Multi-Chamber PD Solution Container Reducing Glucose Degradation
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Solution Overview
Problem
Commercially available peritoneal dialysis solutions contain glucose degradation products (GDPs) that can damage the peritoneal wall and affect proteins in the body, and existing methods to reduce these products are not effective in maintaining physiologically optimal concentrations and pH levels during storage and sterilization.
Innovation Solution
A container system with separate compartments for the osmotic agent and buffer agent, where the buffer agent is highly concentrated and alkaline, and the osmotic agent is at physiological concentrations and low pH, allowing for separate sterilization and mixing before use, using a frangible seal to prevent premature contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If PD solutions are stored and sterilized as single-phase compositions, then sterilization can be performed, but glucose degradation products form and damage the peritoneal wall
Solution Approach 1:
The patent divides the PD solution into separate compartments: a first compartment containing the osmotic agent (glucose) at low pH and a second compartment containing the buffer agent at high pH. This segmentation prevents contact between the osmotic agent and buffer agent during storage and sterilization, thereby preventing glucose degradation while still allowing both components to be present in the final administered solution.
2Stability of the object's composition
If buffer agent is added to PD solution before sterilization, then pH balance is maintained, but glucose degradation products increase
Solution Approach 1:
The patent performs the pH balancing action after sterilization by combining the sterile osmotic agent from the first compartment with the sterile buffer agent from the second compartment. This preliminary separation before sterilization prevents glucose degradation during the sterilization process, while the pH balance is established afterward when the compartments are combined.
3Duration of action of stationary object
If PD solution is stored for extended periods, then availability is improved, but glucose degradation products accumulate
Solution Approach 1:
The patent uses separate compartments for storing the osmotic agent and buffer agent, preventing their contact during extended storage periods. This allows the solution components to be stored for extended durations without generating glucose degradation products, as the degradation reaction requires contact between the osmotic agent and the buffer agent that occurs only after compartments are combined.
4Object-generated harmful factors
If multi-chamber PVC bag is used to separate PD constituents, then some glucose degradation is reduced, but not sufficient to maintain physiologically optimal conditions
Solution Approach 1:
The patent applies different pH conditions to different compartments: the first compartment maintains low pH (acidic) conditions suitable for storing the osmotic agent without degradation, while the second compartment maintains high pH (alkaline) conditions for the buffer agent. This local quality differentiation prevents glucose degradation while preserving the ability to achieve physiologically optimal pH when compartments are combined.
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
This approach reduces glucose degradation products by up to 80% and maintains physiologically optimal pH levels, improving the safety and efficacy of peritoneal dialysis solutions.
Implementation Method 1
the buffer agent can be about 3-fold higher in concentration than the chemically 'Normal' concentration... the PD buffer agent has a pH of about 8.0 to about 14.0
Implementation Method 2
a solution is introduced into the patient's abdomen, where it remains for up to several hours, removing blood toxins via osmotic transfer through that membrane
Data Source
AI summary
The invention provides container systems, kits and methods for peritoneal dialysis (PD) solutions. Such a system, for example, includes a first compartment that contains a PD osmotic agent and a second compartment that contains a PD buffer agent. The compartments maintain their respective contents separately from one another for purposes of transport, storage and/or sterilization. However, the compartments are fluidly couplable, so that their respective contents can be combined with one another, e.g., following sterilization of the agents and prior to their introduction into the patient's abdomen. The invention provides, in other aspects, such systems, kits and methods that provide protective structure which inhibits breaking of a seal prior between the second compartment and an outlet of the system, prior to breaking of a seal between the first and second compartments.