Transcatheter Embolic Filter With Funnel Passage and Distal Sealing
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Solution Overview
Problem
Existing transcatheter heart valve implantation procedures, such as TAVI, face significant challenges with embolic events due to the presence of heavily calcified native valves, leading to macro- and micro-embolic cerebral events, vascular dementia, and complications like acute kidney injury, with current antiembolic devices failing to provide comprehensive protection and often interfering with other catheters.
Innovation Solution
An antiembolic filter with a proximal funnel and distal closure mechanism, allowing catheters to pass through without contact, ensuring protection against both macro- and microemboli, and featuring a design that can be collapsed and repositioned to prevent emboli release during and after the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transcatheter heart valve prosthesis is implanted to treat aortic valve disease, then the valve function is improved, but embolic events occur due to calcified tissue disruption
Solution Approach 1:
An embolic protection filter is introduced as an intermediary device between the calcified aortic valve and the cerebral circulation. The filter captures embolic debris generated during TAVI procedures while allowing blood flow and catheter passage, thereby protecting the brain from emboli without interfering with the valve implantation procedure
Solution Approach 2:
The embolic protection system is segmented into distinct functional components: a filter element with specific pore sizes to capture different sizes of emboli, a delivery catheter system for minimally invasive placement, and a retrieval mechanism. This segmentation allows each component to be optimized for its specific function while working together as an integrated system
2Reliability
If the filter structure is made complex to ensure comprehensive embolic protection, then protection effectiveness is improved, but interference with other catheters increases
Solution Approach 1:
The filter device is designed with a nested structure where the filter element is contained within a delivery catheter, which itself is nested within an outer sheath. This nested configuration allows the complex filter structure to be compressed into a small profile for easy catheter navigation and delivery, then expanded at the target site to provide comprehensive embolic protection
Solution Approach 2:
The filter employs dynamic structures including expandable frames and flexible membrane materials that allow the device to adapt its configuration. The filter can be compressed to a low profile for catheter passage, then expanded at the implantation site to provide comprehensive embolic protection, and later collapsed for retrieval
3Adaptability or versatility
If the filter is designed to capture all emboli types, then protection coverage is improved, but device complexity increases
Solution Approach 1:
The filter employs porous materials with specifically engineered pore size distributions to capture emboli of different sizes. The porous structure provides large surface area for emboli capture while maintaining blood flow permeability, achieving comprehensive protection without requiring complex mechanical structures
Data Source
AI summary
An intra-vessel transcatheter filter device (1) designed to capture and remove emboli, thus preventing distal embolization, comprising: • a tubular filter (2) comprising a flexible porous material and defined by a distal element and a proximal element, namely a main body (3) and a funnel (4); i. said main body (3) having a length adapted to extend within a suitable vessel zone; said main body (3) comprising: a) a distal end (5) that is adapted to be radially coupled with said zone and hermetically sealed to it when the device is in an active configuration, said distal end (5) being provided of selectively actionable closure means so that said distal end is designed to be open when the device is in an active configuration and closed before the device retraction, b) a proximal end (6); ii. said funnel (4) forming an extension of said main body (3), with the funnel base located at said proximal end (6). • a support structure assembly (8) comprising: i. a supporting catheter (11) extending within said main body (3), ii. one radially expandable distal structure (9) fixed to said distal end (5), iii. one radially expandable proximal structure (10) positioned in correspondence of said proximal end (6), said distal structure (9) and said proximal structure (10) being fixed at least in an end to said supporting catheter (11).