Two-Part Heart Valve Reducing Crimped Profile and Leakage
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Solution Overview
Problem
Current percutaneous heart valve implantation methods face challenges in achieving a small crimped profile for wider population treatment and reducing paravalvular leakage, with existing techniques requiring additional surgical steps and potential complications.
Innovation Solution
A two-part implantable heart valve system where a temporary valvular structure is used for initial expansion and positioning, followed by deployment of a second part that compresses the temporary valve between two frames to enhance friction and reduce leakage, allowing for a smaller crimped profile and eliminating the need for additional surgical steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-part heart valve implantation method is used, then the procedure is simpler, but the crimped profile cannot be sufficiently reduced and paravalvular leakage occurs
Solution Approach 1:
The heart valve implantation device is divided into two separate parts: a first part with a first frame and a second part with a second frame. The first frame is deployed first to provide initial support and positioning, then the second part is deployed within the first part to achieve the final valve configuration. This segmentation allows each frame to be optimized independently for its specific function, enabling reduced crimped profile while maintaining procedural feasibility.
Solution Approach 2:
The second frame is nested within the first frame during deployment. The second part is positioned inside the first part, with the second frame nested within the radial support structure of the first frame. This nested configuration allows the valve to achieve a compact crimped profile for catheter delivery while maintaining adequate expansion and sealing when deployed, directly addressing the contradiction between profile size and functional performance.
2Strength
If friction-based attachment is used between the valve and native valve, then secure attachment is achieved, but paravalvular leakage occurs
Solution Approach 1:
The valve assembly incorporates localized sealing structures at critical interfaces. The first and second frames include radially extending sealing elements positioned at the periphery where contact with the native valve occurs. These localized sealing features concentrate the sealing function at specific locations rather than relying on uniform friction across the entire interface, thereby preventing paravalvular leakage while maintaining secure attachment.
Solution Approach 2:
The valve assembly combines different material properties in the first and second frames to achieve both secure attachment and leakage prevention. The frames utilize composite construction with radially extending sealing elements made of materials having different compliance and friction characteristics. This composite approach allows optimization of both attachment strength and sealing performance, eliminating the trade-off between these two requirements.
3Ease of operation
If a temporary valve is used for initial expansion, then positioning is improved, but additional surgical steps are required to remove the temporary valve
Solution Approach 1:
The first frame and second frame are combined in a sequential deployment process where the first frame provides initial positioning and the second frame is then deployed within it to complete the valve assembly. This merging of two frames into a unified structure eliminates the need for separate temporary valve removal surgery, as the second frame serves as the permanent component that remains in place after deployment. The combined structure maintains positioning accuracy while reducing surgical complexity.
Solution Approach 2:
The first frame is deployed first as a preliminary action to establish the valve positioning and provide initial structural support. This preliminary deployment creates a stable foundation for the subsequent deployment of the second frame. By performing the positioning action in advance with the first frame, the system achieves accurate positioning without requiring additional surgical steps to remove temporary structures, as the first frame serves as a permanent positioning 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
The two-part system enables a wider range of patients to be treated with reduced paravalvular leakage and eliminates the need for removing a temporary valve, improving safety and efficacy in heart valve replacement procedures.
Implementation Method 1
The second part of the implantable valve displaces the temporary valve and compresses the temporary valve between a first frame associated with the first part and second frame associated with the second part to increase friction therebetween and reduce paravalvular leakage
Implementation Method 2
compresses the temporary valve between a first frame associated with the first part and second frame associated with the second part to increase friction therebetween and reduce paravalvular leakage
Data Source
AI summary
A two-part implantable heart valve and procedure are disclosed that allow expansion and positioning of a first part of the implantable heart valve having a temporary or transient valvular structure. A second part of the implantable heart valve is deployed within the first part and attaches thereto. The valvular structure of the second part then acts to function as the heart valve replacement. A tool or system is provided for determining an adequate percutaneous heart valve size for a given stenotic valve. A balloon can be inflated inside the stenotic valve to a desired pressure. When this pressure is reached an angiographic image is taken and the balloon diameter is measured at a waist area created by contact between the balloon and the stenotic valve. The diameter represents the minimum percutaneous heart valve diameter to be implanted.