Aortic Graft Radio-Opague Markers for Distal End Positioning

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Solution Overview

Problem

The existing 'Elephant Trunk' graft procedure for treating aortic aneurysms requires a two-stage process, increasing the risk of rupture before the second stage can be completed, especially with larger aneurysms, due to size mismatch and complex assembly challenges, necessitating improved methods for precise placement and identification of the distal graft end during surgery.

Innovation Solution

Incorporating two diametrically opposed rows of spaced radio-opaque markers on the distal portion of the graft during manufacture, made from biocompatible materials like gold, platinum, or radio-opaque plastics, to facilitate precise positioning of the endovascular device and ensure accurate trimming and placement of the graft.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a two-stage Elephant Trunk graft procedure is used to treat large aortic aneurysms, then the graft can be initially placed to replace the ascending aorta and arch, but the risk of aneurysm rupture increases before the second stage can be completed due to size mismatch and inability to fully secure the distal end

Engineering Contradiction:
Improverisk of aneurysm ruptureVSAvoidtwo-stage procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The graft is prepared with pre-marked distal end indicators (radio-opaque markers and external landmarks) during manufacture, allowing the surgeon to accurately identify and position the distal end during the second stage procedure. This preliminary marking action enables precise placement without requiring complex intraoperative measurement or adjustment, thereby reducing the risk of rupture while maintaining procedural feasibility

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If the distal end of the graft is trimmed to match patient anatomy during the first stage, then the graft can be properly sized, but the position of the distal end becomes unknown and cannot be precisely identified during the second stage

Engineering Contradiction:
Improvegraft size adaptationVSAvoiddistal end position information
Core Design Contradiction:
Adaptability or versatilityVSLoss of information

Solution Approach 1:

External landmarks (such as sutures, clips, or surface markings) and radio-opaque markers are attached to the distal end of the graft during manufacture, creating a visible copy or representation of the distal end position that remains on the external surface after trimming. This allows the true distal end position to be identified during the second stage even though the actual distal end has been trimmed to fit the patient's anatomy

Inventive Principle:
Principle #26Copying

3Measurement precision

If radio-opaque markers are added to the graft, then precise identification and positioning of the distal graft end can be achieved under X-ray, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvedistal end positioning accuracyVSAvoidgraft manufacturing complexity
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The marking system is divided into separate components: radio-opaque markers (such as metal clips or beads) are attached to the distal end of the graft during manufacture, while external landmarks (such as sutures or surface markings) are applied separately. This segmentation allows the graft body to be manufactured using standard processes, with the marking components added as separate, simple steps that do not significantly complicate the overall manufacturing process

Inventive Principle:
Principle #1Segmentation

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 inclusion of radio-opaque markers allows for precise identification and correct positioning of the distal graft end under X-ray, reducing the risk of rupture and simplifying the second-stage procedure by enabling accurate alignment and overlap assessment, thus enhancing surgical efficiency and safety.

Implementation Method 1

two diametrically opposed rows of spaced radio-opaque markers on the distal portion thereof... allows for precise identification and correct positioning of the distal graft end under X-ray

Methodology Applied
Scientific EffectX-ray: X-Ray

Data Source

PatentEP1736116B1Graft for aneurysm repair
Publication Date: 2009.11.18 VASCUTEK LIMITED
  • EP1736116B1 patent drawingFigure 1~2

AI summary

There is provided an improved graft for treatment of diseased, typically aneurysmal, tissue of the ascending aorta and aortic arch. The graft described is based on the "Elephant Trunk" graft which requires a two-stage procedure for completion of treatment. The modified graft includes a series of markers to allow visualisation of the distal end of the graft, irrespective of the requirements to trim the distal end of the graft to match the patient's anatomy. The markers are typically radio-opaque allowing visualisation by X-ray.