Intradialytic Sodium Thiosulfate Delivery Through Spiked Dialysate
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Solution Overview
Problem
Existing methods fail to maintain physiological levels of thiosulfate in patients undergoing hemodialysis, leading to increased risks of atherosclerosis, myocardial infarction, sudden cardiac death, stroke, cardiovascular disease, high blood pressure, pulmonary hypertension, and renal hypertension, as thiosulfate is rapidly removed during dialysis.
Innovation Solution
Intradialytic administration of sodium thiosulfate through a dialyzer membrane using a thiosulfate-spiked dialysate with a pH greater than 7.0, prepared by adding an aqueous solution of sodium thiosulfate to a mixture of water, acid concentrate, and bicarbonate concentrate before reaching the dialyzer membrane.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hemodialysis is performed to remove waste products from blood, then waste excretion is improved, but thiosulfate levels in blood are reduced
Solution Approach 1:
The patent uses the dialysate as an intermediary medium to achieve dual objectives: the dialysate facilitates waste removal from blood while simultaneously serving as a vehicle to deliver thiosulfate to the patient. By adding thiosulfate to the dialysate solution, the system transforms the dialysate from a purely filtrative medium into a therapeutic delivery vehicle, resolving the contradiction between waste removal and thiosulfate maintenance
Solution Approach 2:
The patent changes the chemical composition parameter of the dialysate by adding thiosulfate to it. This parameter change allows the dialysate to perform dual functions: maintaining its primary role in waste removal while acquiring the additional function of thiosulfate delivery. The pH adjustment to greater than 7.0 is also a parameter change that optimizes thiosulfate stability and efficacy
2Quantity of substance
If sodium thiosulfate is added to dialysate to maintain physiological levels, then thiosulfate maintenance is improved, but dialysate composition complexity increases
Solution Approach 1:
The patent merges the waste removal function and thiosulfate delivery function into a single integrated process. By combining thiosulfate addition with the existing dialysate preparation流程, the system eliminates the need for separate thiosulfate administration equipment and procedures. The thiosulfate is incorporated into the dialysate mixing process, thereby reducing overall system complexity despite the added chemical component
3Reliability
If thiosulfate is administered during hemodialysis to prevent cardiovascular diseases, then patient safety is improved, but treatment protocol complexity increases
Solution Approach 1:
The patent implements preliminary action by adding thiosulfate to the dialysate before the hemodialysis treatment begins. This advance preparation ensures that thiosulfate is already present in the dialysate solution, eliminating the need for complex intravenous administration protocols during the procedure. The thiosulfate is pre-mixed into the dialysate at a concentration that will achieve therapeutic levels during treatment
Solution Approach 2:
The dialysis machine itself performs the thiosulfate administration function by incorporating it into the dialysate delivery system. The machine automatically controls the dosing through the dialysate flow, eliminating the need for separate manual administration procedures. This self-service approach integrates safety monitoring and delivery into the existing hemodialysis equipment and protocol
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
Maintains physiological levels of thiosulfate, preventing atherosclerosis, myocardial infarction, sudden cardiac death, stroke, cardiovascular disease, high blood pressure, pulmonary hypertension, and renal hypertension by effectively administering sodium thiosulfate during hemodialysis.
Implementation Method 1
Dialysis is defined as the movement of solutes and water between two liquids that are separated by a semipermeable 'dialyzer membrane.' The concentrations of solutes that are present in these two liquids equilibrate as osmotic forces push them out of the high concentration liquid, through the dialyzer membrane pores, and into the low concentration liquid.
Implementation Method 2
Dialyzer membranes are designed with different pore sizes to limit the solutes that can pass through during hemodialysis.
Implementation Method 3
The concentrations of solutes that are present in these two liquids equilibrate as osmotic forces push them out of the high concentration liquid, through the dialyzer membrane pores, and into the low concentration liquid.
Data Source
AI summary
Provided herein are methods for maintaining physiological levels of thiosulfate in a subject undergoing hemodialysis. Also provided herein are methods of administering pharmaceutically acceptable sodium thiosulfate to a subject undergoing hemodialysis.