Spinal Cord Stimulation Self-Reprogramming via Automated Parameter Adjustment
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Solution Overview
Problem
Current spinal cord stimulation systems face challenges in efficiently adjusting stimulation parameters to optimize pain relief without paresthesia, as patients may experience shifts in pain locations and changes in pain tolerance over time, requiring frequent reprogramming and manual adjustments.
Innovation Solution
A method using a graphical user interface on an external controller to evaluate stimulation efficacy, automatically determining whether to perform reprogramming algorithms for sub-perception or supra-perception stimulation, and adjusting neural dosage, with pre-loaded rescue programs and patient-controlled location algorithms to optimize electrode placement and stimulation intensity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual reprogramming and adjustments are performed by clinicians, then stimulation parameters can be optimized for pain relief, but the frequency of clinical visits increases and patient convenience deteriorates
Solution Approach 1:
The patent implements automated reprogramming algorithms that enable the spinal cord stimulation system to self-adjust stimulation parameters based on patient feedback and efficacy monitoring. The system automatically determines when reprogramming is needed and executes parameter adjustments without requiring clinician intervention, allowing the device to serve itself while maintaining optimized pain relief.
Solution Approach 2:
The system incorporates continuous monitoring of stimulation efficacy through patient feedback mechanisms (such as pain rating scales and paresthesia perception assessment). This feedback loop enables the automated algorithms to evaluate current parameter effectiveness and trigger reprogramming when degradation is detected, ensuring reliable pain relief while minimizing unnecessary clinical visits.
2Adaptability or versatility
If stimulation parameters are adjusted frequently to adapt to changing pain locations and tolerance, then pain relief optimization is improved, but device complexity and reprogramming requirements increase
Solution Approach 1:
The system pre-loads multiple rescue programs with different stimulation parameter configurations into the IPG before deployment. When adaptation is needed, the automated algorithm selects and activates appropriate pre-configured programs rather than requiring complex real-time parameter calculations, simplifying the reprogramming process while maintaining adaptability to changing pain conditions.
Solution Approach 2:
The automated reprogramming algorithm systematically varies stimulation parameters (amplitude, pulse width, frequency, electrode selection) according to predefined search patterns and optimization criteria. This structured parameter exploration enables the system to adapt to changing pain locations and patient tolerance levels while keeping the adjustment process automated and relatively simple.
3Object-affected harmful factors
If sub-perception stimulation is used to avoid paresthesia, then patient comfort is improved, but the ability to evaluate stimulation efficacy and optimize parameters becomes more difficult
Solution Approach 1:
The system implements periodic switching between sub-perception stimulation (for comfortable ongoing therapy) and supra-perception stimulation (for efficacy evaluation and parameter optimization). During scheduled evaluation periods, the algorithm temporarily increases stimulation intensity to perceptible levels to assess paresthesia coverage and pain relief effectiveness, then returns to comfortable sub-perception levels for continued therapy, thus maintaining both comfort and optimization capability.
Data Source
AI summary
Methods and systems for assisting a patient to reprogram parameters of an implantable medical device, such as a spinal cord stimulator, are disclosed. A patient may use an external controller, which may be either a dedicated device or a personal computing device, to interact with their implantable medical device and evaluate the efficacy of their therapy. If the efficacy diminishes, the patient may use their external controller to adjust either the neural dosage (i.e., frequency, pulse width, and/or amplitude) and/or the location at which stimulation is provided. A reprogramming assistant is provided, which guides the patient in adjusting their stimulation using their external controller. The patient may use supra-perception or sub-perception stimulation for the adjustment. The implantable medical device may include pre-programmed “rescue programs” to assist the patient in recovering the efficacy of their therapy.