Segmented Transcatheter Valve Prosthesis for Curved Vasculature
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Solution Overview
Problem
Transcatheter delivery methods for heart valve prostheses face complications such as vessel trauma, inaccurate placement, conduction disturbances, coronary artery obstruction, and undesirable paravalvular leakage due to large delivery profiles and curved anatomy challenges.
Innovation Solution
A transcatheter valve prosthesis with a tubular fabric body and independent self-expanding scaffolds at each end, an unsupported intermediate portion housing a prosthetic valve component, allowing for a compressed delivery profile and expanded deployment within a native valve, reducing stress and facilitating precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a single continuous stent structure is used to support the prosthetic valve, then the valve provides structural stability and anchoring, but the delivery profile becomes too large to navigate curved vasculature safely
Solution Approach 1:
The stent structure is divided into multiple independent stent segments (first stent, second stent, third stent) that can be delivered separately through the vasculature. Each segment can navigate curved anatomy independently with a smaller profile, then expand and connect at the implantation site to form a stable continuous structure, resolving the contradiction between deliverability and structural stability.
Solution Approach 2:
The stent segments are designed to be nested within each other during delivery, with smaller stent sections contained within larger ones. This nested configuration reduces the overall delivery profile to navigate curved vasculature, while the segments expand in sequence to form the full stable structure at the implantation site.
2Measurement precision
If the stent structure is made rigid to maintain valve position, then accurate placement is achieved, but the ability to navigate highly curved anatomy is reduced
Solution Approach 1:
The stent segments transition from a flexible, compressible state during navigation to a rigid, expanded state at implantation. The segments can be bent and shaped to navigate curved vasculature in their compressed state, then expand to provide rigid structural support and precise valve positioning at the target site.
Solution Approach 2:
Multiple independent stent segments provide flexibility during navigation, as each segment can be maneuvered separately through curved anatomy. Once deployed, the segments connect to form a rigid continuous structure that ensures accurate and stable valve placement.
3Reliability
If a large stent structure is used to prevent paravalvular leakage, then sealing is improved, but vessel trauma increases due to large delivery profile
Solution Approach 1:
The sealing function is distributed across multiple stent segments rather than requiring a single large stent. Each segment contributes to the overall seal, and their combined expansion creates effective sealing against paravalvular leakage while maintaining a smaller individual delivery profile that reduces vessel trauma.
Solution Approach 2:
The stent segments undergo parameter changes from compressed to expanded state, transitioning from small delivery dimensions to large sealing dimensions at implantation. This allows the structure to provide effective sealing performance while being delivered through smaller vasculature with minimal trauma.
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
The design enables safer, more precise placement and reduced stress during delivery through curved anatomy, minimizing complications like vessel trauma and leakage, while maintaining effective valve function.
Implementation Method 1
The first and second tubular scaffolds are configured to be self-expanding and are sized to anchor the prosthesis against native valve tissue
Data Source
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AI summary
Embodiments hereof relate to a transcatheter valve prosthesis (100) including a tubular fabric body (102), a first or inflow tubular scaffold (110) attached to a first end portion (102A) of the tubular fabric body, and a second or outflow tubular scaffold (120) attached to a second end portion (102C) of the tubular fabric body. A prosthetic valve component (114) is disposed within and secured to an intermediate portion (102B) of the tubular fabric body that longitudinally extends between the first and second end portions of the tubular fabric body. The intermediate portion is unsupported such that neither of the first and second tubular scaffolds surrounds the intermediate portion of the tubular fabric body. The intermediate portion may include one or more windows for coronary access and may include one or more commissure reinforcement members coupled thereto to provide support for the prosthetic valve component.