Implantable Medical Device Second-Factor Authorization via Inductive Pulse

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Solution Overview

Problem

Existing systems for implantable medical devices lack secure pairing mechanisms, leaving patients vulnerable to accidental or malicious manipulation during the connection with external devices.

Innovation Solution

Implementing a second-factor authorization system that uses a charging device to send an authorization pulse to an implantable medical device, ensuring that only authorized external devices can pair by requiring close proximity and user approval, thereby enhancing security through a window of exclusivity and encrypted communication.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If encryption and communication security measures are implemented, then data protection is improved, but the pairing process becomes vulnerable to accidental or malicious manipulation due to lack of security steps

Engineering Contradiction:
Improvedata protectionVSAvoidaccidental or malicious manipulation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by requiring the patient to manually activate pairing mode on the implantable medical device before the external device initiates connection. This pre-action ensures the patient is aware of and authorizes the pairing process, preventing accidental or malicious manipulation while maintaining secure communication through encryption

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements feedback by providing visual indicators on the external device to show pairing status and requiring patient confirmation. This feedback mechanism ensures the patient is aware of the pairing process and can control it, adding a layer of security against unauthorized access while maintaining data protection

Inventive Principle:
Principle #23Feedback

2Reliability

If a window of exclusivity is implemented to prevent other devices from pairing, then security against signal misappropriation is improved, but the pairing process complexity increases

Engineering Contradiction:
Improvesecurity against signal misappropriationVSAvoidpairing process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by having the implantable medical device enter a window of exclusivity state automatically when pairing mode is activated. This pre-established time window prevents other devices from interfering with the pairing signal, enhancing security without requiring complex manual intervention during the pairing process

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements self-service by having the implantable medical device automatically manage the window of exclusivity and pairing authentication without requiring continuous user input. The device autonomously controls the pairing process security features, reducing the burden on the user while maintaining strong security measures

Inventive Principle:
Principle #25Self-service

3Reliability

If authorization pulse transmission requiring close proximity is implemented, then user awareness and approval of pairing is improved, but the authorization process becomes more restrictive

Engineering Contradiction:
Improveuser awareness and approvalVSAvoidauthorization process accessibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies universality by using the existing charging coil of the implantable medical device to transmit the authorization pulse. This multi-functional use of the charging coil for both charging and authorization purposes eliminates the need for separate authorization hardware, maintaining close proximity requirements for security while preserving ease of operation through the familiar charging interaction

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 solution ensures secure pairing by preventing unauthorized access and ensuring that only intended devices can communicate with the implantable medical device, thereby protecting patient data and preventing accidental or malicious manipulation.

Implementation Method 1

The IMD may receive, via a second communication path, an authorization pulse from an authorization device (e.g., a charging device of the IMD), where the authorization device is not the external device

Methodology Applied
Scientific EffectElectromagnetic induction: Electromagnetic Induction

Data Source

PatentUS20240205685A1Authorizing programming of an implanted device using second factor
Publication Date: 2024.06.20 VERILY HEALTH INC
  • US20240205685A1 patent drawing
  • US20240205685A1 patent drawing
  • US20240205685A1 patent drawing

AI summary

Described herein are techniques to ensure a user using an external device is authorized to connect and connecting to a correct implantable medical device using a wireless communication protocol. A request for authorization is sent to the external device from the implantable medical device, and the authorization can be provided by an authorization pulse sent using the implantable medical device charger over the inductive link between the charging device and the implanted device. The authorization pulse can be trusted because the inductive link is short range, ensuring the patient is aware of the connection to the implanted device. Once the implanted device receives the authorization pulse, it may finalize the pairing over the first connection.