Fossa Ovalis Localization via Electrophysiological Signal Analysis
Solution Overview
Problem
Current methods for transseptal puncture, such as those used in left atrial and ventricular catheterization, face complications due to the difficulty in accurately locating the fossa ovalis, leading to potential puncture of adjacent structures and increased risk of complications like cardiac tamponade, despite the use of ultrasound guidance, which is time-consuming and expensive.
Innovation Solution
A method utilizing unipolar and bipolar electrograms to identify the fossa ovalis by measuring electrophysiological parameters like voltage reduction, signal fractionation, broadened signals, reduced slew rate, reduced local myocardial impedance, increased phase angle, and increased pacing threshold, allowing for precise localization and subsequent transseptal puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If ultrasound guidance is used to locate the fossa ovalis, then the accuracy of puncture location is improved, but the procedure time and cost increase
Solution Approach 1:
The patent replaces the mechanical/physical ultrasound imaging system with an electrophysiological sensing system. Electrodes record electrical signals from cardiac tissue, and signal characteristics (amplitude, morphology, fractionation) are analyzed to identify the fossa ovalis location, eliminating the need for ultrasound equipment and reducing procedure time while maintaining accuracy
Solution Approach 2:
The patent uses electrical signal characteristics as a proxy or copy of the anatomical structure. Instead of directly visualizing the fossa ovalis with ultrasound, the system analyzes electrophysiological signals that reflect the underlying tissue properties and anatomy, providing indirect but sufficient information for accurate puncture placement
2Measurement precision
If ultrasound guidance is used to locate the fossa ovalis, then the accuracy of puncture location is improved, but the procedure cost increases
Solution Approach 1:
The patent substitutes expensive ultrasound imaging equipment with standard electrophysiological recording equipment. The electrical signal analysis system uses existing catheter-based electrodes and amplifiers, eliminating the need for costly ultrasound machines, transducers, and associated infrastructure while achieving comparable or superior localization accuracy
Solution Approach 2:
The patent relies on disposable or reusable electrophysiological catheters with integrated electrodes that are already standard in cardiac procedures. These inexpensive sensing elements replace expensive ultrasound equipment, providing a cost-effective solution that uses readily available medical consumables
3Ease of operation
If transseptal puncture is performed without accurate localization, then the procedure simplicity is maintained, but the risk of complications increases
Solution Approach 1:
The patent implements real-time feedback through electrophysiological signal monitoring during the puncture procedure. As the catheter approaches and contacts the fossa ovalis, characteristic changes in electrical signals (amplitude reduction, signal fractionation, morphology changes) provide immediate feedback to guide the operator, enabling safe and accurate puncture without complex imaging while maintaining procedural simplicity
Solution Approach 2:
The cardiac tissue itself provides the localization information through its inherent electrophysiological properties. The fossa ovalis region generates distinctive electrical signals that serve as self-identifying markers, eliminating the need for external imaging systems or complex guidance tools. The tissue's own electrical activity guides the puncture procedure
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 enables accurate and safe transseptal puncture by providing reliable electrophysiological markers for identifying the fossa ovalis, reducing the risk of complications and minimizing the need for extensive ultrasound guidance, thus improving procedural safety and efficiency.
Implementation Method 1
reduced local myocardial impedance
Implementation Method 2
acquiring unipolar and/or bipolar electrograms of the tissue of the interatrial septum
Data Source
AI summary
The instant disclosure relates to a family of devices and methods for both measuring electrophysiological signals and delivering elongate medical devices. In an embodiment, a kit is described that includes a hollow catheter adapted to navigate a patient's vasculature having a hollow lumen terminating at a distal end, structure configured for sensing cardiac electrical activity adjacent the distal end of the hollow catheter and for acquiring electrograms. The fossa ovalis of a subject can be located therefrom and a second medical device can be advanced into and through the hollow lumen to such an extent that a distal tip of the second medical device protrudes beyond a proximal end and the distal end of the hollow catheter at the same time.