Nitinol Stent Delivery System for Below-the-Knee Revascularization

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Solution Overview

Problem

Current stent delivery systems for treating critical limb ischemia (CLI) are limited by the need for multiple stents to achieve full lesion coverage, which restricts vessel-wall compliance and flexibility, and are not well-suited for procedures below the knee.

Innovation Solution

A novel stent delivery system that includes a self-expanding nitinol stent with a platinum alloy for enhanced radiopacity, designed for below-the-knee revascularization, which provides improved visibility and maintains super elastic properties, and a unique liner for increased strength and lubricity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple stents are used to achieve full lesion coverage, then the coverage and support are improved, but the vessel-wall compliance and flexibility are restricted

Engineering Contradiction:

Improvelesion coverageVSAvoidvessel-wall compliance

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The stent is divided into multiple expandable cell units along its length, allowing selective expansion at different segments to cover the entire lesion while maintaining flexibility in non-lesion areas

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stent transitions from a compressed delivery state to an expanded deployed state, and can dynamically adjust to vessel movements and physiological changes, maintaining compliance while providing structural support where needed

Inventive Principle:

Principle #15Dynamics

2Reliability

If traditional balloon-expandable stents are used, then the stent can be deployed, but the vessel-wall compliance and flexibility are significantly restricted

Engineering Contradiction:

Improvestent deploymentVSAvoidvessel-wall compliance

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The stent is constructed with thin, flexible nitinol struts that can bend and conform to vessel wall movements, unlike rigid balloon-expandable stents, while still providing adequate structural support

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The stent material properties are changed by using nitinol alloy with specific elastic characteristics that allow it to flex and comply with vessel wall movements while maintaining structural integrity

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If nitinol alloy is used for the stent, then super elastic properties are maintained, but radiopacity is reduced

Engineering Contradiction:

Improvesuper elastic propertiesVSAvoidradiopacity

Core Design Contradiction:

Stability of the object's compositionVSDifficulty of detecting and measuring

Solution Approach 1:

The stent combines nitinol alloy for superelasticity with platinum or radiopaque polymer coatings for enhanced X-ray visibility, creating a composite structure that maintains both mechanical and imaging properties

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

Radiopaque material is applied selectively to specific areas of the stent such as marker bands at the ends or selective strut coating, providing sufficient visibility without compromising the overall superelastic properties of the nitinol structure

Inventive Principle:

Principle #3Local quality

4Ease of operation

If a delivery system is designed for below-the-knee procedures, then access to distal vessels is improved, but the system complexity increases

Engineering Contradiction:

Improveaccess to distal vesselsVSAvoiddelivery system structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The stent is nested within a catheter delivery system that can be advanced through the vascular system to below-the-knee locations, with the stent compressed within the catheter and deployed at the target site

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The delivery system is designed to handle various stent types and deliver them to different vascular locations including below-the-knee vessels, making it a multi-functional system that can address various anatomical challenges

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 system enables effective recanalization of arteries below the knee, reduces the need for multiple stents, and maintains vessel compliance, thereby improving blood flow and reducing the risk of amputation in CLI patients.

Implementation Method 1

a self-expanding nitinol stent with a platinum alloy for enhanced radiopacity, designed for below-the-knee revascularization, which provides improved visibility and maintains super elastic properties

Methodology Applied

Scientific EffectSuper elasticity: Pseudoelasticity

Implementation Method 2

a self-expanding nitinol stent with a platinum alloy for enhanced radiopacity

Methodology Applied

Scientific EffectRadiopacity: X-Ray

Implementation Method 3

a unique liner for increased strength and lubricity

Methodology Applied

Scientific EffectLubrication: Lubrication

Data Source

PatentUS20250177175A1Stent Delivery System

Publication Date: 2025.06.05 MICRO MEDICAL SOLUTIONS INC

AI summary

The present disclosure relates to a stent delivery system that is specifically designed for the treatment of chronic limb-threatening ischemia (CLTI) below the knee (BTK), through ankle, and to be utilized as a primary treatment or as a bailout treatment.