Split Stimulation Current Pulse Generator for Neurostimulation
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Solution Overview
Problem
Existing implantable pulse generators (IPGs) for neurostimulation systems face challenges in fine-tuning the electric field due to misalignment or shifting of lead electrodes, requiring invasive procedures for adjustments and potentially leading to suboptimal therapy delivery.
Innovation Solution
The system employs a pulse generator with a current regulator that splits the stimulation current into multiple segments, which can be selectively mapped to electrodes using a current mapping/routing control module, allowing for programmable distribution and adjustment of the electric field to optimize therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead electrodes are implanted in the patient, then neurostimulation therapy can be delivered, but misalignment or shifting of the lead electrodes occurs causing suboptimal therapy delivery
Solution Approach 1:
The system dynamically adjusts the electric field configuration by selectively activating different electrode combinations based on detected misalignment conditions. The controller modifies stimulation parameters in real-time to compensate for lead electrode shifting, transforming a static implantable system into a dynamically adaptable therapy delivery system.
Solution Approach 2:
The system changes electrical stimulation parameters including amplitude, pulse width, and frequency to optimize therapy delivery when misalignment is detected. By adjusting these parameters, the system compensates for positional deviations of the lead electrodes without requiring surgical intervention.
2Manufacturing precision
If surgical procedures are performed to realign lead electrodes, then electrode positioning accuracy improves, but patient trauma and procedural complexity increase
Solution Approach 1:
The implantable system performs self-adjustment by detecting misalignment conditions and automatically modifying its stimulation output to compensate. This self-service capability eliminates the need for repeated surgical procedures to realign electrodes, allowing the system to adapt to positioning changes autonomously.
Solution Approach 2:
The system replaces mechanical surgical adjustment procedures with electrical parameter modifications. Instead of physically repositioning the lead electrodes through invasive surgery, the system uses controlled electrical stimulation changes to achieve optimal therapy delivery despite positional deviations.
3Reliability
If the electric field is adjusted to compensate for misalignment, then therapy effectiveness improves, but system complexity increases
Solution Approach 1:
The controller serves multiple functions by integrating misalignment detection, analysis, and compensation capabilities within a single device component. This multi-functional approach allows the system to perform therapy delivery, monitoring, and adaptive adjustment without adding separate complex subsystems.
Solution Approach 2:
The system implements a feedback mechanism where misalignment conditions are detected and analyzed, then compensation adjustments are made to the electric field configuration. This closed-loop feedback approach enables automatic adaptation to positioning changes while maintaining manageable system complexity through intelligent control algorithms.
4Adaptability or versatility
If multiple electrodes are used to provide flexible field shaping, then adaptability to misalignment improves, but device complexity and energy consumption increase
Solution Approach 1:
The system segments the total stimulation current and distributes it selectively to different electrode groups based on detected misalignment conditions. By dividing the current into controllable segments that can be independently directed to different electrode combinations, the system achieves flexible field shaping while maintaining energy efficiency through selective activation.
Solution Approach 2:
The system activates only the necessary subset of electrodes required to achieve optimal therapy delivery for the detected misalignment condition, rather than continuously stimulating all available electrodes. This partial action approach reduces overall energy consumption while maintaining the adaptability to compensate for positioning deviations.
Data Source
AI summary
An apparatus and method for providing split stimulation currents in a pulse generator. In one embodiment, a current regulator of the pulse generator includes a digitally-programmable analog voltage generator coupled to a first input of an error amplifier that receives a second input controlled by a programmable resistor network configured to control a programmable total stimulation current output. A plurality of current splitting switches are operative to split the programmable total stimulation current output into a corresponding plurality of split current segments, which may be individually mapped to a selected set of lead electrodes across one or more implantable leads associated with the pulse generator.