Expandable Aortic Root Implant for Coronary Flow and Stable Anchoring
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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 surgical outcomes, with a need for improved devices and methods to manage and treat AADs effectively.
Innovation Solution
The development of prosthetic aortic implants with expandable support structures and branches, designed to be positioned within the aortic root and arch, featuring telescoping and pivoting capabilities, and a non-porous layer to anchor to the native aorta, allowing for blood flow to coronary arteries and branch vessels, and potentially incorporating a valved conduit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical treatment is performed for AADs, then the dissected aorta can be removed and blood leakage can be stopped, but mortality and neurological damage rates remain high (15-30%)
Solution Approach 1:
The aortic root is divided into multiple segments with separate expandable branches for each coronary artery, allowing independent expansion and sealing at each location. This segmented approach enables precise localization of the implant to critical areas while maintaining blood flow to branch vessels.
Solution Approach 2:
The implant employs dynamic expandable structures that transition from a compressed delivery state to an expanded sealing state upon deployment. The expandable branches can be selectively expanded to engage with the aortic wall at specific locations, providing adaptive sealing that accommodates anatomical variations.
2Ease of operation
If medications are used to reduce heart rate and lower blood pressure, then the aortic dissection can be managed non-invasively, but mortality remains high (15-30% within 24 hours)
Solution Approach 1:
The implant acts as an intermediary device that bridges the gap between conservative medical management and high-risk surgery. It can be deployed in patients who are not surgical candidates, providing mechanical support and sealing without requiring open surgery, thus reducing perioperative mortality while maintaining hemodynamic stability.
3Reliability
If an implant is designed with expandable branches for coronary arteries, then blood flow to coronary vessels can be maintained, but the device complexity increases
Solution Approach 1:
The expandable branches are nested within the main implant body during delivery, with each branch capable of independent expansion. This nested configuration allows multiple functional elements (main body plus multiple coronary branches) to be contained within a single delivery catheter, reducing the complexity of simultaneous deployment while maintaining all necessary blood flow pathways.
4Stability of the object's composition
If a non-porous layer is used to anchor to the native aorta, then device movement and dislocation can be reduced, but the manufacturing precision requirements increase
Solution Approach 1:
The non-porous anchoring layer is designed with specific material parameters (porosity, surface energy, mechanical properties) that enable effective bonding to the aortic wall. By optimizing these material parameters rather than relying solely on precise geometric placement, the manufacturing tolerance requirements are relaxed while maintaining stable anchoring.
Data Source
AI summary
The present disclosure generally relates to implantable medical devices, and, in some embodiments, to a prosthetic implant. Such implantable devices may be, in some cases, useful in the treatment of acute aortic dissections (AADs). In some embodiments, the prosthetic implant comprises an inner frame and an outer frame, the inner frame comprising an expandable support structure. The expandable support structure may comprise one or more expandable branches. The expandable branch may comprise a proximal portion, a middle portion, and a distal portion configured to permit flattening, telescoping, pivoting, and/or expansion of the one or more portions of the expandable branch. The one or more expandable branches may be, in some cases, configured to be placed into a vessel, e.g., a coronary artery. Additionally, a first expandable support structure comprising one or more expandable branches may be, in some cases, coupled to a second expandable support structure comprising one or more expandable branches.