Self-Expanding Tubular Device for Iliac Artery Dilation

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Solution Overview

Problem

Endovascular procedures for treating stenosis in iliac arteries are challenging due to the narrow and tortuous nature of these vessels, which can lead to damage during dilation and access issues, limiting the effectiveness of current methods and potentially requiring surgical intervention.

Innovation Solution

A dilation device comprising a removable expansion component, such as an inflatable balloon, and a self-expanding tubular body with stents, which expands to maintain the dilated lumen, allowing for successive dilation steps and reducing the risk of vessel damage, enabling access for endovascular procedures without open surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If an introducer sheath is used to guide catheters and deliver devices into the target site within the vasculature, then access to the target site is achieved, but the sheath may cause damage such as laceration or avulsion to the iliac artery

Engineering Contradiction:
Improveaccess to target siteVSAvoidvessel damage
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by performing dilation of the iliac artery before introducing the sheath and delivery system. The balloon catheter dilates the artery ahead of time, creating a larger, safer pathway that reduces the risk of damage during subsequent sheath insertion and manipulation. This preparatory dilation ensures the vessel can accommodate the delivery system without compromising its integrity.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If multiple introducer sheaths are successively inserted and removed for dilation, then the vessel lumen can be enlarged to improve access, but the repeated manipulation increases the risk of damaging the vessel walls

Engineering Contradiction:
Improveaccess improvementVSAvoidvessel integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent performs preliminary balloon dilation to enlarge the vessel lumen before introducing the sheath and delivery system. This advance preparation creates sufficient space for the delivery system to pass through without requiring repeated sheath insertions and removals, thereby minimizing manipulation-induced damage to the vessel walls.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the iliac artery is intentionally ruptured by surgical incision to achieve adequate access, then delivery access is improved, but the procedure becomes more invasive and carries higher risk

Engineering Contradiction:
Improvedelivery accessVSAvoidinvasiveness
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical surgical incision approach with a less invasive endovascular balloon dilation technique. Instead of physically cutting into the artery to create access, a balloon catheter is inflated within the vessel to dilate it from the inside, achieving adequate luminal enlargement without breaking the arterial wall or requiring open surgical intervention.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Ease of operation

If a low profile device is used to accomplish endovascular procedure in narrow lumen iliac arteries, then access through the vessel is facilitated, but the device may have limited functionality or require complex delivery systems

Engineering Contradiction:
Improveaccess through vesselVSAvoiddevice functionality
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent employs a self-expanding stent that transitions from a compressed low-profile state during delivery to an expanded functional state at the target site. The stent is delivered in a compact configuration that can pass through narrow vessels, then automatically expands or is balloon-expanded to provide structural support and maintain vessel patency, combining low-profile delivery with full functional capability.

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

The solution provides a safer and more effective means of accessing and treating stenotic iliac arteries by maintaining patency of the dilated lumen, reducing the risk of adverse events, and allowing for subsequent endovascular procedures without the need for open surgical intervention.

Implementation Method 1

a removable expansion component such as an inflatable balloon

Methodology Applied
Scientific EffectInflation: Pressure Increase

Implementation Method 2

a self-expanding tubular body with stents, which expands to maintain the dilated lumen

Methodology Applied
Scientific EffectSelf-expanding: Elastic Recovery

Data Source

PatentUS20230119898A1Tubular medical device
Publication Date: 2023.04.20 VASCUTEK LIMITED
  • US20230119898A1 patent drawing
  • US20230119898A1 patent drawing
  • US20230119898A1 patent drawing

AI summary

Apparatus for progressively dilating the lumen of a narrow natural vessel such as an iliac artery and implanting a tubular device enabling access through the dilated lumen to conduct subsequent procedures via the dilated lumen, includes an inflatable integrated balloon locatable at least partially within the tubular device, the tubular device having a length L1 providing a self-expanding tubular body having at least a portion including stents, so that when the integrated balloon is removed the dilated lumen of the natural vessel remains dilated and supported by the tubular device.