Personalized Coronary Stent Design for Arterial Geometry
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Solution Overview
Problem
Current stents used in PCI procedures often face complications due to malapposition and incorrect sizing, leading to in-stent restenosis and stent thrombosis, as they are not tailored to the individual patient's complex arterial geometry, resulting in inadequate contact with the arterial wall and increased risk of cell proliferation and clot formation.
Innovation Solution
A method is developed to create personalized coronary stents by generating a 3-D model of the unstenosed blood vessel geometry, using a parametric description to adjust stent parameters for optimal expansion and apposition, and 3-D printing the stent to match the specific arterial geometry, including a mandrel with asymmetric pillars for supporting the stent during expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If standard stents are used for PCI procedures, then the procedure can be performed with conventional equipment, but the stent does not match the patient's complex arterial geometry, leading to malapposition and incorrect sizing
Solution Approach 1:
The patent performs preliminary actions by creating a 3-D model of the patient's specific arterial geometry before the PCI procedure, generating a customized stent design that matches the patient's anatomy. This preliminary customization allows the stent to be tailored to the specific arterial geometry, ensuring proper fit and apposition while avoiding the complications of using standard off-the-shelf stents.
Solution Approach 2:
The patent applies local quality by creating a stent with non-uniform strut characteristics - varying strut thickness, length, and density in different regions of the stent to match the local geometry of the arterial segment. This allows the stent to accommodate complex arterial geometry with bends, curves, and varying diameters, ensuring optimal apposition in each specific location rather than using a uniform design throughout.
2Reliability
If standard stents are used, then manufacturing and deployment are straightforward, but the stent struts may break during plastic deformation due to mismatched geometry
Solution Approach 1:
The patent applies parameter changes by modifying the stent design parameters - specifically strut thickness, length, and cross-sectional area - based on the local geometric requirements derived from the 3-D arterial model. This customization of structural parameters ensures that each strut is appropriately sized and shaped to withstand the plastic deformation forces during balloon expansion, preventing strut breakage while maintaining the ability to manufacture the stent using conventional techniques.
3Reliability
If standard stents are deployed, then the procedure is simpler, but the stent does not appose properly to the arterial wall, increasing risk of restenosis and thrombosis
Solution Approach 1:
The patent performs preliminary actions by creating a 3-D model of the patient's specific arterial geometry before the PCI procedure, generating a customized stent design that matches the patient's anatomy. This preliminary customization allows the stent to be tailored to the specific arterial geometry, ensuring proper fit and apposition while avoiding the complications of using standard off-the-shelf stents.
Solution Approach 2:
The patent applies asymmetry by designing stents with asymmetric strut patterns and varying radial profiles that match the asymmetric nature of real arterial geometry. This allows the stent to conform to complex arterial shapes including bends, curves, and irregular lumens, ensuring uniform apposition to the arterial wall throughout the entire stent length rather than relying on symmetric cylindrical designs.
Data Source
AI summary
A method including generating a 3-D model of an unstenosed geometry of a blood vessel responsive to a 3-D model of an actual geometry of the blood vessel, establishing a parametric description of a stent that is expanded from a collapsed configuration to a final configuration that apposes the unstenosed geometry, developing a design for the stent by varying parameters of the parametric description responsive to a design heuristic that includes risk of stent strut breakage during a plastic deformation between the collapsed configuration and the final configuration, embodying the stent according to the design for the stent, inserting the stent into a blood vessel in its collapsed configuration, maneuvering the stent through the blood vessel to a stenosis, and expanding the stent to its final configuration.