Neurostimulator with titration assist

Patent metadata

Field	Value
Publication number	US-12263343-B2
Application number	US-202318234186-A
Country	US
Kind code	B2
Filing date	Aug 15, 2023
Priority date	Jun 13, 2016
Publication date	Apr 1, 2025
Grant date	Apr 1, 2025

Abstract

A method of neurostimulation titration includes titrating a neurostimulation signal from a first set of parameters toward a target set of parameters according to a titration aggressiveness profile having a titration hold point. The method further includes receiving a hold indicator indicating that the titration has reached the titration hold point. The method further includes initiating an intermediate hold of the titrating of the neurostimulation signal in response to receiving the hold indicator. The method further includes receiving an indication of a titration resumption that discontinues the intermediate hold.

First claim

What is claimed is:

1. A method of titrating a neurostimulation signal delivered to a patient from an implantable pulse generator, the method comprising:
titrating the neurostimulation signal from a first set of parameters toward a target set of parameters according to a titration aggressiveness profile having a titration hold point corresponding to a holding set of stimulation parameters, the holding set of stimulation parameters being a point in the titration aggressiveness profile at which the implantable pulse generator is configured to hold titration until a titration resumption is received from an external device;
receiving a hold indicator indicating that the titration has reached the holding set of stimulation parameters;
initiating an intermediate hold of the titrating of the neurostimulation signal in response to receiving the hold indicator; and
receiving an indication of a titration resumption from the external device that discontinues the intermediate hold.

2. The method of claim 1 , wherein the receiving of the indication of the titration resumption is preceded by a time interval sufficient to allow the patient to at least one of obtain assistance from a health care provider or activate a sensor communicating with the implantable pulse generator.

3. The method of claim 1 , further comprising:
subsequent to receiving the indication of the titration resumption, delivering the neurostimulation signal at the holding set of stimulation parameters associated with the titration hold point; and
titrating the neurostimulation signal from the holding set of stimulation parameters toward the target set of parameters.

4. The method of claim 3 , wherein the hold indicator is a first hold indicator, the titration hold point is a first titration hold point, the holding set of stimulation parameters is a first holding set of stimulation parameters, the intermediate hold is a first intermediate hold, and the indication of the titration resumption is a first indication of a first titration resumption; and
wherein the method further comprises:
receiving a second hold indicator, the second hold indicator indicating that at least one of the neurostimulation signal is being delivered at a second holding set of stimulation parameters of a second titration hold point or a side effect is being experienced by the patient in response to the neurostimulation signal;
initiating a second intermediate hold of the titrating of the neurostimulation signal in response to the second hold indicator; and
receiving a second indication of a second titration resumption that discontinues the second intermediate hold.

5. The method of claim 4 , wherein the receiving of the second indication of the second titration resumption is preceded by a time interval sufficient to allow the patient to at least one of obtain assistance from a health care provider or activate a sensor communication with the implantable pulse generator.

6. The method of claim 1 , wherein the indication of the titration resumption includes an instruction to modify the neurostimulation signal to a second set of parameters; and
wherein the method further comprises:
subsequent to receiving the indication of the titration resumption, delivering the neurostimulation signal at the second set of parameters; and
titrating the neurostimulation signal from the second set of parameters toward the target set of parameters.

7. The method of claim 6 , wherein the hold indicator is a first hold indicator, the titration hold point is a first titration hold point, the intermediate hold is a first intermediate hold, and the indication of the titration resumption is a first indication of a first titration resumption; and
wherein the method further comprises:
receiving a second hold indicator, the second hold indicator indicating that at least one of the neurostimulation signal is being delivered at a second holding set of stimulation parameters of a second titration hold point or a side effect is being experienced by the patient in response to the neurostimulation signal;
initiating a second intermediate hold of the titrating of the neurostimulation signal in response to the second hold indicator; and
receiving a second indication of a second titration resumption that discontinues the second intermediate hold.

8. The method of claim 7 , wherein the receiving of the second indication of the second titration resumption is preceded by a time interval sufficient to allow the patient to at least one of obtain assistance from a health care provider or activate a sensor communication with the implantable pulse generator.

9. The method of claim 1 , wherein the indication of the titration resumption is received from an external device indicating instructions to discontinue the intermediate hold.

10. The method of claim 1 , wherein the titration aggressiveness profile has a more aggressive level and a less aggressive level, the more aggressive level defined by at least one of the following as compared to the less aggressive level:
a shorter time interval associated with a transition from the first set of parameters to the target set of parameters,
a greater target intensity, or
a greater increment value between parameter levels at subsequent titration steps.

11. A neurostimulation system capable of providing a neurostimulation signal to a patient, the neurostimulation system comprising:
an implantable pulse generator that generates the neurostimulation signal according to a titration protocol executed by a processor;
an electrode configured to deliver the neurostimulation signal to the patient; and
a lead coupling the electrode to the implantable pulse generator,
wherein the processor is configured to implement the titration protocol by issuing control signals that allow the implantable pulse generator to:
titrate the neurostimulation signal from a first set of parameters toward a target set of parameters according to a titration aggressiveness profile having a titration hold point corresponding to a holding set of stimulation parameters, the holding set of stimulation parameters being a point in the titration aggressiveness profile at which the implantable pulse generator is configured to hold titration until a titration resumption is received from an external device;
receive a hold indicator indicating that the titration has reached the holding set of stimulation parameters;
initiate an intermediate hold of the titrating of the neurostimulation signal in response to receiving the hold indicator; and
receive an indication of a titration resumption from the external device that discontinues the intermediate hold.

12. The neurostimulation system of claim 11 , wherein the receiving of the indication of the titration resumption is preceded by a time interval sufficient to allow the patient to at least one of obtain assistance from a health care provider or activate a sensor communicating with the implantable pulse generator.

13. The neurostimulation system of claim 11 , wherein the processor is further configured to issue additional control signals that allow the implantable pulse generator to:
subsequent to receiving the indication of the titration resumption, deliver the neurostimulation signal at the holding set of stimulation parameters associated with the titration hold point; and
titrate the neurostimulation signal from the holding set of stimulation parameters toward the target set of parameters.

14. The neurostimulation system of claim 13 , wherein the hold indicator is a first hold indicator, the titration hold point is a first titration hold point, the holding set of stimulation

Assignees

• Livanova Usa Inc

Inventors

• Stubbs Scott
• Libbus Imad
• Mazar Scott
• Kenknight Bruce H
• Amurthur Badri

Classifications

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/36053

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title

• A61N1/18

  Applying electric currents by contact electrodes · CPC title

• A61N1/32

  alternating or intermittent currents {(applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02)} · CPC title

• A61N1/05

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title