Valvular Embolic Filter for Aortic Root Protection
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Solution Overview
Problem
During transcatheter aortic valve implantation (TAVI), the generation of calcium debris can cause post-operative coronary embolism and paravalvular leaks due to the irregularity of calcifications, which complicates blood circulation and patient safety, especially when extracorporeal circulation is not used.
Innovation Solution
A device with a valvular embolic filter assembly is introduced into the aortic root, featuring a cone-shaped part with angularly offset shells and a filtering membrane to create a safety chamber that mimics the native valve's function, preventing debris migration and regurgitation, and includes a radiopaque balloon for tissue protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If transcatheter decalcification is performed to remove calcium debris from the aortic valve, then the quality of the implantation surface is improved and paravalvular leaks are reduced, but calcium debris may migrate into the aortic root and cause embolic accidents
Solution Approach 1:
An embolic protection device is introduced as an intermediary between the decalcification process and the aortic root. The device includes a filter assembly with a mesh structure that intercepts calcium debris generated during decalcification, preventing its migration into the aortic root while allowing blood flow to pass through. The device is deployed in the aortic root and can be selectively positioned to protect critical areas during the decalcification procedure.
Solution Approach 2:
The embolic protection device is divided into multiple functional segments: a delivery catheter for minimally invasive introduction, a deployable filter assembly with mesh structure for debris capture, and a retrieval mechanism. This segmentation allows the device to be introduced through a catheter, deployed to create a protective barrier, and subsequently retrieved after decalcification is complete, enabling the implantation surface improvement without exposing the aortic root to embolic risk.
2Object-affected harmful factors
If a filtering membrane with small porosity is used to block tissue debris, then embolic protection is improved, but blood flow passage may be obstructed
Solution Approach 1:
The filter assembly employs local quality by using a mesh structure with selectively sized openings distributed across its surface. The mesh geometry is designed so that individual openings are small enough to intercept calcium debris and tissue fragments, while the cumulative open area across the entire mesh surface maintains adequate blood flow capacity. This local optimization of pore size and distribution allows simultaneous debris blocking and blood flow preservation.
Solution Approach 2:
The filter assembly utilizes a porous mesh material with controlled porosity characteristics. The mesh structure provides a high surface area-to-volume ratio with interconnected pores that trap embolic debris through physical filtration while maintaining permeability to blood cells and plasma. The porous architecture allows blood to pass through the filter assembly at physiological flow rates while capturing particulate matter that would otherwise cause embolic complications.
3Reliability
If the conical part is deployed to create a safety chamber, then a temporary valve function is achieved and regurgitation is prevented, but the device complexity increases
Solution Approach 1:
The conical part is designed as a dynamic, deployable structure rather than a static component. It can be collapsed into a compact configuration for delivery through the catheter and then expanded to its functional conical shape once positioned in the aortic root. The deployable nature allows the structure to transition between low-profile delivery and high-functionality deployment states, providing temporary valve function only when needed during the procedure.
Solution Approach 2:
The conical part with its angularly offset shells is nested within the catheter assembly during delivery, similar to a nested doll structure. The shells are collapsed together in a compact configuration that fits within the catheter lumen, and upon deployment, they expand outward to form the functional conical safety chamber. This nesting approach minimizes the delivery profile while maximizing the deployed functional geometry.
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 device enables safe transcatheter decalcification and valve implantation by preventing embolic accidents and paravalvular leaks, ensuring physiological blood circulation and minimizing the risk of acute aortic insufficiency and iatrogenic stroke.
Implementation Method 1
a filtering membrane (4) which comprises a layer (4a) designated as lower layer, composed of a mesh network with a porosity suitable for blocking tissue debris while allowing the passage of the blood flow
Implementation Method 2
an upper layer made of a soft and extensible polymer material for acting as a temporary valve, by simple deformation determined by the systolic pressure
Implementation Method 3
The catheter (1) has a radiopaque end able to protect the surrounding tissue during its introduction and its navigation in the aorta
Data Source
AI summary
A device for transcatheter insertion into the aortic root at the sinotubular junction by a wire guide and a catheter for protecting surrounding tissues, the device including an assembly serving as a valvular embolic filter, configured to slide in a guided manner inside the catheter, the assembly configured to form, in the aortic root of an aorta, a safety enclosure ensuring a valve function and a protective function against embolic accidents, wherein the assembly includes, a tubular body, and a filtration and valve part configured to deploy outside the catheter or retract inside the catheter, wherein the tubular body is secured, at one end, to the filtration and valve part, wherein the filtration and valve part forms the valvular embolic filter and a temporary valve, wherein the filtration and valve part is configured to prevent regurgitation of blood when deployed outside the catheter for covering a native aortic valve with a seat secured in the aortic root at sinuses of valsalva without obstructing a blood flow.