IP Library Granted Patent US 12,076,566
Granted Patent B2
US 12,076,566 · App. 17/129,467 · Granted Sep 3, 2024

Neurostimulation titration utilizing T-wave alternans

Inventors: Imad Libbus (St. Paul, MN); Bruce H. KenKnight (Maple Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/36139A61B5/349A61N1/0551A61N1/36114A61N1/36132A61N1/3615A61N1/36167A61N1/3702A61N1/37223A61N1/37235G16H20/30G16H20/40G16H40/20G16H40/63G16Z99/00
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Quick Facts
Patent No.
US 12,076,566
App. No.
17/129,467
Granted
Sep 3, 2024
Kind
B2
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 (37)

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:

activating the IMD to deliver the stimulation signal to the patient;

monitoring a T-wave alternans (TWA) magnitude value for the patient while delivering the stimulation signal to the patient;

transmitting the TWA magnitude value for the patient to an external device to be communicated to a health care provider; and

adjusting, based on the TWA magnitude value being above a threshold value, an intensity of the stimulation signal until a target TWA change is achieved, wherein the stimulation signal is adjusted in accordance with an instruction provided via the external device by the health care provider.

2. The method of claim 1 , further comprising:

determining a baseline TWA magnitude value prior to activating the IMD to deliver the stimulation signal;

increasing the intensity of the stimulation signal until the target TWA change between the baseline TWA magnitude value and the TWA magnitude value is reached, the target TWA change corresponding to a desired therapeutic effect; and

delivering the stimulation signal at the intensity resulting in the target TWA change.

3. The method of claim 2 , wherein the target TWA change from the baseline TWA magnitude value to the TWA magnitude value is a decrease of least one of 5 μV, 7.5 μV, 10 μV, 12.5 μV, 15 μV, 20 μV, or 30 μV.

4. The method of claim 1 , further comprising:

increasing the intensity of the stimulation signal until the TWA magnitude value reaches a target TWA magnitude value, the target TWA magnitude value corresponding to a desired therapeutic effect; and

delivering the stimulation signal at the intensity resulting in the target TWA magnitude value.

5. The method of claim 4 , wherein the target TWA magnitude value is at least one of 45 μV, 47 μV, or 50 μV.

6. The method of claim 1 , wherein monitoring the TWA magnitude value comprises determining the TWA magnitude value on a continuous basis while delivering the stimulation signal to the patient.

7. The method of claim 1 , wherein monitoring the TWA magnitude value comprises determining the TWA magnitude value on a periodic basis while delivering the stimulation signal to the patient.

8. The method of claim 1 , wherein determining the TWA magnitude value is performed utilizing at least one of a modified moving average analysis or a spectral analysis.

9. The method of claim 1 , further comprising transmitting historical TWA magnitude value measurements for the patient to the external device to be communicated to the health care provider.

10. 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:

activate the IMD to deliver to the stimulation signal to the patient;

monitor a T-wave alternans (TWA) magnitude value for the patient while delivering the stimulation signal to the patient;

transmit the TWA magnitude value for the patient to an external device to be communicated to a health care provider;

receive, based on the TWA magnitude value being above a threshold value, a command to adjust the stimulation signal from the health care provider; and

adjust an intensity of the stimulation signal based on the command until a target TWA change is achieved.

11. The neurostimulation system of claim 10 , wherein the control system is further programmed to:

determine a baseline TWA magnitude value prior to activating the IMD to deliver the stimulation signal;

increase the intensity of the stimulation signal until the target TWA change between the baseline TWA magnitude value and the TWA magnitude value is reached, the target TWA change corresponding to a desired therapeutic effect; and

deliver the stimulation signal at the intensity resulting in the target TWA change.

12. The neurostimulation system of claim 11 , wherein the target TWA change from the baseline TWA magnitude value to the TWA magnitude value is a decrease of least one of 5 μV, 7.5 μV, 10 μV, 12.5 μV, 15 μV, 20 μV, or 30 μV.

13. The neurostimulation system of claim 10 , wherein the control system is further programmed to:

increase the intensity of the stimulation signal until the TWA magnitude value reaches a target TWA magnitude value, the target TWA magnitude value corresponding to a desired therapeutic effect; and

deliver the stimulation signal at the intensity resulting in the target TWA magnitude value.

14. The method of claim 13 , wherein the target TWA magnitude value is at least one of 45 μV, 47 μV, or 50 μV.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 6, 2024
From: LIBBUS, IMAD; KENKNIGHT, BRUCE
To: CYBERONICS, INC.
Reel/Frame 068194/0232 →
CHANGE OF NAME Recorded Aug 6, 2024
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 068338/0313 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
Continuity (4)
Continuation 16159415 · Oct 12, 2018
Continuation 14938641 · Nov 11, 2015
Provisional Application 62078600 · Nov 12, 2014
Related Publication 20210178163A1 · Jun 17, 2021