Neurostimulation titration process
Inventors
Libbus, Imad • Kenknight, Bruce H. • Amurthur, Badri
Assignees
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Publication Number
US-11918813-B2
Publication Date
2024-03-05
Expiration Date
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.
Core Innovation
The disclosure relates to neurostimulation for chronic heart failure, using an implantable vagus nerve stimulator that delivers a stimulation signal via a neurostimulator and electrode lead assembly. The system includes a processor and a memory storing stimulation parameters, and an external programmer for parameterization. The therapy is defined using stimulation parameters including an output current, a frequency, a pulse width, and a duty cycle with ON/OFF cycles.
During an initial titration session, the processor activates the neurostimulator to deliver an initial parameter set and then increases the output current. After increasing output current, the processor receives a first input indicating that an acceptable side effect level has been exceeded, and in response decreases the pulse width while increasing the output current. A key concept is a neural fulcrum zone where afferent and efferent effects can balance so that net heart-rate change is minimized.
When a target physiological response has been achieved, the system receives a second input and, in response, maintains the stimulation at a current parameter set. The target physiological response includes target heart-rate change, described as a target intensity that is achieved at an adequate adaptation or within a target heart-rate change range, while remaining within a side-effect tolerance zone.
Claims Coverage
The provided excerpt identifies three independent claims (clm-00001, clm-00008, clm-00014). Across these independent claims, the inventive features focus on a titration session for neurostimulation that adjusts stimulation parameters based on side-effect and physiological-response inputs, followed by maintenance at a current parameter set.
Titration with side-effect input and physiological-response maintenance
At an initial titration session, activating a neurostimulator to deliver a stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle; increasing the output current; receiving a first input indicating that an acceptable side effect level has been exceeded; in response to the first input, decreasing the pulse width and increasing the output current; receiving a second input indicating that a target physiological response has been achieved; and in response to the second input, maintaining the stimulation signal at a current parameter set.
Output-current target then frequency, pulse width, or duty cycle adjustment
At an initial titration session, activating the neurostimulator to deliver the stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle; increasing the output current; receiving a first input indicating that an acceptable side effect level has been exceeded; in response to the first input, decreasing the pulse width and increasing the output current; in response to the output current reaching a target output current, increasing at least one of the frequency, the pulse width, or the duty cycle while maintaining the target output current; receiving a second input indicating that a target physiological response has been achieved; and in response to the second input, maintaining the stimulation signal at a current parameter set.
Method of operating neurostimulation with pulse-width reduction and maintenance
Operating a neurostimulation system comprising a neurostimulator delivering a stimulation signal; at an initial titration session, activating the neurostimulator to deliver the stimulation signal with an initial parameter set comprising an output current, a frequency, a pulse width, and a duty cycle; increasing the output current; receiving a first input indicating that an acceptable side effect level has been exceeded; in response to the first input, decreasing the pulse width and increasing the output current; receiving a second input indicating that a target physiological response has been achieved; and in response to the second input, maintaining the stimulation signal at a current parameter set.
All independent claims share the same core titration logic: start with an initial parameter set, increase output current, respond to an acceptable side effect level exceeded by decreasing pulse width and increasing output current, and then maintain the stimulation when a target physiological response is achieved. One independent claim further specifies that after reaching a target output current, at least one of frequency, pulse width, or duty cycle is increased while maintaining the target output current.
Stated Advantages
Documented Applications
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