Shockwave Cell Dissociation for Rapid Sterile Isolation
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Solution Overview
Problem
Current cellular manufacturing processes are highly user-dependent, tedious, variable, expensive, and result in low yields, often requiring multiple handling steps that compromise sterility and prolong the time to deliver therapeutic cells to patients, especially those in need of immediate care.
Innovation Solution
A closed system using extracorporeal shockwaves or mechanical impacts to isolate cellular fractions directly at the point-of-care, without physical contact with the sample, combined with centrifugation and sterile transfer methods to maintain sterility and efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional cell separation methods (enzymatic digestion, mechanical separation, high-powered sonication) are used, then cell separation can be achieved, but the processes are tedious, highly variable, expensive, and produce low yields
Solution Approach 1:
The patent replaces traditional mechanical separation methods (enzymatic digestion, mechanical separation, high-powered sonication) with a shockwave-based system. The shockwave generator delivers focused shockwaves through a coupling medium to dissociate cells from tissue, eliminating the need for manual intervention in the separation process and significantly improving both productivity and ease of operation.
Solution Approach 2:
The system enables automated cell separation where the shockwave generator automatically performs the dissociation and separation functions that previously required extensive user intervention. The closed-loop system with automated sample transfer and processing steps allows the system to serve itself, reducing operational complexity and improving consistency.
2Productivity
If multiple handling steps are used to process cellular samples, then processing can be completed, but sterility is compromised and time is prolonged
Solution Approach 1:
The patent merges multiple processing steps into a single integrated system. The shockwave generator, sample container, and processing chambers are combined in one unit, allowing cell dissociation, separation, and concentration to occur in a continuous, closed-loop process without transferring samples between separate containers, thereby maintaining sterility while improving processing speed.
Solution Approach 2:
The system uses a coupling medium as an intermediary to transmit shockwaves from the generator to the tissue sample. This intermediary allows energy transfer without direct contact between the shockwave generator and the biological sample, maintaining sterility while enabling effective cell dissociation.
3Productivity
If high-powered sonication is used to separate cells, then cell separation can be achieved, but heat is introduced into the sample which damages cells and reduces yield
Solution Approach 1:
The patent substitutes high-powered sonication with a shockwave-based mechanical dissociation system. The shockwaves deliver focused mechanical energy to break cell-tissue adhesion without the thermal effects of sonication, achieving effective cell separation while avoiding heat damage to the cells and maintaining higher yields.
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 method enables rapid isolation of cellular fractions, such as stem cells from adipose tissue, in 30 minutes or less, with improved sterility and reduced user intervention, enhancing the availability of therapeutic cells for immediate patient use.
Implementation Method 1
contacting the tissue sample with shock waves, force from mechanical impacts, or both
Implementation Method 2
contacting the tissue sample with shock waves, force from mechanical impacts, or both
Implementation Method 3
isolating a cellular fraction from the tissue sample
Data Source
AI summary
Methods provided by the present disclosure utilize extracorporeal shockwaves, mechanical impacts and/or principles of lithotripsy to break up a tissue sample into smaller fragments-clusters of cells and/or single cells-after which a desired cellular fraction can be isolated from the sample. Devices provided by the present disclosure deploy focused and/or directed shockwaves, and/or focused and directed mechanical impacts, to break apart a tissue sample. The devices maintain the sample in a sterile, closed environment during exposure to the shockwaves or mechanical impacts. Therefore, the shockwaves and/or mechanical impacts are generated outside of a closed device and are transmitted through one or more walls of the device into its interior, where the sample is located.