Adjustable Hollow Fiber Oxygenator for ECMO CO2 Removal
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Solution Overview
Problem
Existing oxygenators for ECMO and ECLS applications are not adequately adaptable to changing clinical requirements, particularly in terms of CO2 removal and O2 input, leading to inefficiencies and increased oxygen consumption.
Innovation Solution
A gas exchange unit with a hollow fiber module that allows adjustable gas exchange characteristics, including adjustable effective surface area, fiber length, and gas flow rate, along with features like orifices, overflow channels, and heating devices, enabling dynamic adaptation to patient needs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the gas flow rate is increased to improve CO2 transfer rate, then CO2 removal efficiency is improved, but oxygen consumption increases
Solution Approach 1:
The hollow fiber module is divided into multiple independently controllable fiber bundles or zones, each with separate gas supply channels. This allows selective activation of only those fiber zones needed to meet the current CO2 removal requirements, rather than increasing flow through the entire module. The segmentation enables precise matching of active exchange surface area to clinical demand, avoiding unnecessary oxygen consumption.
Solution Approach 2:
The gas exchange unit incorporates dynamic control mechanisms including adjustable orifices, throttle valves, and controllable flow distributors that enable real-time adjustment of gas flow distribution across different fiber zones. This dynamic adaptability allows the system to optimize the balance between CO2 transfer rate and oxygen consumption by adjusting flow patterns based on changing clinical requirements.
2Productivity
If the effective surface area is increased to improve gas exchange characteristics, then gas exchange efficiency is improved, but device complexity increases
Solution Approach 1:
The hollow fiber module is designed with multi-functional integrated components that serve multiple purposes. For example, the fiber bundle holders and support structures simultaneously provide mechanical support, gas distribution pathways, and flow control functions. The inlet and outlet chambers are designed to accommodate multiple connection configurations. This multi-functionality reduces the number of separate components needed, thereby reducing overall device complexity while maintaining large effective surface area.
Solution Approach 2:
The design employs nested arrangements where smaller functional components are integrated within larger structures. Fiber bundles are nested within support matrices, which are in turn nested within the module housing. Gas distribution channels are integrated within the wall structures of chambers. This nesting approach maximizes the effective surface area within a compact volume without proportionally increasing device complexity.
3Productivity
If the fiber length is extended to improve CO2 removal, then gas exchange performance is improved, but oxygen consumption increases
Solution Approach 1:
Different regions of the hollow fiber module are designed with locally optimized fiber lengths and configurations based on specific functional requirements. Zones with higher CO2 partial pressure gradients can utilize longer fiber paths, while zones with lower gradients use shorter fibers. This local optimization ensures that oxygen consumption is minimized by activating only the necessary fiber length in each zone, rather than uniformly extending all fibers throughout the module.
4Ease of manufacture
If the gas flow distribution is made uniform across all fiber areas, then manufacturing simplicity is maintained, but adaptability to changing clinical requirements decreases
Solution Approach 1:
The gas distribution system incorporates pre-configured flow pathways and control elements that are built into the module during manufacturing. Multiple inlet channels, outlet channels, and flow control orifices are pre-positioned to enable various flow distribution patterns. This preliminary configuration allows the system to be easily reconfigured for different clinical scenarios without requiring complex real-time manufacturing adjustments, thus maintaining ease of manufacture while achieving high adaptability.
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
Enhances the efficiency of gas exchange by reducing oxygen consumption and improving CO2 removal, while allowing for flexible operation to meet varying clinical demands.
Implementation Method 1
the gas exchange characteristics of which are adjustable... Adjusting the gas exchanger characteristics refers in particular to changing the effective surface area or the effective fiber length... According to Fick's first law, the CO2 transfer rate decreases
Implementation Method 2
install a gas-side humidification and heating device upstream of the hollow fiber module. This allows the gas to be heated before entering the hollow fiber module
Implementation Method 3
the gas releases heat, and some of the water vapor condenses, transferring the condensation energy to the blood
Implementation Method 4
This allows for different gas supply to the fiber areas by means of varying pressure gradients
Data Source
Figure 1~3
Figure 4~5c
Figure 6~7b
AI summary
The present invention relates to a gas exchange unit for use in extracorporeal membrane oxygenation (ECMO) or extracorporeal live support (ECLS), to a method for producing such a gas exchange unit and to a set having a gas exchange unit and a humidifying and heating device.