Disposable Foil Punch for Immunohematology Analyzer

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Solution Overview

Problem

Current immunodiagnostic testing systems face challenges with cross-contamination and inefficiency due to the use of single-use reagent packs and complex piercing mechanisms, leading to false positive results and increased waste generation.

Innovation Solution

A method and apparatus that utilize disposable punches with compatibility testing and alignment to pierce sealed elements, ensuring that only compatible punches are used to prevent cross-contamination, and a pre-stressed foil wrap design for easy puncture without touching the seal, reducing the need for frequent punch replacement and manual cleaning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If disposable punches are used to pierce sealed elements, then cross-contamination is reduced, but device complexity increases due to compatibility testing and alignment mechanisms

Engineering Contradiction:
Improvecross-contamination preventionVSAvoidpunch compatibility testing and alignment
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs compatibility testing of disposable punches with sealed elements before the actual piercing operation. The scheduler estimates the time required for this preliminary compatibility check, ensuring that only compatible punches are used to pierce specific sealed elements, thereby preventing cross-contamination while maintaining systematic control over the process

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The scheduler acts as an intermediary between the disposable punch selection and the piercing operation. It coordinates the compatibility testing process, determines appropriate punch-element pairings, and manages the timing of these preliminary actions to ensure reliable operation without direct manual intervention

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If pre-stressed foil wrap design is used, then puncture ease is improved, but manufacturing complexity increases

Engineering Contradiction:
Improvefoil puncture easeVSAvoidpre-stressed foil design
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The foil wrap is pre-stressed during manufacturing to create specific mechanical properties that facilitate easy puncture. The pre-stressing modifies the physical state and stress distribution of the foil, creating a weakened portion that can be easily pierced by the disposable punch while maintaining seal integrity during storage and transport

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If compatibility testing is implemented, then test accuracy is improved, but loss of time increases due to preliminary testing

Engineering Contradiction:
Improvetest accuracyVSAvoidcompatibility testing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

Compatibility testing is performed as a preliminary action before the actual test analysis, allowing the system to pre-determine appropriate punch-element pairings. The scheduler estimates and manages the time required for these preliminary compatibility checks, ensuring that accurate test results are achieved without excessive delays

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system uses feedback from compatibility testing results to determine whether a specific disposable punch is suitable for piercing a sealed element. This feedback mechanism ensures that only compatible combinations are used, improving test accuracy while the scheduler optimizes the timing to minimize overall process duration

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP2574928B1A test analyser comprising a disposable foil punch for immunohematology test elements
Publication Date: 2020.06.17 ORTHO CLINICAL DIAGNOSTICS INC
  • EP2574928B1 patent drawingFigure 1
  • EP2574928B1 patent drawingFigure 2
  • EP2574928B1 patent drawingFigure 3

AI summary

Disclosed is a device and method of using the device to reduce false positives when using sealed packs in an immunodiagnostic analyzer while allowing use of the reagents in multiple tests as well as reuse of disposable punches employed for piercing foil covering the reagent aliquots. The disclosed devices and methods are useful in carrying out tests in immunohematology such as for a blood type or a screen.