Renal Nerve Modulation Monitoring with Impedance Sensing

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Solution Overview

Problem

Existing nerve modulation techniques, such as renal nerve ablation, face challenges in detecting tissue changes when the ablation electrode is positioned away from the vessel wall, leading to reduced monitoring capabilities and potential 'blind' ablation scenarios due to lack of thermal feedback.

Innovation Solution

A system comprising an elongate shaft with an ablation electrode and sensing electrodes, where the sensing electrodes monitor impedance changes between them to detect tissue modifications, allowing for real-time monitoring and adjustment of ablation parameters, even in off-the-wall configurations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the ablation electrode is positioned away from the vessel wall (off-the-wall configuration), then the ability to ablate perivascular renal nerves is improved, but the capability to detect tissue changes through thermal feedback is worsened

Engineering Contradiction:

Improveability to ablate perivascular renal nervesVSAvoiddetection of tissue changes

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent introduces sensing electrodes as intermediary elements that detect impedance changes in the tissue. These sensing electrodes serve as mediators between the ablation electrode and the target tissue, allowing indirect monitoring of tissue changes during off-the-wall ablation procedures where direct thermal contact is not available.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the thermal feedback mechanism (which requires direct contact) with an electrical impedance-based detection system. By substituting thermal sensing with electrical impedance measurement through sensing electrodes, the system enables tissue change detection without requiring the ablation electrode to be in direct contact with the vessel wall.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If the ablation electrode is positioned away from the vessel wall, then access to perivascular nerves is improved, but real-time monitoring capability deteriorates due to lack of thermal feedback

Engineering Contradiction:

Improveaccess to perivascular nervesVSAvoidthermal feedback for monitoring

Core Design Contradiction:

Ease of operationVSLoss of information

Solution Approach 1:

The patent implements an electrical impedance-based feedback system using sensing electrodes. This feedback mechanism allows real-time monitoring of tissue changes during ablation by measuring impedance variations, compensating for the loss of thermal feedback that occurs in off-the-wall configurations.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

Sensing electrodes are introduced as intermediary elements that provide the missing monitoring capability. These electrodes act as mediators that capture electrical property changes in the tissue, translating them into usable feedback signals for real-time monitoring without requiring direct thermal contact.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Measurement precision

If sensing electrodes are used to monitor impedance changes, then tissue change detection capability is improved, but device complexity increases

Engineering Contradiction:

Improvetissue change detectionVSAvoidnumber of electrodes and monitoring systems

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies multi-functionality by designing sensing electrodes that can serve both as monitoring elements for impedance detection and as part of the overall ablation system. This universal approach allows the same electrode structure to perform multiple functions, reducing the need for entirely separate monitoring hardware and thereby limiting the increase in device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 effective tissue modulation and monitoring, ensuring precise ablation by tracking impedance changes, thereby optimizing treatment outcomes and minimizing tissue damage.

Implementation Method 1

an impedance of the target region may be calculated from the current. Voltage may be applied to at least one of the first or second electrodes to effect tissue modulation on the target region. The current between the first and second electrodes may be monitored for changes in the impedance of the target region.

Methodology Applied

Scientific EffectElectrical impedance: Electrical Resistance

Implementation Method 2

Voltage may be applied to at least one of the first or second electrodes to effect tissue modulation on the target region

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS10314651B2Device and methods for renal nerve modulation monitoring

Publication Date: 2019.06.11 BOSTON SCIENTIFIC SCIMED INC

AI summary

Systems and methods for monitoring and performing tissue modulation are disclosed. An example system may include an elongate shaft having a distal end region and a proximal end and having at least one modulation element and one sensing electrode disposed adjacent to the distal end region. The sensing electrode may be used to determine and monitor changes in tissue adjacent to the modulation element.