Neuromodulation System Sub-threshold Therapy Feedback Control
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Solution Overview
Problem
Current neuromodulation systems face challenges in effectively delivering sub-threshold therapy, as it is difficult to determine if the therapy is optimized without causing paresthesia, and neurological accommodation can lead to diminished neural response over time, making it hard to maintain therapeutic efficacy.
Innovation Solution
A neuromodulation system that automatically varies modulation parameters such as electrode combinations, pulse amplitude, and pulse duration to maintain electrical energy at a sub-threshold level, preventing accommodation by cycling through different modulation programs and adjusting based on patient feedback and physiological parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If sub-threshold electrical energy is delivered to treat chronic pain without causing paresthesia, then patient comfort is improved, but it becomes difficult to determine if the therapy is optimized
Solution Approach 1:
The system employs feedback mechanisms where the neuromodulation device monitors physiological parameters and patient responses to automatically adjust modulation parameters. This closed-loop feedback enables detection of therapy optimization without requiring patient perception of paresthesia, resolving the contradiction between comfort and detectability of optimal therapy delivery.
2Duration of action of moving object
If continuous electrical stimulation is delivered to maintain therapeutic effect, then pain relief is sustained, but neurological accommodation occurs leading to diminished neural response over time
Solution Approach 1:
The system dynamically varies modulation parameters including pulse amplitude, pulse width, frequency, and electrode configurations over time. This dynamic adaptation prevents neurological accommodation by continuously changing the stimulation pattern while maintaining therapeutic efficacy, thus sustaining pain relief without diminishing neural response.
Solution Approach 2:
The neuromodulation device implements periodic variation of stimulation parameters through burst patterns and cyclic changes in electrode activation. This periodic action disrupts accommodation mechanisms while maintaining sustained therapeutic effect, addressing the contradiction between continuous treatment and response consistency.
3Reliability
If modulation parameters are manually programmed to optimize therapy, then treatment efficacy can be improved, but the system requires frequent reprogramming to maintain effectiveness
Solution Approach 1:
The neuromodulation device performs self-adjustment of modulation parameters based on monitored physiological data and detected therapy response. This self-service capability eliminates the need for frequent manual reprogramming by automatically maintaining optimal treatment efficacy, resolving the contradiction between sustained effectiveness and time loss from adjustments.
Solution Approach 2:
The system automatically changes modulation parameters including amplitude, pulse width, frequency, and electrode configurations based on real-time feedback. These automatic parameter changes maintain treatment efficacy without requiring manual intervention, reducing reprogramming frequency while sustaining therapeutic reliability.
4Object-affected harmful factors
If multiple electrode configurations are available to target different tissue volumes, then therapy can be customized to minimize non-target tissue modulation, but the number of modulation parameter sets increases exponentially
Solution Approach 1:
The electrode array is segmented into multiple independently controllable electrode groups or contacts. This segmentation allows selective activation of specific electrode combinations to target precise tissue volumes while minimizing non-target modulation. The segmented architecture manages complexity by organizing electrodes into manageable groups rather than treating all electrodes as a single configuration set.
Solution Approach 2:
Different electrode configurations provide localized stimulation to specific tissue regions with distinct properties. Each electrode or electrode pair is optimized for particular spatial targeting, allowing customization of therapy to minimize non-target tissue effects. This local quality approach reduces the need to evaluate all possible global configurations by focusing on locally optimized solutions.
Data Source
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AI summary
A neuromodulation system and method of providing therapy to a patient. Electrical energy is delivered to the patient in accordance with a modulation parameter, thereby providing therapy to the patient, and the modulation parameter of the delivered electrical energy is varied over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time. The sub-threshold level may be referred to as a patient-perception threshold, which may be referred to as a boundary below which a patient does not sense delivery of the electrical energy. For example, in a spinal cord modulation system, the patient-perception threshold may be a boundary below which a patient does not experience paresthesia.