Multi-Source Compounding Fluid Path for Accurate Low-Volume Mixing
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Solution Overview
Problem
Compounding devices face inefficiencies in setup time, downtime during source container replacement, and accuracy at small dispensed volumes, with challenges in maintaining aseptic conditions and preventing errors, especially in transfer set and fluid path connections.
Innovation Solution
A compounding device with a housing featuring micro and macro valve actuation devices and pumps, a junction structure for combining materials from multiple sources, and a controller for precise material transfer and mixing, along with an aesthetically pleasing and intuitive interface for improved usability and cleaning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional compounding devices use volumetric measurement methods with peristaltic pumps, then they can deliver materials based on calculated volume, but delivery accuracy is affected by pump tubing material, length, elasticity, diameter, temperature, viscosity, and wear over time
Solution Approach 1:
The patent replaces the mechanical volumetric measurement system (peristaltic pump with tubing) with a gravimetric measurement system (load cell scale). Instead of calculating volume based on pump rotations and tubing dimensions, the system directly measures the weight of dispensed material and converts it to volume using specific gravity, eliminating errors from tubing wear, elasticity, and dimensional variations.
Solution Approach 2:
The patent changes the measurement parameter from volumetric (based on pump displacement) to gravimetric (based on weight). By measuring the weight of dispensed material on a load cell and dividing by specific gravity, the system achieves more reliable and accurate volume measurement that is not affected by mechanical wear or environmental conditions.
2Adaptability or versatility
If compounding devices require frequent setup and container replacement, then they can accommodate different compounding needs, but operational efficiency and productivity decrease
Solution Approach 1:
The patent implements a universal container system where source containers can be hung from a movable rack that can be repositioned along a track. The system can accommodate different container sizes (macro and micro) and types (bottles, bags, syringes) using the same basic infrastructure, reducing the need for device reconfiguration while maintaining versatility.
Solution Approach 2:
The patent allows source containers to be pre-loaded and hung on the rack before the compounding process begins. The system can queue multiple compounding tasks and automatically sequence them, reducing setup time between operations and improving overall productivity.
3Reliability
If compounding devices operate in aseptic conditions, then they can prevent contamination, but cleaning and disinfection processes become more complex and time-consuming
Solution Approach 1:
The patent employs disposable transfer sets and fluid path components that are pre-sterilized and discarded after a single use. This eliminates the need for complex cleaning and sterilization processes for these components, while maintaining aseptic conditions throughout the compounding process.
Solution Approach 2:
The patent divides the fluid handling system into separable sterile and non-sterile zones. The transfer set and fluid paths are designed as removable, disposable components that can be easily detached and discarded, while the main device body remains for repeated use with simplified cleaning requirements.
4Device complexity
If compounding devices use traditional interfaces and layouts, then they can be simple in design, but usability and ease of operation decrease
Solution Approach 1:
The patent implements a touchscreen interface that replicates the familiar layout and operation of standard pharmacy compounding software. The display shows virtual representations of the physical rack, containers, and compounding process, allowing users to interact with the system through an intuitive graphical interface rather than complex physical controls.
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 solution enhances operational efficiency, reduces downtime, improves accuracy at small volumes, and facilitates easier cleaning and disinfection to maintain aseptic conditions, while preventing errors and improving user experience.
Implementation Method 1
variances in the pump tubing's material, length, elasticity, and diameter
Implementation Method 2
Gravimetric devices generally use a peristaltic pump mechanism combined with a weight scale or load cell to measure volume delivered. The volume delivered is calculated by dividing the weight delivered by the specific gravity of the ingredient.
Implementation Method 3
temperature, which affects solution viscosity and tubing size
Data Source
AI summary
An exemplary compounding system and method can include two pump heads for simultaneously drawing two different fluids from at least two separate input containers such that the at least two different fluids are mixed and distributed to an output container. The system can include a manifold that maintains separation of certain of the different fluids until after passing by a first pump and a second pump and/or additional pumps. A junction can be placed in the fluid line downstream of the first and second pumps and/or additional pumps such that all or some of the fluids are mixed prior to output to the output container. The method of using the system can include incorporating software that selects various fluids at certain times and sequences to ensure optimum efficiency and safety for the system, and can continue compounding actions even when an input supply container runs out or otherwise fails to supply a particular fluid/material. The method of use also includes connection of a transfer set to a housing in a manner that further ensures optimum efficiency and safety.