# US 10,118,041 B2 · Automatic lead functionality testing

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- Number: US 10,118,041 B2
- Document ID: US10118041B2
- Status: Granted
- Kind: B2
- Application number: 11/414,786
- Filed: 2006-04-28
- Published: 2006-11-23
- Granted: 2018-11-06
- Earliest claimed: 2005-04-29
- Assignees: Medtronic, Inc.
- Applicants: Steven M. Goetz; Nathan A. Torgerson; Michael T. Lee
- Inventors: Steven M. Goetz; Nathan A. Torgerson; Michael T. Lee
- Web page: https://patentgrep.com/patent/US10118041B2

## CPC

- A61N 1/37: Monitoring; Protecting
- A61N 1/3706: {Pacemaker parameters (stimulation threshold A61N1/371)}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/3603: {Control systems}
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- 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

Techniques for performing lead functionality tests, e.g., lead impedance tests, for implantable electrical leads are described. In some of the described embodiments, an implantable medical device determines whether a patient is in a target activity state, e.g., an activity state in which lead impedance testing will be unobtrusive, such as when a patient is asleep, or capture information of particular interest, such as when the patient is active, in a particular posture, or changing postures. The implantable medical device performs the lead functionality test based on this determination. Additionally, in some embodiments, the implantable medical device may group a plurality of measurements for a single lead functionality test into a plurality of sessions, and perform the measurement sessions interleaved with delivery of therapeutic stimulation.

## Claims

### Claim 1

A method comprising:
determining whether a patient is within at least one of a target activity state or a target posture based on a physiological sensor signal, wherein determining whether the patient is within the target activity state comprises determining at least one of whether body movement of the patient exceeds a threshold, whether the patient is changing postures, or whether the patient is exercising;
automatically performing a lead functionality test for at least one electrical lead of a medical device in response to the physiological sensor signal indicating that the patient is within the target activity state or target posture, wherein the at least one electrical lead is implanted in the patient and the medical device is configured to deliver therapy to the patient using the at least one electrical lead, wherein automatically performing the lead functionality test comprises measuring an electrical parameter for at least two different combinations of electrodes of the medical device; and
generating information that indicates at least one of whether the functionality of the at least one electrical lead has degraded or whether the at least one electrical lead has failed based on the measurements of the electrical parameter for the at least two different combination of electrodes, wherein at least one of the determining, automatically performing, or generating is performed via a processor.

### Claim 2 (depends on 1)

The method of claim 1, wherein performing the lead functionality test comprises:
iteratively combining a plurality of electrodes that includes electrodes carried by the electrical lead; and
measuring an electrical parameter for each of the combinations of electrodes.

### Claim 3 (depends on 2)

The method of claim 2, wherein measuring an electrical parameter for each of the combinations of electrodes comprises measuring an impedance for each of the combinations of electrodes.

### Claim 4 (depends on 2)

The method of claim 2, wherein measuring an electrical parameter for each of the combinations comprises measuring the electrical parameter for each of the combinations over a plurality of sessions, each of the sessions including at least one of the combinations, the method further comprising delivering therapeutic stimulation to the patient via the lead between each of the sessions.

### Claim 5 (depends on 1)

The method of claim 1, wherein determining whether the patient is within the at least one of the target activity state or the target posture based on the physiological sensor signal comprises determining whether the patient is within the target activity state or the target posture based on an accelerometer signal.

### Claim 6 (depends on 1)

The method of claim 1, wherein determining whether the patient is within the target activity state or the target posture based on the physiological sensor signal comprises periodically monitoring the physiological sensor signal.

### Claim 7 (depends on 1)

The method of claim 1, wherein automatically performing a lead functionality test comprises automatically measuring an impedance associated with the lead.

### Claim 8 (depends on 1)

The method of claim 1, further comprising
generating an alert indicating a detected lead fault if results of the lead functionality test indicate degraded lead functionality.

### Claim 9 (depends on 1)

The method of claim 1, wherein generating information comprises generating values of the electrical parameter.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
based on the measurements, determining that at least one of the functionality of the at least one electrical lead has degraded or the at least one electrical lead has failed; and
generating an alert indicating a detected lead fault based on the determination.

### Claim 11 (depends on 1)

The method of claim 1, wherein automatically performing a lead functionality test for the at least one electrical lead of the medical device in response to the physiological sensor signal indicating that the patient is within the target activity state or the target posture comprises automatically performing the lead functionality test for the at least one electrical lead implanted in response to the physiological sensor signal indicating that the patient is within the target activity state.

