# US 10,369,353 B2 · Seizure disorder evaluation based on intracranial pressure and patient motion

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- Number: US 10,369,353 B2
- Document ID: US10369353B2
- Status: Granted
- Kind: B2
- Application number: 12/359,037
- Filed: 2009-01-23
- Published: 2010-05-13
- Granted: 2019-08-06
- Earliest claimed: 2008-11-11
- Assignees: Medtronic, Inc.
- Applicants: Jonathon E. Giftakis; Nina M. Graves; Jonathan C. Werder; Eric J. Panken; Timothy J. Denison; Keith A. Miesel; Michele H. Herzog
- Inventors: Jonathon E. Giftakis; Nina M. Graves; Jonathan C. Werder; Eric J. Panken; Timothy J. Denison; Keith A. Miesel; Michele H. Herzog
- Web page: https://patentgrep.com/patent/US10369353B2

## CPC

- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61B 5/031: {Intracranial pressure}
- A61B 5/4094: {Diagnosing or monitoring seizure diseases, e.g. epilepsy}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- 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

Intracranial pressure of a patient may be monitored in order to evaluate a seizure disorder. In some examples, trends in the intracranial pressure over time may be monitored, e.g., to detect changes to the patient's condition. In addition, in some examples, a seizure metric may be generated for a detected seizure based on sensed intracranial pressures. The seizure metric may indicate, for example, an average, median, or highest relative intracranial pressure value observed during a seizure, a percent change from a baseline value during the seizure, or the time for the intracranial pressure to return to a baseline state after the occurrence of a seizure. In addition to or instead of intracranial pressure, patient motion or posture may be monitored in order to assess the patient's seizure disorder. For example, a seizure type or severity may be determined based on patient motion sensed during a seizure.

## Claims

### Claim 1

A method comprising:
receiving, by one or more processors and from a pressure sensor, a pressure signal indicative intracranial pressure of a patient;
determining, with the one or more processors and based on the pressure signal, a trend in the intracranial pressure over time;
determining, with the one or more processors, a change in a seizure disorder of the patient based on the determined trend;
generating, with the one or more processors, an intracranial pressure indication in response to determining the change in the seizure disorder; and
controlling, with the one or more processors, a medical device to deliver therapy to the patient based on the determined change in the seizure disorder of the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pressure sensor is implanted within a cranium of the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pressure signal is indicative of the intracranial pressure of the patient sensed at a frequency of at least one of once per second, once per minute, once per hour or once per day.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pressure signal is indicative of the intracranial pressure within a ventricle of a brain of the patient.

### Claim 5 (depends on 1)

The method of claim 1, wherein determining the trend in the intracranial pressure over time comprises determining whether the intracranial pressure increases over time.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
detecting, with the one or more processors, a seizure of the patient;
determining, with the one or more processors, a seizure metric based on the intracranial pressure indicated by the pressure signal; and
associating, with the one or more processors, the seizure metric with the detected seizure in a memory.

### Claim 7 (depends on 6)

The method of claim 6, wherein the seizure metric comprises at least one of an average intracranial pressure value sensed during the detected seizure, a median intracranial pressure value sensed during the detected seizure, or a highest intracranial pressure value sensed during the detected seizure.

### Claim 8 (depends on 6)

The method of claim 6, wherein the seizure metric comprises a percent change of a value of the intracranial pressure during the detected seizure relative to a baseline value, a standard deviation of the intracranial pressure from the baseline value during the detected seizure, or a change in the intracranial pressure values over time during the detected seizure.

### Claim 9 (depends on 6)

The method of claim 6, further comprising:
detecting, with the one or more processors, an intracranial pressure value that is greater than a baseline value after detecting the seizure; and
detecting, with the one or more processors, when the intracranial pressure value returns to the baseline value after detecting the seizure, wherein the seizure metric comprises a duration of time during which the intracranial pressure returned to the baseline value.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
detecting, with the one or more processors, a seizure of the patient;
monitoring motion of the patient during the detected seizure; and
determining, with the one or more processors, a seizure metric based on the monitored motion.

### Claim 11 (depends on 10)

The method of claim 10, further comprising determining, with the one or more processors and based on the seizure metric, that the patient experienced a change in patient posture during the seizure.

### Claim 12 (depends on 10)

The method of claim 10, further comprising determining, with the one or more processors and based on the seizure metric, that the patient experienced an increase in patient motion during the seizure.

### Claim 13 (depends on 1)

The method of claim 1, wherein determining the change in the seizure disorder of the patient based on the determined trend comprises determining that at least one value of the sensed intracranial pressure is greater than or equal to a threshold value.

### Claim 14 (depends on 13)

The method of claim 13, wherein the threshold value is 15 millimeters of mercury (mmHg) to 20 mmHg.

### Claim 15 (depends on 13)

The method of claim 13, wherein determining that the at least one value of the intracranial pressure is greater than or equal to the threshold value comprises determining that at least one of a mean intracranial pressure value or a median intracranial pressure value of a plurality of intracranial pressure values sensed over a predetermined period of time is greater than or equal to the threshold value.

