Vascular Branch Characterization for Cardiac Lead Placement
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Solution Overview
Problem
The challenge in cardiac resynchronization therapy is the difficulty in navigating and placing a left ventricular pacing lead in the left ventricle due to variable venous anatomy, which can lead to complications such as dissection or perforation, and the inability to determine a priori whether a lead will fit well within a particular branch.
Innovation Solution
A method and device for characterizing a region of interest within the body using a sensor to measure position and orientation data, generating geometric data sets that include length, bifurcation location, angle, and curvature characteristics, and estimating dimensions such as diameter and tortuosity to aid in selecting the appropriate lead and implantation site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Difficulty of detecting and measuring
If fluoroscopic imaging is used to guide lead implantation, then real-time visualization of the lead position is achieved, but the patient and clinician are exposed to extensive fluoroscopic radiation
Solution Approach 1:
The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.
2Productivity
If lead implantation is performed without prior venous characterization, then the procedure can be completed quickly, but the ability to determine a priori whether a lead will fit well within a particular branch is lost
Solution Approach 1:
The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.
Solution Approach 2:
The system creates a three-dimensional digital copy or map of the patient's coronary venous anatomy based on position data acquired during a preliminary mapping procedure. This digital replica allows the physician to visualize branch dimensions, angles, and tortuosity, and to simulate lead placement before the actual implantation, thereby preserving venous anatomy information for future reference.
3Adaptability or versatility
If the venous anatomy is highly variable with sharp or acute takeoff angles, then anatomical diversity is accommodated, but the possibility of complications such as dissection or perforation increases
Solution Approach 1:
The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.
Solution Approach 2:
The system provides detailed three-dimensional information about specific local characteristics of the venous anatomy, including branch diameter, takeoff angles, and curvature at each segment. This localized information allows the physician to identify segments with sharp angles or small diameters that may be prone to complications and to select alternative target sites with more favorable anatomy.
4Adaptability or versatility
If multiple lead models with different lengths and diameters are available, then lead selection flexibility is improved, but the ability to determine before implantation whether a particular lead will fit in a particular branch is reduced
Solution Approach 1:
The system creates a three-dimensional digital copy or map of the patient's coronary venous anatomy based on position data acquired during a preliminary mapping procedure. This digital replica allows the physician to visualize branch dimensions, angles, and tortuosity, and to simulate lead placement before the actual implantation, thereby preserving venous anatomy information for future reference.
Solution Approach 2:
The system provides feedback by comparing the dimensions and characteristics of available lead models with the measured venous branch characteristics from the 3D map. This allows the physician to determine in advance which lead models are appropriate for each branch, reducing the need for trial-and-error implantation and minimizing the complexity of lead selection.
Data Source
AI summary
An apparatus and method for characterizing a region of interest (ROI) including measuring position and orientation data within the ROI; and generating a geometric data set to include one or more of: length, bifurcation location, angle and curvature characteristics of the ROI. Also, sequentially taking an image of a tool within the ROI; comparing tool dimensions with ROI dimensions; and estimating diameter, length, take-off angle, and/or tortuosity characteristics based on the comparisons.


