Insulating Sheath Window for Selective Vagus Nerve Stimulation

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Solution Overview

Problem

Current nerve stimulation technologies face challenges in selectively stimulating the vagus nerve while avoiding stimulation of adjacent structures, leading to inefficient treatment outcomes and potential side effects.

Innovation Solution

A system comprising a medical lead with electrodes and an insulating element, where the insulating element is configured to be implanted within the internal jugular vein, featuring a stent-like fixation member and an electrically insulative sheath with a window to deliver targeted electrical stimuli to the vagus nerve, minimizing stimulation of nearby nerves and tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimuli are delivered to the vagus nerve from within the internal jugular vein, then the treatment effectiveness is improved, but adjacent nerve structures may be unintentionally stimulated causing side effects

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidstimulation of adjacent structures

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The insulating sheath is designed with a window at a specific location to allow electrical stimuli to be delivered locally to the vagus nerve while the rest of the sheath provides insulation to prevent stimulation of adjacent structures. This creates different functional zones: an insulating region and a non-insulating window region, enabling selective stimulation of the target nerve while protecting surrounding tissues.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The insulating sheath is segmented into different functional zones: an insulating portion that prevents unwanted stimulation and a window portion that allows targeted stimulation. The sheath is also divided into a proximal portion for insulation and a distal portion with the window for stimulus delivery, enabling differentiated functionality along the length of the device.

Inventive Principle:

Principle #1Segmentation

2Reliability

If an insulating sheath is implanted within the internal jugular vein, then selective stimulation of the vagus nerve is achieved, but the device complexity increases

Engineering Contradiction:

Improveselective stimulationVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The insulating sheath combines multiple functions into a single integrated component: it provides electrical insulation, structural support, positioning within the vein, and defines the stimulation window. By merging these functions into one element rather than using separate components, the device complexity is minimized while achieving selective stimulation.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insulating sheath serves multiple purposes simultaneously: it insulates electrical stimuli, provides mechanical support for the lead, anchors the device within the vein, and creates the stimulation window. This multi-functionality reduces the need for additional separate components, thereby managing device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Measurement precision

If the insulating sheath is disposed about the lead within the internal jugular vein, then the lead is stabilized and positioned accurately, but the insertion and implantation procedure becomes more complex

Engineering Contradiction:

Improvelead positioning accuracyVSAvoidimplantation procedure

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The insulating sheath is pre-formed with the window positioned and oriented before implantation. The proximal portion is pre-configured to provide anchoring engagement with the vein wall. These preliminary preparations enable accurate positioning and stable placement during the implantation procedure without requiring complex intra-procedural adjustments.

Inventive Principle:

Principle #10Preliminary action

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 effectively directs electrical stimuli to the vagus nerve while preventing unwanted stimulation of adjacent structures, enhancing treatment efficacy and safety by confining the energy to the target area.

Implementation Method 1

The insulating sheath is configured to be implanted within the internal jugular vein and disposed about the lead and to insulate nerve structures proximate the vagus nerve from stimulation

Methodology Applied

Scientific EffectElectrical insulation: Electrical Resistance

Implementation Method 2

The electrode is configured to transvascularly deliver an electrical stimuli to the target region of the vagus nerve from a location within the internal jugular vein

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS8903509B2Systems and methods for stimulation of vagus nerve

Publication Date: 2014.12.02 CARDIAC PACEMAKERS INC

AI summary

Described is a system for stimulating a target region of a vagus nerve from a location within an internal jugular vein. The system comprises a medical lead and an insulating element. The insulating element is formed from a flexible sheet of electrically insulative material, and is to be implanted within the internal jugular vein to insulate nerve structures proximate the vagus nerve from stimulation. The insulating sheath includes at least one window through which the electrical stimuli can be delivered to the target region of the vagus nerve.