IP Library Granted Patent US 10,870,005
Granted Patent B2
US 10,870,005 · App. 16/159,415 · Granted Dec 22, 2020

Neurostimulation titration utilizing T-wave alternans

Inventors: Imad Libbus (St. Paul, MN); Bruce H. KenKnight (Maple Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/36139A61B5/0452A61N1/0551A61N1/3615A61N1/36114A61N1/36132A61N1/36167A61N1/3702A61N1/37223A61N1/37235G06F19/325G16H20/40G16H40/20G16H40/63G16Z99/00
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Quick Facts
Patent No.
US 10,870,005
App. No.
16/159,415
Granted
Dec 22, 2020
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 (46)

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.

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

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

4. 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.

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

6. 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.

7. 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.

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.

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

10. 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.

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

12. 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.

13. 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.

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.

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

16. 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.

17. 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.

18. 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.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
CHANGE OF NAME Recorded Jun 29, 2020
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 053306/0229 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 5, 2018
From: LIBBUS, IMAD; KENKNIGHT, BRUCE
To: CYBERONICS, INC.
Reel/Frame 047410/0140 →
Continuity (3)
Continuation 14938641 · Nov 11, 2015
Provisional Application 62078600 · Nov 12, 2014
Related Publication 20190046804A1 · Feb 14, 2019