PEF Ablation Balloon with Electrode Irrigation Channels
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Solution Overview
Problem
Current pulsed electric field (PEF) ablation techniques face challenges in creating adequate lesions while minimizing thermal damage to non-targeted tissues, as they often result in collateral damage and inadequate energy delivery to the targeted myocardium, with edge effects causing excessive heating at electrode edges.
Innovation Solution
A medical device with an expandable element and irrigation channels around electrodes delivers pulsed electric field energy, using an irrigant that is cooler and less conductive than blood, with a higher thermal conductivity perimeter to reduce edge effects and a controller that modulates fluid delivery based on temperature and energy parameters to mitigate thermal damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If higher energies are applied with PEF to treat a larger region of tissue, then the treatment coverage is improved, but the temperature rise and thermal damage to non-targeted tissue increases
Solution Approach 1:
Cooling irrigant is delivered to the tissue before and during PEF energy application to pre-cool the treatment area. This preliminary cooling action allows higher energies to be applied subsequently while maintaining temperature control and preventing excessive thermal damage to non-targeted tissue.
Solution Approach 2:
A cooling irrigant is introduced as an intermediary substance between the PEF electrodes and the tissue. The irrigant absorbs excess heat and acts as a thermal buffer, enabling higher energy delivery while protecting surrounding non-targeted tissue from thermal damage through convective cooling and heat dissipation.
2Reliability
If higher energies are applied with PEF to create adequate lesions, then the lesion formation efficacy is improved, but the risk of char or coagulum formation increases
Solution Approach 1:
Cooling irrigant is delivered before high-energy PEF application to pre-cool the tissue and electrodes. This preliminary cooling prevents the tissue and electrode surfaces from reaching temperatures that would cause char or coagulum formation, enabling reliable lesion formation without these harmful byproducts.
Solution Approach 2:
The potential harmful effect of high-energy PEF causing thermal damage, char, or coagulum is converted into a beneficial outcome by using the same high energy for effective lesion formation while simultaneously applying cooling irrigant. The cooling transforms what would be a harmful thermal effect into a controlled therapeutic process that achieves reliable lesion formation without char or coagulum.
3Reliability
If PEF energy is delivered to disrupt cellular membranes, then the ablation effect is achieved, but edge effects cause excessive heating at electrode edges
Solution Approach 1:
Cooling irrigant is delivered specifically to the electrode edges through circumferential irrigation channels, creating a localized cooling zone at the areas most susceptible to edge effects. This local quality approach cools only the critical edge regions without affecting the overall treatment efficacy, preventing excessive heating at electrode perimeters while maintaining reliable ablation in the treatment zone.
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 solution effectively reduces thermal damage and enhances lesion formation by selectively irrigating electrodes during energy delivery, improving the safety and efficacy of PEF ablation treatments by minimizing thermal effects and promoting more controlled energy distribution.
Implementation Method 1
The expandable element comprising one or more irrigation channels proximate to or on the plurality of electrodes, the one or more irrigation channels being configured to irrigate at least one of the plurality of electrodes
Implementation Method 2
an irrigant is disposed within the one or more irrigation channels and the irrigant only flows toward respective electrodes which are energized during the delivery of energy to tissue
Implementation Method 3
Certain energy modalities, such as pulsed electric field (PEF) ablation, however, use electric fields to disrupt cellular membranes and these electric fields are delivered in short bursts
Implementation Method 4
The electric field itself is established between conductive elements such as electrodes and flows current through the target tissue acting as a resistive medium, and this necessarily results in energy dissipation or temperature rise in the tissue
Implementation Method 5
the irrigant is cooler than an ambient temperature of blood
Data Source
AI summary
A medical device is configured to deliver pulsed electric field (PEF) energy to tissue and includes an elongated shaft having a proximal portion and a distal portion. A balloon is coupled to the distal portion of the elongated shaft. A plurality of electrodes is disposed on an outer surface of the balloon and configured to apply PEF energy to tissue. The balloon defines one or more irrigation channels proximate to or on the plurality of electrodes, the one or more irrigation channels being configured to irrigate at least one of the plurality of electrodes.