Ambulatory Medical Device Parameter Outlier Detection

Solution Overview

Problem

Ambulatory medical devices require optimized programming parameters, but current methods lack a standardized approach, often relying on trial-and-error and outlier values that may not be suitable for individual patients, potentially affecting hemodynamic function.

Innovation Solution

A system with a communication circuit, user interface, memory, and processor circuit that compares received programmable parameter values to a distribution of values from a patient population, providing feedback to users on optimal settings through a display, aiding in identifying outlier changes and improving device-based therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If manufacturers continue to improve and add functionality to medical devices, then device capability and therapy optimization are improved, but device complexity and programming difficulty increase

Engineering Contradiction:

Improvedevice capabilityVSAvoidprogramming complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system provides feedback to physicians by comparing programmed parameter values against a distribution of values from a patient population. The processor circuit analyzes whether a programmed parameter is an outlier and presents this information to the user interface, enabling physicians to adjust programming decisions based on population-based feedback rather than relying solely on trial-and-error approaches.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system introduces an intermediary layer between the physician and the device programming process. This intermediary (the processor circuit and user interface) mediates by providing population-based reference data and outlier detection, helping physicians navigate the complexity of programming decisions without requiring them to become experts in all device parameters.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If physicians program outlier parameter values to improve patient outcomes, then therapy optimization may be improved, but the risk of adverse effects increases due to lack of standardized guidance

Engineering Contradiction:

Improvetherapy optimizationVSAvoidadverse effects from outlier programming

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system provides feedback to physicians by comparing programmed parameter values against a distribution of values from a patient population. The processor circuit analyzes whether a programmed parameter is an outlier and presents this information to the user interface, enabling physicians to adjust programming decisions based on population-based feedback rather than relying solely on trial-and-error approaches.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system performs preliminary analysis of parameter values against population distributions before the physician finalizes programming decisions. By presenting outlier status and population-based reference data in advance, the system allows physicians to reconsider potentially harmful outlier values before they are programmed into the device.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS9440085B2System and method for alerting to unusual/atypical programming changes of a medical device

Publication Date: 2016.09.13 CARDIAC PACEMAKERS INC

AI summary

An apparatus comprises a communication circuit configured to communicate information with an ambulatory medical device, a user interface configured to receive a programmable parameter for the ambulatory medical device from a user, a memory to store a distribution of values for the programmable parameter, wherein the distribution is representative of values of the parameter programmed for a patient population, and a processor circuit configured to compare a received value of the programmable parameter to a distribution of programmed values for the programmable parameter and present results of the comparison to the user via a display of the user interface.