Transcatheter Heart Valve Plication Window Anchoring
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Solution Overview
Problem
Current transcatheter heart valve replacement technologies face challenges such as paravalvular leakage and movement/migration during the cardiac cycle, due to anatomical variations and material limitations, which affect the alignment and stability of prosthetic valves.
Innovation Solution
A transcatheter delivered prosthetic valve with an asymmetric pericardial tissue-covered wire frame, featuring an upper angled collar with scalloped diamond shapes and a middle ring of longitudinally vertical diamond shapes, connected to a reciprocating flow control conduit, and equipped with plication windows and tissue anchors to secure the valve in place, promoting tissue ingrowth and reducing stenosis and calcification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transcatheter prosthetic valve is deployed to replace a diseased heart valve, then minimally invasive treatment is achieved, but paravalvular leakage and valve migration occur due to anatomical variations and lack of secure anchoring
Solution Approach 1:
The prosthetic valve is divided into multiple functional components: a delivery catheter for minimally invasive access, an expandable valve body for replacement, and separate anchoring mechanisms (tissue anchors or plication systems) that can be independently deployed to secure the valve to the annulus, addressing both ease of operation and reliability
Solution Approach 2:
The anchoring mechanism is deployed before or during valve expansion to pre-establish secure attachment to the annular tissue. Tissue anchors are positioned and engaged with the annulus prior to full valve deployment, or plication windows are prepared in advance to receive anchoring elements, ensuring the valve remains stable during subsequent cardiac cycles
2Reliability
If the prosthetic valve is expanded to engage tissue at the diseased heart valve region, then the valve is held in position, but leakage around the implanted replacement valve occurs due to deformities in the valvular area
Solution Approach 1:
The sealing solution addresses local anatomical variations by providing targeted sealing mechanisms at specific regions of the annulus. Plication windows are strategically positioned to address areas of annular deformity or enlargement, and tissue anchors are placed at critical locations to prevent leakage without requiring uniform expansion of the entire valve structure
Solution Approach 2:
The prosthetic valve incorporates a flexible sealing cuff or skirt made of compliant material that can conform to irregular annular geometries. This thin film structure adapts to the local tissue topology, filling gaps and preventing paravalvular leakage while accommodating anatomical variations in the diseased valve region
3Reliability
If the prosthetic valve structure is made more complex with additional anchoring mechanisms, then valve stability is improved, but device complexity and difficulty of deployment increase
Solution Approach 1:
The anchoring function is integrated with the valve structure itself rather than being a separate system. Tissue anchors are incorporated into the valve frame, or plication windows are formed as part of the valve body, combining the valve replacement and anchoring functions into a single unified device that reduces overall system complexity while maintaining stability
Solution Approach 2:
The anchoring mechanism is designed to be self-deploying or self-anchoring upon valve expansion. Plication windows automatically engage with the annular tissue when the valve expands, or tissue anchors deploy passively as the valve is positioned, eliminating the need for separate manual anchoring steps and reducing deployment complexity
Data Source
AI summary
The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular a device and method for percutaneous annular plication, as a replacement device for a heart valve, whereby the prosthesis has an atrial annular flange or cuff having one or more integral plication windows connected to a pressure actuated flow control member extending into the ventricle, wherein the is a reciprocating mechanical member that is compressed by pressurized working fluid within the heart during ventricular systole.