US2018200514A1PendingUtilityA1

Non-invasive nerve stimulation

52
Assignee: NEUROSTIM OAB INCPriority: May 30, 2013Filed: Mar 5, 2018Published: Jul 19, 2018
Est. expiryMay 30, 2033(~6.9 yrs left)· nominal 20-yr term from priority
A61B 5/388A61B 5/395A61B 5/318A61B 2562/164A61B 5/6807A61B 5/01A61B 5/1495A61B 2562/029A61B 5/0531A61B 5/6825A61B 5/6832A61B 5/11A61B 2562/0247A61B 5/4824A61B 5/6829A61B 5/0022A61B 2562/063A61N 1/36021A61N 1/3603A61N 1/0456A61N 1/0476A61B 5/4836A61N 1/0492A61B 5/24A61B 5/389A61B 5/0036A61N 1/36007A61N 1/0452
52
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Claims

Abstract

A topical nerve stimulator patch and system are provided including a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A topical nerve stimulation patch comprising:
 a flexible substrate;   a malleable dermis conforming bottom surface of the substrate comprising adhesive and adapted to contact the dermis;   a flexible top outer surface of the substrate approximately parallel to the bottom surface;   a plurality of electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and coupled to the flexible substrate; and   electronic circuitry embedded in the patch and located beneath the top outer surface and coupled to the flexible substrate, the electronic circuitry comprising:
 an electrical signal generator integral to the malleable dermis conforming bottom surface configured to electrically activate the electrodes; 
 an antenna in communication with the electrical signal generator; 
 a signal activator coupled to the electrical signal generator; and 
 a power source in electrical communication with the electrical signal generator, the antenna and the signal activator. 
   
     
     
         2 . The topical nerve stimulation patch of  claim 1 , further comprising:
 a nerve stimulation sensor that provides feedback in response to a stimulation of one or more nerves and is coupled to the flexible substrate.   
     
     
         3 . The topical nerve stimulation patch of  claim 2 ,
 the antenna configured to communicate with a remote activation device;   the signal activator configured to activate in response to receipt of a communication with the activation device by the antenna;   the electrical signal generator configured to generate one or more electrical stimuli in response to activation by the signal activator;   the electrical stimuli configured to stimulate one or more nerves of a user wearing the nerve stimulation patch at least at one location proximate to the patch.   
     
     
         4 . The topical nerve stimulation patch of  claim 2  that when coupled to a user is configured to generate a treatment comprising:
 determining a target charge level; 
 outputting a series of pulses from the electrodes; 
 for each pulse outputted, measuring a charge value of the pulse and compare the charge value to the target charge level; 
 if the charge value is greater than the target charge level, reducing a strength level of a subsequent outputted pulse; and 
 if the charge value is less than the target charge level, increasing the strength level of a subsequent outputted pulse. 
 
     
     
         5 . The topical nerve stimulation patch of  claim 4 , in which the series of pulses are defined based on a frequency and duration. 
     
     
         6 . The topical nerve stimulation patch of  claim 4 , in which determining the target charge level Q target    comprises generating an acquisition series of pulses and   
       
         
           
             
               
                 
                   Q 
                   target 
                 
                 = 
                 
                   
                     ∑ 
                     
                       i 
                       = 
                       1 
                     
                     
                       T 
                       * 
                       f 
                     
                   
                    
                   
                       
                   
                    
                   
                     
                       Q 
                       pulse 
                     
                      
                     
                       ( 
                       i 
                       ) 
                     
                   
                 
               
               , 
             
           
         
         where T is a duration of the acquisition series of pulses, f is a frequency of the acquisition series of pulses and Q pulse (i) is a measured charge of each of the acquisition series of pulses. 
       
     
     
         7 . The topical nerve stimulation patch of  claim 4 , the electronic circuitry further comprising a differential integrator, the charge value of the pulse based on an output of the differential integrator. 
     
     
         8 . The topical nerve stimulation patch of  claim 3 , further comprising a shape that is based on the location and causes the electrodes to generally be arranged along an axis of the nerves to be stimulated. 
     
     
         9 . A method of using a topical nerve stimulation system patch for electrical stimulation, the method comprising:
 applying the patch to a dermis using adhesive, the patch comprising:
 a flexible substrate; 
 a malleable dermis conforming bottom surface of the substrate comprising adhesive and adapted to contact the dermis; 
 a flexible top outer surface of the substrate approximately parallel to the bottom surface; 
 a plurality of electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and coupled to the flexible substrate; and 
 electronic circuitry embedded in the patch and located beneath the top outer surface and coupled to the flexible substrate, the electronic circuitry comprising:
 an electrical signal generator integral to the malleable dermis conforming bottom surface configured to electrically activate the electrodes; 
 an antenna in communication with the electrical signal generator; 
 a signal activator coupled to the electrical signal generator; and 
 a power source in electrical communication with the electrical signal generator, the antenna and the signal activator; 
 
   generating one or more electrical stimuli in response to activation by the signal activator; and   receiving feedback from the electrical stimuli.   
     
