Dialysis Backflow Prevention with Differential-Pressure Drain Control

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Solution Overview

Problem

Conventional backflow prevention devices, such as check valves and reduced-pressure zone devices, are not reliable for medical applications due to incomplete closure issues, contamination risks, and incompatibility with medical-grade materials, which can lead to bacterial re-contamination and chemical toxicity in dialysis treatments.

Innovation Solution

A backflow prevention device with an inlet chamber, a chamber-separating component, and an outlet chamber, utilizing a spring-loaded inlet check valve or differential pressure generator to create pressure differences, along with an outlet check valve and a drain port for reliable fluid flow and leak detection, constructed from biocompatible materials to prevent contamination and ensure safe operation in medical settings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If check valves or double-check valve backflow preventers are used, then the device complexity is reduced, but the reliability deteriorates because valves may be incompletely closed due to particles or debris

Engineering Contradiction:
Improvedevice complexityVSAvoidreliability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The backflow prevention device is divided into two separate chambers (first chamber and second chamber) separated by a separating member. The first chamber contains a first check valve while the second chamber contains a second check valve and drain port. This segmentation ensures that even if one valve fails due to particles or debris, the other chamber maintains backflow prevention functionality, thereby improving reliability without excessive complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates a drain port in the second chamber that can be opened to drain accumulated particles or debris before they cause valve malfunction. This proactive drainage mechanism cushions against potential reliability failures by removing harmful accumulations before they can compromise the check valves' sealing effectiveness.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If reduced-pressure zone (RTZ) devices are used, then the reliability is improved with redundancies, but the object-generated harmful factors worsen due to bacterial contamination and chemical toxicity risks

Engineering Contradiction:
ImprovereliabilityVSAvoidbacterial contamination and chemical toxicity
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device extracts and eliminates the problematic features of conventional RTZ devices by using a separating member that creates separate sealed chambers. This prevents atmospheric vents and test valves from introducing bacteria into the fluid path. The design removes the sources of bacterial contamination and chemical trapping that plague traditional RTZ devices while maintaining the redundant chamber structure for reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The sealed chamber design creates an inert, closed environment that prevents external contamination. By eliminating atmospheric vents and using sealed separating members, the device maintains a sterile internal environment that prevents bacterial colonization and eliminates the risk of chemical disinfectants being trapped and released into the treated fluid.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

3Reliability

If conventional RTZ devices are used, then the reliability is improved, but the ease of manufacture worsens due to incompatible materials that can contaminate fluid

Engineering Contradiction:
ImprovereliabilityVSAvoidease of manufacture
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The device applies local quality by specifying biocompatible materials specifically for components in contact with the fluid path (separating member, chamber walls, valves). This localized material selection ensures medical-grade compatibility and prevents fluid contamination while allowing other non-critical components to use standard, easier-to-manufacture materials. The separating member and chamber surfaces are specifically designed with smooth, non-porous finishes to prevent bacterial adhesion.

Inventive Principle:
Principle #3Local quality

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

The device provides a reliable, compact, and easily disinfected backflow prevention solution with reduced dead space, ensuring safe fluid delivery and minimizing the risk of contamination in medical applications, particularly in dialysis treatments.

Implementation Method 1

a second port of the inlet chamber is fluidly connected with a spring-loaded inlet check valve for delivering the fluid flowing across the inlet chamber from the first port

Methodology Applied
Scientific EffectSpring-loaded mechanism: Spring

Implementation Method 2

a second port of the inlet chamber is fluidly connected with a differential pressure generator and an inlet check valve for delivering the fluid flowing across the inlet chamber from the first port

Methodology Applied
Scientific EffectDifferential pressure generation: Pressure Gradient

Implementation Method 3

the inlet check valve is fluidly connected between the inlet chamber and the outlet chamber to only allow the fluid to flow from the inlet chamber toward the outlet chamber along a forward flowing path of the fluid

Methodology Applied
Scientific EffectCheck valve mechanism: Valve

Implementation Method 4

the relief valve being operatively connected with the separating member for opening or closing a drain port of the outlet chamber

Methodology Applied
Scientific EffectPressure-actuated valve: Valve

Data Source

PatentUS11273242B2Backflow prevention device and dialysis apparatus with the backflow prevention device
Publication Date: 2022.03.15 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US11273242B2 patent drawing
  • US11273242B2 patent drawing
  • US11273242B2 patent drawing

AI summary

The present disclosure provides a backflow prevention device, comprising: an inlet chamber comprising at least two ports, in which a first port is used for receiving a fluid; a chamber-separating component comprising a separating member and a relief valve; an outlet chamber separated from the inlet chamber by the separating member; the relief valve being operatively connected with the separating member for opening or closing a drain port of the outlet chamber; wherein the fluid is allowed to be delivered from the outlet chamber only when the relief valve is closed by means of a differential pressure applied on the separating member. Also provided is a dialysis apparatus comprising the backflow prevention device. According to the present disclosure, the backflow prevention device has simple structure, reduced dead space and small sizes and can work reliably.