Ablation Catheter Flushing Annulus Design
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Solution Overview
Problem
Current renal denervation catheters, particularly unipolar and bipolar balloon-based systems, face challenges such as uncontrolled tissue heating, longer treatment times, bleeding risks, and inefficiencies due to lack of precise nerve location identification during renal artery ablation procedures.
Innovation Solution
A catheter assembly with a collapsible and adjustable basket-shaped electrode array made of shape-memory material, equipped with multiple ablation electrodes and orientation electrodes, allows for precise mapping and ablation of renal sympathetic nerves, incorporating a switching module for electrical mapping and ablation energy generation, and a flexible design for easy navigation and flushing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If unipolar catheters are used for renal ablation, then ablation energy can be delivered through a single electrode, but the treatment time increases substantially and tissue heating becomes uncontrolled
Solution Approach 1:
The catheter employs multiple bipolar electrode pairs segmented along the balloon surface, allowing simultaneous ablation at multiple locations. This segmentation enables parallel processing of tissue ablation, significantly reducing overall treatment time compared to single-electrode unipolar systems.
Solution Approach 2:
The catheter performs electrical mapping and nerve location identification before ablation treatment. This preliminary action allows precise targeting of sympathetic nerves, ensuring that ablation energy is delivered only to relevant tissue, thereby reducing total treatment time and avoiding unnecessary ablation of non-target areas.
2Ease of operation
If unipolar catheters with grounding pad are used, then ablation can be performed, but current flows throughout the body causing uncontrolled temperature increase in tissues and organs
Solution Approach 1:
The design extracts and eliminates the external grounding pad requirement by implementing bipolar electrodes directly on the balloon surface. Each bipolar pair uses the balloon itself as the return path, confining current flow to the immediate treatment site and preventing systemic current distribution that causes uncontrolled heating of distant tissues.
Solution Approach 2:
The balloon acts as an intermediary structure that provides both the active electrode surface and the return path for current. This intermediary configuration ensures that electrical current is contained within the renal artery lumen and does not flow through surrounding organs and tissues, thereby preventing uncontrolled thermal damage.
3Productivity
If bipolar balloon-based ablation catheters are used, then treatment time is reduced, but blood flow through the renal artery is blocked increasing patient risk
Solution Approach 1:
The catheter applies ablation energy at multiple bipolar pairs simultaneously but only to the extent needed for effective nerve denervation. The treatment is delivered in a controlled, partial manner across different electrode pairs rather than requiring complete occlusion for extended periods, thereby achieving therapeutic effect while minimizing ischemia time and associated risks.
4Ease of manufacture
If conventional ablation catheters are used, then ablation can be performed, but the physician cannot locate sympathetic nerves precisely leading to extended treatment time
Solution Approach 1:
The catheter integrates multiple functions into a single device: electrical mapping capability, nerve location identification, and ablation delivery. This multi-functional design allows the physician to perform mapping and locate sympathetic nerves using the same catheter that will deliver ablation, eliminating the need for separate mapping procedures and reducing overall treatment time.
Solution Approach 2:
The catheter provides real-time electrical mapping feedback during the procedure, allowing the physician to identify sympathetic nerve locations based on electrical signal characteristics. This feedback mechanism guides precise positioning of the catheter and electrodes, enabling targeted ablation without requiring trial-and-error approaches or extended procedural time for localization.
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 solution enables targeted and efficient renal denervation with reduced treatment time, minimized tissue damage, and improved precision in locating over-active nerve pathways, thereby enhancing the effectiveness and safety of the procedure.
Implementation Method 1
a collapsible and adjustable basket-shaped electrode array made of shape-memory material
Implementation Method 2
By applying RF energy to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated
Data Source
AI summary
A catheter assembly comprises a catheter having an axial lumen that houses electrical wires. A plurality of splines, each supporting at least one electrode, are connected to the wires and a distal cap. The splines have a basket shape in a deployed position and a collapsed shape when received inside the catheter axial lumen. A flexible tube extending outwardly from the catheter lumen has a tube lumen of a first, inner diameter and a distal tube end that is spaced proximally from the distal cap. A guide shaft extending proximally from the distal cap has a second, outer diameter that is less than the first diameter of the tube lumen. With the guide shaft received in the tube lumen, an annulus is formed by the tube lumen surrounding the guide shaft. With the splines in the deployed position, the annulus permits flushing of the area adjacent to the deployed splines.