Optical Leak Detection in Blood Treatment Functional Units

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Solution Overview

Problem

Existing blood treatment devices face safety risks due to the potential leakage of blood from the extracorporeal blood circuit into the dialysate system, particularly when using external functional units, which are difficult to monitor reliably for operability and operating state.

Innovation Solution

A blood treatment device equipped with a disposable monitoring unit featuring a light transmitter and receiver, integrated into the attachment unit, allowing for optical measurement and detection of light intensity changes to assess the functional unit's state, including leaks and fluid presence, without requiring structural modifications to the attachment unit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If an external functional unit is used for blood treatment, then the ease of operation and disposability are improved, but the reliability and safety against blood leakage into dialysate deteriorate

Engineering Contradiction:
ImprovedisposabilityVSAvoidsafety against blood leakage
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The monitoring unit performs preliminary detection of blood in the dialysate before significant leakage occurs. The light transmitter and receiver continuously monitor the dialysate compartment, enabling early warning of membrane rupture or connection leaks, allowing corrective action before patient safety is compromised.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary monitoring system between the blood circuit and dialysate system. The optical sensors act as a mediator that detects the presence of blood in the dialysate without directly contacting either fluid, enabling indirect monitoring that maintains system integrity while providing safety verification.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If photometric measurement is used to detect blood in dialysate, then the measurement capability is improved, but the device complexity increases

Engineering Contradiction:
Improveblood detection capabilityVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the monitoring function into a separate, integrated monitoring unit within the disposable functional unit. This allows the main blood treatment device to remain simple while the disposable unit contains the optical measurement components, enabling precise blood detection without permanently increasing the complexity of the reusable equipment.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The monitoring unit with light transmitter and receiver is integrated into the disposable functional unit. This allows the use of precise photometric measurement components in a single-use configuration, eliminating the need for complex, expensive, permanently installed monitoring systems while maintaining measurement precision throughout the device lifecycle.

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

3Ease of operation

If monitoring components are integrated into the attachment unit, then the ease of operation is improved, but the manufacturing complexity increases

Engineering Contradiction:
Improveintegration of monitoringVSAvoidmanufacturing complexity
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The patent segments the blood treatment system into reusable and disposable components, with the monitoring unit integrated into the disposable functional unit. This segmentation allows the monitoring components to be manufactured and tested separately as a complete disposable assembly, simplifying the manufacturing process compared to integrating monitoring into the complex reusable attachment unit.

Inventive Principle:
Principle #1Segmentation

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

Enhances the safety and reliability of blood treatment by enabling effective monitoring of the functional unit's operability and operating state, detecting leaks and fluid presence, and preventing blood entry into the dialysate system, thus ensuring proper device operation and patient safety.

Implementation Method 1

a monitoring unit (disposable) for monitoring the operability and/or the operating state of the functional unit, which comprises at least one light transmitter and at least one light receiver

Methodology Applied
Scientific EffectLight transmission and detection: Light

Implementation Method 2

In the prior art, blood (haemoglobin) in the dialysate system is detected by means of a photometric measurement method in which the reduction in the intensity of a ray passing through the dialysate as a result of the entry of blood is detected

Methodology Applied
Scientific EffectPhotometric measurement: Absorption Spectroscopy

Data Source

PatentUS10471198B2Blood treatment device comprising a functional unit for carrying out the blood treatment and method for monitoring the functionality and/or the operating state of the functional unit
Publication Date: 2019.11.12 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US10471198B2 patent drawing
  • US10471198B2 patent drawing

AI summary

The invention relates to a blood treatment device comprising an attachment unit 7 for attaching a functional unit 1 intended for single use for carrying out the blood treatment. The blood treatment device according to the invention is characterised by a monitoring unit 8 for monitoring the operability and/or the operating state of the functional unit 1, which functional unit comprises at least one light transmitter 17A, 18A and at least one light receiver 17B, 18B. The light transmitter and light receiver are arranged in the monitoring unit 8 according to the invention on one side of the functional unit 1. The arrangement of the light transmitter and light receiver on the same side has the advantage that the monitoring unit 8 can be integrated into the attachment unit 7 of the blood treatment device without any major structural modifications. The monitoring of the functional unit 1 is based on an optical measurement method in which the light reflected on a part of the functional unit 1 or a part of the attachment unit 7 is detected. A calculation- and evaluation unit 13 is configured such that conclusions can be drawn as to a defective state and/or a certain operating state of the functional unit 1 based on the intensity of the light falling on the functional unit and the light reflected on the functional unit or the attachment unit.