Expandable Radial Dilator for Fast ECMO Cannula Insertion

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Solution Overview

Problem

Current percutaneous vascular cannula insertion methods, such as axial dilation, are time-consuming, require significant manpower, and pose risks of vascular injury and blood loss due to the need for multiple dilators and high forces applied during the procedure.

Innovation Solution

An expandable-retractable single radial dilator system utilizing shape memory alloy technology for controlled radial dilation and retraction, allowing for fast and minimally invasive insertion of cannulas with reduced risk of injury and blood loss, and enabling single-operator procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If axial dilation technique with serial axial dilators is used, then cannula insertion can be achieved, but operation time is prolonged and manpower requirements increase

Engineering Contradiction:
Improveoperation timeVSAvoidnumber of dilators
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent combines multiple dilator functions into a single radial dilator device that can perform sequential dilation in one instrument, eliminating the need for multiple separate axial dilators and reducing procedure time

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The radial dilator employs a dynamic expansion mechanism that allows the device to transition from a compressed delivery profile to an expanded dilation profile, enabling single-device sequential dilation across multiple tissue layers

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If axial dilation with high force is applied, then cannula insertion can be achieved, but risk of vascular injury and vessel rupture increases

Engineering Contradiction:
Improvecannula insertionVSAvoidvascular injury
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent inverts the traditional axial dilation approach by using radial expansion perpendicular to the vessel axis, which distributes force more evenly across tissue layers and reduces the risk of longitudinal vessel rupture

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The radial dilator incorporates a staged expansion design that gradually dilates tissue from subcutaneous layers to vascular entry, cushioning the transition and preventing sudden force application that could cause vessel injury

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Productivity

If multiple serial dilators are used, then cannula insertion can be achieved, but blood loss increases during dilator changes

Engineering Contradiction:
Improvecannula insertionVSAvoidblood loss
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

By consolidating multiple dilation functions into a single radial dilator device, the patent eliminates repeated punctures and tissue manipulations associated with changing multiple dilators, thereby reducing blood loss

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The radial dilator maintains continuous contact with the guidewire and performs sequential dilation in a single continuous motion, eliminating the discontinuous actions and repeated insertions required by serial dilator changes

Inventive Principle:
Principle #20Continuity of useful action

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

This solution reduces operation time, minimizes vascular injuries and blood loss, and facilitates the rapid insertion of large cannulas, including during critical situations like out-of-hospital cardiac arrest and ECMO cannulation, while allowing for controlled dilation and retraction to accommodate different cannula sizes.

Implementation Method 1

a dilator comprising: a guidewire; a shape memory alloy tube disposed over the guidewire, the shape memory alloy tube having an initial configuration and an expanded configuration

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

the shape memory alloy tube having an initial configuration and an expanded configuration transformable between the initial configuration and the expanded configuration

Methodology Applied
Scientific EffectThermal expansion: Thermal Expansion

Data Source

PatentUS12109380B1Expandable-retractable apparatus for fast insertion of ECMO and other cannulas (ERIC) via radial dilatation and methods of making
Publication Date: 2024.10.08 UNM RAINFOREST INNOVATIONS
  • US12109380B1 patent drawing
  • US12109380B1 patent drawing
  • US12109380B1 patent drawing

AI summary

A dilation system comprising a plurality of springs axially disposed in an elastic tube.