Expandable Sheath for Intravascular Catheter Insertion

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Solution Overview

Problem

Current medical devices for intravascular procedures face challenges in accommodating varying diameters of catheters and guides, particularly in smaller radial arteries, requiring multiple sheaths and potentially causing trauma and blood loss due to the need for different sheath sizes for different procedures.

Innovation Solution

An expandable sheath system with a flexible tubular member and a linear array of perforations or a slit, allowing for expansion from a smaller inner diameter to a larger one, enabling the use of multiple-sized catheters within a single system without the need for multiple sheaths, reducing trauma and blood loss.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single sheath is used for multiple catheter sizes, then device complexity is reduced, but the sheath must accommodate varying diameters which increases manufacturing complexity

Engineering Contradiction:
Improvenumber of sheaths requiredVSAvoidsheath manufacturing complexity
Core Design Contradiction:
Device complexityVSEase of manufacture

Solution Approach 1:

The sheath transitions from a static single-diameter structure to a dynamic expandable structure. The sheath includes an expandable section with radial expansion capability, allowing it to change its inner diameter from a first diameter to a second diameter during use, accommodating different catheter sizes within a single sheath device.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sheath's inner diameter parameter is made variable through the expandable mechanism. The expandable section can change its dimensional parameter (inner diameter) from an initial state to an expanded state, enabling the same sheath to accommodate catheters of different sizes by adjusting its diameter parameter.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If multiple sheaths are used for different catheter sizes, then adaptability is improved, but trauma and blood loss increase

Engineering Contradiction:
Improvecatheter size accommodationVSAvoidvascular trauma and blood loss
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The sheath is designed as a universal device that can accommodate multiple catheter sizes through its expandable capability. The expandable section allows the sheath to adapt its inner diameter to match different catheter outer diameters, making a single sheath suitable for multiple procedures and catheter types, thereby reducing the need for multiple sheaths and associated trauma.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The sheath's dynamic expandability allows it to adapt to different catheter sizes without requiring multiple static sheaths. The expandable section can be expanded to accommodate larger catheters or maintained at a smaller diameter for smaller catheters, providing versatility while minimizing vascular trauma through a single insertion site.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If the sheath is made expandable, then versatility is improved, but device complexity increases

Engineering Contradiction:
Improvecatheter size rangeVSAvoidsheath structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The sheath is divided into distinct sections: a first section with a first inner diameter and a second expandable section with a second inner diameter. This segmentation allows each section to serve specific functions, with the expandable section providing versatility while the first section maintains structural simplicity for initial insertion.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The expandable sheath structure can be nested within or around a dilator during insertion. The expandable section is positioned to be expanded by the dilator, allowing the complex expandable mechanism to be compact during insertion and then expand to provide the required versatility for different catheter sizes.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 sheath system allows for safe and efficient insertion of catheters of varying diameters through a single system, minimizing trauma and blood loss by expanding to accommodate larger diameters, thus facilitating more versatile and less invasive vascular procedures.

Implementation Method 1

The wall has a first portion, a transitional portion and a second portion respectively having first, transitional and second inner diameters associated therewith... the tubular member includes a linear array of perforations formed therethrough... such that the linear array of perforations allow the second and transitional portions to expand

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3180064B1Expandable sheath and system for intravascular insertion of a medical implement using the same
Publication Date: 2020.04.22 AL RASHDAN IBRAHIM RASHID
  • EP3180064B1 patent drawingFigure 1
  • EP3180064B1 patent drawingFigure 2
  • EP3180064B1 patent drawingFigure 3

AI summary

The expandable sheath and system (10) for intravascular insertion of a medical implement includes a cannula (70) for entering a lumen of a vascular vessel of a patient, a guide wire (72) insertable into the lumen, an introducer and dilator (62) adapted to follow the guide wire (72) into the lumen, an expandable sheath (40) positioned on the introducer and dilator (62), with the expandable sheath (40) being adapted to be positioned in the vessel, and an extension collar (76). The medical implement is received within the vessel by passing through the sheath (40) upon separating the introducer and dilator (62) therefrom. In one embodiment, a linear array of perforations (50) formed through the expandable sheath (40) allow for expansion. Alternatively, an external slit (16) may be provided for selective expansion of the sheath (40).