Catheter Tip Electrode for Combined RF and Pulsed Field Ablation
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Solution Overview
Problem
Current cardiac ablation techniques for treating atrial fibrillation often require separate catheters for electropotentials and temperature measurements, lacking a single device that can predict the desired lesion depth during pulsed field ablation.
Innovation Solution
A catheter system that includes a tip electrode capable of emitting pulsed electric fields or radiofrequency signals and measuring contact force, allowing for the determination of a pulsed field ablation index based on contact force and the number of applications, facilitating effective pulmonary vein isolation with a single catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If separate catheters are used for electropotentials and temperature measurements, then measurement accuracy is improved, but device complexity increases
Solution Approach 1:
The patent combines multiple measurement functions (electropotential mapping, temperature sensing, and contact force measurement) and ablation capability into a single integrated catheter system. The catheter includes a tip electrode for electropotential measurement, temperature sensors for thermal monitoring, and contact force sensors for applying and measuring pressure against tissue, all within one device that can also deliver RF and pulsed field ablation energy.
2Ease of operation
If pulsed field ablation parameters are preset, then ease of operation is improved, but manufacturing precision of lesion depth is worsened
Solution Approach 1:
The system dynamically adjusts pulsed field ablation parameters based on real-time feedback from contact force sensors and ablation index calculations. Instead of using fixed preset parameters, the controller modifies pulse amplitude, duration, and number of applications according to the measured contact force and desired lesion depth, allowing the operator to achieve precise lesion depth while maintaining ease of operation through automated parameter optimization.
3Manufacturing precision
If contact force is increased to achieve desired lesion depth, then manufacturing precision is improved, but force applied to tissue increases
Solution Approach 1:
The system incorporates contact force sensors that continuously monitor the force applied by the catheter tip against tissue during pulsed field ablation. The controller receives real-time feedback from these sensors and automatically adjusts ablation parameters to achieve the desired lesion depth without requiring excessive contact force. This feedback mechanism prevents tissue damage from excessive pressure while ensuring sufficient contact for effective ablation.
4Adaptability or versatility
If multiple catheters are used for different ablation modalities, then adaptability is improved, but device complexity increases
Solution Approach 1:
The integrated catheter system is designed to perform multiple ablation modalities including radiofrequency ablation and pulsed field ablation using a single device. The catheter can switch between different energy delivery modes and measurement functions, providing versatility in treating various arrhythmia conditions without requiring multiple separate catheters, thereby reducing overall device complexity.
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
Enables precise and effective pulmonary vein isolation by predicting the ablation index, improving the accuracy and efficiency of the ablation process while reducing the need for multiple devices.
Implementation Method 1
IRE ablation is a more recently developed technique which involves applying short duration high voltage pulses across tissue to cause cell death, sometimes referred to as pulsed field ablation (PFA)
Implementation Method 2
Presently the most common ablation technique involves applying radio frequency (RF) electrical signals via electrodes to tissue to generate heat
Implementation Method 3
measure a contact force experienced by the tip electrode against cardiac tissue during pulsed electric field ablation
Data Source
AI summary
The disclosed technology includes a method of treating atrial fibrillation in a predetermined group of patients meeting predetermined inclusion and exclusion criteria, including delivering a catheter into a pulmonary vein of each patient of the predetermined group of patients, ablating one or more locations of targeted tissues of the pulmonary vein using the catheter, determining an ablation index as a function of the measured contact force and number of pulsed electric field applications for each location of the one or more locations from the pulsed electric field ablation, and achieving a predetermined effectiveness rate of pulmonary vein isolation in the group of patients within an effectiveness evaluation period. The catheter can include a tip electrode configured to emit either a pulsed electric field or a radiofrequency signal to cardiac tissue and measure a contact force experienced by the tip electrode against cardiac tissue during pulsed electric field ablation.