Biosensor Embedded Conductors Non-Sliding Connection

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Solution Overview

Problem

Current biosensors face issues with material removal during insertion and removal from test meters, durability during handling, and usability challenges for patients with poor eyesight or motor skills, particularly in diabetes management.

Innovation Solution

The development of biosensors with embedded conductors in a substrate that are robust, orientationally independent, and feature non-sliding connections to reduce material removal and enhance durability, along with improved manufacturing processes for increased stiffness and ease of use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sliding contacts are used to connect test elements to test meters, then electrical connection is achieved, but material is removed from the test element through plowing or scraping

Engineering Contradiction:
Improveelectrical connectionVSAvoidmaterial removal
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent extracts the harmful sliding contact mechanism from the system and replaces it with a non-sliding push-in connection. The test element simply inserts into the test meter without requiring sliding motion, eliminating the plowing and scraping that causes material removal while maintaining reliable electrical connection through direct contact of embedded conductors with meter contacts.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical sliding contact system with a simpler push-in connection system. Instead of relying on sliding friction and contact pressure during insertion/removal, the new system uses a friction-fit or snap-fit mechanism where the test element is pushed directly into the meter housing, eliminating the harmful mechanical interaction that caused material loss.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If test elements are made thin and flexible, then ease of handling is improved, but durability during manufacturing and storage deteriorates

Engineering Contradiction:
ImprovehandlingVSAvoiddurability
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent employs composite construction by embedding conductive wires within a flexible substrate matrix. This composite structure provides both the flexibility needed for easy handling and the structural integrity required for durability during manufacturing and storage. The substrate protects the embedded conductors while maintaining overall flexibility of the test element.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent uses a flexible substrate as the base material for the test element, which allows the device to be thin and easy to handle while providing sufficient mechanical strength. The flexible nature of the substrate enables bending and manipulation without breaking, while its inherent strength prevents damage during manufacturing processes and storage handling.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If reagent application is performed with greater force and higher temperatures, then reagent bonding is improved, but test element durability deteriorates

Engineering Contradiction:
Improvereagent bondingVSAvoidtest element integrity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The composite structure of embedded conductors within a reinforced substrate provides enhanced mechanical strength that can withstand the stresses of high-temperature reagent application processes. The robust construction allows the test element to maintain its integrity during aggressive reagent bonding operations without compromising durability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent designs the test element with pre-reinforced structural features and embedded conductors that provide mechanical cushioning and support before reagent application. This beforehand strengthening ensures the test element can withstand the thermal and mechanical stresses of high-temperature reagent bonding without damage, maintaining both reagent bonding quality and element integrity.

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

4Ease of manufacture

If conventional test elements are used, then manufacturing simplicity is maintained, but material accumulation in test meter occurs over time

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidmaterial accumulation
Core Design Contradiction:
Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and eliminates the sliding contact mechanism that causes material to be plowed or scraped off during insertion and removal. By replacing it with a non-sliding push-in connection, the source of material accumulation in the test meter is removed, preventing debris buildup over time while maintaining manufacturing simplicity through the straightforward embedded conductor design.

Inventive Principle:
Principle #2Taking out (Extraction)

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 solution enhances the durability and usability of biosensors, reducing material accumulation and improving user accessibility, particularly for patients with impaired vision or dexterity, while maintaining accurate analyte detection.

Implementation Method 1

a reagent layer 120 coated about the exterior surface of the cylindrical test element body 110 at the test end 104. The reagent layer 120 is adapted to electrochemically react with an analyte in a body fluid sample

Methodology Applied
Scientific EffectElectrochemical reaction:

Implementation Method 2

at least two electrical conductors embedded within the single-piece body and extending between the two end surfaces, the at least two electrical conductors being exposed at the two end surfaces

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP2531851B1Biosensor and methods for manufacturing
Publication Date: 2018.07.11 ROCHE DIABETES CARE GMBH
  • EP2531851B1 patent drawingFigure 1~3
  • EP2531851B1 patent drawingFigure 4~6
  • EP2531851B1 patent drawingFigure 7~9

AI summary

A biosensor for detecting an analyte in a sample of body fluid and methods for manufacturing the biosensor are disclosed. In one embodiment, a biosensor includes at least two electrical conductors embedded within an electrically insulating test element body. The electrical conductors are exposed at two ends of the test element body and a reagent, for example a reagent adapted to test for blood glucose, is applied to one end. In one form, the test element body is cylindrical with a circular or non-circular cross-sectional shape. In other embodiments, the test elements are manufactured by a resin pultrusion process in which resin embedded with electrical conductors is dried or cured, shaped and cut into segments, and reagent applied to one end of each segment.