Expandable Foam LAA Closure Device with Protective Sheath
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Solution Overview
Problem
Current medical devices for closing the left atrial appendage (LAA) face challenges in effectively occluding the LAA and ensuring reliable deployment and expansion within the LAA.
Innovation Solution
The proposed solution involves a left atrial appendage closure (LAAC) device featuring an expandable foam implant with a polymeric covering for protection during delivery. The device includes a tubular support rod and tethers for secure positioning, and the foam expands upon reaching body temperature or exposure to moisture, facilitating occlusion of the LAA.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If an expandable foam implant is used to occlude the LAA, then the device can adapt to the complex geometry of the LAA and provide effective occlusion, but the device requires a protective covering during delivery that complicates the delivery system
Solution Approach 1:
The expandable foam implant is nested within a collapsible sheath during delivery, allowing the device to be delivered through a catheter in a compressed state and then expanded in situ within the LAA to adapt to its complex geometry
Solution Approach 2:
The device is divided into functional segments including the expandable foam implant, the protective sheath, and the delivery catheter system, allowing each component to be optimized independently for its specific function
2Ease of operation
If the expandable foam implant is delivered through a catheter, then the procedure becomes minimally invasive, but the implant must be compressed to a small size which may affect its expansion capability
Solution Approach 1:
The foam implant material is designed with specific viscoelastic properties that allow it to be compressed to a small fraction of its final volume for catheter delivery, then reliably expand to its full configured size and shape upon deployment in the LAA
Solution Approach 2:
The implant uses a composite foam structure combining materials with different mechanical properties to achieve both compressibility for delivery and reliable expansion to the desired final configuration for effective occlusion
3Reliability
If a polymeric covering is used to protect the implant during delivery, then the implant is protected from damage, but the covering must be removed or breached which adds complexity to the deployment process
Solution Approach 1:
The polymeric covering is pre-configured with a breakable seal or predetermined failure point that automatically breaches upon deployment, eliminating the need for separate removal steps and simplifying the overall deployment process
Solution Approach 2:
The polymeric covering serves its protective function during delivery and is then intentionally discarded by breaching the seal, allowing the implant to expand freely without the constraint of the covering
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
This solution enables efficient occlusion of the LAA, reducing the risk of thrombi formation and stroke, while providing a reliable and minimally invasive deployment method that adapts to the complex geometry of the LAA.
Implementation Method 1
the implant may include an expandable foam that expands upon exposure to moisture
Implementation Method 2
the implant may include an expandable foam that expands upon reaching a temperature elevated from ambient temperature
Implementation Method 3
A polymeric covering is disposed over the implant and is adapted to protect the implant during trans-septal delivery to the LAA
Data Source
AI summary
A left atrial appendage closure device adapted for occluding the left atrial appendage includes a cone-shaped insert formed of an expandable foam and adapted for trans-septal delivery to the LAA. A polymeric covering is disposed over the cone-shaped insert, the polymeric covering adapted to protect the cone-shaped insert during trans-septal delivery to the LAA, the polymeric covering adapted for removal after trans-septal delivery to the LAA. An insert lumen extends through the cone-shaped insert prior to expansion of the cone-shaped insert. A tubular support rod extends through the insert lumen, the tubular support rod operably coupled with at least a portion of the polymeric covering, the tubular support rod itself defining a tubular support rod lumen adapted to accommodate a guidewire over which the insert may be advanced into the LAA and/or a radio frequency (RF) energy wire adapted for making a trans-septal puncture.