Implantable Medical Device Remote Programming With Safety Thresholds

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Solution Overview

Problem

Existing medical devices, particularly implantable medical devices (IMDs), lack effective remote control and programming capabilities, leading to potential errors and inefficiencies in updating software and firmware, which can harm patients and increase travel and operational costs for field representatives.

Innovation Solution

A communication system with remote electronic devices that control local programming devices to program IMDs, incorporating static and dynamic thresholds to safely terminate persistent user actions, ensuring safe and timely updates by monitoring patient, clinician, and device characteristics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If remote electronic devices are used to control local programming devices for programming IMDs, then the need for on-site visits by field representatives is reduced and operational costs decrease, but the risk of errors in updating software and firmware increases without proper safety controls

Engineering Contradiction:

Improveefficiency of remote programmingVSAvoidintegrity of programming updates

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

A local programming device serves as an intermediary between the remote electronic device and the IMD. The local device receives commands from the remote device, validates them against safety criteria, and executes approved programming updates. This intermediary architecture enables remote programming while maintaining safety controls, resolving the contradiction between improved productivity and maintained reliability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If field representatives travel to patient locations for device programming, then direct control and verification are possible, but travel expenses and operational costs increase

Engineering Contradiction:

Improvedirect control of programmingVSAvoidtravel and operational costs

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The patent replaces the mechanical system of field representatives physically traveling to patient locations with an electronic communication system. Remote electronic devices transmit programming commands wirelessly through local programming devices to IMDs, eliminating the need for physical travel while maintaining programming control and verification capabilities.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Loss of time

If remote users have full control over IMD programming, then timely updates can be provided without waiting for field representatives, but safety risks increase without proper thresholds and monitoring

Engineering Contradiction:

Improveresponse time for programming updatesVSAvoidsafety risks of remote programming

Core Design Contradiction:

Loss of timeVSObject-affected harmful factors

Solution Approach 1:

The patent implements dynamic safety thresholds that adapt based on the programming context, device state, and user credentials. The system dynamically adjusts what remote users can control and when safety warnings or interruptions should occur. This dynamic approach enables timely remote programming while adapting safety controls to specific situations, resolving the contradiction between response time and safety.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system continuously monitors programming operations and provides feedback to both the remote user and the local programming device. Safety thresholds trigger warnings or interruptions when abnormal conditions are detected. This feedback mechanism enables timely updates while maintaining safety through continuous monitoring and user awareness.

Inventive Principle:

Principle #23Feedback

4Reliability

If static persistent state thresholds are implemented to terminate remote sessions, then safety is improved by preventing excessive remote control, but the complexity of the programming system increases

Engineering Contradiction:

Improvesafety of remote programmingVSAvoidcomplexity of session management

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a time parameter (persistent state threshold) that automatically terminates remote sessions if exceeded. This parameter-based control simplifies safety management by providing a clear, quantifiable limit on remote session duration. The system monitors session length and automatically enforces the threshold, managing complexity through standardized parameter control rather than complex decision logic.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentEP4621797A1System and method for implantable medical device remote programming

Publication Date: 2025.09.24 PACESETTER INC

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AI summary

A communication system (100, 300) is provided that includes a remote electronic device (116, 304) configured to communicate with a medical device (114, 212, 302) of a patient via a local programming electronic device (106, 306). The remote electronic device (116, 304) can include one or more processors (202, 316) configured to control operations of the local programming electronic device (106, 306) to program the medical device (114, 212, 302) during a dynamic session. The one or more processors (202, 316) can also be configured to terminate the dynamic session in response to 1) a persistent action of a user (112) of the remote electronic device (116, 304) exceeding a static persistent state threshold and 2) a monitored event exceeding a dynamic threshold.