Axisymmetric Adjustable Mitral Seal With Annular Anchoring
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Solution Overview
Problem
Existing heart valve repair methods, such as annuloplasty and bow-tie techniques, often interfere with the natural motion of leaflets and chordae tendinae, leading to complications and inefficiencies, particularly in treating mitral valve regurgitation.
Innovation Solution
A minimally-invasive device with an expandable prosthetic sealing member and anchoring member is deployed between the mitral valve leaflets, allowing for proper coaptation without obstructing native leaflet motion, using a low delivery profile and self-expanding materials like nitinol to minimize interference and maintain valve function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If annuloplasty ring is implanted to stabilize the annulus, then valve closure is improved, but natural leaflet motion is interfered with
Solution Approach 1:
A prosthetic sealing member is introduced as an intermediary element between the native leaflets to facilitate proper coaptation and sealing without requiring constriction of the leaflets themselves. This sealing member acts as a mediator that enables valve closure while preserving the natural motion and function of the leaflets and subvalvular apparatus.
Solution Approach 2:
The device is divided into separate functional components: an anchoring member for securing the device to the annulus, a prosthetic sealing member for coaptation assistance, and a delivery catheter for minimally-invasive placement. This segmentation allows each component to perform its specific function independently, preserving natural leaflet motion while achieving reliable valve closure.
2Reliability
If bow-tie technique is used to repair mitral valve, then regurgitation is treated, but leaflet mobility and subvalvular apparatus function are compromised
Solution Approach 1:
The prosthetic sealing member serves as a mediator that enables regurgitation treatment by providing a sealing surface for the leaflets to coapt against, without requiring the leaflets to be constricted or repositioned. This preserves natural leaflet mobility and subvalvular apparatus function while effectively treating regurgitation.
Solution Approach 2:
The device extracts the constricting element from the leaflet assembly and places it in the annulus as a separate anchoring member. This separates the sealing function from the leaflet motion, allowing the leaflets and subvalvular apparatus to move naturally while still achieving effective regurgitation treatment through the prosthetic sealing member.
3Reliability
If conventional valve repair methods are used, then valve regurgitation is addressed, but complications increase and heart efficiency decreases
Solution Approach 1:
The prosthetic sealing member acts as a benign intermediary that treats regurgitation without creating harmful constraints on leaflet motion or subvalvular apparatus function. By providing a simple sealing surface rather than constricting the leaflets, the device reduces complications and maintains heart efficiency.
Solution Approach 2:
The device allows the natural leaflet motion and subvalvular apparatus function to serve the sealing process without external constraint. The prosthetic sealing member passively receives the coaptation forces from the natural leaflets, eliminating the need for active constriction or manipulation that would increase complications and reduce heart efficiency.
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 device effectively reduces or eliminates mitral valve regurgitation by preserving leaflet mobility and subvalvular apparatus function, reducing complications and maintaining heart efficiency, while avoiding the need for extracorporeal circulation.
Implementation Method 1
using a low delivery profile and self-expanding materials like nitinol to minimize interference and maintain valve function
Data Source
AI summary
A prosthetic device for treating a native valve of a heart includes a sealing element and an anchoring element. The sealing element comprises a braided mesh material. The sealing element is dimensioned to be deployed at the native valve. The sealing element is configured to both be radially expanded and radially reduced while at a position between the native valve leaflets. The anchoring element is coupled to the sealing element and is configured to support the sealing element between the native valve leaflets.