Self-Expandable Aortic Valve Anchoring for Low-Calcification Implantation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing transcatheter prostheses face challenges in safely and correctly implanting aortic valve replacements due to the absence or limited presence of calcium, dilation of the aortic root, and the risk of embolization/migration, especially in cases of pure aortic insufficiency, where traditional surgical methods are not viable.
Innovation Solution
A self-expandable prosthetic heart valve with a support structure made of nitinol, featuring a selective and reversible control mechanism through connection means, allowing gradual expansion and attachment to the native aortic valve, with magnetic elements for enhanced anchorage and a mesh for debris filtration, enabling precise positioning and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcatheter prostheses are implanted percutaneously in patients with pure aortic insufficiency, then percutaneous treatment becomes possible, but stable anchoring cannot be guaranteed due to absence or limited calcium
Solution Approach 1:
The prosthesis is divided into multiple independent anchoring elements (legs) that can individually engage with the aortic root anatomy. Each leg can be independently positioned and secured, providing distributed anchoring that does not rely solely on calcium deposits. This segmentation allows the prosthesis to achieve stable fixation through multiple attachment points along the aortic root.
Solution Approach 2:
The patent introduces an intermediary anchoring mechanism that mediates between the prosthesis body and the aortic root tissue. This intermediary system uses expandable arms or legs that can engage with the aortic root anatomy independently of calcium deposits, providing a reliable connection interface that bridges the prosthesis and the soft tissue aortic root.
2Ease of operation
If aortic valve prosthesis is implanted in dilated aortic root, then treatment of aortic insufficiency becomes possible, but prosthesis size may exceed maximum sizes allowed by size charts
Solution Approach 1:
The prosthesis incorporates dynamic sizing capabilities through expandable anchoring elements that can adapt their dimensions to match the patient's specific aortic root anatomy. The anchoring legs or arms can be deployed in a staged manner, allowing the prosthesis to accommodate a range of aortic root sizes without being constrained by fixed size charts. This dynamic adaptation enables the same prosthesis design to be used across a broader patient population.
Solution Approach 2:
The patent employs parameter changes in the prosthesis design, particularly in the anchoring mechanism dimensions and deployment characteristics. By varying the deployable length, expansion ratio, and engagement depth of the anchoring elements, the prosthesis can be adapted to different aortic root diameters and anatomical configurations, extending its applicability beyond traditional size chart limitations.
3Reliability
If anchoring mechanism based on prosthetic oversizing is used, then anchoring can be achieved, but risk of embolization/migration increases
Solution Approach 1:
The anchoring function is segmented into multiple independent elements distributed around the aortic root circumference. This distribution of anchoring forces prevents excessive localized stress that could lead to tissue damage and subsequent embolization. The segmented approach also provides redundancy, where failure of one anchoring element does not compromise the overall stability of the prosthesis.
Solution Approach 2:
The prosthesis design incorporates local quality variations in the anchoring elements, with different engagement strategies for different anatomical locations. The anchoring legs can be designed with varying lengths, diameters, and engagement depths to optimize local fixation while minimizing trauma to the aortic root tissue. This localized optimization reduces the risk of tissue injury and embolization compared to uniform oversizing approaches.
4Ease of repair
If reversible control mechanism is implemented, then recapture and repositioning become possible, but device complexity increases
Solution Approach 1:
The patent replaces complex mechanical retrieval mechanisms with a simpler controlled expansion system. The recapture capability is achieved through controlled expansion and contraction of the anchoring elements, which can be actuated by a simple delivery system. This substitution of mechanical retrieval with controlled dimensional change simplifies the overall device architecture while maintaining the essential recapture function.
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 safe and precise percutaneous implantation of the prosthetic heart valve, reducing the risk of embolization and migration, and providing stable anchorage even in anatomical contexts with limited calcium, while minimizing paravalvular leaks.
Implementation Method 1
The support structure is made of a shape-memory material, such as a metal alloy, in particular nitinol. The passage of the support structure from the first compressed conformation to the second expanded conformation can occur gradually as it is removed from the catheter
Implementation Method 2
The upper portion and the lower portion comprise a plurality of magnetic elements, so that in the expanded conformation the plurality of magnetic elements of the upper portion and of the lower portion are close enough for an attractive force to form between them
Data Source
Figure 1~2
Figure 3~6
Figure 7~9
AI summary
Prosthetic heart valve (10), of the self-expandable type, for the percutaneous correction of heart valve defects, in particular for the replacement of a native aortic valve (A), wherein the prosthetic heart valve (10) is suitable to be inserted into a catheter (11) in order to be introduced into a body by means of an insertion tool (B) which can be associated with the catheter (11), wherein the prosthetic heart valve (10) comprises a support structure (12) configured to self-expand in a substantially radial manner from a first compressed conformation when inserted into said catheter (11), to a second expanded, or implant, conformation, when removed from said catheter (11), and a valve prosthesis (15) configured to replace the native aortic valve (A), disposed inside the support structure (12).