Hybrid Aortic Graft With Eversible Cuff for Single-Entry Repair

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Solution Overview

Problem

Current surgical procedures for treating Type A patients with aortic arch and descending aorta issues are complex, painful, and associated with high morbidity and mortality due to the need for multiple access points and prolonged surgery times, often resulting in complications like paraplegia and false lumen thrombosis.

Innovation Solution

A hybrid graft assembly with a stented portion and a non-stented cuff portion allows for a single-entry point deployment in the descending aorta, enabling prosthetic replacement of the aortic arch and ascending aorta, facilitating distal perfusion and reducing surgical trauma through a transparent sheath and easy deployment system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical procedures are used to replace the aortic arch and descending aorta, then complete prosthetic replacement can be achieved, but the patient must undergo multiple access points (sternotomy and thoracotomy) which causes extensive trauma, pain, and prolonged recovery

Engineering Contradiction:

Improveprosthetic replacement completenessVSAvoidsurgical trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The graft is divided into two distinct portions: a stented first portion for implantation in the descending aorta and a non-stented second portion (cuff) for anastomosis. This segmentation allows the procedure to be performed through a single sternotomy approach rather than requiring both sternotomy and thoracotomy, reducing surgical trauma while maintaining complete prosthetic replacement of the aortic arch and descending aorta

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The non-stented cuff portion acts as an intermediary element that facilitates connection between the stented graft and the aortic arch graft. This cuff can be everteb over the aortic arch graft to create a secure anastomosis, enabling complete prosthetic replacement while avoiding the need for a second surgical access point

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If traditional surgical procedures are used for aortic arch and descending aorta replacement, then complete repair can be achieved, but surgery time is prolonged and morbidity and mortality rates remain high

Engineering Contradiction:

Improveaortic repair completenessVSAvoidsurgery duration

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The stented portion of the graft is pre-formed with radial support elements that self-expand upon deployment. This preliminary preparation allows for rapid deployment through the delivery system without requiring complex assembly during surgery, significantly reducing surgical time while ensuring complete and reliable repair of the aortic arch and descending aorta

Inventive Principle:

Principle #10Preliminary action

3Reliability

If stent grafts are deployed in the descending aorta, then false lumen thrombosis can be enhanced, but paraplegia risk increases due to extended non-perfusion period

Engineering Contradiction:

Improvefalse lumen thrombosis rateVSAvoidparaplegia risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The graft design allows for dynamic control of blood flow during the procedure. The stented portion can be deployed to enhance false lumen thrombosis when needed, while the ability to maintain patency during deployment and the rapid deployment capability allow surgeons to minimize non-perfusion time, thereby reducing paraplegia risk while maintaining high false lumen thrombosis rates

Inventive Principle:

Principle #15Dynamics

4Reliability

If a collar is used for distal anastomosis in known devices, then connection can be achieved, but positioning is difficult and distal perfusion is impossible during anastomosis

Engineering Contradiction:

Improveanastomosis connectionVSAvoidanastomosis procedure ease

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

Instead of using a collar that requires precise positioning on the aortic arch graft, the non-stented cuff is designed to be everteb over the graft. This inversion of the traditional approach eliminates positioning difficulties and allows the cuff to self-align with the graft, making the anastomosis procedure easier while maintaining secure connection. Additionally, this design allows distal perfusion to be maintained during the anastomosis process

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS11628056B2Graft for treating the distal aortic arch and descending aorta in type a patients

Publication Date: 2023.04.18 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A prosthetic graft assembly (40, 120) is disclosed for placement of a patient's aortic arch and repair of the descending aorta in a procedure which requires only a sternotomy. The assembly includes a descending graft element (40) which includes an eversible cuff (52) which can be wrapped over a cut end (26) of the descending aorta (18). Distal perfusion can be re-established prior to aortic arch replacement. A second prosthetic element (120), optimised to the patient, is fitted with a replacement for the aortic arch and attached to the descending aorta graft (40). An introducer assembly (30) having a transparent or translucent sheath (70) enables the descending aortic graft element (40) to be deployed without the use of x-rays.