External Controller Steering for Precise Spinal Cord Stimulation
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Solution Overview
Problem
Patients with spinal cord stimulation implants face challenges in adjusting stimulation parameters independently, as traditional controllers lack the ability to move stimulation locations effectively, leading to reduced therapeutic efficacy over time due to lead migration and changing patient activities.
Innovation Solution
A steering algorithm implemented in patient external controllers allows patients to adjust stimulation by entering pain scores and coverage data, computing targeting precision values, and determining a steering vector to move stimulation in the electrode array for improved symptom targeting, optionally adjusting neural dose.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional external controllers are used for spinal cord stimulation, then the device structure remains simple, but the ability to independently adjust stimulation parameters and target symptoms precisely is limited
Solution Approach 1:
The external controller enables patients to independently adjust stimulation parameters without clinician intervention. The controller computes targeting precision values based on patient inputs (pain scores, coverage data) and automatically determines steering vectors to move stimulation locations, allowing self-service parameter adjustment and symptom targeting.
Solution Approach 2:
The controller implements a feedback loop where patients provide inputs about symptom targeting, the controller computes targeting precision values and steering vectors, adjusts stimulation parameters accordingly, and can iterate the process to optimize therapeutic efficacy over time.
2Reliability
If stimulation parameters are fixed, then the device operation is simple, but therapeutic efficacy decreases over time due to lead migration and changing patient activities
Solution Approach 1:
The system transitions from fixed stimulation parameters to dynamic, adjustable parameters. The controller enables real-time modification of stimulation location and parameters in response to patient needs, lead migration, or changing activities, maintaining therapeutic efficacy through continuous optimization.
Solution Approach 2:
The controller computes steering vectors that indicate directions and distances for moving stimulation locations within the electrode array. By changing stimulation parameters (location, intensity, duration) based on computed values, the system adapts to maintain optimal therapeutic effect despite lead migration or patient lifestyle changes.
3Productivity
If manual adjustment of stimulation location is required, then the control mechanism remains simple, but the time needed for optimization increases
Solution Approach 1:
The system replaces manual mechanical adjustment of stimulation parameters with automated computational processes. The controller calculates steering vectors and computes optimal parameter changes based on algorithmic analysis of patient inputs, eliminating the need for manual trial-and-error adjustment and significantly reducing optimization time.
Data Source
AI summary
Systems and methods are disclosed to permit a patient to use his external controller to move the location of stimulation in an implantable stimulator system. The external controller can be programmed with a steering algorithm, which prompts the patient to enter certain data regarding their symptoms (e.g., pain), such as pain scores and stimulation coverage. Such data is preferably entered for a plurality of different regions of the patient's body. The algorithm can compute for each body regions a targeting precision value (TP), and from these values determine a steering vector D that suggests a direction and/or a magnitude that stimulation can be moved in the electrode array to more precisely target the patient's pain. The patient may then move the location of the stimulation in accordance with the steering vector using their external controller. The algorithm can be repeated if necessary to again move the stimulation.