Nested Transcatheter Mitral Valve Assembly for Precise Anchoring
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Solution Overview
Problem
Existing therapies for mitral valve regurgitation are complex and invasive, leading to prolonged recovery times, patient discomfort, and elevated risks, while percutaneous access procedures can cause pain and infection.
Innovation Solution
A transcatheter mitral valve replacement system with a two-part prosthetic mitral valve, comprising an expandable valve frame and anchor assembly, is deployed in a nested configuration using control wires for precise control and minimally invasive implantation, anchoring to the native mitral valve without large incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing therapies for mitral valve regurgitation are used, then the regurgitation can be treated, but the procedures are complex and invasive leading to prolonged recovery times and patient discomfort
Solution Approach 1:
The prosthetic mitral valve is divided into two separate components: an anchor assembly that engages with the native valve annulus and a valve assembly that provides the actual valve function. This segmentation allows each component to be optimized independently and simplifies the deployment process, as the anchor assembly can be positioned first to provide a stable foundation for subsequent valve assembly deployment.
Solution Approach 2:
The valve assembly is nested within the anchor assembly during delivery, with both components contained within a single delivery sheath. This nested configuration reduces the overall profile of the implant system, enabling percutaneous access through minimal incisions while maintaining both anchoring and valve functions in a compact arrangement that simplifies delivery.
2Object-affected harmful factors
If percutaneous access procedures are used, then large incisions and associated risks are avoided, but pain and infection risks remain
Solution Approach 1:
Both the anchor assembly and valve assembly are contained within a single delivery sheath in a nested configuration, allowing the entire implant system to be delivered through a single percutaneous access point. This minimizes the number and size of incisions required, reducing patient discomfort and infection risk while maintaining ease of deployment.
3Ease of operation
If a two-part prosthetic valve with nested configuration is used, then minimally invasive implantation is achieved, but precise control during deployment becomes more challenging
Solution Approach 1:
Control wires serve as intermediaries between the operator and the two-part prosthetic valve components. These wires extend through the delivery catheter and attach to both the anchor assembly and valve assembly, allowing precise manipulation and positioning of each component during deployment while maintaining a simple percutaneous access approach.
Solution Approach 2:
The two-part design with separate anchor and valve assemblies allows independent control and positioning of each component through dedicated control mechanisms. This segmentation enables precise deployment sequencing, where the anchor assembly can be positioned and secured first, followed by controlled deployment of the valve assembly, ensuring accurate placement without requiring complex single-component mechanisms.
4Loss of time
If traditional single-component prosthetic valves are replaced with two-part nested valves, then implantation complexity increases, but recovery time and patient discomfort decrease
Solution Approach 1:
The nested configuration of the valve assembly within the anchor assembly allows both components to be delivered through a single percutaneous access point in a compact arrangement. This reduces the invasiveness of the procedure and patient recovery time, while the modular two-part structure provides surgical flexibility for precise positioning and deployment control.
Solution Approach 2:
Dividing the prosthetic valve into separate anchor and valve assemblies allows each component to be optimized for its specific function and deployed in a controlled sequence. This segmentation reduces overall procedure time and patient trauma despite the increased structural complexity, as each component can be independently positioned and secured without requiring complex manual manipulation.
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 minimally invasive implantation with reduced recovery time, patient discomfort, and procedural costs, ensuring hemodynamic stability and accurate component control, suitable for surgeons of varying skill levels.
Implementation Method 1
The two-part prosthetic mitral valve is configured to be disposed within the delivery sheath in a radially compressed condition and to radially self-expand when the two-part prosthetic mitral valve is outside of the delivery sheath and is unconstrained by the one or more control wires
Data Source
AI summary
Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. Deployment systems and methods for using the deployment systems described herein facilitate implanting a two-part prosthetic heart valve that is arranged in a nested configuration during the transcatheter delivery and deployment processes.