Pulsed Field Ablation Spasm Mapping for Phrenic Nerve Protection
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Solution Overview
Problem
Pulsed field ablation (PFA) treatments can cause nerve stimulation, leading to muscle spasm and potential nerve damage, particularly affecting the phrenic nerve, resulting in discomfort and risk of irreversible damage during cardiac ablation procedures.
Innovation Solution
A system and method for monitoring muscle spasm during PFA using motion sensors to create a spatial spasm map and assess real-time spasm development, providing guidance to avoid or reduce nerve stimulation by adjusting ablation parameters or catheter movement to prevent nerve damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If PFA electrical pulses are delivered to ablate cardiac tissue, then ablation effectiveness is improved, but nerve stimulation and muscle spasm increase
Solution Approach 1:
The system performs preliminary spasm mapping by delivering test pacing signals to multiple locations in the target tissue region before actual ablation. This advance assessment identifies which areas are likely to cause muscle spasm, allowing the operator to plan ablation paths that avoid high-risk zones or use lower power settings in those areas.
Solution Approach 2:
The system continuously monitors for muscle spasm during ablation and provides real-time feedback to the operator. When spasm is detected, the system can automatically adjust ablation parameters or alert the operator to change the ablation path, creating a closed-loop control system that dynamically prevents excessive nerve stimulation.
2Reliability
If continuous monitoring of muscle spasm is implemented, then nerve damage risk is reduced, but system complexity increases
Solution Approach 1:
The system uses the patient's own muscle responses as the monitoring mechanism. Motion sensors detect natural muscle movements and spasms without requiring complex invasive monitoring of nerve function. The system self-adjusts based on these simple motion detections, avoiding the need for sophisticated neural monitoring equipment.
Solution Approach 2:
The system introduces motion sensors as an intermediary between the ablation field and nerve function assessment. Instead of directly monitoring complex nerve electrical activity, the system uses simple motion detection of associated muscles as a proxy indicator, significantly simplifying the monitoring requirement while still providing effective nerve damage prevention.
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
Reduces muscle spasm and minimizes the risk of irreversible nerve damage by optimizing ablation procedures, enhancing patient comfort and safety during cardiac treatments.
Implementation Method 1
Pulse Field Ablation (PFA), in which Irreversible electroporation (IRE) is applied via short electrical pulses referred to in the following electrical PFA pulses, that generate high enough electrical fields (typically greater than 450 Volts per centimeter) to irreversibly damage the cells
Implementation Method 2
providing at least one motion sensor to be arranged at at least one respective location on a patient's tissue/skin near the patient's diaphragm
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Systems and methods to process motion signals obtained from at least one motion sensor during delivery of plurality of PFA pulses or pacing signals to heart tissue location(s) and determine degrees of diaphragm spasm affected by the PFA or pacing signals. In some embodiments the system identifies reduction of diaphragm spasm during delivery of PFA pulses to a certain location and upon such identification indicates that continued delivery of further PFA pulses to that certain location may cause irreversible damage to the Phrenic nerve. Additionally, or alternatively, the system utilizes the diaphragm spasm degrees measured following pacing or ablation of at least two heart tissue locations, to map the degrees of spasm affected by the ablation of various heart tissue locations and thereby enables to conduct ablation at location associated with reduced spasm.