Valve Prosthesis Anchoring Members for Native Tissue Preservation

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Solution Overview

Problem

Current valve replacement techniques often require removal of native valve structures, leading to higher morbidity and lower life expectancy compared to repair techniques, as they do not conserve the native valve leaflets and chordae tendineae.

Innovation Solution

A collapsible valve prosthesis with sutureless anchoring members that can be implanted without radial expansion, using an annular structure with anchoring members that attach to the native valve site, including biological tissue or polymer leaflets, and a delivery system involving a sliding sleeve and balloon for expansion to match the implant site dimensions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional valve replacement techniques are used, then the valve prosthesis can be implanted, but the native valve leaflets and chordae tendineae must be removed, leading to higher morbidity and lower life expectancy

Engineering Contradiction:
Improvelife expectancyVSAvoidremoval of native valve structures
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The valve prosthesis is segmented into distinct functional components: an annular structure for anchoring, leaflets for valve function, and chordae tendineae for structural support. This segmentation allows the prosthesis to be implanted while preserving the native valve structures, as each component can be independently positioned and secured without requiring removal of native tissues.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The prosthesis acts as an intermediary structure that bridges the native valve site and the required valve function. By using an annular structure with anchoring members that attach to the native annulus while supporting artificial leaflets and chordae, the device mediates between preserving native structures and providing reliable valve replacement function, thereby improving life expectancy without removing native valve leaflets and chordae tendineae.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If sutureless anchoring members are used, then the implantation is simplified and native valve structures are preserved, but secure anchoring without radial expansion must be achieved

Engineering Contradiction:
Improvesimplified implantationVSAvoidsecure anchoring
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The anchoring members are designed with dynamic characteristics, allowing them to be compressed into a low-profile configuration for delivery and then expand or engage upon deployment. This dynamic behavior enables simplified implantation through catheter-based delivery while ensuring secure anchoring to the native annulus without requiring radial expansion of the entire prosthesis, thus maintaining both ease of operation and reliability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The traditional suture-based mechanical anchoring system is replaced with self-expanding or self-anchoring members that utilize elastic recovery or shape memory effects. This substitution eliminates the need for complex suturing procedures during implantation while providing reliable anchoring through the inherent mechanical properties of the anchoring members, which automatically engage with the native annulus structure.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If the prosthesis is designed to be collapsible for delivery, then minimally invasive implantation is enabled, but the structure must be expanded to match implant site dimensions

Engineering Contradiction:
Improveminimally invasive implantationVSAvoiddimensional matching
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The prosthesis utilizes parameter changes in its structural properties during deployment. The collapsible frame is designed with specific geometric characteristics that allow it to be compressed to a small diameter for delivery through minimally invasive access, then expand to precise dimensional specifications that match the implant site. This is achieved through controlled changes in radial dimension while maintaining the structural integrity and dimensional accuracy required for proper fitting.

Inventive Principle:
Principle #35Parameter changes

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 secure anchoring of the prosthesis without displacing native valve structures, minimizing radial expansion and preserving the native valve leaflets and chordae tendineae, thus reducing morbidity and potentially increasing life expectancy.

Implementation Method 1

a valve prosthesis may include an annular structure (e.g. cylindrical), open or closed, adapted to define a blood flow lumen having an inflow side and an outflow side and to support therein one or more prosthetic valve leaflets

Methodology Applied
Scientific EffectRadial expansion:

Implementation Method 2

a set of anchoring members attached (mounted) therearound for coupling the prosthesis to the natural valve site, e.g. the annulus, leaflets, chordae tendineae

Methodology Applied
Scientific EffectMechanical attachment: Mechanical Fastener

Data Source

PatentEP2695586B1A valve prosthesis and kit
Publication Date: 2019.05.08 LIVANOVA PLC
  • EP2695586B1 patent drawingFigure 1~4
  • EP2695586B1 patent drawingFigure 5a~6b
  • EP2695586B1 patent drawingFigure 7~12

AI summary

A valve prosthesis (1) for location at a valve annulus (A), e.g. mitral, includes an annular structure (2, 3) with an axial blood flow lumen and at least one valve leaflet (3a, 3b, 3c) movable under the action of blood between an open position and a closed position to permit and to impede, respectively, blood flow through said axial blood flow lumen. A set of anchoring members (10) are attached around the annular structure (2), the anchoring members (10) including a web portion (10a) coupled to the annular structure (2, 3) and extending axially thereto, and two end portions (10b, 10c) at axially opposed sides of the web portion (10a). The end portions (10b, 10c) admit: - a) an insertion condition for insertion of the prosthesis (1), wherein the end portions (10b, 10c) are aligned to the web portion (10a) and extend axially with respect to the annular structure (2, 3); - b) an anchoring position, for anchoring the prosthesis (1), wherein the end portions (10b, 10c) extend at an angle to the web portion (10a) radially outwardly from the annular structure (2) to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus (A)