Dynamic Stimulation Location Control in Spinal Cord Electrode Arrays
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Solution Overview
Problem
Spinal Cord Stimulation (SCS) therapy can cause paresthesia, and achieving sub-perception therapy without paresthesia is challenging due to the dynamic nature of the implantation environment, which can lead to misalignment of the stimulation location over time, requiring frequent clinician intervention for readjustment.
Innovation Solution
An external system with software and algorithms that automatically vary the stimulation location within a defined area using a probability distribution function (PDF) to maintain effective therapy by adjusting the location as a function of time, ensuring the stimulation remains proximate to the neural pain site despite movements of the electrode array.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fixed stimulation location is used in electrode array, then initial pain relief is achieved, but misalignment occurs over time due to dynamic implantation environment
Solution Approach 1:
The system dynamically adjusts the stimulation location within the electrode array over time based on a probability distribution function, transitioning from a fixed location to a moving location that adapts to changes in the implantation environment while maintaining therapeutic effectiveness
Solution Approach 2:
The system changes the spatial parameter of stimulation location by selecting different electrodes or electrode combinations within the array according to a probability distribution function, allowing the stimulation focus to shift and maintain alignment with the neural pain site despite physiological movements
2Reliability
If stimulation location is adjusted frequently to maintain alignment, then pain relief effectiveness is maintained, but clinician intervention time and visits increase
Solution Approach 1:
The system performs self-adjustment of stimulation location through automated algorithms that select appropriate electrodes based on a probability distribution function, eliminating the need for frequent manual clinician interventions while maintaining therapeutic effectiveness
Solution Approach 2:
The system incorporates feedback mechanisms that monitor stimulation effectiveness and automatically adjust the stimulation location in response to detected changes, reducing the need for external clinician adjustments
3Reliability
If higher frequency stimulation is used to ensure coverage, then pain relief is maintained, but battery life decreases
Solution Approach 1:
The system applies stimulation at lower frequencies by selectively activating specific electrodes or electrode combinations within the array according to a probability distribution function, providing sufficient pain relief coverage without the excessive energy consumption of high-frequency stimulation across all electrodes
Data Source
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AI summary
External system software is disclosed that automatically varies the location at which stimulation is applied to the patient in an Implantable Pulse Generator (IPG). Location variation occurs in an area defined with reference to the electrode array, and may occur randomly or via pre-defined path within the area. Preferably the area is defined around a single location deemed optimal for the patient. Parameters relating to the area and to how often the stimulation is moved can be set automatically or manually by a user of the software. The area may be defined using a probability distribution function (PDF) that tends to keep the stimulation at or close to an optimal position, while still allowing the location to be set anywhere in the area. The area may also be defined in the software using measured parameters indicative of the effectiveness of stimulation at different locations.