Ablation Catheter Insulation Balloon for Renal Denervation
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Solution Overview
Problem
Current ablation catheters face challenges in effectively delivering radiofrequency energy to target tissues while minimizing tissue damage and ensuring uniform lesion formation, particularly in renal artery denervation procedures, due to limitations in electrode-tissue contact and heat dissipation.
Innovation Solution
The ablation catheter features a radially expanding tubular insulation member with ablation electrodes mounted on its outer surface, an expansion mechanism for fitting within blood vessels, and a control unit for conveying ablation signals, along with a dispersive electrode for unipolar ablation, which allows for efficient energy delivery and heat management through fluid flow as a heat sink.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If a balloon is used to support ablation electrodes and provide cooling, then cooling capability is improved, but the device complexity increases
Solution Approach 1:
The patent combines the cooling function and electrode support function into a single integrated balloon structure. The balloon serves dual purposes: it provides cooling through fluid circulation and supports the ablation electrodes in contact with the vessel wall, eliminating the need for separate cooling and positioning mechanisms.
Solution Approach 2:
The balloon is designed as a multi-functional component that simultaneously performs cooling, electrode positioning, and tissue contact stabilization. This universal component approach reduces overall device complexity while maintaining multiple critical functions needed for effective ablation therapy.
2Productivity
If electrodes are positioned at the electrode-tissue interface, then ablation effectiveness is improved, but tissue damage increases
Solution Approach 1:
The balloon acts as an intermediary between the ablation electrodes and the tissue. It provides controlled contact through its compliant structure, distributing the thermal energy more evenly across the tissue surface and preventing concentrated heat damage while maintaining effective ablation zones.
Solution Approach 2:
The balloon modifies the thermal parameters by conducting heat away from the electrode-tissue interface through its material properties and fluid circulation. This changes the temperature distribution profile, reducing peak temperatures that cause tissue damage while maintaining sufficient heat for effective ablation.
3Manufacturing precision
If the balloon is fully expanded to contact vessel walls, then ablation uniformity is improved, but the hydraulic radius of the passageway decreases
Solution Approach 1:
The balloon provides localized contact with the vessel wall at specific zones where ablation is needed, rather than requiring complete circumferential expansion. This allows uniform lesion formation in the treatment zone while leaving other portions of the vessel lumen open for adequate fluid flow.
Solution Approach 2:
The balloon is partially expanded to achieve sufficient tissue contact for uniform ablation without fully occluding the vessel lumen. This partial expansion provides the necessary compression and contact pressure for consistent lesion formation while maintaining adequate hydraulic radius for fluid circulation.
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 design enhances the precision and effectiveness of ablation therapy by maintaining electrode-tissue contact, reducing tissue damage, and achieving uniform lesion formation, while allowing for real-time monitoring and control of ablation progress.
Implementation Method 1
Ablation electrodes, supported by a balloon wall, are arranged in a predefined pattern. The electrodes deliver electrical energy sufficient to ablate target tissue
Implementation Method 2
A cooling arrangement is encompassed at least in part by the balloon and provides cooling to at least the electrodes during ablation such that a location at which steady-state ablative heating begins is translated from an electrode-tissue interface at the target vessel wall to a location a predetermined distance away from the electrode-tissue interface
Data Source
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AI summary
An ablation device and/or method of ablation may include placing one or more ablation electrodes in contact with a target tissue in a lumen. An electrical insulator may be positioned between the electrode and a lumen fluid and an electrical signal (for example a radio frequency signal) may be conveyed between the electrodes to heat and/or ablate the target tissue. Ablation may be bipolar and/or an in lumen disperse electrode may be supplied for unipolar ablation. Ablation progress may be sensed and ablation may be adjusted to produce a desired level and/or geometry of ablation.