Balloon Catheter Electrode System for Valve Annulus Sizing
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Solution Overview
Problem
Current methods for sizing the valve annulus for trans-catheter valve implantation, such as imaging techniques, are not standardized, expensive, and do not accurately account for alterations post-balloon valvuloplasty, leading to uncertainties and increased risks of paravalvular aortic regurgitation.
Innovation Solution
A system and method using a balloon catheter with electrodes to generate and detect electrical fields, allowing for the determination of valve annulus dimensions and geometry, including major and minor axes and eccentricity, through the application of currents and voltage measurements, which can be confined within an insulative balloon to ensure accurate sizing post-valvuloplasty.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If imaging techniques (TTE, TEE, angiography) are used to size the valve annulus, then the annulus dimensions can be obtained, but the results are not standardized and yield different results depending on the view obtained, leading to measurement uncertainty
Solution Approach 1:
The patent replaces complex imaging systems (ultrasound, angiography) with a simple electrical measurement system consisting of electrodes and a voltage measurement device. The electrodes are positioned on the balloon surface to detect voltage changes that directly correlate with annulus dimensions, eliminating the need for complex image acquisition and interpretation while providing standardized, view-independent measurements.
Solution Approach 2:
The patent changes the measurement parameter from visual/image-based dimensions to electrical voltage measurements. By measuring voltage changes across the balloon surface as it expands against the annulus, the system directly quantifies annulus dimensions through electrical parameters rather than image analysis, achieving standardized and reproducible results.
2Reliability
If 3D computed tomographic (CT) imaging is used to size the valve annulus, then less paravalvular aortic regurgitation occurs, but the technique is expensive and requires independent patient preparation/assessment prior to the implantation procedure
Solution Approach 1:
The patent combines the sizing function with the existing balloon catheter used in the TAVI procedure. The electrodes are integrated onto the balloon surface, allowing dimension measurement to be performed as part of the routine procedural steps rather than as a separate pre-procedural assessment, thereby eliminating the need for independent patient preparation while maintaining reliable sizing accuracy.
Solution Approach 2:
The balloon catheter performs dual functions: it both sizes the annulus through electrode measurements and delivers the valve. The sizing information is obtained directly during the procedure itself, making the system self-sufficient and eliminating the need for external pre-procedural imaging assessments.
3Reliability
If 3D computed tomographic (CT) imaging is used to size the valve annulus, then less paravalvular aortic regurgitation occurs, but the technique poses the risk of exposure to harmful radiation
Solution Approach 1:
The patent replaces radiation-based CT imaging with non-ionizing electrical measurements. The electrode system detects voltage changes caused by balloon expansion against the annulus, providing accurate sizing information without any harmful radiation exposure to the patient.
4Ease of operation
If balloon valvuloplasty is performed to open the diseased native valve, then valve access is improved, but the annulus dimensions are altered making it difficult to correctly size the annulus with current imaging techniques
Solution Approach 1:
The patent performs the sizing measurement immediately after balloon valvuloplasty while the balloon is still inflated against the annulus. This timing captures the post-valvuloplasty annulus dimensions before any further procedural alterations occur, providing accurate sizing information that reflects the actual conditions during valve implantation.
Solution Approach 2:
The patent maintains continuous measurement capability throughout the procedure. The electrodes remain on the balloon surface, allowing sizing measurements to be taken at any point during balloon inflation or deflation, ensuring that the most relevant post-valvuloplasty dimensions are captured without interrupting the procedural flow.
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
This approach provides a cost-effective, accurate, and radiation-reduced method for determining valve annulus dimensions, enabling precise valve sizing and reducing the risk of paravalvular leaks, while allowing for immediate post-procedural measurements without the need for pre-procedural assessments.
Implementation Method 1
a first pair of drive electrodes affixed to the interior surface of the balloon, the first pair of drive electrodes configured to produce a first electrical field based on a first predetermined current/voltage
Implementation Method 2
the balloon may be made of an insulative material such that the first electrical field and the second electrical field are confined to an area inside the balloon
Data Source
AI summary
A system for detecting the dimensions and geometry of a native valve annulus for trans-catheter valve implantation includes a compliant balloon and a shaft within the balloon. One or more drive electrodes may be affixed to a surface of the balloon, and one or more sense electrodes may be affixed to the shaft. After insertion of the balloon into the native valve annulus, the drive electrodes may be energized with a predetermined voltage. Using a trained statistical model and the voltages measured at the sense electrodes, initial estimates of the cross-section of the valve annulus may be obtained. The initial estimates may then be provided to an optimization model of the valve annulus to obtain a highly accurate prediction of the cross-section of the valve annulus.