Implantable Device Remote Control via Biologic Identification
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Solution Overview
Problem
Modern implantable cardioverter-defibrillators (ICDs) have complex programmable parameters that can lead to inappropriate shocks due to inadequate initial programming, and there is a need for secure remote control and management to prevent device malfunction and unauthorized access.
Innovation Solution
The system allows for remote control of implantable medical devices like ICDs, pacemakers, and other IMDs, with secure user identification using biologic features, and ensures reliable communication by initiating communication only when needed, using pre-programmed notification criteria, and includes robust biologic identification methods such as ECG and pulse oximetry to confirm device ownership.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If remote control capability is added to IMDs, then device management and reprogramming can be improved, but security risks from unauthorized access and reliability issues from faulty communication links worsen
Solution Approach 1:
The patent introduces a central station as an intermediary between the IMD and the external world. This central station acts as a secure gateway that verifies communication authenticity, manages device reprogramming, and coordinates remote operations. The intermediary prevents direct unauthorized access to the IMD while enabling controlled remote management functions.
Solution Approach 2:
The IMD incorporates onboard security features including cryptographic authentication, secure key storage, and self-verification capabilities. The device can independently verify the authenticity of incoming commands and the identity of remote users, providing self-service security without requiring constant external verification infrastructure.
2Ease of operation
If alphanumeric user identification is used for device access, then ease of operation is improved, but security against unauthorized access deteriorates
Solution Approach 1:
The patent transitions from simple alphanumeric identification parameters to biometric parameters for user verification. The system captures and analyzes unique physiological characteristics (fingerprints, facial features, iris patterns) to authenticate users. This parameter change fundamentally improves security while maintaining ease of operation, as biometric verification is both more secure and more convenient than memorizing complex codes.
Solution Approach 2:
The patent replaces mechanical/alphanumeric authentication systems with biometric authentication systems. Instead of relying on users to remember and input alphanumeric codes, the system uses physiological特征 recognition. This substitution eliminates weaknesses in alphanumeric systems (theft, loss, forgetting) while providing more reliable security.
3Adaptability or versatility
If ICDs have numerous programmable parameters, then device functionality and adaptability are improved, but programming complexity and risk of inappropriate shocks worsen
Solution Approach 1:
The central station serves as an intelligent intermediary that manages the complexity of ICD programming. It provides pre-configured programming templates, guides physicians through parameter selection, and stores optimal settings for different clinical scenarios. This intermediary reduces the burden on physicians while maintaining access to full device functionality.
Solution Approach 2:
The system incorporates pre-programmed parameter sets and default configurations that are optimized for common clinical situations. These preliminary programming options allow physicians to quickly deploy appropriate settings without manually configuring numerous parameters from scratch, reducing both complexity and the risk of inappropriate programming.
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 reduces inappropriate shocks, enhances device security, and ensures reliable remote management of IMDs by verifying the identity of both the device and its owner, thereby preventing unauthorized access and ensuring accurate command delivery.
Implementation Method 1
ECG and pulse oximetry to confirm device ownership
Implementation Method 2
ECG and pulse oximetry to confirm device ownership
Data Source
AI summary
An implantable electrical stimulating device and system provides for a remote determination of the identity of the person in whom the stimulating device is implanted. The stimulating device may be a pacemaker, a defibrillator, another medical device or a non-medical device. The bases for the remote identification are (1) the comingling of (A) biologic identification information of the person linked to the stimulating device, and (B) information pertaining to a physiologic parameter (e.g. heart rate information) of that person, and (2) the modulation of the physiologic parameter by external information. Embodiments of the invention in which the stimulating device is external to the person are possible. By utilizing the apparatus providing for the remote identification of a person plus stimulating device, one aspect of secure communication—that based on reliable mutual identification of each participant in a communication—is achieved.