Expandable Introducer Sheath with Predetermined Incisions

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Solution Overview

Problem

Existing introducer sheaths for catheters face difficulties in navigating and removing large-caliber catheters, often causing vessel wall injuries due to their rigidity and inability to maintain adjusted diameters post-use.

Innovation Solution

An introducer sheath with a reversibly changing insertion tube featuring longitudinally extending incisions designed as predetermined breaking points, allowing expansion to accommodate large-caliber catheters and subsequent contraction to original diameter for easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If large-caliber introducer sheaths are used to accommodate large-caliber catheters, then the catheter can be introduced, but the sheath becomes difficult to navigate and causes vessel wall injuries during removal

Engineering Contradiction:

Improvecatheter size accommodationVSAvoidnavigation and removal ease

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The introducer sheath transitions from a small caliber state to a large caliber state dynamically. The sheath body includes expandable elements that can be activated to increase the internal diameter, allowing it to accommodate large-caliber catheters temporarily, then return to its original small caliber for easy removal. This dynamic transformation resolves the contradiction by making the sheath adaptable to different catheter sizes while maintaining navigability and removal ease.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The internal diameter parameter of the introducer sheath is changed temporarily to accommodate large-caliber catheters. The sheath maintains its original small caliber during navigation and removal, then expands to a large caliber state during the procedure when needed, and finally returns to the original small caliber. This parameter change allows the sheath to adapt to different catheter sizes without permanently compromising its navigability or removal characteristics.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If the introducer sheath expands to accommodate large-caliber catheters, then it can perform the required function, but it maintains the expanded diameter even after catheter removal causing difficulties

Engineering Contradiction:

Improvediameter adaptationVSAvoiddiameter maintenance

Core Design Contradiction:

Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The introducer sheath undergoes periodic transformation between small caliber and large caliber states. It starts in a small caliber state for navigation, expands to a large caliber state to accommodate the catheter, performs the procedure, then returns to the small caliber state for removal. This periodic action ensures the sheath adapts to the required diameter during the procedure while automatically returning to its original stable configuration after use.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The sheath is designed with pre-configured expandable elements that are prepared in advance to enable temporary expansion. These elements are integrated into the sheath structure beforehand, allowing the sheath to expand to the required diameter when needed and then automatically return to its original configuration, preventing permanent diameter maintenance that would complicate removal.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If conventional introducer sheaths are used, then they provide access for catheters, but they cause vessel wall injuries and tissue damage during insertion and removal

Engineering Contradiction:

Improvevascular access provisionVSAvoidvessel wall injury

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The introducer sheath dynamically adjusts its diameter to match the catheter size being used. By expanding only to the necessary diameter temporarily during the procedure and returning to its original small caliber for removal, the sheath minimizes contact with and potential damage to the vessel wall and surrounding tissue, while still providing reliable vascular access when needed.

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

Enables safe and efficient insertion and removal of catheters of varying sizes with reduced risk of vascular injuries by allowing diameter adjustment and self-contracting mechanism post-treatment.

Implementation Method 1

The incisions are so designed that they tear open when a catheter of larger caliber is being inserted

Methodology Applied

Scientific EffectMechanical Force: Mechanical Force

Implementation Method 2

after the catheter has been removed cause the tube to reduce to its original diameter

Methodology Applied

Scientific EffectElastic Recovery: Elastic Recovery

Data Source

PatentUS11738178B2Expandable introducer sheath

Publication Date: 2023.08.29 BENTLEY INNOMED GMBH

AI summary

The invention relates to an introducer sheath for catheters to be inserted into a vascular system comprising a connecting valve (2) and an insertion tube (3) having a proximal portion (4) and a distal portion (5), said distal portion (5) being of reduced diameter in comparison with the proximal portion (4), and to enable its diameter to be reversibly changed the insertion tube (3) is provided with longitudinally extending expansion elements with incisions (11, 11′, 12) designed as predetermined breaking points.