Braided Vascular Occluder With Recessed End for Tissue Coverage
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Solution Overview
Problem
Existing occlusion devices for vascular abnormalities, such as the left atrial appendage, atrial and ventricular septal defects, and patent ductus arteriosus, face challenges with inadequate tissue coverage, increased thrombogenicity, flexibility, retention, and ease of deployment and retrieval, leading to potential thrombotic embolisms.
Innovation Solution
A medical device with a recessed end feature and a tapered transition portion that self-expands from a contracted state to an expanded state, featuring a tubular structure with braided strands and polymer fabric, facilitating tissue ingrowth and minimizing thrombotic embolisms by ensuring only a small surface area is exposed to blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the end feature protrudes from the device surface, then deployment and retrieval are easier, but tissue coverage is reduced and thrombogenicity increases
Solution Approach 1:
The end feature is inverted from a protruding configuration to a recessed configuration within the device surface. This inversion eliminates the protrusion that causes thrombus formation while maintaining accessibility for deployment and retrieval through the recessed design.
Solution Approach 2:
The device surface is differentiated into regions with different properties: the end feature is recessed to minimize thrombogenicity, while other portions of the device maintain appropriate surface characteristics for tissue coverage and anchoring. This local variation in surface quality optimizes both safety and functionality.
2Ease of operation
If the device surface is fully exposed to blood flow, then deployment is easier, but tissue in-growth is reduced
Solution Approach 1:
Different portions of the device surface are designed with different exposure characteristics. The end feature is recessed to minimize blood flow exposure and thrombogenicity, while other portions remain exposed to facilitate tissue in-growth and anchoring, creating localized functional zones.
Solution Approach 2:
The end feature is moved from a two-dimensional surface plane into a third-dimensional recessed configuration. This dimensional change allows the feature to be integrated into the device surface rather than protruding, reducing thrombogenicity while maintaining deployment accessibility.
3Reliability
If the end feature is recessed within the device, then tissue coverage is enhanced, but deployment complexity increases
Solution Approach 1:
The recessed end feature design provides localized tissue coverage enhancement without requiring complex overall device structures. The simplicity of the recessed configuration minimizes additional deployment steps while maximizing tissue integration benefits.
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 device enhances tissue coverage and reduces the risk of thrombotic embolisms by promoting rapid tissue integration, while allowing easy deployment and retrieval, thus improving safety and efficacy in occluding vascular abnormalities.
Implementation Method 1
The medical device is configured to self-expand from a contracted state when constrained within a delivery device toward an expanded state when deployed from the delivery device
Data Source
AI summary
A medical device is provided in which one or both ends of the device encourage the formation of tissue across substantially the entire area of the respective end that is exposed to the blood flow for reducing the risk of a thrombotic embolism. The medical device includes a tubular structure having at least one expanded volume portion and a tapered transition portion. The tubular structure may be made through the braiding of a number of strands, and a first end feature may be used to secure the proximal strand ends. The proximal strand ends may be secured via the proximal end of the first end feature, such that the tapered transition portion is formed over the circumferential surface of the first end feature, and only a proximal end surface (or a portion of the proximal end surface) of the first end feature is exposed to the path of flowing blood.