Left Atrial Appendage 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, face challenges with inadequate tissue coverage, increased thrombogenicity, and difficulty in deployment and retrieval, leading to a risk of 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, facilitating tissue ingrowth and minimizing thrombotic embolisms, featuring a tubular structure with braided strands and polymer fabric for enhanced flexibility and retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional occlusion device with protruding end features is used, then the device structure is simple and easy to manufacture, but tissue coverage is inadequate and thrombogenicity increases
Solution Approach 1:
The patent inverts the conventional design by making the end features recessed rather than protruding. The end features are positioned within the tapered transition portion, creating a recessed configuration that reduces thrombogenicity while improving tissue coverage, thereby resolving the contradiction between reliability and device complexity
Solution Approach 2:
The patent applies local quality by creating a tapered transition portion with specific geometric properties at the end of the device. This tapered structure with recessed end features provides localized improvement in tissue coverage and reduced thrombogenicity at critical areas where blood flow contacts the device, without compromising the overall device structure
2Reliability
If a recessed end feature with tapered transition portion is used, then tissue coverage and thrombogenicity are improved, but manufacturing complexity increases
Solution Approach 1:
The patent utilizes parameter changes by employing shape memory material that undergoes phase transformation between contracted and expanded states. This allows the complex recessed end feature geometry to be formed during manufacturing through controlled heating and shaping, then maintained in the recessed configuration at body temperature, thereby improving thrombogenicity while managing manufacturing complexity through material property changes
3Ease of operation
If the device is made flexible for easy deployment and retrieval, then ease of operation is improved, but structural stability and retention may be compromised
Solution Approach 1:
The patent applies dynamics by using shape memory material that can dynamically change its structure between a contracted flexible state for easy deployment and retrieval, and an expanded stable state for maintaining position and providing structural stability at the occlusion site, thereby resolving the contradiction between ease of operation and structural stability
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 promotes rapid tissue coverage over the exposed surface, reducing the risk of clot formation and embolisms, while allowing easy deployment and retrieval, thereby improving safety and efficacy in occluding vascular abnormalities.
Implementation Method 1
an occlusion device comprising a first disk shaped portion made of shape memory material, a second disk shaped portion made of shape memory material
Data Source
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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.