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EP-4333972-B1 - DISTRIBUTED DEVICE CONTROL AND WEARABLE SYSTEM FOR VAGUS NERVE STIMULATION

EP4333972B1EP 4333972 B1EP4333972 B1EP 4333972B1EP-4333972-B1

Inventors

  • MEYERS, ERIC
  • GANZER, Patrick
  • LOEIAN, Seyed Masoud
  • BAUMGART, Ian
  • Branch, Joshua

Dates

Publication Date
20260506
Application Date
20220506

Claims (12)

  1. A stimulation system comprising: a sensor (102) configured to detect a physiological signal of a user (100), the physiological signal having a biomarker therein associated with a disorder of the user; a stimulator (110) configured to deliver (240) electrical stimulation to the user; and a hub device (104) configured to receive the physiological signal from the sensor and to output a control signal to the stimulator, wherein the control signal causes the stimulator to deliver the electrical stimulation to the user according to a stimulation protocol, the stimulation protocol treating the disorder, wherein the hub device (104) is configured to output the control signal based on the biomarker of the received physiological signal, and wherein the hub device (104) is configured to generate another control signal for treating another disorder based on a biomarker not included in the physiological signal received from the sensor, wherein the stimulation system further comprises a trained machine learning system (106, 118), wherein the trained machine learning system (106, 118) is configured to: extract one or more biomarkers of the physiological signal of the user that are indicative of one or more disorders; predict an outcome of the stimulation protocol based on an analysis of the one or more biomarkers; and determine, based on the prediction, whether to deliver the electrical stimulation the user according to the stimulation protocol, wherein the control signal is based on the determination made by the trained machine learning system (118).
  2. The stimulation system of claim 1, further comprising a database configured to store detected physiological signals and/or associated stimulation protocols from a plurality of users (100), the physiological signals being transmitted to the database by a hub device (104) associated with each of the plurality of users.
  3. The stimulation system of claim 1, wherein the disorder is a cardiovascular disorder and the biomarker is a pre-ejection period.
  4. The stimulation system of claim 1, wherein the hub device (104) is in communication with another device associated with a clinician and is configured to transmit information indicating a physiological state of the user (100) and/or the delivery of electrical stimulation to the another device associated with the clinician.
  5. The stimulation system of claim 1, wherein the electrical stimulation is delivered to the Vagus nerve of the user.
  6. The stimulation system of claim 1, wherein the sensor and/or the stimulator are external to and distinct from the hub device (104), and the hub device (104) is portable.
  7. The stimulation system of claim 1, wherein the hub device is configured to change the control signal to the stimulator based on the physiological signal received from the sensor.
  8. A stimulation system comprising: a sensor (102) configured to detect a physiological signal of a user, the physiological signal having a biomarker therein associated with a disorder of the user; a stimulator (110) configured to deliver electrical stimulation to the user; and a hub device (104) configured to receive the physiological signal from the sensor and to output a control signal to the stimulator, wherein the control signal causes the stimulator to deliver the electrical stimulation to the user according to a stimulation protocol, the stimulation protocol treating the disorder, wherein the hub device (104) is configured to output the control signal based on the biomarker of the received physiological signal, and wherein the sensor and/or the stimulator are external to and distinct from the hub device (104), and the hub device (104) is portable, wherein the stimulation system further comprises a trained machine learning system (106, 118), wherein the trained machine learning system (106, 118) is configured to: extract one or more biomarkers of the physiological signal of the user that are indicative of one or more disorders; predict an outcome of the stimulation protocol based on an analysis of the one or more biomarkers; and determine, based on the prediction, whether to deliver the electrical stimulation the user according to the stimulation protocol, wherein the control signal is based on the determination made by the trained machine learning system (118).
  9. The stimulation system of claim 8, wherein the trained machine learning system (118) is remote from, and in communication with, the hub device, wherein the trained machine learning system (118) is configured to: determine whether to deliver the electrical stimulation, and/or to determine the stimulation protocol, based on the physiological signal; and transmit the determination to the hub device, wherein the hub device (104) is further configured to transmit the physiological signal of the user to the trained machine learning system.
  10. The stimulation system of claim 9, further comprising: a remote database configured to store detected physiological signals and/or associated stimulation protocols from a plurality of users, the physiological signals being transmitted to the remote database by a hub device (104) associated with each of the plurality of users, wherein the trained machine learning system (118) is repeatedly retrained based on the detected physiological signals and/or associated stimulation protocols stored in the remote database.
  11. The stimulation system of claim 8, wherein the hub device (104) is in communication with another device associated with a clinician and is configured to transmit information indicating a physiological state of the user and/or the delivery of electrical stimulation to the another device associated with the clinician.
  12. The stimulation system of claim 8, wherein the electrical stimulation is delivered to the Vagus nerve of the user.

