Point-of-Care Dialysis Fluid Preparation With Sterile Fluid Circuits
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Solution Overview
Problem
Existing peritoneal dialysis systems require pre-packaged dialysis fluid bags, limiting flexibility and increasing costs, while existing automated systems are not adaptable to different dialysis cycles without customization.
Innovation Solution
A system for preparing dialysis fluid at the point of care using a daily sterile disposable fluid circuit and long-term concentrate containers, allowing for automated preparation of dialysis fluid without requiring modifications to the dialysis cycler, ensuring compatibility with various dialysis processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pre-packaged dialysis fluid bags are used, then sterility and convenience are ensured, but flexibility and cost-effectiveness are limited
Solution Approach 1:
The system divides the dialysis fluid preparation into separate sterile components (concentrate containers and fluid circuit) that are assembled at the point of care. The concentrate containers are sterilized separately and connected to the disposable fluid circuit, allowing sterility to be maintained while enabling flexibility in preparation timing and customization of dialysis solutions.
Solution Approach 2:
The concentrate containers are pre-sterilized and stored ready for use, while the actual mixing and preparation of dialysis fluid is performed just before use at the point of care. This preliminary sterilization ensures reliability, while the on-demand preparation provides flexibility and reduces waste from pre-packaged bags.
2Reliability
If pre-packaged dialysis fluid bags are used, then sterility is ensured, but cost-effectiveness and waste reduction are compromised
Solution Approach 1:
The system allows the dialysis fluid to be prepared on-demand at the point of care using concentrate containers and a disposable fluid circuit. This self-service approach eliminates the need for pre-packaged bags, reducing waste from unused or partially used fluid while maintaining sterility through the sterile barrier system and proper connection protocols.
Solution Approach 2:
The system changes the physical state and concentration parameters by storing dialysis concentrate in a concentrated form and performing dilution at the point of care. This allows precise control over the final fluid composition and volume, reducing waste from fixed-volume pre-packaged bags while maintaining sterility through controlled mixing in a sterile disposable circuit.
3Reliability
If automated systems are customized for different dialysis cycles, then dialysis performance is optimized, but device complexity and adaptability are reduced
Solution Approach 1:
The automated dialysis system is designed with universal components that can handle different dialysis cycles and fluid preparation requirements without customization. The disposable fluid circuit and concentrate container interface are standardized, allowing the same system to perform various dialysis treatments (APD, CCPD, IPD) by simply changing the software parameters and fluid recipes, not the hardware.
Solution Approach 2:
The system uses dynamic, programmable control to adapt to different dialysis cycles. The automated fluid preparation and delivery parameters can be dynamically adjusted through software to match different treatment protocols, eliminating the need for physical customization while maintaining optimized dialysis performance for each cycle type.
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 flexible and cost-effective preparation of dialysis fluid at the point of care, ensuring compatibility with different dialysis cycles and reducing the need for pre-packaged bags, thus enhancing operational efficiency and reducing waste.
Implementation Method 1
A peristaltic pump moves water from the water source into the mixing container through a water line
Implementation Method 2
The peristaltic pump moves concentrate from the concentrate source into the mixing container through a concentrate line
Implementation Method 3
automated mixing in a mixing container
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
A system for preparing a medicament for use by a medicament user includes a proportioning machine with a controller and pumping and clamping actuators to engage a fluid circuit having pumping and clamping portions that engage with respective actuators of the proportioning machine. The fluid circuit includes a mixing container that is initially empty and later filled with a concentrated medicament from a concentrate container. The proportioning machine is configured to receive purified water and to mix it with the concentrated medicament to produce a medicament and to output the medicament to a medicament consumer in such a way that to the medicament consumer the medicament appears to be provided from a bag of medicament.