Growth-Accommodating Prosthetic Valve with Constant-Path Leaflet Attachment
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Solution Overview
Problem
Current prosthetic heart valves implanted in children to replace diseased pulmonary valves often need to be replaced multiple times as the child grows, as they do not accommodate growth effectively, leading to repeated surgical interventions.
Innovation Solution
A growth-accommodating prosthetic valve system featuring an expandable stent with leaflets sutured along a path that maintains its length as it expands, allowing the valve to increase in diameter while maintaining full coaptation of leaflets, and optionally includes a skirt to mitigate paravalvular leaks, constructed from materials like biological tissue or stretchable polymers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size prosthetic valve is implanted in a child, then the valve structure remains stable and simple, but the valve cannot accommodate growth and requires multiple replacements
Solution Approach 1:
The patent applies the dynamics principle by designing a valve stent that can transition between different size configurations. The stent includes expandable cells that can be inflated from a compressed delivery state to an expanded functional state, and can be re-inflated later to accommodate growth. This dynamic capability allows the same valve structure to adapt to the child's growth without requiring replacement.
Solution Approach 2:
The patent applies the nesting principle by designing a valve that can be compressed into a small delivery profile for initial implantation, then expanded to its full functional size. The same valve can be compressed again and re-expanded at a later date to accommodate growth. This nested capability allows a single valve to serve multiple size requirements over time.
2Adaptability or versatility
If the stent diameter is increased to accommodate growth, then the valve can fit a larger patient, but the leaflet attachment path length would change causing improper coaptation
Solution Approach 1:
The patent applies the local quality principle by making the leaflet attachment path on the stent surface longer than the straight-line distance between attachment points. This extra path length provides compensation for the changes in geometry that occur during expansion and growth accommodation, ensuring that the leaflets maintain proper coaptation despite the changing stent diameter.
Solution Approach 2:
The patent applies the parameter changes principle by designing the stent with variable cell dimensions and attachment point spacing that change in a controlled manner during expansion. The stent structure is engineered so that as the diameter increases, the attachment path geometry changes in a way that maintains the effective leaflet coaptation length, allowing size adaptation without sacrificing manufacturing precision.
3Adaptability or versatility
If the stent expands radially to increase diameter, then the valve accommodates growth, but the height decreases which may affect valve positioning
Solution Approach 1:
The patent applies the dynamics principle by designing the stent with expandable cells that can change their vertical dimension dynamically. When the stent is first implanted, the cells are in a compressed vertical state providing adequate height. As the child grows and the stent is re-inflated to increase diameter, the cells expand radially and their vertical dimension decreases, which is accommodated by the dynamic nature of the implantation and re-inflation process.
Data Source
AI summary
A growth-accommodating prosthetic valve system that can accommodate a patient's growth over time. The system features an expandable stent that can expand from a contracted configuration to an expanded configuration and leaflets attached to the scaffold that is sewn along a path such that the length of the path stays generally the same as the scaffold moves from the contracted configuration to the expanded configuration.