     
         10 . The method of  claim 9 , the feedback provided by a nerve stimulation sensor that provides the feedback in response to a stimulation of one or more nerves and is coupled to the flexible substrate. 
     
     
         11 . The method of  claim 10 ,
 the antenna configured to communicate with a remote activation device;   the signal activator configured to activate in response to receipt of a communication with the activation device by the antenna; and   the electrical signal generator configured to generate one or more electrical stimuli in response to activation by the signal activator.   
     
     
         12 . The method of  claim 9 , further comprising:
 determining a target charge level;   outputting a series of pulses from the electrodes;   for each pulse outputted, measuring a charge value of the pulse and compare the charge value to the target charge level;   if the charge value is greater than the target charge level, reducing a strength level of a subsequent outputted pulse; and   if the charge value is less than the target charge level, increasing the strength level of a subsequent outputted pulse.   
     
     
         13 . The method of  claim 12 , in which the series of pulses are defined based on a frequency and a duration. 
     
     
         14 . The method of  claim 12 , in which determining the target charge level Q target  comprises generating an acquisition series of pulses and 
       
         
           
             
               
                 
                   Q 
                   target 
                 
                 = 
                 
                   
                     ∑ 
                     
                       i 
                       = 
                       1 
                     
                     
                       T 
                       * 
                       f 
                     
                   
                    
                   
                       
                   
                    
                   
                     
                       Q 
                       pulse 
                     
                      
                     
                       ( 
                       i 
                       ) 
                     
                   
                 
               
               , 
             
           
         
         where T is duration of the acquisition series of pulses, f is a frequency of the acquisition series of pulses and Q pulse  (i) is a measured charge of each of the acquisition series of pulses. 
       
     
     
         15 . The method of  claim 12 , the electronic circuitry further comprising a differential integrator, the charge value of the pulse based on an output of the differential integrator. 
     
     
         16 . A topical nerve stimulation patch comprising:
 a flexible substrate;   a malleable dermis conforming bottom surface of the substrate comprising adhesive and adapted to contact the dermis;   a flexible top outer surface of the substrate approximately parallel to the bottom surface;   a plurality of electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and coupled to the flexible substrate; and   a processor coupled to the flexible substrate and a storage device that stores instructions, the processor, when executing the instructions:
 determining a target charge level; 
 outputting a series of pulses from the electrodes; 
 for each pulse outputted, measuring a charge value of the pulse and compare the charge value to the target charge level; 
 if the charge value is greater than the target charge level, reducing a strength level of a subsequent outputted pulse; and 
 if the charge value is less than the target charge level, increasing the strength level of a subsequent outputted pulse. 
   
     
     
         17 . The patch of  claim 16 , in which the series of pulses are defined based on a frequency and duration. 
     
     
         18 . The patch of  claim 16 , in which determining the target charge level Q target  comprises generating an acquisition series of pulses and 
       
         
           
             
               
                 
                   Q 
                   target 
                 
                 = 
                 
                   
                     ∑ 
                     
                       i 
                       = 
                       1 
                     
                     
                       T 
                       * 
                       f 
                     
                   
                    
                   
                       
                   
                    
                   
                     
                       Q 
                       pulse 
                     
                      
                     
                       ( 
                       i 
                       ) 
                     
                   
                 
               
               , 
             
           
         
         where T is duration of the acquisition series of pulses, f is a frequency of the acquisition series of pulses and Q pulse  (i) is a measured charge of each of the acquisition series of pulses. 
       
     
     
         19 . The patch of  claim 16 , further comprising a differential integrator, the charge value of the pulse based on an output of the differential integrator. 
     
     
         20 . The patch of  claim 16  having a shape that is based on a location on the dermis and causes the electrodes to generally be arranged along an axis of the nerves to be stimulated. 
     
     
         21 . A topical nerve stimulation patch for treatment of overactive bladder, comprising:
 a flexible substrate comprising a dermis conforming bottom surface and a flexible top outer surface;   an adhesive for topically attaching the patch to tissue;   a plurality of electrodes positioned on the patch on the bottom surface of the substrate and located beneath the top outer surface;   electronic circuitry embedded within the patch and located beneath the top outer surface of the substrate, comprising:
 an electrical signal generator providing a train of voltage regulated waves across the electrodes to generate an electric current that stimulates a nerve to inhibit a user's sensation of needing to urgently empty the user's bladder; 
 an antenna for communicating with a remote device and receiving a signal therefrom to activate the signal generator; and 
 a power source in electrical communication with the signal generator. 
   
     
     
         22 . The patch of  claim 21 , the electrodes adapted to generate a current between about 20 mA and 100 mA during use. 
     
     
         23 . The patch of  claim 22 , the voltage regulated waves comprising square waves. 
     
     
         24 . The patch of  claim 23 , the squares waves comprising a frequency between approximately 15 Hz and 50 Hz. 
     
     
         25 . The patch of  claim 21 , the remote device comprising a FOB and depressing a button on the FOB activates the signal generator of the patch. 
     
     
         26 . The patch of  claim 21 , the remote device comprising a smartphone or tablet comprising software configured to allow a user to communicate, using the smartphone or tablet, with the antenna of the patch and activate the signal generator.

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