# US 12,485,277 B2 · Devices, systems and methods for cortical stimulation

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- Number: US 12,485,277 B2
- Document ID: US12485277B2
- Status: Granted
- Kind: B2
- Application number: 17/792,149
- Filed: 2021-01-14
- Published: 2023-03-09
- Granted: 2025-12-02
- Earliest claimed: 2020-01-14
- Assignees: Inner Cosmos Inc.
- Applicants: Inner Cosmos Inc.
- Inventors: Daniel W. Moran; Eric Claude Leuthardt; Meron Gribetz
- Web page: https://patentgrep.com/patent/US12485277B2

## CPC

- A61N 1/0529: {Electrodes for brain stimulation}
- A61N 1/0531: {Brain cortex electrodes}
- A61B 5/165: {Evaluating the state of mind, e.g. depression, anxiety}
- A61B 5/168: {Evaluating attention deficit, hyperactivity}
- A61B 5/37: Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
- A61B 5/372: Analysis of electroencephalograms
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/36135: {using physiological parameters}
- A61N 1/37211: {Means for communicating with stimulators}
- A61N 1/37514: {Brain implants}
- A61N 1/3787: {from an external energy source}
- A61N 1/36071: {Pain}
- A61N 1/36085: {Eating disorders or obesity}
- A61N 1/36089: {Addiction or withdrawal from substance abuse such as alcohol or drugs}
- A61N 1/36096: {Mood disorders, e.g. depression, anxiety or panic disorder}
- A61N 1/37235: {Aspects of the external programmer}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems including intra-calvarial implants and/or subdermal implants are capable of stimulating cortical regions and sensing and electrical signals is implanted within or on a calvarial bone of a skull. The implants have current steering capability to change the current density profiles applied to selected cortical regions underlying the implant. The systems may track changes in the position and/or spatial parameters of a neural network by recording cortical electrical signals and processing them to compute the values of one or more network activity biomarkers. The systems may spatially track changes detected in network anatomical position and deliver the stimulation of the cortex to the network detected position by using current steering methods.

## Claims

### Claim 1

A system for tracking a cortical region to be stimulated in a patient, the system comprising:
at least one implantable device configured to be implanted in the head of the patient, the implantable device includes a plurality of recording electrodes for recording electrical signals from the cortical region, a plurality of stimulating electrodes for delivering stimulating electrical signals to at least part of the cortical region, a controller/processor for controlling the recording of the electrical signals from the cortical region and for controlling the delivering of the stimulating signals, a telemetry unit for wirelessly bi-directionally communicating with one or more external devices and a power source for energizing the implantable device,
one or more external devices disposed outside the body of the patient, the one or more external devices includes at least one processor/controller configured for processing data and at least one telemetry unit for wirelessly bi-directionally communicating with the at least one implantable device,
wherein the at least one implantable device and one or more external devices are in wireless communication there between and are programmed to perform the steps of,
recording electrical cortical signals using the plurality of recording electrodes,
processing the recorded electrical signals to compute spatial parameters representing the spatial distribution of the magnitude of at least one biomarker indicative of the cortical region to be stimulated,
selecting from a look-up table (LUT) available in the system and including a plurality of simulated current spatial distribution data sets or datasets derived from the plurality of simulated current spatial distribution sets, a matched data set of stimulation parameters to be applied to the plurality of stimulating electrodes responsive to the spatial parameters representing the spatial distribution of the at least one biomarker computed in the step of processing, and
applying to the cortical region stimulating electrical signals using the matched set of stimulation parameters selected in the step of selecting.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the at least one implantable device comprises a plurality of implantable devices implanted in the head of the patient.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the one or more external devices are selected from the list consisting of, a hand held computing device, a wearable computing device, a smartwatch, a smartphone, a personal computer, a personal laptop, a remote clinical workstation, a remote server and any combination thereof.

