Peritoneal Dialysis Fluid Mixing With Sterile Filtration
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Solution Overview
Problem
Existing dialysis machines in clinics are underutilized during off-peak hours, and there is a need for a system that can efficiently produce high-quality dialysis fluids, such as peritoneal dialysis (PD) fluid, closer to the point of use to reduce patient travel and manage increased demand.
Innovation Solution
A tubing set and assembly that utilizes an in-center hemodialysis machine to produce PD fluid by mixing purified water with concentrates, incorporating sterile sterilizing grade filters, and using pressure transmission and volumetric controls to ensure quality and completeness, with optional component solution storage for later mixing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If dialysis machines are used during off-peak hours to produce PD fluid, then productivity is improved by utilizing underutilized resources, but device complexity increases due to the need for additional control systems and filtration components
Solution Approach 1:
The hemodialysis machine is adapted to perform multiple functions: its existing water purification system produces purified water that can be used for both hemodialysis treatments and for generating peritoneal dialysis fluid. The machine's pump system, mixing chambers, and delivery mechanisms are utilized to mix purified water with PD concentrates and deliver the final PD fluid through sterile filters to storage containers or directly to patients during off-peak hours.
Solution Approach 2:
A sterile sterilizing grade filter acts as an intermediary component between the fluid mixing system and the final PD fluid output. This filter ensures that the mixed PD fluid is sterilized before being delivered to storage containers or patients, enabling the use of standard hemodialysis machine components for PD fluid generation while maintaining the required sterility standards.
2Loss of time
If PD fluid is produced closer to the point of use, then loss of time is reduced by eliminating patient travel to clinics, but manufacturing precision requirements increase to ensure proper mixing ratios and sterility
Solution Approach 1:
The system incorporates sensors and control mechanisms that monitor the mixing process of purified water and PD concentrates. The hemodialysis machine's existing control system tracks the volumes of each component being mixed, ensuring precise formulation of the PD fluid according to prescribed concentrations. This feedback control ensures consistent quality and sterility of the produced PD fluid.
3Productivity
If substitution fluid is delivered directly to the extracorporeal circuit during hemofiltration, then productivity of waste removal is improved through convective transport, but object-generated harmful factors increase due to potential contamination risks
Solution Approach 1:
A sterile sterilizing grade filter is positioned in the fluid path to act as an intermediary barrier between the substitution fluid reservoir and the extracorporeal circuit. This filter prevents potential contamination from the reservoir or tubing while allowing the substitution fluid to pass through and deliver convective clearance of middle and large molecules from the patient's blood during hemofiltration treatment.
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 the production of high-quality dialysis fluids efficiently, reducing the need for patient travel and managing fluid demand by producing fresh dialysis fluids near the point of use, minimizing resource impact and storage requirements.
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
Hemodiafiltration ('HDF') is a treatment modality that combines convective and diffusive clearances. HDF uses dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance.
Implementation Method 4
Waste, toxins and excess water pass from the patient's bloodstream, through the capillaries in the peritoneal membrane, and into the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. An osmotic agent in the PD dialysis fluid provides the osmotic gradient.
Data Source
Figure 1A~1B
Figure 1C
Figure 2
AI summary
A peritoneal dialysis fluid generation system including water purification equipment configured to provide purified water; a presterilized tubing set including a container for storing peritoneal dialysis fluid; at least one glucose or buffer concentrate; and a hemodialysis machine in fluid communication with the water purification equipment, the hemodialysis machine including at least one mixing pump for mixing the at least one glucose or buffer concentrate with the purified water to form peritoneal dialysis fluid, a dialysis fluid pump for delivering the peritoneal dialysis fluid to the container, and a control unit configured to control the at least one mixing pump to form the peritoneal dialysis fluid and the dialysis fluid pump to deliver the peritoneal dialysis fluid to the container.