Dialysis Fluid Status Calibration via Weight Change

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Solution Overview

Problem

Current methods for managing fluid status in dialysis patients are inefficient, costly, and uncomfortable, often failing to accurately detect changes in fluid overload or normohydration weight, leading to potential over- or underhydration due to limitations in bioimpedance techniques and other monitoring approaches.

Innovation Solution

A method involving the calibration of body parameters such as relative blood volume and hemoglobin concentration using polynomial regression, allowing for regular and cost-effective monitoring of fluid status changes during dialysis sessions, with the goal of maintaining optimal fluid status by adjusting ultrafiltration rates and volumes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If bioimpedance technology is used to determine fluid status, then fluid monitoring capability is improved, but patient comfort and ease of operation deteriorate due to the complexity and discomfort of the measurement process

Engineering Contradiction:
Improvefluid status detection accuracyVSAvoidpatient comfort
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent extracts only the essential calibration information from complex bioimpedance measurements by using simple weight measurements before and after dialysis to determine fluid removal volume. This eliminates the need for repeated uncomfortable bioimpedance measurements while maintaining the ability to monitor fluid status changes.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces expensive, complex, and uncomfortable bioimpedance measurement devices with simple, inexpensive weight measurements that can be performed routinely without patient discomfort. The weight-based method serves as a disposable, simple alternative to the complex monitoring system.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Measurement precision

If bioimpedance spectroscopy is used for fluid status assessment, then measurement precision is improved, but device complexity and cost increase

Engineering Contradiction:
Improvefluid status assessment accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the essential functional information (fluid removal volume) from complex bioimpedance spectroscopy by using simple weight measurements. The calibration process captures the relationship between weight change and fluid status without requiring the complex measurement equipment.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a simplified model that copies the essential functionality of bioimpedance spectroscopy using weight measurements. The calibration curve establishes a relationship between weight change and fluid status that replicates the information obtained from complex bioimpedance analysis without requiring the complex device.

Inventive Principle:
Principle #26Copying

3Reliability

If frequent fluid status monitoring is implemented, then reliability of fluid management is improved, but loss of time and increased operational burden occur

Engineering Contradiction:
Improvefluid management reliabilityVSAvoidmonitoring time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent enables continuous monitoring of fluid status by using weight measurements that can be taken at every dialysis session without significant time burden. The calibration established during initial sessions allows for ongoing reliable assessment of fluid status changes through simple weight tracking.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system uses automatically recorded weight data from the dialysis machine to determine fluid status, eliminating the need for manual measurement or complex analysis. The calibration model automatically processes the weight change data to provide fluid status information.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS10195328B2Calibration of a body parameter for monitoring dialysis
Publication Date: 2019.02.05 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US10195328B2 patent drawing
  • US10195328B2 patent drawing
  • US10195328B2 patent drawing

AI summary

A method and an apparatus for detecting a change of the fluid status or determining the fluid status of an individual are disclosed. The method comprises the following steps: determining a change of the body parameter (ΔRBV) of the individual during a first treatment session (201); determining a first fluid status of the individual (202); calibrating the determined change of the body parameter (ΔRBV) based on the first fluid status (205); determining the change of the body parameter (ΔRBV) of the individual during at least one further treatment session (207); and deriving a fluid status or a change of fluid status individual from the change of the body parameter (ΔRBV) (208).