Self-Collapsing LAA Suturing Clip for Internal Ostium Closure
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Solution Overview
Problem
Existing methods for closing the left atrial appendage (LAA) are invasive or leave artificial materials exposed, increasing the risk of thrombosis and requiring anticoagulant treatment, while minimally invasive approaches lack effective closure mechanisms.
Innovation Solution
A suturing clip with resilient arms and anchors that self-expand and self-collapse to anchor and close the LAA ostium from within, using a trans-vascular approach, minimizing exposure and ensuring complete closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a trans-vascular approach is used to close the LAA, then minimally invasive closure is achieved, but effective closure mechanisms are lacking
Solution Approach 1:
The closure device is divided into multiple arms (typically 3-6 arms) that can independently expand and anchor into the LAA wall. Each arm functions as a separate anchoring element, distributing the closure force across multiple points to achieve reliable sealing while maintaining minimal invasiveness through the trans-vascular approach.
Solution Approach 2:
The device transitions from a compressed delivery configuration to an expanded anchoring configuration through self-expansion or controlled expansion. The arms dynamically change from a compact state for delivery to an expanded state for anchoring, enabling effective closure while maintaining minimal invasive access through the catheter.
2Reliability
If open thoracic approach with suturing is used, then reliable closure is achieved, but invasive surgery and chest opening are required
Solution Approach 1:
A delivery catheter acts as an intermediary to introduce and deploy the closure device through the vascular system. The catheter provides a minimally invasive pathway, allowing the closure device to be placed inside the LAA without opening the chest, thus maintaining closure reliability while eliminating major surgery.
Solution Approach 2:
Traditional mechanical suturing and chest opening are replaced by a self-expanding or catheter-assisted expanding mesh-like structure that anchors into the LAA wall from the inside. This substitution eliminates the need for external sutures and thoracic incisions while achieving reliable closure through internal anchoring.
3Ease of operation
If plug or stent-like construction is deployed inside the LAA, then minimally invasive closure is achieved, but artificial materials may be exposed increasing thrombosis risk
Solution Approach 1:
The mesh structure is designed with local quality variations, including anchoring elements that extend into the LAA wall to provide secure fixation. The mesh configuration and material properties are optimized locally to ensure complete coverage and sealing, preventing thrombosis while maintaining minimal invasiveness through the trans-vascular delivery approach.
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 suturing clip effectively seals the LAA without external exposure, reducing thrombosis risk and eliminating the need for anticoagulants, while providing a minimally invasive and reliable closure mechanism.
Implementation Method 1
the suturing clip resiliently self-expands from the collapsed delivery configuration to the expanded anchoring configuration
Implementation Method 2
the suturing clip is configured to resiliently self-collapse from the expanded anchoring configuration to the collapsed suturing configuration
Data Source
AI summary
Suturing clips which may be guided to a heart by a trans-vascular/trans-septal approach, and yet operate to close the left atrial appendage (LAA) from a position located entirely within the LAA are described. Arms of suturing clips constructed of a superelastic alloy are expanded from a catheter delivery system, anchored within the LAA and/or ostium of the LAA, and then collapsed again to a suturing configuration. Collapse is optionally by a reverting mechanism, wherein arms are constrained to collapse back in a direction reverse to their original expansion; or by an everting mechanism, wherein arm portions move past their expanded position to close with each other on an opposite side of their original position. In some embodiments, delivery systems include further elements to assist in clip placement at the LAA, for example a spreader for spreading the LAA, and/or a stopper for preventing deep intrusion to the LAA.