Transcatheter Valve Prosthesis Sub-Annular Anchoring
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Solution Overview
Problem
Current transcatheter valve prostheses face challenges in effectively replacing atrio-ventricular heart valves due to issues with fixation and sealing, leading to potential blood flow complications such as leakage or resistance.
Innovation Solution
A transcatheter atrio-ventricular valve prosthesis with a radially expandable tubular body and circumferential groove structure, featuring projections that engage with the native valve tissue to secure the prosthesis in place, combined with an elongate outer member that radially forces tissue into the groove for sub-annular anchoring and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transcatheter valve prosthesis is designed with fixation members to secure the prosthesis in place, then the reliability of valve replacement is improved, but the device complexity increases due to additional components needed for anchoring and sealing
Solution Approach 1:
The prosthesis is divided into distinct functional segments: a tubular body for structural support, an outer member for tissue engagement, and multiple projections for anchoring. This segmentation allows each component to perform its specific function efficiently while maintaining overall system reliability without excessive complexity.
Solution Approach 2:
The projections are integrated into the tubular body structure, with the outer member encompassing both the tubular body and projections. This nested arrangement consolidates multiple fixation functions into a compact integrated structure, improving reliability while controlling device complexity.
2Reliability
If an outer member is used to radially force tissue into the groove for sub-annular anchoring, then the sealing performance is improved, but the ease of operation deteriorates due to additional steps required for deployment
Solution Approach 1:
The outer member is pre-positioned around the tubular body before tissue engagement. This preliminary positioning ensures that when the prosthesis is deployed, the tissue is already guided into the groove by the pre-formed structure, improving sealing performance while simplifying the actual deployment process.
Solution Approach 2:
The outer member acts as an intermediary between the tubular body and the native tissue. It facilitates tissue engagement by providing a controlled interface that guides tissue into the groove and engages with the projections, achieving reliable sealing without requiring complex manual manipulation during deployment.
3Strength
If projections are provided on the tubular body to engage with native valve tissue, then the fixation strength is improved, but the difficulty of detecting and measuring the implantation position increases
Solution Approach 1:
The prosthesis components, particularly the projections and outer member, are designed with radiopaque properties that enable visualization under fluoroscopic or other imaging guidance. This allows the medical team to detect and measure the implantation position and verify proper engagement of the projections with native tissue, overcoming the detection difficulty while maintaining strong fixation.
Data Source
Figure 1~1b
Figure 2~2a
Figure 3
AI summary
A transcatheter atrio-ventricular valve prosthesis (1) for functional replacement of an atrio-ventricular heart valve in a connection channel ( 10), having a circumferential connection channel wall structure (25), between the atrial chamber (15) and the ventricular chamber (20) of a heart, comprising a radially expandable tubular body (30) to be disposed in the interior of the connection channel (10) and extending along an axis (35), and a valve (40) arranged within and attached to the tubular body (30), wherein the tubular body (30) is provided with an outer circumferential groove (45) which is open to the radial outside of the tubular body (30) and which defines a groove bottom (46), whereby the tubular body (30) is separated by the outer circumferential groove into first (31) and second (32) body sections, and wherein the tubular body (30) is provided with a first plurality of projections (50, 55) which extend from the first or second body section (31, 32) in an axial direction of the tubular body (30) and each of which has a free end (60, 65) arranged to overlap the outer circumferential groove (45), further comprising an elongate outer member (75) to be disposed at the exterior of the connection channel wall structure (25) at a level of the circumferential grove (45), wherein the outer member (75) can at least partially extend around the tubular body (30) with valve tissue of the connection channel wall structure (25) being correspondingly circumferentially arranged between the tubular body (30) and the outer member (75) and in such a radial distance (R5) to the axis (35) of the tubular body (30) that the valve tissue of the connection channel wall structure (25) can be radially forced into the outer circumferential groove (45) so as to be at least partially located radially below the projections (50, 55).