Endovascular Heart Valve Anchor Locking Mechanism

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Solution Overview

Problem

Current endovascular heart valve replacement techniques face challenges with inaccurate valve placement, lack of radial strength in self-expanding stent systems, and the inability to visualize valve function before final deployment, leading to potential migration and dysfunction of the replacement valve.

Innovation Solution

The proposed solution involves a deployment system with an expandable anchor that can be collapsed and re-expanded, featuring anchor actuating elements, lock elements, and a deployment tool that allows for precise positioning and permanent fixation of the anchor, ensuring proper placement and radial strength to prevent migration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If self-expanding stent systems are used for endovascular valve replacement, then the delivery process becomes simpler, but the placement accuracy deteriorates due to jumping action upon release

Engineering Contradiction:
Improvedelivery processVSAvoidplacement accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent employs a dynamic deployment mechanism where the stent transitions from a constrained state during delivery to an expanded state at the target site. The deployment tool maintains control over the stent's expansion timing and location, allowing the operator to verify fluoroscopic positioning before final release, thereby eliminating the jumping action problem while preserving ease of delivery.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements preliminary positioning verification through fluoroscopy before final stent release. The deployment tool allows the operator to position the stent within the delivery catheter, verify the location relative to anatomical landmarks, and only then initiate expansion. This preliminary action ensures accurate placement while maintaining the simplicity of the endovascular approach.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If self-expanding stent systems are used, then the device can be easily delivered through the sheath, but the radial strength is insufficient to prevent valve migration

Engineering Contradiction:
Improvedelivery easeVSAvoidradial strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent utilizes phase transition of shape-memory alloy materials from austenite to martensite phases. During delivery, the stent is in a flexible martensitic state that allows easy compression within the sheath. Upon deployment, temperature or stress changes trigger transformation to the rigid austenitic phase, providing sufficient radial strength for anchoring while maintaining delivery ease.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite construction combining shape-memory alloy struts with reinforcing elements or coatings. The stent structure integrates multiple materials with complementary properties: the shape-memory alloy provides superelasticity for delivery and radial expansion, while additional layers or patterns enhance radial strength and friction against the vessel wall to prevent migration.

Inventive Principle:
Principle #40Composite materials

3Productivity

If the stent is released from the delivery system, then the valve can be deployed, but the position cannot be verified or adjusted due to jumping action

Engineering Contradiction:
Improvedeployment speedVSAvoidposition verification
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent implements preliminary positioning verification through fluoroscopy before final stent release. The deployment tool allows the operator to position the stent within the delivery catheter, verify the location relative to anatomical landmarks, and only then initiate expansion. This preliminary action ensures accurate placement while maintaining the simplicity of the endovascular approach.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs a dynamic deployment mechanism where the stent transitions from a constrained state during delivery to an expanded state at the target site. The deployment tool maintains control over the stent's expansion timing and location, allowing the operator to verify fluoroscopic positioning before final release, thereby eliminating the jumping action problem while preserving ease of delivery.

Inventive Principle:
Principle #15Dynamics

4Strength

If thicker struts are used to increase radial force, then the anchoring strength improves, but the profile increases and plastic deformation risk increases

Engineering Contradiction:
Improveanchoring strengthVSAvoidprofile diameter
Core Design Contradiction:
StrengthVSLength of moving object

Solution Approach 1:

The patent utilizes phase transition of shape-memory alloy materials from austenite to martensite phases. During delivery, the stent is in a flexible martensitic state that allows easy compression within the sheath. Upon deployment, temperature or stress changes trigger transformation to the rigid austenitic phase, providing sufficient radial strength for anchoring while maintaining delivery ease.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite construction combining shape-memory alloy struts with reinforcing elements or coatings. The stent structure integrates multiple materials with complementary properties: the shape-memory alloy provides superelasticity for delivery and radial expansion, while additional layers or patterns enhance radial strength and friction against the vessel wall to prevent migration.

Inventive Principle:
Principle #40Composite materials

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

This solution enables accurate and stable placement of the heart valve, preventing migration and ensuring proper function by allowing for repositioning and permanent fixation of the expandable anchor, thereby improving the efficacy of endovascular heart valve replacement procedures.

Implementation Method 1

an expandable anchor adapted to be disposed within the sheath and expanded by the deployment tool following deployment of the expandable anchor from the sheath

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a plurality of lock elements fixedly attached to a proximal portion of the expandable anchor and adapted to engage the plurality of first members to lock the expandable anchor in a deployed shape

Methodology Applied
Scientific EffectMechanical interlocking: Mechanical Fastener

Implementation Method 3

the plurality of anchor actuating elements is adapted to apply a proximally directed force on a distal portion of the expandable anchor

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Data Source

PatentUS9393114B2Apparatus for endovascularly replacing a heart valve
Publication Date: 2016.07.19 BOSTON SCIENTIFIC SCIMED INC
  • US9393114B2 patent drawing
  • US9393114B2 patent drawing
  • US9393114B2 patent drawing

AI summary

An apparatus for endovascular replacement of a heart valve may include first and second members which are releasably attached to each other such that the second member participates in engaging the first member with a locking element which cooperates with the first member to lock an expandable anchor of the replacement heart valve in a deployed configuration. Prior to locking and removal of the second member, the locking element may be prevented from engaging the first member by a portion of the second member. Following locking, the second member may be removed.