Braided Stent Heart Valve Remodeling Device
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Solution Overview
Problem
Current methods for remodeling native heart valves, such as balloon aortic valvuloplasty, often restrict blood flow and require rapid pacing of the heart, which can be risky and invasive, necessitating a less invasive and safer approach for preparing the valve for replacement.
Innovation Solution
A heart valve remodeling device featuring a braided stent and polymer valve structure that can be translated between elongated and deployed configurations, allowing for radial expansion of the native valve without the need for rapid pacing, using a delivery device with an inner and outer shaft, and a polymer valve structure with leaflets that function as a temporary heart valve during remodeling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If balloon aortic valvuloplasty is used to remodel native heart valves, then the valve can be prepared for replacement, but blood flow is restricted and rapid pacing is required which increases invasiveness and risk
Solution Approach 1:
The braided stent is deployed in advance of the replacement valve to remodel the native valve annulus, creating a stable platform for subsequent valve installation. This preliminary remodeling action eliminates the need for rapid pacing and minimizes blood flow restriction during the preparation phase.
Solution Approach 2:
The braided stent acts as an intermediary device between the delivery system and the replacement valve. It provides a structural framework that supports the replacement valve while simultaneously remodeling the native valve annulus, thereby eliminating the need for direct balloon expansion and rapid pacing.
2Reliability
If a stable platform is provided for replacement valve installation, then valve replacement success is improved, but the device structure becomes more complex
Solution Approach 1:
The device is segmented into distinct functional components: the braided stent for annulus remodeling, the delivery device with inner and outer shafts for deployment control, and the replacement valve. This segmentation allows each component to perform its specific function efficiently while maintaining overall system manageability.
Solution Approach 2:
The delivery device employs a nested structure where the inner shaft is contained within the outer shaft, and the braided stent is mounted on the inner shaft. This nesting arrangement compactly houses complex components within a manageable delivery profile, reducing operational complexity despite the sophisticated functionality.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables stable remodeling of the native heart valve without restricting blood flow or requiring rapid pacing, providing a more stable platform for replacement valve installation and reducing invasive procedures.
Implementation Method 1
an elongated braided structure, which is expanded radially and outwards upon being longitudinally compressed
Implementation Method 2
a polymer valve structure with leaflets that function as a temporary heart valve during remodeling
Data Source
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AI summary
A heart valve remodeling device may include a delivery device including an inner shaft slidably disposed over a guidewire and an outer shaft slidably disposed over the inner shaft, and a braided stent fixedly attached to the inner shaft and the outer shaft. The braided stent may be translatable between an elongated configuration and a deployed configuration by movement of the inner shaft relative to the outer shaft. The braided stent may include a valve having two or more leaflets disposed within the braided stent. Adjacent leaflets of the two or more leaflets may form longitudinally-oriented commissures proximate a perimeter of the valve, the commissures being fixedly secured to the braided stent along their length.