Biodegradable Left Atrial Appendage Occlusion for Temporary Support
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Solution Overview
Problem
Patients with atrial fibrillation are at high risk of forming blood clots in the left atrial appendage, which can lead to stroke, and existing treatments like blood thinners are not tolerated by all patients, necessitating a method to occlude or exclude the left atrial appendage to prevent clot formation.
Innovation Solution
A catheter-based occlusion device that is plastically deformable and biodegradable, expandable to fit the left atrial appendage, and made of materials such as biodegradable metals or polymers, which are deployed using a balloon catheter to block the appendage and allow endothelialization over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a non-biodegradable occlusion device is used, then the device provides long-term structural support and reliability, but it causes long-term foreign body presence and potential complications
Solution Approach 1:
The patent applies parameter changes by transitioning the device material from non-biodegradable to biodegradable, changing the temporal characteristics of the material properties. The device maintains structural integrity during the critical occlusion period and then gradually degrades, transforming from a permanent foreign body to a temporary support structure that naturally disappears after serving its purpose.
Solution Approach 2:
The patent implements discarding and recovering by designing the occlusion device to naturally degrade and be absorbed by the body over time. The biodegradable material breaks down into harmless byproducts that are metabolized or excreted, allowing the device to fulfill its occlusion function and then safely disappear, eliminating long-term foreign body presence.
2Object-generated harmful factors
If a biodegradable occlusion device is used, then the device avoids long-term foreign body presence, but it may reduce structural durability and reliability
Solution Approach 1:
The patent uses parameter changes by carefully selecting biodegradable materials with controlled degradation rates that match the clinical timeline. The material properties are engineered to maintain strength during the occlusion period (typically 6-12 months) and then progressively degrade, ensuring structural durability when needed while ultimately eliminating foreign body presence.
Solution Approach 2:
The patent may employ composite materials combining different biodegradable components with complementary properties. This allows optimization of both structural durability for immediate occlusion effectiveness and controlled biodegradation rate for eventual absorption, resolving the contradiction between strength and biodegradability.
3Ease of manufacture
If the occlusion device is made with uniform cross-sectional profile, then the device structure is simpler and easier to manufacture, but it may not provide optimal occlusion fit for the varying geometry of the left atrial appendage
Solution Approach 1:
The patent applies asymmetry by designing the occlusion device with a non-uniform cross-sectional profile that varies along its length. The device geometry is tailored to match the specific anatomical shape of the left atrial appendage, with larger cross-sections in regions requiring greater occlusion force and smaller cross-sections in narrower regions, optimizing fit and effectiveness.
Solution Approach 2:
The patent implements local quality by varying the cross-sectional profile at different locations along the device to match local anatomical requirements. Each section of the device is designed with specific dimensional characteristics suited for its particular position within the appendage, providing locally optimized occlusion rather than a uniform approach.
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 occlusion device effectively prevents blood clots from escaping the left atrial appendage, reducing the risk of stroke, while being gradually absorbed by the body, thus avoiding long-term foreign body presence.
Implementation Method 1
the occlusion device is biodegradable
Data Source
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AI summary
An occlusion device for the left atrial appendage is provided. The occlusion device comprises an occlusion portion plastically deformable from a radially compressed configuration to a radially expanded configuration. The occlusion device further comprises a first collar (204, 304) and a second collar (206, 306), wherein a first longitudinal end of the occlusion portion is coupled to the first collar and a second longitudinal end of the occlusion portion is coupled to the second collar.