Expandable Introducer With Folded Liner for Reduced Insertion Profile

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Solution Overview

Problem

Percutaneous medical procedures often require large medical devices that apply undesirable forces to vessel walls, necessitating the development of an introducer with a reduced insertion profile that can expand to protect the vessel wall.

Innovation Solution

An introducer comprising a layered tubular member with an inner liner, reinforcing member, and outer sheath, featuring folded portions and perforations, allowing for radial expansion to accommodate larger devices while minimizing vessel wall stress.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a large medical device is inserted through a patient's vasculature, then the device can perform the required medical procedure, but undesirable forces are applied to the vessel walls

Engineering Contradiction:
Improvedevice capabilityVSAvoidvessel wall force
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The introducer employs a nested structure where the inner liner is folded back upon itself multiple times, creating a compact delivery configuration. This nesting allows the introducer to achieve a small insertion profile while containing the full length and capability of the inner liner for subsequent expansion.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The introducer transitions from a static folded configuration during insertion to a dynamic expanded configuration during device passage. The inner liner is designed to radially expand when forces are applied, transforming the structure from a compact protective sheath to an expanded protective barrier, thereby adapting to different operational requirements.

Inventive Principle:
Principle #15Dynamics

2Length of moving object

If the inner liner is folded back upon itself to reduce insertion profile, then the introduction is facilitated, but the lumen becomes occluded

Engineering Contradiction:
Improveinsertion profileVSAvoidlumen patency
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The inner liner is segmented into multiple sections that can be folded back upon itself in a controlled manner. This segmentation allows the liner to be compressed into a compact form for insertion while maintaining the ability to expand and open the lumen when needed, preventing occlusion during the procedure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The inner liner is pre-folded into a compact configuration before insertion to achieve a small insertion profile. However, the folding is designed to be reversible, and the liner is prepared to expand when forces are applied during device passage, ensuring lumen patency is restored when needed.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the inner liner is made inelastic to prevent expansion during insertion, then insertion forces are reduced, but the liner cannot expand to protect vessel wall during device passage

Engineering Contradiction:
Improveinsertion forceVSAvoidexpansion capability
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The inner liner is designed with dynamic mechanical properties that allow it to remain collapsed during insertion but expand when radial forces are applied. The material and structural design enable the liner to transition from a non-expanding protective sheath during insertion to an expanding protective barrier during device passage, providing adaptability to different operational phases.

Inventive Principle:
Principle #15Dynamics

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 introducer provides a reduced insertion profile with expandable capabilities, protecting vessel walls and facilitating the passage of medical devices without excessive force.

Implementation Method 1

the inner liner is configured to radially expand from the delivery configuration to an expanded configuration

Methodology Applied
Scientific EffectRadial expansion: Elasticity

Data Source

PatentEP4129382B1Introducer with expandable capabilities
Publication Date: 2025.10.29 BOSTON SCIENTIFIC SCIMED INC
  • EP4129382B1 patent drawingFigure 1
  • EP4129382B1 patent drawingFigure 2
  • EP4129382B1 patent drawingFigure 3

AI summary

An introducer (10) including a layered tubular member (14) having an inner liner (20) including at least one folded portion (34) extending along a distal region (26) of the inner liner in a delivery configuration; a reinforcing member (40) disposed over at least a portion of the inner liner, the reinforcing member including a plurality of longitudinal spines (44) defining a plurality of openings (46) disposed between adjacent longitudinal spines, wherein each folded portion is circumferentially overlapped by one of the plurality of openings; and an outer sheath (30) disposed over the reinforcing member, wherein the outer sheath includes at least one perforation (32) circumferentially overlapping each folded portion; and a tip member (28) fixedly attached to a tapered distal region of the layered tubular member. The inner liner may extend to a distal end of the layered tubular member. At least a portion of each folded portion may terminate proximal of the distal end of the layered tubular member.