Adjustable-Lumen Prosthetic Valve Support for Mitral Sealing
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to incomplete coaptation of valve leaflets, increased stroke volume, and cardiac output reduction.
Innovation Solution
A prosthetic valve support system that facilitates the transluminal implantation of a prosthetic valve at a native heart valve, allowing for the replacement of native valve functionality with a prosthetic valve, using expandable components and tissue-engaging elements to anchor the prosthetic valve securely while allowing native leaflet movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace native valve functionality, then regurgitation is reduced and cardiac output is improved, but the complexity of the device and implantation procedure increases
Solution Approach 1:
The prosthetic valve support system is divided into separate components: a prosthetic valve and a prosthetic valve support. The support comprises an upstream support portion and a downstream support portion that can be independently positioned and secured, allowing for modular implantation and reducing overall system complexity.
Solution Approach 2:
The prosthetic valve is nested within the prosthetic valve support structure. The support provides a framework that holds the valve in place, with the upstream support portion positioned in the atrium and the downstream support portion positioned in the ventricle, creating a nested configuration that simplifies the overall device architecture.
2Stability of the object's composition
If tissue-engaging elements are used to anchor the prosthetic valve securely, then the valve stability is improved, but the risk of tissue damage and complications increases
Solution Approach 1:
The tissue-engaging elements are localized to specific regions of the prosthetic valve support. The upstream support portion has tissue-engaging elements positioned to engage the native valve annulus or surrounding tissue in the atrium, while the downstream support portion has elements to engage tissue in the ventricle, distributing the anchoring function to specific locations rather than requiring widespread tissue engagement.
Solution Approach 2:
The prosthetic valve support acts as an intermediary structure between the prosthetic valve and the native heart tissue. Instead of directly anchoring the valve to tissue, the support provides a mechanical framework that distributes anchoring forces across multiple tissue-engaging elements, reducing localized tissue damage while maintaining overall stability.
3Reliability
If the prosthetic valve is expanded within an opening defined by the support, then the valve-seal interface is improved, but the difficulty of implantation and positioning increases
Solution Approach 1:
The prosthetic valve support is pre-formed with a defined opening structure before implantation. The upstream support portion and downstream support portion are configured to create a predetermined opening geometry that guides the expansion and positioning of the prosthetic valve, ensuring proper sealing without requiring complex intra-procedural adjustments.
Data Source
AI summary
An apparatus for use with a prosthetic heart valve at a native heart valve comprises an adjustable-lumen prosthetic valve support. In a delivery state, the prosthetic valve support is transluminally deliverable to the heart. The prosthetic valve support is transitionable, within the heart, into an implantation state for implantation at the native valve. In the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter. After the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen has a second diameter that is greater than the first diameter. In the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.