Pancreas Suitability Scoring for Islet Isolation

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Solution Overview

Problem

Islet isolation from pancreas remains notoriously difficult due to challenges in determining suitable donor pancreas quality, leading to variable yields and efficiencies in islet replacement therapy.

Innovation Solution

A scoring system evaluating five criteria - warm ischemia time, pancreatic color, fat content, islet demarcation, islet size, and other factors - to assess the suitability of a pancreas for islet isolation, followed by a method involving collagenase perfusion and purification using density gradients to maximize islet yield and purity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated islet isolation methods are used, then isolation efficiency is improved, but yield consistency and purity remain problematic

Engineering Contradiction:
Improveislet isolation efficiencyVSAvoidyield consistency
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by evaluating pancreas quality before isolation using a scoring system that assesses multiple parameters (color, consistency, fat content, islet demarcation, warm ischemia time). This pre-assessment allows selection of only suitable pancreases for isolation, ensuring consistent high yields and purity while maintaining efficient processing of selected samples.

Inventive Principle:
Principle #10Preliminary action

2Productivity

If pancreas quality assessment is performed, then islet yield is improved, but time and complexity of the process increase

Engineering Contradiction:
Improveislet yieldVSAvoidassessment process complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the quality assessment into five distinct, easily observable parameters: pancreas color, consistency, fat content, islet demarcation, and warm ischemia time. Each parameter is scored independently (+1 or -1), and the scores are summed to produce an overall quality score. This segmented approach makes the assessment systematic and relatively simple to perform while effectively predicting islet yield.

Inventive Principle:
Principle #1Segmentation

3Manufacturing precision

If strict quality criteria are applied, then islet purity is improved, but number of suitable donors decreases

Engineering Contradiction:
Improveislet purityVSAvoidnumber of suitable donors
Core Design Contradiction:
Manufacturing precisionVSQuantity of substance

Solution Approach 1:

The patent applies parameter changes by establishing specific threshold values for five quality parameters (color, consistency, fat content, islet demarcation, warm ischemia time) that define suitable donors. By quantifying these parameters and setting clear cutoffs, the method achieves high purity (>90%) and viability (>89%) while maintaining a practical supply of suitable donors through the standardized scoring system.

Inventive Principle:
Principle #35Parameter changes

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 scoring system effectively identifies suitable pancreas donors, resulting in high islet yields with purity over 90% and viability greater than 89%, enabling successful islet transplantation and long-term insulin production.

Implementation Method 1

a method involving collagenase perfusion

Methodology Applied
Scientific EffectCollagenase digestion: Enzyme

Implementation Method 2

purification using density gradients

Methodology Applied
Scientific EffectDensity gradient separation: Density Gradient

Data Source

PatentUS7413871B2Scoring method for determining pancreas suitability for islet isolation
Publication Date: 2008.08.19 ROGOSIN INSTITUTE INC
  • US7413871B2 patent drawing

AI summary

The invention relates to a method for evaluating a pancreas as a source of therapeutically useful islets. A scoring system is set forth whereby 5 criteria are listed. If three criteria are positive, then the pancreas is a suitable source of therapeutically useful islets.