DBS Lead Placement Using ERNA Feedback for Selective Stimulation
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Solution Overview
Problem
Existing deep brain stimulation (DBS) systems face challenges in optimizing electrode placement and stimulation parameters, leading to non-selective activation of neural elements, excessive energy consumption, inadequate treatment, and undesirable side effects due to the dynamic nature of the brain and changes in patient needs, such as medication state.
Innovation Solution
A method and apparatus for DBS that utilize evoked resonant neural activity (ERNA) to determine optimal lead placement and stimulation parameters by fractionalizing current to multiple electrodes, detecting ERNA responses, and adjusting lead position or stimulation parameters based on these responses, with closed-loop feedback for dynamic adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrical stimulation is applied at high amplitude to ensure therapeutic effect, then treatment efficacy is improved, but energy consumption increases and non-target tissue is stimulated
Solution Approach 1:
The patent applies different stimulation amplitudes to different electrodes based on their specific locations and orientations relative to the target neural tissue. Each electrode receives a customized amplitude that is optimized for its local anatomical context, ensuring sufficient stimulation of the target while minimizing energy waste and non-target activation. This local optimization resolves the contradiction by matching stimulation intensity to local needs rather than applying uniform high amplitude throughout.
Solution Approach 2:
The system dynamically adjusts stimulation parameters including amplitude, pulse width, and frequency based on real-time ERNA feedback and pre-planned optimization. By changing these parameters adaptively rather than maintaining fixed high amplitude, the system achieves effective treatment while reducing overall energy consumption. The parameters are modified based on measured neural responses and anatomical considerations to optimize the energy-efficiency trade-off.
2Reliability
If electrical stimulation is applied at high amplitude to ensure therapeutic effect, then treatment efficacy is improved, but stimulation of neighboring cell populations causes undesirable side effects
Solution Approach 1:
Each electrode is assigned a customized stimulation amplitude based on its precise location, orientation, and proximity to target versus non-target neural structures. This local quality approach ensures that electrodes closer to the target receive appropriate stimulation while those near sensitive non-target areas receive reduced or no stimulation, thereby achieving effective treatment without activating neighboring cell populations that would cause side effects.
Solution Approach 2:
The stimulation system divides the electrode array into individually controllable segments, allowing independent amplitude adjustment for each electrode. This segmentation enables precise spatial control of the stimulation field, permitting high amplitude stimulation only at electrodes positioned over the target tissue while maintaining low or zero amplitude at electrodes adjacent to non-target structures, thus eliminating non-selective activation.
3Ease of operation
If stimulation parameters are fixed to simplify device operation, then ease of operation is improved, but the system cannot adapt to dynamic brain changes and patient needs
Solution Approach 1:
The system incorporates ERNA feedback mechanisms that automatically monitor neural responses to stimulation and use this information to optimize stimulation parameters. This closed-loop feedback enables the system to adapt to dynamic brain changes, medication state variations, and individual patient needs without requiring manual reconfiguration. The feedback-driven optimization maintains ease of operation while achieving high adaptability.
Solution Approach 2:
The system performs preliminary optimization of stimulation parameters based on pre-planned anatomical models and ERNA measurements taken during an initial phase. This preliminary action establishes an optimized parameter set that is then maintained or automatically adjusted, eliminating the need for continuous manual intervention while allowing the system to adapt to ongoing brain dynamics and patient condition changes.
4Manufacturing precision
If multiple electrodes are used to improve stimulation precision, then manufacturing complexity increases
Solution Approach 1:
The patent optimizes the electrode array by assigning different amplitudes to different electrodes based on their local anatomical positions and orientations. This local quality approach allows the system to achieve high precision stimulation using a distributed electrode array where each electrode contributes optimally to the overall stimulation field, managing the complexity through intelligent parameter distribution rather than simplifying the physical structure.
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
Enhances the precision of DBS by optimizing lead placement and stimulation parameters, reducing side effects, and ensuring effective treatment by dynamically adapting to patient needs and brain dynamics.
Implementation Method 1
detecting an evoked response evoked at a neural target for each of the stimulation locations
Data Source
Figure 1A~1B
Figure 2A~3
Figure 4~5
AI summary
Methods and systems for implanting stimulation leads in a patient's brain are disclosed. The methods and systems use sensed evoked resonant neural activity (ERNA) evoked in neural regions of the brain to guide the implantation and positioning of the stimulation lead(s). In addition to providing surgical support during lead implantation, the ERNA information can be used to facilitate stimulation parameter fitting and maintenance of effective therapeutic stimulation.