# US 2014/0194945 A1 · Target therapy delivery site selection

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- Number: US 2014/0194945 A1
- Document ID: US20140194945A1
- Status: Published application
- Kind: A1
- Application number: 14/207,926
- Filed: 2014-03-13
- Published: 2014-07-10
- Earliest claimed: 2011-01-25
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Paul H. Stypulkowski; Jonathon E. Giftakis
- Web page: https://patentgrep.com/patent/US20140194945A1

## CPC

- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61N 1/36064: {Epilepsy}
- A61N 1/36171: {Frequency}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/36135: {using physiological parameters}
- 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)

## Abstract

In some examples of selecting a target therapy delivery site for treating a patient condition, a relatively high frequency electrical stimulation signal is delivered to at least two areas within a first region (e.g., an anterior nucleus of the thalamus) of a brain of a patient, and changes in brain activity (e.g., as indicated by bioelectrical brain signals) within a second region (e.g., a hippocampus) of the brain of the patient in response to the delivered stimulation are determined. The target therapy delivery site, an electrode combination, or both, may be selected based on the changes in brain activity.

## Claims

### Claim 1

A method comprising:
mapping functional connections between a first region of a brain of a patient and a second region of the brain, wherein mapping functional connections comprises:
controlling a stimulation generator to deliver electrical stimulation to a plurality of different areas of the first region of the brain of the patient, wherein the electrical stimulation is delivered to each area of the plurality of different areas of the first region of the brain at different times; and
for each area of the plurality of different areas of the first region of the brain, determining a level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and
with a processor, selecting at least one of the areas of the plurality of different areas of the first region of the brain as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first and second regions are within a Circuit of Papez of the brain.

### Claim 3 (depends on 2)

The method of claim 2, wherein the Circuit of Papez includes an anterior nucleus of a thalamus, an internal capsule, a cingulate, a hippocampus, a formix, an entorhinal cortex, mammillary bodies, and a mammillothalamic tract.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

### Claim 5 (depends on 1)

The method of claim 1, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

### Claim 6 (depends on 1)

The method of claim 1, further comprising sensing a bioelectrical brain signal in the second region of the brain of the patient, wherein determining, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining the level of brain activity in the second region of the brain of the patient based on the sensed bioelectrical brain signal.

### Claim 7 (depends on 1)

The method of claim 1, further comprising sensing a bioelectrical brain signal in the first region of the brain of the patient, wherein determining, for each area of the plurality of different areas of the first region, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining the level of brain activity in the second region of the brain of the patient based on the sensed bioelectrical brain signal.

### Claim 8 (depends on 1)

The method of claim 1, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient comprises controlling the stimulation generator to deliver electrical stimulation to a first area of the first region of the brain via a subset of electrodes of a lead, and wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises determining, with the stimulation generator, a first level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the first area, the method further comprising:
receiving an indication that the lead has been moved within the brain of the patient;
after receiving the indication, controlling the stimulation generator to deliver electrical stimulation to a second area of the first region of the brain via the subset of electrodes, wherein the plurality of different areas comprises the second area; and
after the stimulation generator delivers electrical to the second area of the first region of the brain, determining a second level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the second area of the first region.

### Claim 9 (depends on 8)

The method of claim 8, further comprising:
determining whether the second level of brain activity in the second region of the brain of the patient is less than the first level of brain activity in the second region,
wherein if the second level is less than the first level, controlling the stimulation generator to deliver electrical stimulation to a third area of the first region of the brain via the subset of electrodes, wherein the plurality of different areas comprises the third area, and after the stimulation generator delivers electrical stimulation to the third area of the first region, determining a third level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the third area of the first region, and
wherein if the second level is not less than the first level, selecting the first area of the first region of the brain of the patient as the target therapy delivery site.

