Asymmetrical Heart Valve Frame with Indentation
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Solution Overview
Problem
Existing heart valve prostheses with expandable tubular frames and mesh structures are not fully satisfactory due to risks of interfering with the aortic valve operation, migration, and obstruction of the ventricular ejection path, and are difficult to place with a shape that is not perfectly adapted to the implantation site, especially in elderly patients.
Innovation Solution
The prosthesis features an asymmetrical ventricular portion with a large indentation and anchoring spikes on both the atrial and ventricular portions, allowing for secure anchoring to the valve annulus without hindering the aortic valve, and a spherical or ovoid shape for the ventricular portion to reduce migration risks and facilitate easy placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a complete tubular frame with mesh structure is used, then structural strength and support are improved, but the risk of interfering with aortic valve operation and obstructing ventricular ejection path increases
Solution Approach 1:
The patent removes a sector of the mesh structure from the ventricular portion to create an indentation. This extraction eliminates the harmful interaction with the aortic valve and ventricular ejection path while preserving the structural integrity of the remaining frame through strategic placement of anchoring spikes and optimized geometry.
Solution Approach 2:
The patent introduces asymmetry by creating a large indentation on one side of the ventricular portion while maintaining a complete structure on the opposite side. This asymmetric design allows the prosthesis to avoid interfering with the aortic valve on the indented side while maintaining adequate support where needed.
2Object-affected harmful factors
If the mesh structure is reduced to avoid aortic valve interference, then harmful factors are reduced, but the anchoring stability and resistance to migration worsen
Solution Approach 1:
The patent segments the anchoring function from the continuous mesh structure by introducing discrete anchoring spikes at critical locations. These spikes are strategically positioned to provide sufficient anchoring stability while the intervening mesh-free zone prevents interference with the aortic valve and ventricular ejection path.
Solution Approach 2:
The anchoring spikes are designed to engage with the annular portion and ventricular wall during the deployment process, establishing secure anchoring before the prosthesis is fully expanded. This preliminary anchoring action ensures stability is achieved even with reduced mesh structure.
3Ease of manufacture
If a symmetrical tubular frame is used, then manufacturing is simplified, but the adaptation to the anatomical implantation site and reduction of migration risk worsen
Solution Approach 1:
The patent introduces asymmetry by creating a large indentation on one side of the ventricular portion while maintaining a complete structure on the opposite side. This asymmetric design allows the prosthesis to avoid interfering with the aortic valve on the indented side while maintaining adequate support where needed.
4Reliability
If anchoring spikes are added to ensure complete anchoring, then migration risk is reduced, but the device complexity increases
Solution Approach 1:
The patent segments the anchoring function from the continuous mesh structure by introducing discrete anchoring spikes at critical locations. These spikes are strategically positioned to provide sufficient anchoring stability while the intervening mesh-free zone prevents interference with the aortic valve and ventricular ejection path.
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 prosthesis effectively prevents interference with the aortic valve operation, reduces migration and obstruction risks, and is easier to place with a shape well-suited to the anatomical site, ensuring secure locking and reduced paravalvular leakage.
Implementation Method 1
The frame may be self-expandable (in particular being made from a shape memory material) or made from an expandable material using a balloon
Data Source
AI summary
This prosthesis (1), comprises an expandable tubular frame (2) with a mesh structure and a prosthetic valve (3) mounted on this frame;the ventricular portion (2v) of the frame (2) has a large indentation (6) on one side, extending lengthwise from the end of this ventricular portion (2v) that is opposite said annular portion (2i) to the part of this ventricular portion (2v) close to the annular portion (2i), this indentation (6) extending over a sector of the circumference of the prosthesis (1) of about 90 to 140°;said atrial portion (2a) flares toward the outside of the prosthesis, from said annular portion (2i) toward the end of this atrial portion opposite this annular portion, and comprises anchoring spikes (5a) on the side of said annular portion (2i); andsaid ventricular portion (2v) has a substantially spherical or ovoid shape and comprises anchoring spikes (5v) on the side of said annular portion (2i).