Replacement Heart Valve Framework With Native Leaflet Clamps

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Solution Overview

Problem

Existing replacement heart valve implants face challenges in effectively securing native leaflets and commissures of the native heart valve, leading to potential displacement and inefficiencies in valve function.

Innovation Solution

The proposed replacement heart valve implant features an expandable framework with interconnected struts, native leaflet clamps, and commissure clamps that shift between delivery and deployed configurations, securely pinching native leaflets and commissures to maintain proper positioning and function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing replacement heart valve implants are used, then the valve replacement procedure can be performed, but the native leaflets and commissures cannot be effectively secured, leading to potential displacement and functional inefficiencies

Engineering Contradiction:

Improvesecuring of native leaflets and commissuresVSAvoidstructure of valve implant

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The valve implant is divided into distinct functional segments: the expandable framework provides structural support, while separate native leaflet clamps and commissure clamps are integrated at specific locations to perform specialized securing functions. This segmentation allows each component to address specific securing needs without requiring complete redesign of the entire valve structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent combines multiple securing mechanisms (native leaflet clamps and commissure clamps) into a single integrated valve implant device. These clamps are merged with the expandable framework to create a unified system that simultaneously addresses both leaflet securing and commissure anchoring, reducing the need for separate devices or procedures.

Inventive Principle:

Principle #5Merging (Combining)

2Stability of the object's composition

If native leaflets and commissures are not securely anchored, then the device structure remains simpler, but displacement occurs and valve function becomes inefficient

Engineering Contradiction:

Improvepositioning of native leaflets and commissuresVSAvoidconfiguration of expandable framework with clamps

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The native leaflet clamps and commissure clamps are pre-positioned and integrated into the expandable framework during manufacturing. This preliminary configuration ensures that when the framework is deployed, the clamps are already in the correct positions to immediately secure the native leaflets and commissures, preventing displacement from the outset rather than requiring post-implantation adjustments.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The expandable framework incorporates clamps at specific local positions where securing is most critical - namely at the native leaflet attachment sites and commissure regions. This localized placement of securing mechanisms provides enhanced stability precisely where needed, rather than uniformly complicating the entire device structure.

Inventive Principle:

Principle #3Local quality

3Force

If clamps extend radially outward from the tubular wall, then securing force on native leaflets is improved, but the device occupies more space and may interfere with surrounding structures

Engineering Contradiction:

Improvepinching force on native leafletsVSAvoidradial extent of clamps

Core Design Contradiction:

ForceVSArea of stationary object

Solution Approach 1:

The clamps are designed to be dynamic in their deployment - they extend radially outward from the tubular wall only when and where needed to engage the native leaflets. This dynamic configuration allows the clamps to provide maximum pinching force during the securing phase while potentially retracting or flexing to minimize interference with surrounding cardiac structures during other phases of the cardiac cycle.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20250352330A1Replacement heart valve implant

Publication Date: 2025.11.20 BOSTON SCIENTIFIC SCIMED INC

AI summary

A replacement heart valve implant includes an expandable framework including a tubular wall comprising a plurality of interconnected struts and defining a central lumen, wherein the wall includes inflow and outflow ends, and a plurality of commissure posts. A plurality of valve leaflets is secured to the commissure posts. The framework may include a plurality of native leaflet clamps extending upstream from the outflow end, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall. The framework may include a plurality of native commissure clamps extending upstream from the commissure posts, wherein the commissure clamps are configured to pinch native commissures of the native heart valve. The framework may include a plurality of native leaflet clamps extending upstream from the commissure posts, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall.