In Vitro Leak Testing of Inflatable Endovascular Stent Grafts
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Solution Overview
Problem
Existing methods for treating aortic aneurysms, particularly thoracic aortic aneurysms, are invasive and carry high morbidity and mortality risks, necessitating the development of reliable and flexible endovascular stent grafts with inflatable portions that require effective testing for integrity before deployment to ensure safety and efficacy.
Innovation Solution
A method for in vitro testing of endovascular prostheses with inflatable portions, involving loading the prosthesis onto a delivery system, inflating it with a sterile removable material at pressures higher than ambient, and inspecting for leaks before deployment, allowing for potential repair or replacement of the delivery system if leaks are detected.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical procedures are used to treat aortic aneurysms, then the aneurysm can be repaired with graft replacement, but the morbidity and mortality rates are high and hospital stays are long
Solution Approach 1:
The patent employs an inflatable balloon within the stent graft structure that can be inflated with fluid or gas to expand the graft to its functional configuration after deployment. This pneumatic/hydraulic mechanism allows for minimally invasive endovascular delivery while achieving the therapeutic effect of graft placement, thereby reducing surgical morbidity and mortality compared to traditional open surgical procedures
2Ease of operation
If an endovascular prosthesis with inflatable portion is used, then flexibility and low profile delivery is achieved, but testing for integrity before deployment is required to ensure safety
Solution Approach 1:
The patent incorporates a testing mechanism that allows integrity verification of the inflatable portion to be performed in advance, before final deployment. The system includes testing ports and configurations that enable pre-deployment inspection of the inflatable structure, ensuring safety is confirmed prior to patient implantation, thereby resolving the contradiction between simplified delivery and rigorous testing requirements
3Reliability
If the inflatable portion is tested for leaks under pressure, then integrity can be confirmed, but the testing process requires additional time and resources
Solution Approach 1:
The patent employs pressure-sensitive indicators or visual markers within the inflatable structure that change state when subjected to testing pressure, providing immediate leak detection without requiring complex measurement equipment or extended testing periods. This substitution of mechanical testing with visual/indicator-based detection reduces testing time while maintaining reliability
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
Ensures the integrity and safety of inflatable endovascular prostheses before deployment, reducing the risk of complications during and after the procedure by identifying and addressing any leaks or imperfections prior to implantation.
Implementation Method 1
the inflation material maintained at a pressure higher than ambient pressure
Data Source
AI summary
Some embodiments relate in part to endovascular devices such as prostheses and methods of testing same prior to deployment. Some embodiments may be directed more specifically to inflatable grafts or stent grafts and methods of in vitro leak testing of such grafts prior to in vivo deployment.