6Fr ICE Catheter Phased Array Imaging for Cardiac Lead Placement
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Solution Overview
Problem
Current ICE catheters are unable to access smaller vascular structures, limiting their use and potentially compromising patient outcomes by requiring femoral access, increasing radiation exposure, and not allowing visualization of soft tissue structures during lead placement for pacemakers and ICD devices.
Innovation Solution
A MEMS-based or bulk PZT-based phased array ultrasound catheter with a 6 French diameter or smaller is used for delivery through the internal jugular, subclavian, or innominate venous system, equipped with a MEMS-based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array and a custom dongle for ICE imaging, enabling visualization of lead placements and facilitating arterial access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If current ICE catheters are used with larger diameter (8Fr or greater), then they can access femoral vein for procedure, but they are unable to access smaller vascular structures and require femoral access which increases radiation exposure and limits patient mobility
Solution Approach 1:
The catheter diameter is reduced from 8Fr or greater to 6Fr or smaller, enabling access to smaller vascular structures such as the subclavian vein while maintaining operational capability through advanced transducer array design and signal processing techniques
Solution Approach 2:
The ultrasonic transducer is divided into multiple array elements that can be independently controlled, allowing the small-diameter catheter to achieve imaging capabilities previously only possible with larger catheters through electronic beamforming and phased array techniques
2Ease of operation
If femoral access is used for catheter delivery, then current larger ICE catheters can be delivered, but radiation exposure increases and patient mobility is reduced
Solution Approach 1:
The catheter diameter is reduced to enable alternative access routes through smaller veins such as the subclavian or internal jugular vein, eliminating the need for femoral access and associated radiation exposure from fluoroscopy-guided femoral vein puncture and catheter insertion
3Measurement precision
If current ICE catheters are used, then imaging of cardiac structures is achieved, but visualization of soft tissue structures during lead placement is not possible
Solution Approach 1:
The ultrasonic transducer is segmented into multiple array elements that can be independently activated and controlled, enabling high-resolution imaging of soft tissue structures such as the interatrial septum, interventricular septum, and lead-tissue interface that were previously not visualizable with conventional single-element transducers
Solution Approach 2:
The phased array transducer enables imaging in multiple dimensions through electronic beamforming, providing cross-sectional and three-dimensional views of soft tissue structures and lead placement that supplement traditional two-dimensional fluoroscopic imaging
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 solution allows for improved visualization of cardiac structures, reduces radiation exposure, and enhances patient mobility by accessing smaller vascular structures without femoral access, thereby improving procedural outcomes and safety.
Implementation Method 1
directing each of the plurality of transducer array elements to transmit and receive, with respect to heart, ultrasound beams
Implementation Method 2
MEMS-based Piezoelectric Micromachined Ultrasonic Transducer (pMUT)
Data Source
AI summary
An ICE imaging system is disclosed, which comprises an Intracardiac echocardiography (ICE) catheter having a longitudinal axis, a proximal end, and a distal end. The ICE catheter corresponds to a micro-electromechanical (MEMS) or other transducer based phased array ultrasound catheter with an out diameter of 6 French or smaller for delivery through an internal jugular, subclavian, axillary, innominate venous system into heart chambers for the purpose of lead placement for a pacemaker or other implantable cardioverter defibrillator (ICD) device. Further, a catheter shaft houses an electronic flex cable which is in communication with at least one signal trace, and is configured to direct a plurality of transducer array elements to transmit and receive ultrasound beams, receive at least one signal from the plurality of transducer array elements, and construct at least one image of at least a portion of the heart based on the at least one signal.