Integrated Aortic Valve Assembly for Accurate Tethered Deployment
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Solution Overview
Problem
Existing percutaneous transcatheter methods for heart valve replacement face challenges such as patient prosthetic mismatch (PPM), para-valvular leakage (PVL), and conductance disorders due to improper valve placement, which are exacerbated by high crossing profiles and inaccurate deployment.
Innovation Solution
An integrated valve assembly comprising an anchor stent, tether component, and valve component, where the tether component flips direction to correctly position the valve component within the anchor stent, ensuring accurate deployment and reducing para-valvular leakage by using a self-expanding tubular frame and tethers or a cylindrical skirt for precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous transcatheter methods are used for heart valve replacement, then patient trauma and recuperation time are reduced, but valve placement accuracy deteriorates leading to PPM, PVL, and conductance disorders
Solution Approach 1:
The patent introduces a delivery system as an intermediary device that includes positioning mechanisms, markers, and imaging integration to enable accurate valve placement through percutaneous access. The delivery system acts as a mediator between the minimally invasive catheter approach and the precise surgical-level placement accuracy required, incorporating features like radiopaque markers, imaging guidance integration, and mechanical positioning systems that ensure accurate valve annulus engagement without requiring open surgery
Solution Approach 2:
The patent employs preliminary positioning actions through the delivery system, including pre-positioning the valve prosthesis within the delivery catheter, pre-marking the valve annulus location using imaging guidance, and pre-engageing anchoring mechanisms before final valve deployment. These preliminary actions ensure that when the valve is deployed percutaneously, it achieves accurate placement without requiring complex real-time adjustments during the minimally invasive procedure
2Ease of operation
If valve prosthesis is compacted for delivery in a catheter, then access to heart valve is improved, but crossing profile increases limiting delivery through vessels
Solution Approach 1:
The patent implements a nested configuration where the valve prosthesis is compressed within a delivery catheter, which itself is delivered through a sheath or access sheath that traverses the vascular system. The valve frame, leaflets, and sealing components are all nested within the delivery system in a compact configuration, allowing the entire assembly to be delivered percutaneously through femoral or other vascular access points without requiring excessive vessel diameter
Solution Approach 2:
The patent utilizes parameter changes in the valve prosthesis and delivery system, including transitioning the valve from a compressed low-profile state during delivery to an expanded functional state at deployment. The delivery system incorporates balloon expandable or self-expanding mechanisms that change the valve's dimensional parameters from a small deliverable size to the required implant size, enabling percutaneous delivery while maintaining adequate valve dimensions for proper function
3Device complexity
If improper valve placement occurs, then procedural complexity is reduced, but para-valvular leakage and patient prosthetic mismatch increase
Solution Approach 1:
The patent incorporates feedback mechanisms through imaging guidance systems (fluoroscopy, echocardiography, or other imaging modalities) that provide real-time or near-real-time feedback on valve prosthesis position, orientation, and engagement with the valve annulus during the percutaneous deployment procedure. This feedback enables the operator to verify accurate placement before final release, ensuring proper sealing and preventing PVL without requiring excessively complex procedural steps
Solution Approach 2:
The patent replaces complex mechanical positioning systems with imaging-guided and potentially image-processing or navigation-system-based approaches to achieve accurate valve placement. Instead of relying solely on complex mechanical alignment mechanisms within the delivery system, the patent uses imaging markers, anatomical landmarks, and potentially automated positioning algorithms to guide accurate valve annulus engagement, reducing mechanical complexity while improving placement accuracy and sealing performance
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 integrated valve assembly achieves reduced crossing profile and accurate deployment, minimizing patient prosthetic mismatch, para-valvular leakage, and conductance disorders, thereby improving procedural safety and efficacy.
Implementation Method 1
The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve
Data Source
AI summary
An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.