# US 10,864,368 B2 · Adaptive deep brain stimulation using homeostatic window

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- Number: US 10,864,368 B2
- Document ID: US10864368B2
- Status: Granted
- Kind: B2
- Application number: 15/714,845
- Filed: 2017-09-25
- Published: 2018-03-29
- Granted: 2020-12-15
- Earliest claimed: 2016-09-27
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Scott R. Stanslaski; Thomas Adamski; Duane L. Bourget; Timothy J. Denison; Benjamin P. Isaacson; Eric J. Panken; Jeffrey Herron
- Web page: https://patentgrep.com/patent/US10864368B2

## CPC

- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/374: Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6868: {Brain}
- A61N 1/36064: {Epilepsy}
- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36071: {Pain}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/36132: {using patient feedback}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36096: {Mood disorders, e.g. depression, anxiety or panic disorder}
- 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

Techniques are disclosed for defining a homeostatic window for controlling delivery of electrical stimulation therapy to a patient. In one example, a method includes generating and delivering electrical stimulation therapy to tissue of a patient via electrodes. Further, the method includes adjusting a level of a parameter of the electrical stimulation therapy such that a signal of the patient is not less than a lower bound and not greater than an upper bound. The lower bound is determined to be the magnitude of the signal while receiving electrical stimulation therapy sufficient to reduce one or more symptoms of a disease while the patient was receiving medication for reduction of the one or more symptoms. Further, the upper bound is determined to be the magnitude of the signal while receiving electrical stimulation therapy sufficient to reduce the one or more symptoms when the patient was not receiving the medication.

## Claims

### Claim 1

A method for delivering electrical stimulation therapy to a patient, the method comprising:
delivering electrical stimulation therapy to tissue of a patient via electrodes; and
adjusting a level of at least one parameter of the electrical stimulation therapy such that a sensed signal indicative of a beta signal of a brain of the patient is not less than a lower bound and not greater than an upper bound of a range;
wherein the lower bound is one of:
a magnitude of the sensed signal while receiving a first level of the electrical stimulation therapy that is a minimum level sufficient to reduce one or more symptoms of a disease and while the patient is receiving medication for reduction of one or more symptoms of the disease or disorder; or
a magnitude of the sensed signal while receiving a second level of the electrical stimulation therapy sufficient to cause maximum reduction of the one or more symptoms of the disease or disorder without inducing substantial side effects in the patient and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; and
wherein the upper bound is one of:
a magnitude of the sensed signal while receiving a third level of the electrical stimulation therapy that is a minimum level sufficient to reduce the one or more symptoms of the disease and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; or
a magnitude of the sensed signal while receiving a fourth level of the electrical stimulation therapy, while the patient is not receiving the medication for reduction of the one or more symptoms of the disease, that is sufficient to reduce the one or more symptoms of the disease or disorder but which above the level, substantially no further substantial reduction in the one or more symptoms is achieved.

### Claim 2 (depends on 1)

The method of claim 1, wherein the lower bound is the magnitude of the sensed signal while receiving the first level of the electrical stimulation therapy that is the minimum level sufficient to reduce the one or more symptoms of the disease and while the patient is receiving the medication for reduction of the one or more symptoms of the disease.

### Claim 3 (depends on 1)

The method of claim 1, wherein the lower bound is the magnitude of the sensed signal while receiving the second level of the electrical stimulation therapy sufficient to cause maximum reduction of the one or more symptoms of the disease or disorder without inducing substantial side effects in the patient and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease.

### Claim 4 (depends on 1)

The method of claim 1, wherein the upper bound is the magnitude of the sensed signal while receiving the third level of the electrical stimulation therapy that is the minimum level sufficient to reduce the one or more symptoms of the disease and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease.

### Claim 5 (depends on 1)

The method of claim 1, wherein the upper bound is the magnitude of the sensed signal while receiving the fourth level of the electrical stimulation therapy, while the patient is not receiving the medication for reduction of the one or more symptoms of the disease, that is sufficient to reduce the one or more symptoms of the disease or disorder but which above the level, substantially no further substantial reduction in the one or more symptoms is achieved.

### Claim 6 (depends on 1)

The method of claim 1, further comprising adjusting, in response to a patient input, at least one of the magnitude of the lower bound and the magnitude of the upper bound.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
determining, on a periodic basis, an average magnitude of the at least one parameter of the electrical stimulation therapy; and
while delivering the electrical stimulation therapy, increasing the level of the at least one parameter of the electrical stimulation therapy by a bias level.

