Biocompatible Peritoneal Dialysate pH Control
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Solution Overview
Problem
Current peritoneal dialysates with a pH of 5.0 to 5.5 compromise immune defense mechanisms, increase the risk of peritonitis, and lead to glucose decomposition, affecting the stability and biocompatibility of icodextrin-based solutions during storage and use.
Innovation Solution
A 2-liquid type peritoneal dialysate system with a sterilized acidic first solution containing icodextrin and an alkaline second solution, mixed just before use, achieving a pH of 6.0 to 7.5, which suppresses glucose decomposition products and enhances biocompatibility by avoiding pH adjusters like lactic acid in the first solution and using pH adjusters like sodium lactate in the second solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the pH of peritoneal dialysate is increased to physiological range (6.0-7.5), then biocompatibility is improved, but icodextrin decomposition and coloration occur during storage
Solution Approach 1:
The dialysate is divided into two separate solutions: an acidic first solution containing icodextrin (pH 3.0-5.0) for stability, and a second solution containing pH adjusters (sodium hydroxide, potassium hydroxide, or calcium hydroxide) for alkalinity. These solutions are mixed immediately before use to achieve physiological pH (6.0-7.5), thus preventing icodextrin decomposition during storage while ensuring biocompatibility during treatment.
Solution Approach 2:
The pH adjuster components are pre-prepared in a separate second solution, ready to be mixed with the first solution containing icodextrin. This preliminary preparation allows the icodextrin to remain in a stable acidic environment during storage, while the alkaline components are ready to neutralize and raise the pH to physiological levels immediately before administration, preventing decomposition during storage.
2Ease of manufacture
If pH adjusters like lactic acid are added to the first solution containing icodextrin, then pH control is simplified, but glucose decomposition products increase during heating sterilization
Solution Approach 1:
The pH adjuster components (sodium hydroxide, potassium hydroxide, or calcium hydroxide) are extracted from the first solution containing icodextrin and placed in a separate second solution. This separation eliminates the harmful interaction between lactic acid and icodextrin during heating sterilization, preventing the formation of glucose decomposition products like 5-HMF and 3-DG, while still allowing pH control when the solutions are mixed before use.
3Stability of the object's composition
If pH is maintained at 5.0-5.5 to prevent icodextrin decomposition, then stability is improved, but immune defense mechanism is reduced and peritonitis risk increases
Solution Approach 1:
The system transitions from a static low pH environment (5.0-5.5) to a dynamic pH system where the solution starts acidic for stability during storage, then dynamically adjusts to physiological pH (6.0-7.5) when the second solution containing pH adjusters is mixed in immediately before use. This dynamic pH change ensures icodextrin stability during storage while protecting immune function during treatment.
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 solution stabilizes icodextrin during heating sterilization and storage, maintains physiological pH, and reduces biomarker expression for fibrosis, angiogenesis, and epithelial mesenchymal transition, ensuring excellent biocompatibility and safety of the peritoneal dialysate.
Implementation Method 1
a sterilized biocompatible peritoneal dialysate composed of an acidic first solution containing icodextrin and a second solution containing a pH adjuster, in which the pH after mixing of the sterilized first solution with the sterilized second solution is 6.0 to 7.5
Implementation Method 2
The icodextrin mainly acts as a colloid osmotic substance and can obtain the water removal effect while maintaining an osmotic pressure with blood plasma
Data Source
AI summary
A biocompatible peritoneal dialysate according to the present invention is a sterilized biocompatible peritoneal dialysate composed of an acidic first solution containing icodextrin and a second solution containing a pH adjuster, wherein the pH after mixing of the sterilized first solution with the sterilized second solution is 6.0 to 7.5.