Mitral Valve Leaflet Augmentation Patch for Regurgitation Repair
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Solution Overview
Problem
Ischemic heart disease leads to mitral regurgitation due to papillary muscle dysfunction and left ventricle dilation, causing incomplete coaptation of mitral valve leaflets and subsequent cardiac output reduction.
Innovation Solution
A system comprising leaflet augmentation patches, artificial chordae tendineae, and delivery tools for implantation, including a patch with a flexible sheet and anchor, a winch assembly, and a delivery tool with a clasp and driveshaft, to enhance leaflet coaptation and anchoring within the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the mitral valve annulus is dilated due to ischemic heart disease, then the left ventricle volume increases, but the valve leaflets cannot fully coapt leading to mitral regurgitation
Solution Approach 1:
The solution segments the valve repair function into multiple components: a proximal portion for anchoring to the annulus, a body portion for reinforcing the leaflet, and a distal portion for coaptation. This segmentation allows each component to address specific aspects of the coaptation failure independently.
Solution Approach 2:
The implant is delivered in a compressed, collapsed state through the catheter before deployment. This preliminary compressed state enables transcatheter delivery through narrow vascular access, and the implant expands to its functional configuration after reaching the target site.
2Shape
If papillary muscles are displaced due to ischemic dysfunction, then leaflet tethering increases, but cardiac output decreases
Solution Approach 1:
The implant provides localized reinforcement at the leaflet attachment region and coaptation zone without requiring global structural changes to the ventricle or papillary muscles. The patch specifically addresses the tethering area to restore leaflet mobility and coaptation.
3Ease of operation
If a delivery tool is used to implant the patch transcatheterly, then minimally invasive access is achieved, but the device complexity increases
Solution Approach 1:
The implant is nested within the delivery catheter in a compressed state, with the proximal portion, body portion, and distal portion sequentially arranged within the catheter lumen. This nesting enables the complex multi-component implant to be delivered through a single catheter access point.
Solution Approach 2:
The delivery system transitions from a constrained state (implant compressed within catheter) to an expanded state (implant deployed at target site). The implant dynamically changes from a low-profile delivery configuration to a high-profile functional configuration.
Data Source
AI summary
An implant comprises a leaflet-augmentation patch, a patch anchor, and a cord. The patch comprises a flexible sheet, and a frame that supports the flexible sheet. The frame defines a spring configured to tension the cord. The cord couples the patch anchor to the patch in a manner in which anchoring the patch anchor to a first leaflet of a heart valve of a subject positions the patch to coapt with a second leaflet of the valve during ventricular systole. Other embodiments are also described.