THAM Buffer Cardioplegic Solution Heat Sterilization Stability
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Solution Overview
Problem
Current cardioplegic solutions, such as the del Nido solution, face challenges with short shelf life and particulate matter formation due to heat sterilization, limiting their commercialization and requiring manual mixing, which introduces human error and stability issues.
Innovation Solution
Replacing sodium bicarbonate in the del Nido solution with tris(hydroxymethyl)aminomethane (THAM) prevents particulate matter formation during heat sterilization and maintains pH and osmolality stability for up to 365 days, allowing for a ready-made, off-the-shelf cardioplegic solution with reduced preparation risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If del Nido solution is heat sterilized, then it achieves commercialization readiness, but particulate matter forms and shelf life is limited
Solution Approach 1:
The patent modifies the chemical composition parameters of the cardioplegic solution by replacing sodium bicarbonate with THAM (tris(hydroxymethyl)aminomethane) as the buffering agent. This parameter change prevents particulate matter formation during heat sterilization while maintaining solution stability for up to 365 days shelf life, resolving the contradiction between commercialization readiness and compositional stability.
2Adaptability or versatility
If manual mixing is used to prepare cardioplegic solution, then customization is possible, but human error and stability issues increase
Solution Approach 1:
The patent applies preliminary action by pre-formulating the cardioplegic solution with optimized concentrations of all components including THAM, mannitol, magnesium sulfate, and other electrolytes in a ready-made stable composition. This eliminates the need for manual mixing at the point of use, preventing human error while maintaining the ability to select from different pre-formulated solutions for specific surgical needs.
3Stability of the object's composition
If sodium bicarbonate is used in cardioplegic solution, then buffering capacity is provided, but particulate matter forms during heat sterilization
Solution Approach 1:
The patent extracts and removes sodium bicarbonate from the cardioplegic solution formulation. By taking out this problematic component, the solution no longer forms particulate matter during heat sterilization. The buffering function is then provided by THAM, which does not exhibit the harmful precipitate formation behavior of sodium bicarbonate when exposed to heat sterilization conditions.
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 cardioplegic solution with THAM demonstrates improved stability and effectiveness in preserving heart functions, reducing cell apoptosis and maintaining critical ion levels, making it suitable for commercialization and minimizing human error in preparation.
Implementation Method 1
Replacing sodium bicarbonate in the del Nido solution with tris(hydroxymethyl)aminomethane (THAM) prevents particulate matter formation during heat sterilization and maintains pH and osmolality stability for up to 365 days
Implementation Method 2
sterilization by heating results in precipitates or particulate matter
Data Source
AI summary
The present invention is a cardioplegic solution that demonstrates better stability in pH, particulate matter formation and osmolality but at the same time demonstrates superior ability to preserve heart functions than currently available cardioplegic solutions. The cardioplegic solution comprises potassium (K+), magnesium (Mg2+), sodium (Na+), chloride (Cl−), gluconate, acetate, sulfate (SO42−), THAM and mannitol dissolved in water.