### Claim 12

A system comprising:
a medical device including at least one electrical lead implanted within a patient, wherein the medical device is configured to deliver therapy to the patient using the at least one electrical lead;
a physiological sensor that generates a physiological sensor signal; and
a processor that:
determines whether the patient is within at least one of a target activity state or a target posture based on the physiological sensor signal, wherein the processor determines whether the patient is within the target activity state based on determining at least one of whether body movement of the patient exceeds a threshold, whether the patient is changing postures, or whether the patient is exercising,
initiates performance of a lead functionality test for the lead in response to the physiological sensor signal indicating that the patient is within the target activity state or target posture, wherein the processor measures an electrical parameter for at least two different combinations of electrodes of the medical device to perform the lead functionality test, and
generates information that indicates at least one of whether the functionality of the at least one electrical lead has degraded or whether the at least one electrical lead has failed based on the measurements of the electrical parameter for the at least two different combination of electrodes.

### Claim 13 (depends on 12)

The system of claim 12, wherein the processor controls performance of the lead functionality test by iteratively combining a plurality of electrodes that includes electrodes carried by the electrical lead, and controlling measurement of an electrical parameter for each of the combinations of electrodes.

### Claim 14 (depends on 13)

The system of claim 13, wherein the processor controls measurement of an impedance for each of the combinations of electrodes.

### Claim 15 (depends on 13)

The system of claim 13, wherein the processor controls measurement of the electrical parameter for each of the combinations over a plurality of sessions, each of the sessions including measurement for at least one of the combinations, and controls delivery of therapeutic stimulation to the patient via the lead between each of the sessions.

### Claim 16 (depends on 12)

The system of claim 12, further comprising an implantable medical device coupled to the lead that includes the processor.

### Claim 17 (depends on 16)

The system of claim 16, wherein the implantable medical device delivers neurostimulation via the lead.

### Claim 18 (depends on 12)

The system of claim 12, wherein the physiological sensor comprises an accelerometer.

### Claim 19 (depends on 12)

The system of claim 12, further comprising a memory to store a schedule, wherein the processor periodically monitors the physiological sensor signal.

### Claim 20 (depends on 12)

The system of claim 12, wherein the processor controls performance of the lead functionality test by controlling measurement of at least one impedance associated with the electrical lead.

### Claim 21 (depends on 12)

The system of claim 12, wherein the processor is configured to determine, based on the measurements, that at least one of the functionality of the at least one electrical lead has degraded or the at least one electrical lead has failed, and generate an alert indicating a detected lead fault based on the determination.

### Claim 22 (depends on 12)

The system of claim 12, wherein the processor is configured to automatically perform the lead functionality test for the at least one electrical lead implanted within the patient in response to the physiological sensor signal indicating that the patient is within the target activity state.

### Claim 23

A system comprising:
means for determining whether a patient is within at least one of a target activity state or a target posture based on a physiological sensor signal, wherein the means for determining whether the patient is within the target activity state comprises means for determining at least one of whether body movement of the patient exceeds a threshold, whether the patient is changing postures, or whether the patient is exercising;
means for performing a lead functionality test for at least one electrical lead of a medical device in response to the physiological sensor signal indicating that the patient is within the target activity state or target posture, wherein the at least one electrical lead is implanted in the patient and the medical device is configured to deliver therapy to the patient using the at least one electrical lead, wherein the means for performing the lead functionality test comprises means for measuring an electrical parameter for at least two different combinations of electrodes of the medical device; and
means for generating information that indicates at least one of whether the functionality of the at least one electrical lead has degraded or whether the at least one electrical lead has failed based on the measurements of the electrical parameter for the at least two different combination of electrodes.

### Claim 24 (depends on 23)

The system of claim 23, wherein the means for performing the lead functionality test comprises means for measuring at least one impedance associated with the lead.

### Claim 25

A system comprising:
a medical device including at least one electrical lead implanted within a patient, wherein the medical device is configured to deliver therapy to the patient using the at least one electrical lead;
a physiological sensor that generates a physiological sensor signal; and
a processor that:
determines at least one of whether body movement of the patient exceeds a threshold, whether the patient is in a target posture, whether the patient is changing postures, or whether the patient is exercising, based on the physiological sensor signal,
initiates performance of a lead functionality test for the lead in response to the physiological sensor signal indicating the at least one of whether the body movement of the patient exceeds the threshold, whether the patient is in the target posture, whether the patient is changing postures, or whether the patient is exercising, wherein the processor measures an electrical parameter for at least two different combinations of electrodes of the medical device to perform the lead functionality test, and
generates information that indicates at least one of whether the functionality of the at least one electrical lead has degraded or whether the at least one electrical lead has failed based on the measurements of the electrical parameter for the at least two different combination of electrodes.
