Portable Device Authorization for Implantable Medical Devices

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Solution Overview

Problem

Current patient programmers for implantable medical devices are costly, difficult to use, and require significant effort for both patients and clinicians, while personal smart devices offer advanced functionality but lack the ability to effectively and safely communicate with implantable medical devices.

Innovation Solution

A method and system that authorize a personal smart device to communicate with an implantable medical device by testing device configuration parameters, ensuring the device meets specific requirements, and providing a graphical user interface for control only if authorized, with optional features for detecting modifications and updating configuration files.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a dedicated patient programmer is provided to communicate with an implantable medical device, then communication reliability and device control capability are improved, but device cost and complexity increase significantly

Engineering Contradiction:
Improvecommunication reliabilityVSAvoidprogrammer complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a configuration file as an intermediary that mediates between the portable device and implantable medical device. This configuration file contains device configuration parameters that define the communication interface and operational constraints, allowing standard portable devices to safely communicate with implantable devices without requiring specialized programmer hardware.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent enables universal portable devices (smartphones, tablets, etc.) to function as patient programmers by implementing a configuration checking program that verifies device compatibility. This eliminates the need for dedicated programmer devices, allowing any compliant portable device to control the implantable medical device through the defined communication interface.

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

2Adaptability or versatility

If a dedicated patient programmer is provided with comprehensive control features, then therapy adjustment capability is improved, but ease of operation deteriorates due to complexity

Engineering Contradiction:
Improvetherapy control capabilityVSAvoidprogrammer usability
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The configuration file acts as an intermediary that pre-defines the communication protocol and operational parameters. This eliminates the need for complex real-time negotiations between the programmer and implantable device, simplifying the user interface and making the device easier to operate while maintaining full therapy control capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The configuration file is prepared in advance with all necessary device configuration parameters and communication protocols defined. This preliminary configuration allows the portable device to immediately communicate with the implantable device without requiring complex setup procedures, improving ease of operation while maintaining full functionality.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If personal smart devices are used to control implantable medical devices, then cost and accessibility are improved, but communication safety and reliability worsen due to unverified device capabilities

Engineering Contradiction:
Improvedevice accessibilityVSAvoidcommunication safety
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The configuration checking program performs preliminary verification of the portable device's capabilities before allowing communication with the implantable medical device. It checks device configuration parameters such as operating system version, available APIs, and communication protocols to ensure compatibility and safety, thereby maintaining communication reliability while using accessible personal smart devices.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The configuration file serves as an intermediary that defines the safe operating parameters and communication interface between the unverified portable device and the implantable medical device. By establishing predefined communication rules and constraints, it ensures safe interaction even between diverse portable device types and the implantable device.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3003474B1Methods and systems for authorizing a portable device to communicate with a medical device
Publication Date: 2020.01.01 BOSTON SCI NEUROMODULATION CORP
  • EP3003474B1 patent drawingFigure 1
  • EP3003474B1 patent drawingFigure 2~3
  • EP3003474B1 patent drawingFigure 4

AI summary

A method, server, and portable device for communicating with an implantable medical device is disclosed. A test that determines whether at least one device configuration parameter respectively corresponding to at least one feature to be tested on the portable device is fulfilled by the portable device is performed. The portable device is authorized to communicate with the implantable medical device only if the feature(s) is fulfilled by the portable device. Authorization of the portable device to communicate with the implantable medical device is denied if the at least one feature is not fulfilled by the portable device.