### Claim 4 (depends on 3)

The system according to claim 3, wherein the system includes at least one remote server and wherein the steps of processing and selecting are performed by cloud processing on the remote server or on the remote clinical workstation.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the one or more implantable devices each include a magnet, and wherein the one or more external devices include one or more detachably attachable wirelessly energizing devices, attachable to the scalp of the patient over the at least one implantable device, wherein the one or more energizing devices are selected from the list consisting of,
an energizing pod comprising a housing, an induction coil electromagnetically couplable to a second induction coil disposed within or on the at least one implantable device for inductively providing electrical energy to the at least one implantable device, a power transmitter electrically connected to the induction coil of the energizing pod, a telemetry unit for wirelessly bi-directionally communicating data and/or commands and/or status signals between the energizing pod and at least one of the one or more external devices, a sensor for detecting attachment of the energizing pod to the scalp of the patient over the at least one implantable device, a memory unit for storing and retrieving data, a processor/controller connected to the sensor, the telemetry unit, the memory unit and the power transmitter for controlling the operation thereof, a power source for providing electrical energy to the components of the pod, and a magnet attached to the housing or disposed within the housing of the energizing pod,
an energizing pod comprising a housing, an induction coil electromagnetically couplable to a second induction coil disposed within or on the at least one implantable device for inductively providing electrical energy to the at least one implantable device, a power transmitter electrically connected to the induction coil of the energizing pod, a telemetry unit for wirelessly bi-directionally communicating data and/or commands and/or status signals between the energizing pod and at least one of the one or more external devices, a sensor for detecting attachment of the energizing pod to the scalp of the patient over the at least one implantable device, a memory unit for storing and retrieving data, a processor/controller connected to the sensor, the telemetry unit, the memory unit and the power transmitter for controlling the operation thereof, a power source for providing electrical energy to the components of the pod, and a permanent magnet attached to the housing or disposed within the housing of the energizing pod,
an energizing pod comprising a housing, an induction coil electromagnetically couplable to a second induction coil disposed within or on the at least one implantable device for inductively providing electrical energy to the at least one implantable device, a power transmitter electrically connected to the induction coil of the energizing pod, a telemetry unit for wirelessly bi-directionally communicating data and/or commands and/or status signals between the energizing pod and at least one of the one or more external devices, a sensor for detecting attachment of the energizing pod to the scalp of the patient over the at least one implantable device, a memory unit for storing and retrieving data, a processor/controller connected to the sensor, the telemetry unit, the memory unit and the power transmitter for controlling the operation thereof, a power source for providing electrical energy to the components of the pod, and a magnet attached to the housing or disposed within the housing of the energizing pod, wherein the inductance coil connected to the power transmitter of the pod is also electrically connected to the telemetry unit and is operable as an antenna of the telemetry unit,
an energizing pod comprising a housing, an induction coil electromagnetically couplable to a second induction coil disposed within or on the at least one implantable device for inductively providing electrical energy to the at least one implantable device, a power transmitter electrically connected to the induction coil of the energizing pod for controllably providing electrical alternating current to the inductance coil, a telemetry unit for wirelessly bi-directionally communicating data and/or commands and/or status signals between the energizing pod and at least one of the one or more external devices, a sensor for detecting attachment of the energizing pod to the scalp of the patient over the at least one implantable device, a memory unit for storing and retrieving data, a processor/controller connected to the sensor, the telemetry unit, the memory unit and the power transmitter for controlling the operation thereof, a power source for providing electrical energy to the components of the pod, and a magnet attached to the housing or disposed within the housing of the energizing pod.

### Claim 6 (depends on 1)

The system according to claim 1, wherein the implantable device is programmed to perform the step of recording and the step of applying and wherein the at least one external device is programmed to perform the steps of processing and selecting.

