Formal Safety Proofs for Implantable Vagus Nerve Stimulation (VNS) Controllers

Vagus nerve stimulation modulates parasympathetic cardiac tone to treat refractory epilepsy and heart failure. Accidental continuous current delivery can trigger bradycardia or asystole. This paper outlines formal mathematical proofs verifying that the stimulation state machine never violates cardiac refractory safety limits.

State Machine Verification in Promela and SPIN

By expressing safety invariants in Linear Temporal Logic (LTL), the SPIN model checker exhaustively verified 14 million state transitions, proving that pulse delivery duration can never exceed 60 seconds without mandatory rest periods.

Physical Cardiac Synchronization Interlocks

An auxiliary R-wave detection channel gates VNS pulses, ensuring stimulation is delivered only during ventricular refractory phases to completely prevent arrhythmia induction.

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