Unipolar PFA System Motion Sensor Spasm Control
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Solution Overview
Problem
During unipolar pulsed field ablation (PFA) treatments, nerve stimulation can lead to muscle spasm, discomfort, and a risk of nerve damage, which complicates the cardiac ablation procedure.
Innovation Solution
The system incorporates motion sensors with electrode patches to monitor and reduce spasm by selectively adjusting the placement and activation of return electrodes, thereby altering the energy flow pathway and minimizing nerve stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If unipolar PFA is used to ablate cardiac tissue, then the ablation procedure can be performed, but nerve stimulation causes muscle spasm and discomfort
Solution Approach 1:
The patent introduces motion sensors as intermediary devices to detect muscle spasm in real-time during PFA procedures. These sensors act as mediators between the ablation system and the patient's physiological state, enabling continuous monitoring and triggering of protective measures when spasm is detected, thus resolving the contradiction between performing ablation and preventing harmful muscle spasm
Solution Approach 2:
The system implements feedback control by continuously monitoring muscle spasm through motion sensors and adjusting the PFA procedure accordingly. When spasm is detected, the system provides feedback to the operator to modify or pause the ablation, creating a closed-loop control system that balances procedural effectiveness with patient comfort and safety
2Reliability
If return electrodes are placed on the skin to complete the electrical circuit, then current flow is established, but nerve stimulation and spasm occur
Solution Approach 1:
The patent applies local quality by placing motion sensors specifically at locations where muscle spasm is most likely to occur during PFA procedures. This localized monitoring approach allows the system to detect and respond to spasm in critical areas without requiring comprehensive body-wide sensing, thereby establishing reliable current flow while minimizing harmful nerve stimulation through targeted intervention
3Productivity
If high voltage pulses are applied to ablate tissue, then effective ablation is achieved, but the risk of nerve damage increases
Solution Approach 1:
The system performs preliminary action by monitoring for signs of nerve stimulation and muscle spasm before and during the application of high voltage pulses. The motion sensors detect early signs of nerve involvement, allowing the operator to adjust or pause the high voltage pulse delivery in advance, thereby maintaining effective tissue ablation while preventing nerve damage through proactive protection
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
This approach effectively reduces or eliminates spasm and nerve stimulation during unipolar PFA treatments, enhancing patient comfort and reducing the risk of nerve damage.
Implementation Method 1
at least one motion sensor for obtaining signals indicative of motion of tissue at a location near the electrode patch
Implementation Method 2
short electrical pulses referred to in the following PFA pulses, that generate high enough electrical fields (typically greater than 450 Volts per centimeter) to irreversibly damage the cells
Implementation Method 3
high voltage electric pulses are applied between the ablation electrode and another electrode
Implementation Method 4
current flows through the media that surrounds it, i.e., blood and tissue, between the tip electrode(s) and a reference electrode
Implementation Method 5
Heating of the tissue occurs due to its electrical resistance
Data Source
AI summary
Systems and methods for unipolar Pulse-Field Ablation (PFA) are disclosed for reducing spasm and/or other adverse nerves stimulation effects during delivery of PFA pulses. The system includes or is connected to one or more motion sensors to be placed at one or more regions of a patient's body for monitoring spasm thereat. The system includes a signal switch capable of selectively connecting a PFA energy generator to selected one or more of return electrode patches for delivery of PFA pulses and/or pacing signals through the selected electrode patches; and a processor that monitors motion sensed by the motion sensor(s) during delivery of the PFA pulses or pacing signals to identify nerve stimulation effects, such as spasm, to facilitate, based on the monitoring, selection of certain electrode patches by which the PFA pulses may be delivered without, or with reduced spasm or other adverse effects of excessive nerves stimulation.