### Claim 16 (depends on 13)

The method of claim 13, wherein determining that the at least one value of the intracranial pressure is greater than or equal to the threshold value comprises determining that a current sensed value of the intracranial pressure is greater than or equal to the threshold value.

### Claim 17 (depends on 13)

The method of claim 13, further comprising generating at least one of an audible, visible, or somatosensory notification in response to determining that the at least one value of the intracranial pressure is greater than or equal to the threshold value.

### Claim 18 (depends on 13)

The method of claim 13, wherein the threshold value comprises a first threshold value, the method further comprising:
detecting, with the one or more processors, a seizure of the patient;
determining, with the one or more processors, a seizure metric based on the intracranial pressure;
after detecting the seizure, determining, with the one or more processors, whether the at least one value of the intracranial pressure is greater than or equal to a second threshold value;
generating, with the one or more processors, a first intracranial pressure category indication if the at least one value of the intracranial pressure is greater than or equal to the second threshold value;
determining, with the one or more processors, whether the value of the intracranial pressure is greater than or equal to a third threshold value if the value of the intracranial pressure is not greater than or equal to the second threshold value;
generating, with the one or more processors, a second intracranial pressure category indication if the at least one value of the intracranial pressure is greater than or equal to the third threshold value; and
generating, with the one or more processors, a third intracranial pressure category indication if the at least one value of the intracranial pressure is not greater than or equal to the third threshold value, wherein the seizure metric comprises at least one of the first, second, or third intracranial pressure category indications.

### Claim 19 (depends on 18)

The method of claim 18, wherein the second threshold value is greater than the third threshold value.

### Claim 20 (depends on 1)

The method of claim 1, wherein the pressure signal indicates a plurality of intracranial pressure values at a relatively high frequency, and wherein determining the trend in the sensed intracranial pressure over time comprises re-sampling the plurality of sensed intracranial pressure values post-hoc.

### Claim 21 (depends on 1)

The method of claim 1, wherein the pressure signal indicates a plurality of intracranial pressure values at a relatively low frequency, and wherein determining the trend in the sensed intracranial pressure over time comprises determining the trend based on each of the plurality of sensed intracranial pressure values.

### Claim 22 (depends on 1)

The method of claim 1, further comprising providing, with the one or more processors, a signal indicative of the intracranial pressure indication to an output device.

### Claim 23

A system comprising:
a pressure sensor configured to sense intracranial pressure of a patient and generate a pressure signal indicative of the sensed intracranial pressure; and a processor configured to:
receive, from the pressure sensor, the pressure signal,
determine a trend in the sensed intracranial pressure over time,
determine a change in a seizure disorder of the patient based on the determined trend, and
generate an intracranial pressure indication in response to determining the change in the seizure disorder; and
a medical device configured to delivery therapy to the patient to manage the seizure disorder,
wherein the processor is further configured to control the medical device to deliver the therapy to the patient based on the determined change in the seizure disorder of the patient.

### Claim 24 (depends on 23)

The system of claim 23, further comprising:
a therapy delivery element coupled to the medical device, wherein the therapy delivery element comprises the pressure sensor.

### Claim 25 (depends on 23)

The system of claim 23, further comprising:
a therapy delivery element coupled to the medical device, wherein the pressure sensor is physically separate from the therapy delivery element.

### Claim 26 (depends on 23)

The system of claim 23, wherein the processor is configured to determine the trend in the sensed intracranial pressure over time by at least determining whether the intracranial pressure increases over time.

### Claim 27 (depends on 23)

The system of claim 23, further comprising a memory, wherein the processor is configured to detect a seizure of the patient, determine a seizure metric based on the intracranial pressure indicated by the pressure signal, and associate the seizure metric with the detected seizure in the memory.

### Claim 28 (depends on 27)

The system of claim 27, further comprising a sensing module configured to sense a bioelectrical brain signal of the patient via two or more electrodes, wherein the processor is configured to detect the seizure based on the sensed bioelectrical brain signal.

### Claim 29 (depends on 27)

The system of claim 27, wherein the seizure metric comprises at least one of an average intracranial pressure value sensed during the detected seizure, a median intracranial pressure value sensed during the detected seizure, or a highest intracranial pressure value sensed during the detected seizure.

### Claim 30 (depends on 27)

The system of claim 27, wherein the seizure metric comprises a percent change of a value of the intracranial pressure during the detected seizure relative to a baseline value, a standard deviation of the intracranial pressure from the baseline value during the detected seizure, or a change in the intracranial pressure values over time during the detected seizure.

### Claim 31 (depends on 27)

The system of claim 27, wherein the processor is configured to:
detect an intracranial pressure value that is greater than a baseline value after detecting the seizure, and
detect when the intracranial pressure value returns to the baseline value after detecting the seizure, wherein the seizure metric comprises a duration of time during which the intracranial pressure returned to the baseline value.

