Endoprosthesis Delivery System Air Embolization Risk Reduction
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Solution Overview
Problem
During the deployment of endoluminal devices such as thoracic aortic stent-graft devices, air embolization can occur due to trapped air in the device, posing a risk of negative effects, and existing technologies do not effectively quantify or reduce this risk.
Innovation Solution
An endoluminal device delivery system with a treatment system that includes a valve and a delivery sheath, where blood is used to flush out air from the device by creating a blood pathway through the device, reducing the volume of entrained air to 10 μL or less, and utilizing visual insertion markers for proper positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If blood is forced through the collapsed implant to flush air from void spaces, then air embolization risk is reduced, but the complexity of the delivery system increases
Solution Approach 1:
The system performs air flushing through the implant before device deployment by forcing blood through the collapsed implant to remove air from void spaces. This preliminary action eliminates air embolization risk prior to the critical deployment phase, resolving the contradiction by addressing the harmful factor in advance rather than adding complexity during deployment.
Solution Approach 2:
Blood acts as an intermediary flushing medium to remove air from the implant's void spaces. The blood pathway serves as a mediator between the delivery system and the implant, carrying air out of the device without requiring direct mechanical intervention or additional complex air-removal mechanisms.
2Productivity
If the implant projects 1 cm from the valve, then air flushing effectiveness is improved, but positioning precision requirements increase
Solution Approach 1:
Visual insertion markers on the implant provide visual feedback for positioning, allowing the operator to see when the implant has projected the correct 1 cm distance from the valve. This visual indication system resolves the positioning precision requirement by making the critical dimension observable rather than requiring complex measurement or control mechanisms.
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
The system effectively reduces the volume of entrained air in the device, minimizing the risk of air embolization and ensuring proper device deployment by using back-bleeding techniques and visual markers for precise positioning.
Implementation Method 1
the valve being actuatable between a sealed and an unsealed configuration, the implant projecting proximally from the valve a projection distance of approximately 1 cm, the treatment system defining a blood pathway between the delivery sheath and the body of the catheter for blood to pass from the first end of the implant to the second end of the implant and into the one or more void spaces defined by the collapsed implant
Data Source
AI summary
Techniques and features for reduction of air potentially released during endoluminal device (e.g., thoracic aortic stent-graft device) deployment. Also addressed are methods for quantifying efficacy of pre-treatment techniques and features for reducing said air. Such air reduction can help reduce risk of air embolization during device (e.g., implant, such as stent-graft) deployment which could potentially decrease the risk of negative effects from such embolization.