### Claim 7 (depends on 1)

The system according to claim 1, wherein the stimulating electrical signals are selected from,
exciting stimulating electrical signals,
inhibiting electrical signals, and
a combination of exciting and inhibiting signals.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the at least one implantable device is selected from the list consisting of, an intra-calvarially implantable device adapted to be implanted within the calvarial bone of the skull of the patient, and, an implantable device adapted to be implanted between a calvarial bone and a scalp of the patient.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the at least one biomarker is selected from the list consisting of, a time resolved phase amplitude coupling of gamma and beta frequency bands [tPAC]γβ, a normalized alpha-theta power difference (ΔPα,θ), a normalized alpha-theta power ratio (PRα,θ), a relative gamma power with respect to the total power (PRELγ), a relative beta power with respect to the total power (PRELβ), a normalized beta-gamma power difference (ΔPβ,γ), a normalized beta-gamma relative power (PRELβγ), a normalized beta-gamma power ratio (PRβ,γ), peak frequency of a spectral analysis, peak frequency power in a specific frequency band, phase coupling, correlation measurements, frequency band variance, frequency band power, ripples, fast ripples.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the plurality of recording electrodes are selected from the list of,
a plurality of identically shaped recording electrodes positioned such that their recording surfaces are disposed on the bottom surface of the implantable device and facing the cortical region,
a plurality of identically shaped recording electrodes positioned such that their recording surfaces are disposed on the bottom surface of the implantable device and facing the cortical region and wherein the recording electrodes are symmetrically disposed with respect to the center point of the bottom of the implantable device,
a plurality of identically shaped recording electrodes positioned such that their recording surfaces are disposed on the bottom surface of the implantable device and facing the cortical region and wherein the recording electrodes are non-symmetrically disposed with respect to the center point of the bottom of the implantable device.

### Claim 11 (depends on 1)

The system according to claim 1, wherein the one or more implantable devices also includes one or more auxiliary electrodes selected from the list consisting of,
one or more reference electrodes,
one or more current return electrodes,
one or more stimulating electrodes,
one or more reference electrodes disposed on one or more attachment tabs of the implantable device,
one or more reference electrodes disposed on a laterally extending member attached to or laterally extending from the implantable device,
one or more current return electrodes disposed on one or more attachment tabs of the implantable device,
one or more current return electrodes disposed on a laterally extending member attached to or laterally extending from the implantable device,
one or more additional stimulating electrodes disposed on one or more attachment tabs of the implantable device,
one or more additional stimulating electrodes disposed on a laterally extending member attached to or laterally extending from the implantable device, and
any combinations thereof.

### Claim 12 (depends on 1)

The system according to claim 1, wherein the step of selecting includes the steps of,
computing the coordinates of the centroid of biomarker peak magnitude in a Cartesian x,y coordinate system within a first plane parallel to the bottom surface of the implanted device from the values of the biomarker computed for each electrode recording electrode,
computing for each parameter set of the LUT the coordinates of the peak current density in a second plane parallel to the first plane and disposed within the cortical region to be stimulated, to obtain a set of computed values of coordinates of peak current densities,
computing the distance between x-y coordinates of the centroid and each of the x-y coordinates to obtain a set of distance values,
selecting from the set of computed distances the set of stimulation parameters having the shortest distance of the set of distance values,
if there are two or more shortest distance values having the same value, randomly or pseudo-randomly choosing a single set of stimulation parameters from the set of two or more equal shortest distance values.

### Claim 13 (depends on 1)

The system according to claim 1, wherein the system includes at least one external device capable of providing EMA data to the system and wherein the step of applying may be prevented or enabled responsive to the EMA data provided to the system.

### Claim 14 (depends on 1)

The system according to claim 1, wherein the system includes at least one external device capable of providing heart rate variability (HRV) data to the system, and wherein the step of applying may be prevented or enabled responsive to the HRV data provided to the system.

### Claim 15 (depends on 1)

The system according to claim 1, wherein the step of processing includes processing the electrical signals recorded by one or more of the recording electrodes and computing from the electrical signals the value of a biomarker indicative of the mood state of the patient, and wherein the step of applying may be prevented or enabled responsive to the computed value of the biomarker data.

### Claim 16 (depends on 1)

The system according to claim 1, wherein the patient is a patient having a disorder or condition selected from the list consisting of, a mood disorder, depression post traumatic syndrome (PTSD), bipolar disorder, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), chronic pain, addiction, obesity, an eating disorder, bulimia, anorexia, a neurodegenerative disorder, anxiety, a dementia, Alzheimer' disease, an age related cognitive decline, Traumatic brain injury (TBI), or any combination thereof.

