Implantable Cell Loading With Aseptic RF Port Sealing
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Solution Overview
Problem
There is a lack of aseptic and semi-automated methods for loading and filling implantable devices with cells and sealing them in a sterile container, which is crucial for cell replacement therapies to minimize immune suppression in patients.
Innovation Solution
A system comprising a rotatable platform, tubing assembly, and sealing means for aseptically loading cells into an implantable device, using radio-frequency energy to selectively seal the device port without sealing the sterile container, and a method to expel residual air from storage bags.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual loading methods are used, then device complexity is reduced, but productivity and sterility assurance deteriorate
Solution Approach 1:
A sterile adapter serves as an intermediary component that connects the cell suspension bag to the implantable device port while maintaining sterility barrier. This adapter enables automated loading without direct manual handling of sterile components, thus improving sterility assurance while managing system complexity through modular design
Solution Approach 2:
The loading system is segmented into distinct sterile and non-sterile zones separated by a sterile barrier. The sterile adapter and tubing form a sealed pathway that isolates the cell suspension from contamination risks, allowing automated manipulation in non-sterile areas while maintaining sterility in the cell delivery path
2Productivity
If full automation is implemented, then productivity improves, but device complexity increases
Solution Approach 1:
The system uses self-contained sterile adapters and pre-filled cell suspension bags that require minimal external intervention. The automated pump system automatically draws cells from the bag through the sterile adapter into the device, reducing the need for complex manual operations while maintaining high loading efficiency
Solution Approach 2:
The sterile adapter design serves multiple functions: maintaining sterility barrier, enabling fluid transfer, and facilitating connection between different components. This multi-functionality reduces the number of separate components needed, thereby improving productivity without proportionally increasing system complexity
3Manufacturing precision
If selective sealing is performed, then manufacturing precision improves, but energy consumption increases
Solution Approach 1:
The sealing system applies radio-frequency energy locally only to the adapter port area that requires sealing, rather than heating the entire assembly. This localized energy application achieves precise sealing at the critical interface while minimizing overall energy consumption
Solution Approach 2:
The patent replaces traditional mechanical heating or flame sealing methods with radio-frequency electromagnetic energy for sealing. This substitution enables more precise control over the sealing process, improving manufacturing precision while potentially reducing total energy consumption through targeted energy delivery
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
Enables aseptic and semi-automated loading of cells into implantable devices, maintaining sterility and reducing the need for long-term immune-suppressive drugs by providing allo-protection.
Implementation Method 1
using radio-frequency energy to selectively seal the device port without sealing the sterile container
Data Source
AI summary
Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.