Self-Expanding Foam LAA Occlusion Device
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Solution Overview
Problem
During atrial fibrillation, blood can pool and thrombose in the left atrial appendage, posing a stroke risk due to the potential for thrombus to be pumped into the cranial circulation, and existing methods for modifying the appendage are either invasive or lack effective occlusion mechanisms.
Innovation Solution
Percutaneously delivered medical devices with self-expanding materials and textured surfaces, including mesh bags and frame members, are used to occlude the left atrial appendage, anchoring within the appendage to prevent embolic material from escaping and promoting tissue growth to create a smooth endothelialized surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical modification is used to reduce stroke risk, then effectiveness is improved, but invasiveness increases
Solution Approach 1:
The patent replaces traditional surgical mechanical modification with a percutaneously delivered device that uses self-expanding foam material to occlude the left atrial appendage. The foam body expands autonomously after delivery, eliminating the need for open surgical intervention while achieving effective occlusion and stroke risk reduction.
2Ease of operation
If percutaneous delivery is used to reduce invasiveness, then ease of operation is improved, but occlusion effectiveness may worsen
Solution Approach 1:
The patent employs a self-expanding foam material that changes its physical parameters after delivery. The foam body transitions from a compressed state during percutaneous delivery to an expanded state within the left atrial appendage, achieving effective occlusion through this parameter change without requiring surgical intervention.
3Object-affected harmful factors
If a smooth occlusion surface is created to prevent thrombus formation, then thrombus risk is reduced, but tissue integration time increases
Solution Approach 1:
The patent applies a textured surface treatment to the foam body before delivery. This preliminary action creates protruding portions that facilitate initial tissue engagement and integration, while the overall foam structure provides a smooth occlusion surface to prevent thrombus formation. The textured surface accelerates tissue ingrowth without compromising the thrombus-preventing smooth exterior.
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 devices effectively reduce the risk of stroke by occluding the left atrial appendage, preventing embolic material from entering the circulation and promoting tissue integration, thus reducing the risk of thrombus formation and embolism.
Implementation Method 1
a body formed of a self-expanding material... The body is discharged from the delivery vehicle into the LAA and expanded such that the body engages a side wall of the LAA
Implementation Method 2
The body exhibits a textured surface including a plurality of protruding portions and a plurality of recesses. Each protruding portion is separated from an adjacent protruding portion by a recess of the plurality of recesses.
Implementation Method 3
The body may be formed from a material that comprises, for example, a reticulated foam... promoting tissue growth to create a smooth endothelialized surface
Data Source
AI summary
Several embodiments are set forth of devices, systems and methods for modifying an atrial appendage such as a left atrial appendage (LAA). In one embodiment, a medical device includes a frame member and a tissue growth member. The frame member includes a unitary, seamless central portion having a plurality of struts defining a multi-cellular structure and an anchoring system, the plurality of struts extending between and configured to self-expand and directly bias the anchor system to anchor the frame member at least partially within the LAA. With this arrangement, the tissue growth member is attached to the frame member to occlude the LAA.