Dynamic Boundary Monitoring in Dialysis Machines

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Solution Overview

Problem

Existing medical fluid circuit systems, particularly in extracorporeal blood treatment, face issues with static limit values that can lead to false alarms due to dynamic changes in system conditions, causing unnecessary interventions and impacting treatment efficacy.

Innovation Solution

A method and device for dynamically setting limit values based on real-time system states, using a status table to associate relevant events with target limit settings, allowing for event-controlled adaptation of limit values and consideration of cross-dependencies between events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If static predetermined limit values are used for monitoring, then patient safety is ensured through constant monitoring, but false alarms occur due to dynamic system changes

Engineering Contradiction:
Improvepatient safetyVSAvoidfalse alarms
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent implements dynamic limit values that automatically adjust based on the current system state. Instead of using fixed predetermined limits, the system continuously adapts limit values according to measured parameters such as blood flow rate, dialysate flow rate, and ultrafiltration rate. This resolves the contradiction by making the monitoring system responsive to dynamic system changes while maintaining safety through state-dependent threshold adjustment.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the parameter values of limit thresholds based on operational conditions. Different limit values are applied for different system states (e.g., different blood flow rates, different treatment phases). This allows the monitoring to accommodate dynamic system variations without generating false alarms, while still ensuring patient safety through appropriate state-specific thresholds.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If static limit values are used, then the monitoring system is simple to operate, but unnecessary interventions are triggered

Engineering Contradiction:
Improvemonitoring system operationVSAvoidresponse time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The monitoring system automatically determines appropriate limit values based on the current system state without requiring manual intervention. The system self-adjusts thresholds according to measured parameters and pre-defined state vectors, eliminating the need for operators to manually adjust limits while avoiding unnecessary interventions. This maintains ease of operation while improving response accuracy.

Inventive Principle:
Principle #25Self-service

3Loss of information

If dynamic limit adjustment is implemented, then false alarms are reduced, but the device complexity increases

Engineering Contradiction:
Improvefalse alarm reductionVSAvoidlimit setting mechanism
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The system pre-defines state vectors and associated limit values for various system conditions before operation begins. During runtime, the system simply matches current measurements against these pre-defined states and applies the corresponding limits. This approach reduces computational complexity during operation while still achieving dynamic adaptation, thereby reducing false alarms without proportionally increasing device complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces a state vector as an intermediary that bridges the gap between raw measurements and limit values. Instead of directly computing complex dynamic limits from multiple parameters, the system uses pre-defined state vectors as intermediaries that map measurement combinations to appropriate limit values. This simplifies the overall system architecture while enabling dynamic limit adjustment.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If complex query logic is used to consider event interdependencies, then monitoring accuracy improves, but the system becomes more complex

Engineering Contradiction:
Improvemonitoring accuracyVSAvoidquery logic
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system pre-defines state vectors that encapsulate combinations of events and their interdependencies before operation. Instead of using complex query logic during runtime to evaluate event relationships, the system matches current measurements against these pre-analyzed state vectors. This approach achieves high monitoring accuracy by considering event interdependencies while keeping the runtime system simple through pattern matching rather than complex logic evaluation.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3206732B1Device for event-dependent boundary monitoring in a dialysis machine
Publication Date: 2023.04.19 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • EP3206732B1 patent drawingFigure 1
  • EP3206732B1 patent drawingFigure 2
  • EP3206732B1 patent drawingFigure 3

AI summary

The invention relates to a method for the event-controlled setting of boundaries in a monitoring process for a dialysis machine (110) to check whether boundaries are being respected. In the method, a plurality of boundary-related events that must be respected during the device monitoring process are established (1000), each of which can be stored as a state variable in a state vector. Reference state vectors (R-ZV) linked in each case to a target boundary setting (Z-GW) are also established (2000). Then, in a monitoring phase, measurement signals (e.g. volume of blood currently being pumped, pressure in the venous branch etc.) for the state variables are obtained (3000) in order to calculate a measurement signal vector. The calculated measurement signal vector is then compared (4000) with the established reference state vector (R-ZV), and if they match the dialysis machine (110) is controlled (6000) by a monitoring process (7000) using the target boundaries (Z-GW). The dialysis machine (110) is then controlled and monitored to check whether the previously set target boundaries (Z-GW) are being respected. The invention also relates to a boundary setting device (200).