Tissue Closure Device with Compliant Compression and Vacuum Adhesion
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Solution Overview
Problem
Current methods for closing the left atrial appendage are invasive, often require transeptal penetration, and can cause tissue necrosis due to excessive closure force, making them difficult to perform on beating hearts and less effective in preventing emboli-related strokes.
Innovation Solution
A tissue closure device with compliant compression bodies and tissue-piercing fasteners that match the softness and dynamic performance of the tissue, allowing for secure closure without necrosis, using vacuum ports for adherence and adjustable fasteners for varying tissue thicknesses, and a device applicator for precise installation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical techniques are used to close the left atrial appendage, then secure closure is achieved, but the procedure becomes highly invasive requiring sternum opening and heart by-pass
Solution Approach 1:
The closure device is divided into separate components including a delivery catheter, compression body, and fastening mechanism that can be deployed independently through the vasculature, eliminating the need for open chest surgery and heart by-pass while maintaining secure closure
Solution Approach 2:
A delivery catheter serves as an intermediary tool to transport the closure device through the vasculature to the left atrial appendage, enabling minimally invasive access without requiring direct surgical exposure of the heart
2Reliability
If transeptal penetration is performed to access the left atrium, then closure can be achieved, but the procedure becomes complex and carries additional risks
Solution Approach 1:
The invention extracts the closure device delivery system from the traditional transeptal approach and routes it instead through the femoral vein and inferior vena cava, eliminating the need for transeptal penetration while maintaining access to the left atrial appendage for closure
3Reliability
If excessive closure force is applied to secure the left atrial appendage, then closure security is improved, but tissue necrosis occurs
Solution Approach 1:
The compression body is designed with controllable compression force parameters that can be adjusted during deployment to achieve secure closure while maintaining tissue viability, preventing necrosis through optimized force application rather than excessive compression
Solution Approach 2:
The closure device incorporates dynamic adjustment capabilities allowing the compression force to be modulated during and after deployment, enabling secure initial closure while preventing excessive sustained force that would cause tissue necrosis
4Strength
If the closure device is made rigid for structural stability, then device strength is improved, but tissue compliance matching is reduced causing necrosis
Solution Approach 1:
The device incorporates localized compliance features in specific regions that contact tissue, while maintaining overall structural strength through the compression body framework, allowing simultaneous tissue compliance matching and structural integrity
Solution Approach 2:
The compression body utilizes composite material construction combining rigid structural elements for strength with compliant surface layers for tissue matching, achieving both structural stability and tissue compatibility to prevent necrosis
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
Enables less invasive, secure closure of the left atrial appendage on beating hearts, reducing the risk of tissue necrosis and emboli, while avoiding the need for transeptal penetration, thus effectively lowering the risk of stroke and other cardiovascular events.
Implementation Method 1
vacuum ports for adherence
Data Source
AI summary
Apparatus, systems, and methods are described for closing the base of a left atrial appendage or other tissue structure. A tissue closure device comprises a pair of legs having compliant surfaces for engaging against opposite sides of the tissue structure. A plurality of axially spaced-apart tissue-penetrating fasteners are delivered from one leg to the other to pierce the intervening tissue and hold the closure device in place on the tissue structure.