Biological Tissue Covered Self-Expanding Occluder for Biocompatibility
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing occluders for closing the left atrial appendage lack sufficient biocompatibility, which can lead to complications such as thrombus formation and increased risk of stroke.
Innovation Solution
An occluder with a self-expanding frame covered by biological tissue, specifically arranged on the outer side to enhance biocompatibility, is proposed. The biological tissue is stabilized using cross-linking methods and can be animal tissue like pericardium membrane.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If synthetic materials like Teflon are used to cover the occluder frame, then the structural integrity and ease of manufacture are improved, but the biocompatibility deteriorates leading to thrombus formation and stroke risk
Solution Approach 1:
The patent applies composite materials by combining the occluder frame with biological tissue (such as pericardium) to create a hybrid structure. The frame provides structural integrity while the biological tissue layer provides biocompatibility, resolving the contradiction between ease of manufacture and reliability. The biological tissue is sutured to the frame to form a composite occluder that combines the advantages of both materials.
2Reliability
If biological tissue is used to cover the occluder frame, then the biocompatibility is improved reducing thrombus formation risk, but the manufacturing complexity increases
Solution Approach 1:
The patent segments the occluder into distinct components: the frame structure and the biological tissue covering. This segmentation allows each component to be manufactured separately using appropriate methods, then assembled together. The frame can be manufactured using standard techniques while the biological tissue is prepared separately and sutured onto the frame, reducing overall manufacturing complexity compared to creating a fully customized biological composite.
3Ease of operation
If the occluder is inserted in a volume-reduced form and expanded at the site of use, then the ease of operation is improved allowing catheter delivery, but the manufacturing precision requirements increase
Solution Approach 1:
The patent utilizes parameter changes by designing the occluder frame with shape memory alloy properties that enable it to transition between a compressed delivery state and an expanded functional state. The frame is manufactured in a compressed configuration for easy catheter delivery, then automatically expands to its predetermined functional shape at the insertion site through shape memory effect, eliminating the need for manual expansion while maintaining manufacturing precision.
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 use of biological tissue on the occluder significantly improves biocompatibility, reducing the risk of thrombus formation and enhancing the fluid-tight closure of the left atrial appendage, thereby lowering the risk of stroke.
Implementation Method 1
The frame can in particular consist of a flexible, self-expanding material or comprise such a material. This material can be a metal or a plastic. Advantageously, however, it is a metal alloy with shape memory properties. Nickel-titanium alloys, for example a nitinol alloy, are particularly preferred.
Implementation Method 2
The biological tissue is stabilized, in particular, by treatment using a cross-linking method. Cross-linking can preferably be carried out using the cross-linking process, particularly glutaraldehyde and/or alcohol.
Implementation Method 3
The occluder is delivered to the site of use, in particular in a volume-reduced form, and expanded there. Self-expanding materials, such as shape memory alloys, are generally used for the occluders.
Data Source
Figure 1
Figure 2
Figure 3
AI summary
Occluder (12), in particular for closing the left auricle of the cord (10) of a patient, system with a catheter and an occluder and method for providing the system, the occluder (12) comprising a self-expanding frame (14), wherein a biological tissue (40) covering at least part of the frame (14), in particular on its outside, is arranged, wherein the biological tissue (40) is stabilized by treatment using a cross-linking method and is moistened or dried with a liquid medium for preservation.