Peritoneal Dialysis Patient-Line Filter With Selective Drain Bypass
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Solution Overview
Problem
Existing medical fluid delivery systems, particularly in peritoneal dialysis, face challenges in ensuring the quality and purity of treatment fluids prepared online or at the point of use, with potential contamination risks during tubing connections and fluid preparation.
Innovation Solution
A system with a cycler and water purifier, featuring a control unit, a disposable set with a pumping cassette, and a sterilizing filter in the patient line that filters fresh fluid through a membrane while bypassing used fluid to prevent contamination, ensuring sterile treatment fluid delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a filter is placed in the patient line to ensure fluid purity, then fluid purity is improved, but the risk of filter clogging and treatment interruption increases
Solution Approach 1:
The patient line is segmented into two separate pathways: a first pathway with a filter for fresh fluid infusion, and a second pathway without a filter for used fluid drainage. This segmentation allows each pathway to be optimized for its specific function, preventing cross-contamination and filter clogging while maintaining fluid purity where needed.
Solution Approach 2:
A three-way cock is introduced as an intermediary device that controls fluid direction between the two pathways. It mediates between the filtered fresh fluid pathway and the unfiltered used fluid pathway, enabling selective connection to the patient based on treatment phase while preventing improper fluid routing that could cause filter clogging.
2Device complexity
If the same patient line is used for both fresh fluid infusion and used fluid drainage, then device complexity is reduced, but contamination risk increases
Solution Approach 1:
The single patient line is divided into two functionally separate pathways: one dedicated to fresh fluid infusion with filtering, and another dedicated to used fluid drainage without filtering. This segmentation eliminates cross-contamination risks while maintaining relatively simple device architecture through the use of a single integrated patient line component.
Solution Approach 2:
The three-way cock acts as an intermediary that enables the single patient line to serve two separate functions at different times. It prevents direct mixing of fresh and used fluids by controlling which pathway is active, thereby reducing contamination risk without requiring completely separate physical lines.
3Reliability
If fresh fluid is filtered through a membrane but used fluid bypasses the filter, then fluid purity is maintained, but device complexity increases
Solution Approach 1:
The filter assembly is segmented into two distinct flow pathways within a single housing: a first pathway that routes fresh fluid through the sterilizing filter membrane, and a second pathway that provides a bypass for used fluid drainage. This segmentation achieves sterile fluid delivery while containing the complexity within a compact, integrated filter unit.
Solution Approach 2:
The three-way cock serves as an intermediary control mechanism that directs fluid flow through the appropriate pathway based on treatment phase. It coordinates between the filtered infusion pathway and the bypass drainage pathway, enabling the system to maintain sterility during infusion while allowing unfiltered drainage without requiring separate filter assemblies.
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 system effectively filters contaminants from treatment fluids, maintaining fluid purity and safety by filtering fresh fluid through a membrane while bypassing used fluid, reducing the risk of reinfusion of contaminants.
Implementation Method 1
a filter having a membrane configured to filter the treatment fluid, the filter configured such that (i) fresh treatment fluid flowing from the pumping portion towards a patient flows through the membrane and (ii) used treatment fluid flowing through the filter from the patient to the pumping portion bypasses the membrane
Data Source
AI summary
A medical fluid treatment system includes a source of purified water; at least one concentrate for mixing with the water from the source to form a treatment fluid; a disposable set including a pumping portion, a concentrate line in fluid communication with the concentrate source and the pumping portion, and a patient line in fluid communication with the pumping portion, the patient line including a filter having a membrane configured to filter the treatment fluid, the filter configured such that (i) fresh treatment fluid flowing from the pumping portion towards a patient flows through the membrane and (ii) used treatment fluid flowing through the filter from the patient to the pumping portion bypasses the membrane; and a medical fluid delivery machine including a pump actuator operable with the pumping portion of the disposable set.