Cardiac Conduction Sensing for Valve Deployment

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Solution Overview

Problem

During the deployment of replacement heart valves, there is a risk of disrupting cardiac conduction signals, particularly the His Bundle, which can lead to cardiac conduction disorders such as left bundle branch block, especially in patients with pre-existing heart conditions, resulting in poor hemodynamic performance and increased mortality.

Innovation Solution

A specialized conduction system tissue activation potential sensing device is used to detect cardiac conduction signals before and during valve deployment, allowing for the repositioning of the valve to avoid the conduction system, thereby minimizing the risk of chronic block and improving patient survival.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If replacement heart valve is deployed without sensing cardiac conduction signals, then valve deployment is faster and simpler, but cardiac conduction disorders such as left bundle branch block occur, resulting in poor hemodynamic performance and increased mortality

Engineering Contradiction:

Improvepatient survivalVSAvoidsensing device complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sensing device is positioned and used to detect cardiac conduction signals before the valve is deployed. This preliminary detection allows the operator to identify the location of the His bundle and adjust the valve placement accordingly, preventing conduction disorders before they occur while maintaining patient safety

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

A specialized sensing device acts as an intermediary between the valve deployment system and the cardiac conduction system. This sensing device detects electrical signals from the His bundle and provides real-time information to guide valve positioning, enabling safe deployment without direct interference with conduction tissue

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If specialized conduction system sensing device is used to detect His Bundle signals, then cardiac conduction disorders are avoided, but the procedure time and operational complexity increase

Engineering Contradiction:

Improveavoidance of cardiac conduction disordersVSAvoidvalve deployment operation

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The sensing device provides real-time feedback about the location of cardiac conduction signals during the valve deployment procedure. This feedback allows the operator to adjust the valve position dynamically based on detected signals, making the complex task of avoiding conduction tissue more controllable and predictable

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The sensing device is activated before valve deployment to map the cardiac conduction system anatomy. This preliminary mapping simplifies the subsequent valve placement process by providing pre-identified safe zones, reducing the operational complexity of avoiding conduction tissue during deployment

Inventive Principle:

Principle #10Preliminary action

3Reliability

If valve is positioned close to the cardiac conduction system for optimal placement, then valve function is maximized, but the risk of disrupting cardiac conduction signals increases

Engineering Contradiction:

Improvevalve functionVSAvoiddisruption of cardiac conduction signals

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The sensing device is used to preliminarily identify the precise location of the His bundle and surrounding conduction tissue before final valve placement. This allows the operator to position the valve as close as possible to the conduction system for optimal function while stopping just short of causing disruption, based on real-time signal detection

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

Instead of relying solely on anatomical landmarks and mechanical positioning, the system uses electrical signal detection to identify conduction tissue location. This substitution of mechanical positioning with electrical field-based detection allows for more precise and safe valve placement, maximizing function while minimizing harm to conduction signals

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 technique effectively avoids cardiac conduction disorders by accurately positioning the heart valve to prevent interference with the cardiac conduction system, enhancing patient survival rates by maintaining efficient heart function.

Implementation Method 1

the sinoatrial (SA) node, the heart's natural pacemaker, generates electrical impulses, called action potentials, that propagate through an electrical conduction system to various regions of the heart

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS8888709B2Method and apparatus for sensing and avoiding cardiac conduction system during valve deployment

Publication Date: 2014.11.18 BOSTON SCIENTIFIC SCIMED INC

AI summary

Various techniques are described for replacement heart valve implantation. In one example, a system includes a specialized conduction system tissue activation potential sensing device, configured for delivery to an intracardiac region, a specialized conduction system tissue activation detector circuit, configured to detect, using the sensing device, a specialized conduction system tissue activation potential, and a processor circuit, configured to use information about the detected specialized conduction system tissue activation potential to generate a heart valve placement indication.