Expandable LAA Containment Device with Slider Assembly
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Solution Overview
Problem
Current methods for preventing thrombus formation in the left atrial appendage, such as pharmacological therapies and invasive surgical techniques, are inadequate due to side effects and unsuitability for all patients, particularly those with compromised conditions or prior cardiac surgery.
Innovation Solution
A minimally invasive device and method involving an expandable frame with a slider assembly and barrier to contain emboli within the left atrial appendage, which is delivered and expanded using a control line and elongate core, allowing for testing of implant stability and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacological therapies (warfarin) are used for stroke prevention, then stroke risk is reduced, but serious side effects occur and patient compliance is poor
Solution Approach 1:
The patent extracts the thrombus containment function from systemic pharmacological therapy and localizes it directly to the left atrial appendage using a mechanical containment device. This eliminates the need for lifelong anticoagulant medication and its associated side effects and compliance issues, while directly addressing the source of embolic stroke.
Solution Approach 2:
The patent introduces a mechanical intermediary device (containment device with frame, barrier, and anchoring structures) that physically prevents thrombus formation and emboli release in the LAA. This mechanical intermediary replaces the chemical intermediary (warfarin) and provides direct, reliable stroke prevention without medication-related harm.
2Reliability
If invasive surgical techniques are used to obliterate the LAA, then thrombus formation is prevented, but many patients are not suitable candidates due to compromised condition or prior cardiac surgery
Solution Approach 1:
The patent segments the LAA obliteration function into a minimally invasive containment device that can be delivered through catheter, avoiding the need for open surgical obliteration. The device includes separate functional components (frame, barrier, anchoring structures) that can be deployed independently, making it adaptable to various patient conditions and surgical histories.
Solution Approach 2:
The patent replaces invasive surgical mechanical obliteration with a minimally invasive catheter-delivered containment device. This substitution maintains effective thrombus prevention while significantly reducing procedural invasiveness and expanding eligibility to patients with compromised conditions or prior cardiac surgery who cannot tolerate open surgery.
3Ease of operation
If the containment device is delivered through a catheter, then minimally invasive delivery is achieved, but the device must be expandable from reduced cross section to enlarged cross section
Solution Approach 1:
The patent employs a nested doll configuration where the expandable frame is collapsed within a delivery catheter for minimally invasive insertion, then expands to its full operational size at the LAA. The frame, barrier, and anchoring structures are nested within each other in a compact configuration that fits through catheter, then deploy in an expanded configuration to provide effective containment.
Solution Approach 2:
The patent incorporates dynamic expandability into the containment device, allowing the frame to transition from a compressed delivery configuration to an expanded operational configuration. The slider assembly mechanism enables controlled expansion along the longitudinal axis, providing both minimal invasiveness during delivery and effective containment when deployed.
4Ease of operation
If the nut is made moveable within the guide tube channel, then the elongate core can be advanced and released, but movement must be limited by interference between nut and guide tube
Solution Approach 1:
The patent incorporates preliminary action through the slider assembly mechanism, where the nut is pre-positioned within the guide tube channel to define the exact travel distance of the elongate core. As the core is advanced, the nut moves with it until the predetermined limit is reached, at which point interference between the nut and guide tube automatically stops further movement. This preliminary configuration enables precise, controlled deployment without complex active control systems.
Data Source
AI summary
A device for containing emboli within a left atrial appendage of a patient includes a frame that is expandable from a reduced cross section to an enlarged cross section and a slider assembly. The frame extends between a proximal hub and a distal hub, and the slider assembly is coupled to the distal hub of the frame. The slider assembly includes a guide tube that has a channel extending proximally away from the distal hub, and a nut. The nut is longitudinally moveable within the channel of the guide tube over a predetermined distance relative to the guide tube. The nut is operable to be releasably coupled with an elongate core, and movement of the nut relative to the guide tube is at least partially limited by interference between a portion of the nut and a portion of the guide tube.