Radiopaque Marker Scheme for Endovascular Stent Graft Alignment

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Solution Overview

Problem

Existing endovascular delivery systems for treating aortic aneurysms have high morbidity and mortality rates due to their invasive nature and require large, stiff devices that are difficult to deploy through tortuous anatomy, necessitating a flexible and adaptable system for varied patient anatomies.

Innovation Solution

An endovascular delivery system with a low-profile, modular prosthesis holder featuring radiopaque markers for precise alignment and deployment, including a bifurcated graft with inflatable channels for structural rigidity and a network of inflatable channels for sealing, allowing for flexible deployment and accurate placement within the body lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing endovascular delivery systems are used, then aortic aneurysms can be treated, but the systems have high morbidity and mortality rates due to invasive procedures and require large, stiff devices that are difficult to deploy through tortuous anatomy

Engineering Contradiction:
Improvesafety and reliability of deploymentVSAvoiddifficulty to deploy through tortuous anatomy
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The delivery system employs a flexible low profile construction with a catheter-based delivery mechanism that can navigate tortuous anatomy. The system uses a flexible delivery catheter with a low profile that can be inserted through peripheral vessels and advanced to the target site, eliminating the need for large, stiff devices that cause high morbidity and mortality rates.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If existing endovascular delivery systems are used, then aortic aneurysms can be treated, but the systems require large transverse profiles up to 24 French

Engineering Contradiction:
Improveeffectiveness of treatmentVSAvoidtransverse profile size
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The system utilizes a low profile delivery catheter with a small transverse profile that can be advanced through peripheral access vessels. The flexible construction allows the device to navigate through the vascular system without requiring large bore access, reducing trauma to the vessel wall and improving patient outcomes.

Inventive Principle:
Principle #30Flexible shells and thin films

3Strength

If existing endovascular delivery systems are used, then aortic aneurysms can be treated, but the systems have greater than desired lateral stiffness which complicates the delivery process

Engineering Contradiction:
Improvestructural support during deploymentVSAvoidcomplexity of delivery process
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The delivery system incorporates a dynamic structure that transitions from a flexible, low-profile delivery configuration to a rigid, self-expanding deployed configuration. The stent graft is compressed within the delivery catheter for easy navigation, then automatically expands to provide structural support upon deployment, eliminating the need for excessive lateral stiffness during the delivery process.

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If stent grafts are sized to accommodate varied patient anatomies, then the treatment can be adapted to different patients, but a large and expensive inventory of stent grafts must be maintained

Engineering Contradiction:
Improveadaptability to varied patient anatomiesVSAvoidinventory of stent grafts
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The system employs a universal delivery platform with a low profile catheter that can accommodate various stent graft sizes and configurations. The modular design allows different stent grafts to be delivered through the same delivery system, reducing the need to maintain separate delivery systems for each stent graft size and reducing inventory requirements.

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

5Manufacturing precision

If custom size stent grafts are manufactured and sent to the treating facility, then precise sizing for patient anatomy is achieved, but intervention is delayed

Engineering Contradiction:
Improveprecise sizing of stent graftVSAvoiddelay in intervention
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The system utilizes pre-sized, off-the-shelf stent grafts that are immediately available for deployment. The universal delivery system is pre-configured to accommodate various stent graft sizes, allowing the interventionalist to select the appropriate size from available inventory and deploy it immediately without waiting for custom manufacturing, thereby reducing procedural delays.

Inventive Principle:
Principle #10Preliminary 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

The system enables safe and reliable deployment of stent grafts across a range of patient anatomies, reducing procedural complexity and improving clinical outcomes by providing precise alignment and structural support during deployment.

Implementation Method 1

at least two generally cylindrical markers aligned in a direction parallel to the axial guidewire... using a known device that provides imaging, such as a radiographic or fluorescopy monitor, to view the location of the generally cylindrical markers

Methodology Applied
Scientific EffectRadiopacity: Absorption (EM radiation)

Data Source

PatentEP2861189B1Endovascular delivery system with an improved radiopaque marker scheme
Publication Date: 2022.12.28 TRIVASCULAR2 INC
  • EP2861189B1 patent drawingFigure 1
  • EP2861189B1 patent drawingFigure 2
  • EP2861189B1 patent drawingFigure 3

AI summary

An endovascular delivery system (100) for an endovascular prosthesis (114) includes a radiopaque marker system for accurate delivery of the prosthesis. The radiopaque marker system is disposed within a prosthesis or stent holder within the delivery system. The radiopaque marker system includes a plurality of radiopaque markers (178; 180) that provide different views of the rotation of the prosthesis or stent holder.