Biodegradable Left Atrial Appendage Occluder for Temporary Closure
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Solution Overview
Problem
Patients with atrial fibrillation are at risk of blood clots forming in the left atrial appendage, which can lead to strokes, and existing treatments like blood thinners are not always viable, necessitating a catheter-based occlusion system to prevent clot formation and escape.
Innovation Solution
A biodegradable occlusion device that can be plastically deformed from a radially compressed to an expanded configuration, delivered via a balloon catheter, to occlude the left atrial appendage, using materials like biodegradable metals or polymers that degrade over time, facilitating endothelialization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a permanent occlusion device is implanted to block the left atrial appendage, then stroke prevention is effective, but long-term foreign body presence causes chronic inflammation and prevents natural tissue healing
Solution Approach 1:
The patent applies parameter changes by transitioning the device material from a stable, non-biodegradable state to a biodegradable state that changes its chemical composition over time. The device is made from biodegradable metals (magnesium, zinc, calcium) or polymers (PLA, PGA, PCL) that gradually degrade through hydrolysis and enzymatic degradation, changing the material parameters from structurally intact to progressively degraded, ultimately allowing natural tissue closure while maintaining initial occlusion effectiveness
Solution Approach 2:
The patent employs the disposable principle by using biodegradable materials that are designed to fulfill their occlusion function temporarily and then degrade naturally. The device serves its purpose of preventing clots during the critical healing period and then disappears as the body heals, eliminating the need for permanent foreign body presence. This is achieved through materials like magnesium alloys, zinc alloys, and biodegradable polymers that break down into harmless byproducts
2Duration of action of stationary object
If a biodegradable material is used for the occlusion device, then natural tissue closure is enabled, but the device strength decreases over time as degradation occurs
Solution Approach 1:
The patent applies beforehand cushioning by designing the device with sufficient initial strength margin to withstand the highest stress period (immediate post-implantation) and then gradually reducing strength as degradation occurs. The biodegradable materials are engineered with controlled degradation rates that ensure structural integrity is maintained during the critical early period when the device needs to resist blood pressure and mechanical forces, while gradually transferring load to the healing tissue
Solution Approach 2:
The patent employs composite materials by combining biodegradable metals (magnesium, zinc, calcium) with polymers or ceramic coatings to create a multi-layered structure. These composites provide enhanced initial strength and controlled degradation characteristics. The different materials degrade at different rates, allowing the structure to maintain strength when needed while progressively enabling tissue takeover
3Strength
If the occlusion device is made from non-biodegradable material, then long-term structural integrity is maintained, but the device requires permanent implantation and prevents natural healing
Solution Approach 1:
The patent applies parameter changes by transitioning from stable, non-biodegradable materials to biodegradable materials that change their chemical composition over time. The device is made from biodegradable metals (magnesium, zinc, calcium) or polymers (PLA, PGA, PCL) that gradually degrade through hydrolysis and enzymatic degradation, changing the material parameters from structurally intact to progressively degraded, ultimately allowing natural tissue closure while maintaining initial occlusion effectiveness
Solution Approach 2:
The patent applies discarding and recovering by designing the occlusion device to be temporarily functional and then naturally discarded by the body. The biodegradable materials break down into harmless byproducts (carbon dioxide, water, mineral ions) that are eliminated or incorporated into normal metabolic processes. The device fulfills its occlusion function during the critical healing period and then is naturally discarded as the body heals, eliminating chronic foreign body presence
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
Effectively blocks clots in the left atrial appendage, reducing stroke risk without long-term implantation, and allows natural tissue closure after degradation.
Implementation Method 1
using materials like biodegradable metals or polymers that degrade over time, facilitating endothelialization
Implementation Method 2
The occlusion device is plastically deformable from a radially compressed configuration to a radially expanded configuration
Data Source
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AI summary
An occlusion device for the left atrial appendage is plastically deformable and biodegradable.