Expandable Introducer Sheath for Low-Trauma Large-Device Delivery

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Solution Overview

Problem

Current medical procedures involving the delivery of large medical devices through the vasculature often cause significant trauma due to the size of the incision and the device's profile, as conventional introducer sheaths do not effectively minimize the cross-sectional area or self-recover to a smaller diameter after expansion.

Innovation Solution

An expandable introducer sheath with a support framework and covering that allows for self-expansion to accommodate larger medical devices and self-recovery to a smaller diameter, minimizing trauma by maintaining a reduced profile and reducing friction with the vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the introducer sheath is expanded to accommodate large medical devices, then the device delivery capability is improved, but the trauma to the vasculature and occlusion of the vessel increases

Engineering Contradiction:
Improvedevice delivery capabilityVSAvoidvessel trauma and occlusion
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The introducer sheath transitions from a compressed low-profile state during insertion to an expanded state during device delivery, then returns to a reduced state. This dynamic size change allows the sheath to adapt to different operational requirements while minimizing harm to the vasculature at each stage.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sheath is divided into a distal portion and a proximal portion that can be independently controlled. The distal portion remains in a reduced profile to minimize vessel trauma, while the proximal portion can be expanded to accommodate large medical devices during delivery.

Inventive Principle:
Principle #1Segmentation

2Object-affected harmful factors

If the introducer sheath maintains a reduced profile to minimize trauma, then the vessel trauma is reduced, but the ability to deliver large medical devices is limited

Engineering Contradiction:
Improvevessel traumaVSAvoiddevice delivery capability
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The sheath's ability to dynamically change size allows it to maintain a reduced profile during insertion and recovery phases to minimize trauma, while temporarily expanding during the device delivery phase to accommodate large medical devices. This temporal separation of functions resolves the contradiction.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sheath is pre-configured with expandable structures and support frameworks that enable it to expand only when needed for device delivery. The expandable distal portion and controllable expansion mechanisms are prepared in advance, allowing the sheath to transition from a low-profile state to an expanded state on demand.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If the introducer sheath is expanded to accommodate large devices, then the device profile accommodation is improved, but the friction with the vasculature increases

Engineering Contradiction:
Improvedevice profile accommodationVSAvoidfriction with vasculature
Core Design Contradiction:
Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

Different portions of the sheath have different properties: the distal portion is designed to remain in a reduced profile with low friction characteristics to minimize interaction with the vasculature, while the proximal portion can be expanded to accommodate large devices. This local differentiation allows the sheath to accommodate large devices without proportionally increasing friction throughout the entire sheath length.

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 introducer sheath effectively delivers large medical devices with minimal trauma by expanding to accommodate the device's profile and then recovering to a smaller diameter, reducing occlusion and vessel trauma.

Implementation Method 1

An expandable introducer sheath with a support framework and covering that allows for self-expansion to accommodate larger medical devices and self-recovery to a smaller diameter

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3958793B1Expandable sheath
Publication Date: 2026.01.28 WL GORE & ASSOC INC
  • EP3958793B1 patent drawingFigure 1
  • EP3958793B1 patent drawingFigure 2
  • EP3958793B1 patent drawingFigure 3~5

AI summary

Described embodiments include a medical device having a frame including a plurality of strut elements arranged to form a tubular framework and a covering extending along a portion of the frame such that the frame and the covering define a sheath having a lumen extending therethrough.