External Programming Device for Safe Cardiac Rhythm Management Parameter Adjustments

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Solution Overview

Problem

Physicians face challenges in addressing patient complaints about implanted cardiac rhythm management devices without specific data on effective parameter adjustments, leading to difficulties in making safe programming changes remotely.

Innovation Solution

A cardiac rhythm management system with an external programming device that presents a list of highly-safe parameter adjustments to clinicians, allowing for safe and incremental changes to device settings, such as adjusting maximum tracking rate, Lower Rate Limit, and Atrioventricular Delay, which can be transmitted to the implanted device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If physicians make parameter adjustments to implanted CRM devices remotely, then patient therapy delivery can be improved, but patient safety risks increase due to lack of specific data on effective adjustments

Engineering Contradiction:
Improvetherapy delivery improvementVSAvoidpatient safety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system pre-calculates and stores multiple parameter adjustment scenarios with their expected outcomes before the physician needs to make a decision. When a patient presents with symptoms, the physician can review pre-simulated adjustment options rather than making unguided changes, thereby improving safety while enabling therapy optimization.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides feedback mechanisms that allow physicians to review predicted outcomes of parameter adjustments before implementing changes remotely. This feedback loop includes simulated therapy delivery data and safety assessments, enabling informed decision-making that balances therapy improvement with patient safety.

Inventive Principle:
Principle #23Feedback

2Adaptability or versatility

If physicians are provided with multiple parameter adjustment options, then the ability to address patient complaints improves, but the complexity of the programming device increases

Engineering Contradiction:
Improveparameter adjustment optionsVSAvoidprogramming device complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The programming device interface is segmented into distinct functional modules: a patient symptom input section, a pre-calculated parameter adjustment options display, and a selection/confirmation interface. This segmentation organizes complexity into manageable sections, allowing physicians to navigate multiple parameter options without being overwhelmed by overall system complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system introduces an intermediary layer between the physician and the implantable device that automatically processes and presents parameter adjustment options. This intermediary handles the complex calculations and simulations, presenting simplified options to the physician while maintaining the full versatility of parameter adjustments behind the scenes.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2361114B1Systems and methods for highly safe adjustment of device parameters
Publication Date: 2018.04.25 CARDIAC PACEMAKERS INC
  • EP2361114B1 patent drawingFigure 1
  • EP2361114B1 patent drawingFigure 2
  • EP2361114B1 patent drawingFigure 3

AI summary

A system and method of programming a cardiac rhythm management device (CRM device) using an external programming device are described, where the user is presented with a list of highly-safe parameter adjustments. Input is received from the user selecting one or more of the highly-safe parameter adjustments. A programming session is initiated wherein the programming device establishes communication with the CRM device, and transmits the selected one or more highly-safe parameter adjustment to the CRM device.