Normothermic Tissue Perfusion Loop for Viability Assessment
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Solution Overview
Problem
Current methods for tissue transplantation face challenges such as high discard rates due to flawed tissue screening, cold storage-induced injury, and inefficient assessment of tissue health, leading to delayed graft function and reduced long-term graft survival rates.
Innovation Solution
A system for tissue perfusion that includes a fluid reservoir, pumps, valves, and a controller to maintain and assess tissue health, utilizing normothermic/subnormothermic perfusion with onboard sensors to monitor vital characteristics like glucose and pH, and provide real-time data for tissue rehabilitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If cold storage is used for tissue transport, then logistical effectiveness is improved, but tissue injury increases
Solution Approach 1:
The system changes the temperature parameter from cold storage (4°C) to normothermic conditions (37°C) during transport, eliminating cold-induced tissue injury while maintaining logistical effectiveness through controlled metabolic activity and real-time monitoring
Solution Approach 2:
The system converts the previously harmful cold storage condition into a beneficial normothermic environment where metabolic activity can be monitored and optimized, transforming a harmful process into a therapeutic one that maintains tissue viability
2Device complexity
If traditional tissue screening is used, then assessment is simplified, but discard rate increases
Solution Approach 1:
The system replaces subjective visual inspection and donor scoring with objective sensor-based measurements of metabolic parameters (glucose consumption, oxygen consumption, lactate production), providing quantitative data that reduces biased decision-making and improves tissue utilization
Solution Approach 2:
The system implements real-time feedback through continuous monitoring of metabolic parameters during perfusion, allowing dynamic adjustment of perfusate composition and flow rates to optimize tissue health and provide accurate viability assessment before transplantation
3Productivity
If donor scoring is used for tissue assessment, then evaluation is streamlined, but real-time tissue health measurement is lost
Solution Approach 1:
The system replaces the human-based donor scoring system with automated sensor arrays that continuously measure metabolic parameters (glucose, oxygen, lactate, pH), providing objective real-time data that eliminates subjectivity and improves measurement precision
Solution Approach 2:
The system introduces metabolic parameters as intermediary measurements that objectively reflect tissue health status, serving as a bridge between donor characteristics and transplant outcomes, allowing quantitative assessment independent of donor scoring biases
4Ease of operation
If incremental portions of supportive tissue are cut during connection and reconnection, then transplantation facilitation is improved, but supportive tissue availability decreases
Solution Approach 1:
The system performs preliminary assessment and optimization of tissue health during the transport and holding period before transplantation, ensuring maximum viability and reducing the need for extensive surgical manipulation and reconnection of supportive tissues
Solution Approach 2:
The perfusion system is designed to maintain multiple functions simultaneously: metabolic support, waste removal, drug delivery, and real-time assessment, reducing the need for separate interventions that would require additional cutting and reconnection of supportive tissues
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 system enables effective tissue maintenance and assessment, reducing discard rates by providing quantitative measures of tissue health, optimizing tissue performance, and enabling ex vivo treatment, thereby improving transplant success rates.
Implementation Method 1
A system for tissue perfusion that includes a fluid reservoir, pumps, valves, and a controller to maintain and assess tissue health, utilizing normothermic/subnormothermic perfusion
Implementation Method 2
utilizing normothermic/subnormothermic perfusion with onboard sensors to monitor vital characteristics like glucose and pH, and provide real-time data for tissue rehabilitation
Implementation Method 3
utilizing normothermic/subnormothermic perfusion with onboard sensors to monitor vital characteristics
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
A perfusion loop for maintaining a tissue to be transplanted, comprising: a fluid reservoir having a tissue platform therein to support said tissue to be transplanted. The fluid reservoir containing fluids associated with perfusion of said tissue to be transplanted. A first end of the perfusion loop operably coupled to an artery of said tissue to be transplanted and a second end of the perfusion loop operably coupled to said fluid reservoir; and a means operably coupled to said perfusion loop between said first and second ends for circulating said fluids from said fluid reservoir to said tissue to be transplanted.