US2022266024A1PendingUtilityA1

Neurostimulation device with recording patch

Assignee: ALEVA NEUROTHERAPEUTICSPriority: May 28, 2019Filed: May 10, 2022Published: Aug 25, 2022
Est. expiryMay 28, 2039(~12.9 yrs left)· nominal 20-yr term from priority
A61B 5/377G16H 40/67A61B 5/4836G16H 40/63A61N 1/36067A61N 1/36135A61B 5/6868A61N 1/0534A61N 1/37211G16H 20/40G16H 20/30A61N 1/37264A61N 1/08A61N 1/3787A61B 5/293A61N 1/3606
64
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Claims

Abstract

The present disclosure describes systems and methods for recording electrical activity, such as local field potentials. The system can include a recording patch that is placed inline between an implanted neurological lead and an implantable pulse stimulator. The recording patch can include recording and amplification circuitry that detects, records, and amplifies electrical activity (also referred to as signals) from a target site. The system can be used to select over which of the lead's electrodes therapeutic stimulations are delivered.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . An implantable device, comprising:
 a housing to secure against a subject;   a circuit disposed in the housing, the circuit to:
 receive, at least partially concurrent with presentation of a prompt to the subject to perform an activity, a first biological signal from the subject passed via a switch connected with a lead; 
 set, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead; 
 receive, subsequent to passing of the stimulation signal from the simulator, a second biological signal from the subject passed via the switch with the lead; and 
 determine a characteristic based on the first biological signal and the second biological signal. 
   
     
     
         22 . The device of  claim 21 , comprising the circuit to:
 receive, prior to the presentation of the prompt for the subject to perform the activity, a third biological signal; and   determine the characteristic corresponding to a difference between the second biological signal and the third biological signal.   
     
     
         23 . The device of  claim 21 , comprising the circuit to:
 receive, at least partially concurrent with presentation of a second prompt to the subject to perform a second activity in accordance with a policy, a third biological signal; and   determine a characteristic based on the first biological signal for the activity and the third biological signal for the second activity.   
     
     
         24 . The device of  claim 21 , comprising the circuit to:
 select, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and   receive the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.   
     
     
         25 . The device of  claim 21 , comprising the circuit to:
 record the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and   record the second biological signal over a second time window relative to the passage of the stimulation signal.   
     
     
         26 . The device of  claim 21 , comprising the circuit to determine the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal. 
     
     
         27 . The device of  claim 21 , comprising the circuit to communicate with a programmer via an antenna to transmit at least one of the first biological signal or the second biological signal. 
     
     
         28 . A programmer device, comprising:
 one or more processors coupled with memory in communication with a recording patch, configured to:
 transmit a first instruction to set the recording patch to receive, at least partially concurrent with presentation of a prompt to the subject to perform an activity, a first biological signal from the subject passed via a switch connected a lead; 
 transmit a second instruction to set the recording patch to set, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead; 
 transmit a third instruction to set the recording patch to receive a second biological signal from the subject passed via the switch connected with the lead; and 
 determine a characteristic based on the first biological signal and the second biological signal from the recording patch. 
   
     
     
         29 . The device of  claim 28 , comprising the one or more processors to:
 select, responsive to a determination to test the subject to perform another activity, a second activity from a plurality of activities in accordance with a policy; and   transmit a fourth instruction to set the recording patch to receive, at least partially concurrent with presentation of a second prompt to perform the second activity, a third biological signal from the subject passed via the switch.   
     
     
         30 . The device of  claim 28 , comprising the one or more processors to:
 determine, subsequent to the completion of the prompt, to not test the subject to perform another activity in accordance with a policy; and   transmit, responsive to the determination to not test the subject to perform another activity, the second instruction to set the switch to connect with the stimulator.   
     
     
         31 . The device of  claim 28 , comprising the one or more processors to:
 select, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and   transmit the third instruction to the recording patch to receive the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.   
     
     
         32 . The device of  claim 28 , comprising the one or more processors to:
 record the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and   record the second biological signal over a second time window relative to the passage of the stimulation signal.   
     
     
         33 . The device of  claim 28 , comprising the one or more processors to determine the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal. 
     
     
         34 . A method, comprising:
 receiving, by a recording patch secured against a skull of a subject, a first biological signal from the subject passed via a switch connected with a lead, concurrent with presentation of a prompt to the subject;   setting, by the recording patch, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead;   receiving, by the recording patch, subsequent to passing of the stimulation signal from the simulator, a second biological signal from the subject passed via the switch connected with the lead; and   determining, by the recording patch, a characteristic of the first biological signal and the second biological signal.   
     
     
         35 . The method of  claim 34 , comprising:
 receiving, by the recording patch, prior to the presentation of the prompt for the subject to perform the activity, a third biological signal; and   determining, by the recording patch, the characteristic corresponding to a difference between the second biological signal and the third biological signal.   
     
     
         36 . The method of  claim 34 , comprising:
 receiving, by the recording patch, at least partially concurrent with presentation of a second prompt to the subject to perform a second activity in accordance with a policy, a third biological signal; and   determining, by the recording patch, a characteristic based on the first biological signal for the activity and the third biological signal for the second activity.   
     
     
         37 . The method of  claim 34 , comprising:
 selecting, by the recording patch, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and   receiving, by the recording patch, the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.   
     
     
         38 . The method of  claim 34 , comprising:
 recording, by the recording patch, the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and   recording, by the recording patch, the second biological signal over a second time window relative to the passage of the stimulation signal.   
     
     
         39 . The method of  claim 34 , comprising:
 determining, by the recording patch, the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal.   
     
     
         40 . The method of  claim 34 , comprising:
 communicating, by the recording patch, with a programmer via an antenna to transmit at least one of the first biological signal or the second biological signal.

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