### Claim 32 (depends on 23)

The system of claim 23, further comprising a motion sensor configured to generate a signal indicative of motion or posture of the patient, wherein the processor is configured to detect a seizure of the patient, monitor the signal indicative of motion or posture of the patient during the detected seizure, and determine a seizure metric based on the monitored signal indicative of motion or posture of the patient.

### Claim 33 (depends on 32)

The system of claim 32, wherein the processor is configured to determine, based on the seizure metric, that the patient experienced a change in patient posture during the seizure.

### Claim 34 (depends on 32)

The system of claim 32, wherein the processor is configured to determine, based on the seizure metric, that the patient experienced an increase in patient motion during the seizure.

### Claim 35 (depends on 23)

The system of claim 23, wherein the processor is configured to determine the change in the seizure disorder of the patient based on the determined trend by at least determining that at least one value of the sensed intracranial pressure is greater than or equal to a threshold value.

### Claim 36 (depends on 35)

The system of claim 35, wherein the threshold value is 15 millimeters of mercury (mmHg) to 20 mmHg.

### Claim 37 (depends on 35)

The system of claim 35, wherein the processor is configured to determine that the at least one value of the intracranial pressure is greater than or equal to the threshold value by at least determining that at least one of a mean intracranial pressure value or median intracranial pressure value of a plurality of intracranial pressure values sensed over a predetermined period of time is greater than or equal to the threshold value.

### Claim 38 (depends on 35)

The system of claim 35, wherein the processor is configured to generate a user notification if the value of the sensed intracranial pressure is greater than or equal to the threshold value.

### Claim 39 (depends on 38)

The system of claim 38, further comprising a user interface configured to transmit the user notification to a user, wherein the user notification comprises at least one of a visual, auditory or somatosensory alert.

### Claim 40 (depends on 38)

The system of claim 38, wherein the processor is configured to generate the user notification by at least causing the medical device to vibrate or generate an audible sound.

### Claim 41 (depends on 35)

The system of claim 35, wherein the threshold value comprises a first threshold value, the processor further configured to detect a seizure of the patient, determine a seizure metric based on the sensed intracranial pressure, determine whether the at least one value of the intracranial pressure is greater than or equal to a second threshold value after detecting the seizure, generate a first intracranial pressure category indication if the at least one value of the intracranial pressure is greater than or equal to the second threshold value, determine whether the at least one value of the intracranial pressure is greater than or equal to a third threshold value if the at least one value of the intracranial pressure is not greater than or equal to the second threshold value, generate a second intracranial pressure category indication if the at least one value of the intracranial pressure is greater than or equal to the third threshold value, and generate a third intracranial pressure category indication if the at least one value of the intracranial pressure is not greater than or equal to the third threshold value, wherein the seizure metric comprises at least one of the first, second, or third intracranial pressure category indications.

### Claim 42 (depends on 23)

The system of claim 23, wherein the pressure sensor is configured to sense intracranial pressure of the patient by at least sensing a plurality of intracranial pressure values at a relatively high frequency, and wherein the processor is configured to determine the trend in the sensed intracranial pressure over time by at least re-sampling the plurality of sensed intracranial pressure values post-hoc.

### Claim 43 (depends on 23)

The system of claim 23, wherein the pressure sensor is configured to sense intracranial pressure of the patient by at least sensing a plurality of intracranial pressure values at a relatively low frequency, and wherein the processor is configured to determine the trend in the sensed intracranial pressure over time by at least determining the trend based on each of the plurality of sensed intracranial pressure values.

### Claim 44 (depends on 23)

The system of claim 23, wherein the processor is further configured to adjust the delivery of the therapy by the medical device to the patient based on the determined change in the seizure disorder of the patient.

### Claim 45 (depends on 23)

The system of claim 23, wherein the processor is further configured to provide a signal indicative of the intracranial pressure indication to an output device.

### Claim 46

A system comprising:
means for sensing intracranial pressure of a patient;
means for determining a trend in the sensed intracranial pressure over time;
means for determining a change in a seizure disorder of the patient based on the determined trend;
means for generating an intracranial pressure indication in response to the determination of the change in the seizure disorder;
means for delivering therapy to the patient to manage the seizure disorder; and
means for controlling the means for delivering therapy to deliver therapy to the patient based on the determined change in the seizure disorder of the patient.

### Claim 47 (depends on 46)

The system of claim 46, further comprising:
means for detecting a seizure of the patient;
means for determining a seizure metric based on the sensed intracranial pressure; and
means for associating the seizure metric with the detected seizure in a memory.

### Claim 48 (depends on 46)

The system of claim 46, further comprising:
means for monitoring motion of the patient; and
means for determining a seizure metric based on the monitored motion of the patient.

### Claim 49 (depends on 46)

The system of claim 46, wherein the means for determining the change in the seizure disorder of the patient based on the determined trend comprises means for determining that a value of the sensed intracranial pressure is greater than or equal to a threshold value.

### Claim 50 (depends on 46)

The system of claim 46, further comprising means for providing a signal indicative of the intracranial pressure indication to an output device.