Peripheral Nerve Stimulation With Fascicle Mapping to Limit Side Effects

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Solution Overview

Problem

The complex anatomy of the vagus nerve poses challenges in determining which portions to stimulate for therapeutic effects while avoiding side effects, as improper stimulation can impair organ function and cause adverse reactions such as dysarthria, cough, and bradycardia.

Innovation Solution

A method and system for selective nerve stimulation using multiple trunk electrodes at different circumferential and longitudinal locations, with current steering and branch electrode recording to map and calibrate the nerve anatomy, allowing selective recruitment of neural populations and avoidance of side-effect inducing branches.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation is delivered to the vagus nerve trunk to achieve therapeutic effects, then therapeutic benefit is obtained, but side effects such as dysarthria, cough, and bradycardia occur due to activation of inappropriate neural elements

Engineering Contradiction:

Improvetherapeutic benefitVSAvoidside effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The vagus nerve trunk is segmented into multiple fascicles, each containing different neural elements. By using multiple circumferential electrodes to deliver fractionated stimulation, the method selectively activates specific fascicles while avoiding others, thereby achieving therapeutic effects without activating neural elements that cause side effects.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the nerve trunk are stimulated with different characteristics. The method delivers stimulation at multiple circumferential locations with different amplitudes and patterns to selectively recruit specific neural populations (e.g., large fibers vs. small fibers) in different fascicles, achieving localized selective activation.

Inventive Principle:

Principle #3Local quality

2Adaptability or versatility

If multiple circumferential electrodes are used to selectively stimulate specific neural populations, then selectivity is improved, but device complexity increases

Engineering Contradiction:

ImproveselectivityVSAvoiddevice complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The multiple circumferential electrodes serve multiple functions: they can be used for both stimulation and sensing. The same electrodes that deliver fractionated stimulation can also record evoked responses, eliminating the need for separate sensing electrodes and reducing overall device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The method combines stimulation and sensing functions into a single electrode array. By using the same circumferential electrodes for both delivering stimulation and recording evoked potentials, the system integrates multiple functions into one component, reducing the number of separate components needed.

Inventive Principle:

Principle #5Merging (Combining)

3Adaptability or versatility

If fractionated stimulation with current steering is used to activate specific neural populations, then manufacturing precision is reduced, but selectivity is improved

Engineering Contradiction:

ImproveselectivityVSAvoidelectrode placement precision

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The system uses evoked potential sensing to provide feedback on which neural elements are being activated. By monitoring the evoked responses and adjusting the stimulation parameters accordingly, the method achieves selective activation without requiring extremely precise electrode placement, as the feedback loop compensates for placement variations.

Inventive Principle:

Principle #23Feedback

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

Enables precise stimulation of therapeutic neural elements while minimizing side effects by mapping and calibrating the nerve anatomy, optimizing therapeutic outcomes and reducing adverse reactions.

Implementation Method 1

delivering electrical stimulation to the trunk using one or more of a plurality of trunk electrodes

Methodology Applied

Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

recording action potentials evoked by the first and second electrical stimulations at at least one of the plurality of branches

Methodology Applied

Scientific EffectAction potentials: Electrical Impedance Tomography

Data Source

PatentUS12551702B2Selective stimulation of peripheral nerves

Publication Date: 2026.02.17 BOSTON SCI NEUROMODULATION CORP

AI summary

Methods and systems for providing peripheral nerve stimulation are disclosed. Stimulation is delivered to a trunk of the nerve using electrodes configured at different circumferential locations about the nerve. Action potentials evoked by the stimulation within branches of the nerve are measured to map neural element within the trunk to the branches. The mapping can inform the selection of stimulation parameters that provide a therapeutic benefit and/or avoid unwanted side effects.