Re-Expandable Growth Stent Frame for Congenital Vessel Narrowing
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Solution Overview
Problem
Current stents have limited operational ranges and cannot grow with patients, leading to complications in young patients due to vessel narrowing and the need for open heart surgery.
Innovation Solution
A re-expandable flexible growth stent with a unique frame structure that allows for expansion from an initial to a second stable state, maintaining axial flexibility and supporting vessel growth from neonatal to adult sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent is implanted in a young patient to treat vessel narrowing, then the vessel opening is maintained at implantation, but the stent cannot grow with the patient as they develop to adult sizes
Solution Approach 1:
The stent is designed with dynamic characteristics allowing it to transition from a compressed delivery state through an initial expanded state to a second expanded state as the patient grows. The frame structure enables controlled expansion phases, where the stent can be re-expanded from the first stable expanded state to a second stable expanded state to accommodate vessel growth while maintaining structural integrity throughout the transformation
Solution Approach 2:
The stent frame is divided into multiple expandable cell structures arranged in repeating patterns along the stent length. These segmented cells allow incremental expansion capability, where each cell can expand independently to accommodate growth while maintaining overall stent coherence and structural support throughout the expansion process
2Adaptability or versatility
If a stent is designed to expand to adult sizes, then growth capability is achieved, but the stent loses axial flexibility needed for implantation and re-expansion
Solution Approach 1:
Different portions of the stent frame are assigned different structural qualities. The frame members connecting adjacent cell structures incorporate localized flexibility features such as reduced cross-sectional areas or hinge-like joints at specific locations, allowing axial bending and compression during delivery and re-expansion while maintaining radial strength and structural integrity when expanded to support the vessel
Solution Approach 2:
The stent frame utilizes thin-walled tubular structures and membrane-like connections between cells that provide axial flexibility while maintaining radial rigidity. These flexible structural elements allow the stent to be compressed for delivery and bent during implantation procedures, yet provide sufficient structural support when expanded to maintain vessel patency
3Strength
If the stent frame is made rigid to maintain strength throughout expansion, then structural integrity is preserved, but the stent cannot be compressed for catheter delivery
Solution Approach 1:
The stent is designed to be nested within a delivery catheter in a compressed state, similar to a nested doll structure. The frame can be crimped or compressed axially to fit within the catheter delivery system, then expanded radially outward to the first and second expanded states. This nested configuration allows the stent to maintain structural integrity when expanded while enabling compact delivery through the catheter
4Ease of manufacture
If the stent is designed for single-size implantation, then manufacturing is simple, but repeated surgeries are needed as the patient grows
Solution Approach 1:
The stent is designed as a universal device that can serve multiple functions across different patient ages and vessel sizes. A single stent implantation can accommodate the patient's growth from childhood through adulthood by enabling re-expansion to a second stable expanded state, eliminating the need for multiple surgical interventions and providing long-term vascular support with one implantable device
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early-stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.