### Claim 10 (depends on 1)

The method of claim 1, wherein the plurality of different areas of the first region comprises a first area and a second area, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient and, for each area of the plurality of different areas, determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area comprises:
controlling the stimulation generator to deliver electrical stimulation to the first area of the first region of the brain of the patient, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz;
immediately after the stimulation generator delivers electrical stimulation to the first area of the first region, determining a first level of brain activity in the second region of the brain of the patient;
controlling the stimulation generator to deliver electrical stimulation to the second area of the first region of the brain, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz; and
immediately after the stimulation generator delivers electrical stimulation to the second area of the first region, determining a second level of brain activity in the second region of the brain of the patient,
wherein selecting at least one of the areas of the first region of the brain of the patient as the target therapy delivery site comprises, with the processor, selecting one of the first area or the second area of the first region of the brain of the patient as the target therapy delivery site based on the first and second levels of brain activity in the second region of the brain.

### Claim 11 (depends on 1)

The method of claim 1, wherein selecting at least one of the areas of the plurality of different areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain comprises selecting the area of the plurality of different areas associated with a lowest level of brain activity in the second region.

### Claim 12 (depends on 1)

The method of claim 1, further comprising implanting an implantable medical lead comprising a plurality of electrodes in the first region of the brain of the patient, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region comprises, for each area of the plurality of different areas, controlling the stimulation generator to deliver to the first region using a different subset of electrodes of the lead.

### Claim 13 (depends on 1)

The method of claim 1, further comprising associating the level of brain activity in the second region with the respective area of the first region and storing the level of brain activity in the second region and associated area of the first region in a memory of a device.

### Claim 14 (depends on 1)

The method of claim 1, wherein the level of brain activity comprises at least one of a time domain characteristic or a frequency domain characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient.

### Claim 15 (depends on 1)

The method of claim 1, wherein the level of brain activity comprises at least one of a change in a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient relative to a baseline characteristic of the bioelectrical brain signal.

### Claim 16 (depends on 1)

The method of claim 1, wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area of the plurality of different areas of the first region comprises determining the level of brain activity in the second region of the brain while electrical stimulation is being delivered to the area.

### Claim 17 (depends on 1)

The method of claim 1, wherein determining the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area of the plurality of different areas of the first region comprises determining the level of brain activity in the second region of the brain after terminating the delivery of electrical stimulation to the area.

### Claim 18 (depends on 1)

The method of claim 1, further comprising:
for each area of the plurality of areas, generating a metric based on the level of brain activity in the second region resulting from the delivery of the electrical stimulation to the area, wherein the metric indicates a relative level of brain activity in the second region resulting from delivery of electrical stimulation to the respective area of the first region; and
displaying, via a display of a device, indications of each area of the plurality of areas and the respective metric.

### Claim 19 (depends on 18)

The method of claim 18, wherein the metric comprises at least one of a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient, a graphical representation of the bioelectrical brain signal, an indication of a distribution of power in the bioelectrical brain signal, a power level of the bioelectrical brain signal at a frequency of about 2 Hertz, or a change in a characteristic of a bioelectrical brain signal relative to a baseline characteristic of the bioelectrical brain signal.

### Claim 20 (depends on 1)

The method of claim 1, further comprising controlling the stimulation generator to deliver electrical stimulation therapy to the target therapy delivery site.

### Claim 21 (depends on 1)

The method of claim 1, wherein controlling the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region comprises controlling the stimulation generator to deliver electrical stimulation via each electrode combination of a plurality of electrode combinations, and wherein selecting at least one of the areas of the plurality of different areas of the first region as the target therapy delivery site based on the associated level of brain activity in the second region of the brain comprises selecting at least one electrode combination of the plurality of electrode combinations based on the associated level of brain activity in the second region of the brain.

### Claim 22

A system comprising:
a stimulation generator configured to generate and deliver electrical stimulation;
a sensing module; and
a processor configured to map functional connections between a first region of a brain of a patient and a second region of the brain, wherein the processor is configured to map the functional connections by at least controlling the stimulation generator to deliver electrical stimulation to each area of a plurality of different areas of the first region of the brain at a different time, and determining, for each area of the plurality of different areas of the first region and based on a bioelectrical brain signal sensed by the sensing module, a level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area.

### Claim 23 (depends on 22)

The system of claim 22, wherein the processor is further configured to select at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

### Claim 24 (depends on 22)

The system of claim 22, wherein the first and second regions are within a Circuit of Papez of the brain.

