Reverse Irrigation Ports for Embolic Mitigation
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Solution Overview
Problem
During tissue ablation procedures, the formation of microbubbles and thromboembolic debris due to heat transfer from ablation energy can lead to adverse events like thromboembolic events and tissue rupture, and existing irrigation methods do not efficiently remove fluid and debris from the ablation site, especially during prolonged procedures.
Innovation Solution
A reverse irrigation device with ablation electrodes and reverse irrigation ports configured for fluid communication with a fluid removal component, such as a vacuum pump, to actively remove fluid and debris from the ablation site synchronously with energy delivery, reducing the risk of adverse events by efficiently managing fluid and debris.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of stationary object
If high energy levels and extended ablation times are used to produce deep lesions, then lesion depth is improved, but the risk of thromboembolic events increases due to microbubble formation and tissue overheating
Solution Approach 1:
The reverse irrigation ports are positioned to remove fluid and debris from the ablation site before they can form microbubbles and thromboembolic debris. The irrigation system proactively counteracts the harmful effects by continuously clearing the treatment zone during high-energy ablation, preventing rather than reacting to microbubble formation and tissue overheating
Solution Approach 2:
The patent employs a fluid delivery system with reverse irrigation ports that use hydraulic flow to remove blood, debris, and potential microbubbles from the ablation site. The fluid dynamics are designed to create a clear zone around the ablation electrode, allowing safe delivery of high-energy radiofrequency waves without generating thromboembolic events
2Object-affected harmful factors
If irrigation fluid is delivered to cool the ablation site and prevent microbubble formation, then thromboembolic risk is reduced, but the amount of fluid introduced to the patient increases significantly during long procedures
Solution Approach 1:
The reverse irrigation ports extract and remove irrigation fluid along with blood and debris from the ablation site, creating a continuous flow that prevents fluid accumulation in the patient's vasculature. This extraction mechanism allows for prolonged irrigation without significantly increasing the net fluid volume retained in the patient, as fluid is constantly being removed rather than merely delivered
Solution Approach 2:
The system discards used irrigation fluid that has contacted the ablation site and picked up debris and blood products. By continuously removing and discarding this contaminated fluid, the system maintains effective cooling and debris removal without allowing fluid volume to accumulate in the patient, thereby reducing the net quantity of substance introduced
3Loss of substance
If standard irrigation methods are used to remove fluid from the ablation site, then some fluid removal is achieved, but efficiency is insufficient during prolonged ablation procedures
Solution Approach 1:
The patent inverts the traditional irrigation approach by positioning ports that actively draw fluid toward the ablation electrode rather than allowing fluid to passively flow away. This reverse flow configuration, where fluid is pulled toward the electrode and then removed, creates a more efficient removal mechanism that maintains higher productivity during extended procedures compared to standard irrigation methods
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 reverse irrigation device effectively reduces the risk of adverse events by minimizing fluid and debris at the ablation site, allowing for higher energy application depths without increasing thromboembolic risks and facilitating safer tissue ablation.
Implementation Method 1
A reverse irrigation device with ablation electrodes and reverse irrigation ports configured for fluid communication with a fluid removal component, such as a vacuum pump, to actively remove fluid and debris from the ablation site
Implementation Method 2
When radiofrequency energy is delivered to tissue, that energy is converted to heat within the tissue near the ablation electrodes and the heat is then transferred to surrounding tissue through radiation and conduction
Implementation Method 3
some ablation devices are irrigated, meaning they are configured to deliver a biocompatible fluid such as saline to the ablation site. This delivery of irrigation fluid may not only reduce the temperature of the ablation electrodes and the tissue being ablated
Data Source
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AI summary
Devices, systems, and methods for reverse irrigation of an ablation or treatment site. In one embodiment, a reverse irrigation device comprises at least one ablation electrode and at least one reverse irrigation port, the at least one reverse irrigation port being located at at least one of immediately proximate the at least one ablation electrode and on the at least one ablation electrode, the at least one reverse irrigation port being configured to be in fluid communication with a fluid removal component. A medical system may include an ablation system and a reverse irrigation system that are configured to operate synchronously such that the reverse irrigation system is activated to remove fluid from the ablation site during a period of time during which the ablation system is activated to deliver ablation energy through the at least one ablation electrode to the ablation site.