Elastomeric Introducer Sheath Support Structure Against Axial Crumpling

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Solution Overview

Problem

Existing introducer sheaths are prone to axial compression, folding, or crumpling during insertion, which can lead to blockages, excessive blood loss, increased recovery time, scarring, and potential damage to the artery due to friction and shear forces, especially when constructed from elastomeric materials.

Innovation Solution

An introducer sheath design featuring a circumferentially continuous elastomeric outer tube with a circumferentially discontinuous support layer, comprising a smooth inner surface and longitudinally extending support elements, which resist longitudinal compression while allowing radial expansion and flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the introducer sheath is constructed from elastomeric or non-rigid materials to provide flexibility and radial expansion, then the radial expansion and flexibility are improved, but the sheath becomes prone to axial compression, folding, and crumpling during insertion

Engineering Contradiction:

Improveradial expansion and flexibilityVSAvoidresistance to axial compression and folding

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent applies composite materials by combining an elastomeric outer layer with an inner support layer made of flexible wire or rod elements. This composite structure allows the sheath to simultaneously achieve radial expansion through the elastomeric material while resisting axial compression through the support layer, resolving the contradiction between flexibility and structural stability

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The support layer is positioned specifically within the elastomeric outer layer to provide localized reinforcement against axial compression and folding. This local quality enhancement allows the sheath to maintain its flexible nature for radial expansion while having targeted support where axial forces are applied during insertion

Inventive Principle:

Principle #3Local quality

2Ease of manufacture

If the sheath is made from a single layer of elastomeric material to simplify construction, then the manufacturing complexity is reduced, but the sheath cannot prevent compression or folding during insertion

Engineering Contradiction:

Improveconstruction simplicityVSAvoidprevention of compression and folding

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent transitions from a single-layer elastomeric construction to a composite structure with an inner support layer. This addition of the support layer provides the necessary resistance to compression and folding while maintaining relative manufacturing simplicity through the use of standard composite construction techniques

Inventive Principle:

Principle #40Composite materials

3Reliability

If the sheath is made from a dual layer structure to prevent compression, then the resistance to compression is improved, but the inner layer may be exposed creating hazards from sharp edges

Engineering Contradiction:

Improveresistance to compressionVSAvoidexposure to sharp edges and shear forces

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The support layer is designed to remain enclosed within the elastomeric outer layer throughout insertion, providing compression resistance while preventing exposure of sharp edges. The outer layer maintains its integrity as a protective barrier, eliminating the hazard of exposed inner layer edges while still providing the necessary structural support

Inventive Principle:

Principle #3Local quality

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 design prevents crumpling and folding during insertion, reducing the risk of blood loss, scarring, and damage to the artery, ensuring smooth passage of medical devices and minimizing complications.

Implementation Method 1

an elastomeric outer tube having a smooth inner surface with a substantially round or circular cross-section

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

a circumferentially discontinuous support layer, wherein the circumferentially discontinuous support layer is formed from one or more support elements extending longitudinally from the distal opening towards the proximal opening

Methodology Applied

Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentUS20250249213A1Improvements to introducer sheaths

Publication Date: 2025.08.07 THREE PEAKS MEDICAL PTY LTD

AI summary

The disclosure generally related to improved introducer sheaths for insertion into the body to provide intravascular access to various medical devices, involving an introducer sheath capable of insertion while providing resistance to frictional forces which may otherwise cause the unintentional compression of the outermost layer of the sheath. Embodiments generally comprise an introducer sheath comprising a circumferentially continuous elastomeric outer layer and a support element. Systems for protecting a luminal surface of a blood vessel are described herein. Also provided herein are methods for the use of these systems. Further, these systems include an elongated sleeve having a proximal opening and a circumferentially continuous elastomeric outer tube, the circumferentially continuous elastomeric outer tube has a smooth inner surface with a substantially round cross-section and includes one or more support elements extending longitudinally from the distal opening towards the proximal opening.