Bifurcated Endoprosthesis Leg Alignment for Branch Vessel Repair
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Solution Overview
Problem
There is a need for advanced devices and methods to treat vascular diseases in regions of branch vessels and main vessel junctions, including the aorta, iliac arteries, and femoral arteries, which existing technologies have not adequately addressed.
Innovation Solution
The development of branched vascular endoprosthetic systems with a first and second leg and a bifurcation, manufactured using a mandrel and tubular graft elements, where a trunk portion is formed with a tab extending across the bifurcation, and optionally reinforced with stents, to provide structural support and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional endoprosthesis design is used, then the device structure is simple, but it cannot effectively treat vascular diseases in branch vessels and main vessel junctions
Solution Approach 1:
The endoprosthesis is divided into multiple tubular graft elements (first tubular graft element, second tubular graft element, third tubular graft element) that form different sections of the device. Each graft element can be independently manufactured and then assembled together, allowing the complex bifurcated structure to be created from simpler components while maintaining the ability to treat branch vessels and main vessel junctions
Solution Approach 2:
The tubular graft elements are applied over mandrel sections in a nested manner during manufacturing, with each graft element positioned over specific mandrel sections and secured with stents. This nested construction approach allows the complex multi-section structure to be built systematically while maintaining structural integrity and adaptability for various vascular configurations
2Shape
If the tubular graft element is folded to define bifurcation, then the bifurcation structure is formed, but maintaining alignment of legs becomes challenging
Solution Approach 1:
The mandrel is pre-configured with distinct sections (first mandrel section, second mandrel section with first and second elongate elements, third mandrel section) before the graft elements are applied. This preliminary structuring of the mandrel provides precise geometric guidance that ensures the folded graft elements will form legs with correct alignment when the device is manufactured, eliminating alignment challenges during the folding process
Solution Approach 2:
The mandrel acts as an intermediary tool during manufacturing that temporarily holds and positions the tubular graft elements in the correct configuration. The mandrel's distinct sections guide the folding and shaping of the graft material to form the bifurcation structure with properly aligned legs, ensuring manufacturing precision without requiring complex post-processing alignment procedures
3Strength
If multiple tubular graft elements are used to form the endoprosthesis, then the structural support is improved, but the manufacturing process becomes more complex
Solution Approach 1:
The endoprosthesis is segmented into multiple tubular graft elements that can be manufactured independently using standardized processes. Each graft element is produced separately and then assembled by applying them over corresponding mandrel sections and securing with stents. This segmentation allows each component to be optimized for manufacturing while the final assembly provides enhanced structural support through the multi-element construction
Solution Approach 2:
The stents serve multiple functions: they provide structural support to the graft elements, maintain the geometric configuration of the bifurcation structure, and facilitate the assembly process by securing the graft elements to the mandrel sections. This multi-functionality of the stents simplifies the overall manufacturing process despite using multiple graft elements, as a single component performs several critical roles
Data Source
AI summary
Bifurcated endoprosthetic devices, systems and methods are disclosed herein for treating disease of human vasculature. In various embodiments, a bifurcated endoprosthesis includes a trunk portion and a plurality of legs, where the legs are constrained such that they maintain alignment with one another. In some examples, the legs and bifurcation of an endoprosthetic device may be formed by cutting a tubular graft component along a portion of less than its entire circumference in a longitudinally central region, and then folding the tubular graft component along the uncut portion to define two legs, where the uncut portion defines the bifurcation. In some such examples, the folded tubular graft component can be coupled with a tubular trunk component to form the bifurcated endoprosthetic device.