# US 10,870,005 B2 · Neurostimulation titration utilizing T-wave alternans

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- Number: US 10,870,005 B2
- Document ID: US10870005B2
- Status: Granted
- Kind: B2
- Application number: 16/159,415
- Filed: 2018-10-12
- Published: 2019-02-14
- Granted: 2020-12-22
- Earliest claimed: 2014-11-12
- Assignees: LivaNova USA, Inc.
- Applicants: LivaNova USA, Inc.
- Inventors: Imad Libbus; Bruce H. KenKnight
- Web page: https://patentgrep.com/patent/US10870005B2

## CPC

- A61N 1/36139: {with automatic adjustment}
- A61B 5/355: Detecting T-waves
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- A61N 1/36132: {using patient feedback}
- A61N 1/3615: {Intensity}
- A61N 1/36167: {Timing, e.g. stimulation onset}
- A61N 1/3702: {Physiological parameters (A61N1/365 takes precedence; evoked response A61N1/371)}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/37235: {Aspects of the external programmer}
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G16H 40/63: for local operation
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level until a target T-wave alternans change from a baseline T-wave alternans is achieved.

## Claims

### Claim 1

A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient, said method comprising:
computationally determining a current cardiac magnitude value for the patient, wherein the cardiac magnitude value comprises a T-wave alternans (TWA) magnitude value;
activating the IMD to deliver to the patient a plurality of stimulation signals at increasing stimulation intensities until the current cardiac magnitude value reaches a target cardiac magnitude; and
activating the IMD to deliver a therapeutic level of stimulation corresponding to the stimulation intensity in response to which the current cardiac magnitude value reached the target cardiac magnitude.

### Claim 2 (depends on 1)

The method of claim 1, wherein computationally determining the cardiac magnitude value for the patient is performed by the IMD.

### Claim 3 (depends on 1)

The method of claim 1, wherein the target cardiac magnitude is a target TWA magnitude comprising approximately 47 μV.

### Claim 4 (depends on 1)

The method of claim 1, further comprising determining a baseline cardiac magnitude value for the patient;
wherein the target cardiac magnitude comprises a target change in the current cardiac magnitude from the baseline cardiac magnitude.

### Claim 5 (depends on 4)

The method of claim 4, wherein the target change is a target TWA change comprising approximately 10 μV.

### Claim 6 (depends on 4)

The method of claim 4, further comprising identifying a neural fulcrum zone corresponding to the stimulation intensity in response to which the target change from the baseline was observed.

### Claim 7 (depends on 4)

The method of claim 4, further comprising performing a baseline update process, the baseline update process comprising:
temporarily ceasing the delivery of the stimulation to the patient;
monitoring an ECG of the patient to determine an updated baseline for the patient;
activating the IMD to deliver to the patient a plurality of stimulation signals at increasing stimulation intensities until the target change from the updated baseline is observed; and
activating the IMD to deliver a therapeutic level of stimulation corresponding to the stimulation intensity in response to which the target change from the updated baseline was observed.

### Claim 8

A neurostimulation system, comprising:
an implantable medical device (IMD) comprising:
an electrode assembly;
a neurostimulator coupled to the electrode assembly, wherein the neurostimulator is adapted to deliver a stimulation signal to a patient; and
a control system programmed to:
computationally determine a current cardiac magnitude value for the patient, wherein the cardiac magnitude value comprises a T-wave alternans (TWA) magnitude value;
activate the IMD to deliver to the patient a plurality of stimulation signals at increasing stimulation intensities until the current cardiac magnitude value reaches a target cardiac magnitude; and
activate the IMD to deliver a therapeutic level of stimulation corresponding to the stimulation intensity in response to which the current cardiac magnitude value reached the target cardiac magnitude.

### Claim 9 (depends on 8)

The neurostimulation system of claim 8, wherein the target cardiac magnitude is a target TWA magnitude comprising approximately 47 μV.

### Claim 10 (depends on 8)

The neurostimulation system of claim 8, wherein the control system is further programmed to determine a baseline cardiac magnitude value for the patient;
wherein the target cardiac magnitude comprises a target change in the current cardiac magnitude from the baseline cardiac magnitude.

### Claim 11 (depends on 10)

The neurostimulation system of claim 10, wherein the target change is a target TWA change comprising approximately 10 μV.

### Claim 12 (depends on 10)

The neurostimulation system of claim 10, wherein the control system is further programmed to identify a neural fulcrum zone corresponding to the stimulation intensity in response to which the target change from the baseline was observed.

### Claim 13 (depends on 10)

The neurostimulation system of claim 10, wherein the control system is further programmed to perform a baseline update process, the baseline update process comprising:
temporarily ceasing the delivery of the stimulation to the patient;
monitoring an ECG of the patient to determine an updated baseline for the patient;
activating the IMD to deliver to the patient a plurality of stimulation signals at increasing stimulation intensities until the target change from the updated baseline is observed; and
activating the IMD to deliver a therapeutic level of stimulation corresponding to the stimulation intensity in response to which the target change from the updated baseline was observed.

### Claim 14

A neurostimulation system, comprising:
an implantable medical device (IMD) comprising:
an electrode assembly;
a neurostimulator coupled to the electrode assembly, wherein the neurostimulator is adapted to deliver a stimulation signal to a patient;
an electrodcardiogram (ECG) sensor; and
a control system programmed to:
activate the IMD to deliver to the patient a plurality of stimulation signals;
monitor the ECG of the patient using the ECG sensor; and
determine a cardiac value based on the monitored ECG, wherein the cardiac value comprises a T-wave alternans (TWA) value.

### Claim 15 (depends on 14)

The neurostimulation system of claim 14, wherein the control system is further programmed to determine a cardiac value baseline for the patient.

### Claim 16 (depends on 15)

The neurostimulation system of claim 15, wherein the control system is further programmed to determine whether a target change from the cardiac value baseline has occurred in response to the delivery of the plurality of stimulation signals.

### Claim 17 (depends on 16)

The neurostimulation system of claim 16, wherein the control system is further programmed to, in response to determining that the target change has occurred, activate the IMD to deliver to the patient therapeutic stimulation at a level causing the target change from the cardiac value baseline.

### Claim 18 (depends on 16)

The neurostimulation system of claim 16, wherein the control system is further programmed to, in response to determining that the target change has occurred, identify a neural fulcrum zone corresponding to a stimulation intensity causing the target change from the cardiac value baseline.