### Claim 25 (depends on 24)

The system of claim 24, wherein the Circuit of Papez includes an anterior nucleus of a thalamus, an internal capsule, a cingulate, a hippocampus, a formix, an entorhinal cortex, mammillary bodies, and a mammillothalamic tract.

### Claim 26 (depends on 22)

The system of claim 22, the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

### Claim 27 (depends on 22)

The system of claim 22, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

### Claim 28 (depends on 22)

The system of claim 22, wherein the sensing module is configured to sense the bioelectrical brain signal in the second region of the brain of the patient and the processor is configured to determine, for each area of the plurality of different areas of the first region, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal sensed in the second region of the brain.

### Claim 29 (depends on 22)

The system of claim 22, wherein the sensing module is configured to sense the bioelectrical brain signal in the first region of the brain of the patient and the processor is configured to determine, for each area of the plurality of different areas of the first region, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal sensed in the first region of the brain.

### Claim 30 (depends on 22)

The system of claim 22, further comprising a lead comprising electrodes, wherein the processor is configured to control the stimulation generator to deliver stimulation to a first area of the first region via a subset of the electrodes of the lead, and determine the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area by at least determining a first level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the first area, wherein the processor is further configured to receive an indication that the lead has been moved within the brain of the patient and, after receiving the indication, control the stimulation generator to deliver stimulation to a second area of the first region via the subset of electrodes, wherein the plurality of different areas comprises the second area, and, determine a second level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the second area of the first region, and wherein the processor is configured to determine whether the second level of brain activity in the second region of the brain of the patient is less than the first level of brain activity in the second region, and, in response to determining the second level is less than the first level, control the stimulation generator to deliver stimulation to a third area of the first region via the subset of electrodes, wherein the plurality of different areas comprises the third area, and determine a third level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the third area of the first region, and wherein the processor is configured to, in response to determining the second level is not less than the first level, select the first area of the first region of the brain of the patient as the target therapy delivery site.

### Claim 31 (depends on 22)

The system of claim 22, wherein the plurality of different areas of the first region of the brain comprises a first area and a second area, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain of the patient and, for each area of the plurality of different areas, determine the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area by at least:
controlling the stimulation generator to deliver electrical stimulation to the first area of the first region of the brain of the patient, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz;
immediately after the stimulation generator delivers the electrical stimulation to the first area of the first region, determining a first level of brain activity in the second region of the brain of the patient;
after determining the first level of brain activity in the second region of the brain, controlling the stimulation generator to deliver stimulation to the second area of the first region of the brain, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz; and
immediately after the stimulation generator delivers electrical stimulation to the second area of the first region, determining a second level of brain activity in the second region of the brain of the patient,
wherein the processor is configured to select one of the first area or the second area of the first region of the brain of the patient as the target therapy delivery site based on the first and second levels of brain activity in the second region of the brain.

### Claim 32 (depends on 22)

The system of claim 22, further comprising a memory, wherein the processor is configured to associate the level of brain activity in the second region with the respective area of the first region of the brain and stores the level of brain activity in the second region and associated area of the first region in the memory.

### Claim 33 (depends on 22)

The system of claim 22, wherein the level of brain activity comprises at least one of time domain characteristic or a frequency domain characteristic of the bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient.

### Claim 34 (depends on 33)

The system of claim 33, wherein the level of brain activity comprises an amplitude of the bioelectrical brain signal sensed in the at least one of the first region or the second region of the brain of the patient.

### Claim 35 (depends on 33)

The system of claim 33, wherein the level of brain activity comprises a power level of the bioelectrical brain signal at a frequency of about 2 Hertz.

### Claim 36 (depends on 22)

The system of claim 22, wherein the level of brain activity comprises at least one of a change in a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient relative to a baseline characteristic of the bioelectrical brain signal.

### Claim 37 (depends on 22)

The system of claim 22, further comprising a display, wherein the processor is configured to, for each area of the plurality of areas, generate a metric based on the level of brain activity in the second region resulting from the delivery of the electrical stimulation to the area, wherein the metric indicates a relative level of brain activity in the second region resulting from delivery of electrical stimulation to the respective area, and present, via the display, indications of each area of the plurality of areas and the respective metric.

