User interface for a titration assist system
Inventors
Libbus, Imad • Stubbs, Scott R. • Kenknight, Bruce H. • Mazar, Scott • Amurthur, Badri
Assignees
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Publication Number
US-11931583-B2
Publication Date
2024-03-19
Expiration Date
Abstract
A neurostimulation system comprises a control system configured to monitor a patient receiving neurostimulation therapy. The neurostimulation therapy has a stimulation cycle comprising a stimulation ON period, in which the patient is receiving neurostimulation, and a stimulation OFF period, in which the patient is not receiving neurostimulation. The control system is programmed to receive electrocardiogram (ECG) data from the patient receiving the neurostimulation therapy. The control system is further programmed to monitor a heart rate of the patient based on the ECG data over at least one stimulation cycle of the neurostimulation therapy. The control system is further programmed to generate an indication of signal stability to be displayed to a user based on the received ECG data.
Core Innovation
The invention relates to a neurostimulation system and related method for assisting titration of vagus nerve stimulation (VNS) for congestive heart failure (CHF) using synchronized electrocardiogram (ECG)-based heart-rate monitoring across stimulation ON and stimulation OFF periods. The system includes a control system configured to receive ECG data from a patient receiving neurostimulation therapy and to monitor a heart rate of the patient based on the ECG data over at least one stimulation cycle.
The control system identifies a stimulation ON period based on a change in the heart rate of the patient across the stimulation cycle and generates an indication of signal stability to be displayed to a user. The indication of signal stability is generated to ensure ECG data reliability by evaluating the signal stability using cycle-to-cycle variability/consistency and related metrics derived from the received ECG data, including R-wave detection and R-R interval analysis.
The user-facing graphical interface provides a stability indication and associated heart-rate visualizations aligned to the stimulation cycle. Embodiments include an ensemble heart rate plot/ensemble average heart rate plotline and overlay plots with multiple instantaneous heart-rate plotlines, an ON period indication block, and a signal stability indicator displayed as a pointer between low and high stability and/or a color gradient red-yellow-green, derived from cycle-to-cycle variability/consistency thresholds.
Claims Coverage
The independent claims cover a neurostimulation system, a method of delivering neurostimulation therapy, and a non-transitory computer-readable medium. Across the independent claims, the inventive features include receiving ECG data, monitoring heart rate over neurostimulation stimulation cycles with ON/OFF periods, generating and displaying a signal stability indication, and identifying the stimulation ON period based on a change in heart rate; additional dependent refinements further specify multi-cycle comparison and particular graphical presentations.
ECG-based heart-rate monitoring over stimulation cycles
receiving electrocardiogram (ECG) data from the patient receiving the neurostimulation therapy; monitoring a heart rate of the patient based on the ECG data over at least one stimulation cycle of the neurostimulation therapy
Graphical indication of ECG signal stability for the user
generate an indication of signal stability to be displayed to a user based on the received ECG data
Stimulation ON period identification based on heart-rate change
identify the stimulation ON period based on a change in the heart rate of the patient
Signal stability determination via multi-cycle heart-rate comparison (dependent feature)
determining and comparing a plurality of patient heart rates measured over two or more stimulation cycles and then deriving signal stability from a resulting ECG-data comparison between the cycles
Stimulation cycle overlay visualization with plotlines and ON indication (dependent feature)
plot a first heart-rate plotline for a first stimulation cycle and a second heart-rate plotline for a second stimulation cycle and overlay them in an overlay plot; including an indication of the stimulation ON period
Ensemble-average heart-rate plotline overlay (dependent feature)
generate an indication of signal stability by creating a third plotline of the patient’s ensemble average heart rate across an averaged stimulation cycle and overlaying this third plotline with the first and second plotlines
Patient analysis checklist gating data recording (dependent feature)
generating a patient analysis checklist with user task indications and completion icons; and it blocks starting a data recording session until at least one task is marked completed
Overall, the independent claims share the same core inventive combination: ECG data reception, heart-rate monitoring over neurostimulation stimulation ON/OFF cycles, generation of a user-displayed signal stability indication, and identification of the stimulation ON period based on a change in heart rate. Dependent refinements add multi-cycle heart-rate comparison, specific overlay plot visualizations including ON-period indication, optional ensemble-average plotline overlay, and a user task checklist that gates initiation of data recording.
Stated Advantages
Ensures ECG data reliability by generating a graphical indication of signal stability to be displayed to a user based on the received ECG data.
Documented Applications
Titration-assist neurostimulation interface for VNS/CHF using synchronized ECG-based heart-rate monitoring across stimulation ON/OFF cycles, including a user-facing signal-stability indication and cycle-aligned heart-rate visualizations.
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