Inflatable LAA Occlusion Device with Segmented Membrane
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Solution Overview
Problem
Current methods for occluding the left atrial appendage to prevent stroke in atrial fibrillation patients are inadequate, particularly for those who cannot take anticoagulants, as they often involve high risks of bleeding and perforation, and require endothelialization, which can be time-consuming and unreliable.
Innovation Solution
An implantable, inflatable occlusion device with a connection system, cap chamber, and bulb chamber made of soft polymeric materials, featuring a one-way sealing system and multiple layers, which can be customized for various usability cases, deployed through a transseptal procedure, and used to occlude the left atrial appendage to prevent blood flow and reduce the risk of bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current occlusion methods are used to prevent stroke in atrial fibrillation patients, then stroke prevention is achieved, but the risk of bleeding and perforation increases
Solution Approach 1:
The occlusion device employs a flexible membrane structure that can conform to the left atrial appendage geometry, providing effective occlusion while distributing mechanical stress to minimize perforation risk. The flexible nature allows the device to adapt to tissue contours rather than imposing rigid forces.
Solution Approach 2:
The device is divided into multiple segments including a proximal portion, distal portion, and intermediate portion with articulation joints. This segmentation allows the device to flex and adapt to the LAA shape while reducing concentrated stress points that could lead to perforation or bleeding complications.
2Reliability
If current occlusion methods are used to occlude the left atrial appendage, then blood flow is prevented, but endothelialization is required which is time-consuming and unreliable
Solution Approach 1:
The device is pre-formed with a configuration that immediately upon deployment creates effective occlusion of the left atrial appendage. The pre-shaped membrane structure eliminates the need for time-consuming endothelialization processes required by other methods, providing immediate and reliable occlusion from the moment of implantation.
3Ease of operation
If a coil is used to puncture the left atrial appendage for permanent deployment, then the balloons can be deployed in place, but the risk of perforation and bleeding increases
Solution Approach 1:
The device uses a delivery catheter system as an intermediary to guide and deploy the occlusion membrane through the vascular system without requiring direct puncture of the left atrial appendage. The membrane is delivered intact through the catheter and expanded in place, eliminating the need for coil puncture and associated bleeding risks.
4Ease of operation
If multiple electromagnetic coils are used for permanent deployment, then the balloons can be deployed in place, but the device complexity and procedure invasiveness increase
Solution Approach 1:
The invention extracts and eliminates the complex electromagnetic coil system from the deployment mechanism. Instead, it uses a simplified delivery catheter approach where the occlusion membrane is delivered pre-formed and expanded using less complex mechanical or pressure-based mechanisms, reducing overall device complexity while maintaining deployment effectiveness.
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 device effectively occludes the left atrial appendage, reducing the risk of ischemic stroke in atrial fibrillation patients by preventing thrombus formation, with a low risk of perforation and bleeding, and does not rely heavily on endothelialization, providing immediate occlusion and alternative therapy to anticoagulation.
Implementation Method 1
the cap chamber and the bulb chamber separated by an elastomeric wall
Data Source
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AI summary
An exemplary occlusion device is disclosed. In various embodiments, the exemplary occlusion device includes a cap chamber and a bulb chamber for occluding a left atrial appendage (LAA). In particular embodiments, after delivery to the LAA, the cap chamber and the bulb chamber are each inflated via various amounts of fluid(s) to occlude the LAA.