Organ Perfusion Solution Composition for Extended Donor Preservation
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Solution Overview
Problem
Current preservation solutions are not designed for perfusion and fail to effectively prolong the viability of donor organs, particularly hearts from deceased cardiac donors, due to issues such as viscosity, incomplete perfusion, and toxicity, limiting the time available for transplantation.
Innovation Solution
A sterile aqueous perfusion solution with specific ion concentrations and additives, including sodium, potassium, magnesium, TRIS, aspartate, bicarbonate, insulin, and reduced glutathione, is used to perfuse donor organs, maintaining cellular integrity and minimizing ischemic damage, with a pH adjusted to 7.4 and oxygenation, and is provided in a kit form for ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional preservation solutions are used, then organ preservation is achieved, but the solutions are not designed for perfusion leading to incomplete perfusion and toxicity
Solution Approach 1:
The patent modifies the chemical composition parameters of preservation solutions by incorporating specific perfusion agents (albumin, fibrinogen, clotting factors) and adjusting osmolarity, pH, and ion concentrations to enable effective perfusion while maintaining preservation benefits
Solution Approach 2:
The invention creates composite preservation solutions by combining multiple components including perfusion agents, buffers, electrolytes, and antioxidants in specific concentrations to achieve both perfusion capability and organ preservation
2Duration of action of stationary object
If hypothermic preservation is used, then organ viability is extended, but the time limit is restricted to 4 hours
Solution Approach 1:
The patent implements continuous perfusion throughout the preservation period, replacing the discontinuous nature of simple cold storage with ongoing blood flow and metabolic support that extends organ viability beyond the traditional 4-hour limit
Solution Approach 2:
The invention changes temperature parameters by implementing normothermic or mild hypothermic perfusion (37°C or slightly below) rather than deep hypothermia, allowing extended preservation time while maintaining cellular function and reducing ischemic damage
3Reliability
If warm perfusion with blood is used, then organ viability is improved, but blood incompatibility reactions and complications occur
Solution Approach 1:
The patent extracts the essential perfusion function from whole blood by using plasma substitutes or blood products without red cells, eliminating ABO incompatibility issues while retaining the beneficial effects of perfusion and oxygen delivery
Solution Approach 2:
The invention introduces intermediary substances such as albumin-based solutions, fibrinogen, and clotting factors that mediate the perfusion process without requiring donor-recipient blood type compatibility, acting as bridges between donor organ and recipient circulation
4Reliability
If complex perfusion devices are used, then perfusion capability is achieved, but the devices are bulky, heavy, and difficult to transport
Solution Approach 1:
The patent employs self-service perfusion concepts where the organ's own vascular anatomy and pressure gradients facilitate the perfusion process without requiring complex external pumping mechanisms, reducing device weight and complexity
Solution Approach 2:
The invention utilizes hydraulic principles by employing pressure-driven flow through the organ's natural vasculature, leveraging the organ's own pressure gradients and using simple external pumps rather than complex mechanical circulatory support systems
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 perfusion solution prolongs organ preservation beyond current limits, facilitates aerobic metabolism, enhances functional and metabolic recovery, allows for successful transplantation, promotes resuscitation of damaged organs, and is simple and practical for clinical application.
Implementation Method 1
facilitates aerobic metabolism
Implementation Method 2
maintaining cellular integrity
Implementation Method 3
minimizing ischemic damage
Data Source
AI summary
A perfusion stock composition, for preserving a donor organ for transplantation, comprising: a source of 60 to 100 mM Na+; a source of 10 to 20 mM K+; a source of 5 to 10 mM Mg2+; a source of 0.25 to 0.75 mM Ca2+; 10 to 40 mM Tris(hydroxymethyl)aminomethane hydrochloride (Tris or THAM), 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES), 3-(N-morpholino)propanesulfonic acid (MOPS), 2-(N-morpholino)ethanesulfonic acid (IviES), N,N-bis-(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), or N/-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid (TES); a source of 10 to 30 mM HCO3; 1 to 30 mM glucose; 1 to 20 U/L insulin; 1 to 10 mM fructose diphosphate or a salt thereof; 1 to 40 mM aspartate or glutamate; 1 to 10 mM adenosine, cAMP or cGMP; 1 to 10 mM reduced glutathione; and 30 to 100 mM lactobionate or mannitol; and, optionally, a diluent. The present disclosure also provides a perfusion composition, a kit, a method, and a perfusion apparatus, each related to the perfusion stock composition.