Dialysis Filter Integrity 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 substantial setup time, and incur high costs due to daily replacement of disposable sets, which also occupy storage space and necessitate daily effort by patients or caregivers.
Innovation Solution
An automated peritoneal dialysis system with a PD machine that delivers heated PD fluid through a dual lumen patient line to a disposable filter set, which includes a hydrophilic filter membrane, and performs pressure integrity and drop tests to ensure filter functionality before and during treatment, allowing reuse of internal lines and filter sets after disinfection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If disposable sets are replaced daily, then patient safety and hygiene are improved, but waste generation increases and costs rise
Solution Approach 1:
The system divides the disposable set into separable components: the filter can be detached and reused, while other parts are discarded. This allows selective replacement of only the necessary components rather than the entire set, reducing waste while maintaining safety.
Solution Approach 2:
The filter is designed to be recoverable and reusable after a single use. The system enables recovery of the filter from the disposable set and its reuse in subsequent treatments, transforming a single-use component into a reusable one, thereby reducing waste generation.
2Reliability
If disposable sets are replaced daily, then hygiene is improved, but setup time and patient effort increase
Solution Approach 1:
The filter is pre-packaged in sterile condition within the disposable set, allowing it to be quickly removed and reused without requiring sterilization preparation. This preliminary sterile packaging enables rapid setup for subsequent uses, reducing patient effort and setup time.
3Reliability
If disposable sets are replaced daily, then contamination risk is reduced, but storage space requirements increase
Solution Approach 1:
By recovering and reusing the filter instead of discarding it daily, the system dramatically reduces the number of disposable sets that need to be stored at home. Patients only need to store enough disposable sets for initial setup and occasional replacement, rather than maintaining a large inventory for daily use.
4Reliability
If filter integrity is tested, then treatment safety is improved, but treatment time increases
Solution Approach 1:
The integrity test is automatically performed as part of the treatment initiation sequence before patient connection. This preliminary testing ensures filter integrity is verified before actual treatment begins, maintaining safety without adding significant time to the therapeutic portion of the treatment.
Solution Approach 2:
The system automatically monitors pressure differential across the filter during treatment and provides real-time feedback on filter integrity. This continuous monitoring detects potential issues without requiring manual intervention or extending treatment time, ensuring safety through automated surveillance.
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 ensuring filter integrity and reusing system components, thereby enhancing the efficiency and convenience of dialysis treatments.
Implementation Method 1
a disposable filter set, which includes a hydrophilic filter membrane
Implementation Method 2
control unit causes a pressure integrity test or a pressure drop test to be performed on the filter membrane
Implementation Method 3
The PD machine is capable of delivering fresh, heated PD fluid to the patient
Data Source
Figure 1
Figure 2
Figure 3~7
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.