### Claim 38 (depends on 37)

The system of claim 37, wherein the metric comprises at least one of a characteristic of a bioelectrical brain signal sensed in at least one of the first region or the second region of the brain of the patient, a graphical representation of the bioelectrical brain signal, an indication of a distribution of power in the bioelectrical brain signal, a power level of the bioelectrical brain signal at a frequency of about 2 Hertz, or a change in a characteristic of a bioelectrical brain signal relative to a baseline characteristic of the bioelectrical brain signal.

### Claim 39 (depends on 22)

The system of claim 22, further comprising a medical device programmer comprising the processor.

### Claim 40 (depends on 22)

The system of claim 22, wherein the processor is configured to control the stimulation generator to generate and deliver electrical stimulation therapy to the target therapy delivery site.

### Claim 41 (depends on 22)

The system of claim 22, wherein the processor is configured to determine, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal while the stimulation generator is delivering the electrical stimulation to the area.

### Claim 42 (depends on 22)

The system of claim 22, wherein the processor is configured to determine, for each area of the plurality of different areas of the first region of the brain, the level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area based on the bioelectrical brain signal after the stimulation generator terminates delivery of the electrical stimulation to the area.

### Claim 43 (depends on 22)

The system of claim 22, further comprising a plurality of electrodes, wherein the processor is configured to control the stimulation generator to deliver electrical stimulation to the plurality of different areas of the first region of the brain by at least controlling the stimulation generator to deliver electrical stimulation to the first region via each of a plurality of combinations of electrodes of the plurality of electrodes, and wherein the processor is configured to select at least one of the areas of the plurality of different areas of the first region of the brain as the target therapy delivery site based on the associated level of brain activity in the second region of the brain by at least selecting at least one electrode combination of the plurality of electrode combinations based on the associated level of brain activity in the second region of the brain.

### Claim 44 (depends on 22)

The system of claim 22, wherein the processor is configured to select at least one of the areas of the plurality of different areas of the first region of the brain of the patient as the target therapy delivery site based on the associated level of brain activity in the second region of the brain by at least selecting the area of the plurality of different areas associated with a lowest level of brain activity in the second region.

### Claim 45

A system comprising:
means for delivering electrical stimulation to a brain of a patient;
means for mapping functional connections between a first region of a brain of a patient and a second region of the brain, wherein the mapping functional connections comprises:
means for controlling the means for delivering electrical stimulation to deliver electrical stimulation to each area of a plurality of different areas of the first region of the brain at different times; and
means for determining, for each area of the plurality of different areas of the first region, a level of brain activity in a second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and
means for selecting at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

### Claim 46 (depends on 45)

The system of claim 45, wherein the first and second regions are within a Circuit of Papez of the brain.

### Claim 47 (depends on 45)

The system of claim 45, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

### Claim 48 (depends on 45)

The system of claim 45, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.

### Claim 49 (depends on 45)

The system of claim 45, further comprising means for sensing a bioelectrical brain signal of the brain of the patient, wherein the means for determining, for each area of the plurality of different areas of the first region, the level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area is configured to determine the level of brain activity in the second region based on the sensed bioelectrical brain signal.

### Claim 50

A computer readable medium comprises instructions that, when executed by a processor, cause the processor to:
map functional connections between a first region of a brain of a patient and a second region of the brain by at least:
controlling a stimulation generator to deliver electrical stimulation to a plurality of different areas of the first region of the brain of the patient, wherein the electrical stimulation is delivered to each area of the plurality of different areas of the first region of the brain at different times; and
for each area of the plurality of different areas of the first region of the brain, determining a level of brain activity in the second region of the brain of the patient resulting from the delivery of the electrical stimulation to the area; and
select at least one of the areas of the first region of the brain of the patient as a target therapy delivery site based on the associated level of brain activity in the second region of the brain.

### Claim 51 (depends on 50)

The computer readable medium of claim 50, wherein the first and second regions are within a Circuit of Papez of the brain.

### Claim 52 (depends on 50)

The computer readable medium of claim 50, wherein the first region is an anterior nucleus of a thalamus of the brain and the second region is a hippocampus of the brain.

### Claim 53 (depends on 50)

The computer readable medium of claim 50, wherein the electrical stimulation comprises a frequency greater than or equal to about 80 Hertz.