Description

BACKGROUND US2016375251A1 relates to a system including a stimulation device such as a vagus nerve stimulation lead, and a controller for controlling the stimulation device according to a set of stimulation parameters. A memory of the stimulation device contains a state transition model, and for each state defines a set of stimulation parameters and at least one expected response during the application of stimulation with the parameters. US2021085979A1 concerns a closed-loop stimulation of the Vagus nerve in response to a detected myocardial ischemia state within a therapeutic window can mitigate or reverse effects of the ischemia. Vagus nerve stimulation (VNS) is as a neuromodulation therapy for the treatment of epilepsy, depression, stroke, and other disorders. Unfortunately, there are currently no reliable biomarkers that can monitor VNS efficacy and the downstream effects of stimulation, and that can be measured longitudinally and non-invasively. Conventional vital signs, such as heart rate and blood pressure, fail to robustly measure stimulation efficacy due to the complex interplay of the sympathetic and parasympathetic nervous systems on these metrics. Thus, current techniques to effectively monitor modulation of the central nervous system involve expensive imaging or blood biomarker analyses. As a result, problems that prevent a VNS stimulator from effectively activating the Vagus nerve can go undetected for weeks or months. Furthermore, determining when to apply stimulation often requires clinical intervention-that is, a clinician monitoring a patient and manually delivering the stimulation therapy. For example, VNS may be used to treat cardiovascular disease, which is the leading cause of mortality worldwide. Although several devices and sensors now exist to monitor cardiovascular state and overall user function, cardiovascular data can be complex. Unfortunately, there is no clear way to combine this information together and analyze it to determine when and how to deliver stimulation and/or to enhance monitoring capability. Similarly, VNS may be delivered as part of a therapy for stress disorders, such as post-traumatic stress disorder (PTSD), which can occur after experiencing a trauma and severely impact a person's wellbeing. About 8% of the population will have PTSD at some point in their lives, and 8 million adults have PTSD during a given year in the United States. Vagus nerve stimulation (VNS) has emerged as a strategy to promote neural plasticity, enhance memory, and reduce conditioned fear when delivered coincidentally with cue presentation during exposure therapy (i.e., 'overwrite' the fear memory). In addition to VNS enhancing memory consolidation and fear extinction, VNS also has an immediate anxiolytic effect that can bring immediate stress relief to the user. Thus, current therapies involve repeatedly exposing a patient, such as a patient with stress disorders, for trigger and then delivering VNS to suppress previously learned associations through the formation of new associations during the therapy-exposed triggers. However, delivering VNS to a user during exposure therapy also requires a therapist to interact with the user and identify when the user has a heightened stress response. The therapist must then manually deliver the VNS. Due to this and other complications, these therapies show high incidence of non-response, dropout, and relapse (>50%). Additionally, electrical stimulation parameters are typically chosen by increasing the stimulation amplitude to just below the maximum tolerable level. Although more effective stimulation parameters may exist, current clinical practice is unable to effectively test and identify those parameter sets. BRIEF SUMMARY According to one example, the present disclosure relates to subject-matter as defined in the independent claims. The invention is defined by the appended claims. The dependent claims set out particular embodiments of the invention. In various embodiments of the above example, the disorder is a cardiovascular disorder and the biomarker is a pre-ejection period; the hub device is in communication with another device associated with a clinician and is configured to transmit information indicating a physiological state of the user and/or the delivery of electrical stimulation to the another device associated with the clinician; the electrical stimulation is delivered to the Vagus nerve of the user; the hub device is portable; and/or the hub device is configured to change a control signal to the stimulator based on the physiological signal received from the sensor. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING Figure 1 illustrates an example stimulation hub system according to the present disclosure.Figure 2 illustrates an example controlled stimulation method according to the present disclosure.Figure 3 illustrates an example design and customization method for a stimulation hub system according to the present disclosure. DET