Bifurcation Stent with Biodegradable Fronds for Side Branch Coverage
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Solution Overview
Problem
Current stent designs face challenges in effectively treating bifurcated lesions, particularly at bifurcation points in blood vessels, due to limitations such as inadequate radial support, surface area coverage, and anchoring issues, leading to increased rates of restenosis and procedural complications.
Innovation Solution
A prosthesis with a radially expansible support and bifurcation traversing portions, including biostable and biodegradable components, is designed to provide enhanced radial support and surface area coverage at bifurcation points, with fronds extending from the support to stabilize the prosthesis and maintain patency of the branch vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional stents are placed in the main vessel over the origin of the side branch, then the main vessel is supported, but the side branch origin is inadequately covered leading to restenosis
Solution Approach 1:
The stent is divided into multiple segments including a main body portion and frond portions that extend into the side branch. This segmentation allows the stent to simultaneously cover the main vessel and the side branch origin, solving the coverage problem while maintaining a manageable structural complexity through modular design
Solution Approach 2:
The stent design transitions from a conventional two-dimensional planar structure to a three-dimensional structure with fronds extending laterally into the side branch. This dimensional change enables coverage of the side branch origin without requiring complex multi-stent configurations
2Reliability
If multiple stents are deployed using T-stent or crush techniques, then side branch coverage is improved, but radial support and structural stability are compromised
Solution Approach 1:
The design merges the functions of main vessel stenting and side branch stenting into a single integrated structure. The frond portions are structurally connected to the main body, providing both side branch coverage and maintained radial support without the need for multiple separate stents
Solution Approach 2:
The stent employs a composite structure with a biostable main body providing structural strength and radial support, combined with biodegradable frond portions that provide temporary side branch coverage and structural integrity during the healing process
3Strength
If permanent stents are used to maintain structural support, then radial strength is preserved, but restenosis rates remain high due to inadequate surface area coverage
Solution Approach 1:
The stent combines biostable material in the main body for permanent radial support with biodegradable material in the frond portions that provide extended surface area coverage for restenosis prevention. The biodegradable portion degrades over time after providing necessary coverage and structural support during the critical healing period
Solution Approach 2:
The stent structure transitions from a static conventional design to a dynamic structure where the biodegradable frond portions gradually degrade over time. This dynamic change allows the stent to provide enhanced coverage during the critical early period and then naturally reduce its presence as healing progresses
4Ease of operation
If the prosthesis structure is simplified for ease of deployment, then procedural complexity is reduced, but anchoring stability and surface area coverage are insufficient
Solution Approach 1:
The prosthesis is segmented into a main body and frond portions that can be deployed in a sequential or simultaneous manner depending on the delivery system. This segmentation allows for relatively simple deployment procedures while achieving complex anchoring and coverage goals through the coordinated expansion of different segments
Data Source
AI summary
A prosthesis is disclosed for placement across an ostium opening from a main body lumen to a branch body lumen. The prosthesis has a radially expansible support and a bifurcation traversing portion. The radially expansible support is configured to be deployed in at least a portion of the branch body lumen. The bifurcation traversing portion has a biostable portion having a first end and a second end. The first end is located adjacent to the radially expansible support. The bifurcation traversing portion also has a biodegradable portion having a first end coupled with the second end of the biostable portion. The biodegradable portion has a second end disposed at an end of the prosthesis opposite the radially expansible support. When deployed, the bifurcation traversing portion extends from the radially expansible support across a bifurcation and into a main body lumen such that the carina is supported thereby.