Self-Expanding Scaffold Cutting Elements Vascular Navigation

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Solution Overview

Problem

Existing angioplasty treatments face challenges in effectively navigating tortuous vasculature due to the rigid structure of cutting elements, which limits their ability to reach and treat stenotic lesions, and are prone to re-stenosis post-procedure.

Innovation Solution

A self-expanding scaffold with cutting elements that can be radially expanded to navigate through tortuous anatomy, combined with a balloon catheter to deploy the cutting elements against the stenotic lesions, allowing for flexible delivery and reduced trauma to healthy tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If rigid cutting elements are used in angioplasty balloons, then cutting effectiveness on stenotic lesions is improved, but the flexibility to navigate tortuous vasculature deteriorates

Engineering Contradiction:

Improvecutting effectivenessVSAvoidflexibility to navigate tortuous vasculature

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The cutting element is divided into multiple segments that can flex relative to each other, allowing the cutting element to navigate tortuous vasculature while maintaining cutting effectiveness. The segmented structure enables the element to conform to vessel curvature without losing its cutting capability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cutting element transitions from a static rigid structure to a dynamic flexible structure that can adapt its shape during navigation and deployment. The element possesses controlled flexibility that allows it to bend and flex during delivery through tortuous vessels while maintaining structural integrity for effective cutting.

Inventive Principle:

Principle #15Dynamics

2Adaptability or versatility

If cutting elements are made flexible to navigate tortuous anatomy, then navigability is improved, but cutting force and structural stability deteriorate

Engineering Contradiction:

Improvenavigability through tortuous anatomyVSAvoidcutting force

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

Different portions of the cutting element have different mechanical properties - the proximal portion is more flexible for navigation while the distal cutting portion maintains greater rigidity and strength for effective cutting. This gradient in mechanical properties allows the element to satisfy both navigability and cutting force requirements.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The cutting element is constructed from composite materials or a composite structure that combines flexible and rigid characteristics. This allows the element to exhibit flexibility in certain directions or regions while maintaining strength and cutting capability in other regions or directions.

Inventive Principle:

Principle #40Composite materials

3Adaptability or versatility

If self-expanding scaffold is used instead of rigid balloon, then flexibility for navigation is improved, but control precision during deployment deteriorates

Engineering Contradiction:

Improveflexibility for navigationVSAvoidcontrol precision during deployment

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

A delivery catheter or sheath acts as an intermediary that provides controlled expansion of the self-expanding scaffold. The intermediary allows the scaffold to expand in a controlled manner at the target site while maintaining flexibility during navigation, resolving the conflict between navigability and deployment precision.

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 solution enables precise and effective incision of stenotic lesions with reduced re-stenosis risk, improving the flexibility of the treatment device for navigating complex vascular structures and enhancing the treatment outcome.

Implementation Method 1

a self-expanding scaffold configured to be expandable from a first contracted configuration to a second expanded configuration. The self-expanding scaffold is biased toward the second expanded configuration.

Methodology Applied

Scientific EffectElastic memory: Elasticity

Data Source

PatentUS9763691B2Expandable scaffold with cutting elements mounted thereto

Publication Date: 2017.09.19 BOSTON SCIENTIFIC SCIMED INC

AI summary

A medical device assembly for incising a stenosis in a blood vessel which includes an incising device, a tubular sheath, and a catheter having an inflatable balloon mounted thereon. The incising device includes a self-expanding scaffold having a plurality of cutting elements projecting radially outward therefrom, and an elongate member extending proximally from the self-expanding scaffold to be manipulated by a user. The self-expanding scaffold is positionable in the lumen of the sheath in a contracted configuration and deployed out of the lumen of the sheath to permit the self-expanding scaffold to expand to an expanded configuration. The inflatable balloon of the catheter is configured to be advanced distally into an interior of the self-expanding scaffold through a proximal opening of the self-expanding scaffold, and inflation of the inflatable balloon urges the cutting elements radially outward to incise a stenosis.