Systems and methods for closed-loop or partially closed-loop baroreflex activation therapy
Systems and methods are provided for delivering closed-loop or partially closed-loop baroreflex activation therapy (BAT) to treat conditions associated with autonomic dysfunction. A pulse generator delivers stimulation while physiological data, such as ECG, heart rate variability, bioimpedance, and physical activity levels, is collected from one or more sensors. The data is analyzed to assess autonomic nervous system activity, and stimulation parameters are dynamically adjusted in response. In some embodiments, adjustments are made on a beat-to-beat basis using ECG input. Artificial intelligence algorithms may be used to predict patient-specific responses, optimize therapy, and evaluate effectiveness. The method may further include integrating patient-reported symptoms, wirelessly transmitting data, or adjusting stimulation duty cycle based on time of day. The system may further incorporate patient-reported symptoms, a clinician dashboard for remote monitoring, and a multi-channel lead. Stimulation may be delivered non-invasively or via an implantable device.
1 . A method of delivering baroreflex activation therapy to a patient in a closed-loop or partially closed-loop configuration, the method comprising:
delivering electrical stimulation to a baroreceptor region with a pulse generator;
collecting physiological data from at least one sensor configured to monitor one or more of electrocardiography (ECG), rate variability (HRV), blood pressure, bioimpedance, acoustics, electromyography (EMG), and physical activity;
analyzing the collected physiological data to assess autonomic nervous system activity; and
adjusting at least one stimulation parameter or stimulation timing in response to the analysis to modulate baroreflex activity,
wherein the adjusting occurs on a beat-to-beat basis using timing information derived from ECG input such that delivery of the electrical stimulation is synchronized to successive cardiac cycles, and wherein the beat-to-beat adjusting is performed independently of longer-term duty-cycle scheduling, circadian modulation, or time-of-day-based therapy programming.
2 . The method of claim 1 , wherein the adjusted stimulation parameter comprises a duty cycle that is dynamically modulated based on time of day or detected patient activity.
3 . The method of claim 1 , wherein the physiological data are fused from at least two sensors selected from wearable sensors, implantable sensors, and external sensors.
4 . The method of claim 1 , further comprising applying artificial intelligence or machine-learning algorithms trained on real-time data, historical data, or both, to guide the adjusting.
5 . The method of claim 1 , wherein ECG-derived HRV is correlated with accelerometer-derived activity data or acoustic signals to detect early signs of heart-failure decompensation and to preemptively modify stimulation.
6 . The method of claim 1 , further comprising receiving patient-reported inputs via a patient application and using the inputs to maintain, increase, or decrease stimulation intensity or frequency.
7 . The method of claim 1 , further comprising wirelessly transmitting physiological data and therapy data to a clinician dashboard for remote review and optional parameter updates.
8 . The method of claim 1 , further comprising establishing a patient-specific physiological baseline, and preemptively adjusting the stimulation parameters when one or more monitored physiological signals deviate from the baseline by a threshold amount indicative of impending autonomic imbalance.
9 . The method of claim 1 , further comprising dynamically weighting or disregarding one or more physiological inputs based on signal quality metrics before adjusting the stimulation parameters.
10 . A method of delivering baroreflex activation therapy to a patient in a closed-loop or partially closed-loop configuration, the method comprising:
delivering electrical stimulation to a baroreceptor region with a pulse generator;
collecting physiological data from at least one sensor configured to monitor one or more of electrocardiography (ECG), rate variability (HRV), blood pressure, bioimpedance, acoustics, electromyography (EMG), and physical activity;
analyzing the collected data to assess autonomic nervous system activity; and
adjusting at least one stimulation parameter in response to the analysis to modulate baroreflex activity,
wherein the adjusting occurs on a beat-to-beat basis using ECG input, and wherein the adjusted stimulation parameter comprises a duty cycle that is dynamically modulated based on time of day or detected patient activity.
11 . A baroreflex activation therapy system configured for closed-loop or partially closed-loop operation, comprising:
a pulse generator configured to deliver electrical stimulation to one or more baroreceptors;
a sensor suite configured to collect physiological data including at least electrocardiography heart rate variability (HRV); and
a controller programmed to analyze the collected physiological data and adjust two or more stimulation parameters in response,
wherein the controller autonomously adjusts stimulation on a beat-to-beat basis using ECG input such that stimulation is synchronized to the cardiac cycle based on timing information derived from ECG, and wherein the beat-to-beat adjusting is performed independently of longer-term duty-cycle scheduling or circadian therapy programming.
12 . The system of claim 11 , wherein the controller implements artificial intelligence or machine-learning algorithms that classify autonomic state from continuous or intermittent data and issue parameter recommendations or autonomous parameter updates.
13 . The system of claim 11 , wherein the pulse generator is implantable and is configured to deliver stimulation to a carotid sinus baroreceptor region.
14 . The system of claim 11 , further comprising a clinician dashboard that displays longitudinal trends of one or more of HRV, blood pressure, bioimpedance, and activity overlaid with stimulation settings and provides alerts upon threshold deviations.
15 . The system of claim 11 , further comprising fail-safe controls including one or more of artifact rejection, stimulation limiters, automatic shutdown on fault, and fallback modes.
16 . The system of claim 11 , wherein the system is configured for bilateral stimulation or sensing with coordinated parameter control between sides.
17 . The system of claim 11 , wherein the controller performs impedance checks and uses impedance results to adjust contact quality assessment or stimulation safety limits.
18 . The system of claim 11 , further comprising a communication interface configured to wirelessly transmit therapy and physiological data and to receive configuration updates.
19 . The system of claim 11 , wherein the controller includes a duty-cycle scheduler configured to vary one or more stimulation characteristics based on circadian patterns or detected activity level.
20 . The system of claim 11 , wherein the controller implements a hierarchical control scheme in which beat-to-beat ECG-synchronous stimulation control has priority over longer-term duty-cycle or circadian scheduling such that scheduled stimulation parameters are overridden in response to real-time physiological conditions.