Medical Fluid Bag Mixing and Particulate Inspection Assembly

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Solution Overview

Problem

The existing medical fluid manufacturing process is limited by production challenges that lead to shortages and uneven market share, particularly affecting saline bags, with recent events like Hurricane Maria exacerbating the issue.

Innovation Solution

A method and system for mixing and inspecting medical fluid bags using a bag retention assembly with rotational orientations, a rotary actuator, and a particulate inspection system with a cradle, illumination, and imaging to ensure thorough mixing and detection of particulates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a single manufacturer provides most saline bags, then production efficiency is high, but market reliability decreases due to shortages and uneven supply

Engineering Contradiction:
Improveproduction efficiencyVSAvoidmarket reliability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent segments the mixing process into multiple stages with different agitation intensities and durations, allowing controlled dissolution of concentrates while preventing premature aggregation. This segmentation enables reliable production of consistent medical fluid formulations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system dynamically adjusts mixing parameters including rotation speed, dwell time at each position, and agitation intensity based on the specific concentrate type and bag volume. This dynamic control ensures optimal mixing for different formulations, improving both productivity and reliability.

Inventive Principle:
Principle #15Dynamics

2Manufacturing precision

If thorough mixing is performed to prevent particulates, then quality control improves, but production time increases

Engineering Contradiction:
Improvequality controlVSAvoidproduction time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The mixing process uses periodic rotation between preset pairs of rotational orientations with defined dwell intervals. This periodic action ensures thorough mixing through repeated cycles of agitation and pause, effectively preventing particulate formation while maintaining efficient production timing.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system maintains continuous mixing action through overlapping rotation cycles and dwell periods, ensuring that mixing is an uninterrupted process rather than discrete steps. This continuity improves quality control while minimizing total production time.

Inventive Principle:
Principle #20Continuity of useful action

3Stability of the object's composition

If multiple rotational orientations are used for mixing, then mixing completeness improves, but device complexity increases

Engineering Contradiction:
Improvemixing completenessVSAvoiddevice complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The bag retention assembly serves multiple functions: it holds the bag during mixing, rotates the bag through preset orientations, and facilitates inspection. This multi-functionality achieves complete mixing through various rotational orientations while avoiding the need for separate complex mixing devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system uses the bag's own geometry and the retention assembly's preset rotational orientations to achieve thorough mixing. The bag rotates through predefined positions that naturally create comprehensive mixing patterns, eliminating the need for complex external mixing mechanisms.

Inventive Principle:
Principle #25Self-service

4Reliability

If particulate inspection is performed, then product quality improves, but manufacturing cost increases

Engineering Contradiction:
Improveproduct qualityVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The inspection system is merged with the mixing and retention assembly, using the same rotational mechanism and positioning system for both mixing and inspection. This integration improves product quality through particulate detection while minimizing additional manufacturing costs by avoiding separate inspection equipment.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The bag retention assembly acts as an intermediary that positions the bag for inspection while maintaining the mixing context. This intermediary role allows inspection to be performed as part of the existing workflow rather than requiring entirely separate manufacturing steps.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enhances the production efficiency and quality control of medical fluid bags by ensuring complete mixing and accurate detection of particulates, reducing the risk of shortages and improving availability.

Implementation Method 1

rotating the bag retention assembly in opposing directions between preset pairs of rotational orientations

Methodology Applied
Scientific EffectMechanical agitation: Stirring

Implementation Method 2

a particulate inspection system with a cradle, illumination, and imaging to ensure thorough mixing and detection of particulates

Methodology Applied
Scientific EffectOptical detection: Light

Data Source

PatentUS20260038679A1Systems, Methods, and Apparatuses for Producing and Packaging Medical Fluids
Publication Date: 2026.02.05 DEKA PRODUCTS LP
  • US20260038679A1 patent drawing
  • US20260038679A1 patent drawing
  • US20260038679A1 patent drawing

AI summary

A particulate inspection system may comprise a reservoir rest body having a pattern of light and dark regions. The system may further comprise a rest body backlight. The system may further comprise an external illuminator. The system may further comprise a vision assembly opposite the rest body. The vision assembly may include at least one imager. Each imager may have a field of view encompassing at least a portion of rest body. The system may further comprise a controller in data communication with each of the at least one imager. The controller may be configured to command capture of a series of images from each imager, receive the images, process the images into processed images, detect regions of interest within the processed images, analyze the regions of interest, and classify the regions of interest as one of a bubble and something other than bubble.