### Claim 8 (depends on 7)

The method of claim 7,
wherein the at least one parameter of the electrical stimulation therapy is a voltage amplitude, and
wherein the bias level of the voltage amplitude of the electrical stimulation therapy is selected from a range of about 0.1 Volts to about 5 Volts.

### Claim 9 (depends on 7)

The method of claim 7,
wherein the at least one parameter of the electrical stimulation therapy is a current amplitude, and
wherein the bias level of the current amplitude of the electrical stimulation therapy is selected from a range of about 0.1 milliamps to about 5 milliamps.

### Claim 10

An implantable medical device (IMD) comprising:
stimulation generation circuitry configured to deliver electrical stimulation therapy to tissue of a patient via electrodes; and
processing circuitry configured to adjust a level of at least one parameter of the electrical stimulation therapy such that a sensed signal indicative of a beta signal of a brain of the patient is not less than a lower bound and not greater than an upper bound of a range;
wherein the lower bound is one of:
a magnitude of the sensed signal while receiving a first level of the electrical stimulation therapy that is a minimum level sufficient to reduce one or more symptoms of a disease and while the patient is receiving medication for reduction of one or more symptoms of the disease or disorder; or
a magnitude of the sensed signal while receiving a second level of the electrical stimulation therapy sufficient to cause maximum reduction of the one or more symptoms of the disease or disorder without inducing substantial side effects in the patient and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; and
wherein the upper bound is one of:
a magnitude of the sensed signal while receiving a third level of the electrical stimulation therapy that is a minimum level sufficient to reduce the one or more symptoms of the disease and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; or
a magnitude of the sensed signal while receiving a fourth level of the electrical stimulation therapy, while the patient is not receiving the medication for reduction of the one or more symptoms of the disease, that is sufficient to reduce the one or more symptoms of the disease or disorder but which above the level, substantially no further substantial reduction in the one or more symptoms is achieved.

### Claim 11 (depends on 10)

The IMD of claim 10, wherein the processing circuitry is further configured to:
determine, on a periodic basis, an average magnitude of the at least one parameter of the electrical stimulation therapy; and
while delivering the electrical stimulation therapy, increase the level of the at least one parameter of the electrical stimulation therapy by a bias level.

### Claim 12 (depends on 11)

The IMD of claim 11,
wherein the at least one parameter of the electrical stimulation therapy is a voltage amplitude, and
wherein the bias level of the voltage amplitude of the electrical stimulation therapy is selected from a range of about 0.1 Volts to about 5 Volts.

### Claim 13 (depends on 11)

The IMD of claim 11,
wherein the at least one parameter of the electrical stimulation therapy is a current amplitude, and
wherein the bias level of the current amplitude of the electrical stimulation therapy is selected from a range of about 0.1 milliamps to about 5 milliamps.

### Claim 14 (depends on 10)

The IMD of claim 10, wherein the processing circuitry determines the upper bound and the lower bound.

### Claim 15 (depends on 10)

The IMD of claim 10, wherein an external programmer determines the upper bound and the lower bound.

### Claim 16

A medical device system comprising:
one or more sensors;
an implantable medical device (1 MB) comprising stimulation generation circuitry configured to deliver electrical stimulation therapy to tissue of a patient via electrodes; and
processing circuitry configured to adjust a level of at least one parameter of the electrical stimulation therapy such that a sensed signal indicative of a beta signal of a brain of the patient is not less than a lower bound and not greater than an upper bound of a range;
wherein the lower bound is one of:
a magnitude of the sensed signal while receiving a first level of the electrical stimulation therapy that is a minimum level sufficient to reduce one or more symptoms of a disease and while the patient is receiving medication for reduction of one or more symptoms of the disease or disorder; or
a magnitude of the sensed signal while receiving a second level of the electrical stimulation therapy sufficient to cause maximum reduction of the one or more symptoms of the disease or disorder without inducing substantial side effects in the patient and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; and
wherein the upper bound is one of:
a magnitude of the sensed signal while receiving a third level of the electrical stimulation therapy that is a minimum level sufficient to reduce the one or more symptoms of the disease and while the patient is not receiving the medication for reduction of the one or more symptoms of the disease; or
a magnitude of the sensed signal while receiving a fourth level of the electrical stimulation therapy, while the patient is not receiving the medication for reduction of the one or more symptoms of the disease, that is sufficient to reduce the one or more symptoms of the disease or disorder but which above the level, substantially no further substantial reduction in the one or more symptoms is achieved.
