Vagus Nerve Microstimulator Authentication for Secure Parameter Expiration

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Solution Overview

Problem

Existing implantable electrical stimulation systems for therapeutic treatment face challenges such as complex implantation procedures, mechanical damage to leads, and difficulty in charging and communicating with deep or misaligned sub-diaphragmatic implants, particularly for sub-diaphragmatic vagus nerve stimulation, which may cause adverse events and have lower efficacy.

Innovation Solution

Development of microstimulators with integral electrodes, inductive charging systems, and cybersecurity measures for secure parameter authentication and expiration management, including digital signature verification and cloud-based authorization, to ensure accurate and tamper-resistant neurostimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional implantable electrical stimulation systems with separate IPG and lead are used, then therapeutic treatment capability is provided, but implantation complexity increases and lead mechanical damage risk increases

Engineering Contradiction:

Improvelead durabilityVSAvoidimplantation procedure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the IPG and lead into a single integrated microstimulator device with electrodes directly attached to the device body, eliminating the need for separate implantation of IPG and lead, and removing the vulnerable lead wire that connects them. This integration directly resolves the contradiction by improving reliability through elimination of mechanical connection points while reducing implantation complexity through single-site implantation.

Inventive Principle:

Principle #5Merging (Combining)

2Object-affected harmful factors

If sub-diaphragmatic vagus nerve stimulation is performed, then adverse events and cardiac effects are reduced, but charging and communication difficulty increases due to deep implant location

Engineering Contradiction:

Improveadverse eventsVSAvoidcharging accessibility

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent replaces mechanical/wire-based charging and communication systems with wireless inductive charging and telemetry capabilities integrated into the microstimulator. This allows the deeply implanted sub-diaphragmatic device to be charged and programmed without physical connection, resolving the contradiction by maintaining safety benefits of sub-diaphragmatic placement while enabling convenient external control.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Device complexity

If microstimulators with integral electrodes are used, then implantation complexity and lead damage risk are reduced, but secure parameter authentication and expiration management capability is lost

Engineering Contradiction:

Improveimplantation procedureVSAvoidparameter security

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent implements self-service security features within the microstimulator, including cryptographic authentication of stimulation parameters, expiration date tracking, and dose counting capabilities. These self-contained security mechanisms ensure that even though the device is simplified and integrated, it maintains robust parameter security and compliance tracking without requiring external verification systems.

Inventive Principle:

Principle #25Self-service

4Ease of operation

If inductive charging system is used for deep implant, then charging accessibility is improved, but charging efficiency decreases due to misalignment and depth

Engineering Contradiction:

Improvecharging accessibilityVSAvoidcharging efficiency

Core Design Contradiction:

Ease of operationVSUse of energy by moving object

Solution Approach 1:

The patent employs dynamic alignment compensation mechanisms in the inductive charging system, including adjustable coil positioning and orientation detection capabilities that allow the external charger to automatically align with the deeply implanted microstimulator. This dynamic adjustment maintains charging efficiency despite the depth and potential misalignment, resolving the contradiction between accessibility and efficiency.

Inventive Principle:

Principle #15Dynamics

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

Facilitates stable, secure, and efficient sub-diaphragmatic vagus nerve stimulation with reduced adverse events, fewer cardiac effects, and improved efficacy, while enabling remote parameter updates and expiration management.

Implementation Method 1

These apparatus may be inductively charged

Methodology Applied

Scientific EffectElectromagnetic induction: Electromagnetic Induction

Data Source

PatentUS20260038677A1Neurostimulation parameter authentication and expiration system for neurostimulation

Publication Date: 2026.02.05 SETPOINT MEDICAL CORP

AI summary

Methods and apparatuses (e.g., devices and systems) for securely accessing, activating and/or updating vagus nerve stimulators. In particular, described herein are methods and apparatuses for securing providing, verifying and/or executing digital prescriptions for implantable (including implanted) vagus nerve stimulation systems that may be used for treating inflammation. These methods and apparatuses (including software and/or firmware) may be adapted for used with low-energy requirements of the implanted components.