Single Frame Tethered Transcatheter Heart Valve Anchoring
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Solution Overview
Problem
Current collapsible and expandable prosthetic heart valves face challenges in anchoring within the native valve annulus, particularly in patients with smaller annuli or reduced calcification, leading to potential migration and paravalvular leakage, limiting their applicability to patients who require less invasive procedures due to frailty or annular size constraints.
Innovation Solution
A prosthetic atrioventricular valve system featuring a self-expandable frame with a body portion, an atrial flare portion, commissure attachment features, and a commissure support ring, designed to provide enhanced anchoring and sealing within the native valve annulus, utilizing a single frame configuration that integrates anchoring and leaflet support, reducing the risk of migration and leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a dual-frame prosthetic heart valve is used to provide strong anchoring in native atrioventricular valves, then anchoring strength is improved, but the valve size becomes too large for patients with smaller annuli, limiting applicability to frail patients who need less invasive procedures
Solution Approach 1:
The valve frame is segmented into two functional portions: an outer frame for anchoring and an inner frame for receiving and supporting the prosthetic leaflets. This segmentation allows each frame to be optimized for its specific function while enabling the valve to accommodate smaller annuli by reducing the overall valve size while maintaining adequate anchoring strength through the outer frame.
Solution Approach 2:
The patent combines the outer frame and inner frame into a single integrated valve assembly where the inner frame is received within the outer frame. This merging allows the valve to achieve both strong anchoring (via the outer frame) and adequate hemodynamic performance (via the inner frame with prosthetic leaflets) in a compact configuration suitable for smaller annuli.
2Reliability
If the radial force exerted by the stent is increased to improve anchoring within the native valve annulus, then anchoring stability is improved, but heart tissue damage occurs
Solution Approach 1:
The outer frame is designed with differentiated local properties: the body portion provides radial expansion force for anchoring, while the atrial flare portion extends into the left atrium to distribute anchoring forces over a larger area, reducing stress concentration on any single tissue point and minimizing tissue damage while maintaining anchoring stability.
Solution Approach 2:
The anchoring mechanism transitions from a single-plane radial force application to a multi-dimensional anchoring system that includes vertical extension into the left atrium through the atrial flare portion. This dimensional extension allows the valve to achieve anchoring stability through multiple vectors of force, reducing the radial force required at any single point and thereby reducing tissue damage risk.
3Object-affected harmful factors
If the radial force exerted by the stent is decreased to avoid heart tissue damage, then tissue injury is reduced, but the heart valve may move from its deployed position or migrate from the native valve annulus
Solution Approach 1:
The outer frame is pre-formed with an expanded configuration that includes an atrial flare portion extending into the left atrium before deployment. This preliminary configuration ensures that when the valve is deployed, the anchoring structures are already in position to prevent migration, while the controlled radial expansion force minimizes tissue injury during the deployment process.
Solution Approach 2:
The atrial flare portion acts as an intermediary structure between the outer frame and the left atrial tissue. It provides a gradual transition zone that distributes anchoring forces over a larger volume of tissue, reducing the peak stress on any single tissue element and thereby preventing both tissue damage and valve migration simultaneously.
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 design allows for effective anchoring and reduced paravalvular leakage, enabling treatment of patients with smaller valve annuli while maintaining hemodynamic performance, simplifying delivery, and potentially reducing manufacturing costs and procedural complexity.
Implementation Method 1
the stent automatically expands as the stent is released from the delivery apparatus
Data Source
AI summary
According to one aspect of the disclosure, a prosthetic atrioventricular valve system includes a prosthetic atrioventricular valve having a self-expandable frame with a collapsed and expanded condition. In the expanded condition, the frame includes (i) a body portion sized to be positioned within, and in contact with, a native atrioventricular valve annulus, (ii) an atrial flare portion positioned in an inflow direction relative to the body portion, the atrial flare portion having an outer diameter that is greater than an outer diameter for the body portion, (iii) a plurality of commissure attachment features (“CAFs”) extending in an outflow direction from the body portion, and (iv) a commissure support ring coupled to and circumferentially supporting the plurality of CAFs. A plurality of prosthetic leaflets may be mounted to the CAFs. The body portion, the atrial flare portion, and the plurality of CAFs may be formed integrally.