Expandable Peel-Away Introducer Sheath for Vessel Access

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Solution Overview

Problem

Existing introducer sheaths face challenges in delivering large medical devices through narrow lumens without occluding blood flow or causing tissue injury, as they often require larger diameters that can disrupt vessel function and are difficult to remove completely due to design constraints.

Innovation Solution

The development of expandable and peel-away introducer sheaths with radially outwardly expandable tubular bodies and split lines that allow for temporary expansion to accommodate larger medical devices, enabling safe passage and easy removal by creating a longitudinal opening along the seam, reducing the risk of occlusion and tissue injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If an introducer sheath with a large diameter is used to deliver large medical devices, then the device can be delivered successfully, but the lumen becomes occluded and blood flow is disrupted

Engineering Contradiction:

Improveability to deliver large medical devicesVSAvoidlumen occlusion and blood flow disruption

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The introducer sheath incorporates an expandable tubular body that can dynamically change its diameter. The body can be expanded radially outwardly to accommodate large medical devices during delivery, then contracted to minimize lumen occlusion after device deployment, thus resolving the contradiction between delivering large devices and maintaining blood flow

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The introducer sheath is divided into separable components including an expandable tubular body and a hub, with split lines allowing the body to be peeled apart. This segmentation enables the sheath to be removed in parts, reducing residual occlusion and facilitating complete removal while maintaining the ability to deliver large devices

Inventive Principle:

Principle #1Segmentation

2Object-affected harmful factors

If a peel-away introducer sheath is used to remove the sheath after device delivery, then the lumen is reopened, but the sheath is difficult to remove completely due to the handle obstructing removal

Engineering Contradiction:

Improvelumen reopeningVSAvoidcomplete sheath removal

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The introducer sheath is designed with split lines that allow the tubular body to be separated into segments. The body can be peeled apart longitudinally and removed in parts, enabling complete removal despite the handle obstruction, while the hub remains in place to maintain lumen access

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The expandable tubular body is extracted or separated from the hub component through the split lines. This extraction allows the body to be removed independently by peeling it apart, solving the problem of incomplete removal caused by the handle obstruction

Inventive Principle:

Principle #2Taking out (Extraction)

3Adaptability or versatility

If an expandable introducer sheath is used to accommodate large devices, then delivery is facilitated, but the sheath requires radial expansion forces that may cause tissue injury

Engineering Contradiction:

Improveaccommodation of large device diametersVSAvoidtissue injury from expansion forces

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The expandable tubular body provides localized expansion capability at specific segments rather than requiring uniform expansion of the entire sheath. This localized expansion reduces the overall radial forces applied to the vessel wall, minimizing tissue injury while still accommodating large device diameters where needed

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

These sheaths provide a versatile solution for delivering devices of varying sizes by temporarily expanding to accommodate larger diameters, minimizing procedural risks and improving patient safety by allowing for safe passage and easy removal, thus enhancing the efficiency and safety of endoluminal procedures.

Implementation Method 1

at least a portion of the tubular body is selectively radially outwardly expandable in response to radially outward force applied against the side wall

Methodology Applied

Scientific EffectRadial expansion:

Implementation Method 2

The peel-away introducer sheath is removed from the shaft by peeling it apart thus opening the lumen of the introducer sheath. The peel-away introducers are adapted to be peeled apart by providing grab tabs connected to separate parts of the sheath held together by one or more seams that tear when shear force is applied by pulling the grab tabs apart

Methodology Applied

Scientific EffectShear force separation:

Data Source

PatentUS20230398330A1Peel-away introducer sheath having an adjustable diameter and method of use

Publication Date: 2023.12.14 KARDION GMBH

AI summary

Peel-away introducer sheath (100) having an adjustable diameter. The present disclosure is directed generally to introducer sheaths used in endoluminal catheterization for medical treatments. More particularly, the present disclosure is directed towards introducer sheaths that are expandable and can be peeled apart.