Multi-Electrode RF Balloon Catheter for Pulmonary Vein Isolation
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Solution Overview
Problem
Conventional balloon or inflatable catheters lack flexibility to accommodate varying heart anatomy and provide sufficient structural support for effective tissue contact, and existing ablation electrodes are not adaptable for different shapes and sizes, posing challenges in treating cardiac arrhythmias like atrial fibrillation.
Innovation Solution
A multi-electrode RF balloon catheter with a compliant balloon and independently controlled electrodes, designed for flexible tissue contact and adaptable energy delivery, is used in conjunction with a multi-electrode diagnostic catheter for precise pulmonary vein isolation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional balloon or inflatable catheters are used, then they can provide a radially symmetrical configuration with multiple electrode elements, but they lack flexibility to accommodate different shapes and sizes of heart anatomy
Solution Approach 1:
The catheter is divided into multiple segments including a compliant balloon segment with electrodes and a support segment with a shape memory alloy structure. This segmentation allows the balloon to conform to varying anatomical shapes while the support segment maintains structural integrity and proper orientation
Solution Approach 2:
The catheter incorporates a shape memory alloy support structure that can change its physical parameters (shape, rigidity) in response to temperature changes or electrical signals, allowing it to adapt from a compressed delivery state to an expanded functional state that matches the target anatomy
2Area of stationary object
If ablation electrodes provide greater surface contact area, then they can improve ablation effectiveness, but they lack sufficient flexibility to accommodate tighter space constraints of ostium and pulmonary vein
Solution Approach 1:
The electrode array on the balloon is segmented into multiple independently controllable electrode elements distributed around the circumference. This allows selective activation of specific electrode segments to match the geometry of ostium or pulmonary vein targets, providing adequate contact area while adapting to confined spaces
Solution Approach 2:
The balloon is designed to be inflatable to different degrees, allowing dynamic adjustment of its expanded diameter. This enables the electrode array to provide sufficient contact area for large targets like the left atrium while being compressed to a smaller size for accessing narrower ostium or pulmonary vein structures
3Device complexity
If a radially symmetrical balloon configuration is used, then multiple electrode elements can surround the balloon for comprehensive ablation, but determining the orientation of the balloon electrode assembly under fluoroscopy becomes challenging
Solution Approach 1:
The catheter incorporates asymmetric radiopaque markers or markers with specific geometric patterns at known positions on the balloon surface. These asymmetric features create distinctive fluoroscopic appearances that allow operators to determine the balloon's rotational orientation and anatomical positioning, breaking the symmetry problem while maintaining the functional multi-electrode configuration
4Measurement precision
If delicate wires such as electrode lead wires and thermocouple wires are used, then they can provide precise electrical connections, but they are vulnerable to breakage and damage during assembly and use in the patient's body
Solution Approach 1:
The catheter incorporates a flexible protective sheath or coating that encases the delicate lead wires and thermocouple wires. This protective layer shields the wires from mechanical damage during navigation through the vasculature and manipulation in the heart, while maintaining electrical conductivity and thermal sensitivity of the underlying wires
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
The multi-electrode RF balloon catheter achieves high success rates in isolating pulmonary veins with minimal collateral damage and reduced incidence of complications such as cerebral lesions and esophageal injury, optimizing safety and efficacy in treating paroxysmal atrial fibrillation.
Implementation Method 1
By selectively ablating cardiac tissue by application of energy via a catheter... The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions
Data Source
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AI summary
The subject of this disclosure is devices, systems, and uses thereof to treat a plurality of patients for paroxysmal atrial fibrillation. The solution can include delivering a multi-electrode radiofrequency balloon catheter and a multi-electrode diagnostic catheter to one or more targeted pulmonary veins; ablating tissue of the one or more targeted pulmonary veins using the multi-electrode radiofrequency balloon catheter; diagnosing the one or more targeted pulmonary veins using the multi-electrode diagnostic catheter; and achieving at least one of a predetermined clinical effectiveness and acute effectiveness of the method or use based on use of the multi-electrode radiofrequency balloon catheter and the multi-electrode diagnostic catheter in the isolation of the one or more targeted pulmonary veins.