Aseptic Cell Loading and RF Port Sealing for Implantable Devices
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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 like pancreatic progenitor cell delivery for diabetes treatment, as existing technologies do not provide adequate allo-protection against host immunity and require long-term immune-suppressive drugs.
Innovation Solution
A system comprising a rotatable platform, tubing assembly, and sealing means for aseptic loading and filling of implantable devices with cells, using radio-frequency energy to selectively seal device ports without compromising sterility, and a method for expelling residual air and sealing materials sensitive to RF energy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual cell loading methods are used, then sterility can be maintained through careful handling, but the process is time-consuming and lacks automation
Solution Approach 1:
The patent replaces manual mechanical handling with an automated system that uses a rotatable platform and robotic positioning mechanisms to load cells into implantable devices. The system maintains sterility through automated aseptic techniques while eliminating time-consuming manual operations.
Solution Approach 2:
The system incorporates self-aligning and self-positioning mechanisms that automatically orient the implantable device and position it for cell loading without requiring manual adjustment, thereby maintaining sterility while reducing loading time.
2Productivity
If automated loading systems are implemented, then productivity increases, but maintaining sterility becomes more difficult
Solution Approach 1:
The system divides the cell loading process into discrete automated steps including device positioning, port alignment, cell suspension injection, and port sealing. Each step is performed by dedicated automated components that maintain sterility while maximizing productivity.
Solution Approach 2:
The patent uses a sterile barrier or seal mechanism as an intermediary between the automated loading system and the sterile cell suspension, allowing automated manipulation while preventing contamination.
3Reliability
If device ports are sealed after cell loading, then sterility is maintained, but residual air and incomplete filling may occur
Solution Approach 1:
The system performs preliminary actions before sealing the device port, including multiple injection cycles to ensure complete filling, air bubble removal maneuvers, and verification of cell suspension delivery. Only after these preliminary actions confirm complete filling does the system seal the port to maintain sterility.
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 immune-suppressive drugs by providing allo-protection, thus enhancing the efficacy of cell replacement therapies.
Implementation Method 1
using radio-frequency energy to selectively seal device ports without compromising sterility
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 scaling a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.