Direct Sodium Removal Infusate Gradient for Heart Failure Fluid Overload
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Solution Overview
Problem
Conventional dialysis techniques fail to effectively reduce fluid overload in patients with heart failure and renal dysfunction while maintaining stable serum sodium levels, often leading to symptomatic drops in blood pressure, dialysis disequilibrium syndrome, and chronic high sodium and fluid retention.
Innovation Solution
The use of low or no sodium dextrose infusates or small volume infusates containing dextrose and icodextrin, administered into the peritoneal cavity, which create a steep sodium gradient for removal, allowing for significant sodium and fluid extraction without disrupting serum sodium levels, potentially reducing the need for loop diuretics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional dialysis techniques are used to remove excess fluid, then fluid overload is reduced, but serum sodium levels become unstable and blood pressure drops
Solution Approach 1:
The patent changes the sodium concentration parameter of the dialysate from conventional levels (132 mMol/L) to low or zero sodium levels. This parameter change enables the dialysate to create a steep concentration gradient that drives sodium diffusion from blood to dialysate, removing excess sodium and fluid while maintaining stable serum sodium levels through controlled gradient-driven transport
Solution Approach 2:
The patent uses low or zero sodium dialysate as an intermediary medium that facilitates sodium removal. The dialysate acts as a mediator by providing a low sodium environment that enables passive diffusion of sodium from the blood across the peritoneal membrane, thereby removing excess sodium and fluid without causing destabilizing effects on serum sodium levels
2Quantity of substance
If low sodium dialysate is used to remove sodium, then sodium removal is enhanced, but dialysis disequilibrium syndrome and cerebral edema occur
Solution Approach 1:
The patent applies partial action by using low or zero sodium dialysate for only portions of the dialysis treatment sessions rather than continuously. This allows sodium removal to be enhanced during specific intervals while giving the body time to equilibrate between sessions, thereby reducing the risk of dialysis disequilibrium syndrome and cerebral edema while still achieving effective sodium removal
Solution Approach 2:
The patent implements periodic action by alternating between low/zero sodium dialysate sessions and conventional sodium dialysate sessions. This periodic approach allows the body to adapt to sodium removal during low sodium sessions while recovering and equilibrating during conventional sessions, thereby enhancing overall sodium removal while minimizing harmful effects like dialysis disequilibrium syndrome
3Stability of the object's composition
If high sodium dialysate is used to maintain serum sodium levels, then sodium retention occurs, but fluid consumption increases and hypertension develops
Solution Approach 1:
The patent changes the sodium concentration parameter of the dialysate to low or zero levels, which reverses the traditional approach. This parameter change creates a concentration gradient that drives sodium diffusion from blood to dialysate, enabling the removal of both excess sodium and associated fluid, thereby reducing fluid retention and hypertension while maintaining stable serum sodium levels through controlled gradient-driven transport
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
This method achieves substantial and durable reduction in fluid overload, maintains stable serum sodium levels, and improves cardiovascular and renal health parameters, reducing the reliance on loop diuretics and enhancing the efficacy of conventional dialysis sessions.
Implementation Method 1
inducing fluid to migrate from the patient's body into the peritoneal cavity, from where it is eliminated
Implementation Method 2
diffusion of sodium ions down a steep concentration gradient between the infusate instilled into patient's peritoneal cavity and surrounding tissues and vessels
Data Source
AI summary
Direct sodium removal (“DSR”) therapy methods are provided for removing sodium and reducing fluid overload in patients with renal failure or heart failure, in which a patient has at least first and second DSR treatments with an infusate comprising 15-40 wt % icodextrin and up to 15 wt % dextrose that is instilled into a patient's peritoneal cavity for dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, after which the infusate, sodium and ultrafiltrate is removed from the peritoneal cavity.