Left Atrial Appendage Closure Device with Shape Memory Alloy
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Solution Overview
Problem
Existing left atrial appendage closure devices rely on a single post-deployment shape and dimensions, leading to improper closure and premature dislodgement, and lack the ability to adjust to individual anatomy, resulting in inadequate anchoring and pressure distribution.
Innovation Solution
A device with a central member and tissue ingrowth member that can change configurations from a pre-deployment to multiple post-deployment shapes, allowing for adjustable pressure and anchoring through extensions, barbs, and shape memory alloy components to secure the device within the left atrial appendage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single post-deployment shape and dimensions are used, then the device structure is simple, but the device cannot adapt to individual LAA anatomy resulting in improper closure and premature dislodgement
Solution Approach 1:
The device incorporates a shape memory alloy central member that can dynamically change its configuration between a pre-deployment shape (linear or substantially linear) and multiple post-deployment shapes (first and second post-deployment shapes with different dimensions and pressure distributions). This dynamic shape-changing capability allows the device to adapt to individual LAA anatomy while maintaining a relatively simple structural design, resolving the contradiction between adaptability and complexity.
2Strength
If a single post-deployment shape is used, then the device is easy to manufacture, but the device exerts fixed pressure that cannot be adjusted to ensure adequate anchoring
Solution Approach 1:
The device utilizes phase transitions of the shape memory alloy central member to change its physical parameters (shape and dimensions) after deployment. The central member can transition between different post-deployment shapes, each exerting different pressure on the LAA wall, thereby allowing adjustment of anchoring strength without complicating the manufacturing process. This resolves the contradiction between anchoring strength and manufacturing simplicity.
3Ease of operation
If the device relies solely on shape memory changes, then the device structure is simple, but the device cannot allow operator adjustment of pressure applied on LAA wall
Solution Approach 1:
The device employs a dynamic shape memory alloy central member that can be actuated to change between pre-deployment and multiple post-deployment shapes. This dynamic capability enables the operator to adjust the pressure applied on the LAA wall by controlling the shape transformation, while maintaining relatively simple device structure. The extensions with barbs or hooks provide additional anchoring mechanisms that work in conjunction with the shape changes, resolving the contradiction between operator adjustability and device complexity.
4Reliability
If a single post-deployment shape with fixed dimensions is used, then the device has simple design, but the device results in improper closure due to inability to adjust to varying LAA sizes
Solution Approach 1:
The device utilizes phase transitions of the shape memory alloy to change its dimensions and configuration between pre-deployment and multiple post-deployment states. This allows the device to adjust to varying LAA sizes and achieve proper closure, while the fundamental structure remains relatively simple. The ability to transition between different post-deployment shapes with different dimensions ensures reliable closure without requiring complex adjustable mechanisms, resolving the contradiction between closure effectiveness and device complexity.
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 provides secure anchoring and adjustable pressure distribution, ensuring effective closure of the left atrial appendage, reducing the risk of dislodgement and improving fit with varying anatomies.
Implementation Method 1
at least one first strut having a distal end and a proximal end, wherein the distal end of the at least one first strut is coupled to at least one first corresponding point along a surface of the tissue ingrowth member, and wherein the proximal end of the at least one first strut is coupled to the second connector; and at least one second strut having a distal end and a proximal end, wherein the proximal end of the at least one second strut is coupled to at least one second corresponding point along a surface of the tissue ingrowth member, and wherein the distal end of the at least one second strut is coupled to the first connector; wherein the device is configurable between a pre-deployment configuration, a first post-deployment configuration, and a second post-deployment configuration
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3C
AI summary
A device to treat a left atrial appendage (LAA) of a patient includes a tissue ingrowth member, at least one connector, a tine, and a plurality of struts connected to the tissue ingrowth member and at least one connector. A plurality of anchors extends from the tissue ingrowth member proximate the connection point of the struts to the tissue ingrowth member. The device is configured to change shape from a compressed pre-deployment configuration to at least one expanded post-deployment configuration such that the anchors puncture and lodge into cardiac tissue, occluding an ostium of the left atrial appendage.