Steerable Ablation Device with Ionically Conductive Balloon
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Solution Overview
Problem
Existing ablation procedures for cardiac arrhythmias, such as atrial fibrillation, face challenges in efficiently isolating tissue with discrete ablation points, leading to potential gaps in electrical isolation and tissue scarring due to metal electrodes, which can result in continued arrhythmia initiation.
Innovation Solution
A steerable ablation device featuring an ionically conductive balloon with a hydrophilic polymeric material and RF electrodes, allowing for controlled lesion creation and electrical isolation within the body tissue, utilizing a steering mechanism and fluid lumens for inflation and temperature control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If discrete ablation points are used to treat cardiac arrhythmias, then ablation therapy can be delivered to target tissue, but gaps in electrical isolation may remain and tissue scarring can occur
Solution Approach 1:
The ablation catheter is divided into multiple segments or sections along its length, with multiple electrodes distributed along the shaft. This segmentation allows for creating multiple discrete ablation lesions that can be spaced apart, reducing the risk of complete tissue scarring while maintaining electrical isolation effectiveness by targeting specific arrhythmia sources at different locations.
Solution Approach 2:
The patent applies ablation energy locally at specific target sites rather than uniformly across the entire tissue surface. By concentrating RF energy at discrete electrode-tissue contact points, the treatment achieves effective electrical isolation at arrhythmia sources while limiting the extent of thermal damage and scarring to only the necessary localized areas.
2Power
If metal ablation electrodes directly contact tissue for ablation, then RF energy can be delivered to create lesions, but dehydration and scarring can result
Solution Approach 1:
The patent introduces a fluid medium or cooling mechanism as an intermediary between the metal electrode and the tissue. This intermediary layer allows RF energy to be delivered effectively through the electrode while preventing direct excessive thermal contact that would cause tissue dehydration and scarring. The fluid may serve as a heat sink or barrier to control the thermal interaction.
Solution Approach 2:
The patent controls ablation parameters such as RF power level, pulse duration, and electrode-tissue contact pressure to optimize the balance between effective lesion creation and minimizing tissue dehydration. By adjusting these parameters, the treatment delivers sufficient energy for electrical isolation while limiting thermal damage to acceptable levels.
3Reliability
If multiple discrete ablation points are created, then arrhythmia sources can be targeted, but time-consuming procedures and potential gaps in isolation occur
Solution Approach 1:
The patent combines multiple ablation functions into a single catheter device with multiple electrodes that can deliver RF energy simultaneously or in rapid sequence. This merging of functions allows for treating multiple arrhythmia sources in one procedure, reducing overall procedure time while maintaining reliable electrical isolation through comprehensive targeting of all identified arrhythmia sources.
Solution Approach 2:
The patent enables continuous or rapid sequential delivery of RF energy through multiple electrodes along the catheter shaft. By maintaining continuous useful action through coordinated activation of multiple electrodes, the procedure achieves comprehensive tissue isolation without the time losses associated with repeated catheter insertions or prolonged positioning adjustments.
Data Source
AI summary
Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. The ablation device can have a steering mechanism configured to deflect the balloon.