Collapsible Embolic Filter for TAVI Debris Trapping
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Solution Overview
Problem
Prosthetic heart valve implantation procedures, such as TAVI, often result in the creation of embolic debris that can cause blockages in smaller blood vessels, necessitating a solution to prevent the circulation of these debris during medical treatments.
Innovation Solution
An apparatus comprising a collapsible and deployable filter with control wires, introduced through a sheath, is positioned in the ascending aorta to trap embolic debris during valve implantation, allowing for the filtration of debris while facilitating the introduction of the valve assembly via the same blood vessel path, with optional use of a guide wire and contrast fluid for precise positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an emboli filter is associated with the TAVI assembly to prevent embolic debris circulation, then patient safety is improved, but the device complexity and difficulty of introduction through blood vessel paths increase
Solution Approach 1:
The filter is nested within the sheath in a collapsed state prior to deployment. The sheath contains the filter structure, allowing both components to be introduced through the same blood vessel access point. Once positioned in the aorta, the filter is deployed from the sheath to its expanded functional state, creating a nested configuration that resolves the contradiction between safety and device complexity.
Solution Approach 2:
The system is segmented into distinct functional components: the sheath for introduction and retrieval, the filter for debris trapping, and the TAVI assembly for valve replacement. This segmentation allows each component to be optimized independently while being introduced through a common access path, managing overall system complexity.
2Reliability
If a filter is deployed in the aorta to trap embolic debris, then debris circulation is prevented, but the difficulty of introducing the apparatus through blood vessel paths increases
Solution Approach 1:
The filter is collapsed within the sheath for introduction, allowing both to pass through the same blood vessel access point without requiring separate incisions or complex routing. The nested configuration reduces the profile during introduction, making the procedure easier to perform while maintaining the filter's full functionality once deployed.
Solution Approach 2:
The filter transitions from a collapsed dynamic state within the sheath to an expanded static state once deployed in the aorta. This dynamic transformation allows the filter to fit through narrow access paths when collapsed, then expand to its full functional size at the target location, improving ease of introduction while maintaining debris prevention capability.
3Object-affected harmful factors
If the filter is positioned to trap all embolic debris, then blockage risk is reduced, but the device complexity and procedural difficulty increase
Solution Approach 1:
The sheath acts as an intermediary device that simplifies the procedure by providing a common introduction path for both the sheath-filter assembly and the TAVI assembly. This intermediary structure allows both components to be routed through the same blood vessel access point, reducing procedural complexity compared to requiring separate access sites.
Data Source
AI summary
Apparatus for implanting a heart valve and removing debris from a blood vessel, composed of: a collapsible and deployable filter for blocking debris in a blood vessel in a patient's body; a circular cuff coupled to a small diameter end of the filter and defining a through passage extending from the small diameter end, the cuff having, at a first end, an internal diameter coaxial with a circular opening at the small diameter end of the filter; a first sheath for housing the filter in its collapsed state and having a length sufficient to extend out of a patient's body when the filter is at a desired location in a blood vessel; and an assembly for implanting a prosthetic valve in the patient's heart, said assembly comprising a second sheath and a catheter housed in the second sheath and carrying an implantable valve.