Prosthetic Heart Valve Sizing and Implantation
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Solution Overview
Problem
Conventional surgical methods for replacing diseased heart valves are invasive and risky, particularly for elderly patients, with high morbidity and mortality rates due to the need for open-chest surgery and cardiopulmonary bypass, limiting the operability of patients with valvular diseases.
Innovation Solution
Development of prosthetic heart valves with a small crimp profile for minimally invasive implantation, featuring a radially collapsible and expandable frame, a valvular structure with leaflets, and a sealing member to control perivalvular leakage, along with methods for sizing and deploying the valves to match native annulus sizes, improving hemodynamic performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-chest surgery with cardiopulmonary bypass is used for valve replacement, then complete valve replacement can be achieved, but patient trauma and mortality risk increase significantly
Solution Approach 1:
The patent replaces the mechanical surgical system (open-chest surgery, cardiopulmonary bypass, suturing) with a catheter-based delivery system that uses balloon inflation or self-expansion to implant the prosthetic valve. This substitution eliminates the need for stopping the heart and using cardiopulmonary bypass, thereby reducing patient trauma and mortality risk while achieving complete valve replacement.
Solution Approach 2:
The prosthetic valve is designed with a collapsible frame and flexible sealing structures that can be compressed into a small profile for catheter delivery and then expanded at the implantation site. This flexible design enables minimally invasive percutaneous or transapical delivery, avoiding the trauma of open-chest surgery while ensuring proper valve deployment and sealing.
2Object-affected harmful factors
If percutaneous catheterization is used for prosthetic valve implantation, then patient trauma is reduced, but the crimp profile size limits the treatable patient population
Solution Approach 1:
The prosthetic valve is divided into modular components including a collapsible frame with struts, separate sealing members, and a valvular structure that can be assembled or delivered in segments. This segmentation allows the valve to be compressed into a smaller crimp profile for catheter delivery while maintaining the capability to treat a wider range of annulus sizes through proper component configuration and selection.
Solution Approach 2:
The patent employs parameter changes by providing prosthetic valves in multiple sizes and configurations that can be selected based on the patient's native annulus dimensions. The collapsible frame design allows adjustment of the expanded diameter parameter to match different annulus sizes, thereby expanding the treatable patient population while maintaining a small crimp profile for minimally invasive delivery.
3Ease of operation
If a small crimp profile is designed for the prosthetic valve, then catheter delivery is facilitated, but perivalvular leakage control becomes more challenging
Solution Approach 1:
The sealing member is nested within or around the collapsible frame structure, with the sealing tissue positioned to contact the native annulus when the valve is expanded. This nested configuration allows the sealing function to be integrated into the compact crimped design for easy catheter delivery while ensuring proper sealing contact is achieved upon expansion at the implantation site.
Solution Approach 2:
The patent introduces a separate sealing member as an intermediary element between the prosthetic valve frame and the native annulus tissue. This sealing member, which may consist of tissue or synthetic material, mediates the sealing function by contacting the native annulus to prevent perivalvular leakage, thereby decoupling the crimp profile size from the sealing capability.
4Adaptability or versatility
If the prosthetic valve is designed to fit a wide range of native annulus sizes, then patient applicability increases, but manufacturing precision requirements increase
Solution Approach 1:
The collapsible frame design provides a universal platform that can be manufactured in multiple standardized sizes to accommodate a wide range of native annulus dimensions. The frame structure with its struts and openings serves multiple functions including structural support, sealing surface provision, and blood flow channeling, allowing a single design family to address diverse patient anatomies through proper size selection rather than requiring custom manufacturing for each case.
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
Enables safer, less invasive implantation of prosthetic heart valves in a wide range of native annulus sizes, reducing risk and improving patient outcomes by minimizing trauma and complications associated with traditional surgical approaches.
Implementation Method 1
the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood to flow through the one or more uncovered openings in the frame and into space between the outer layer and the frame
Implementation Method 2
a frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration
Data Source
AI summary
A method of implanting a prosthetic heart valve includes selecting a prosthetic heart valve. The selected prosthetic heart valve has a nominal diameter that is greater than a native annulus diameter of a native annulus by up to forty percent. The method further comprises compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the nominal diameter, positioning the selected prosthetic heart valve within the native annulus, and expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration in which the selected prosthetic heart valve has a second diameter which is less than the nominal diameter by up to ten percent and which is greater than the first diameter.