Neurostimulation titration process

• US 10,220,212 B2
• Filed: 12/30/2016
• Issued: 03/05/2019
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Libbus, Imad, Kenknight, Bruce H., Amurthur, Badri
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/395,872
• Publication Number:
  US 20170106194A1
• Time in Patent Office: 795 Days
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. This titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Claims

1. A neurostimulation system, comprising:

an electrode assembly;

a neurostimulator coupled to the electrode assembly, the neurostimulator adapted to deliver a stimulation signal to a patient;

a physiological sensor configured to acquire a physiological signal from the patient; and

a processor coupled to the neurostimulator and the physiological sensor, the processor being configured to;

at an initial titration session, activate the neurostimulator to deliver the stimulation signal with an initial stimulation parameter set, the initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle;

perform a titration process, the titration process comprising;

increasing the output current of the stimulation signal until the stimulation signal comprises a target output current or adequate adaption is achieved, wherein adequate adaptation comprises at least one of a side effect level below a side effect tolerance zone boundary, a target physiological response or a target parameter set;

after increasing the output current of the stimulation signal, in response to the patient exceeding the side effect tolerance zone boundary before the stimulation signal comprises the target output current, decreasing the frequency and subsequently increasing the output current until either the stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary; and

after the stimulation signal comprises the target output current, increasing at least one of the frequency, the pulse width or the duty cycle while maintaining the target output current until a composite threshold is reached, wherein the composite threshold is reached when the stimulation signal comprises the target parameter set or the patient exceeds the side effect tolerance zone boundary.

2. The neurostimulation system of claim 1, wherein the target parameter set comprises a target frequency of between 8 Hz and 12 Hz.

3. The neurostimulation system of claim 1, wherein subsequently increasing the output current comprises maintaining the frequency, the pulse width and the duty cycle of the stimulation signal.

4. The neurostimulation system of claim 1, wherein decreasing the frequency and subsequently increasing the output current comprises decreasing the frequency to about 5 Hz or less.

5. The neurostimulation system of claim 1, wherein the titration process further comprises:

after decreasing the frequency to a lowered frequency level and subsequently increasing the output current, in response to the patient again exceeding the side effect tolerance zone boundary before the stimulation signal comprises the target output current while at the lowered frequency level, increasing the frequency to an elevated frequency level and subsequently increasing the duty cycle until either the stimulation signal comprises a target duty cycle or the patent subsequently exceeds the side effect tolerance zone boundary.

6. The neurostimulation system of claim 1, wherein decreasing the frequency and subsequently increasing the output current the further comprises after increasing the output current of the stimulation signal, in response to the patient exceeding the side effect tolerance zone boundary before the stimulation signal comprises the target output current, decreasing the frequency and the pulse width and subsequently increasing the output current until either the stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary.

7. The neurostimulation system of claim 1, wherein the processor is further configured to:

determine a physiological response to the stimulation signal by;

monitoring a baseline signal acquired by the physiological sensor during OFF time periods of the stimulation signal; and

monitoring a response signal acquired by the physiological sensor during ON time periods of the stimulation signal.

8. A neurostimulation system, comprising:

an electrode assembly;

a neurostimulator coupled to the electrode assembly, the neurostimulator adapted to deliver a stimulation signal to a patient;

a physiological sensor configured to acquire a physiological signal from the patient; and

a processor coupled to the neurostimulator and the physiological sensor, the processor configured to;

at an initial titration session, activate the neurostimulator to deliver the stimulation signal with an initial stimulation parameter set, the initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle;

perform a titration process, the titration process comprising;

increasing the output current of the stimulation signal until the stimulation signal comprises a target output current;

after increasing the output current of the stimulation signal, in response to the patient exceeding a side effect tolerance zone boundary before the stimulation signal comprises the target output current, decreasing the frequency and subsequently increasing the output current until either the stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary; and

after the stimulation signal comprises the target output current, increasing at least one of the frequency, the pulse width or the duty cycle while maintaining the target output current.

9. The neurostimulation system of claim 8, wherein subsequently increasing the output current comprises maintaining the frequency, the pulse width and the duty cycle of the stimulation signal.

10. The neurostimulation system of claim 8, wherein decreasing the frequency and subsequently increasing the output current comprises decreasing the frequency to about 5 Hz or less.

11. The neurostimulation system of claim 8, wherein the titration process further comprises:

after decreasing the frequency to a lowered frequency level and subsequently increasing the output current, in response to the patient again exceeding the side effect tolerance zone boundary before the stimulation signal comprises the target output current while at the lowered frequency level, increasing the frequency to an elevated frequency level and subsequently increasing the duty cycle until either the stimulation signal comprises a target duty cycle or the patent subsequently exceeds the side effect tolerance zone boundary.

12. The neurostimulation system of claim 8, wherein decreasing the frequency and subsequently increasing the output current further comprises after increasing the output current of the stimulation signal, in response to the patient exceeding the side effect tolerance zone boundary before the stimulation signal comprises the target output current, decreasing the frequency and the pulse width and subsequently increasing the output current until either the stimulation signal comprises the target output current or the patient again exceeds the side effect tolerance zone boundary.

13. The neurostimulation system of claim 8, wherein the processor is further configured to:

determine a physiological response to the stimulation signal by;

monitoring a baseline signal acquired by the physiological sensor during OFF time periods of the stimulation signal; and

monitoring a response signal acquired by the physiological sensor during ON time periods of the stimulation signal.