Allograft Cleaning System with Segmented Sterile Bag
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Solution Overview
Problem
Current methods for cleaning and disinfecting allograft materials are laborious, inconsistent, and prone to environmental cross-contamination, with existing processes often failing to ensure thorough removal of microbial contaminants and residual tissue components, and they can be technician-dependent and inefficient in ultrasonic energy penetration.
Innovation Solution
A system comprising a sterile bag with a motorized paddle blender and an allograft retaining section that prevents paddle contact with the allograft material, allowing for staged or continuous solution pumping and ultrasonic treatment to effectively clean and disinfect allografts while minimizing handling and ensuring thorough microbial extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional cleaning and disinfecting methods are used on allografts, then microbial contamination can be reduced, but the process becomes laborious and technician-dependent with inconsistent results
Solution Approach 1:
The system segments the cleaning process into distinct phases: a washing phase with agitated solution to remove gross contaminants, and a disinfection phase with stationary allograft exposure to eliminate microbial contamination. This segmentation allows each phase to be optimized independently, improving reliability while maintaining manageable process complexity.
Solution Approach 2:
The system introduces an intermediary sterile barrier bag between the allograft and the external environment. The allograft remains contained within this barrier throughout processing, eliminating the need for repeated manual handling and reducing technician-dependent variability. The barrier acts as a mediator that allows solution exchange while protecting the allograft.
2Ease of operation
If manual handling and manipulation of allografts is performed during cleaning, then cleaning steps can be executed, but environmental cross-contamination risk increases
Solution Approach 1:
The system performs preliminary containment by placing the allograft into a sterile barrier bag before any cleaning or disinfection steps. This preliminary action establishes a protected environment that eliminates cross-contamination risks during subsequent automated processing, while the system maintains ease of operation through automated solution exchange and processing.
Solution Approach 2:
The system enables self-service processing where the allograft, contained within its sterile barrier, undergoes automated washing and disinfection without requiring manual manipulation. The automated fluid exchange and processing systems handle all cleaning operations, reducing human contact and cross-contamination risk while maintaining operational simplicity.
3Reliability
If ultrasonic energy is applied to clean allografts, then microbial reduction is achieved, but shielding effects reduce energy penetration and cleaning effectiveness
Solution Approach 1:
The system employs periodic action by alternating between agitated washing phases and stationary disinfection phases. During disinfection, the allograft remains stationary to allow uniform ultrasonic energy penetration without shielding effects, while the periodic agitated phases remove surface contaminants that could interfere with energy penetration. This periodic alternation ensures both effective microbial reduction and adequate energy utilization.
4Measurement precision
If destructive testing with companion tissues is used to assess microbial contamination, then contamination levels can be evaluated, but the companion tissue may not be representative of the entire allograft lot
Solution Approach 1:
The system applies universal processing to the entire allograft within the sterile barrier, ensuring that all portions of the allograft receive identical washing and disinfection treatment. This universal approach eliminates the need for separate companion tissue testing, as the entire allograft serves as both the treatment target and the assessment subject, improving both measurement precision and sample representativeness.
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 non-destructive, efficient method for cleaning and disinfecting allografts, ensuring high log reductions in microbial contamination, reducing the risk of cross-contamination, and promoting allograft viability, with improved control and consistency in the cleaning process.
Implementation Method 1
a motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag
Implementation Method 2
Existing processes also tend to have a shielding or layering effect that can greatly reduce ultrasonic energy penetration and thus not clean as effectively
Implementation Method 3
ultrasonic energy penetration... liberation of contaminant microorganisms off of the tissues
Data Source
AI summary
There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.