Toroidal-Space Prosthetic Valve for Native Valve Anchoring
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and valve annulus dilation, leading to blood leakage and decreased cardiac output.
Innovation Solution
A prosthetic valve implant with a tubular portion and flanges that can be percutaneously delivered and expanded to secure the native valve, using a delivery tool with controlled capsule portions to facilitate precise deployment and expansion, ensuring secure anchoring and one-way blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the implant is delivered in a compressed state through a delivery tool, then percutaneous deliverability is improved, but the complexity of the delivery system increases
Solution Approach 1:
The delivery tool is divided into multiple capsule portions (first capsule portion, second capsule portion, third capsule portion) that can move independently relative to each other. Each capsule portion can be advanced or retracted separately, allowing the implant to be delivered in a compressed state while maintaining manageable system complexity through modular design.
Solution Approach 2:
The delivery tool employs dynamic control of capsule portions through controllers that enable sequential movement. The capsule portions transition between advanced and retracted states dynamically during the delivery process, allowing compression for delivery and expansion for implantation without requiring a completely complex static system.
2Strength
If the tubular portion is expanded to bring support portion and flanges closer together, then anchoring strength is improved, but the radial dimension increases
Solution Approach 1:
The tubular portion is designed to be expandable from a compressed delivery state to an expanded implantation state. This dynamic expansion allows the tubular portion to reduce its radial dimension during delivery and then increase it during implantation to bring the support portion and flanges closer together, achieving strong anchoring without excessive radial dimension during the critical delivery phase.
Solution Approach 2:
The tubular portion undergoes parameter changes in its dimensional state - transitioning from a compressed state with larger radial dimension for delivery to an expanded state with reduced radial dimension for implantation. This parameter change enables the anchoring elements to be positioned closer together, enhancing anchoring strength while maintaining compatibility with the delivery system.
3Manufacturing precision
If multiple capsule portions are used for controlled deployment, then deployment precision is improved, but the device complexity increases
Solution Approach 1:
The delivery tool is segmented into multiple independently controllable capsule portions, each responsible for delivering specific portions of the implant. This segmentation allows precise control over the deployment sequence and positioning of different implant components, achieving high deployment precision while distributing the control complexity across manageable segments.
Solution Approach 2:
The controllers are operatively coupled to the capsule portions to monitor and control their movement. This feedback mechanism enables precise deployment by adjusting the position and movement of each capsule portion based on real-time information, ensuring accurate implant placement while managing the complexity through automated control loops.
Data Source
AI summary
An implant for implantation at a native atrioventricular valve of a subject, includes a frame assembly, including a valve frame and an outer frame coupled to each other. The valve frame includes a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, and an upstream support portion including a plurality of arms. Each arm extends radially outward from the tubular portion to engage tissue in the atrium. The outer frame includes a ring that circumscribes the tubular portion, and a plurality of ventricular anchors that extend radially outward from the ring and are configured to anchor the implant to tissue of the ventricle. In an expanded state of the frame assembly, the implant defines a toroidal space between the plurality of ventricular anchors and the upstream support portion. Other embodiments are also described.