Implantable Device Wireless Interface Segmentation for Secure Remote Updates
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Solution Overview
Problem
Current methods for updating the Bluetooth stack in implantable medical devices require patients to be called in for updates, resulting in significant costs and prolonged time for area-wide updates, especially for urgent updates.
Innovation Solution
Implementing an implantable medical device with a wireless communication interface that allows for Bluetooth stack updates without requiring patient presence, using consumer mobile devices and separate authentication mechanisms to ensure secure and independent updates of diagnostic and therapeutic control units and wireless communication interfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If firmware updates are performed using a programming device, then update security and reliability are ensured, but patient recall costs and update time increase significantly
Solution Approach 1:
The patent segments the update process into two independent channels: (1) a secure programming device channel for initial implantation and critical updates, and (2) a wireless consumer device channel for routine firmware updates. This segmentation allows different update types to use appropriate methods, reducing overall update time while maintaining security for critical operations.
Solution Approach 2:
The patent introduces a wireless communication interface as an intermediary between consumer mobile devices and the implantable medical device. This intermediary enables secure over-the-air updates without requiring patient recall, significantly reducing update time and costs while maintaining adequate security through authenticated communication protocols.
2Reliability
If firmware updates are performed using a programming device, then update authenticity is verified, but area-wide update efficiency decreases
Solution Approach 1:
The patent divides update authentication into two levels: (1) programming device authentication for initial device authorization and critical updates, and (2) wireless authentication using consumer devices for routine firmware distribution. This enables parallel updating of multiple implants across different geographic locations, dramatically improving area-wide update efficiency.
Solution Approach 2:
The wireless communication interface is designed to support multiple functions: initial device activation, routine firmware updates, and telemonitoring capabilities. By making the wireless interface multi-functional, the system achieves both universal communication capability and efficient area-wide update deployment without requiring specialized programming device infrastructure.
3Reliability
If Bluetooth stack is updated regularly, then communication security is improved, but patient recall costs increase
Solution Approach 1:
The patent enables the implantable medical device to perform self-updating of its Bluetooth stack through wireless communication with consumer mobile devices. The device can autonomously receive, authenticate, and install firmware updates without requiring patient recall or physician intervention, thereby maintaining communication security while eliminating the operational burden on patients.
Solution Approach 2:
Consumer mobile devices serve as intermediaries that enable patients to receive security updates conveniently at home. The wireless communication interface mediates between the mobile device and the implant, allowing regular Bluetooth stack updates to occur automatically in the background without affecting patient convenience or requiring clinical visits.
4Reliability
If wireless communication interface is updated independently, then update risk to therapy function is reduced, but system complexity increases
Solution Approach 1:
The patent implements physical or logical segmentation of memory into separate areas: one dedicated to therapy control code and another to wireless communication interface code. This segmentation ensures that updates to the wireless interface cannot corrupt therapy functions, maintaining system reliability while the added memory structure complexity is justified by the safety benefits.
Solution Approach 2:
The patent extracts the wireless communication interface functionality into a separate, independently updatable module with its own dedicated memory space. By taking out the communication interface from the core therapy control system, the patent enables independent updates that isolate update risks, preventing potential corruption of critical therapy functions while accepting the necessary increase in system complexity.
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
Enables remote and secure updates of implantable medical devices, reducing costs and time for updates while preventing interference with therapy functions and ensuring secure authentication processes.
Implementation Method 1
a wireless communication interface, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices
Implementation Method 2
a programmer configured to communicate with the implantable medical device using inductive communication
Data Source
AI summary
The invention relates to an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator, comprising a diagnostic and/or therapeutic control unit, a wireless communication interface, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices, in particular smartphones and/or tablet computing devices, a first memory area, in which executable code for controlling the diagnostic and/or therapy control unit is stored, and a second memory area, in which executable code for controlling the wireless communication interface is stored, wherein the software and/or hardware of the wireless communication interface is configured to update the executable code of the wireless communication interface via the wireless communication interface. The invention further relates to an implant communication system, a method for updating an executable code of an implantable medical device and a computer program.