Expandable Aortic Arch Implants for Dissection Vessel Support
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Solution Overview
Problem
Existing treatments for acute aortic dissections (AADs) are inadequate, particularly for inoperable cases, leading to high mortality and poor outcomes, with a need for improved devices and methods to stabilize the aortic wall and maintain blood flow to critical vessels.
Innovation Solution
Prosthetic aortic implants with expandable arch and root support structures, featuring telescoping branches and non-porous layers, are designed to anchor to the native aorta, maintaining blood flow to critical vessels and preventing dislocation, using ePTFE and expandable metallic frames to stabilize the aortic wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to treat acute aortic dissections, then the aortic wall can be stabilized and blood flow maintained, but 10-30% of cases are deemed inoperable and mortality remains high at 15-30%
Solution Approach 1:
The aortic implant is divided into multiple segments including an expandable arch support structure with multiple openings, and separate expandable branches that can be independently positioned into different vessels. This segmentation allows the device to adapt to various dissection locations and vessel configurations that traditional single-structure implants cannot address.
Solution Approach 2:
The implant utilizes expandable structures that can transition from a compressed delivery state to an expanded functional state. The expandable arch support structure and branches can dynamically adjust to accommodate different aortic geometries and dissection severities, making the device versatile for both operable and previously inoperable cases.
2Reliability
If an expandable arch support structure with multiple branches is used, then blood flow to critical vessels can be maintained and aortic wall stabilization improved, but device complexity increases
Solution Approach 1:
The expandable branches are nested within the expandable arch support structure, with each branch containing telescoping segments. The branches can be independently deployed from the main structure, allowing for complex functionality while maintaining a relatively simple delivery profile. This nested arrangement enables multiple vessels to be addressed simultaneously without requiring separate implants.
Solution Approach 2:
The expandable arch support structure serves multiple functions: it provides aortic wall stabilization, maintains blood flow to the arch, and serves as a platform for deploying branches to multiple critical vessels. This multi-functionality reduces the need for multiple separate devices while achieving comprehensive protection of all critical vessels.
3Adaptability or versatility
If telescoping structures are used in expandable branches, then the branches can be positioned within openings and vessels, but manufacturing precision requirements increase
Solution Approach 1:
The telescoping structures are designed with localized engagement features at specific positions along the branch length. Rather than requiring precision throughout the entire telescoping mechanism, critical precision is concentrated at the engagement points where branches interface with the arch support structure and where they contact the aortic wall, reducing overall manufacturing complexity.
Solution Approach 2:
The design incorporates tolerance compensation features in the telescoping mechanism that accommodate manufacturing variations. By building in mechanical compliance and adjustment capabilities during the design phase, the system can compensate for minor manufacturing imprecisions without compromising the ability to properly position branches within vessels.
Data Source
AI summary
The present disclosure generally relates to prosthetic implants, prosthetic implant systems, and their methods of use, for example, for treating a dissection. The prosthetic implants contemplated herein comprise an expandable arch support structure comprising one or more expandable branches configured to be placed within one or more vessels. Certain aspects of the disclosure relate to methods for treating a dissection, e.g., an aortic dissection, using said prosthetic implants and implant systems. The methods comprise advancing one or more guidewires into an ascending aorta, a descending aorta, and/or one or more one or more vessels of an aortic root or aortic arch. The methods further comprise exposing one or more components of the expandable arch support structure from a sheath. In some cases, the exposed component is an expandable branch that is advanced into the one or more vessels of the aortic root or aortic arch, thus anchoring the implant to the native aorta.


