Implantable Stimulation Waveforms With Random Parameter Variation
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Solution Overview
Problem
Existing implantable devices for treating pain and other conditions are limited by their size, power efficiency, and the need for invasive procedures and battery replacement, preventing their widespread use in various applications.
Innovation Solution
An implantable system with a first implantable device delivering stimulation energy and an implantable controller providing a stimulation waveform with randomly varied parameters, including energy storage and optional external system support, to treat pain and other conditions while minimizing undesired effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a patient has a chronic condition requiring long-term implantable device therapy, then the patient requires continuous stimulation treatment, but the patient is at increased risk for lead infection and device failure
Solution Approach 1:
The patent implements periodic interruption of stimulation therapy through random on/off patterns. The controller randomly varies the duration that stimulation is delivered versus withheld, creating periods of no stimulation that allow infection resolution while maintaining overall therapeutic benefit. This periodic action directly addresses the contradiction by enabling long-term treatment duration while reducing continuous infection risk.
Solution Approach 2:
The patent applies dynamic adjustment of stimulation parameters including random variation in pulse width, amplitude, frequency, and duty cycle. This dynamic approach allows the system to adapt stimulation delivery in real-time, creating unpredictable patterns that prevent infection establishment while maintaining therapeutic effectiveness. The dynamic nature of the stimulation delivery resolves the contradiction between long-term treatment and infection risk.
2Reliability
If stimulation parameters are kept constant to ensure reliable therapeutic effect, then treatment effectiveness is maintained, but the patient may develop tolerance or pain from continuous stimulation
Solution Approach 1:
The patent implements dynamic random variation of stimulation parameters including pulse width, amplitude, frequency, and duty cycle. This dynamic approach prevents patient tolerance and pain by creating unpredictable stimulation patterns that adapt over time. The controller randomly adjusts parameters within therapeutic ranges, maintaining effectiveness while preventing harmful tolerance development. This directly resolves the contradiction between consistent therapeutic effect and prevention of patient tolerance.
Solution Approach 2:
The patent applies random variation in stimulation parameters such as pulse width, amplitude, frequency, and duty cycle. By changing these parameters randomly within therapeutic ranges, the system maintains effective treatment while preventing patient adaptation and tolerance. This parameter changes approach resolves the contradiction by ensuring therapeutic reliability while preventing harmful tolerance and pain from continuous identical stimulation.
3Object-affected harmful factors
If stimulation is delivered continuously to manage chronic pain, then pain control is maintained, but the risk of bacterial biofilm formation on leads increases
Solution Approach 1:
The patent implements periodic interruption of stimulation delivery through random on/off patterns controlled by the controller. During periods when stimulation is withheld, bacterial biofilm formation is interrupted and resolved. The random variation in duration of stimulation versus interruption creates unpredictable patterns that prevent biofilm establishment while maintaining overall pain control. This periodic action directly resolves the contradiction between continuous pain control and biofilm formation risk.
Solution Approach 2:
The patent applies preliminary random variation of stimulation parameters before biofilm formation can establish. By randomly varying pulse width, amplitude, frequency, and duty cycle from the outset, the system prevents bacterial adaptation and biofilm formation. The preliminary dynamic adjustment creates conditions that are hostile to biofilm development while maintaining therapeutic effectiveness, resolving the contradiction between pain control and biofilm risk.
Data Source
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AI summary
A medical apparatus for a patient comprises an implantable system. The implantable system comprises a first implantable device comprising: at least one implantable functional element configured to deliver stimulation energy to tissue of the patient; and an implantable controller configured to provide a stimulation waveform to the at least one implantable functional element, the stimulation waveform comprising one or more stimulation parameters. The apparatus is configured to randomly vary at least one of the one or more stimulation parameters. Methods of providing stimulation energy with randomly varying stimulation parameters are also provided.