Glucose Sensor Perfusion Apparatus for Organ Viability Assessment

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Solution Overview

Problem

A significant portion of donated organs are subjectively determined to be non-viable for diagnosis, treatment, storage, and transport, leading to a substantial waste of potentially usable tissue.

Innovation Solution

A perfusion apparatus equipped with a glucose sensor that detects Kidney Injury Molecule-1 (KIM-1) as a biomarker for organ viability, allowing for quantitative measurement and assessment of organ viability, which can be wirelessly communicated for display or external analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If subjective determination methods are used to assess organ viability, then the assessment process is simple, but many viable organs are incorrectly discarded

Engineering Contradiction:
Improveorgan viability assessment accuracyVSAvoidassessment system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces subjective mechanical assessment methods with an automated biochemical sensing system. A glucose sensor detects glucose levels in the perfusate, which serves as an objective biomarker for organ viability. This substitution eliminates human subjectivity while maintaining operational simplicity through automated measurement and interpretation of glucose concentrations.

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

Solution Approach 2:

The patent introduces glucose as an intermediary biomarker that indirectly indicates organ viability. Instead of directly assessing complex organ function, the system measures glucose consumption or production by the organ tissue, which serves as a reliable proxy indicator. This intermediary approach simplifies the assessment while improving accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If quantitative biomarker measurement is implemented, then organ viability determination accuracy improves, but the device complexity increases

Engineering Contradiction:
Improveviability determination accuracyVSAvoidsensor system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs a glucose sensor that utilizes electrochemical detection principles to quantitatively measure glucose concentrations in the perfusate. This replaces complex manual biochemical assays with an automated electronic sensing system that provides continuous, precise measurements of the viability biomarker through electrochemical reactions.

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

Solution Approach 2:

The patent monitors changes in glucose concentration parameters in the perfusate as the organ is perfused. By tracking the dynamic changes in glucose levels over time during the perfusion process, the system can quantitatively assess organ metabolic function and viability without requiring complex diagnostic procedures.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If storage periods are extended to transport organs greater distances, then more organs become available for transplantation, but organ viability may deteriorate

Engineering Contradiction:
Improveorgan availabilityVSAvoidorgan viability during storage
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent implements a feedback mechanism where glucose sensor measurements during storage and transport provide real-time information about organ viability status. This feedback allows for monitoring and adjustment of storage conditions, ensuring that organs remain viable throughout extended storage periods and can be safely transported to distant transplantation sites.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent performs viability assessment using glucose measurement during the storage and transport phase, before the organ is implanted. This preliminary action during storage allows for identification of viable organs that can withstand extended storage, enabling better planning and selection for transplantation while maintaining organ reliability.

Inventive Principle:
Principle #10Preliminary action

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

This approach enables the identification of previously discarded organs as viable, thereby increasing the number available for medical use by objectively determining organ viability and reducing ischemia and reperfusion injury.

Implementation Method 1

a glucose sensor that is able to detect a target agent such as a biomarker that is indicative of the viability of the organ or tissue and quantitatively measure the target agent by sensing an amount of generated glucose

Methodology Applied
Scientific EffectGlucose sensing:

Data Source

PatentEP2967026B1Perfusion apparatus with a glucose sensor for determining viability of an organ or tissue
Publication Date: 2021.04.21 LIFELINE SCIENTIFIC INC
  • EP2967026B1 patent drawingFigure 1
  • EP2967026B1 patent drawingFigure 2A~2B

AI summary

An apparatus for perfusing an organ or tissue includes a perfusion circuit and a glucose sensor operatively connected to the perfusion circuit. The glucose sensor is configured to detect a target agent that is an indicator of viability of the organ or tissue. The target agent may be Kidney Injury Molecule-1 (KIM-1). The sensor includes a solid support, such as a bead or membrane, to which is attached a recognition molecule that specifically binds to the target agent but not significantly to other agents. The sensor also includes an enzyme that can catalyze the conversion of a substance to glucose. In the presence of the target agent the enzyme can convert the substance into glucose, which can then be detected and optionally be quantified by the sensor.