Low-Sodium Peritoneal Infusate Regimen for Direct Sodium Removal
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Solution Overview
Problem
Existing dialysis techniques fail to effectively remove sodium and fluid overload in patients with severe renal dysfunction, leading to complications such as hyponatremia and fluid retention, while maintaining stable serum sodium levels.
Innovation Solution
A regimen of low or no sodium infusates with varying osmolality and composition is administered sequentially to the peritoneal cavity, followed by conventional dialysis sessions, using an implantable pump to transfer excess fluid to the bladder, thereby managing fluid and sodium balance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional dialysis techniques are used, then dialysis sessions are performed regularly, but sodium and fluid overload are not effectively removed leading to hyponatremia and fluid retention
Solution Approach 1:
The patent changes the sodium concentration parameter of the dialysate from conventional levels (typically 130-140 mEq/L) to low or zero sodium levels. This parameter change enables effective sodium removal from patients with severe renal dysfunction while avoiding the complications of conventional dialysis, as the low sodium dialysate creates a gradient that promotes sodium diffusion from blood to dialysate without causing hyponatremia
Solution Approach 2:
The patent employs dynamic adjustment of dialysate sodium concentration based on patient response and serum sodium levels. The sodium-free or low-sodium dialysate regimen can be modified sequentially, and the treatment protocol adapts to individual patient needs, allowing effective sodium removal while maintaining safety margins against hyponatremia
2Quantity of substance
If low or zero sodium dialysate is used, then sodium removal is enhanced, but symptomatic drops in blood pressure and dialysis disequilibrium syndrome may occur
Solution Approach 1:
The patent incorporates monitoring and feedback mechanisms to detect early signs of blood pressure drops and dialysis disequilibrium syndrome. Serum sodium levels, blood pressure, and clinical symptoms are monitored during treatment, allowing及时调整 of the dialysis protocol to prevent severe complications while maintaining effective sodium removal
Solution Approach 2:
The patent uses low or zero sodium dialysate at controlled concentrations and volumes, applying partial action rather than extreme measures. The dialysate sodium concentration is kept low but not necessarily zero in all cases, and treatment duration and frequency are adjusted to achieve sufficient sodium removal without overwhelming the patient's physiological compensatory mechanisms
3Productivity
If patients with severe renal dysfunction undergo conventional dialysis, then regular dialysis sessions are performed, but fluid overload and sodium accumulation persist
Solution Approach 1:
The patent changes the osmolality parameter of the dialysate by using low or zero sodium formulations. This creates an osmotic gradient that enhances ultrafiltration and promotes fluid removal from the patient's body. The altered dialysate composition enables more effective fluid and sodium elimination during each dialysis session, addressing the persistent fluid overload problem in severe renal dysfunction
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 method effectively reduces fluid and sodium overload, stabilizes serum sodium levels, improves renal function, and enhances the efficacy of loop diuretics, allowing patients to maintain a healthier fluid balance and reduce the need for diuretic drugs.
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
A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.