Closed-Loop Nerve Stimulation Using EEG and ECAP Feedback
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Solution Overview
Problem
Existing nerve stimulation systems, particularly for vagus nerve stimulation, are invasive and complex, and often fail to provide timely and effective therapy following cranial acute health events like stroke due to inadequate sensing and stimulation parameters.
Innovation Solution
A closed-loop nerve tissue stimulation system that senses EEG and ECAP signals to determine personalized nerve tissue stimulation commands, adjusting parameters based on these signals to provide timely and effective therapy for conditions such as stroke, using implantable devices and leads positioned endovascularly near nerves like the vagus nerve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cuff electrodes are used for vagus nerve stimulation, then nerve stimulation therapy can be provided, but the surgical procedure becomes invasive and complex
Solution Approach 1:
The patent uses vascular access leads that travel through blood vessels as an intermediary pathway to reach the vagus nerve, avoiding direct surgical exposure of the nerve. The lead is positioned in proximity to the vagus nerve through the vascular system, serving as a mediator between the external stimulator and the target nerve, thereby reducing surgical invasiveness while maintaining therapeutic effectiveness.
2Object-affected harmful factors
If nerve stimulation is delayed after cranial acute health event, then surgical risk is reduced, but therapy effectiveness decreases
Solution Approach 1:
The patent implements preliminary positioning of vascular access leads through the vascular system before acute health events occur. The leads are already in place and can be immediately activated when needed, allowing rapid delivery of nerve stimulation therapy within the critical time window after stroke or other cranial events, thus maintaining therapy effectiveness while avoiding emergency surgical procedures.
Solution Approach 2:
The system incorporates sensing capabilities that continuously monitor physiological parameters and can detect cranial acute health events in real-time. When an event is detected, the system automatically triggers nerve stimulation therapy, providing rapid closed-loop response that ensures timely treatment without requiring emergency surgical intervention.
3Ease of operation
If standardized nerve stimulation parameters are used, then device operation is simplified, but patient response rate decreases
Solution Approach 1:
The patent implements dynamic adjustment of stimulation parameters based on real-time sensing of patient-specific physiological data. The system continuously adapts stimulation amplitude, frequency, and pulse width to match the patient's current neurological state and response, transforming static standardized parameters into dynamic personalized parameters that optimize patient response rate while maintaining ease of operation through automated control.
Solution Approach 2:
The system automatically modifies stimulation parameters such as amplitude, frequency, and pulse duration based on sensed ECAP signals and patient response. By changing these parameters in real-time according to individual patient characteristics and therapeutic response, the system achieves personalized therapy that improves patient response rates without requiring manual intervention to simplify operation.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables quicker, more responsive nerve tissue stimulation, reducing complications and improving patient outcomes by accurately detecting and confirming cranial acute health events, thereby enhancing treatment efficacy.
Implementation Method 1
a first implantable medical device (IMD) configured to sense electroencephalogram (EEG) signals of a patient
Implementation Method 2
a second IMD configured to determine evoked compound action potential (ECAP) of the patient
Implementation Method 3
the second IMD is further configured to apply an electrical signal to stimulate nerve tissue based on the nerve tissue stimulation command
Data Source
AI summary
An example system includes a first implantable medical device (IMD) configured to sense electroencephalogram (EEG) signals of a patient; a second IMD configured to determine evoked compound action potential (ECAP) of the patient; and processing circuitry of at least one of the first IMD, the second IMD, or a computing device configured for wireless communication with at least one of the first IMD or the second IMD, the processing circuitry configured to determine a nerve tissue stimulation command based on at least one of the EEG signals and the ECAP, wherein the second IMD is further configured to apply an electrical signal to stimulate nerve tissue based on the nerve tissue stimulation command.