Cell Washing Protocol Control With Authorization-Based Parameter Limits
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Solution Overview
Problem
Current biological fluid processing systems lack effective control over process parameters, leading to potential misuse and variability in results due to lack of authorization and flexibility in adapting procedures across different systems.
Innovation Solution
A cell washing system incorporating a disposable fluid circuit and reusable processing machine with a touch screen interface and controller that receives user input for protocols, applies authorization-based process parameter controls, and stores protocols for secure operation, ensuring reproducible results and adaptability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the processing machine is designed to permit operation to be varied in hundreds of different ways to maintain maximum flexibility, then adaptability is improved, but control over process parameters deteriorates
Solution Approach 1:
The patent segments process parameters into different authorization levels (administrator vs. operator). Administrators can modify parameters to adapt to different processes, while operators are restricted to predefined protocols. This segmentation resolves the contradiction by allowing flexibility at the administrator level while maintaining control at the operator level.
Solution Approach 2:
The patent applies different control qualities to different users and parameters. Administrator accounts have full access to modify any process parameter, while operator accounts have restricted access to only specific parameters or predefined protocols. This local differentiation of access rights enables both flexibility for administrators and control for operators simultaneously.
2Adaptability or versatility
If process parameters can be freely modified to adapt to different processes, then adaptability is improved, but manufacturing precision deteriorates
Solution Approach 1:
The patent implements preliminary action by pre-configuring standardized protocols with optimized process parameters for common cell processing procedures. Operators can select from these pre-defined protocols without modifying parameters, ensuring reproducibility. When new processes are needed, administrators can create new standardized protocols rather than allowing ad-hoc parameter changes, thus maintaining both adaptability and precision.
3Adaptability or versatility
If the system allows extensive parameter modification for different fluid circuits, then versatility is improved, but device complexity increases
Solution Approach 1:
The patent implements a universal authorization framework that works across all process parameters and fluid circuit configurations. The same administrator/operator distinction and protocol selection mechanism apply regardless of the specific process or fluid circuit being used. This universal approach enables versatility across different applications while avoiding the need for separate complex control systems for each process 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
The system provides a versatile and adaptable cell processing solution that minimizes unexpected modifications, ensures reproducibility, and allows for standardized procedures across multiple systems while maintaining the option for addressing local variations in biological fluid processing.
Implementation Method 1
Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation
Implementation Method 2
The reusable hardware may include at least one drive to spin the spinning membrane, at least one scale to weigh the at least container and contents thereof, and at least one pump
Data Source
AI summary
A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.