Prosthetic Heart Valve Leaflet Trapping for Stable Catheter Anchoring
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Solution Overview
Problem
Traditional surgical heart valve replacement is invasive and not suitable for all patients, while minimally invasive techniques like TMVR and TTVR face challenges in device design and long-term outcomes.
Innovation Solution
A prosthetic heart valve support structure with a body portion, atrial flange, and leaflet engaging portion that expands to trap native valve leaflets between the leaflet engaging portion and the body portion, using a framework of shape memory materials like Nitinol for deployment and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical valve replacement is used, then reliable valve replacement is achieved, but patient trauma and recovery time increase significantly
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter in a compressed state, allowing it to be delivered through a minimally invasive transcutaneous access point. The valve is then deployed from within the catheter into the native valve position, eliminating the need for open surgical chest opening while achieving reliable valve replacement.
Solution Approach 2:
The prosthetic valve utilizes a flexible frame structure that can be compressed into a small profile for delivery through catheters, then expands to its functional shape at the implantation site. This flexibility enables minimally invasive delivery while maintaining structural integrity and valve function.
2Object-affected harmful factors
If minimally invasive valve replacement techniques are used, then patient trauma is reduced, but device anchoring stability and seal performance worsen
Solution Approach 1:
The prosthetic valve employs a dynamic expansion mechanism where the frame transitions from a compressed delivery state to an expanded functional state. During deployment, the frame radially expands to engage with the native valve annulus, creating stable anchoring and sealing through controlled mechanical expansion rather than static fixation.
Solution Approach 2:
The valve utilizes shape memory materials or phase transition materials that change their mechanical properties during deployment. The frame material transitions from a flexible, compressible state during delivery to a rigid, stable state when expanded, providing both ease of delivery and reliable anchoring.
3Reliability
If the prosthetic valve expands to trap native leaflets, then paravalvular leaks are reduced, but device complexity increases
Solution Approach 1:
The expanding frame serves multiple functions simultaneously: it provides structural support for the prosthetic valve, anchors the device to the native valve annulus, and creates a sealing mechanism by trapping the native leaflets between the frame and the annulus. This multi-functionality reduces the need for separate sealing components.
Solution Approach 2:
The sealing function is merged with the anchoring function by using the same expanding frame structure. The frame both secures the prosthetic valve in position and prevents paravalvular leaks through its sealing action on the native leaflets, combining two critical functions into a single structural element.
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
Facilitates less invasive heart valve replacement by securely anchoring the prosthetic valve, reducing the risk of paravalvular leaks and promoting tissue integration, thus offering a viable alternative for complex valve replacements.
Implementation Method 1
using a framework of shape memory materials like Nitinol for deployment and expansion
Data Source
AI summary
Prosthetic valve support structures of this specification include a body portion, an atrial flange portion, and a leaflet engaging portion. As the support structure (and the valve as a whole) is pushed out of or otherwise unrestrained from a delivery device, the free end(s) of the leaflet engaging portion will begin to bend radially outward or away from the body portion and will continue bending as more is exposed until its free end(s) are angled in an inflow direction, thereby positioning themselves between the radial outside of the native valve leaflets and the outflow track beyond the native valve annulus. As the support structure fully expands, the native valve leaflets remain trapped or engaged between the leaflet engaging portion and the body portion.