Perfusion Fluid DNA Analysis for Organ Quality Prediction
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Solution Overview
Problem
Current organ preservation methods, particularly mechanical perfusion, do not effectively assess organ quality during the perfusion process, leading to potential ischemia-reperfusion injury and negative transplantation outcomes, and there is a lack of routine analysis of perfusion and flush fluids for predicting organ suitability and transplantation success.
Innovation Solution
The method involves sampling and analyzing nucleic acids from perfusion or flush fluids to isolate and quantify DNA and RNA, evaluating their amounts, molecular weights, and fragment sizes, which can predict transplantation outcomes and inform adjustments to perfusion parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical perfusion is used to preserve and re-condition organs, then organ viability and oxygen supply are improved, but the ability to assess organ quality during perfusion is insufficient leading to potential ischemia-reperfusion injury
Solution Approach 1:
The patent uses cell-free DNA (cfDNA) in the perfusion fluid as an intermediary biomarker to indirectly assess organ quality. Instead of directly measuring organ function, the system analyzes cfDNA fragmentation patterns and concentrations in the perfusate, which serve as mediators reflecting the organ's physiological state and injury levels.
Solution Approach 2:
The patent replaces direct mechanical or physiological assessment methods with molecular analysis. Instead of relying on functional tests or direct organ examination, the system substitutes mechanical perfusion assessment with biochemical analysis of nucleic acids in the perfusion fluid to evaluate organ quality.
2Device complexity
If perfusion and flush fluids are discarded without analysis, then processing time and complexity are reduced, but valuable information about organ suitability and transplantation outcome is lost
Solution Approach 1:
The patent performs preliminary analysis of perfusion and flush fluids during the perfusion process itself, before the organ is transplanted. By analyzing cfDNA in the perfusate early on, the system predicts transplantation outcomes in advance, allowing for informed decision-making about organ suitability before commitment to transplantation.
Solution Approach 2:
The perfusion fluid serves a dual function: it performs its primary role of preserving and re-conditioning the organ while simultaneously serving as a diagnostic medium containing cfDNA biomarkers. The same fluid that maintains organ viability also provides the information needed to assess organ quality, eliminating the need for separate diagnostic sampling.
3Measurement precision
If nucleic acid analysis is performed on perfusion fluids, then transplantation outcome prediction is improved, but sampling and analysis complexity increases
Solution Approach 1:
The patent focuses on analyzing specific parameters of cfDNA in the perfusion fluid, such as fragmentation patterns, molecular weight distributions, and concentration levels. By targeting these specific molecular parameters rather than performing comprehensive genomic analysis, the system achieves precise outcome prediction while managing analytical complexity.
Data Source
AI summary
Systems and methods are provided herein for preparing a non-naturally-occurring preparation of DNA from perfusion fluid or flush, the preparation being useful for assessing transplantation outcomes of a donor organ or donor tissue which was perfused with the perfusion fluid or prepared for transplantation with flush. The preparation may also be useful for evaluating quality of the organ or tissue. Analysis of the DNA may be used to make clinical decisions. Analysis of the DNA may also be used for adaptive control of a mechanical perfusion system used for preserving the organ or tissue, by generating and executing appropriate parameter adjustments based on characteristics of the sampled DNA.