Peripheral Nerve Cuff Stimulation Using Microbursts for Selective Recruitment
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Solution Overview
Problem
Conventional peripheral nerve stimulation methods often result in off-target effects due to non-directional stimulation of nerves like the vagus nerve, which innervates multiple organs, leading to side effects such as coughing or vomiting.
Innovation Solution
A system using a cuff lead with electrodes configured around the nerve and a control module that delivers targeted stimulation through macrobursts comprising multiple microbursts, each with specific pulse patterns and timings, allowing for precise recruitment or modulation of specific axons, fibers, or tracts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional peripheral nerve stimulation methods are used, then therapy can be provided for various treatments, but off-target effects occur due to non-directional stimulation leading to side effects such as coughing or vomiting
Solution Approach 1:
The stimulation pattern is segmented into multiple microbursts within a macroburst, where each microburst consists of multiple pulses delivered at specific intervals. This temporal segmentation allows selective activation of different nerve fibers based on their response characteristics, enabling directional stimulation that reduces off-target effects while maintaining therapeutic efficacy.
Solution Approach 2:
The system employs periodic microbursts repeated within a macroburst pattern, with specific pulse widths (10-100 μs) and amplitudes (10-100 μA). This periodic stimulation pattern creates temporal discrimination that allows selective recruitment of specific axons and fibers, reducing non-directional stimulation effects.
2Reliability
If higher stimulation amplitudes are used to ensure therapeutic effect, then stimulation reliability improves, but side effects and off-target effects increase
Solution Approach 1:
The system utilizes specific parameter combinations including pulse widths of 10-100 μs, amplitudes of 10-100 μA, and microburst intervals of 10-100 μs. These parameter changes enable selective activation of nerve fibers based on their electrophysiological properties, achieving reliable stimulation at lower amplitudes compared to conventional methods while minimizing side effects.
Solution Approach 2:
Different regions of the nerve are stimulated with different pulse patterns and amplitudes through selective electrode activation. This local differentiation allows targeted stimulation of specific fascicles or axon groups, ensuring therapeutic effect at the desired location while avoiding activation of fibers that cause side effects.
3Device complexity
If simple stimulation patterns are used, then device complexity is reduced, but precision in recruiting specific axons or fibers decreases
Solution Approach 1:
The stimulation pattern is divided into multiple microbursts (each with multiple pulses) repeated within a macroburst framework. This segmented approach, while increasing temporal complexity, provides precise control over which axons and fibers are activated based on their differential response to the pulsed stimulation pattern.
Solution Approach 2:
Nerve mapping is performed beforehand to identify and characterize the electrical response of different axons and fibers to stimulation. This preliminary characterization enables the selection of optimal pulse patterns for recruiting specific fiber types, achieving high precision in axonal recruitment through algorithmic control of the microburst parameters.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system reduces off-target effects by enabling targeted nerve stimulation with lower amplitudes and specific pulse patterns, thereby minimizing side effects and enhancing therapeutic efficacy.
Implementation Method 1
The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue
Data Source
AI summary
A system for stimulating a nerve includes a control module and a cuff lead with electrodes. The control module includes stimulation circuitry, a memory, and a processor configured to direct the stimulation circuitry to deliver a macroburst to the cuff lead for stimulation using the electrodes. The macroburst includes multiple microbursts. Each microburst includes pulses arranged in a temporal sequence. Each pulse has a pulse width of no more than 100 μs and a total amplitude of no more than 100 μA. A system for mapping a nerve can include a processor for directing the control module to deliver stimulation pulses according to at least one nerve mapping paradigm that includes a temporal sequence of pulses; associating stimulation effects with the electrodes of the cuff lead based on the temporal sequence; and mapping the electrodes to one or more axons, fascicles, nerve fibers, tracts of the nerve, or peripheral organs.