Expandable Annular Base for Prosthetic Heart Valve

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Solution Overview

Problem

The challenge in valve-in-valve procedures is that the diameter of the surgical heart valve limits the size of the transcatheter heart valve that can be implanted, leading to patient-prosthesis mismatch, which is associated with increased mortality, especially in older patients who cannot undergo invasive surgery for replacement.

Innovation Solution

A prosthetic heart valve with an annular base formed of a coil that expands from an initial to a larger diameter when a predetermined force is applied, allowing a sufficiently sized transcatheter valve to be implanted, and a system for repairing a damaged native heart valve with a non-collapsible annular frame that expands to accommodate a larger transcatheter valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If a small surgical heart valve is implanted, then the initial surgical procedure is successful, but the valve diameter limits the size of transcatheter valve that can be implanted later, causing patient-prosthesis mismatch

Engineering Contradiction:
Improvesurgical heart valve diameterVSAvoidability to accommodate larger transcatheter valve
Core Design Contradiction:
Length of moving objectVSAdaptability or versatility

Solution Approach 1:

The surgical heart valve incorporates an expandable annular base that can transition from an initial compressed state to an expanded state. The base includes a coil structure with multiple turns that allows radial expansion when force is applied, enabling the valve diameter to increase from an initial size (e.g., 19-21 mm) to a larger size (e.g., 23-29 mm) to accommodate adequately-sized transcatheter valves during VIV procedures

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The valve frame structure is designed to change its dimensional parameters through expansion. The annular base's maximum diameter is changed from a first maximum diameter in an initial condition to a second maximum diameter in an expanded condition, where the second diameter is larger than the first, allowing the valve to adapt to different sizing requirements

Inventive Principle:
Principle #35Parameter changes

2Length of moving object

If a large surgical heart valve is implanted, then adequate blood flow is ensured, but the patient requires more invasive surgery and has higher surgical risk

Engineering Contradiction:
Improvesurgical heart valve diameterVSAvoidsurgical invasiveness and mortality risk
Core Design Contradiction:
Length of moving objectVSObject-affected harmful factors

Solution Approach 1:

The valve is divided into functional segments: an expandable annular base and a leaflet frame assembly. This segmentation allows the base to be compressed for implantation and then expanded to the required size, separating the implantation procedure from the size-adjustment function

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The expandable base is prepared in a compressed state for initial implantation, and the expansion capability is built into the structure in advance. This preliminary configuration allows the valve to be implanted first and then expanded later when needed, rather than requiring a larger valve to be implanted initially

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If the surgical heart valve is made expandable, then larger transcatheter valves can be implanted to reduce patient-prosthesis mismatch, but the valve structure becomes more complex

Engineering Contradiction:
Improveability to expand in vivoVSAvoidvalve frame structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The annular base utilizes a coil structure with multiple turns that provides flexibility and expandability. This coil configuration allows the base to expand radially when force is applied to its inner surface, achieving the required diameter increase without requiring complex mechanical actuation systems

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The leaflet frame assembly is positioned within or upon the expandable annular base structure. The commissure posts extend from the base, and the leaflets are attached to the frame, creating a nested arrangement where the expandable base serves as the foundation for the valve components

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Enables the implantation of a larger transcatheter valve within the surgical heart valve, reducing the risk of patient-prosthesis mismatch and minimizing the need for invasive surgery by allowing the surgical heart valve to expand in vivo, thus improving blood flow and reducing mortality risks.

Implementation Method 1

The base is configured to expand from an initial condition having a first maximum diameter of the annular base in the initial condition to an expanded condition having a second maximum diameter of the annular base in the expanded condition, the second maximum diameter being larger than the first maximum diameter, when a predetermined force is applied to an inner surface of the base

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3556323B1Prosthetic heart valve
Publication Date: 2023.07.19 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP3556323B1 patent drawingFigure 1A~1B
  • EP3556323B1 patent drawingFigure 2~3
  • EP3556323B1 patent drawingFigure 4~5

AI summary

A surgical heart valve includes a non-collapsible frame having features that enable the frame to expand from an initial condition having a first diameter to an expanded condition having a second diameter larger than the first diameter after the valve has been implanted within a patient. The frame may include members that prevent the unintended expansion of the frame, such as during implantation, and members that prevent the over-expansion of the frame. The surgical heart valve further includes a valve assembly connected to the frame and including a plurality of leaflets.