ECMO Sheath-Cannula Hub for Single-Access Blood Flow and Intervention
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Solution Overview
Problem
Existing ECMO systems face challenges in enabling safe, rapid, and effective deployment outside the operating room due to the need for additional vascular access, difficulty in making wet-to-wet connections, risk of air embolization, and complications from clamping interventional equipment, which are exacerbated by peripheral vascular disease or occupied vessels.
Innovation Solution
A sheath and cannula combination device that allows for selective blood flow direction and interventional procedures, featuring a connector hub with a collinear port and angled sidearm for seamless integration with ECMO circuits, enabling both cannula and sheath modes without additional punctures, and includes features like hemostatic valves and caps to prevent blood pooling and equipment disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If additional vascular access is obtained for interventional equipment during ECMO, then interventional procedures can be performed, but the risk of complications increases and patient safety deteriorates
Solution Approach 1:
The patent combines the ECMO cannula and the interventional sheath into a single integrated device. The sheath is positioned within the cannula lumen, allowing both ECMO blood flow and interventional equipment passage through one vascular access site. This merging eliminates the need for separate vascular punctures, thereby reducing complications while maintaining versatility for both life support and interventional procedures
Solution Approach 2:
The integrated device serves multiple functions simultaneously: it provides ECMO blood flow through the cannula while also serving as a delivery sheath for interventional equipment. The device can transition between ECMO mode and interventional mode, and even allow both functions to operate concurrently. This multi-functionality eliminates the need for separate devices and vascular accesses, reducing patient risk while maintaining adaptability
2Ease of operation
If clamps are applied to stop blood flow during interventional procedures, then procedural control is improved, but interventional equipment may be crushed and device reliability deteriorates
Solution Approach 1:
The patent extracts the blood flow control function from the interventional equipment itself and places it in the sheath structure. A dedicated control mechanism within the sheath can stop or redirect blood flow independently of the interventional device. This separation allows procedural control to be achieved without applying clamps to the interventional equipment, thereby maintaining equipment integrity and reliability
Solution Approach 2:
The sheath acts as an intermediary between the blood flow system and the interventional equipment. The sheath's control mechanism mediates blood flow control, preventing direct interaction between clamps and interventional equipment. This intermediary function allows procedural control while protecting the interventional equipment from crushing forces
3Reliability
If wet-to-wet connections are made between sheath and ECMO circuit, then air embolization risk is reduced, but connection complexity increases
Solution Approach 1:
The patent merges the connection interface between the sheath and ECMO circuit into a single integrated connection point. The sheath proximal end is directly connected to the ECMO circuit without requiring separate connection steps for different components. This unified connection simplifies the wet-to-wet connection procedure while maintaining air embolization prevention benefits
4Object-affected harmful factors
If single vascular access is used for both ECMO and interventional procedures, then patient safety is improved, but the ability to perform both functions simultaneously is limited
Solution Approach 1:
The patent implements a nested structure where the interventional sheath is positioned within the ECMO cannula lumen. This nesting allows the sheath to pass through the cannula and deploy interventional equipment while the cannula continues to provide ECMO blood flow. The nested configuration enables both functions to operate simultaneously through a single vascular access, maintaining patient safety while achieving full versatility
Data Source
AI summary
Systems are provided including a sheath and cannula combination device for permitting a user to select between directing blood flow through a first cannula portion of the combination device in a cannula mode and enabling an interventional medical procedure through a second sheath portion of the combination device in a sheath mode, or performing both the cannula mode and the sheath mode simultaneously. The combination device may include a connector hub configured to auto-washout stasis regions of blood within the first cannula portion. The systems may include a series of removable caps for temporarily sealing the first cannula portion and/or the second sheath portion of the combination device, such that the user may seamlessly select when to use the combination device in the cannula mode, the sheath mode, both the cannula mode and the sheath mode simultaneously, or neither the cannula mode nor the sheath mode.