Spinal Cord Stimulation With Supra-Perception Electrode Search
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Solution Overview
Problem
Spinal Cord Stimulation (SCS) therapy for chronic pain can cause paresthesia, and high-frequency sub-perception therapy, while effective, drains the implantable pulse generator (IPG) battery quickly, necessitating frequent replacement or charging, and electrode selection is challenging without patient feedback.
Innovation Solution
Utilize supra-perception stimulation during the sweet spot search to quickly determine effective electrodes, allowing for immediate patient feedback and reducing the wash-in period, followed by titrating to sub-perception therapy, thereby accelerating the selection process and conserving battery life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high-frequency sub-perception therapy is used, then pain relief effectiveness is improved, but IPG battery life is reduced
Solution Approach 1:
The system employs periodic stimulation pulses with specific frequency ranges (40-100 Hz) to achieve pain relief while managing power consumption. The periodic nature of the stimulation allows for effective neuromodulation while conserving battery life compared to continuous high-frequency stimulation.
Solution Approach 2:
The system dynamically adjusts stimulation parameters including frequency (40-100 Hz), pulse width (60-200 microseconds), and amplitude to achieve sub-perception threshold stimulation. By optimizing these parameters, the system maintains therapeutic effectiveness while minimizing power consumption and extending battery life.
2Object-affected harmful factors
If sub-perception therapy is used, then paresthesia is reduced, but electrode selection difficulty increases
Solution Approach 1:
The system incorporates patient feedback mechanisms where patients report perceived benefits and side effects. This feedback loop allows clinicians to adjust stimulation parameters and electrode configurations to achieve optimal sub-perception therapy while minimizing paresthesia. The feedback also helps in identifying effective electrode combinations.
Solution Approach 2:
The system performs preliminary electrode identification and parameter optimization during initial programming sessions. By establishing effective electrode configurations and parameter sets in advance, the system reduces the difficulty of subsequent adjustments and maintains effective sub-perception therapy without requiring extensive patient feedback for basic electrode selection.
3Productivity
If supra-perception stimulation is used during sweet spot search, then electrode determination speed is improved, but patient feedback time is reduced
Solution Approach 1:
The system uses supra-perception stimulation during the initial sweet spot search phase to quickly identify effective electrode locations and configurations. This preliminary action accelerates the electrode selection process by providing obvious sensory feedback to patients, enabling rapid identification of target areas before transitioning to sub-perception therapy parameters.
Solution Approach 2:
The system employs periodic switching between supra-perception (for rapid electrode identification) and sub-perception (for therapeutic stimulation) modes. This periodic action allows for efficient electrode determination followed by transition to therapeutic parameters, optimizing both speed and patient comfort.
Data Source
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AI summary
The present invention relates to a spinal cord stimulator device, comprising a plurality of electrodes insertable within a patient's spinal column, and control circuitry programmed to provide sub-perception stimulation pulses to a patient's tissue at at least one of the plurality of electrodes in accordance with a stimulation program defined by a plurality of stimulation parameters including pulse frequency, wherein the stimulation parameters comprise an energy and a frequency that is on or within one or more linearly-bounded regions defined by points (i) (10 Hz, 6 µC/s), (10 Hz, 12 µC/s), (50 Hz, 55 µC/s), and (50 Hz, 27 µC/s); or (ii) (50 Hz, 27 µC/s), (50 Hz, 55 µC/s), (100 Hz, 88 µC/s), and (100 Hz, 40 µC/s); or (iii) (100 Hz, 40 µC/s), (100 Hz, 88 µC/s), (200 Hz, 151 µC/s), and (200 Hz, 67 µC/s); or (iv) (200 Hz, 67 µC/s), (200 Hz, 151 µC/s), (400 Hz, 274 µC/s), and (400 Hz, 118 µC/s).