Blood Leak Detection Control Unit for Dialysate Discharge Lines

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Solution Overview

Problem

Existing blood leak detectors in dialysis devices fail to accurately detect blood in the dialysate discharge line, especially during bypass operation, leading to false alarms and potential misinterpretation of detector failures, due to flow rate-dependent limit values and dilution effects.

Innovation Solution

A control unit that adjusts the limit value for detecting blood concentration downstream of the dialyser, using a constant third limit value independent of flow rate, allowing for accurate detection of blood overshoot in both normal and bypass operations without additional detectors, and considers pre-dilution and post-dilution conditions to intensify clouding visibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the dialysate flows at higher speed through the dialysate discharge line, then the productivity of fluid removal is improved, but the measurement precision of blood concentration detection deteriorates due to dilution effects

Engineering Contradiction:
Improvefluid removal rateVSAvoidblood concentration detection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies dynamics by making the limit value adaptive to the flow rate. Instead of using a fixed threshold, the system dynamically adjusts the limit value based on the actual dialysate flow rate measured during treatment. This allows the detection system to maintain appropriate sensitivity across varying productivity levels, resolving the contradiction between high fluid removal rates and accurate blood leak detection.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the parameter of the limit value from a constant to a flow-rate-dependent variable. By establishing a functional relationship between flow rate and limit value (where the limit value decreases as flow rate increases), the system compensates for dilution effects and maintains measurement precision across different productivity conditions.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the bypass line is opened to short-circuit the dialyser, then the ease of operation for stopping haemodialysis is improved, but the reliability of blood leak detection deteriorates due to continued dilution of blood in the dialysate discharge line

Engineering Contradiction:
Improveability to stop haemodialysisVSAvoidblood leak detection accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system dynamically adapts the limit value based on bypass operation status. When the bypass line is opened, the control unit recognizes this state and adjusts the limit value accordingly, preventing false negative detections that would otherwise occur due to continued dilution of blood in the discharge line despite ultrafiltration removal of fluid.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements feedback by monitoring the operational state of the bypass line and using this information to adjust the detection threshold. The control unit receives feedback about bypass status and flow rate conditions, then adapts the limit value to maintain reliable blood leak detection across different operational modes including bypass operation.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If a flow rate-dependent limit value is used to maintain detection sensitivity, then the measurement precision is improved, but the device complexity increases due to additional control logic

Engineering Contradiction:
Improveblood concentration detection accuracyVSAvoidcontrol logic complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The control unit performs multiple functions: it monitors flow rate, determines bypass operation status, calculates the appropriate limit value, and controls the blood leak detector. By making the control unit universal and multi-functional, the patent avoids adding separate dedicated components for each function, thereby limiting the increase in device complexity while achieving flow-rate-dependent detection.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Ensures reliable detection of high blood concentrations in the dialysate discharge line during bypass operation, preventing false alarms and correctly identifying blood leaks, thus reducing patient and operator uncertainty and avoiding misinterpretation of detector failures.

Implementation Method 1

blood is detected in the dialysate generally by means of a photo-optical sensor, with which the concentration of blood in the dialysate, which is clear per se, can be determined

Methodology Applied
Scientific EffectPhoto-optical detection: Absorption (EM radiation)

Implementation Method 2

the blood is purified by a dialyser which has a blood chamber disposed in the extracorporeal blood circuit and also a dialysate chamber, which are separated from one another by a semipermeable membrane

Methodology Applied
Scientific EffectSemipermeable membrane separation: Semipermeable Membrane

Implementation Method 3

An ultrafiltration pump generates the necessary negative pressure in the dialysate chamber of the dialyser so that fluid that is not replaced by substitution fluid can be removed from the patient

Methodology Applied
Scientific EffectNegative pressure generation: Pressure Gradient

Data Source

PatentUS10881776B2Control unit for detecting blood in a dialysate discharge line of a blood treatment device, and blood treatment device
Publication Date: 2021.01.05 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US10881776B2 patent drawing

AI summary

The invention relates to a control unit (30) for detecting an overshoot of a first limit value (G1) of a first blood concentration (B1) in a first portion (17a) of a dialysate discharge line (17) downstream of a dialysate chamber (7) of a dialyser (4) of a blood treatment device and upstream of a node point (110) at which a bypass line (100) bypassing the dialyser (4) leads into the dialysate discharge line (17), wherein the bypass line (100) branches off, upstream of the dialysate chamber (7), from a dialysate supply line (15) suitable for supplying dialysate from a dialysate source (16) to the dialysate chamber (7).