Prosthetic Aortic Valve Frame for Precise Transcatheter Deployment
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Solution Overview
Problem
Existing transcatheter prosthetic heart valves face challenges in achieving accurate placement and precise deployment at the orthotopic position, risking embolization, interference with cardiac conduction musculature, and obstruction of coronary arteries due to inadequate structural design and delivery systems.
Innovation Solution
A radially expandable and collapsible prosthetic aortic valve with a unique support frame structure, featuring interlaced octagonal cells and diamond-shaped links, and a delivery system with fluoroscopic markers for precise deployment, ensuring minimal protrusion and optimal positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional support frame structure is used, then the valve can be delivered through a catheter, but accurate placement and precise deployment at the orthotopic position cannot be achieved
Solution Approach 1:
The support frame is divided into multiple rows of cells (first row, second row, third row) with different configurations. The first row has a first configuration optimized for certain aspects of placement accuracy, while the second and third rows have a second configuration optimized for deployment precision and minimizing protrusion. This segmentation allows each row to contribute specific functional characteristics to achieve overall accurate placement and precise deployment.
Solution Approach 2:
Different rows of the support frame have different cell configurations tailored to specific local requirements. The first row uses a first configuration for its specific zone, while the second and third rows use a second configuration for their zones. This local differentiation optimizes the structural properties in different regions to achieve accurate placement and precise deployment at the orthotopic position while minimizing overall device complexity through standardized cell designs.
2Reliability
If the valve is deployed with inadequate structural design, then the delivery process is simpler, but risks of embolization and interference with cardiac conduction musculature increase
Solution Approach 1:
The support frame is segmented into multiple rows with different configurations to provide graduated structural support. The first row with the first configuration provides initial structural integrity to prevent embolization, while the second and third rows with the second configuration provide additional support to prevent interference with cardiac conduction musculature. This segmentation allows the valve to achieve reliable anchoring and positioning without requiring an overly complex monolithic structure.
Solution Approach 2:
The support frame transitions from a simple single-row structure to a multi-row three-dimensional configuration. By adding multiple rows of cells with different configurations, the structure gains enhanced radial strength and axial stability in the vertical dimension, preventing embolization and interference with cardiac conduction musculature while maintaining deliverability through the catheter.
3Ease of operation
If the valve protrudes excessively, then the delivery and deployment is easier, but obstruction of coronary arteries occurs
Solution Approach 1:
The support frame is divided into multiple rows that collectively provide the necessary structural support for easy deployment while minimizing overall protrusion. The first row with the first configuration provides baseline structural integrity, while the second and third rows with the second configuration provide additional support that reduces the need for excessive protrusion, thereby preventing coronary artery obstruction.
Solution Approach 2:
The cell configurations in different rows are optimized to change structural parameters such as cell size, shape, and arrangement. These parameter changes allow the support frame to achieve adequate radial strength and deployment ease while minimizing axial protrusion, thereby preventing obstruction of coronary arteries that arise from excessive valve protrusion.
4Strength
If a simple support frame is used, then the manufacturing is easier, but adequate radial strength and fatigue resistance cannot be achieved
Solution Approach 1:
The support frame is segmented into multiple rows of cells that can be manufactured using standardized processes. Each row (first row with first configuration, second and third rows with second configuration) can be produced using the same manufacturing methodology, maintaining ease of manufacture while achieving adequate radial strength through the cumulative effect of multiple rows.
Solution Approach 2:
The support frame utilizes a composite structure combining multiple rows of cells with different configurations. This composite design achieves adequate radial strength and fatigue resistance through the synergistic contribution of multiple rows, while maintaining manufacturability through the use of standardized cell designs that can be produced using conventional techniques.
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 solution enables accurate and precise deployment of the prosthetic valve at the orthotopic position, minimizing risks of embolization, cardiac conduction interference, and coronary artery obstruction, while maintaining optimal hemodynamics and reducing paravalvular regurgitation.
Implementation Method 1
The valve is allowed to expand to its functional size at the site of the defective native valve by inflating the balloon on which the valve is mounted
Implementation Method 2
The prosthetic aortic valve has fluoroscopic properties and when crimped on a balloon of the delivery catheter, exhibits alternate light and dense areas when viewed under fluoroscopy
Data Source
Figure 1~1a
Figure 1b
Figure 1c
AI summary
A radially expandable and collapsible prosthetic aortic valve suitable for mounting on a balloon of a delivery catheter in a radially collapsed condition is disclosed. The prosthetic aortic valve includes a support frame having three circumferentially extending rows of angled struts. Any two consecutive angled struts of a row of circumferentially extending angled struts form a peak/a valley. The adjacent rows of angled struts are connected to each other by links (either a diamond shaped cell or a rhombus body, thereby forming two rows of cells. The prosthetic aortic valve includes three leaflets, an internal skirt and an external skirt. The support frame and the delivery catheter provide an easy and accurate method for deployment of the prosthetic aortic valve at a target location.