Bifurcated Endoluminal Graft Segmented Delivery
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Solution Overview
Problem
Current bifurcated endoluminal grafts for treating abdominal aortic aneurysms face challenges such as complex implantation procedures, device migration, high costs, and endoleaks due to their design and manufacturing processes, which complicate the treatment and increase morbidity and expenses.
Innovation Solution
A novel bifurcated endoluminal graft system with simpler device modules that reduces the number of vascular access sites to one, incorporates radially compressible components for easier delivery, and features a self-expandable tubular structure with a side-looking engagement aperture for improved anchoring and reduced migration risks, along with a method for implanting the graft system at a bifurcation in a body lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional bifurcated stent-grafts are implanted via two working channels, then the device can be positioned in the aorta, but the implantation procedure becomes complicated and time-consuming
Solution Approach 1:
The device is divided into a main body portion and a separate iliac graft extension. The main body is delivered first through one working channel, then the extension is delivered through a second working channel and connected to the main body. This segmentation allows each component to be optimized independently and simplifies the overall implantation process by breaking down the complex single-step deployment into manageable stages.
Solution Approach 2:
The iliac graft extension is designed to be delivered through a delivery catheter that passes through the main body of the stent-graft. The extension is compressed within the main body during delivery, then expanded in place to form the complete bifurcated structure. This nested delivery approach reduces the number of separate implantation steps and simplifies the procedure.
2Reliability
If barbs are used to anchor the graft to the aortic wall, then the graft is secured in position, but the implantation time is prolonged and X-ray radiation exposure increases
Solution Approach 1:
The barbs are pre-formed as integral parts of the stent structure during manufacturing, rather than requiring post-deployment attachment or adjustment. The self-expanding stent framework includes barbs that automatically engage the aortic wall upon deployment, eliminating the need for additional anchoring steps and reducing implantation time and radiation exposure.
3Ease of operation
If self-expandable stent-grafts are used, then the implantation is less invasive, but device migration occurs along the longitudinal axis
Solution Approach 1:
The stent-graft structure incorporates asymmetric features including barbs that protrude in specific directions and a non-circular cross-section in some portions. These asymmetric elements prevent rotation and migration along the longitudinal axis by creating directional engagement with the aortic wall, while maintaining the self-expanding less-invasive deployment characteristics.
4Reliability
If hand stitching is used to connect graft fabric to metallic frame, then the graft structure is assembled, but manufacturing cost and complexity increase
Solution Approach 1:
The connection method between graft fabric and metallic frame transitions from mechanical hand stitching to thermal bonding or adhesive bonding processes. These alternative connection methods can be automated in manufacturing, reducing labor costs and improving consistency while maintaining the structural integrity and reliability of the graft assembly.
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 solution simplifies the medical procedure, reduces device migration, lowers costs, and enhances the reliability and safety of the treatment by using fewer access sites and a more stable anchoring mechanism, thereby reducing complications and follow-up times.
Implementation Method 1
both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support
Implementation Method 2
One or both of the first and second components may be adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section
Data Source
AI summary
A multiple-component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member comprising a substantially blood impervious polymeric liner secured therealong; both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support.