Layered Biomarker Detection Structure for Clear Sample Readout
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Solution Overview
Problem
Existing biomarker detection devices integrated within medical devices face challenges due to environmental sensitivity of detection reactions and complexity in visualizing results, leading to inaccurate detection and interpretation, especially in small form factors.
Innovation Solution
A biomarker detection device with a direct contact transfer layer delivering the biological sample to a detection layer without an intervening adhesive, featuring an observation window free of adhesive, ensuring optimal reaction environment and clear visualization of results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If an adhesive layer is used to bond the transfer layer and detection layer, then the device can be manufactured with standard adhesive processes, but the adhesive interferes with the biological sample delivery and detection reaction environment
Solution Approach 1:
The patent removes the adhesive layer from between the transfer layer and detection layer, extracting the harmful element that interfered with sample delivery. The transfer layer and detection layer are bonded using alternative methods (heat sealing, ultrasonic welding, or mechanical interlocking) that do not introduce interfering substances into the detection environment.
Solution Approach 2:
The patent introduces an intermediary bonding mechanism that does not involve adhesive chemicals. The bonding is achieved through physical methods (heat, ultrasound, or mechanical features) that allow the transfer layer and detection layer to be securely connected without introducing substances that would interfere with the biological detection process.
2Volume of moving object
If the device size is reduced for integration into medical devices, then the device can be integrated into swab tubes and wound dressings, but the visualization of detection results becomes difficult
Solution Approach 1:
The patent uses a transparent or translucent detection layer that allows visualization through the layer itself, effectively using the third dimension (transparency) to overcome the size limitation. The observation window provides a clear view through the compact device structure, allowing results to be seen despite the small form factor.
Solution Approach 2:
The detection layer incorporates color-changing indicators that provide high-contrast visual signals for biomarker detection. These color changes are highly visible even in the compact device format, allowing clear result interpretation despite the reduced size necessary for integration into medical devices.
3Stability of the object's composition
If adhesive is used to ensure layer fixation, then the layers remain in position, but the adhesive creates an obstacle to biological sample flow and reaction
Solution Approach 1:
The patent removes the adhesive layer from the sample flow path, eliminating the obstacle that blocked biological sample delivery. The adhesive is either completely removed from the interface or replaced with a bonding method that does not create flow resistance, allowing unobstructed sample movement from the transfer layer to the detection layer.
Solution Approach 2:
The patent replaces the chemical bonding mechanism (adhesive) with a physical bonding mechanism (heat sealing, ultrasonic welding, or mechanical interlocking). This substitution eliminates the chemical barrier to sample flow while maintaining the structural integrity and positional stability of the layered construction.
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 accuracy and predictability of biomarker detection by optimizing the reaction environment and providing clear visual results, suitable for integration into various medical devices.
Implementation Method 1
a transfer layer in direct contact with a first surface of the detection layer, wherein the transfer layer is configured to deliver the biological sample directly to the detection layer
Data Source
AI summary
A biomarker detection device having a detection layer configured to detect one or more biomarkers in a biological sample and a transfer layer in direct contact with a first surface of the detection layer; wherein the transfer layer is configured to deliver the biological sample directly to the detection layer and wherein an observation window is provided on a second surface of the detection layer opposite the transfer layer and wherein there is no adhesive between the transfer layer and the detection layer in the region in register with the observation window. The detection layer may comprise two or more detection zones. The biomarker detection device may be part of a medical device, such as a swab receptacle. The device may comprise any one or more of: an adhesive layer, a label comprising a printed marking, a fixing element configured to attach or adhere the device to another object.