Biocompatibility Test Assembly with Deformable Seal

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Solution Overview

Problem

Current in-vitro biocompatibility testing methods for materials, especially in medical technology, face challenges in standardizing surface area and volume ratios, handling sterility, and accommodating varying sample geometries and sizes, leading to inaccurate and labor-intensive biological evaluations.

Innovation Solution

A modular arrangement featuring a base plate with a receiving element and a cover element that forms a high-cavity structure with a fluid-tight seal, allowing precise alignment and deformation to create standardized cavities for biological testing, eliminating the need for adhesives and ensuring easy sterile handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If samples of different sizes and geometries are tested in standard microtiter plates, then various materials can be evaluated, but the surface area-to-volume ratio varies significantly leading to high error rates and reduced measurement precision

Engineering Contradiction:
Improveability to test different sample geometriesVSAvoidbiological result quantification
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The invention divides the testing system into modular components: standardized cavities with defined geometry, removable sample holders, and interchangeable plate formats. This segmentation allows different sample types to be tested in standardized conditions without compromising measurement precision

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention standardizes critical parameters including cavity volume, surface area, and sample positioning coordinates. By controlling these parameters across different test configurations, the system maintains measurement precision while accommodating various sample geometries and sizes

Inventive Principle:
Principle #35Parameter changes

2Reliability

If adhesive solutions are used to secure samples in cavities, then samples are fixed in position, but adhesive migration into cell culture medium causes cytotoxic effects and requires additional cleaning steps

Engineering Contradiction:
Improvesample positioning stabilityVSAvoidcytotoxic effect from adhesive migration
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the adhesive function from the sample securing mechanism. Instead of using chemical adhesives, the system employs mechanical retention through recessed sample holders and friction-fit interfaces, eliminating cytotoxic effects while maintaining reliable sample positioning

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces an intermediary mechanical retention structure between the sample and the cavity. The sample holder acts as a mediator that secures the sample through physical interlocking rather than chemical bonding, preventing harmful substance migration while ensuring stable positioning

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If hydrophobic barrier solutions are applied to cavity boundaries, then fluid containment is achieved, but cell growth and cultivation on material surfaces is negatively impacted

Engineering Contradiction:
Improvefluid containmentVSAvoidnegative impact on cell growth
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention removes hydrophobic barrier coatings from the cavity boundaries and replaces them with physical containment through raised cavity walls and overflow channels. This extraction eliminates the harmful effect on cell growth while maintaining reliable fluid containment through geometric design

Inventive Principle:
Principle #2Taking out (Extraction)

4Ease of operation

If manual handling of samples in microtiter plates is used, then testing can be performed, but sterility maintenance becomes labor-intensive and error-prone

Engineering Contradiction:
Improvemanual handling flexibilityVSAvoidsterility maintenance
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention implements preliminary sterility preparation through pre-sterilized modular components that can be assembled in a controlled manner. Sample plates, cavities, and holders are pre-packaged in sterile containers, allowing rapid assembly without compromising sterility while maintaining operational flexibility

Inventive Principle:
Principle #10Preliminary action

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

This solution enables precise, reproducible biological evaluations by standardizing the surface area and volume for each sample, reducing errors, and facilitating the testing of diverse materials with varying geometries and sizes, while ensuring sterility and gas exchange.

Implementation Method 1

a compressive force acts on the receiving element, with the result that the receiving element deforms at least partially and closes the first opening of the at least one aperture, which is arranged toward the base plate, in a fluid-tight manner

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3852930B1Assembly for performing in vitro biocompatibility tests
Publication Date: 2024.10.30 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
  • EP3852930B1 patent drawingFigure 1a~1c
  • EP3852930B1 patent drawingFigure 2~3
  • EP3852930B1 patent drawingFigure 4~5

AI summary

The invention relates to an assembly for performing in vitro biocompatibility tests, wherein at least one sample (3) is arranged on a surface of a base plate (1) or the at least one sample (3) forms a surface or a surface region of the base plate (1). A holding element (2) having at least one through-hole (2.1) can be placed onto the at least one sample (3) in such a way that a first opening of the at least one through-hole (2.1), which first opening is arranged facing the base plate (1), is arranged in the region of the at least one sample (3). The at least one through-hole (2.1), with the hollow space thereof, and the sample (3) form a cavity. A cover element (4) can be placed onto and fastened on the holding element (2) in such a way that a compressive force acts on the holding element (2), which compressive force leads to at least partial deformation of the holding element (2) and to the fluid-tight closure of the first opening of the at least one through-hole (2.1), which first opening is arranged facing the base plate (1).