Solid Dissolvable Reagent Film for Automated Staining Precision

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Solution Overview

Problem

Current reagent dispenser systems for automated cell stainers face issues with precise delivery of antibodies and other reagents due to potential mis-dispensing and residue formation, leading to inaccurate volumes and slide staining failures, especially with limited shelf life and storage requirements.

Innovation Solution

Development of a solid, dissolvable reagent composition using a water-soluble polymer like polyvinyl alcohol (PVA) that incorporates reagents such as antibodies, which can be safely heated without degradation, allowing for precise delivery and improved stability, eliminating the need for rehydration and reducing the number of dispensers required.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If liquid reagent dispenser systems are used for automated cell stainers, then reagents can be delivered to slides, but mis-dispense and residue formation occur leading to inaccurate volumes and staining failures

Engineering Contradiction:
Improvedelivery precisionVSAvoidstaining success rate
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent changes the physical state of reagents from liquid to solid form by incorporating them into a water-soluble polymer matrix. This parameter change eliminates the issues of mis-dispense and residue formation associated with liquid dispensing, as the solid composition is applied as a paste or semi-solid that does not drip or form residues, thereby improving both delivery precision and staining success rate.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite material consisting of reagents (antibodies, probes, enzymes) embedded in a water-soluble polymer matrix such as polyvinyl alcohol. This composite structure allows the reagent to be delivered in a controlled solid form that dissolves upon contact with aqueous buffers, providing precise delivery without the harmful effects of liquid dispensing while maintaining reagent functionality.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If reagents are stored in liquid form with limited shelf life, then they can be used immediately, but they require refrigeration at 4°C and have limited stability

Engineering Contradiction:
Improvereagent stabilityVSAvoidstorage temperature
Core Design Contradiction:
Stability of the object's compositionVSTemperature

Solution Approach 1:

The patent changes the physical state of reagents from liquid to solid by embedding them in a water-soluble polymer matrix. This parameter change dramatically improves stability, allowing reagents to be stored at room temperature instead of requiring refrigeration at 4°C. The solid composition prevents degradation and maintains reagent functionality without the need for cold chain storage, extending shelf life and simplifying storage requirements.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If multiple liquid reagents are dispensed using automated dispensers, then assays can be performed, but the number of dispensers required increases system complexity

Engineering Contradiction:
Improveassay throughputVSAvoidnumber of dispensers
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent merges multiple reagents into a single solid composition by incorporating different reagents (antibodies, probes, enzymes, buffers) into one water-soluble polymer matrix. This single composition can be applied to the slide and then dissolved by adding aqueous buffer, releasing all incorporated reagents simultaneously or in sequence. This merging approach reduces the number of dispensers needed from multiple liquid dispensing units to a single application mechanism plus buffer addition, significantly simplifying the automated staining system while maintaining assay throughput.

Inventive Principle:
Principle #5Merging (Combining)

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 solid, dissolvable reagent composition ensures precise and reliable delivery of reagents, enhances stability, reduces waste, and simplifies the process by allowing for room temperature storage, making it suitable for both automated and manual systems, and supports a range of assays from single to multiple slides.

Implementation Method 1

When the composition is applied to a sample, the water-soluble polymer contacts the sample and dissolves, allowing the reagent to contact the sample

Methodology Applied
Scientific EffectDissolution:

Data Source

PatentUS11686738B2Methods, systems and solid compositions for reagent delivery
Publication Date: 2023.06.27 VENTANA MEDICAL SYSTEMS INC
  • US11686738B2 patent drawing
  • US11686738B2 patent drawing
  • US11686738B2 patent drawing

AI summary

Methods, systems, and compositions featuring a solid, dissolvable reagent composition for delivering the reagent, such as an antibody, probe, chromogen, etc., to a sample. The present invention also features methods of producing said compositions, and automated systems featuring the use of the solid, dissolvable reagent compositions. The solid, dissolvable reagent composition may comprise a water-soluble polymer film, such as a polyvinyl alcohol film, infused with the reagent, wherein when applied to the sample, the water-soluble polymer film with reagent contacts the sample (e.g., tissue) and dissolves.