### Claim 17 (depends on 1)

A method for detecting and tracking in a cortex of a patient the present anatomical position of a cortical neural network to be stimulated by an implantable device by using the system according to claim 1, the method comprising the steps of:
recording electrical cortical signals from a cortical region of the patient using the plurality of recording electrodes,
processing the recorded electrical signals to compute spatial parameters representing the spatial distribution of the magnitude of at least one biomarker indicative of the cortical region to be stimulated,
selecting from an available plurality of simulated current spatial distribution data or data sets derived from the plurality of simulated current spatial distribution data sets, a matched set of stimulation parameters to be applied to the cortex responsive to the spatial parameters representing the spatial distribution of the at least one biomarker computed in the step of processing, and
applying to the cortex stimulating electrical signals using the matched set of stimulation parameters selected in the step of selecting.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the step of applying is performed by one or more implantable devices implanted within a calvarial bone of the patient or between the calvarial bone and a scalp of the patient, the one or more implantable devices have a plurality of stimulating electrodes for stimulating the cortex of the patient.

### Claim 19 (depends on 17)

The method according to claim 17, wherein the step of recording includes the steps of conditioning and amplifying the cortical signals prior to the step of processing.

### Claim 20 (depends on 17)

The method according to claim 17, wherein the method includes the step of wirelessly transmitting the signal recorded in the step of recording to at least one computing device disposed outside the body of the patient, wherein one or more of the steps of processing and selecting is performed by the at list one computing device.

### Claim 21 (depends on 18)

The method according to claim 18, wherein the method also includes the step of wirelessly transmitting the matched set of stimulation parameters selected in the step of selecting to one or more implantable devices for controlling the application of cortical stimulation by a plurality of stimulating electrodes included in the one or more implantable devices, using the matched set of stimulation parameters.

### Claim 22 (depends on 17)

The method according to claim 17, wherein the step of selecting includes the steps of,
computing the coordinates of the centroid of the at least one biomarker in a Cartesian x,y coordinate system within a first plane passing through the bottom surface of the implanted device from the values of the biomarker computed for each recording electrode of the plurality of recording electrodes,
computing for each parameter set of the LUT the coordinates of the peak current density in a second plane parallel to the first plane and disposed within the cortical region to be stimulated, to obtain a set of computed values of coordinates of peak current densities,
computing the distance between the x,y coordinates of the centroid and each of the x-y coordinates to obtain a set of distance values,
selecting from the set of computed distances the set of stimulation parameters having the shortest distance of the set of distance values, and
if there are two or more shortest distance values having the same value, randomly or pseudo-randomly choosing a single set of stimulation parameters from the set of two or more equal shortest distance values.

### Claim 23 (depends on 17)

The method according to claim 17, wherein the method includes the step of receiving EMA data from a device outside the body of the patient and wherein the step of applying may be prevented or enabled responsive to the EMA data.

### Claim 24 (depends on 17)

The method according to claim 17, wherein the system includes the step of receiving heart rate variability (HRV) data, and wherein the step of applying may be prevented or enabled responsive to the HRV data.

### Claim 25 (depends on 17)

The method according to claim 17, wherein the step of processing includes processing the electrical signals recorded from the cortex in the step of recording and computing from the electrical signals the value of one or more biomarkers indicative of the mood state of the patient, and wherein the step of applying may be prevented or enabled responsive to the computed value of the biomarker data.

### Claim 26 (depends on 25)

The method according to claim 25, wherein the one or more biomarkers are selected from the list consisting of: a time resolved phase amplitude coupling of gamma and beta frequency bands [tPAC]γβ, or a normalized alpha-theta power difference (ΔPα,θ), a normalized alpha-theta power ratio (PRα,θ), or a relative gamma power with respect to the total power (PRELγ), a relative beta power with respect to the total power (PRELβ), a normalized beta-gamma power difference (ΔPβ,γ), a normalized beta-gamma relative power (PRELβγ), a normalized beta-gamma power ratio (PRβ,γ), peak frequency of a spectral analysis, peak frequency power in a specific frequency band, phase coupling, correlation measurements, frequency band variance, frequency band power, ripples, and fast ripples.

### Claim 27 (depends on 17)

The method according to claim 17, wherein the patient is a patient having a disorder or condition selected from the list consisting of, a mood disorder, post traumatic syndrome (PTSD), bipolar disorder, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), chronic pain, addiction, obesity, a neurodegenerative disorder, a dementia, or Alzheimer' disease, an age related cognitive decline, Traumatic brain injury (TBI), or any combination thereof.