claim 1 , further comprising presenting, on a display, the desired stimulation region and the estimated stimulation region. 
     
     
         15 . The method of  claim 14 , further comprising determining, and displaying on the display, at least one of the following: an amount or percentage coverage of the desired stimulation region by the estimated stimulation region, an amount or percentage of the desired stimulation region that is outside the estimated stimulation region, an amount or percentage of the estimated stimulation region that covers the desired stimulation region, or an amount or percentage of the estimated stimulation region that is outside the desired stimulation region. 
     
     
         16 . The method of  claim 1 , wherein the providing the at least one function map comprises registering at least one patient image into a common atlas space. 
     
     
         17 . The method of  claim 1 , further comprising providing the corresponding set of electrical stimulation parameters for the selected one of the estimated stimulation regions to a user. 
     
     
         18 . The method of  claim 1 , wherein the functional map represents an aggregate of clinical effects across at least 10 patients. 
     
     
         19 . The method of  claim 1 , wherein the identifying the at least one desired stimulation effect or the at least one undesired stimulation side effect comprises identifying both the at least one desired stimulation effect and a plurality of the undesired stimulation side effects. 
     
     
         20 . A method of providing electrical stimulation of a patient, the method comprising:
 identifying a region of synchronous neural activity;   dividing the region into a plurality of subregions;   comparing the plurality of subregions with a plurality of estimated stimulation regions, wherein each of the estimated stimulation regions is a calculated estimate of a stimulation volume for a corresponding set of electrical stimulation parameters using an electrical stimulation lead;   selecting, for each of the subregions, one of the estimated stimulation regions based on the comparisons such that each of the selected estimated stimulation regions overlaps with any of the other selected estimated stimulation regions by no more than a predetermined threshold; and   delivering electrical stimulation to the patient according to the corresponding set of electrical stimulation parameters for each of the selected estimated stimulation regions.

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