Support Structure for Native Heart Valve Anchoring
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Solution Overview
Problem
Current methods for replacing native heart valves, particularly in cases of aortic or mitral insufficiency, face challenges such as the need for precise and controlled delivery of prosthetic valves, especially when native leaflets are soft or the valve annulus is dilated, leading to complications like further dilation and difficulty in securing the prosthetic valve.
Innovation Solution
The use of a support structure, such as a stent or band, is delivered to the native heart valve, which is then used to secure an expandable prosthetic valve in place by frictionally engaging the native leaflets, allowing for precise positioning and anchoring without relying on calcified tissue, and can be adjusted to ensure a secure fit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a self-expanding prosthetic valve is used to replace a defective native valve, then the valve can be implanted without relying on calcified tissue, but the continuous outward force causes the valve annulus to dilate further and the valve to be ejected quickly from the delivery sheath
Solution Approach 1:
A support structure is delivered and expanded within the native valve annulus before the prosthetic valve is implanted. This support structure provides preliminary counteraction to the outward force of the self-expanding prosthetic valve, preventing further annulus dilation and maintaining structural stability during and after implantation.
Solution Approach 2:
The support structure serves as an intermediary element between the delivery system and the prosthetic valve. It provides a stable foundation within the native annulus that allows controlled deployment of the prosthetic valve while preventing direct interaction between the prosthetic valve's outward force and the native annulus tissue.
2Ease of manufacture
If a self-expanding prosthetic valve is advanced from a delivery sheath, then the valve can be deployed without a balloon, but the outward biasing force causes the valve to be ejected very quickly from the distal end of the delivery sheath
Solution Approach 1:
The support structure is delivered and positioned within the native valve annulus before the prosthetic valve is advanced from the delivery sheath. This preliminary action creates a stable receiving environment that allows the prosthetic valve to be deployed in a controlled manner without being ejected prematurely.
Solution Approach 2:
The support structure acts as an intermediary that receives and stabilizes the prosthetic valve during deployment. It provides a stable foundation that allows controlled positioning of the prosthetic valve while preventing uncontrolled ejection from the delivery sheath.
3Strength
If a balloon-expandable prosthetic valve is used, then the catheter balloon can apply sufficient expanding force to anchor the frame to calcified tissue, but the native leaflets are too soft to provide sufficient support when the annulus is dilated
Solution Approach 1:
The support structure serves as an intermediary that provides reliable anchoring in the dilated annulus. It creates a stable foundation that compensates for the insufficient support from soft native leaflets, allowing the balloon-expandable prosthetic valve to be securely anchored even in the absence of calcified tissue.
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
This approach enables safer and more precise delivery and anchoring of prosthetic valves, reducing the risk of further valve dilation and improving the reliability of the procedure by providing a stable foundation for the prosthetic valve, even in cases where native leaflets are soft or the annulus is dilated.
Implementation Method 1
securing the prosthetic valve in place by frictionally engaging the native leaflets
Data Source
AI summary
A method includes advancing a delivery assembly through a patient's vasculature toward a native heart valve of the patient, wherein the delivery assembly comprises a first catheter assembly and a second catheter assembly extending through a shaft of the first catheter assembly, and wherein a support member is in an uncoiled, elongated configuration within a sheath of the first catheter assembly. The support member is deployed from the sheath by pushing the second catheter assembly distally relative to the first catheter assembly so that the support member is uncovered by the sheath and the support member extends around native chordae tendineae and native leaflets of the native heart valve. A prosthetic valve is implanted within the native leaflets of the native heart valve such that the native leaflets are frictionally engaged between the support member and the prosthetic valve.