Expandable Left Atrial Appendage Occlusion Device
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Solution Overview
Problem
The left atrial appendage poses a risk for thrombus formation and thromboembolic complications in patients with atrial fibrillation, as blood can collect and clots form within it, leading to potential cerebral stroke or peripheral embolism, and existing methods to prevent this are either ineffective or require strict medication regimens that not all patients can follow.
Innovation Solution
A catheter-based occlusion system featuring an expandable hollow device with a proximal, central, and distal portion, where the central portion has a waist region and is reinforced with woven material and nitinol struts, which can be inflated with biogel to securely engage with the left atrial appendage, preventing blood flow and clot formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If medications are used to control blood clotting, then the risk of stroke is decreased, but patients cannot follow the strict regimen necessary for continued protection
Solution Approach 1:
The invention extracts the function of clot prevention from the medication regimen and relocates it to a mechanical occlusion device implanted in the left atrial appendage. The occlusion device physically blocks the LAA, preventing thrombus formation at the source, thereby eliminating the need for lifelong anticoagulation medication and its associated compliance issues.
2Reliability
If the left atrial appendage is occluded using existing methods, then thrombus formation is reduced, but the occlusion may not be secure or durable
Solution Approach 1:
The occlusion device employs a dynamic deployment mechanism that transitions from a compressed delivery state to an expanded occlusion state. The device is delivered in a low-profile configuration through catheter access, then expanded within the LAA to achieve secure engagement with the appendage wall, ensuring both ease of delivery and durable occlusion.
Solution Approach 2:
The occlusion device utilizes composite material construction, combining biocompatible materials that provide both structural integrity for durable occlusion and flexibility for safe delivery. The device may incorporate radiopaque materials for imaging visibility and surface treatments to enhance engagement with the LAA wall, ensuring long-term stability.
3Ease of operation
If an occlusion device is delivered via catheter, then the procedure is minimally invasive, but the device must be small enough to pass through vessels yet large enough to effectively occlude the LAA
Solution Approach 1:
The occlusion device employs a dynamic deployment mechanism that transitions from a compressed delivery state to an expanded occlusion state. The device is delivered in a low-profile configuration through catheter access, then expanded within the LAA to achieve secure engagement with the appendage wall, ensuring both ease of delivery and durable occlusion.
Solution Approach 2:
The occlusion device is nested within a delivery catheter system, allowing the device to be contained in a compressed state during delivery. The catheter serves as a protective sheath that guides the device through the vascular system to the LAA, where the device is deployed from its nested configuration to its functional occlusion configuration.
Data Source
AI summary
The present application relates to an occlusion device for occluding a left atrial appendage. The device has an expandable hollow body with an internal volume. The expandable body includes a proximal portion having a first diameter, wherein the proximal portion is arranged to sealingly engage against an opening of the left atrial appendage, a distal portion having a second diameter, wherein the distal portion is arranged to be positioned inside and at least partially fill the left atrial appendage and a central portion extending between the proximal and distal portion, wherein the central portion comprises a waist region with a third diameter. The third diameter of the waist region is smaller than the first diameter of the proximal portion and the second diameter of the distal portion.