Anterior Mitral Leaflet Tethering to Limit LVOT Obstruction

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Solution Overview

Problem

Prosthetic heart valves can cause native mitral valve leaflet displacement leading to systolic anterior motion (SAM) and undesirable flow gradients, necessitating additional procedures or medication, and native leaflet stiffening can further complicate the issue.

Innovation Solution

A prosthetic heart valve system with an anchor and tether mechanism that secures to the fibrous trigone or native leaflet, adjusting the geometry to prevent SAM by biasing the leaflet away from the left ventricular outflow tract (LVOT) and using a native leaflet cutter or ablation to reshape the valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a prosthetic heart valve is implanted to replace a diseased mitral valve, then valve function is improved, but native leaflet displacement occurs causing systolic anterior motion (SAM) and undesirable flow gradients

Engineering Contradiction:

Improvevalve functionVSAvoidsystolic anterior motion and flow gradients

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A native leaflet tether is introduced as an intermediary element that connects the native anterior leaflet to the prosthetic valve or annulus, mediating the interaction between the prosthetic valve and native leaflet to prevent SAM while preserving leaflet function

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The native leaflet tether is deployed before or during prosthetic valve implantation to preemptively secure the native anterior leaflet in a favorable position, preventing SAM from occurring in the first place rather than correcting it after the fact

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If additional procedures or medication are used to correct SAM, then LVOT obstruction is reduced, but device complexity and treatment duration increase

Engineering Contradiction:

ImproveLVOT obstructionVSAvoidadditional procedures

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The native leaflet tether system is combined with the prosthetic valve implantation procedure itself, integrating the SAM prevention mechanism into the primary treatment rather than requiring separate corrective procedures later

Inventive Principle:

Principle #5Merging (Combining)

3Stability of the object's composition

If the native valve leaflets are left in place during prosthetic valve implantation, then native leaflet tissue is preserved, but they can stiffen due to calcification causing turbulence and degradation of prosthetic valve leaflets

Engineering Contradiction:

Improvenative leaflet tissue preservationVSAvoidturbulence and eddies from calcification

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The native leaflet tether acts as a mediator that isolates the native leaflet from direct interaction with the prosthetic valve components, allowing the native leaflet to be preserved and tethered in a position that prevents calcification-induced turbulence while maintaining tissue integrity

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS12588986B2Apparatus and methods for anterior valve leaflet management

Publication Date: 2026.03.31 TENDYNE HOLDINGS INC

AI summary

In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.