Angled ECMO Access Adaptors for Hemostatic Endovascular Entry
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Solution Overview
Problem
Existing ECMO systems face challenges in obtaining vascular access due to anticoagulation requirements, which increase the risk of bleeding, and current introducer sheaths are incompatible with the right angle side port of ECMO cannulas, leading to complications like uncontrolled bleeding and misdirection of intervention devices.
Innovation Solution
Adaptors and modified cannulas with angled side ports, along with occlusive caps and tube couplers, enable the ECMO circuit to serve as a vascular access point, allowing for safe insertion of intervention devices while preventing thrombus formation by providing directional guidance and hemostatic sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If percutaneous endovascular access is performed during ECMO cannulation, then vascular access for subsequent procedures is established, but the risk of infection and bleeding increases due to additional skin punctures
Solution Approach 1:
The ECMO cannula is designed to perform multiple functions: it provides both ECMO support and serves as a conduit for endovascular access devices. The introducer sheath passes through the cannula lumen, allowing the same cannulation site to be used for both respiratory support and vascular access procedures, eliminating the need for separate skin punctures.
Solution Approach 2:
The endovascular access device (introducer sheath) is nested within the ECMO cannula structure. The introducer sheath is inserted through the cannula lumen and positioned in the target vessel, creating a nested configuration where one device passes through another, thereby utilizing the existing cannula tract for additional access without requiring separate puncture sites.
2Productivity
If separate venous and arterial cannulas are used for ECMO, then adequate blood flow is achieved, but the number of skin punctures and procedural complexity increases
Solution Approach 1:
The dual-lumen cannula combines the functions of separate venous and arterial cannulas into a single device. One lumen provides venous drainage while the other provides arterial reinfusion, allowing the single cannula to perform both ECMO functions that traditionally required two separate cannulas and two separate surgical sites.
Solution Approach 2:
The patent merges the venous and arterial cannulation functions into a single dual-lumen cannula structure. The two lumens are positioned within a single cannula body that is inserted through a single surgical site, combining what were previously separate procedures into one integrated device and procedure.
3Ease of operation
If large-bore arterial access is obtained through traditional surgical cutdown, then adequate access for vascular procedures is achieved, but surgical trauma and recovery time increase
Solution Approach 1:
The patent replaces the mechanical surgical cutdown procedure with a percutaneous transluminal approach. Instead of making a surgical incision and dissecting to the vessel, the device is introduced through a small puncture and advanced through the vessel lumen under fluoroscopic guidance, substituting surgical mechanics with a minimally invasive catheter-based approach.
Solution Approach 2:
The ECMO cannula serves as an intermediary device that facilitates endovascular access. By establishing the cannula through a relatively small puncture, it creates a tract that can accommodate the introducer sheath and subsequent vascular devices, using the cannula as a mediator to achieve large-bore access with minimal surgical trauma.
Data Source
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AI summary
Adaptors, cannulas, caps, tube couplers, and systems thereof provide endovascular access through an established ECLS system. Adaptors having curved or angled shafts navigate right angle side ports of standard bypass cannulas and permit hemostatic introduction and direction of an intervention device to the axial flow path of the cannula lumen and bypass system. A modified cannula having an angled side port is also provided for use as an arterial cannula. A cap having an occluding surface may be inserted into the angled side port to prevent blood from stagnating in the angled side port. A tube coupler is also provided having an access port, such as an angled access port, and may be spliced into an established bypass system for vascular access point. Multiple couplers can be used to provide multiple access points. The adaptors and occlusive cap are interchangeable with each other and with secondary circuits.