Heart Failure Management via Multi-Parameter Status Index
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Solution Overview
Problem
Current medical devices for managing heart failure often experience false positives, leading to unnecessary therapy delivery, battery depletion, and the risk of overstimulation due to inaccurate determination of heart failure status.
Innovation Solution
A system comprising a stimulator, sensors, and a controller that creates a heart failure status index using multiple measurements to modulate therapy delivery, reducing false positives and efficiently managing battery power by integrating neural stimulation to adjust autonomic balance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single parameter threshold is used to trigger therapy, then the device is simple to operate, but false positives occur leading to unnecessary therapy delivery
Solution Approach 1:
The patent segments the single parameter threshold approach into multiple parameter thresholds (e.g., first parameter threshold, second parameter threshold, third parameter threshold). Each parameter is monitored independently with its own threshold, and therapy is triggered only when multiple parameters simultaneously exceed their thresholds, thereby reducing false positives while maintaining operational simplicity through programmable multi-criteria monitoring.
Solution Approach 2:
The patent introduces an intermediary logic layer that processes multiple parameter measurements before triggering therapy. This intermediary evaluation mechanism combines information from multiple parameters (such as heart rate, activity level, and respiratory rate) and applies weighted criteria to determine whether therapy is truly needed, acting as a mediator between raw sensor data and therapy delivery to eliminate false positives.
2Reliability
If therapy is delivered frequently to ensure adequate treatment, then heart failure management is improved, but battery power is depleted faster
Solution Approach 1:
The patent implements a feedback mechanism where the device continuously monitors multiple parameters, evaluates whether therapy thresholds are met, delivers therapy only when necessary, and then re-evaluates the patient's status. This closed-loop feedback system ensures therapy is delivered frequently enough to be effective while avoiding unnecessary deliveries that would waste battery power, as therapy is triggered only when multiple parameters indicate genuine need.
Solution Approach 2:
The patent changes the parameters used for therapy triggering from a single parameter to multiple parameters (e.g., combining heart rate, activity level, and respiratory rate). By requiring simultaneous threshold exceedance across multiple parameters, the system reduces false positives and unnecessary therapy deliveries, thereby conserving battery power while maintaining effective treatment through more accurate parameter-based decision making.
3Measurement precision
If multiple parameters are monitored to reduce false positives, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent applies universality by designing a multi-functional controller that can monitor multiple parameters (heart rate, activity level, respiratory rate) using the same hardware platform and processing architecture. The controller is programmed to evaluate different parameter combinations and apply various threshold criteria, making a single device capable of handling multiple sensing functions and therapy decision-making processes without requiring separate dedicated systems for each parameter.
Data Source
AI summary
Various system embodiments comprise a stimulator adapted to deliver a stimulation signal for a heart failure therapy, a number of sensors adapted to provide at least a first measurement of a heart failure status and a second measurement of the heart failure status, and a controller. The controller is connected to the stimulator and to the number of sensors. The controller is adapted to use the first and second measurements to create a heart failure status index, and control the stimulator to modulate the signal using the index. Other aspects and embodiments are provided herein.