Termination-Tube Fluid Lumen Assembly for Flexible RF Ablation Tips
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Solution Overview
Problem
Existing electrophysiology catheters face challenges in navigating through vasculature, managing heat generation during RF ablation, and ensuring effective irrigation to prevent tissue damage and blood coagulation during cardiac procedures.
Innovation Solution
A catheter tip assembly with a flexible tip electrode, manifold assembly, and thermal sensor, featuring a fluid lumen manifold with sideholes and a lumen cap, allowing for irrigation and temperature monitoring, along with a deflectable catheter shaft section and multiple lumens for enhanced maneuverability and functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Power
If RF ablation is applied to create lesions in cardiac tissue, then arrhythmias can be treated, but excessive heat generation can cause tissue damage such as steam pop and charring
Solution Approach 1:
Irrigation fluid serves as an intermediary substance between the ablation electrode and cardiac tissue. The fluid absorbs excess heat through convection and conduction, preventing direct thermal damage to the tissue while allowing controlled lesion formation. The irrigation system delivers cooling fluid to the electrode-tissue interface, managing heat transfer and preventing harmful thermal effects.
Solution Approach 2:
The system dynamically adjusts irrigation flow rate and temperature parameters to control heat removal from the ablation electrode. By changing the flow rate and temperature of the irrigation fluid, the system can modulate the cooling effect to prevent tissue damage while maintaining effective ablation power delivery.
2Ease of operation
If mechanical steering features are used to navigate the catheter through vasculature, then the catheter can be positioned at the intended site, but the catheter structure becomes more complex
Solution Approach 1:
The catheter is divided into multiple segments including a deflectable catheter shaft section with distinct proximal and distal portions. The pull wire system is segmented into multiple wires (first pull wire for upward deflection, second pull wire for downward deflection) that can be independently controlled. This segmentation allows complex navigation maneuvers through coordinated activation of individual segments while maintaining overall system manageability.
3Object-affected harmful factors
If irrigation is applied during ablation to prevent tissue damage, then thermal injury is reduced, but fluid management becomes more complex
Solution Approach 1:
The irrigation system is integrated into the existing catheter structure, with the fluid lumen manifold serving multiple functions: delivering irrigation fluid to the electrode, draining excess fluid, and potentially serving as a pathway for other therapeutic agents. The manifold assembly with its barbed connector and stop shoulder provides universal applicability across different ablation catheter designs without requiring entirely separate fluid management infrastructure.
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
Enhances navigation and temperature control during ablation procedures, preventing tissue damage and blood coagulation while enabling deeper and more effective lesion creation.
Implementation Method 1
A distal portion of the fluid lumen manifold can further comprise a plurality of sideholes
Implementation Method 2
The use of irrigated ablation electrode assemblies can also prevent the formation of soft thrombus and/or blood coagulation
Implementation Method 3
A catheter tip assembly with a flexible tip electrode, manifold assembly, and thermal sensor
Implementation Method 4
radio frequency (RF) ablation... The catheter imparts ablative energy to cardiac tissue to create one or more lesions
Data Source
AI summary
A catheter tip is disclosed comprising a tip electrode comprising a ledge feature, and a center cavity and a manifold assembly comprising a fluid lumen manifold and a stop tube. The stop tube can be coupled to the fluid lumen manifold and configured to abut the ledge feature such that a distal end of the fluid lumen manifold extends a pre-determined distance into the center cavity of the tip electrode. The fluid lumen manifold can comprise a plurality of sideholes which can be sized and configured to distribute an irrigant to the tip electrode. The catheter tip can comprise a flexible tip electrode.