Cryogenic Ablation Balloon Pressure Relief for Complete PV Isolation
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Solution Overview
Problem
Existing ablation catheters struggle with inconsistent lesion lines and incomplete electrical impulse blockage around the pulmonary veins due to lack of continuous contact during therapy delivery, leading to ineffective treatment of cardiac arrhythmias.
Innovation Solution
An electrophysiology catheter system with a cryogenic ablation balloon that deploys from an un-deployed configuration, engages target tissue, and delivers cryogenic therapy, featuring an exhaust lumen with a pressure blow-off valve to manage pressure buildup, ensuring consistent contact and effective tissue ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing ablation catheters are used to deliver therapy around pulmonary veins, then ablation lesions are created, but continuous contact is not maintained resulting in inconsistent lesion lines and incomplete electrical impulse blockage
Solution Approach 1:
The catheter is divided into multiple independent contact elements (balloons or pads) arranged circumferentially around the pulmonary vein. Each contact element can be independently inflated or activated to ensure continuous circumferential contact, solving the problem of inconsistent lesion lines by distributing the ablation function across multiple stable contact points rather than relying on single-point contact
Solution Approach 2:
The catheter incorporates sensors (such as force sensors, pressure sensors, or impedance sensors) that provide real-time feedback on contact status between the ablation elements and target tissue. This feedback is used to dynamically adjust inflation pressure, positioning, or activation timing to maintain continuous contact during therapy delivery, ensuring complete electrical impulse blockage
2Reliability
If cryogenic fluid is delivered to the ablation balloon to achieve effective tissue ablation, then complete lesion formation is achieved, but pressure buildup occurs within the balloon and exhaust lumen
Solution Approach 1:
The exhaust lumen is designed as a separate, dedicated pathway that extracts gaseous cryogen from the balloon during the ablation process. This extraction function is spatially and functionally separated from the cryogen delivery system, allowing pressure to be actively managed by removing gas phase cryogen while maintaining liquid cryogen flow for continuous cooling and effective tissue ablation
Solution Approach 2:
The system uses controlled fluid dynamics principles by regulating the flow rates of cryogenic liquid delivery and gaseous exhaust removal. Pressure buildup is managed through hydraulic control of the balloon inflation/deflation cycles and pneumatic control of the exhaust flow, ensuring that pressure remains within safe operating limits while maintaining effective ablation temperatures
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 system achieves continuous and complete lesion formation around pulmonary veins, effectively disrupting undesirable electrical pathways and reducing arrhythmia symptoms by ensuring consistent contact and managing pressure within the ablation balloon.
Implementation Method 1
an ablation balloon that receives a cryogenic fluid for administering an ablation therapy on a pulmonary vein
Implementation Method 2
delivers a cryogenic ablation therapy to the target tissue
Implementation Method 3
The pressure blow-off valve releases excess pressure build-up within the exhaust lumen
Data Source
AI summary
The instant disclosure relates to electrophysiology catheters for tissue ablation. In particular, the instant disclosure relates to a cryogenic ablation balloon with a catheter handle that interfaces with capital equipment.