2D ICE LAA Sizing With 3D Validation for Closure Device Selection
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Solution Overview
Problem
Current imaging methods for measuring the size of the Left Atrial Appendage (LAA) in patients with atrial fibrillation, such as cardiac CT and transesophageal echocardiogram (TEE), involve ionizing radiation, general anesthesia, and operator dependence, making them inconvenient and risky for LAA closure device selection.
Innovation Solution
A system using 2D Intracardiac Echo (ICE) imaging to acquire and process images of the left atrium, generate a 3D model, and validate the sufficiency of LAA images for accurate measurement, providing guidance for LAA closure device selection through a processor that ensures proper catheter positioning and image orientation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If cardiac CT is used to measure LAA size, then measurement accuracy is improved, but ionizing radiation exposure increases
Solution Approach 1:
The patent extracts the essential function of pre-procedure LAA sizing from CT imaging and relocates it to intraprocedural ICE imaging combined with 3D reconstruction. This removes the harmful radiation exposure while preserving the measurement accuracy needed for device selection.
Solution Approach 2:
The patent creates a 3D reconstructed model of the LAA from multiple 2D ICE image frames. This digital copy allows accurate measurement of LAA dimensions without requiring ionizing radiation, effectively replacing the CT-based measurement approach.
2Measurement precision
If TEE is used to measure LAA size, then measurement capability is improved, but procedural complexity and risk increase due to general anesthesia requirements
Solution Approach 1:
The patent extracts the LAA imaging function from the complex TEE procedure requiring general anesthesia and separates it into a simpler ICE-based approach. The 3D reconstruction capability is built into the ICE system, eliminating the need for anesthesia and associated procedural complexity.
Solution Approach 2:
The patent replaces the mechanical TEE probe insertion requiring general anesthesia with a catheter-based ICE system that uses echo location principles. This substitution eliminates the need for general anesthesia while maintaining measurement accuracy through 3D reconstruction.
3Measurement precision
If TEE is used for LAA imaging, then imaging capability is improved, but operator dependence increases affecting image quality
Solution Approach 1:
The patent implements a feedback mechanism where the ICE system captures multiple 2D frames, automatically reconstructs a 3D model, and validates the LAA visualization quality. This automated feedback loop reduces operator dependence by providing objective quality assessment and enabling re-imaging if quality is insufficient.
Solution Approach 2:
The system performs self-service through automated 3D reconstruction from captured 2D frames. The processing system automatically evaluates whether sufficient LAA visualization is achieved and guides whether additional imaging is needed, reducing reliance on operator skill and experience.
4Measurement precision
If pre-procedure CT or TEE imaging is performed, then LAA measurement accuracy is improved, but procedural time increases
Solution Approach 1:
The patent merges the LAA sizing measurement function with the intraprocedural ICE imaging already required for the closure procedure. By combining these functions into a single 3D reconstruction process, the patent eliminates separate pre-procedure imaging steps and reduces total procedural time while maintaining measurement accuracy.
Solution Approach 2:
The patent performs the 3D reconstruction and LAA measurement assessment during the procedure itself rather than requiring separate pre-procedure imaging sessions. This preliminary integration of measurement capability into the procedural workflow eliminates waiting time and accelerates the overall process.
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 accurate and safe measurement of LAA dimensions under local anesthesia, reducing procedural risks and turnaround time, and eliminating the need for pre-procedure imaging, thereby facilitating effective LAA closure device selection.
Implementation Method 1
a 2D ICE imaging system configured to acquire left atrium image data of a patient's heart and left atrial appendage image data of the patient's heart
Data Source
AI summary
Systems and methods for left atrial appendage closure device specification from two dimensional (2D) Intracardiac Echo imaging (ICE). In an imaging procedure, 2D ICE is used to acquire images of the left atrium of a patient. A model of the left atrium is generated from the images of the left atrium. The model of the left atrium is used to validate subsequent imaging of the left atrial appendage of the patient. Anatomical measurements from the validated subsequent imaging may be used to select or specify a left atrial appendage closure device in order to, for example, treat atrial fibrillation patients.