Sterile Dialysate Concentrate Interface With Spring-Loaded Needle
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Solution Overview
Problem
Traditional peritoneal dialysis systems require batch preparation of terminally sterilized fluid and numerous fluid connections, making home treatment difficult and increasing the risk of infection.
Innovation Solution
A peritoneal dialysis system that includes a water purification system connected to a disposable source of dialysate concentrates via a sterile interface connection, using a spring-loaded needle and disinfectant plug to sterilize and seal the connection, minimizing fluid connections and reducing the risk of infection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional peritoneal dialysis systems use batch preparation of terminally sterilized fluid, then the fluid can be sterilized effectively, but the setup becomes complex and difficult for home treatment
Solution Approach 1:
The dialysate concentrates are pre-sterilized in the disposable source before use. The chamber is pre-sterilized and the spring-loaded needle is pre-positioned, eliminating the need for batch preparation and terminal sterilization at the point of use. This preliminary action simplifies the setup while maintaining sterilization effectiveness.
Solution Approach 2:
The sterilization process is extracted from the point-of-use setup and performed in advance during manufacturing. The disposable source contains pre-sterilized concentrates, and the chamber is pre-sterilized, removing the complex terminal sterilization step from the patient's home setup procedure.
2Object-affected harmful factors
If traditional peritoneal dialysis systems require numerous fluid connections, then fluid can be properly managed, but the risk of infection increases and setup becomes difficult
Solution Approach 1:
Multiple fluid connections are merged into a single integrated interface. The disposable source connects to the chamber through a single sterile interface, which then connects to the peritoneal catheter. This consolidation reduces the number of connection points and minimizes infection risk while simplifying setup.
Solution Approach 2:
The chamber acts as an intermediary component that consolidates multiple fluid pathways. It receives concentrates from the disposable source through a single sterile interface and distributes them to the peritoneal catheter, reducing the number of direct connections and minimizing infection risks.
3Extent of automation
If a spring-loaded needle is used to connect water purification system to disposable source, then the connection is automated and sealed, but the device structure becomes more complex
Solution Approach 1:
The spring-loaded needle automatically extends and retracts based on pressure differentials and mechanical triggers during the dialysis cycle. The needle self-extends to connect with the disposable source and self-retracts when not in use, eliminating manual connection steps while maintaining a relatively simple overall structure.
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
Enables real-time preparation of sterile dialysis solution, simplifying setup and reducing physical effort for patients, while minimizing infection risk through automated mixing and monitoring, thus enhancing the safety and efficiency of peritoneal dialysis.
Implementation Method 1
a spring-loaded needle disposed in the chamber, a proximal end of the spring-loaded needle being connected to the inlet
Implementation Method 2
a disinfectant plug adjacent to the alignment feature, the disinfectant plug being configured to sterilize the needle as it passes through the disinfectant plug
Implementation Method 3
a sealing septum adjacent to the disinfectant plug, the scaling septum adapted to form a seal around the needle when the needle punctures the sealing septum
Implementation Method 4
the sterile interface connection being configured to, in the retracted position, receive fluid from the water purification system via the inlet to sterilize the chamber and the spring-loaded needle
Data Source
AI summary
Described herein are systems and methods for performing peritoneal dialysis. According to one aspect, the disclosure provides a sterile interface connection for connecting a water purification system to a disposable source of dialysate concentrates. The sterile interface connection can include a chamber comprising an inlet adapted to be connected to the water purification system on a proximal end and a valve on a distal end. The sterile interface connection can also include spring-loaded needle disposed in the chamber. The spring-loaded needle can move between a retracted configuration in which the spring-loaded needle is fully retracted into the chamber and the valve is closed and sealed, and an extended configuration in which the spring-loaded needle extends through the valve into the disposable source of dialysate concentrates.