Gallbladder Ablation Catheter With Expandable Cryogenic Flow Control
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Solution Overview
Problem
Existing ablation technologies, such as cryoablation, face challenges in safely and effectively treating large, high-surface area tissues like the gallbladder due to ice build-up and complications during procedures, leading to potential injury and ineffective ablation.
Innovation Solution
A catheter system with an outer and inner shaft, featuring expandable structures and nozzles, is designed to deliver and evacuate ablation medium uniformly and prevent debris clogging, allowing for controlled ablation and defunctionalization of the gallbladder.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If cryoablation is used for high-surface area tissue ablation, then ablation coverage is improved, but ice build-up and complications occur leading to injury and ineffective ablation
Solution Approach 1:
The ablation catheter is divided into multiple segments with separate nozzles distributed around the circumference of the balloon. Each nozzle delivers ablation medium independently, allowing controlled distribution across the high-surface area target while preventing excessive ice build-up at any single location.
Solution Approach 2:
The system employs periodic cycling of ablation medium delivery and evacuation. The balloon is inflated to deliver ablation medium, then deflated to evacuate ice and debris, preventing harmful ice accumulation while maintaining effective ablation coverage across large tissue surfaces.
2Reliability
If ablation medium is delivered into closed lumens, then ablation effect is improved, but ice build-up and complications occur
Solution Approach 1:
The system cycles between inflation phases for ablation medium delivery and deflation phases for evacuation. This periodic action allows effective ablation during inflation while preventing harmful ice accumulation by evacuating during deflation, thereby improving reliability.
Solution Approach 2:
The system extracts and removes ice and debris from the closed lumen through evacuation openings in the balloon wall during deflation. This extraction prevents harmful ice build-up while maintaining the ability to deliver effective ablation during the inflation phase.
3Manufacturing precision
If expandable structure is used to position nozzle from tissue, then ablation control is improved, but device complexity increases
Solution Approach 1:
The catheter employs a dynamic expandable balloon structure that can transition between collapsed and expanded states. When expanded, the balloon positions multiple nozzles at a predetermined distance from tissue; when collapsed, it allows easy navigation. This dynamic behavior provides positioning precision without permanent structural complexity.
Solution Approach 2:
The catheter design nests the expandable balloon structure within a delivery sheath. The balloon is compressed within the sheath during navigation, then expanded at the target site to achieve precise nozzle positioning. This nesting approach minimizes structural complexity during delivery while enabling precise positioning during ablation.
4Productivity
If evacuation openings are provided, then debris removal is improved, but risk of clogging increases
Solution Approach 1:
The evacuation system is segmented into multiple separate evacuation openings distributed around the balloon circumference rather than a single opening. This segmentation prevents debris clogging by providing multiple pathways, improving both evacuation efficiency and reliability.
Solution Approach 2:
The expandable balloon structure acts as an intermediary between the ablation chamber and the external environment. During deflation, the balloon walls open to allow evacuation of ice and debris through the evacuation openings, facilitating efficient removal while the balloon structure itself prevents direct contact between debris and the evacuation openings, reducing clogging risk.
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 enables safe and efficient ablation of the gallbladder, reducing the risk of complications and providing a minimally invasive solution for patients at high surgical risk, leveraging existing interventional radiology workflows.
Implementation Method 1
the ablation fluid transitions into an ablation gas that contacts and ablates the tissue within the body lumen
Implementation Method 2
the expandable structure configured to transition into an expanded state within the body lumen
Data Source
AI summary
Provided herein are catheter devices, systems, and methods to ablate a tissue location. The devises, systems, and methods disclosed herein include ablation systems including a catheter system with inner and outer shafts that deliver an ablation medium (e.g., a cryogenic ablation medium) to a body lumen and evacuate the ablation medium from the body lumen. In some embodiments, devices, systems, and methods disclose herein include expandable structures that facilitate in positioning of nozzles and/or evacuation of ablation medium from a body lumen.