Segmented Organ Preservation Solution for Extended Shelf Life
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Solution Overview
Problem
Current tissue and organ preservation solutions, such as GALA, have limited shelf life due to instability, which affects the preservation of vascular conduits and their endothelial function, leading to graft failure.
Innovation Solution
Separating the GALA formulation into two solutions, Solution A with a pH of 7.4-8 and Solution B with a pH below 7, where Solution A includes a balanced salt solution and Solution B contains antioxidants like L-glutathione and ascorbic acid, along with L-Arginine and a sugar, maintaining zero oxygen content, to enhance stability and shelf life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If GALA preservation solution is formulated with antioxidants and reducing agents, then endothelial function is maintained, but shelf life is limited due to instability
Solution Approach 1:
The GALA solution is divided into two separate solutions: Solution A containing balanced salt solution at pH 7.4-8, and Solution B containing antioxidants (ascorbic acid, glutathione), L-Arginine, and sugar at pH 3-5. This segmentation allows Solution B to maintain stability at lower pH while Solution A provides the physiological environment needed for endothelial function, resolving the contradiction between maintaining function and extending shelf life.
Solution Approach 2:
The invention changes the pH parameter of Solution B to be below 7 (preferably 3-5), which significantly improves the stability and shelf life of antioxidants and reducing agents. When mixed with Solution A at the point of use, the final pH becomes physiological (7.2-7.4), maintaining endothelial function while achieving extended shelf life of at least two years.
2Reliability
If antioxidants and reducing agents are included in the preservation solution, then tissue viability is improved, but solution stability deteriorates
Solution Approach 1:
The solution is segmented into two separate containers: Solution A (balanced salt solution) and Solution B (containing antioxidants, reducing agents, L-Arginine, and sugar). This physical separation prevents degradation reactions that would occur in a single mixed solution, maintaining both tissue viability and solution stability.
Solution Approach 2:
Solution B is formulated at a lower pH (3-5) which stabilizes antioxidants and reducing agents against oxidation and degradation. This parameter change allows the solution to maintain its composition stability for at least two years while still providing the necessary protective agents for tissue viability when mixed with Solution A.
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 separated solutions provide a stable tissue preservation formulation with a significantly extended shelf life of at least two years, maintaining endothelial function and structural viability of vascular conduits, thereby improving graft performance and viability.
Implementation Method 1
Solution B has a pH of less than 7, preferably 5, 4 or 3, and preferably with an oxygen content at zero parts per million
Implementation Method 2
Solution B includes water, an antioxidant such as ascorbic acid, a reducing agent, in particular L-glutathione
Data Source
AI summary
Organ and tissue preservation solutions having improved stability are disclosed. The solutions are comprised of two separate solutions. The first solution, Solution A, is comprised of a balanced salt solution that is stable in solution at a pH of 7.0 or above. A second solution, Solution B, is comprised of an aqueous solution containing L-glutathione and/or cysteinylglycine, a sugar such as D-glucose, L-Arginine, a reducing agent such as ascorbic acid and water at a pH of below 7.0, preferably from about 3.0 to 5.0. The two Solutions are then mixed together at the point of use and the pH adjusted to about 7.3 resulting in the organ and tissue preservation solution having improved stability. Preferably, solution A has a pH of about 7.6 and solution B has a pH of about 5.0. The present invention is also comprised of kits 20 that contain the two Solutions in two separate containers 22, 24. In an alternate embodiment, the sugar can be in Solution A.