Stent Graft Reloading for Patient-Specific Fenestration Alignment
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Solution Overview
Problem
Current stent grafts are limited in their applicability to juxtarenal aneurysms due to the need for precise fenestrations that align with renal arteries, which cannot be easily added post-manufacture without removing the graft from the delivery sheath, posing challenges in minimally invasive endovascular treatment.
Innovation Solution
A method and kit for modifying stent grafts with patient-specific fenestrations using a template and tools for reloading the graft into the delivery system, involving compressing devices, fenestration templates, and fenestration rings, ensuring precise alignment with branch vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the stent graft is removed from the delivery sheath to add fenestrations, then the physician can create patient-specific fenestrations, but the graft may be damaged and the reloading process becomes complex and time-consuming
Solution Approach 1:
The patent applies preliminary action by providing a template with pre-defined fenestration locations and configurations before the graft is removed from the delivery sheath. The template includes marked positions for fenestrations that correspond to branch vessel locations, allowing the physician to quickly and accurately create patient-specific fenestrations without complex measurements or calculations during the procedure.
Solution Approach 2:
The patent uses a template as an intermediary tool between the physician and the graft. The template serves as a guide that facilitates the creation of accurate fenestrations while protecting the graft from damage. It includes features such as alignment marks and fenestration templates that ensure precise positioning without requiring the physician to directly manipulate or measure the graft itself.
2Ease of operation
If the stent graft is fully compressed for reloading, then it can be reinserted into the delivery sheath, but the compression force may damage the graft structure or fenestrations
Solution Approach 1:
The patent applies parameter changes by using a compression device with controllable compression force and gradual compression stages. The device allows the physician to adjust the compression parameters to achieve sufficient compression for reloading while maintaining the structural integrity of the graft and its fenestrations. The compression force can be modified to match the specific requirements of different graft types and sizes.
3Measurement precision
If precise measurements are taken from medical images to create fenestrations, then accurate alignment with branch vessels is achieved, but the process requires complex calculations and time-consuming procedures
Solution Approach 1:
The patent applies copying by using a template that replicates the anatomical relationships and branch vessel positions directly onto the graft. Instead of performing complex calculations from medical images, the template provides a pre-configured copy of the required fenestration pattern with accurate spacing and positioning. This allows the physician to transfer the fenestration design directly to the graft without intermediate measurement or calculation steps.
Data Source
AI summary
Systems and methods for reloading a stent graft delivery device are disclosed. Additionally, a kit including a patient-specific fenestration template, fenestration rings and sutures can be provided for forming fenestrations in a preexisting, or generic, stent graft with the fenestrated stent graft then reloaded within the sheath of the delivery device for deployment within a patient.