Methods and systems for measuring brain activity

Abstract

The invention encompasses systems and methods allowing for minimally invasive insertion and functional optimization of implantable electrode arrays designed for placement within the subgaleal space to record brain electrical activity. The implantable arrays comprise a support structure capable of being implanted in the subgaleal space and comprising at least one reference element; at least one ground element; and one or more recording elements; and wherein said array is capable of detecting and/or transmitting a subgaleal electrical signal.

1 - 14 . (canceled) 
     
     
         15 . A system for detecting and/or transmitting subgaleal electrical signals, comprising:
 at least one subgaleal electrode array including:
 a flexible support structure having a shape implantable into and configured to conform to a shape of a subgaleal space of a patient; and 
 a plurality of electrodes distributed along a length of the flexible support structure, each of the plurality of electrodes arranged circumferentially about the flexible support structure, and the plurality of electrodes configured to one or more of detect or transmit a subgaleal electrical signal; and 
   an interface configured to electrically connect the plurality of electrodes to an external processor.   
     
     
         16 . The system of  claim 15 , further comprising:
 a needle including a tip that is tapered and that is straight or angled, the needle operable to insert the at least one subgaleal electrode array into the subgaleal space without an incision.   
     
     
         17 . The system of  claim 16 , wherein the needle further includes a curved portion extending from the straight or angled tip. 
     
     
         18 . The system of  claim 16 , wherein:
 the needle is formed from a material having sufficient stiffness to enable directional tunneling of the needle within the subgaleal space; and   the material further has a sufficient flexibility to enable shaping of the needle one or more of prior to or during insertion of the needle into the subgaleal space.   
     
     
         19 . The system of  claim 16 , wherein the needle is integral with the at least one subgaleal electrode array. 
     
     
         20 . The system of  claim 16 , further comprising:
 a sheath having:
 a hollow structure configured to enable passage of the at least one subgaleal electrode array therethrough; and 
 at least one hole from an exterior of the sheath into the hollow structure, the at least one hole configured to enable deployment of the at least one subgaleal electrode array out from the hollow structure and into the subgaleal space. 
   
     
     
         21 . The system of  claim 20 , wherein the needle is integral with the sheath. 
     
     
         22 . The system of  claim 15 , further comprising:
 at least one stopper that is configured to attach to an end of the at least one subgaleal electrode array and to the patient at an entry or exit site of the end so as to inhibit movement of the at least one subgaleal electrode array.   
     
     
         23 . The system of  claim 22 , wherein the at least one stopper, in a state of attachment to the end of the at least one subgaleal electrode array and to the patient, is configured to cover the entry or exit site and maintain a sterility of the insertion of the at least one subgaleal electrode array. 
     
     
         24 . The system of  claim 22 , wherein the at least one stopper is integral with the interface. 
     
     
         25 . The system of  claim 15 , further comprising:
 the external processor, wherein the external processor is configured to perform operations, including:
 monitoring the plurality of electrodes of the at least one electrode array for an indication that an electrode of the plurality of electrodes is providing undesirable signal quality; and 
 responsive to the monitoring, excluding a recording channel of the at least one electrode array providing the undesirable signal quality. 
   
     
     
         26 . The system of  claim 25 , wherein the external processor is integral with the at least one stopper. 
     
     
         27 . The system of  claim 25 , wherein the external processor is integral with the interface. 
     
     
         28 . A system for detecting and/or transmitting subgaleal electrical signals, comprising:
 at least one subgaleal electrode array including:
 a flexible support structure having a shape implantable into and configured to conform to a shape of a subgaleal space of a patient; and 
 a plurality of electrodes distributed along a length of the flexible support structure, each of the plurality of electrodes arranged circumferentially about the flexible support structure, and the plurality of electrodes configured to one or more of detect or transmit a subgaleal electrical signal; 
   an interface configured to electrically connect the plurality of electrodes to an external processor;   a needle including a tip that is tapered and that is straight or angled, the needle operable to insert the at least one electrode array into the subgaleal space without an incision; and   at least one stopper that is configured to attach to an end of the at least one electrode array and to the patient at an entry or exit site of the end so as to inhibit movement of the at least one electrode array.   
     
     
         29 . The system of  claim 28 , further comprising:
 a passage assistant attachment configured to one or more of push or pull the needle through the subgaleal space.   
     
     
         30 . The system of  claim 28 , further comprising:
 an insertion guide usable to identify an anatomically appropriate area for insertion of the at least one subgaleal electrode array.   
     
     
         31 . The system of  claim 28 , wherein the at least one stopper includes a first retention element configured to be located at a skin entry site. 
     
     
         32 . The system of  claim 31 , wherein the at least one stopper further includes a second retention element configured to be located at a skin exit site. 
     
     
         33 . The system of  claim 28 , further comprising:
 an exit guide configured to facilitate passage of the needle through a skin layer at an-exit point.   
     
     
         34 . A system for detecting and/or transmitting subgaleal electrical signals, comprising:
 at least one subgaleal electrode array including:
 a flexible support structure having a shape implantable into and configured to conform to a shape of a subgaleal space of a patient; and 
 a plurality of electrodes distributed along a length of the flexible support structure, each of the plurality of electrodes arranged circumferentially about the flexible support structure, and the plurality of electrodes configured to one or more of detect or transmit a subgaleal electrical signal wherein:
 the plurality of electrodes includes at least one reference electrode, at least one ground electrode, and one or more recording electrodes; an interface; 
 a first portion of the flexible support structure includes the one or more recording electrodes, and 
 a second portion of the flexible support structure includes the reference electrode and the ground electrode, with no recording electrodes between the second portion and a first end of the at least one electrode array; and 
 
 an interface; and 
   an external processor electrically connected to the interface, wherein the external processor is configured to perform operations, including:
 monitoring the plurality of electrodes of the at least one electrode array for an indication that an electrode of the plurality of electrodes is providing undesirable signal quality; and 
 responsive to the monitoring, excluding a recording channel of the at least one electrode array providing the undesirable signal quality.