Expandable Introducer With Radial Expansion for Atraumatic Vascular Access

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Solution Overview

Problem

Conventional introducers lack the ability to accommodate objects of varying sizes and shapes while minimizing damage to the patient's vasculature during medical procedures, leading to potential injury and blood loss.

Innovation Solution

An expandable introducer apparatus with a flexible tubular member that expands and contracts to accommodate objects, featuring a radially expandable inner layer and a bonded flexible region to minimize trauma and facilitate safe passage through the vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a conventional introducer with fixed size is used, then the structure is simple and easy to manufacture, but it cannot accommodate objects of varying sizes and shapes, leading to potential vascular injury

Engineering Contradiction:

Improveability to accommodate objects of varying sizes and shapesVSAvoidstructural complexity of the introducer

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The introducer employs a radially expandable tubular member that can dynamically change its diameter from a first (contracted) size to a second (expanded) size. This dynamic structure allows the same introducer to accommodate objects of varying sizes and shapes while maintaining structural integrity, resolving the contradiction between adaptability and device complexity.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The introducer changes its radial dimension parameter through expansion and contraction. The tubular member transitions between different radial states to match the size requirements of different medical objects, enabling versatile accommodation without requiring multiple fixed-size introducers, thus improving adaptability without proportionally increasing complexity.

Inventive Principle:

Principle #35Parameter changes

2Object-affected harmful factors

If a rigid introducer is used to provide support during insertion and removal, then structural support is maintained, but it causes trauma to the patient's vasculature

Engineering Contradiction:

Improvedamage to patient's vasculatureVSAvoidsupport capability during insertion and removal

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The introducer transitions from a rigid fixed-size structure to a dynamic expandable structure that can adjust its rigidity. When expanded, it provides sufficient support strength for safe insertion and removal; when contracted or conforming to the vasculature, it minimizes trauma. This dynamic adaptation resolves the contradiction between providing support and reducing vascular damage.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The radially expandable tubular member functions as a flexible shell that can conform to the vascular structure while providing necessary support. The flexible nature allows it to adapt to the vasculature shape, reducing trauma, while its expandable capability ensures adequate support strength during critical operations.

Inventive Principle:

Principle #30Flexible shells and thin films

3Adaptability or versatility

If an expandable introducer is used to accommodate various objects, then versatility is improved, but the complexity of introducing and removing objects increases

Engineering Contradiction:

Improvecapability to accommodate objects during medical proceduresVSAvoidcomplexity of introducing and removing objects

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The expandable introducer uses a dynamic radial expansion mechanism rather than complex mechanical assemblies. The tubular member expands and contracts in response to radial forces, providing versatility for different object sizes through a relatively simple dynamic mechanism, thus improving adaptability without excessively increasing operational complexity.

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 expandable introducer reduces vascular injury and blood loss by accommodating objects of varying sizes and shapes, ensuring atraumatic insertion and removal while maintaining support during medical procedures.

Implementation Method 1

a flexible region which is not bonded to the radially expandable region of the inner tubular layer along an axial length of the distal segment, wherein the radially expandable region of the inner tubular layer along the axial length of the distal segment extends under the flexible region of the flexible tubular member

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS20250276153A1Expandable introducer apparatus and methods of guiding an object

Publication Date: 2025.09.04 MEDTRONIC INC

AI summary

An expandable introducer apparatus comprising an inner tubular layer comprising an inner lumen and a radially expandable region extending along an elongated axis of the inner lumen and configured to at least partially radially expand relative to the elongated axis from a contracted orientation to an expanded orientation. An outer tubular layer comprising an inner surface bonded to the inner tubular layer, wherein a distal segment of the inner tubular layer extends beyond a distal end of the outer tubular layer. A flexible tubular member comprising a bonded region and a flexible region, wherein an inner surface of the bonded region is bonded to an outer surface of the distal segment of the inner tubular layer, and the flexible region is not bonded to the radially expandable region of the inner tubular layer.