Y-Lock Tracheal Stent Resilient Anchor Loop

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Solution Overview

Problem

Current laryngeal and tracheal stents face challenges in providing secure, biologically non-reactive, conformal, atraumatic, repositionable, and removable support for the larynx, especially in conditions like presbylarynx, vocal cord paresis, and laryngomalacia, due to issues with anchoring and tissue compatibility.

Innovation Solution

A laryngeal/tracheal stent design featuring a resilient anchor loop, a Y-lock crown, and a delivery system with a deployment connector, made from nickel-titanium or similar materials, which self-expands to conform to the laryngeal anatomy, providing upward force on vocal folds and secure anchoring, while being repositionable and removable with minimal tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a mechanical support mechanism or stent is placed to restore laryngeal geometry, then the desired abduction force is applied, but the anchoring must be sufficiently secure which may cause tissue damage or migration

Engineering Contradiction:
Improveanchoring securityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The stent employs a flexible, thin-film construction that can conform to the laryngeal anatomy and provide secure anchoring through deformation rather than rigid fixation. The flexible material allows the stent to adapt to tissue contours and maintain position without causing significant tissue damage through rigid anchoring mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The stent utilizes changes in physical parameters such as material flexibility and structural configuration to achieve secure anchoring. By adjusting the flexibility and geometric parameters of the stent structure, it can achieve stable positioning through conformal contact with the laryngeal walls rather than through aggressive anchoring that would cause tissue damage.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If the stent is made rigid to provide stable support force, then the abduction force is maintained, but the stent cannot conform to the dimensions of the installation site

Engineering Contradiction:
Improvesupport force stabilityVSAvoidconformal fit
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The stent employs dynamic structural elements that can change configuration between a compressed delivery state and an expanded functional state. The structure transitions from a low-profile configuration during endoscopic delivery to a three-dimensional configuration that provides stable support force while conforming to the laryngeal anatomy.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stent utilizes flexible shell structures that can deform to match the contours of the laryngeal installation site while maintaining structural integrity. The flexible construction allows the stent to conform to varying dimensions of the larynx while the engineered flexibility provides stable support force through elastic recovery.

Inventive Principle:
Principle #30Flexible shells and thin films

3Strength

If the stent is made from rigid materials to provide structural support, then the geometry is restored, but the stent causes degradation to the surface of contacting tissue

Engineering Contradiction:
Improvestructural supportVSAvoidtissue degradation
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The stent employs flexible shell structures that distribute contact forces over larger surface areas, reducing localized stress and preventing tissue degradation. The flexible construction allows the stent to adapt to tissue movements and physiological changes without causing erosion or degradation of the contacting tissue surface.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The stent utilizes composite material construction that combines structural strength with tissue-compatible properties. The composite structure provides the necessary structural support to restore laryngeal geometry while the outer surface properties are optimized to minimize tissue degradation through reduced friction and improved biocompatibility.

Inventive Principle:
Principle #40Composite materials

4Duration of action of stationary object

If the stent is designed for permanent placement to maintain laryngeal structure, then the support is continuous, but the stent cannot be repositioned or removed by endoscopic methods

Engineering Contradiction:
Improvesupport durationVSAvoidrepositionability
Core Design Contradiction:
Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The stent employs dynamic locking and unlocking mechanisms that allow transition between a permanently anchored state and a removable state. The structure can be locked in place to provide continuous long-term support, yet can be unlocked through endoscopic access to allow repositioning or removal when clinically indicated.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stent utilizes intermediary attachment mechanisms that provide stable long-term fixation while allowing for controlled release. The intermediary structures enable the stent to maintain continuous support during the treatment period while providing access points for endoscopic manipulation to facilitate repositioning or removal when needed.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 stent effectively stabilizes the laryngeal structure, maintains vocal fold function, and allows for endoscopic placement and removal, addressing the need for secure, biocompatible, and adjustable support for various laryngeal pathologies.

Implementation Method 1

a resilient anchor loop portion and a Y-lock crown portion. The resilient anchor loop portion is configured to self-expand to a first diameter upon deployment

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

made from nickel-titanium or similar materials, which self-expands to conform to the laryngeal anatomy

Methodology Applied
Scientific EffectShape Memory Alloy: Shape Memory Alloy

Implementation Method 3

the resilient anchor loop portion is configured to self-expand to a first diameter upon deployment and conform to dimensions of a subglottal region or trachea

Methodology Applied
Scientific EffectElastic Recovery: Elastic Recovery

Data Source

PatentEP3107491B1A y-lock tracheal stent system
Publication Date: 2018.10.17 MULABDIC FEDJA
  • EP3107491B1 patent drawingFigure 1~2
  • EP3107491B1 patent drawingFigure 3
  • EP3107491B1 patent drawingFigure 4~6

AI summary

A Y-Lock tracheal stent system consisting of a stent device, for emplacement in the larynx, and a stent delivery system. A method for employing the stent delivery system to emplace the stent device.