Hydrophilic Dialysis Filter Testing for Reusable PD Sets
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Solution Overview
Problem
Existing dialysis systems, particularly automated peritoneal dialysis machines, generate significant disposable waste, require extensive setup time, and incur high costs due to daily disposable sets, posing challenges for home use.
Innovation Solution
An automated peritoneal dialysis system with a PD machine that delivers heated PD fluid through a dual lumen patient line, includes a disposable filter set for last chance filtration, and reuses internal lines with heat disinfection, incorporating pressure integrity and drop tests to ensure filter functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If daily disposable sets are used, then reliability is improved, but loss of substance worsens
Solution Approach 1:
The patent implements a reusable dialysis system where the dialyzer and internal lines are recovered and reprocessed for multiple uses. Heat disinfection recovers the functional integrity of components while eliminating the need for daily disposable sets, directly reducing disposable waste while maintaining reliability through verified filter integrity testing
Solution Approach 2:
The patent changes the operational parameters of the dialysis system by implementing heat disinfection cycles and pressure integrity testing protocols. These parameter changes enable the transition from single-use to reusable components, reducing substance loss while maintaining or improving reliability through controlled processing parameters
2Reliability
If daily disposable sets are used, then reliability is improved, but loss of time worsens
Solution Approach 1:
The patent performs preliminary actions by conducting pressure integrity tests and heat disinfection cycles before each dialysis treatment. This preliminary verification of filter integrity and component readiness eliminates time-consuming setup procedures during treatment preparation, as the reusable system is pre-validated for safety and functionality
Solution Approach 2:
The reusable dialysis system with automated heat disinfection and pressure testing capabilities performs self-verification of its own integrity, eliminating the need for extensive manual setup and checking procedures that would otherwise be required to ensure safety and functionality
3Reliability
If daily disposable sets are used, then reliability is improved, but device complexity worsens
Solution Approach 1:
The patent implements a universal reusable dialysis system where the same dialyzer and internal lines can be used for multiple treatments after heat disinfection and integrity verification. This multi-functional approach consolidates the system configuration, reducing the complexity associated with managing multiple disposable sets and their varying configurations
4Loss of substance
If disposable filter sets are reused with heat disinfection, then loss of substance is reduced, but reliability worsens
Solution Approach 1:
The patent implements feedback mechanisms through pressure integrity testing that continuously monitors and verifies filter integrity after heat disinfection and before each treatment. This feedback loop ensures that reused disposable filter sets maintain required reliability standards by detecting any degradation or damage that may have occurred during reprocessing
Solution Approach 2:
The patent applies beforehand cushioning by conducting pressure integrity tests and heat disinfection cycles prior to each treatment to pre-verify the condition of reusable components. This proactive verification cushions against potential reliability issues by identifying and addressing problems before they can affect treatment safety or effectiveness
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
Reduces disposable waste, minimizes setup time, and lowers costs by reusing components while ensuring the integrity and functionality of the hydrophilic filter, enhancing the reliability and efficiency of dialysis treatments.
Implementation Method 1
Hemodialysis (HD), which in general uses diffusion to remove waste products from a patient's blood. A diffusive gradient occurs across the semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion.
Implementation Method 2
Hemofiltration (HF) is an alternative renal replacement therapy that relies on a convective transport of toxins from the patient's blood. The substitution fluid and the fluid accumulated by the patient in between treatments is ultrafiltered over the course of the HF treatment, providing a convective transport mechanism
Implementation Method 3
A PD machine or cycler capable of delivering fresh, heated PD fluid to a patient
Implementation Method 4
control unit to cause a pressure integrity test or a pressure drop test to be performed on the hydrophilic filter
Data Source
AI summary
A peritoneal dialysis (“PD”) system includes a housing; a PD fluid pump housed by the housing; a filter set including a filter housing and a hydrophilic filter membrane dividing an upstream chamber from a downstream chamber; a dual lumen patient line including a fresh PD fluid lumen in fluid communication with the upstream chamber and a used PD fluid lumen in fluid communication with the downstream chamber; a pressure sensor positioned and arranged to provide a pressure sensor output indicative of pressure in the downstream chamber of the filter housing; and a control unit configured to perform a pressure integrity test on the hydrophilic filter membrane by monitoring the pressure sensor output over a period of time, the pressure sensor output indicative of a negative pressure created in the downstream chamber by the PD fluid pump. A pressure drop test for evaluating the filter membrane is also disclosed.