Implantable Medical Device Remote Programming With Dynamic Thresholds

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Solution Overview

Problem

There is a need for improved methods and systems to ensure safe and reliable remote programming of implantable medical devices (IMDs) to prevent errors and ensure timely, efficient care without relying on field representatives, while allowing for independent operation with minimal local user intervention.

Innovation Solution

A communication system that includes a remote electronic device controlling a local programming device, with dynamic and static thresholds to terminate persistent actions by users, ensuring safe and secure programming sessions through real-time monitoring and configurable timers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If remote programming is enabled to reduce field representative travel and enable timely care, then productivity and accessibility are improved, but the risk of programming errors and loss of control increases

Engineering Contradiction:

Improvetimely careVSAvoidprogramming safety

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The system continuously monitors the programming session state and provides feedback to both local and remote users. The microprocessor tracks session parameters, communication status, and user actions in real-time, enabling automatic termination when unsafe conditions are detected. This feedback mechanism allows the system to maintain safety while enabling remote programming capabilities.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system establishes multiple safety thresholds and monitoring mechanisms before the programming session begins. Static thresholds are pre-configured for session duration, user inactivity, and action frequency. These pre-established safety nets cushion against potential errors by automatically terminating the session if parameters exceed safe limits, thereby enabling remote programming with reduced risk.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If dynamic monitoring of programming sessions is implemented to improve safety, then reliability is improved, but device complexity and processing requirements increase

Engineering Contradiction:

Improvesession safetyVSAvoidmonitoring system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The monitoring function is segmented into distinct threshold types (static thresholds for session parameters, dynamic thresholds for real-time conditions). Each threshold monitors specific aspects of the programming session independently, making the complex safety monitoring system modular and manageable. The microprocessor evaluates each threshold separately based on predefined criteria.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system monitors changes in session parameters (duration, inactivity time, action frequency) and adjusts the programming session state accordingly. By tracking parameter changes rather than maintaining complex continuous monitoring, the system achieves reliable safety monitoring with reduced processing complexity. Thresholds are evaluated based on parameter transitions.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If automatic termination of persistent actions is implemented to prevent errors, then reliability is improved, but ease of operation decreases due to reduced user control

Engineering Contradiction:

Improveerror preventionVSAvoiduser control

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The system provides users with extended time windows (excessive action tolerance) to complete programming actions, but automatically terminates if the extended period elapses without completion. This partial automation maintains user control for normal operations while preventing errors through automatic termination of excessively persistent actions that may indicate system failures or unsafe conditions.

Inventive Principle:

Principle #16Partial or excessive action

Solution Approach 2:

The system performs self-monitoring and self-termination of unsafe sessions without requiring external intervention. The microprocessor automatically detects when programming parameters exceed safe thresholds and terminates the session independently, reducing the need for continuous user oversight while maintaining operational ease for legitimate programming tasks.

Inventive Principle:

Principle #25Self-service

4Loss of substance

If field representatives are replaced by remote programming to reduce travel expenses, then loss of substance is improved, but loss of time for complex cases increases

Engineering Contradiction:

Improvetravel expensesVSAvoidcomplex case handling

Core Design Contradiction:

Loss of substanceVSLoss of time

Solution Approach 1:

The system dynamically adjusts monitoring intensity and available controls based on the complexity and risk level of the programming task. For routine programming, full remote control is enabled with standard monitoring. For complex cases, the system can escalate to local user involvement or modify session parameters, thereby maintaining efficient remote programming while preserving the ability to handle complex situations when necessary.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20250295927A1System and method for implantable medical device remote programming

Publication Date: 2025.09.25 PACESETTER INC

AI summary

A communication system is provided that includes a remote electronic device configured to communicate with a medical device of a patient via a local programming electronic device. The remote electronic device can include one or more processors configured to control operations of the local programming electronic device to program the medical device during a dynamic session. The one or more processors can also be configured to terminate the dynamic session in response to 1) a persistent action of a user of the remote electronic device exceeding a static persistent state threshold and 2) a monitored event exceeding a dynamic threshold.