Personalized Self-Expanding Prosthesis Anchoring
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Solution Overview
Problem
Current endoluminal grafts for treating aneurysms face challenges such as geometrical incompatibility, high incidence of leakage (endoleaks), and complications like windsocking, particularly in non-fusiform geometries and proximity to sensitive structures, leading to poor anchoring and increased procedural risks.
Innovation Solution
A personalized self-expanding prosthesis system that matches the patient's anatomy, featuring a retractable sheath for progressive self-expansion and self-orientation, with a textured outer surface and apertures aligned with ostia, to ensure secure anchoring and prevent endoleaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If endoluminal grafts are installed using minimally invasive endovascular methods, then patient trauma and procedural risk are reduced, but anchoring stability and sealing reliability deteriorate
Solution Approach 1:
The prosthesis is divided into multiple segments including a proximal anchoring zone, a body section, and a distal anchoring zone. Each zone contains multiple anchors distributed circumferentially, allowing the graft to achieve stable fixation through distributed anchoring points rather than relying on a single anchoring mechanism.
Solution Approach 2:
The prosthesis is pre-formed with a memorized geometric configuration that matches the target blood vessel anatomy. The self-expanding frame and anchors are pre-positioned in their functional geometry before implantation, enabling automatic alignment and anchoring upon deployment without requiring complex positioning maneuvers.
2Ease of manufacture
If standard cylindrical endoluminal grafts are used, then manufacturing and deployment are simplified, but anatomical compatibility and sealing effectiveness deteriorate
Solution Approach 1:
The prosthesis features a non-cylindrical, asymmetric geometry with varying cross-sectional dimensions along its length. The body section may include flattened regions, angled orientations, or irregular contours that specifically match the asymmetric anatomy of the target blood vessel and aneurysm, improving apposition and sealing.
Solution Approach 2:
Different sections of the prosthesis have locally optimized properties: the anchoring zones contain embedded anchors for secure fixation, the body section has a shape tailored to the aneurysm geometry, and the fabric material may vary in porosity or coating to control blood flow and thrombosis at different locations.
3Productivity
If self-expanding prostheses with memorized geometry are used, then deployment simplicity and procedural time are improved, but precision in matching complex aneurysm geometries deteriorates
Solution Approach 1:
The self-expanding frame is pre-formed during manufacturing with a memorized geometric configuration that precisely matches the patient-specific aneurysm anatomy obtained from imaging studies. This pre-positioning ensures that upon deployment, the prosthesis automatically assumes its final functional geometry without requiring complex positioning or adjustment procedures.
Solution Approach 2:
The prosthesis utilizes shape memory materials that can be programmed to expand to specific dimensional parameters. By controlling the memorized geometry and expansion characteristics, the device can be tailored to match complex aneurysm shapes while maintaining a simple delivery profile, achieving both procedural efficiency and geometrical precision.
4Reliability
If anchors are embedded in the prosthesis for secure fixation, then anchoring stability is improved, but device complexity and manufacturing difficulty worsen
Solution Approach 1:
The anchors are integrated directly into the self-expanding frame structure, forming a unified component rather than separate attachments. The frame and anchors are manufactured as a single piece using the same shape memory material, simplifying the overall device architecture while maintaining secure fixation capability.
Solution Approach 2:
The anchors are designed to be temporarily flexible during delivery but automatically engage and lock into the vessel wall upon expansion. The shape memory effect allows the anchors to transition from a compliant delivery state to a rigid anchored state, providing secure fixation without requiring complex locking mechanisms or additional components.
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 personalized prosthesis system provides improved anchoring, reduces endoleak occurrences, and allows for more precise fitting, expanding the range of treatable aneurysms with reduced procedural time and complications.
Implementation Method 1
a self-expanding prosthesis having a collapsed configuration and an expanded configuration
Implementation Method 2
the prosthesis is configured to self-orient as the prosthesis is moved axially toward the treatment site so that contours of the outer surface of the prosthesis rotationally align with the contours of the inner wall of the treatment site
Data Source
AI summary
A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh and/or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration is oversized relative to the treatment site and configured to engage the personalized prosthesis with the treatment site. The self-expanding mesh is configured to reduce in one or more dimensions in response to being constrained in the one or more dimensions, such that the mesh in the expanded configuration self-adjusts to the treatment site without buckling of the mesh. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.