Pericardial Balloon Mapping for Brugada Syndrome Diagnosis
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Solution Overview
Problem
Current methods for diagnosing Brugada syndrome, such as electrogram recordings, do not provide sufficient information about ion channels and myocardial tissue viability, making it difficult to identify the condition effectively.
Innovation Solution
A device and system for mapping myocardial tissue, featuring a distal assembly with an inflatable outer shell and a plurality of mapping electrodes, which expands to enhance contact with the tissue and record monophasic action potentials, allowing for comparison with healthy tissue signals to determine the presence of Brugada syndrome.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If electrogram recordings are used for cardiac mapping, then the procedure is simple and widely available, but the data does not provide sufficient information about ion channels and myocardial tissue viability
Solution Approach 1:
The mapping device segments the measurement function by using multiple independent electrodes (at least two electrodes) that can record electrical signals from different locations simultaneously. This segmentation allows comprehensive capture of electrical activity patterns needed to assess ion channel function and tissue viability, overcoming the information limitation of single-point electrogram recordings.
Solution Approach 2:
The mapping device achieves multi-functionality by integrating both electrogram recording capability and electrical stimulation capability into a single system. The electrodes can both record endogenous electrical signals and deliver controlled electrical stimuli, enabling comprehensive assessment of myocardial tissue including ion channel function, action potential characteristics, and tissue viability through multiple measurement modalities.
2Measurement precision
If the mapping device uses multiple electrodes to improve measurement accuracy, then diagnostic precision increases, but the device structure becomes more complex
Solution Approach 1:
The device divides the measurement task across multiple electrodes positioned at different locations. Each electrode records local electrical activity, and the combined data from segmented measurement points provides comprehensive information about electrical propagation patterns, enabling precise diagnosis of Brugada syndrome through analysis of spatial and temporal electrical characteristics.
Solution Approach 2:
The mapping device merges multiple measurement functions into a single integrated electrode assembly. The electrodes are combined with stimulation circuitry and signal processing capabilities, allowing simultaneous recording and stimulation functions to be performed by one unified device structure, thereby achieving high diagnostic precision without proportionally increasing overall device complexity.
3Ease of manufacture
If the device structure is simplified for ease of manufacture, then production cost decreases, but contact force between electrode and tissue becomes unreliable
Solution Approach 1:
The device employs adjustable electrical stimulation parameters (voltage, duration, frequency) that can be optimized to achieve reliable tissue activation without requiring complex mechanical pressure control systems. By changing the electrical parameters rather than mechanical contact parameters, the device maintains manufacturing simplicity while ensuring reliable electrical contact and consistent measurement quality.
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 maps myocardial tissue, enhancing contact between electrodes and tissue, and enables accurate identification of Brugada syndrome by comparing recorded signals with healthy tissue standards, improving diagnostic capabilities.
Implementation Method 1
at least one inflatable element within the outer shell... expanding the outer shell by inflating the at least one inflatable element, expansion of the outer shell exerting a force against electrode assembly
Data Source
AI summary
A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.